Bicara Therapeutics Inc. Common Stock

Bicara Therapeutics announced CEO Claire Mazumdar will step into a Vice Chair and Strategic Adviser role at the start of next year, handing the top job to President and Chief Operating Officer Ryan Cohlhepp. The leadership change comes as the company reported three-year follow-up data for ficerafusp alfa, its lead drug candidate for frontline recurrent or metastatic HPV-negative head and neck cancer, showing about one in three patients alive at three years at the 1,500 milligram weekly dose, roughly double the survival rate seen with standard-of-care pembrolizumab. Bicara is on track for substantial enrollment in its pivotal Phase III FORTIFI-HN01 study by the end of 2026, with a mid-2027 interim readout that could support accelerated approval. The company also announced several other executive transitions, including a new CFO, and reported operating expenses rose in the second quarter of 2026, with management expecting costs to keep climbing as it builds commercial and medical affairs teams. Bicara holds roughly $497 million in cash, which it says funds operations through the first half of 2029.

Bicara Therapeutics announced a planned leadership transition, elevating Ryan Cohlhepp to CEO effective January 2027 to leverage his commercial oncology experience as the company nears a potential launch. The company's pivotal Phase III FORTIFI-HN01 study for HPV-negative head and neck cancer is on track for substantial enrollment by year-end 2026, with a top-line interim analysis expected in mid-2027. Three-year follow-up data presented at ASCO 2026 showed that TGF-beta inhibition nearly doubled overall survival versus standard of care pembrolizumab in the pivotal dose cohort. Bicara ended the quarter with $497 million in cash, which is expected to fund operations into the first half of 2029. The company also initiated the FORTIFI-FLEX study to optimize dosing regimens and plans to disclose early safety and efficacy data from two signal-seeking Phase Ib cohorts in third-line colorectal cancer by year-end 2026.

Bicara Therapeutics has appointed Jeremy Bender and Christy Oliger to its board of directors. Dr. Bender most recently served as CEO of Day One Biopharmaceuticals through its approximately $2.5 billion acquisition by Servier in 2026, and brings more than 20 years of biotech corporate strategy and operating experience. Ms. Oliger brings more than 30 years of commercial and operating experience, having most recently served as Senior Vice President of the Oncology Business Unit at Genentech, where she managed a portfolio of 15 products contributing U.S. revenue exceeding $13 billion. The company also announced that founding board member Kiran Mazumdar-Shaw has retired from the board.