Bicara Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $442.3 million as of September 30, 2026, compared to $414.8 million as of December 31, 2025.
• Research and development expenses were $56.5 million for the third quarter of 2026, an increase from $33.0 million in the same period of 2025.
• General and administrative expenses were $19.2 million for the third quarter of 2026, up from $7.7 million in the third quarter of 2025.
• Net loss was $71.2 million for the third quarter of 2026, compared to a net loss of $36.3 million in the third quarter of 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $195.9 million, compared to $114.5 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $182.9 million, compared to $100.6 million in the prior year period.
• Net loss per share (basic and diluted) was $1.04 for the three months ended September 30, 2026, compared to $0.67 in the prior year period.
• Stock-based compensation expense was $9.98 million for the third quarter of 2026, compared to $3.61 million in the third quarter of 2025.

Guidance and Future Outlook:

• The company expects its existing cash, cash equivalents, and marketable securities to fund operations into the first half of 2029.
• Topline results from the interim analysis of the FORTIFI-HN01 pivotal trial in 1L R/M HPV-negative HNSCC are expected in mid-2027.
• Data from the FORTIFI-FLEX alternate dosing study is expected by the time of a potential U.S. approval in 1L R/M HPV-negative HNSCC.
• Data from the Phase 1b expansion cohort in 3L+ mCRC (RAS/BRAF wild type MSS) is expected to be presented in January 2027.

Business Segments and Product Lines:

• Ficerafusp alfa is being developed as a bifunctional therapy targeting EGFR and TGF-β for solid tumors, specifically HPV-negative head and neck squamous cell carcinoma (HNSCC).
• The FORTIFI-HN01 pivotal trial in 1L R/M HPV-negative HNSCC achieved substantial enrollment.
• The FORTIFI-FLEX trial is enrolling to evaluate ficerafusp alfa administered as a 12-week loading dose of 1500mg weekly followed by maintenance dosing of 2250mg every three weeks, compared to 1500mg weekly, each in combination with pembrolizumab.
• The company has established a commercial leadership team to prepare for potential commercialization.

Market and Competitive Landscape:

• The company highlights significant unmet need in HPV-negative HNSCC and emphasizes the distinct biology of the disease requiring a targeted approach.
• Management notes growing recognition among investigators regarding the need for a targeted approach grounded in the distinct biology of HPV-negative disease.
• The company aims for ficerafusp alfa to enter the market with a competitive profile that provides physicians, patients, and payers a clear reason to choose it.

Risks and Challenges:

• Forward-looking statements are subject to risks including uncertainties related to clinical development, the ability to obtain regulatory approvals on expected timelines, and dependence on third parties.
• Risks include the need for additional funds to commercialize ficerafusp alfa if approved, regulatory developments, and maintaining intellectual property protections.
• The competitive landscape for ficerafusp alfa is cited as a potential risk factor.

Management Commentary and Tone:

• Ryan Cohlhepp, President, Interim CEO, and COO, stated that ficerafusp alfa is purpose-built for HPV-negative HNSCC and that its depth and durability of response set it apart in a disease with significant unmet need.
• Management described the substantial enrollment in the FORTIFI-HN01 trial as reflecting strong execution and growing recognition of the disease's biology.
• The company's focus is described as moving with speed while aiming for a competitive market profile, alongside evaluating less-frequent dosing to enhance the drug's profile.

Other Key Points:

• Bicara Therapeutics will host a conference call and webcast on November 9, 2026, at 8:30 a.m. ET to discuss results.
• The company will participate in the Stifel Healthcare Conference (November 11), Jefferies Global Healthcare Conference (November 16), and Piper Sandler 38th Annual Healthcare Conference (December 2).
• Preclinical data evaluating the effect of tumor-targeted TGF-β neutralization with ficerafusp alfa on fibrosis and drug penetration will be presented at the ESMO Immuno-Oncology & Advanced Therapies Congress 2026 in London (December 14-16).
• The company disclosed that it intends to use its Investor Relations website to disclose material nonpublic information in compliance with Regulation FD.