Bicara Therapeutics (BCAX) Stifel 2024 Healthcare Conference summary

Company overview and strategy

• Focuses on targeted tumor modulation, developing molecules that combine tumor targeting with direct modulation of the tumor microenvironment for improved efficacy and tolerability.

• Lead program, ficerafusp alfa, is an EGFR-directed antibody with a TGF-β ligand trap, aiming to enhance response rates and durability in difficult-to-treat cancers.

• Well-capitalized with over $520 million in cash, funding operations into the first half of 2029.

Clinical data and development plans

• Phase IB data in frontline head and neck cancer (HPV-negative) showed response rates nearly triple those of standard Pembro monotherapy, with a 64% overall response rate and 18% complete response rate.

• Median progression-free survival (PFS) reached 9.8–10 months, significantly exceeding historical controls.

• Safety profile is favorable, with manageable EGFR-related rash and low-grade mucosal bleeds, and no treatment-related deaths.

• Expansion cohorts are ongoing in other squamous cell carcinomas, including cutaneous and colorectal cancers.

Regulatory and trial design updates

• Alignment reached with FDA on registrational trial (FORTIFY-HN01), a double-blind, placebo-controlled study comparing ficerafusp plus Pembro to Pembro alone, with response rate as the primary endpoint and overall survival as confirmatory.

• Sample size reduced from 750 to about 650 based on updated dropout rate assumptions, with no change to statistical powering.

• Interim analysis will focus on response rate with six months durability, and descriptive overall survival analysis at accelerated approval decision.