Core Viewpoint - Bicara Therapeutics Inc. announced updated interim data from its Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab for patients with recurrent/metastatic head and neck squamous cell carcinoma, highlighting promising efficacy and safety results [1][2][4]. 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 [10]. - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β) [8][10]. Clinical Trial Details - The Phase 1/1b trial evaluated ficerafusp alfa in patients with first line recurrent/metastatic head and neck squamous cell carcinoma, specifically those with a PD-L1 combined positive score (CPS) of ≥1 [4]. - Updated interim data showed a 64% objective response rate in the HPV-negative population, with 21% achieving a complete response [4]. - Median progression-free survival was reported at 9.8 months, and the 12-month overall survival rate was 61% [4]. Presentation and Data Sharing - Bicara Therapeutics will present the full dataset during an oral presentation at the 2025 ASCO Annual Meeting, scheduled for June 1, 2025 [1][3][4]. - The conference call will provide further insights into the overall survival and duration of response data following the ASCO presentation [1][5]. Industry Context - Head and neck squamous cell carcinoma (HNSCC) is a common malignancy with a rising incidence, expected to reach one million new cases globally by 2030 [6]. - Approximately 80% of patients with recurrent/metastatic HNSCC are HPV-negative, which is associated with worse survival outcomes and a critical unmet need for effective therapies [7].

Financial Performance - The company has incurred net losses of $36.8 million and $12.5 million for the three months ended March 31, 2025 and 2024, respectively, with an accumulated deficit of $257.9 million as of March 31, 2025[113]. - Total operating expenses increased by $26.4 million from $15.4 million for the three months ended March 31, 2024, to $41.8 million for the same period in 2025[130]. - Net cash used in operating activities was $28.1 million in Q1 2025, compared to $14.6 million in Q1 2024, reflecting a net loss of $36.8 million[139][141]. - The company expects to incur significant operating losses and expenses as it advances clinical development of product candidates[134][135]. Research and Development - Research and development expenses rose by $22.3 million from $12.0 million in Q1 2024 to $34.3 million in Q1 2025, primarily due to increased manufacturing and clinical operation costs[131]. - Ficerafusp alfa is being developed for head and neck squamous cell carcinoma, with a pivotal Phase 2/3 trial initiated early in Q4 2024[111]. - The company has not generated any revenue from product sales since its inception in December 2018 and does not expect to do so until regulatory approval is obtained for ficerafusp alfa or future product candidates[116]. - Future capital requirements will depend on clinical trial costs, regulatory reviews, and market acceptance of product candidates[140]. Cash and Funding - The company has raised aggregate net proceeds of $687.7 million and had cash and cash equivalents of $462.1 million as of March 31, 2025[112]. - The company expects to fund operations into the first half of 2029 with existing cash and cash equivalents, but may need additional funding for future commercialization efforts[115]. - Cash provided by financing activities was $0.5 million in Q1 2025, up from $0.1 million in Q1 2024, mainly from stock option exercises[143]. - The company has raised a total of $687.7 million since inception in December 2018 through various financing activities, including IPO and private placements[134]. Operating Expenses - The company anticipates significant increases in general and administrative expenses to support research and development activities and compliance with regulatory requirements[125]. - General and administrative expenses increased by $4.1 million from $3.3 million in Q1 2024 to $7.5 million in Q1 2025, primarily due to increased personnel costs and professional fees[132][136]. - General and administrative expenses included approximately $2.4 million in personnel costs, $1.0 million in professional service expenses, and $0.7 million in IT-related expenses[136]. - Manufacturing costs increased by approximately $14.1 million due to drug substance batch manufacturing for clinical trials[131]. Interest Income - Interest income for the three months ended March 31, 2025, was $5.0 million, an increase from $2.9 million in the same period in 2024[130]. - Interest income rose to $5.0 million in Q1 2025 from $2.9 million in Q1 2024, attributed to a significant increase in cash equivalents from stock sales[133]. Company Classification - The company qualifies as an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of reduced disclosure requirements[146][148].

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]