Processa Pharmaceuticals(US:PCSA)2025-11-06 21:07Financial Performance - Processa Pharmaceuticals reported a net loss of $3,436,573 for the three months ended September 30, 2025, compared to a net loss of $3,384,703 for the same period in 2024, reflecting an increase of $51,870[78]. - Operating loss for the nine months ended September 30, 2025, was $10,286,616, compared to $9,316,475 for the same period in 2024[78]. - The company generated a net loss of $10.2 million during the nine months ended September 30, 2025, with an accumulated deficit of $97.4 million[98]. - Other income for the three months ended September 30, 2025 was approximately $52,000, compared to $40,000 for the same period in 2024, and for the nine months ended September 30, 2025, it was approximately $74,000 versus $195,000 in 2024[88]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $8,484,617, a decrease from $8,997,321 in 2024, attributed to timing of prepaid asset payments[92]. - The company has incurred losses since inception and does not expect positive cash flow from operations in the foreseeable future[98]. Research and Development - Research and development expenses for the three months ended September 30, 2025, were $1,661,646, a decrease of $625,879 from $2,287,525 in the same period in 2024[78]. - The NGC-Cap Phase 2 trial for advanced or metastatic breast cancer is actively enrolling patients, with preliminary safety-efficacy data expected to inform protocol modifications[69]. - PCS12852, a drug for gastroparesis, is Phase 2B ready, with a binding term sheet signed with Intact Therapeutics for potential licensing, including a $2.5 million payment upon execution[73]. - The company is evaluating the clinical safety and efficacy of PCS499 for primary glomerular diseases, with plans to meet with the FDA in Q4 2025 to discuss the Phase 3 study design[70]. - The company has a pipeline of Next Generation Cancer therapies, with NGC-Cap currently in Phase 2 and NGC-Iri in preclinical development[65]. Expenses and Cash Management - General and administrative expenses for the three months ended September 30, 2025 increased by approximately $681,000 to $1.8 million from $1.1 million for the same period in 2024, primarily due to salary increases and professional fees[86]. - For the nine months ended September 30, 2025, general and administrative expenses rose by approximately $831,000 to $4.6 million from $3.8 million in 2024, driven by salary increases and stock-based compensation[87]. - As of September 30, 2025, the company had cash and cash equivalents totaling $6.3 million, which, along with subsequent proceeds of $945,000, is expected to satisfy capital needs into the first quarter of 2026[97]. Capital Raising and Financing - The company raised net proceeds of $10.6 million through public offerings during the nine months ended September 30, 2025, selling 15,340,972 shares of common stock[71]. - During the nine months ended September 30, 2025, the company raised net proceeds of $12.9 million from selling shares and warrants in various offerings[95]. - The company plans to raise additional funds through equity offerings, debt financings, and strategic alliances, but may face challenges if adequate financing is not obtained[100]. - As of September 30, 2025, the company did not have any off-balance sheet arrangements[103]. Strategic Initiatives - Processa Pharmaceuticals is exploring options for its non-oncology drugs, which may include out-licensing or partnership opportunities[66]. - As of November 3, 2025, Processa Pharmaceuticals owned $850,000 in Digital Assets and plans to engage in capital raising transactions to purchase more Digital Assets[68].