On March 30, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX) reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update.

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"Bicara enters the year with exceptional momentum across our clinical, regulatory, and corporate priorities," said Claire Mazumdar, Ph.D., Chief Executive Officer at Bicara Therapeutics. "The continued advancement of our pivotal FORTIFI-HN01 study, the robust body of clinical data supporting ficerafusp alfa’s differentiated profile, and the alternate dosing option for ficerafusp alfa all underscore the significant progress we’ve made toward transforming outcomes for patients with HPV-negative head and neck cancer. Coupled with our fortified financial position from our recent financing, we are well positioned to execute on our milestones, scale our organization for potential commercialization, if approved, and deliver meaningful value for patients and shareholders throughout the year."

Fourth Quarter 2025 Highlights and Recent Progress

FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in First Line (1L) Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC)

Selected 1500mg of ficerafusp alfa as the optimal dose for the treatment of 1L HPV-negative R/M HNSCC in Phase 3 of the FORTIFI-HN01 pivotal trial.
Initiated Phase 3 of the FORTIFI-HN01 study, and expect to be substantially enrolled by the end of the year.
Announced plans to develop ficerafusp alfa with a loading and every-three-week (Q3W) maintenance schedule, with the goal of achieving regulatory alignment to enable data generation for potential U.S. approval.
Phase 1b Data of Ficerafusp Alfa in 1L R/M HPV-Negative HNSCC

Presented Phase 1b data at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress 2025 demonstrating that ficerafusp alfa 750mg QW plus pembrolizumab was generally well-tolerated with an ORR comparable to 1500mg QW. Read the full presentation here. Biomarker analyses demonstrated that the 1500mg dose achieved greater TGF-β inhibition, stronger immune activation, and deeper clinical responses, supporting higher dose selection and further derisking the ORR interim analysis for the FORTIFI-HN01 pivotal study.
Presented Phase 1b data at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) showing that ficerafusp alfa 2000mg Q2W plus pembrolizumab was generally well‑tolerated and produced rapid, deep, and durable responses. Read the full presentation here. Updated biomarker analyses confirmed that the 2000mg Q2W regimen maintains TGF‑β inhibition and immune activation consistent with the differentiated profile of 1500mg QW, supporting development of a loading and Q3W maintenance schedule that maintains efficacy and safety while providing additional convenience.
Development of Ficerafusp Alfa Across Other Solid Tumor Types

Continued to enroll a Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic colorectal cancer (mCRC) (RAS/BRAF wild type MSS).
Corporate Highlights

Raised net proceeds of $161.8 million through an oversubscribed public offering. Net proceeds from the offering will be used to further invest in and build Bicara’s medical and commercial infrastructure to support a planned regulatory filing and commercial launch for ficerafusp alfa, if approved, in the U.S.; to further accelerate the development of ficerafusp alfa in 1L R/M HPV-negative HNSCC, including a less frequent dosing schedule; to fund manufacturing costs for ficerafusp alfa for ongoing and anticipated drug development efforts; to fund early signal-finding to support future indication expansion for ficerafusp alfa; and for other general corporate purposes.
Key Anticipated Upcoming Milestones

HNSCC

Present long-term follow-up data from Phase 1b study of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from May 29-June 2, 2026 in Chicago, IL.
Achieve substantial enrollment in FORTIFI-HN01 pivotal study by the end of 2026 to enable interim analysis readout in the middle of 2027.
Make critical commercial hires, including a Chief Commercial Officer, by the end of 2026 to advance organizational preparation for launch readiness.
Other Solid Tumors, Including mCRC

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 the second half of 2026.
Fourth Quarter 2025 Financial Results

Cash, Cash Equivalents and Marketable Securities: As of December 31, 2025, Bicara had cash, cash equivalents and marketable securities of $414.8 million, compared to $489.7 million in cash and cash equivalents as of December 31, 2024. An additional $161.8 million in net proceeds was raised via an oversubscribed public offering in the first quarter of 2026. 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 $33.0 million for the fourth quarter of 2025 as compared to $19.9 million for the fourth quarter of 2024, and $125.1 million for the full year 2025 as compared to $63.6 million for the full year 2024. The increase was primarily due to costs associated with ongoing pivotal Phase 2/3 clinical trial, FORTIFI-HN01, as well as the Company’s ongoing Phase 1/1b dose expansion cohorts, and an increase in personnel costs.
General and Administrative Expenses: General and administrative expenses were $8.1 million for the fourth quarter of 2025 as compared to $6.8 million for the fourth quarter of 2024, and $30.5 million for the full year 2025 as compared to $18.8 million for the full year 2024. The increase was primarily due to additional personnel costs and professional fees to support advancement of our clinical trials and operations as a public company.
Net Loss: Net loss totaled $37.4 million and $138.0 million for the fourth quarter and full year ended December 31, 2025, respectively, as compared to $21.0 million and $68.0 million for the fourth quarter and full year ended December 31, 2024, respectively.
Upcoming Investor Conferences

Bicara Therapeutics will participate in one upcoming investor conference:

BofA Securities Health Care Conference 2026 on Wednesday, May 13, 2026 at 9:20 a.m. PT.
A live webcast of the fireside chat will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. A replay of the webcast will be archived and available for 30 days following the event.

Conference Call Information

Bicara will host a live conference call and webcast at 8:30 a.m. ET today to discuss fourth quarter and full year 2025 financial results and recent business activities. 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, MAR 30, 2026, View Source [SID1234664046])