Bicara Therapeutics (BCAX) investor relations material

Company overview and lead program

• Focuses on large molecules and bifunctional antibodies for solid tumor oncology, with lead program ficerafusp alfa targeting EGFR and TGF-β.

• Founded in 2020, based in Boston, and has grown rapidly post-2024 IPO to about 100 employees.

• Aims to use tumor targeting to deliver TGF-β directly to tumors, addressing previous limitations in the field.

Clinical development and differentiation

• Lead indication is head and neck cancer, chosen due to strong EGFR and TGF-β roles and high unmet need.

• Achieved a 21% complete response rate in head and neck cancer, considered unprecedented.

• Differentiates from competitors by focusing on HPV-negative patients, where efficacy is higher.

• Median duration of response exceeds 21 months, with median overall survival approaching 22 months.

Competitive landscape and trial design

• Competing assets include Genmab's petosemtamab and J&J's EGFR/c-Met bispecifics, with differences in secondary targets and trial populations.

• Pivotal phase III trial randomizes 2:1 to ficerafusp alfa plus pembro vs. pembro monotherapy, focusing on HPV-negative patients.

• Top-line data expected mid-2025, with substantial enrollment by end of 2024.