Preparing to submit Investigational New Drug applications for the treatment of psoriasis with CYPS317 and the treatment of multiple sclerosis with CYMS101
HOUSTON, Oct. 31, 2025 (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 third quarter 2025 financial results and provided a corporate update.
Recent Highlights
Announced positive IND-enabling updates from the psoriasis research program demonstrating the potential of human dermal fibroblast spheroids as a novel therapeutic approach for chronic-relapse psoriasis.
Advanced the Bone Marrow Organoid platform, offering promising new treatment options for hematopoietic cancers and age-related immune decline.
Filed patent application with the United States Patent and Trademark Office covering methods of generating multipotent cells from fibroblasts found in donor tissue for clinical applications.
Published a leadership-authored article in the Opinion Pages presenting the scientific case for fibroblast cells' therapeutic advantages compared to stem cell therapies.
Presented recent updates on fibroblast-based therapies for chronic disease treatments at the Cell & Gene Meeting on the Mesa, H.C. Wainwright 27th Annual Global Investment Conference, and the 2025 ThinkEquity Conference.
Implemented cost efficient measures to reduce operating expenses and focus resources on near-term pipeline priorities.
Upcoming Milestones
Complete manufacturing training runs for CYWC628 and confirm sterility of the manufacturing process by the end of 2025.
Complete the manufacturing of CYWC628 in accordance with FDA Good Manufacturing Practices (cGMP).
Initiate Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in diabetic foot ulcers (DFU) patients in the first quarter of 2026.
Complete Phase 1/2 clinical trial in Australia in DFU patients in the third quarter of 2026.
Complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317, FibroBiologics' fibroblast spheroid product candidate, and submit IND.
Complete pre-clinical IND-enabling studies for the treatment of multiple sclerosis with CYMS101, FibroBiologics' fibroblast spheroid product candidate, and submit IND.
"This quarter brought our strategy into greater focus," said Pete O'Heeron, Founder and Chief Executive Officer of FibroBiologics. "We are efficiently moving ...
