FibroBiologics Reports $18.6 Million Net Loss and Advances Clinical Pipeline in 2025

FibroBiologics Inc., a clinical-stage biotechnology company, reported a net loss of $18.6 million for the year ended December 31, 2025, compared to a net loss of $11.2 million for the previous year. The company, which focuses on developing fibroblast-based therapies for chronic diseases, has not generated any revenue from product sales to date. Research and development expenses increased to $7.4 million in 2025 from $4.5 million in 2024, driven by higher drug product, CRO expenses, personnel costs, research facility costs, and depreciation. General, administrative, and other expenses remained relatively stable at $9.2 million for both years.

The company's financial performance was also impacted by changes in the fair value of various financial instruments. A loss of $1.8 million was recorded for the change in fair value of convertible debt, compared to a gain of $0.2 million in the prior year. The change in fair value of the SEPA put option liability resulted in a gain of $0.4 million in 2025, versus a loss of $0.5 million in 2024. Interest expense increased to $0.2 million in 2025 from approximately $20,000 in 2024 due to the payoff of convertible notes. The company's cash and cash equivalents decreased from $14.0 million at the end of 2024 to $4.9 million at the end of 2025.

Operationally, FibroBiologics has advanced its pipeline of product candidates. The company filed a Phase 1/2 Investigational New Drug (IND) application with the FDA for CYPS317, a therapy for psoriasis. It is also planning to initiate a Phase 1/2 clinical trial in Australia for CYWC628, a wound healing treatment, in the first quarter of 2026. The company completed a Phase 1 study in Mexico for CYMS101, a treatment for multiple sclerosis, and plans to file an IND application for a Phase 1/2 clinical trial in the United States in the first half of 2026. The company also received IND clearance from the FDA for CybroCellTM, a treatment for degenerative disc disease, conditional upon approval of its master cell bank.

FibroBiologics is actively expanding its intellectual property portfolio, owning 124 issued patents and 175 pending patent applications as of December 31, 2025. The company's strategy involves prioritizing clinical development efforts on product candidates with significant unmet treatment needs, partnering with Clinical Research Organizations (CROs), attracting and retaining scientists, investing in critical capabilities for fibroblast production, and protecting its intellectual property. However, the company identified a material weakness in its internal controls over financial reporting due to a lack of segregation of duties. Management is implementing initiatives to improve internal controls, but there is no assurance that these efforts will be successful. The company's auditors have expressed substantial doubt about its ability to continue as a going concern, contingent upon raising capital to maintain operations and continue research and development efforts.