Bicara Therapeutics (BCAX) Company Report

Bicara's lead program, ficerafusp alfa, is a TGF-β EGFR bifunctional agent focused on developing multifunctional agents for solid tumors.
A Phase 2-3 pivotal trial for ficerafusp alfa in frontline recurrent metastatic head and neck cancer was initiated in February 2025.
Clinical data from ASCO 2025 for the 1500mg dose demonstrated an almost tripling of response rates compared to pembrolizumab therapy, with a median duration of response over 20 months and median overall survival close to 22 months in the responder population.
Dose optimization is ongoing within the pivotal trial, comparing 750mg and 1500mg doses. The 750mg dose showed a 55% confirmed response rate, similar to 1500mg, but with a 10% complete response rate versus 21% at 1500mg, suggesting TGF-β's contribution to response depth.
Bicara plans to meet with the FDA in H1 2026 to make a dose selection for the pivotal trial, which will be publicly disclosed, and an update on the 2000mg Q2W expansion cohort is also expected in early 2026.

3 days ago

Bicara Provides Update on Ficerafusp Alfa Clinical Development and Pivotal Trial

BCAX

New Projects/Investments

Guidance Update

Bicara's lead program, ficerafusp alfa, a TGF-β EGFR bifunctional, is in a pivotal Phase II/III trial for frontline recurrent metastatic head and neck cancer.
Clinical data for the 1,500 mg dose of ficerafusp alfa showed a tripling of response rates and a median duration of response of over 20 months, with a 21% complete response rate.
Data for the 750 mg dose indicated a 55% confirmed response rate, similar to the 1,500 mg dose, but a lower 10% complete response rate, suggesting the 1,500 mg dose provides higher TGF-β inhibition.
Bicara plans to meet with the FDA in the first half of 2026 to select between the 750 mg and 1,500 mg doses for the pivotal trial, with only the selected dose being publicly disclosed.
An update on a 2,000 mg Q2W expansion cohort is expected in early 2026, aiming for less frequent dosing and demonstrating continued dose responsiveness of TGF-β.

3 days ago

Bicara Provides Update on Ficerafusp Alfa Pivotal Trial and Dose Optimization

BCAX

New Projects/Investments

Guidance Update

Bicara's lead program, ficerafusp alfa, a TGF-β EGFR bifunctional, is in a phase 2-3 pivotal trial for frontline recurrent metastatic head and neck cancer, which began in February 2025.
Clinical data presented at ASCO 2023 and ASCO 2025 showed meaningful improvements in response rate, PFS, duration of response, and overall survival.
The pivotal trial is evaluating 750 mg and 1500 mg doses, with the 750 mg dose demonstrating a 55% confirmed response rate and a 10% complete response rate, while the 1500 mg dose showed a 21% complete response rate.
Dose selection for the pivotal trial is anticipated in the first half of 2026 following FDA consultation, with only the selected dose to be publicly disclosed.
Bicara highlights the TGF-β component's contribution to depth and durability of response, citing a median duration of response exceeding 20 months for ficerafusp alfa, compared to 12-13 months for cetuximab plus pembrolizumab.

3 days ago

Bicara Therapeutics Inc. Reports Q3 2025 Financial Results and Business Updates

BCAX

Earnings

Guidance Update

Management Change

Bicara Therapeutics Inc. reported a net loss of $36.3 million for the third quarter of 2025, compared to $17.5 million for the third quarter of 2024.
The company maintains a strong financial position with approximately $408 million in cash, cash equivalents, and investments as of September 30, 2025, which is expected to fund operations into the first half of 2029.
Research and development expenses increased to $33.0 million for Q3 2025, up from $15.9 million in Q3 2024, primarily due to costs for the FORTIFI-HN01 pivotal Phase 2/3 clinical trial and ongoing Phase 1/1b dose expansion cohorts.
The company received FDA Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab for first-line HPV-negative R/M HNSCC.
Bicara Therapeutics Inc. expanded its management team with the appointments of Jenna Cohen as Chief Corporate Affairs Officer, Tanya Green as Chief Development Officer, and Bill Schelman as Senior Vice President, Clinical Development.

Nov 10, 2025, 12:32 PM

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