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Palatin Technologies(PTN) - 2025 Q3 - Quarterly Report

Revenue and Sales - For the nine months ended March 31, 2025, the company recognized $0 in product revenue, a decrease from $4,140,090 for the same period in 2024 due to the sale of worldwide rights to Vyleesi[152]. - The company reported a gain of $2,500,000 on the sale of Vyleesi for the nine months ended March 31, 2025, compared to a gain of $7,798,280 for the same period in 2024[159]. - The company has no recurring source of revenue following the sale of worldwide rights to Vyleesi[171]. Research and Development - Research and development expenses for the nine months ended March 31, 2025, were $12,928,391, down from $17,728,516 in the prior year, primarily due to reduced spending on MCr programs[154]. - The Phase 2 clinical trial for PL8177, an oral peptide formulation for ulcerative colitis, reported that one-third of patients achieved clinical remission, while the placebo group saw no clinical remission[143]. - The company plans to file an IND for a novel once-weekly peptide MC4R agonist in 2025, with CMC activities expected to be completed in the first quarter of 2025[145]. - The company intends to utilize existing capital resources for general corporate purposes and working capital, including preclinical and clinical development of its MC1r and MC4r programs[170]. Financial Performance - Selling, general and administrative expenses decreased to $5,176,794 for the nine months ended March 31, 2025, from $8,266,267 in the prior year, due to the elimination of selling expenses related to Vyleesi[158]. - Net cash used in operating activities was $17,217,595 for the nine months ended March 31, 2025, a decrease from $24,988,985 in the prior year, attributed to a reduction in net loss and working capital changes[164]. - For the nine months ended March 31, 2025, net cash provided by investing activities was $2,500,000, a decrease from $12,455,275 for the same period in 2024[165]. - Net cash provided by financing activities for the nine months ended March 31, 2025, was $7,710,261, down from $14,558,216 in the prior year[166]. Liquidity and Funding - As of March 31, 2025, the company had cash and cash equivalents of $2,520,062 and current liabilities of $10,048,349, indicating a significant liquidity challenge[168]. - The company has incurred cumulative negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern for the next year[171]. - Additional funding will be required to complete clinical trials and regulatory submissions, with current economic conditions posing risks to financial stability and capital access[172]. - The company is evaluating strategies for obtaining additional funding, including equity financing and cost reductions, to sustain operations[171]. - The existing cash and cash equivalents are expected to fund operations into the second half of calendar year 2025, contingent on successful funding efforts[171]. Strategic Partnerships - The company is actively engaged in discussions with potential partners for ocular conditions to progress product development and commercialization[143]. - The company aims to maintain strategic alliances and partnerships to facilitate the development and commercialization of its product candidates[146].