Financial Position - Bicara Therapeutics reported a cash position of approximately $462 million as of March 31, 2025, down from $489.7 million at the end of 2024, with expectations to fund operations into the first half of 2029[11]. - Research and development expenses for Q1 2025 were $34.3 million, a significant increase from $12.0 million in Q1 2024, primarily due to costs associated with the initiation of the FORTIFI-HN01 trial[11]. - General and administrative expenses rose to $7.5 million in Q1 2025, compared to $3.3 million in Q1 2024, driven by increased personnel costs and professional fees[11]. - The net loss for Q1 2025 was $36.8 million, compared to a net loss of $12.5 million in Q1 2024[11]. Clinical Trials - The ongoing FORTIFI-HN01 trial is a pivotal Phase 2/3 study evaluating ficerafusp alfa in combination with pembrolizumab for HPV-negative recurrent/metastatic head and neck squamous cell carcinoma[4]. - An oral presentation at the 2025 ASCO Annual Meeting will highlight updated data from the ongoing Phase 1/1b trial of ficerafusp alfa, scheduled for June 1, 2025[8]. - Preliminary findings from the Phase 1/1b trial indicated an overall response rate of 30.4% in patients with second line or later cutaneous squamous cell carcinoma, with a median progression-free survival of 7.0 months[8]. - Bicara is developing ficerafusp alfa as a first-in-class dual-action bifunctional antibody targeting EGFR and TGF-β for various solid tumor types[3]. - Additional Phase 1b expansion cohorts for ficerafusp alfa are ongoing, including evaluations in HPV-negative patients and those with metastatic colorectal cancer[8]. - The company plans to initiate a cohort evaluating ficerafusp alfa in combination with pembrolizumab for HPV-positive patients with a history of heavy smoking in 2025[8].

Core Insights - Bicara Therapeutics is advancing its clinical programs, particularly the pivotal Phase 2/3 trial of ficerafusp alfa in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [2][4] - The company has a strong financial position with approximately $462 million in cash and cash equivalents, expected to fund operations into the first half of 2029 [1][11] - Updated data from ongoing clinical trials will be presented at the 2025 ASCO Annual Meeting, showcasing the potential of ficerafusp alfa to demonstrate differentiated depth and durability of response [2][7] Clinical Development - Enrollment is ongoing in the FORTIFI-HN01 trial, which is a global, randomized, double-blind, placebo-controlled study of ficerafusp alfa in combination with pembrolizumab for first-line treatment of R/M HNSCC [4] - The ongoing Phase 1/1b trial is expected to provide insights into the drug's efficacy and mechanisms of action, with preliminary findings indicating effective TGF-β signaling blockade [11][6] - Several expansion cohorts are evaluating different dosing regimens of ficerafusp alfa in combination with pembrolizumab for various patient populations, including those with HPV-negative and HPV-positive cancers [7][6] Financial Performance - For the first quarter of 2025, research and development expenses increased to $34.3 million from $12.0 million in the same period of 2024, primarily due to costs associated with the initiation of clinical trials [11][9] - General and administrative expenses rose to $7.5 million in Q1 2025 from $3.3 million in Q1 2024, reflecting increased personnel costs and professional fees [11][9] - The net loss for the first quarter of 2025 was $36.8 million, compared to a net loss of $12.5 million in the first quarter of 2024 [11][9]

Core Viewpoint - Bicara Therapeutics Inc. is advancing its lead product, ficerafusp alfa, a bifunctional antibody targeting EGFR and TGF-β, showing promising results in treating solid tumors, particularly in head and neck squamous cell carcinoma and cutaneous squamous cell carcinoma [1][2][9] 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 [9] - The company aims to address significant unmet needs in cancer treatment, particularly in patients with advanced or metastatic diseases [4][9] Product Development - Ficerafusp alfa is a first-in-class bifunctional antibody that combines an EGFR-directed monoclonal antibody with a TGF-β binding domain, potentially enhancing anti-tumor activity by targeting both cancer cell survival and immunosuppressive signaling [7][9] - The drug is currently being evaluated in pivotal Phase 2/3 clinical trials for first-line recurrent/metastatic head and neck squamous cell carcinoma [8] Clinical Data Highlights - Recent presentations at the AACR Annual Meeting 2025 showcased data supporting ficerafusp alfa's ability to block TGF-β signaling, which may prevent resistance mechanisms in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma [2][3] - In a Phase 1/1b trial for second-line metastatic cutaneous squamous cell carcinoma, ficerafusp alfa demonstrated an overall response rate of 30.4% and a clinical benefit rate of 82.6%, with a median progression-free survival of 7.0 months [3][4] - The drug also showed potential in reversing acquired resistance to KRAS G12C inhibitors in KRAS G12C-mutant lung cancer, indicating its broad therapeutic potential [5][11] Market Context - Cutaneous squamous cell carcinoma is the second most common skin cancer, with rising incidence highlighting the need for effective treatment options, especially for patients who progress on anti-PD-1 therapies [4][6] - The lack of approved second-line therapies for patients with advanced or metastatic cutaneous squamous cell carcinoma underscores the importance of ficerafusp alfa's development [4][6]

Core Viewpoint - Bicara Therapeutics Inc. is advancing its clinical-stage bifunctional therapy, ficerafusp alfa, for treating recurrent/metastatic head and neck squamous cell carcinoma, with updated data to be presented at the 2025 ASCO Annual Meeting [1][2]. Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing transformative bifunctional therapies for patients with solid tumors [6]. - The lead program, ficerafusp alfa, is a first-in-class bifunctional antibody targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β) [4][6]. Clinical Trial Information - Ficerafusp alfa is currently being evaluated in the pivotal Phase 2/3 clinical trial (FORTIFI-HN01) for first-line recurrent/metastatic head and neck squamous cell carcinoma [5]. - The updated results from an expansion cohort of an open-label, multicenter, Phase 1/1b trial will be presented at the ASCO meeting [3][8]. Presentation Details - The oral presentation is scheduled for June 1, 2025, from 12:12 to 12:18 p.m. CT at the McCormick Place Convention Center [8].

Group 1 - The central challenge in oncology is to develop therapies that are both effective against tumors and have a manageable safety profile, addressing issues of tumor resistance and toxicity [1] - There is a strong inclination towards investing in high-growth companies within sectors that are expected to experience exponential expansion, particularly those involved in disruptive technologies [1] Group 2 - The approach to investment combines fundamental analysis with predictions of future trends, emphasizing the potential of innovation to generate substantial returns [1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission file number 001-42271 _________________________ Bicara Therapeutics Inc. (Exact name of registrant as specified in its charte ...

Financial Performance - As of December 31, 2024, Bicara had cash and cash equivalents of $489.7 million, up from $230.4 million as of December 31, 2023, indicating a 112% increase[12] - Research and development expenses for Q4 2024 were $19.9 million, compared to $10.6 million in Q4 2023, representing an increase of 88%[12] - General and administrative expenses for Q4 2024 were $6.8 million, up from $3.1 million in Q4 2023, reflecting a 119% increase[12] - The net loss for Q4 2024 was $21.0 million, compared to a net loss of $12.4 million in Q4 2023, marking a 69% increase in losses[12] - The total operating expenses for the full year 2024 were $82.4 million, compared to $39.9 million for the full year 2023, indicating a 106% increase[12] Assets and Liabilities - Total assets increased to $509,996 thousand in 2024 from $233,982 thousand in 2023, representing a growth of 118%[18] - Current assets rose to $502,533 thousand in 2024, up from $231,073 thousand in 2023, marking an increase of 117%[18] - Total liabilities increased to $18,121 thousand in 2024 from $15,474 thousand in 2023, showing a rise of 17%[18] - Current liabilities rose to $17,990 thousand in 2024, up from $15,085 thousand in 2023, which is an increase of 19%[18] - Accounts payable increased to $3,893 thousand in 2024 from $2,142 thousand in 2023, representing a growth of 82%[18] - Accrued expenses and other current liabilities rose to $12,875 thousand in 2024, compared to $8,053 thousand in 2023, marking an increase of 60%[18] - Operating lease liability – current portion increased to $607 thousand in 2024 from $285 thousand in 2023, reflecting a growth of 113%[18] - Other assets increased to $6,618 thousand in 2024 from $2,094 thousand in 2023, representing a growth of 216%[18] Cash Flow and Funding - The company expects its existing cash resources to fund operations into the first half of 2029[12] Research and Development - Bicara commenced dosing in the FORTIFI-HN01 pivotal Phase 2/3 trial of ficerafusp alfa in 1L recurrent/metastatic head and neck squamous cell carcinoma in February 2025[4] - Updated data from the ongoing Phase 1/1b trial of ficerafusp alfa will be presented at the 2025 ASCO Annual Meeting[5] - Bicara plans to initiate a Phase 1b expansion cohort for ficerafusp alfa in patients with 3L+ metastatic colorectal cancer in 2025[8] - Bicara's lead program, ficerafusp alfa, is being developed for multiple solid tumor types, including head and neck squamous cell carcinoma[10] Stockholders' Equity - Total stockholders' equity improved to $491,875 thousand in 2024, compared to a deficit of $(148,769) thousand in 2023, indicating a positive turnaround[18]

Core Insights - Bicara Therapeutics has initiated dosing in the pivotal Phase 2/3 trial, FORTIFI-HN01, for ficerafusp alfa in first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][4] - The company reported a strong financial position with approximately $490 million in cash and cash equivalents, expected to fund operations into the first half of 2029 [1][12] - The year 2024 was significant for Bicara, marked by its transition to a public company and advancements in its lead asset, ficerafusp alfa [2] Pipeline Highlights - Ficerafusp alfa is a first-in-class bifunctional antibody targeting both epidermal growth factor receptor (EGFR) and transforming growth factor beta (TGF-β) for various solid tumors [3][10] - The ongoing Phase 1/1b trial data will be presented at the 2025 ASCO Annual Meeting, showcasing the potential of ficerafusp alfa in HNSCC [5] Clinical Trials - The FORTIFI-HN01 trial is a global, randomized, double-blind, placebo-controlled study combining ficerafusp alfa with pembrolizumab in first-line R/M HNSCC, excluding HPV-positive oropharyngeal cases [4] - Additional expansion cohorts for ficerafusp alfa are planned in various cancer types, including cutaneous squamous cell carcinoma and colorectal cancer [8] Financial Results - For the fourth quarter of 2024, research and development expenses were $19.9 million, up from $10.6 million in the same period of 2023, primarily due to costs associated with the FORTIFI-HN01 trial [12] - General and administrative expenses increased to $6.8 million for Q4 2024, compared to $3.1 million in Q4 2023, reflecting costs related to operating as a public company [12] - The net loss for the fourth quarter of 2024 was $21.0 million, compared to $12.4 million in Q4 2023 [12][15] Cash Position - As of December 31, 2024, Bicara had cash and cash equivalents of $489.7 million, significantly up from $230.4 million at the end of 2023 [12][17] - The company expects its cash resources to sustain operations through the first half of 2029, supporting ongoing clinical trials and development efforts [12][13]

Core Viewpoint - Bicara Therapeutics Inc. is advancing its lead product candidate, ficerafusp alfa, a bifunctional antibody targeting solid tumors, with three abstracts to be presented at the AACR Annual Meeting 2025 [1] Group 1: Product Candidate Overview - Ficerafusp alfa is a first-in-class bifunctional antibody that combines an EGFR-directed monoclonal antibody with a domain that binds to TGF-β, aimed at treating various solid tumor types [1][5] - The dual-targeting mechanism of ficerafusp alfa is designed to block both cancer cell survival and immunosuppressive signaling within the tumor microenvironment [5] Group 2: Presentation Details - The first presentation will cover the results of a Phase 1/1b dose expansion cohort of ficerafusp alfa monotherapy in patients with metastatic or advanced cutaneous squamous cell carcinoma (cSCC) [2] - The second presentation will discuss the potential of ficerafusp alfa to overcome resistance mechanisms in first-line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) when combined with Pembrolizumab [3] - The third presentation will highlight preclinical data showing how ficerafusp alfa can reverse acquired resistance to the KRAS-G12C inhibitor sotorasib in KRAS-G12C-mutated lung tumors [4] Group 3: Event Information - The AACR Annual Meeting 2025 will take place from April 25-30, 2025, in Chicago, IL, with specific sessions for the presentations scheduled on April 28 and 29 [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 bifunctional antibody targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β) [3] - Ficerafusp alfa aims to provide potent anti-tumor activity by blocking EGFR survival and proliferation while also inhibiting TGF-β signaling in the tumor microenvironment [3] Upcoming Events - Claire Mazumdar, PhD, MBA, the CEO of Bicara Therapeutics, will present at the TD Cowen 45th Annual Health Care Conference on March 3, 2025, at 3:10 p.m. ET [1] - A live webcast of the presentation will be available, with a replay archived for later access [2] Market Need - Bicara Therapeutics is developing ficerafusp alfa for head and neck squamous cell carcinoma, addressing a significant unmet medical need, as well as for other solid tumor types [3]