Relay Therapeutics(RLAY) - 2025 FY - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported a median progression-free survival (PFS) of about 10 months for RLY-2608, which is consistent with previous data and shows strong performance compared to competitors [3][4] - In second-line patients, the median PFS is around 11 months, indicating a solid efficacy profile [4] Business Line Data and Key Metrics Changes - RLY-2608 is specifically targeting HR-positive, HER2-negative, PIK3CA-mutated breast cancer, with a median PFS of 10.3 months in this population, nearly doubling the current standard of care [5] - The company is moving forward with a phase 3 trial for RLY-2608 based on the evolving data from the rediscover trial [4][10] Market Data and Key Metrics Changes - The total addressable market (TAM) for RLY-2608 in the U.S. and major global geographies is estimated to be between $2 to $3 billion, with approximately 30,000 patients in these regions [18] - The unmet medical need in the second-line setting has remained largely unchanged over the past decade, with PFS consistently reported between five to seven months for existing therapies [19][20] Company Strategy and Development Direction - The company is focusing on the development of RLY-2608 in both breast cancer and vascular malformations, prioritizing these areas due to their significant market potential [37][38] - There is an ongoing exploration of triplet combinations with other CDK4/6 inhibitors, which may lead to a frontline registration study in breast cancer [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of RLY-2608, which is expected to enhance real-world adherence and treatment duration compared to existing therapies [6][8] - The company is cautious about capital access and has reorganized to extend its cash runway into 2029, allowing it to reach key milestones in its clinical programs [38] Other Important Information - The phase 3 REDISCOVER-2 trial has been initiated, comparing RLY-2608 plus fulvestrant against capivasertib plus fulvestrant [10] - The company is also exploring the potential of RLY-2608 in treating PIK3CA-related overgrowth spectrum (PROS) and other vascular malformations, with a significant patient population identified [30][34] Q&A Session Summary Question: Can you provide an overview of the phase 3 REDISCOVER-2 trial? - The trial is a global randomized study involving 540 patients, comparing RLY-2608 plus fulvestrant to capivasertib plus fulvestrant, with a focus on second-line patients [10] Question: What are the expectations regarding the control arm of capivasertib plus fulvestrant? - The control arm is benchmarked against the CAPItella 291 study, which reported a median PFS of five and a half months in a similar patient population [15] Question: How does the company view the competitive landscape for NextGen PI3K inhibitors? - The company believes it has established a high bar with RLY-2608, showing superior clinical data compared to competitors, which have not demonstrated significant differentiation [28]