Bicara Names Cohlhepp Successor as CEO in 2027
Cash, cash equivalents and marketable securities were $497.3 million as of June 30, 2026, and the company said existing cash will fund operations into the first half of 2029.
Bicara Therapeutics Inc. (BCAX), a clinical-stage biopharmaceutical company developing bifunctional therapies for solid tumors, said President and Chief Operating Officer Ryan Cohlhepp, Pharm.D., will succeed Claire Mazumdar, Ph.D., MBA, as chief executive officer effective January 1, 2027.
Dr. Mazumdar will move to Vice Chair of the Board and Strategic Advisor. The company framed the change as a planned evolution as it prepares for potential commercialization of ficerafusp alfa in first-line recurrent or metastatic HPV-negative head and neck squamous cell carcinoma, with topline data from an interim analysis of the FORTIFI-HN01 pivotal trial expected in mid-2027.
Tanya Green, Chief Development Officer, will succeed Dr. Cohlhepp as COO on the same date. Jenn Larson, CPA, was appointed chief financial officer effective August 12, 2026, succeeding Ivan Hyep. Jenna Cohen will be promoted from Chief Corporate Affairs Officer to Chief Business Officer effective January 1, 2027. Greg Shiferman, J.D., was appointed Chief Legal Officer effective August 31, 2026.
Dr. Mazumdar said the transition marks a natural evolution as the company maintains enrollment momentum that enables a line of sight to a topline interim analysis, which she said the company believes will lead to an accelerated approval and subsequent launch of ficerafusp alfa in head and neck cancer. Chairman Mike Powell said the Board has confidence in Dr. Cohlhepp to lead the company into its next era of execution and growth.
Clinically, Bicara initiated FORTIFI-FLEX, a randomized, open-label study of ficerafusp alfa in combination with pembrolizumab using a 12-week loading dose of 1500 mg weekly followed by maintenance dosing of 2250 mg every three weeks. In the first quarter, the company had said it planned to initiate that study in the third quarter of 2026. Bicara said it expects results from FORTIFI-FLEX by the time of a potential U.S. accelerated approval in the same indication.
The company also presented extended follow-up out to three years from the Phase 1/1b study of ficerafusp alfa plus pembrolizumab at the 2026 American Society of Clinical Oncology Annual Meeting. Three-year follow-up from the 1500 mg weekly cohort showed an estimated overall survival rate of 31%, which the company said approximately doubled the survival rate observed in retrospective analysis with standard-of-care pembrolizumab in HPV-negative patients. Bicara said the responses were driven by TGF-β inhibition allowing direct tumor penetration.
Phase 3 enrollment in FORTIFI-HN01 continued. The company still expects to be substantially enrolled by year-end, enabling topline results from an interim analysis in mid-2027, matching the timeline it gave in the first quarter. It also plans to present data in the second half of 2026 from a Phase 1b expansion cohort evaluating ficerafusp alfa as monotherapy and with pembrolizumab in patients with third-line or later metastatic colorectal cancer who are RAS/BRAF wild type and microsatellite stable.
Research and development expenses were $45.8 million for the three months ended June 30, 2026, compared with $24.8 million a year earlier. The increase was primarily due to costs associated with the ongoing FORTIFI-HN01 pivotal trial, Phase 1/1b dose expansion cohorts, and higher personnel costs. General and administrative expenses were $14.2 million, compared with $7.2 million a year earlier, attributed to additional personnel costs and professional fees as the organization expands for a pivotal study and potential commercialization.
Net loss totaled $55.4 million for the second quarter of 2026, compared with $27.4 million a year earlier. Net loss per share was $0.82. Weighted-average common shares outstanding, basic and diluted, were 67,925,963.
Cash, cash equivalents and marketable securities were $497.3 million as of June 30, 2026, compared with $414.8 million as of December 31, 2025. Cash and cash equivalents were $96.6 million, and marketable securities were $400.7 million. Based on current operating and development plans, existing cash, cash equivalents and marketable securities will fund operations into the first half of 2029.
Bicara will participate in the 2026 Cantor Global Healthcare Conference on September 9, 2026.