FibroBiologics (FBLG) investor relations material

Platform and pipeline

• Fibroblasts are presented as a scalable, allogeneic platform for tissue repair and immune modulation, with accessible sourcing, disease-specific cell subtypes and spheroid delivery.

• The platform is protected by more than 270 issued and pending patents, including coverage for fibroblasts and derived materials such as microvesicles, proteins and secretions.

• Pipeline spans diabetic wound care, psoriasis, multiple sclerosis, thymic function, degenerative disc disease, diabetes and cancer immunotherapy.

• Management cited animal-model evidence for remyelination in MS, reduced inflammation and cartilage repair in disc disease, and potential immune restoration in psoriasis.

Clinical and preclinical progress

• CYWC628 phase I/II DFU trial is enrolling and dosing; up to 120 patients are randomized across standard care, low-dose and high-dose arms, with weekly treatment for up to 12 weeks and six-month follow-up.

• Six-week interim data on wound-area reduction is expected before year-end; recruitment was described as encouraging, with sufficient enrollment expected for the interim analysis.

• In animal models, fibroblast spheroids achieved 83.8% average wound closure by day 19 versus 66% for GRAFIX; results were statistically significant versus control at every dose and versus GRAFIX at the third and fourth doses.

• Psoriasis IND has been filed and awaits FDA clearance; one administration reduced disease-severity scores 67% in the first relapse and 39% in the second in an animal model, both statistically significant.

• CYMS101 MS IND filing is planned before year-end; thymic involution remains preclinical, with IND-enabling studies in progress.

Regulatory path and milestones

• Depending on six-week DFU results, management may request an FDA Type B meeting to assess proceeding to a BLA without phase III; the potential route remains conditional on results and FDA feedback.

• Management identified DFU interim results as the nearest catalyst, followed by psoriasis IND clearance and completion of thymic-program IND-enabling studies toward year-end and early next year.

• Management said increased partnership discussions are expected after interim data and expressed interest in licensing, collaboration or co-development opportunities.