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 Announces Closing of Public Offering
BCAX
New Projects/Investments
Product Launch
- Bicara Therapeutics Inc. (Nasdaq: BCAX) announced the closing of its underwritten public offering on February 26, 2026.
- The offering included 8,581,250 shares of common stock and pre-funded warrants to purchase 2,200,000 shares, with the underwriters' option for 1,406,250 additional shares exercised in full.
- The public offering price was $16.00 per share of common stock and $15.9999 per pre-funded warrant, generating aggregate gross proceeds of approximately $172.5 million.
- Bicara intends to use the net proceeds to invest in medical and commercial infrastructure to support a planned regulatory filing and commercial launch for ficerafusp alfa, accelerate its development, fund manufacturing, and for general corporate purposes.
1 day ago
Bicara Therapeutics Prices Public Offering
BCAX
New Projects/Investments
- Bicara Therapeutics Inc. announced the pricing of an underwritten public offering, including 7,175,000 shares of common stock at $16.00 per share and 2,200,000 pre-funded warrants at $15.9999 per pre-funded warrant.
- The offering is expected to generate approximately $150 million in gross proceeds and is anticipated to close on or about February 26, 2026.
- The net proceeds will be used to invest in medical and commercial infrastructure to support a planned regulatory filing and commercial launch for ficerafusp alfa, accelerate its development, fund manufacturing costs, and support future indication expansion, as well as for general corporate purposes.
- Underwriters have been granted a 30-day option to purchase up to 1,406,250 additional shares of common stock.
3 days ago
Bicara Therapeutics Announces Proposed Public Offering of Common Stock
BCAX
New Projects/Investments
Product Launch
- Bicara Therapeutics Inc. (Nasdaq: BCAX) has commenced an underwritten public offering of $150 million of its common stock.
- The company intends to grant the underwriters a 30-day option to purchase up to an additional $22,500,000 of shares.
- Net proceeds from the offering will be used to invest in medical and commercial infrastructure for a planned regulatory filing and commercial launch of ficerafusp alfa in the U.S., accelerate its development, fund manufacturing costs, and for general corporate purposes.
- Morgan Stanley, TD Cowen, BofA Securities, Cantor, and Stifel are serving as joint book-running managers for the offering.
4 days ago
Bicara Therapeutics Provides Clinical Update on Ficerafusp Alfa and Dosing Strategy
BCAX
New Projects/Investments
- Bicara Therapeutics announced the advancement of ficerafusp alfa into the Phase III FORTIFY-HN01 pivotal study for first-line recurrent metastatic HPV-negative head and neck squamous cell cancer, with the 1,500 mg weekly dose in combination with pembrolizumab confirmed as the go-forward regimen.
- The company presented preliminary safety and efficacy data for a less frequent 2,000 mg dose of ficerafusp alfa every other week, which demonstrated a 48% confirmed response rate and 85% disease control rate in 27 efficacy-evaluable HPV-negative patients.
- This less frequent dosing regimen also showed 77% of responders achieving greater than 80% tumor shrinkage and a 26% complete response rate, with a rapid median time to response of 1.6 months.
- Bicara plans to explore an alternative dosing regimen involving a loading phase followed by an every 3-week maintenance schedule for ficerafusp alfa, aiming for regulatory alignment and a parallel randomized study.
- Ficerafusp alfa has demonstrated a 2- to 3-fold improvement in response rates, complete response rate, duration of response, and overall survival compared to standard of care pembrolizumab, with the 1,500 mg dose showing a median PFS of 9.9 months.
Feb 20, 2026, 1:30 PM
Bicara Therapeutics Provides Update on Ficerafusp Alfa Development and Dosing Strategy
BCAX
Product Launch
New Projects/Investments
- Bicara Therapeutics announced a significant milestone for ficerafusp alfa in frontline recurrent and metastatic head and neck squamous cell carcinoma, with clinical data showing a 2- to 3-fold improvement in response rates, complete response rate, duration of response, and overall survival compared to standard of care pembrolizumab, and a durability of response of almost 22 months.
- The 1,500 mg weekly dose of ficerafusp alfa in combination with pembrolizumab has been aligned with the FDA as the go-forward dose for the phase III FORTIFY-HN01 pivotal study, which has now commenced.
- The company is also exploring an alternative, less frequent dosing regimen, including a 2,000 mg every two weeks dose, which demonstrated comparable or greater TGF-beta inhibition and rapid, deep responses, with plans for a loading phase and every 3-week maintenance schedule.
- Bicara expects to initially seek accelerated approval for the 1500 mg weekly regimen and plans a parallel randomized study to have loading and maintenance data available by the time of potential approval, aiming for earlier adoption of a streamlined regimen.
Feb 20, 2026, 1:30 PM
Bicara Therapeutics Provides Clinical Update on FICERA for HPV-Negative HNSCC
BCAX
Product Launch
New Projects/Investments
- Bicara Therapeutics provided a clinical update on February 20, 2026, for its product candidate FICERA (Ficerafusp alfa) in HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC).
- Preliminary efficacy data for the 2000mg Q2W FICERA + pembrolizumab regimen showed a confirmed Overall Response Rate (ORR) of 48% (13/27) and a Complete Response (CR) rate of 26% (7/27) in 1L R/M HPV-neg, CPS≥1 HNSCC patients.
- The 2000mg Q2W FICERA + pembrolizumab combination demonstrated a generally well-tolerated safety profile with no treatment-related deaths, consistent with the established safety profile of the 1500mg FICERA + pembrolizumab regimen.
- The company is pursuing a less frequent dosing strategy for FICERA, with the 2000mg Q2W data supporting its development and potential for a US launch.
- The FORTIFI-HN01 trial, a seamless registration-enabling Phase 2/3 study, has initiated Phase 3 and is currently enrolling patients with 1500mg QW FICERA.
Feb 20, 2026, 1:30 PM
Bicara Therapeutics Updates on Ficerafusp Alfa Clinical Data and Dosing Strategy
BCAX
New Projects/Investments
- Bicara Therapeutics presented preliminary safety and efficacy data for ficerafusp alfa (FICERA), an EGFR TGF-β bifunctional antibody, at the 2026 Multidisciplinary Head and Neck Cancer Symposium on February 20, 2026.
- Data for a 2,000 mg every other week dose of ficerafusp alfa in combination with pembrolizumab demonstrated a 48% confirmed response rate and an 85% disease control rate in 27 efficacy-evaluable HPV-negative patients.
- The company plans to explore a less frequent dosing regimen, starting with a 1,500 mg weekly loading phase and transitioning to an every three-week maintenance schedule, with a parallel randomized study planned to gather data for potential approval.
- The 1,500 mg weekly dose of ficerafusp alfa in combination with pembrolizumab has been established as the go-forward dose for the Phase III portion of the pivotal FORTIFI-HN01 study.
Feb 20, 2026, 1:30 PM
Bicara Therapeutics Reports Positive Ficerafusp Alfa Phase 1b Data and Plans New Dosing Regimen
BCAX
New Projects/Investments
Guidance Update
- Bicara Therapeutics presented preliminary safety and efficacy data from a Phase 1b expansion cohort for ficerafusp alfa 2000mg every other week (Q2W) in combination with pembrolizumab for first-line (1L) HPV-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 2026 Multidisciplinary Head and Neck Cancers Symposium on February 19, 2026.
- The 2000mg Q2W regimen demonstrated a 48% confirmed overall response rate (ORR), with 26% of patients achieving a complete response (CR), and 77% of responders showing deep responses (at least 80% tumor shrinkage).
- Based on these results, Bicara plans to develop a loading and every-three-week maintenance regimen for ficerafusp alfa, pending regulatory alignment.
- A conference call and webcast are scheduled for February 20, 2026, to discuss these findings.
Feb 19, 2026, 9:32 PM
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.
Jan 12, 2026, 7:15 PM
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.
Jan 12, 2026, 7:15 PM
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