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 Provides 2026 Corporate Outlook and Clinical Updates
BCAX
Guidance Update
Product Launch
New Projects/Investments
- Bicara Therapeutics (BCAX) announced the selection of the 1,500 milligram dose for the Phase III portion of its pivotal FORTIFY-HNS study for ficerafusp alfa in HPV-negative head and neck cancer, following recent FDA interaction. This enables an anticipated interim analysis by mid-2027 for potential accelerated approval and an early launch in early 2028.
- Clinical data for ficerafusp alfa in HPV-negative head and neck cancer demonstrated a confirmed response rate of 54%, a median duration of response of 21.7 months, and a median overall survival of greater than 21 months, significantly exceeding standard of care.
- The company reiterated its cash runway guidance of north of $400 million to fully fund the pivotal study through its confirmatory endpoint and expects early data from proof-of-concept cohorts in metastatic colorectal cancer in the second half of 2026.
3 days ago
Bicara Therapeutics Provides 2026 Corporate Outlook and Clinical Updates
BCAX
Guidance Update
New Projects/Investments
Hiring
- Bicara Therapeutics announced the selection of the 1,500 milligram dose for the Phase III portion of its pivotal FORTIFY-HNS study for ficerafusp alfa in frontline HPV-negative recurrent and metastatic head and neck cancer. This decision, supported by a recent FDA interaction, is expected to accelerate enrollment, enabling an interim analysis by mid-2027 for potential accelerated approval and an anticipated early launch in early 2028.
- The company aims for ficerafusp alfa to achieve blockbuster status in the head and neck cancer market, which is projected to exceed $5 billion by 2030, and is preparing for commercial success by making key hires, including a Chief Commercial Officer, in 2026.
- Clinical data for ficerafusp alfa in combination with Pembro demonstrated a confirmed response rate of 54%, a median duration of response of 21.7 months, and a median overall survival of greater than 21 months in HPV-negative head and neck cancer patients, leading to the FDA granting Breakthrough Designation.
- Bicara is expanding its pipeline beyond head and neck cancer, with early data from proof-of-concept cohorts in metastatic colorectal cancer expected in the second half of 2026.
- The company reiterated its cash runway guidance from Q3 earnings, confirming north of $400 million to fully fund the pivotal study through its confirmatory endpoint.
3 days ago
Bicara Therapeutics Provides 2026 Corporate Outlook and 2025 Accomplishments
BCAX
Guidance Update
New Projects/Investments
Product Launch
- Bicara Therapeutics (BCAX) presented its 2026 corporate outlook and 2025 accomplishments, focusing on its lead program, ficerafusp alfa, for HPV-negative recurrent and metastatic head and neck cancer.
- In 2025, the company achieved Breakthrough Designation from the FDA and initiated its pivotal seamless phase II/III study, FORTIFY-HNS, for which it has now selected the 1,500 milligram dose for the phase III portion.
- The company anticipates an interim analysis by mid-2027 to support a potential accelerated approval and an early launch in 2028 for ficerafusp alfa in frontline HPV-negative head and neck cancer.
- Clinical data for ficerafusp alfa demonstrated a confirmed response rate of 54%, a median duration of response of 21.7 months, and a median overall survival of greater than 21 months, significantly outperforming the standard of care.
- Bicara also plans to explore ficerafusp alfa's potential in other solid tumors, including metastatic colorectal cancer, with early data expected in the second half of 2026, and reiterated its cash runway guidance of north of $400 million.
3 days ago
Bicara Therapeutics Announces Phase 3 Optimal Dose and 2026 Corporate Outlook
BCAX
New Projects/Investments
Guidance Update
- Bicara Therapeutics Inc. has selected 1500 mg of ficerafusp alfa as the optimal dose for its Phase 3 FORTIFI-HN01 pivotal study for 1L HPV-negative R/M HNSCC.
- The company expects to achieve substantial enrollment in the FORTIFI-HN01 study by the end of 2026, with an interim analysis anticipated in mid-2027 to support a potential accelerated filing.
- Bicara anticipates multiple expansion cohort data readouts in 2026 for ficerafusp alfa, including for metastatic colorectal cancer, and plans to make critical commercial hires in 2026 to prepare for a potential launch.
4 days ago
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
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more