Bicara Secures $161.8M, Holds $539.8M Cash, Q3 Ficerafusp Combo Trial
Bicara ended Q1 with $539.8 million in cash and marketable securities after raising $161.8 million in a public offering, expecting funding through the first half of 2029. The company plans to initiate a randomized ficerafusp alfa/pembrolizumab study in Q3 and aims for interim FORTIFI-HN01 analysis by mid-2027.
1. Clinical Pipeline Progress
Bicara continued strong execution of the FORTIFI-HN01 Phase 2/3 trial in first-line HPV-negative R/M HNSCC, expecting substantial enrollment by year-end to enable an interim analysis in mid-2027. Following FDA discussions, the company will launch a randomized study in Q3 2026 evaluating a 12-week 1500mg weekly loading dose of ficerafusp alfa with pembrolizumab followed by 2250mg every three weeks.
2. Strong Financial Position
As of March 31, 2026, Bicara had $539.8 million in cash, cash equivalents, and marketable securities, up from $414.8 million at year-end, bolstered by a $161.8 million net public offering. Based on current plans, this funding is expected to support operations into the first half of 2029, while R&D expenses rose to $47.5 million.
3. Executive Appointments
Effective May 8, 2026, Bill Schelman, M.D., Ph.D., was promoted to Chief Medical Officer, succeeding David Raben, M.D., who will serve as Senior Executive Advisor. The company also appointed Chris Sarchi as Chief Commercial Officer to lead commercialization preparations ahead of ficerafusp alfa’s potential launch.
4. Upcoming Milestones
Bicara will present long-term follow-up data from three Phase 1b expansion cohorts at ASCO 2026, detailing TGF-β inhibition’s impact on response durability in 1L R/M HNSCC. In the second half of 2026, the company plans to report results from a Phase 1b cohort evaluating monotherapy and combination therapy in third-line or later metastatic colorectal cancer.