BOSTON, November 10, 2025 — Leads & Copy — Bicara Therapeutics Inc. (Nasdaq: BCAX) announced its third-quarter financial results for the period ending September 30, 2025, and provided a business update, including that the FDA granted Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC.
The company anticipates presenting data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients at the ESMO Asia 2025 Meeting.
Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics, said that the FDA’s Breakthrough Therapy Designation represents an important milestone for Bicara and validates the strength of the company’s clinical data and development plan. Mazumdar also noted the growing recognition of HPV-negative disease as a distinct clinical indication within HNSCC. As the company heads into 2026, its focus continues to be on executing the enrollment of its pivotal Phase 2/3 FORTIFI-HN01 trial in first-line HPV-negative HNSCC and presenting additional data for ficerafusp alfa across dose cohorts to further characterize its tolerability and efficacy profile and inform the dose selection for the pivotal FORTIFI-HN01 study.
Highlights from the third quarter of 2025 and recent progress include:
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for ficerafusp alfa in combination with pembrolizumab for the first-line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma.
The company is continuing to enroll patients in FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab 1L HPV-negative R/M HNSCC, and has initiated a Phase 1b expansion cohort evaluating ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-positive HNSCC patients with a history of heavy smoking.
The company also continues to enroll patients in a Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic colorectal cancer (CRC) (RAS/BRAF wild type MSS).
At the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, Bicara presented data demonstrating the significantly improved and sustained anti-tumor effects of ficerafusp alfa compared to cetuximab in KRAS/BRAF wild-type MSS CRC cell lines.
At the European Society for Medical Oncology (ESMO) 2025 Congress, Bicara presented data demonstrating the ability of ficerafusp alfa to block epithelial-mesenchymal transition (EMT) and fibroblast-myofibroblast transition (FMT) in tumor cells and cancer-associated fibroblasts (CAFs).
Bicara expanded its management team with the appointments of Jenna Cohen, Chief Corporate Affairs Officer; Tanya Green, Chief Development Officer; and Bill Schelman, Senior Vice President, Clinical Development.
Key Anticipated Upcoming Milestones include presenting data from multiple Phase 1b expansion cohorts evaluating ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients at the ESMO Asia 2025 Meeting, data from a Phase 1b expansion cohort evaluating 2000mg of ficerafusp alfa every other week in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients in the first quarter of 2026, data from a Phase 1b expansion cohort evaluating 1500mg weekly of ficerafusp alfa in combination with pembrolizumab in HPV-negative patients with combined positive scores (CPS) of 0 in 2026, and data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic CRC (RAS/BRAF wild type MSS) in 2026.
As of September 30, 2025, Bicara had cash, cash equivalents and investments of $407.6 million, compared to $489.7 million in cash and cash equivalents as of December 31, 2024. The company expects that its existing cash, cash equivalents and investments will fund operations into the first half of 2029.
Research and development expenses were $33.0 million for the third quarter of 2025, compared to $15.9 million for the third quarter of 2024. General and administrative expenses were $7.7 million for the third quarter of 2025, compared to $4.8 million for the third quarter of 2024. Net loss totaled $36.3 million for the third quarter of 2025, compared to $17.5 million for the third quarter of 2024.
Bicara will participate in three upcoming investor conferences: Stifel Healthcare Conference 2025 on Tuesday, November 11, 2025, the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025, and the Evercore 8th Annual Healthcare Conference on Wednesday, December 3, 2025. Live webcasts of the fireside chats will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations.
Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Its lead program, ficerafusp alfa, is designed to drive tumor penetration by breaking barriers in the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types.
Jenna Cohen, Chief Corporate Affairs Officer, can be reached at IR@bicara.com.
Amanda Lazaro, 1AB, can be reached at Amanda@1abmedia.com.
Source: Bicara Therapeutics Inc.
