FibroBiologics (FBLG) Q4 2025 earnings summary

Executive summary

• Secured HREC approvals in Australia for a Phase 1/2 trial of CYWC628 in diabetic foot ulcers, enabling enrollment of 120 patients at up to 10 sites.

• Filed IND with FDA for CYPS317 in psoriasis and expanded patent portfolio for orthopedic and musculoskeletal therapies.

• Raised $7.2M through direct offerings and repaid all outstanding debt.

• Received Nasdaq extension to regain compliance for continued listing.

Financial highlights

• Research and development expenses rose to $7.4M for 2025, up from $4.5M in 2024, mainly due to higher CRO, lab, and personnel costs.

• General and administrative expenses remained flat at $9.2M year-over-year, with shifts in personnel, professional fees, and reduced offering and insurance expenses.

• Net loss increased to $18.6M for 2025 from $11.2M in 2024, driven by higher R&D and G&A expenses.

• Cash and cash equivalents were $4.9M at year-end 2025.

Outlook and guidance

• Plans to complete manufacturing and site enrollment for CYWC628 in Q1 2026, dose first patient and report interim results in H1 2026, and report final results by year-end 2026.

• Expects IND clearance for CYPS317 in psoriasis and to submit IND for CYMS101 in multiple sclerosis in H1 2026.

• Plans to amend IND for degenerative disc disease by end of 2026.