Bicara Therapeutics (BCAX) Corporate presentation summary

Strategic focus and clinical development

• Advancing ficerafusp alfa (FICERA), a bifunctional EGFR-directed antibody with a TGF-β ligand trap, targeting HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and exploring other solid tumors with similar biological profiles.

• FICERA is designed to improve tumor penetration, drive deep and durable responses, and overcome resistance in solid tumors, particularly in HPV-negative HNSCC.

• Clinical data show FICERA combined with pembrolizumab achieves a 54% objective response rate (ORR), 21.7 months median duration of response (mDOR), and 21.3 months median overall survival (mOS) in HPV-negative HNSCC, outperforming standard of care.

• FICERA has received Breakthrough Therapy Designation and initiated a pivotal Phase 2/3 FORTIFI-HN01 trial, with accelerated dose selection and efficient Phase 3 initiation.

• The 1500 mg QW dose is generally well-tolerated, with most adverse events being mild to moderate and no treatment-related deaths reported.

Market opportunity and commercial strategy

• HPV-negative HNSCC represents a large, underserved market, with ~50,000 patients annually in the US, EU5, and Japan, and a projected $5B+ global market by 2030.

• FICERA's clinical profile could more than double survival and response rates, potentially expanding the market and establishing a new treatment paradigm.

• Commercial preparations are underway, including key hires and readiness for launch, with a focus on maximizing franchise value and expanding into additional indications.

Pipeline expansion and future milestones

• FICERA is being evaluated in other solid tumors with EGFR/TGF-β signatures, including metastatic colorectal cancer (mCRC) and advanced pancreatic cancer.

• In mCRC, FICERA targets both anti-EGFR and anti-angiogenic pathways, with ongoing Phase 1/1b studies in 3L+ MSS RASwt patients.

• Key 2026 milestones include dose determination, data presentations from expansion cohorts, long-term follow-up, and substantial enrollment in pivotal studies to enable interim analysis in 2027.