BOSTON, Feb. 05, 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 it awarded inducement grants on February 2, 2026 to two new employees under Bicara’s 2026 Inducement Plan as a material inducement to employment. The employees received, in the aggregate, non-qualified stock options to purchase 158,900 shares of Bicara’s common stock, par value ...

Bicara Therapeutics (NasdaqGM:BCAX) FY Conference January 12, 2026 02:15 PM ET Company ParticipantsClaire Mazumdar - CEORyan Kohlhepp - President and CEOAlex Kramer - AssociateAlex KramerGood morning, everyone, and welcome to day one of the 44th Annual J.P. Morgan Healthcare Conference here in San Francisco. My name is Alex Kramer, and I'm a member of the JPMorgan Healthcare Investment Banking team. It is my pleasure to introduce our next presenting company, Bicara Therapeutics. I'm joined by CEO Claire Maz ...

Selected 1500 mg of ficerafusp alfa as the optimal dose for the treatment of 1L HPV-negative R/M HNSCC in Phase 3 FORTIFI-HN01 pivotal study Expects to achieve substantial enrollment in FORTIFI-HN01 in 2026 to enable interim analysis in mid-2027 Anticipates multiple expansion cohort data readouts in 2026 to further characterize ficerafusp alfa’s profile in HPV-negative HNSCC and support potential expansion into other solid tumor types, including colorectal cancer Claire Mazumdar, PhD, MBA, Chief Executive ...

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 Inc. 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% of responders 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 being 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 combined with pembrolizumab was well-tolerated, maintaining 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] Industry Context - HNSCC is one of the most common cancers globally, with an anticipated rise to one million new cases annually by 2030 [8] - Approximately 80% of patients with recurrent/metastatic HNSCC are HPV-negative, highlighting a significant unmet need for effective therapies [9]

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]

Summary of Bicara Therapeutics FY Conference Call Company Overview - Bicara Therapeutics focuses on developing bifunctional, trifunctional, and multifunctional agents targeting solid tumors, with a primary emphasis on TGF- and EGFR [4][5][6] Key Clinical Developments - The lead program, ficerafusp alfa, is in a pivotal phase 2-3 trial for frontline recurrent metastatic head and neck cancer, initiated in February 2025 [5][6] - Clinical data presented at ASCO 2023 showed significant improvements in response rates, progression-free survival (PFS), duration of response, and overall survival [6][9] - The response rate in the trial has nearly tripled compared to standard treatments, with a median duration of response exceeding 20 months [10][11] Mechanism of Action Insights - TGF- is believed to enhance the depth and durability of responses, while EGFR primarily drives response rates [14][15] - The trial has demonstrated a 55% confirmed response rate at the 750 mg dose, comparable to the 1500 mg dose, indicating effective saturation of the EGFR target [14][15] - The data suggests that TGF- contributes significantly to the clinical benefits observed, particularly in terms of duration of response [12][34] Safety Profile - The safety profile at the 1500 mg dose includes transient, low-grade bleeding events, primarily epistaxis and gingival bleeding, which are common in head and neck cancer patients [21][22] - Anemia rates are higher at the 1500 mg dose, but this has not led to treatment discontinuations [22] Trial Design and Regulatory Strategy - The phase 2 component of the trial aims to determine the optimal dose between 750 mg and 1500 mg, with a seamless design allowing for accelerated approval based on overall response rate [25][27] - The FDA has guided that approximately 350 events will be sufficient for a data cut to facilitate potential accelerated approval [25] Competitive Landscape - Bicara's approach is differentiated by its focus on TGF- in combination with EGFR, which has shown superior duration of response compared to other treatments [33][34] - The company has excluded HPV-positive patients from its pivotal study to focus on a population with a higher likelihood of response [36][37] Future Outlook - Bicara plans to provide updates on the 2000 mg Q2W expansion cohort in early 2026, which may allow for less frequent dosing and better synchronization with pembrolizumab [28][30] - The company is expanding its clinical trial sites globally, including North America, Europe, Asia, and South America, to enhance patient recruitment [40]

Core Insights - Bicara Therapeutics announced early data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa in combination with pembrolizumab for first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2] - The results indicate a high overall response rate and a safety profile consistent with the 1500mg dose, supporting ongoing pivotal trials [1][2] 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 [11] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both epidermal growth factor receptor (EGFR) and transforming growth factor beta (TGF-β) [9][11] Clinical Trial Data - In the efficacy evaluable population of 30 patients, the objective response rate was 57%, with 50% achieving partial responses and 7% achieving complete responses [6] - The disease control rate was reported at 83%, and complete neutralization of TGF-β1 was observed [6] - Safety findings were consistent with the known safety profile of ficerafusp alfa plus pembrolizumab in R/M HNSCC [6] Upcoming Events - Bicara Therapeutics will present the findings at the European Society for Medical Oncology (ESMO) Asia Congress on December 6, 2025, and will host a conference call and webcast on the same day [1][5][3]

Core Insights - The article emphasizes the importance of staying updated on stocks within the biotech, pharma, and healthcare sectors, highlighting key trends and catalysts that influence market valuations [1]. Group 1: Industry Overview - The biotech, pharma, and healthcare industries are experiencing significant movements, necessitating investors to track developments closely [1]. - The Haggerston BioHealth investing group provides insights into catalysts for investment decisions, including buy and sell ratings, product sales forecasts, and integrated financial analyses [1]. Group 2: Analyst Background - Edmund Ingham, a biotech consultant with over five years of experience, has compiled detailed reports on more than 1,000 companies in the sector [1]. - The investing group led by Ingham caters to both novice and experienced investors, offering comprehensive market analyses and forecasts [1].

Financial Performance - The company has incurred net losses of $36.3 million and $100.6 million for the three and nine months ended September 30, 2025, respectively, compared to $17.5 million and $47.0 million for the same periods in 2024[117]. - The company has an accumulated deficit of $321.6 million as of September 30, 2025[117]. - Total operating expenses for the three months ended September 30, 2025, increased to $40.7 million from $20.6 million in 2024, representing a 97.1% increase[136]. - For the nine months ended September 30, 2025, total operating expenses reached $114.5 million, compared to $55.8 million in 2024, a 105.2% increase[141]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $82.9 million, compared to $44.7 million for the same period in 2024, reflecting an increase in net loss from $47.0 million to $100.6 million[152][153]. - The total net decrease in cash and cash equivalents for the nine months ended September 30, 2025, was $318.0 million, compared to an increase of $290.3 million in 2024[151]. Cash and Funding - As of September 30, 2025, the company had raised aggregate net proceeds of $688.3 million and had cash, cash equivalents, and investments totaling $407.6 million[116]. - The company expects its existing cash will be sufficient to fund operations into the first half of 2029, but anticipates significant commercialization expenses related to product sales, marketing, manufacturing, and distribution[119]. - The company plans to finance its cash needs through equity offerings, debt financings, or other capital sources until it can generate significant revenue[119]. - The company filed a Registration Statement for an offering of up to $400.0 million in securities to fund operations and provide additional liquidity[146]. - Net cash provided by financing activities decreased to $1.0 million for the nine months ended September 30, 2025, down from $335.0 million in 2024, which was mainly from proceeds of the initial public offering[155]. Research and Development - Research and development expenses are expected to increase substantially as the company advances ficerafusp alfa into late-stage clinical trials and expands manufacturing efforts[128]. - Research and development expenses rose by $17.1 million to $33.0 million for the three months ended September 30, 2025, compared to $15.9 million in 2024, a 107.7% increase[137]. - Research and development expenses for the nine months ended September 30, 2025, increased by $48.4 million to $92.1 million from $43.7 million in 2024, a 110.7% increase[142]. Clinical Trials and Product Development - The ongoing pivotal FORTIFI-HN01 Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab is expected to provide data in 2025 and 2026 for various cohorts[120]. - In a Phase 1/1b clinical trial, the combination of ficerafusp alfa and pembrolizumab demonstrated a confirmed objective response rate of 54% in HPV-negative patients, with a median overall survival of 21.3 months[121]. - The company has not generated any revenue from product sales to date and does not expect to do so until successful development and regulatory approval of ficerafusp alfa[123]. Administrative Expenses - General and administrative expenses are anticipated to rise to support increased research and development activities and compliance with regulatory requirements[132]. - General and administrative expenses increased by $2.9 million to $7.7 million for the three months ended September 30, 2025, from $4.8 million in 2024, a 60.8% increase[138]. - General and administrative expenses for the nine months ended September 30, 2025, rose by $10.4 million to $22.4 million from $12.0 million in 2024, a 86.7% increase[143]. Interest Income - Interest income for the three months ended September 30, 2025, was $4.4 million, up from $3.1 million in 2024, a 41.0% increase[139]. - Interest income for the nine months ended September 30, 2025, was $14.1 million, compared to $8.7 million in 2024, a 62.6% increase[144]. Non-Cash Charges - The company reported non-cash charges of $11.2 million for the nine months ended September 30, 2025, which included stock-based compensation, depreciation, and non-cash lease expenses[152]. Company Classification - The company is classified as an "emerging growth company," allowing it to take advantage of reduced disclosure requirements for up to five years[157]. - The company qualifies as a "smaller reporting company," which permits it to utilize scaled disclosures as long as certain market value and revenue thresholds are not exceeded[160]. Operational Enhancements - The company is focused on enhancing operational systems and hiring additional personnel to meet public company obligations, which will incur associated costs[150]. - The company is assessing the costs and timing of establishing sales and marketing capabilities for future product candidates, contingent on regulatory approvals[150]. Accounting Policies - There were no material changes to the company's critical accounting policies during the three months ended September 30, 2025[156].