On November 9, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, reported financial results for the third quarter ended September 30, 2026 and provided a business update.

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"Ficerafusp alfa was purpose-built for HPV-negative head and neck cancer by inhibiting both EGFR and TGF-β, and the depth and durability of response it has demonstrated to date continue to set it apart in a disease with significant unmet need," said Ryan Cohlhepp, President, Interim Chief Executive Officer and Chief Operating Officer of Bicara Therapeutics. "Achieving substantial enrollment in the FORTIFI-HN01 pivotal trial reflects strong execution by our team and growing recognition among investigators that HPV-negative disease requires a targeted approach grounded in its distinct biology. As we advance toward our planned interim analysis, our focus is twofold: moving with speed and aiming for ficerafusp alfa to enter the market with a competitive profile that gives physicians, patients, and payers a clear reason to choose it. At the same time, we are evaluating less-frequent dosing through FORTIFI-FLEX, which has the potential to further enhance ficerafusp alfa’s profile. With our commercial leadership team now in place, we are well-positioned as we continue to prepare to bring ficerafusp alfa to patients."

Third Quarter 2026 Highlights and Recent Progress

Ficerafusp Alfa in 1L R/M HPV-Negative HNSCC

Achieved substantial enrollment in the FORTIFI-HN01 pivotal trial in first-line (1L) recurrent or metastatic (R/M) human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC), to enable topline results from an interim analysis in mid-2027.
Continue to enroll FORTIFI-FLEX, a randomized, open-label clinical trial that is evaluating ficerafusp alfa, administered as a 12-week loading dose of 1500mg weekly (QW) followed by maintenance dosing of 2250mg every three weeks (Q3W) as compared to 1500mg QW of ficerafusp alfa, each in combination with pembrolizumab. The company expects to have results from this study by the time of a potential U.S. approval in 1L R/M HPV-negative HNSCC.
Key Anticipated Upcoming Milestones

HNSCC

Expect topline results from an interim analysis of the FORTIFI-HN01 pivotal trial in 1L R/M HPV-negative HNSCC in mid-2027.
Other Solid Tumors and Translational Data

Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ mCRC (RAS/BRAF wild type MSS) in January 2027.
Present preclinical data evaluating the effect of tumor-targeted TGF-β neutralization with ficerafusp alfa on fibrosis and drug penetration at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology & Advanced Therapies Congress 2026, taking place December 14-16 in London, United Kingdom.
Third Quarter 2026 Financial Results

Cash, Cash Equivalents and Marketable Securities: As of September 30, 2026, Bicara had cash, cash equivalents and marketable securities of $442.3 million, compared to $414.8 million in cash, cash equivalents and marketable securities as of December 31, 2025. Based on its current operating and development plans, the company expects that its existing cash, cash equivalents and marketable securities will fund operations into the first half of 2029.
Research and Development Expenses: Research and development expenses were $56.5 million for the third quarter of 2026 as compared to $33.0 million for the third quarter of 2025. The increase was primarily due to costs associated with the ongoing FORTIFI-HN01 pivotal trial, FORTIFI-FLEX trial, Phase 1/1b dose expansion cohorts, and an increase in personnel costs.
General and Administrative Expenses: General and administrative expenses were $19.2 million for the third quarter of 2026 as compared to $7.7 million for the third quarter of 2025. The increase was primarily due to additional personnel costs and professional fees associated with expanding the organization as the company advances its pivotal trial and prepares for potential commercialization.
Net Loss: Net loss totaled $71.2 million for the third quarter of 2026 compared to $36.3 million for the third quarter of 2025.
Upcoming Investor Conferences

Bicara will participate in the following upcoming investor conferences:

Stifel Healthcare Conference 2026 on November 11 at 9:20 a.m. ET
Jefferies Global Healthcare Conference on November 16 at 12:00 p.m. GMT
Piper Sandler 38th Annual Healthcare Conference on December 2 at 8:30 a.m. ET
Live webcasts of the fireside chats will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. Replays of the webcasts will be archived and available for 30 days following each event.

Conference Call Information
Bicara will host a live conference call and webcast at 8:30 a.m. ET today to discuss third quarter 2026 financial results and business updates. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the event.

(Press release, Bicara Therapeutics, NOV 9, 2026, View Source [SID1234674525])