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** |

Core Insights - IO Biotech is advancing its pipeline of immune-modulatory cancer vaccines, with a pivotal Phase 3 trial expected to read out in Q3 2025 [1][5][6] - The company aims to submit a Biologics License Application (BLA) for its lead candidate, Cylembio, in 2025, with a potential launch in the US in 2026 [2][6] - IO Biotech was recognized as one of the most innovative biotechnology companies by Fast Company, ranking 9th in the biotechnology category [5][6] Financial Performance - For Q1 2025, the company reported a net loss of $22.4 million, compared to a net loss of $19.5 million in Q1 2024 [13] - Research and development expenses increased to $16.4 million in Q1 2025 from $14.3 million in Q1 2024 [13] - Cash and cash equivalents decreased to $37.1 million as of March 31, 2025, down from $60.0 million at the end of 2024 [13] Clinical Trials and Developments - The pivotal Phase 3 trial (IOB-013/KN-D18) is evaluating Cylembio in combination with Merck's KEYTRUDA for advanced melanoma, with 407 patients enrolled [11] - Initial data from the perioperative Phase 2 trial (IOB-032/PN-E40) is expected in the second half of 2025 [6][13] - The company completed enrollment in its ongoing clinical trials, which include studies for various solid tumors [9][14][15] Upcoming Events - IO Biotech will participate in TD Cowen's 6th Annual Oncology Innovation Summit on May 27, 2025, and the Jefferies Global Healthcare Conference on June 4, 2025 [5][6]

Core Insights - IO Biotech is advancing novel immune-modulatory therapeutic cancer vaccines, with a focus on reshaping the tumor microenvironment and enhancing T cell activation [1][2][3] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company based in Copenhagen, Denmark, with a US headquarters in New York, specializing in off-the-shelf therapeutic cancer vaccines [3] - The company is developing its lead investigational cancer vaccine candidate, Cylembio® (IO102-IO103), which has received Breakthrough Therapy Designation from the FDA for advanced melanoma treatment [3] Scientific Contributions - Dr. Mads Hald Andersen, a co-founder of IO Biotech, presented at the 2025 AACR Annual Meeting, discussing advancements in cancer vaccine research and the dual mechanism of action of IO102-IO103 [1][2] - The vaccine targets both tumor cells and immune-suppressive cells, potentially reprogramming the tumor microenvironment to be more immune-permissive [2] Research and Development - The educational session at AACR highlighted key developments in RNA-based and immune-modulatory vaccines, showcasing the latest innovations in cancer immunotherapy [1][2] - IO Biotech's T-win® platform is designed to activate T cells against both tumor and immune-suppressive cells, representing a novel approach in cancer vaccine development [3]

Core Insights - IO Biotech presented new preclinical data for its dual-antigen and TGF-β-directed vaccines at the AACR Annual Meeting 2025, highlighting their potential to reshape the tumor microenvironment and enhance anti-tumor immunity [1][2] 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, which aims to activate T cells against both tumor cells and immune-suppressive cells [4] - The company is advancing its lead investigational cancer vaccine candidate, Cylembio® (IO102-IO103), which has received Breakthrough Therapy Designation from the FDA for treating advanced melanoma in combination with Merck's KEYTRUDA® [4] Vaccine Candidates - IO102-IO103, a dual-antigen vaccine targeting IDO1+ and PD-L1+ cells, demonstrated strong T-cell responses and modulated the tumor microenvironment in mouse models, indicating a potentially synergistic mechanism compared to conventional PD-1 or PD-L1 inhibitors [7] - IO170, targeting TGF-β, showed significant tumor growth inhibition in breast and prostate cancer mouse models, leading to increased infiltration of vaccine-specific T cells and reshaping the tumor microenvironment to favor immune activation [7]

Financial Reporting and Compliance - The company is classified as an "emerging growth company" and has elected to use an extended transition period under the JOBS Act, which allows it to delay the adoption of new accounting standards until they apply to private companies [569]. - The company is also a "smaller reporting company," with a market value of stock held by non-affiliates below $700 million and annual revenue under $100 million, allowing for reduced disclosure obligations [570]. - A material weakness in internal control over financial reporting was identified as of December 31, 2024, related to the accounting models for ongoing clinical trials [573]. - The company has remediated a previously identified material weakness for the fiscal year ending December 31, 2022, but future difficulties with internal controls may arise [577]. - Changes in financial accounting standards may lead to unexpected revenue fluctuations and affect reported results of operations [584]. - New tax laws or regulations could adversely impact the company's business, cash flow, and financial condition [585]. Operational Risks - The company faces significant operational risks due to global business operations, including fluctuations in currency exchange rates, tax complexities, and compliance burdens [592]. - The company relies on third parties for various operations, increasing the risk of liability for their illegal activities, which could have serious consequences [596]. - The company does not have a comprehensive disaster recovery plan, which could lead to substantial expenses and operational disruptions in the event of natural disasters or terrorism [595]. Cybersecurity and Technology - The company relies on information technology systems, and any failures or security breaches could disrupt product development and compromise sensitive information [588]. - Cybersecurity risks are increasing, with potential significant costs related to data protection and compliance with laws, which may adversely affect the company's financial condition [591]. - The costs of mitigating cybersecurity risks are expected to rise, including expenses for cybersecurity services and compliance with data protection laws [591]. Regulatory and Compliance Challenges - The company is subject to extensive regulatory obligations that may change, potentially leading to unexpected delays and increased costs in product development [603]. - Failure to comply with environmental, health, and safety laws could result in significant fines and penalties, adversely affecting the company's operations [597]. - The company may face reputational harm and regulatory scrutiny if it fails to meet evolving expectations regarding environmental, social, and corporate governance (ESG) matters [602]. Geopolitical and Market Risks - The company is exposed to geopolitical conflicts, such as the situation in Ukraine and the Middle East, which could delay clinical trials and increase costs [594]. - The company has broad discretion in the use of existing cash and cash equivalents, which may not be applied effectively, potentially affecting financial condition [587]. - The company is vulnerable to potential securities class action litigation, especially following stock price volatility, which could divert management's attention and resources [600].

Core Insights - IO Biotech is advancing its lead investigational candidate, IO102-IO103, in a pivotal Phase 3 trial for advanced melanoma, with new non-clinical data supporting its efficacy in tumor growth control through T-cell activation [1][2] - The company is also presenting new preclinical data for IO170, which targets TGF-beta, further emphasizing the potential of immune-modulatory therapeutic cancer vaccines [1][2] - The American Association for Cancer Research (AACR) Annual Meeting 2025 will feature presentations on these candidates, highlighting their mechanisms of action and contributions to cancer immunotherapy [1][3] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its proprietary T-win platform [6] - The T-win platform aims to activate T cells to target both tumor cells and immune-suppressive cells within the tumor microenvironment [6] - The company has received Breakthrough Therapy Designation from the US FDA for IO102-IO103 in combination with Merck's KEYTRUDA for treating advanced melanoma [6] Presentation Details - Two abstracts will be presented at the AACR Annual Meeting: one on IO102-IO103 and another on IO170, both scheduled for April 28, 2025 [3] - The educational session on cancer vaccines will be chaired by Dr. Mads Hald Andersen, focusing on advancements in cancer vaccine research [3][5]

Core Insights - IO Biotech has been recognized as the 9th most innovative company in the biotechnology category by Fast Company for its development of immune-modulatory therapeutic cancer vaccines [1][2][4] - The company is focused on creating off-the-shelf cancer vaccines that can be available at the time of patient diagnosis, aiming to change the oncology treatment paradigm [2][4] - IO Biotech's T-win® platform is designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment, potentially leading to improved patient outcomes [2][4][6] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company headquartered in Copenhagen, Denmark, with a US office in New York [6] - The company is advancing its lead investigational cancer vaccine candidate, Cylembio® (imsapepimut and etimupepimut, adjuvanted), which is currently in a global Phase 3 clinical trial for advanced melanoma [4][6] - Cylembio® has received Breakthrough Therapy Designation from the US FDA for the treatment of advanced melanoma in combination with Merck's KEYTRUDA® (pembrolizumab) [6] Industry Recognition - Fast Company's list of the Most Innovative Companies is a highly anticipated feature that evaluates thousands of submissions to recognize organizations driving progress across various industries [3] - The recognition highlights companies that are leveraging innovative technologies and strategies to enhance customer experiences and introduce vital competition in their sectors [4][3]

Core Insights - IO Biotech has been recognized as the 9th most innovative company in the biotechnology category by Fast Company for its innovative approach to immune-modulatory cancer vaccines [1][2][4] - The company is focused on developing off-the-shelf cancer vaccines that can be available at the time of patient diagnosis, aiming to change the oncology treatment paradigm [2][4] - IO Biotech's lead investigational cancer vaccine candidate, Cylembio®, is currently in a global Phase 3 clinical trial for advanced melanoma, with primary endpoint readout expected in Q3 2025 [4][6] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company headquartered in Copenhagen, Denmark, with a US office in New York [6] - The company specializes in immune-modulatory therapeutic cancer vaccines based on its T-win® platform, which targets both tumor cells and immune-suppressive cells in the tumor microenvironment [6] - Cylembio® has received Breakthrough Therapy Designation from the US FDA for the treatment of advanced melanoma, based on positive Phase 1/2 data [6] Industry Recognition - Fast Company's list of the World's Most Innovative Companies includes 609 organizations across 58 sectors, highlighting companies that drive progress and innovation [3] - The recognition reflects IO Biotech's commitment to enhancing patient outcomes through innovative cancer treatment solutions [4][5]