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FibroBiologics (FBLG) investor relations material

FibroBiologics Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary31 Oct, 2025

Executive summary

  • Focused on developing fibroblast-based therapies for chronic diseases, with lead candidates in wound healing, multiple sclerosis, degenerative disc disease, and psoriasis.

  • Advanced preparations for manufacturing CYWC628, with Phase 1/2 clinical trial for diabetic foot ulcers set to begin in Q1 2026 and complete in Q3 2026, pending resolution of manufacturing process issues.

  • Preparing to submit IND applications for CYPS317 (psoriasis) and CYMS101 (multiple sclerosis) following completion of preclinical studies.

  • No revenue generated to date; operations funded through equity, convertible notes, and preferred stock sales.

  • Net losses continue as R&D and administrative expenses rise, with substantial additional funding required for ongoing operations and clinical development.

Financial highlights

  • Net loss of $15.4 million for the nine months ended September 30, 2025, compared to $8.1 million for the same period in 2024.

  • Research and development expenses rose to $6.6 million for the nine months, up from $3.1 million year-over-year, driven by increased contract research, CRO, lab, and personnel costs.

  • General and administrative expenses increased to $7.4 million from $6.9 million year-over-year, mainly due to higher personnel and professional fees.

  • Cash and cash equivalents were $4.9 million as of September 30, 2025, down from $14.0 million at December 31, 2024.

  • Accumulated deficit reached $50.9 million as of September 30, 2025.

Outlook and guidance

  • Plans to initiate a Phase 1/2 clinical trial for CYWC628 in Australia in Q1 2026, with completion expected in Q3 2026, pending manufacturing process resolution.

  • IND submissions for CYPS317 and CYMS101 anticipated after completion of preclinical studies.

  • Ongoing need for substantial additional capital; management has implemented cost controls and is prioritizing near-term projects.

  • No expectation of product revenue in the near term; continued operating losses anticipated.

  • Manufacturing training runs and sterility confirmation for CYWC628 expected by end of 2025, with cGMP-compliant manufacturing to follow.

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Frequently asked questions

FibroBiologics Inc. is a biotechnology company that specializes in regenerative medicine and cell therapy. The company is focused on developing innovative treatments and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds over 150 U.S. and international patents and patents pending, covering various clinical pathways including orthopedics, multiple sclerosis, psoriasis, wound healing, and cancer. The company is headquartered in Houston, Texas, and its shares are listed on the NASDAQ.

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