Summary of Bicara Therapeutics FY Conference Call Company Overview - Bicara Therapeutics is a clinical-stage biotech company focused on targeted tumor modulation, developing bifunctional molecules that enhance efficacy and durability while eliciting an immunotherapy-like response [3][4] Lead Molecule: Ficerafusp Alfa - Ficerafusp alfa is a bifunctional EGFR-TGF-1/3 inhibitor that entered clinical trials in summer 2020 [3] - Recent data presented at ASCO showed that combining ficerafusp alfa with pembrolizumab in first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) tripled response rates and doubled overall survival compared to pembrolizumab monotherapy [3][12] Unmet Medical Need - HPV-negative head and neck cancer has a poor prognosis, with a 19% overall response rate and a median overall survival of about nine months [7][12] - Ficerafusp alfa shows significantly better efficacy in HPV-negative patients, which are primarily driven by smoking and alcohol use [8][19] Mechanism of Action - Ficerafusp alfa targets TGF-1 and TGF-3, known cancer-associated isoforms, while avoiding cardiotoxicities associated with TGF-2 [4][5] - The molecule is designed to localize TGF- inhibition directly to the tumor microenvironment, enhancing its therapeutic effect [5] Clinical Development and Regulatory Path - The Phase 2/3 trial is designed to satisfy Project Optimus, allowing for accelerated approval based on interim analyses of overall response rates and survival [15][17] - The company anticipates full enrollment by 2027 and is actively engaging with the FDA to ensure compliance with regulatory requirements [14][17][36] Market Opportunity - The majority of recurrent and metastatic head and neck cancer patients are HPV-negative, with estimates of 80-85% in the U.S. and up to 99% in some regions of Europe and Asia [20][21] - The company is developing a companion diagnostic to harmonize HPV testing, which is crucial for patient stratification [21][22] Financial Position - Bicara Therapeutics has over $440 million in cash, sufficient to fund pivotal studies and support ongoing clinical trials [36] Competitive Landscape - The company believes that the market for head and neck cancer is large enough to accommodate multiple therapies, with ficerafusp alfa positioned favorably due to its unique mechanism of action [32][34] Future Directions - Bicara is exploring ficerafusp alfa in other solid tumor indications, including colorectal cancer and cutaneous squamous cell carcinoma, with data expected next year [28][29] - The company is also considering geographic-specific partnerships to enhance market access and commercialization strategies [44] Key Takeaways - Ficerafusp alfa demonstrates promising clinical efficacy in a high unmet need area, with a strong regulatory strategy and financial backing to support its development [3][12][36] - The company is well-positioned to navigate the competitive landscape of oncology therapeutics, particularly in head and neck cancer [32][34]

Financial Data and Key Metrics Changes - The company reported a median overall survival of over 21 months in head and neck cancer, showing a significant improvement over the current standard of care, which is approximately 12.3 months with pembro monotherapy [5][13]. - The confirmed response rate for the company's treatment was reported at 54%, indicating a tripling of the responder population compared to pembro monotherapy [12]. Business Line Data and Key Metrics Changes - The lead asset is an EGFR TGF beta bifunctional molecule, which has been in clinical development since 2020 across various tumor types [3]. - The company is currently enrolling patients in the FORTIFY HN-one trial, which is a pivotal trial for the treatment in head and neck cancer [6]. Market Data and Key Metrics Changes - HPV negative patients account for about 85% of overall head and neck cancer cases in the recurrent and metastatic setting, indicating a substantial target market for the company's treatment [35]. - The total annual incidence of head and neck cancer in the U.S. is around 57,000, with recurrent metastatic cases accounting for approximately 23,000 patients [42]. Company Strategy and Development Direction - The company aims to optimize dosing in its pivotal trial by evaluating two different doses (750 mg and 1500 mg) in combination with pembro, with plans to select the most effective dose based on initial patient data [17][34]. - There are ongoing plans to expand into the locally advanced setting, where the company believes its treatment could show differential effects due to the TGF beta component [40][41]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the treatment's ability to mitigate acquired resistance pathways associated with EGFR monoclonal antibodies by combining it with TGF beta [10]. - The company has sufficient cash reserves, with $437 million on hand, providing a runway to fund operations through 2029, allowing it to complete its pivotal trial [61]. Other Important Information - The company is developing a PCR HPV test as a companion diagnostic to improve sensitivity over traditional testing methods [38]. - The company is exploring the potential of its treatment in colorectal cancer, particularly in heavily pretreated populations, with preliminary data expected in 2026 [56]. Q&A Session Summary Question: What is the relative contribution of the two different targets in the mechanism? - The combination of EGFR and TGF beta is designed to mitigate acquired resistance and enhance efficacy in head and neck cancer treatment [10]. Question: What safety events are being observed? - The most common adverse events include acneiform rash and anemia, with manageable side effects and no treatment discontinuations reported [14][15]. Question: How is the pivotal study designed? - The pivotal study includes a dose optimization portion, where initial data from 10 to 20 patients per group will inform the selection of the most effective dose [17]. Question: What is the expected market opportunity for the treatment? - The recurrent metastatic head and neck cancer market is significant, with a large percentage of patients being HPV negative, which the company is targeting [35][42]. Question: What is the company's cash position and funding for future trials? - The company has raised $362 million at its IPO and has $437 million in cash, providing a runway to fund its current pivotal trial through 2029 [61].

Summary of Bicara Therapeutics Conference Call Company Overview - Bicara Therapeutics is a clinical-stage biotechnology company focused on targeted tumor modulation, specifically through its lead program, an EGFR TGF beta trap, which entered clinical trials in 2020 [2][4] Core Points and Arguments Market Opportunity - The recurrent and metastatic head and neck cancer market presents a significant unmet need, with approximately 30,000 patients annually in the US alone, and a larger global market due to high rates of smoking and chewing tobacco [4] - The majority of patients in this market are HPV negative, accounting for about 80% of the frontline opportunity in the US and 90-95% in Europe and Asia [5] Treatment Mechanism - Fisera, the company's lead drug, combines EGFR and TGF beta targeting, which is particularly relevant for the immunosuppressive HPV negative tumor microenvironment [6][7] - The drug has shown a greater than 50% response rate and a tripling of progression-free survival (PFS) compared to standard treatments [16] Clinical Data - At ASCO, data indicated a greater than 50% response rate in HPV negative patients, with a median overall survival (OS) exceeding 20 months, compared to 9 months with standard pembrolizumab [16][30] - The company has observed a 25% complete response rate, which is notable in head and neck cancer [23] Competitive Landscape - Bicara faces competition from Merus, which is developing a bispecific EGFR LGR5 molecule. However, Bicara argues that their mechanism as an immunotherapy leads to deeper and more durable responses [19][20] - The company emphasizes the importance of overall survival and durability over short-term response rates, which have historically not translated into long-term benefits [21] Future Clinical Trials - Bicara plans to expand its clinical trials to include 90 HPV negative patients and is exploring alternative dosing schedules [35][36] - The phase two-three design includes a seamless transition to a larger study, with an interim analysis expected in 2027 [44][56] Financial Position - As of Q2, Bicara reported over $440 million in cash, sufficient to fund its pivotal study and ongoing research [70] Additional Important Points - The company is developing its own HPV PCR test to improve diagnostic accuracy, which is expected to be part of the drug's label [13] - Bicara is also exploring treatment options in colorectal cancer, targeting TGF beta's role in resistance to existing therapies [68][69] - The CPS zero cohort is being enrolled to assess the drug's efficacy in patients who typically do not respond to pembrolizumab [65] This summary encapsulates the key points discussed during the conference call, highlighting Bicara Therapeutics' strategic focus, clinical advancements, and market positioning.

Group 1 - Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for patients with solid tumors [2] - The company's lead program, ficerafusp alfa, is a first-in-class bifunctional antibody that targets the tumor microenvironment to enhance treatment efficacy [2] - Ficerafusp alfa combines an EGFR-directed monoclonal antibody with a domain that binds to TGF-β, aiming to reverse the fibrotic and immune-excluded tumor microenvironment [2] Group 2 - Bicara Therapeutics will participate in multiple investor conferences, including the Cantor Global Healthcare Conference and the Wells Fargo Healthcare Conference [3] - The live webcasts of the investor presentations will be available on the company's Investor Relations website [1][3] - Replays of the webcasts will be archived for access after each event [1]

Core Viewpoint - Bicara Therapeutics Inc. (BCAX) has seen a 5% increase in share price over the past four weeks, closing at $11.33, with a mean price target of $32.6 indicating a potential upside of 187.7% [1] Price Targets - The average price target consists of five estimates ranging from a low of $8.00 to a high of $48.00, with a standard deviation of $15.26, suggesting variability in analyst predictions [2] - The lowest estimate indicates a potential decline of 29.4%, while the highest suggests a 323.7% upside [2] Analyst Consensus and Earnings Estimates - Analysts are optimistic about BCAX's earnings prospects, as indicated by a trend of upward revisions in earnings estimates, which historically correlates with stock price movements [4][11] - Over the past 30 days, one earnings estimate has increased, leading to a 3.6% rise in the Zacks Consensus Estimate for the current year [12] Zacks Rank - BCAX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13] Caution on Price Targets - While price targets are a common metric, they should not be the sole basis for investment decisions due to concerns about analysts' biases and the reliability of their estimates [3][10]

PART I: FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements (Unaudited)](index=10&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Bicara Therapeutics Inc., including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining the company's business, significant accounting policies, and specific financial line items [Condensed Consolidated Balance Sheets](index=10&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position at specific points in time, detailing assets, liabilities, and stockholders' equity | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $436,606 | $489,711 | | Total current assets | $444,391 | $502,533 | | Total assets | $453,587 | $509,996 | | Total current liabilities | $17,227 | $17,990 | | Total liabilities | $18,391 | $18,121 | | Total stockholders' equity | $435,196 | $491,875 | | Accumulated deficit | $(285,250) | $(221,016) | - Cash and cash equivalents decreased from **$489.7 million** at December 31, 2024, to **$436.6 million** at June 30, 2025. Total assets also decreased from **$509.9 million** to **$453.5 million** during the same period. The accumulated deficit increased significantly from **$(221.0) million** to **$(285.2) million**[24](index=24&type=chunk) [Condensed Consolidated Statements of Operations](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's revenues, expenses, and net loss over specific periods, reflecting operational performance | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total operating expenses | $32,018 | $19,750 | $73,806 | $35,124 | | Loss from operations | $(32,018) | $(19,750) | $(73,806) | $(35,124) | | Interest income | $4,682 | $2,701 | $9,696 | $5,568 | | Net loss | $(27,388) | $(17,049) | $(64,234) | $(29,557) | | Net Loss per share, basic and diluted | $(0.50) | $(19.01) | $(1.18) | $(38.19) | - Net loss increased significantly year-over-year for both the three-month and six-month periods ended June 30, 2025, primarily due to higher operating expenses. Net loss per share (basic and diluted) for the three months ended June 30, 2025, was **$(0.50)** compared to **$(19.01)** in the prior year, and for the six months, it was **$(1.18)** compared to **$(38.19)**, reflecting a substantial increase in weighted-average shares outstanding[27](index=27&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in the company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit | Metric (in thousands) | December 31, 2024 | March 31, 2025 | June 30, 2025 | | :-------------------- | :---------------- | :------------- | :------------ | | Total Stockholders' Equity | $491,875 | $458,957 | $435,196 | | Accumulated Deficit | $(221,016) | $(257,862) | $(285,250) | | Additional Paid-in Capital | $712,884 | $716,812 | $720,439 | - Total stockholders' equity decreased from **$491.8 million** at December 31, 2024, to **$435.1 million** at June 30, 2025, driven by net losses of **$(36.8) million** and **$(27.3) million** in Q1 and Q2 2025, respectively. Additional paid-in capital increased due to stock-based compensation and option exercises[34](index=34&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=14&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities over specific periods | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(53,700) | $(27,495) | | Net cash provided by investing activities | $0 | $39 | | Net cash provided by financing activities | $595 | $871 | | Net decrease in cash and cash equivalents | $(53,105) | $(26,585) | | Cash and cash equivalents at end of period | $436,606 | $203,855 | - Net cash used in operating activities increased to **$53.7 million** for the six months ended June 30, 2025, from **$27.5 million** in the prior year, primarily due to increased net loss. Cash and cash equivalents decreased by **$53.1 million** in the first half of 2025, ending at **$436.6 million**[37](index=37&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=15&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Description of Business, Organization, and Liquidity](index=15&type=section&id=1.%20Description%20of%20Business,%20Organization,%20and%20Liquidity) This section describes the company's core business, organizational structure, and its current liquidity position and future funding needs - Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with its lead program, ficerafusp alfa, targeting EGFR and TGF-β[38](index=38&type=chunk) - The company has incurred significant operating losses since inception, with an accumulated deficit of **$285.3 million** as of June 30, 2025. It expects its **$436.6 million** cash and cash equivalents to fund operations for at least one year from the issuance date of the financial statements[44](index=44&type=chunk)[45](index=45&type=chunk) - In September 2024, the company completed a **9.2435-to-1** reverse stock split and an IPO, issuing **20,125,000** shares of common stock for net proceeds of **$332.4 million**[40](index=40&type=chunk)[41](index=41&type=chunk) [2. Summary of Significant Accounting Policies](index=16&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the key accounting principles and methods used in preparing the financial statements, including revenue recognition and R&D expenses - The financial statements are prepared in conformity with U.S. GAAP on a going concern basis, including the accounts of Bicara and its wholly-owned subsidiary[46](index=46&type=chunk)[47](index=47&type=chunk) - Bicara is an 'emerging growth company' and has elected to use the extended transition period for complying with new or revised accounting standards, which may make its financial statements not comparable to other public companies[49](index=49&type=chunk)[150](index=150&type=chunk) - Research and development costs are expensed as incurred. R&D expenses were **$24.8 million** and **$15.8 million** for the three months ended June 30, 2025 and 2024, respectively, and **$59.1 million** and **$27.9 million** for the six months ended June 30, 2025 and 2024, respectively[52](index=52&type=chunk)[54](index=54&type=chunk) - Stock-based compensation is recognized using a fair-value based method, with fair value of options determined by the Black-Scholes model. Total stock-based compensation expense was **$3.5 million** and **$1.0 million** for the three months ended June 30, 2025 and 2024, respectively, and **$6.9 million** and **$2.2 million** for the six months ended June 30, 2025 and 2024, respectively[56](index=56&type=chunk)[84](index=84&type=chunk) [3. Fair Value Measurements](index=

Investment Highlights - Bicara Therapeutics is advancing ficerafusp alfa (FICERA), a bifunctional EGFR-directed antibody x TGF-β ligand trap, designed to enable tumor penetration by breaking barriers in the tumor microenvironment to drive deep and durable responses[8, 125] - FICERA + pembro offers a potential new 1L therapy for HPV-negative R/M HNSCC, with the FORTIFI-HN01 Ph 2/3 trial ongoing and enrolling[8, 125] - The company has a robust financial position with approximately $437 million in cash and equivalents[8, 125] Clinical Trial & Market Opportunity - There is a significant market opportunity with approximately 23,000 cases of R/M HNSCC annually in the U S, and a significant unmet need for better treatment options (13% 5yr survival)[8, 33, 125] - In a Ph 1b trial of FICERA + Pembrolizumab in HPV-neg, CPS≥1 1L R/M HNSCC, the confirmed ORR was 54% (15/28)[60, 75] - The same trial showed a median PFS of 9 9 months and a median OS of 21 3 months, with a 2-year OS rate of 46%[66, 72, 75] - The median DOR was 21 7 months, with DOR rates of 79% at 6 months, 65% at 12 months, and 57% at 18 months[69, 75] Expansion Opportunities - The company is expanding into other squamous cell carcinomas and solid tumors, with encouraging clinical activity observed in Ph 1b expansion cohorts to date[8, 125] - In 2L+ cutaneous squamous cell carcinoma (cSCC), FICERA monotherapy showed an ORR of 30% (7/23) and a mPFS of 7 0 months in PD-1-refractory patients[114] - In 2L+ squamous cancer of the anal canal (SCAC), FICERA + pembro showed a 25% ORR (7/28) and a 12-month PFS rate of 40 7%[118]

[Company Overview & Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20%26%20Q2%202025%20Highlights) Bicara Therapeutics reported Q2 2025 financial results and business updates, showcasing positive Phase 1/1b trial data for ficerafusp alfa and a strong financial position [Key Highlights](index=1&type=section&id=Key%20Highlights) Bicara Therapeutics reported Q2 2025 results, highlighting updated Phase 1/1b ficerafusp alfa data and a strong $437 million cash position - Updated data from Phase 1/1b trial of ficerafusp alfa presented at 2025 ASCO Annual Meeting showed **deep and durable responses** in 1L HPV-negative R/M HNSCC[1](index=1&type=chunk) - Data from additional Phase 1/1b expansion cohorts evaluating alternate dose regimens in HPV-negative patients are expected by **Q1 2026**[1](index=1&type=chunk) Cash Position | Metric | Value (million USD) | | :-------------------------------- | :------------------- | | Cash and Cash Equivalents (June 30, 2025) | $437 | | Expected Funding Runway | Into the first half of 2029 | [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Claire Mazumdar highlighted ficerafusp alfa's progress, with ASCO 2025 data supporting its differentiated mechanism and pivotal trial design - CEO highlighted excellent progress with ficerafusp alfa development, noting updated Phase 1/1b data presented at ASCO 2025[2](index=2&type=chunk) - The data from the 1500mg weekly cohort demonstrated ficerafusp alfa's ability to remodel tumor stroma and drive tumor penetration, resulting in **deep, durable anti-tumor responses** in HPV-negative R/M HNSCC patients[2](index=2&type=chunk) - The ASCO data provides a strong foundation for the pivotal Phase 2/3 FORTIFI-HN01 trial and reinforces confidence in its design, with additional Phase 1/1b expansion cohort data expected to further characterize the safety and efficacy profile[2](index=2&type=chunk) [Business Update: Pipeline Highlights](index=1&type=section&id=Business%20Update%3A%20Pipeline%20Highlights) This section details the development of ficerafusp alfa, including its mechanism, pivotal trial progress, and data from Phase 1/1b studies [Ficerafusp Alfa Overview](index=1&type=section&id=Ficerafusp%20Alfa%20Overview) Ficerafusp alfa is a first-in-class, dual-action bifunctional antibody targeting EGFR and TGF-β, designed to enhance tumor penetration - Ficerafusp alfa is a **first-in-class, dual-action bifunctional epidermal growth factor receptor (EGFR)/transforming growth factor beta (TGF-β) antibody**[3](index=3&type=chunk) - It is designed to enhance tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers[3](index=3&type=chunk) [FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial](index=1&type=section&id=FORTIFI-HN01%3A%20Pivotal%20Phase%202/3%20Clinical%20Trial) Enrollment is ongoing for FORTIFI-HN01, a pivotal Phase 2/3 trial evaluating ficerafusp alfa plus pembrolizumab in 1L R/M HNSCC (HPV-negative) - Enrollment is ongoing in FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, **pivotal Phase 2/3 trial**[4](index=4&type=chunk) - The trial evaluates ficerafusp alfa in combination with pembrolizumab in **first-line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)**[4](index=4&type=chunk) - Patients with oropharyngeal squamous cell carcinoma associated with human papillomavirus infection (HPV-positive) are excluded[4](index=4&type=chunk) [Phase 1/1b Clinical Trial Data in 1L R/M HNSCC](index=2&type=section&id=Phase%201/1b%20Clinical%20Trial%20Data%20in%201L%20R/M%20HNSCC) Updated Phase 1/1b trial data for ficerafusp alfa in 1L R/M HNSCC (HPV-negative) showed promising efficacy and safety, with further data expected [1500mg Weekly Cohort (ASCO 2025 Data)](index=2&type=section&id=1500mg%20Weekly%20Cohort%20(ASCO%202025%20Data)) ASCO 2025 data for the 1500mg weekly ficerafusp alfa cohort in 1L R/M HNSCC (HPV-negative) demonstrated significant efficacy and a manageable safety profile - Updated data with extended follow-up from a Phase 1/1b trial evaluating 1500mg ficerafusp alfa weekly in patients with 1L R/M HNSCC was highlighted at the 2025 ASCO Annual Meeting[8](index=8&type=chunk) Efficacy in HPV-negative population (n=28) | Metric | Value | | :-------------------------------- | :------------------- | | Median Duration of Response (DOR) | **21.7 months** (among responders, n=15) | | Median Overall Survival (OS) | **21.3 months** | | 2-year OS rate | **46%** | | Confirmed Objective Response Rate (ORR) | **54%** (15/28) | | Total ORR (including unconfirmed) | **64%** (18/28) | | Complete Response Rate (CRR) | **21%** (6/28) | | Responders achieving deep response (≥80% tumor shrinkage) | **80%** (12/15) | | Disease Control Rate (DCR) | **89%** (25/28) | | Median Progression-Free Survival (PFS) | **9.9 months** | | Safety Profile | Manageable, consistent with previously reported adverse events | [Additional Phase 1b Expansion Cohorts](index=2&type=section&id=Additional%20Phase%201b%20Expansion%20Cohorts) Data from additional Phase 1b expansion cohorts evaluating alternate ficerafusp alfa dose regimens and patient populations are anticipated in late 2025 and 2026 - Data from a cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in HPV-negative patients are expected to be presented at a medical meeting in **Q4 2025 or Q1 2026**[8](index=8&type=chunk) - Data from a cohort evaluating 2000mg of ficerafusp alfa every other week in combination with pembrolizumab in HPV-negative patients are expected to be presented at a medical meeting in **Q1 2026**[8](index=8&type=chunk) - A cohort evaluating 1500mg weekly of ficerafusp alfa in combination with pembrolizumab in HPV-negative patients with combined positive scores (CPS) of 0 continues to enroll, with data expected in **2026**[8](index=8&type=chunk) [Development Across Other Solid Tumor Types](index=2&type=section&id=Development%20Across%20Other%20Solid%20Tumor%20Types) Bicara is expanding ficerafusp alfa's development into other solid tumor types, including an ongoing Phase 1b expansion cohort in metastatic colorectal cancer - A Phase 1b expansion cohort evaluating ficerafusp alfa as monotherapy and in combination with pembrolizumab in patients with **3L+ metastatic colorectal cancer (RAS/BRAF wild type)** is currently enrolling[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section details Bicara's Q2 2025 financial performance, including cash position, operating expenses, and net loss [Financial Highlights](index=2&type=section&id=Financial%20Highlights) Bicara Therapeutics reported decreased cash, increased R&D and G&A expenses, and a higher net loss for Q2 2025 year-over-year Cash Position | Date | Cash and Cash Equivalents (million USD) | | :---------------- | :------------------------ | | June 30, 2025 | $436.6 | | December 31, 2024 | $489.7 | * **Change:** Decrease of **$53.1 million** (-10.8%) QoQ * **Funding Runway:** Expected to fund operations into the first half of 2029 Research and Development Expenses (Q2 YoY) | Period | Amount (million USD) | | :---------------- | :------------------- | | Q2 2025 | $24.8 | | Q2 2024 | $15.8 | * **Change:** Increase of **$9.0 million** (+57.0%) YoY * **Primary Reason:** Additional costs for FORTIFI-HN01 initiation, ongoing Phase 1/1b trials, and increased personnel costs General and Administrative Expenses (Q2 YoY) | Period | Amount (million USD) | | :---------------- | :------------------- | | Q2 2025 | $7.2 | | Q2 2024 | $3.9 | * **Change:** Increase of **$3.3 million** (+84.6%) YoY * **Primary Reason:** Additional personnel costs and professional fees to support clinical trials and public company operations Net Loss (Q2 YoY) | Period | Amount (million USD) | | :---------------- | :------------------- | | Q2 2025 | $27.4 | | Q2 2024 | $17.0 | * **Change:** Increase of **$10.4 million** (+61.2%) YoY [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations show increased operating expenses and net loss for Q2 and H1 2025, driven by higher R&D and G&A costs Condensed Consolidated Statements of Operations (in thousands USD) | | Three Months Ended June 30, | | Six Months Ended June 30, | | :------------------------------------------------- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Operating expenses | | | | | | Research and development - related party | $ 2,932 | $ 1,510 | $ 9,507 | $ 5,091 | | Research and development | 21,866 | 14,331 | 49,624 | 22,782 | | General and administrative | 7,220 | 3,909 | 14,675 | 7,251 | | **Total operating expenses** | **32,018** | **19,750** | **73,806** | **35,124** | | Loss from operations | (32,018) | (19,750) | (73,806) | (35,124) | | Other income | | | | | | Interest income | 4,682 | 2,701 | 9,696 | 5,568 | | Total other income | 4,682 | 2,701 | 9,696 | 5,568 | | Net loss before income taxes | (27,336) | (17,049) | (64,110) | (29,556) | | Income tax expense | (52) | – | (124) | (1) | | **Net loss** | **$ (27,388)** | **$ (46,606)** | **$ (64,234)** | **$ (29,557)** | | Net Loss per share, basic and diluted | $ (0.50) | $ (19.01) | $ (1.18) | $ (38.19) | | Weighted-average number common shares outstanding, basic and diluted | 54,539,230 | 896,744 | 54,496,862 | 774,012 | | Expenses include the following non-cash stock-based compensation expense | | | | | | Research & Development | $ 1,159 | $ 251 | $ 2,300 | $ 481 | | General and administrative | 2,333 | 787 | 4,643 | 1,704 | | **Total stock-based compensation expense** | **$ 3,492** | **$ 1,038** | **$ 6,943** | **$ 2,185** | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Bicara's balance sheet as of June 30, 2025, reflects decreased cash and total assets, stable liabilities, and reduced stockholders' equity Condensed Consolidated Balance Sheets (in thousands USD) | | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $ 436,606 | $ 489,711 | | Prepaid expenses and other assets | 7,785 | 12,822 | | Total current assets | 444,391 | 502,533 | | Property and equipment, net | 117 | 155 | | Right of use asset – operating lease | 2,237 | 690 | | Other assets | 6,842 | 6,618 | | **Total assets** | **$ 453,587** | **$ 509,996** | | **Liabilities and stockholders' equity** | | | | Accounts payable | $ 2,041 | $ 3,893 | | Accounts payable – related party | 870 | 615 | | Accrued expenses and other current liabilities | 12,000 | 12,875 | | Accrued expenses and other current liabilities – related party | 1,242 | — | | Operating lease liability – current portion | 1,074 | 607 | | Total current liabilities | 17,227 | 17,990 | | Operating lease liability – net of current portion | 1,164 | 131 | | **Total liabilities** | **18,391** | **18,121** | | **Total stockholders' equity** | **435,196** | **491,875** | | **Total liabilities and stockholders' equity** | **$ 453,587** | **$ 509,996** | [About Bicara Therapeutics](index=3&type=section&id=About%20Bicara%20Therapeutics) Bicara Therapeutics is a clinical-stage biopharmaceutical company developing transformative bifunctional therapies for solid tumors, with ficerafusp alfa as its lead program - Bicara Therapeutics is a **clinical-stage biopharmaceutical company** committed to bringing transformative bifunctional therapies to patients with solid tumors[10](index=10&type=chunk) - Ficerafusp alfa, the lead program, is a **first-in-class bifunctional antibody** designed to drive tumor penetration by breaking barriers in the tumor microenvironment[10](index=10&type=chunk) - It combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β), reversing the fibrotic and immune-excluded tumor microenvironment[10](index=10&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines standard forward-looking statements regarding Bicara's strategy, clinical development, and financial outlook, subject to inherent risks and uncertainties - The press release contains forward-looking statements regarding Bicara's strategy, business plans, clinical development of ficerafusp alfa (including enrollment, progress, and anticipated data readouts), expected therapeutic potential, and cash runway[11](index=11&type=chunk) - These statements are based on management's current expectations and beliefs and are subject to risks and uncertainties, including those related to product candidate development, clinical trial results, regulatory developments, and sufficiency of cash resources[11](index=11&type=chunk) - Bicara explicitly disclaims any obligation to update forward-looking statements and advises against relying on them as representing views as of any subsequent date[11](index=11&type=chunk) [Investor Relations](index=4&type=section&id=Investor%20Relations) Bicara Therapeutics uses its Investor Relations website as a primary channel for disclosing material nonpublic information and fulfilling Regulation FD obligations - Bicara intends to use its Investor Relations website for disclosing **material nonpublic information** and complying with Regulation FD[12](index=12&type=chunk) - Investors should monitor the Company's Investor Relations website in addition to press releases, SEC filings, public conference calls, presentations, and webcasts[12](index=12&type=chunk) [Contacts](index=7&type=section&id=Contacts) This section provides essential contact information for investor and media inquiries - Contact information for investors (Rachel Frank, IR@bicara.com) and media (Amanda Lazaro, 1AB, Amanda@1abmedia.com) is provided[17](index=17&type=chunk)

Core Insights - Bicara Therapeutics Inc. has presented updated data from its Phase 1/1b trial at the 2025 ASCO Annual Meeting, showing significant anti-tumor responses in patients with HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2] - The company maintains a strong financial position with approximately $437 million in cash and cash equivalents, expected to fund operations into the first half of 2029 [1][11] Clinical Development - Ficerafusp alfa, a first-in-class bifunctional antibody, is being developed to enhance tumor penetration by addressing barriers in the tumor microenvironment [3][8] - The ongoing pivotal Phase 2/3 FORTIFI-HN01 trial is evaluating ficerafusp alfa in combination with pembrolizumab for first-line treatment in recurrent/metastatic HNSCC [4][8] - Updated Phase 1/1b trial data indicates a median duration of response of 21.7 months and a median overall survival of 21.3 months in the HPV-negative population [5] Efficacy Data - In the efficacy evaluable HPV-negative population (n=28), the confirmed objective response rate (ORR) was 54%, with a complete response rate of 21% [5] - The disease control rate was reported at 89%, and 80% of responders achieved a deep response (≥80% tumor shrinkage) [5] Financial Performance - For the second quarter of 2025, research and development expenses increased to $24.8 million from $15.8 million in the same quarter of 2024, primarily due to costs associated with the FORTIFI-HN01 trial [11] - General and administrative expenses rose to $7.2 million from $3.9 million year-over-year, reflecting increased personnel costs and professional fees [11] - The net loss for the second quarter of 2025 was $27.4 million, compared to $17.0 million in the same quarter of 2024 [11]

Group 1 - May 23 marked a significant day for patients, oncologists, and investors in the treatment of head and neck cancer, with key presentations scheduled at the American Society of Clinical Oncology (ASCO) [1] - Bicara Therapeutics Inc. is involved in the development of treatments for head and neck cancer, indicating potential investment opportunities in this sector [1]