FibroBiologics (FBLG) investor relations material

Strategic platform and clinical progress

• Advancing a differentiated fibroblast-based cell therapy platform targeting chronic diseases, leveraging fibroblasts' unique regenerative and immune-modulating properties across multiple indications.

• Lead clinical program CYWC628 for diabetic foot ulcers is enrolling and dosing patients in a phase I/II trial, with interim six-week data expected before year-end.

• IND filed for psoriasis program (CYPS317), with preclinical data showing significant and durable disease reduction in animal models; IND for multiple sclerosis program (CYMS101) planned by year-end.

• Over 270 issued and pending patents protect the platform, supporting a broad pipeline in wound care, autoimmune, regenerative, and oncology indications.

• Platform enables rapid, cost-effective expansion into new indications, with each program building on shared knowledge and manufacturing capabilities.

Clinical trial design and milestones

• Diabetic foot ulcer trial is a randomized, controlled study with up to 120 patients, testing standard of care versus low and high doses of CYWC628, focusing on safety, wound closure, and area reduction.

• Six-week interim data will inform potential for a single pivotal trial and possible BLA submission, leveraging new FDA guidance.

• Psoriasis program uses allogeneic dermal fibroblasts to restore immune homeostasis, targeting multiple cytokines simultaneously for durable benefit.

• Key upcoming milestones: interim wound care data, IND approval for psoriasis, and completion of IND-enabling studies for thymic involution/longevity program.

Competitive differentiation and scalability

• Fibroblasts offer advantages over stem cells: easier sourcing, lower manufacturing costs, stable differentiation, and scalable production.

• Spheroid delivery platform enhances cell viability, efficacy, and duration of therapeutic effect compared to single-cell or stem cell approaches.

• Patented spheroid technology reduces immunogenicity and supports both topical and intravenous administration.

• Cold chain logistics enable global shipment and long-term storage of fibroblast spheroids.

• Plans to bring manufacturing in-house to support scaling for commercialization.