Bicara Records $56 Mln Loss In Q1; Provides Updates On Ficerafusp Alfa Trials

(RTTNews) - Bicara Therapeutics Inc. (BCAX), a clinical-stage biopharmaceutical company, on Monday released the first quarter financial results and provided business updates for its lead candidate ficerafusp alfa. Q1 2026: The company received $161.8 million in net proceeds from an oversubscribed public offering in the first quarter. A net loss of $56.21 million was recorded in Q1 2026, while Q1 2025 showed a loss of $36.85 million. Research and development expenses (R&D) for the first quarter were $47.50 million, while in the same period of the previous year, R&D expenses were $24.33 million. Cash, cash equivalents, and marketable securities amounted to $539.80 million as of March 31, 2026. Business Updates: The company is advancing Ficerafusp alfa, which drives inhibition of tumor growth factor-ß (TGF-ß), in the treatment of HPV-negative head and neck squamous cell carcinoma (HNSCC) and other solid tumors. The pivotal Phase 2/3 FORTIFI-HN01 trial is evaluating ficerafusp alfa as a first-line treatment for recurrent/metastatic HPV-negative HNSCC. The company expects enrolment to be completed by the end of this year, facilitating interim analysis by mid-2027, followed by a submission for accelerated approval to the U.S. food and drug administration (FDA). Based on recent discussions with the FDA, the company also plans to initiate a randomized clinical study for ficerafusp alfa in combination with pembrolizumab by the third quarter of 2026. Enrolment is ongoing in the Phase 1b trials evaluating ficerafusp alfa as a monotherapy, or in combination with pembrolizumab for the treatment of solid tumors and metastatic colorectal cancer (mCRC). Data from the expansion cohort is anticipated for the second half of this year. BCAX is currently trading at $23.38, up 3.54%. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.