Bicara Therapeutics (BCAX) TD Cowen 46th Annual Health Care Conference summary

Strategic program updates and clinical development

• Lead program FICERA targets EGFR and TGF-beta, overcoming prior delivery limitations to the tumor microenvironment.

• FORTIFY trial in HPV-negative recurrent metastatic head and neck cancer is progressing, with global site expansion and strong enrollment momentum.

• FDA alignment achieved for 1,500 mg weekly dose; phase III component underway with 2:1 randomization versus pembrolizumab monotherapy.

• Commercial infrastructure buildout planned for 2026, with launch targeted for 2028.

• Additional capital raised to support commercial build and critical hires.

Clinical data highlights and efficacy

• FICERA shows a confirmed overall response rate of 54%, with 21% complete response and rapid median time to response of 1.4 months.

• High response rates observed across all CPS scores and tumor sizes, with a median duration of response of 21.7 months.

• Depth and durability of response increase with higher doses, with 2,000 mg every two weeks showing median depth of 100%.

• Tolerability profile includes expected EGFR and TGF-beta related adverse events, such as acneiform rash and transient mucosal bleeds.

• Maintenance dosing phase planned to synchronize with pembrolizumab every three weeks.

Regulatory and competitive landscape

• FDA supports 1,500 mg dose selection, granting Breakthrough designation based on open-label data.

• Accelerated approval filing will require doubling control arm response rate; confidence in meeting FDA thresholds based on pooled data.

• Overall survival benefit expected, with trial powered for a clinically meaningful two to three-month increase.

• Competitive landscape includes amivantamab and other regimens, but FICERA aims to differentiate on efficacy, safety, and dosing convenience.