Bicara Therapeutics (BCAX) Corporate presentation summary

Strategic focus and clinical development

• Advancing a bifunctional antibody, ficerafusp alfa (FICERA), targeting EGFR and trapping TGF-β, with a focus on HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

• FICERA is the first and only EGFR-directed antibody bound to a TGF-β ligand trap, designed for deep tumor penetration and durable responses.

• Clinical development includes pivotal Phase 3 FORTIFI-HN01 trial and exploration of alternate dosing regimens for patient convenience.

• Expansion into other solid tumors with EGFR x TGF-β biological fingerprint, including metastatic colorectal cancer (mCRC).

Clinical efficacy and safety

• FICERA plus pembrolizumab in 1L 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, with rapid and durable tumor shrinkage observed.

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

• Alternate dosing (2000mg Q2W) maintained efficacy and safety, supporting less frequent dosing options.

Market opportunity and commercial strategy

• HPV-negative HNSCC represents a large, underserved market with over 50,000 patients annually in the US, EU5, and Japan, and a projected global market exceeding $5B by 2030.

• FICERA has potential to double or triple response rates, duration of response, and survival compared to current standard of care.

• Commercial preparations underway, including key hires and readiness for launch.