Core Insights - Relay Therapeutics is a clinical-stage precision medicine company focused on transforming the drug discovery process through advanced computational and experimental technologies [2] - The company will report its second quarter 2025 financial results and corporate highlights on August 7, 2025, after U.S. financial markets close [1] Company Overview - Relay Therapeutics aims to develop life-changing therapies by integrating cutting-edge computational and experimental techniques [2] - The company utilizes its Dynamo platform to address challenging protein targets in drug discovery, particularly in targeted oncology and genetic diseases [2] Contact Information - Media inquiries can be directed to Dan Budwick at 1AB [3]

Core Insights - Recursion Pharmaceuticals (RXRX) and Relay Therapeutics (RLAY) are utilizing artificial intelligence (AI) to innovate drug discovery across various disease areas, positioning themselves as leaders in the AI-driven biotech sector [1][2] Group 1: Drug Discovery and Development - Traditional biotech companies face high costs and failure rates due to a "trial-and-error" approach, leading to financial instability [2] - AI models can identify promising drug candidates with higher success probabilities, reducing research costs and improving efficiency [3] - Both companies generate additional revenue by licensing their AI platforms, allowing them to refine their models even when clinical candidates fail [4] Group 2: Recursion Pharmaceuticals (RXRX) - RXRX employs its AI-driven platform, Recursion OS, developed with NVIDIA, to test clinical compounds against a virtual library of human biology [5] - The company faced setbacks after discontinuing three key drug candidates but is now focusing on more promising candidates like REC-4881, which showed a 43% reduction in polyp burden in early phase II data [6][7] - RXRX has expanded its pipeline by acquiring Rallybio's stake in a joint venture for developing REV102, a potential first oral treatment for hypophosphatasia [8] - The company ended Q1 2025 with a cash balance of $509 million, expected to sustain operations into mid-2027 [9] - RXRX has collaboration agreements with major pharmaceutical companies, generating $15 million in collaboration revenues in Q1 2025, a slight increase from the previous year [10] Group 3: Relay Therapeutics (RLAY) - RLAY utilizes its proprietary Dynamo platform to target difficult protein targets, focusing on small-molecule therapies for oncology and genetic diseases [12] - The company has a narrower pipeline and implemented cost-cutting measures, reducing research costs by 80% and workforce by approximately 70 people [13] - RLAY ended Q1 2025 with a cash balance of $710.3 million, expected to fund operations into 2029 [13] - The company is preparing to initiate a phase III study for its lead candidate, RLY-2608, for metastatic breast cancer [14] - RLAY entered a licensing agreement with Elevar Therapeutics for lirafugratinib, allowing it to receive milestone payments and royalties [15] - The termination of a partnership with Roche has limited RLAY's revenue streams, as it no longer receives collaboration payments from Roche [16][17] Group 4: Financial Estimates and Performance - The Zacks Consensus Estimate for RXRX's 2025 revenues implies a 16% year-over-year improvement, while the loss per share estimate has widened slightly [18] - RLAY's 2025 revenue estimate suggests a 91% year-over-year improvement, but the loss per share estimate has also widened [21] - Year-to-date, RXRX's stock has decreased by 7.4%, while RLAY's stock has declined by 10.7%, compared to a 2% decline in the industry [23] Group 5: Valuation Comparison - RXRX is trading at 2.73 times its book value, while RLAY is at 0.88 times, making RLAY more attractive from a valuation perspective [25] - Both companies are trading below their respective five-year averages, indicating potential investment opportunities [25] Group 6: Competitive Landscape - RXRX and RLAY face competition from other biotech firms and tech-driven drug discovery companies, which may challenge their market position [29] - Despite challenges, both companies have the potential to revolutionize drug discovery and deliver breakthrough therapies at lower costs [30]

Company Overview - Relay Therapeutics, Inc. is a clinical-stage precision medicine company focused on transforming the drug discovery process through advanced computational and experimental technologies [4] - The company aims to enhance small molecule therapeutic discovery in targeted oncology and genetic disease indications [4] Leadership Appointment - Claire Mazumdar, Ph.D., has been appointed to the Board of Directors of Relay Therapeutics, effective June 9, 2025 [1] - Dr. Mazumdar brings extensive strategic and operational experience in clinical-stage oncology, which will be valuable as the company prepares to initiate its Phase 3 ReDiscover-2 trial in breast cancer [2][3] Dr. Mazumdar's Background - Dr. Mazumdar is the founding CEO of Bicara Therapeutics and has held significant roles in business development and corporate strategy at Rheos Medicines and Third Rock Ventures [3] - She holds a B.S. in biological engineering from MIT, an MBA from Stanford, and a Ph.D. in cancer biology from Stanford [3] Clinical Development Focus - Relay Therapeutics is preparing to initiate the Phase 3 ReDiscover-2 trial, which focuses on breast cancer [2] - The company utilizes its Dynamo® platform to address previously intractable protein targets in drug discovery [4]

Summary of the Conference Call Company Overview - The conference call features Relay Therapeutics, focusing on their Dynamo platform and pipeline strategy, particularly in the biotechnology sector [1][2]. Key Points on the Dynamo Platform and Pipeline - The Dynamo platform integrates computational and experimental techniques for drug discovery, leading to several programs entering clinical trials [2]. - Relay has streamlined its research portfolio to focus on generating clinical data and value for stakeholders due to current capital market conditions [2]. - The company has cash reserves projected to last until 2029, providing a strong runway for upcoming clinical catalysts [4]. Pipeline Developments - The FGFR2 program has been out-licensed to Elavar, which is expected to file an NDA soon [3][40]. - The PI3K alpha mutant selective program (ROI 2,608) is set to begin a pivotal Phase III trial, targeting a large patient population [3]. - Other pipeline assets include a vascular malformations program and two assets nearing IND status: an NRAS selective program and a fibrous program [3]. Clinical Data and Competitive Landscape - The PI3K alpha inhibitor targets a large patient population with a 40% mutation rate in hormone receptor-positive, HER2-negative breast cancer [5]. - Current therapies have shown a progression-free survival (PFS) of 5-7 months, while Relay's data indicates a PFS of over 10 months in heavily pretreated patients [11][15]. - The company aims to differentiate itself from competitors like AstraZeneca's capivasertib, which has a PFS benchmark of 5.5 months [14][15]. Safety and Efficacy - Relay's PI3K alpha inhibitor has demonstrated a clean safety profile with low rates of common toxicities associated with non-selective inhibitors [12]. - The confirmed objective response rate across all PI3K alpha mutations is 39%, with a 67% response rate in a subset of kinase domain mutations [11]. Future Trials and Strategy - The Phase III trial will focus on patients pretreated with CDK4/6 inhibitors, with plans to explore triplet combinations for earlier lines of therapy [16][24]. - The company is also considering expanding into other tumor types beyond breast cancer, such as colon and lung cancers, but will maintain focus on the current pivotal trials [31]. Vascular Malformations Program - Relay is targeting vascular malformations, a condition affecting approximately 300,000 patients in the US, with a focus on two phenotypes: PI3K-related overgrowth spectrum and lymphatic malformations [33][34]. - The company acknowledges the need for education and identification of patients due to the broad manifestations of the condition [38][39]. Manufacturing and Commercialization - Manufacturing for the small molecules is outsourced, allowing flexibility in scaling up production as needed [48]. - The company is preparing for potential commercial supply for ROI 2608, anticipating a launch later this decade [48]. Research and Development Focus - Relay is committed to generating proof of concept data and engaging with the FDA regarding accelerated approval pathways for their programs [36][46]. - The company emphasizes the importance of tangible clinical data and successful execution of pivotal trials as key to their strategy [55]. Conclusion - Relay Therapeutics is positioned strongly within the biotechnology sector, focusing on innovative drug discovery and development, with a clear strategy for clinical trials and commercialization. The company is optimistic about its pipeline and the potential for significant advancements in treating various cancers and vascular malformations [55].

Summary of Relay Therapeutics Conference Call Company Overview - **Company**: Relay Therapeutics (Ticker: RLAY) - **Focus**: Development of selective PI3K alpha inhibitors for breast cancer and vascular malformations Key Points on Breast Cancer Treatment - **Mechanism**: Relay Therapeutics is developing a selective PI3K alpha inhibitor, ROI 2,608, which has shown promising results in clinical trials - **Clinical Data**: - Achieved an **11-month progression-free survival (PFS)** in the second line of therapy combined with fulvestrant - Reported a **39% overall response rate** and a **67% response rate** in the kinase-only subset of patients [4][9] - **Patient Population**: Approximately **40%** of hormone receptor-positive, HER2-negative breast cancer patients have a PI3K alpha mutation, indicating a significant market opportunity [5] - **Comparison with Competitors**: - ROI 2,608's PFS is **2x** that of capivasertib, which has a PFS of **5.5 months** [10] - Relay's drug is positioned to have a better safety profile, addressing issues like grade three hyperglycemia and diarrhea seen with other treatments [12][13] - **Future Trials**: Plans to initiate pivotal trials in the post-CDK4/6 population, aiming to establish ROI 2,608 as a frontline therapy [8][20] Insights on Competitive Landscape - **Roche's Data**: Roche has shown an overall survival benefit with a **15-month PFS** in a triplet therapy setting, but concerns about toxicity remain [14][16] - **Patient Selection**: Relay's trials are designed to include a broader patient population, allowing for those with pre-diabetic conditions, which may enhance the applicability of their treatment [27] Vascular Malformations Opportunity - **Market Size**: Approximately **170,000** patients in the U.S. have PI3KCA mutation-driven vascular malformations, with **5,000 to 15,000** specifically in the PIK3CA-related overgrowth spectrum [46][47] - **Current Treatments**: - Sirolimus is used off-label, and alpelisib (Vijoice) has received accelerated approval but has shown significant side effects like hyperglycemia [50][54] - **Relay's Approach**: The company aims to provide a more effective and tolerable treatment option, starting with a **400 mg BID** dosing regimen in their studies [57] Regulatory Path and Future Studies - **Accelerated Approval**: There is potential for an accelerated approval pathway due to the lack of fully approved treatments in the vascular malformations space [55] - **Study Design**: The upcoming trials will utilize a randomized dose selection approach, starting at the oncology phase three dose [57] Conclusion - Relay Therapeutics is positioned to capitalize on significant unmet needs in both breast cancer and vascular malformations through innovative therapies that promise improved efficacy and safety profiles. The company is actively preparing for pivotal trials and regulatory discussions to advance its promising drug candidates.

Group 1: Amgen (AMGN.US) - Amgen's Imdelltra shows positive results in Phase 3 trial for small cell lung cancer, significantly extending patient survival compared to chemotherapy [2][3] - The trial involved 509 patients, with Imdelltra reducing the risk of death by 40%, leading to an average survival of 13.6 months versus 8.3 months for chemotherapy [2][3] - Imdelltra also demonstrated a 29% reduction in the risk of disease progression or death, with improved patient-reported symptoms and a lower incidence of severe adverse events compared to chemotherapy [3][2] - Goldman Sachs rates Amgen as "Buy" with a 12-month target price of $400, indicating a 38% upside potential from the June 3 closing price [3] Group 2: Regeneron Pharmaceuticals (REGN.US) - Regeneron's linvoseltamab shows promising results in Phase 1b LINKER-MM2 trial for relapsed/refractory multiple myeloma, achieving an 85% objective response rate (ORR) when combined with bortezomib [4][5] - The combination therapy demonstrated a 50% complete response rate (CR) and a 78% six-month progression-free survival (PFS) rate [4] - In another cohort with carfilzomib, linvoseltamab achieved a 90% ORR and a 76% CR rate, with an estimated 12-month PFS rate of 83% [7] - Goldman Sachs rates Regeneron as "Buy" with a 12-month target price of $804, indicating a 35% upside potential from the June 3 closing price [8] Group 3: Relay Therapeutics (RLAY.US) - Relay's RLY-2608 combined with fulvestrant shows encouraging results in treating PIK3CA-mutated HR+/HER2- advanced breast cancer, with a median PFS of 10.3 months [9][10] - The trial included 118 patients, with a clinical benefit rate of 67% and an objective response rate of 67% in patients with kinase mutations [9][10] - Goldman Sachs rates Relay as "Buy" with a 12-month target price of $11, indicating a 234% upside potential from the June 3 closing price [11]

Core Insights - Relay Therapeutics announced updated interim clinical data for RLY-2608, showing a median progression-free survival (PFS) of 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer [1][2] - The company plans to initiate a pivotal Phase 3 trial, ReDiscover-2, in mid-2025 [2][16] - RLY-2608 is the first known allosteric, pan-mutant, and isoform-selective inhibitor of PI3Kα, designed to improve tolerability and efficacy compared to standard treatments [11][12] Clinical Data Summary - The updated data indicate a median PFS of 10.3 months overall and 11.0 months for second-line patients, with a clinical benefit rate of 67% [7][8] - Among 64 patients receiving the recommended Phase 3 dose (RP3D) of 600mg BID, 44% had received two or more prior lines of therapy [5][8] - The study enrolled 118 patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer [4][8] Safety and Tolerability - RLY-2608 + fulvestrant was generally well tolerated, with low-grade treatment-related adverse events (TRAEs) being manageable and reversible [8][15] - Only 36% of patients experienced a Grade 3 TRAE, with no Grade 4-5 TRAEs reported [15] Future Directions - The company is progressing two front-line triplet regimens, one with atirmociclib and another with ribociclib, both currently in dose escalation [9][16] - Continued enrollment in the Phase 1/2 ReInspire study for vascular malformations is also planned [16]

Core Insights - Relay Therapeutics is a clinical-stage precision medicine company focused on transforming the drug discovery process through advanced computational and experimental technologies [2] Group 1: Company Overview - Relay Therapeutics aims to bring life-changing therapies to patients by integrating cutting-edge computational and experimental approaches [2] - The company utilizes its Dynamo® platform to target previously intractable protein targets, enhancing small molecule therapeutic discovery in oncology and genetic diseases [2] Group 2: Upcoming Events - Management will participate in two fireside chats in June 2025, specifically at the Jefferies Global Healthcare Conference on June 4 and the Goldman Sachs Global Healthcare Conference on June 11 [3] - The fireside chats will be webcast live and available for replay for up to 30 days after the events [1]

Summary of Relay Therapeutics (RLAY) FY Conference Call - May 27, 2025 Company Overview - **Company**: Relay Therapeutics (RLAY) - **Event**: Sixth Annual Oncology Innovation Summit - **Key Speakers**: Sajeev Patel (President and CEO), Don Bergstrom (President of R&D), Peter Romer (Chief Commercial Development Officer) Key Industry Insights - **Focus Area**: Oncology, specifically targeting hormone receptor positive, HER2 negative breast cancer with PI3K alpha mutations - **Market Size**: Approximately 40% of patients with hormone receptor positive, HER2 negative breast cancer have a PI3K alpha mutation, indicating a significant patient segment that is poorly treated [7][8] Core Data and Efficacy - **Drug in Focus**: RLY2608, a selective PI3K alpha inhibitor - **Clinical Data**: - Previous data showed a median progression-free survival (PFS) of 9.2 months with RLY2608 compared to 5.5 months for the control (TruCap) [4][5] - Objective response rate (ORR) for RLY2608 was 39%, with 67% in kinase mutant patients [5][10] - Upcoming ASCO presentation expected to show over a year of follow-up data, aiming to confirm the durability and consistency of these results [6][50] Clinical Trial Insights - **Phase III Trial**: Focused on CDK4 experienced patients, with a randomized design of 540 patients comparing RLY2608 to capivasertib [41][42] - **Patient Population**: Primarily second-line patients, with potential inclusion of first-line patients who have received adjuvant CDK4 inhibitors [17][29] - **Exclusion Criteria**: Patients with prior PI3K pathway inhibitors will be excluded from the trial [48] Competitive Landscape - **Current Treatments**: Previous generation non-selective PI3K inhibitors have shown limited efficacy, with PFS typically between 5.5 to 7.5 months [8] - **Market Dynamics**: The approval of Roche's triplet therapy presents competition, but RLY2608's data suggests a strong position in the market [28] Financial Position - **Cash Position**: As of Q1 2025, the company reported a cash position of $710 million, sufficient to fund the phase III trial and other ongoing studies through 2029 [85][86] - **Partnership Considerations**: The company is open to partnerships, especially given current capital market conditions [87][88] Additional Considerations - **Vascular Malformations**: The company is also exploring RLY2608 for vascular malformations, with an estimated 170,000 patients in the U.S. having PIK3CA-related conditions, of which 5,000 to 15,000 are within the PROS population [64][65] - **Regulatory Landscape**: The failure of a confirmatory study for a competing drug (Alpalocep) leaves Relay Therapeutics in a favorable position as there are currently no fully approved agents for vascular malformations [66] Conclusion - The upcoming ASCO presentation is critical for Relay Therapeutics to validate its clinical data and establish its competitive edge in the oncology market, particularly for patients with PI3K alpha mutations in breast cancer. The company is well-positioned financially and strategically to advance its clinical programs and explore potential partnerships.

Core Viewpoint - Relay Therapeutics, Inc. (RLAY) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, indicating that revisions in earnings estimates can lead to significant price changes [4][6]. - For Relay Therapeutics, the rising earnings estimates suggest an improvement in the company's underlying business, which is expected to positively influence its stock price [5]. Earnings Estimate Revisions - For the fiscal year ending December 2025, Relay Therapeutics is projected to earn -$1.85 per share, reflecting a 21.6% change from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for Relay Therapeutics has increased by 32.4%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating, highlighting their potential for market-beating returns [9][10]. - The upgrade of Relay Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a favorable outlook for the stock in the near term [10].