Bicara Therapeutics (BCAX) investor relations material

Executive summary

• Advanced pivotal FORTIFI-HN01 trial for ficerafusp alfa in 1L HPV-negative R/M HNSCC, aiming for substantial enrollment by year-end 2026 and interim analysis in mid-2027 for potential accelerated approval.

• Initiated alternate dosing study for ficerafusp alfa with pembrolizumab in Q3 2026, targeting results to support U.S. accelerated approval.

• Published peer-reviewed Phase 1b data in Journal of Clinical Oncology, highlighting deep and durable responses and chemotherapy-free potential.

• Leadership transitions included new Chief Medical Officer and Chief Commercial Officer appointments to support late-stage development and commercialization.

• No product revenue to date; operations funded by equity offerings, including a $161.8M raise in February 2026.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $539.8M as of March 31, 2026, up from $414.8M at year-end 2025, bolstered by a $161.8M public offering.

• Q1 2026 operating expenses increased year-over-year, driven by higher R&D, clinical operations, and personnel costs, reaching up to $60.2M.

• Net loss for Q1 2026 was $56.2M, compared to $36.8M in Q1 2025.

• Non-cash stock-based compensation expense was $5.9M in Q1 2026.

• Net cash used in operating activities was $37.5M for Q1 2026; net cash provided by financing activities was $163.3M.

Outlook and guidance

• Cash runway projected into the first half of 2029 based on current operating plans.

• Interim analysis for FORTIFI-HN01 trial targeted for mid-2027, focusing on overall response rates and durability.

• Plans to initiate a randomized study of ficerafusp alfa with pembrolizumab in Q3 2026, aiming for results to support accelerated approval.

• No revenue expected until at least several years post-approval of ficerafusp alfa or future candidates.

• Preparing for commercial launch in the U.S. and expanding ficerafusp alfa's indications across solid tumors.