Core Insights - Relay Therapeutics, Inc. is positioned as a leader in AI-powered oncology, focusing on protein dynamics to develop small-molecule drugs for complex cancer pathways [1] - The lead candidate RLY-2608, a PIK3CA inhibitor, is in late-stage trials for breast cancer and shows strong efficacy and safety, attracting significant analyst attention [2] - Collaborations with Pfizer and Elevar Therapeutics are expected to enhance commercialization and clinical adoption of Relay's therapies [3] Company Overview - Relay Therapeutics utilizes computational modeling, structural biology, and molecular simulations to advance its drug development [1] - The company is expanding its portfolio of small-molecule inhibitors to address hard-to-treat cancers [3] Product Pipeline - RLY-2608 is being evaluated not only for breast cancer but also for vascular malformations, indicating potential for rare pediatric indications [2] - Recent data on RLY-2608 has led analysts to assign a buy rating with a projected price target nearly four times its current levels [2] Strategic Partnerships - Collaborations with Pfizer and Elevar Therapeutics are aimed at accelerating the commercialization of Relay's products [3] - These partnerships are expected to broaden clinical adoption and strengthen the company's pipeline [3]

Core Insights - The session features Relay Therapeutics, highlighting key executives including Sanjiv Patel (President and CEO), Don Bergstrom (President, R&D), and Peter Rahmer (Chief Corporate Development Officer) [2] Company Overview - Relay Therapeutics is represented at the Morgan Stanley Global Healthcare Conference, indicating its active engagement in the healthcare investment community [2] Leadership Introduction - The presence of top executives suggests a focus on strategic discussions regarding the company's direction and research initiatives [2]

Group 1 - The session features Relay Therapeutics, with key executives including Sanjiv Patel (President and CEO), Don Bergstrom (President, R&D), and Peter Rahmer (Chief Corporate Development Officer) participating [2]

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]

Core Viewpoint - Relay Therapeutics is experiencing a positive market response, with a significant increase in share price attributed to a bullish analyst note and promising developments in its drug pipeline [1][2]. Group 1: Analyst Coverage and Price Target - Guggenheim Securities initiated coverage of Relay Therapeutics, designating it as a buy with a price target of $15 per share, which is nearly four times its recent closing price [2]. - The stock has been labeled as the firm's Best Idea, indicating strong confidence in its potential [2]. Group 2: Drug Development and Clinical Trials - The company is currently conducting a late-stage trial for its orally administered drug RLY-2608, which shows promise in treating breast cancer [4]. - The drug has a clean safety profile and has performed well in clinical studies, with additional potential for treating vascular malformations, an orphan disease affecting children [4]. Group 3: Financial Performance - Relay Therapeutics is trading below its cash position, which may attract stock bargain hunters [5]. - In the second quarter, the company reported earnings of $677,000, a significant improvement from $0 in the same period last year, and narrowed its per-share net loss by almost 41% to $0.41 [6].

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]

Core Insights - Relay Therapeutics, Inc. is a clinical-stage company focused on developing small molecule precision medicine for cancer and genetic diseases [2] - The company will participate in two fireside chats in September 2025, which will be available for live streaming and archived for 30 days [1] Company Overview - Relay Therapeutics utilizes its Dynamo platform to address challenging protein targets, aiming to create impactful therapies [2] - The lead clinical asset, RLY-2608, is the first pan-mutant selective PI3Kα inhibitor in clinical development, currently in Phase 3 trials for HR+/HER2- metastatic breast cancer [2] - RLY-2608 is also being explored for PI3Kα-driven vascular malformations and the company has additional research programs targeting NRAS-driven solid tumors and Fabry disease [2] Upcoming Events - Relay Therapeutics will present at the Wells Fargo Healthcare Conference on September 4, 2025, at 2:15 p.m. ET [3] - The company will also participate in the Morgan Stanley 23rd Annual Global Conference on September 10, 2025, at 11:30 a.m. ET [3]

Core Viewpoint - Relay Therapeutics, Inc. (RLAY) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling actions that affect stock prices [4][5]. Recent Performance and Outlook - For the fiscal year ending December 2025, Relay Therapeutics is expected to earn -$1.73 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 6.6% over the past three months [8]. - The upgrade to Zacks Rank 2 places Relay Therapeutics in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of generating significant returns, particularly for Zacks Rank 1 stocks [7][9].

Group 1 - Relay Therapeutics reported a quarterly loss of $0.41 per share, better than the Zacks Consensus Estimate of a loss of $0.49, and an improvement from a loss of $0.69 per share a year ago, resulting in an earnings surprise of +16.33% [1] - The company achieved revenues of $0.68 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 35.40%, compared to zero revenues a year ago [2] - Relay Therapeutics shares have declined approximately 14.3% since the beginning of the year, contrasting with the S&P 500's gain of 7.9% [3] Group 2 - The earnings outlook for Relay Therapeutics is mixed, with the current consensus EPS estimate for the coming quarter at -$0.45 on $0.5 million in revenues, and -$1.86 on $19.09 million in revenues for the current fiscal year [7] - The Zacks Industry Rank indicates that the Medical - Drugs sector is currently in the top 35% of over 250 Zacks industries, suggesting that stocks in the top 50% outperform those in the bottom 50% by more than 2 to 1 [8]

Core Insights - Relay Therapeutics reported a strong second quarter for 2025, exceeding analyst expectations in both earnings and revenue, with GAAP earnings per share of $0.41 compared to an expected $(0.49) and GAAP revenue of $0.7 million versus an estimate of $0.07 million [1][2] Financial Performance - The company achieved a year-over-year reduction in R&D expenses by 30.6%, amounting to $63.9 million, and a decrease in G&A expenses by 32.3%, totaling $13.6 million [2][7] - Cash, cash equivalents, and investments stood at $656.8 million as of June 30, 2025, down from $710.4 million at the end of Q1 2025, but projected to fund operations into 2029 [2][8] Clinical Development - The lead drug candidate, RLY-2608, demonstrated positive results in clinical trials, with a median progression-free survival of 10.3 months and a 39% objective response rate in patients with specific breast cancer mutations [5][6] - The initiation of the Phase 3 ReDiscover-2 trial for RLY-2608 combined with fulvestrant marks a significant milestone, with additional studies exploring combination therapies for advanced breast cancer [6][9] Strategic Focus - The company is concentrating on advancing its clinical trials, managing costs effectively, and leveraging strategic collaborations to enhance drug development and commercialization [4][10] - Relay Therapeutics did not provide specific financial guidance for future quarters but emphasized the importance of enrolling patients for the pivotal Phase 3 trial of RLY-2608 [9][10]