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Processa Pharmaceuticals Announces Third Quarter 2021 Results and Provides Corporate Update
Clinical Drug Pipeline is Funded and Targeting Major Milestones mid-2022 HANOVER, Md., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc.
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"Clinical Drug Pipeline is Funded and Targeting Major Milestones mid-2022 HANOVER, Md., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (\"Processa\" or the \"Company\"), 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, today announces financial results for the quarter ended September 30, 2021, and provides a corporate update. Dr. David Young, CEO and Chairman of Processa, commented, “During the first three quarters we made substantial progress advancing our three clinical drugs, each having a potential market exceeding $1 billion. 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. While we have experienced slower than expected enrollment in PCS499 and currently have three patients in the trial, we are expanding our efforts and outreach to identify new patients, and still anticipate completing the trial in 2022.” Recent Highlights and New Developments The Next Generation Capecitabine Phase 1B trial confirmed our hypothesis and provided insight into the importance of obtaining greater clarity on DPD inhibition and de novo formation, which could possibly lead to a personalized or precision medicine approach to treating cancer patients. We received clearance from FDA to proceed with a Phase 2A trial for the treatment of Gastroparesis and anticipate enrolling the first patient in the first half of 2022 and complete the conduct of the trial in 2022.We are conducting a critical review of our clinical assets to assess opportunities to accelerate development and approval timelines. Financial Results for the third quarter of 2021 Our cash and cash equivalents totaled $19.1 million as of September 30, 2021, compared...