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 reported its financial and corporate results for the first quarter of 2021, the period ended March 31, 2021. In the report, PCSA noted that its clinical drug pipeline is funded and targeting major milestones throughout this year. Corporate highlights for the company included the selection of five clinical sites around the United States for the upcoming phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of PCS499 in treating patients who have necrobiosis lipoidica along with ulcerations; the initiation of clinical sites to enroll patients in the phase 1B study of the safety and PK of PCS6422 with capecitabine in patients with refractory GI tract tumors; and the plan to submit an IND application in the third quarter of 2021 for PCS12852, a small molecule drug in development for the treatment of gastroparesis and functional gastrointestinal motility disorders. The company also closed a private placement resulting in gross proceeds of $10.2 million. Other financial highlights for PCSA were its cash and cash equivalents, which totaled $23 million at the end of Q1 2021, an increase from the Q1 2020 total of $15.4 million as of December 31, 2020; R&D expenses reaching $1.5 million for the quarter; and general and administrative expenses for Q1 2021 totaling an estimated $717,000, compared to $484,000 for the comparable period in 2020. “During the first quarter we made substantial progress advancing our three clinical in-licensed drugs, each with a potential market exceeding $1 billion,” said Processa Pharmaceuticals CEO and president Dr. David Young in the press release. “We expect first patients to be dosed with PCS6422 and PCS499 within the next six weeks, and to receive interim data for PCS6422 near the end of the third quarter of 2021 and interim data for PCS499 during the first quarter of 2022.”
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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. PCSA’s active clinical pipeline programs include PCS6422 (“PCS6422”) (metastatic colorectal cancer and breast cancer), PCS499 (“PCS499”) (ulcerative Necrobiosis Lipoidica) and PCS12852 (“PCS12852”) (gastroparesis). The markets of each indication are in excess of $1 billion each. The members of the Processa development team have been involved with more than 30 FDA drug approvals, 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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