Relay Therapeutics (NasdaqGM:RLAY) FY Conference Transcript

Summary of Relay Therapeutics FY Conference Call Company Overview - Company: Relay Therapeutics (NasdaqGM: RLAY) - Location: Boston, Massachusetts - Financial Position: Well-capitalized with cash reserves projected to last until 2029 [2] Key Initiatives - RLY-2608: A first-in-class, PI3K mutant-selective inhibitor - Phase 3 Trial: Initiated for post-CDK4/6 treated metastatic breast cancer patients [2] - Triplet Combinations: Ongoing trials with RLY-2608, fulvestrant, ribociclib, and temaciclib for CDK4/6 naive metastatic breast cancer patients [2][3] - Vascular Malformations: Exploring RLY-2608 for conditions driven by PI3K alpha mutations, targeting a large unserved population [3] Competitive Landscape - China's Biotech Innovation: Acknowledged as a significant factor influencing Relay's R&D and business development strategy, focusing on first-in-class targets due to competitive pressures [4] AI Integration - AI in Drug Discovery: AI is viewed as a tool to enhance efficiency in drug discovery, but not as a complete solution. Human involvement remains crucial [5][6] Regulatory Environment - Regulatory Interactions: Limited impact from recent regulatory changes, with most interactions occurring in the previous year [7] RLY-2608 Mechanism and Efficacy - Mechanism of Action: RLY-2608 is designed to selectively inhibit mutant PI3K alpha, avoiding side effects associated with non-selective inhibitors [8][9] - Clinical Data: - Efficacy: 39% confirmed objective response rate and 10.3 months median progression-free survival (PFS) in a subset of 52 patients [12][14] - Safety Profile: Low rates of high-grade hyperglycemia and other adverse events compared to existing treatments [15][17] Market Opportunity - Breast Cancer: Approximately 13,000 PI3K alpha mutated patients in the U.S., with potential to double in the frontline setting, representing a multi-billion dollar total addressable market (TAM) [22][38] - Vascular Malformations: Estimated 170,000 patients with PI3KCA mutant-driven disease in the U.S., with significant potential for chronic therapy [45][46] Clinical Trials - Rediscover 2 Phase 3 Trial: Enrolling 540 patients, comparing RLY-2608 plus fulvestrant to fulvestrant plus Capivasertib, with primary endpoint of PFS [18][20] - Vascular Malformations Trial: Initiated in Q1 2025, focusing on three biologically active doses of RLY-2608 [44] Platform and Technology - Dynamo® Platform: Combines computational and experimental approaches to enhance drug discovery efficiency [49][50] - Anton II Supercomputer: Previously instrumental in early discoveries, now supplemented by cloud computing capabilities [54] Conclusion - Future Outlook: Relay Therapeutics is positioned to leverage its innovative drug development strategies and AI integration to address significant unmet medical needs in oncology and beyond, with RLY-2608 as a key asset in its portfolio [56]