Financial Performance - The company has incurred net losses of $15.4 million and $8.1 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $50.9 million as of September 30, 2025[116]. - The net loss for Q3 2025 was $5.8 million, significantly higher than the $0.5 million loss in Q3 2024, reflecting an increase of 1,056%[132]. - The net loss for the nine months ended September 30, 2025, was $15.4 million, compared to $8.1 million in 2024, reflecting an increase of 90.5%[147]. - The company reported a net cash used in operating activities of $13.2 million for the nine months ended September 30, 2025, compared to $8.8 million in 2024, a 49.5% increase[163]. - The company recognized a net loss of approximately $0.9 million on the conversion of $9.7 million of convertible debt into shares of Common Stock during the nine months ended September 30, 2025[155]. - As of September 30, 2025, the company had cash and cash equivalents of $4.9 million and an accumulated deficit of $50.9 million[161]. - The company expects to continue incurring operating losses as it builds infrastructure and conducts research and development activities, raising substantial doubt about its ability to continue as a going concern[169]. Research and Development - The company expects to initiate a twelve-week Phase 1/2 clinical trial for CYWC628 in Australia in Q1 2026, with completion anticipated in Q3 2026[118]. - The company has completed IND-enabling pre-clinical studies for CYWC628, showing statistically significant acceleration in wound closure compared to a marketed product[106]. - The company plans to file an IND application for a Phase 1/2 clinical trial for CYMS101 in the U.S. in Q4 2025, following a successful Phase 1 study in Mexico[107]. - The company has completed two animal studies for CybroCell™, supporting its IND application for a "first in human" trial[108]. - The company expects research and development expenses to increase substantially as it advances product candidates into later clinical stages[124]. - Research and development expenses increased to $2.8 million for the three months ended September 30, 2025, up from $1.2 million in 2024, representing a 130% increase[133]. - For the nine months ended September 30, 2025, research and development expenses totaled $6.6 million, up from $3.1 million in 2024, a 111% increase[148]. Operating Expenses - General, administrative and other expenses rose to $2.2 million in Q3 2025 from $2.1 million in Q3 2024, a 4.7% increase attributed to added personnel costs[134]. - Total operating expenses for Q3 2025 were $5.0 million, compared to $3.4 million in Q3 2024, marking a 50.3% increase[132]. - Total operating expenses for the nine months ended September 30, 2025, were $14.1 million, compared to $10.0 million in 2024, an increase of 40.5%[147]. Funding and Capital Requirements - The company has funded operations through $15.0 million in convertible promissory notes, $18.6 million in preferred stock, and $10.4 million from common stock sales[113]. - The company anticipates needing substantial additional funding to support ongoing operations and growth strategy[117]. - Future funding requirements will depend on various factors, including the progress and costs of clinical trials and regulatory requirements[170]. - The company may seek additional capital through public or private equity offerings, debt financings, collaborations, and licensing arrangements, which may involve relinquishing certain rights[169]. Cash Flow - Net cash used in operating activities was $13.2 million for the nine months ended September 30, 2025, compared to $8.8 million for the same period in 2024, primarily due to net losses of $15.4 million and $8.1 million, respectively[165]. - Net cash used in investing activities was $0.3 million for the nine months ended September 30, 2025, compared to $0.1 million in 2024, mainly for laboratory equipment purchases[166]. - Net cash provided by financing activities was $4.4 million for the nine months ended September 30, 2025, down from $7.6 million in 2024, with a principal balance of $5.0 million in short-term convertible debt issued[167]. Operational Risks - The company is subject to risks related to the development of new product candidates, which may lead to unforeseen expenses and operational needs[171]. - Material cash requirements and contractual obligations are related to office and lab rent[172]. - The company has implemented measures to reduce operating expenses, including delaying certain research and development projects and limiting administrative costs[169].
FibroBiologics(FBLG) - 2025 Q3 - Quarterly Report