Bicara Therapeutics (BCAX) Corporate presentation summary

Strategic focus and pipeline overview

• Developing bifunctional antibodies targeting tumor microenvironment, with lead candidate ficerafusp alfa (FICERA) showing potential in HPV-negative head and neck squamous cell carcinoma (HNSCC).

• FICERA is the first EGFR-directed antibody bound to a TGF-β ligand trap, designed for deep tumor penetration and durable responses.

• Exploring FICERA's application in additional solid tumors with EGFR x TGF-β biological signatures.

• Strong cash position of $497.3 million expected to fund operations into 1H 2029.

Clinical development and efficacy data

• Phase 1b data in 1L R/M HPV-negative HNSCC show FICERA plus pembrolizumab delivers 54–73% ORR, over 3x higher than pembrolizumab monotherapy.

• Median progression-free survival (PFS) reached up to 12.7 months and median overall survival (OS) surpassed 21.3 months in pivotal dose cohorts.

• Deep responders (≥80% tumor shrinkage) maintained median duration of response (DOR) of 31.6 months and showed significant reductions in risk of progression and death.

• Safety profile was generally well-tolerated with low discontinuation rates and no new safety signals.

Regulatory and commercial strategy

• FORTIFI-HN01 pivotal Phase 3 trial in 1L R/M HPV-negative HNSCC is enrolling, with interim analysis expected mid-2027 and potential U.S. launch in 2028.

• Alternate dosing regimen (FORTIFI-FLEX) initiated to enhance patient convenience, with results expected by potential accelerated approval.

• Market opportunity estimated at $5B+ globally by 2030, with ~50,000 annual incident patients in the US, EU5, and Japan.

• Expansion into other solid tumors, including metastatic colorectal cancer (mCRC), is underway.