Faron Pharmaceuticals (FARN) Investor update summary

Scientific and clinical rationale

• Macrophages support 13 of 14 cancer hallmarks, making them critical targets in cancer therapy.

• CLEC-1 is highly expressed on immunosuppressive tumor-associated macrophages and malignant blasts in high-risk MDS.

• Bexmarilimab (BEX), a first-in-class anti-CLEVER-1 antibody, targets CLEC-1 to reprogram monocytes/macrophages, activate immune responses, and sensitize malignant cells to standard treatments.

• BEX shows potential to overcome treatment resistance in myeloid malignancies.

Clinical trial progress and results

• BEX combined with azacitidine achieved a 45% complete remission (CR) rate in frontline high-risk MDS, compared to 16-18% for azacitidine alone.

• Duration of CR in the frontline setting reached 12 months, a strong result for this aggressive cancer.

• In relapsed/refractory MDS, overall survival with BEX+AZA was 14.5 months, versus 5-6 months for salvage therapy.

• Safety profile of BEX+AZA is favorable, with reduced toxicity and fewer dose reductions compared to AZA alone.

• BEX has shown superior remission and survival outcomes in HR MDS compared to standard care.

Upcoming trials and milestones

• A randomized, double-blind, placebo-controlled phase IIb trial of BEX+AZA in high-risk MDS is launching, with interim data after 90 patients and final readout in November 2027.

• Multiple solid tumor trials (BLAZE, BEXAR, FINPROVE) are set to begin, targeting melanoma, lung, sarcoma, and breast cancer.

• Five investigator-initiated trials (IITs) will further validate BEX in combination regimens.

• Key milestones include trial enrollment, interim analyses, and final data readouts, with a focus on CR rate and duration as FDA-accepted endpoints.

• Enables achievement of key clinical milestones and value inflection points through November 2027.