Processa Pharmaceuticals, Inc. reported a net loss of $11.9 million for the fiscal year ending December 31, 2024, compared to a net loss of $11.1 million in the previous year. The company's total operating expenses increased to $12.1 million, driven primarily by a rise in research and development costs, which reached $7.3 million, up from $5.8 million in 2023. This increase was largely attributed to ongoing clinical trials, particularly the Phase 1B trial for its Next Generation Cancer therapy, NGC-Cap, and the initiation of a Phase 2 trial for the same drug. The company did not generate any revenue during the reporting period, maintaining its status as a clinical-stage biopharmaceutical firm.
In terms of financial position, Processa's cash and cash equivalents decreased to $1.2 million as of December 31, 2024, down from $4.7 million a year earlier. The company raised $4.5 million in net proceeds from a public offering completed in January 2025, which it plans to use to fund ongoing research and development activities. However, the company has expressed substantial doubt about its ability to continue as a going concern, emphasizing the need for additional capital to support its operations and clinical trials.
Strategically, Processa is focused on developing a pipeline of Next Generation Cancer therapies, with three key candidates: NGC-Cap (PCS6422), NGC-Gem (PCS3117), and NGC-Iri (PCS11T). The company has made significant progress, including the initiation of a Phase 2 trial for NGC-Cap in advanced breast cancer patients, which began in October 2024. The company is also exploring options for its non-oncology drug candidates, PCS12852 and PCS499, which may include licensing or partnership opportunities.
Operationally, Processa's workforce consisted of 10 full- and part-time employees as of March 2024. The company has faced challenges in meeting certain milestones under its licensing agreements, particularly with Elion Oncology, which has led to ongoing litigation regarding the validity of a license termination. The company intends to vigorously defend its position in these legal matters, which could have significant implications for its business operations and future prospects.
Looking ahead, Processa Pharmaceuticals aims to continue advancing its clinical trials and securing additional funding to support its development programs. The company acknowledges the inherent risks associated with drug development, including the potential for clinical trial failures and regulatory hurdles, which could impact its ability to achieve profitability and sustain operations in the long term.
About Processa Pharmaceuticals, Inc.
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