Financial Performance - The company reported an operating loss of $12.1 million for the year ended December 31, 2024, compared to an operating loss of $11.5 million in 2023, reflecting an increase in research and development costs [343]. - The company had no revenue during the years ended December 31, 2024 and 2023, with no immediate sales prospects [344]. - The company has an accumulated deficit of approximately $87.2 million as of December 31, 2024, with a net loss of approximately $11.9 million for the year [355]. Research and Development - Research and development expenses increased by approximately $1.5 million to $7.3 million in 2024, primarily due to ongoing testing and related expenses for the Phase 1B trial for NGC-Cap [346]. - The company is focused on developing drugs that improve patient survival and quality of life while providing a more efficient path to FDA approval [335]. - The company is exploring options for PCS12852, a potential treatment for diabetic gastroparesis, which has a global prevalence of over 30 million [338]. - The company has recorded $1.3 million in prepaid expenses for advanced payments made to CROs and other vendors for the NGC-Cap Phase 2 clinical trial [350]. Cash Flow and Financing - Net cash used in operating activities increased to $11,245,042 in 2024 from $8,063,346 in 2023, primarily due to higher costs associated with clinical trials and payroll expenses [361]. - Net cash provided by financing activities amounted to $7,733,414 in 2024, up from $6,268,724 in 2023, driven by the sale of common stock and warrants [359]. - The company raised gross proceeds of $5.0 million from a public offering on January 27, 2025, with net proceeds of $4.5 million intended for research and development and general corporate purposes [340]. - The company raised net proceeds of $6.3 million from a public offering in 2024, selling 476,000 shares of common stock [364]. - The company plans to continue pursuing financing alternatives to support its clinical trials and operational plans, with no assurance of obtaining necessary funding in the future [355]. - The company has an effective shelf registration statement on file with the SEC, allowing for potential future capital raises [358]. Expenses and Obligations - General and administrative expenses decreased by approximately $875,000 to $4.8 million in 2024, mainly due to a reduction in professional fees [351]. - Total contractual obligations at December 31, 2024, were $77,432, primarily related to operating lease obligations [365]. - As of December 31, 2024, the company had prepaid expenses of approximately $1.8 million related to advanced payments for clinical trials [362]. Future Outlook - The company anticipates ongoing negative cash flows from operating activities as it continues its Phase 2 trial for NGC-Cap and evaluates other drugs in its portfolio [361]. - The increase in cash used in operating activities was attributed to costs related to closing Phase 1B and commencing Phase 2 trials for NGC-Cap [361]. - The company has not recorded any unrecognized tax benefits as of December 31, 2024, and does not expect significant changes in the next twelve months [379].
Processa Pharmaceuticals(PCSA) - 2024 Q4 - Annual Report