FibroBiologics, Inc. (Nasdaq: FBLG) reported financial results for the first quarter ended March 31, 2026, and provided a corporate update on its clinical and preclinical pipeline.
Clinical progress and corporate updates
The company said it remains on track for first patient dosing in a phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers in the second quarter of 2026.
Recent highlights
- Completed manufacturing of the first two batches of CYWC628 drug product in accordance with FDA Good Manufacturing Practices (cGMP) for the phase 1/2 trial for diabetic foot ulcers (DFUs).
- Completed site onboarding for the phase 1/2 CYWC628 trial.
- Reported positive preclinical results for its burn program using proprietary fibroblast spheroid technology, including increases in a cytokine associated with tissue repair and wound healing and a significant reduction in a cytokine linked to inflammation in burn wounds.
- Announced positive preclinical results for a fibroblast spheroid-derived chondrocyte spheroid therapy for degenerative disc disease, showing significant improvement in recovering intervertebral disc integrity versus single-cell fibroblasts and fibroblast spheroids in animal models.
- Raised $3 million through a direct offering.
- Regained compliance with all Nasdaq listing requirements.
- Expanded its patent portfolio with a U.S. patent covering fibroblast cell therapy for osteoporosis and a Canadian patent covering a novel fibroblast-based treatment for cachexia.
- Presented pipeline updates on fibroblast-based therapies at the 9th Annual BFC Global Healthcare Business Development and Investment Conference, DealFlow Discovery Conference, and BIO Investment & Growth Summit.
Upcoming milestones
Wound healing (CYWC628 for DFUs)
- GMP batch 1 clinical drug product release and shipping to Australia.
- Dose first patient in the second quarter of 2026.
- Report interim results in the third quarter of 2026.
- Complete and report primary safety and efficacy results by the end of 2026.
Psoriasis (CYPS317)
- Receive IND clearance for CYPS317 in the third quarter of 2026.
Multiple sclerosis (CYMS101)
- Submit an IND application with the FDA for CYMS101 in the second half of 2026.
Degenerative disc disease
- Amend the IND clearance with the FDA to replace single-cell fibroblasts with fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank by the end of 2026.
CEO commentary
CEO and Founder Pete O’Heeron said the company made progress during the first quarter, including completing cGMP manufacturing of the first CYWC628 batch and site onboarding to support first patient dosing in the second quarter. He added that the company continued building momentum across its pipeline, citing positive preclinical data in burn and degenerative disc disease programs, and said it strengthened its cash position with additional capital. He noted the company’s focus moving forward on initiating its clinical study, generating meaningful data, and advancing programs in psoriasis and multiple sclerosis.
Financial highlights for the quarter ended March 31, 2026
- Research and development (R&D) expenses: approximately $3.0 million for the three months ended March 31, 2026, compared with approximately $1.8 million for the same period in 2025. The increase was primarily attributed to increased CRO costs of $1.8 million to prepare for a clinical trial, partially offset by decreased contract research costs of $0.3 million and decreased supplies expenses of $0.3 million.
- General and administrative (G&A) expenses: approximately $2.1 million for the three months ended March 31, 2026, compared with approximately $2.8 million for the same period in 2025. The net change reflected decreased personnel expenses of $0.2 million, decreased professional fees of $0.4 million for accounting, legal and marketing expenses, decreased travel expenses of $0.1 million, and increased listing expenses of $0.1 million.
- Net loss: approximately $5.0 million for the three months ended March 31, 2026, primarily driven by R&D and G&A expenses.
- Cash position: cash and cash equivalents totaled approximately $1.5 million at March 31, 2026. Subsequent to March 31, 2026, the company raised approximately $2.5 million net in a registered direct offering.
