Bicara Therapeutics (BCAX) investor relations material

Program overview and scientific differentiation

• Lead molecule ficerafusp alfa is a bifunctional EGFR-TGF-β1/3 inhibitor targeting tumor microenvironment for enhanced efficacy and immunotherapy-like response.

• Tumor-targeted approach localizes TGF-β inhibition, reducing toxicity and improving outcomes, especially in EGFR-overexpressing, immunosuppressive tumors.

• Focus is on HPV-negative recurrent/metastatic head and neck squamous cell carcinoma, a population with high unmet need and poor prognosis.

• Combination with pembrolizumab has shown tripled response rates and doubled overall survival compared to standard care.

• Activity is most pronounced in HPV-negative patients due to biological characteristics and disease etiology.

Clinical development and trial design

• Phase 2/3 trial is designed as a seamless study to meet Project Optimus and Project Front Runner requirements, with interim and confirmatory analyses.

• Enrollment is on track, with full enrollment expected by 2027, and strong investigator engagement following recent ASCO data.

• Dose selection is informed by both blinded and open-label datasets, with upcoming data from the 750mg cohort to guide decisions.

• Only HPV-negative patients are enrolled, reflecting the majority of the recurrent/metastatic population and aligning with companion diagnostic development.

• Less frequent dosing regimens (every two weeks) are being explored, with bridging studies planned to support convenience at launch.

Regulatory and commercial strategy

• Regulatory path aims for accelerated approval, with ongoing FDA dialogue and study design tailored to meet evolving agency expectations.

• Companion diagnostic for HPV status is being developed to harmonize testing and streamline patient identification.

• Addressable market is substantial, with HPV-negative cases dominating in the U.S., Europe, and Asia.

• Commercial strategy anticipates a large market with room for multiple players, and strong conviction in the EGFR bifunctional class.

• Cash runway exceeds $440 million, funding pivotal studies and key cohort expansions through confirmatory endpoints.