Bicara Therapeutics (BCAX) investor relations material

Key accomplishments and clinical progress in 2025

• Achieved significant clinical milestones for ficerafusp alfa in HPV-negative recurrent and metastatic head and neck cancer, including two data sets showing deep, durable responses and meaningful overall survival benefits compared to standard of care.

• Received FDA breakthrough designation for ficerafusp alfa in HPV-negative head and neck cancer, recognizing the distinct clinical subtype and high unmet need.

• Initiated the pivotal FORTIFY-HNS study as a seamless phase II/III trial for potential accelerated approval in the frontline setting.

• Selected the 1,500 mg dose for phase III after positive FDA interaction and robust clinical data, accelerating the study timeline.

• Presented long-term follow-up data at ASCO 2025, showing a confirmed response rate of 54%, deep tumor shrinkage, and a median overall survival greater than 21 months.

Strategic outlook and growth drivers for 2026 and beyond

• Focused on executing the pivotal study in head and neck cancer, aiming for substantial enrollment by year-end and interim analysis by mid-2027.

• Preparing for commercial success with key hires, including a chief commercial officer, and building a commercial framework for an anticipated early 2028 launch.

• Expanding ficerafusp alfa's potential into other solid tumors, including metastatic colorectal and pancreatic cancers, following the EGFR TGF-β biological fingerprint.

• Maintaining financial discipline while exploring new indications and pipeline opportunities.

• Cash runway exceeds $400 million, fully funding the pivotal study through its confirmatory endpoint.

Differentiation and market opportunity

• Ficerafusp alfa uniquely combines EGFR targeting with TGF-β inhibition, driving both deep and durable responses, unlike prior combinations that traded response rate for durability.

• Demonstrated more than a tripling in response rates and a twofold increase in median overall survival compared to standard of care.

• The head and neck cancer market is projected to exceed $5 billion by 2030, with ficerafusp alfa positioned to achieve blockbuster status.

• Global strategy prioritizes early U.S. launch via accelerated approval, with subsequent expansion to ex-U.S. markets where HPV-negative prevalence is even higher.

• Strong conviction in expanding the addressable patient population and duration of response, exponentially growing the market opportunity.