Financial Performance - The company reported an operating loss of $6.4 million for the nine months ended September 30, 2025, compared to a loss of $5.3 million for the same period in 2024, indicating an increase in losses year-over-year [147]. - For the three months ended September 30, 2025, net loss was $4.6 million, compared to a net income of $1.4 million for the same period in 2024, representing a decrease of $5.98 million [168]. - The net loss for the nine months ended September 30, 2025 was $15.9 million, compared to a net loss of $8.5 million in the same period of 2024 [193][194]. - Other income for the three months ended September 30, 2025, was $1.8 million, down from $6.7 million in 2024, a decrease of $4.9 million [175]. Cash and Financing - As of September 30, 2025, the company had an accumulated deficit of $60.2 million and $8.6 million in cash and cash equivalents, raising concerns about its ability to continue as a going concern [148]. - The company had $8.6 million in cash and cash equivalents, with significant reliance on financing from stock issuances and convertible notes [178]. - The company entered into a Securities Purchase Agreement resulting in net proceeds of $4.9 million from the issuance of Series A Convertible Preferred Stock [179]. - The company has an at-the-market offering program with a potential aggregate offering price of up to $13.3 million, having sold 385,851 shares at an average price of $5.96, resulting in net proceeds of $2.2 million [181]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $16.9 million, an increase of 107.0% from $8.2 million in 2024 [195][196]. - The financing activities in 2025 included $4.9 million from the issuance of common stock to Juvenescence and $4.9 million from a securities purchase agreement [195]. Research and Development - The company expects to incur substantial expenditures for the development of its product candidates and anticipates that research and development expenses will continue to increase significantly [149]. - The company has not yet had any products approved for sale and does not expect to generate product sales until regulatory approval is obtained for its product candidates [150]. - The company announced a clinical hold on its IND application for SER-252, its lead development program for advanced Parkinson's disease, due to the FDA's request for additional information [162]. - The company plans to advance SER 252 into Phase I clinical trials and further invest in its pipeline, including hiring additional personnel to support development efforts [155]. - Research and development expenses are expected to increase substantially as the company continues to invest in clinical trials and other development activities [158]. - Research and development expenses increased to $3.6 million for the three months ended September 30, 2025, up from $2.4 million in 2024, marking a $1.2 million increase [170]. Operating Expenses - Total operating expenses for the nine months ended September 30, 2025, were $17.9 million, compared to $11.6 million for the same period in 2024, an increase of $6.4 million [174]. - General and administrative expenses are projected to rise over the next several years to support ongoing research and development, manufacturing activities, and compliance with public company regulations [164]. - General and administrative expenses decreased to $2.7 million for the three months ended September 30, 2025, from $2.9 million in 2024, a net decrease of $0.2 million [173]. Risks and Uncertainties - The company faces numerous risks and uncertainties in product development, including the potential need for additional clinical trials and the unpredictability of regulatory approvals [162]. - The accumulated deficit as of September 30, 2025, was $60.2 million, raising substantial doubt about the company's ability to continue as a going concern [186].
Serina Therapeutics, Inc.(SER) - 2025 Q3 - Quarterly Report