Improved balance sheet through multiple direct offerings; completed payments of outstanding debt
HOUSTON, Feb. 24, 2026 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (NASDAQ:FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced full year 2025 financial results and provided a corporate update.
Recent Highlights
Secured both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial evaluating CYWC628 for the treatment of refractory diabetic foot ulcers (DFU), enabling the enrollment of 120 patients at up to 10 sites across Australia.
Filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) to advance the clinical development of CYPS317 in patients with psoriasis.
Raised a total of $7.2M through multiple direct offerings.
Repaid all outstanding debt.
Expanded the patent portfolio with the filing of a patent application with the U.S. Patent and Trademark Office (USPTO) covering a proprietary fibroblast-derived therapy platform for use in orthopedic and musculoskeletal conditions, including degenerative disc repair, cartilage repair, and joint restoration.
Presented recent updates on fibroblast-based therapies for chronic disease treatments at the 2025 ThinkEquity and Bio-Europe conferences.
Received a favorable determination from a Nasdaq Hearings Panel granting an extension to regain compliance for the continued listing of the Company's common stock on The Nasdaq Capital Market.
Upcoming Milestones
Wound Healing: Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients
Complete manufacturing of CYWC628 drug product in accordance with FDA Good Manufacturing Practices (cGMP) in Q1 2026.
Complete enrollment of up to 10 clinical sites in Q1 2026.
Dose first patient in the first half of 2026.
Report interim results in the first half of 2026.
Complete and report final results by the end of 2026.
Psoriasis
Receive IND clearance for the treatment of psoriasis with CYPS317, the Company's fibroblast spheroid product candidate, in the first half of 2026.
Multiple Sclerosis
Submit an IND application with the FDA for the treatment of multiple sclerosis with FibroBiologics' fibroblast spheroid product candidate, CYMS101, in the first half of 2026.
Degenerative ...
