[Introduction & Disclaimer](index=1&type=section&id=Introduction%20%26%20Disclaimer) This section outlines the standard disclaimer for forward-looking statements and presents the agenda for the conference call [Disclaimer & Forward-Looking Statements](index=2&type=section&id=Disclaimer%20%26%20Forward-Looking%20Statements) This section provides a standard disclaimer for forward-looking statements, highlighting inherent risks and uncertainties without guaranteeing future results - Forward-looking statements are based on current beliefs and expectations of management, involving risks, potential changes in circumstances, assumptions, and uncertainties[5](index=5&type=chunk) - Actual results and developments could be materially different from those expressed or implied by forward-looking statements due to known or unknown risks and uncertainties[5](index=5&type=chunk) [Agenda for Today's Call](index=3&type=section&id=Agenda%20for%20Today's%20Call) The agenda outlines the key topics to be discussed during the conference call, including an introduction, detailed Phase 3 data for Cylembio, an overview of the first-line advanced melanoma treatment landscape, and company milestones Agenda Topics | Topic | | :--- | | Introduction | | Cylembio Phase 3 Data | | First-line Advanced Melanoma Treatment Landscape | | Company Milestones | [Cylembio Overview & Phase 3 Results](index=4&type=section&id=Cylembio%20Overview%20%26%20Phase%203%20Results) This section provides an overview of Cylembio, presents its Phase 3 trial results, explains its mechanism of action, and details the company's pipeline [Cylembio Product Overview](index=4&type=section&id=Cylembio%20Product%20Overview) Cylembio (imsapepimut and etimupepimut, adjuvanted) is an investigational drug candidate for non-resectable/advanced melanoma, with Phase 3 results demonstrating clinical improvement - Cylembio is an investigational drug candidate that has not been approved for marketing by the US FDA or other regulatory authorities[9](index=9&type=chunk) - Cylembio in combination with pembrolizumab demonstrated clinical improvement across subgroups, with plans to engage with the FDA in Fall 2025 for potential BLA submission[11](index=11&type=chunk) Cylembio Phase 3 Topline Data | Metric | Cylembio + Pembrolizumab | Pembrolizumab Alone | | :--- | :--- | :--- | | Months mPFS | 19.4 | 11.0 | | HR (95% CI) | 0.77 (0.58-1.00) | | | p-value | 0.056* | | *Statistical significance threshold for this study was p=0.045 [Phase 3 Trial Topline Results](index=7&type=section&id=Phase%203%20Trial%20Topline%20Results) The Phase 3 trial for Cylembio plus pembrolizumab demonstrated improved median Progression-Free Survival, with notable benefits in specific subgroups and a favorable safety profile Phase 3 Trial Key Endpoints | Endpoint | Cylembio + Pembrolizumab | Pembrolizumab Alone | HR (95% CI) | p-value | | :--- | :--- | :--- | :--- | :--- | | Median PFS (ITT) | 19.4 months | 11.0 months | 0.77 (0.58-1.00) | 0.056* | | Median PFS (excl. prior anti-PD1) | 24.8 months | 11.0 months | 0.74 (0.56-0.98) | 0.037 (nominal) | | Median PFS (PD-L1 negative) | 16.6 months | 3.0 months | 0.54 (0.35-0.85) | 0.006 (nominal) | | Overall Survival (trend, not mature) | Favoring combination arm | | 0.79 (0.57, 1.10) | | *Statistical significance threshold for this study was p=0.045 - Cylembio demonstrated PFS benefit regardless of prespecified subgroups or stratification factors[17](index=17&type=chunk)[53](index=53&type=chunk) - The treatment was well-tolerated with no significant added systemic toxicity compared to pembrolizumab alone[17](index=17&type=chunk)[53](index=53&type=chunk) [Clinical Trial Design](index=11&type=section&id=Clinical%20Trial%20Design) This section details the Phase 3 clinical trial design, including patient enrollment, eligibility criteria, and primary and secondary endpoints - The Phase 3 clinical trial enrolled **407 patients** across over 100 sites in Europe, Australia, South Africa, Israel, and the US[28](index=28&type=chunk) - Eligibility criteria included advanced melanoma (unresectable stage III or metastatic stage IV) and measurable disease (RECIST 1.1)[28](index=28&type=chunk) - The primary endpoint was Progression-Free Survival (PFS) by central review, with secondary/exploratory endpoints including Overall Response Rate (ORR), Disease Control Rate (DCR), Overall Survival (OS), Duration of Response (DoR), and incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)[28](index=28&type=chunk) [Progression-Free Survival (PFS) Analysis](index=12&type=section&id=Progression-Free%20Survival%20(PFS)%20Analysis) This section presents the Progression-Free Survival analysis, highlighting the median PFS and early separation of treatment arms - PFS curves showed early separation at **3 months**, widening over time, indicating a sustained benefit for the Cylembio combination arm[30](index=30&type=chunk)[31](index=31&type=chunk) PFS Analysis Results | Arm | Median PFS (months) | Events | | :--- | :--- | :--- | | Cylembio + Pembro | 19.4 | 99 | | Pembro | 11.0 | 119 | | HR (95% CI) | 0.77 (0.58 to 1.00) | | | Log-rank p-value | 0.0558* | | *Statistical significance threshold for this study was p=0.045 [Baseline Characteristics & Subgroup Analysis](index=13&type=section&id=Baseline%20Characteristics%20%26%20Subgroup%20Analysis) This section analyzes baseline patient characteristics and consistent PFS improvements observed across various demographic and clinical subgroups - Baseline characteristics were balanced across treatment arms and reflected real-world melanoma patient populations[33](index=33&type=chunk)[34](index=34&type=chunk) - Consistent improvement in PFS was observed across the majority of subgroups, including age, disease stage, BRAF mutation status, PD-L1 status, geographical region, ECOG status, LDH levels, prior treatment, melanoma subtype, and baseline tumor size[35](index=35&type=chunk)[38](index=38&type=chunk)[41](index=41&type=chunk)[45](index=45&type=chunk) Subgroup Analysis of PFS | Subgroup | Cylembio + Pembro Events (Patients) | Pembro Events (Patients) | Unstratified HR (95% CI) | | :--- | :--- | :--- | :--- | | Overall | 99 (203) | 119 (204) | 0.77 [0.59; 1.01] | | PD-L1 Negative | 34 (67) | 49 (63) | **0.54 [0.35; 0.85]** | | PD-L1 Positive | 63 (129) | 63 (127) | 0.93 [0.65; 1.32] | | Excluding prior anti-PD1 exposure | N/A (mPFS **24.8 months**) | N/A (mPFS **11.0 months**) | **0.74 (0.56-0.98)** (nominal p=0.037) | | Excluding acral/mucosal patients | N/A (mPFS **22.1 months**) | N/A (mPFS **11.1 months**) | N/A | [Overall Survival (OS) Trend](index=20&type=section&id=Overall%20Survival%20(OS)%20Trend) This section presents the early, not yet mature, Overall Survival data, indicating a favorable trend for the Cylembio combination arm - Overall Survival (OS) data is not yet mature, but a trend favoring the Cylembio combination arm was observed, with early separation of survival curves that widened over time[48](index=48&type=chunk)[49](index=49&type=chunk) Overall Survival Trend | Arm | Events | Median OS (months) | | :--- | :--- | :--- | | IO + Pembro | 58 | 31.9 | | Pembro | 77 | N/A | | HR (95% CI) | 0.79 (0.57, 1.10) | | [Safety Data](index=21&type=section&id=Safety%20Data) This section provides safety data, demonstrating that Cylembio did not significantly increase systemic toxicity compared to monotherapy - Treatment with Cylembio did not add significant systemic toxicity compared to patients treated with pembrolizumab monotherapy[51](index=51&type=chunk) Safety Profile Comparison | Safety Metric | IO102-IO103 + Pembrolizumab (N=200) | Pembrolizumab (N=198) | | :--- | :--- | :--- | | Patients with AEs, n (%) | 194 (97.0) | 187 (94.4) | | Patients with treatment-related AEs, n (%) | 171 (85.5) | 161 (81.3) | | Patients with SAEs, n (%) | 64 (32.0) | 64 (32.3) | | Patients with treatment-related SAEs, n (%) | 19 (9.5) | 25 (12.6) | | Patients with AEs leading to death, n (%) | 4 (2.0) | 5 (2.5) | | Patients with immune-mediated AEs (imAE), n (%) | 68 (34.0) | 76 (38.4) | | Patients with injection site reactions, n (%) | 112 (56.0) | 2 (1.0) | [Mechanism of Action: T-win® Vaccine Platform](index=8&type=section&id=Mechanism%20of%20Action%3A%20T-win%C2%AE%20Vaccine%20Platform) IO Biotech's T-win® cancer vaccine platform activates T cells with a dual mechanism to target tumor and immune-suppressive cells, modulating the tumor micro-environment - The T-win® vaccine activates T cells with a dual mechanism to attack both target-expressing tumor cells and immune-suppressive cells (e.g., IDO1, PD-L1)[20](index=20&type=chunk) - The platform aims to provide a new therapeutic strategy with the potential to improve outcomes for cancer patients by killing tumor cells and turning the tumor micro-environment hostile to cancer[21](index=21&type=chunk) [Pipeline Overview](index=9&type=section&id=Pipeline%20Overview) IO Biotech's pipeline includes three T-win® product candidates in various clinical phases for multiple cancer indications, alongside preclinical candidates IO Biotech Pipeline | Product Candidates | Targets | Line of therapy/indication | Phase | Takeaways & next steps | | :--- | :--- | :--- | :--- | :--- | | Cylembio® (IOB-013) | IDO1, PD-L1 | First Line Advanced Melanoma | Phase 3 | Demonstrates clinical improvement in mPFS, narrowly missed statistical significance. Plans to discuss data with FDA in Fall 2025; potential US BLA submission | | Cylembio® (IOB-022) | IDO1, PD-L1 | First Line Solid Tumors (Lung (NSCLC), Head & Neck (SCCHN)) | Phase 2 | SCCHN: Primary endpoint met. NSCLC: Encouraging data | | Cylembio® (IOB-032) | IDO1, PD-L1 | Neoadjuvant / Adjuvant Solid Tumors (Melanoma, Head & Neck (SCCHN)) | Phase 2 | Enrollment completed in 2025. Initial data in 2H25 | | IO112 | Arginase 1 | Solid Tumors (Indications TBD) | Pre-clinical | Next pipeline candidate expected to enter clinical development | | IO170 | TGF-B1 | Solid Tumors (Indications TBD) | Pre-clinical | Early-stage pipeline candidate | [Advanced Melanoma Treatment Landscape](index=23&type=section&id=Advanced%20Melanoma%20Treatment%20Landscape) This section analyzes the advanced melanoma treatment landscape, including patient needs, market opportunity, and competitive positioning [Melanoma Patient Journey & Unmet Needs](index=6&type=section&id=Melanoma%20Patient%20Journey%20%26%20Unmet%20Needs) This section highlights the significant unmet medical needs in unresectable or metastatic melanoma due to current treatment limitations - Unresectable or Metastatic Melanoma affects **~15,000 patients annually** in the U.S., representing a high unmet medical need due to lack of efficacy and toxicity issues with available standard of care[14](index=14&type=chunk) - Cylembio, if approved, has the potential to address this high unmet medical need by providing patients and healthcare professionals with a new treatment option[14](index=14&type=chunk) [Market Opportunity & Forecast](index=24&type=section&id=Market%20Opportunity%20%26%20Forecast) This section details the growing global melanoma market, driven by increasing incidence and a high unmet need for more effective therapies - Melanoma incidence is increasing globally, with **~331,000 patients newly diagnosed** and **~58,000 patient deaths annually**[56](index=56&type=chunk) - The 5-year survival rate for patients in stage IV is **30%**, and **~50% of patients progress within one year** of treatment, indicating a significant unmet need for more effective options[56](index=56&type=chunk)[58](index=58&type=chunk) Melanoma Drug Sales Forecast | Metric | 2024 (USD billions) | 2030 (USD billions) | CAGR | | :--- | :--- | :--- | :--- | | US Melanoma Drug Sales | 8.4 | 13.2 | +9% | | Global Melanoma Drug Sales | 9.4 | 14 | | [Competitive Landscape](index=25&type=section&id=Competitive%20Landscape) This section positions Cylembio favorably within the first-line advanced melanoma market, acknowledging the caveats of cross-trial comparisons - If approved, Cylembio would be well-positioned for the treatment of first-line advanced melanoma[59](index=59&type=chunk) Median PFS Comparison of Therapies | Drug (Combination) | Median PFS | | :--- | :--- | | Cylembio + Pembro | **19.4m** | | Pembro (KN-006) | 11.6m | | Opdualag (Nivo+Rela) | 10.2m | | Ipi/Nivo (CM-067) | 11.5m | | Nivo | 4.6m | | Ipi | 6.9m | - Comparisons across clinical trials should be interpreted with caution due to differences in study design, patient populations, endpoints, and other factors[60](index=60&type=chunk) [Company Milestones & Financials](index=26&type=section&id=Company%20Milestones%20%26%20Financials) This section outlines key company milestones, including regulatory plans and pipeline advancements, alongside its current financial position [Key Milestones](index=27&type=section&id=Key%20Milestones) This section details anticipated key milestones through 2026, encompassing regulatory submissions, clinical data readouts, and preclinical candidate advancements - Discussions with FDA for Cylembio (1L Advanced Melanoma) are planned for **Fall 2025**, with potential US BLA submission and launch thereafter[63](index=63&type=chunk) - Potential EU Marketing Authorization Application (MAA) submission for Cylembio (1L Advanced Melanoma) is expected in **2026**[63](index=63&type=chunk) - Initial data from Cylembio's neoadjuvant/adjuvant Phase 2 cohorts is expected in **H2 2025**, with final data from first-line Phase 2 for NSCLC and SCCHN also anticipated[63](index=63&type=chunk) - IND submission for IO112 (Solid Tumors) and IND enabling studies for IO170 (Solid Tumors) are planned for **2026**[63](index=63&type=chunk) [Financial Position](index=27&type=section&id=Financial%20Position) The company maintains a cash runway into Q1 2026, supported by its Q2 cash balance and a recent EIB loan tranche - Cash position extends into **Q1 2026**[62](index=62&type=chunk) Financial Metrics | Metric | Value | | :--- | :--- | | Q2 Cash Balance | **$28 million** | | EIB Loan | Second tranche received on **July 4, 2025** |

Core Insights - IO Biotech reported significant advancements in its cancer therapy pipeline, particularly with the Phase 3 trial results for Cylembio, an immune-modulatory cancer vaccine for advanced melanoma [2][6][7] - The company plans to engage with the FDA regarding the trial results and potential submission of a Biologics License Application (BLA) [2][6] Recent Business Highlights - The company achieved clinical improvement in progression-free survival (PFS) in the Phase 3 trial of Cylembio combined with KEYTRUDA, although statistical significance was narrowly missed [6][7] - IO Biotech ended Q2 2025 with approximately $28.1 million in cash and cash equivalents, expecting this to fund operations into Q1 2026 [6][12] - Upcoming presentations at the Morgan Stanley Global Healthcare Conference and H.C. Wainwright Global Investment Conference are scheduled for September 2025 [6][7] Financial Results - For Q2 2025, IO Biotech reported a net loss of $26.2 million, compared to a net loss of $20.7 million in Q2 2024 [5][12] - Research and development expenses increased to $16.7 million in Q2 2025 from $15.8 million in Q2 2024, while general and administrative expenses rose to $6.5 million from $5.7 million in the same period [12][20] - The total comprehensive loss for Q2 2025 was $26.4 million, compared to $20.8 million in Q2 2024 [20] Clinical Trials Overview - The pivotal Phase 3 trial (IOB-013/KN-D18) enrolled 407 patients and evaluated Cylembio in combination with KEYTRUDA against KEYTRUDA alone for advanced melanoma [10][11] - The company is also conducting two Phase 2 trials: IOB-022/KN-D38 for advanced solid tumors and IOB-032/PN-E40 for resectable squamous cell carcinoma and melanoma [11][13] - Initial data from the ongoing Phase 2 trials is expected in the second half of 2025 [7][10] Company Background - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win platform [14] - The company is headquartered in Copenhagen, Denmark, with a US office in New York [14]

Core Insights - The article discusses the investment position of IOBT, indicating a beneficial long position held by the analyst [1]. Group 1 - The analyst expresses personal opinions regarding IOBT shares, emphasizing that no compensation is received for the article beyond Seeking Alpha [1]. - There is a clear distinction made regarding the lack of business relationships with any company mentioned in the article [1]. Group 2 - The article highlights that past performance does not guarantee future results, indicating a cautious approach to investment advice [2]. - It is noted that Seeking Alpha does not act as a licensed securities dealer or investment adviser, which underscores the independent nature of the analysis [2].

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.