Bicara Therapeutics (BCAX) Corporate presentation summary

Strategic focus and clinical development

• Advancing bifunctional antibodies targeting EGFR and TGF-β, with lead candidate ficerafusp alfa (FICERA) positioned for blockbuster potential in first-line recurrent/metastatic HPV-negative head and neck squamous cell carcinoma (HNSCC).

• FICERA is the first and only EGFR-directed antibody bound to a TGF-β ligand trap, designed to enhance tumor penetration and overcome resistance.

• Pivotal Phase 3 FORTIFI-HN01 trial is underway, with substantial enrollment targeted by end of 2026 and interim analysis expected mid-2027.

• Expansion into additional solid tumors with EGFR × TGF-β biological fingerprint, including metastatic colorectal cancer (mCRC), is ongoing.

Clinical efficacy and safety data

• FICERA 1500 mg QW plus pembrolizumab in HPV-negative HNSCC showed a confirmed ORR of 54%, deep responses in 80% of responders, and a median OS of 21.3 months.

• Median duration of response reached 21.7 months, more than tripling standard of care outcomes.

• Safety profile is generally well-tolerated, with most adverse events being mild to moderate and no treatment-related deaths.

• Alternate dosing (2000 mg Q2W) demonstrated similar efficacy and safety, supporting less frequent dosing regimens.

Market opportunity and commercialization

• FICERA targets a $5B+ global HNSCC market, with ~50,000 annual HPV-negative HNSCC patients in the US, EU5, and Japan.

• Proven clinical data more than doubles median overall survival in HPV-negative patients compared to standard of care.

• Commercial readiness includes key hires and preparation for potential US launch, with regulatory alignment on dosing strategies.