FibroBiologics, Inc. (Nasdaq: FBLG), a clinical-stage biotechnology company with over 270 issued and pending patents, is focused on developing fibroblast-based therapeutics to address chronic diseases. Today, the company announced its financial results for the third quarter of 2025 and provided a corporate update.
Key Developments:
- CYWC628 Manufacturing Preparations: Progressing toward manufacturing fibroblast-based spheroids for a Phase 1/2 clinical trial in diabetic foot ulcer (DFU) patients, set to begin in Q1 2026.
- Psoriasis and MS INDs: Preparing to submit Investigational New Drug (IND) applications for CYPS317 (psoriasis) and CYMS101 (multiple sclerosis).
- Psoriasis Program Success: Positive IND-enabling updates demonstrated the potential of fibroblast spheroids as a novel therapeutic for chronic-relapse psoriasis.
- Bone Marrow Organoid Platform: Advanced development of this platform, offering new treatment possibilities for hematopoietic cancers and age-related immune decline.
- Patent Expansion: Filed a new patent application with the USPTO for generating multipotent cells from fibroblasts in donor tissue for clinical use.
- Thought Leadership: Published an article advocating the therapeutic advantages of fibroblast cells over stem cell therapies.
- Scientific Engagement: Presented updates on fibroblast-based therapies at key industry conferences, including the Cell & Gene Meeting on the Mesa, H.C. Wainwright 27th Annual Global Investment Conference, and the 2025 ThinkEquity Conference.
- Cost Optimization: Implemented measures to reduce operating expenses and focus resources on near-term pipeline priorities.
Upcoming Milestones:
- CYWC628 Manufacturing: Complete training runs and confirm sterility by year-end 2025, followed by cGMP manufacturing.
- DFU Clinical Trial: Launch Phase 1/2 trial in Australia for CYWC628 in Q1 2026, with trial completion expected in Q3 2026.
- Psoriasis and MS INDs: Finalize preclinical IND-enabling studies for CYPS317 and CYMS101 and submit IND applications.
CEO Perspective:
“This quarter has sharpened our focus on advancing our most promising product candidates toward the clinic,” said Pete O’Heeron, Founder and CEO of FibroBiologics. “We are demonstrating that fibroblasts can serve as a scalable platform, not just a single-asset approach. With our Phase 1/2 trial for diabetic foot ulcers set to begin early next year, we are executing on key milestones to validate the biology, technology, and regulatory path forward.”
Financial Highlights (Nine Months Ended September 30, 2025):
- R&D Expenses: $6.6 million, up from $3.1 million in 2024, driven by increased contract research costs ($0.4M), CRO costs ($2.1M), lab facilities expenses ($0.2M), personnel costs ($0.3M), and research materials/supplies ($0.5M).
- G&A Expenses: $7.4 million, up from $6.9 million in 2024, due to higher personnel costs ($0.7M), professional fees ($0.2M), and travel expenses ($0.1M), partially offset by lower Direct Listing expenses ($0.4M).
- Net Loss: $15.4 million, compared to $8.1 million in 2024, reflecting increased R&D and G&A expenses.
- Cash Position: $4.9 million in cash and cash equivalents as of September 30, 2025.
FibroBiologics remains committed to advancing its fibroblast-based platform and achieving key clinical and regulatory milestones. For additional information, visit the company’s website or contact info@fibrobiologics.com.
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