Summary of IO Biotech Conference Call Company and Industry - **Company**: IO Biotech - **Industry**: Biotechnology, specifically focused on cancer treatment and immunotherapy Key Points and Arguments 1. **Phase Three Trial Results**: The conference call discussed the top line results of the phase three pivotal trial of CELMBIA, which showed clinical improvement in progression-free survival (PFS) when combined with pembrolizumab for advanced melanoma patients [3][6][22] 2. **Statistical Significance**: The trial achieved a median PFS of 19.4 months for the combination therapy versus 11.0 months for the control, with a hazard ratio of 0.77 and a p-value of 0.056, narrowly missing the threshold for statistical significance [7][22] 3. **Subgroup Analysis**: Improvement in PFS was observed across virtually all pre-specified subgroups, including those with poor prognostic factors like PD-L1 negative and BRAF mutant patients [24][30] 4. **Unmet Medical Need**: There is a significant unmet need in the first-line advanced melanoma setting, with 50% of patients progressing within one year of treatment [9][12] 5. **FDA Submission Plans**: IO Biotech plans to discuss the path forward with the FDA in the fall and aims to submit a Biologics License Application (BLA) by the end of the year [8][18][36] 6. **Safety Profile**: The combination therapy was well tolerated, with no new safety signals observed, and injection site reactions were the most common local side effects [27][28] 7. **Market Opportunity**: The company sees a strong market opportunity for CELMBIA, especially given the high unmet need and the favorable safety profile compared to existing therapies [33][60] Additional Important Content 1. **Mechanism of Action**: The T1 technology platform used in CELMBIA activates T cells to target both tumor cells and immune suppressive cells, enhancing the immune response against cancer [16][17] 2. **Future Trials**: IO Biotech is also testing CELMBIA in other indications and earlier stages of cancer, indicating a broader application of their technology [18][19] 3. **Cash Position**: The company ended the quarter with over $28 million in cash, which is expected to cover several important milestones, including the potential BLA submission [35][36] 4. **Regulatory Engagement**: IO Biotech has had multiple meetings with the FDA and has received breakthrough designation, indicating a positive regulatory outlook [72][78] 5. **Competitive Landscape**: The combination therapy is positioned favorably against existing treatments, with a focus on ease of administration and reduced toxicity [60][61] This summary encapsulates the critical insights from the conference call, highlighting the company's advancements, statistical findings, and strategic plans moving forward in the biotechnology sector.

Core Insights - IO Biotech announced topline results from the pivotal Phase 3 trial of its investigational cancer vaccine Cylembio, showing clinical improvement in progression-free survival (PFS) when combined with Merck's KEYTRUDA compared to KEYTRUDA alone [1][2][5] Study Results - The trial involved 407 patients with unresectable or metastatic melanoma, with 203 receiving Cylembio plus KEYTRUDA and 204 receiving KEYTRUDA alone [2][8] - The primary endpoint of PFS showed a hazard ratio of 0.77, with a median PFS of 19.4 months for the combination group versus 11.0 months for the control group [2][5] - A trend towards improved overall survival (OS) was observed, with a hazard ratio of 0.79, although OS data is not yet mature [2][5] Subgroup Analysis - Improvement in PFS was noted across nearly all subgroups, particularly in patients with PD-L1 negative tumors, achieving a median PFS of 16.6 months compared to 3.0 months for the control group [3][5] - In patients without prior anti-PD-1 treatment, the combination therapy resulted in a median PFS of 24.8 months versus 11.0 months for the control group [3][5] Safety and Tolerability - The combination therapy was well tolerated, with no new safety signals reported; the most common adverse events were transient injection site reactions, reported by 56% of patients in the combination arm [4][5] Future Plans - IO Biotech plans to engage with the FDA to discuss the data and potential regulatory submission for Cylembio [2][6][12] - The company will present more detailed results at an upcoming medical meeting [6][12]

Core Insights - IO Biotech will hold a conference call and webcast on August 11, 2025, to disclose topline results from the pivotal Phase 3 trial of its cancer vaccine Cylembio [1][2] - Cylembio is being tested in combination with pembrolizumab for the treatment of unresectable or metastatic melanoma [1][3] - The company is advancing its lead candidate Cylembio and has received Breakthrough Therapy Designation from the FDA for another candidate in combination with KEYTRUDA [3] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines using its T-win® platform [3] - The T-win platform aims to activate T cells to target tumor cells and immune-suppressive cells in the tumor microenvironment [3] - The company is headquartered in Copenhagen, Denmark, with a US office in New York [3]

Cylembio (IO102-IO103) Development and Clinical Trials - Cylembio, in combination with pembrolizumab, has Breakthrough Therapy Designation for advanced melanoma[11, 12] - Phase 3 pivotal trial in advanced melanoma with PFS as the primary endpoint, readout expected in Q3 2025[12, 23, 27] - Phase 1/2 trial (MM1636) showed 80% ORR, 50% CRR, and 255 months mPFS in melanoma[13, 55] - Completed enrollment of 407 patients in the Phase 3 trial in December 2023[27, 55] - A Phase 2 neoadjuvant/adjuvant basket study is fully enrolled[57] Pipeline and Platform - T-win platform delivers investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccines[11, 35, 66] - The company has 3 pipeline programs, including IO170 targeting Melanoma, SCCHN, NSCLC, and other cancers[11, 35] - IO112, targeting Arginase 1, is a next pipeline candidate expected to enter clinical development, with an IND filing planned in 2025[35, 63, 64] Market and Financial Outlook - The global melanoma market is expected to reach >$13 billion by 2030[15] - The US melanoma market was approximately $45 billion in 2023, growing at 9%[32] - The global NSCLC market is expected to reach approximately $60 billion by 2030[36, 37] - The global SCCHN market is expected to reach approximately $5 billion by 2030[40]

Summary of IO Biotech (IOBT) Conference Call Company Overview - **Company**: IO Biotech - **Lead Product**: Silenbio (US brand name for IO102, IO103) - **Technology Platform**: TWAN technology platform, focusing on cancer vaccines Core Industry Insights - **Cancer Treatment Focus**: The company is targeting unmet medical needs in cancer treatment, specifically in melanoma, lung, and head and neck cancers - **Market Growth**: - Melanoma market projected to grow to $30 billion by 2030, with a 9% annual growth rate [12] - Lung cancer market projected to reach $60 billion by 2030, with a 10% annual growth rate [23] - Head and neck cancer market expected to grow to $5 billion by 2030, with a 6% annual growth rate [24] Key Product Insights - **Efficacy Data**: - Phase I/II trial showed an 80% overall response rate and a 25.5-month median progression-free survival (PFS) [9] - Phase III trial data expected in Q3 2025, with potential for a Biologics License Application (BLA) filing by the end of 2025 [10] - **Safety Profile**: The product candidates have shown a clear safety profile, allowing patients to remain on treatment longer [5][16] Pipeline Development - **Current Trials**: - Phase III trial with 407 patients randomized to receive either pembrolizumab alone or in combination with IO102 and IO103 [15] - Two Phase II basket trials in first-line solid tumors and perioperative settings [19] - **Future Targets**: - IO112 targeting arginase and IO170 targeting TGF beta are in development, with potential applications in harder-to-treat cancers [21] Market Positioning - **Unmet Needs**: - 50% of melanoma patients do not respond to current standard of care, and 50% of responders experience adverse events [13] - The company aims to address these gaps with its innovative treatment options [12][43] - **Launch Strategy**: Focus on top treaters in both academic and community settings to ensure broad access to the product [18] Competitive Landscape - **Standard of Care**: Current treatments like ipilimumab and nivolumab have a median PFS of 10-11 months, with safety concerns [48] - **Expectations from Key Opinion Leaders**: There is significant excitement and anticipation for the Phase III trial results, with expectations that Silenbio could become the new standard of care if it demonstrates superior efficacy and safety [47][49] Financial Position - **Cash Position**: The company has sufficient cash to support operations through Q2 2026, following recent funding activities [41] Conclusion - **Transformational Potential**: IO Biotech is positioned to potentially transform treatment paradigms in melanoma, lung, and head and neck cancers, with a strong pipeline and promising clinical data [43]

Group 1 - IO Biotech, Inc. (IOBT) has reached an important support level and recently experienced a "golden cross," indicating a potential bullish trend [1][2] - A golden cross occurs when a stock's short-term moving average, typically the 50-day, crosses above its long-term moving average, such as the 200-day, suggesting a strong breakout [2][3] - IOBT has rallied 20.6% over the past four weeks, and its current Zacks Rank is 3 (Hold), indicating it could be poised for further gains [4] Group 2 - The positive earnings outlook for IOBT is supported by no earnings estimate cuts and two revisions higher in the past 60 days, with the Zacks Consensus Estimate also increasing [4] - The combination of favorable earnings estimate revisions and the technical breakout signals that investors should monitor IOBT for potential gains in the near future [5]

Summary of IO Biotech (IOBT) FY Conference Call - May 27, 2025 Company Overview - **Company**: IO Biotech (IOBT) - **Lead Asset**: Xilenvio (IL-102, IL-103) - **Focus**: Immuno-oncology, specifically targeting advanced melanoma Key Points Upcoming Data and Trials - **Pivotal Phase III Trial**: Expected readout in Q3 2025 for advanced melanoma patients, with 407 patients fully enrolled as of December 2023 [4][7] - **Primary Analysis**: Based on 226 progression-free survival (PFS) events, with a target of achieving this by Q3 2025 [10][11] - **Event Rate**: Slower than anticipated, leading to a revised guidance for PFS events [8][11] Trial Design and Expectations - **Trial Design**: Randomized 1:1 comparison of Xilenvio plus pembrolizumab (pembro) versus pembro alone [7][17] - **Response Rate**: Previous studies indicated an 80% response rate with 50% complete responses (CRs) and a median PFS of approximately 26 months [13] - **Statistical Power**: The study is powered at 89% with a hazard ratio of 0.65, indicating a 35% improvement in PFS over Keytruda [26][27] Safety and Efficacy - **Safety Profile**: Favorable safety profile with no significant added systemic toxicity compared to pembrolizumab [31][32] - **PD-L1 Status**: The trial includes both PD-L1 positive and negative patients, which may provide a broader efficacy profile compared to emerging treatments that target only PD-L1 negative patients [40] Financial Position - **Cash Position**: Ended Q1 2025 with over €37 million, with a recent drawdown of €10 million from a financing tranche [63][64] - **Future Financing**: Eligible for additional tranches totaling €20 million, contingent on product approval [65][66] Manufacturing and Logistics - **Manufacturing**: Secured manufacturing capabilities in Europe with multiple suppliers for drug substance and product [44][46] - **Adjuvant Used**: Monostinide, which allows for slow release of antigens upon injection [49] Future Developments - **Neoadjuvant Melanoma Study**: Preliminary data expected by the end of 2025, focusing on major pathological response (MPR) as a primary endpoint [74][76] - **Head and Neck Cancer Data**: Encouraging response rates observed, with updates on PFS and durability expected in the second half of 2025 [61][62] Regulatory Interactions - **FDA Communication**: Ongoing interactions with the FDA, including feedback and review meetings, with breakthrough status confirmed [58][59] Additional Insights - **Market Context**: The competitive landscape in immuno-oncology is evolving, with IO Biotech positioning itself to address both PD-L1 positive and negative patient populations [40][78] - **Clinical Relevance**: Emphasis on not just statistical significance but also clinical relevance and quality of life for patients [31][32] This summary encapsulates the critical aspects of IO Biotech's current status, upcoming milestones, and strategic positioning within the immuno-oncology sector.

Core Insights - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines [5] - The company will participate in the TD Cowen 6th Annual Oncology Summit and the Jefferies Global Healthcare Conference, showcasing its leadership and ongoing clinical trials [1][2] Company Overview - IO Biotech is headquartered in Copenhagen, Denmark, with a US office in New York, New York [5] - The company is advancing its lead cancer vaccine candidate, Cylembio, through various clinical trials, including a pivotal Phase 3 trial in combination with Merck's KEYTRUDA [3][5] - Cylembio is designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment [3] Clinical Trials - IO Biotech is conducting three ongoing clinical trials for Cylembio, with enrollment now complete [3] - The pivotal Phase 3 trial (IOB-013/KN-D18) is investigating Cylembio in combination with KEYTRUDA for patients with advanced melanoma [3] - Additional Phase 2 trials are exploring Cylembio's efficacy in various treatment settings for advanced solid tumors [3] Collaborations - The clinical trials are sponsored by IO Biotech in collaboration with Merck, which supplies KEYTRUDA [4] - IO Biotech retains global commercial rights to Cylembio, indicating a strong position in the market [4]

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Interim Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Interim%20Financial%20Statements%20(Unaudited)) IO Biotech reported a **$22.4 million net loss** for Q1 2025, with cash decreasing to **$37.1 million**, raising going concern doubts without further financing Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $37,086 | $60,031 | | Total current assets | $42,342 | $64,951 | | Total assets | $45,736 | $67,699 | | Total current liabilities | $18,286 | $19,486 | | Total liabilities | $19,314 | $20,684 | | Total stockholders' equity | $26,422 | $47,015 | Consolidated Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Research and development | $16,375 | $14,311 | | General and administrative | $6,209 | $5,886 | | Loss from operations | $(22,584) | $(20,197) | | Net loss | $(22,421) | $(19,457) | | Net loss per share, basic and diluted | $(0.34) | $(0.30) | Consolidated Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(23,071) | $(24,932) | | Net cash used in investing activities | $(28) | $(11) | | Net decrease in cash, cash equivalents and restricted cash | $(23,099) | $(24,943) | - Management has concluded that there is **substantial doubt** about the Company's ability to continue as a **going concern** for one year after the financial statements are issued, as existing cash of **$37.1 million** is not sufficient to fund operating expenses for at least **12 months**[44](index=44&type=chunk)[47](index=47&type=chunk) - The company plans to fund operations through financing activities, including drawing down on its **EIB loan facility** On May 6, 2025, the company drew down **€10.0 million** from Tranche A of this facility[45](index=45&type=chunk)[109](index=109&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the T-win® platform and Cylembio® Phase 3 trial, reporting a **$22.4 million net loss** for Q1 2025, with **$37.1 million cash** raising going concern doubts and ongoing efforts to remediate a material weakness in internal controls [Overview](index=28&type=section&id=Overview) IO Biotech, a clinical-stage biopharmaceutical company, has its lead candidate Cylembio® in a Phase 3 trial for advanced melanoma, with PFS data expected in Q3 2025, facing an accumulated deficit of **$381.7 million** and going concern doubts - The lead candidate, **Cylembio®** (IO102-IO103), is being evaluated in a potentially registrational **Phase 3 trial** (IOB-013/KN-D18) for first-line advanced melanoma, with **407 patients** enrolled[113](index=113&type=chunk)[118](index=118&type=chunk) - The primary endpoint readout for **PFS** in the Phase 3 trial is expected in the **third quarter of 2025**[119](index=119&type=chunk) - As of March 31, 2025, the company had an **accumulated deficit of $381.7 million** and **$37.1 million in cash and cash equivalents**[138](index=138&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) For Q1 2025, R&D expenses increased **14.4% to $16.4 million**, and G&A expenses rose **5.5% to $6.2 million**, leading to a **net loss of $22.4 million** due to higher costs and lower other income Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change ($ in thousands) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $16,375 | $14,311 | $2,064 | 14.4% | | General and administrative | $6,209 | $5,886 | $323 | 5.5% | | **Total operating expenses** | **$22,584** | **$20,197** | **$2,387** | **11.8%** | - The increase in R&D expenses was primarily driven by a **$1.4 million** rise in personnel compensation costs and a **$0.5 million** increase in clinical trial-related activities for Cylembio®[156](index=156&type=chunk) - The decrease in other income was mainly due to a **$1.2 million** reduction in interest income from the company's money market fund[158](index=158&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity relies on equity and an EIB loan facility, with **$37.1 million cash** as of March 31, 2025, raising substantial doubt about its going concern ability without further financing, including a recent **€10.0 million** EIB drawdown - The company's operations are financed by proceeds from equity offerings and a new **EIB Loan Facility** On May 6, 2025, the company drew down **€10.0 million** from this facility[159](index=159&type=chunk) - Management believes existing cash of **$37.1 million** as of March 31, 2025, will be sufficient to fund development activities into **Q2 2026** only if it draws down on the first three committed tranches of the **EIB loan facility**[163](index=163&type=chunk)[171](index=171&type=chunk) Cash Flow Summary (in thousands) | Period | Net cash used in operating activities (in thousands) | | :--- | :--- | | Q1 2025 | $(23,071) | | Q1 2024 | $(24,932) | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, IO Biotech is not required to provide market risk disclosures for this item - As a **smaller reporting company** as defined by Item 10 of Regulation S-K, IO Biotech is not required to provide the information otherwise required under this item[199](index=199&type=chunk) [Item 4. Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were not effective as of March 31, 2025, due to a material weakness in internal control over financial reporting related to CRO accruals, which the company is actively remediating - Management, including the CEO and CFO, concluded that disclosure controls and procedures were **not effective** as of March 31, 2025[202](index=202&type=chunk) - The ineffectiveness is due to a **material weakness** in **internal control over financial reporting** related to the accounting for **CRO-related accruals and prepayments**[202](index=202&type=chunk) - The company is implementing enhancements to **remediate the material weakness**, with full implementation expected during the **fiscal year ending December 31, 2025**[203](index=203&type=chunk) [PART II. OTHER INFORMATION](index=50&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, nor is it aware of any pending or threatened - The company is **not currently a party** to any **material legal proceedings**[206](index=206&type=chunk) [Item 1A. Risk Factors](index=51&type=section&id=Item%201A.%20Risk%20Factors) Key risks include limited operating history, net losses, going concern doubts, dependence on Cylembio®, funding needs, competition, potential Nasdaq delisting, intellectual property, and a material weakness in internal controls - The company has a **limited operating history**, has incurred **net losses** since inception (including **$22.4M for Q1 2025**), and has **substantial doubt** about its ability to continue as a **going concern**[211](index=211&type=chunk)[214](index=214&type=chunk) - The company will need **substantial additional funding** to complete development and commercialization Existing cash of **$37.1 million** as of March 31, 2025, is **not sufficient** to fund operations for **one year** without drawing on the **EIB loan facility**[216](index=216&type=chunk)[217](index=217&type=chunk) - A **material weakness** in **internal control over financial reporting** has been identified, which could impact the ability to provide timely and reliable financial information[213](index=213&type=chunk)[450](index=450&type=chunk) - The company received a notice from **Nasdaq** on December 26, 2024, for **non-compliance** with the **minimum bid price requirement of $1.00 per share** and must regain compliance by **June 24, 2025**, to avoid **potential delisting**[429](index=429&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=123&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[482](index=482&type=chunk) [Item 3. Defaults Upon Senior Securities](index=123&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[483](index=483&type=chunk) [Item 4. Mine Safety Disclosures](index=123&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports no mine safety disclosures - None[484](index=484&type=chunk) [Item 5. Other Information](index=123&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - None[485](index=485&type=chunk) [Item 6. Exhibits](index=124&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including CEO and CFO certifications required under the Sarbanes-Oxley Act of 2002 and Inline XBRL documents - The exhibits include **certifications** from the **Principal Executive Officer** and **Principal Financial Officer** pursuant to **Sections 302 and 906 of the Sarbanes-Oxley Act of 2002**[486](index=486&type=chunk)

[IO Biotech Q1 2025 Financial Results and Business Highlights](index=1&type=section&id=IO%20Biotech%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Business%20Highlights) [Business Highlights and Strategic Outlook](index=1&type=section&id=Recent%20Business%20Highlights) IO Biotech advanced its pivotal Phase 3 Cylembio® trial for melanoma, preparing for 2025 BLA submission and 2026 U.S. launch, while securing EIB financing - Primary focus on delivering **Phase 3 data** for Cylembio®, preparing for BLA submission, and commercialization planning[3](index=3&type=chunk) - Pivotal **Phase 3 trial (IOB-013/KN-D18)** for advanced melanoma expects **PFS readout in Q3 2025**[2](index=2&type=chunk)[4](index=4&type=chunk)[5](index=5&type=chunk) - **BLA submission** to FDA planned for **2025**, with potential **U.S. launch for Cylembio® in 2026**[4](index=4&type=chunk) - In May 2025, **€10.0 million** (tranche A) drawn from **EIB loan facility**[9](index=9&type=chunk) - Recognized by Fast Company as one of the **World's Most Innovative Companies of 2025**[5](index=5&type=chunk)[9](index=9&type=chunk) [Clinical Pipeline Update](index=3&type=section&id=Clinical%20Pipeline%20Update) IO Biotech's pipeline, centered on Cylembio®, includes a fully enrolled pivotal Phase 3 melanoma trial and two Phase 2 basket trials with data expected H2 2025 [Pivotal Phase 3 Trial (IOB-013/KN-D18)](index=3&type=section&id=About%20the%20IOB-013%2FKN-D18%20Pivotal%20Phase%203%20Clinical%20Trial) The Phase 3 trial evaluates Cylembio® with pembrolizumab in 407 advanced melanoma patients, targeting PFS as primary endpoint with Q3 2025 data - Patient Population: **407 patients** with previously untreated, unresectable or metastatic (advanced) melanoma[13](index=13&type=chunk) - Primary Endpoint: **Progression-Free Survival (PFS)**[13](index=13&type=chunk) - Expected Readout: Top-line data anticipated in **Q3 2025**[13](index=13&type=chunk) [Phase 2 Solid Tumor Basket Trials](index=4&type=section&id=About%20IOB-022%2FKN-D38%20%26%20IOB-032%2FPN-E40%20Phase%202%20Solid%20Tumor%20Basket%20Trials) Two Phase 2 basket trials, IOB-022 and IOB-032, are fully enrolled, investigating Cylembio® in NSCLC, SCCHN, and melanoma, with data expected H2 2025 - **IOB-022/KN-D38** investigates Cylembio® plus pembrolizumab in first-line metastatic **NSCLC and SCCHN**[14](index=14&type=chunk) - **IOB-032/PN-E40** enrollment completed in January 2025, investigating neo-adjuvant/adjuvant treatment in resectable **SCCHN and melanoma**[9](index=9&type=chunk)[15](index=15&type=chunk) - Data from both **Phase 2 trials** (IOB-032 initial, IOB-022 longer-term) expected in **H2 2025**[9](index=9&type=chunk) [Financial Performance](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results%20Summary) IO Biotech reported a **net loss of $22.4 million** in Q1 2025 due to increased expenses, ending with **$37.1 million cash**, projecting runway into Q2 2026 Q1 2025 Key Financial Metrics (vs. Q1 2024) | Financial Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Loss (Millions USD) | $22.4 | $19.5 | | R&D Expenses (Millions USD) | $16.4 | $14.3 | | G&A Expenses (Millions USD) | $6.2 | $5.9 | | Net Loss Per Share (USD) | $0.34 | $0.30 | Cash Position | Metric | As of Mar 31, 2025 (Millions USD) | As of Dec 31, 2024 (Millions USD) | | :--- | :--- | :--- | | Cash and Cash Equivalents | $37.1 | $60.0 | - Current cash, supplemented by first three tranches of EIB loan facility, expected to fund operations into **Q2 2026**[10](index=10&type=chunk) [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) Consolidated financial statements show a **net loss of $22.4 million** for Q1 2025, with **total assets of $45.7 million** and **equity of $26.4 million** as of March 31, 2025 [Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Total operating expenses reached **$22.6 million** for Q1 2025, resulting in a **net loss of $22.4 million** or **$0.34 per share** Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | **2025 (Thousands USD)** | **2024 (Thousands USD)** | | **Operating Expenses** | | | | Research and development | $16,375 | $14,311 | | General and administrative | $6,209 | $5,886 | | **Total operating expenses** | **$22,584** | **$20,197** | | **Loss from operations** | **($22,584)** | **($20,197)** | | **Net loss** | **($22,421)** | **($19,457)** | | **Net loss per common share (USD)** | **($0.34)** | **($0.30)** | [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2025, **total assets were $45.7 million**, with **total liabilities of $19.3 million** and **stockholders' equity of $26.4 million** Consolidated Balance Sheet Highlights (in thousands) | | March 31, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $37,086 | $60,031 | | Total current assets | $42,342 | $64,951 | | **Total assets** | **$45,736** | **$67,699** | | **Liabilities & Equity** | | | | Total current liabilities | $18,286 | $19,486 | | **Total liabilities** | **$19,314** | **$20,684** | | **Total stockholders' equity** | **$26,422** | **$47,015** |