Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient’s survival and/or quality of life, is reporting financial numbers and clinical program updates for the quarter ended June 30, 2022. Highlights of the report include news that PCSA’s PCS12852 program is on target to complete enrollment by September and that expanded efforts to increase enrollment in PCS 499 and PCS 6422 are showing results. The company also reported a cash balance on June 30, 2022, of $12.1 million, which PCSA expects to be sufficient to complete its three ongoing clinical trials and fund operations into the third quarter of 2023. “Our efforts to enhance enrollment through adding new sites, extensive marketing campaigns and working with our CRO partners are showing results,” said Processa president and CEO Dr. David Young in the press release. “We expect to close out enrollment for PCS12852 for gastroparesis within the next month and present top-line data from the trial before the end of the year. We now have a sufficient number of patients in the screening queue for PCS6422 to complete our interim cohorts, which we believe will provide valuable insights on de novo formation of DPD. We anticipate we will determine the maximum tolerated dose by early 2023. Patients are beginning to show a willingness to travel, and we are seeing increased patient activity in our PCS499 ulcerative necrobiosis lipoidica (uNL) trial. We are optimistic that we will enroll our interim analysis cohort before the end of the year. [And] as part of our efforts to increase enrollment on our PCS499 trial, we recently launched a website to increase awareness of uNL and to inform patients of the ongoing phase 2B study of PCS499. Advancing these three drugs in their respective clinical trial allows us to obtain the clinical data to better define each pivotal trial as well as provide us with more insight into how FDA will review each of these products when we submit the New Drug Applications to FDA.”
To view the full press release, visit https://ibn.fm/FQU6f
About Processa Pharmaceuticals Inc.
The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The company uses these criteria for selection to further develop its pipeline programs to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include Next Generation Capecitabine (formerly identified as PCS6422) for metastatic colorectal cancer and breast cancer program; PCS499 (“PCS499”), an ulcerative necrobiosis lipoidica program; and PCS12852 (“PCS12852”) (a GI motility/gastroparesis program). The members of the Processa development team have been involved with more than 30 drug approvals by the FDA, including drug products targeted to orphan disease conditions, and more than 100 FDA meetings throughout their careers. For more information, visit the company’s website at www.ProcessaPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at https://ibn.fm/PCSA
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