Processa Pharmaceuticals Inc
NASDAQ:PCSA
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Processa Pharmaceuticals Inc
NASDAQ:PCSA
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Processa Pharmaceuticals Inc
Processa Pharmaceuticals, Inc. engages in the discovery, development, and commercialization of drug products for the treatment of serious medical conditions. The company is headquartered in Hanover Maryland, Maryland and currently employs 15 full-time employees. The company went IPO on 2013-10-07. The company is focused on development of drug products that are intended to provide treatment for patients who have unmet medical need condition that effects survival or the patient’s life and no treatment options. The company has five drugs: four in various stages of clinical development (PCS499, PCS12852, PCS3117 and PCS6422) and one in nonclinical development (PCS11T). PCS499 is an oral tablet that is a deuterated analog of one of the major metabolites of pentoxifylline (PTX ). PCS12852 is a highly specific and potent 5-hydroxytryptamine 4 (5-HT4) receptor agonist. is a novel, investigational, oral small molecule nucleoside compound. PCS3117 is an analog of the endogenous nucleoside, cytidine, and an analog of the cancer drug gemcitabine. PCS6422 is an oral, potent, selective and irreversible inhibitor of dihydropyrimidine dehydrogenase (DPD). PCS11T is being developed for the treatment of the solid tumor.
Processa Pharmaceuticals, Inc. engages in the discovery, development, and commercialization of drug products for the treatment of serious medical conditions. The company is headquartered in Hanover Maryland, Maryland and currently employs 15 full-time employees. The company went IPO on 2013-10-07. The company is focused on development of drug products that are intended to provide treatment for patients who have unmet medical need condition that effects survival or the patient’s life and no treatment options. The company has five drugs: four in various stages of clinical development (PCS499, PCS12852, PCS3117 and PCS6422) and one in nonclinical development (PCS11T). PCS499 is an oral tablet that is a deuterated analog of one of the major metabolites of pentoxifylline (PTX ). PCS12852 is a highly specific and potent 5-hydroxytryptamine 4 (5-HT4) receptor agonist. is a novel, investigational, oral small molecule nucleoside compound. PCS3117 is an analog of the endogenous nucleoside, cytidine, and an analog of the cancer drug gemcitabine. PCS6422 is an oral, potent, selective and irreversible inhibitor of dihydropyrimidine dehydrogenase (DPD). PCS11T is being developed for the treatment of the solid tumor.
Cash Position: Processa ended 2022 with $6.5 million in cash and raised an additional $6.4 million post-year-end, expecting these funds to last into Q3 2024.
Larger Net Loss: Net loss widened to $27.4 million in 2022, mainly due to a $7.3 million non-cash impairment and higher R&D and stock compensation.
Pipeline Focus: The company is now prioritizing three next-generation chemotherapy drugs in oncology, narrowing its focus from a broader portfolio.
Clinical Progress: Phase 1b for next-generation capecitabine is ongoing, with plans to meet the FDA in April and to launch Phase 2b in the second half of 2023.
Regulatory Strategy: Management emphasized early adoption of FDA's Project Optimus principles to optimize trial design and dosing.
Operational Efficiency: Heavy use of stock-based compensation conserved cash and aligned management with shareholders.
Potential Licensing: The company is seeking to outlicense non-oncology assets and might monetize next-gen chemotherapy drugs as well.
