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 2021 year end. Highlights of the report included the success of the company’s next-generation capecitabine Phase 1B trial and the fact that PCSA has replaced nonperforming sites and added remedial recruitment procedures to its PCS499 Phase 2B trial, which is slated to complete enrollment of interim analysis patients in the coming weeks. The company also received clearance from the FDA to proceed with its planned phase 2A trial for the treatment of gastroparesis and is working to assess opportunities to accelerate development and approval timelines. The report noted that as of Dec. 31, 2021, Processa had a cash balance of $16.5 million, an increase of $1.1 million compared to Dec. 31, 2020. The company reported overhead expenses, or general and administrative expenses plus the salaries for development and administrative teams, of $3 million, and a net loss of $11.4 million compared with $14.4 million for the same period of 2020. “Although COVID presented challenges for us and our industry in 2021, we commenced and enrolled patients in PCS499 for the treatment of uNL, PCS6422 (next-generation capecitabine) for the treatment of GI cancer, and received clearance for an IND for PCS12852 for gastroparesis,” said Process Pharmaceuticals CEO and chair Dr. David Young in the press release. “We were excited to learn that next-generation capecitabine is 50 times more potent than presently approved capecitabine and modified the protocol to further enhance the efficacy and safety of next-generation capecitabine. In addition, our modifications to the protocol now allow us to evaluate the possibility of treating patients using an individualized-personalized medicine approach for next-generation capecitabine. We completed the administrative efforts to commence our study in gastroparesis with the first patient to be dosed imminently. These efforts will produce three catalytic data events in the coming 9 to 10 months each in indications that could potentially exceed markets of $1 billion.”
To view the full press release, visit https://ibn.fm/cxANo
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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