Processa Pharmaceuticals, Inc. reported a net loss of approximately $13.6 million for the fiscal year ending December 31, 2025, compared to a net loss of $11.9 million in the previous year. The company's total operating expenses increased to $14 million, driven primarily by a rise in research and development costs, which amounted to $7.8 million, up from $7.3 million in 2024. General and administrative expenses also saw a significant increase, totaling $6.2 million, compared to $4.8 million in the prior year. The company has not generated any revenue during the reported periods, maintaining an accumulated deficit of approximately $100.8 million as of December 31, 2025.
In terms of operational developments, Processa is advancing its pipeline of Next Generation Cancer therapies, with two candidates currently in or having completed Phase 2 trials. The lead candidate, NGC-Cap, is a combination of PCS6422 and capecitabine, which has shown a better safety profile in clinical trials. The company has also initiated a Phase 2 trial for NGC-Cap in advanced or metastatic breast cancer, with the first patient dosed on October 2, 2024. The trial is currently on temporary hold pending an interim analysis of the first 20 patients, expected to be completed in the first half of 2026.
Financially, Processa's cash and cash equivalents stood at $5.5 million at the end of 2025, with additional funding anticipated to be necessary in the second quarter of 2026 to support ongoing clinical trials and operations. The company raised approximately $16.6 million through various capital-raising activities during the year, including a successful at-the-market offering. However, the company has expressed substantial doubt about its ability to continue as a going concern without securing additional financing.
Strategically, Processa is exploring options to monetize its non-oncology drug assets, including PCS12852, a treatment for diabetic gastroparesis, and PCS499, aimed at primary glomerular diseases. The company is also evaluating its digital asset treasury strategy, having invested in CHZ tokens, which have appreciated in value, contributing to unrealized gains of $295,180 for the year. The company plans to continue leveraging its digital assets to enhance financial flexibility and support clinical development programs.
Looking ahead, Processa Pharmaceuticals aims to advance its clinical trials and secure necessary funding to support its operations. The company remains focused on its goal of developing safer and more effective cancer therapies, while navigating the challenges of regulatory approvals and market competition.
About Processa Pharmaceuticals, Inc.
Processa Pharmaceuticals is a clinical-stage biopharmaceutical company developing Next Generation Cancer therapies by modifying existing, well-understood cancer drugs to enhance efficacy and reduce toxicity. Its pipeline includes small molecules in Phase 2 trials targeting solid tumors, with a focus on improving safety profiles. The company leverages proprietary regulatory science to streamline development and aims for rapid adoption of more effective, less toxic cancer treatments.
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