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Bicara Therapeutics Highlights Ficerafusp Alfa Progress and Reports Strong Cash Runway into 2029 Bicara reported Q1 2026 results, highlighting progress for its lead asset ficerafusp alfa in solid tumors, including HPV-negative head and neck squamous cell carcinoma, and a loss of $0.93 per share with an estimated cash balance of about $540m that management expects to fund operations into mid-2029.
The pivotal Phase 2/3 FORTIFI-HN01 trial of ficerafusp alfa in head and neck cancer is progressing, with an interim analysis planned by mid-2027 and a separate randomized loading and maintenance dosing study with pembrolizumab expected to start in Q3 2026.
Mature Phase 1/1b data presented at ASCO 2026 for the 1,500 mg weekly dose showed a 31% overall survival rate at roughly three years and deep responses in 80% of responders, while leadership additions include a new Chief Medical Officer and Chief Commercial Officer.
The key takeaway is that Bicara is increasingly a single-asset clinical story built around ficerafusp alfa, supported by a sizable cash runway and growing clinical data in first-line recurrent or metastatic HPV-negative head and neck cancer.
Investors may want to monitor upcoming trial milestones, dosing strategy readouts, and any regulatory interactions, since setbacks or delays in this lead program could have an outsized impact on the stock. Board Change • May 20
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Chairman of the Board Mike Powell was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. 공시 • May 12
Bicara Therapeutics Inc. Announces Executive Changes Bicara Therapeutics Inc. announced that effective May 8, 2026, Bill Schelman, M.D., Ph.D., previously the company’s Executive Vice President, Clinical Development, has succeeded David Raben, M.D., as Chief Medical Officer, and Dr. Raben has transitioned to serve as a Senior Executive Advisor. With this promotion, Dr. Schelman is responsible for medical affairs and clinical development. In his new role, Dr. Raben will advise on clinical development strategy across the company’s portfolio. Announced that effective May 8, 2026, Chris Sarchi was appointed as Chief Commercial Officer. In this role, he will lead the commercial organization in preparation for launch readiness. 공시 • May 04
Bicara Therapeutics Inc. to Report Q1, 2026 Results on May 11, 2026 Bicara Therapeutics Inc. announced that they will report Q1, 2026 results Pre-Market on May 11, 2026 공시 • Apr 30
Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2026 Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2026. 공시 • Mar 23
Bicara Therapeutics Inc. to Report Q4, 2025 Results on Mar 30, 2026 Bicara Therapeutics Inc. announced that they will report Q4, 2025 results Pre-Market on Mar 30, 2026 공시 • Feb 20
Bicara Therapeutics Inc. Presents Preliminary Safety and Efficacy Data from an Exploratory Phase 1b Expansion Cohort Evaluating 2000mg of Ficerafusp Alfa Every Other Week in Combination with Pembrolizumab in 1L HPV-Negative HNSCC Bicara Therapeutics Inc. presented preliminary safety and efficacy data from an exploratory Phase 1b expansion cohort evaluating 2000mg of ficerafusp alfa every other week (Q2W) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent metastatic (R M) head and neck squamous cell carcinoma (HNSCC). Bicara is currently evaluating ficerafusp alfa at 1500mg weekly (QW) in Phase 3 of the ongoing FORTIFI-HN01 pivotal study. Results from this alternative dosing cohort, including rapid, deep and durable responses, a consistent safety profile, and sustained TGF- neutralization in 1L HPV-negative R M HNSCC patients, reinforce the strength of ficerafusp alFA's differentiated mechanism of action," said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. The Phase 1b expansion cohort data presented at MHNCS show that 2000mg Q2W ficerafusp alfa in combination with pembrolIZumab was generally well-tolerated, with a safety profile consistent with the known safety profile of ficerafusp alf plus pembrolizumab In R M HNSCC. The growing body of pharmacokinetic, translational and clinical data supports development of an additional dose regimen that optimizes efficacy, safety and convenience without compromising the depth nor durability of response that are characteristic of ficeraf Susp alfa's differentiated clinical profile. Bicara plans to develop ficerafusp alfa with a loading and every-three-week maintenance schedule and aims to achieve regulatory alignment to enable data generation by potential U.S. approval. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ficerafusp alfa In combination with pembrolizUMab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R M) head and Neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand1 with combined positive score (CPS)1, excluding human papillomav virus (HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-H N01, a pivotal Phase 2 clinical trial in patients with 1L R M HNSCC. Factors that could cause actual results to difference include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials uncertainties as to the availability and timing of results and data from clinical trials whether results from prior preclinical studies, preliminary or interim data from earlier stage clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials regulatory developments in the United States and foreign countries whether Bicara's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements as well as the risks and uncertainties identified in Bicara's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10--FDA), including its annual Report on Form 10-FDA (SEC), including its Annual report on Form 10-FDA). 공시 • Jan 13
Bicara Therapeutics Announces Phase 3 Optimal Dose for the Treatment of 1L HPV-negative R/M HNSCC in Phase 3 FORTIFI-HN01 Pivotal Study Bicara Therapeutics Inc. has aligned with the U.S. Food and Drug Administration (FDA) on a clear path to implement, by the end of the first quarter, the optimal dose for Phase 3 of FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal trial of ficerafusp alfa in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The company anticipates that FORTIFI-HN01 will be substantially enrolled by the end of 2026 to enable an interim analysis in the middle of 2027.Ficerafusp alfa has the potential to achieve blockbuster status in HPV-negative R/M HNSCC, a multi-billion-dollar market that continues to grow. HPV-negative R/M HNSCC is a biologically distinct disease, often marked by immune exclusion and a hostile tumor microenvironment that limits the depth and durability of response to currently available therapies. Moreover, the majority of patients rapidly develop therapeutic resistance, underscoring the urgent need for more effective and durable treatment options. Ficerafusp alfa has a proven clinical dataset that more than doubles median overall survival in HPV-negative patients compared to standard of care and substantially improves upon median duration of response compared to other pembrolizumab combinations, including other approved and investigational EGFR-targeting agents. With increased conviction in ficerafusp alfa’s clinical potential, and as the company accelerates enrollment in the FORTIFI-HN01 pivotal study, Bicara plans to make critical commercial hires in 2026 to establish a strong foundation for future commercial success. Ficerafusp alfa is the first and only bifunctional EGFR-directed antibody combined with a TGF-ß ligand trap designed to drive increased tumor penetration and improve survival outcomes. By simultaneously targeting EGFR-expressing tumor cells and modulating TGF-ß–driven tumor microenvironment signaling, ficerafusp alfa is designed to improve tumor accessibility and enable more effective immune activity within the tumor. This bifunctional approach is intended to support deeper and more durable anti-tumor responses when used in combination with immune checkpoint inhibitors. There is a compelling biological rationale to explore ficerafusp alfa’s potential in solid tumors outside of HNSCC, especially in indications where EGFR is overexpressed and TGF-ß signaling contributes to tumor progression. Bicara is currently evaluating ficerafusp alfa in metastatic colorectal cancer (mCRC) and plans to expand signal-finding efforts in other solid tumors with significant unmet need to further evaluate ficerafusp alfa’s pipeline-in-a-product potential. 공시 • Dec 08
Bicara Therapeutics Inc. Presents Preliminary Phase 1b Expansion Cohort Data Evaluating 750mg of Ficerafusp Alfa Weekly Plus Bicara Therapeutics Inc. presented preliminary data from a Phase 1b expansion cohort evaluating 750 mg of ficerafusp alfa weekly (QW) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The data were highlighted in an oral presentation by Deborah Wong, MD, PhD of UCLA Medical Center at the European Society for Medical Oncology (ESMO) Asia Congress and will be discussed on a company conference call and webcast today, December 6, at 9:00 a.m. ET. Phase 1/1b expansion cohort data presented at ESMO Asia show that 750mg ficerafusp alfa in combination with pembrolIZumab was generally well-tolerated, with a safety profile consistent with the known safety profile of ficerafusp alFA plus pembrolizumab In R/M HNSCC. New biomarker data to be presented during Bicara's corporate call and webcast show that 1500mg of ficerafusp alfa yielded a greater increase TGF-b inhibition within the tumor microenvironment and greater immune activation, compared to 750mg of ficerafusp Alfa. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ficerafusp alfa In combination with pembrolizUMab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) Head and neck squamous cell carcinomas (HNSCC) whose tumors express programmed death-ligand1 with combined positive score (CPS)1, excluding human papillomavirus ("HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with 1L R/M HNSCC". Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies, preliminary or interim data from earlier stage clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; whether Bicara's cash resources will be sufficient to fund its unforeseeable and unforeseeable operating expenses and capital expenditure requirements; as a result of the development of product candidates, as a result of the results of subsequent pre clinical studies and clinical trials; and whether Bicara's cash Resources will be sufficient to fund its future and unforeseeable operating costs and capital expenditure requirements; as a result of the results in the U.S. and the results of the first quarter of 2026. 공시 • Dec 01
Bicara Therapeutics Announces Publication of an Abstract with Preliminary Phase 1B Expansion Cohort Data Evaluating 750Mg of Ficerafusp Alfa Weekly Plus Pembrolizumab in 1L Hpv-Negative R/M Hnscc At Esmo Asia 2025 Bicara Therapeutics Inc. announced the publication of an abstract with early data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly (QW) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The results will be highlighted in an oral presentation at the upcoming European Society for Medical Oncology (ESMO) Asia Congress and will be discussed on a company conference call and webcast on Saturday, December 6, at 9:00 a.m. ET. Key highlights of the abstract include: Expansion cohort data (July 9, 2025 cutoff date) from the Phase 1/1b clinical trial of ficerafusp alf in patients with 1L HPV-negative R/M HNSCC evaluating 750mg of Ficerafusp alfa weekly in combination with pembrolIZumab. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizeumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) Head and neck squamous cell carcinomas (HNSCC) whose tumors express programmed death-ligand1 with combined positive score (CPS)1, excluding human papillomavirus ("HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with 1L R/M HNSCC. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; whether Bicara's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Bicara's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and the Company to host conference call and webcast on December 6, 2025. 공시 • Oct 13
Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA for 1L HPV-Negative R/M HNSCC Bicara Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand1 with combined positive score (CPS)1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. This designation from the FDA underscores the growing recognition of HPV-negative HNSCC as a distinct clinical indication within head and neck cancer - one with particularly poor outcomes, limited therapeutic options, and that represents the vast majority of patients. BTD was supported by results from multiple Phase 1/1b dose cohorts evaluating ficerafusp alfa In combination with pembrolizUMab in patients with 1L HPV-negative R/M HNSCC. Data most recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated deep and durable clinical benefit with a median duration of response of 21.7 months, and a median overall survival of 21.3 months, alongside a favorable safety and tolerability profile. BTD is intended to expedite the development and review of potential new medicines that show substantial improvement over available therapies for serious or life-threatening conditions, providing greater interaction with the FDA, involvement of senior agency leadership, and eligibility for rolling and priority review. 공시 • Jun 02
Bicara Therapeutics Inc. Demonstrates Deep and Durable Responses with Ficerafusp Alfa Plus Pembrolizumab in 1L HPV-Negative R/M HNSCC at ASCO 2025 Bicara Therapeutics Inc. presented updated data from the company’s Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-ß). In the Phase 1/1b trial, ficerafusp alfa in combination with pembrolizumab resulted in deep and durable anti-tumor activity with improved overall survival (OS) compared to historical benchmarks in patients with 1L R/M human papillomavirus (HPV)-negative HNSCC with a PD-L1 combined positive score (CPS) of =1 and with at least 24 months of follow-up. In the efficacy evaluable human papillomavirus (HPV)-negative population (n=28): Median duration of response (DOR) of 21.7 months amongst responders (n=15). Median OS of 21.3 months; 2-year OS rate of 46%. 54% (15/28) confirmed objective response rate (ORR); 64% (18/28) ORR, including an additional three unconfirmed responses. 21% (6/28) complete response rate. 80% (12/15) of responders achieved a deep response (=80% tumor shrinkage). Disease control rate of 89% (25/28 patients). Median progression-free survival of 9.9 months. Manageable safety profile consistent with previously reported adverse events. 공시 • Apr 29
Bicara Therapeutics Inc. Highlights Broad Potential of Ficerafusp Alfa at AACR Annual Meeting 2025 Bicara Therapeutics Inc. announced multiple presentations related to ficerafusp alfa at the American Association for Cancer Research (AACR) Annual Meeting 2025. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-b) and is being evaluated across multiple solid tumor types. 공시 • Apr 28
Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2025 Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2025. 공시 • Apr 23
Bicara Therapeutics to Present Updated Data from Ongoing Phase 1/1B Trial of Ficerafusp Alfa in 1L R/M HNSCC At the 2025 American Society of Clinical Oncology Annual Meeting Bicara Therapeutics Inc. announced that updated data from the company's ongoing Phase 1/1b clinical trial of ficerafusp alfa in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) will be highlighted in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 30-June 3, 2025 in Chicago, IL. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-b) and is being evaluated across multiple solid tumor types. Ficerafusp alf is a first-in- class bifunctional antibody that combine two clinically validated targets, an epidermal growth factor receptors (EGFR) directed monOClonal antibody with a domain That binds to human transforming growth factor Beta (TGF-b). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment. Ficerafusp alFA is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial 1L (first line)urrent/metastatic (R-M) head and neck squ Famous cell carcinoma (H NSCC). 공시 • Feb 13
Bicara Therapeutics Announces First Patients Enrolled in FORTIFI-HN01, a Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in 1L Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Bicara Therapeutics Inc. announced the first patients have been enrolled in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-ß). FORTIFI-HN01 is a global, randomized, double-blinded, placebo-controlled, pivotal Phase 2/3 trial that aims to enroll approximately 650 R/M HNSCC patients, excluding patients with human papillomavirus (HPV)-positive with oropharyngeal squamous cell carcinoma. Patients enrolled in the trial must have a PD-L1 CPS greater than or equal to one, and not have received systemic therapy in the R/M setting. The primary endpoints are overall response rate based on RECIST v1.1 and overall survival, with results potentially supporting filings for both accelerated approval and full approval. Secondary endpoints include progression free survival and duration of response. 공시 • Jan 28
Bicara Therapeutics Presents Phase 1/1B Dose Expansion Results with Ficerafusp Alfa in Advanced Squamous Cancer of the Anal Canal At the 2025 Asco Gastrointestinal Cancers Symposium Bicara Therapeutics Inc. announced the presentation of data from the Phase 1/1b dose expansion cohort of ficerafusp alfa in combination with pembrolizumab in patients with second line (2L) or later squamous cancer of the anal canal (SCAC). The results were presented in a poster session during the 2025 ASCO Gastrointestinal (GI) Cancers Symposium on Saturday, January 25, 2025. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-b), and is being evaluated in multiple solid tumor types. The addition of ficeraf Susp alfa shows the potential to improve efficacy compared to historical data with pembrolizumib monotherapy in SCAC, with increased overall response rate, disease control rate, and 12-month progression-free survival, indicative of improved speed, depth, and durability of response. Importantly, responses were observed even in patients with liver metastases, which is a significant outcome in this setting. Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment. 공시 • Sep 14
Bicara Therapeutics Inc. has completed an IPO in the amount of $315 million. Bicara Therapeutics Inc. has completed an IPO in the amount of $315 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 17,500,000
Price\Range: $18
Discount Per Security: $1.26
Transaction Features: Reserved Share Offering; Sponsor Backed Offering 
