Bicara Therapeutics (BCAX) investor relations material

Executive summary

• Multiple strategic leadership transitions announced, including new CEO, CFO, COO, and other executive appointments effective January 2027, to support commercialization and growth.

• Focus remains on advancing FICERA (ficerafusp alfa), a bifunctional EGFR/TGF-β inhibitor, with pivotal FORTIFI-HN01 trial in HPV-negative head and neck cancer and alternate dosing study FORTIFI-FLEX underway.

• Three-year follow-up data from ASCO 2026 showed FICERA nearly doubled overall survival versus standard of care in HNSCC, with deep and durable responses and a consistent safety profile.

• Broad development strategy includes proof of concept in cutaneous squamous cell carcinoma, anal canal cancer, and ongoing exploration in colorectal cancer.

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

Financial highlights

• Q2 2026 operating expenses rose to $60.0M from $32.0M in Q2 2025, mainly due to higher R&D, clinical operations, manufacturing, and personnel costs.

• Research & development expenses for the six months ended June 30, 2026 were $93.2M, up $34.1M year-over-year; G&A expenses increased to $27.0M for the same period.

• Net loss for Q2 2026 was $55.4M, compared to $27.4M in Q2 2025; six-month net loss was $111.6M.

• Cash, cash equivalents, and marketable securities totaled $497.3M as of June 30, 2026, up from $414.8M at year-end 2025.

• Non-cash stock-based compensation expense for Q2 2026 was $8.2M.

Outlook and guidance

• Cash runway expected to fund operations into the first half of 2029.

• Substantial enrollment for FORTIFI-HN01 expected by year-end 2026, with interim analysis planned for mid-2027 and potential U.S. launch in 2028.

• FORTIFI-FLEX data anticipated to be available by the time of first U.S. approval, supporting inclusion in the initial label.

• Increased investment in medical affairs and commercial infrastructure to enable launch readiness.

• Data from Phase 1b expansion cohort in mCRC expected in the second half of 2026.