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]

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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.

NEW YORK, May 20, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, announced today that Mai-Britt Zocca, PhD, the company’s President and CEO, along with Amy Sullivan, the company’s CFO, and Qasim Ahmad, MD, the company’s CMO, will be participating in a fireside chat at the TD Cowen 6th Annual Oncology Summit: Insights for ASCO & EHA being held virtually May 27-28, 2025. Additionally ...

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].