• Genentech for next-generation cancer antibody therapies.
• A specialized Regeneron Pharmaceuticals (REGN), focused on innovative cancer biologics.

• BCA101: A lead clinical-stage bifunctional antibody candidate designed to target both the epidermal growth factor receptor (EGFR) and transforming growth factor-beta (TGF-β) pathways for the treatment of various solid tumors.
• Preclinical Pipeline: A portfolio of earlier-stage bifunctional immune checkpoint enhancer (BICE®) candidates aimed at undisclosed targets and indications, currently in research and preclinical development.

Claire Mazumdar, PhD, MBA Chief Executive Officer

Claire Mazumdar is the founding CEO of Bicara Therapeutics. She previously led business development and corporate strategy at Rheos Medicines, where she helped secure a significant partnership with Roche. As a Senior Associate at Third Rock Ventures, a venture capital firm, she focused on company formation and supported business development for its portfolio companies, indicating a pattern of involvement with privately backed firms.

Ivan Hyep, MBA Chief Financial Officer

Ivan Hyep previously served as Head of Finance at MOMA Therapeutics and as Director of Finance at Third Rock Ventures, LLC. Prior to that, he spent 10 years as a Financing Manager at Bain Capital, LP, a private investment firm, demonstrating a clear pattern of managing companies backed by private equity firms.

Ryan Cohlhepp, PharmD President & Chief Operating Officer

Ryan Cohlhepp serves as the President & Chief Operating Officer of Bicara Therapeutics.

David Raben, MD Chief Medical Officer

David Raben brings over 25 years of experience in biopharma and academic translational oncology. Before joining Bicara, he was Vice President of Global Product Development and Product General Manager, Oncology, at Amgen. Prior to Amgen, he served as Vice President and Franchise Leader, Clinical Development Oncology, at Genentech. He also spent more than 20 years as a professor and associate member at the University of Colorado Cancer Center.

Lara Meisner, JD Chief Legal Officer & Corporate Secretary

Lara Meisner previously held the position of Chief Legal Officer at Viridian Therapeutics, Inc., and served in various senior legal roles at Astria Therapeutics, Inc. and Verastem Oncology, Inc.

The key risks to Bicara Therapeutics (BCAX) primarily revolve around clinical development, financial sustainability, and market competition.

1. Clinical Execution and Trial Data Risk: As a clinical-stage biopharmaceutical company, Bicara Therapeutics' success hinges on the successful progression and positive outcomes of its clinical trials. A significant risk is associated with the upcoming full dataset from the Phase 1/1b study and the ongoing pivotal Phase 2/3 FORTIFI-HN01 trial for its lead candidate, ficerafusp alfa, particularly in combination with KEYTRUDA for head and neck squamous cell carcinoma (HNSCC). Even with promising interim data and Breakthrough Therapy Designation, there is no assurance that final data will be positive or that it will translate into similar positive outcomes in later stages or broader patient populations. Negative or disappointing results, delays in trials, or a lack of translation from early-stage data to a viable commercial pathway could significantly impact the company.
2. Financing Needs and Dilution Risk: Bicara Therapeutics is currently a company with no revenue and widening losses, having reported significant year-to-date losses. The company relies on its existing cash resources and the ability to raise additional capital to fund its research and development activities and operating expenses. While it has an at-the-market equity program in place, continued losses and the need for future funding introduce the risk of shareholder dilution through additional equity offerings. The ability to raise capital on reasonable terms is influenced by market confidence and clinical milestones.
3. Competition Risk: Bicara Therapeutics operates in a highly competitive oncology market. Its lead candidate, ficerafusp alfa, faces direct competition from other companies developing therapies for similar indications, such as Merus's petosemtamab in the HNSCC field. Perceived superiority of rival clinical data, even if cross-trial comparisons are unreliable, can negatively impact Bicara's stock performance and future market positioning.

Bicara Therapeutics' (NASDAQ: BCAX) main product is ficerafusp alfa (BCA101), a first-in-class, dual-action, bifunctional antibody targeting EGFR and TGF-β.

The total addressable market for ficerafusp alfa in head and neck squamous cell carcinoma (HNSCC) is estimated to exceed $1.5 billion annually. This market size is presented in the context of the company's overall market potential, and while a specific region is not explicitly stated for the $1.5 billion figure, the global incidence of HNSCC is noted to approach one million new patients by 2030, with a significant incidence in the U.S.

• Commercialization of Ficerafusp Alfa in Head and Neck Squamous Cell Carcinoma (HNSCC): The most significant driver is the potential approval and launch of ficerafusp alfa for the treatment of first-line recurrent/metastatic HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC). The company has reported promising Phase 1/1b trial results and has initiated a pivotal Phase 2/3 trial (FORTIFI-HN01) in this indication. Ficerafusp alfa has also been granted Breakthrough Therapy Designation by the U.S. FDA for 1L HPV-negative R/M HNSCC, which may facilitate an accelerated regulatory pathway.
• Expansion of Ficerafusp Alfa into Other Solid Tumor Indications: Beyond HNSCC, Bicara Therapeutics is evaluating ficerafusp alfa in other EGFR-driven advanced solid tumors. These include squamous cell carcinoma of the anal canal (SCAC) and cutaneous squamous cell carcinoma (CSCC), among others such as epithelial ovarian cancer, colorectal cancer, pancreas cancer, and squamous cell carcinoma of the lung. Successful clinical development and subsequent regulatory approvals in these additional indications would significantly broaden the market opportunity for ficerafusp alfa.
• Potential for Accelerated Regulatory Approval Pathways: The Breakthrough Therapy Designation granted to ficerafusp alfa for 1L HPV-negative R/M HNSCC could lead to increased interaction with the FDA, senior leadership involvement, and eligibility for rolling and priority review. This accelerated pathway has the potential to bring the drug to market sooner, thereby enabling earlier revenue generation.

Share Issuance

• Bicara Therapeutics completed its Initial Public Offering (IPO) on September 16, 2024, raising approximately $362 million in gross proceeds.
• The IPO involved the offering of 20,125,000 shares of common stock at a price of $18.00 per share, which included the full exercise of the underwriters' option for additional shares.
• As of October 2025, the number of outstanding shares for Bicara Therapeutics was 54,539,230.

Inbound Investments

• Bicara Therapeutics closed an oversubscribed $165 million Series C financing round on December 12, 2023.
• This Series C financing was co-led by Braidwell LP and TPG, with participation from other new and existing investors.
• The company has raised a total of $313 million across three funding rounds (Seed, Early-Stage, and Late-Stage), with the first round occurring on March 15, 2021.

Capital Expenditures

• In the last 12 months (as of August 12, 2025), Bicara Therapeutics reported capital expenditures of -$48,000.
• Annual capital expenditures were -$0.05 million in the most recent fiscal year (as of August 12, 2025), and were also reported as -$0.07 million, -$0.59 million, and -$0.19 million in prior years.
• As a clinical-stage biopharmaceutical company, Bicara Therapeutics relies on third-party manufacturing and service agreements to support its clinical trials and research and development, indicating a focus away from large internal manufacturing capital outlays.