We are a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Our lead program ficerafusp alfa is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor, or EGFR, directed monoclonal antibody with a domain that binds to human transforming growth factor beta, or TGF-ß. 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-ß signaling within the tumor microenvironment, or TME. Ficerafusp alfa directs the TGF-ß inhibitor into the immediate TME through the binding of EGFR on tumor cells, which we believe will lead to durable responses and an increase in overall survival, or OS, while reducing the adverse effects typically associated with systemic TGF-ß inhibition. Ficerafusp alfa is initially being developed in head and neck squamous cell carcinoma, or HNSCC, where there remains a significant unmet need. We intend to initiate a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab as a first-line therapy in recurrent/metastatic, or R/M, HNSCC excluding patients associated with human papillomavirus infection, or HPV-positive patients, with oropharyngeal squamous cell carcinoma, or OPSCC, late in the fourth quarter of 2024 or early in the first quarter of 2025. We are conducting an ongoing Phase 1/1b trial of ficerafusp alfa in the U.S., which includes a cohort of HNSCC patients who were treatment-naïve in the R/M setting. In this cohort, treatment with ficerafusp alfa in combination with pembrolizumab resulted in a 54% (21/39) overall response rate, or ORR, in the efficacy evaluable population, and a 64% (18/28) ORR in patients not associated with human papillomavirus infection, or HPV-negative patients. The historical response rate observed in a Phase 3 trial with pembrolizumab monotherapy, the current standard of care in R/M HNSCC, was 19%. Furthermore, treatment with ficerafusp alfa in combination with pembrolizumab demonstrated an 18% (5/28) complete response rate, or CR rate, and a median progression-free survival, or mPFS, of 9.8 months in HPV-negative patients. With at least 12 months of follow-up, median OS and median duration of response, or mDOR, have not yet been reached, and we expect to announce updated interim Phase 1/1b data at future medical meetings in 2025. Based on the clinical data generated to date, we believe that ficerafusp alfa in combination with pembrolizumab has the potential to become a first-line standard of care therapy in HPV-negative R/M HNSCC. We also believe ficerafusp alfa has the potential to provide meaningful clinical benefit in other solid tumors where there is a strong biologic rationale for the dual inhibition of both EGFR and TGF-ß, such as colorectal cancer and other squamous cell carcinomas which typically overexpress EGFR and TGF-ß pathways. We have demonstrated preliminary activity of ficerafusp alfa in combination with pembrolizumab or as a monotherapy across several squamous cell carcinomas, including cutaneous squamous cell carcinoma, or CSCC. Within our Phase 1/1b dose expansion cohorts conducted in the U.S. and Canada, we have observed to date a preliminary 42% (5/12) ORR with ficerafusp alfa monotherapy in relapsed and/or refractory CSCC patients. We have built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site. This dual-targeting approach both enhances drug exposure within the TME and limits systemic toxicity. This approach was deployed in the development of ficerafusp alfa, where we believe the bifunctional design can improve upon the therapeutic profile of immunotherapies and targeted therapies by addressing resistance mechanisms and limiting off-target toxicity, therefore, enhancing the treatment effect and tolerability for targeted patient populations with cancer. We were incorporated under the laws of the State of Delaware on December 12, 2018 under the name “Bicara Therapeutics Inc.” Our principal corporate office is located at 116 Huntington Avenue, Suite 703, Boston, MA 02116, and our telephone number is 617-468-4219. We have one subsidiary, Bicara Securities Corporation, formed in October 2023 under the laws of the Commonwealth of Massachusetts.