UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ IO Biotech, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 87-0909276 (State or other jurisdictio ...

Recent Business Highlights • The company's pivotal Phase 3 trial (IOB-013/KN-D18) is progressing as planned with the readout of the primary endpoint of progression free survival (PFS) still expected in the third quarter of 2025. The trial is evaluating the company's lead investigational vaccine, Cylembio® (imsapepimut and etimupepimut, adjuvanted), in combination with Merck's (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of advanced mela ...

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]

Clinical Trials and Development - The primary endpoint readout of the pivotal Phase 3 trial for Cylembio is now expected in the third quarter of 2025, with a total enrollment of 407 patients completed ahead of schedule[4] - Initial data from the Phase 2 basket trial of Cylembio as neoadjuvant/adjuvant treatment for resectable melanoma or head and neck cancer is anticipated in the second half of 2025[4] - The Phase 2 basket trial IOB-022/KN-D38 showed promising activity in first-line treatment for metastatic non-small cell lung cancer, with approximately 50% of patients having no disease progression at 12 months[7] - The primary endpoint of overall response rate (ORR) was met in the Phase 2 basket trial investigating Cylembio in combination with pembrolizumab for squamous cell carcinoma of the head and neck[7] - The pivotal Phase 3 trial IOB-013/KN-D18 is evaluating Cylembio in combination with Merck's KEYTRUDA in patients with advanced melanoma, with top-line data readout expected in Q3 2025[11] Financial Position - Cash and cash equivalents at the end of Q4 2024 were approximately $60.0 million, with secured debt financing of up to €57.5 million from the European Investment Bank, extending the cash runway into Q2 2026[4] Regulatory Submissions - The company plans to submit a Biologics License Application (BLA) for Cylembio to the FDA by the end of 2025, with a potential launch in the US in 2026[3] - The company plans to submit an Investigational New Drug Application (IND) for its second candidate, IO112, targeting Arginase-1, to the FDA in 2025[7] Product Development - Cylembio has been adopted as the US brand name for the lead investigational therapeutic cancer vaccine, previously known as IO102-IO103[7] - The company is advancing its lead cancer vaccine candidate, Cylembio, in clinical trials while also developing additional pipeline candidates through preclinical development[15]