Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage biopharmaceutical company developing products to improve the survival and quality of life for patients who have unmet medical needs, has announced its financial results for Q2 2021, the quarter ended June 30, 2021. The company also shared a corporate update. Highlights of the report include that Processa dosed its first two patients in its PCS499 phase 2B ulcerative Necrobiosis Lipoidica (“NL”) trial and dosed its first patient in its phase 1B trial evaluating the safety and PK of PCS6422 and capecitabine when administered to patients with advanced, refractory GI cancer. The company also licensed in PCS3117 (formerly RX-3117), an oral, anticancer agent with an improved pharmacological profile relative to gemcitabine and joined the Russell Microcap(R).
The report also noted that Processa has cash and cash equivalents totaling $20.8 million as of the end of Q2, an increase from the $15.4 million in reserves at end of year 2021; the company also had 15.6 million shares of common stock outstanding as of Aug. 2, 2021. Processa’s R&D expenses for second quarter 2021 reached $1.6 million, with general and administrative expenses for the same quarter totaling $1.3 million. The company also announced a conference call to discuss its Q2 results and to provide an update on its drug development pipeline. The call is scheduled for Aug. 12, 2021, at 5:30 p.m EST. Interested individuals and organization can call 1-888-506-0062 toll free, using the entry code 628453. International callers should dial 973-528-0011 using the same entry code. Callers are encouraged to dial in a few minutes before the call begins. The call is also available on a live webcast. In addition, a replay of the call will be available by phone or webcast as well. Those interested in accessing that can call 1-877-481-4010 toll free, using the entry code 42137. International callers should dial 919-882-2331, using the same entry code. “During the second quarter, we made significant progress advancing our clinical programs, in-licensed another clinical asset — RX-3117 — and will have four clinical programs with addressable markets of $500 million to $1.5 billion,” said Processa CEO and chair Dr. David Young in the press release. “Looking at upcoming milestones, we have begun to develop the biomarker assays for 3117 in pancreatic cancer patients with the expectation that the assay validation will be completed in the first half of 2022. We also anticipate filing an IND in September for PCS12852 with site initiation beginning before year end. Additionally, we expect interim data for PCS6422 in the fourth quarter of 2021 and interim data for PCS499 during the first half of 2022. Taken altogether, we see a consistent cadence of upcoming catalysts and tremendous amount of near-term value creation.”
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About Processa Pharmaceuticals Inc.
The mission of Processa is to develop drug products that improve the survival and/or quality of life for patients with high unmet medical need conditions. Processa is a development company, not a discovery company, that seeks to identify and develop drugs for patients who need better treatment options than presently exist for their medical condition. To increase the probability of development success, the company’s pipeline only includes drugs that have previously demonstrated some efficacy in the targeted population or a drug with similar pharmacological properties that has been shown to be effective in the population. Processa currently has three drugs in various stages of clinical development: PCS499 for ulcerative necrobiosis in phase 2B, PCS3117 for metastatic pancreatic cancer and non-small cell lung cancer in phase 2B, and PCS6422 for metastatic colorectal cancer and breast cancer in phase 1B. The PCS12852 IND for the treatment of gastroparesis will be submitted in 3Q2021. Members of the Processa development team throughout their careers have been involved with more than 30 FDA drug approvals (including drug products targeted to orphan disease conditions), more than 100 FDA meetings and two FDA regulatory science contracts. 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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