Bicara Reports Substantial Enrollment in FORTIFI-HN01 Cancer Trial

Bicara Therapeutics Inc. reported substantial enrollment in its pivotal FORTIFI-HN01 cancer trial, with topline results from an interim analysis expected in mid-2027 for patients with human papillomavirus (HPV)-negative recurrent or metastatic disease.

The study is evaluating ficerafusp alfa in first-line treatment of HPV-negative head and neck squamous cell carcinoma.

Bicara had $442.3 million in cash, cash equivalents and marketable securities as of Sept. 30, 2026. Under its current operating and development plans, the company expects those resources to fund operations into the first half of 2029.