sv1za
As filed with the Securities and Exchange Commission on
August 15, 2006
Registration
No. 333-134311
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 2
TO
FORM S-1
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
ImaRx Therapeutics, Inc.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware |
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2834 |
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86-0974730 |
(State or Other Jurisdiction of
Incorporation or Organization) |
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(Primary Standard Industrial
Classification Code Number) |
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(I.R.S. Employer
Identification Number) |
1635 East 18th Street
Tucson, AZ 85719
(520) 770-1259
(Address, Including Zip Code, and Telephone Number, Including
Area Code, of Registrants Principal Executive Offices)
Evan C. Unger
1635 East 18th Street
Tucson, AZ 85719
(520) 770-1259
(Name, Address, Including Zip Code, and Telephone Number,
Including Area Code, of Agent for Service)
Copies to:
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John M. Steel, Esq.
Mark F. Hoffman, Esq.
DLA Piper Rudnick Gray Cary US LLP
701 Fifth Ave., Ste. 7000
Seattle, WA 98104-7044
(206) 839-4800 |
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Laura A. Berezin, Esq.
Glen Y. Sato, Esq.
Cooley Godward LLP
Five Palo Alto Square
3000 El Camino Real
Palo Alto, CA 94306-2155
(650) 843-5000 |
Approximate date of commencement of proposed sale to the
public:
As soon as practicable after the effective date of this
Registration Statement.
If any of the securities being registered on this form are to be
offered on a delayed or continuous basis pursuant to
Rule 415 under the Securities Act, check the following
box. o
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act,
check the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same
offering. o
If this Form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
If this Form is a post-effective amendment filed pursuant to
Rule 462(d) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering. o
The registrant hereby amends this Registration Statement on
such date or dates as may be necessary to delay its effective
date until the Registrant shall file a further amendment that
specifically states that this Registration Statement shall
thereafter become effective in accordance with Section 8(a)
of the Securities Act of 1933, as amended, or until the
Registration Statement shall become effective on such date as
the Securities and Exchange Commission, acting pursuant to said
Section 8(a), may determine.
The
information in this prospectus is not complete and may be
changed. We may not sell these securities until the registration
statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these
securities and it is not soliciting an offer to buy these
securities in any state where the offer or sale is not
permitted.
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Subject to Completion, Dated
August 15, 2006
PROSPECTUS
Shares
Common Stock
$ per
share
We are
selling shares
of our common stock. We have granted the underwriters an option
for a period of 30 days to purchase up
to additional
shares of common stock to cover over-allotments.
This is the initial public offering of our common stock. We
currently expect the initial public offering price to be between
$ and
$ per
share. We will apply to have our common stock approved for
quotation on The Nasdaq Global Market under the symbol
IMRX.
Investing in our common stock involves risks. See Risk
Factors beginning on page 8.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
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Per Share | |
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Total | |
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Public Offering Price
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$ |
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$ |
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Underwriting Discounts
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$ |
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$ |
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Proceeds to ImaRx Therapeutics, Inc. (before expenses)
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$ |
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$ |
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The underwriters expect to deliver the shares to purchasers on
or
about ,
2006.
CIBC World Markets
The date of this prospectus
is ,
2006
Table of Contents
You should rely only on the information contained in this
prospectus or any filed issuer free writing prospectus. We have
not, and the underwriters have not, authorized anyone to provide
you with information different from that contained in this
prospectus or any filed issuer free writing prospectus. We are
offering to sell, and are seeking offers to buy, shares of
common stock only in jurisdictions where offers and sales are
permitted. The information contained in this prospectus or any
filed issuer free writing prospectus is accurate only as of its
date, regardless of its time of delivery or of any sale of the
common stock.
Summary
You should read the entire prospectus carefully before
deciding to invest in shares of our common stock.
ImaRx Therapeutics, Inc.
Overview
We are a biopharmaceutical company developing and
commercializing innovative therapies for vascular disorders
associated with blood clots. Our development and
commercialization efforts are primarily focused on therapies for
treating ischemic stroke and massive pulmonary embolism,
respectively, by restoring the flow of blood and oxygen to the
brain and vital tissues. Over eight million patients in the
U.S. are afflicted each year with these and other
complications related to blood clots, yet available treatment
options are subject to significant therapeutic limitations. For
example, the most widely used treatment for ischemic stroke can
be administered only during a narrow time window and poses a
risk of bleeding, resulting in less than 6% of ischemic stroke
patients receiving treatment. We believe our products and
clinical development programs, including two product candidates
with Phase 3 clinical trial data and one product approved
for marketing, may address significant unmet needs in these
markets.
We are pursuing two development programs as the foundation for
our products. The first program is a group of clot-dissolving
drugs, or thrombolytics, that are variants of urokinase, a
natural human protein primarily produced in the kidneys that
stimulates the bodys natural clot-dissolving processes.
The second program,
SonoLysistm
therapy, centers on a novel treatment that we believe breaks
blood clots apart by applying ultrasound to our submicron-sized
bubbles, which we call SonoLysis bubbles. We believe these
therapeutic approaches can be used either alone or in
combination to treat ischemic stroke and a broad variety of
vascular disorders associated with blood clots, and may expand
the number of patients for whom safe and effective
clot-dissolving therapies are available.
Our Products
The following table summarizes our product candidates and their
current development status:
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Product |
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Indication |
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Candidate |
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Product Elements |
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Development Status |
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Ischemic Stroke |
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PROLYSEtm |
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Recombinant pro-urokinase |
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Completed one Phase 3 clinical trial |
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SonoLysis combination therapy |
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SonoLysis bubbles, ultrasound and a thrombolytic |
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Investigational New Drug application open for Phase
1/2 dose escalation clinical trial expected to begin second
half of 2006 |
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SonoLysis therapy |
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SonoLysis bubbles and ultrasound |
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Preclinical |
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Acute Massive Pulmonary Embolism |
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Abbokinase® |
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Tissue-culture urokinase |
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Approved for marketing |
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Catheter Clearance |
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Open-Cath-R® |
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Recombinant urokinase |
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Completed two Phase 3 clinical trials |
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1
We have a broad portfolio of product candidates to treat
ischemic stroke that is aimed at expanding the number of
patients eligible for treatment. We believe our ischemic stroke
product portfolio may have advantages related to safety, time to
market, expanded window of administration, faster initiation of
treatment, speed of restoration of blood flow and the ability to
address the needs of multiple physician groups.
PROLYSE is a recombinant pro-urokinase, or a pro-drug form of
urokinase that we believe, based on a number of published
third-party scientific studies, does not become active until it
reaches a blood clot, which may reduce the risk of bleeding.
PROLYSE has been shown, in a Phase 3 clinical trial of
180 patients conducted by Abbott Laboratories between 1996
and 1998, to be well tolerated and to demonstrate activity in
dissolving cerebral blood clots when administered as long as six
hours after the onset of stroke symptoms. This treatment window
is twice as long as the three-hour restriction that the
U.S. Food and Drug Administration, or FDA, has imposed on
alteplase, or tPA, the only thrombolytic approved for use in
ischemic stroke patients. We believe PROLYSE may become the
first thrombolytic approved for intra-arterial therapy for
treating ischemic stroke during a treatment window longer than
three hours after onset of symptoms. As with other
thrombolytics, the administration of PROLYSE involves a risk of
bleeding complications. We are planning to initiate an
additional Phase 3 clinical trial to evaluate PROLYSE
delivered intra-arterially directly to the site of a blood clot
for ischemic stroke in 2007. We plan to request that the FDA
allow us to use the preclinical testing and clinical trial data
generated by Abbott Laboratories PROLYSE clinical trials
in support of our eventual application to obtain regulatory
approval for the use of PROLYSE for ischemic stroke. To use the
clinical trial data generated by Abbott Laboratories in support
of our application for regulatory approval, we will, at a
minimum, be required to show the drug substance and drug product
produced by our contract manufacturer is comparable to the drug
substance and drug product produced previously by Abbott
Laboratories.
SonoLysis combination therapy is the combination of SonoLysis
bubbles and ultrasound in conjunction with a thrombolytic. We
believe that SonoLysis combination therapy incorporates
complementary mechanisms of action that will both reduce the
time required to dissolve a blood clot and enable a lower dose
of thrombolytic to be used. In addition, we believe a lower dose
of thrombolytic will reduce the risk of bleeding and extend the
current treatment window beyond that of a thrombolytic alone for
ischemic stroke patients. We have an open Investigational New
Drug application, or IND, and expect to initiate a
Phase 1/2 dose-escalation clinical trial in the second half
of 2006 using our SonoLysis bubbles, ultrasound and tPA to
expand upon the prior work of academic investigators in this
area.
SonoLysis therapy is the combination of SonoLysis bubbles and
ultrasound that we believe breaks up blood clots through a
mechanical mechanism of action. Because SonoLysis therapy does
not include a thrombolytic and its associated risk of bleeding,
we believe SonoLysis therapy may offer several advantages over
other treatments for ischemic stroke, including an extended
treatment window, rapid initiation of treatment through
intravenous administration and availability for use in patients
for whom thrombolytics are contraindicated due to risk of
bleeding. We are planning to conduct additional preclinical
studies of SonoLysis therapy in 2007.
In addition to our product candidates for ischemic stroke, we
recently acquired Abbokinase, a form of urokinase that is
approved and marketed for the treatment of acute massive
pulmonary embolism. We intend to begin selling Abbokinase in the
second half of 2006. Abbokinase sales will provide us with
near-term revenue, an opportunity to form sales relationships
with vascular physicians and acute care institutions that
regularly administer blood clot therapies and a
commercialization infrastructure that we believe can grow to
support our future products.
2
Open-Cath-R, another form of urokinase we acquired in 2005, has
been shown in two Phase 3 multinational clinical trials
conducted by Abbott Laboratories prior to 2003 to be well
tolerated and active as a treatment for clearing blocked
intravascular catheters. We are investigating the remaining
regulatory and manufacturing requirements and the opportunity to
license Open-Cath-R to a third party. We cannot be certain that
the FDA will allow us to use the data generated by Abbott
Laboratories clinical trials in support of our application
to obtain regulatory approval of
Open-Cath-R.
We acquired PROLYSE,
Open-Cath-R and
Abbokinase from Abbott Laboratories. In connection with these
acquisitions, we issued a $15.0 million promissory note
that matures in December 2006 and another $15.0 million
promissory note that matures in December 2007. If we are unable
to satisfy these debt obligations when due, Abbott Laboratories
will have a right to reclaim the acquired assets and our rights
relating to PROLYSE and
Open-Cath-R, in the
case of the December 2006 promissory note, and Abbokinase,
including a portion of the cash from our sales of Abbokinase, in
the case of the December 2007 promissory note.
Our Business Strategy
Our goal is to become the leading provider of innovative
therapies for vascular disorders associated with blood clots.
The key elements of our business strategy are to:
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expand the number of patients eligible for treatment by
developing and commercializing our portfolio of ischemic stroke
product candidates; |
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capitalize on near-term revenue opportunities and develop an
initial commercial infrastructure; |
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leverage our product candidates to address additional vascular
indications; and |
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expand the use of our bubble technology to create a deep
pipeline with broad therapeutic applications. |
Risks Related to Our Business and Business Strategy
Our business is subject to numerous risks that could prevent us
from successfully operating our business and implementing our
business strategy. These risks are highlighted in the section
entitled Risk Factors immediately following this
prospectus summary, and they include the following:
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we have a history of operating losses, including an accumulated
deficit of approximately $68.5 million and an overall
stockholders deficit of approximately $36.3 million
at June 30, 2006, and expect to continue to incur
substantial losses for the foreseeable future; |
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we will need substantial additional capital to fund our
operations; |
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we may never complete clinical development of our product
candidates or have more than one product approved for marketing,
and if approved our product candidates may never achieve market
acceptance; |
3
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failure to comply with various government regulations in
connection with the development, manufacture and
commercialization of our product candidates and post-approval
manufacturing and marketing of our products could result in
significant interruptions or delays in our development and
commercialization activities; |
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if we fail to satisfy our obligations to Abbott Laboratories
that we assumed in connection with our acquisition of PROLYSE,
Open-Cath-R, Abbokinase
and related assets, Abbott Laboratories could reclaim the
acquired technologies and other assets; |
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if we are not able to use the clinical trial data acquired from
Abbott Laboratories in support of our applications for
regulatory approval, we will not be able to maintain our current
development and commercialization timelines; and |
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we compete against companies that have longer operating
histories, more established products and greater resources than
we do. |
In addition, our independent registered public accounting firm
has expressed doubt about our ability to continue as a going
concern as of March 10, 2006.
Our Corporate Information
We were organized as an Arizona limited liability company on
October 7, 1999, which was our date of inception for
accounting purposes. We were subsequently converted to an
Arizona corporation on January 12, 2000, and then
reincorporated as a Delaware corporation on June 23, 2000.
Our principal executive offices are located at
1635 E. 18th St., Tucson, Arizona 85719, and our
telephone number at that location is (520) 770-1259. Our
corporate website address is www.imarx.com. The information
contained in or that can be accessed through our corporate
website is not part of this prospectus. Unless the context
indicates otherwise, as used in this prospectus, the terms
ImaRx, we, us and
our refer to ImaRx Therapeutics, Inc., a Delaware
corporation.
We have rights to use
Abbokinase®
and
Open-Cath-R®,
which are U.S. registered trademarks owned by Abbott
Laboratories. We use
PROLYSEtm,
Sonolysistm
and the ImaRx Therapeutics logo as trademarks in the U.S. and
other countries. All other trademarks and trade names mentioned
in this prospectus are the property of their respective owners.
4
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Common stock offered |
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shares |
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Common stock to be outstanding after this offering |
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shares |
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Initial public offering price |
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$ |
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Use of proceeds |
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To repay indebtedness, to continue the development of our
product candidates, including clinical trials, to fund
manufacturing of our product candidates and for working capital
and other general corporate purposes. See Use of
Proceeds. |
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Proposed Nasdaq Global Market symbol |
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IMRX |
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The number of shares to be outstanding immediately after this
offering as shown above is based on 21,197,795 shares
outstanding as of June 30, 2006 and excludes:
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2,897,024 shares of common stock issuable upon the exercise
of options outstanding under our 2000 Stock Plan, having a
weighted average exercise price of $3.07 per share; |
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1,761,749 shares of common stock issuable upon the exercise
of warrants outstanding, having a weighted average exercise
price of $3.16 per share; |
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1,538,376 shares of common stock reserved for future grants
under our 2000 Stock Plan; and |
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an aggregate of 1,800,000 shares of common stock reserved
for future issuance under our 2006 Performance Incentive Plan,
which will become effective immediately upon the signing of the
underwriting agreement for this offering. |
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Except as otherwise indicated, all information in this
prospectus assumes:
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the conversion of all our outstanding shares of preferred stock
into 8,164,157 shares of common stock upon the closing of
this offering, assuming a one-for-one conversion ratio of our
Series F preferred stock. See Conversion of
Series F Preferred Stock; |
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a -for- reverse
stock split of our common stock that was effected
on ,
2006; |
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the filing of our amended and restated certificate of
incorporation upon completion of this offering; and |
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no exercise of the underwriters over-allotment option. |
5
Summary Consolidated Financial Data
The following tables summarize certain of our consolidated
financial data. We derived the consolidated statements of
operations data for the years ended December 31, 2003, 2004
and 2005 from our consolidated audited financial statements
included elsewhere in this prospectus. We derived the
consolidated statements of operations data for the six months
ended June 30, 2005 and 2006, as well as the balance sheet
data at June 30, 2006, from our unaudited financial
statements included elsewhere in this prospectus. You should
read this data together with our financial statements and
related notes included elsewhere in this prospectus and the
information under Selected Consolidated Financial
Data and Managements Discussion and Analysis
of Financial Condition and Results of Operations.
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Six Months Ended | |
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Years Ended December 31, | |
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June 30, | |
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2003 | |
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2004 | |
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2005 | |
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2005 | |
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2006 | |
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(unaudited) | |
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(in thousands, except share and per share data) | |
Consolidated Statements of Operations Data:
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Grant and other revenue
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$ |
224 |
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$ |
575 |
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$ |
619 |
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$ |
294 |
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$ |
429 |
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Costs and expenses:
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Research and development
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1,878 |
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2,490 |
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3,579 |
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1,496 |
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3,990 |
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General and administrative
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1,654 |
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3,183 |
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4,142 |
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1,501 |
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3,127 |
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Depreciation and amortization
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209 |
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186 |
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194 |
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95 |
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332 |
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Acquired in-process research and development
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24,000 |
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Total operating expenses
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3,741 |
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5,859 |
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31,915 |
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3,092 |
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7,449 |
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Interest and other income
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22 |
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29 |
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122 |
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50 |
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215 |
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Interest expense
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(325 |
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(469 |
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(587 |
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(53 |
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(615 |
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Gain on extinguishment of note
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3,835 |
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3,835 |
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Net (loss) income
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(3,820 |
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(5,724 |
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(27,926 |
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1,034 |
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(7,420 |
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Accretion of dividends on preferred stock
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(1,287 |
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(301 |
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(601 |
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(300 |
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(300 |
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Net (loss) income available to common stockholders
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$ |
(5,107 |
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$ |
(6,025 |
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$ |
(28,527 |
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$ |
734 |
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$ |
(7,720 |
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Net (loss) income available to common stockholders per
share Basic
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$ |
(1.74 |
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$ |
(1.07 |
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$ |
(3.01 |
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$ |
0.09 |
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$ |
(0.60 |
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Weighted average shares outstanding Basic
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2,936,094 |
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5,637,042 |
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9,463,279 |
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8,335,776 |
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12,968,424 |
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Net (loss) income available to common stockholders per
share Diluted
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$ |
(1.74 |
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$ |
(1.07 |
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$ |
(3.01 |
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$ |
0.05 |
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$ |
(0.60 |
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Weighted average shares outstanding Diluted
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2,936,094 |
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5,637,042 |
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9,463,279 |
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13,803,797 |
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12,968,424 |
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6
The following table sets forth a summary of our consolidated
balance sheet data at June 30, 2006:
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on an actual basis; |
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on a pro forma basis to reflect the conversion of all
outstanding shares of preferred stock, valued at approximately
$39.0 million, into 8,164,157 shares of common stock
upon the closing of this offering; and |
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on a pro forma as adjusted basis to reflect our receipt of the
estimated net proceeds from our sale
of shares
of common stock in this offering at an assumed initial public
offering price of
$ ,
the midpoint of the range on the front cover of this prospectus,
after deducting underwriting discounts and commissions and
estimated offering expenses payable by us. |
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At June 30, 2006 | |
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Pro Forma | |
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Actual | |
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Pro Forma | |
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as Adjusted | |
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(unaudited) | |
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(in thousands) | |
Consolidated Balance Sheet Data:
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Cash and cash equivalents
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$ |
9,834 |
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$ |
9,834 |
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$ |
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Working capital
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10,072 |
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10,072 |
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Total assets
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32,110 |
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32,110 |
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Long-term notes payable, less current portion
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15,165 |
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15,165 |
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Total stockholders equity (deficit)
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(36,312 |
) |
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(1,316 |
) |
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7
Risk Factors
Investing in our common stock involves a high degree of risk.
You should carefully consider the following risk factors and all
other information contained in this prospectus before purchasing
our common stock. If any of the following events were to occur,
our business, financial condition or results of operations could
be materially and adversely affected. In these circumstances,
the market price of our common stock could decline, and you may
lose some or all of your investment.
Risks Relating to Our Business
Unless we are able to generate sufficient product or other
revenue, we will continue to incur losses from operations and
may never achieve or maintain profitability.
We are a development stage company with a history of net losses
and negative cash flow from operations since inception. To date,
we have not generated any product revenue and have funded our
operations primarily from private sales of our securities. Net
losses for the fiscal years ended December 31, 2003,
December 31, 2004, and December 31, 2005 were
approximately $5.1 million, $6.0 million, and
$28.5 million, respectively. At June 30, 2006, we had
an accumulated deficit of approximately $68.5 million.
Except for Abbokinase, which is approved and marketed for the
treatment of acute massive pulmonary embolism and which we
acquired from Abbott Laboratories in April 2006, we do not have
regulatory approval for any of our product candidates. Even if
we receive regulatory approval for any product candidates, sales
of such products may not generate sufficient revenue for us to
achieve or maintain profitability.
Our ability to generate revenue depends on a number of factors,
including our ability to:
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successfully market and sell our recently-acquired Abbokinase
product or any of our product candidates following regulatory
approval, if ever; |
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obtain regulatory approval for PROLYSE, SonoLysis combination
therapy, SonoLysis therapy and Open-Cath-R; |
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obtain commercial quantities of our approved products at
acceptable cost levels; and |
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successfully enter into partnerships for some of our product
candidates, including Open-Cath-R. |
We anticipate that our expenses will increase substantially
following this offering as a result of:
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research and development programs, including significant
requirements for contract manufacturing, clinical trials,
preclinical testing and potential regulatory submissions; |
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developing additional infrastructure and hiring additional
management and other employees to support the anticipated growth
of our sales, development and regulatory activities; |
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regulatory submissions and commercialization activities; and |
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additional costs for intellectual property protection and
enforcement and expenses as a result of being a public company. |
Because of the numerous risks and uncertainties associated with
developing and commercializing our potential products, we may
experience larger than expected future losses and may never
become profitable.
Our independent registered public accounting firm has
expressed substantial doubt about our ability to continue as a
going concern.
We have received an audit report from our independent registered
accounting firm containing an explanatory paragraph stating that
our historical recurring losses from operations and net capital
deficiency raise substantial doubt about our ability to continue
as a going concern. We believe that the successful completion of
this offering will eliminate this doubt and allow us to continue
as a going concern at least in the near term. We estimate that
the net proceeds from this offering together with our existing
cash and cash
8
equivalents will be sufficient to meet our anticipated cash
requirements until December 2007. If we are unable to
successfully complete this offering, we will need to obtain
alternative financing and modify our operational plans to
continue as a going concern.
We incurred significant indebtedness in connection with our
acquisitions of assets from Abbott Laboratories. If we are
unable to satisfy these obligations in 2006 and 2007 when due,
Abbott Laboratories will have a right to reclaim the assets and
our rights relating to PROLYSE, Open-Cath-R and Abbokinase,
including a portion of the cash from our sales of Abbokinase.
In connection with our acquisition of PROLYSE, Open-Cath-R and
related assets in September 2005, we issued a $15.0 million
promissory note, which is secured by the acquired technologies
and matures in December 2006. If we are unable to repay the
promissory note, Abbott Laboratories has the right to reclaim
the acquired technologies.
Similarly, in connection with our April 2006 acquisition of the
remaining inventory of and certain rights related to Abbokinase,
we issued an additional $15.0 million promissory note that
is secured by the inventory and rights acquired and matures in
December 2007. Although we plan to commence selling Abbokinase
to obtain near-term revenue that will help fund our cash needs
while our other product candidates remain in development, the
asset purchase agreement provides that after we have received
initial net revenue of $5.0 million from the sale of
Abbokinase, we are then required to deposit 50% of the
additional net revenue we receive from sales of Abbokinase into
an escrow account to secure the repayment of the promissory
note. If the escrow amount is not adequate to repay the
promissory note and we are otherwise unable to repay the
promissory note by its maturity date, Abbott Laboratories has
the right to reclaim the remaining inventory and rights related
to Abbokinase.
We will need substantial additional capital to fund our
operations. If we are unable to raise capital when needed, we
may be forced to delay, reduce or eliminate our research and
development programs or commercialization efforts, and we may be
unable to timely pay our debts or may be forced to sell or
license assets or otherwise terminate further development of one
or more of our programs.
Since our inception, we have financed our operations principally
through the private placement of shares of our common and
preferred stock and convertible notes and the receipt of
government grants. We currently have working capital sufficient
to meet our anticipated cash needs through December 2006.
We expect our expenses to increase substantially following the
offering, and we will require substantial additional financing
at various times in the future as we expand our operations and
as our debt obligations mature.
Our funding requirements will, however, depend on numerous
factors, including:
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the timing, scope and results of our preclinical studies and
clinical trials; |
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the timing of initiation of manufacturing for our product
candidates; |
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the timing and amount of revenue; |
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the timing of, and the costs involved in, obtaining regulatory
approvals; |
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our ability to establish and maintain collaborative
relationships; |
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personnel, facilities and equipment requirements; and |
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the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims and other patent-related
costs, including litigation costs, if any, and the result of any
such litigation. |
We intend to seek additional funding from a variety of sources,
which may include collaborations involving our technology,
technology licensing, grants and public or private equity and
debt financings. We cannot be certain that any additional
funding will be available on terms acceptable to us, or at all.
Accordingly, we may not be able to secure the substantial
funding that is required to maintain and continue our
commercialization and development programs at levels that may be
required in the future. We may be forced to accept funds on
9
terms or pricing that are highly dilutive or otherwise
disadvantageous to our existing stockholders. We are restricted
from granting a security interest in the assets we acquired in
2005 and 2006. Raising additional funds through debt financing,
if available, may involve covenants that restrict our business
activities. To the extent that we raise additional funds through
collaborations and licensing arrangements, we may have to
relinquish valuable rights and control over our technologies,
research programs or product candidates, or grant licenses on
terms that may not be favorable to us. If we are unable to
secure adequate financing, we could be required to sell or
license assets, delay, scale back or eliminate one or more of
our development programs or enter into licenses or other
arrangements with third parties to commercialize products or
technologies that we would otherwise seek to develop and
commercialize ourselves.
We recently expanded our business strategy to include
development and sale of thrombolytics that expose us to
additional risks, which we may not overcome successfully.
Until September 2005, our business strategy focused on the
development of SonoLysis bubbles for the treatment of blood
clots and various vascular disorders. In September 2005, we
began to broaden our focus to also include the development of
thrombolytics and therapies involving both SonoLysis bubbles and
thrombolytics by acquiring the technology and development assets
relating to two thrombolytic product candidates, PROLYSE and
Open-Cath-R.
In the second half of 2006 we plan to begin selling Abbokinase,
a thrombolytic that we acquired in April 2006. Abbokinase is
approved by the FDA for marketing in the U.S. for acute
massive pulmonary embolism. We have no experience in marketing,
selling, developing or manufacturing thrombolytics, and we may
not be successful in one or more of these undertakings. Use of
thrombolytics in general involves significant risks, such as
bleeding. In addition, adding these product candidates and
Abbokinase to our business will place additional burdens on our
management and technical staff to undertake additional
commercialization activities and may distract them from
development activities.
The thrombolytic market is highly competitive and dominated
by products from Genentech. We have limited sales and marketing
capabilities and will depend on drug wholesalers to distribute
our products.
The market for thrombolytics is currently dominated by
thrombolytics offered by Genentech, Inc., in particular
alteplase, or tPA. Any resistance to change among practitioners
could delay or hinder market acceptance of our thrombolytic
product candidates, which could have a material adverse effect
on our business. In addition, a number of different competing
thrombolytics are under development for treating blood clots,
such as alfimeprase and desmoteplase. These competitive products
are being developed or are marketed by companies with
significantly greater resources and commercial capabilities than
we currently possess. If we are unable to manage or overcome
these competitive risks, our planned thrombolytics business, as
well as our overall financial condition and prospects, could be
severely damaged.
We cannot be certain that we will have sufficient resources to
effectively market or sell Abbokinase and continue to develop
and commercialize new thrombolytic product candidates. We have a
limited sales and marketing staff and will depend on the efforts
of third parties for the sale and distribution of Abbokinase and
our other product candidates to hospitals and clinics. If we are
unable to arrange for effective and successful third party
distribution of our products on commercially reasonable terms,
we may be unable to successfully market and sell Abbokinase. In
particular, we will need to enter into agreements with a
majority of the major drug wholesale companies that have
historically sold Abbokinase to customers. Drug wholesale
companies may be unwilling to continue selling Abbokinase, or we
may be forced to accept lower prices or other unfavorable terms
or to expend significant additional resources to sell our
Abbokinase inventory. If any of these events occurs, we may be
unable to recover the cash portion of the purchase price we have
already invested in Abbokinase or to achieve or maintain
meaningful revenue unless or until our other product candidates
are approved for sale, any of which could harm our financial
condition. Additionally, even if we are able to successfully
market and sell Abbokinase, we do not expect sales of Abbokinase
to generate enough revenue for us to achieve profitability.
10
Our competitors generally are larger than we are, have
greater financial resources available to them than we do and may
have a superior ability to develop and commercialize competitive
products. In addition, if our competitors have products that are
approved in advance of ours, marketed more effectively or
demonstrated to be safer or more effective than ours, our
commercial opportunity will be reduced or eliminated and our
business will be harmed.
Our industry sector is intensely competitive, and we expect
competition to continue to increase. Many of our actual or
potential competitors have substantially longer operating
histories and greater financial, research and development and
marketing capabilities than we do. Many of them also have
substantially greater experience than we have in undertaking
preclinical studies and clinical trials, obtaining regulatory
approvals and manufacturing and distributing products. Smaller
companies may also prove to be significant competitors,
particularly through collaborative arrangements with large
pharmaceutical companies. In addition, academic institutions,
government agencies and other public and private research
organizations also conduct research, seek patent protection and
establish collaborative arrangements for product development and
marketing. We may not be able to develop products that are more
effective or achieve greater market acceptance than our
competitors products. Any company that brings competitive
products to market before us may achieve a significant
competitive advantage.
We believe that the primary competitive factors in the market
for treatments of vascular disorders include safety and
efficacy, access to and acceptance by leading physicians,
cost-effectiveness, physician relationships and sales and
marketing capabilities. We may be unable to compete successfully
on the basis of any one or more of these factors, which could
have a material adverse affect on our business, financial
condition and results of operations.
If we are unable to successfully develop, manufacture and
commercialize our product candidates, we may not generate
sufficient revenue to continue our business.
We currently have only one product, urokinase, currently
marketed as Abbokinase, that has received regulatory approval,
and we have no experience commercializing Abbokinase. The
process to develop, obtain regulatory approval for and
commercialize potential drug candidates is long, complex and
costly. Two of our product candidates, PROLYSE and Open-Cath-R,
are in advanced stages of development. The related clinical data
for these product candidates were acquired from Abbott
Laboratories. We cannot be certain that the acquired clinical
data will be sufficient for us to pursue additional clinical
trials of PROLYSE or achieve approval for Open-Cath-R without
further clinical trials, and we have not determined whether we
will be able to commercialize either of these products. Our
proprietary SonoLysis bubbles technology has not been used in
clinical trials, and we are using diagnostic ultrasound contrast
agent microbubbles in our proof of concept clinical trial. We do
not expect to have the results of any clinical trials using our
proprietary SonoLysis bubbles until at least 2008. As a result,
our business in the near term is substantially dependent upon
our ability to sell Abbokinase and to complete development,
obtain regulatory approval for and successfully commercialize
our other thrombolytic product candidates in a timely manner. If
we are unable to further develop, commercialize or license
PROLYSE or Open-Cath-R, we may not be able to earn sufficient
revenue to continue our business.
We may be unable to sell our existing inventory of Abbokinase
before product expiration, and even if we are able to sell the
existing inventory, the product may be returned prior to use by
hospitals and clinics. Additionally, if we are successful in
extending the product expiration dates, we will need to re-brand
the product.
In our acquisition of Abbokinase, we received 153,000 vials of
Abbokinase manufactured between 2003 and 2005 that we believe
represents approximately a four-year supply of inventory.
Approximately $16.7 million of the $20.0 million
purchase price for Abbokinase was allocated to this inventory.
Based on current stability data, approximately 75% of this
inventory will expire by September 2007 with the remainder
expiring at various times up to August 2009. We have not
commenced sales of Abbokinase and do not intend to begin selling
Abbokinase until the second half of 2006. We do not expect to
sell the entire inventory we acquired
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before the product expires, and we are not permitted to sell
this inventory after expiration. Moreover, even if we are able
to sell the Abbokinase inventory to wholesalers prior to
expiration, unless the product is administered prior to
expiration, the product may be returned to us and our sales
could be significantly reduced. As a result, we may be unable to
recover our purchase price for this inventory.
We intend to continue an ongoing stability program to
potentially extend the expiration dates for this inventory.
However, our license to use the Abbokinase trademark does not
cover any inventory with extended expiration dates. Accordingly,
if we are successful in demonstrating extended stability and
shelf life, we would need to re-brand the inventory to
commercialize it. We cannot be certain that we will be
successful in establishing an alternate brand name for
Abbokinase and obtaining market acceptance.
If we want to sell urokinase beyond our existing inventory of
Abbokinase, we would need to undertake manufacturing and secure
regulatory approval for a new manufacturing process and
facility.
As part of our acquisition of Abbokinase, we acquired cell lines
that could be used to manufacture urokinase. If we want to sell
urokinase beyond our existing inventory of acquired Abbokinase,
we would need to undertake manufacturing and to demonstrate that
our manufactured material is comparable to the urokinase we
purchased from Abbott Laboratories. To demonstrate this, we
would need to have our manufacturing process validated by the
FDA and may be required to conduct additional preclinical
studies, and possibly additional clinical trials. In addition,
the manufacturing process for Abbokinase involves a roller
bottle production method that is used infrequently today and is
available only from a limited number of manufacturers worldwide.
We do not currently intend to undertake these efforts in the
near term and we cannot be certain that we would be able to
successfully manufacture and receive regulatory approval for
additional sales of urokinase beyond our existing inventory.
If we are not able to use the data and drug substance
acquired from Abbott Laboratories for further clinical
development of our PROLYSE and Open-Cath-R product candidates
and our Abbokinase product, we will not be able to maintain our
current timelines for further development and commercialization
of these potential products and Abbokinase. Any additional
clinical trial requirements could significantly increase our
expenses and reduce the commercial value of PROLYSE, Open-Cath-R
and Abbokinase.
As a result of our acquisitions of our thrombolytic product and
product candidates, we acquired Phase 3 clinical data and
drug substance for PROLYSE and Open-Cath-R as well as data in
support of additional indications for Abbokinase. We need FDA
approval to market PROLYSE and Open-Cath-R and to market
Abbokinase for indications other than acute massive pulmonary
embolism. In seeking such approval, we intend to rely on the
Phase 3 clinical trial data related to PROLYSE and
Open-Cath-R and to
conduct additional clinical trials using our existing clinical
grade drug substance that we acquired. The FDA may not allow us
to rely on the clinical data, or may determine that such
clinical data are insufficient to support approval, either of
which would result in a need to conduct additional clinical
trials with drug product manufactured for us. We may not be able
to use the drug substance if it does not have activity within
its original specifications. If we are unable to use either the
data or drug substance that we acquired as the basis for further
development or commercialization of these product candidates and
Abbokinase, our clinical development and commercialization
timelines would be significantly delayed and the commercial
viability of these potential products may be jeopardized. We
cannot be certain that the FDA will permit us to proceed with
further development consistent with our current clinical
development plans, and even if permitted to proceed with those
plans, that we would succeed with those efforts.
To receive FDA marketing approval for PROLYSE or
Open-Cath-R, we must
demonstrate that the material manufactured for commercial use is
equivalent to the material previously manufactured.
To receive FDA approval to market PROLYSE or
Open-Cath-R, we must
demonstrate that the drug substance and drug product we
manufacture are equivalent to the drug substance and drug
product we acquired and that
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was used in clinical testing. As part of the FDA approval
process, we expect the FDA will require us to manufacture
PROLYSE and Open-Cath-R
to equivalent specifications and within the same tolerances as
the drug substance that we acquired. The production of each of
PROLYSE and Open-Cath-R
involves a multi-step recombinant manufacturing process using
cell lines that we acquired. If we obtain regulatory approvals,
we will have to produce commercial supplies of PROLYSE and
Open-Cath-R in
accordance with current Good Manufacturing Process, or cGMP,
through contract manufacturers to be able to sell either
product. We cannot be certain that the manufacturing process we
utilize will produce PROLYSE and Open-Cath-R to cGMP standards
within the same tolerances as the manufacturing process
previously managed by Abbott Laboratories and used in its
clinical trials. If we are unable to produce PROLYSE and
Open-Cath-R that the FDA determines to be equivalent, we will
not receive FDA approval to market and sell these products
without additional clinical trials.
If we engage Abbott Laboratories services in connection
with the transfer to us of manufacturing technologies related to
PROLYSE or Open-Cath-R
and Abbott Laboratories completes the services on or prior to
December 31, 2006, we will become obligated to pay Abbott
Laboratories $5.0 million.
On September 30, 2005, we entered into an asset purchase
agreement pursuant to which we acquired certain assets and
rights related to PROLYSE and
Open-Cath-R from Abbott
Laboratories. In connection with this acquisition, we also
entered into a services agreement pursuant to which Abbott
Laboratories agreed to provide to us, upon our request, interim
transitional services relating to the PROLYSE and
Open-Cath-R
manufacturing technologies that we acquired. We have not engaged
and do not plan to engage any services under the services
agreement because we believe we will be able to transition the
manufacturing technologies without Abbott Laboratories
assistance. However, if we engage Abbott Laboratories
services to assist us with the transfer of manufacturing
technologies related to PROLYSE or Open-Cath-R and Abbott
Laboratories completes the services on or prior to
December 31, 2006, we will become obligated to pay Abbott
Laboratories $5.0 million.
We do not plan to manufacture any of our product candidates
and will depend on commercial contract manufacturers to
manufacture our products.
We do not have our own manufacturing facilities, have no
experience in large-scale product manufacturing, and do not
intend to develop such facilities or capabilities. Our ability
to conduct clinical trials and commercialize our product
candidates will depend, in part, on our ability to manufacture
our products through contract manufacturers. For all of our
product candidates, we or our contract manufacturers will need
to have sufficient production and processing capacity to support
human clinical trials, and if those clinical trials are
successful and regulatory approvals are obtained, to produce
products in commercial quantities. Delays in providing or
increasing production or processing capacity could result in
additional expense or delays in our clinical trials, regulatory
submissions and commercialization of our products. In addition,
we will be dependent on such contract manufacturers to adhere to
cGMP and other regulatory requirements.
Establishing contract manufacturing is costly and time-consuming
and we cannot be certain that we will be able to engage contract
manufacturers who can meet our quantity and quality requirements
in a timely manner and at competitive costs. The manufacturing
processes for our product candidates have not yet been tested at
commercial levels, and it may not be possible to manufacture
such materials in a cost-effective manner. Further, there is no
guarantee that the components of our proposed drug product
candidates will be available to our manufacturers when needed on
terms acceptable to us. If we are unable to obtain contract
manufacturing on commercially reasonable terms, we may not be
able to conduct or complete planned or necessary clinical trials
or commercialize our product candidates.
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If our clinical trials are not successful, or if we are
unable to obtain regulatory approvals, we will not be able to
commercialize our products and we will continue to incur
significant operating losses.
Abbokinase is our only product approved for commercial sale. The
sale of all of our product candidates in the U.S. requires
approval from the FDA and from foreign regulatory agencies for
sales outside the U.S. To gain regulatory approval for the
commercial sale of our products, we must demonstrate the safety
and efficacy of each product candidate in human clinical trials.
This process is expensive and can take many years, and failure
can occur at any stage of the testing process. There are many
risks associated with our clinical trials. For example:
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we did not conduct any of the prior clinical trials related to
PROLYSE and Open-Cath-R, and we may be unable to demonstrate the
same level of safety and effectiveness in clinical trials we
conduct with these product candidates; |
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the only clinical trials related to our development of SonoLysis
therapy or SonoLysis combination therapy that we have conducted
or are conducting use neither our SonoLysis bubbles nor PROLYSE
and may not be indicative of the safety and effectiveness of our
product candidates; |
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clinicians, physicians and regulators may not favorably
interpret the results of our preclinical studies and clinical
trials; |
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some patients in our clinical trials may experience unforeseen
adverse medical events related or unrelated to the use of our
product candidates; |
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we may be unable to secure a sufficient number of clinical trial
sites or patients to enroll in our clinical trials; |
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we may experience delays in securing the services of, or
difficulty scheduling, clinical investigators for our clinical
trials; |
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third parties who conduct our clinical trials may not fulfill
their obligations; |
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we may in the future experience, and have in the past
experienced, deviations from the approved clinical trial
protocol by our clinical trial investigators; |
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the FDA or the local institutional review board, or IRB, at one
or more of our clinical trial sites may interrupt, suspend or
terminate a clinical trial or the participation of a particular
site in a clinical trial; and |
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the FDA or other regulatory bodies may change the policies and
procedures we are required to follow in connection with our
clinical trials. |
Any of these or other unexpected events could cause us to delay
or terminate our ongoing clinical trials, increase the costs
associated with our clinical trials or affect the statistical
analysis of the safety and efficacy of our product candidates.
If we fail to adequately demonstrate the safety and efficacy of
our product candidates, we will not obtain regulatory approval
to commercialize our products. Significant delays in clinical
development could materially increase our product development
costs or impair our competitive position. In addition, any
approvals we may obtain may not cover all of the clinical
indications for which we seek approval, or an approval may
contain significant limitations in the form of narrow labeling
and warnings, precautions or contraindications with respect to
limitations on use. Accordingly, we may not be able to obtain
our desired product registration or marketing approval for any
of our product candidates.
We rely on third parties to conduct our clinical trials who
may not successfully carry out their contractual duties, with
resulting negative impacts on our clinical trials.
We depend on contract research organizations, or CROs, for
managing some of our preclinical testing and clinical trials. If
we are not able to retain CROs in a timely manner and on
commercially reasonable terms, we may not be able to conduct or
complete clinical trials or commercialize our product candidates
and we do not know whether we will be able to develop or attract
partners with such capabilities. We have established
relationships with multiple CROs for our existing clinical
trials, although there is no guarantee that the CROs
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will be available for future clinical trials on terms acceptable
to us. We may not be able to control the amount and timing of
resources that CROs devote to our clinical trials. In the event
that we are unable to maintain our relationship with any of our
CROs or elect to terminate the participation of any of these
CROs, we may lose the ability to obtain
follow-up information
for patients enrolled in ongoing clinical trials unless we are
able to transfer the care of those patients to another qualified
CRO.
Our product candidates may never achieve market
acceptance.
We cannot be certain that our products will achieve any degree
of market acceptance among physicians and other health care
providers and payors, even if necessary regulatory approvals are
obtained. We believe that recommendations by physicians and
other health care providers and payors will be essential for
market acceptance of our products, and we cannot be certain we
will ever receive any positive recommendations or reimbursement.
Physicians will not recommend our products unless they conclude,
based upon clinical data and other factors, that our products
are safe and effective. We are unable to predict whether any of
our product candidates will ever achieve market acceptance,
either in the U.S. or internationally. A number of factors
may limit the market acceptance of our products, including:
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the timing and scope of regulatory approvals of our products and
market entry compared to competitive products; |
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the safety and efficacy of our products, including any
inconveniences in administration, as compared to alternative
treatments; |
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the rate of adoption of our products by hospitals, doctors and
nurses and acceptance by the health care community; |
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the product labeling permitted or required by regulatory
agencies for each of our products; |
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the competitive features of our products, including price, as
compared to other similar products; |
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the availability of sufficient third party coverage or
reimbursement for our products; |
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the extent and success of our sales and marketing
efforts; and |
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possible unfavorable publicity concerning our products or any
similar products. |
If our products are not commercially successful, our business
will be materially harmed.
Technological change and innovation in our market sector may
cause our products to become obsolete shortly after or even
before such products reach the market.
New products and technological development in the pharmaceutical
and medical device industries may adversely affect our ability
to complete required regulatory requirements and introduce our
product candidates into the market or may render our products
obsolete. The markets into which we plan to introduce our
products are characterized by constant and sometimes rapid
technological change, new and improved product introductions,
changes in regulatory requirements, and evolving industry
standards. Our future success will depend to a substantial
extent on our ability to successfully identify new market trends
and develop, introduce and support our candidate products on a
timely basis. If we fail to successfully develop and
commercialize our product candidates on a timely basis, we may
be unable to compete effectively. For example, we are aware of
other thrombolytics in development such as alfimeprase and
desmoteplase, which are currently in Phase 3 clinical
trials as treatments for acute peripheral arterial occlusion and
catheter occlusions, and acute ischemic stroke, respectively. In
addition, we are aware of mechanical device-based treatments for
blood clots such as the
MERCI®
(Mechanical Embolus Removal in Cerebral Ischemia) Retriever as
well as mechanical thrombectomy devices that are also approved
and marketed for removing blood clots associated with peripheral
vascular and coronary indications and dialysis access grafts.
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If we are unable to obtain acceptable prices or adequate
reimbursement from third-party payors for any product candidates
that we seek to commercialize, our revenue and prospects for
profitability will suffer.
The commercial success of our product candidates is
substantially dependent on whether third-party coverage and
reimbursement is available from governmental payors such as
Medicare and Medicaid, private health insurers, including
managed care organizations and other third-party payors. The
U.S. Centers for Medicare and Medicaid Services, health
maintenance organizations and other third-party payors in the
U.S. and in other jurisdictions are increasingly attempting to
contain health care costs by limiting both coverage and the
level of reimbursement for new drugs and medical devices and, as
a result, they may not cover or provide adequate payment for our
products. Our products may not be considered cost-effective and
reimbursement may not be available to consumers or may not be
sufficient to allow our products to be marketed on a competitive
basis. Large private payors, managed care organizations, group
purchasing organizations and similar organizations are exerting
increasing influence on decisions regarding the use of, and
reimbursement levels for, particular treatments. Such
third-party payors, including Medicare, are challenging the
prices charged for medical products and services, and many
third-party payors limit or delay reimbursement for newly
approved medical products and indications. Cost-control
initiatives could lower the price we may establish for our
products which could result in product revenue lower than
anticipated. If the prices for our product candidates decrease
or if governmental and other third-party payors do not provide
adequate coverage and reimbursement levels, our prospects for
profitability could suffer.
We intend to rely heavily on third parties to implement
critical aspects of our business strategy, and our failure to
enter into and maintain these relationships on acceptable
business terms, or at all, would materially adversely affect our
business.
We intend to rely on third parties for certain critical aspects
of our business, including:
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manufacturing of our thrombolytics and SonoLysis bubbles; |
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conducting clinical trials; |
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preparing, submitting and maintaining regulatory records
sufficient to meet the requirements of the FDA; and |
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marketing and distribution of our products. |
We do not currently have many of these relationships in place.
Although we use a third party manufacturer to produce SonoLysis
bubbles for our clinical trials on a purchase order basis, that
third party does not have the capacity to produce the volume of
SonoLysis bubbles necessary for large-scale clinical trials or
commercial sales. We currently have an agreement with a contract
research organization to manage our clinical trials, an
agreement with a clinical auditing company to audit our closed
clinical trials, and an agreement with a clinical writing
organization to help us write protocols and study reports for
our clinical trials. To the extent that we are unable to
maintain these relationships or to enter into any one or more of
the additional relationships necessary to our business on
commercially reasonable terms, or at all, or to eliminate the
need for any such relationship by establishing our own
capabilities in a particular functional area in a timely manner,
we could experience significant delays or cost increases that
could have a material adverse effect on our ability to develop
and commercialize our product candidates.
We rely on third party products, technology and intellectual
property, which could negatively affect our ability to sell our
SonoLysis bubble or other products commercially or adversely
affect our ability to derive revenue from such products.
A number of our development programs, including, for example,
our SonoLysis therapy development program, may require the use
of multiple proprietary technologies, including commercially
available ultrasound devices and patented technologies.
Manufacturing our products or customizing related ultrasound
devices may also require licensing technologies and intellectual
property from third parties. Obtaining and
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maintaining licenses for these technologies may require us to
make royalty payments or other payments to several third
parties, potentially reducing our revenue or making the cost of
our products commercially prohibitive. We cannot be certain that
we will be able to establish any or all of the partnering
relationships and technology licenses that may be necessary for
the successful pursuit of our business strategy, or, even if
such relationships can be established, that they will be on
terms favorable to us or that they can be managed successfully.
As a highly specialized scientific business enterprise, our
success is substantially dependent on certain key members of our
scientific and management staff, the loss of any of whom could
have a material adverse effect on our business.
A small number of key officers and members of our professional
staff are responsible for certain critical areas of our
business, such as product research and development, clinical
trials, regulatory affairs, manufacturing, intellectual property
protection and licensing. The services provided by our key
personnel, including: Evan Unger, our founder and Chief
Executive Officer, Lynne Weissberger, our Vice President,
Regulatory Affairs, Quality Assurance and Regulatory Compliance;
Walter Singleton, our Chief Medical Officer; Terry Matsunaga,
our Vice President, Research; Rajan Ramaswami, our Vice
President, Product Development; Brad Zakes, our Chief Operating
Officer; John McCambridge, our Vice President, Sales and
Marketing; and Greg Cobb, our Chief Financial Officer, would be
difficult to replace. All of our employees are employed at will.
Our business and future operating results also depend
significantly on our ability to attract and retain qualified
management, manufacturing, technical, marketing, regulatory,
sales and support personnel for our operations, and competition
for such personnel is intense. We cannot be certain that our key
executive officers and scientific staff members will remain with
us or that we will be successful in attracting or retaining such
personnel. Our inability to retain and continue to attract
qualified management and technical staff could significantly
delay and may prevent the achievement of our research,
development and business objectives.
We will need to increase the size of our organization, and we
may experience difficulties in managing our growth.
As of June 30, 2006, we had 47 full-time employees. In
the future, we will need to expand our managerial, operational,
financial, clinical, regulatory and other personnel to manage
and expand our operations, undertake clinical trials,
manufacture our product candidates, continue our research and
development and collaborative activities and commercialize our
product candidates. Our management and scientific personnel,
systems and facilities currently in place will not be adequate
to support our planned future growth. Our need to effectively
manage our operations, growth and various projects requires that
we:
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successfully utilize a small sales and marketing organization; |
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identify and manage third party manufacturers for our products; |
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manage our clinical trials effectively; |
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manage our internal research and development efforts effectively
while carrying out our contractual obligations to collaborators
and other third parties; |
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continue to improve our operational, financial and management
controls, reporting systems and procedures under increasing
regulatory requirements; and |
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attract and retain sufficient numbers of talented employees. |
We may be unable to successfully implement many of these tasks
on a larger scale or in a timely manner and, accordingly, may
not achieve our research, development and commercialization
goals.
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We depend on patents and other proprietary rights, some of
which are uncertain and unproven. Further, our patent portfolio
and other intellectual property rights are expensive to
maintain, protect against infringement claims by third parties,
and enforce against third party infringements, and are subject
to potential adverse claims.
Because we are developing product candidates that rely on
advanced and innovative technologies, our success will depend in
large part on our ability to obtain and effectively use patents
and licensed patent rights, preserve trade secrets and operate
without infringing upon the proprietary rights of others. Our
Abbokinase product does not have patent protection. We have
method of production patents for our PROLYSE and
Open-Cath-R products
that expire in 2014 and 2015. Some of our intellectual property
rights are based on licenses that we have entered into with
owners of patents.
Although we have rights to 97 issued U.S. patents,
plus some foreign equivalents and numerous pending patent
applications, the patent position of pharmaceutical, medical
device and biotechnology companies in general is highly
uncertain and involves complex legal and factual questions.
Effective intellectual property protection may also be
unavailable or limited in some foreign countries. We have not
pursued foreign patent protection in all jurisdictions or for
all of our patentable intellectual property. As a result, our
patent protection for our intellectual property will likely be
less comprehensive if and when we commence international sales.
In the U.S. and internationally, enforcing intellectual property
rights against infringing parties is often costly. Pending
patent applications may not issue as patents and may not issue
in all countries in which we develop, manufacture or sell our
products or in countries where others develop, manufacture and
sell products using our technologies. Patents issued to us may
be challenged and subsequently narrowed, invalidated or
circumvented. We have been notified that, in February 2005, a
third party filed an opposition claim to one of our patents in
Europe that relates to targeted bubbles for therapeutic and
diagnostic use. This claim, if granted, and other such conflicts
could limit the scope of the patents that we may be able to
obtain or may result in the denial of our patent applications.
If a third party were to obtain intellectual property protection
for any of the technologies upon which our business strategy is
based, we could be required to challenge such protections,
terminate or modify our programs that rely on such technologies
or obtain licenses for use of these technologies. For example,
in July 2003 we received a notice from a third party who owns a
patent relating to the administration of ultrasound to break up
blood clots indicating that we may need a license to its patent
if we intend to administer our therapies according to its
patented method. Such third party patents, if valid, could
require us to seek a license that may not be available on terms
acceptable to us or at all, could impose limitations on how we
administer our therapies, and may require us to adopt
restrictions or requirements as to the manner of administration
of our products that we might not otherwise adopt to avoid
infringing patents of others. Moreover, we may not have the
financial resources to protect our patent and other intellectual
property rights and, in that event, our patents may not afford
meaningful protection for our technologies or product
candidates, which would materially adversely affect our ability
to develop and market our product candidates and to generate
licensing revenue from our patent portfolio.
Additional risks related to our patent rights and other
proprietary rights include:
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challenge, invalidation, circumvention or expiration of issued
patents already owned by or licensed to us; |
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claims by our consultants, key employees or other third parties
that our products or technologies are the result of
technological advances independently developed by them and,
therefore, not owned by us; |
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our failure to pay product development costs, license fees,
royalties, milestone payments or other compensation required
under our technology license and technology transfer agreements,
and the subsequent termination of those agreements; |
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failure by our licensors or licensees to comply with the terms
of our license agreements; |
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misrepresentation by technology owners of the extent to which
they have rights to the technologies that we purport to acquire
or license from them; |
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a potentially shorter patent term as a result of legislation
which sets the patent termination date at 20 years from the
earliest effective filing date of the patent application instead
of 17 years from the date of the grant; and |
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loss of rights that we have licensed due to our failure or
decision not to fund further research or failure to achieve
required development or commercialization milestones or
otherwise comply with our obligations under the license and
technology transfer agreements. |
If any of these events occurs, our business may be harmed.
We do not have any patent protection for Abbokinase, and
third parties could develop urokinase without a license from us,
which could decrease the market opportunity for Abbokinase.
The patents held by Abbott Laboratories relating to Abbokinase
have expired, and we did not acquire rights to any patents in
connection with our acquisition. We do not own any proprietary
rights to Abbokinase other than our license to use the
Abbokinase trademark that expires when the current
inventory of 153,000 vials is sold or expires and trade secrets
relating to the manufacturing process for Abbokinase. A third
party could acquire or develop a cell line capable of producing
urokinase and could devise a manufacturing process that could
yield a product consistent with our Abbokinase product in
quality, safety and activity, in each case without a license
from us, which could decrease the market opportunity for
Abbokinase.
Other companies may claim that we infringe their patents or
trade secrets, which could subject us to substantial damages.
A number of third parties, including certain of our competitors,
have developed technologies, filed patent applications or
obtained patents on technologies and compositions that are
related to aspects of our business, including thrombolytic drug
therapy and ultrasound. Such third parties may sue us for
infringing their patents. If we face an infringement action,
defending against such an action could require substantial
resources that may not be available to us. In the event of a
successful claim of infringement against us, we may be required
to:
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pay substantial damages; |
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stop using infringing technologies and methods; |
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stop certain research and development efforts; |
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develop non-infringing products or methods; and |
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obtain one or more licenses from third parties. |
Any claims of infringement could cause us to incur substantial
costs defending against the claim, even if the claim is invalid.
A party making a claim could secure a judgment that requires us
to pay substantial damages. A claim of infringement could also
be used by our competitors to delay market introduction or
acceptance of our products. If we are sued for infringement, we
could encounter substantial delays in development, manufacture
and commercialization of our product candidates. Any litigation,
whether to enforce our patent rights or to defend against
allegations that we infringe third party rights, will be costly
and time consuming and will likely distract management from
other important tasks.
Our rights to develop and commercialize certain of our
product candidates are subject to the terms and conditions of
licenses or sublicenses granted to us by third parties,
including other pharmaceutical companies, that contain
restrictions that may limit our ability to capitalize on these
products.
Our SonoLysis therapy and SonoLysis combination therapy product
candidates are based in part on patents and other intellectual
property that we license or sublicense from third parties. Our
rights to develop and
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commercialize these product candidates using intellectual
property licensed from UNEMED Corporation may terminate, in
whole or in part, if we fail to meet the following remaining
milestones:
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commence studies in humans using the licensed intellectual
property by October 10, 2007; or |
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commence a Phase 2 clinical trial using the licensed
intellectual property by October 10, 2009. |
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While we believe our clinical trials using
Definity®
microbubbles together with ultrasound satisfied these
requirements and, in addition, that our planned Phase 1/2
clinical trial using our SonoLysis combination therapy will also
satisfy these requirements, if we are deemed not to have met the
remaining milestones, we may be in breach of our license
agreement. We may also lose our rights to develop and
commercialize such product candidates if we fail to pay
royalties to third party licensors, or if we fail to comply with
certain restrictions regarding our development activities. In
the event of an early termination of any such license or
sublicense agreement, rights licensed and developed by us under
such agreements may be extinguished, and our rights to the
licensed technology may revert back to the licensor. Any
termination or reversion of our rights to develop or
commercialize any such product candidate may have a material
adverse effect on our business.
We are party to an agreement with Bristol-Myers Squibb that
restricts us from using our bubble technology for non-targeted
diagnostic imaging applications. Bristol-Myers Squibb also has a
right of first negotiation should we wish to license to a third
party any of our future products or technology related to the
use of bubbles for targeted imaging of blood clots, or breaking
up blood clots with ultrasound and bubbles. Bristol-Myers Squibb
has waived its rights under this agreement with respect to our
current generation of SonoLysis bubbles that we are developing
for breaking up blood clots, as well as a new generation of
SonoLysis bubbles that we are developing for breaking up blood
clots that include targeting mechanisms to cause the bubbles to
attach to blood clots. This right of first negotiation for
future technology we may develop in these applications could
adversely impact our ability to attract a partner or acquirer
for SonoLysis therapy.
In addition, we have been awarded various government funding
grants and contracts from The National Institutes of Health and
other government agencies. These grants include provisions that
provide the U.S. government with the right to use the
technologies developed under such grants for certain uses, under
certain circumstances. If the government were to exercise its
rights, our ability to commercialize such technology would
likely be impaired.
We could be exposed to significant product liability claims,
which could be time consuming and costly to defend, divert
management attention and adversely impact our ability to obtain
and maintain insurance coverage. The expense and potential
unavailability of insurance coverage for our company or our
customers could adversely affect our ability to sell our
products, which would negatively impact our business.
We face a risk of product liability exposure related to the
testing of our product candidates in clinical trials and will
face even greater risks upon any commercialization by us of our
product candidates. Thrombolytics are known to involve certain
medical hazards, such as risks of bleeding or immune reactions.
Our other product candidates may also involve presently unknown
medical risks of equal or even greater severity. Product
liability claims or other claims related to our products, or
their off-label use, regardless of their merits or outcomes,
could harm our reputation in the industry, and reduce our
product sales. Additionally, any lawsuits or product liability
claims against us may divert our management from pursuing our
business strategy and may be costly to defend. Further, if we
are held liable in any of these lawsuits, we may incur
substantial liabilities and may be forced to limit or forego
further commercialization of one or more of our products. A
product liability related claim or recall could be materially
detrimental to our business. Our current product liability
insurance, which provides us with $10 million of coverage
in the aggregate, may be insufficient. We may not be able to
obtain or maintain such insurance in adequate amounts, or on
acceptable terms, to provide coverage against potential
liabilities. The product liability coverage we currently have
for our clinical trials may be insufficient to cover fully the
costs of any claim or any ultimate damages we may be required to
pay. Our inability to obtain or maintain sufficient insurance
coverage at an acceptable cost or
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otherwise to protect against potential product liability claims
could prevent or limit the commercialization of any products we
develop, and could leave us exposed to significant financial
losses relating to any products that we do develop and
commercialize.
Moreover, Abbokinase is made from human neonatal kidney cells.
Products made from human source material may contain infectious
agents, such as viruses, that can cause disease. We believe the
risk that Abbokinase will transmit an infectious agent has been
reduced by changes to the tissue acquisition and related
manufacturing process that included screening donors for prior
exposure to certain viruses, testing donors for the presence of
certain current virus infections, testing for certain viruses
during manufacturing and inactivating and/or removing certain
viruses. Despite these measures, Abbokinase may still present a
risk of transmitting infectious agents, which could expose us to
product liability lawsuits.
If we use hazardous or biological materials in a manner that
causes injury or violates applicable law, we may be liable for
damages.
Our research and development activities involve the controlled
use of potentially hazardous substances, including toxic
chemical and biological materials. Our recent expansion of our
business strategy to include the development and sale of
urokinase-based thrombolytics will increase our involvement in
the development, handling, manufacture and distribution of
biological materials. In addition, our operations produce
hazardous waste products. Federal, state and local laws and
regulations govern the use, manufacture, storage, handling and
disposal of these hazardous and biological materials. While we
believe that we are currently in compliance with these laws and
regulations, continued compliance may be expensive, and current
and future environmental regulations may impair our research,
development and manufacturing efforts. In addition, if we fail
to comply with these laws and regulations at any point in the
future, we may be subject to criminal sanctions and substantial
civil liabilities and could be required to suspend or modify our
operations. Even if we continue to comply with all applicable
laws and regulations regarding hazardous materials, we cannot
eliminate the risk of accidental contamination or discharge and
our resultant liability for any injuries or other damages caused
by these accidents. Although we maintain general liability
insurance, this insurance may not fully cover potential
liabilities for these damages, and the amount of uninsured
liabilities may exceed our financial resources and materially
harm our business.
The FDA approval process for drugs involves substantial time,
effort and financial resources, and we may not receive any new
approvals for our product candidates on a timely basis, or at
all.
The process required by the FDA before product candidates may be
marketed in the U.S. generally involves the following:
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preclinical laboratory and animal testing; |
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submission of an IND application which must become effective
before clinical trials may begin; |
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adequate and well-controlled human clinical trials to establish
the safety and efficacy of proposed drugs or biologics for their
intended use; |
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pre-approval inspection of manufacturing facilities, company
regulatory files and selected clinical investigators; and |
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FDA approval of a new drug application, or NDA, or FDA approval
of an NDA supplement in the case of a new indication if the
product is already approved for another indication. |
The testing and approval process requires substantial time,
effort and financial resources, and we cannot be certain that
any new approvals for our product candidates will be granted on
a timely basis, if at all. We have failed in the past, and may
in the future fail, to make timely submissions of required
reports or modifications to clinical trial documents, and such
delays as well as possible errors or omissions in such
submissions could endanger regulatory acceptance of clinical
trial results or even our ability to continue with our clinical
trials.
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The results of product development, preclinical tests and
clinical trials are submitted to the FDA as part of an NDA, or
as part of an NDA supplement. The FDA may deny approval of an
NDA or NDA supplement if the applicable regulatory criteria are
not satisfied, or it may require additional clinical data or an
additional pivotal Phase 3 clinical trial. Even if such
data are submitted, the FDA may ultimately decide that the NDA
or NDA supplement does not satisfy the criteria for approval.
The FDA may move to withdraw product approval, once issued, if
ongoing regulatory standards are not met or if safety problems
occur after the product reaches the market. In addition, the FDA
may require testing and surveillance programs to monitor the
effect of approved products which have been commercialized, and
the FDA may move to prevent or limit further marketing of a
product based on the results of these post-marketing programs.
Satisfaction of FDA requirements or similar requirements of
state, local and foreign regulatory agencies typically takes
several years and the actual time required may vary
substantially based upon the type, complexity and novelty of the
product or disease. Government regulation may delay or prevent
marketing of product candidates for new indications for a
considerable period of time and impose costly procedures upon
our activities. The FDA or any other regulatory agency may not
grant approvals for new indications for our product candidates
on a timely basis, if at all. Success in early stage clinical
trials does not ensure success in later stage clinical trials.
Data obtained from clinical trials is not always conclusive and
may be susceptible to varying interpretations, which could
delay, limit or prevent regulatory approval. Even if a product
candidate receives regulatory approval, the approval may be
significantly limited to specific disease states, patient
populations and dosages. Further, even after regulatory approval
is obtained, later discovery of previously unknown problems with
a product may result in restrictions on the product or even
complete withdrawal of the product from the market. Delays in
obtaining, or failures to obtain, additional regulatory
approvals for our products would harm our business. In addition,
we cannot predict what adverse governmental regulations may
arise from future U.S. or foreign governmental action.
The FDAs policies may change and additional government
regulations may be enacted, which could prevent or delay
regulatory approval of our product candidates or approval of new
indications for our product candidates. We cannot predict the
likelihood, nature or extent of adverse governmental regulation
that might arise from future legislative or administrative
action, either in the U.S. or internationally.
If we or our contract manufacturers fail to comply with
applicable regulations, sales of our products could be delayed
and our revenue could be harmed.
Every medical product manufacturer is required to demonstrate
and maintain compliance with cGMP. We and any third party
manufacturers or suppliers with whom we enter into agreements
will be required to meet these requirements. Our contract
manufacturers will be subject to unannounced inspections by the
FDA and corresponding foreign and state agencies to ensure
strict compliance with cGMP and other applicable government
quality control and record-keeping regulations. In addition,
transfer of ownership of products triggers a mandatory
manufacturing inspection requirement from the FDA. We cannot be
certain that we or our contract manufacturers will pass any of
these inspections. If we or our contract manufacturers fail one
of these inspections in the future, our operations could be
disrupted and our manufacturing and sales delayed significantly
until we can demonstrate adequate compliance. If we or our
contract manufacturers fail to take adequate corrective action
in a timely fashion in response to a quality system regulations
inspection, the FDA could shut down our or our contract
manufacturers manufacturing operations and require us,
among other things, to recall our products, either of which
would harm our business.
Failure to comply with cGMP or other applicable legal
requirements can lead to federal seizure of violative products,
injunctive actions brought by the federal government, and
potential criminal and civil liability on the part of a company
and its officers and employees. Because of these and other
factors, we may not be able to replace our manufacturing
capacity quickly or efficiently in the event that our contract
manufacturers are unable to manufacture our products at one or
more of their facilities. As a result, the sale and marketing of
our products could be delayed or we could be forced to develop
our own manufacturing capacity, which would require substantial
additional funds and personnel and compliance with extensive
regulations.
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Our products will remain subject to ongoing regulatory review
even if they receive marketing approval. If we fail to comply
with applicable regulations, we could lose these approvals, and
the sale of our products could be suspended.
Even if we receive regulatory approval to market a particular
product candidate, the FDA or foreign regulatory authority could
condition approval on conducting additional and costly
post-approval clinical trials or could limit the scope of
approved labeling. For example, to sell Abbokinase, we are
required to continue an ongoing
200-patient
immunogenicity clinical trial. As of June 30, 2006,
approximately 65 patients had been enrolled in this trial.
Moreover, the product may later cause adverse effects that limit
or prevent its widespread use, force us to withdraw it from the
market or impede or delay our ability to obtain regulatory
approvals in additional countries. In addition, the manufacturer
of the product and its facilities will continue to be subject to
FDA review and periodic inspections to ensure adherence to
applicable regulations. After receiving marketing approval, the
FDA imposes extensive regulatory requirements on the
manufacturing, labeling, packaging, adverse event reporting,
storage, advertising, promotion and record keeping related to
the product. We may not promote or advertise any future
FDA-cleared or approved products for use outside the scope of
our products label or make unsupported promotional claims
about the benefits of our products. If the FDA determines that
our claims are outside the scope of our label or are
unsupported, it could require us to revise our promotional
claims, correct any prior statements or bring an enforcement
action against us. Moreover, the FDA or other regulatory
authorities may bring charges against us or convict us of
violating these laws, and we could become subject to third party
litigation relating to our promotional practices and there could
be a material adverse effect on our business.
If we fail to comply with the regulatory requirements of the FDA
and other applicable U.S. and foreign regulatory authorities or
discover previously unknown problems with our products,
manufacturers or manufacturing processes, we could be subject to
administrative or judicially imposed sanctions, including:
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restrictions on the products, manufacturers or manufacturing
processes; |
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warning letters; |
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civil or criminal penalties or fines; |
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injunctions; |
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product seizures, detentions or import bans; |
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voluntary or mandatory product recalls and publicity
requirements; |
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suspension or withdrawal of regulatory approvals; |
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total or partial suspension of production; and |
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refusal to approve pending applications of marketing approval of
new drugs or supplements to approved applications. |
If we were subject to any of the foregoing actions by the FDA,
our sales could be delayed, our revenue could decline and our
reputation among clinicians, doctors, inventors and research and
academic institutions could be harmed.
Marketing and reimbursement practices and claims processing
in the pharmaceutical and medical device industries are subject
to significant regulation in the U.S.
In addition to FDA restrictions on marketing of pharmaceutical
products, several other state and federal laws have been applied
to regulate certain marketing practices in the pharmaceutical
and medical device industries in recent years, in particular
anti-kickback statutes and false claims statutes.
The federal health care program anti-kickback statute prohibits,
among other things, knowingly and willfully offering, paying,
soliciting or receiving remuneration to induce or in return for
purchasing, leasing, ordering or arranging for the purchase,
lease or order of any health care item or service reimbursable
under Medicare,
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Medicaid or other federally financed healthcare programs. This
statute has been interpreted to apply to arrangements between
pharmaceutical manufacturers on one hand and prescribers,
purchasers and formulary managers on the other. Although there
are a number of statutory exemptions and regulatory safe harbors
protecting certain common activities from potential liability,
the exemptions and safe harbors are drawn narrowly. Practices
that involve remuneration intended to induce prescribing,
purchases or recommendations may be subject to scrutiny if they
do not qualify for an exemption or safe harbor. Our future
practices may not in all cases meet the criteria for safe harbor
protection from anti-kickback liability.
Federal false claims laws prohibit any person from knowingly
presenting, or causing to be presented, a false claim for
payment to the federal government, or knowingly making, or
causing to be made, a false statement to have a false claim
paid. For example, several pharmaceutical and other health care
companies have been prosecuted under these laws for allegedly
providing free product to customers with the expectation that
the customers would bill federal programs for the product. Other
companies have been prosecuted for causing false claims to be
submitted because of the companys marketing of the product
for unapproved, and thus non-reimbursable, uses. The majority of
states also have statutes or regulations similar to the federal
anti-kickback and false claims laws, which apply to items and
services reimbursed under Medicaid and other state programs, or,
in several states, apply regardless of the payor. Sanctions
under these federal and state laws may include civil monetary
penalties, exclusion of a manufacturers products from
reimbursement under government programs, criminal fines and
imprisonment.
Because of the breadth of these laws and the limited safe
harbors, it is possible that some of our commercial activities
in the future could be subject to challenge under one or more of
such laws. Such a challenge could have a material adverse effect
on our business.
If we seek regulatory approvals for our products in foreign
jurisdictions, we may not obtain any such approvals.
We may market our products outside the U.S., either with a
commercial partner or alone. To market our products in foreign
jurisdictions, we may be required to obtain separate regulatory
approvals and comply with numerous and varying regulatory
requirements. The approval procedure varies among countries and
jurisdictions and can involve additional testing, and the time
required to obtain foreign approvals may differ from that
required to obtain FDA approval. We have no experience with
obtaining any such foreign approvals. Additionally, the foreign
regulatory approval process may include all of the risks
associated with obtaining FDA approval. For all of these
reasons, we may not obtain foreign regulatory approvals on a
timely basis, if at all. Approval by the FDA does not ensure
approval by regulatory authorities in other countries or
jurisdictions, and approval by one foreign regulatory authority
does not ensure approval by regulatory authorities in other
foreign countries or jurisdictions or by the FDA. We may not be
able to submit applications for regulatory approvals and may not
receive necessary approvals to commercialize our products in any
market. The failure to obtain these approvals could materially
adversely affect our business, financial condition and results
of operations.
Risks Related to this Offering
We have broad discretion in the use of the net proceeds from
this offering and may not use them effectively.
After payment of our debt obligations, our management will have
broad discretion in the application of the remaining net
proceeds of this offering, including for any of the purposes
described in Use of Proceeds. The failure of our
management to apply these funds effectively could result in
financial losses and materially harm our business, cause the
price of our common stock to decline and delay product
development.
Our principal stockholders and management own a significant
percentage of our stock and will be able to exercise significant
influence over our affairs.
Our executive officers, current directors and holders of five
percent or more of our common stock, as of June 30, 2006,
beneficially owned approximately 27.5% of our common stock. We
expect that upon the closing of this offering, that same group
will continue to hold
approximately % of our outstanding
common stock. Consequently, even after this offering, these
stockholders will likely continue to have significant
24
influence over our operations. The interests of these
stockholders may be different than the interests of other
stockholders. This concentration of ownership could also have
the effect of delaying or preventing a change in control of our
company or otherwise discouraging a potential acquirer from
attempting to obtain control of us, which in turn could reduce
the price of our common stock.
We will incur increased costs as a public company which may
make it more difficult to achieve profitability.
Upon effectiveness of the registration statement for this
offering, we will become subject to the reporting obligations
set forth in the Securities Exchange Act of 1934, as amended. As
a public company, we will incur significant legal, accounting,
insurance, investor relations and other expenses that we did not
incur as a private company. The disclosures that we will be
required to make will generally involve a substantial
expenditure of financial resources. In addition, the
Sarbanes-Oxley Act of 2002, as well as new rules subsequently
implemented by the Securities and Exchange Commission, or SEC,
and The Nasdaq Global Market have required changes in corporate
governance practices of public companies. We expect that full
compliance with these new rules and regulations will
significantly increase our legal and financial compliance costs
and make some activities more time-consuming and costly. For
example, in connection with becoming a reporting company, we
have created additional board committees and will be required to
adopt and maintain policies regarding internal controls and
disclosure controls and procedures. We have retained a
consultant to assist us in developing our internal controls to
comply with regulatory requirements and may have to retain
additional consultants and employees to assist us with other
aspects of complying with regulatory requirements applicable to
public companies. Such additional reporting and compliance costs
may negatively impact our financial results and may make it more
difficult to achieve profitability. The rules and regulations
imposed by the SEC and as implemented under the Sarbanes-Oxley
Act may also make it more difficult and expensive for us to
obtain director and officer liability insurance, and we may be
required to accept reduced policy limits and coverage or incur
substantially higher costs to obtain the same or similar
coverage. To the extent our earnings suffer as a result of the
financial impact of our SEC reporting or compliance costs, our
business could be harmed.
If you purchase shares of common stock in this offering, you
will suffer immediate and substantial dilution of your
investment.
Purchasers of common stock in this offering will pay a price per
share that substantially exceeds the per share book value of our
tangible assets after subtracting our liabilities and the per
share price paid by our existing stockholders and by persons who
exercise currently outstanding options to acquire our common
stock. In addition, purchasers of common stock in this offering
will have
contributed %
of our total capital raised through the sale of our stock but
will own
only %
of the outstanding common stock and voting rights.
There has been no prior public market for our common stock,
and an active trading market for our common stock may not
develop, potentially lessening the value of your shares and
impairing your ability to sell.
Prior to this offering, there has been no public market for our
common stock. Although we have applied to have our common stock
quoted on The Nasdaq Global Market, an active trading market for
our shares may never develop or be sustained following this
offering. Accordingly, you may not be able to sell your shares
quickly or at the market price if trading in our stock is not
active. We will negotiate and determine the initial public
offering price with representatives of the underwriters and this
price may not be indicative of prices that will prevail in the
trading market after the offering. Investors may not be able to
sell their common stock at or above the initial public offering
price. In addition, there are continuing eligibility
requirements for companies listed on The Nasdaq Global Market.
If we are not able to continue to satisfy the eligibility
requirements of The Nasdaq Global Market, then our stock may be
delisted. This could result in a lower price of our common stock
and may limit the ability of our stockholders to sell our stock,
any of which could result in your losing some or all of your
investment.
25
We expect the price of our common stock to be volatile, and
if you purchase shares of our common stock you could incur
substantial losses if you are unable to sell your shares at or
above the offering price.
The price for the shares of our common stock sold in this
offering will be determined by negotiation between the
representatives of the underwriters and us, but this price may
not reflect the market price for our common stock following the
offering. In addition, our stock price is likely to be volatile.
The stock markets in general and the market for small health
care companies in particular have experienced extreme volatility
that has often been unrelated to the operating performance of
particular companies. As a result of this volatility, investors
may not be able to sell their common stock at or above the
initial public offering price. The price for our common stock
may be influenced by many factors, including:
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announcements of technological innovations or new products by us
or our competitors; |
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announcements of the status of FDA review of our products; |
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the success rate of our discovery efforts, animal studies and
clinical trials; |
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developments or disputes concerning patents or proprietary
rights, including announcements of infringement, interference or
other litigation regarding these rights; |
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the willingness of collaborators to commercialize our products
and the timing of commercialization; |
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changes in our strategic relationships which adversely affect
our ability to acquire or commercialize products; |
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announcements concerning our competitors or the health care
industry in general; |
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public concerns over the safety of our products or our
competitors products; |
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changes in governmental regulation of the health care industry; |
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changes in the reimbursement policies of third-party insurance
companies or government agencies; |
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actual or anticipated fluctuations in our operating results from
period to period; |
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variations in our quarterly results; |
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changes in financial estimates or recommendations by securities
analysts; |
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changes in accounting principles; and |
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the loss of any of our key scientific or management personnel. |
A decline in the market price of our common stock could cause
investors to lose some or all of their investment and may
adversely impact our ability to attract and retain employees and
raise capital.
A significant portion of our outstanding common stock may be
sold into the market in the near future. Substantial sales of
common stock, or the perception that such sales are likely to
occur, could cause the price of our common stock to decline.
If our existing stockholders sell a large number of shares of
common stock or the public market perceives that existing
stockholders might sell shares of common stock, the market price
of our common stock could decline significantly. All of the
shares offered under this prospectus will be freely tradable
without restriction or further registration under the federal
securities laws, unless purchased by our affiliates
as that term is defined in Rule 144 under the Securities
Act of 1933. An aggregate of 17,352,795 shares of our
common stock may be sold pursuant to Rule 144, 144(k) and
701 upon the expiration of
180-day
lock-up agreements.
In addition, as of June 30, 2006, holders of an aggregate
of 16,779,831 shares of common stock and warrants to
purchase an aggregate of 1,474,739 shares of common stock
have rights with respect to the registration of their shares of
common stock with the SEC. See Description of Capital
Stock Registration Rights. If we
26
register their shares of common stock following the expiration
of the lock-up
agreements, they can immediately sell those shares in the public
market.
Promptly following this offering, we intend to file a
registration statement covering up to a maximum of
6,235,400 shares of common stock that are authorized for
issuance under our equity incentive plans. As of June 30,
2006, 2,897,024 shares were subject to outstanding options,
of which 947,875 shares were vested. Once we register these
shares, they can be freely sold in the public market upon
issuance, subject to
lock-up agreements and
restrictions on our affiliates. For more information, see the
discussion under the caption Shares Eligible for Future
Sale.
If we fail to develop and maintain an effective system of
internal controls, we may not be able to accurately report our
financial results or prevent fraud; as a result, current and
potential stockholders could lose confidence in our financial
reporting, which could harm our business and the trading price
of our common stock, should a market for such securities ever
develop.
Effective internal controls are necessary for us to provide
reliable financial reports and effectively prevent fraud. We
have not undertaken any efforts to develop a sophisticated
financial reporting system. Section 404 of the
Sarbanes-Oxley Act of 2002 will require us, beginning with our
fiscal year 2007, to evaluate and report on our internal
controls over financial reporting and will require our
independent registered public accounting firm annually to attest
to such evaluation, as well as issue their own opinion on our
internal control over financial reporting. Because we have
historically operated as a private company, we have limited
experience attempting to comply with public company obligations,
including Section 404 of the Sarbanes-Oxley Act. The
process of strengthening our internal controls and complying
with Section 404 is expensive and time consuming, and
requires significant management attention, especially given that
we have not previously undertaken any efforts to comply with the
requirements of Section 404. We have recently retained a
consultant to assist us in developing our internal controls to
comply with regulatory requirements and may be required to
retain additional consultants or employees to assist us with
other aspects of complying with regulatory requirements
applicable to public companies in the future. The implementation
of compliance efforts with Section 404 will be challenging
in the face of our planned rapid growth to support our
operations as well as the establishment of infrastructure to
support our commercial operations. We cannot be certain that the
measures we will undertake will ensure that we will maintain
adequate controls over our financial processes and reporting in
the future. Furthermore, if we are able to rapidly grow our
business, the internal controls that we will need will become
more complex, and significantly more resources will be required
to ensure our internal controls remain effective. Failure to
implement required controls, or difficulties encountered in
their implementation, could harm our operating results or cause
us to fail to meet our reporting obligations. If we or our
auditors discover a material weakness, the disclosure of that
fact, even if quickly remedied, could diminish investors
confidence in our financial statements and harm our stock price.
In addition, non-compliance with Section 404 could subject
us to a variety of administrative sanctions, including
ineligibility for listing on The Nasdaq Global Market and the
inability of registered broker-dealers to make a market in our
common stock.
Anti-takeover defenses that we have in place could prevent or
frustrate attempts to change our direction or management.
Provisions of our certificate of incorporation and bylaws and
applicable provisions of Delaware law may make it more difficult
or impossible for a third party to acquire control of us without
the approval of our board of directors. These provisions:
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limit who may call a special meeting of stockholders; |
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establish advance notice requirements for nominations for
election to our board of directors or for proposing matters that
can be acted on at stockholder meetings; |
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prohibit cumulative voting in the election of our directors,
which would otherwise permit holders of less than a majority of
our outstanding shares to elect directors; |
27
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prohibit stockholder action by written consent, thereby
requiring all stockholder actions to be taken at a meeting of
our stockholders; and |
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provide our board of directors the ability to designate the
terms of and issue a new series of preferred stock without
stockholder approval. |
In addition, Section 203 of the Delaware General
Corporation Law generally prohibits us from engaging in any
business combination with certain persons who own 15% or more of
our outstanding voting stock or any of our associates or
affiliates who at any time in the past three years have owned
15% or more of our outstanding voting stock. These provisions
may have the effect of entrenching our management team and may
deprive you of the opportunity to sell your shares to potential
acquirors at a premium over prevailing prices. This potential
inability to obtain a control premium could reduce the price of
our common stock.
We may become involved in securities class action litigation
that could divert managements attention and harm our
business.
The stock market in general, and The Nasdaq Global Market and
the market for biopharmaceutical companies in particular, have
experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating
performance of those companies. These broad market and health
care industry factors may materially harm the market price of
our common stock, regardless of our operating performance. In
the past, following periods of volatility in the market price of
a particular companys securities, securities class action
litigation has often been brought against that company. We may
become involved in this type of litigation in the future,
regardless of the merits. Litigation often is expensive and
diverts managements attention and resources, which could
materially harm our financial condition and results of
operations.
We do not intend to pay cash dividends on our common stock in
the foreseeable future.
We have never declared or paid any cash dividends on our common
stock or other securities, and we currently do not anticipate
paying any cash dividends in the foreseeable future. Instruments
governing any future indebtedness may also contain various
covenants that would limit our ability to pay dividends.
Accordingly, our stockholders will not realize a return on their
investment unless the trading price of our common stock
appreciates. Our common stock may not appreciate in value after
the offering and may not even maintain the price at which
investors purchased shares.
28
Forward-looking Statements
This prospectus contains forward-looking statements that are
based on our managements beliefs and assumptions and on
information currently available to our management. The
forward-looking statements are contained principally in the
sections entitled Summary, Risk Factors,
Managements Discussion and Analysis of Financial
Condition and Results of Operations and Our
Business. Forward-looking statements include, but are not
limited to, statements about:
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our ability to market and sell Abbokinase; |
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our ability to conduct and complete our clinical trials and our
use of acquired data; |
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our expectations with respect to regulatory submissions and
approvals; |
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our ability to engage and retain qualified third parties to
manufacture our product candidates in a timely and
cost-effective manner; |
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our ability to commercialize our product candidates; |
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our estimates regarding our capital requirements and our need
for additional financing; and |
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our expectations with respect to our intellectual property
position. |
In some cases, you can identify forward-looking statements by
terms such as may, will,
should, could, would,
expects, plans, intends,
anticipates, believes,
estimates, projects,
predicts, potential and similar
expressions intended to identify forward-looking statements. We
may not actually achieve the plans, intentions or expectations
disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements. Actual
results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking
statements we make. We have included important factors in the
cautionary statements included in this prospectus, particularly
in the Risk Factors section, that could cause actual
results or events to differ materially from the forward-looking
statements that we make.
You should read this prospectus, any filed issuer free writing
prospectus and the documents that we have filed as exhibits to
the registration statement, of which this prospectus is a part,
completely and with the understanding that our actual future
results may be materially different from what we expect. We do
not assume any obligation to update any forward-looking
statements.
29
Use of Proceeds
We estimate that we will receive approximately
$ million
in net proceeds from this offering, or
$ million
if the underwriters over-allotment option is exercised in
full, based upon an assumed initial public offering price of
$ per
share, the midpoint of the range on the front cover of this
prospectus, after deducting underwriting discounts and
commissions and estimated offering expenses payable by us.
A $1.00 increase (decrease) in the assumed initial public
offering price of
$ per
share, the midpoint of the range on the front cover of this
prospectus, would increase (decrease) the net proceeds to us
from this offering by
$ million
after deducting underwriting discounts and commissions and
estimated offering expenses payable by us, assuming the number
of shares offered by us, as set forth on the cover page of this
prospectus, remains the same. Regardless of whether there is a
decrease by $1.00 in the assumed initial public offering price,
we anticipate that the net proceeds from this offering together
with our existing cash and cash equivalents will be sufficient
to meet our anticipated cash requirements until
December 2007.
We estimate that we will use the net proceeds from this offering
in the following manner:
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approximately $16 million for payment of a $15 million
promissory note plus accrued interest, that we issued in
connection with our 2005 acquisition of recombinant urokinase
drug technologies, which matures on December 31, 2006 and
accrues interest at 6% annually; |
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approximately $12 million to fund a portion of our PROLYSE
development activities, including a portion of a Phase 3
clinical trial (approximately $15 million in additional
funds will likely be required to complete the Phase 3
clinical trial), and manufacturing and materials costs related
to the trial; |
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approximately $9 million to fund a portion of our SonoLysis
combination therapy development activities, including a
Phase 1/2 clinical trial, preclinical safety studies,
manufacturing and material costs related to the trial; |
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approximately $4 million to fund a portion of our SonoLysis
therapy development activities, including a preclinical safety
and mechanism of action studies, manufacturing and material
costs related to the studies; |
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approximately $5 million to fund research and development
activities for Abbokinase, Open-Cath-R and our other preclinical
and research-stage product candidates; |
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approximately $4 million to fund Abbokinase sales and
marketing costs and other business development
activities; and |
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for working capital and other general corporate purposes. |
The amounts we actually expend in these areas may vary
significantly from our expectations and will depend on a number
of factors, including operating costs and capital expenditures.
Accordingly, management will retain broad discretion in the
allocation of the net proceeds of this offering. A portion of
the net proceeds may also be used to acquire or invest in
complementary businesses, technologies, services or products. We
have no current plans, agreements or commitments with respect to
any such material acquisition or investment, and we are not
currently engaged in any negotiations with respect to any such
transaction. Pending such uses, the net proceeds of this
offering will be invested in short-term, interest-bearing,
investment-grade securities.
Dividend Policy
We have never declared or paid any cash dividends on our capital
stock. We currently intend to retain any future earnings to
finance the growth and development of our business. We do not
anticipate paying any cash dividends in the foreseeable future.
30
Capitalization
The following table sets forth our capitalization as of
June 30, 2006:
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On an actual basis; |
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On a pro forma basis after giving effect to the conversion of
all outstanding shares of preferred stock, valued at
approximately $39.0 million, into 8,164,157 shares of
common stock upon the closing of this offering; and |
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On a pro forma as adjusted basis to reflect our receipt of the
estimated net proceeds from our sale
of shares
of common stock in this offering at an assumed initial public
offering price of
$ ,
the midpoint of the range on the front cover of this prospectus,
after deducting underwriting discounts and commissions and
estimated offering expenses payable by us. |
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At June 30, 2006 | |
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Pro Forma | |
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Actual | |
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Pro Forma | |
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as Adjusted | |
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(unaudited) | |
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(in thousands) | |
Long-term notes payable, less current portion
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$ |
15,165 |
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$ |
15,165 |
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$ |
15,165 |
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Mandatorily redeemable convertible preferred stock,
$0.0001 par value: 6,443,316 shares issued and
outstanding, actual, no shares issued or outstanding, pro
forma and pro forma as adjusted
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34,996 |
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Stockholders (deficit) equity:
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Preferred stock, $0.0001 par value: 30,000,000 shares
authorized, actual and pro forma, 5,000,000 shares
authorized, pro forma as adjusted; 1,000,000 shares issued
and outstanding, actual, no shares issued or outstanding, pro
forma and pro forma as adjusted
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4,000 |
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Common stock, $0.0001 par value: 70,000,000 shares
authorized, actual and pro forma, 100,000,000 shares authorized,
pro forma as adjusted; 13,033,638 shares issued and
outstanding, actual, 21,197,795 shares issued and
outstanding, pro forma,
and shares
issued and outstanding, pro forma as adjusted
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1 |
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2 |
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Additional paid-in capital
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28,169 |
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67,164 |
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Deficit accumulated during the development stage
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(68,482 |
) |
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(68,482 |
) |
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( |
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Total stockholders (deficit) equity
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(36,312 |
) |
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(1,316 |
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Total capitalization
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$ |
13,849 |
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$ |
13,849 |
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$ |
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The pro forma number of shares to be outstanding immediately
after this offering as shown above is based on
21,197,795 shares outstanding as of June 30, 2006 and
excludes:
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2,897,024 shares of common stock issuable upon the exercise
of options outstanding having a weighted average exercise price
of $3.07 per share; |
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1,761,749 shares of common stock issuable upon the exercise
of warrants outstanding having a weighted average exercise price
of $3.16 per share; |
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1,538,376 shares of common stock reserved for future grants
under our 2000 Stock Plan; and |
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an aggregate of 1,800,000 shares of common stock reserved
for future issuance under our 2006 Performance Incentive Plan,
which will become effective immediately upon the signing of the
underwriting agreement for this offering. |
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31
Dilution
If you invest in our common stock in this offering, the amount
you pay per share will be substantially more than the net
tangible book value per share of the common stock you purchase.
Our actual net tangible book value as of June 30, 2006 was
a deficit of approximately $40.5 million, or approximately
$(3.11) per share of common stock. Net tangible book value
per share represents total tangible assets less total
liabilities, divided by the number of shares of common stock
outstanding as of June 30, 2006. Our pro forma net tangible
book value as of June 30, 2006 was a deficit of
approximately $5.5 million, or approximately
$(0.26) per share of common stock. Our pro forma net
tangible book value gives effect to the conversion of all
outstanding shares of preferred stock, valued at approximately
$39.0 million, into 8,164,157 shares of common stock
upon the closing of this offering.
After giving effect, based on an assumed initial public offering
price of
$ per
share, the midpoint of the range on the front cover of this
prospectus, to (i) the automatic conversion of our
outstanding preferred stock into 8,164,157 shares of common
stock in connection with the closing of this offering and
(ii) receipt of the net proceeds from the sale
of shares
of common stock in this offering, after deducting underwriting
discounts and commissions and estimated offering expenses, our
pro forma as adjusted net tangible book value as of
June 30, 2006 would have been approximately
$ million, or
$ per
share. See Conversion of Series F Preferred
Stock. This represents an immediate increase in pro forma
as adjusted net tangible book value per share of
$ to
existing stockholders and an immediate dilution of
$ per
share to new investors purchasing shares of common stock in this
offering at the assumed initial offering price.
The following table illustrates this dilution on a per share
basis:
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Assumed initial public offering price per share
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$ |
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Actual net tangible book value (deficit) per share as of
June 30, 2006
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$ |
(3.11 |
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Increase per share due to pro forma adjustments
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2.85 |
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Pro forma net tangible book value (deficit) per share as of
June 30, 2006, before this offering
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(0.26 |
) |
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Increase in pro forma net tangible book value per share
attributable to this offering
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Pro forma as adjusted net tangible book value per share after
this offering
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Dilution in pro forma net tangible book value per share to new
investors in this offering
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$ |
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If the underwriters exercise their over-allotment option to
purchase additional
shares from us in this offering, our pro forma as adjusted net
tangible book value per share will increase to
$ per
share, representing an immediate increase to existing
stockholders, of
$ per
share and an immediate dilution of
$ per
share to new investors assuming conversion of all shares of our
preferred stock. If any shares are issued in connection with
outstanding options, you will experience further dilution.
32
The following table summarizes, on the pro forma as adjusted
basis described above, as of June 30, 2006, the number of
shares of common stock purchased from us, the total
consideration paid and the average price per share paid to us by
existing stockholders and to be paid by new investors purchasing
shares of common stock in this offering. The table assumes an
initial public offering price of
$ per
share, the midpoint of the range on the front cover of this
prospectus, before deducting underwriting discounts and
commissions and estimated offering expenses payable by us.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Shares | |
|
Total Consideration | |
|
|
|
|
| |
|
| |
|
Average Price | |
|
|
Number | |
|
% | |
|
Amount | |
|
% | |
|
Per Share | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Existing stockholders
|
|
|
21,197,795 |
|
|
|
|
|
|
$ |
46,764,000 |
|
|
|
|
|
|
$ |
2.21 |
|
New investors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
100.0 |
% |
|
|
|
|
|
|
100.0 |
% |
|
|
|
|
The number of shares to be outstanding immediately after this
offering as shown above is based on 21,197,795 shares
outstanding as of June 30, 2006 and excludes:
|
|
|
|
|
|
2,897,024 shares of common stock issuable upon the exercise
of options outstanding having a weighted average exercise price
of $3.07 per share; |
|
|
|
|
1,761,749 shares of common stock issuable upon the exercise
of warrants outstanding having a weighted average exercise price
of $3.16 per share; |
|
|
|
|
1,538,376 shares of common stock reserved for future grants
under our 2000 Stock Plan as of June 30, 2006; and |
|
|
|
|
|
an aggregate of 1,800,000 shares of common stock reserved
for future issuance under our 2006 Performance Incentive Plan,
which will become effective immediately upon the signing of the
underwriting agreement for this offering. |
|
If the underwriters over-allotment option is exercised in
full, the following will occur:
|
|
|
|
|
the percentage of shares of common stock held by existing
stockholders will decrease to
approximately % of the total
number of shares of common stock outstanding after this
offering; and |
|
|
|
the number of shares held by new investors will increase
to ,
or approximately %, of the total
number of shares of common stock outstanding after this offering. |
Assuming the exercise in full of all of our options and warrants
outstanding as of June 30, 2006, pro forma net tangible
book value as of June 30, 2006 would be a deficit of
approximately $ per share
and, after giving effect to the sale
of shares
of common stock in this offering, there would be an immediate
dilution of
$ per
share to new investors purchasing shares in this offering. If
all options and warrants outstanding as of June 30, 2006
are exercised in full, new investors would have
contributed % of the total
consideration paid but would own
only % of our capital stock
outstanding after the offering and exercise of all such
outstanding options and warrants.
33
Conversion of Series F Preferred Stock
In connection with the closing of this offering, all of our
outstanding preferred stock will convert into common stock. The
per share conversion rate of our Series F preferred stock
is variable and will be determined by dividing $5.00 (as
adjusted for any stock dividends, combinations, splits,
recapitalizations and the like with respect to such shares) by
the lesser of (a) $5.00 (as adjusted for any stock
dividends, combinations, splits, recapitalizations and the like
with respect to such shares) or (b) 85% of the price per
share paid in this offering. Therefore, depending on the price
of the shares sold in this offering, the holders of the
Series F preferred stock may receive more than one share of
common stock for each share of Series F preferred stock
converted in connection with this offering. We will not know the
conversion rate of our Series F preferred stock until the
public offering price is determined.
In this prospectus, we have estimated the number of shares of
common stock issuable upon conversion of the Series F
preferred stock assuming an initial public offering price of
greater than $5.88 per share (as adjusted for any stock
dividends, combinations, splits, recapitalizations and the like
with respect to such shares), meaning that we have assumed a
one-to-one conversion
ration of our Series F preferred stock.
Upon completion of this offering, our existing stockholders will
continue to have significant influence over the outcome of
corporate actions requiring stockholder approval, including the
election of directors, any merger, consolidation or sale of all
or substantially all of our assets or any other significant
corporate transaction. Because only some of our stockholders own
Series F preferred stock, changes in our valuation in
connection with this offering will impact the conversion ratio
of our Series F preferred stock and thus the relative
ownership of our common stock upon completion of this offering
among our existing stockholders.
34
Selected Consolidated Financial Data
You should read the following selected consolidated financial
data in conjunction with our consolidated financial statements
and the related notes appearing elsewhere in this prospectus and
the Managements Discussion and Analysis of Financial
Condition and Results of Operations. We have derived the
consolidated statements of operations data for the years ended
December 31, 2003, 2004 and 2005 and the consolidated
balance sheet data at December 31, 2004 and 2005 from our
consolidated audited financial statements, which are included
elsewhere in this prospectus. We have derived the consolidated
statements of operations data for the years ended
December 31, 2001 and 2002 and the consolidated balance
sheet data as of December 31, 2001, 2002 and 2003, from our
audited financial statements, which are not included in this
prospectus. The selected consolidated statements of operations
data for the six months ended June 30, 2005 and 2006, and
the selected consolidated balance sheet data at June 30,
2006, are derived from our unaudited consolidated financial
statements, which are included elsewhere in this prospectus. Our
historical results for any prior period are not necessarily
indicative of results to be expected for any future period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
Six Months Ended June 30, | |
|
|
| |
|
| |
|
|
2001 | |
|
2002 | |
|
2003 | |
|
2004 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
|
(in thousands, except share and per share data) | |
Consolidated Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant and other revenue
|
|
$ |
261 |
|
|
$ |
71 |
|
|
$ |
224 |
|
|
$ |
575 |
|
|
$ |
619 |
|
|
$ |
294 |
|
|
$ |
429 |
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,812 |
|
|
|
1,399 |
|
|
|
1,878 |
|
|
|
2,490 |
|
|
|
3,579 |
|
|
|
1,496 |
|
|
|
3,990 |
|
|
General and administrative
|
|
|
2,943 |
|
|
|
1,840 |
|
|
|
1,654 |
|
|
|
3,183 |
|
|
|
4,142 |
|
|
|
1,501 |
|
|
|
3,127 |
|
|
Depreciation and amortization
|
|
|
210 |
|
|
|
245 |
|
|
|
209 |
|
|
|
186 |
|
|
|
194 |
|
|
|
95 |
|
|
|
332 |
|
|
Acquired in-process research and development(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,000 |
|
|
|
|
|
|
|
|
|
|
License fees to development partner(2)
|
|
|
10,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
14,965 |
|
|
|
3,484 |
|
|
|
3,741 |
|
|
|
5,859 |
|
|
|
31,915 |
|
|
|
3,092 |
|
|
|
7,449 |
|
Minority interest in loss of consolidated subsidiary
|
|
|
2,269 |
|
|
|
369 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
|
162 |
|
|
|
14 |
|
|
|
22 |
|
|
|
29 |
|
|
|
122 |
|
|
|
50 |
|
|
|
215 |
|
Interest expense
|
|
|
(53 |
) |
|
|
(170 |
) |
|
|
(325 |
) |
|
|
(469 |
) |
|
|
(587 |
) |
|
|
(53 |
) |
|
|
(615 |
) |
Gain on extinguishment of note(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,835 |
|
|
|
3,835 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
|
(12,326 |
) |
|
|
(3,200 |
) |
|
|
(3,820 |
) |
|
|
(5,724 |
) |
|
|
(27,926 |
) |
|
|
1,034 |
|
|
|
(7,420 |
) |
Accretion of dividends on preferred stock
|
|
|
(537 |
) |
|
|
(1,640 |
) |
|
|
(1,287 |
) |
|
|
(301 |
) |
|
|
(601 |
) |
|
|
(300 |
) |
|
|
(300 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income available to common stockholders
|
|
$ |
(12,863 |
) |
|
$ |
(4,840 |
) |
|
$ |
(5,107 |
) |
|
$ |
(6,025 |
) |
|
$ |
(28,527 |
) |
|
$ |
734 |
|
|
$ |
(7,720 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income available to common stockholders per
share Basic
|
|
$ |
(4.39 |
) |
|
$ |
(1.65 |
) |
|
$ |
(1.74 |
) |
|
$ |
(1.07 |
) |
|
$ |
(3.01 |
) |
|
$ |
0.09 |
|
|
$ |
(0.60 |
) |
Weighted average shares outstanding Basic
|
|
|
2,927,961 |
|
|
|
2,938,706 |
|
|
|
2,936,094 |
|
|
|
5,637,042 |
|
|
|
9,463,279 |
|
|
|
8,335,776 |
|
|
|
12,968,424 |
|
Net (loss) income available to common stockholders per
share Diluted
|
|
$ |
(4.39 |
) |
|
$ |
(1.65 |
) |
|
$ |
(1.74 |
) |
|
$ |
(1.07 |
) |
|
$ |
(3.01 |
) |
|
$ |
0.05 |
|
|
$ |
(0.60 |
) |
Weighted average shares outstanding Diluted
|
|
|
2,927,961 |
|
|
|
2,938,706 |
|
|
|
2,936,094 |
|
|
|
5,637,042 |
|
|
|
9,463,279 |
|
|
|
13,803,797 |
|
|
|
12,968,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, | |
|
|
|
|
|
|
| |
|
|
|
At June 30, | |
|
|
2001 | |
|
2002 | |
|
2003 | |
|
2004 | |
|
2005 | |
|
|
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
|
|
|
|
|
(in thousands) | |
|
|
(in thousands) | |
|
|
|
|
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
368 |
|
|
$ |
2,104 |
|
|
$ |
736 |
|
|
$ |
1,538 |
|
|
$ |
8,513 |
|
|
|
|
|
|
$ |
9,834 |
|
Working capital (deficit)
|
|
|
(102 |
) |
|
|
1,568 |
|
|
|
(1,440 |
) |
|
|
739 |
|
|
|
(8,111 |
) |
|
|
|
|
|
|
10,072 |
|
Total assets
|
|
|
1,438 |
|
|
|
2,908 |
|
|
|
1,298 |
|
|
|
2,122 |
|
|
|
9,516 |
|
|
|
|
|
|
|
32,110 |
|
Long-term notes payable, less current portion
|
|
|
|
|
|
|
3,740 |
|
|
|
4,002 |
|
|
|
4,282 |
|
|
|
|
|
|
|
|
|
|
|
15,165 |
|
Mandatorily redeemable convertible preferred stock
|
|
|
16,715 |
|
|
|
19,189 |
|
|
|
20,826 |
|
|
|
21,127 |
|
|
|
21,727 |
|
|
|
|
|
|
|
34,996 |
|
Total stockholders deficit
|
|
|
(16,113 |
) |
|
|
(20,971 |
) |
|
|
(26,003 |
) |
|
|
(24,529 |
) |
|
|
(29,327 |
) |
|
|
|
|
|
|
(36,312 |
) |
|
|
(1) |
Research and development expense for the year ended
December 31, 2005 includes the purchase of in-process
research and development operations valued at $24,000,000 in
accordance with an Asset Purchase Agreement entered into with
Abbott Laboratories in September 2005 related to our
acquisition of PROLYSE and Open-Cath-R. |
(2) |
License fees in the amount of $10,000,000 were incurred in
conjunction with entering into a joint development agreement
with a development partner in January 2001. |
|
(3) |
Extinguishment of the note payable to the development partner in
the joint development agreement entered into in 2001 resulted in
a gain on extinguishment of note of $3.8 million in March
2005. |
|
35
Managements Discussion and Analysis of
Financial Condition and Results of Operations
The following discussion and analysis should be read in
conjunction with Selected Consolidated Financial
Information and our consolidated financial statements and
related notes included elsewhere in this prospectus. This
discussion and analysis and other parts of the prospectus
contain forward-looking statements based upon current beliefs,
plans and expectations that involve risks, uncertainties and
assumptions. Our actual results and the timing of selected
events could differ materially from those anticipated in these
forward-looking statements as a result of several factors,
including those set forth under Risk Factors and
elsewhere in this prospectus. You should carefully read the
Risk Factors section of this prospectus to gain an
understanding of the important factors that could cause actual
results to differ materially from our forward-looking
statements. Please also see the section entitled
Forward-looking Statements.
Overview
We are a biopharmaceutical company developing and
commercializing innovative therapies for vascular disorders
associated with blood clots. Our development and
commercialization efforts are primarily focused on therapies for
treating ischemic stroke and massive pulmonary embolism,
respectively, by restoring the flow of blood and oxygen to the
brain and vital tissues.
We were organized as an Arizona limited liability company on
October 7, 1999, which was our date of inception for
accounting purposes. We were subsequently converted to an
Arizona corporation on January 12, 2000, and then
reincorporated as a Delaware corporation on June 23, 2000.
We have not yet generated any significant revenue from
operations and remain a development stage company. From our
inception through June 30, 2006, we accumulated a deficit
from operations of $68.5 million. We have funded our
operations to date primarily through private placements of our
preferred and common stock as well as the sale of convertible
notes and the receipt of government grants. Through
June 30, 2006, we had received net proceeds of
approximately $46.8 million from the issuance of shares of
our preferred and common stock and convertible notes.
Since our inception, we have devoted substantially all of our
efforts toward acquiring technology and potential products,
planning, conducting and funding the various stages of
development for our product candidates and researching potential
new product opportunities based upon our proprietary
technologies.
In September 2005, we acquired the technology and development
assets of Abbott Laboratories relating to two thrombolytic
product candidates, PROLYSE and
Open-Cath-R, including
data and rights under various agreements and related
applications filed with the U.S. Food and Drug
Administration, or FDA, drug substance, raw materials, cell
banks, related intellectual property and manufacturing know-how.
Although these product candidates may have significant future
importance, we determined that, since they had not yet received
FDA approval and presented no alternative future use, they did
not meet established guidelines for technological feasibility
sufficiently to be recorded as assets. As a result, the full
purchase price consideration of $24.0 million was recorded
as acquired in-process research and development expense for the
year ended December 31, 2005.
In April 2006, we also acquired from Abbott Laboratories the
assets related to Abbokinase, including the remaining inventory
of finished product, all regulatory and clinical documentation,
validated cell lines, and intellectual property rights,
including trade secrets and know-how relating to the manufacture
of urokinase using the tissue culture method. Since no
employees, equipment, manufacturing facilities or arrangements
or sales and marketing organization were included in this
transaction, we accounted for it as an acquisition of assets
rather than as an acquisition of a business, with a purchase
price of $20.0 million. The purchase price has been
allocated to the assets acquired based upon the fair value
assessments.
We expect our operating losses to increase for at least the next
several years due to increasing expenses associated with
proposed clinical trials, product development, selling, general
and administrative costs and
36
regulatory activities. We also have significant
acquisition-related financial obligations, including a
$15.0 million note that we issued in connection with our
2005 acquisition of PROLYSE,
Open-Cath-R and related
assets that matures on December 31, 2006, and an additional
$15.0 million note that we issued in connection with our
April 2006 acquisition of Abbokinase assets that matures on
December 31, 2007.
We have generated only a limited amount of revenue to date,
primarily by providing research services for projects funded
under various government grants. We anticipate that we will
begin to generate additional revenue during the second half of
2006 from sales of Abbokinase. However, any such revenue is
difficult to predict as to both timing and amount, may not be
achieved in any consistent or predictable pattern, and in any
case will not be sufficient to prevent us from incurring
continued and increasing losses from our development and other
activities.
|
|
|
Research and Development Expenses |
We classify our research and development expenses into five
categories of activity, namely, research, development, program
management, clinical and regulatory. To date, our research and
development efforts have been focused primarily on product
candidates from our bubble technology program. Historically we
have not tracked research and development expenses by product
candidate. However, with our recently acquired portfolio of
thrombolytic product candidates, in the future we intend to
separately track expenses related to activities such as
manufacturing and preclinical studies or clinical trials for
each of our primary product candidates. Beginning in September
2005, we expanded our research and development focus to include
urokinase-based thrombolytic product candidates for dissolving
blood clots. We expect our research and development expenses to
increase with the planned commencement of clinical trials for
our ischemic stroke product candidates. Clinical development
timelines, likelihood of success and associated costs are
uncertain and therefore vary widely. We anticipate that we will
make determinations as to which research and development
projects to pursue and how much funding to direct toward each
project on an ongoing basis in response to the scientific and
clinical success of each product candidate. From inception
through June 30, 2006, we have incurred approximately
$16.7 million in research and development expenses. These
were incurred primarily to develop our SonoLysis bubble
technology program. We currently estimate we will complete the
current or imminent stage of development for each primary
product candidate as follows:
|
|
|
|
|
|
For PROLYSE, we intend to establish contract manufacturing and
to commence a Phase 3 clinical trial for ischemic stroke in
2007 after, and if, we secure regulatory approvals. We estimate
these activities will cost approximately $40 million to
complete. However, we have not yet discussed this planned
clinical trial with the FDA. The outcome of our discussions with
the FDA could significantly alter the costs to complete this
stage of development of PROLYSE. We expect to allocate
approximately $12 million of the net proceeds from this
offering toward PROLYSE development. |
|
|
|
|
|
For SonoLysis combination therapy, we intend to establish
commercial-scale contract manufacturing of our SonoLysis bubbles
and conduct a Phase 1/2 clinical trial for ischemic stroke
using tPA beginning in the second half of 2006. We estimate that
these efforts will cost approximately $9 million. We intend
to allocate the costs of SonoLysis bubble manufacturing equally
between our SonoLysis therapy and our SonoLysis combination
therapy product candidates. We expect to allocate approximately
$9 million of the net proceeds from this offering toward
development of our SonoLysis combination therapy. |
|
|
|
|
|
For SonoLysis therapy, we intend to establish commercial-scale
contract manufacturing of our SonoLysis bubbles and conduct
additional preclinical studies in 2007. We estimate that these
efforts will cost approximately $4 million. We expect to
allocate approximately $4 million of the net proceeds from
this offering toward development of our SonoLysis therapy. |
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|
We intend to maintain the regulatory status of Abbokinase as an
FDA-approved product
and to investigate the feasibility and challenges of
reestablishing manufacturing of the product. We estimate that
these efforts may cost approximately $3 million through
2007, some or all of which would be funded by anticipated
Abbokinase product sales. |
37
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|
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|
The next stage of development for
Open-Cath-R is to
establish contract manufacturing and to demonstrate
comparability with the recombinant urokinase previously
manufactured by Abbott Laboratories. We estimate this effort may
cost approximately $12 million, some or all of which may be
financed through a development partner. |
In addition, we intend to further pursue research of our bubble
technology and thrombolytic programs and estimate that this
effort may cost approximately $2 million through 2007, some
or all of which may be financed through government grants or
research collaborations. Any new government grants or research
collaborations could significantly alter our total research
expense depending on the timing and amount of any such awards or
agreements. We expect to allocate an aggregate of approximately
$5 million of the net proceeds from this offering toward
expenses related to Abbokinase,
Open-Cath-R and
research projects.
At this time, due to the risks inherent in the clinical trial
process and the related regulatory process, our development
completion dates and costs vary significantly for each product
candidate and are very difficult to estimate. Furthermore, we
only recently acquired our thrombolytic product candidates, and
we are continuing to assess the related clinical and regulatory
requirements necessary to develop the product candidates. The
lengthy process of seeking regulatory approvals and the
subsequent compliance with applicable regulations require the
expenditure of substantial additional resources. Any failure by
us to obtain, or any delay in obtaining, regulatory approvals
for our product candidates could cause our research and
development expenditures to increase and, in turn, have a
material adverse effect on our results of operations. We cannot
be certain when, if ever, any cash flows from our current
product candidates will commence.
|
|
|
General and Administrative Expenses |
General and administrative expenses consist primarily of
personnel-related expenses and other costs and fees associated
with our general corporate activities, such as administrative
support, business development, intellectual property protection,
corporate compliance and preparing to become a public reporting
company, as well as a portion of our overhead expenses. We
anticipate that our selling expenses will increase as we expand
our infrastructure to support planned increases in our
development and commercialization efforts relating primarily to
the initiation of our Abbokinase selling efforts. If we are
successful in obtaining required regulatory approvals for any of
our other product candidates, we will likely incur substantial
additional sales and marketing expenses as we continue to build
our U.S. sales force and marketing capabilities. We also
anticipate incurring additional expenses of $1.5 million to
$2.0 million per year as a public company following the
completion of this offering as a result of additional legal,
accounting and corporate governance expenses, including costs
associated with tax return preparations, accounting support
services, Sarbanes-Oxley compliance expenses, filing annual and
quarterly reports with the SEC, directors fees,
directors and officers insurance, listing and
transfer agent fees, and investor relations expenses.
Critical Accounting Policies and Significant Judgments and
Estimates
Our managements discussion and analysis of our financial
condition and results of operations are based on our
consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the
U.S. The preparation of these consolidated financial
statements requires us to make estimates and assumptions that
affect the reported amounts of assets and liabilities, the
disclosed amounts of contingent assets and liabilities and our
reported revenue and expenses. Significant management judgment
is required to make estimates in relation to clinical trial
costs and costs related to public reporting company preparation.
We evaluate our estimates, and judgments related to these
estimates, on an ongoing basis. We base our estimates of the
carrying values of assets and liabilities that are not readily
apparent from other sources on historical experience and on
various other factors that we believe are reasonable under the
circumstances. Actual results may differ from these estimates
under different assumptions or conditions.
We believe that the following accounting policies are critical
to a full understanding of our reported financial results. Our
significant accounting policies are more fully described in
Note 2 of our consolidated financial statements.
38
|
|
|
Clinical Trial Accrued Expenses |
We record accruals for clinical trial costs associated with
clinical research organizations, investigators and other vendors
based upon the estimated amount of work completed on each
clinical trial. All such costs are charged to research and
development expenses based on these estimates. These estimates
may or may not match the actual services performed by the
organizations as determined by patient enrollment levels and
related activities. We monitor patient enrollment levels and
related activities to the extent possible through internal
reviews, correspondence and discussions with contract research
organizations and review of contractual terms. However, if we
have incomplete or inaccurate information, we may underestimate
or overestimate activity levels associated with various clinical
trials at a given point in time. In this event, we could record
significant research and development expenses in future periods
when the actual level of activities becomes known. To date, we
have not experienced material changes in these estimates.
|
|
|
Deferred Tax Asset Valuation Allowance |
Our estimate of the valuation allowance for deferred tax assets
requires us to make significant estimates and judgments about
our future operating results. Our ability to realize the
deferred tax assets depends on our future taxable income as well
as limitations on utilization. A deferred tax asset must be
reduced by a valuation allowance if it is more likely than not
that some portion or all of the deferred tax asset will not be
realized prior to its expiration. The projections of our
operating results on which the establishment of a valuation
allowance is based involve significant estimates regarding
future demand for our products, competitive conditions, product
development efforts, approvals of regulatory agencies and
product cost. We have recorded a full valuation allowance on our
net deferred tax assets as of December 31, 2004 and 2005
due to uncertainties related to our ability to utilize our
deferred tax assets in the foreseeable future. These deferred
tax assets primarily consist of net operating loss carryforwards
and research and development tax credits.
In the first quarter of 2006, we adopted Statement of Financial
Accounting Standards, or SFAS, No. 123R, Share-Based
Payment or SFAS 123R, which revises SFAS 123,
Accounting for Stock-Based Compensation, and supersedes
Accounting Principles Board Opinion, or APB, No. 25,
Accounting for Stock Issued to Employees. SFAS 123R
requires that share-based payment transactions with employees be
recognized in the financial statements based on their value and
recognized as compensation expense over the vesting period.
Prior to SFAS 123R, we disclosed the pro forma effects of
SFAS 123R under the minimum value method. We adopted
SFAS 123R effective January 1, 2006, prospectively for
new equity awards issued subsequent to January 1, 2006. The
adoption of SFAS 123R through June 30, 2006 has
resulted in the recognition of additional stock-based
compensation expense and a reduction in net income of
approximately $505,000 and no change in basic and diluted
earnings per share.
Under SFAS 123R we calculated the fair value of stock
option grants using the Black-Scholes option-pricing model. The
weighted average assumptions used in the Black-Scholes model
were 7 years for the expected term, 75% for the expected
volatility, 4.50% for the risk free rate and 0% for dividend
yield for the six month period ended June 30, 2006. Future
expense amounts for any particular quarterly or annual period
could be affected by changes in our assumptions or changes in
market conditions.
The weighted average expected option term for 2006 reflects the
application of the simplified method set out in SEC Staff
Accounting Bulletin No., or SAB, 107 which was issued
in March 2005. The simplified method defines the life as the
average of the contractual term of the options and the weighted
average vesting period for all option tranches.
Estimated volatility for fiscal 2006 also reflects the
application of SAB 107 interpretive guidance and,
accordingly, incorporates historical volatility of similar
public entities.
39
Prior to January 1, 2006, we accounted for employee
stock-based compensation in accordance with provisions of
APB 25 and FASB Interpretation No. 44, Accounting
for Certain Transactions Involving Stock
Compensation an Interpretation of APB
No. 25, and comply with the disclosure provisions of
SFAS 123 and related SFAS 148, Accounting for
Stock-Based Compensation Transaction and
Disclosure. Under APB 25, compensation expense is based
on the difference, if any, on the date of the grant, between the
fair value of our stock and the exercise price of the option. We
amortize deferred stock-based compensation using the
straight-line method over the vesting period.
The accounting for and disclosure of employee equity instruments
requires judgment by our management on a number of assumptions,
including the fair value of the underlying instrument, estimated
lives of the outstanding instruments, and the instruments
volatility. Changes in key assumptions will impact the valuation
of such instruments. Because there has been no public market for
our stock, our board of directors has determined the fair value
of our common stock based on several factors, including, but not
limited to, our operating and financial performance and internal
valuation analyses considering key terms and rights of the
related instruments.
Our board of directors estimated the fair value of common stock
for options granted during the two-year period prior to the
filing of this registration statement, with input from our
management, using the market approach and sales to third parties
of our common and preferred shares.
Results of Operations
|
|
|
Six Months Ended June 30, 2005 Compared to
2006 |
Grant and Other Revenue. Our revenue-producing activities
during the first six months of 2005 and 2006 consisted of
providing services under research grants and contracts. Our
revenue increased from approximately $295,000 in the first six
months of 2005 to approximately $429,000 in the first six months
of 2006, primarily due to the receipt of an additional grant.
Research and Development Expenses. Research and
development expenses increased from approximately
$1.5 million in the first six months of 2005 to
approximately $4.0 million in the first six months of 2006.
This increase is principally a result of the Companys
transition from a research organization to a clinical
development organization, thus requiring the creation of both
clinical and regulatory departments. The main components of cost
incurred during this transition were additional compensation
expenses, clinical trial costs and consulting expenses.
Specifically, this increase was due to approximately $906,000 in
increased compensation and $142,000 for recruitment and
relocation expense to support increased headcount, approximately
$375,000 in increased expenses for the initiation of a clinical
trial in stroke which began in March 2005 as well as other
ongoing clinical trials, approximately $127,000 in increased
preclinical study costs related to our Sonolysis bubble therapy
and approximately $911,000 in increased third party service
costs and other expenses.
General and Administrative Expenses. General and
administrative expenses increased from approximately
$1.5 million in the first six months of 2005 to
approximately $3.1 million in the first six months of 2006.
This increase is principally a result of our expansion of
financing and business development activities, resulting in
additional headcount and third party services. Specifically,
this increase resulted from approximately $795,000 in increased
third party service costs, principally legal and accounting
expenses related to financing matters, asset acquisitions and
matters associated with becoming a public company and
approximately $609,000 in additional compensation expense to
support increased headcount, stock-based compensation expense
including the expense under SFAS 123R and public relations
costs associated with company financings.
Interest and Other Income. Interest and other income
increased from approximately $50,000 in the first six months of
2005 to approximately $216,000 in the first six months of 2006,
as a result of a higher cash balance throughout the six months
and higher interest rates.
40
Interest Expense. Interest expense increased from
approximately $53,000 in the first six months of 2005 to
approximately $615,000 in the first six months of 2006, due to
the interest on notes payable in September 2005 and April 2006
and the early extinguishment of a note payable to a former
development partner in March 2005.
Gain on Extinguishment of Note. In March 2005, we
repurchased a note from a former development partner at a
discount. The outstanding principal and accrued interest,
totaling approximately $4.3 million, was settled in cash
for approximately $500,000, resulting in a non-recurring gain of
approximately $3.8 million.
|
|
|
Year Ended December 31, 2004 Compared to 2005 |
Grant and Other Revenue. Our revenue-producing activities
during 2004 and 2005 consisted of providing services under
research grants and contracts. Revenue increased from
approximately $575,000 in 2004 to approximately $619,000 in
2005, primarily due to an additional grant received in July 2005.
Research and Development Expenses. Research and
development expenses increased from approximately
$2.5 million in 2004 to approximately $3.6 million in
2005. This increase is principally a result of the
Companys transition from a research-focused organization
to a clinical development organization, thus requiring the
creation of both clinical and regulatory departments. The main
components of cost incurred during this transition were clinical
trial costs, consulting, compensation and cost of hiring and
increased overhead. Of the total increase, approximately
$560,000 was for the initiation of our current clinical trial in
stroke which began in March 2005, approximately $230,000
resulted from increased third party service costs, approximately
$200,000 resulted from increased compensation expense to support
increased headcount, and approximately $450,000 resulted from
increased overhead, laboratory chemicals and supplies, travel
and other expenses. An offset of approximately $360,000 was due
to timing of preclinical and manufacturing expenses.
General and Administrative Expenses. General and
administrative expenses increased from approximately
$3.2 million in 2004 to approximately $4.1 million in
2005. This increase resulted primarily from the expenditure of
approximately $610,000 in increased compensation expense to
support increased headcount, approximately $220,000 in increased
third party service costs, principally legal and accounting
expenses related to financing matters and asset acquisitions,
and approximately $69,000 in increased business development and
other expenses.
Interest and Other Income. Interest and other income
increased from approximately $29,000 in 2004 to approximately
$122,000 in 2005, as a result of higher cash balances and higher
interest rates.
Interest Expense. Interest expense increased from
approximately $469,000 in 2004 to approximately $587,000 in
2005, primarily due to the interest on the promissory note
issued in September 2005 and the early extinguishment of the
note payable to a former development partner in March 2005.
Gain on Extinguishment of Note. In April 2004, our
development partner was experiencing financial difficulty and
began auctioning portions of its investment portfolio. In March
2005, we repurchased a note from the development partner at a
discount. The outstanding principal and accrued interest,
totaling approximately $4.3 million, was settled in cash
for $500,000, resulting in a non-recurring gain of approximately
$3.8 million. No other consideration was paid in connection
with the repurchase of the note.
|
|
|
Year Ended December 31, 2003 Compared to 2004 |
Grant and Other Revenue. Our revenue producing activities
during 2003 and 2004 consisted of providing services for
research grants and contracts. Revenue increased from
approximately $224,000 in 2003 to approximately $575,000 in
2004, as a result of the newly issued grants.
Research and Development Expenses. Research and
development expenses increased from approximately
$1.9 million in 2003 to approximately $2.5 million in
2004. The increase was primarily due to the initiation of our
first clinical trial using our SonoLysis therapy in dialysis
grafts, which included approximately
41
$285,000 in increased clinical trial costs, approximately
$200,000 in increased compensation expense to support increased
headcount and approximately $175,000 in increased contract
manufacturing costs for our Sonolysis bubble therapy and offset
by a decrease of $60,000 in general laboratory supplies and
other expenses.
General and Administrative Expenses. General and
administrative expenses increased from approximately
$1.7 million in 2003 to approximately $3.2 million in
2004. The increase resulted primarily from approximately
$790,000 in increased third party service costs for the
engagement of financial advisors and investor relations
consultants pursuant to long-term financial strategies,
approximately $450,000 in increased warrant expense for
terminated services, approximately $145,000 in increased
compensation expense to support increased headcount and year-end
bonuses and approximately $100,000 in increased travel and other
expenses for development activities with potential business
partners and other potential funding sources.
Interest and Other Income. Interest and other income
increased from approximately $22,000 in 2003 to approximately
$29,000 in 2004, as a result of increased cash balances.
Interest Expense. Interest expense increased from
approximately $326,000 in 2003 to approximately $469,000 in
2004. The increase was due to the issuance of additional
convertible notes in January 2004, including a discount for the
value of warrants issued as consideration for the notes.
Liquidity and Capital Resources
We have incurred losses since our inception. At June 30,
2006 we had an accumulated deficit of $68.5 million. We
have historically financed our operations principally through
the private placement of shares of our common and preferred
stock, convertible notes and government grants. During the years
ended December 31, 2003, 2004 and 2005, the six months
ended June 30, 2005 and 2006, and the period from
October 7, 1999 (inception) to June 30, 2006, we
received net proceeds of approximately $1.8 million,
$5.0 million, $17.9 million, $5.5 million, $13.0
million and $46.7 million, respectively, from the issuance
of shares of our common and preferred stock and convertible
notes. These amounts do not include the $15.0 million
secured promissory note and $4.0 million of Series E
preferred stock that we issued as partial consideration for an
asset acquisition in September 2005 and the $15.0 million
secured promissory note that we issued to acquire Abbokinase and
related assets in April 2006.
At June 30, 2006, we had $9.8 million in cash and cash
equivalents. We intend to begin selling Abbokinase in the second
half of 2006, although the exact timing of commencement of these
efforts will depend on a number of external factors, such as our
ability to establish new sales relationships with current
wholesalers and customers for that product, inventory levels of
the wholesalers that are currently stocking the product and
other competitive and regulatory factors. Based on annualized
Intercontinental Marketing Services, or IMS, sales data, we
believe the inventory that we acquired represents approximately
a four-year supply. Based on current stability data,
approximately 75% of this inventory will expire by September
2007 with the remainder expiring at various times up to August
2009. We do not expect to sell the entire inventory we acquired
before the product expires, and we are not permitted to sell
this inventory after expiration. However, we intend to continue
the current stability program and believe we will be able to
extend the expiration dates of this inventory. If the expiration
dates of this inventory are extended we will need to re-brand
the remaining inventory because our license to use the
Abbokinase trademark does not extend beyond the current
inventory expiration dates.
We allocated the $20 million purchase price for Abbokinase
as follows:
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|
|
|
|
Asset |
|
Estimated Value | |
|
|
| |
Inventory
|
|
$ |
16.7 million |
|
Abbokinase trade name
|
|
$ |
0.5 million |
|
Other identifiable intangibles
|
|
$ |
2.8 million |
|
42
The anticipated carrying value of the inventory does not include
a reserve for excess inventory. The estimated useful life of the
Abbokinase trade name is one year, and the estimated useful life
of the other identifiable intangibles is four years. While
we intend to investigate the requirements for us to manufacture
Abbokinase, we currently have no plans to manufacture Abbokinase
in the near term. Not manufacturing Abbokinase reduces the
period of benefit to the Company to four years, which is
directly related to the years of inventory supply.
Net Cash Used in Operating Activities. Net cash used in
operating activities was approximately $3.0 million,
$4.1 million and $11.2 million for the years ended
December 31, 2003, 2004 and 2005, respectively, and
approximately $2.6 million and $9.5 million for the
six months ended June 30, 2005 and 2006, respectively. The
net cash used in each of these periods primarily reflects the
net loss for those periods, offset in part by depreciation,
amortization of warrant expense and debt discount, stock-based
compensation and changes in working capital. In 2006 net cash
used was also affected by the acquisition of Abbokinase
inventory.
Net Cash Used in Investing Activities. Net cash used in
investing activities was approximately $16,000, $65,000 and
$564,000 for the years ended December 31, 2003, 2004 and
2005, respectively, and approximately $356,000 and
$1.1 million for the six months ended June 30, 2005
and 2006, respectively. Net cash used in investing activities
primarily reflects purchases of property and equipment,
including manufacturing, information technology, laboratory and
office equipment. In 2006 net cash used was also affected by the
purchase of intangible assets related to the acquisition of
Abbokinase.
Net Cash Provided by Financing Activities. Net cash
provided by financing activities was approximately
$1.6 million, $5.0 million and $18.7 million for
the years ended December 31, 2003, 2004 and 2005,
respectively, and approximately $5.7 million and
$11.9 million for the six months ended June 30, 2005
and 2006, respectively. Net cash provided by financing
activities was primarily attributable to the issuance of
Series D preferred stock, totaling $350,000 net of
issuance costs and the issuance of convertible notes totaling
$1.4 million in 2003; the issuance of common stock totaling
$4.4 million net of issuance costs and the issuance of
convertible notes totaling $600,000 in 2004; the issuance of
common stock totaling $17.9 million net of issuance costs
and the issuance and repayment of secured promissory notes
totaling $4.0 million in 2005; and the issuance of
Series F preferred stock totaling $13.0 million net of
issuance costs in 2006.
Our cash flows for the remainder of 2006 and beyond will depend
on a variety of factors, including the anticipated revenue and
funding requirements discussed above, as well as the timing of
completion of the offering contemplated by this prospectus and
our use of offering proceeds as described under Use of
Proceeds elsewhere in this prospectus. Despite our
anticipated commencement of sales of our Abbokinase product
during the second half of 2006, we expect our net cash outflows
to continue increasing as we expand our research and
development, manufacturing, regulatory and sales and marketing
activities.
Based on our existing liquid assets, including the proceeds of
our recently concluded offering of Series F preferred
stock, we believe we have sufficient capital to fund anticipated
levels of operations, and pay our debt obligations as they come
due, until December 2006. We have received an audit report from
our independent registered public accounting firm containing an
explanatory paragraph stating that our historical recurring
losses and net capital deficiency raise substantial doubt about
our ability to continue as a going concern. We believe that the
successful completion of this offering will enable us to
continue as a going concern at least in the near term. If we are
unable to successfully complete this offering, we will need to
obtain alternative financing and modify our operational plan to
continue as a going concern.
Our funding requirements will, however, depend on numerous
factors, including:
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|
|
the timing, scope and results of our preclinical studies and
clinical trials; |
|
|
|
the timing of initiation of manufacturing for our product
candidates; |
43
|
|
|
|
|
the timing and amount of revenue from sales of Abbokinase; |
|
|
|
the timing and amount of revenue; |
|
|
|
the timing of, and the costs involved in, obtaining regulatory
approvals; |
|
|
|
our ability to establish and maintain collaborative
relationships; |
|
|
|
personnel, facilities and equipment requirements; and |
|
|
|
the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims and other patent-related
costs, including litigation costs, if any, and the result of any
such litigation. |
Until we can generate significant cash from our operations, we
expect to continue to fund our operations primarily from the
proceeds of offerings of our equity securities, including this
offering, from revenue or payments received under
collaborations, grants, and possibly from debt financing.
However, we may not be successful in obtaining additional
collaboration agreements or grants, or in receiving milestone or
royalty payments under any such agreements. If we do not
generate sufficient revenue from collaborations and grants, we
may require additional funding sooner than we currently
anticipate. We cannot be sure that our existing cash and cash
equivalents will be adequate, or that additional financing will
be available when needed, or that, if available, financing will
be obtained on terms favorable to us or our stockholders. Having
insufficient funds may require us to delay, scale back or
eliminate some or all of our research or development programs or
to relinquish greater or all rights to product candidates at an
earlier stage of development or on less favorable terms than we
would otherwise choose. Failure to obtain adequate financing may
also adversely affect our ability to operate as a going concern.
If we raise additional funds by issuing equity securities,
substantial dilution to existing stockholders will likely
result. If we raise additional funds by incurring debt
obligations, the terms of the debt will likely involve
significant cash payment obligations as well as covenants and
specific financial ratios that may restrict our ability to
operate our business.
Contractual Obligations
The following table summarizes our outstanding contractual
obligations as of December 31, 2005:
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period | |
|
|
| |
|
|
|
|
Less than | |
|
|
|
More than | |
Total |
|
Total | |
|
1 Year | |
|
1-3 Years | |
|
3-5 Years | |
|
5 Years | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Operating leases
|
|
$ |
182,546 |
|
|
$ |
64,428 |
|
|
$ |
118,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
182,546 |
|
|
$ |
64,428 |
|
|
$ |
118,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
The contractual summary above does not reflect a total of
$30.0 million of debt represented by two $15.0 million
secured promissory notes accruing interest at 6% annually and
due on December 31, 2006 and 2007, respectively.
We enter into agreements with clinical sites and contract
research organizations, or CROs, that conduct our clinical
trials. We make payments to these sites and CROs based upon the
number of patients enrolled. For the years ended
December 31, 2003, 2004 and 2005, we incurred clinical
trial expenses of approximately $49,000, $334,000 and $892,000,
and for the six months ended June 30, 2005 and 2006, we
incurred clinical trial expenses of approximately $435,000, and
$735,000, respectively. Due to the variability associated with
these agreements, we are unable to estimate with certainty the
future patient enrollment costs we will incur and therefore have
excluded these costs from the above table. We do, however,
anticipate that these costs will increase significantly in
future periods as a result of our initiation of multiple
clinical trials for ischemic stroke. We also have contractual
payment obligations that are contingent on future events. In
addition, if we or our sublicensees sell products or processes
that utilize the intellectual property we license from UNEMED
Corporation, we will be obligated pay a royalty to UNEMED of 2%
of such net sales. The UNEMED license also requires us to meet
certain regulatory and product development milestones. If we or
our sublicensees sell products or processes that utilize the
intellectual property we license from the University of
Arkansas, we will
44
be obligated to pay, in addition to a one-time fee of $25,000,
royalties to the University of Arkansas of (i) 4% of net
sales up to $1 million; (ii) 3% of net sales between
$1 million and $10 million; and (iii) 2% of net
sales greater than $10 million, subject to minimal royalty
thresholds and a maximum aggregate royalty of $20 million.
If we or our sublicensees sell products or processes that
utilize the intellectual property that we license from
Dr. Schlief, we will be obligated to pay a royalty to
Dr. Schlief of 2% of such net sales by us and 3% of any net
sales by sublicensees.
Quantitative and Qualitative Disclosure About Market Risk
Our exposure to market risk is confined to our cash and cash
equivalents. We invest in high-quality financial instruments,
primarily money market funds, which we believe are subject to
limited credit risk. We currently do not hedge interest rate
exposure. The effective duration of our portfolio is less than
three months and no security has an effective duration in excess
of three months. Due to the short-term nature of our
investments, we do not believe that we have any material
exposure to interest rate risk arising from our investments.
Most of our transactions are conducted in U.S. dollars,
although we do have some development and clinical trial
agreements with vendors located outside the
U.S. Transactions under certain of these agreements are
conducted in U.S. dollars while others occur in the local
currency. If the exchange rate were to change by ten percent, we
do not believe that it would have a material impact on our
results of operations or cash flows.
Off-Balance Sheet Transactions
At December 31, 2003, 2004 and 2005, and at June 30,
2006, we did not have any relationships with unconsolidated
entities or financial partnerships, such as entities often
referred to as structured finance or special purpose entities,
which would have been established for the purpose of
facilitating off-balance sheet arrangements or other
contractually narrow or limited purposes.
Recently Issued Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board, or
FASB, issued SFAS 153, Exchanges of Nonmonetary
Assets, which is an amendment to APB 29, Accounting
for Nonmonetary Transactions. SFAS 153 eliminates
certain differences in the guidance in APB 29 as compared
to the guidance contained in standards issued by the
International Accounting Standards Board. The amendment to
APB 29 eliminates the fair value exception for nonmonetary
exchanges of similar productive assets and replaces it with a
general exception for exchanges of nonmonetary assets that do
not have commercial substance. Such an exchange has commercial
substance if the future cash flows of the entity are expected to
change significantly as a result of the exchange. SFAS 153
is effective for nonmonetary asset exchanges occurring in
periods beginning after June 15, 2005. Management does not
expect adoption of SFAS 153 to have a material impact on
our financial statements.
In May 2005, the FASB issued SFAS 154, Accounting
Changes and Error Corrections A Replacement of APB Opinion
No. 20 and FASB Statement No. 3. SFAS 154
requires the retrospective application to prior periods
financial statements of changes in accounting principle, unless
it is impractical to determine either the period-specific
effects or cumulative effect of the accounting change.
SFAS 154 also requires that a change in depreciation,
amortization, or depletion method for long-lived non-financial
assets be accounted for as a change in accounting estimate
affected by a change in accounting principle. SFAS 154 is
effective for accounting changes and corrections of errors made
in fiscal years beginning after December 15, 2005 and we
will adopt this provision, as applicable, during 2006.
45
In November 2005, the FASB issued FASB Staff Position, or FSP,
Financial Accounting Standard, or
FAS, 115-1 and
FAS, 124-1, The
Meaning of Other-Than-Temporary Impairment and Its Application
to Certain Investments, which provides guidance on
determining when investments in certain debt and equity
securities are considered impaired, whether that impairment is
other-than-temporary, and on measuring such impairment loss.
FSP 115-1 also includes accounting considerations
subsequent to the recognition of other-than-temporary impairment
and requires certain disclosures about unrealized losses that
have not been recognized as other-than-temporary impairments. We
are required to apply FSP 115-1 to reporting periods
beginning after December 15, 2005 and to adopt
FSP 115-1 in the first quarter of fiscal 2006. We are
currently evaluating the effect that the adoption of
FSP 115-1 will have on our consolidated results of
operations and financial condition but do not expect it to have
a material impact.
46
Our Business
Overview
We are a biopharmaceutical company developing and
commercializing innovative therapies for vascular disorders
associated with blood clots. Our development and
commercialization efforts are primarily focused on therapies for
treating ischemic stroke and massive pulmonary embolism,
respectively, by restoring the flow of blood and oxygen to the
brain and vital tissues. Over eight million patients in the
U.S. are afflicted each year with these and other
complications related to blood clots, yet available treatment
options are subject to significant therapeutic limitations. For
example, the most widely used treatment for ischemic stroke can
be administered only during a narrow time window and poses a
risk of bleeding, resulting in less than 6% of ischemic stroke
patients receiving treatment. We believe our products and
clinical development programs, including two product candidates
with Phase 3 clinical trial data and one product approved
for marketing, may address significant unmet needs in these
markets.
We are pursuing two development programs as the foundation for
our products. The first program is a group of clot-dissolving
drugs, or thrombolytics, that are variants of urokinase, a
natural human protein primarily produced in the kidneys that
stimulates the bodys natural clot-dissolving processes.
The second program, SonoLysis therapy, centers on a novel
treatment that we believe breaks blood clots apart by applying
ultrasound to submicron-sized bubbles, which we call SonoLysis
bubbles. We believe these therapeutic approaches can be used
either alone or in combination to treat ischemic stroke and a
broad variety of vascular disorders associated with blood clots,
and may expand the number of patients for whom safe and
effective clot-dissolving therapies are available.
We have a broad portfolio of product candidates to treat
ischemic stroke that is aimed at expanding the number of
patients eligible for treatment. We believe our ischemic stroke
product portfolio may have advantages related to safety, time to
market, expanded window of administration, faster initiation of
treatment, speed of restoration of blood flow and the ability to
address the needs of multiple physician groups. Our ischemic
stroke product portfolio consists of:
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PROLYSE, one of our proprietary thrombolytics; |
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SonoLysis combination therapy, our SonoLysis bubbles with
ultrasound and a thrombolytic; and |
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SonoLysis therapy, our proprietary SonoLysis bubbles with
ultrasound. |
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PROLYSE is a recombinant pro-urokinase, or a pro-drug form of
urokinase that we believe, based on a number of published
third-party scientific studies, does not become active until it
reaches a blood clot, which may reduce the risk of bleeding.
Like other thrombolytics, the administration of PROLYSE involves
a risk of bleeding complications. PROLYSE has been shown in a
Phase 3 clinical trial of 180 patients conducted by
Abbott Laboratories between 1996 and 1998 to be well tolerated
and to demonstrate activity in dissolving cerebral blood clots
when administered as long as six hours after the onset of stroke
symptoms. This treatment window is twice as long as the
three-hour restriction that the U.S. Food and Drug
Administration, or FDA, has imposed on alteplase, or tPA, the
only thrombolytic approved for use in ischemic stroke patients.
In addition, we believe there is an emerging trend to use
device-based, or interventional, therapy delivered directly to
the site of the blood clot in treating ischemic stroke. We
believe PROLYSE may become the first thrombolytic approved for
intra-arterial therapy for treating ischemic stroke. We are
planning to initiate an additional Phase 3 clinical trial
evaluating PROLYSE delivered intra-arterially directly to the
site of a blood clot for ischemic stroke in 2007. We plan to
request that the FDA allow us to use the preclinical study and
clinical trial data generated by Abbott Laboratories
PROLYSE preclinical studies and clinical trials in support of
our eventual application to obtain regulatory approval for the
use of PROLYSE for ischemic stroke. We cannot be certain that
the FDA will allow us to use that data in support of further
clinical studies or our application for approval.
SonoLysis combination therapy is the combination of SonoLysis
bubbles and ultrasound in conjunction with a thrombolytic. We
believe that SonoLysis combination therapy incorporates
complementary mechanisms of action that will both reduce the
time required to dissolve a blood clot and enable a lower dose of
47
thrombolytic to be used. In addition, we believe a lower dose of
thrombolytic will reduce the risk of bleeding and extend the
current treatment window beyond that of a thrombolytic alone for
ischemic stroke patients. We have an open Investigational New
Drug application, or IND application, and we are planning to
initiate a Phase 1/2 dose-escalation clinical trial in the
second half of 2006 using our SonoLysis therapy and tPA to
expand upon the prior work of academic investigators in this
area.
SonoLysis therapy is the combination of SonoLysis bubbles and
ultrasound that we believe breaks up blood clots via a
mechanical mechanism of action. Because SonoLysis therapy does
not include a thrombolytic and its associated risk of bleeding,
we believe SonoLysis therapy may offer several advantages over
other treatments for ischemic stroke, including an extended
treatment window, rapid initiation of treatment via intravenous
administration and availability for use in patients for whom
thrombolytics are contraindicated due to risk of bleeding. We
are planning to conduct additional preclinical studies of
SonoLysis therapy in 2007.
In addition to our product candidates for ischemic stroke, we
recently acquired Abbokinase, a form of urokinase that is
marketed for the treatment of acute massive pulmonary embolism.
We intend to begin selling Abbokinase in the second half of
2006. Abbokinase sales will provide us with near-term revenue,
an opportunity to form sales relationships with vascular
physicians and acute care institutions that regularly administer
blood clot therapies and a commercialization infrastructure that
we believe can grow to support our future products.
Open-Cath-R, another form of urokinase we acquired in 2005, has
been shown in two Phase 3 multinational clinical trials
conducted by Abbott Laboratories prior to 2003 to be well
tolerated and active as a treatment for clearing blocked
intravascular catheters. We are investigating the remaining
regulatory and manufacturing requirements and the opportunity to
license Open-Cath-R to a third party. We cannot be certain that
the FDA will allow us to use the data generated by Abbott
Laboratories clinical trials in support of our application
to obtain regulatory approval of Open-Cath-R.
We acquired PROLYSE,
Open-Cath-R and
Abbokinase from Abbott Laboratories. In connection with these
acquisitions, we issued a $15.0 million promissory note
that matures in December 2006 and another $15.0 million
promissory note that matures in December 2007. If we are unable
to satisfy these debt obligations when due, Abbott Laboratories
will have a right to reclaim the assets and our rights relating
to PROLYSE, and
Open-Cath-R in the case
of the December 2006 promissory note, and Abbokinase, including
a portion of the cash from our sales of Abbokinase in the case
of the December 2007 promissory note.
The following table summarizes our product candidates and their
current development status:
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Product |
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Indication |
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Candidate |
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Product Elements |
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Development Status |
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Ischemic Stroke |
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PROLYSE |
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Recombinant pro-urokinase |
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Completed one Phase 3 clinical trial |
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SonoLysis combination therapy |
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SonoLysis bubbles, ultrasound and a thrombolytic |
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Investigational New Drug application open for
Phase 1/2 dose escalation clinical trial expected to begin
second half of 2006 |
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SonoLysis therapy |
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SonoLysis bubbles and ultrasound |
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Preclinical |
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Acute Massive Pulmonary Embolism |
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Abbokinase |
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Tissue-culture urokinase |
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Approved for marketing |
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Catheter Clearance |
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Open-Cath-R |
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Recombinant urokinase |
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Completed two Phase 3 clinical trials |
|
48
Business Strategy
Our goal is to become the leading provider of innovative
therapies for vascular disorders associated with blood clots.
The key elements of our business strategy are to:
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Expand the number of patients eligible for treatment by
developing and commercializing our portfolio of ischemic stroke
product candidates. We are focused on further developing our
ischemic stroke product portfolio that includes PROLYSE,
SonoLysis combination therapy and SonoLysis therapy. We believe
these product candidates may address significant unmet medical
needs and expand the number of patients eligible for treatment.
We believe our product candidates may lengthen the treatment
window beyond three hours, treat patients contraindicated for
thrombolytic therapy, shorten the time required to restore blood
flow and provide both interventional and intravenous treatment
options. |
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Capitalize on near-term revenue opportunities and develop an
initial commercial infrastructure. In the second half of
2006, we intend to begin selling Abbokinase. We are also
clarifying the regulatory and manufacturing requirements and
investigating possible licensing opportunities related to
Open-Cath-R. We believe that these late-stage product
opportunities will provide us with a source of revenue that will
help fund our development programs and allow us to broaden our
domestic sales and marketing efforts. If we are successful in
obtaining FDA approval to commercialize our portfolio of
ischemic stroke product candidates, we plan to build on the
sales relationships that we form with vascular physicians and
acute care institutions through our Abbokinase sales and
marketing program. |
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Leverage our product candidates to address additional
vascular indications. We intend to explore using our core
thrombolytic and SonoLysis bubble product candidates in other
potential indications. We believe PROLYSE may be well suited for
intravenous administration as a treatment for sub-massive
pulmonary embolism. In addition, we plan to explore further
developing Abbokinase or Open-Cath-R for the prevention of
catheter occlusion. For example, Abbokinase demonstrated
activity in a Phase 3 clinical trial in preventing catheter
occlusions as compared to heparin. In addition, we believe that
opportunities exist for the expansion of our SonoLysis
combination therapy for the treatment of myocardial infarction,
peripheral arterial occlusion and deep vein thrombosis. |
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Expand the use of our bubble technology to create a deep
pipeline with broad therapeutic applications. We believe
that our bubble technology could be adapted, by changing the
composition and size of the bubbles, to a variety of
applications that involve the delivery of gases such as oxygen,
drugs or genetic materials, either systemically or to targeted
sites in the body. We have conducted preclinical studies
relating to the delivery of oxygen using a proprietary bubble
formulation that we call
NanO2.
We intend to further investigate the potential use of our
NanO2
as an oxygen-delivery agent to help preserve tissues that are at
risk due to blood clots in ischemic stroke, myocardial
infarction and other ischemic indications. Separately, we are
researching other classes of bubbles that could be used to
deliver drugs to targeted cells and remove vulnerable plaque.
Further, these various classes of bubbles may be applicable in
neurovascular and oncology indications, as well as additional
cardiovascular disorders. |
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Industry Background
The formation of a blood clot is a natural process by which
blood thickens and coagulates into a mass of blood cells,
platelets and strands of fibrin. Thrombosis occurs when a blood
clot, or thrombus, begins to block a blood vessel. An embolism
occurs if all or part of the thrombus breaks away and lodges in
another part of the body. Formation of a clot is the bodys
primary mechanism for obstructing blood flow and curtailing
bleeding from wounds or other injuries to blood vessels. When a
blood clot blocks normal blood flow within the body, it can have
a variety of undesirable effects, such as causing pain and
swelling, tissue damage, stroke or even death. Blood clots can
also arise in connection with surgical and other medical
procedures, such as catheter-based administration of dialysis or
other treatments, which can lead to clotting around the site of
an incision or within a penetrated blood vessel.
We are initially targeting three segments of the thrombosis
market in which safe and rapid removal of blood clots is
essential for patient care, including ischemic stroke, pulmonary
embolism and catheter occlusion.
49
Ischemic Stroke
When blood clots block arteries that supply blood to the brain,
they reduce the oxygen supply to brain tissues, a condition
known as cerebral ischemia which can gradually degrade the
oxygen-deprived tissues and result in long-term impairment of
brain functions. More than 600,000 people each year in the
U.S. have an ischemic stroke. Stroke is the third leading
cause of death and the leading cause of serious long-term
disability in the U.S., according to the American Stroke
Association. Approximately 80% of U.S. ischemic stroke
patients reach an emergency room within 24 hours after the onset
of stroke symptoms, according to Datamonitor. In contrast, only
approximately 23% of U.S. ischemic stroke patients reach an
emergency room within the FDA-mandated three-hour time window
for treatment with the currently approved thrombolytic,
according to Datamonitor. However, due to the three-hour
treatment window and other limitations, according to Datamonitor
only 1.6% to 2.7% of patients with ischemic stroke treated in
community hospitals and 4.1% to 6.3% treated in academic
hospitals or specialized stroke centers currently are treated
with a thrombolytic.
Interventional therapy administering a drug with a catheter,
also commonly referred to as intra-arterial therapy, is an
emerging trend in ischemic stroke therapy. Interventional
therapy requires specialized facilities and trained personnel
that enables localized treatment at the site of the clot. The
only currently approved ischemic stroke therapy using a
thrombolytic includes intravenous therapy, which can be
initiated more quickly, such as in the emergency room, but it is
not a therapeutic approach targeted directly to the site of the
blood clot.
Pulmonary Embolism
Blood clots that lodge in the lungs are called pulmonary emboli
and occur in approximately 600,000 people in the U.S. every
year. A portion of these are classified as massive pulmonary
emboli, meaning the obstruction of blood flow to a lobe or
multiple segments which result in nearly 60,000 deaths in the
U.S. annually. Massive pulmonary emboli must be treated
quickly, as most of these deaths occur within 30 to 60 minutes
after the onset of symptoms.
Catheter Occlusion
The formation of a blood clot within or around an indwelling
vascular catheter can cause a condition known as catheter
occlusion. Over five million intravascular catheters are
placed in patients, and approximately 750,000 of those become
occluded by blood clots, in the U.S. annually.
Existing Blood Clot
Therapies and Their Limitations
Different treatments currently exist for the prevention and
treatment of blood clots. Aspirin and other anti-platelets as
well as heparin and other anticoagulants are commonly used to
prevent or reduce the incidence of blood clots, but have no
effect in eliminating such blood clots once they have formed. We
focus on the treatment of blood clots once they have formed.
Currently available therapeutic approaches for dissolving or
otherwise eradicating blood clots before they cause serious
medical consequences or death fall into two categories:
clot-dissolving drugs, or thrombolytics, and mechanical devices
and procedures.
Thrombolytics dissolve blood clots by breaking up fibrin, the
protein that provides the structural scaffold of blood clots.
The most widely used thrombolytic today is a form of tissue
plasminogen activator, commonly referred to as tPA. tPA is
marketed in several different formulations that are approved for
a variety of specific vascular disorders, such as: alteplase for
acute ischemic stroke, acute massive pulmonary embolism, central
venous catheter clearance and acute myocardial infarction; and
reteplase and tenecteplase for acute myocardial infarction.
Other thrombolytic agents include urokinase, or Abbokinase,
which is approved for treatment of acute massive pulmonary
embolism; and streptokinase, which is approved for treatment of
acute massive pulmonary embolism, acute myocardial infarction
and deep vein thrombosis. Worldwide annual sales of
thrombolytics are approximately $500 million.
50
Thrombolytics involve a variety of identified risks and
potential side effects that can limit their usefulness:
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Risk of Bleeding Thrombolytics dissolve blood
clots, including those formed naturally as a protective response
to vessel injury, which can result in bleeding. The risk of
bleeding increases relative to the dosage and duration of
treatment and differs among the various thrombolytics. Patients
who are already taking other medications to prevent formation of
clots, such as anticoagulants or antiplatelets, also may not be
good candidates for the use of thrombolytics, due to the
increased difficulty of controlling bleeding. As such,
thrombolytics approved by the FDA are subject to strict
limitations on when, how long and in what dosages they can be
administered. |
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Time Window for Administration Due to the risk of
bleeding, which increases over time, tPA is only approved for
administration to ischemic stroke patients within three hours
after the onset of stroke symptoms. This three- hour window is
considered to be one of the primary limiting factors in treating
ischemic stroke. Approximately 23% of ischemic stroke patients
in the U.S. recognize their symptoms and reach an emergency
room within the three-hour window, however, due to this and
other limitations, only between 10.4% to 18.8% of these patients
ultimately receive treatment with a thrombolytic. |
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Possible Immune Response Some patients experience
an immune response due to the continued administration of
thrombolytics. For example, thrombolytics that are based on
non-human biological material, such as streptokinase, which is
produced using streptococcus bacteria, may stimulate such an
immune reaction. |
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Mechanical Devices and Procedures |
There are several mechanical means for removing or destroying
blood clots. Thrombectomy, or surgical clot removal, is used to
treat patients with occluded dialysis grafts or some clots in
the peripheral vascular system. These procedures are invasive
and entail delays, costs and risks that accompany any major
surgery. Although these procedures are less suitable for
removing blood clots from the brain, there are devices approved
for these procedures.
In addition, there are some mechanical devices that can be
introduced through a catheter-based delivery system to
mechanically break up a blood clot, or to ensnare and retract a
clot through the vascular system and out of the body. These
mechanical devices are generally not found outside of major
medical centers, as they require a catheter laboratory and
skilled personnel to administer the therapy. While they do not
cause the same bleeding risk as thrombolytics, these mechanical
interventions pose some risk of damaging other tissues during
treatment, as well as a risk of breaking off a piece of the clot
that can itself become the cause of a stroke or embolism in some
other part of the body.
Our Development Programs and Product Candidates
We are pursuing two development programs as our foundation for
treatments of vascular disorders associated with blood clots:
our urokinase-based thrombolytics and our proprietary bubble
technology.
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Urokinase-based Thrombolytic Programs |
Our thrombolytic product and product candidates are based on
urokinase, a natural human protein primarily produced in the
kidneys that stimulates the bodys natural clot-dissolving
processes. Urokinase breaks up blood clots by converting
plasminogen, the inactive precursor, into the enzyme plasmin,
which in turn degrades fibrin protein strands that are essential
to the structural integrity of a clot. We have acquired three
different proprietary forms of urokinase-based drugs from Abbott
Laboratories: recombinant pro-urokinase (PROLYSE), which is in
development for the treatment of patients with ischemic stroke;
tissue culture urokinase (Abbokinase), which is approved for the
treatment of acute massive pulmonary embolism; and recombinant
urokinase (Open-Cath-R), which is in development for the
treatment of patients with catheter occlusions. A pro-drug is an
inactive compound or molecule that is converted in the body to
an active drug either by spontaneous chemical reactions or
enzymatic processes. As a pro-drug, PROLYSE is an inactive form
of urokinase that we believe converts to its active form only
after it has reached a blood clot. Once
51
activated by coming into contact with the blood clot, PROLYSE
works in the same manner as other forms of urokinase to dissolve
the clot. Recombinant urokinase is substantially equivalent in
overall structure and function to tissue culture urokinase, but
is manufactured using a recombinant technology, meaning that it
is genetically engineered rather than derived from a human
tissue culture process.
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Bubble Technology Program |
Our proprietary bubbles are biocompatible spheres of varying
size and composition that we believe could be injected into the
bloodstream to treat a variety of vascular disorders and other
therapeutic applications. We believe our bubble technology could
be adapted, by changing their composition and size, for a
variety of applications that involve the delivery of gases such
as oxygen, drugs or genetic materials, either systemically or to
selected sites in the body. Certain bubbles, such as those used
to break up clots or as a drug delivery technology, are
energized by ultrasound. Conversely, other bubbles may not
require an energy source and could be used to deliver oxygen or
drugs. Our current focus is on the development of our
proprietary SonoLysis bubbles to dissolve blood clots in
combination with ultrasound.
Our scientific team invented the bubble technology that became
Definity®,
a microbubble product that has been administered safely as a
diagnostic ultrasound contrast agent since it received
regulatory approval in 2001. Our proprietary SonoLysis bubbles
are similar in composition to Definity microbubbles, which we
believe may improve the prospects for acceptance of our
SonoLysis bubbles by physicians, regulators, health care
providers and third-party payors. We have designed our SonoLysis
bubbles with a proprietary formulation for use as a therapeutic
agent. We believe the small size of our SonoLysis bubbles allows
them to penetrate and disperse within a blood clot, so that
their cavitation will break the clot into very small particles,
which we believe reduces the risk that an embolism may occur
downstream from the original blood clot. In addition, we have
developed a proprietary SonoLysis bubble manufacturing process
that we believe enables us to reliably and cost-effectively
create sterile and stable sub-micron sized bubbles from a
suspension of lipid nanoparticles. We believe our manufacturing
know-how enables us to create bubble product candidates having
unique and useful characteristics such as a defined size
distribution, increased functionality and
batch-to-batch
consistency.
Our Product Candidates for Treatment of Ischemic Stroke
PROLYSE is recombinant pro-urokinase that we are developing for
the treatment of ischemic stroke. We acquired PROLYSE from
Abbott Laboratories in September 2005.
Following four Phase 1 clinical trials between 1990 and
1995 in which Abbott Laboratories studied the safety of PROLYSE,
Abbott Laboratories evaluated PROLYSE delivered intra-arterially
to treat ischemic stroke in two clinical trials between 1994 and
1998, involving a total of 220 patients, including a
randomized 180-patient
Phase 3 clinical trial. The first clinical trial, known as
the PROACT trial, was a randomized, double-blind Phase 2
clinical trial in 40 patients that evaluated the safety and
recanalization efficacy, or restored blood flow, of PROLYSE
versus placebo administered within six hours of onset of stroke
symptoms. This clinical trial evaluated patients with ischemic
stroke caused by a middle cerebral artery occlusion, the most
frequent site of arterial occlusion in patients with severe
stroke presenting within six hours. The median time from onset
of symptoms to treatment was 5.5 hours in this clinical
trial. Of the 40 patients, 26 received PROLYSE plus
heparin, a widely used anticoagulant, and the control group of
14 received heparin only. The primary efficacy endpoint was the
percentage of patients who had partial or complete
recanalization of the blocked artery two hours after receiving
treatment. The trial showed that 57% of the patients who
received PROLYSE plus heparin had partial or complete
recanalization after two hours, compared to 14% of the patients
who received heparin alone. This difference was statistically
significant, with a p-value of 0.017. A
p-value measures
the likelihood that a difference between the investigational and
control groups is due to random chance. A
p-value of less than or
equal to 0.05 means the likelihood that the difference is due to
52
random chance is less than 5.0%, and is a commonly accepted
threshold for denoting a meaningful difference between
investigational and control groups. The primary measure of
safety was intracranial hemorrhage with clinical deterioration,
which occurred in 15% of PROLYSE patients and 7% of placebo
patients. Although the participating investigators concluded
that symptomatic hemorrhage was a concern, there was not a
statistically significant difference between patients treated
with PROLYSE and placebo patients with a p-value of 0.64. Both
recanalization and hemorrhage frequencies were influenced by
heparin dose.
The second clinical trial, known as the PROACT II trial,
was conducted by Abbott Laboratories between 1996 and 1998. The
PROACT II trial was a randomized Phase 3 clinical
trial in 180 patients that evaluated the clinical efficacy
and safety of PROLYSE versus heparin administered within six
hours of onset of stroke symptoms. This clinical trial evaluated
patients with ischemic stroke caused by a middle cerebral artery
occlusion. Of the 180 patients, 121 received PROLYSE plus
heparin and the control group of 59 patients received
heparin only. In each case the heparin was administered
intravenously. The median time from onset of symptoms to
treatment was 5.3 hours in this clinical trial. The primary
clinical efficacy endpoint was an assessment at 90 days of
patients modified Rankin score, a clinically-accepted test
for assessing neurological functioning in stroke patients,
wherein a score of two or less signifies slight or no
neurological disability. Of the patients who received PROLYSE
plus heparin, 40% had a modified Rankin score of two or less at
the 90-day follow up,
compared to 25% of the patients in the control group. This
difference was statistically significant, with a p-value of 0.04.
Secondary outcomes measured in the PROACT II trial included
recanalization, the frequency of intracranial hemorrhage with
neurological deterioration and mortality. Of the patients who
received PROLYSE plus heparin, 66% had partial or complete
recanalization after two hours, compared to 18% of the patients
who received heparin alone. This difference was statistically
significant, with a p-value of less than 0.001. Of the patients
treated with PROLYSE in the PROACT II trial, 10%
experienced intracranial hemorrhage with clinical deterioration
within 24 hours following treatment, as compared to 2% of
the control group, with a p-value of 0.06. We believe the rate
of hemorrhage seen with PROLYSE may be due to the severe nature
of the strokes in the PROACT II trial patients, with a
median baseline NIH Stroke Scale, or NIHSS, score of 17. NIHSS
is a scale used to determine the level of disability of a
patient following a stroke, ranging from 0 to 22+, with a score
of 2 or less indicating minimal neurological deficit, and a
score of 20 or more indicating severe neurological deficit. Two
other secondary outcomes measured in the PROACT II trial
did not show statistically significant differences between the
investigational and control groups. The first of these is the
ability of patients to live at home without assistance at
90 days after treatment, or the Barthel index. The second
of these measured patients degree of neurological damage
based on the NIHSS. Mortality was 25% for the PROLYSE group and
27% for the control group. This difference was not statistically
significant, with a p-value of 0.80. However, the PROACT II
trial demonstrated that ischemic stroke patients treated with
PROLYSE plus heparin within six hours of the onset of stroke
symptoms had a statistically significantly higher probability of
avoiding moderate or severe neurological disabilities after
90 days when compared with patients treated with only
heparin. The participating investigators concluded that the
PROACT II trial has demonstrated the therapeutic window for
a significant number of patients with major ischemic stroke may
extend to at least six hours. We intend to use the results
of the PROACT II trial to conduct additional trials
refining patient selection, with a goal of reducing the risk of
hemorrhage, optimizing delivery techniques and combining
treatment strategies to build on these results.
53
The following table illustrates the results of the PROACT and
PROACT II clinical trials:
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Total | |
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Patients | |
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Patients | |
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Patients | |
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Randomized | |
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Randomized | |
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in | |
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to | |
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to | |
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Clinical | |
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PROLYSE | |
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Heparin | |
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PROLYSE | |
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Clinical Trial | |
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Trial | |
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+ Heparin | |
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(control) | |
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Primary and Selected Secondary Endpoints |
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Therapy | |
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Control | |
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P-value | |
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| |
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PROACT |
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40 |
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26 |
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14 |
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Recanalization (%) at
2 hours(1) |
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57% |
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|
14 |
% |
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|
0.017 |
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Intracranial Hemorrhage (%) at 24 hours
(1) |
|
|
15% |
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|
7 |
% |
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|
0.64 |
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PROACT II |
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|
180 |
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|
121 |
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|
59 |
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Modified Rankin Score£ 2 at
90 days
(1) |
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40% |
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25 |
% |
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0.04 |
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Recanalization (%) at
2 hours(2) |
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66% |
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|
18 |
% |
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0.001 |
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Intracranial Hemorrhage (%) at 24 hours
(3) |
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10% |
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2 |
% |
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0.06 |
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Mortality at 90 days |
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25% |
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27 |
% |
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0.80 |
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Barthel Index³
90 at 90 days |
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41% |
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32 |
% |
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0.24 |
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NIHSS Score£
1 at 90 days |
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18% |
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12 |
% |
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0.30 |
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(1) |
Primary endpoints |
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(2) |
Per protocol analysis: n = 108 (treated), 50 (control) |
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(3) |
Per protocol analysis: n = 108 (treated), 54 (control) |
|
Including the PROACT and PROACT II trials, PROLYSE has been
studied in eight clinical trials where 480 patients with
acute ischemic stoke, peripheral arterial occlusion, acute
myocardial infarction or occluded dialysis access grafts were
treated. Safety data for thrombolytics are generally broken into
two categories, bleeding complications and non-hemorrhagic
adverse events. PROLYSE has been shown to have bleeding
complications similar to other thrombolytics, including
superficial or surface bleeding, observed mainly at invaded or
disturbed sites, as well as internal bleeding, involving the
gastrointestinal tract, genital/urinary tract, or intramuscular,
retroperitoneal, or intracranial sites. A wide array of
treatment-emergent non-hemorrhagic adverse events were noted in
PROLYSE subjects, including back pain, injection site
hemorrhage, fever, injection site pain, peripheral vascular
disorder and anemia. Some of these treatment-related effects
were also seen in control subjects and may not have been related
to treatment with PROLYSE. At the request of Abbott
Laboratories, in August 2003 the FDA placed the IND application
for PROLYSE in the FDAs inactive files, and all clinical
investigations of PROLYSE ceased.
We believe that PROLYSE may be less likely than other marketed
thrombolytics to cause bleeding as it circulates through the
bloodstream, because it is an inactive form of urokinase that we
believe becomes active only after it comes into contact with a
blood clot. Because of its pro-drug nature, we also believe that
PROLYSE may be safely administered within a longer window of
time after an ischemic stroke. The PROACT II clinical trial
demonstrated that ischemic stroke patients treated with PROLYSE
in conjunction with an anticoagulant within six hours of the
onset of stroke symptoms had a statistically significant higher
probability of avoiding moderate or severe neurological
disabilities after 90 days when compared with patients
treated with only the anticoagulant. This six-hour treatment
window is twice as long as the three-hour label claim permitted
for tPA, the only thrombolytic currently approved by the FDA for
treatment of ischemic stroke. This three-hour window is
considered to be one of the primary limiting factors in
currently available treatments for acute ischemic stroke.
According to Datamonitor, approximately 47% of
U.S. ischemic stroke patients reach an emergency room
within six hours after onset of symptoms. We believe there is a
significant unmet need for safe and effective therapies that can
be used in an extended window of administration. We believe
PROLYSE may become the first thrombolytic approved for
intra-arterial therapy for treating ischemic stroke during a
treatment window longer than three hours after the onset of
symptoms.
54
|
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|
Planned Clinical Development |
We believe that the FDA will require at least a second
Phase 3 clinical trial to be conducted to confirm the
safety and efficacy of PROLYSE in improving clinical outcomes in
ischemic stroke patients. We are planning to initiate an
additional Phase 3 clinical trial using PROLYSE for
ischemic stroke in 2007. The FDA has been notified of our
acquisition of PROLYSE. We plan to request that the FDA allow us
to use the preclinical testing and clinical trial data generated
by Abbott Laboratories PROLYSE clinical trials in support
of our eventual application to obtain regulatory approval for
the use of PROLYSE for ischemic stroke. The PROLYSE clinical
trials were conducted with drug substance produced by Abbott
Laboratories at its manufacturing facility using Abbott
Laboratories original manufacturing process. We intend to
manufacture PROLYSE at a different facility through a contract
manufacturer. In addition, we intend to improve the
manufacturing process for PROLYSE and update it to more current
good manufacturing practices. To use the preclinical study and
clinical trial data generated by Abbott Laboratories in support
of our applications for regulatory approval, we will be required
to show that the drug substance produced by our contract
manufacturer using our improved manufacturing process is
comparable to the drug substance produced previously by Abbott
Laboratories. We cannot be certain that we will be able to show
that the drug substance we produce is comparable to the drug
substance used in prior tests and clinical trials, and, as a
result, we cannot be certain that the FDA will allow us to use
that preclinical testing and clinical trial data in support of
further clinical studies or our application for approval.
|
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SonoLysis Combination Therapy |
We plan to combine our SonoLysis therapy and a thrombolytic for
the treatment of ischemic stroke. We believe that, due to their
complementary mechanisms of action, a combination treatment
using our SonoLysis therapy and a thrombolytic may shorten the
time required to dissolve a blood clot, enable a lower dose of
thrombolytic to be used, reduce the risk of bleeding and extend
the treatment window for ischemic stroke patients.
An independent academic investigator has conducted a clinical
trial to evaluate the effects of administering diagnostic
microbubbles (not our SonoLysis bubbles) on the speed and degree
of cerebral artery recanalization in combination with a
thrombolytic and ultrasound. That clinical trial involved
111 patients with acute ischemic stroke who presented
within three hours after onset of symptoms. Of the patients in
the clinical trial, 38 patients were treated with
ultrasound and microbubbles administered after administration of
tPA. The results of the clinical trial indicated that the rate
of complete recanalization after two hours in the patients who
received tPA, ultrasound and microbubbles was significantly
higher, at 54.5%, than the 40.8% rate in patients who received
tPA and ultrasound only, or the 23.9% rate in patients who
received tPA alone. These differences were statistically
significant, with a
p-value of 0.038.
The data from other investigators provides proof of concept data
to support initiation of a Phase 1/2 clinical trial using
SonoLysis bubbles and ultrasound in combination with tPA that we
plan to initiate in the second half of 2006.
We believe that the synergistic combination of the mechanical
action of SonoLysis therapy, together with the enzymatic
activity of a thrombolytic will both reduce the time required to
dissolve a blood clot and restore blood flow more quickly as
well as enable a lower dose of thrombolytic to be used than
would be needed for administration of a thrombolytic alone. In
addition, we believe a lower dose of thrombolytic will reduce
the risk of bleeding and extend the treatment window beyond that
of thrombolytic therapy alone for ischemic stroke patients. We
believe that our combination therapy may have an improved safety
profile that may support a window for treatment of ischemic
stroke patients beyond the three-hour window applicable to the
currently approved product. In addition, we believe our
combination therapy may be suitable for intravenous
administration of both SonoLysis bubbles and a thrombolytic. We
believe our combination therapy could
55
potentially make treatment available to many ischemic stroke
patients for whom thrombolytic therapy would not otherwise be
available.
|
|
|
Planned Clinical Development |
We plan to initiate a Phase 1/2 dose-escalation clinical
trial that will employ our proprietary SonoLysis bubbles,
ultrasound and tPA in the second half of 2006.
SonoLysis therapy is the combination of Sonolysis bubbles and
ultrasound that we believe breaks up blood clots by means of
mechanical action resulting from the application of ultrasound
to our proprietary SonoLysis bubbles. To administer this
therapy, SonoLysis bubbles are injected intravenously into the
bloodstream, dispersed naturally throughout the body and are
carried to the site of the blood clot. Our SonoLysis bubbles,
predominantly submicron in size, are composed of a lipid shell
and an inert biocompatible gas. We believe that the small size
of our SonoLysis bubbles enables them to penetrate into the
clot. Ultrasound is then administered to the site of the blood
clot, and the energy from the ultrasound causes the SonoLysis
bubbles to expand and contract vigorously, or cavitate, and then
collapse, we believe mechanically breaking up the blood clot.
The gas released by the SonoLysis bubbles is then cleared from
the body by exhaling, and the lipid shell is processed like
other fats in the body. We believe that the ability of our
proprietary SonoLysis bubbles to penetrate and break up blood
clots, and their activity, whether administered with or without
a thrombolytic, will make them suitable for use in the treatment
of ischemic stroke patients with limited treatment options.
We believe SonoLysis therapy represents a new approach to the
treatment of ischemic stroke. Recent studies have shown that
nearly 25% of ischemic stroke victims still have at-risk but
viable brain tissue as long as 24 hours after onset of
stroke symptoms. We believe that SonoLysis therapy breaks up
blood clots through a mechanical mechanism of action. Because
SonoLysis therapy does not include a thrombolytic and its
associated risk of bleeding, we believe SonoLysis therapy may
offer several advantages over other treatments for ischemic
stroke, including an extended treatment window, rapid initiation
of treatment through intravenous administration and availability
for use in patients for whom thrombolytics are contraindicated
due to risk of bleeding. This unique treatment approach could
enable us to offer an effective therapy to stroke patients with
fewer risks and restrictions, such as bleeding and narrow time
window for application, than those associated with thrombolytic
drugs, thus potentially affording a treatment option to more
patients than can be treated with thrombolytics today.
Furthermore, since SonoLysis bubbles can be administered
intravenously, the treatment does not require a catheter
laboratory or personnel with highly specialized skills to
administer the therapy. In addition to these therapeutic and
administration advantages, we believe that the competitive
position of SonoLysis therapy will be aided by our broad
portfolio of issued patents, patent applications and exclusive
licenses relating to the use of bubbles and ultrasound for
treatment of blood clots in various parts of the body.
|
|
|
Planned Clinical Development |
We have not yet conducted any clinical trials using our
proprietary SonoLysis bubbles with ultrasound to treat blood
clot indications. However, we conducted a
23-patient proof of
concept clinical trial that applied ultrasound to Definity
microbubbles as a means for breaking up blood clots in
thrombosed dialysis grafts. This clinical trial demonstrated
improved restoration of blood flow based on imaging. There was
one adverse event reported, involving moderate bleeding and
oozing at an unspecified site, that may have been related to the
treatment. All other adverse events were determined to be
unrelated to the treatment. Based on our research to date, we
intend to develop SonoLysis therapy as a stand-alone therapy for
ischemic stroke patients, including those for whom treatment
with thrombolytics may be contraindicated. SonoLysis therapy has
been designated as a combination product for review as both a
drug and a device by the FDA, and has been assigned to the
Center for Devices and Radiological Health as the lead center
for review. We intend to conduct additional preclinical studies
of SonoLysis therapy in 2007.
56
Our Product for Treatment of Massive Pulmonary Embolism
Abbokinase is the tissue culture form of urokinase that is
currently approved by the FDA for treating acute massive
pulmonary embolism. Abbokinase has been used in more than four
million patients in a variety of peripheral vascular disorders,
which has established its reputation as a safe and effective
thrombolytic therapy. Abbokinase is currently on formulary and
approved for dispensing at approximately 400 U.S. hospital
pharmacies.
Prior to 1998, Abbokinase was approved by the FDA for catheter
occlusion clearance, acute massive pulmonary embolism and acute
myocardial infarction. The product was withdrawn from the market
in 1998 due to concerns over the manufacturing process,
including failure to screen donors and test materials for
infectious disease, and inadequate storage and handling of
materials to prevent contamination with infectious agents. After
revising its manufacturing processes to the FDAs
satisfaction, in 2002 Abbott Laboratories obtained FDA approval
to resume commercial sales of Abbokinase for use in treating
acute massive pulmonary embolism, but then halted its sales and
marketing effort in 2004 when it decided to divest its
thrombolytic assets. Based upon generally recognized industry
sales measures, known as IMS data, sales of Abbokinase to end
user customers since the products relaunch were
approximately $4 million, $27 million,
$33 million and $19 million in 2002, 2003, 2004 and
2005, respectively. IMS reports show Abbokinase sales of
approximately $1 million per month for each of the nine
months ending March 2006. In our acquisition of Abbokinase in
April 2006, we purchased substantially the entire inventory of
Abbokinase in existence (except for that previously sold to and
held by wholesalers and end user customers), and we will be the
only company selling the product into the distribution network
when we initiate our commercial efforts in the second half of
2006.
We acquired Abbokinase and related assets from Abbott
Laboratories, including the remaining inventory of finished
product, all regulatory and clinical documentation, validated
cell lines, and intellectual property rights, including trade
secrets and know-how relating to the manufacture of urokinase
using the tissue culture method. There are no patent rights
associated with Abbokinase, and our right to use the Abbokinase
trademark does not extend to additional product that we could
manufacture in the future. We believe the Abbokinase inventory
of 153,000 vials we acquired represents an estimated four-year
supply based on annualized IMS data, although the expiration
dates for the inventory based on available stability data range
from July 2007 to August 2009. Based on current stability data,
approximately 75% of these vials will expire by September 2007
and the remainder will expire by August 2009. We do not expect
that we will be able to sell all of this inventory prior to the
current expiration dates. However, we intend to continue the
current stability program to seek to extend the expiration dates
of this inventory. If the expiration dates of this inventory are
extended, we will need to re-brand the remaining inventory
because our license to use the Abbokinase trademark does not
extend beyond the current inventory expiration dates. We intend
to begin selling Abbokinase in the second half of 2006. We
believe that Abbokinase sales will provide us with a source of
near-term revenue, an opportunity to form sales relationships
with vascular physicians and acute care institutions that
regularly administer blood clot therapies and a
commercialization infrastructure for our future products.
To sell Abbokinase for the treatment of acute massive pulmonary
embolism, we are required to continue an ongoing 200-patient
immunogenicity clinical trial that commenced in 2003. The
purpose of this trial is to evaluate the rate and severity of
immune response in patients who are treated with Abbokinase.
Since the original approval of Abbokinase, the FDA has changed
its requirements for approval of biologic agents and now
requires the sponsor to demonstrate in clinical trials that the
biologic product does not induce an immune, or allergic,
response in the patients treated. This is now one of the routine
safety evaluations for all biologic agents. Abbokinase is a
biologic agent and, although its original approval pre-dated
this requirement, the FDA required this study to be done as a
condition of
re-approval. We can
market and sell the product
57
while this trial progresses. As of June 30, 2006,
approximately 65 of a targeted 200 subjects had been
enrolled in the clinical trial.
Our Product Candidate for Treatment of Catheter Occlusions
In 2005, we acquired the rights to a recombinant form of
urokinase known as
Open-Cath-R, which
Abbott Laboratories tested as a therapy for dissolving central
venous catheter occlusions.
Between 1990 and 2002, Abbott Laboratories evaluated Open-Cath-R
in 11 clinical trials involving 1,941 patients. These
trials evaluated Open-Cath-R for treatment of acute myocardial
infarction, peripheral arterial occlusion, deep vein thrombosis
and catheter occlusions. Five of these clinical trials primarily
evaluated the ability of Open-Cath-R to clear blood clots from
central venous catheters, which is our intended use of
Open-Cath-R, including two Phase 3 clinical trials for
catheter clearance.
The first of these Phase 3 clinical trials was a
randomized, double-blind, placebo-controlled clinical trial
involving 180 patients, 119 of whom were treated with
Open-Cath-R and 61 of whom were treated with placebo. The
primary endpoint in this clinical trial was for the restoration
of function to central venous catheters. Of the 119 patients
treated with Open-Cath-R, one patient was excluded from the
statistical analysis due to a protocol violation. This clinical
trial demonstrated that 54% of the catheters in the
118 evaluated patients treated with one or two doses of
Open-Cath-R were cleared within 60 minutes of Open-Cath-R
administration compared to only 30% in the control group. This
difference was considered statistically significant, with a
p-value of 0.002.
The primary safety endpoint was the occurrence of hemorrhagic or
non-hemorrhagic adverse events within 72 hours after
instillations. No statistically significant differences were
observed between the randomized treatment groups in the rates of
hemorrhagic or non-hemorrhagic adverse events. The overall
incidence of hemorrhagic and non-hemorrhagic adverse events was
5% and 19.6% respectively for all patients receiving
Open-Cath-R. The adverse events included vomiting, thrombosis,
nosebleed, blood in urine and infection. Three subjects
experienced major hemorrhagic events, none of which was
considered related to study drug.
The second Phase 3, involving 878 patients, clinical
trial was an open-label, single-arm, clinical trial to evaluate
the safety of Open-Cath-R to restore patency to occluded central
venous access devices. Safety was measured by adverse events
within 72 hours after the first infusion of Open-Cath-R. A
clinical efficacy measure was the percentage of patients whose
catheters were cleared after a single dose of Open-Cath-R and
after two doses of Open-Cath-R. In the clinical trial, 60% of
the patients had catheter function restored after one dose, and
75% of the patients had catheter function restored after two
doses. The adverse events included injection site bleeding,
fever, abdominal pain, nosebleed and blood in urine.
|
|
|
Planned Clinical Development |
The FDA has been notified of our acquisition of
Open-Cath-R, and we
intend to seek FDA concurrence to be able to use the clinical
trial data from the six
Open-Cath-R catheter
occlusion clearance clinical trials conducted by Abbott
Laboratories. There can be no assurance, however, that the FDA
will allow us to use these clinical trial data in support of an
application to commercialize
Open-Cath-R. To use the
clinical trial data generated by Abbott Laboratories in support
of our application for regulatory approval, we will be required
to show that the material produced by our contract manufacturer
is comparable to the material produced previously by Abbott
Laboratories. In addition, we believe we will be required to
conduct an immunogenicity clinical trial of approximately 200
catheter occlusion patients.
We may outlicense
Open-Cath-R to a third
party if we determine that a partnering relationship would be
the most cost-effective way to commercialize
Open-Cath-R.
58
Future Research and Development
We have identified and plan to explore a number of potential
future product development opportunities that are based on our
core thrombolytic program, such as:
|
|
|
|
|
|
SonoLysis combination therapy with PROLYSE or another
thrombolytic delivered intravenously or intra-arterially via a
catheter for stroke; |
|
|
|
|
intravenous application of PROLYSE as a treatment for
sub-massive pulmonary embolism; |
|
|
|
a catheter occlusion prophylaxis indication for Abbokinase or
Open-Cath-R. Abbokinase
has been shown in a Phase 3 clinical trial to be generally
well tolerated and has demonstrated activity in preventing
catheter occlusions when compared to heparin; and |
|
|
|
SonoLysis and thrombolytic combination therapy for myocardial
infarction, peripheral arterial occlusion and deep vein
thrombosis. |
Combination Treatment of Vascular Disorders. We believe
that the ability of our proprietary SonoLysis bubbles to
penetrate and break up blood clots from within the clot and
their flexibility in being administered with or without a
thrombolytic or an intra-arterial catheter will make them
suitable for use in treating a broad variety of vascular
disorders beyond ischemic stroke. We also believe SonoLysis
combination therapy could potentially enable the more rapid
treatment of recently formed acute clots, such as those in
myocardial infarction. We are conducting preclinical studies to
treat myocardial infarction with SonoLysis PROLYSE combination
therapy. In addition, we believe this combination therapy could
be applied to treat more established sub-acute and chronic
clots, such as those in peripheral vascular indications, that
cannot be effectively treated with thrombolytic therapy alone.
We have treated several patients in clinical proof of concept
clinical trials using microbubbles with and without a
thrombolytic to treat occluded dialysis grafts, peripheral
artery occlusive disease and deep vein thrombosis. Our
combination therapy clinical strategy beyond ischemic stroke is
in an early stage of development.
Bubbles for Oxygen and Targeted Drug Delivery. We believe
our proprietary bubble technology could be adapted, by changing
the composition and size of the bubbles, for a variety of
applications that involve delivery of gases such as oxygen or
nitric oxide, drugs or genetic materials, either systemically or
to selected sites in the body. We have conducted preclinical
studies relating to the delivery of oxygen using a proprietary
bubble formulation that we call
NanO2.
We intend to further investigate the potential use of our
NanO2
bubbles as oxygen-delivery agents to help preserve tissues that
are at risk due to blood clots in ischemic stroke, myocardial
infarction and other ischemic indications. Separately, we are
researching other classes of targeted bubbles to deliver drugs
to specific cells, or that are targeted to vulnerable plaque. We
have been awarded an aggregate of $3.6 million in grants to
fund various applications of our bubble technology.
Manufacturing
We currently do not have, and do not intend to establish, our
own manufacturing facilities. Instead, we plan to engage third
parties to manufacture our products, which we believe will allow
us to focus on our core research and product development
programs. We also believe that the use of experienced
manufacturers will provide facilities and processes qualified
for current Good Manufacturing Practices, or cGMP, greater
manufacturing specialization and expertise, higher levels of
flexibility and responsiveness and faster delivery of products
than we might achieve through in-house manufacturing.
Specialized manufacturers are often used in the
biopharmaceutical industry because they relieve product
developers from the infrastructure required to support
applicable cGMP required by the FDA, and other rules and
regulations required by foreign regulatory authorities.
Our contract manufacturers will be subject to unannounced
inspections by the FDA and corresponding foreign and state
agencies to ensure strict compliance with cGMP and other
applicable government quality control and record-keeping
regulations. In addition, transfer of ownership of products
triggers a mandatory manufacturing inspection requirement from
the FDA. However, we do not have control over and cannot ensure
third-party manufacturers compliance with these
regulations and standards. If one of our
59
manufacturers fails to maintain compliance, the production of
our products or product candidates could be interrupted, which
could result in substantial delays, additional costs and lost
sales.
We have contracted with a third party to produce small
quantities of our SonoLysis bubbles for research purposes. We
plan to enter into a services agreement with another third party
to test and revalidate our inventory of clinical grade PROLYSE
for use in anticipated clinical trials. We acquired the
remaining inventory of Abbokinase in April 2006. Abbokinase is
not currently being manufactured. We may, however, investigate
alternatives for third-party manufacturing of Abbokinase,
including availability of a cell source that meets
FDA safety requirements, at a later date. The manufacturing
process for Abbokinase involves a roller bottle production
method that is used infrequently today and is available from a
very limited number of manufacturers worldwide.
Sales and Marketing
We intend to begin selling Abbokinase in the U.S. in the
second half of 2006. We plan to develop an internal sales and
marketing staff of initially not more than eight people to
manage our relationships with third-party distribution partners
and institutional Abbokinase customers, and to oversee our
related direct and indirect advertising and promotional
activities. We intend to limit our initial sales and marketing
activities to servicing the existing demand for Abbokinase
through existing sales channels, and we believe that our planned
staffing will be sufficient to meet these needs.
For the marketing and sale of potential future products in the
U.S, we intend to build on our Abbokinase commercialization
experience to gradually expand our U.S. sales force and
broaden our domestic sales and marketing efforts to the
community of vascular physicians and acute care institutions
that we believe will be most critical to acceptance and
widespread adoption of our innovative therapies. Outside of the
U.S., we intend to rely primarily on distribution partners. We
may also enter into strategic relationships with pharmaceutical
and other companies for the marketing and distribution of some
of our products, and may rely on third parties for advertising
and promotion of our products, particularly for markets outside
the U.S. We intend to have our distribution partners manage
any third-party logistics.
Competition
The market for therapies to treat vascular disorders associated
with blood clots is highly competitive. Numerous companies
either offer or are developing competing treatments for ischemic
stroke, massive pulmonary embolism and catheter occlusion, the
three indications we are currently targeting. Many of these
competitors have significantly greater financial resources and
expertise in development and regulatory matters than we do, as
well as more established products, distribution and
reimbursement. We expect that our competitors will also continue
to develop new or improved treatments for the vascular disorders
we are targeting.
To become accepted as treatments for ischemic stroke, massive
pulmonary embolism or catheter occlusions, we believe competing
therapies must offer a combination of efficacy, safety, rapid
effect, ease of administration, approved window of
administration and cost-effectiveness. While we believe that our
product candidates will offer advantages over many of the
currently available competing therapies, our business could be
negatively impacted if our competitors present or future
offerings are more effective, safer or less expensive than ours,
or more readily accepted by regulators, health care providers or
third-party payors.
There are two principal groups of competitors offering
treatments to break up or remove blood clots, thrombolytic
companies and vendors of mechanical thrombectomy or similar
devices.
The U.S. market for thrombolytics is dominated by
Genentech, Inc., which manufactures tPA, the most widely used
thrombolytic. We are not a significant competitor in the sale of
thrombolytics, since we recently acquired our only approved
product, Abbokinase, which is approved by the FDA for treatment
of acute massive pulmonary embolism. Genentechs tPA in
various formulations is currently the only thrombolytic that
60
has been approved by the FDA for treatment of ischemic stroke
and catheter occlusion clearance, and is also approved for
myocardial infarction and pulmonary embolism indications. We are
aware that other thrombolytics are also under development, such
as alfimeprase and desmoteplase. Alfimeprase is a recombinant
form of a derivative of copperhead snake venom being developed
by Nuvelo, Inc. and is in clinical trials for use in catheter
occlusion clearance and peripheral arterial occlusions, with
clinical trials planned for ischemic stroke and deep vein
thrombosis indications. Desmoteplase is a recombinant form of a
derivative of vampire bat saliva being developed by PAION AG
that is currently in Phase 3 clinical trials for treatment
of ischemic stroke. Other companies also offer or are developing
thrombolytics for treatment of blood clots associated with
myocardial infarction and peripheral vascular occlusions. We do
not consider those product offerings or programs to be
competitive with our current business strategy.
We believe that the primary device-based treatment for ischemic
stroke clots on the market is the MERCI (Mechanical Embolus
Removal in Cerebral Ischemia) Retriever, which is an
intravascular catheter-based therapy marketed by Concentric
Medical, Inc. This device is used to engage the clot and retract
it through the catheter and out of the body. Mechanical
thrombectomy devices are also approved and marketed for removing
blood clots associated with peripheral vascular and coronary
indications and dialysis access grafts, such as AngioJet by
Possis Medical, Inc., Micro-Infusion Catheter by EKOS Corp., and
Resolution Endovascular System by OmniSonics Medical
Technologies, Inc. A variety of companies also offer
catheter-delivery systems for thrombolytics or other drugs used
in the treatment of blood clots. We do not consider these
devices to be directly competitive with our current business
strategy.
We do not know whether any other companies are developing bubble
technologies for therapeutic use in vascular disorders.
Material Contracts
Following is a summary of our material contracts, other than
contracts entered into in the ordinary course of business, to
which we are a party:
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September 2005 Agreements with Abbott Laboratories
(Open-Cath-R and
PROLYSE) |
On September 30, 2005, we entered into an asset purchase
agreement pursuant to which we acquired certain assets and
rights used in the manufacture of Open-Cath-R and PROLYSE from
Abbott Laboratories. The consideration for these assets included
one million shares of our Series E preferred stock, valued
at an aggregate of $4.0 million and including conversion,
voting, antidilution and redemption rights, $5.0 million in
cash, a $15.0 million promissory note that bears a 6%
interest rate and matures on December 31, 2006 and is
secured by the acquired assets, and our assumption of a 0.33%
royalty obligation on net sales of
Open-Cath-R and PROLYSE
in Canada. The Series E preferred stock will automatically
convert into common stock upon the closing of this offering and
all special voting, antidilution and redemption rights will
cease upon such conversion. We will be required to indemnify
Abbott Laboratories, within limits, for any loss that arises out
of our breach of the purchase agreement, liabilities that we
expressly assumed under the purchase agreement or the
manufacture, sale or use of any products we acquired from Abbott
Laboratories.
In connection with the asset purchase agreement, we also entered
into a services agreement to provide for transfer to us of the
Open-Cath-R and PROLYSE manufacturing technologies that we
acquired. Under this agreement, Abbott Laboratories agreed to
provide interim transitional services to assist us with the use
of the acquired technologies through, at the latest,
December 31, 2006. We are billed quarterly for Abbott
Laboratories services based on scheduled hourly rates. We
have not engaged and do not plan to engage these services. If
the contractual services are engaged and completed on or prior
to December 31, 2006, we will be obligated to make a final
payment to Abbott Laboratories in an amount equal to the
difference between $5.0 million and all amounts that we
previously paid under the contract. However, since we do not
plan to engage such services we do not anticipate having to make
any payments in the future under this arrangement.
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We have reviewed the documentation relating to manufacturing
Open-Cath-R and PROLYSE
that we acquired from Abbott Laboratories, including the master
production batch records, operating procedures, product and raw
material specifications and analytical methods, equipment, and
process justification and validation criteria. Based on our
review of these records, we believe we are capable, with
assistance from contract manufacturing organizations, contract
research organizations and consultants, of transitioning the
manufacturing technologies that we acquired without the
assistance of Abbott Laboratories personnel. We believe that our
decision not to engage Abbott Laboratories services
pursuant to the services agreement will have no impact on our
current development plans.
In connection with the asset purchase agreement, we also entered
into a license agreement whereby Abbott Laboratories granted us
an exclusive, transferable, royalty-free, worldwide license to
its patents related to incorporating certain sequences of
genetic material into cells. Under the license, we are entitled
to make, distribute and sell thrombolytics that incorporate the
licensed method. Abbott Laboratories retains all right, title
and interest in and to the patents and may practice the patents
in fields other than the development of thrombolytics. The
license will terminate upon expiration of the last patent to
which it relates on April 21, 2015. We may terminate the
license agreement at any time, for any reason, upon written
notice to Abbott Laboratories. Either party may terminate the
agreement upon 30 days written notice for certain
contractual breaches.
Abbott Laboratories rights in the licensed assets derive
from a settlement agreement that it entered into on
August 10, 1990 with Genentech, Inc. to settle a lawsuit
relating to a patent dispute covering urokinase composition of
matter and manufacturing technology. Pursuant to the terms of
this settlement agreement, Genentech granted Abbott Laboratories
a royalty-free license in limited territories, with a right to
sublicense, to certain intellectual property and patents for the
purposes of making, using and selling urokinase/pro-urokinase as
a single entity product unaccompanied by any other plasminogen
activator. In addition, Genentech granted to Abbott Laboratories
a royalty-free, non-exclusive license, with no right to
sublicense, to certain patented intellectual property to the
extent that such license is employed for the manufacture of
urokinase/pro-urokinase for use and sale. Finally, Genentech
also granted Abbott Laboratories a royalty-free license to grant
sublicenses under Genentechs patents to a single third
party in each country in the designated territory (other than
the U.S.) to sell urokinase/pro-urokinase in the event that
Abbott Laboratories chose not to market in such country itself.
This settlement agreement was assigned to us on
September 30, 2005 in connection with our acquisition of
the Open-Cath-R and PROLYSE assets from Abbott.
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April 2006 Agreements with Abbott Laboratories
(Abbokinase) |
On April 10, 2006, we entered into an asset purchase
agreement with Abbott Laboratories to acquire its entire
remaining finished-product inventory of Abbokinase, for
consideration consisting of $5.0 million in cash and a 6%
non-recourse promissory note for $15.0 million that matures
on December 31, 2007. The note is secured by the acquired
inventories and related assets and an escrow of 50% of proceeds
from our sales of such inventories in excess of
$5.0 million, up to a maximum escrow of $15.0 million,
and is subject to certain offsets in the event of a failure to
transfer certain related distribution contracts to us.
As part of this arrangement we entered into a trademark license
agreement with Abbott Laboratories in which it granted to us an
exclusive, non-transferable license, without any sublicense
rights, to use the Abbokinase trademark. We must adhere to
certain quality control standards when marketing and selling the
Abbokinase inventory under the trademark. This trademark license
automatically terminates on the earlier to occur of the
completion of our sale of the acquired Abbokinase inventory or
the expiration date for all such Abbokinase inventory as of the
date it was transferred to us. Abbott Laboratories is also
entitled to terminate the license if we are in material breach
of the agreement and fail to cure such breach within
15 days notice. Abbott Laboratories may also terminate the
license if we commit a non-material breach of the agreement and
fail to correct such breach within 30 days.
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License Agreement with Bristol-Myers Squibb Medical Imaging,
Inc. |
We are party to an exclusive, worldwide, royalty-free license
agreement with Bristol-Myers Squibb Medical Imaging, Inc. (as
successor to DuPont Contrast Imaging, Inc.) dated
October 7, 1999 for the use of
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intellectual property related to targeted and tissue-specific
diagnostic ultrasound products, outside the field of contrast
enhancement of diagnostic ultrasound imaging. Under the
agreement, to the extent we develop any products or technology
in the area of thrombus imaging or sonothrombolysis, which is
the use of ultrasound to break up blood clots, we must first
offer Bristol-Myers the right to negotiate an exclusive license
for such product or technology for development and
commercialization for a period of 90 days before offering
it to any third party for license. This license is indefinite in
duration and contains no express termination provisions. On
September 1, 2005, Bristol-Myers executed a letter
agreement confirming that it has no interest in our current
SonoLysis bubbles, and that we have satisfied all of our
obligations under the license agreement with respect to our
SonoLysis bubbles, as they existed on that date. This
acknowledgement encompasses our proprietary SonoLysis bubbles
together with ultrasound, with or without a thrombolytic,
currently under development.
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License Agreement with UNEMED Corporation |
On October 10, 2003, UNEMED Corporation granted us an
exclusive, worldwide license, with sublicense rights, to
intellectual property and patents relating to the use of
microbubbles together with ultrasound for the treatment of
thrombosis. To maintain this license we must meet certain
product development milestones. We are obligated to pay UNEMED a
royalty of 2% on any future net sales of products or processes
which utilize the licensed technology, of which there have been
no sales to date. We are also obligated to pay license
maintenance fees in amounts from $3,000 to $7,000
annually for the life of the agreement. These fees are
creditable against any royalty payments owed by us to UNEMED in
the applicable calendar year. The license agreement will
terminate contemporaneously with the expiration of the licensed
patents, or on October 17, 2015. We may terminate the
agreement, in our sole discretion, upon 90 days written
notice for any reason. UNEMED may terminate the agreement for
cause upon either 45 days or 90 days written notice,
depending on the cause for termination, or at any time if we
fail to meet certain milestones. Upon termination of the
license, we would likely be required to change our SonoLysis
therapy product development plans.
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License Agreement with Dr. med. Reinhard Schlief |
On January 4, 2005, Dr. med. Reinhard Schlief granted
us an exclusive, worldwide license, with the right to
sublicense, to intellectual property and patents relating to
methods of destroying cells by applying ultrasound to them in
the presence of microbubbles. As consideration for this license,
we reimbursed Dr. Schlief for certain past out-of-pocket
costs, such as maintenance fees and patent transfer fees, and
also granted Dr. Schlief a five-year warrant to purchase up
to 20,000 shares of our common stock at an exercise price
of $3.00 per share. We are obligated to pay Dr. Schlief a
royalty of 2% of net sales revenue derived from the sale of
products that utilize the licensed technology. The license
agreement will terminate contemporaneously with the expiration
of the licensed patents, or on January 10, 2012. We may
terminate the license, with or without cause, upon 60 days
written notice and Dr. Schlief may terminate the agreement,
with cause, 60 days after notice of the default is provided
if the default has not been cured. Upon termination or
expiration of the license, our plans for developing our
SonoLysis bubbles would likely not change.
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License Agreement with University of Arkansas |
On February 14, 2006, the University of Arkansas granted us
an exclusive, worldwide license, with the right to sublicense,
intellectual property and patents relating to the use of a
specific ultrasound device to be used in conjunction with
bubbles, a thrombolytic, or a combination of bubbles and a
thrombolytic to break up blood clots. To maintain this license
we must meet certain product development milestones. We are
obligated to pay the University of Arkansas a one-time fee of
$25,000 within 30 days after the first commercial sale of a
product incorporating the licensed technology, and varying
royalties depending on the amount of net revenue derived from
the sale of products using the licensed technology, subject to
minimum annual royalties of $5,000 per year commencing
February 10, 2007, increasing to $7,000 per year on
February 10, 2009, and each year thereafter. The maximum
aggregate royalty payable under this license is
$20.0 million. We are also obligated to pay a one-time
success fee of $250,000 in the first year that net revenue
derived from the sale of products using the licensed technology
exceeds $10.0 million. The license agreement will terminate
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contemporaneously with the expiration of the licensed patents,
or on September 8, 2023. In addition, we may terminate this
license at any time upon 90 days written notice to the
University of Arkansas and the University may terminate the
agreement for cause upon 90 days written notice. Upon
termination or expiration of the license, our plans for
developing our SonoLysis bubbles would likely not change.
Patents and Proprietary Rights
Our success depends in part on our ability to develop a
competitive advantage over potential competitors for the use of
bubbles and ultrasound for treatment of blood clots and vascular
diseases in various parts of the body. Our ability to obtain
intellectual property that protects our SonoLysis bubbles and
ultrasound treatment in the presence or absence of drugs will be
important to our success. Our strategy is to protect our
proprietary positions by, among other things, filing U.S. and
foreign patent applications related to our technology,
inventions and improvements that are directed to the development
of our business and our competitive advantages. Our strategy
also includes developing know-how and trade secrets, and
licensing technology related to bubbles and ultrasound from
third parties. As of June 30, 2006 we owned 49 issued
U.S. patents, 39 U.S. pending patent applications, 37
foreign patents and 68 international or foreign patent
applications. In addition, as of June 30, 2006 we have
licensed patents from third parties that grant us exclusive
rights to 47 U.S. patents, at least one U.S. patent
application, and their respective international and foreign
patent and patent application counterparts.
The U.S. patents that we own cover certain applications
related to bubble compositions and methods of making and using
such bubbles with ultrasound for the treatment of blood clots.
Patents that cover our core technology expire between 2009 and
2021.
We have several pending patent claims, including allowed claims
that have not yet issued, that cover additional elements of our
bubble technology. For example, we have pending claims directed
to the following aspects of bubble technology:
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methods of preparing gas filled bubbles; |
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methods of using gas filled bubbles in combination with
ultrasound for eliminating or reducing thrombi or for delivering
drug compounds; |
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methods of preparing gas filled bubbles that are targeted to
specific cells in the body or that are activated at a specified
temperature; and |
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apparatus for preparing gas filled bubbles described above. |
We plan to file additional patent applications on inventions
that we believe are patentable and important to our business and
intend to aggressively pursue and defend patent protection on
our proprietary technologies.
Our ability to operate without infringing the intellectual
property rights of others and to prevent others from infringing
our intellectual property rights will also be important to our
success. To this end, we have reviewed all patents owned by
third parties of which we are aware and are related to bubble
technology and gas filled vesicles, in the presence or absence
of ultrasound, and thrombolysis using gas filled vesicles, and
believe that our current products do not infringe any valid
claims of the third party patents that we have analyzed. There
are a large number of patents directed to therapies for blood
clots, and there may be other patents or pending patent
applications of which we are currently unaware that may impair
our ability to operate. We are currently not aware of any third
parties infringing our issued claims.
We have been notified that, in February 2005, a third party
filed an opposition claim to one of our patents in Europe that
relates to targeted bubbles for therapeutic and diagnostic use.
In addition, in July 2003 we received a notice from a third
party who owns a patent relating to the administration of
ultrasound to break up blood clots indicating that we may need a
license to its patent if we intend to administer our therapies
according to the methods claimed in its patent.
When appropriate, we actively seek protection for our products,
technologies, know-how and proprietary information by licensing
intellectual property from third parties. We have obtained
rights relating to our product candidates and future development
programs from third parties as appropriate.
64
Government Regulation
We are subject to extensive regulation by the FDA and comparable
regulatory agencies in state, local and foreign jurisdictions in
connection with the development, manufacture and
commercialization of our product candidates.
In the U.S., our product candidates may be subject to regulation
as drugs, biologics, which are drugs derived from a living
source, or medical devices. In some cases, our product
candidates may fall into multiple categories and require
regulatory approval in more than one category. For example, our
thrombolytic product candidates are biologics, but they are
subject to regulation as drugs. Our SonoLysis therapy and our
SonoLysis combination therapy involve a combination of drug and
device, which would require approval in each category before we
could market either of these therapies. Our proprietary
SonoLysis bubbles, which are injected into the bloodstream, have
been designated as a drug by the FDA. However, we may request
the FDA to consider regulation of our SonoLysis therapy as a
medical device rather than as a drug, since we believe its
mechanism of action is principally mechanical in nature. Outside
the U.S., our product candidates are also subject to regulation
as drugs, biologics or medical devices, and must meet similar
regulatory hurdles as in the U.S. to gain approval and
reach the market.
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Drug and Biologics Regulation |
The process required by the FDA before drug or biologic product
candidates may be marketed in the U.S. generally involves
the following:
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preclinical laboratory and animal tests; |
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submission and approval of an Investigational New Drug
application, or IND application; |
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adequate and well-controlled human clinical trials to establish
the safety and efficacy of proposed drugs for their intended use
and safety, purity and potency of biologic products for their
intended use; |
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preapproval inspection of manufacturing facilities, company
regulatory files and selected clinical investigators; |
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for drugs, FDA approval of a new drug application, or NDA, or
FDA approval of an NDA supplement in the case of a new
indication if the product is already approved for another
indication; and |
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for biologics, FDA approval of a biologics license application,
or BLA, or FDA approval of a BLA supplement in the case of a new
indication if the product is already approved for another
indication. |
Prior to commencing the first human clinical trial, we must
submit an IND application to the FDA. The IND application
automatically becomes effective 30 days after receipt by
the FDA, unless the FDA within such period raises concerns or
questions about the preclinical drug testing or nonclinical
safety evaluation in animals, or the design or conduct of the
first proposed clinical trial. In such a case, the IND
application sponsor and the FDA must resolve any outstanding
concerns before the clinical trial may begin. A separate IND
application submission must be made for each successive clinical
trial conducted during product development, and the FDA must not
object to the submission before each clinical trial may start
and continue. Further, an independent Institutional Review
Board, or IRB, for investigations in human subjects within each
medical center in which an investigator wishes to participate in
the clinical trial must review and approve the preclinical drug
testing and nonclinical safety evaluation and efficacy in
animals or prior human clinical trials as well as the design and
goals of the proposed clinical trial before the clinical trial
commences at that center. Regulatory authorities, an IRB or the
sponsor may suspend a clinical trial at any time on various
grounds, including a finding that the subjects or patients are
being exposed to an unacceptable health risk.
For purposes of NDA or BLA approval, human clinical trials are
typically conducted in three sequential phases that may overlap.
Moreover, the objectives of each phase may be split or combined,
leading to
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Phase 1/2 and other similar trials that may be used to
satisfy the requirements of otherwise separate clinical trials
as follows:
Phase 1: Phase 1 clinical trials are usually
conducted in normal, healthy volunteers or a limited patient
population to evaluate the product candidate for safety, dosage
tolerance, absorption, metabolism, distribution and excretion.
Phase 2: Phase 2 clinical trials are conducted
in a limited patient population, the population for which the
indication applies, to further identify and measure possible
adverse effects or other safety risks, to determine the efficacy
of the product candidate for the specific targeted disease and
to determine dosage tolerance and optimal dosage. Multiple
Phase 2 clinical trials may be conducted to obtain
information prior to beginning Phase 3 clinical trials.
Phase 3: When Phase 2 clinical trials
demonstrate that a dose range of the product candidate appears
to be effective and has an acceptable safety profile,
Phase 3 clinical trials are undertaken in a larger patient
population to confirm clinical efficacy and to further evaluate
safety at multiple, and often internationally located, clinical
trial sites.
The FDA may require, or companies may pursue, additional
clinical trials after a product is approved. These so-called
Phase 4 clinical studies may be made a condition to be
satisfied after a drug receives approval. The results of
Phase 4 clinical studies may confirm the effectiveness of a
product and may provide important safety information to augment
the FDAs voluntary adverse drug reaction reporting system.
The results of product development, preclinical testing and
clinical trials are submitted to the FDA as part of an NDA or
BLA. The FDA may deny approval of an NDA or BLA if the
applicable regulatory criteria are not satisfied or for any
other reason, or it may require additional clinical data or an
additional Phase 3 clinical trial. Satisfaction of FDA
requirements or similar requirements of state, local and foreign
regulatory agencies typically takes several years.
Any products manufactured or distributed by us pursuant to FDA
approvals are subject to continuing regulation by the FDA,
including record-keeping requirements and reporting of adverse
experiences with the drug. The FDA also closely regulates the
marketing and promotion of drugs. A company is permitted to make
only those claims relating to safety and efficacy that are
approved by the FDA. Failure to comply with these requirements
can result in adverse publicity, warning letters, corrective
advertising and potential civil and criminal penalties.
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Medical Device Regulation |
The process required by the FDA before medical devices may be
marketed in the U.S. generally involves the following:
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product design, development and manufacture; |
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product safety, testing, labeling and storage; |
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preclinical testing in animals and in the laboratory; |
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clinical investigations in humans; |
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pre-marketing clearance or approval; |
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record keeping and document retention procedures; |
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advertising and promotion; |
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product marketing, sales and distribution; and |
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post-marketing surveillance and medical device reporting,
including reporting of deaths, serious injuries, device
malfunctions or other adverse events. |
Unless an exemption applies, each medical device distributed
commercially in the U.S. will require either prior 510(k)
clearance or pre-market approval, referred to as a PMA, from the
FDA. The FDA classifies medical devices into one of three
classes. Class I devices are subject only to general
controls, such as
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establishment registration and device listing, labeling, medical
devices reporting, and prohibitions against adulteration and
misbranding. Class II medical devices require prior 510(k)
clearance before they may be commercially marketed in the U.S.
The FDA will clear marketing of a medical device through the
510(k) process if the FDA is satisfied that the new product has
been demonstrated to have the same intended use and is
substantially equivalent to another legally marketed device,
including a 510(k)-cleared, or predicate, device, and otherwise
meets the FDAs requirements. Devices deemed by the FDA to
pose the greatest risk, such as life-sustaining, life-supporting
or implantable devices, or devices deemed not substantially
equivalent to a predicate device, are placed in Class III,
generally requiring submission of a PMA supported by clinical
trial data. We believe all of our product candidates that are
classified as devices will be deemed to be Class III
devices subject to pre-market approval.
To obtain 510(k) clearance, we must submit a notification to the
FDA demonstrating that our proposed device is substantially
equivalent to a predicate device or a device that was in
commercial distribution before May 28, 1976 for which the
FDA has not yet called for the submission of a PMA application.
The FDAs 510(k) clearance process generally takes from
three to 12 months from the date the application is
submitted, but can take significantly longer. If the FDA
determines that the device, or its intended use, is not
substantially equivalent to a previously-cleared device or use,
the device is automatically placed into Class III,
requiring the submission of a PMA. Any modification to a
510(k)-cleared device that would constitute a major change in
its intended use, design or manufacture, requires a new 510(k)
clearance or, possibly, in connection with safety and
effectiveness, a PMA.
Clinical trials are generally required to support a PMA
application and are sometimes required for 510(k) clearance. To
perform a clinical trial in the U.S. for a significant risk
device, prior submission of an application for an IDE to the FDA
is required. An IDE amendment must also be submitted before
initiating a new clinical study under an existing IDE, such as
initiating a pivotal clinical trial following the conclusion of
a feasibility clinical trial. The FDA responds to an IDE or an
IDE amendment for a new clinical trial within 30 days. The
FDA may approve the IDE or amendment, grant an approval with
certain conditions, or identify deficiencies and request
additional information. It is common for the FDA to require
additional information before approving an IDE or amendment for
a new clinical trial, and thus final FDA approval on a
submission may require more than the initial 30 days. The
IDE application must be supported by appropriate data, such as
animal and laboratory testing results, and any available data on
human clinical experience, showing that it is safe to test the
device in humans and that the testing protocol is scientifically
sound. The animal and laboratory testing must meet the
FDAs good laboratory practice requirements.
Clinical trials are subject to extensive recordkeeping and
reporting requirements. Our clinical trials must be conducted
under the oversight of an IRB for the relevant clinical trial
sites and must comply with FDA regulations, including but not
limited to those relating to good clinical practices. We, the
FDA or the IRB may suspend a clinical trial at any time for
various reasons, including a belief that the risks to study
subjects outweigh the anticipated benefits. Even if a clinical
trial is completed, the results of clinical testing may not
adequately demonstrate the safety and efficacy of the device or
may otherwise not be sufficient to obtain FDA approval to market
the product in the U.S. Similarly, in Europe the clinical study
must be approved by a local ethics committee and in some cases,
including studies with high-risk devices, by the ministry of
health in the applicable country.
Failure to comply with applicable regulatory requirements can
result in enforcement action by the FDA or state authorities,
which may include any of the following sanctions:
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warning letters, fines, injunctions, consent decrees and civil
penalties; |
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product recalls or market withdrawals; |
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customer notifications, repair, replacement, refunds, recall or
seizure of our products; |
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operating restrictions, partial suspension or total shutdown of
production; |
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refusal to grant new regulatory approvals; |
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withdrawing NDAs, BLAs, 510(k) clearance or PMA that have
already been granted; and |
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criminal prosecution. |
Employees
We had 47 full-time employees as of June 30, 2006.
Seventeen of our employees are engaged in executive,
administrative, business development and intellectual property
functions, and 30 are engaged in research, development and
clinical or regulatory activities. We anticipate that we will
need to recruit additional personnel to manage our expanded
research and development programs, manage our planned clinical
trials and regulatory applications and commence sales and
marketing functions, in accordance with our business strategy.
We believe relations with our employees are generally good. None
of our employees is covered by a collective bargaining agreement.
Facilities
Our current facilities are located in two leased buildings in
Tucson, Arizona. One facility serves as office and storage space
and laboratory facility, is approximately 3,500 square
feet, and is subject to a one-year lease at approximately
$28,886 per year that terminates December 31, 2006. We
plan to extend this lease for at least another year. The other
facility serves as our corporate headquarters and principal
laboratory facility, is approximately 6,200 square feet,
and is subject to a six-year lease at approximately
$64,428 per year that terminates on October 31, 2008.
This lease may be extended at our option for up to four
additional six-year periods. Our headquarters facility is owned
by a partnership whose beneficial owners include a director,
several of our executive officers and stockholders, including
our President and Chief Executive Officer, Dr. Evan Unger.
Legal Proceedings
From time to time, we may be involved in litigation relating to
claims arising out of our operations. We are not currently
subject to any material legal proceedings and are also not aware
of any pending legal, arbitration or governmental proceedings
against us that may have material effects on our financial
position or results of operations.
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Management
Our executive officers and directors and their respective ages
and positions as of June 30, 2006 are as follows:
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Evan C. Unger, M.D.
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52 |
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President, Chief Executive Officer and Director |
Greg Cobb
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36 |
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Chief Financial Officer, Secretary and Treasurer |
Terry Matsunaga, Ph.D.
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53 |
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Vice President, Research |
John McCambridge
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57 |
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Vice President, Sales and Marketing |
Rajan Ramaswami, Ph.D.
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53 |
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Vice President, Product Development |
Walter Singleton
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Chief Medical Officer |
Lynne E. Weissberger, Ph.D.
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58 |
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Vice President, Regulatory Affairs, Quality Assurance and
Regulatory Compliance |
Brad Zakes
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40 |
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Chief Operating Officer |
Reena Zutshi, Ph.D.
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38 |
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Vice President, Program Management |
Richard
Otto(1)(3)
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56 |
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Chairman of the Board and Director |
Richard
Love(2)(3)
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Director |
Thomas W.
Pew(2)(3)
|
|
|
67 |
|
|
Director |
Philip
Ranker(1)(3)
|
|
|
46 |
|
|
Director |
James M.
Strickland(1)(2)
|
|
|
63 |
|
|
Director |
|
|
(1) |
Member of the audit committee. |
(2) |
Member of the compensation committee. |
(3) |
Member of the nominating and corporate governance committee. |
Evan C. Unger, M.D. has served as our President and
Chief Executive Officer and as a director since our inception in
October 1999. Dr. Unger also served as the Chairman of our
board from our inception until March 2004. Dr. Unger is a
board-certified radiologist and a Fellow of the American College
of Radiology. Since September 2004 he has been on a leave of
absence from his position as Professor of Radiology and
Bioengineering at the University of Arizona, Radiology
Department to devote his efforts full time to our business. From
January 1994 to January 1999, Dr. Unger served as
Director of Cross-Sectional Imaging at the University of Arizona
Health Sciences Center. Dr. Unger holds a B.A. in Economics
from the University of California, Berkeley and an M.D. from the
University of California, San Francisco.
Greg Cobb has served as our Chief Financial Officer since
April 2005. He was a co-founder and Managing Director of
Catalyst Partners, LLC, a boutique merger, acquisition and
business development firm, from April 2002 to April 2005.
Mr. Cobb served as our interim Chief Financial Officer from
October 2001 to April 2002. From July 2000 to November 2001, he
was a Managing Director of the Arizona Angels Investor Network,
Inc. Mr. Cobb holds a B.S. in Computer Engineering from
Iowa State University and a J.D. and an M.B.A. from Arizona
State University.
Terry Matsunaga, Ph.D. has served as our Vice
President, Research since March 2004. From October 1999 to March
2004, he served as our Senior Director, New Product Development.
Dr. Matsunaga holds an AB from the University of
California, Berkeley, and a Ph.D. in Pharmaceutical Chemistry
and a Pharm.D. degree in Clinical Pharmacy from the University
of California, San Francisco.
John McCambridge has served as our Vice President, Sales
and Marketing since May 2006. From December 1997 to February
2006, Mr. McCambridge was the President and Chief Operating
Officer of MRI Medical, a designer and manufacturer of highly
engineered silicone medical devices. From December 1987 to
January 1997, Mr. McCambridge was Senior Vice President of
Sales and Marketing for Genzyme Tissue Repair, formerly
BioSurface Technology, a developer of novel biologic
therapeutics for the repair of human skin and cartilage tissue.
Mr. McCambridge holds a B.S. in Business Administration
from the University of Delaware.
Rajan Ramaswami, Ph.D. has served as our Vice
President, Product Development since March 2005. From September
2001 to February 2005, Dr. Ramaswami served as our Vice
President, Research and Development,
69
and from October 1999 to September 2001, he served as our Senior
Director of Product Development. Dr. Ramaswami holds a
MS/Ph.D. in Polymer Chemistry from Carnegie-Mellon University.
Walter Singleton has served as our Chief Medical Officer
since May 2006. From August 2005 to April 2006,
Dr. Singleton served as a consultant to us and other
pharmaceutical and biotechnology companies through New Drug
Development Services, a company that he founded in 1996 to
advise companies in all areas of drug development and medical
affairs. From October 2004 to July 2005, Dr. Singleton
served as Vice President, Regulatory Affairs for Inovio, Inc., a
biotechnology company. From October 2000 to December 2003,
Dr. Singleton was Senior Vice President of New Drug
Development at Chugai Pharma U.S.A. (formerly Chugai
Biopharmaceuticals, Inc.) a Japanese biotechnology company.
Dr. Singleton holds a Masters Degree, B.M. and a B.Ch.
degree (equivalent to M.D. in the U.S.) and a Masters Degree in
Animal Physiology from Oxford University Medical School.
Lynne E. Weissberger, Ph.D. has served as our Vice
President, Regulatory Affairs, Quality Assurance and Regulatory
Compliance since February 2006. From January 2004 to December
2005, Dr. Weissberger served as Senior Director at Myogen,
Inc., a biotechnology company. From April 1996 to December 2003,
Dr. Weissberger served as an Associate Director for
G.D. Searle, Pharmacia and Pfizer, which are pharmaceutical
companies. Dr. Weissberger holds a Ph.D. in Nutrition and
Physiology from Cornell University.
Brad Zakes has served as our Chief Operating Officer
since July 2006. From August 2005 to July 2006, Mr. Zakes served
as our Vice President, Business Development. From December 2001
to August 2005, Mr. Zakes served as Director, Business
Management at ICOS Corporation, a biotechnology company.
From March 1999 to December 2001, Mr. Zakes served as
President of Heart Research Centers International, a clinical
research organization. Mr. Zakes holds a B.S. in Biology
from Oregon State University, an M.S. degree in Toxicology
from the American University and an M.B.A. from Duke
Universitys Fuqua School of Business.
Reena Zutshi, Ph.D. has served as our Vice
President, Program Management since October 2005. From June 2001
to October 2005, Dr. Zutshi held various positions with us,
including Director of Research and Development. Dr. Zutshi
holds a Ph.D. in Organic Chemistry from Purdue University. She
received her postdoctoral training at Yale University,
Department of Chemistry.
Richard E. Otto has served as a director since July 2004
and as Chairman of the Board of Directors since February 2006.
Since February 2003 Mr. Otto has served as President and
Chief Executive Officer of Corautus Genetics, Inc., a gene
therapy company. Mr. Otto founded Clique Capital, a venture
capital company, in January 1999, where he was employed until
January 2002. Mr. Otto serves on the board of directors of
Medi-Hut Co., Inc. Mr. Otto holds a B.S. in Chemistry and
Zoology from the University of Georgia and engaged in graduate
studies in Biochemistry at Medical College of Georgia.
Richard L. Love has served as a director since March
2006. From January 2005 to January 2006 Mr. Love served as
Managing Director of TGEN Accelerator LLC for his employer
Translational Genomics Research Institute. From January 2003 to
January 2005, Mr. Love served as Chief Operating Officer
for Translational Genomics Research Institute, from January 2002
to January 2003 Mr. Love served as a director of Parexel
International, a pharmaceutical services company, and ILEX
Oncology, Inc., a biotechnology company evaluating cancer
therapeutics, and from June 1993 to January 2002 Mr. Love
served as Chief Executive Officer and a director of ILEX
Oncology, Inc. Mr. Love also serves as a director for
Parexel International, Systems Medicine Inc., Medical Consultant
Services, Xilas Medical and Molecular Profiling Institute.
Mr. Love holds B.S. and M.S. degrees in Chemical
Engineering from the Virginia Polytechnic Institute.
Thomas W. Pew has served as a director since January
2004. Since 1994, Mr. Pew has been a private investor in
formative-stage biotechnology companies and currently serves as
a director for AGF Pharma. He holds a B.A. in Economics from
Cornell University.
Philip Ranker has served as a director since February
2006. Since August 2004, Mr. Ranker has served as the Chief
Financial Officer and Vice President of Finance of Nastech
Pharmaceutical Company, Inc. From September 2001 to August 2004,
Mr. Ranker served as Director of Finance for
ICOS Corporation. From July
70
1998 to December 2000, Mr. Ranker served as Assistant
Controller of Scholastic Corporation. Mr. Ranker holds a
B.A. in Accounting from the University of Kansas.
James M. Strickland has served as a director since August
2000. Since February 2004, Mr. Strickland has served as the
Chief Executive Officer of Thayer Medical Corporation, a medical
device company. Since March 1998, Mr. Strickland has served
as the General Partner and Managing Director of the Coronado
Venture Funds, a group of venture investing partnerships formed
in 1988. Mr. Strickland serves on the board of directors of
MetaLink Corporation. Mr. Strickland holds B.S. and M.S.
degrees in Electrical Engineering from the University of New
Mexico and an M.S. in Industrial Administration from Carnegie
Institute of Technology (now Carnegie-Mellon University).
Board Composition
Our board of directors is currently composed of six members,
including five non-employee members and our President and Chief
Executive Officer, Evan C. Unger. Upon completion of this
offering, our bylaws will be amended and restated to provide
that the authorized number of directors may be changed only by
resolution of the board of directors.
We believe that the composition of our board of directors meets
the requirements for independence under the current requirements
of The Nasdaq Global Market. As required by The Nasdaq Global
Market, we anticipate that our independent directors will meet
in regularly scheduled executive sessions at which only
independent directors are present. We intend to comply with any
governance requirements that are or become applicable to us.
Committees of the Board of Directors
Our board of directors has an audit committee, a compensation
committee and a nominating and corporate governance committee,
each of which has the composition and responsibilities described
below.
Our audit committee is comprised of Richard Otto, James
Strickland and Philip Ranker, each of whom is a non-employee
member of our board of directors. Mr. Otto is the
chairperson of the audit committee. Our board of directors has
determined that each of Messrs. Otto, Strickland and Ranker
is an audit committee financial expert as defined
under SEC rules and regulations. We believe that the composition
of our audit committee meets the requirements for independence
and financial sophistication under the current requirements of
The Nasdaq Global Market and SEC rules and regulations. In
addition, our audit committee has the specific responsibilities
and authority necessary to comply with the current requirements
of The Nasdaq Global Market and SEC rules and regulations.
Our audit committee is responsible for, among other things,
overseeing the independent auditors, reviewing the financial
reporting, policies and processes, overseeing risk management,
related party transactions and legal compliance and ethics and
preparing the audit committee reports required by SEC rules.
Our compensation committee is comprised of James Strickland,
Thomas Pew and Richard Love, each of whom is a non-employee
member of our board of directors. James Strickland is the
chairperson of the compensation committee. We believe that the
composition of our compensation committee meets the requirements
for independence under the current requirements of The Nasdaq
National Market and SEC rules and regulations.
Our compensation committee is responsible for, among other
things, reviewing and recommending compensation and annual
performance objectives and goals for our Chief Executive
Officer, reviewing and making recommendations to the board of
directors regarding incentive-based or equity-based compensation
plans, employment agreements, severance arrangements, change in
control agreements and other benefits,
71
compensations, compensation policies or arrangement for other
executive officers and preparing the compensation committee
reports required by SEC rules.
|
|
|
Nominating and Corporate Governance Committee |
Our nominating and corporate governance committee is comprised
of Richard Otto, Richard Love, Thomas Pew and Philip Ranker.
Mr. Otto is the chairperson of the nominating and corporate
governance committee. We believe that the composition of our
nominating and corporate governance committee meets the
requirements for independence under the current requirements of
The Nasdaq Global Market.
Our nominating and corporate governance committee is responsible
for, among other things, identifying, evaluating and
recommending individuals qualified to become directors,
reviewing and making recommendations to the board of directors
regarding board of director and committee compensation,
committee composition and reviewing compliance with corporate
governance principles applicable to our company.
Compensation Committee Interlocks and Insider
Participation
None of our executive officers currently serves, or served
during 2005, on the compensation committee or board of directors
of any other entity that has one or more executive officers
serving as a member of our board of directors or compensation
committee. Prior to establishing the compensation committee, our
full board of directors made decisions relating to compensation
of our executive officers. No member of our compensation
committee has ever been an officer or employee of the company.
Director Compensation
The non-employee members of our board of directors receive the
following compensation:
|
|
|
|
|
$1,500 for each board and committee meeting attended in person; |
|
|
|
$250 for each board and committee meeting attended via
teleconference; |
|
|
|
|
$1,500 annual retainer for each non-employee director that
participates on a committee, plus an additional $1,000 annual
retainer for each non-employee director that is the chairman of
a committee; |
|
|
|
|
one-time grant upon joining the board of directors of an option
to purchase 55,000 shares of common stock with a
four-year annual vesting schedule and an exercise price equal to
fair market value of our common stock on the date of
grant; and |
|
|
|
reimbursement of actual, reasonable travel expenses incurred in
connection with attending board or committee meetings. |
Upon completion of this offering, and annually thereafter, each
non-employee director will receive a $25,000 retainer and the
other compensation described above will remain unchanged.
The following directors have each received the following option
grants in connection with their services to us as directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name |
|
Number of Shares | |
|
Exercise Price | |
|
Grant Date | |
|
Termination Date | |
|
|
| |
|
| |
|
| |
|
| |
Richard Otto
|
|
|
55,000 |
|
|
$ |
3.00 |
|
|
|
July 19, 2004 |
|
|
|
July 19, 2014 |
|
James M. Strickland
|
|
|
55,000 |
|
|
$ |
3.00 |
|
|
|
August 2, 2004 |
|
|
|
August 2, 2014 |
|
Thomas W. Pew
|
|
|
55,000 |
|
|
$ |
3.00 |
|
|
|
August 2, 2004 |
|
|
|
August 2, 2014 |
|
Richard Love
|
|
|
55,000 |
|
|
$ |
5.00 |
|
|
|
May 6, 2006 |
|
|
|
May 6, 2016 |
|
Philip Ranker
|
|
|
55,000 |
|
|
$ |
5.00 |
|
|
|
May 6, 2006 |
|
|
|
May 6, 2016 |
|
Each of these options vests in four equal annual installments
measured from the grant date, although each may be exercised
prior to vesting. To the extent exercised prior to vesting, we
retain a right to repurchase at cost the unvested shares if the
optionholder ceases to be a director of ours. As of
June 30, 2006, none of these options has been exercised.
72
Executive Compensation
The following table sets forth all compensation paid or accrued
during the fiscal year ended December 31, 2005 to our Chief
Executive Officer and to each of our four other most highly
compensated executive officers whose salary and bonus exceeded
$100,000 for the year ended December 31, 2005. We refer to
these officers collectively as our named executive
officers. The compensation described in this table does
not include medical, group life insurance or other benefits
which are available generally to all of our salaried employees.
Summary Compensation Table
|
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|
|
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|
|
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|
|
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|
|
|
|
|
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|
|
Long-Term Compensation | |
|
|
|
|
| |
|
|
Annual Compensation | |
|
Securities | |
|
|
|
|
| |
|
Underlying | |
|
All Other | |
Name and Principal Position |
|
Salary | |
|
Bonus | |
|
Options | |
|
Compensation | |
|
|
| |
|
| |
|
| |
|
| |
Evan Unger, M.D.
|
|
$ |
229,617 |
|
|
$ |
58,334 |
|
|
|
665,000 |
|
|
$ |
|
|
|
President and Chief Executive Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
John
Moore(1)
|
|
|
125,000 |
|
|
|
18,750 |
|
|
|
|
|
|
|
|
|
|
Chairman and Executive Vice President |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Randall Miller,
Ph.D.(2)
|
|
|
132,809 |
|
|
|
12,000 |
|
|
|
195,000 |
|
|
|
22,212 |
(3) |
|
Chief Operating Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Greg
Cobb(4)
|
|
|
100,963 |
|
|
|
24,000 |
|
|
|
195,000 |
|
|
|
10,434 |
(3) |
|
Chief Financial Officer, Secretary and Treasurer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Terry Matsunaga, Ph.D
|
|
|
120,770 |
|
|
|
19,750 |
|
|
|
32,000 |
|
|
|
|
|
|
Vice President, Research |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Mr. Moore joined us in February 2004. Mr. Moores
employment with us terminated in February 2006, and he resigned
as a director on March 31, 2006. |
(2) |
Dr. Miller joined us in April 2005. Dr. Miller
voluntarily terminated his employment with us in February 2006. |
(3) |
Amount represents relocation expense reimbursement. |
(4) |
Mr. Cobb provided consulting services to us from
April 11, 2005 to April 26, 2005, and began full-time
employment as our chief financial officer on April 27,
2005. The amounts reflected in the table include all
compensation paid to Mr. Cobb in 2005. |
73
Stock Option Grants in 2005
The following table provides information concerning stock
options granted to each of our named executive officers during
the fiscal year ended December 31, 2005.
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Individual Grants | |
|
Potential Realizable | |
|
|
| |
|
Value at Assumed | |
|
|
Number of | |
|
% of Total | |
|
|
|
Annual Rates of Stock | |
|
|
Securities | |
|
Options | |
|
Exercise | |
|
|
|
Price Appreciation for | |
|
|
Underlying | |
|
Granted to | |
|
Price | |
|
|
|
Option Term | |
|
|
Options | |
|
Employees in | |
|
Per | |
|
Expiration | |
|
| |
Name |
|
Granted(1) | |
|
2005(2) | |
|
Share | |
|
Date | |
|
5% | |
|
10% | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Evan Unger
|
|
|
30,303 |
|
|
|
2.0 |
% |
|
$ |
3.30 |
|
|
|
08/08/10 |
|
|
|
|
|
|
|
|
|
|
|
|
149,697 |
(3) |
|
|
9.9 |
% |
|
|
3.00 |
|
|
|
08/08/15 |
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
(4) |
|
|
6.6 |
% |
|
|
3.00 |
|
|
|
08/08/15 |
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
(4) |
|
|
6.6 |
% |
|
|
3.00 |
|
|
|
08/08/15 |
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
(5) |
|
|
6.6 |
% |
|
|
3.00 |
|
|
|
08/08/15 |
|
|
|
|
|
|
|
|
|
|
|
|
120,000 |
(6) |
|
|
8.0 |
% |
|
|
3.00 |
|
|
|
08/08/15 |
|
|
|
|
|
|
|
|
|
|
|
|
65,000 |
|
|
|
4.3 |
% |
|
|
4.00 |
|
|
|
12/14/15 |
|
|
|
|
|
|
|
|
|
John Moore
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Randall Miller
|
|
|
175,000 |
(4) |
|
|
11.6 |
% |
|
|
3.00 |
|
|
|
04/18/15 |
|
|
|
|
|
|
|
|
|
|
|
|
20,000 |
(4) |
|
|
1.3 |
% |
|
|
4.00 |
|
|
|
12/14/15 |
|
|
|
|
|
|
|
|
|
Greg Cobb
|
|
|
150,000 |
(7) |
|
|
10.0 |
% |
|
|
3.00 |
|
|
|
04/27/15 |
|
|
|
|
|
|
|
|
|
|
|
|
45,000 |
|
|
|
3.0 |
% |
|
|
4.00 |
|
|
|
12/14/15 |
|
|
|
|
|
|
|
|
|
Terry Matsunaga
|
|
|
22,000 |
|
|
|
1.5 |
% |
|
|
4.00 |
|
|
|
11/01/15 |
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
0.7 |
% |
|
|
4.00 |
|
|
|
12/14/15 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
All options were granted under our 2000 Stock Plan. Unless
otherwise indicated, options vest in equal annual installments
over four years. |
|
(2) |
Percentages shown under % of Total Options Granted to
Employees in 2005 are based on an aggregate of
1,504,099 shares of common stock subject to stock options
granted to our employees during 2005. These percentages do not
include 250,000 shares of common stock subject to stock
options granted to our consultants during 2005. |
|
(3) |
14,697 shares are vested, and the remaining shares vest in
equal annual installments over three years. |
(4) |
These options were not exercised and have expired in accordance
with their terms. |
(5) |
Vesting subject to achievement of financial milestones which
have not been met. |
(6) |
Vesting subject to achievement of regulatory milestones which
have not been met. |
(7) |
Options to purchase 15,000 shares of our common stock
vested on the date of the grant and options to purchase
33,750 shares of our common stock vest in equal annual
installments and become exercisable annually over
four years. |
Each stock option may be exercised prior to vesting, subject to
repurchase by us at the original exercise price. The repurchase
right lapses over time in accordance with the vesting schedules
set forth in the table above. Under certain circumstances in
connection with a change of control, the vesting of the option
grants may accelerate and become immediately exercisable and
fully vested. See Employment Agreements. Our board
of directors retains the discretion, under certain circumstances
relating to changes in corporate structure that may affect our
common stock, to modify the terms of outstanding options to
reflect such changes and prevent the diminution or enlargement
of benefits or potential benefits intended to be made available
under the applicable stock plan.
Each stock option was granted with an exercise price equal to or
greater than the fair market value of our common stock on the
grant date, as determined by our board of directors. Because
there was no public market for our common stock prior to this
offering, the board of directors determined the fair market
value of our common stock by considering a number of factors,
including, but not limited to, aggregate liquidation preference
of our preferred stock, status of product development, our
financial condition and prospects for future growth.
Amounts presented under the caption Potential Realizable
Value at Assumed Annual Rates of Stock Price Appreciation for
Option Term represent hypothetical gains that could be
achieved for the respective stock options if exercised at the
end of the ten year option term. Stock price appreciation of 5%
and 10% is
74
assumed pursuant to rules promulgated by the SEC and does not
represent our prediction of our stock price performance. The
potential realizable values at 5% and 10% appreciation are
calculated by:
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|
multiplying the number of shares of common stock subject to a
given stock option by an assumed initial public offering price
of
$ per
share, the midpoint of the range on the front cover of this
prospectus; |
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|
assuming that the aggregate stock value derived from that
calculation compounds at the annual 5% or 10% rate shown in the
table until the expiration of the option and |
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|
subtracting from that result the aggregate option exercise price. |
Aggregated Option Exercises in 2005 and Fiscal Year-End
Option Values
The following table provides information concerning stock
options exercised during 2005, and unexercised stock options
held as of December 31, 2005, by each of our named
executive officers:
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|
Number of Securities Underlying | |
|
Value of Unexercised | |
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|
Unexercised Options at | |
|
In-the-Money Options at | |
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|
Shares | |
|
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|
December 31, 2005 | |
|
December 31, 2005(1) | |
|
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Acquired on | |
|
Value | |
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| |
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| |
Name |
|
Exercise | |
|
Realized(1) | |
|
Exercisable(2) | |
|
Unexercisable | |
|
Exercisable | |
|
Unexercisable | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Evan Unger
|
|
|
200,000 |
|
|
$ |
|
|
|
|
565,000 |
|
|
|
0 |
|
|
$ |
|
|
|
$ |
|
|
John Moore
|
|
|
|
|
|
|
|
|
|
|
250,000 |
|
|
|
0 |
|
|
|
|
|
|
|
|
|
Randall Miller
|
|
|
|
|
|
|
|
|
|
|
195,000 |
(3) |
|
|
0 |
|
|
|
|
|
|
|
|
|
Greg Cobb
|
|
|
|
|
|
|
|
|
|
|
195,000 |
|
|
|
0 |
|
|
|
|
|
|
|
|
|
Terry Matsunaga
|
|
|
|
|
|
|
|
|
|
|
120,000 |
|
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
There was no public trading market for our common stock as of
December 31, 2005. Accordingly, the amounts presented under
the captions Value Realized and Value of
Unexercised
In-the-Money Options at
December 31, 2005 are based on an assumed initial
public offering price of
$ per share, the
midpoint of the range on the front cover of this prospectus,
less the exercise price per share, multiplied by the number of
shares subject to the stock option, without taking into account
any taxes that may be payable in connection with the transaction. |
(2) |
All options are immediately exercisable, and, when and if
exercised, will be subject to a repurchase right held by us,
which right lapses in accordance with the respective vesting
schedules for such options. |
(3) |
These options were not exercised and have expired in accordance
with their terms. |
Employment Agreements
We currently have employment agreements with our President and
Chief Executive Officer, Evan C. Unger, M.D., and our Chief
Financial Officer, Greg Cobb. In addition, during 2005 we had
employment agreements with our former Chairman and Executive
Vice President, John Moore, and our former Chief Operating
Officer, Randall Miller, Ph.D. Mr. Moores employment
agreement terminated in accordance with its terms in February
2006. Dr. Miller voluntarily terminated his employment with
us in February 2006. Material terms of each of these agreements
are described below.
Evan C. Unger, M.D., President and Chief Executive
Officer
The employment agreement provides for an annual base salary of
$250,000, which is subject to review by our compensation
committee at least annually. Under the employment agreement,
Dr. Unger is eligible to earn an annual bonus of up to 50%
of his base salary upon completion of certain milestones. If
Dr. Ungers employment is terminated by us without
cause or by Dr. Unger with good reason, including a
material reduction in title, authority or responsibility, a
material reduction in benefits without comparable reductions of
other senior management, relocation of principal place of
employment outside Tucson, Arizona or our breach of material
obligations under the employment agreement, Dr. Unger will
continue to receive his then-current base salary as severance
for the six-month
period following the date of termination, followed by a one-time
lump sum payment equal to six months of his then-current base
salary. If within six month periods preceding or following a
change in control Dr. Ungers employment is terminated
by the us or a successor without cause or by Dr. Unger for
good reason, then we or our successor must pay Dr. Unger a
lump sum payment equal to 100% of his then-current base salary.
In addition, all of Dr. Ungers unvested stock options
75
would automatically vest and the exercise period for all such
stock options would be extended an additional 12 months.
Greg Cobb, Chief Financial Officer
The employment agreement provides for an annual base salary of
$150,000. Under the employment agreement, Mr. Cobb is
eligible to earn an annual bonus of up to 50% of his base salary
upon completion of certain milestones. Upon a change of control,
all of Mr. Cobbs 150,000 options in his initial
option grant vest immediately.
John Moore, Former Chairman of the Board and Executive Vice
President
We paid Mr. Moore base salary and bonuses in the aggregate
amount of $143,750 in 2005 pursuant to the terms of his
employment agreement.
Randall Miller Ph.D., Former Chief Operating Officer
We paid Dr. Miller base salary and bonuses in the aggregate
amount of $144,809 in 2005 pursuant to the terms of his
employment agreement.
Benefit Plans
Our board of directors adopted, and our stockholders approved,
our 2000 Stock Plan on January 12, 2000. We have reserved
5,000,000 shares of common stock for issuance under the
plan. As of June 30, 2006, options to purchase
2,897,024 shares of our common stock were outstanding under
our 2000 Stock Plan. Under certain circumstances, shares
underlying awards granted under the plan may again be available
for issuance under the plan. Upon the closing of this offering
the 2000 Stock Plan will terminate and no additional options may
be granted thereunder. Although the 2000 Stock Plan will
terminate, all outstanding options will continue to be governed
by their existing terms.
The compensation committee of our board of directors administers
our 2000 Stock Plan. Our compensation committee has the
authority to interpret the plan and any agreement entered into
under the plan, grant awards and make all other determinations
for the administration of the plan. Under our 2000 Stock Plan,
our compensation committee can grant stock options and stock
purchase rights to our employees, consultants and directors.
Our 2000 Stock Plan provides for the grant of both incentive
stock options that qualify for favorable tax treatment under
Section 422 of the Internal Revenue Code for their
recipients and nonqualified stock options. Incentive stock
options may be granted only to our employees. The exercise price
of incentive stock options must be at least equal to the fair
market value of our common stock on the date of grant. The
exercise price of incentive stock options granted to 10%
stockholders must be at least equal to 110% of the fair market
value of our common stock on the date of grant. Nonstatutory
stock options granted under the 2000 Stock Plan must have an
exercise price not less than 85% of the fair market value of our
common stock on the date of grant. Nonstatutory stock options
granted under the 2000 Stock Plan to 10% stockholders must have
an exercise price not less than 110% of the fair market value of
our common stock on the date of the grant. Except in the case of
options granted to officers, directors and third-party
consultants, options are exercisable at a rate of no less than
20% per year over five years from the date the options
are granted. The maximum permitted term of options granted under
our 2000 Stock Plan is ten years and the maximum term of
options granted to 10% stockholders is five years. Our
standard form of option agreement also allows for the early
exercise of options. All options exercised early are subject to
repurchase by us at the original exercise price. The repurchase
right lapses over time, at a rate of not less than 20% per
year over five years from the date the options are granted.
In the event of a change of control, our 2000 Stock Plan
provides that options and stock purchase rights held by current
employees, directors and consultants that are not assumed or
substituted will immediately vest in
76
full and become exercisable prior to the transaction and all
options and stock purchase rights shall expire prior to the
consummation of the transaction.
|
|
|
2006 Performance Incentive Plan |
In May 2006, our board of directors adopted and in July 2006 our
stockholders approved, our 2006 Performance Incentive Plan, or
the Incentive Plan. The Incentive Plan will become effective
upon the signing of the underwriting agreement for this offering.
The Incentive Plan is intended to make available incentives that
will assist us to attract, retain and motivate employees,
consultants and members of the board of directors, whose
contributions are essential to our success. We may provide these
incentives through the grant of stock options, stock
appreciation rights, restricted stock awards, restricted stock
units, performance shares and units, deferred compensation
awards, other cash-based or stock-based awards and non-employee
director awards.
A total of 1,800,000 shares of our common stock are
initially authorized and reserved for issuance under the
Incentive Plan, plus up to an additional 2,897,024 shares
that are subject to outstanding options under our 2000 Stock
Plan as of the date of the plans termination and for which
such options expire or otherwise terminate without having been
exercised in full.
The administrator of our Incentive Plan will generally be the
compensation committee of our board of directors, although the
board of directors or compensation committee may delegate to one
or more of our officers limited authority to grant awards to
service providers who are neither officers nor directors. The
administrator has the sole authority to construe and interpret
the terms of the Incentive Plan and awards granted under it.
Subject to the provisions of the Incentive Plan, the
administrator has the discretion to determine the persons to
whom and the times at which awards are granted, the types and
sizes of such awards, and all of their terms and conditions.
Our employees and consultants are eligible to receive grants of
nonstatutory stock options, stock appreciation rights,
restricted stock awards, restricted stock units and performance
shares or units under the Incentive Plan, while only employees
are eligible for incentive stock option awards. For all options
granted under the Incentive Plan, the exercise price may not be
less than the fair market value of a share of our common stock
on the date of grant. Deferred compensation awards may be
granted only to officers, directors or members of a select group
of highly compensated employees. Non-employee director awards
may be granted only to members of the board of directors who are
not employees of the company or any affiliate of the company.
Non-employee directors may be granted nonstatutory stock
options, stock appreciation rights, restricted stock or
restricted stock units. Non-employee director awards are limited
to no more than 75,000 shares in any fiscal year, except
that this limit may be increased on the basis of the attainment
of certain milestones, including the individuals initial
appointment or election to the board of directors, service as
the chairman or lead director of the board of directors, service
on a committee of the board of directors, and service as
chairman on a committee of the board of directors.
In the event of certain changes in control of the company, stock
options and stock appreciation rights outstanding under the
Incentive Plan may be assumed or substituted by the successor
entity. Any stock options or stock appreciation rights that are
not assumed in connection with a change in control or exercised
prior to a change in control will terminate without further
action by the administrator. However, the administrator may
choose to:
|
|
|
|
|
accelerate the vesting and exercisability of any or all
outstanding options and stock appreciation rights upon such
terms as it determines; or |
|
|
|
cancel each or any outstanding option or stock appreciation
right in exchange for a payment to the holder with respect to
each share. |
In the event of a change in control, the administrator may also,
in certain cases, choose to accelerate the vesting or settlement
of any restricted stock award, restricted stock unit award,
performance share or performance unit award, deferred
compensation award, or cash-based or other stock-based award
upon such
77
conditions as it determines. In addition, the vesting of all
non-employee director awards will automatically be accelerated
in full upon a change in control.
The Incentive Plan will continue in effect until it is
terminated by the administrator, provided, however, that all
awards will be granted, if at all, within ten years of the
effective date of the Incentive Plan. The administrator may
amend, suspend or terminate the Incentive Plan at any time,
provided, that without stockholder approval, the plan cannot be
amended to increase the number of shares authorized, change the
class of persons eligible to receive incentive stock options or
effect any other change that would require stockholder approval
under any applicable law or listing rule. Amendment, suspension
or termination of the Incentive Plan may not adversely affect
any outstanding award without the consent of the participant,
unless such amendment, suspension or termination is necessary to
comply with any applicable law, regulation or rule.
Management Bonus Plan
In August 2006, our board of directors adopted our Management
Bonus Plan, or Bonus Plan, which will be administered by our
compensation committee. The Bonus Plan is effective as of
July 1, 2006. The Bonus Plan allows our executive officers
and other senior officers designated by our independent
directors to earn quarterly and annual performance-based cash
bonuses in addition to their annual base salary. The quarterly
and annual performance goals will be identified by our
compensation committee based upon recommendations from
management. The maximum annual bonus amount that can be earned
by each individual under the Bonus Plan is equal to 10% of the
individuals base salary as of the end of each calendar
quarter with respect to which a bonus is being determined, and
an additional 10% of the individuals base salary as of the
end of the fiscal year, for an aggregate possible annual bonus
of up to 50% of the individuals base salary.
To determine an individuals quarterly bonus, if any, the
compensation committee will:
|
|
|
|
|
|
first, determine the percentage of corporate performance goals
that have been satisfied during the quarter. The corporate
performance goals will be determined quarterly by the
compensation committee and will be comprised of significant
corporate milestones that relate to our company-wide strategic
plan for the quarter; |
|
|
|
|
|
second, determine the percentage of department performance goals
for each department of the company that have been satisfied
during the quarter. The department performance goals will be
determined quarterly by the compensation committee and will be
comprised of significant department milestones that relate to
our company-wide strategic plan for the quarter. If the
department performance goals for all departments of the company
are not met, then the amount of quarterly bonus that may be paid
will be reduced by 20%; and |
|
|
|
|
|
third, determine the percentage of individual performance goals
that have been satisfied during the quarter. The individual
performance goals, and their relative weighting, will be
determined quarterly by the compensation committee and will be
comprised of significant performance milestones that relate to
the individuals position and our company-wide strategic
plan for the quarter. To be eligible for a bonus, all of the
corporate performance goals must have been met for the quarter,
and all of the department performance goals for the department
to which an individual belongs must have been met. The
percentage of an eligible individuals performance goals
deemed satisfied will be multiplied by the maximum bonus amount
payable to the individual under the Bonus Plan to determine the
amount of the individuals quarterly bonus. |
|
The corporate performance goals for the third quarter of 2006
relate to financing, Investigational New Drug application
filing, and clinical trial milestones. The department
performance goals for the third quarter of 2006 relate to
preclinical research and clinical trial milestones,
Investigational New Drug application filing, product development
milestones, financing, and other significant department
milestones.
To determine an individuals annual bonus, if any, the
compensation committee will:
|
|
|
|
|
first, determine the percentage of individual performance goals
that have been satisfied during the year with respect to which a
bonus is being determined, and multiply the result by an amount
equal to five percent of the individuals base
salary; and |
78
|
|
|
|
|
second, determine the percentage of annual individual
performance goals that have been satisfied during the year with
respect to which a bonus is being determined, and multiply the
result by an amount equal to five percent of the
individuals base salary. The annual individual performance
goals, and their relative weighting, will be determined annually
by the compensation committee and will be comprised of measures
that evaluate the overall performance and management skills for
each individual for the year. |
Limitation of Liability and Indemnification
Our amended and restated certificate of incorporation, which
will become effective upon the closing of this offering, limits
the liability of directors to the maximum extent permitted by
Delaware law. Delaware law provides that directors of a
corporation will not be personally liable for monetary damages
for breach of their fiduciary duties as directors, except for
liability for any:
|
|
|
|
|
breach of their duty of loyalty to the corporation or its
stockholders; |
|
|
|
act or omission not in good faith or that involves intentional
misconduct or a knowing violation of law; |
|
|
|
unlawful payment of dividends or redemption of shares; or |
|
|
|
transaction from which the directors derived an improper
personal benefit. |
These limitations of liability do not apply to liabilities
arising under federal securities laws and do not affect the
availability of equitable remedies such as injunctive relief or
rescission.
Our amended and restated bylaws, which will become effective
upon the closing of this offering, provide that we will
indemnify our directors and executive officers, and may
indemnify other officers, employees and other agents, to the
fullest extent permitted by law. Our amended and restated bylaws
also permit us to secure insurance on behalf of any officer,
director, employee or other agent for any liability arising out
of his or her actions in connection with their services to us,
regardless of whether our amended and restated bylaws permit
such indemnification. We maintain a liability insurance policy
pursuant to which our directors and officers may be indemnified
against liability incurred for serving in their capacities as
directors and officers.
Prior to completion of this offering, we intend to enter into
separate indemnification agreements with our directors and
executive officers, in addition to the indemnification provided
for in our amended and restated bylaws. These agreements, among
other things, require us to indemnify our directors and
executive officers for certain expenses, including
attorneys fees, judgments, fines and settlement amounts
incurred by a director or executive officer in any action or
proceeding arising out of their services as one of our directors
or executive officers, or any of our subsidiaries or any other
related company or enterprise to which the person provides
services at our request.
We believe provisions in our new amended and restated
certificate of incorporation and indemnification agreements are
necessary to attract and retain qualified persons as directors
and officers. The limitation of liability and indemnification
provisions in our certificate of incorporation and bylaws may
discourage stockholders from bringing a lawsuit against our
directors for breach of their fiduciary duty. They may also
reduce the likelihood of derivative litigation against our
directors and officers, even though an action, if successful,
might benefit us and other stockholders. Furthermore, a
stockholders investment may be adversely affected to the
extent that we pay the costs of settlement and damage awards
against directors and officers as required by these
indemnification provisions.
At present we are not aware of any pending litigation or
proceeding involving any of our directors, officers, employees
or agents in their capacity as such, for which indemnification
will be required or permitted. In addition, we are not aware of
any threatened litigation or proceeding that may result in a
claim for indemnification by any director or officer.
79
Certain Relationships and Related Transactions
Since January 1, 2003, we have engaged in the following
transactions involving amounts exceeding $60,000 with our
executive officers, directors and holders of 5% or more of our
stock. We believe that all of these transactions were on terms
as favorable as could have been obtained from related third
parties.
Lease
We lease a 6,200 square foot facility located at
1635 E. 18th St., Tucson, Arizona 85719 as our
headquarters and laboratory facility for approximately
$64,000 per year. This facility is owned by a partnership
whose beneficial owners include Evan Unger, our President and
Chief Executive Officer and a director, Dean Unger, father of
Evan Unger and a former director, Rajan Ramaswami, our Vice
President Development; and Terry Matsunaga, our Vice President
Research. This lease provides for a rental rate of
$10.39 per square foot per year, triple-net, and expires in
October 2008.
Stock Sales
During 2003 and 2004, the Evan and Susan Unger Family Trust
dated October 24, 1995 purchased convertible secured
promissory notes from us in the aggregate principal amount of
$150,000. On March 30, 2004, the outstanding principal and
accrued interest under these convertible secured promissory
notes converted into 78,217 shares of our common stock at a
conversion price of $2.00 per share. In January 2005, the
Unger Family Trust also purchased 34,000 shares of our
common stock at a purchase price of $3.00 per share pursuant to
a private placement conducted by First Montauk Securities Corp.
as placement agent. In November 2005, the Unger Family Trust
also purchased 1,250 shares of our common stock at a purchase
price of $4.00 per share pursuant to a private placement
conducted by First Montauk Securities Corp. as placement agent.
On January 22, 2003, Edson Moore Healthcare Ventures, Inc.,
an entity controlled by John Moore, our former Executive Vice
President and a former director, purchased 54,545 shares of
our Series D preferred stock. The Series D preferred
stock includes voting and redemption rights, a liquidation
preference, and anti-dilution protection. The Series D
preferred stock will automatically convert into common stock
upon the closing of this offering. In 2003, Edson Moore
Healthcare Ventures also purchased a convertible promissory note
from us in the aggregate principal amount of $215,000. On
March 30, 2004, the outstanding principal amount and
accrued interest under this note converted into
112,318 shares of our common stock at a conversion price of
$2.00 per share. In July 2003, we issued 38,809 shares
of Series B preferred stock in payment of dividends on
outstanding shares of Series B preferred stock held by
Edson Moore Healthcare Ventures. The Series B preferred
stock is non-voting but includes redemption rights, a
liquidation preference and anti-dilution protection. The
Series B preferred stock will automatically convert into
common stock upon the closing of this offering. On
January 30, 2005, Edson Moore Healthcare Ventures purchased
40,000 shares of our common stock pursuant to a private
placement conducted by First Montauk Securities as placement
agent.
We sold the convertible secured promissory notes, common stock
and Series D preferred stock pursuant to securities
purchase agreements, under which we made standard
representations, warranties, and covenants, and granted certain
rights to the purchasers of these securities. The only rights
that survive beyond this offering are registration rights. See
Description of Capital Stock Registration
Rights.
Consulting Agreement
On March 31, 2006 we entered into an agreement with Edson
Moore Healthcare Ventures and John Moore that provides for the
payment of $250,000, plus, if the proceeds of the Series F
preferred stock financing exceed $25,000,000, an additional
$50,000, to Edson Moore Healthcare Ventures in exchange for past
consulting services and future financial consulting services on
an as-needed basis through March 2008. The agreement also
includes, with respect to Edson Moore Healthcare Ventures, a
waiver of certain of the protective provisions of the
Series B preferred stock and Series C preferred stock
set forth in our charter in
80
connection with the Series F preferred stock financing, a
mutual nondisparagement provision and our agreement not to
provide, after the date that our stock is traded on a national
securities exchange or quoted on The Nasdaq Global Market, any
non-public information to Edson Moore Healthcare Ventures. The
Agreement also includes, with respect to John Moore,
Mr. Moores resignation as a director, a mutual
nondisparagement provision and our agreement not to provide,
after the date that our stock is traded on a national securities
exchange or quoted on The Nasdaq Global Market, any non-public
information to Mr. Moore.
Agreements and Future Agreements with Executive Officers and
Directors
We have entered into separate indemnification agreements with
our directors and executive officers, in addition to the
indemnification provided for in our amended and restated bylaws.
See Management Limitation of Liability and
Indemnification.
We also have entered into employment and other agreements with
some of our executive officers and former executive officers.
See Management Employment Agreements. All
future transactions between us and our officers, directors,
principal stockholders and their affiliates will be approved by
a majority of our board of directors, including a majority of
the independent and disinterested directors in these
transactions, or by a committee comprised of independent
directors.
81
Principal Stockholders
The following table sets forth, as of June 30, 2006,
information regarding beneficial ownership of our capital stock
by the following:
|
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|
|
each person, or group of affiliated persons, known by us to be
the beneficial owner of 5% or more of any class of our voting
securities; |
|
|
|
each of our current directors; |
|
|
|
each of our named executive officers; and |
|
|
|
all current directors and executive officers as a group. |
Beneficial ownership is determined according to the rules of the
SEC. Beneficial ownership means that a person has or shares
voting or investment power of a security, and includes shares
underlying options and warrants that are currently exercisable
or exercisable within 60 days after the measurement date.
This table is based on information supplied by officers,
directors and principal stockholders. Except as otherwise
indicated, we believe that the beneficial owners of the common
stock listed below, based on the information each of them has
given to us, have sole investment and voting power with respect
to their shares, except where community property laws may apply.
Options and warrants to purchase shares of our common stock that
are exercisable within 60 days after June 30, 2006 are
deemed to be beneficially owned by the persons holding these
options and warrants for the purpose of computing percentage
ownership of that person, but are not treated as outstanding for
the purpose of computing any other persons ownership
percentage. Unless otherwise indicated, all footnotes below the
table reflect options and warrants exercisable within
60 days after June 30, 2006.
This table lists applicable percentage ownership based on
21,197,795 shares of common stock outstanding as of
June 30, 2006, assuming conversion of all outstanding
shares of our preferred stock, but assuming no exercise of
outstanding warrants or options, and also lists applicable
percentage ownership based
on shares
of common stock outstanding after the closing of the offering.
Unless otherwise indicated, the address for each of the
stockholders in the table below is c/o ImaRx Therapeutics,
Inc., 1635 East 18th Street, Tucson, AZ 85719.
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Shares of | |
|
Percent | |
|
|
Common Stock | |
|
| |
|
|
Beneficially | |
|
Before | |
|
After | |
Name and Address of Beneficial Owner |
|
Owned(1) | |
|
Offering | |
|
Offering(1) | |
|
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| |
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| |
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| |
5% Stockholders
|
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|
|
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Evan and Susan Unger Family Trust dated
10/24/95(2)
|
|
|
2,047,476 |
|
|
|
9.7 |
% |
|
|
|
% |
|
Edson Moore Healthcare Ventures, Inc.
(3)
|
|
|
1,480,710 |
|
|
|
7.0 |
|
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|
101 Brook Meadow Road
Wilmington, DE 19807 |
|
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Directors and Named Executive Officers
|
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Evan C. Unger,
M.D.(4)
|
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2,713,726 |
|
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12.5 |
|
|
|
|
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John
Moore(5)
|
|
|
1,829,962 |
|
|
|
8.5 |
|
|
|
|
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James M.
Strickland(6)
|
|
|
460,476 |
|
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2.2 |
|
|
|
|
|
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Greg
Cobb(7)
|
|
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255,000 |
|
|
|
1.2 |
|
|
|
|
|
|
Terry
Matsunaga(8)
|
|
|
155,924 |
|
|
|
* |
|
|
|
|
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Randall Miller
|
|
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12,500 |
|
|
|
* |
|
|
|
|
|
|
Richard
Otto(9)
|
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55,000 |
|
|
|
* |
|
|
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Thomas W.
Pew(10)
|
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348,042 |
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1.6 |
|
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Richard
Love(11)
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55,000 |
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* |
|
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Phil
Ranker(12)
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55,000 |
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* |
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All Directors and Officers as a Group
(14 persons)(13)
|
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4,848,168 |
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21.1 |
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* |
Less than one percent (1%). |
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(1) |
Upon completion of this offering, our existing stockholders will
own shares,
representing %
of our outstanding common stock. |
(2) |
Consists of 2,031,832 shares of common stock and
15,644 shares issuable upon exercise of warrants to
purchase common stock held by the Evan and Susan Unger Family
Trust dated 10/24/95, of which Dr. Unger and Susan J. Unger are
co-trustees and share voting and dispositive power. |
(3) |
Consists of 1,330,930 shares of common stock held by Edson
Moore Corp, and 127,317 shares of common stock and
22,463 shares issuable upon exercise of warrants to
purchase common stock held by Edson Moore Healthcare Ventures,
Inc. |
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(4) |
Consists of 2,031,832 shares of common stock and
15,644 shares of common stock issuable upon exercise of
warrants to purchase common stock held by Evan C. and Susan J.
Unger Trust dated 10/24/95, of which Dr. Unger and Susan J.
Unger are co-trustees and share voting and dispositive power,
200,000 shares of common stock held by Dr. Unger,
1,250 shares of common stock held by Evan C. Unger and
Susan J. Unger, and 465,000 shares issuable upon exercise
of stock options, 375,000 of which, if exercised, are subject to
repurchase by us within 60 days after June 30, 2006. |
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(5) |
Consists of 1,458,247 shares of common stock and
22,463 shares issuable upon exercise of warrants to
purchase common stock held by Edson Moore Healthcare Ventures,
Inc., and 96,618 shares of common stock,
250,000 shares issuable upon exercise of stock options and
2,634 shares issuable upon exercise of warrant to purchase
common stock held by Mr. Moore. |
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(6) |
Consists of 395,476 shares of common stock held by Coronado
Venture Fund IV, LP, 10,000 shares of common stock
held by Mr. Strickland, and 55,000 shares of common
stock issuable upon exercise of options held by Mr. Strickland,
27,500 of which, if exercised, are subject to repurchase by us
within 60 days after June 30, 2006. With regard to
Coronado Venture Fund IV, LP, Coronado Venture Management LLC is
the sole general partner of and may be deemed to have voting and
dispositive power over shares held by Coronado Venture Fund IV,
LP. Mr. Strickland is a managing director of Coronado Venture
Management LLC. Mr. Strickland disclaims beneficial ownership of
the shares held by Coronado Venture Fund IV, LP, except to
the extent of his direct pecuniary interest therein. |
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(7) |
Consists of 255,000 shares of common stock issuable upon
exercise of options, 206,250 of which, if exercised, are subject
to repurchase by us within 60 days after June 30, 2006. |
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(8) |
Consists of 35,924 shares of common stock and
120,000 shares of common stock issuable upon exercise of
options, 39,500 of which, if exercised, are subject to
repurchase by us within 60 days after June 30, 2006. |
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(9) |
Consists of 55,000 shares of common stock issuable upon
exercise of options, 27,500 of which, if exercised, are subject
to repurchase by us within 60 days after June 30, 2006. |
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(10) |
Consists of 276,629 shares of common stock,
16,413 shares of common stock issuable upon exercise of
warrants and 55,000 shares of common stock issuable upon
exercise of options, 27,500 of which, if exercised, are subject
to repurchase by us within 60 days after June 30, 2006. |
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(11) |
Consists of 55,000 shares of common stock issuable upon
exercise of options, all of which, if exercised, are subject to
repurchase by us within 60 days after June 30, 2006. |
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(12) |
Consists of 55,000 shares of common stock issuable upon
exercise of options, all of which, if exercised, are subject to
repurchase by us within 60 days after June 30, 2006. |
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(13) |
Includes shares described in Footnotes (4), (6) through (8) and
(10) through (12) above, 95,000 shares of common stock held
by Rajan Ramaswami, and 655,000 shares issuable upon
exercise of stock options held by Brad Zakes, Rajan Ramaswami,
Reena Zutshi, Walter Singleton, Lynne E. Weissberger and
John McCambridge, 537,200 of which, if exercised, are subject to
repurchase. |
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Description of Capital Stock
Upon the effectiveness of this offering and the filing of our
amended and restated certificate of incorporation with the
Delaware Secretary of State, our authorized capital stock will
consist of 100,000,000 shares of common stock,
$0.0001 par value per share, and 5,000,000 shares of
preferred stock, $0.0001 par value per share. The following
description of our capital stock does not purport to be complete
and is subject to, and qualified in its entirety by, our amended
and restated certificate of incorporation and bylaws, which are
exhibits to the registration statement of which this prospectus
forms a part.
Common Stock
As of June 30, 2006, 21,197,795 shares of our common
stock were outstanding and held of record by 345 stockholders.
This amount assumes the conversion of all outstanding shares of
our preferred stock into common stock, which will occur
immediately prior to the effectiveness of this offering. In
addition, as of June 30, 2006, 2,897,024 shares of our
common stock were subject to outstanding options and
1,761,749 shares of our common stock were subject to
outstanding warrants. Upon the closing of this
offering, shares
of our common stock will be outstanding, assuming no exercise of
outstanding stock options or warrants or the underwriters
over-allotment option.
Each share of our common stock entitles its holder to one vote
on all matters to be voted on by our stockholders. Subject to
preferences that may apply to any of our outstanding preferred
stock, holders of our common stock will participate equally in
all dividends payable with respect to our common stock, if and
when declared by our board of directors. If we liquidate,
dissolve or wind up, the holders of common stock are entitled to
share ratably in all distributions of assets subject to any
liquidation rights and preferences of any of our outstanding
preferred stock. Our common stock has no preemptive rights,
conversion rights or other subscription rights or redemption or
sinking fund provisions. The shares of our common stock to be
issued upon the closing of this offering will be fully paid and
non-assessable.
Preferred Stock
After the offering, our board of directors will have the
authority, without further action by our stockholders, to issue
up to 5,000,000 shares of our preferred stock in one or
more series. Our board of directors may designate the rights,
preferences, privileges and restrictions of our preferred stock,
including any qualifications, limitations or restrictions
thereon. The issuance of our preferred stock could have the
effect of restricting dividends on our common stock, diluting
the voting power of our common stock, impairing the liquidation
rights of our common stock, or delaying or preventing a change
in control. Even the ability to issue preferred stock could
delay or impede a change in control. Immediately after the
closing of this offering, no shares of our preferred stock will
be outstanding, and we currently have no plan to issue any
shares of our preferred stock.
Warrants
As of June 30, 2006 the following warrants were outstanding:
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Warrant to purchase 11,407 shares of our common stock, at
an exercise price of $2.75 per share. This warrant may be
exercised at any time prior to the later of either
January 16, 2011 or five years after our initial public
offering. |
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Warrant to purchase an aggregate of 3,071 shares of our
common stock at an exercise price of $7.00 per share. This
warrant may be exercised at any time prior to March 6, 2011. |
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Warrant to purchase an aggregate of 5,000 shares of our
common stock at an exercise price of $2.00 per share. This
warrant may be exercised at any time prior to October 10,
2013. |
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Warrants to purchase an aggregate of 188,938 shares of our
common stock at an exercise price of $2.00 per share issued
pursuant to our March 2003 bridge financing. These warrants may
be exercised from time to time prior to January 28, 2011. |
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Warrants to purchase an aggregate of 500,000 shares of our
common stock at an exercise price of $3.00 per share. These
warrants may be exercised at any time prior to March 28,
2009. |
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Warrants to purchase an aggregate of 250,000 shares of our
common stock at an exercise price of $2.00 per share. These
warrants may be exercised at any prior to October 5, 2008. |
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Warrant to purchase an aggregate of 20,000 shares of our
common stock at an exercise price of $3.00 per share. This
warrant may be exercised at any time prior to January 3,
2010. |
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Warrants to purchase an aggregate of 233,333 shares of our
common stock at an exercise price of $3.30 per share. These
warrants may be exercised at any time prior February 27,
2010. |
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Warrants to purchase an aggregate of 100,000 shares of our
common stock at an exercise price of $4.00 per share. These
warrants may be exercised at any time prior to
September 27, 2015. |
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Warrants to purchase an aggregate of 375,000 shares of our
common stock at an exercise price of $4.25 per share. These
warrants may be exercised at any time prior to October 6,
2012. |
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Warrants to purchase an aggregate of 75,000 shares of our
common stock at an exercise price of $4.00 per shares.
These warrants may be exercised at any time prior to
January 13, 2013. |
All of our outstanding warrants contain provisions for the
adjustment of the exercise price and the number of shares
issuable upon the exercise of the warrant in the event of stock
dividends, stock splits, reorganizations, reclassifications and
consolidations. In addition, certain of the warrants contain a
net exercise provision.
Registration Rights
Commencing 180 days after the effective date of the
registration statement of which this prospectus is a part, the
holders of 7,164,157 shares of our common stock or certain
transferees will be entitled to require us to register these
shares under the Securities Act, subject to limitations and
restrictions. In addition, the holders of these shares may
require us, at our expense and on not more than one occasion in
any twelve month period, to file a registration statement on
Form S-3 under the
Securities Act, if we become eligible to use such form, covering
their shares of our common stock, and we will be required to use
our best efforts to have the registration statement declared
effective. Also, if at any time, we propose to register any of
our securities under the Securities Act, either for our own
account or for the account of other security holders, the
holders of these shares, the holders of 9,615,674 shares of
common stock, and the holders of 1,474,739 shares of common
stock issuable upon the exercise of outstanding warrants, will
be entitled to notice of the registration and, subject to
certain exceptions, will be entitled to include, at our expense,
their shares of our common stock in the registration. These
rights terminate on the earlier of seven years after the closing
of this offering, or, with respect to an individual holder, such
time as Rule 144 or another similar exemption under the
Security Act is available for the sale of all of such
holders shares during a three-month period without
registration. These registration rights are subject to
conditions and limitations, including the right of the
underwriters to limit the number of shares of our common stock
included in the registration statement.
Anti-Takeover Provisions
Delaware Anti-Takeover Law
We are subject to Section 203 of the Delaware General
Corporation Law, which regulates, subject to some exceptions,
acquisitions of publicly held Delaware corporations. In general,
Section 203 prohibits us from engaging in a business
combination with an interested stockholder for
a period of three years following the date the person becomes an
interested stockholder, unless:
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our board of directors approved the business combination or the
transaction in which the person became an interested stockholder
prior to the date the person attained this status; |
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upon consummation of the transaction that resulted in the person
becoming an interested stockholder, the person owned at least
85% of our voting stock outstanding at the time the transaction
commenced, excluding shares owned by persons who are directors
and also officers and issued under employee stock plans under
which employee participants do not have the right to determine
confidentially whether shares held subject to the plan will be
tendered in a tender or exchange offer; or |
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on or subsequent to the date the person became an interested
stockholder, our board of directors approved the business
combination and the stockholders other than the interested
stockholder authorized the transaction at an annual or special
meeting of stockholders by the affirmative vote of at least
two-thirds of the outstanding stock not owned by the interested
stockholder. |
Section 203 defines a business combination to
include:
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any merger or consolidation involving us and the interested
stockholder; |
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any sale, transfer, pledge or other disposition involving the
interested stockholder of 10% or more of our assets; |
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in general, any transaction that results in the issuance or
transfer by us of any of our stock to the interested stockholder; |
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any transaction involving us that has the effect of increasing
the proportionate share of our stock owned by the interested
stockholders; and |
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the receipt by the interested stockholder of the benefit of any
loans, advances, guarantees, pledges, or other financial
benefits provided by or through us. |
In general, Section 203 defines an interested
stockholder as any person who, together with the
persons affiliates and associates, owns, or within three
years prior to the time of determination of interested
stockholder status did own, 15% or more of a corporations
voting stock.
Certificate of Incorporation
and Bylaw Provisions
Upon completion of this offering, our amended and restated
certificate of incorporation and bylaws will include a number of
provisions that may have the effect of deterring hostile
takeovers or delaying or preventing changes in control or our
management. These provisions include the following:
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our board can issue up to 5,000,000 shares of preferred
stock, with any rights or preferences, including the right to
approve or not approve an acquisition or other change in control; |
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our bylaws provide that our board of directors may be removed
with or without cause by the affirmative vote of a majority of
our stockholders; |
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our bylaws limit who may call a special meeting of stockholders
to our board of directors, chairman of the board, president and
one or more stockholders holding not less than 25% of all shares
entitled to be cast on any issue proposed to be considered at
that meeting; |
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our bylaws provide that stockholders seeking to present
proposals before a meeting of stockholders or to nominate
candidates for election as directors at a meeting of
stockholders must provide timely advance written notice to us in
writing; |
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our bylaws specify requirements as to the form and content of a
stockholders notice; |
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our bylaws provides that, subject to the rights of the holders
of any outstanding series of our preferred stock, all vacancies,
including newly created directorships, may, except as otherwise
required by law, be filled by the affirmative vote of a majority
of our directors then in office, even if less than a quorum; |
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our bylaws provides that our board of directors may fix the
number of directors by resolution; |
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our amended and restated certificate of incorporation provide
that all stockholder actions must be effected at a duly called
meeting of stockholders and not by written consent; and |
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our amended and restated certificate of incorporation do not
provide for cumulative voting for our directors. The absence of
cumulative voting may make it more difficult for stockholders
owning less than a majority of our stock to elect any directors
to our board. |
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Transfer Agent and Registrar
Registrar and Transfer Company has been appointed as the
transfer agent and registrar for our common stock.
Listing
We have applied to have our common stock approved for quotation
on The Nasdaq Global Market under the trading symbol
IMRX.
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Material U.S. Federal Tax Consequences
To
Non-U.S. Holders
The following is a summary of material U.S. federal income
and estate tax consequences of the ownership and disposition of
our common stock by a
non-U.S. holder.
For purposes of this discussion, a
non-U.S. holder is
any beneficial owner that for U.S. federal income tax
purposes is not a U.S. person; the term U.S. person
means:
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an individual citizen or resident of the U.S.; |
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a corporation or other entity taxable as a corporation created
or organized in the U.S. or under the laws of the
U.S. or any political subdivision thereof, other than a
partnership treated as foreign under the U.S. treasury
regulations; |
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an estate whose income is subject to U.S. federal income
tax regardless of its source; or |
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a trust (x) whose administration is subject to the primary
supervision of a U.S. court and which has one or more
U.S. persons who have the authority to control all
substantial decisions of the trust or (y) which has made an
election to be treated as a U.S. person. |
An individual may, in certain cases, be treated as a resident of
the U.S., rather than a nonresident, among other ways, by virtue
of being present in the U.S. on at least 31 days in
that calendar year and for an aggregate of at least
183 days during the three-year period ending in that
calendar year (counting for such purposes all the days present
in the current year, one-third of the days present in the
immediately preceding year and one-sixth of the days present in
the second preceding year). Residents are subject to
U.S. federal income tax as if they were U.S. citizens.
If a partnership or other pass-through entity holds common
stock, the tax treatment of a partner or member in the
partnership or other entity will generally depend on the status
of the partner or member and upon the activities of the
partnership or other entity. Accordingly, we urge partnerships
or other pass-through entities which hold our common stock and
partners or members in these partnerships or other entities to
consult their tax advisors.
This discussion assumes that
non-U.S. holders
will acquire our common stock pursuant to this offering and will
hold our common stock as a capital asset (generally, property
held for investment). This discussion does not address all
aspects of U.S. federal income taxation that may be
relevant in light of a
non-U.S. holders
special tax status or special tax situations.
U.S. expatriates, controlled foreign corporations, passive
foreign investment companies, corporations that accumulate
earnings to avoid federal income tax, life insurance companies,
tax-exempt organizations, dealers in securities or currency,
brokers, banks or other financial institutions, certain trusts,
hybrid entities, pension funds and investors that hold common
stock as part of a hedge, straddle or conversion transaction are
among those categories of potential investors that are subject
to special rules not covered in this discussion. This discussion
does not consider the tax consequences for partnerships or
persons who hold their interests through a partnership or other
entity classified as a partnership for U.S. federal income
tax purposes. This discussion does not address any
U.S. federal gift tax consequences, or state or local or
non-U.S. tax
consequences. Furthermore, the following discussion is based on
current provisions of the Internal Revenue Code, and Treasury
Regulations and administrative and judicial interpretations
thereof, all as in effect on the date hereof, and all of which
are subject to change, possibly with retroactive effect. We have
not sought any ruling from the Internal Revenue Service, or IRS,
with respect to statements made and conclusions reached in this
discussion, and there can be no assurance that the IRS will
agree with these statements and conclusions.
This discussion is for general purposes only. Prospective
investors are urged to consult their own tax advisors regarding
the application of the U.S. federal income and estate tax
laws to their particular
88
situations and the consequences under U.S. federal gift
tax laws, as well as foreign, state, and local laws and tax
treaties.
Dividends
We have not paid any dividends on our common stock and we do not
plan to pay any dividends for the foreseeable future. However,
if we do pay dividends on our common stock, those payments will
constitute dividends to the extent paid from our current or
accumulated earnings and profits, as determined under
U.S. federal income tax principles. To the extent those
dividends exceed our current and accumulated earnings and
profits, the dividends will constitute a return of capital and
will first reduce a holders basis, but not below zero, and
then will be treated as gain from the sale of stock.
The gross amount of any dividend (out of earnings and profits)
paid to a
non-U.S. holder of
common stock generally will be subject to U.S. withholding
tax at a rate of 30% unless the holder is entitled to an
exemption from or reduced rate of withholding under an
applicable income tax treaty. To receive a reduced treaty rate,
prior to the payment of a dividend a
non-U.S. holder
must provide us with a properly completed IRS Form W-8BEN
(or successor form) certifying qualification for the reduced
rate.
Dividends received by a
non-U.S. holder
that are effectively connected with a U.S. trade or
business conducted by the
non-U.S. holder
(or dividends attributable to a
non-U.S. holders
permanent establishment in the U.S. if an income tax treaty
applies) are exempt from this withholding tax. To obtain this
exemption, prior to the payment of a dividend a
non-U.S. holder
must provide us with a properly completed IRS Form W-8ECI
(or successor form) properly certifying this exemption.
Effectively connected dividends (or dividends attributable to a
permanent establishment), although not subject to withholding
tax, are subject to U.S. federal income tax at the same
graduated rates applicable to U.S. persons, net of certain
deductions and credits. In addition, dividends received by a
corporate
non-U.S. holder
that are effectively connected with a U.S. trade or
business of the corporate
non-U.S. holder
(or dividends attributable to a corporate
non-U.S. holders
permanent establishment in the U.S. if an income tax treaty
applies) may also be subject to a branch profits tax at a rate
of 30% (or such lower rate as may be specified in an income tax
treaty).
A non-U.S. holder
who provides us with an IRS Form W-8BEN or an IRS
Form W-8ECI will
be required to periodically update such form.
A non-U.S. holder
of common stock that is eligible for a reduced rate of
withholding tax pursuant to an income tax treaty may obtain a
refund of any excess amounts currently withheld if an
appropriate claim for refund is timely filed with the IRS.
Gain on Disposition of Common Stock
A non-U.S. holder
generally will not be subject to U.S. federal income or
withholding tax on gain realized on the sale or other
disposition of our common stock unless:
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the gain is effectively connected with a U.S. trade or
business of the
non-U.S. holder
(or attributable to a permanent establishment in the
U.S. if an income tax treaty applies), which gain, in the
case of a corporate
non-U.S. holder,
must also be taken into account for branch profits tax purposes; |
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the
non-U.S. holder is
an individual who is present in the U.S. for a period or
periods aggregating 183 days or more during the calendar
year in which the sale or disposition occurs and certain other
conditions are met; or |
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our common stock constitutes a U.S. real property interest
by reason of our status as a U.S. real property
holding corporation for U.S. federal income tax
purposes at any time within the shorter of the five-year period
preceding the disposition or the holders holding period
for our common stock. We believe that we are not currently, and
that we are not likely to become, a U.S. real
property holding corporation for U.S. federal income
tax purposes. |
If we were to become a U.S. real property holding
corporation, so long as our common stock is regularly traded on
an established securities market and continues to be traded, a
non-U.S. holder
would be subject to U.S. federal income tax on any gain
from the sale, exchange or other disposition of shares of our
common
89
stock, by reason of such U.S. real property holding
corporation status, only if such
non-U.S. holder
actually or constructively owned, more than 5% of our common
stock during the shorter of the five-year period preceding the
disposition or the holders holding period for our common
stock.
Backup Withholding and Information Reporting
Generally, we must report annually to the IRS the amount of
dividends paid, the name and address of the recipient, and the
amount, if any, of tax withheld. A similar report is sent to the
holder. Pursuant to income tax treaties or other agreements, the
IRS may make its reports available to tax authorities in the
non-U.S. holders
country of residence.
Payments of dividends or of proceeds on the disposition of stock
made to a
non-U.S. holder
may be subject to additional information reporting and backup
withholding (currently at a rate of 28%). Backup withholding
will not apply if the
non-U.S. holder
establishes an exemption, for example, by properly certifying
its
non-U.S. status on
an IRS Form W-8BEN (or successor form). Notwithstanding the
foregoing, backup withholding may apply if either we or our
paying agent has actual knowledge, or reason to know, that the
holder is a U.S. person.
Backup withholding is not an additional tax. Rather, the
U.S. income tax liability of persons subject to backup
withholding will be reduced by the amount of tax withheld. If
withholding results in an overpayment of U.S. federal
income tax, a refund may be obtained, provided that the required
information is furnished to the IRS in a timely manner.
Federal Estate Tax
If an individual
non-U.S. holder is
treated as the owner, or has made certain lifetime transfers, of
an interest in our common stock then the value thereof will be
included in his or her gross estate for U.S. federal estate
tax purposes, and such individuals estate may be subject
to U.S. federal estate tax unless an applicable estate tax
or other treaty provides otherwise.
The foregoing discussion of U.S. federal income and
estate tax considerations is not tax advice. Accordingly, each
prospective
non-U.S. holder of
our common stock should consult that holders own tax
advisor with respect to the federal, state, local and
non-U.S. tax
consequences of the ownership and disposition of our common
stock.
90
Shares Eligible for Future Sale
Prior to this offering, no public market existed for our common
stock. Market sales of shares of our common stock after this
offering and from time to time, and the availability of shares
for future sale, may reduce the market price of our common
stock. Sales of substantial amounts of our common stock, or the
perception that these sales could occur, could adversely affect
prevailing market prices for our common stock and could impair
our future ability to obtain capital, especially through an
offering of equity securities.
Based on shares outstanding on June 30, 2006 and assuming
the outstanding shares of Series F preferred stock convert
on a one-for-one basis, upon the closing of this
offering, shares
of common stock will be outstanding, assuming no outstanding
options or warrants are exercised prior to the closing of this
offering. Of these outstanding shares,
the shares
sold in this offering will be freely tradable without
restrictions or further registration under the Securities Act,
assuming no exercise of the underwriters over-allotment
option, unless the shares are purchased by our affiliates as
that term is defined under Rule 144 under the Securities
Act.
The remaining 21,197,795 shares of common stock outstanding
upon the closing of this offering are restricted securities as
defined under Rule 144. Restricted securities may be sold
in the U.S. public markets only if registered or if they
qualify for an exemption from registration, including by reason
of Rule 144, 144(k) or 701 under the Securities Act, which
rules are summarized below. These remaining shares will be
available for sale as follows:
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6,908,525 shares of common stock will be immediately
eligible for sale in the public market without restriction; |
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10,444,270 shares of common stock will be eligible for sale
in the public market under Rule 144 or Rule 701,
beginning 90 days after the effective date of the
registration statement of which this prospectus is a part,
subject to the volume, manner of sale and other limitations
under those rules; and |
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the remaining 3,845,000 shares of common stock will become
eligible under Rule 144 for sale in the public market from
time to time after the effective date of the registration
statement of which this prospectus is a part upon expiration of
their respective holding periods. |
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The above table does not take into consideration the effect of
the lock-up agreements
described below.
Additionally, of the 2,897,024 shares of common stock
issuable upon exercise of options outstanding as of
June 30, 2006,
approximately shares
will be vested and eligible for sale 180 days after the
date of this prospectus.
Rule 144
In general, under Rule 144 as currently in effect,
beginning 90 days after the effective date of this
offering, a person who has beneficially owned restricted
securities for at least one year, including the holding period
of any prior owner other than one of our affiliates, is entitled
to sell a number of restricted shares within any three-month
period that does not exceed the greater of:
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one percent of the number of shares of our common stock then
outstanding, which will equal
approximately shares
immediately after this offering; and |
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the average weekly trading volume of our common stock on The
Nasdaq Global Market during the four calendar weeks preceding
the filing of a notice on Form 144 with respect to the sale. |
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Sales of restricted shares under Rule 144 are also subject
to requirements regarding the manner of sale, notice, and the
availability of current public information about us.
Rule 144 also provides that affiliates relying on
Rule 144 to sell shares of our common stock that are not
restricted shares must nonetheless comply with the same
restrictions applicable to restricted shares, other than the
holding period requirement.
91
Rule 144(k)
Under Rule 144(k), a person who is not and has not been
deemed to be our affiliate at any time during the three months
preceding a sale and who has beneficially owned the restricted
securities proposed to be sold for at least two years, including
the holding period of any prior owner other than an affiliate of
us, may sell those shares without complying with the
manner-of-sale, public
information, volume limitation or notice provisions of
Rule 144.
Rule 701
Under Rule 701, shares of our common stock acquired upon
the exercise of currently outstanding options or pursuant to
other rights granted under our stock plans may be resold, to the
extent not subject to
lock-up agreements, by:
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persons other than affiliates, beginning 90 days after the
effective date of this offering, subject only to the
manner-of-sale
provisions of Rule 144; and |
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our affiliates, beginning 90 days after the effective date
of this offering, subject to the
manner-of-sale, current
public information, and filing requirements of Rule 144, in
each case, without compliance with the one-year holding period
requirement of Rule 144. |
As of June 30, 2006, options to purchase a total of
2,897,024 shares of common stock were outstanding, of which
947,875 were vested. Of the total number of shares of our common
stock issuable under these options, all are subject to
contractual lock-up
agreements with us or the underwriters.
Form S-8
Registration Statements
We intend to file one or more registration statements on
Form S-8 under the
Securities Act after the closing of this offering to register
the shares of our common stock that are issuable pursuant to our
2006 Performance Incentive Plan and 2000 Stock Plan. These
registration statements are expected to become effective upon
filing. Shares covered by these registration statements will
then be eligible for sale in the public markets, subject to any
applicable lock-up
agreements and to Rule 144 limitations applicable to
affiliates.
Lock-up
Agreements
Prior to the effectiveness of the offering, our officers and
directors and holders of substantially all of our outstanding
securities will have agreed, subject to customary exceptions,
not to, among other things, sell or otherwise transfer the
economic benefit of, directly or indirectly, any shares of our
common stock, or any security convertible into or exchangeable
or exercisable for our common stock, without the prior written
consent of CIBC World Markets Corp. for a period of
180 days after the date of this prospectus. The
180-day
lock-up period is
subject to extension if (i) during the last 17 days of
the lock-up period we
issue an earnings release or material news or a material event
relating to us occurs or (ii) prior to the expiration of
the lock-up period, we
announce that we will release earnings results during the
16-day period beginning
on the last day of the
lock-up period, in
which case the restrictions imposed in these
lock-up agreements
shall continue to apply until the expiration of the
18-day period beginning
on the issuance of the earnings release or the occurrence of the
material news or material event. The
lock-up agreements
signed by our security holders generally permit them, among
other customary exceptions, to make bona fide gifts, to
transfer securities to trusts for their or their immediate
familys benefit, to transfer securities by will or under
the laws of descent or to a former spouse, child or other
dependent pursuant to a domestic relations order or settlement
agreement and, if the security holder is a partnership, limited
liability company or corporation, to transfer securities to its
partners, members or stockholders. However, the recipients of
these transfers must agree to be bound by the
lock-up agreement for
the remainder of the 180 days. CIBC World Markets Corp.
may, in its sole discretion, at any time and without notice,
release for sale in the public market all or any portion of the
shares subject to the
lock-up agreements.
Substantially all of the shares that are not subject to the
underwriters
lock-up agreements are
subject to similar
180-day contractual
lock-up restrictions
with us.
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Underwriting
We have entered into an underwriting agreement with the
underwriters named below. CIBC World Markets Corp.,
Jefferies & Company, Inc., and First Albany Capital
Inc. are acting as the representatives of the underwriters.
The underwriting agreement provides for the purchase of a
specific number of shares of common stock by each of the
underwriters. The underwriters obligations are several,
which means that each underwriter is required to purchase a
specified number of shares, but is not responsible for the
commitment of any other underwriter to purchase shares. Subject
to the terms and conditions of the underwriting agreement, each
underwriter has severally agreed to purchase the number of
shares of common stock set forth opposite its name below:
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Underwriter |
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CIBC World Markets Corp.
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Jefferies & Company, Inc.
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First Albany Capital Inc.
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Total
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The underwriters have agreed to purchase all of the shares
offered by this prospectus (other than those covered by the
over-allotment option described below) if any are purchased.
Under the underwriting agreement, if an underwriter defaults in
its commitment to purchase shares, the commitments of
non-defaulting underwriters may be increased or the underwriting
agreement may be terminated, depending on the circumstances.
The shares should be ready for delivery on or
about ,
2006 against payment in immediately available funds. The
underwriters are offering the shares subject to various
conditions and may reject all or part of any order. The
representatives have advised us that the underwriters propose to
offer the shares directly to the public at the public offering
price that appears on the cover page of this prospectus. In
addition, the representatives may offer some of the shares to
other securities dealers at such price less a concession of
$ per
share. The underwriters may also allow, and such dealers may
reallow, a concession not in excess of
$ per
share to other dealers. After the shares are released for sale
to the public, the representatives may change the offering price
and other selling terms at various times.
We have granted the underwriters an over-allotment option. This
option, which is exercisable for up to 30 days after the
date of this prospectus, permits the underwriters to purchase a
maximum of additional shares from us to cover
over-allotments. If the underwriters exercise all or part of
this option, they will purchase shares covered by the option at
the public offering price that appears on the cover page of this
prospectus, less the underwriting discount. If this option is
exercised in full, the total price to the public will be
$ and
the total proceeds to us will be
$ .
The underwriters have severally agreed that, to the extent the
over-allotment option is exercised, they will each purchase a
number of additional shares proportionate to the
underwriters initial amount reflected in the foregoing
table.
The following table provides information regarding the amount of
the discount to be paid to the underwriters by us:
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Total Without | |
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Exercise of | |
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Exercise of | |
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Over-Allotment | |
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Over-Allotment | |
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Per Share | |
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Option | |
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Option | |
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ImaRx Therapeutics, Inc.
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$ |
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$ |
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$ |
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We estimate that the total expenses of the offering, excluding
the underwriting discount, will be approximately
$ .
We have agreed to indemnify the underwriters against certain
liabilities, including liabilities under the Securities Act.
93
Prior to the effectiveness of the offering, our officers and
directors and holders of substantially all of our outstanding
securities will have agreed to a
180-day
lock-up with respect to our shares of common stock
and other of our securities that they beneficially own,
including securities that are convertible into shares of common
stock and securities that are exchangeable or exercisable for
shares of common stock. This means that, subject to certain
exceptions, for a period of 180 days following the date of
this prospectus, we and such persons may not offer, sell, pledge
or otherwise dispose of these securities without the prior
written consent of CIBC World Markets Corp. The
180-day
lock-up period is
subject to extension if (i) during the last 17 days of
the lock-up period we
issue an earnings release or material news or a material event
relating to us occurs or (ii) prior to the expiration of
the lock-up period, we
announce that we will release earnings results during the
16-day period beginning
on the last day of the
lock-up period, in
which case the restrictions imposed in these
lock-up agreements
shall continue to apply until the expiration of the
18-day period beginning
on the issuance of the earnings release or the occurrence of the
material news or material event. The
lock-up provisions do
not prevent security holders from transferring their shares or
other securities as gifts, to a trust for the benefit of
themselves of member of their immediate family, for corporations
to wholly-owned subsidiaries, for limited liability companies to
their members or affiliated limited liability companies or for
partnerships to their partners or affiliated partnerships,
provided in each case, that the transferee of such shares of
other securities agree to be
locked-up to the same
extent as the security holder from whom they received the shares.
The representatives have informed us that they do not expect
discretionary sales by the underwriters to exceed five percent
of the shares offered by this prospectus.
There is no established trading market for the shares. The
offering price for the shares will be determined by us and the
representatives, based on the following factors:
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the history and prospects for the industry in which we compete; |
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our past and present operations; |
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our historical results of operations; |
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our prospects for future business and earning potential; |
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our management; |
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the general condition of the securities markets at the time of
this offering; |
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the recent market prices of securities of generally comparable
companies; |
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the market capitalization and stages of development of other
companies which we and the representatives believe to be
comparable to us; and |
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other factors deemed to be relevant. |
Rules of the SEC may limit the ability of the underwriters to
bid for or purchase shares before the distribution of the shares
is completed. However, the underwriters may engage in the
following activities in accordance with the rules:
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Stabilizing transactions The representative may
make bids or purchases for the purpose of pegging, fixing or
maintaining the price of the shares, so long as stabilizing bids
do not exceed a specified maximum. |
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Over-allotments and syndicate covering transactions
The underwriters may sell more shares of our common stock in
connection with this offering than the number of shares that
they have committed to purchase. This over-allotment creates a
short position for the underwriters. This short sales position
may involve either covered short sales or
naked short sales. Covered short sales are short
sales made in an amount not greater than the underwriters
over-allotment option to purchase additional shares in this
offering described above. The underwriters may close out any
covered short position either by exercising their over-allotment
option or by purchasing shares in the open market. To determine
how they will close the covered short position, the underwriters
will consider, among other things, the price of shares available
for purchase in the open market, as compared to the price at
which they may purchase shares through the over-allotment
option. Naked short sales are short sales in excess of the
over-allotment |
94
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option. The underwriters must close out any naked short position
by purchasing shares in the open market. A naked short position
is more likely to be created if the underwriters are concerned
that, in the open market after pricing, there may be downward
pressure on the price of the shares that could adversely affect
investors who purchase shares in this offering. |
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Penalty bids If the representatives purchase shares
in the open market in a stabilizing transaction or syndicate
covering transaction, they may reclaim a selling concession from
the underwriters and selling group members who sold those shares
as part of this offering. |
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Passive market making Market makers in the shares
who are underwriters or prospective underwriters may make bids
for or purchases of shares, subject to limitations, until the
time, if ever, at which a stabilizing bid is made. |
Similar to other purchase transactions, the underwriters
purchases to cover the syndicate short sales or to stabilize the
market price of our common stock may have the effect of raising
or maintaining the market price of our common stock or
preventing or mitigating a decline in the market price of our
common stock. As a result, the price of the shares of our common
stock may be higher than the price that might otherwise exist in
the open market. The imposition of a penalty bid might also have
an effect on the price of the shares if it discourages resales
of the shares. Neither we nor the underwriters make any
representation or prediction as to the effect that the
transactions described above may have on the price of the
shares. These transactions may occur on The Nasdaq Global Market
or otherwise. If such transactions are commenced, they may be
discontinued without notice at any time.
Notice to
Non-U.S. Investors
The offering is exclusively conducted under applicable private
placement exemptions and therefore it has not been and will not
be notified to, and this document or any other offering material
relating to the shares has not been and will not be approved by,
the Belgian Banking, Finance and Insurance Commission
(Commission bancaire, financière et des assurances/
Commissie voor het Bank-, Financie- en Assurantiewezen).
Any representation to the contrary is unlawful.
Each underwriter has undertaken not to offer sell, resell,
transfer or deliver directly or indirectly, any shares, or to
take any steps relating/ancillary thereto, and not to distribute
or publish this document or any other material relating to the
shares or to the offering in a manner which would be construed
as: (a) a public offering under the Belgian Royal Decree of
7 July 1999 on the public character of financial transactions;
or (b) an offering of shares to the public under Directive
2003/71/ EC which triggers an obligation to publish a prospectus
in Belgium. Any action contrary to these restrictions will cause
the recipient and us to be in violation of the Belgian
securities laws.
Neither this prospectus nor any other offering material relating
to the shares has been submitted to the clearance procedures of
the Autorité des marchés financiers in France.
The shares have not been offered or sold and will not be offered
or sold, directly or indirectly, to the public in France.
Neither this prospectus nor any other offering material relating
to the shares has been or will be: (a) released, issued,
distributed or caused to be released, issued or distributed to
the public in France; or (b) used in connection with any
offer for subscription or sale of the shares to the public in
France. Such offers, sales and distributions will be made in
France only: (i) to qualified investors (investisseurs
qualifiés) and/or to a restricted circle of investors
(cercle restreint dinvestisseurs), in each case
investing for their own account, all as defined in and in
accordance with Articles L.411-2, D.411-1, D.411-2,
D.734-1, D.744-1, D.754-1 and D.764-1 of the French Code
monétaire et financier; (ii) to investment
services providers authorised to engage in portfolio management
on behalf of third parties; or (iii) in a transaction that,
in accordance with article L.411-2-II-1°-or-2°-or
3° of the French Code monétaire et financier
and article 211-2 of the General Regulations
(Règlement Général) of the
Autorité des marchés financiers, does not
constitute a public offer (appel publicà
95
lépargne). Such shares may be resold only in
compliance with Articles L.411-1, L.411-2, L.412-1 and
L.621-8 through L.621-8-3 of the French Code monétaire
et financier.
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United Kingdom/Germany/Norway/The Netherlands |
In relation to each Member State of the European Economic Area
which has implemented the Prospectus Directive, or each Relevant
Member State an offer to the public of any shares that are the
subject of the offering contemplated by this prospectus may not
be made in that Relevant Member State except that an offer to
the public in that Relevant Member State of any shares may be
made at any time under the following exemptions under the
Prospectus Directive, if they have been implemented in that
Relevant Member State:
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(a) |
to legal entities which are authorised or regulated to operate
in the financial markets or, if not so authorised or regulated,
whose corporate purpose is solely to invest in securities; |
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(b) |
to any legal entity which has two or more of (1) an average
of at least 250 employees during the last financial year;
(2) a total balance sheet of more
than 43,000,000
and (3) an annual net turnover of more
than 50,000,000,
as shown in its last annual or consolidated accounts; |
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(c) |
by the underwriter to fewer than 100 natural or legal persons
(other than qualified investors as defined in the Prospectus
Directive) subject to obtaining the prior consent of CIBC World
Markets Corp. for any such offer; or |
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(d) |
in any other circumstances falling within Article 3(2) of
the Prospectus Directive, |
provided that no such offer of shares shall result in a
requirement for the publication by us or any underwriter of a
prospectus pursuant to Article 3 of the Prospectus
Directive.
For the purposes of this provision, the expression an
offer to the public in relation to any shares in any
Relevant Member State means the communication in any form and by
any means of sufficient information on the terms of the offer
and any shares to be offered so as to enable an investor to
decide to purchase any shares, as the same may be varied in that
Member State by any measure implementing the Prospectus
Directive in that Member State and the expression
Prospectus Directive means Directive 2003/71/ EC and
includes any relevant implementing measure in each Relevant
Member State.
Each underwriter has represented, warranted and agreed that:
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(a) |
it has only communicated or caused to be communicated and will
only communicate or cause to be communicated any invitation or
inducement to engage in investment activity (within the meaning
of section 21 of the Financial Services and Markets Act
2000, or the FSMA, received by it in connection with the issue
or sale of any shares in circumstances in which
section 21(1) of the FSMA does not apply to us; and |
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(b) |
it has complied with and will comply with all applicable
provisions of the FSMA with respect to anything done by it in
relation to the shares in, from or otherwise involving the
United Kingdom. |
In the State of Israel, the shares offered hereby may not be
offered to any person or entity other than the following:
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(a) |
a fund for joint investments in trust (i.e., mutual fund), as
such term is defined in the Law for Joint Investments in Trust,
5754-1994, or a management company of such a fund; |
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(b) |
a provident fund as defined in Section 47(a)(2) of the
Income Tax Ordinance of the State of Israel, or a management
company of such a fund; |
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(c) |
an insurer, as defined in the Law for Oversight of Insurance
Transactions, 5741-1981, (d) a banking entity or satellite
entity, as such terms are defined in the Banking Law
(Licensing), 5741-1981, other than a joint services company,
acting for their own account or fro the account of investors of
the type listed in Section 15A(b) of the Securities Law
1968; |
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(d) |
a company that is licensed as a portfolio manager, as such term
is defined in Section 8(b) of the Law for the Regulation of
Investment Advisors and Portfolio Managers, 5755-1995, acting on
its own account or for the account of investors of the type
listed in Section 15A(b) of the Securities Law 1968; |
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(e) |
a company that is licensed as an investment advisor, as such
term is defined in Section 7(c) of the Law for the
Regulation of Investment Advisors and Portfolio Managers,
5755-1995, acting on its own account; |
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(f) |
a company that is a member of the Tel Aviv Stock Exchange,
acting on its own account or for the account of investors of the
type listed in Section 15A(b) of the Securities Law 1968; |
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(g) |
an underwriter fulfilling the conditions of Section 56(c)
of the Securities Law, 5728-1968; |
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(h) |
a venture capital fund (defined as an entity primarily involved
in investments in companies which, at the time of investment,
(i) are primarily engaged in research and development or
manufacture of new technological products or processes and
(ii) involve above-average risk); |
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(i) |
an entity primarily engaged in capital markets activities in
which all of the equity owners meet one or more of the above
criteria; and |
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(j) |
an entity, other than an entity formed for the purpose of
purchasing shares in this offering, in which the shareholders
equity (including pursuant to foreign accounting rules,
international accounting regulations and U.S. generally
accepted accounting rules, as defined in the Securities Law
Regulations (Preparation of Annual Financial Statements), 1993)
is in excess of NIS 250 million. |
Any offeree of the shares offered hereby in the State of Israel
shall be required to submit written confirmation that it falls
within the scope of one of the above criteria. This prospectus
will not be distributed or directed to investors in the State of
Israel who do not fall within one of the above criteria.
The offering of the shares offered hereby in Italy has not been
registered with the Commissione Nazionale per la Società e
la Borsa, or CONSOB pursuant to Italian securities legislation
and, accordingly, the shares offered hereby cannot be offered,
sold or delivered in the Republic of Italy, or Italy, nor may
any copy of this prospectus or any other document relating to
the shares offered hereby be distributed in Italy other than to
professional investors (operatori qualificati) as defined
in Article 31, second paragraph, of CONSOB
Regulation No. 11522 of 1 July, 1998 as
subsequently amended. Any offer, sale or delivery of the shares
offered hereby or distribution of copies of this prospectus or
any other document relating to the shares offered hereby in
Italy must be made:
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by an investment firm, bank or intermediary permitted to conduct
such activities in Italy in accordance with Legislative Decree
No. 58 of 24 February 1998 and Legislative Decree
No. 385 of 1 September 1993, or the Banking Act; |
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(b) |
in compliance with Article 129 of the Banking Act and the
implementing guidelines of the Bank of Italy; and |
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(c) |
in compliance with any other applicable laws and regulations and
other possible requirements or limitations which may be imposed
by Italian authorities. |
This prospectus has not been nor will it be registered with or
approved by Finansinspektionen (the Swedish Financial
Supervisory Authority). Accordingly, this prospectus may not be
made available, nor may the shares offered hereunder be marketed
and offered for sale in Sweden, other than under circumstances
which are deemed not to require a prospectus under the Financial
Instruments Trading Act (1991:980). This offering will only be
made to qualified investors in Sweden. This offering will be
made to no more than 100 persons or entities in Sweden.
97
The shares offered pursuant to this prospectus will not be
offered, directly or indirectly, to the public in Switzerland
and this prospectus does not constitute a public offering
prospectus as that term is understood pursuant to art. 652a
or art. 1156 of the Swiss Federal Code of Obligations. We
have not applied for a listing of the shares being offered
pursuant to this prospectus on the SWX Swiss Exchange or on any
other regulated securities market, and consequently, the
information presented in this prospectus does not necessarily
comply with the information standards set out in the relevant
listing rules. The shares being offered pursuant to this
prospectus have not been registered with the Swiss Federal
Banking Commission as foreign investment funds, and the investor
protection afforded to acquirers of investment fund certificates
does not extend to acquirers of shares.
Investors are advised to contact their legal, financial or tax
advisers to obtain an independent assessment of the financial
and tax consequences of an investment in shares.
98
Legal Matters
The validity of the issuance of the shares of common stock
offered by this prospectus will be passed upon for us by our
counsel, DLA Piper Rudnick Gray Cary US LLP, Seattle,
Washington. Cooley Godward LLP is counsel for the underwriters
in connection with this offering.
Experts
The consolidated financial statements of ImaRx Therapeutics,
Inc. (a development stage company) at December 31, 2004 and
2005, and for each of the three years in the period ended
December 31, 2005 and for the period from inception
(October 7, 1999) through December 31, 2005 appearing
in this prospectus and registration statement have been audited
by Ernst & Young LLP, an independent registered public
accounting firm, as set forth in their report thereon appearing
elsewhere herein, and are included in reliance upon such report
given on the authority of such firm as experts in accounting and
auditing.
Where You Can Find Additional Information
We have filed with the SEC a registration statement on
Form S-1 under the
Securities Act that registers the shares of our common stock to
be sold in this offering. The registration statement, including
the attached exhibits and schedules, contains additional
relevant information about us and our capital stock. The rules
and regulations of the SEC allow us to omit from this prospectus
certain information included in the registration statement. For
further information about us and our common stock, you should
refer to the registration statement and the exhibits and
schedules filed with the registration statement. With respect to
the statements contained in this prospectus regarding the
contents of any agreement or any other document, in each
instance, the statement is qualified in all respects by the
complete text of the agreement or document, a copy of which has
been filed as an exhibit to the registration statement. In
addition, upon the closing of this offering, we will file
reports, proxy statements and other information with the SEC
under the Securities Exchange Act of 1934, as amended. You may
obtain copies of this information by mail from the Public
Reference Room of the SEC at 100 F Street, N.E., Room 1580,
Washington, D.C. 20549, at prescribed rates. You may obtain
information on the operation of the public reference rooms by
calling the SEC at
1-800-SEC-0330. The SEC
also maintains an internet website that contains reports, proxy
statements and other information about issuers that file
electronically with the SEC. The address of that site is
www.sec.gov.
We intend to provide our stockholders with annual reports
containing consolidated financial statements that have been
examined and reported on, with an opinion expressed by an
independent registered public accounting firm, and to file with
the SEC quarterly reports containing unaudited consolidated
financial data for the first three quarters of each year.
99
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Index to Consolidated Financial Statements
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F-4 |
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F-5 |
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F-9 |
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F-1
Report of Independent Registered Public Accounting Firm
Board of Directors and Stockholders
ImaRx Therapeutics, Inc.
We have audited the accompanying consolidated balance sheets of
ImaRx Therapeutics, Inc. (a development stage company) as of
December 31, 2004 and 2005, and the related consolidated
statements of operations, mandatorily redeemable convertible
preferred stock and stockholders deficit, and cash flows
for each of the three years in the period ended
December 31, 2005, and the period from October 7, 1999
(date of inception) through December 31, 2005. These
financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. We were not engaged to perform an
audit of the Companys internal control over financial
reporting. Our audits included consideration of internal control
over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not
for the purpose of expressing an opinion on the effectiveness of
the Companys internal control over financial reporting.
Accordingly, we express no such opinion. Our audit also includes
examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by
management and evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable
basis for our opinion.
In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the
consolidated financial position of ImaRx Therapeutics, Inc. (a
development stage company) at December 31, 2004 and 2005,
and the consolidated results of their operations and their cash
flows for each of the three years in the period ended
December 31, 2005, and for the period from October 7,
1999 (date of inception) through December 31, 2005, in
conformity with U.S. generally accepted accounting
principles.
The accompanying consolidated financial statements have been
prepared assuming that ImaRx Therapeutics, Inc. (a development
stage company) will continue as a going concern. As more fully
described in Note 2, the Company has historical recurring
losses and a net capital deficiency at December 31, 2005.
These conditions, among others, raise substantial doubt about
the Companys ability to continue as a going concern.
Management plans in regards to these matters are also described
in Note 2. The financial statements do not include any
adjustments to reflect possible future effects on the
recoverability and classification of assets or the amounts and
classification of liabilities that may result from the outcome
of this uncertainty.
Phoenix, Arizona
March 10, 2006
F-2
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
|
|
| |
|
June 30, | |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
|
|
|
|
|
(unaudited) | |
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
1,538,290 |
|
|
$ |
8,513,387 |
|
|
$ |
9,833,609 |
|
|
Inventories
|
|
|
36,251 |
|
|
|
|
|
|
|
16,700,000 |
|
|
Prepaid expenses and other
|
|
|
187,875 |
|
|
|
272,486 |
|
|
|
482,098 |
|
|
Deferred offering costs
|
|
|
|
|
|
|
|
|
|
|
1,098,281 |
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
1,762,416 |
|
|
|
8,785,873 |
|
|
|
28,113,988 |
|
Property and equipment, net
|
|
|
359,965 |
|
|
|
729,961 |
|
|
|
895,828 |
|
Intangible assets, net
|
|
|
|
|
|
|
|
|
|
|
3,100,000 |
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
2,122,381 |
|
|
$ |
9,515,834 |
|
|
$ |
32,109,816 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
389,850 |
|
|
$ |
775,684 |
|
|
$ |
958,851 |
|
|
Accrued expenses
|
|
|
633,329 |
|
|
|
893,198 |
|
|
|
1,405,777 |
|
|
Short-term notes payable
|
|
|
|
|
|
|
15,227,500 |
|
|
|
15,677,500 |
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
1,023,179 |
|
|
|
16,896,382 |
|
|
|
18,042,128 |
|
Long-term notes payable, less current portion
|
|
|
4,281,992 |
|
|
|
|
|
|
|
15,165,000 |
|
Other long-term liabilities
|
|
|
218,856 |
|
|
|
218,856 |
|
|
|
218,856 |
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
5,524,027 |
|
|
|
17,115,238 |
|
|
|
33,425,984 |
|
Mandatorily redeemable convertible preferred stock:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A 8% Redeemable Convertible Preferred Shares
$.0001 par, at carrying value including accrued dividends
(liquidation value of $8,902,752 and $9,154,778 at
December 31, 2005 and June 30, 2006 (unaudited),
respectively):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized shares2,400,000 at December 31, 2004 and
2005 and 2,302,053 at June 30, 2006 (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued and outstanding shares2,291,144 at
December 31, 2004 and 2005 and June 30, 2006
(unaudited)
|
|
|
8,320,643 |
|
|
|
8,824,695 |
|
|
|
9,076,720 |
|
|
Series B 7% Redeemable Convertible Preferred Shares,
$.0001 par, at carrying value (liquidation value of $9,491,622
at December 31, 2005 and June 30, 2006 (unaudited),
respectively):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized shares800,000 at December 31, 2004 and
2005 and 593,226 at June 30, 2006 (unaudited): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued and outstanding shares593,226 at December 31,
2004 and 2005 and June 30, 2006 (unaudited)
|
|
|
9,491,622 |
|
|
|
9,491,622 |
|
|
|
9,491,622 |
|
|
Series C Redeemable Convertible Preferred Shares,
$.0001 par at carrying value (liquidation value of $1,999,998 at
December 31, 2005 and June 30, 2006 (unaudited),
respectively):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized shares1,700,000 at December 31, 2004 and
2005 and 285,714 at June 30, 2006 (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued and outstanding shares285,714 at December 31,
2004, 2005 and June 30, 2006 (unaudited)
|
|
|
1,945,563 |
|
|
|
1,945,563 |
|
|
|
1,945,563 |
|
|
Series D 8% Redeemable Convertible Preferred Shares,
$.0001 par at carrying value including accrued dividends
(liquidation value of $1,487,332 and $1,535,535 at
December 31, 2005 and June 30, 2006 (unaudited),
respectively):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized shares545,500 at December 31, 2004 and
2005 and 438,232 at June 30, 2006 (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued and outstanding shares438,232 at December 31,
2004, 2005 and June 30, 2006
(unaudited)
|
|
|
1,369,193 |
|
|
|
1,465,593 |
|
|
|
1,513,798 |
|
|
Series F 8% Redeemable Convertible Preferred Shares,
$.0001 par at carrying value including accrued dividends
(liquidation value of $-0- and $14,175,000 at December 31,
2005 and June 30, 2006 (unaudited), respectively):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized shares4,000,000
Issued and outstanding shares2,835,000 at June 30,
2006 (unaudited) |
|
|
|
|
|
|
|
|
|
|
12,968,559 |
|
|
|
|
|
|
|
|
|
|
|
Total redeemable convertible preferred stock
|
|
|
21,127,021 |
|
|
|
21,727,473 |
|
|
|
34,996,262 |
|
Stockholders deficit:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series E Redeemable Convertible Preferred Shares, $.0001
par:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized shares1,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued and outstanding sharesno shares in 2004, and
1,000,000 shares at December 31, 2005 and June 30,
2006 (unaudited)
|
|
|
|
|
|
|
4,000,000 |
|
|
|
4,000,000 |
|
|
Common stock, $.0001 par:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized shares70,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued and outstanding shares6,505,306 at
December 31, 2004, 12,923,438 at December 31, 2005 and
13,033,638 at June 30, 2006 (unaudited)
|
|
|
651 |
|
|
|
1,293 |
|
|
|
1,304 |
|
|
|
Additional paid-in capital
|
|
|
7,706,137 |
|
|
|
27,434,074 |
|
|
|
28,168,365 |
|
|
|
Deficit accumulated during the development stage
|
|
|
(32,235,455 |
) |
|
|
(60,762,244 |
) |
|
|
(68,482,099 |
) |
|
|
|
|
|
|
|
|
|
|
Total stockholders deficit
|
|
|
(24,528,667 |
) |
|
|
(29,326,877 |
) |
|
|
(36,312,430 |
) |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders deficit
|
|
$ |
2,122,381 |
|
|
$ |
9,515,834 |
|
|
$ |
32,109,816 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-3
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
|
|
|
|
Period from | |
|
|
|
|
|
|
|
|
October 7, 1999 | |
|
|
|
|
|
October 7, 1999 | |
|
|
|
|
|
|
|
|
(Date of | |
|
|
|
|
|
(Date of | |
|
|
|
|
Inception) | |
|
|
|
Inception) | |
|
|
Years ended December 31, | |
|
Through | |
|
Six Months ended June 30, | |
|
Through | |
|
|
| |
|
December 31, | |
|
| |
|
June 30, | |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
|
Grant and other revenue
|
|
$ |
224,231 |
|
|
$ |
575,014 |
|
|
$ |
619,046 |
|
|
$ |
2,214,980 |
|
|
$ |
294,783 |
|
|
$ |
428,761 |
|
|
$ |
2,643,741 |
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,877,393 |
|
|
|
2,489,640 |
|
|
|
3,578,703 |
|
|
|
12,751,391 |
|
|
|
1,496,144 |
|
|
|
3,990,649 |
|
|
|
16,742,040 |
|
|
General and administrative
|
|
|
1,654,251 |
|
|
|
3,183,850 |
|
|
|
4,142,279 |
|
|
|
15,169,734 |
|
|
|
1,500,902 |
|
|
|
3,126,661 |
|
|
|
18,296,395 |
|
|
Depreciation and amortization
|
|
|
209,032 |
|
|
|
185,905 |
|
|
|
194,206 |
|
|
|
1,684,849 |
|
|
|
95,390 |
|
|
|
331,872 |
|
|
|
2,016,721 |
|
|
Acquired in-process research and development
|
|
|
|
|
|
|
|
|
|
|
24,000,000 |
|
|
|
24,000,000 |
|
|
|
|
|
|
|
|
|
|
|
24,000,000 |
|
|
License fees to development partner
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000,000 |
|
|
|
|
|
|
|
|
|
|
|
10,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,740,676 |
|
|
|
5,859,395 |
|
|
|
31,915,188 |
|
|
|
63,605,974 |
|
|
|
3,092,436 |
|
|
|
7,449,182 |
|
|
|
71,055,156 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(3,516,445 |
) |
|
|
(5,284,381 |
) |
|
|
(31,296,142 |
) |
|
|
(61,390,994 |
) |
|
|
(2,797,653 |
) |
|
|
(7,020,421 |
) |
|
|
(68,411,415 |
) |
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income
|
|
|
22,475 |
|
|
|
29,109 |
|
|
|
122,187 |
|
|
|
371,621 |
|
|
|
50,268 |
|
|
|
215,796 |
|
|
|
587,417 |
|
|
Interest expense
|
|
|
(325,779 |
) |
|
|
(468,536 |
) |
|
|
(587,341 |
) |
|
|
(1,850,357 |
) |
|
|
(53,180 |
) |
|
|
(615,000 |
) |
|
|
(2,465,357 |
) |
|
Minority interest in net loss of consolidated subsidiary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,638,446 |
|
|
|
|
|
|
|
|
|
|
|
2,638,446 |
|
|
Gain on extinguishment of note payable to development partner
|
|
|
|
|
|
|
|
|
|
|
3,834,959 |
|
|
|
3,834,959 |
|
|
|
3,834,959 |
|
|
|
|
|
|
|
3,834,959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
|
(3,819,749 |
) |
|
|
(5,723,808 |
) |
|
|
(27,926,337 |
) |
|
|
(56,396,325 |
) |
|
|
1,034,394 |
|
|
|
(7,419,625 |
) |
|
|
(63,815,950 |
) |
Accretion of dividends on preferred stock
|
|
|
(1,286,715 |
) |
|
|
(301,031 |
) |
|
|
(600,452 |
) |
|
|
(4,365,919 |
) |
|
|
(300,236 |
) |
|
|
(300,230 |
) |
|
|
(4,666,149 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income available to common stockholders
|
|
$ |
(5,106,464 |
) |
|
$ |
(6,024,839 |
) |
|
$ |
(28,526,789 |
) |
|
$ |
(60,762,244 |
) |
|
$ |
734,158 |
|
|
$ |
(7,719,855 |
) |
|
$ |
(68,482,099 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income available to common stockholders per
shareBasic
|
|
$ |
(1.74 |
) |
|
$ |
(1.07 |
) |
|
$ |
(3.01 |
) |
|
|
|
|
|
$ |
0.09 |
|
|
$ |
(0.60 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstandingBasic
|
|
|
2,936,094 |
|
|
|
5,637,042 |
|
|
|
9,463,279 |
|
|
|
|
|
|
|
8,335,776 |
|
|
|
12,968,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income available to common stockholders per
shareDiluted
|
|
$ |
(1.74 |
) |
|
$ |
(1.07 |
) |
|
$ |
(3.01 |
) |
|
|
|
|
|
$ |
0.05 |
|
|
$ |
(0.60 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstandingDiluted
|
|
|
2,936,094 |
|
|
|
5,637,042 |
|
|
|
9,463,279 |
|
|
|
|
|
|
|
13,803,797 |
|
|
|
12,968,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-4
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Consolidated Statements of Mandatorily Redeemable Convertible
Preferred Stock and Stockholders (Deficit) Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mandatorily Redeemable Convertible Preferred Stock | |
|
|
Stockholders (Deficit) Equity | |
|
|
|
|
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
Series E | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable | |
|
|
|
|
|
|
|
|
Series A | |
|
Series B | |
|
Series C | |
|
Series D | |
|
Series F | |
|
|
|
|
|
|
Convertible | |
|
|
|
Deficit | |
|
|
|
|
|
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
Preferred | |
|
|
|
|
|
Accumulated | |
|
Total | |
|
|
|
|
Per | |
|
|
|
|
|
|
|
|
|
|
|
Stock | |
|
|
|
|
Shares | |
|
Common Stock | |
|
Additional | |
|
During the | |
|
Stockholders | |
|
|
|
|
Share | |
|
|
|
Carrying | |
|
|
|
Carrying | |
|
|
|
Carrying | |
|
|
|
Carrying | |
|
|
|
Carrying | |
|
Subscription | |
|
|
Members | |
|
| |
|
| |
|
Paid-in | |
|
Development | |
|
(Deficit) | |
|
|
Date |
|
Amount | |
|
Shares | |
|
Value | |
|
Shares | |
|
Value | |
|
Shares | |
|
Value | |
|
Shares | |
|
Value | |
|
Shares | |
|
Value | |
|
Receivable | |
|
|
Equity | |
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Stage | |
|
Equity | |
|
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Initial capitalization at October 7, 1999
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
$ |
59,626 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
59,626 |
|
Net loss for the period (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(553,485 |
) |
|
|
(553,485 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 30, 1999
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59,626 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(553,485 |
) |
|
|
(493,859 |
) |
Conversion of members equity to common stock
|
|
8/2/2000 |
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(59,626 |
) |
|
|
|
|
|
|
|
|
|
|
2,825,833 |
|
|
|
283 |
|
|
|
59,343 |
|
|
|
|
|
|
|
|
|
Issuance of Series A Redeemable Convertible Preferred
Stock, net of issuance costs of $64,146
|
|
8/19/2000 |
|
|
2.75 |
|
|
|
1,294,772 |
|
|
|
3,719,313 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of Series A Redeemable Convertible Preferred
Stock, upon conversion of unsecured notes
|
|
9/1/00-12/27/00 |
|
|
2.75 |
|
|
|
880,075 |
|
|
|
2,442,205 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options
|
|
5/1/00-12/31/00 |
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
83,500 |
|
|
|
8 |
|
|
|
41,742 |
|
|
|
|
|
|
|
41,750 |
|
Stock subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(244,834 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,849,139 |
) |
|
|
(2,849,139 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 30, 2000
|
|
|
|
|
|
|
|
|
2,174,847 |
|
|
|
6,161,518 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(244,834 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,909,333 |
|
|
|
291 |
|
|
|
101,085 |
|
|
|
(3,402,624 |
) |
|
|
(3,301,248 |
) |
Issuance of Series A Redeemable Convertible Preferred
Stock, net of issuance costs of $13,911
|
|
1/9/01-1/30/01 |
|
|
2.75 |
|
|
|
116,297 |
|
|
|
61,071 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
244,834 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of Series B Redeemable Convertible Preferred Stock
|
|
1/19/2001 |
|
|
16.00 |
|
|
|
|
|
|
|
|
|
|
|
500,625 |
|
|
|
8,010,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of Series C Redeemable Convertible Preferred
Stock, net of issuance costs of $54,436
|
|
1/19/2001 |
|
|
7.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
285,714 |
|
|
|
1,945,563 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of undeclared dividends on Series B Redeemable
Convertible Preferred Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
537,328 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(537,328 |
) |
|
|
(537,328 |
) |
Exercise of stock options
|
|
5/1/01-10/31/01 |
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,250 |
|
|
|
3 |
|
|
|
15,122 |
|
|
|
|
|
|
|
15,125 |
|
Issuance of 23,980 warrants
|
|
1/1/01-12/31/01 |
|
|
1.49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,734 |
|
|
|
|
|
|
|
35,734 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,325,328 |
) |
|
|
(12,325,328 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2001
|
|
|
|
|
|
|
|
|
2,291,144 |
|
|
|
6,222,589 |
|
|
|
500,625 |
|
|
|
8,547,328 |
|
|
|
285,714 |
|
|
|
1,945,563 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,939,583 |
|
|
|
294 |
|
|
|
151,941 |
|
|
|
(16,265,280 |
) |
|
|
(16,113,045 |
) |
Issuance of Series D Redeemable Convertible Preferred
Stock, net of issuance costs of $20,111
|
|
10/10/2002 |
|
|
2.75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
310,232 |
|
|
|
833,031 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Declared dividends on Series B Redeemable Convertible
Preferred Stock
|
|
7/18/2002 |
|
|
16.00 |
|
|
|
|
|
|
|
|
|
|
|
53,792 |
|
|
|
323,346 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(323,346 |
) |
|
|
(323,346 |
) |
Accretion of undeclared dividends on Series A Redeemable
Convertible Preferred Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
1,037,193 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,037,193 |
) |
|
|
(1,037,193 |
) |
Accretion of undeclared dividends on Series B Redeemable
Convertible Preferred Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
279,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(279,854 |
) |
|
|
(279,854 |
) |
Repurchase and retirement of common stock
|
|
11/1/2002 |
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,250 |
) |
|
|
|
|
|
|
(2,625 |
) |
|
|
|
|
|
|
(2,625 |
) |
Contractual reduction of warrants issued in 2001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,110 |
) |
|
|
|
|
|
|
(16,110 |
) |
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,198,479 |
) |
|
|
(3,198,479 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
|
|
|
|
|
|
2,291,144 |
|
|
|
7,259,782 |
|
|
|
554,417 |
|
|
|
9,150,528 |
|
|
|
285,714 |
|
|
|
1,945,563 |
|
|
|
310,232 |
|
|
|
833,031 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,934,333 |
|
|
|
294 |
|
|
|
133,206 |
|
|
|
(21,104,152 |
) |
|
|
(20,970,652 |
) |
Issuance of Series D Redeemable Convertible Preferred
Stock, net of issuance costs of $1,629
|
|
1/21/2003 |
|
|
2.75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
128,000 |
|
|
|
350,371 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Declared dividends on Series B Redeemable Convertible
Preferred Stock
|
|
7/18/2003 |
|
|
16.00 |
|
|
|
|
|
|
|
|
|
|
|
38,809 |
|
|
|
341,094 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(341,094 |
) |
|
|
(341,094 |
) |
Accretion of undeclared dividends on Series A and D
Redeemable Convertible Preferred Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
556,809 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89,371 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(646,180 |
) |
|
|
(646,180 |
) |
Accretion of undeclared dividends on Series B Redeemable
Convertible Preferred Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
299,441 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(299,441 |
) |
|
|
(299,441 |
) |
Issuance of 145,790 warrants with convertible subordinated notes
|
|
6/1/03-10/30/03 |
|
|
0.48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70,000 |
|
|
|
|
|
|
|
70,000 |
|
Issuance of 5,000 warrants
|
|
10/10/2003 |
|
|
0.54 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,688 |
|
|
|
|
|
|
|
2,688 |
|
Exercise of stock options
|
|
2/1/03-12/31/03 |
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,300 |
|
|
|
1 |
|
|
|
1,149 |
|
|
|
|
|
|
|
1,150 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,819,749 |
) |
|
|
(3,819,749 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
|
|
|
|
|
|
2,291,144 |
|
|
|
7,816,591 |
|
|
|
593,226 |
|
|
|
9,791,063 |
|
|
|
285,714 |
|
|
|
1,945,563 |
|
|
|
438,232 |
|
|
|
1,272,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,936,633 |
|
|
|
295 |
|
|
|
207,043 |
|
|
|
(26,210,616 |
) |
|
|
(26,003,278 |
) |
F-5
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Consolidated Statements of Mandatory Redeemable Convertible
Preferred Stock and Stockholders (Deficit) Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mandatorily Redeemable Convertible Preferred Stock | |
|
|
Stockholders (Deficit) Equity | |
|
|
|
|
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series E | |
|
|
|
|
|
|
|
|
Series A | |
|
Series B | |
|
Series C | |
|
Series D | |
|
Series F | |
|
|
|
|
|
|
Redeemable | |
|
|
|
Deficit | |
|
|
|
|
|
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
Convertible | |
|
|
|
|
|
Accumulated | |
|
Total | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock | |
|
|
|
|
Preferred Shares | |
|
Common Stock | |
|
Additional | |
|
During the | |
|
Stockholders | |
|
|
|
|
Per Share | |
|
|
|
Carrying | |
|
|
|
Carrying | |
|
|
|
Carrying | |
|
|
|
Carrying | |
|
|
|
Carrying | |
|
Subscription | |
|
|
Members | |
|
| |
|
| |
|
Paid-in | |
|
Development | |
|
(Deficit) | |
|
|
Date |
|
Amount | |
|
Shares | |
|
Value | |
|
Shares | |
|
Value | |
|
Shares | |
|
Value | |
|
Shares | |
|
Value | |
|
Shares | |
|
Value | |
|
Receivable | |
|
|
Equity | |
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Stage | |
|
Equity | |
|
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at December 31, 2003
|
|
|
|
|
|
|
|
|
2,291,144 |
|
|
$ |
7,816,591 |
|
|
|
593,226 |
|
|
$ |
9,791,063 |
|
|
|
285,714 |
|
|
$ |
1,945,563 |
|
|
|
438,232 |
|
|
$ |
1,272,773 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
2,936,633 |
|
|
$ |
295 |
|
|
$ |
207,043 |
|
|
$ |
(26,210,616 |
) |
|
$ |
(26,003,278 |
) |
Issuance of 60,679 warrants with convertible subordinated notes
|
|
1/30/2004 |
|
$ |
1.08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,325 |
|
|
|
|
|
|
|
65,325 |
|
Discount related to beneficial conversion feature of warrants
issued with convertible subordinated notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32,961 |
|
|
|
|
|
|
|
32,961 |
|
Exercise of warrants
|
|
3/17/2004 |
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
1 |
|
|
|
4,999 |
|
|
|
|
|
|
|
5,000 |
|
Issuance of Common Stock, net of issuance costs of $598,334
|
|
3/30/2004 |
|
|
2.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,500,000 |
|
|
|
250 |
|
|
|
4,401,416 |
|
|
|
|
|
|
|
4,401,666 |
|
Conversion of convertible subordinated notes to Common Stock
|
|
3/30/2004 |
|
|
2.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,032,343 |
|
|
|
103 |
|
|
|
2,064,583 |
|
|
|
|
|
|
|
2,064,686 |
|
Issuance of 500,000 warrants in conjunction with consulting
agreements
|
|
3/29/2004 |
|
|
0.93 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
464,378 |
|
|
|
|
|
|
|
464,378 |
|
Issuance of 250,000 warrants to placement agent
|
|
10/6/2004 |
|
|
1.81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
452,269 |
|
|
|
|
|
|
|
452,269 |
|
Accretion of undeclared dividends on Series A and D
Redeemable Convertible Preferred Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
504,052 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,420 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(600,472 |
) |
|
|
(600,472 |
) |
Contractual reduction of Series B Redeemable Convertible
Preferred stock undeclared dividend accrual
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(299,441 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
299,441 |
|
|
|
299,441 |
|
Exercise of stock options
|
|
2/9/04-12/31/04 |
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26,330 |
|
|
|
2 |
|
|
|
13,163 |
|
|
|
|
|
|
|
13,165 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,723,808 |
) |
|
|
(5,723,808 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
|
|
|
|
|
|
2,291,144 |
|
|
|
8,320,643 |
|
|
|
593,226 |
|
|
|
9,491,622 |
|
|
|
285,714 |
|
|
|
1,945,563 |
|
|
|
438,232 |
|
|
|
1,369,193 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,505,306 |
|
|
|
651 |
|
|
|
7,706,137 |
|
|
|
(32,235,455 |
) |
|
|
(24,528,667 |
) |
Issuance of Common Stock, net of issuance costs of $593,100
|
|
1/31/2005 |
|
|
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,390,000 |
|
|
|
139 |
|
|
|
3,576,761 |
|
|
|
|
|
|
|
3,576,900 |
|
Issuance of 20,000 warrants in conjunction with patent licensing
|
|
1/31/2005 |
|
|
1.79 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,870 |
|
|
|
|
|
|
|
35,870 |
|
Issuance of Common Stock, net of issuance costs of $885,931
|
|
2/28/2005 |
|
|
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
943,331 |
|
|
|
94 |
|
|
|
1,943,968 |
|
|
|
|
|
|
|
1,944,062 |
|
Issuance of 233,333 warrants to placement agent
|
|
2/28/2005 |
|
|
1.78 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
415,200 |
|
|
|
|
|
|
|
415,200 |
|
Issuance of Preferred Stock related to acquisition of assets
|
|
9/30/2005 |
|
|
4.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,000,000 |
|
|
|
4,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,000,000 |
|
Issuance of 100,000 warrants with subordinated notes
|
|
9/30/2005 |
|
|
2.73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
273,327 |
|
|
|
|
|
|
|
273,327 |
|
Issuance of Common Stock, net of issuance costs of $1,487,527
|
|
10/20/2005 |
|
|
4.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,658,750 |
|
|
|
266 |
|
|
|
9,147,207 |
|
|
|
|
|
|
|
9,147,473 |
|
Issuance of Common Stock, net of issuance costs of $1,510,645
|
|
11/8/2005 |
|
|
4.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,091,250 |
|
|
|
109 |
|
|
|
2,854,246 |
|
|
|
|
|
|
|
2,854,355 |
|
Issuance of 375,000 warrants to placement agent
|
|
11/8/2005 |
|
|
2.52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
943,195 |
|
|
|
|
|
|
|
943,195 |
|
Accretion of undeclared dividends on Series A and D
Redeemable Convertible Preferred Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
504,052 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(600,452 |
) |
|
|
(600,452 |
) |
Exercise of warrants
|
|
10/11/2005 |
|
|
2.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,531 |
|
|
|
2 |
|
|
|
35,060 |
|
|
|
|
|
|
|
35,062 |
|
Exercise of stock options
|
|
01/05-12/05 |
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
317,270 |
|
|
|
32 |
|
|
|
296,103 |
|
|
|
|
|
|
|
296,135 |
|
Issuance of stock options
|
|
7/1/2005 |
|
|
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
82,000 |
|
|
|
|
|
|
|
82,000 |
|
Acceleration of stock options
|
|
8/8/2005 |
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
125,000 |
|
|
|
|
|
|
|
125,000 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(27,926,337 |
) |
|
|
(27,926,337 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
|
|
|
|
|
|
2,291,144 |
|
|
|
8,824,695 |
|
|
|
593,226 |
|
|
|
9,491,622 |
|
|
|
285,714 |
|
|
|
1,945,563 |
|
|
|
438,232 |
|
|
|
1,465,593 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,000,000 |
|
|
|
4,000,000 |
|
|
|
12,923,438 |
|
|
|
1,293 |
|
|
|
27,434,074 |
|
|
|
(60,762,244 |
) |
|
|
(29,326,877 |
) |
Issuance of 75,000 warrants to consultant (unaudited)
|
|
2/1/2006 |
|
|
2.32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
173,909 |
|
|
|
|
|
|
|
173,909 |
|
Issuance of Series F Redeemable Convertible Preferred Stock
net of issuance costs of $726,500 (unaudited)
|
|
4/14/2006 |
|
|
5.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,070,000 |
|
|
|
9,623,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of Series F Redeemable Convertible Preferred Stock
net of issuance costs of $479,941 (unaudited)
|
|
5/15/2006 |
|
|
5.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
765,000 |
|
|
|
3,345,059 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of undeclared dividends on Series A and D
Redeemable Convertible Preferred Stock (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
252,025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,205 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(300,230 |
) |
|
|
(300,230 |
) |
Issuance of stock options (unaudited)
|
|
01/06-06/06 |
|
|
4.00-5.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
112,676 |
|
|
|
|
|
|
|
112,676 |
|
Exercise of stock options (unaudited)
|
|
01/06-06/06 |
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
110,200 |
|
|
|
11 |
|
|
|
55,089 |
|
|
|
|
|
|
|
55,100 |
|
Modification of stock options (unaudited)
|
|
03/06-06/06 |
|
|
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
262,617 |
|
|
|
|
|
|
|
262,617 |
|
Acceleration of stock options (unaudited)
|
|
4/27/2006 |
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
130,000 |
|
|
|
|
|
|
|
130,000 |
|
Net loss (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,419,625 |
) |
|
|
(7,419,625 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 (unaudited)
|
|
|
|
|
|
|
|
|
2,291,144 |
|
|
$ |
9,076,720 |
|
|
|
593,226 |
|
|
$ |
9,491,622 |
|
|
|
285,714 |
|
|
$ |
1,945,563 |
|
|
|
438,232 |
|
|
$ |
1,513,798 |
|
|
|
2,835,000 |
|
|
$ |
12,968,559 |
|
|
$ |
|
|
|
|
$ |
|
|
|
|
1,000,000 |
|
|
$ |
4,000,000 |
|
|
|
13,033,638 |
|
|
$ |
1,304 |
|
|
$ |
28,168,365 |
|
|
$ |
(68,482,099 |
) |
|
$ |
(36,312,430 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-6
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
|
|
|
|
Period from | |
|
|
|
|
|
|
|
|
October 7, | |
|
|
|
|
|
October 7, | |
|
|
|
|
|
|
|
|
1999 | |
|
|
|
|
|
1999 | |
|
|
|
|
|
|
|
|
(Date of | |
|
|
|
(Date of | |
|
|
|
|
Inception) | |
|
Six Months Ended | |
|
Inception) | |
|
|
Years Ended December 31, | |
|
Through | |
|
June 30, | |
|
Through | |
|
|
| |
|
December 31, | |
|
| |
|
June 30, | |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
|
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$ |
(3,819,749 |
) |
|
$ |
(5,723,808 |
) |
|
$ |
(27,926,337 |
) |
|
$ |
(56,396,325 |
) |
|
$ |
1,034,394 |
|
|
$ |
(7,419,625 |
) |
|
$ |
(63,815,950 |
) |
Adjustments to reconcile net (loss) income to net cash used
in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
209,032 |
|
|
|
185,905 |
|
|
|
194,206 |
|
|
|
1,684,849 |
|
|
|
95,390 |
|
|
|
331,872 |
|
|
|
2,016,721 |
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
207,000 |
|
|
|
209,689 |
|
|
|
|
|
|
|
505,293 |
|
|
|
714,982 |
|
|
Warrant amortization expense
|
|
|
|
|
|
|
916,647 |
|
|
|
35,870 |
|
|
|
952,517 |
|
|
|
35,870 |
|
|
|
173,909 |
|
|
|
1,126,426 |
|
|
Amortization of debt discount
|
|
|
15,565 |
|
|
|
156,688 |
|
|
|
273,327 |
|
|
|
458,548 |
|
|
|
|
|
|
|
|
|
|
|
458,548 |
|
|
Loss on patent and trademark costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
876,811 |
|
|
|
|
|
|
|
|
|
|
|
876,811 |
|
|
Minority interest in net loss of consolidated subsidiary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,638,446 |
) |
|
|
|
|
|
|
|
|
|
|
(2,638,446 |
) |
|
Gain on extinguishment of note
|
|
|
|
|
|
|
|
|
|
|
(3,834,959 |
) |
|
|
(3,834,959 |
) |
|
|
(3,834,959 |
) |
|
|
|
|
|
|
(3,834,959 |
) |
|
Note issued for acquisition of technology expensed to operations
|
|
|
|
|
|
|
|
|
|
|
15,000,000 |
|
|
|
15,000,000 |
|
|
|
|
|
|
|
|
|
|
|
15,000,000 |
|
|
Preferred stock issued for acquisition of technology expensed to
operations
|
|
|
|
|
|
|
|
|
|
|
4,000,000 |
|
|
|
4,000,000 |
|
|
|
|
|
|
|
|
|
|
|
4,000,000 |
|
|
(Loss) gain on sale of property and equipment
|
|
|
(10,871 |
) |
|
|
2,681 |
|
|
|
|
|
|
|
(8,190 |
) |
|
|
|
|
|
|
2,983 |
|
|
|
(5,207 |
) |
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventories
|
|
|
63,649 |
|
|
|
8,494 |
|
|
|
36,251 |
|
|
|
|
|
|
|
|
|
|
|
(4,175,000 |
) |
|
|
(4,175,000 |
) |
|
|
Prepaid expenses and other
|
|
|
(14,994 |
) |
|
|
(154,367 |
) |
|
|
(84,611 |
) |
|
|
(55,742 |
) |
|
|
19,446 |
|
|
|
(209,612 |
) |
|
|
(265,354 |
) |
|
|
Receivables due from related parties and employees
|
|
|
11,892 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
423,928 |
|
|
|
(245,911 |
) |
|
|
385,834 |
|
|
|
543,823 |
|
|
|
(110,953 |
) |
|
|
183,167 |
|
|
|
726,990 |
|
|
|
Accrued expenses and other liabilities
|
|
|
163,376 |
|
|
|
753,930 |
|
|
|
540,548 |
|
|
|
977,462 |
|
|
|
146,752 |
|
|
|
1,127,579 |
|
|
|
2,105,041 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(2,958,172 |
) |
|
|
(4,099,741 |
) |
|
|
(11,172,871 |
) |
|
|
(38,229,963 |
) |
|
|
(2,614,060 |
) |
|
|
(9,479,434 |
) |
|
|
(47,709,397 |
) |
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
(33,530 |
) |
|
|
(64,719 |
) |
|
|
(564,202 |
) |
|
|
(1,371,841 |
) |
|
|
(356,181 |
) |
|
|
(300,722 |
) |
|
|
(1,672,563 |
) |
Proceeds from sale of property and equipment
|
|
|
17,500 |
|
|
|
|
|
|
|
|
|
|
|
17,500 |
|
|
|
|
|
|
|
|
|
|
|
17,500 |
|
Purchase of intangibles
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(391,472 |
) |
|
|
|
|
|
|
(825,000 |
) |
|
|
(1,216,472 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(16,030 |
) |
|
|
(64,719 |
) |
|
|
(564,202 |
) |
|
|
(1,745,813 |
) |
|
|
(356,181 |
) |
|
|
(1,125,722 |
) |
|
|
(2,871,535 |
) |
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal payments under capital lease obligations
|
|
|
(15,131 |
) |
|
|
(1,404 |
) |
|
|
|
|
|
|
(165,667 |
) |
|
|
|
|
|
|
|
|
|
|
(165,667 |
) |
Net change in borrowings under lines of credit
|
|
|
(132,186 |
) |
|
|
(52,060 |
) |
|
|
|
|
|
|
(175,071 |
) |
|
|
|
|
|
|
|
|
|
|
(175,071 |
) |
Increase in note payable to development partner
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,610,075 |
|
|
|
53,180 |
|
|
|
|
|
|
|
3,610,075 |
|
Payment upon extinguishment of note
|
|
|
|
|
|
|
|
|
|
|
(500,212 |
) |
|
|
(500,212 |
) |
|
|
(500,212 |
) |
|
|
|
|
|
|
(500,212 |
) |
Minority investment in consolidated subsidiary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,638,446 |
|
|
|
|
|
|
|
|
|
|
|
2,638,446 |
|
Proceeds from issuance of common stock
|
|
|
1,150 |
|
|
|
4,419,831 |
|
|
|
17,853,987 |
|
|
|
22,329,218 |
|
|
|
5,699,694 |
|
|
|
55,100 |
|
|
|
22,384,318 |
|
Proceeds from bridge notes payable
|
|
|
1,400,000 |
|
|
|
600,000 |
|
|
|
|
|
|
|
4,410,226 |
|
|
|
|
|
|
|
|
|
|
|
4,410,226 |
|
Issuance of promissory note for acquisition of technology
|
|
|
|
|
|
|
|
|
|
|
4,000,000 |
|
|
|
4,000,000 |
|
|
|
|
|
|
|
|
|
|
|
4,000,000 |
|
Payment of promissory note for acquisition of technology
|
|
|
|
|
|
|
|
|
|
|
(4,000,000 |
) |
|
|
(4,000,000 |
) |
|
|
|
|
|
|
|
|
|
|
(4,000,000 |
) |
Deferred offering costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,098,281 |
) |
|
|
(1,098,281 |
) |
Issuance of warrants
|
|
|
2,688 |
|
|
|
|
|
|
|
1,358,395 |
|
|
|
1,361,083 |
|
|
|
415,200 |
|
|
|
|
|
|
|
1,361,083 |
|
Net proceeds from issuance of preferred stock
|
|
|
350,371 |
|
|
|
|
|
|
|
|
|
|
|
14,919,349 |
|
|
|
|
|
|
|
12,968,559 |
|
|
|
27,887,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
1,606,892 |
|
|
|
4,966,367 |
|
|
|
18,712,170 |
|
|
|
48,427,447 |
|
|
|
5,667,862 |
|
|
|
11,925,378 |
|
|
|
60,352,825 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(1,367,310 |
) |
|
|
801,907 |
|
|
|
6,975,097 |
|
|
|
8,451,671 |
|
|
|
2,697,621 |
|
|
|
1,320,222 |
|
|
|
9,771,893 |
|
Cash and cash equivalents at the beginning of the period
|
|
|
2,103,693 |
|
|
|
736,383 |
|
|
|
1,538,290 |
|
|
|
61,716 |
|
|
|
1,538,290 |
|
|
|
8,513,387 |
|
|
|
61,716 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at the end of the period
|
|
$ |
736,383 |
|
|
$ |
1,538,290 |
|
|
$ |
8,513,387 |
|
|
$ |
8,513,387 |
|
|
$ |
4,235,911 |
|
|
$ |
9,833,609 |
|
|
$ |
9,833,609 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of cash flow information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period for interest
|
|
$ |
37,732 |
|
|
$ |
16,425 |
|
|
$ |
116,999 |
|
|
$ |
227,710 |
|
|
$ |
83,665 |
|
|
$ |
|
|
|
$ |
227,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-7
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Consolidated Statements of Cash Flows (continued)
Supplemental Schedule of Noncash Investing and Financing
Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
|
|
|
|
Period from | |
|
|
|
|
|
|
|
|
October 7, 1999 | |
|
|
|
|
|
October 7, 1999 | |
|
|
|
|
|
|
|
|
(Date of | |
|
|
|
(Date of | |
|
|
|
|
Inception) | |
|
Six Months ended | |
|
Inception) | |
|
|
Years ended December 31, | |
|
Through | |
|
June 30, | |
|
Through | |
|
|
| |
|
December 31, | |
|
| |
|
June 30, | |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
2005 | |
|
2005 | |
|
2006 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
|
|
|
|
|
|
|
|
|
(unaudited) | |
|
|
Accretion of undeclared dividends on Series A/ D Redeemable
Convertible Preferred Stock
|
|
$ |
646,180 |
|
|
$ |
600,472 |
|
|
$ |
600,452 |
|
|
$ |
2,884,297 |
|
|
$ |
300,236 |
|
|
$ |
300,230 |
|
|
$ |
3,184,527 |
|
Accretion (reversal) of undeclared dividends on
Series B Redeemable Convertible Preferred Stock
|
|
|
299,441 |
|
|
|
(299,441 |
) |
|
|
|
|
|
|
817,182 |
|
|
|
|
|
|
|
|
|
|
|
817,182 |
|
Declared dividends on Series B Redeemable Convertible
Preferred Stock
|
|
|
341,094 |
|
|
|
|
|
|
|
|
|
|
|
664,440 |
|
|
|
|
|
|
|
|
|
|
|
664,440 |
|
Fair value of stock warrants issued for consulting services and
placement agreement amendment
|
|
|
|
|
|
|
916,647 |
|
|
|
|
|
|
|
920,161 |
|
|
|
|
|
|
|
173,909 |
|
|
|
1,094,070 |
|
Fair value of detachable stock warrants in connection with
borrowings under lines of credit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,110 |
|
|
|
|
|
|
|
|
|
|
|
16,110 |
|
Fair value of stock warrants issued for patents
|
|
|
|
|
|
|
|
|
|
|
35,870 |
|
|
|
35,780 |
|
|
|
35,870 |
|
|
|
|
|
|
|
35,780 |
|
Fair value of stock warrants issued for bridge notes
|
|
|
70,000 |
|
|
|
65,325 |
|
|
|
273,327 |
|
|
|
408,652 |
|
|
|
|
|
|
|
|
|
|
|
408,652 |
|
Fair value of stock warrants issued in connection with private
placement
|
|
|
|
|
|
|
|
|
|
|
1,358,395 |
|
|
|
1,358,395 |
|
|
|
415,200 |
|
|
|
|
|
|
|
1,358,395 |
|
Fair value of beneficial conversion feature of stock warrants
issued for convertible subordinated notes
|
|
|
|
|
|
|
32,961 |
|
|
|
|
|
|
|
32,961 |
|
|
|
|
|
|
|
|
|
|
|
32,961 |
|
Issuance of note in connection with subscription for preferred
stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
244,834 |
|
|
|
|
|
|
|
|
|
|
|
244,834 |
|
Issuance of preferred stock upon conversion of unsecured
convertible notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,031,979 |
|
|
|
|
|
|
|
|
|
|
|
1,031,979 |
|
Issuance of common stock upon conversion of convertible
subordinated notes
|
|
|
|
|
|
|
2,064,686 |
|
|
|
|
|
|
|
2,064,686 |
|
|
|
|
|
|
|
|
|
|
|
2,064,686 |
|
Assets recorded under capital lease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
121,169 |
|
|
|
|
|
|
|
|
|
|
|
121,169 |
|
Note issued for acquisition of technology and related inventory
and intangibles
|
|
|
|
|
|
|
|
|
|
|
15,000,000 |
|
|
|
15,000,000 |
|
|
|
|
|
|
|
15,000,000 |
|
|
|
30,000,000 |
|
Preferred stock issued for acquisition of technology
|
|
|
|
|
|
|
|
|
|
|
4,000,000 |
|
|
|
4,000,000 |
|
|
|
|
|
|
|
|
|
|
|
4,000,000 |
|
See accompanying notes.
F-8
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
(Information subsequent to December 31, 2005 and
pertaining to
June 30, 2006 and the six-months ended June 30,
2005 and 2006 is unaudited)
ImaRx Therapeutics, Inc. (ImaRx or the Company), is a
biopharmaceutical company developing and commercializing
therapies for vascular disorders associated with blood clots.
The Companys development efforts are primarily focused on
therapies for treating ischemic stroke and massive pulmonary
embolism by restoring the flow of blood and oxygen to the brain
and vital tissues, and clearing occluded catheters.
ImaRx organized as an Arizona limited liability company on
October 7, 1999, which was the Companys date of
inception for accounting purposes. The Company was subsequently
converted to an Arizona corporation on January 12, 2000,
and then reincorporated as a Delaware corporation on
June 23, 2000. The Company has not yet generated any
significant revenue from core operations as of June 30,
2006, and remains a development stage company.
|
|
2. |
Significant Accounting Policies |
The consolidated financial statements include the accounts of
the Company and its consolidated subsidiaries, ImaRx Oncology,
Ltd. (IOL) and ImaRx Europe Limited (IEL). On
January 19, 2001, the Company acquired an 80.1% ownership
interest in IOL, a Bermuda limited liability company formed for
the purpose of joint development activities between ImaRx and
its development partner. The development partner owned the
remaining 19.9% of IOL until October 2, 2002, when a
termination agreement was entered into between the parties. The
Company acquired the remaining 19.9% interest in IOL in exchange
for an interest in future royalties. Since October 2, 2002,
IOL has been a wholly-owned subsidiary of ImaRx. The Company is
in the process of dissolving IOL. All significant intercompany
accounts and transactions have been eliminated. IEL is a wholly
owned subsidiary created in 2005 by the Company to facilitate
clinical trials in Europe. IEL operations have not yet commenced.
|
|
|
Interim Financial Information |
The financial statements at June 30, 2006 and for the six
months ended June 30, 2005 and 2006 are unaudited. The
unaudited financial statements have been prepared on the same
basis as the audited financial statements and, in the opinion of
management, include all adjustments, consisting only of normal
recurring adjustments, necessary to state fairly the financial
information therein in accordance with U.S. generally accepted
accounting principles (GAAP). The results of operations for the
six months ended June 30, 2006 are not necessarily
indicative of the results that may be reported for the year
ending December 31, 2006.
The Company has been in the development stage since its
inception and has no products commercialized or technologies
licensed that will provide significant revenue in the immediate
future. In addition, the Company requires additional financing
to meet its near-term obligations. During the years ended
December 31, 2004, 2005, the six months ended June 30,
2006 and for the period from October 7, 1999 (date of
inception) to June 30, 2006, the Company has had historical
recurring losses, and a net capital deficiency at June 30,
2006. These conditions, among others, raise substantial doubt
about the Companys ability to continue as a going concern.
The financial statements do not include any adjustments relating
to the recoverability and classification of recorded assets, or
the amounts and classification of liabilities that might be
necessary in the event the Company cannot acquire additional
financing. The Company has received financing through a private
placement of Series F preferred stock to acquire
Abbokinase, from Abbott Laboratories, Inc. (Abbott)
F-9
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
a revenue-generating product and to provide sufficient capital
for the near-term future. In addition, management is seeking to
secure additional capital as may be required as well as
long-term development agreements with several potential
partners. The Companys ability to continue as a going
concern depends on the successful commercialization or licensing
of its technologies.
The Company considers all highly liquid investments with a
maturity of three months or less when purchased to be cash
equivalents. Cash equivalents are recorded at cost, which
approximates market value.
|
|
|
Fair Value of Financial Instruments |
The Company measures its financial assets and liabilities in
accordance with GAAP. The carrying amounts of financial
instruments, including cash and cash equivalents, accounts
payable, accrued expenses and short-term notes payable,
approximate fair value based on the liquidity or on the
short-term maturities of these financial instruments.
Inventories, consisting principally of chemicals used in
research in 2004 and finished drug product in 2006, are stated
at the lower of cost or market. Cost of inventories is
determined using the first-in, first-out method. During 2005,
the Company terminated a research project and inventory
associated with this project was expensed.
All property and equipment are recorded at cost and depreciated
over their estimated useful lives, ranging from three to seven
years, using the straight-line method. Leasehold improvements
are amortized using the straight-line method over the lesser of
the lease term or the estimated useful life.
Intangible assets include customer relationships, trade name,
contracts and technology and are accounted for based on
Statement of Financial Accounting Standards,
(SFAS No. 142), Goodwill and Other Intangible
Assets.
Intangible assets with finite useful lives are amortized over
the estimated useful lives from the date of acquisition, ranging
from 1 to 4 years, using the straight-line method:
In accordance with Statement of Financial Accounting Standards,
(SFAS No. 144), Accounting for the Impairment or
Disposal of Long-Lived Assets, if indications of impairment
exist, the Company assures the recoverability of the affected
long-lived assets by determining whether the carrying value of
such assets can be recovered through undiscounted future cash
flows. If impairment is indicated, the Company measures the
amounts of such impairments by comparing the carrying value of
the asset to the present value of the expected cash flows
associated with the use of the asset. Although the Company has
accumulated losses since inception, the Company believes that
future cash flows will exceed the carrying value of the
Companys long-lived assets.
F-10
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
The Company provides research services under certain contract
and grant agreements, including federal grants from the National
Institutes of Health. The Company recognizes revenue for these
research services as the services are performed. Revenue from
grants is recognized over the contractual period of the related
award.
We anticipate that we will recognize revenue from product sales
when all four of the following criteria are met:
(i) persuasive evidence that an arrangement exists;
(ii) delivery of the products has occurred; (iii) the
selling price is both fixed and determinable; and
(iv) collectibility is reasonably probable. Product sales
are recorded net of discounts, rebates and sales incentives to
customers. Returns and other adjustments will be provided for in
the period the related sales are recorded, in accordance with
our return policy as established.
The Company maintains performance incentive plans under which
incentive and non-qualified stock options are granted primarily
to employees and non-employee directors. Prior to
January 1, 2006, the Company accounted for stock-based
compensation in accordance with Accounting Principles Board
Opinion No. 25 (APB No. 25), Accounting for Stock
Issued to Employees, SFAS No. 123 Accounting
for Stock Based Compensation, and related interpretations.
The Companys policy is to grant all stock options at the
fair market value of the underlying stock at the date of grant.
Accordingly, compensation expense is not recognized for the
stock options at the date of grant prior to January 1,
2006. For non-employee grants issued prior to January 1,
2006, the calculation of expense was determined using the
Black-Scholes option pricing model. We calculated the expense
using the exercise price of the option, the fair market value of
the underlying stock at the date of the grant, the expected
volatility of the stock price, the life of the option and the
risk-free interest rate. The expense was recorded in accordance
with the vesting period of the option.
In December 2004, the Financial Accounting Standards Board
(FASB) issued SFAS No. 123 (revised 2004), Share
Based Payment (SFAS No. 123(R).
SFAS No. 123(R) supersedes APB No. 25.
SFAS No. 123(R) requires that the cost of share-based
payment transactions (including those with employees and
non-employees) be recognized in the financial statements. For
non-employees this expense is recognized as the service is
provided, in accordance with guidance in EITF Issue
No. 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring or in Conjunction with Selling,
Goods or Services. SFAS No. 123(R) applies to all
share-based payment transactions in which an entity acquires
goods or services by issuing (or offering to issue) its shares,
share options, or other equity instruments (except for those
held by an ESOP) or by incurring liabilities (1) in amounts
based on the price of the entitys shares or other equity
instruments, or (2) that require (or may require)
settlement by the issuance of an entitys shares or other
equity instruments.
Effective January 1, 2006, the Company adopted
SFAS 123(R), requiring measurement of the cost of employee
services received in exchange for all equity awards granted,
based on the fair market value of the award as of the grant
date. Under this standard the fair value of each employee stock
option is estimated on the date of grant using an option pricing
model that meets certain requirements. We currently use the
Black-Scholes option pricing model to estimate the fair value of
our share-based payments. The determination of the fair value of
share based payment awards utilizing the Black-Scholes model is
affected by our stock price and a number of assumptions,
including expected volatility, expected life, risk-free interest
rate and expected dividends. We use guideline companies to
determine volatility. The expected life of the stock options is
based on historical data and future expectations. The risk-free
interest rate assumption is based on observed interest rates
appropriate for the terms of our stock options. The dividend
yield assumption is based on our history and expectation of
dividend payouts. Stock based compensation expense recognized in
our financial statements in 2006 and thereafter is based on
awards that are ultimately expected to vest. The amount of
F-11
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
stock-based compensation expense in 2006 and thereafter will be
reduced for estimated forfeitures. Forfeitures are required to
be estimated at the time of the grant and revised, if necessary,
in subsequent periods if actual forfeitures differ from those
estimates. We will evaluate the assumptions used to value stock
awards on a quarterly basis. If factors change and we employ
different assumptions, stock-based compensation expense may
differ significantly from what we have previously recorded. To
the extent that we grant additional equity securities to
employees, our stock based compensation expense will be
increased by the additional compensation resulting from those
additional grants. The Company has adopted SFAS 123(R)
using the prospective application method of adoption which
requires recording compensation cost related to awards granted
after December 31, 2005 based on the fair value related to
stock options at the grant dates.
The weighted average expected option term for the six month
period ending June 30, 2006 reflects the application of the
simplified method set out in SEC Staff Accounting
Bulletin No. 107 (SAB 107), which was issued in
March 2005. The simplified method defines the life as the
average of the contractual term of the options and the weighted
average vesting period for all option tranches. Estimated
volatility for the six month period ended June 30, 2006
also reflects the application of SAB 107 interpretive
guidance and, accordingly incorporates historical volatility of
similar entities whose share prices are publicly available.
Volatility for 2003, 2004 and 2005 was based on the minimum
value method.
The Company used the Black-Scholes model, weighted average
risk-free interest rate of 4.9%, expected volatility of 75%,
expected term vesting of 7 years, and 0% dividend yield to
determine the total fair value of approximately $1,560,000 for
options to purchase 642,500 shares of the Companys
common stock issued during the six months ended June 30,
2006. The Company recorded approximately $99,000 in stock-based
compensation expense related to options granted during the six
months ended June 30, 2006 and there was no income tax
benefit related to this expense. There was no incremental impact
of adopting SFAS 123(R) on loss per share for the six
months ended June 30, 2006.
The pro forma amounts required by SFAS No. 123 was
applied to the stock-based compensation during the years ended
December 31, 2003, 2004 and 2005 and for the six months
ended June 30, 2005. The pro forma effect on net (loss)
income was determined as if the fair value of the stock-based
compensation had been recognized as compensation expense on a
straight-line basis over the vesting period of the stock options
in each period.
Pro forma information regarding net (loss) income is required by
SFAS No. 123 which requires that the information be
determined as if the Company has accounted for its employee
stock options granted during the years ended December 31,
2003, 2004 and 2005 and the six months ended June 30, 2005,
under the fair value method of SFAS 123. The deemed fair
value for options granted was estimated at the date of grant
using the minimum value option valuation model, which assumes
the stock price has no volatility since the common stock is not
publicly traded. The following assumptions were used to
calculate the deemed fair value of the option awards at the date
of grant: no dividend payout expected, expected option life of
five years and a risk-free interest rate averaging 3% for the
years ended December 31, 2003, 2004 and 2005 and the six
months ended June 30, 2005. The weighted average estimated
fair value of stock options granted with an exercise price equal
to the fair value of the underlying common stock on the date of
the grant during fiscal years 2003, 2004 and 2005 were $0.08,
$0.43 and $0.62, respectively.
The minimum value option valuation model was developed for use
in estimating the fair value of traded options that have no
vesting restrictions and are fully transferable. In addition,
option valuation models require the input of highly subjective
assumptions, including the expected life of the option. Because,
among other things, changes in the subjective input assumptions
can materially affect the fair value estimate, in
managements opinion, the existing models do not
necessarily provide a reliable single measure of the fair
F-12
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
value of its stock options. For purposes of pro forma
disclosures, the deemed fair value of the options is amortized
to expense over the vesting periods.
If compensation for options granted under the plan had been
determined based on the deemed fair value at the grant date
consistent with the method provided under SFAS 123, then
the Companys net income (loss) would have been as
indicated in the pro forma amounts below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
|
|
| |
|
Six Months Ended | |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
June 30, 2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
(unaudited) | |
Net income (loss) available to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported
|
|
$ |
(5,106,464 |
) |
|
$ |
(6,024,839 |
) |
|
$ |
(28,526,789 |
) |
|
$ |
734,158 |
|
Pro forma SFAS No. 123 expense
|
|
|
20,591 |
|
|
|
56,504 |
|
|
|
141,781 |
|
|
|
54,271 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma
|
|
$ |
(5,127,055 |
) |
|
$ |
(6,081,343 |
) |
|
$ |
(28,668,570 |
) |
|
$ |
679,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
Six Months | |
|
|
| |
|
Ended June 30, | |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
(unaudited) | |
Net income (loss) available to common stockholders per
share basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(1.74 |
) |
|
$ |
(1.07 |
) |
|
$ |
(3.01 |
) |
|
$ |
0.09 |
|
|
Diluted
|
|
$ |
(1.74 |
) |
|
$ |
(1.07 |
) |
|
$ |
(3.01 |
) |
|
$ |
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma income (loss) available to common stockholders per
share basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(1.75 |
) |
|
$ |
(1.08 |
) |
|
$ |
(3.03 |
) |
|
$ |
0.08 |
|
|
Diluted
|
|
$ |
(1.75 |
) |
|
$ |
(1.08 |
) |
|
$ |
(3.03 |
) |
|
$ |
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and Development Expenses |
Research and development costs primarily consist of salaries and
related expenses for personnel, fees paid to consultants and
outside service providers, facilities costs, and the costs
associated with clinical trials and research and development.
The Company charges all research and development expenses to
operations as incurred.
The Company accounts for income taxes under the liability method
pursuant to SFAS No. 109, Accounting for Income
Taxes. Under the liability method, deferred tax assets and
liabilities are determined based on the differences between the
financial reporting and tax bases of assets and liabilities
using the enacted tax rates and laws that will be in effect when
the differences are expected to reverse. A valuation allowance
is provided when the Company determines that it is more likely
than not that some portion or all of a deferred tax asset will
not be realized.
The preparation of financial statements in conformance with GAAP
requires management to make estimates and assumptions that
affect the amounts reported in the consolidated financial
statements and accompanying notes. Actual results could differ
from those estimates.
F-13
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
|
|
|
Concentration of Credit Risk and Limited Suppliers |
The Company has no significant off-balance sheet concentrations
of credit risk such as foreign exchange contracts, options
contracts or other foreign hedging arrangements. Financial
instruments that potentially subject the Company to credit risk
consist principally of cash investments and uncollateralized
accounts receivable. The Company maintains the majority of its
cash balances in the form of cash deposits in bank checking and
money market accounts with a highly rated commercial bank.
The Company relies on certain materials used in its research and
development processes which are procured from single sources.
The failure of any of these suppliers to deliver the materials
could delay or interrupt the development timelines and thereby
adversely affect the Companys operating results.
|
|
|
Net (Loss) Income Available to Common Stockholders per
Share |
Basic and diluted net loss available to common stockholders per
share is calculated by dividing the net loss applicable to
common stockholders by the weighted-average number of common
shares outstanding during the period. Diluted net loss per
common share is the same as basic net loss per common share for
all periods presented other than the six months ended
June 30, 2005 in which the Company reported net income. The
effects of potentially dilutive securities are antidilutive in
the loss periods. Diluted net income per share for the six
months ended June 30, 2005 is computed based upon the
weighted average number of shares of common stock outstanding
during the period increased by the weighted-average number of
dilutive common stock equivalents outstanding using the treasury
stock method.
|
|
|
|
|
|
|
|
Six Months Ended | |
|
|
June 30, 2005 | |
|
|
| |
|
|
(unaudited) | |
Weighted-average common shares outstanding used to compute basic
net income per share
|
|
|
8,335,776 |
|
Add dilutive common equivalents:
|
|
|
|
|
|
Stock options
|
|
|
862,100 |
|
|
Convertible preferred stock
|
|
|
4,330,301 |
|
|
Warrants
|
|
|
275,620 |
|
|
|
|
|
Shares used to compute diluted net income per share
|
|
|
13,803,797 |
|
|
|
|
|
The following potential common shares have been excluded from
the computation of diluted net loss per share since their effect
would be antidilutive in each of the loss periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
|
|
| |
|
Six Months Ended | |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
June 30, 2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
|
|
(unaudited) | |
Convertible preferred stock
|
|
|
4,330,301 |
|
|
|
4,330,301 |
|
|
|
5,330,301 |
|
|
|
8,165,301 |
|
Stock options
|
|
|
1,077,250 |
|
|
|
1,967,761 |
|
|
|
2,670,724 |
|
|
|
2,897,024 |
|
Warrants
|
|
|
163,071 |
|
|
|
973,071 |
|
|
|
1,686,749 |
|
|
|
1,761,749 |
|
Convertible notes payable
|
|
|
1,024,721 |
|
|
|
329,384 |
|
|
|
|
|
|
|
|
|
|
|
|
Recently Issued Accounting Pronouncements |
In December 2004, the FASB issued SFAS No. 153,
Exchanges of Nonmonetary Assets, which is an amendment to
APB No. 29, Accounting for Nonmonetary Transactions.
SFAS No. 153 eliminates certain differences in the
guidance in APB No. 29 as compared to the guidance
contained in standards issued by the
F-14
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
International Accounting Standards Board. The amendment to APB
No. 29 eliminates the fair value exception for nonmonetary
exchanges of similar productive assets and replaces it with a
general exception for exchanges of nonmonetary assets that do
not have commercial substance. Such an exchange has commercial
substance if the future cash flows of the entity are expected to
change significantly as a result of the exchange.
SFAS No. 153 is effective for nonmonetary asset
exchanges occurring in periods beginning after June 15,
2005. The adoption of SFAS No. 153 had no material
impact on our financial statements.
In May 2005, the FASB issued SFAS No. 154,
Accounting Changes and Error Corrections A
Replacement of APB Opinion No. 20 and FASB Statement
No. 3. SFAS No. 154 requires the
retrospective application to prior periods financial
statements of changes in accounting principle, unless it is
impractical to determine either the period-specific effects or
cumulative effect of the accounting change.
SFAS No. 154 also requires that a change in
depreciation, amortization, or depletion method for long-lived
non-financial assets be accounted for as a change in accounting
estimate affected by a change in accounting principle.
SFAS No. 154 is affective for accounting changes and
corrections of errors made in fiscal years beginning after
December 15, 2005. The adoption of SFAS No. 154
had no material impact on our financial statements.
In November 2005, the FASB issued FASB Staff Position FAS 115-1
and FAS 124-1
(collectively,
FSP 115-1), The
Meaning of Other-Than-Temporary Impairment and Its Application
to Certain Investments, or
FSP 115-1, which
provides guidance on determining when investments in certain
debt and equity securities are considered impaired, whether that
impairment is other-than-temporary, and on measuring such
impairment loss.
FSP 115-1 also
includes accounting considerations subsequent to the recognition
of other-than-temporary impairment and requires certain
disclosures about unrealized losses that have not been
recognized as other-than-temporary impairments. We are required
to apply FSP 115-1
to reporting periods beginning after December 15, 2005 and
we adopted
FSP 115-1 in the
first quarter of fiscal 2006. The adoption had no impact on our
financial statements.
Property and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, | |
|
|
|
|
| |
|
At June 30, | |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
|
|
|
|
|
(Unaudited) | |
Leasehold improvements
|
|
$ |
567,896 |
|
|
$ |
622,663 |
|
|
$ |
622,663 |
|
Laboratory machinery and equipment
|
|
|
862,677 |
|
|
|
937,697 |
|
|
|
1,437,098 |
|
Computer and communications equipment
|
|
|
243,695 |
|
|
|
347,856 |
|
|
|
391,389 |
|
Office furniture and equipment
|
|
|
152,463 |
|
|
|
184,377 |
|
|
|
215,730 |
|
Construction in progress
|
|
|
|
|
|
|
292,229 |
|
|
|
2,178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,826,731 |
|
|
|
2,384,822 |
|
|
|
2,669,058 |
|
Less accumulated depreciation
|
|
|
1,466,766 |
|
|
|
1,654,861 |
|
|
|
1,773,230 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
359,965 |
|
|
$ |
729,961 |
|
|
$ |
895,828 |
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, 2004 and 2005 and for the
six months ended June 30, 2006, the Company recorded
depreciation expense of $185,905, $194,206 and $131,872,
respectively.
F-15
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
Accrued Expenses
Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, | |
|
|
|
|
| |
|
At June 30, | |
|
|
2004 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
|
|
|
|
|
(Unaudited) | |
Accrued salaries and vacation benefits
|
|
$ |
199,153 |
|
|
$ |
118,940 |
|
|
$ |
537,291 |
|
Accrued contract services
|
|
|
434,176 |
|
|
|
574,024 |
|
|
|
373,293 |
|
Other accrued expenses
|
|
|
|
|
|
|
200,234 |
|
|
|
495,192 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
633,329 |
|
|
$ |
893,198 |
|
|
$ |
1,405,777 |
|
|
|
|
|
|
|
|
|
|
|
A reconciliation of the U.S. federal statutory income tax rate
to the effective rate follows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2003 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
Tax benefit at statutory rate
|
|
$ |
(1,299,000 |
) |
|
$ |
(1,946,000 |
) |
|
$ |
(9,245,000 |
) |
State taxes (net of federal benefit)
|
|
|
(223,000 |
) |
|
|
(385,000 |
) |
|
|
(1,328,000 |
) |
Foreign rates lower than U.S. statutory rates
|
|
|
454,000 |
|
|
|
61,000 |
|
|
|
|
|
Net benefit from research and development credits
|
|
|
(77,000 |
) |
|
|
(91,000 |
) |
|
|
(129,000 |
) |
Other
|
|
|
14,000 |
|
|
|
11,000 |
|
|
|
393,000 |
|
Valuation allowance
|
|
|
1,131,000 |
|
|
|
2,350,000 |
|
|
|
10,309,000 |
|
|
|
|
|
|
|
|
|
|
|
Tax benefit at statutory rate
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income taxes reflect the net tax effects of temporary
differences between the carrying amounts of assets and
liabilities for financial reporting purposes and the amounts
used for income tax purposes. The Companys deferred tax
assets and liabilities are attributed to the following temporary
differences:
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, | |
|
|
| |
|
|
2004 | |
|
2005 | |
|
|
| |
|
| |
Current deferred tax assets:
|
|
|
|
|
|
|
|
|
|
Reserves and accrued liabilities
|
|
$ |
93,000 |
|
|
$ |
26,000 |
|
|
Other
|
|
|
|
|
|
|
3,000 |
|
|
|
|
|
|
|
|
|
|
|
93,000 |
|
|
|
29,000 |
|
Noncurrent deferred tax assets:
|
|
|
|
|
|
|
|
|
|
Property and equipment
|
|
|
144,000 |
|
|
|
165,000 |
|
|
Intangibles
|
|
|
992,000 |
|
|
|
9,805,000 |
|
|
Research and development credits
|
|
|
1,089,000 |
|
|
|
1,507,000 |
|
|
Net operating loss carryforward
|
|
|
4,744,000 |
|
|
|
5,865,000 |
|
|
|
|
|
|
|
|
|
|
|
6,969,000 |
|
|
|
17,342,000 |
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
7,062,000 |
|
|
|
17,371,000 |
|
Valuation allowance
|
|
|
(7,062,000 |
) |
|
|
(17,371,000 |
) |
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
At December 31, 2004 and 2005, the Company had net
operating loss carryforwards of approximately $12,291,000 and
$15,474,000, respectively, for federal tax purposes that begin
to expire in the year 2020. For state income tax purposes, the
Company had net operating loss carryforwards at
December 31, 2005 of
F-16
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
$13,121,000 that expire within five years of being incurred and
will begin to expire for state purposes in the year 2007.
Additionally, the Company has research and development credit
carryforwards of approximately $753,000 that begin to expire in
2020 and 2015 for federal and state purposes, respectively.
For financial reporting purposes, a valuation allowance of
$7,062,000 and $17,371,000 has been established for the year
ended December 31, 2004 and 2005, respectively, to offset
deferred tax assets relative to the net operating loss
carryforwards and other deferred tax assets. The gross deferred
tax assets resulted from accumulated net operating loss
carryforwards since inception. Pursuant to SFAS 109, the
Company has established a valuation allowance against the entire
tax asset. As a result, the Company does not recognize any tax
benefit until the Company is in a tax paying position, and
therefore, more likely to realize the tax benefit. The
Companys valuation allowance changed by $206,000,
$2,350,000 and $10,309,000 during the years ended
December 31, 2003, 2004 and 2005, respectively. Equity
offerings by the Company, and other transactions which may
impact the Companys ownership structure, have triggered
IRC Section 382 and 383 provisions, which may limit or
eliminate the potential future tax benefit to be realized by the
Company from its accumulated net operating loss carryforwards
and research and development credits.
|
|
5. |
Investment in ImaRx Oncology, Ltd. |
During 2001, the Company entered into a joint venture agreement
with a development partner to form ImaRx Oncology, Ltd.
(IOL) for the development of certain patents and
technology. Upon the formation of IOL, the Company acquired an
80.1% interest in IOL by purchase of 100% of IOLs voting
common shares for $5,000,000 and 60.2% of IOLs preferred
shares for $3,010,000, representing a total of 80.1% of
IOLs outstanding shares. The development partner acquired
the remaining 39.8% of IOLs preferred shares for
$1,990,000, representing a total of 19.9% of IOLs
outstanding shares.
On October 2, 2002, the Company entered into a termination
agreement (Termination Agreement) of the joint venture with the
development partner whereby the Company acquired the remaining
19.9% interest in IOL in exchange for consideration equal to
approximately $56,279 plus future contingent consideration in
the form of a net royalty interest in the sale, licensing or
other commercialization proceeds, as defined in the Termination
Agreement, of all IOL operations. This acquisition cost was
expensed to research and development in 2002 at the time the
Company entered into the Termination Agreement. IOL received
funding pursuant to a convertible promissory note (Development
Note) with the development partner for funding of the
development partners pro rata share of the development
costs.
Under the Termination Agreement, the Development Note was
amended and restated (Restated Development Note) to provide for
funding by the development partner up to a maximum principal
amount of $3,610,076. Refer to Note 8 for the terms of the
Restated Development Note and its extinguishment in full in
March 2005. The Company is in the process of dissolving IOL.
6. Related Party Transactions
The Company leases its office facility from a partnership whose
beneficial owners include a director and certain of the
Companys officers and stockholders. Rent expense related
to this lease, which has a remaining life of three years,
amounted to approximately $60,000 in both 2003 and 2004, $64,000
in 2005, and $32,000 for the six months ended June 30,
2006. The Companys related party rent expense will be
approximately $64,000 in both 2006 and 2007 and $54,000 in 2008
for the office facility.
F-17
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
7. Short-term
Notes Payable
|
|
|
Convertible Subordinated Notes |
Beginning in April 2003 and continuing through January 2004, the
Company issued $2,000,000 in convertible subordinated notes with
a maturity date of November 15, 2004. The notes were
unsecured, subordinated to senior indebtedness of the Company
and accrued interest at the rate of 7% annually. On
March 30, 2004, the principal and accrued interest related
to the convertible subordinated notes, totaling $2,064,686, was
automatically converted into 1,032,343 shares of common stock.
|
|
|
Secured Promissory Notes Payable |
In September 2005, $4,000,000 in secured promissory notes were
issued by the Company for cash. The notes were secured by all
assets of the Company other than those represented by research
and development stage technologies acquired by the Company
during September 2005 from Abbott. In October 2005, the Company
repaid the notes in full.
|
|
|
Note Payable for Technology Acquisition |
In connection with an Asset Purchase Agreement dated
September 30, 2005 with Abbott, the Company issued a
$15,000,000 secured promissory note payable. The note is due
December 31, 2006, accrues interest at 6% annually and is
secured by the Companys right, title and interest in the
purchased assets. The balance outstanding at December 31,
2005 and June 30, 2006 is $15,227,500 and $15,677,500,
respectively. Refer to Note 13 for a description of the
technology acquisition.
8. Long-term
Notes Payable
|
|
|
Note Payable to Development Partner |
Long-term notes payable at December 31, 2004 represent the
Restated Development Note entered into with the Companys
development partner upon execution of the Termination Agreement.
The outstanding balance at December 31, 2004 represents the
principal balance of $3,610,076 and accrued interest at 7% of
$671,916. In April 2004, the Companys development partner
experienced financial difficulty and began auctioning portions
of its investment portfolio. Although the Restated Development
Note was not being auctioned, following negotiations, on
March 6, 2005 the Company executed a Securities Purchase
Agreement with its former development partner whereby the
outstanding principal and accrued interest totaling $4,335,171
as of that date was purchased by the Company for $500,212,
resulting in a gain on the extinguishment of $3,834,959. No
other consideration was given by the Company in connection with
the Securities Purchase Agreement.
|
|
|
Note Payable for Technology Acquisition |
In connection with an Asset Purchase Agreement dated
April 25, 2006 with Abbott, the Company issued a
$15,000,000 secured promissory note payable. The note is due
December 31, 2007, accrues interest at 6% annually and is
secured by the Companys right, title and interest in the
purchased assets. The balance outstanding at June 30, 2006
is $15,165,000. Refer to Note 14 for a description of the
technology acquisition.
F-18
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
9. Equity Transactions
The Company has authorized a total of 30,000,000 shares as
preferred stock. At June 30, 2006, the following series of
stock were issued and outstanding.
|
|
|
Series A, D and F Preferred Stock |
The Company entered into a Series A Preferred Stock
Purchase Agreement in August 2000, a Series D Preferred
Stock Purchase Agreement in October 2002 and a Series F
Preferred Stock Purchase Agreement in April 2006 (collectively,
Series A/D/F). The Series A/D/F shares have a par
value of $0.0001. In the event of liquidation, the holders of
Series A/D/F shares are entitled to receive preference to
any distributions of the assets of the Company equal to the
original purchase price of the shares and cumulative accrued
dividends of 8% per year, less the amount of any dividends
actually paid. The shares are convertible into the
Companys common stock based on the original issue price,
subject to certain adjustments. In the event dividends are paid
on any shares of common stock, the holders of the
Series A/D/F shares will be entitled, if and when declared
by the Board of Directors of the Company, to dividends based on
the number of shares of common stock into which the
Series A/D/F shares are convertible. Series A
preferred stock (Series A) has a conversion rate of 1.05 or
2,395,687 shares of common stock as of June 30, 2006. The
conversion rate for Series D preferred stock
(Series D) is 1.38 or 602,569 shares of common stock
at June 30, 2006. The per share conversion rate of
Series F preferred stock (Series F) is variable and
will be determined by dividing $5.00 (as adjusted for any stock
dividends, combinations, splits, recapitalizations and the like
with respect to such shares) by the lesser of (a) $5.00 (as
adjusted for any stock dividends, combinations, splits,
recapitalizations and the like with respect to such shares) or
(b) 85% of the price per share paid in this offering.
Therefore, depending on the price of the shares sold in this
offering, the holders of the Series F may receive more than
one share of common stock for each share of Series F
preferred stock converted in connection with this offering. The
Company will not know the conversion rate of the Series F
until the public offering price is determined. The holders of
the Series A/D/F shares are also entitled to the number of
votes equal to the number of shares of common stock into which
the Series A/D/F shares are convertible.
At any time after December 31, 2008, holders of a majority
of Series A/D/F shares may elect to redeem, in three annual
installments, their shares in cash.
During 2000, the Company issued 1,294,772 shares of
Series A and received net proceeds of $3,538,625.
Additionally, the Company converted unsecured notes plus accrued
interest in the amount of $2,442,205 into 880,075 shares of
Series A. During 2001, an additional 116,297 shares of
Series A were issued, including certain shares subscribed
in 2000, and received net proceeds of $305,905. In October 2002,
the Company issued 310,232 shares of Series D and received
net proceeds of $833,031. In January 2003, the Company issued an
additional 128,000 shares of Series D and received net
proceeds of $350,371. In April 2006, the Company issued
2,070,000 shares of Series F and received net proceeds of
$9,623,500. In May 2006, the Company issued an additional
765,000 shares of Series F and received net proceeds
of $3,345,059.
Cumulative undeclared dividends on Series A and
Series D were $2,283,845, $2,884,297 and $3,184,531 at
December 31, 2004 and 2005, and the six months ending
June 30, 2006, respectively. Series F begins accruing
dividends in July 2006. In connection with consulting services
received during the Series A equity financing, in March
2001, warrants were issued for 3,071 shares of common stock
with an exercise price of $7.00 per share. The warrants are
exercisable at any time for a period of ten years from the
date of issue. The fair value of the warrants was charged to
paid-in capital as a cost of issuance of the Series A in
the amount of $3,514.
F-19
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
In connection with the formation of the IOL joint venture with
its development partner in January 2001, the Company entered
into a Securities Purchase Agreement (Agreement). Under the
Agreement, the Company issued 500,625 shares of
Series B preferred stock (Series B) and
285,714 shares of Series C preferred stock
(Series C), each having a par value of $.0001. Net proceeds
from the issuance of the Series B shares were $8,010,000.
These proceeds were used to acquire the Companys 80.1%
interest in the IOL joint venture.
The holder of Series B is entitled to receive preference to
any distributions of the assets of the Company equal to the
original purchase price of the shares ($16.00). Mandatory
Series B dividends were payable every year beginning
July 19, 2002, in shares of Series B at the original
issue price per share at the rate of 7% of $8,010,000 compounded
annually. In March 2004, the holder of Series B permanently
waived its right of payment of accrued and unpaid dividends and
its right to the accrual on or payment of any future dividends
on the Series B shares in exchange for reduction in the
adjusted conversion price of the shares to $9.17. Cumulative
undeclared dividends on Series B were $299,441 at
December 31, 2003. Additional dividends through the
subsequent date of declaration in 2003 of $341,094 were declared
and paid in 38,809 shares of Series B in 2003. Upon
waiver of the right of payment of accrued and unpaid dividends
in March 2004, the cumulative undeclared dividends were reversed.
The Series B shares are convertible into the Companys
common stock at $9.17 per share, subject to certain
adjustments, at the option of the holder at any time after
January 19, 2003, and before December 31, 2008.
To the extent ImaRx has funds legally available for payment,
redemption of the Series B is mandatory on
December 31, 2008, as in the amount of the liquidation
preference, either in cash or shares of common stock of ImaRx
(if registered pursuant to a public offering), or in shares of
Series C, at the option of the Company.
Net proceeds of $1,945,563 were received from the sale of the
Series C preferred stock (Series C), also in
connection with the formation of the IOL joint venture in
January 2001.
The holder of the Series C is entitled to receive
preference to any distributions of the assets of the Company
equal to the $7.00 original purchase price of the shares. The
Series C is convertible into the Companys common
stock at a conversion price of $6.76 per share, subject to
certain adjustments, which price reflects an adjustment to the
Series C conversion price made in conjunction with
amendments to the terms of the Series B in 2004. The
conversion privilege at the option of the holder is exercisable
at any time before December 31, 2008.
To the extent ImaRx has funds legally available for payment,
redemption of the Series C is mandatory on
December 31, 2008, in the amount of the liquidation
preference either in cash or shares of common stock (if
registered pursuant to a public offering), at the option of the
Company.
In September 2005, the Company entered into an Asset Purchase
Agreement (September Abbott Agreement) with Abbott to acquire
certain assets. As partial consideration related to the
September Abbott Agreement, the Company issued
1,000,000 shares of Series E preferred stock
(Series E) valued at $4.00 per share. The
Series E has a par value of $.0001. The shares are
convertible into the Companys common stock based on the
original issue price of $4.00 per share, subject to certain
adjustments. The holders of Series E participate equally in
all dividends payable to common stockholders, if and when
declared by the Board of Directors of the Company, based on the
number of shares of common stock into which the Series E
are convertible.
The Series E has been classified as equity as this series
of preferred stock carries neither dividend preferences nor
mandatory redemption rights. The redemption is contingent on the
following: (i) the Company
F-20
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
has not become subject to the public reporting requirements of
the Securities Exchange Act of 1934 (1934 Act) before
September 30, 2007 and (ii) the Company has sold
substantially all of the technologies purchased from Abbott
under the September Abbott Agreement. The Company has sole
discretion with respect to the sale or disposition of the
technologies purchased under the September Abbott Agreement. The
Company has no intention to sell substantially all of the
technologies as the potential products to be developed with
these technologies could be significant to the Company. The
redemption price is $10.00 per share in cash. Refer to
Note 13 for a description of the purchase transaction.
All shares of each series of preferred stock will automatically
convert into shares of common stock in connection with the
closing of an initial public offering.
In March 2004, the Company issued 2,500,000 shares of
common stock in a private placement at $2.00 per share and
received net proceeds of $4,401,666. Additionally, the Company
converted convertible subordinated notes plus accrued interest
in the amount of $2,064,686 into 1,032,343 shares of common
stock. The holders of the common stock issued in the offering
and conversion of the notes are entitled to certain additional
rights and privileges, among them (i) the right to put the
shares back to the Company at $3.00 per share under certain
circumstances in the event of a merger or consolidation or sale
of substantially all of the assets of the Company where the
Company is not the surviving company, (ii) the right to
additional shares of common stock of the Company should the
Company not become a reporting company under the 1934 Act by
February 28, 2007, equal to (A) 10% of the original
($2.00 per share) investment amount and (B) thereafter
5% of the original investment amount each quarter until the
reporting requirement is met, (C) weighted-average
anti-dilution rights should shares subsequently be issued at
less than $2.00 per share, and (D) certain
registration rights.
In January and February 2005, the Company completed two closings
of a $7,000,000 private placement offering at $3.00 per share
for the issuance of 2,333,331 shares of common stock. These
common stock shares include certain additional rights and
privileges, among them (i) the right to put the shares back
to the Company at $4.50 per share under certain circumstances in
the event of a merger or consolidation or sale of substantially
all of the assets of the Company where the Company is not the
surviving company, (ii) the right to additional shares of
common stock of the Company should the Company not become a
reporting company under the 1934 Act by February 28, 2007,
equal to (A) 10% of the original ($3.00 per share)
investment amount and (B) thereafter 5% of the original
investment amount each quarter until the reporting requirement
is met, (C) full ratchet anti-dilution should shares
subsequently be issued at less than $3.00 per share, and
(D) registration rights. Net proceeds to the Company were
$5,521,000, including offset of the value of warrants issued to
the placement agent in the offering of $415,200.
In October and November 2005, the Company completed two closings
of a private placement of $15,000,000 at $4.00 per share
for the issuance of 3,750,000 shares of common stock. These
shares of common stock include certain additional contractual
rights and privileges, among them (i) the right to put the
shares back to the Company at $6.00 per share under certain
circumstances in the event of a merger or consolidation or sale
of substantially all of the assets of the Company where the
Company is not the surviving company, (ii) the right to
additional shares of common stock of the Company should the
Company not become a reporting company under the 1934 Act, as
amended, by November 8, 2007 equal to (A) 10% of the
original ($4.00 per share) investment amount and
(B) thereafter 5% of the original investment amount each
quarter until the reporting requirement is met, (C) full
ratchet anti-dilution should shares subsequently be issued at
less than $4.00 per share, and (D) registration rights. Net
proceeds to the Company were $12,001,453, including offset of
the value of warrants issued to the placement agent in the
offering of $943,195.
The Company has recorded these shares of stock as equity since
redemption is triggered only by a merger, consolidation or sale
of assets, which events are within the control of the company.
In addition, should the
F-21
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
Company be required to issue additional shares of common stock
because it does not become a 1934 Act reporting company by one
or more of the dates specified, it will be required to issue
additional unregistered shares of common stock. In
accordance with
EITF 00-19,
paragraph 14, because the Company can deliver unregistered
shares of common stock, which decision is within its control,
these shares are considered as permanent equity.
|
|
|
Warrants to Purchase Common and Preferred Stock |
A warrant to purchase 3,071 shares of common stock with a
fair value of $3,514 at date of issue was issued in connection
with a consulting agreement in March 2001. The exercise price of
the warrant is $7.00 per share and has not been exercised.
In addition, a warrant to purchase 10,000 shares of common stock
with a fair value of $2,689 at the date of issue was issued in
connection with a consulting agreement with a related party on
December 1, 2001. The warrant was exercised in March 2004
at a price of $.50 per share. A warrant to purchase 10,909
shares of Series A with an exercise price of $2.75 per
share, was issued in connection with a line of credit in January
2001. The fair value of the warrant, $16,110, was recorded as a
loan discount during the term of the loan, and the warrant has
not yet been exercised. A warrant to purchase 20,000 shares of
common stock with a fair value of $35,870 at date of issue was
issued in connection with a licensed patent in January 2005. The
exercise price of this warrant is $3.00 per share and has not
been exercised.
In connection with the issuance of the convertible subordinated
notes during 2003 and 2004, the Company issued warrants to
purchase 145,790 and 60,679 shares of common stock,
respectively. The warrants are exercisable at any time for a
period of seven years at a price of $2.00 per share. Of
these warrants, 17,531 were exercised in October 2005. The value
of the warrants was recorded as debt discount and amortized to
interest expense using the interest rate method over the
maturity of the notes. The fair values of the warrants issued in
2003 and 2004 were $72,410 and $138,475, respectively. On
March 30, 2004, the conversion date of the notes, all
remaining unamortized debt discount was expensed to interest. In
addition, debt discount related to the beneficial conversion
feature of the warrants in the amount of $32,961 was expensed to
interest at the date of conversion of the notes.
In addition to the warrants for the purchase of shares of common
stock issued with the convertible subordinated notes, in January
2004, the Company engaged the services of a financial advisor
and an investor relations consultant pursuant to consulting
agreements, each of which provided that the consultants receive
a warrant to purchase 250,000 shares of the Companys
common stock at an exercise price of $3.00 per share. The
warrants are exercisable at any time for a term of five years.
The fair value of the warrants totaling $464,378 was charged to
expense in 2004.
In October 2004, the Company issued a warrant for the purchase
of 250,000 shares of common stock at an exercise price of
$2.00 per share to the placement agent of the offering of
2,500,000 shares of common stock closed in March 2004. The
Company issued the warrant and agreed to pay $170,000 upon or
immediately prior to closing of a public offering in exchange
for the placement agents permanent waiver of its right of
first refusal to undertake public offerings on behalf of the
Company. The warrant is exercisable at any time on a cashless
basis for a term of four years. The fair value of the warrant at
the date of issue totaling $452,269 was charged to expense in
2004.
A warrant to purchase 233,333 shares of common stock
exercisable at any time at $3.30 per share on a cashless
basis was issued on February 28, 2005, for a term of five
years as provided in the placement agent agreement relative to
the $7,000,000 common stock offering. The fair value of the
warrant at the date of issue of $415,200 was offset against
proceeds of the offering.
In September 2005, warrants to purchase 100,000 shares of
common stock were issued in connection with the issuance of
$4,000,000 in secured promissory notes. The warrants are
exercisable at any time for a period of
F-22
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
ten years at a price of $4.00 per share. The value of
the warrants were recorded as debt discount and amortized to
interest expense over the expected maturity of the notes. The
fair value of the warrants outstanding at September 30,
2005 of $273,327 was amortized to interest as the expected
maturity date of the notes was less than one month. The warrants
were fully expensed in October 2005.
A warrant to purchase 375,000 shares of common stock
exercisable at any time at $4.25 per share on a cashless basis
was issued on November 8, 2005, for a term of
seven years as provided in the placement agent agreement
relative to the $15,000,000 common stock offering. The fair
value of the warrant at the date of issue of $943,195 was offset
against proceeds of the offering.
In connection with a consulting agreement, warrants to purchase
75,000 shares of common stock were issued on
February 1, 2006. The warrants are exercisable at any time
at $4.00 per share on a cashless basis for a term of
seven years. The fair value of the warrant at the date of
issue of $173,909 has been recorded as expense.
The following table summarizes the warrants that were
outstanding as of June 30, 2006 (unaudited):
Warrants Issued
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average | |
|
|
|
|
Warrants | |
|
Remaining Life | |
|
Warrants | |
Exercise Price |
|
Outstanding | |
|
in Years | |
|
Exercisable | |
|
|
| |
|
| |
|
| |
$2.00
|
|
|
443,938 |
|
|
|
3.18 |
|
|
|
443,938 |
|
$2.75
|
|
|
11,407 |
|
|
|
4.55 |
|
|
|
11,407 |
|
$3.00
|
|
|
520,000 |
|
|
|
2.77 |
|
|
|
520,000 |
|
$3.30
|
|
|
233,333 |
|
|
|
3.67 |
|
|
|
233,333 |
|
$4.00
|
|
|
175,000 |
|
|
|
8.11 |
|
|
|
175,000 |
|
$4.25
|
|
|
375,000 |
|
|
|
6.36 |
|
|
|
375,000 |
|
$7.00
|
|
|
3,071 |
|
|
|
4.68 |
|
|
|
3,071 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,761,749 |
|
|
|
4.30 |
|
|
|
1,761,749 |
|
|
|
|
|
|
|
|
|
|
|
F-23
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
10. Stock Options
A summary of activity under the Companys 2000 Stock Plan
is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise Price | |
|
Weighted-Average | |
|
|
Options | |
|
Per Share | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
Balance at January 1, 2003
|
|
|
834,700 |
|
|
$ |
0.50 |
|
|
$ |
0.50 |
|
Granted
|
|
|
273,000 |
|
|
|
0.50 |
|
|
|
0.50 |
|
Exercised
|
|
|
(2,300 |
) |
|
|
0.50 |
|
|
|
0.50 |
|
Canceled
|
|
|
(28,150 |
) |
|
|
0.50 |
|
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
1,077,250 |
|
|
|
0.50 |
|
|
|
0.50 |
|
Granted
|
|
|
1,151,041 |
|
|
|
2.003.00 |
|
|
|
2.73 |
|
Exercised
|
|
|
(26,330 |
) |
|
|
0.50 |
|
|
|
0.50 |
|
Canceled
|
|
|
(234,200 |
) |
|
|
0.50 |
|
|
|
0.50 |
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
1,967,761 |
|
|
|
0.503.00 |
|
|
|
1.83 |
|
Granted
|
|
|
1,754,899 |
|
|
|
3.004.00 |
|
|
|
3.25 |
|
Exercised
|
|
|
(317,270 |
) |
|
|
0.503.00 |
|
|
|
0.93 |
|
Canceled
|
|
|
(734,666 |
) |
|
|
0.503.00 |
|
|
|
2.87 |
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
2,670,724 |
|
|
|
0.504.00 |
|
|
|
2.56 |
|
Granted
|
|
|
642,500 |
|
|
|
4.005.00 |
|
|
|
4.73 |
|
Exercised
|
|
|
(110,200 |
) |
|
|
0.50 |
|
|
|
0.50 |
|
Canceled
|
|
|
(306,000 |
) |
|
|
0.504.00 |
|
|
|
3.06 |
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 (unaudited)
|
|
|
2,897,024 |
|
|
$ |
0.505.00 |
|
|
$ |
3.07 |
|
|
|
|
|
|
|
|
|
|
|
Available for grant at June 30, 2006 (unaudited)
|
|
|
1,538,376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Below is a summary of stock option grant activity and related
fair value information for the 12 months ended
June 30, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value of | |
|
|
Options | |
|
Exercise | |
|
Common Stock on | |
2005 Grants |
|
Granted | |
|
Price | |
|
Date of Grant | |
|
|
| |
|
| |
|
| |
July
|
|
|
250,000 |
|
|
$ |
3.00 |
|
|
$ |
3.00 |
|
August
|
|
|
170,000 |
|
|
|
3.00 |
|
|
|
3.00 |
|
September
|
|
|
20,000 |
|
|
|
4.00 |
|
|
|
4.00 |
|
October
|
|
|
35,000 |
|
|
|
4.00 |
|
|
|
4.00 |
|
November
|
|
|
159,900 |
|
|
|
4.00 |
|
|
|
4.00 |
|
December
|
|
|
214,999 |
|
|
|
4.00 |
|
|
|
4.00 |
|
|
|
|
|
|
|
|
|
|
|
2005 Subtotal
|
|
|
849,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 Grants (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February
|
|
|
160,000 |
|
|
$ |
4.00 |
|
|
$ |
4.00 |
|
March
|
|
|
12,500 |
|
|
|
4.00 |
|
|
|
4.00 |
|
May
|
|
|
470,000 |
|
|
|
5.00 |
|
|
|
5.00 |
|
|
|
|
|
|
|
|
|
|
|
2006 Subtotal
|
|
|
642,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-24
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
All outstanding options are currently exercisable. The following
table summarizes information relating to currently outstanding
and vested options at June 30, 2006 (unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average | |
|
|
|
|
Options | |
|
Remaining Life | |
|
Options | |
Range of Exercise Prices |
|
Outstanding | |
|
(Years) | |
|
Vested | |
|
|
| |
|
| |
|
| |
$0.000.50
|
|
|
431,625 |
|
|
|
5.14 |
|
|
|
384,125 |
|
0.512.00
|
|
|
250,000 |
|
|
|
7.75 |
|
|
|
250,000 |
|
2.013.00
|
|
|
1,170,000 |
|
|
|
8.85 |
|
|
|
286,250 |
|
3.014.00
|
|
|
575,399 |
|
|
|
9.45 |
|
|
|
12,500 |
|
4.015.00
|
|
|
470,000 |
|
|
|
9.86 |
|
|
|
15,000 |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
2,897,024 |
|
|
|
8.48 |
|
|
|
947,875 |
|
|
|
|
|
|
|
|
|
|
|
The Company provides a stock option plan for employees,
directors and consultants. Under the plan, options to purchase
common stock of the Company are granted to certain employees and
directors at the estimated fair value of the underlying common
stock at the date of grant. The options generally have a term of
10 years and generally vest over four years commencing on
the date of the grant. During 2005, the Companys Board of
directors and stockholders approved an amendment to the stock
option plan to increase the number of shares that can be issued
under the plan by 2,000,000 shares of common stock to a
total of 5,000,000 shares. As of June 30, 2006, the
total compensation cost related to nonvested options not yet
recognized is approximately $1,461,000 (unaudited). The
weighted-average period of time over which the Company expects
to recognize this cost is 3.8 years.
In July 2005, the Company entered into a consulting agreement
with a physician and approved an option grant as part of the
compensation for consulting services. The option provided that
45,000 of the shares subject to the option would be immediately
vested, and the remaining shares would vest in accordance with
milestone achievements. The charge that resulted was
approximately $82,000 and was charged to expense in 2005. The
remaining shares under the option were treated as
performance-based awards and will be expensed at the time the
milestones are achieved. In March 2006, the performance-based
vesting applied to these options was modified and converted to
time-based vesting. This modification resulted in a $221,000
charge to expense in the six months ended June 30,
2006. The remaining cost will be charged to expense as the
services are provided.
In August 2005, the Company approved the acceleration of vesting
in stock option awards previously granted to the Companys
former and retired Chief Financial Officer, who retired on
April 27, 2005. The Board of Directors approved the
acceleration of the vesting in the two option grants made
previously effective as of the date of her retirement.
Furthermore, the Board of Directors extended the
post-termination of employment/service exercise period from
July 26, 2005 (90 days after termination of
employment/service) to April 27, 2006. The Company recorded
a charge of $125,000 on the new measurement in 2005. In April
2006, these options were exercised, resulting in an additional
charge of $130,000 to expense in the period ended June 30,
2006.
In August 2005, the Company issued a performance-based option
grant to an employee. The shares originally vested in accordance
with milestone achievements. In March 2006, the
performance-based vesting applied to these options was modified
and converted to time-based vesting. This modification resulted
in a $42,000 charge to expense in the six months ended
June 30, 2006. The remaining cost will be charged to
expense over the vesting period of the option.
F-25
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
On January 17, 2001, the Company entered into an equipment
line of credit agreement with a bank for $500,000. Advances
under the equipment line accrued interest at the U.S. Treasury
Note rate plus 3.0% and were secured by all of the
Companys assets. In connection with the line of credit,
the Company issued warrants at an exercise price of $2.75 per
share to purchase 21,818 shares of Series A. The
warrants (determined to have a value of $32,220) were recorded
as a loan discount. The warrants were reduced to 10,909 in
January 2002, with a fair value of $16,110. The fair value of
the warrants was recorded as a loan discount during the term of
the outstanding loan. Both the final payments of 8.5% of the
advances and the estimated fair value of the warrants were
amortized over the term of the equipment line to interest
expense. The line of credit expired in 2002, and the Company has
no obligations thereunder.
The Company has a 401(k) profit sharing benefit plan (401(k)
Plan) covering substantially all employees who are at least
twenty-one years of age and provide a certain number of hours of
service. Under the terms of the 401(k) Plan, employees may make
voluntary contributions, subject to Internal Revenue Code
limitations. The Company matches 25% of the employees
contributions up to a total of 15% of the employees gross
salary. The Companys contributions to the 401(k) Plan vest
equally over five years. Company contributions to the 401(k)
Plan were $13,476, $22,466, $24,476 and $3,667 for 2003, 2004,
2005 and for the six months ended June 30, 2006,
respectively.
|
|
13. |
Technology Acquisition |
In September 2005, the Company entered into the September Abbott
Agreement to acquire certain assets related to Abbotts
development of recombinant pro-urokinase (rproUK) and
recombinant urokinase (rUK). The total purchase price under the
September Abbott Agreement of $24,000,000 included a payment of
$5,000,000 in cash, a $15,000,000 note payable to Abbott and the
issuance of 1,000,000 shares of Series E valued at $4.00
per share.
The purchase of these assets did not constitute the purchase of
a business as defined in EITF No. 98-3, Determining
Whether a Nonmonetary Transaction Involves Receipt of Productive
Assets or of a Business. Assets included in the purchase,
among others, were rproUK and rUK drug substance and drug
product inventories, raw materials including master and working
cell banks, intellectual property related to these drug
products, rights under existing contractual agreements and all
related applications and supplements filed with the U.S. Food
and Drug Administration (FDA). Although these product candidates
may have significant future importance, the Company determined
that, since they had not yet received FDA approval and presented
no alternative future use, they did not meet established
guidelines for technological feasibility sufficiently to be
recorded as assets. As a result, the full amount of the purchase
price of $24,000,000 has been expensed as acquired in-process
research and development expense in September 2005.
In April 2006, the Company acquired from Abbott Abbokinase, an
FDA-approved urokinase compound, and related rights, for a total
purchase price of $20,000,000. The purchase price is comprised
of $5,000,000 in cash and a $15,000,000 secured promissory note.
The note is due December 31, 2007, accrues interest at 6%
annually and is secured by the Companys right, title and
interest in the purchased assets. The purchase of these assets
did not constitute the purchase of a business as defined in EITF
No. 98-3,
Determining Whether a Nonmonetary Transaction Involves
Receipt of Productive Assets or of a Business, since no
employees, equipment, manufacturing facilities or arrangements,
or sales and marketing organization were included in the
F-26
ImaRx Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements (continued)
transaction. Since the purchase was not a business, the purchase
price has been allocated based upon fair value assessments as
follows: inventory $16,700,000, Abbokinase trade name $500,000
and other identifiable intangibles $2,800,000. The Company plans
to commence selling Abbokinase in the latter part of 2006. Under
the purchase agreement, after the Company has received initial
net revenue of $5,000,000 from the sale of Abbokinase, the
Company is required to deposit 50% of the revenue received from
sales of Abbokinase into an escrow account securing the
repayment of the $15,000,000 promissory note. If the promissory
note is not repaid by its maturity date, Abbott has the right to
the amount held in the escrow account and to reclaim any
remaining inventory of Abbokinase and related rights.
|
|
15. |
Commitments and Contingencies |
Total rent expense was $89,000, $89,000, $91,000 and $61,000 in
2003, 2004 and 2005 and the six months ended June 30, 2006,
respectively. Payments under noncancelable operating leases are
$64,000 for the years 2006 and 2007, and $54,000 in 2008.
|
|
|
License Agreement with UNEMED Corporation |
On October 10, 2003, UNEMED Corporation granted the Company
an exclusive, worldwide license, with sublicense rights, to
intellectual property and patents relating to the use of a
thrombolytic agent together with microbubbles for the treatment
of thrombosis. To maintain this license, the Company must meet
certain product development milestones. The Company is obligated
to pay UNEMED a royalty on any future net sales of products or
processes which utilize the licensed technology, of which there
have been no sales to date. The Company is also obligated to pay
maintenance fees and expenses related to the maintenance of one
of the patents covered by the license. The license agreement
will terminate contemporaneously with the expiration of the
licensed patents. Warrants were issued for the purchase of
10,000 shares of common stock at $2.00 per share with a fair
value of $3,000 to acquire these rights.
|
|
|
License Agreement with Dr. med. Reinhard Schlief |
On January 4, 2005, Dr. med. Reinhard Schlief granted
the Company an exclusive, worldwide license, with the right to
sub-license, to intellectual property and patents relating to
methods of destroying cells by applying ultrasound to them in
the presence of microbubbles. The Company is obligated to pay
Dr. Schlief a royalty of 2% of net sales revenue derived
from the sale of products that utilize the licensed technology.
The license agreement will terminate contemporaneously with the
expiration of the licensed patents. Warrants were issued for the
purchase of 20,000 shares of common stock at $3.00 per
share with a fair value of $37,500 to acquire these rights.
|
|
|
License Agreement with University of Arkansas |
On February 14, 2006, the University of Arkansas granted
the Company an exclusive, worldwide license, with the right to
sublicense, intellectual property and patents relating to the
use of a specific ultrasound device to be used in conjunction
with bubbles, a thrombolytic, or a combination of bubbles and a
thrombolytic to break up blood clots. To maintain this license
the Company must meet certain product development milestones.
The Company is obligated to pay the University of Arkansas a
one-time fee of $25,000 within 30 days after the first
commercial sale of a product incorporating the licensed
technology, and varying royalties depending on the amount of net
revenue derived from the sale of products using the licensed
technology, of which there have been no sales to date. The
Company is also obligated to pay a one-time success fee of
$250,000 in the first year that net revenue derived from the
sale of products using the licensed technology exceeds
$10.0 million. The license will terminate upon expiration
of the last patent to which it relates.
F-27
Shares
Common Stock
PROSPECTUS
,
2006
Through and
including ,
2006 (25 days after the date of this prospectus), all
dealers that buy, sell or trade our common stock, whether or not
participating in this offering, may be required to deliver a
prospectus. This is in addition to the dealers obligation
to deliver a prospectus when acting as underwriters and with
respect to their unsold allotments or subscriptions.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
|
|
Item 13. |
Other Expenses of Issuance and Distribution |
The following table sets forth all expenses, other than the
underwriting discounts and commissions, payable by the
registrant in connection with the sale of the common stock being
registered. All the amounts shown are estimates except the
registration fee, the NASD filing fee and The Nasdaq Global
Market initial listing fee. We intend to pay all expenses of
registration, issuance and distribution.
|
|
|
|
|
SEC registration fee
|
|
$ |
8,025 |
|
NASD filing fee
|
|
|
8,000 |
|
Nasdaq Global Market initial listing fee
|
|
|
100,000 |
|
Blue sky qualification fees and expenses
|
|
|
5,000 |
|
Printing and engraving expenses
|
|
|
160,000 |
|
Legal fees and expenses
|
|
|
800,000 |
|
Accounting fees and expenses
|
|
|
380,000 |
|
Transfer agent and registrar fees and expenses
|
|
|
8,000 |
|
Miscellaneous
|
|
|
* |
|
|
|
|
|
Total
|
|
$ |
* |
|
|
|
* |
To be provided by amendment. |
|
|
Item 14. |
Indemnification of Officers and Directors |
The registrant is a Delaware corporation. Section 145 of
the Delaware General Corporation Law, or the DGCL, provides that
a corporation may indemnify any person who is or was a director,
officer, employee or agent of a corporation of an enterprise,
against expenses (including attorneys fees), judgments,
fines and amounts paid in settlement actually and reasonably
incurred by such person in connection with any threatened,
pending or completed action, suit or proceeding, whether civil,
criminal, administrative or investigative, by reason of being or
having been in any such capacity, if he acted in good faith in a
manner reasonably believed to be in or not opposed to the best
interest of the corporation, and, with respect to any criminal
action or proceeding, had no reasonable cause to believe his
conduct was unlawful, except that with respect to an action
brought by or in the right of the corporation, such
indemnification is limited to expenses (including
attorneys fees). Under the DGCL, Section 145 is not
exclusive of other rights to which those seeking indemnification
may be entitled under any bylaw, agreement vote of stockholders
or disinterested directors or otherwise.
In addition, Section 102(b)(7) of the DGCL permits a
corporation to provide in its certificate of incorporation that
a director of the corporation shall not be personally liable to
the corporation or its stockholders for monetary damages for
breach of fiduciary duty as a director, except for liability for
any breach of the directors duty of loyalty to the
corporation or its stockholders, for acts or omissions not in
good faith or which involve intentional misconduct or a knowing
violation for law, for unlawful payments of dividends or
unlawful stock repurchases, redemptions or other distributions,
or for any transaction from which the director derived an
improper personal benefit.
The registrants amended and restated certificate of
incorporation includes a provision that eliminates the personal
liability of its directors for monetary damages for breach of
fiduciary duty as a director to the fullest extent permitted by
the DGCL. The registrants amended and restated certificate
of incorporation requires indemnification of its directors and
officers to the fullest extent permissible under the DGCL and
the registrants amended and restated bylaws provide for
indemnification of officers and directors to the fullest extent
authorized by the DGCL.
II-1
The registrant maintains a liability insurance policy pursuant
to which its directors and officers may be indemnified against
liability incurred for serving in their capacities as directors
and officers.
Prior to the completion of this offering, the registrant intends
to enter into stockholder-approved indemnification agreements
with each of its directors and officers and we intend to enter
into indemnification agreements with any new directors and
officers in the future. The indemnification agreements set forth
certain procedures that will apply in the event of a claim for
indemnification thereunder. At present, no litigation or
proceeding is pending that involves a director or officer of the
registrant regarding which indemnification is sought, nor is the
registrant aware of any threatened litigation that may result in
claims for indemnification.
The form of underwriting agreement filed as an exhibit to this
registration statement provides for indemnification under
certain circumstances by the underwriters of the registrant, its
directors, certain of its officers and its controlling persons
for certain liabilities arising under the Securities Act or
otherwise.
The Second Amended and Restated Investors Rights Agreement
between the registrant and certain investors provides for
cross-indemnification in connection with registration of the
registrants common stock on behalf of such investors.
See also the undertakings set out in response to Item 17.
Reference is made to the following documents filed as exhibits
to this registration statement regarding relevant
indemnification provisions described above and elsewhere herein:
|
|
|
|
|
Exhibit Document |
|
Number | |
|
|
| |
Form of Underwriting Agreement
|
|
|
1.1 |
|
Registrants Amended and Restated Certificate of
Incorporation, to be effective upon closing of this
offering
|
|
|
3.3 |
|
Form of Indemnification Agreement
|
|
|
10.1 |
|
Second Amended and Restated Investors Rights Agreement,
dated April 14, 2006
|
|
|
10.2 |
|
|
|
Item 15. |
Recent Sales of Unregistered Securities |
Since January 1, 2003, the registrant has sold the
following securities that were not registered under the
Securities Act:
|
|
1. |
We sold an aggregate of 456,100 shares of our common stock
to certain of our employees, directors and consultants for cash
consideration in the aggregate amount of $365,550 upon the
exercise of stock options granted under our 2000 Stock Plan,
none of which have been repurchased by us. |
|
|
2. |
We granted stock options to certain employees, directors and
consultants under our 2000 Stock Plan covering an aggregate of
3,821,440 shares of common stock, at exercise prices
ranging from $0.50 to $5.50 per share. Of these, options
covering an aggregate of 1,303,016 shares were canceled
without being exercised. |
|
|
3. |
In January 2003, we sold 128,000 shares of Series D
preferred stock to accredited investors at a price of
$2.75 per share. This securities issuance was a follow-on
closing to an offering of Series D preferred stock that
took place in October 2002 and was conducted on the same terms
as the October 2002 offering. No underwriters were involved in
these sales of securities. |
|
4. |
Between June 2003 and January 2004, we sold 7% unsecured
convertible promissory notes in the aggregate principal amount
of $2,000,000 and warrants to purchase up to an aggregate of
206,469 shares of common stock, with an exercise price of
$2.75 per share to accredited investors. The principal
amount of the promissory notes plus accrued interest was
automatically converted into |
II-2
|
|
|
1,032,343 shares of our common stock in connection with our
March 2004 private placement at a conversion price of
$2.00 per share. No underwriters were involved in this sale
of securities. |
|
5. |
In October 2003, in connection with the grant of a sublicense,
we issued a warrant to UNEMED Corporation, an accredited
investor, to purchase up to an aggregate of 5,000 shares of
our common stock at an exercise price of $2.00 per share. |
|
6. |
In March 2004, we issued a warrant to each of Bridge Ventures,
Inc. and Saggi Capital Corp., each of which is an accredited
investor, as partial consideration for annual consulting
services. Each warrant is for the purchase of
250,000 shares of our common stock at an exercise price of
$3.00 per share. |
|
7. |
In March 2004, we sold 2,500,000 shares of our common stock
to accredited investors at a purchase price of $2.00 per
share pursuant to a private placement in which First Montauk
Securities Corp. served as our exclusive placement agent. |
|
8. |
In October 2004, we issued a warrant to First Montauk Securities
Corp. and certain executive officers of First Montauk Securities
Corp., each of whom is an accredited investor, to purchase up to
an aggregate of 250,000 shares of common stock at an
exercise price of $2.00 per share. |
|
9. |
Between October 2004 and February 2005, we sold an aggregate of
2,333,331 shares of common stock to accredited investors at
a purchase price of $3.00 per share pursuant to a private
placement in which First Montauk Securities Corp. served as our
exclusive placement agent. In connection with this offering and
as partial consideration for entering into the placement agency
agreement, First Montauk Securities Corp. and certain executive
officers of First Montauk Securities Corp. also received
warrants to purchase up to an aggregate of 233,333 shares
of our common stock at an exercise price of $3.30 per share. |
|
|
10. |
In January 2005, as partial consideration for a patent license,
we granted Dr. med. Reinhard Schlief a warrant to purchase
up to an aggregate of 20,000 shares of common stock at an
exercise price of $3.00 per share. |
|
11. |
In September 2005, we sold 1,000,000 shares of
Series E preferred stock, valued at $4.0 million, to
Abbott Laboratories, an accredited investor, as partial
consideration for our acquisition of certain technologies from
Abbott Laboratories pursuant to an Asset Purchase Agreement
dated September 30, 2005. In connection with this Asset
Purchase Agreement, we also issued Abbott Laboratories a
secured 6% of promissory note in the principal amount of
$15,000,000. No underwriters were involved in this sale of
securities. |
|
12. |
In September 2005, we issued secured 6% promissory notes in the
aggregate principal amount of $4,000,000 and warrants for the
purchase of an aggregate of 100,000 shares of our common
stock at an exercise price of $4.00 per share to accredited
investors. No underwriters were involved in this sale of
securities. The secured promissory notes issued in this offering
were repaid in full in October 2005 with proceeds from the
private placement offering described below. |
|
13. |
In October 2005 and November 2005, we sold an aggregate of
3,750,000 shares of our common stock to accredited
investors at a purchase price of $4.00 per share in a
private placement in which First Montauk Securities Corp. served
as our exclusive placement agent. In connection with its
placement agency agreement, First Montauk Securities Corp. and
certain executive officers of First Montauk Securities Corp.
received warrants to purchase up to 375,000 shares of our
common stock at an exercise price of $4.25 per share. |
|
14. |
In April 2006 and May 2006, we sold an aggregate of
2,835,000 shares of Series F preferred stock to
accredited investors at a price of $5.00 per share pursuant
to a private placement in which First Albany Capital, First
Montauk Securities Corp. and Maxim Group LLC served as our
placement agents. |
II-3
|
|
15. |
In April 2006, we issued Abbott Laboratories a secured 6%
promissory note in the principal amount of $15,000,000 in
partial consideration for assets we acquired. No underwriters
were involved in this sale of securities. |
The sales of the above securities described in items
(1) and (2) above were exempt from registration under
the Securities Act in reliance on Rule 701 promulgated
under the Securities Act as transactions pursuant to
compensatory benefit plans and contracts relating to
compensation as provided under Rule 701. The recipients of
securities in each of these transactions represented their
intention to acquire the securities for investment only and not
with view to or for sale in connection with any distribution
thereof and appropriate legends were affixed to the share
certificates and instruments issued in such transactions. All
recipients had adequate access, through their relationship with
the registrant, to information about the registrant.
The sale of securities described in items (3), (4), (7), (9),
(12), (13) and (14) above were exempt from
registration under the Securities Act in reliance on
Rule 506 of Regulation D promulgated thereunder as
transactions by an issuer not involving a public offering. The
recipients of securities in each of these transactions were
sophisticated entities, all of whom are accredited
investors, as such term is defined in Rule 501
promulgated under the Securities Act, and all of whom had
adequate access, through their relationship with us, to
information about us.
The sale of securities described in items (5), (6), (8), (10),
(11) and (15) above were exempt from registration
under Section 4(2) of the Securities Act as transactions by
an issuer not involving a public offering. The recipients of
securities in each of these transactions represented their
intention to acquire the securities for investment only and not
with view to or for sale in connection with any distribution
thereof and appropriate legends were affixed to the share
certificates and instruments issued in such transactions. All
recipients had adequate access, through their relationship with
the registrant, to information about the registrant.
No underwriters were involved in the foregoing sales of
securities.
|
|
Item 16. |
Exhibits and Financial Statement Schedules |
(a) Exhibits.
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
|
1 |
.1 |
|
Form of Underwriting Agreement |
|
3 |
.1 |
|
Fourth Amended and Restated Certificate of Incorporation of the
registrant |
|
3 |
.2* |
|
Amendment to Certificate of Incorporation of the registrant to
effect
a for reverse
stock split |
|
3 |
.3 |
|
Form of Amended and Restated Certificate of Incorporation of the
registrant, to be effective following this offering |
|
3 |
.4 |
|
Bylaws of the registrant, as amended |
|
3 |
.5 |
|
Form of Amended and Restated Bylaws of the registrant, to be
effective following this offering |
|
4 |
.1* |
|
Specimen certificate evidencing shares of common stock |
|
5 |
.1* |
|
Opinion of DLA Piper Rudnick Gray Cary US LLP |
|
10 |
.1 |
|
Form of Indemnification Agreement to be entered into between the
registrant and each of its directors and officers |
|
10 |
.2 |
|
Second Amended and Restated Investors Rights Agreement,
dated April 14, 2006, by and among the registrant and
certain stockholders |
|
10 |
.3 |
|
2000 Stock Plan and related agreements |
|
10 |
.4 |
|
2006 Performance Incentive Plan and related agreements |
|
10 |
.5 |
|
Executive Management Bonus Plan |
II-4
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
|
10 |
.6** |
|
Asset Purchase Agreement, dated September 30, 2005, between
the registrant and Abbott Laboratories |
|
10 |
.7 |
|
Security Agreement, dated September 30, 2005, between the
registrant and Abbott Laboratories |
|
10 |
.8 |
|
Patent License Agreement, dated September 30, 2005, between
the registrant and Abbott Laboratories |
|
10 |
.9 |
|
Secured Promissory Note, dated September 30, 2005, between
the registrant and Abbott Laboratories |
|
10 |
.10 |
|
Services Agreement, dated September 30, 2005, between the
registrant and Abbott Laboratories |
|
10 |
.11 |
|
License Agreement, dated January 4, 2005, between the
registrant and Dr. med. Reinhard Schlief |
|
10 |
.12 |
|
Exclusive Sublicense Agreement, dated October 10, 2003,
between the registrant and UNEMED Corporation |
|
10 |
.13 |
|
Assignment, Assumption and License Agreement, dated
October 7, 1999, between the registrant and Bristol-Myers
Squibb Medical Imaging, Inc. (as successor to DuPont Contrast
Imaging, Inc.) dated October 7, 1999, and amendments thereto |
|
10 |
.14 |
|
License Agreement, dated February 10, 2006, between the
registrant and the University of Arkansas for Medical Sciences |
|
10 |
.15 |
|
Asset Purchase Agreement, dated April 10, 2006, between the
registrant and Abbott Laboratories, and amendments thereto |
|
10 |
.16 |
|
Escrow Agreement, dated April 14, 2006, between the
registrant and Abbott Laboratories |
|
10 |
.17 |
|
Inventory Trademark License Agreement, dated April 14,
2006, between the registrant and Abbott Laboratories |
|
10 |
.18 |
|
Security Agreement, dated April 14, 2006, between the
registrant and Abbott Laboratories |
|
10 |
.19 |
|
Secured Promissory Note, dated April 14, 2006, between the
registrant and Abbott Laboratories |
|
10 |
.20 |
|
Second Amended Executive Employment Agreement, dated
May 15, 2006, between the registrant and Evan C. Unger |
|
10 |
.21 |
|
Consulting Agreement, dated April 11, 2005, between the
registrant and Greg Cobb |
|
10 |
.22 |
|
Executive Employment Agreement, dated April 27, 2005,
between the registrant and Greg Cobb |
|
10 |
.23 |
|
Executive Employment Agreement, dated April 18, 2005,
between the registrant and Randall Miller |
|
10 |
.24 |
|
Executive Employment Agreement, dated February 18, 2004,
between the registrant and John A. Moore |
|
10 |
.25 |
|
Agreement, dated March 31, 2006, by and among the
registrant, John A. Moore and Edson Moore Healthcare Ventures |
|
10 |
.26 |
|
Subscription Agreement and Investor Questionnaire, dated March
2004, between the registrant and each of the signatory
investors, offering price $2.00 per share |
|
10 |
.27 |
|
Subscription Agreement and Investor Questionnaire, dated
December 2004, between the registrant and each of the signatory
investors, offering price $3.00 per share |
|
10 |
.28 |
|
Subscription Agreement and Investor Questionnaire, dated
September and October 2004, between the registrant and each of
the signatory investors, offering price $4.00 per share |
|
10 |
.29 |
|
Commercial Lease Triple Net, dated November 1, 2002,
between the registrant and ImaRx Investments L.L.C. |
|
10 |
.30 |
|
Standard Commercial Industrial Lease, dated
December 30, 1997, between the registrant and Tucson Tech
Park and addenda thereto |
|
21 |
.1 |
|
Subsidiaries of the registrant |
|
23 |
.1 |
|
Consent of Ernst & Young LLP |
|
23 |
.2* |
|
Consent of DLA Piper Rudnick Gray Cary US LLP (included in
Exhibit 5.1) |
|
24 |
.1 |
|
Power of Attorney |
II-5
|
|
* |
To be filed by amendment |
|
|
|
Previously filed |
|
|
** |
Portions of this exhibit have been omitted pursuant to a
confidential treatment request, and this information has been
filed separately with the Commission. |
|
All schedules are omitted because they are not required, are not
applicable or the information is included in the financial
statements or notes thereto.
The undersigned registrant hereby undertakes to provide to the
underwriters at the closing specified in the underwriting
agreement certificates in such denominations and registered in
such names as required by the underwriters to permit prompt
delivery to each purchaser.
Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers, and
controlling persons of the registrant pursuant to the foregoing
provisions or otherwise, the registrant has been advised that in
the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other
than the payment by the registrant of expenses incurred or paid
by a director, officer, or controlling person of the registrant
in the successful defense of any action, suit, or proceeding) is
asserted by such director, officer, or controlling person in
connection with the securities being registered, the registrant
will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Act and will be governed by the final adjudication of such
issue.
The undersigned registrant undertakes that:
(1) for purposes of determining any liability under the
Securities Act, the information omitted from the form of
prospectus filed as part of this registration statement in
reliance upon Rule 430A and contained in the form of
prospectus filed by the registrant pursuant to
Rule 424(b)(1) or (4) or 497(h) under the Securities
Act shall be deemed to be part of this registration statement as
of the time it was declared effective,
(2) for the purpose of determining any liability under the
Securities Act, each post-effective amendment that contains a
form of prospectus shall be deemed to be a new registration
statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof,
(3) for purposes of determining any liability under the
Securities Act, if the registrant is subject to Rule 430C,
each prospectus filed pursuant to Rule 424(b) as part of a
registration statement relating to an offering, other than
registration statements relying on Rule 430B or other than
prospectuses filed in reliance on Rule 430A, shall be
deemed to be part of and included in the registration statement
as of the date it is first used after effectiveness. Provided,
however, that no statement made in a registration statement or
prospectus that is part of the registration statement or made in
a document incorporated or deemed incorporated by reference into
the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of
contract of sale prior to such first use, supersede or modify
any statement that was made in the registration statement or
prospectus that was part of the registration statement or made
in any such document immediately prior to such date of first
use, and
(4) for purposes of determining any liability under the
Securities Act, in a primary offering of securities of the
undersigned registrant pursuant to this registration statement,
regardless of the underwriting method used to sell the
securities to the purchaser, if the securities are offered or
sold to such purchaser by means of any
II-6
of the following communications, the undersigned registrant will
be a seller to the purchaser and will be considered to offer or
sell such securities to such purchaser:
|
|
|
(i) Any preliminary prospectus or prospectus of the
undersigned registrant relating to the offering required to be
filed pursuant to Rule 424; |
|
|
(ii) Any free writing prospectus relating to the offering
prepared by or on behalf of the undersigned registrant or used
or referred to by the undersigned registrant; |
|
|
(iii) The portion of any other free writing prospectus
relating to the offering containing material information about
the undersigned registrant or its securities provided by or on
behalf of the undersigned registrant; and |
|
|
(iv) Any other communication that is an offer in the
offering made by the undersigned registrant to the purchaser. |
II-7
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as
amended, the registrant has duly caused this
Amendment No. 2 to Registration Statement to be signed
on its behalf by the undersigned, thereunto duly authorized, in
the city of Tucson, in the County of Pima, State of Arizona, on
the
15th day
of August, 2006.
|
|
|
|
By: |
/s/ Evan C.
Unger, M.D.
|
|
|
|
|
|
Evan C. Unger, M.D. |
|
President and Chief Executive Officer |
Pursuant to the requirements of the Securities Act of 1933, as
amended, this Amendment No. 2 to Registration
Statement has been signed below by the following persons in the
capacities and on the dates indicated.
|
|
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ Evan C.
Unger, M.D.
Evan C. Unger, M.D. |
|
President, Chief Executive Officer and Director
(principal executive officer) |
|
August 15, 2006 |
|
/s/ Greg Cobb
Greg Cobb |
|
Chief Financial Officer
(principal financial and accounting officer) |
|
August 15, 2006 |
|
/s/ Richard Love*
Richard Love |
|
Director |
|
August 15, 2006 |
|
/s/ Richard Otto*
Richard Otto |
|
Director |
|
August 15, 2006 |
|
/s/ Thomas W. Pew*
Thomas W. Pew |
|
Director |
|
August 15, 2006 |
|
/s/ Philip Ranker*
Philip Ranker |
|
Director |
|
August 15, 2006 |
|
/s/ James M.
Strickland*
James M. Strickland |
|
Director |
|
August 15, 2006 |
|
*By: |
|
/s/ Greg Cobb
Greg
Cobb
Attorney-in-Fact |
|
|
|
|
II-8
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
|
1 |
.1 |
|
Form of Underwriting Agreement |
|
3 |
.1 |
|
Fourth Amended and Restated Certificate of Incorporation of the
registrant |
|
3 |
.2* |
|
Amendment to Certificate of Incorporation of the registrant to
effect
a for reverse
stock split |
|
3 |
.3 |
|
Form of Amended and Restated Certificate of Incorporation of the
registrant, to be effective following this offering |
|
3 |
.4 |
|
Bylaws of the registrant, as amended |
|
3 |
.5 |
|
Form of Amended and Restated Bylaws of the registrant, to be
effective following this offering |
|
4 |
.1* |
|
Specimen certificate evidencing shares of common stock |
|
5 |
.1* |
|
Opinion of DLA Piper Rudnick Gray Cary US LLP |
|
10 |
.1 |
|
Form of Indemnification Agreement to be entered into between the
registrant and each of its directors and officers |
|
10 |
.2 |
|
Second Amended and Restated Investors Rights Agreement,
dated April 14, 2006, by and among the registrant and
certain stockholders |
|
10 |
.3 |
|
2000 Stock Plan and related agreements |
|
10 |
.4 |
|
2006 Performance Incentive Plan and related agreements |
|
10 |
.5 |
|
Executive Management Bonus Plan |
|
10 |
.6** |
|
Asset Purchase Agreement, dated September 30, 2005, between
the registrant and Abbott Laboratories |
|
10 |
.7 |
|
Security Agreement, dated September 30, 2005, between the
registrant and Abbott Laboratories |
|
10 |
.8 |
|
Patent License Agreement, dated September 30, 2005, between
the registrant and Abbott Laboratories |
|
10 |
.9 |
|
Secured Promissory Note, dated September 30, 2005, between
the registrant and Abbott Laboratories |
|
10 |
.10 |
|
Services Agreement, dated September 30, 2005, between the
registrant and Abbott Laboratories |
|
10 |
.11 |
|
License Agreement, dated January 4, 2005, between the
registrant and Dr. med. Reinhard Schlief |
|
10 |
.12 |
|
Exclusive Sublicense Agreement, dated October 10, 2003,
between the registrant and UNEMED Corporation |
|
10 |
.13 |
|
Assignment, Assumption and License Agreement, dated
October 7, 1999, between the registrant and Bristol-Myers
Squibb Medical Imaging, Inc. (as successor to DuPont Contrast
Imaging, Inc.) dated October 7, 1999, and amendments thereto |
|
10 |
.14 |
|
License Agreement, dated February 10, 2006, between the
registrant and the University of Arkansas for Medical Sciences |
|
10 |
.15 |
|
Asset Purchase Agreement, dated April 10, 2006, between the
registrant and Abbott Laboratories, and amendments thereto |
|
10 |
.16 |
|
Escrow Agreement, dated April 14, 2006, between the
registrant and Abbott Laboratories |
|
10 |
.17 |
|
Inventory Trademark License Agreement, dated April 14,
2006, between the registrant and Abbott Laboratories |
|
10 |
.18 |
|
Security Agreement, dated April 14, 2006, between the
registrant and Abbott Laboratories |
|
10 |
.19 |
|
Secured Promissory Note, dated April 14, 2006, between the
registrant and Abbott Laboratories |
|
10 |
.20 |
|
Second Amended Executive Employment Agreement, dated
May 15, 2006, between the registrant and Evan C. Unger |
|
10 |
.21 |
|
Consulting Agreement, dated April 11, 2005, between the
registrant and Greg Cobb |
|
10 |
.22 |
|
Executive Employment Agreement, dated April 27, 2005,
between the registrant and Greg Cobb |
|
10 |
.23 |
|
Executive Employment Agreement, dated April 18, 2005,
between the registrant and Randall Miller |
|
10 |
.24 |
|
Executive Employment Agreement, dated February 18, 2004,
between the registrant and John A. Moore |
|
10 |
.25 |
|
Agreement, dated March 31, 2006, by and among the
registrant, John A. Moore and Edson Moore Healthcare Ventures |
|
10 |
.26 |
|
Subscription Agreement and Investor Questionnaire, dated March
2004, between the registrant and each of the signatory
investors, offering price $2.00 per share |
|
10 |
.27 |
|
Subscription Agreement and Investor Questionnaire, dated
December 2004, between the registrant and each of the signatory
investors, offering price $3.00 per share |
|
10 |
.28 |
|
Subscription Agreement and Investor Questionnaire, dated
September and October 2004, between the registrant and each of
the signatory investors, offering price $4.00 per share |
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
|
10 |
.29 |
|
Commercial Lease Triple Net, dated November 1, 2002,
between the registrant and ImaRx Investments L.L.C. |
|
10 |
.30 |
|
Standard Commercial Industrial Lease, dated
December 30, 1997, between the registrant and Tucson Tech
Park and addenda thereto |
|
21 |
.1 |
|
Subsidiaries of the registrant |
|
23 |
.1 |
|
Consent of Ernst & Young LLP |
|
23 |
.2* |
|
Consent of DLA Piper Rudnick Gray Cary US LLP (included in
Exhibit 5.1) |
|
24 |
.1 |
|
Power of Attorney |
|
|
* |
To be filed by amendment |
|
|
|
Previously filed |
|
|
** |
Portions of this exhibit have been omitted pursuant to a
confidential treatment request, and this information has been
filed separately with the Commission. |
|