Artelo Biosciences Reports First Quarter Fiscal Year 2020 Financial Results and Provides Business Update

LA JOLLA, Calif., Jan. 14, 2020 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that modulate the endocannabinoid system, today reported financial and operating results for the first quarter of its fiscal year ended November 30, 2019.

The Company continues to advance its clinical and pre-clinical pipeline which consists of three therapeutic candidates for cancer-related anorexia, cancer, and PTSD.  During the quarter, the Company held a positive meeting with the U.K. Medicines and Healthcare Products Regulatory Agency on the initiation of a Phase 1b/2a study with ART27.13, successfully manufactured drug substance at scale, and increased its public profile.  In particular, a pre-clinical study published in October 2019 demonstrated that the Company’s Fatty Acid Binding Protein 5 (FABP5) inhibitor can increase the cytotoxic and tumor suppressive effects in prostate cancer cells when coadministered with taxanes. “Artelo Biosciences is well positioned to reach a number of meaningful milestones in 2020, including the initiation of a clinical study with ART27.13 by mid-year,” stated Gregory D. Gorgas, Chief Executive Officer. “Given these and other developments, we plan to pursue strategic discussions with potential partners about each of our programs.”

First Quarter FY2020 Corporate Highlights

  • Successfully manufactured drug substance material and selected a contract research organization for our upcoming Phase 1b/2a study of ART27.13 for the treatment of anorexia and weight loss associated with cancer. 
  • Concluded a productive meeting with The U.K. Medicines and Healthcare Products Regulatory Agency to discuss our upcoming Phase 1b/2a study of ART27.13.
  • Published positive pre-clinical data on ART26.12, our FABP5 inhibitor program, under development in collaboration with The Research Foundation of the State University of New York Stony Brook, in The Prostate October 2019 issue. Study identified combinations of taxanes and FABP5 inhibitors which resulted in complete prostate cell death at lower concentrations when compared to docetaxel or cabazitaxel alone.
  • Artelo conducted research studies featured in the Nature Medicine September 2019 issue. Nature Medicine recognized the importance the Company’s research findings and highlighted the scarcity of data on CBD as well the limited availability of quality clinical research identifying the dose of CBD useful to treat certain diseases and conditions.
  • Presented the Company at multiple, well-attended investment conferences in New York and London.

Financial Highlights

  • Operating expenses for the three months ended November 30, 2019 were $1,336,448 compared to $556,903 for the same period in 2018. The Company’s operating expenses were primarily related to ongoing regulatory filing requirements, research and development contracts and general and administrative expenses.
  • Net loss was approximately $1,306,361, or $0.39 per basic and $0.40 per diluted share for the quarter ended November 30, 2019 compared to a net loss of $556,903, or $0.32 per basic and diluted share for the quarter ended November 30, 2018. Net loss for the first quarter ended November 30, 2019 included a gain of $29,501 related to the change in the fair value of derivative liabilities. As of November 30, 2019, derivative liabilities amount to $0.
  • As of November 30, 2019, the Company had approximately $3,374,683 in cash, compared to $4,423,965 as of August 31, 2019. 

About Artelo Biosciences
Artelo Biosciences, Inc. is a San Diego-based biopharmaceutical company dedicated to the development and commercialization of proprietary therapeutics targeting the endocannabinoid system and related pathways. Artelo is rapidly advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the company applies leading edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at and Twitter: @ArteloBio.

Forward Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission, including our ability to raise additional capital in the future. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable securities laws.

Investor Relations Contact:
Crescendo Communications, LLC
Tel: 212-671-1020

Consolidated Balance Sheets
  November 30,  August 31,
 2019  2019 
Current Assets     
Cash and cash equivalents $  3,374,683   $  4,423,965 
Prepaid expenses   86,133     8,336 
Deposits   1,500     1,500 
Other receivable   45,587     8,787 
Total Current Assets   3,507,903     4,442,588 
Equipment, net of accumulated depreciation of $886 and $792, respectively   598     721 
Intangible asset   2,039,417     2,039,417 
TOTAL ASSETS   5,547,918     6,482,726 
Current Liabilities     
Accounts payable and accrued liabilities $  574,530   $  348,863 
Due to related parties   10,024     3,732 
Derivative liability   -      29,501 
Stock payable   -      639,417 
  Total Current Liabilities   584,554     1,021,513 
Preferred Stock, par value $0.001, 6,250,000 shares authorized,     
0 and 0 shares issued and outstanding, respectively   -      -  
Common Stock, par value $0.001, 18,750,000 shares authorized,     
3,426,276 and 3,353,616 shares issued and outstanding, respectively   3,426     3,354 
Additional paid-in capital   11,070,517     10,278,421 
Accumulated deficit   (6,117,117)    (4,810,756)
Accumulated other comprehensive loss   6,538     (9,806)
Total Stockholders' Equity   4,963,364     5,461,213 

Consolidated Statements of Operations
 Three months ended
 November 30,
 2019  2018 
General and administrative $  403,159   $  205,501 
Professional fees   266,227     167,293 
Research and development   666,938     184,039 
Depreciation   124     70 
  Total Operating Expenses   1,336,448     556,903 
  Loss from Operations   (1,336,448)    (556,903)
Other income   586     -  
Change in fair value of derivative liabilities   29,501     -  
  Total other income   30,087     -  
NET LOSS   (1,306,361)  $  (556,903)
Foreign currency translation adjustments   16,344     4,888 
  Total Other Comprehensive Income (Loss)   16,344     4,888 
TOTAL COMPREHENSIVE LOSS $  (1,290,017)  $  (552,015)
Basic Loss per Common Share $  (0.39)  $  (0.32)
Diluted Loss per Common Share $  (0.40)  $  (0.32)
Basic Weighted Average Common Shares Outstanding   3,361,601     1,754,494 
Diluted Weighted Average Common Shares Outstanding   3,379,000     1,754,494 

Consolidated Statements of Stockholders’ Equity (Deficit)
    Additional   Accumulated Other   
  Common stock paid-in Accumulated Comprehensive  
  Shares Amount capital Deficit Income (loss) Total
Balance, August 31, 2019   3,353,616 $  3,354 $  10,278,421  $  (4,810,756) $  (9,806) $  5,461,213 
Common stock issuance costs   -    -    (15,151)   -     -     (15,151)
Common shares issued for services - officers   -    -    13,000    -     -     13,000 
Common shares issued for acquisition of license   61,297   61   539,356    -     -     539,417 
Common shares issued for settlement of debt   11,363   11   99,989    -     -     100,000 
Refund for fractional stock   -    -    (117)   -     -     (117)
Stock option expense   -    -    155,019    -     -     155,019 
Net loss for the period     -      (1,306,361)   -     (1,306,361)
Foreign currency translation adjustments     -      -     16,344    16,344 
Balance, November 30, 2019   3,426,276   3,426   11,070,517    (6,117,117)   6,538    4,963,364 

    Additional   Accumulated Other   
  Common stock paid-in Accumulated Comprehensive  
  Shares Amount capital Deficit Income (loss) Total
Balance, August 31, 2018 1,750,268$1,750$2,514,136$(2,638,580)$(12,280)$(134,974)
Common shares issued for cash 29,300 29 170,745 -  -  170,774 
Common shares issued for services - officers   - 13,000 -  -  13,000 
Stock option granted for services   - 28,051 -  -  28,051 
Net loss for the period   -   (556,903) -  (556,903)
Foreign currency translation adjustments   -   -  4,888  4,888 
Balance, November 30, 2018 1,779,568 1,779 2,725,932 (3,195,483) (7,392) (475,164)

Consolidated Statements of Cash Flows
  Three months ended
  November 30,
 2019  2018 
Net loss$  (1,306,361) $  (556,903)
Adjustments to reconcile net loss to net cash used in operating activities:     
Stock based compensation   168,019     41,051 
Depreciation   124     70 
Change in fair value of derivative liabilities   (29,501)    -  
Changes in operating assets and liabilities:     
  Prepaid expenses   (77,797)    (9,462)
  Other receivable   (36,800)    18,665 
  Accounts payable and accrued liabilities   230,667     105,427 
Net cash used in operating activities   (1,051,649)    (401,152)
Issuance of common shares for cash   -      170,774 
Common stock issuance costs   (15,151)    -  
Refund for fractional stock   (117)    -  
Advance from related parties   4,334     3,686 
Repayments to related parties   (3,040)    (558)
Net cash provided by financing activities   (13,974)    173,902 
Effects on changes in foreign exchange rate   16,341     4,900 
Net decrease in cash and cash equivalents   (1,049,282)    (222,350)
Cash and cash equivalents - beginning of period   4,423,965     337,424 
Cash and cash equivalents - end of period$  3,374,683  $  115,074 
Supplemental Cash Flow     
  Cash paid for interest$  -   $  -  
  Cash paid for income taxes$  -   $  -  
Non-cash financing and investing activities:     
Common shares issued for acquisition of license offset against stock payable$  539,417    
Common shares issued for settlement of stock payable$  100,000  $  -  

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