Processa Pharmaceuticals (NASDAQ: PCSA), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve survival and/or quality of life, has reported its financial numbers and corporate highlights for third quarter 2021. Included in the report was results of the company’s next-generation capecitabine phase 1B trial, which confirmed the study hypothesis and provided insight into the importance of obtaining greater clarity on DPD inhibition and de novo formation. Processa also received FDA clearance to proceed with a phase 2A trial for the treatment of gastroparesis and is evaluating opportunities to accelerate development and approval timelines. On the financial end, the company reported cash and cash equivalents totaled $19.1 million as of Sept. 30, 2021, an increase over the $15.4 million reported on Dec. 31, 2020. In addition, the company had 15.7 million shares of common stock outstanding as of Nov. 2, 2021. “During the first three quarters, we made substantial progress advancing our three clinical drugs, each having a potential market exceeding $1 billion,” said Processa CEO and chair Dr. David Young in the press release. “We initiated and commenced enrollment in both PCS499 and PCS6422 (next-generation capecitabine) and received a Safe to Proceed letter from FDA for the PCS12852 IND. We recently reported results confirming our hypothesis that inhibiting DPD produced significantly lower levels of FBAL and demonstrated 50 times greater exposure than reported for FDA-approved capecitabine. We are amending the protocol in the PCS6422 study to ascertain a more precise understanding of DPD in the presence of capecitabine and expect these insights to dramatically improve the safety and efficacy of one of the cornerstones of chemotherapy.”
To view the full press release, visit https://ibn.fm/HjzG6
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 PCS6422 (“PCS6422”), a metastatic colorectal cancer and breast cancer program; PCS499 (“PCS499”), an ulcerative necrobiosis lipoidica program; and PCS12852 (“PCS12852”), 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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