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]

Core Insights - Bicara Therapeutics Inc. has initiated the enrollment of patients in the FORTIFI-HN01 trial, a pivotal Phase 2/3 study evaluating ficerafusp alfa in combination with pembrolizumab for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2] - Ficerafusp alfa is a first-in-class bifunctional antibody targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β), aiming to provide a novel treatment option for patients with advanced HNSCC [2][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 [6][7] - The company aims to address significant unmet medical needs in oncology, particularly in HNSCC, where current treatment options are limited [2][4] Industry Context - HNSCC is a prevalent cancer type with increasing incidence, projected to reach one million new cases globally by 2030, highlighting the urgent need for innovative therapies [3] - Approximately 80% of patients with recurrent/metastatic HNSCC are HPV-negative, facing severe morbidities and low survival rates, which underscores the critical demand for effective treatment options [4][3] Trial Details - The FORTIFI-HN01 trial is designed as a global, randomized, double-blinded, placebo-controlled study aiming to enroll around 650 patients with recurrent/metastatic HNSCC, focusing on those with a PD-L1 CPS of 1 or higher [2] - Primary endpoints include overall response rate and overall survival, with potential implications for regulatory filings for accelerated and full approval [2]

Core Insights - Bicara Therapeutics Inc. presented data from the Phase 1/1b dose expansion cohort of ficerafusp alfa combined with pembrolizumab for treating second line or later squamous cancer of the anal canal (SCAC) at the 2025 ASCO Gastrointestinal Cancers Symposium [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 [8] Drug Mechanism and Efficacy - Ficerafusp alfa is a first-in-class bifunctional antibody targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β), potentially enhancing anti-tumor activity [6][8] - The combination of ficerafusp alfa and pembrolizumab showed a confirmed overall response rate of 25.0% in a cohort of 28 patients, with 6 partial responses and 1 complete response [6] - The median progression-free survival (PFS) was reported at 2.9 months, with a 12-month PFS rate of 40.7% [6] Clinical Insights - Preliminary data indicated improved efficacy in SCAC patients, including those with liver metastases, suggesting the combination may enhance treatment outcomes compared to historical data with pembrolizumab alone [2][6] - The safety profile was deemed tolerable, with common treatment-related adverse events including acneiform dermatitis (57.1%), epistaxis (50.0%), and pruritus (46.4%) [6] Future Development - The data supports further investigation into the combination's potential in treating squamous cell carcinomas, particularly in first-line recurrent/metastatic head and neck squamous cell carcinoma [2][6]

Financial Position - As of September 30, 2024, the company has raised aggregate net proceeds of $686.5 million and has cash and cash equivalents of $520.8 million[138]. - The company believes its existing cash and cash equivalents will be sufficient to fund operations into the first half of 2029[141]. - As of September 30, 2024, the company had cash and cash equivalents of $520.8 million, expected to fund operations into the first half of 2029[173]. - The company has incurred significant operating losses and negative cash flows since inception, with aggregate net proceeds of $686.5 million from various financing activities[170]. Operating Losses and Expenses - The net loss for the nine months ended September 30, 2024, was $47.0 million, compared to a net loss of $39.5 million for the same period in 2023, resulting in an accumulated deficit of $200.1 million[139]. - Total operating expenses for the three months ended September 30, 2024, were $20.6 million, an increase of $11.1 million from $9.5 million in the same period in 2023[156]. - The company expects its expenses and operating losses to increase substantially as it conducts current and future clinical trials and expands its workforce[139]. - General and administrative expenses are anticipated to increase due to heightened research and development activities and compliance costs associated with being a public company[150]. - General and administrative expenses increased by $5.9 million from $6.1 million for the nine months ended September 30, 2023, to $12.0 million for the nine months ended September 30, 2024[168]. - Stock-based compensation expense totaled $4.2 million for the nine months ended September 30, 2024, an increase from $1.1 million in the same period of 2023[194]. Research and Development - Research and development expenses increased by $8.9 million from $6.9 million for the three months ended September 30, 2023, to $15.9 million for the same period in 2024[157]. - Research and development expenses increased by $23.7 million from $20.1 million for the nine months ended September 30, 2023, to $43.7 million for the nine months ended September 30, 2024[165]. - The increase in research and development expenses was primarily due to approximately $12.6 million in increased manufacturing costs and approximately $6.5 million in increased clinical operation and development costs[165]. - The ficerafusp alfa program accounted for approximately $20.2 million of the increased research and development expenses for the nine months ended September 30, 2024[166]. - The company plans to initiate a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in late Q4 2024 or early Q1 2025[137]. Revenue and Financing Activities - The company has not generated any revenue from product sales since its inception in December 2018 and does not expect to do so for several years[138]. - Interest income for the three months ended September 30, 2024, was $3.1 million, a significant increase compared to the previous period[156]. - Interest income for the nine months ended September 30, 2024, was $8.7 million, compared to $0.1 million for the same period in 2023, primarily due to significant increases in cash equivalents from financing activities[169]. - Net cash provided by financing activities was $335.0 million during the nine months ended September 30, 2024, significantly up from $77.8 million in the same period of 2023[180][181]. - The net increase in cash and cash equivalents for the nine months ended September 30, 2024, was $290.3 million, compared to $40.1 million for the same period in 2023[176]. Future Capital Requirements - The company expects to finance future capital needs through equity offerings, debt financings, or other capital sources, which may dilute existing stockholders' ownership[174]. - The company anticipates that its future capital requirements will depend on various factors, including product candidates and regulatory reviews[174]. - The company may need to delay or limit product development if it is unable to raise additional funds when needed[174]. Compliance and Reporting - The company did not have any off-balance sheet arrangements during the periods presented[182]. - The company may take advantage of exemptions for up to five years as an emerging growth company, ceasing to be one when total annual gross revenues reach $1.235 billion or more[197]. - The company qualifies as a "smaller reporting company" and can utilize scaled disclosures as long as the market value of its shares held by non-affiliates is less than $250 million or annual revenue is less than $100 million[198]. - The company has elected to avail itself of exemptions from new or revised accounting standards while being an emerging growth company, potentially affecting comparability with other public companies[197]. - Recent accounting pronouncements that may impact the company's financial position are disclosed in the consolidated financial statements[199]. - The company is electing scaled disclosure requirements available to Smaller Reporting Companies regarding market risk, indicating a simplified reporting approach[199].