Bicara Therapeutics Inc.

Bicara Therapeutics Inc. (Nasdaq: BCRA) is a clinical-stage biopharmaceutical company dedicated to developing bifunctional therapies for patients with solid tumors. The company's website is www.bicaratherapeutics.com.

Bicara's lead program is ficerafusp alfa, a bifunctional antibody that combines an anti-EGFR monoclonal antibody with a human transforming growth factor beta ligand trap. The therapy is designed to simultaneously block cancer cell-intrinsic EGFR survival and proliferation while inhibiting immunosuppressive TGF-β signaling within the tumor microenvironment. By localizing TGF-β inhibition directly to EGFR-expressing tumor cells, ficerafusp alfa aims to enhance drug exposure within tumors while limiting systemic toxicity and enabling immune cell penetration to drive deep and durable responses.

The company is currently focused on developing ficerafusp alfa in head and neck squamous cell carcinoma, where there is strong biologic rationale for dual EGFR and TGF-β inhibition. Bicara's global Phase 2/3 FORTIFI-HN01 pivotal trial is evaluating ficerafusp alfa at 1500mg dosed weekly in combination with pembrolizumab as a first-line treatment for recurrent or metastatic HPV-negative HNSCC. The company expects substantial enrollment by the end of 2026 to enable an interim analysis in mid-2027, with a potential path to accelerated approval based on overall response rate and durability endpoints.

Beyond HNSCC, Bicara is exploring ficerafusp alfa's potential in other squamous cell carcinomas and solid tumors, including cutaneous squamous cell carcinoma, anal squamous cell carcinoma, and colorectal cancer. The company has also initiated expansion cohorts evaluating additional patient populations within HNSCC and is supporting investigator-sponsored trials in locally-advanced disease settings.

Bicara acquired rights to ficerafusp alfa through a 2019 license agreement with Biocon Limited and maintains a clinical trial collaboration with MSD for the combination of ficerafusp alfa with pembrolizumab. As a clinical-stage company, Bicara has incurred significant losses since inception and anticipates continued losses as it advances its development programs toward potential regulatory approval and commercialization.