Summit Therapeutics FY Conference Summary Company Overview - **Company**: Summit Therapeutics (NasdaqGM:SMMT) - **Focus**: Development of Ivanesimab, a bispecific antibody targeting PD-1 and VEGF Key Accomplishments in 2025 - **Clinical Trials**: Launched 14 phase 3 clinical trials globally, with 4 in the US and 10 in China, involving over 3,000 patients administered Ivanesimab [2][3] - **Patient Administration**: Over 40,000 patients have received Ivanesimab in the commercial market in China [2] - **Study Results**: Positive results from Harmony 2 and Harmony 6 studies, showing strong progression-free survival (PFS) signals [3][4] Clinical Data Insights - **Harmony 6 Study**: Demonstrated a strong PFS signal, indicating that the addition of chemotherapy did not dilute the benefits of Ivanesimab [3][4] - **Overall Survival (OS)**: Harmony A study showed a statistically significant benefit in OS with a hazard ratio of 0.777, indicating a clinically meaningful early look [5][29] - **Consistency Across Regions**: Data showed remarkable consistency in PFS and OS across different regions, including East and West populations [6][40] Competitive Landscape - **First-Mover Advantage**: Emphasized the importance of being first to market in large indications like lung cancer, citing historical data on PD-1 drugs [10][11] - **Differentiation**: Ivanesimab is positioned as both first-in-class and best-in-class, with four successful phase 3 trials, setting a high bar for competitors [11][12] Expansion Beyond Lung Cancer - **New Indications**: Initiated studies in colorectal cancer and other solid tumors, expanding the potential application of Ivanesimab [7][62] - **Combination Therapies**: Plans to explore novel combinations with RAS inhibitors and antibody-drug conjugates (ADCs) to enhance treatment efficacy [17][19] Regulatory Strategy - **FDA Engagement**: Ongoing discussions with the FDA regarding the need for statistically significant OS improvements for approval [51] - **Ethical Considerations**: Emphasized the importance of making Ivanesimab available to patients with unmet needs, particularly in the relapsed EGFR mutant patient population [49][50] Future Outlook - **Upcoming Data Releases**: Anticipated data readouts from Harmony 3 and Harmony 6 studies in 2026, with a focus on both PFS and OS as co-primary endpoints [58][60] - **Strategic Partnerships**: Discussion on the potential for partnerships, emphasizing the importance of maintaining control over the drug's development and commercialization [69][77] Additional Insights - **Market Positioning**: The company believes it can achieve significant market presence without a large pharma partner, leveraging its unique data and clinical insights [69][75] - **Patient-Centric Approach**: The leadership emphasizes a commitment to patient-first therapy, aiming to provide effective treatments based on robust clinical data [74][78] This summary encapsulates the key points discussed during the Summit Therapeutics FY Conference, highlighting the company's achievements, clinical data, competitive positioning, regulatory strategy, and future outlook.

Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash position of approximately $238.66 million [38] - Total GAAP operating expenses for 2025 were $234.2 million, a decrease from $568.4 million in the previous year, primarily due to higher stock-based compensation expenses recorded in the previous quarter [39] Business Line Data and Key Metrics Changes - The company announced the extension of its Phase III clinical development programs, including a global Phase III study in first-line colorectal cancer [3][24] - The HARMONY six study demonstrated a median progression-free survival (PFS) of 11.14 months for ivanesumab plus chemotherapy compared to 6.90 months for tislelizumab plus chemotherapy, indicating a significant improvement [12][19] Market Data and Key Metrics Changes - The HARMONY six trial included a predominantly male population with advanced squamous non-small cell lung cancer, showing a consistent benefit across various PD-L1 expression levels [11][19] - The company plans to expand its clinical trials beyond lung cancer, with the addition of the HARMONY GI III trial for unresectable colorectal cancer [24][31] Company Strategy and Development Direction - The company intends to submit a Biologics License Application (BLA) for ivanesumab based on the results of the HARMONY study, aiming to establish it as a new standard of care for advanced squamous non-small cell lung cancer [4][27] - The strategic focus includes increasing the number of ongoing Phase III clinical trials to 14, evaluating ivanesumab in multiple solid tumors [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the results of the HARMONY six study and its implications for future studies, highlighting the potential of ivanesumab to provide clinically meaningful improvements for patients [19][24] - The company is actively engaging with the FDA regarding the BLA submission and is confident in the strength of its data package [55][62] Other Important Information - The HARMONY six study was conducted in China and sponsored by Akeso, with all relevant data generated and analyzed by them [3][10] - The company has plans to activate clinical trial sites in the U.S. for the HARMONY GI III study by the end of 2025 [31] Q&A Session Summary Question: When could the first overall survival (OS) cut from HARMONY six be expected? - Management indicated that while they cannot provide specific timelines, they anticipate something can be reviewed in 2026, but it is event-driven [42][45] Question: What are the funding options being evaluated to extend the runway? - Management mentioned that they have an ATM out there with approximately $350 million and have received inbound interest for additional capital [49][51] Question: Can you provide any color on the BLA submission and interactions with the FDA? - Management confirmed that they are actively finalizing the BLA package and have had continued interactions with the FDA, looking forward to feedback after submission [54][55] Question: What prompted the protocol amendments to HARMONY three? - The amendments were made to accelerate the frontline lung cancer opportunity and reduce regulatory risks by separating the two histologies into individual analyses [80][84]