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Processa Pharmaceuticals, Inc. (symbol: PCSA) is a clinical-stage biopharmaceutical company, founded in October 2017 and headquartered in Hanover, Maryland. The company's mission is to develop products that can significantly improve the survival and quality of life for patients with high unmet medical needs, particularly in the field of oncology.
Processa Pharmaceuticals specializes in the development of Next Generation Chemotherapy (NGC) oncology drug products using a unique 'regulatory science' approach. The company's primary focus is to advance its pipeline of proprietary small molecule oncology drugs. These NGC products are new chemical entities designed to alter the metabolism, distribution, and/or elimination of already FDA-approved cancer drugs or their active metabolites, while preserving the original mechanisms of action that kill cancer cells.
The company's current pipeline includes three promising NGC treatments:
- NGC-Capecitabine (NGC-Cap): This therapy involves Capecitabine administered with PCS6422, aiming to enhance efficacy and reduce side effects.
- PCS3117 (NGC-Gemcitabine or NGC-Gem): A novel formulation intended to improve the therapeutic profile of Gemcitabine.
- PCS11T (NGC-Irinotecan or NGC-Iri): Another innovative treatment designed to optimize the benefits of Irinotecan.
Processa Pharmaceuticals is committed to leveraging its expertise in regulatory science to bring these next-generation treatments to market. The company's strategic partnerships and ongoing clinical trials play a crucial role in advancing its mission and providing hope to patients battling cancer. For the latest updates and more information, investors can contact Patrick Lin at plin@processapharma.com.
On May 5, 2022, Processa Pharmaceuticals (NASDAQ: PCSA) announced a conference call scheduled for May 12, 2022, at 4:30 p.m. EST to review Q1 results and update its clinical pipeline. Interested participants can join via phone or a live webcast. The company focuses on developing treatments for unmet medical needs, with active programs in metastatic colorectal cancer, breast cancer, and gastroparesis. The call will provide insights into the company's progress and future goals.
Processa Pharmaceuticals has initiated dosing for the first patient in its amended Phase 1B trial for Next Generation Capecitabine, targeting advanced gastrointestinal cancer. The trial tests the combination of PCS6422 and capecitabine, aiming to enhance capecitabine's potency significantly. Preliminary data suggest PCS6422 can make capecitabine approximately 50 times more potent per mg administered. The company aims to finalize the maximum tolerated dose (MTD) by the end of 2022 and plans to advance to Phase 2B or Phase 3 trials in 2023.
Processa Pharmaceuticals (NASDAQ: PCSA) has initiated a Phase 2A clinical trial for its drug PCS12852 aimed at treating moderate to severe gastroparesis, a serious gastric motility disorder affecting many patients. The study, involving 24 patients across 8 U.S. centers, seeks to demonstrate PCS12852's efficacy in improving gastric emptying rates and alleviating associated symptoms. This trial follows positive results from previous studies and is expected to provide pivotal data for future trials, targeting a market potentially exceeding $1B. The topline data is anticipated by the end of 2022.
Processa Pharmaceuticals (Nasdaq: PCSA) announced its financial results for 2021 and provided a corporate update. Despite challenges from COVID-19, the company progressed in clinical trials for PCS499 (uNL treatment), PCS6422 (GI cancer), and PCS12852 (gastroparesis). In 2021, Processa managed to raise its cash balance to $16.5 million, reporting a reduced net loss of $11.4 million. The upcoming milestones for 2022 include clinical trials and a focus on personalized medicine approaches, highlighting potential markets exceeding $1 billion.
Processa Pharmaceuticals (Nasdaq: PCSA) has announced a conference call scheduled for March 30, 2022, at 4:30 p.m. EST. The purpose of the call is to discuss the fourth quarter 2021 results and provide an update on its clinical pipeline. Interested participants can join via live webcast or by dialing in. Notable pipeline programs include PCS6422 for cancer and PCS499 for ulcerative necrobiosis lipoidica. The company focuses on developing treatments for patients with unmet medical needs.
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) announced that CEO Dr. David Young will present at the Oppenheimer 32nd Annual Healthcare Conference on March 17, 2022, at 10:00 AM Eastern. The live webcast will be available in the Investor Relations section of Processa's website, with a replay to follow. Processa focuses on developing treatments for patients with unmet medical needs, including programs for metastatic colorectal and breast cancer, ulcerative necrobiosis lipoidica, and GI motility disorders. The company has a team with extensive FDA drug approval experience.
Processa Pharmaceuticals (Nasdaq: PCSA) shared a letter to shareholders detailing its accomplishments in 2021 and future plans for 2022. The company aims to initiate multiple Phase 3 trials and has a pipeline targeting unmet medical needs. Despite challenges in patient enrollment due to COVID-19, Processa successfully in-licensed PCS3117 for pancreatic cancer and progressed on several trials including PCS499 for ulcerative necrobiosis lipoidica and PCS12852 for gastroparesis. The company emphasizes its 'Regulatory Science' approach to de-risk drug development. Cash reserves are sufficient for upcoming clinical trials.
Processa Pharmaceuticals (Nasdaq: PCSA) reported its financial results for Q3 2021, with cash and cash equivalents at $19.1 million. The company is developing three clinical drugs with potential markets over $1 billion each. Progress includes FDA clearance for PCS12852 and ongoing trials for PCS499 and PCS6422. Enrollment in PCS499 has been slower than anticipated, with three patients currently in the trial. R&D expenses surged to $1.7 million, up from $533 thousand in Q3 2020, while the net loss slightly decreased to $3.0 million compared to $3.1 million last year.
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) announced positive results from its Phase 1b trial of the Next Generation Capecitabine, which combines PCS6422 with capecitabine. The trial demonstrated that PCS6422 successfully inhibited dihydropyrimidine dehydrogenase (DPD), leading to less than 10% of 5-FU being metabolized to non-effective FBAL, compared to 80% with the FDA-approved capecitabine. This resulted in a significantly longer half-life and increased potency of 5-FU. However, the DPD inhibition was not sustained beyond 48 hours, which may necessitate protocol modifications.
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) will report its financial results for Q3 2021 on November 11, 2021. The company plans to hold a conference call at 5:30 PM ET on the same day to discuss its financial performance and business highlights. Processa focuses on developing treatments for patients with unmet medical needs, with active programs targeting metastatic colorectal and breast cancer, as well as conditions like ulcerative necrobiosis lipoidica and GI motility disorders. The company emphasizes efficient development to meet critical milestones.
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