PresentationI would now like to turn the call over to your speaker for today, Jenna Cohen, Chief Corporate Affairs Officer of Bicara Therapeutics. Please go ahead.Good day, and thank you for standing by. Welcome to the Bicara MHNCS Clinical Call Update. [Operator Instructions] Please be advised that today's call is being recorded.Jenna CohenChief Corporate Affairs Officer Thank you, and good morning, everyone. It's a pleasure to welcome you to Bicara Therapeutics' conference call. Yesterday, coinciding with ...

Core Viewpoint - Bicara Therapeutics Inc. has announced a public offering of 7,175,000 shares at $16.00 per share, aiming to raise approximately $150 million to support its clinical and commercial initiatives for ficerafusp alfa, a bifunctional therapy for solid tumors [1][2]. Group 1: Offering Details - The public offering includes pre-funded warrants for 2,200,000 shares at a price of $15.9999 each, with gross proceeds expected to be around $150 million before expenses [1]. - The offering is set to close on or about February 26, 2026, pending customary closing conditions [1]. - Underwriters have a 30-day option to purchase up to 1,406,250 additional shares at the public offering price [1]. Group 2: Use of Proceeds - Net proceeds will be used to enhance medical and commercial infrastructure for a planned regulatory filing and launch of ficerafusp alfa in the U.S. [2]. - Funds will also support the development of ficerafusp alfa in first-line recurrent/metastatic HPV-negative head and neck squamous cell carcinoma, including a less frequent dosing schedule [2]. - Additional uses include covering manufacturing costs for ongoing drug development and early signal-finding for future indication expansion [2]. Group 3: Company Overview - Bicara Therapeutics is focused on developing bifunctional therapies for solid tumors, with its lead program, ficerafusp alfa, designed to penetrate tumors by overcoming barriers in the tumor microenvironment [6]. - Ficerafusp alfa combines an EGFR-directed monoclonal antibody with a domain that binds to TGF-β, aiming to reverse the fibrotic and immune-excluded tumor microenvironment [6]. - The therapy is being developed for head and neck squamous cell carcinoma and other solid tumor types, addressing significant unmet medical needs [6].

BOSTON, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that it has commenced an underwritten public offering of $150 million of shares of its common stock. Bicara intends to grant the underwriters a 30-day option to purchase up to an additional $22,500,000 of shares of common stock offered in the public offering, at the public offer ...

Bicara Therapeutics (NasdaqGM:BCAX) Update / briefing February 20, 2026 08:30 AM ET Company ParticipantsBill Schelman - EVP of Clinical DevelopmentClaire Mazumdar - CEOJenna Cohen - Chief Corporate Affairs OfficerReni Benjamin - Managing DirectorStephen Willey - Managing DirectorConference Call ParticipantsEric Schmidt - Biotechnology AnalystJeet Mukherjee - VP and Biotechnology AnalystJudah Frommer - Executive Director and Senior Equity Research AnalystKelsey Goodwin - Director and Senior Research AnalystT ...

Core Insights - Bicara Therapeutics presented preliminary data from a Phase 1b expansion cohort evaluating ficerafusp alfa in combination with pembrolizumab for treating first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), showing rapid, deep, and durable responses with a well-tolerated safety profile [1][3][4] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa being its lead program [12][13] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration and improve survival outcomes by combining an EGFR-directed antibody with a TGF-β ligand trap [2][10] Clinical Data - The Phase 1b expansion cohort data indicated a 48% confirmed overall response rate (ORR) for the 2000mg every other week (Q2W) dosing regimen, with 26% of patients achieving a complete response (CR) and 77% of responders showing at least 80% tumor shrinkage [3][4] - The safety profile of the 2000mg Q2W regimen was consistent with previous findings for ficerafusp alfa combined with pembrolizumab [3][4] - Updated biomarker results confirmed that the 2000mg Q2W regimen maintains TGF-β inhibition and immune activation while delivering deep responses [5] Future Development Plans - The company plans to develop a loading and every-three-week maintenance regimen for ficerafusp alfa, pending regulatory alignment [1][6] - Ongoing enrollment in the pivotal FORTIFI-HN01 study continues to evaluate ficerafusp alfa at 1500mg weekly in combination with pembrolizumab [6][11] Industry Context - HNSCC is one of the most common cancers globally, with a rising incidence expected to reach one million new cases annually by 2030, highlighting a significant unmet need for effective therapies [8][9]

Core Insights - Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for patients with solid tumors [4] Group 1: Employee Inducement Grants - Bicara awarded inducement grants to two new employees on February 2, 2026, under its 2026 Inducement Plan [1] - The employees received non-qualified stock options to purchase a total of 158,900 shares at an exercise price of $16.76 per share, which is the closing price on the grant date [2] - The stock options vest one-fourth on the first anniversary of the employees' start date, with the remaining options vesting in 12 equal quarterly installments, contingent on continued service [2][3] Group 2: Company Overview - Bicara's lead program, ficerafusp alfa, is a first-in-class bifunctional antibody aimed at enhancing tumor penetration by addressing barriers in the tumor microenvironment [4] - Ficerafusp alfa targets two clinically validated components: an epidermal growth factor receptor (EGFR) directed monoclonal antibody and a domain that binds to human transforming growth factor beta (TGF-β) [4] - The therapy is being developed for head and neck squamous cell carcinoma and other solid tumor types, addressing significant unmet medical needs [4]

Bicara Therapeutics FY Conference Summary Company Overview - **Company Name**: Bicara Therapeutics (NasdaqGM:BCAX) - **Industry**: Biotechnology, specifically focused on targeted tumor modulation - **Headquarters**: Boston, Massachusetts - **Employee Count**: Approximately 100 Core Product - **Lead Program**: Ficerafusp alfa - **Mechanism**: Bifunctional antibody targeting solid tumors, specifically designed to penetrate tumors and modulate the tumor microenvironment - **Indications**: Primarily focused on HPV-negative recurrent and metastatic head and neck cancer Key Highlights from 2025 - **Clinical Development**: Significant progress in the clinical development of ficerafusp alfa, with two important data sets showing: - Depth and durability of response - Meaningful overall survival benefits compared to standard care in HPV-negative head and neck cancer [6][14] - **FDA Breakthrough Designation**: Granted for the HPV-negative subtype, recognizing it as a distinct clinical subtype with limited treatment options [6][7] - **Pivotal Study Initiation**: Launched the FORTIFY-HNS study, a seamless phase II/III trial for potential accelerated approval of ficerafusp alfa plus Pembrolizumab (Pembro) [8][19] 2026 Corporate Outlook - **Key Focus Areas**: - Execute the strategic development plan for ficerafusp alfa in frontline HPV-negative recurrent and metastatic head and neck cancer [9] - Anticipate an early launch in early 2028, with a focus on building a commercial foundation [9][10] - Hire a Chief Commercial Officer to support commercial strategy [10] - **Market Potential**: The head and neck cancer market is projected to exceed $5 billion by 2030, with 50,000 annual incidence cases of HPV-negative recurrent and metastatic head and neck cancer [20][34] Clinical Data Insights - **Response Rates**: Ficerafusp alfa demonstrated a confirmed response rate of 54%, with 80% of responders achieving at least 80% tumor shrinkage [12] - **Durability of Response**: Median duration of response was reported at 21.7 months, significantly exceeding standard care [13] - **Overall Survival**: Median overall survival greater than 21 months, tripling the standard of care outcomes [14][15] Safety Profile - **Well-Tolerated**: Ficerafusp alfa has shown a favorable safety profile, designed to minimize TGF- related toxicities [16] Future Development Plans - **Expansion into Other Tumor Types**: Plans to explore ficerafusp alfa's potential in metastatic colorectal cancer and pancreatic cancer, leveraging preclinical data [23][24] - **Proof-of-Concept Studies**: Initiated cohorts for ficerafusp alfa monotherapy and combination therapy in third-line MSS RAS wild-type metastatic colorectal cancer [24] Financial Guidance - **Cash Runway**: Bicara has over $400 million to fund its pivotal study through its confirmatory endpoint [40] Conclusion - **Strategic Vision**: Bicara Therapeutics is positioned for significant growth in 2026, focusing on executing its pivotal study, building a commercial foundation, and expanding its pipeline beyond head and neck cancer [41]

Core Insights - Bicara Therapeutics has selected 1500 mg of ficerafusp alfa as the optimal dose for the Phase 3 FORTIFI-HN01 pivotal study targeting HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2][3] - The company anticipates substantial enrollment in the FORTIFI-HN01 study by the end of 2026, enabling an interim analysis in mid-2027 [1][4] - Ficerafusp alfa is positioned to address a significant unmet need in the HPV-negative HNSCC market, which is a multi-billion-dollar sector [5] Company Strategy - Bicara aims to accelerate enrollment in the FORTIFI-HN01 study and is focused on achieving a clear path for potential accelerated filing based on interim analysis results [2][4] - The company plans to make critical commercial hires in 2026 to prepare for the launch of ficerafusp alfa, ensuring a strong foundation for future commercial success [6][15] - Bicara is exploring ficerafusp alfa's potential in other solid tumors, including metastatic colorectal cancer (mCRC), to further evaluate its pipeline-in-a-product potential [9][11] Clinical Development - Ficerafusp alfa has demonstrated a clinical dataset that more than doubles median overall survival in HPV-negative patients compared to standard care [6] - The drug is designed to improve tumor penetration and survival outcomes by targeting EGFR-expressing tumor cells and modulating TGF-β signaling [7][8] - The company plans to present data from various studies in 2026, including long-term follow-up data and exploratory studies evaluating different dosing strategies [11][15] Market Potential - The HPV-negative R/M HNSCC market is characterized by immune exclusion and a hostile tumor microenvironment, highlighting the need for more effective treatment options [5] - Ficerafusp alfa's unique mechanism of action positions it to potentially achieve blockbuster status in this growing market [5][6]

Company Overview - Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing transformative bifunctional therapies for patients with solid tumors [3] - The company's lead program, ficerafusp alfa, is a first-in-class bifunctional antibody aimed at enhancing tumor penetration by addressing challenges in the tumor microenvironment [3] Product Details - Ficerafusp alfa combines an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β) [3] - This targeted mechanism aims to reverse the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling, facilitating deeper and more durable responses in treatment [3] - Ficerafusp alfa is currently being developed for head and neck squamous cell carcinoma and other solid tumor types, addressing significant unmet medical needs [3] Upcoming Events - Claire Mazumdar, PhD, MBA, the CEO of Bicara Therapeutics, will present at the J.P. Morgan 2026 Healthcare Conference on January 12, 2026, at 11:15 a.m. PT [1] - A live webcast of the presentation will be available on the Investor Relations section of Bicara's website, with a replay accessible after the event [2]

Core Insights - Bicara Therapeutics presented preliminary data from a Phase 1b expansion cohort evaluating 750 mg of ficerafusp alfa in combination with pembrolizumab for treating HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [2][3] - The data showed a 57% confirmed overall response rate with 10% of patients achieving a complete response and 29% demonstrating deep responses of at least 80% tumor shrinkage [3][4] - The company plans to declare the optimal biologic dose for the pivotal FORTIFI-HN01 study in the first quarter of 2026 [5] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa as its lead program [12] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration and drive durable responses by targeting both EGFR and TGF-β [10][12] - The FDA has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizumab for first-line treatment of R/M HNSCC [10] Clinical Data - The Phase 1b expansion cohort data indicated that 750 mg of ficerafusp alfa was well-tolerated, with a safety profile consistent with previous studies [3][4] - Higher doses of ficerafusp alfa (1500 mg) showed greater TGF-β inhibition and immune activation, leading to deeper clinical responses, with a median depth of response of 82% compared to 63% at the 750 mg dose [4][5] - The totality of data suggests that increased TGF-β inhibition correlates with more durable outcomes for patients [5]