Earnings summaries and quarterly performance for Bicara Therapeutics.
Executive leadership at Bicara Therapeutics.
Claire Mazumdar
Detailed
Chief Executive Officer
CEO
DR
David Raben
Detailed
Chief Medical Officer
IH
Ivan Hyep
Detailed
Chief Financial Officer
JC
Jenna Cohen
Detailed
Chief Corporate Affairs Officer
LM
Lara Meisner
Detailed
Chief Legal Officer
RC
Ryan Cohlhepp
Detailed
President and Chief Operating Officer
TG
Tanya Green
Detailed
Chief Development Officer
Board of directors at Bicara Therapeutics.
Research analysts covering Bicara Therapeutics.
Recent press releases and 8-K filings for BCAX.
Bicara Therapeutics Presents Preliminary Phase 1b Data for Ficerafusp Alfa and Provides Update on Optimal Dose Selection
BCAX
New Projects/Investments
- Bicara Therapeutics presented preliminary Phase 1b expansion cohort data for 750mg of ficerafusp alfa weekly in combination with pembrolizumab for first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma at the ESMO Asia Congress on December 6, 2025.
- The 750mg dose demonstrated a 57% confirmed overall response rate (ORR), with 10% of patients achieving a complete response and 29% of responders showing deep responses (at least 80% tumor shrinkage), and a safety profile consistent with the 1500mg dose.
- New biomarker data indicated that the 1500mg dose yielded greater TGF-β inhibition and immune activation, resulting in a median depth of response of 82% compared to 63% for the 750mg dose.
- The company anticipates declaring the optimal biologic dose for the pivotal FORTIFI-HN01 study in the first quarter of 2026.
Dec 8, 2025, 12:11 PM
Bicara Therapeutics Provides Update on Ficerafusp Alfa Data and FORTIFY-HN01 Study
BCAX
New Projects/Investments
Guidance Update
- Bicara Therapeutics presented preliminary safety and efficacy data for ficerafusp alfa (Physera), an investigational EGFR TGF-beta bifunctional antibody, at the ESMO Asia Congress 2025.
- The 750 mg weekly dose of Physera combined with pembrolizumab demonstrated a 57% confirmed response rate and an 83% disease control rate in 30 efficacy evaluable HPV-negative head and neck squamous cell carcinoma (HNSCC) patients.
- This data, along with previous 1,500 mg dose data, will inform the dose selection for the pivotal FORTIFY-HN01 study, with a decision expected in the first quarter of 2026.
- Across both doses, an approximate 55% overall response rate was observed in 58 patients, nearly tripling the 19% ORR seen with pembrolizumab alone.
- Physera has received Breakthrough Therapy Designation in combination with pembrolizumab for first-line treatment of HPV-negative recurrent or metastatic HNSCC.
Dec 6, 2025, 2:00 PM
BCAX Provides Clinical Update on Ficerafusp Alfa and FORTIFI-HN01 Trial
BCAX
New Projects/Investments
Guidance Update
- BCAX's ficerafusp alfa (FICERA), an EGFR x TGF-\u03b2 bifunctional antibody, has received Breakthrough Therapy Designation from the U.S. FDA for the first-line treatment of specific recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
- Preliminary clinical data for the 750mg QW FICERA + pembrolizumab combination in HPV-negative, CPS\u22651 1L R/M HNSCC showed a Confirmed Objective Response Rate (ORR) of 57% (17/30) and a Disease Control Rate of 83% (25/30), with a median time to response of 1.6 months. The treatment was generally well-tolerated with no treatment-related deaths.
- The 750mg QW dose demonstrated a safety and efficacy profile consistent with the 1500mg QW dose, both achieving significantly higher ORR compared to pembrolizumab monotherapy (57% and 54% vs. 19%, respectively).
- BCAX expects to make an optimal dose selection for the pivotal FORTIFI-HN01 trial in Q1 2026, which is designed for an efficient path to market with potential for accelerated and full approval.
Dec 6, 2025, 2:00 PM
Bicara Therapeutics Updates on Ficerafusp Alfa Data and FORTIFY-HN01 Trial Progress
BCAX
Guidance Update
New Projects/Investments
- Bicara Therapeutics presented new data on ficerafusp alfa (Physera), an EGFR TGF-beta bifunctional antibody, in combination with pembrolizumab for first-line recurrent or metastatic HPV-negative head and neck squamous cell carcinoma (HNSCC).
- The 750 mg weekly dose of Physera demonstrated an encouraging 57% response rate and a manageable safety profile in HPV-negative HNSCC patients.
- The company expects to make a dose selection for the pivotal FORTIFY-HN01 study in Q1 2026, with biomarker data suggesting the 1,500 mg dose drives greater TGF-beta inhibition and potentially deeper responses.
- Ficerafusp alfa in combination with Pembro recently received Breakthrough Therapy Designation for the treatment of HPV-negative recurrent or metastatic HNSCC.
Dec 6, 2025, 2:00 PM
Bicara Therapeutics Updates on Ficera Data and Dose Selection for FORTIFY-HN01 Study
BCAX
New Projects/Investments
Guidance Update
- Bicara Therapeutics' drug, Ficera, an EGFR TGF-beta bifunctional antibody, has been granted breakthrough therapy designation in combination with Pembro for the first-line treatment of HPV-negative recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
- Preliminary safety and efficacy data for the 750 mg dose of Ficera plus Pembro in HPV-negative HNSCC patients showed a 57% confirmed response rate and an 83% disease control rate.
- While both the 750 mg and 1500 mg doses demonstrated strong efficacy, the 1500 mg dose showed deeper responses and greater TGF-beta inhibition in the tumor, which is hypothesized to drive durability and overall survival.
- The final dose selection for the pivotal FORTIFY-HN01 study is now expected in Q1 2026, with the totality of data, particularly the depth and durability of response, pointing towards the higher dose.
Dec 6, 2025, 2:00 PM
Bicara Updates on Ficerafusp Alfa Clinical Trial Progress
BCAX
New Projects/Investments
Guidance Update
- 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.
Dec 2, 2025, 9:30 PM
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.
Dec 2, 2025, 9:30 PM
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.
Dec 2, 2025, 9:30 PM
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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