Bicara Achieves Substantial FORTIFI-HN01 Enrollment

The Tip Desk · November 12, 2026 · 3 min read

Cash, cash equivalents and marketable securities were $442.3 million as of September 30, 2026, and the company said that balance 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 it achieved substantial enrollment in the FORTIFI-HN01 pivotal trial in first-line recurrent or metastatic HPV-negative head and neck squamous cell carcinoma, a step the company had previously described as on track by year-end. Topline results from an interim analysis remain expected in mid-2027.

In the second-quarter update, Bicara said it was on track for substantial enrollment of the pivotal study by year-end, enabling that mid-2027 interim readout. The third-quarter release marked the enrollment milestone as achieved.

President, Interim Chief Executive Officer and Chief Operating Officer Ryan Cohlhepp said ficerafusp alfa was purpose-built for HPV-negative head and neck cancer by inhibiting both EGFR and TGF-β, and that the enrollment result reflected execution by the team and growing recognition among investigators that HPV-negative disease requires a targeted approach. He said the company’s focus is moving with speed toward the planned interim analysis and evaluating less-frequent dosing through FORTIFI-FLEX.

FORTIFI-FLEX, a randomized, open-label trial comparing a 12-week loading dose of 1500 mg weekly followed by 2250 mg every three weeks of maintenance, each with pembrolizumab, against 1500 mg weekly of ficerafusp alfa with pembrolizumab, continued to enroll. The company expects results from that study by the time of a potential U.S. approval in the same indication.

Research and development expenses were $56.5 million for the three months ended September 30, 2026, compared with $33.0 million a year earlier. Bicara said the increase was primarily due to costs associated with the ongoing FORTIFI-HN01 pivotal trial, the FORTIFI-FLEX trial, Phase 1/1b dose expansion cohorts, and an increase in personnel costs.

General and administrative expenses were $19.2 million in the third quarter of 2026, compared with $7.7 million in the third quarter of 2025. The company said the increase was primarily due to additional personnel costs and professional fees associated with expanding the organization as it advances its pivotal trial and prepares for potential commercialization.

Net loss totaled $71.2 million for the third quarter of 2026, compared with $36.3 million a year earlier. Net loss per share was $1.04, versus $0.67.

Cash, cash equivalents and marketable securities were $442.3 million as of September 30, 2026, compared with $414.8 million as of December 31, 2025. Based on current operating and development plans, Bicara said existing cash, cash equivalents and marketable securities will fund operations into the first half of 2029.

The company said it will present data from a Phase 1b expansion cohort evaluating ficerafusp alfa as monotherapy and in combination with pembrolizumab in patients with third-line or later metastatic colorectal cancer (RAS/BRAF wild type MSS) in January 2027. It also said it will present preclinical data on tumor-targeted TGF-β neutralization with ficerafusp alfa on fibrosis and drug penetration at the ESMO Immuno-Oncology & Advanced Therapies Congress 2026, December 14–16 in London.

Cohlhepp said the commercial leadership team is now in place as the company continues to prepare to bring ficerafusp alfa to patients.