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) in first-line recurrent/metastatic HPV-negative HNSCC, aiming for blockbuster potential and expansion into other solid tumors like mCRC.

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

• Pivotal FORTIFI-HN01 Phase 3 trial is ongoing, with interim analysis expected mid-2027 and potential U.S. launch in 2028.

• Alternate dosing regimens are being explored to enhance patient convenience and maintain efficacy, with a new study planned for Q3 2026.

Clinical efficacy and safety data

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

• Median duration of response reached 21.7 months, significantly exceeding standard of care.

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

• Higher, less frequent dosing (2000mg Q2W) demonstrated similar efficacy and safety, supporting alternate dosing strategies.

Market opportunity and expansion

• Projected global HNSCC market exceeds $5B by 2030, with ~50,000 annual HPV-negative HNSCC cases in the US, EU5, and Japan.

• FICERA has potential to double median overall survival and expand the market by increasing response rates and duration.

• Additional expansion opportunities include earlier-line settings, CPS<1, HPV-positive smokers, and rapidly recurrent disease.

• FICERA is also being evaluated in metastatic colorectal cancer, targeting both anti-EGFR and anti-angiogenic pathways.