Summary of Relay Therapeutics Conference Call Company Overview - **Company**: Relay Therapeutics (NasdaqGM: RLAY) - **Focus**: Development of targeted therapies, particularly in oncology, with a focus on PI3K alpha mutant selective inhibitors Key Points Industry and Product Development - **Current Phase**: Relay Therapeutics is in execution mode for Phase 3 trials of RLY-2608, a PI3K alpha mutant selective inhibitor, believed to be the first of its kind in clinical trials [2][3] - **Financial Position**: The company has approximately $600 million in cash, providing a runway into 2029 for ongoing and future projects [2][37] Clinical Data and Efficacy - **Efficacy Metrics**: The company reported a 39% overall response rate (ORR) and a progression-free survival (PFS) of 10.3 months, with 11 months in the second-line setting [3][5] - **Competitive Landscape**: The current competitive bar for second-line treatments has not improved significantly, with some treatments showing lower PFS than previously established benchmarks [4][5] - **Trial Design**: The Rediscovery II trial is designed to be commercially viable, aiming for a minimum of 2-3 months improvement over Capivasertib [6][19] Safety and Tolerability - **Dosing Strategy**: The company has shifted to a 400 mg BID fed dosing regimen, which shows similar pharmacokinetic coverage compared to previous dosing strategies [8][9] - **Hyperglycemia Monitoring**: Relay Therapeutics does not anticipate the fed dosing to impact hyperglycemia rates, and they will not require at-home glucose monitoring for their study [10][11] Competitive Analysis - **Scorpion Molecule**: The company is monitoring the competitive landscape, particularly the Scorpion molecule, which has shown early data but remains difficult to interpret [12][14] - **Triplet Therapy**: Relay is exploring triplet therapy options, with a focus on safety and efficacy compared to existing treatments like Inavolisib and Roche's triplet data [17][20] Future Opportunities - **Vascular Malformations**: The company is conducting trials for vascular malformations driven by PI3K alpha mutations, learning from previous studies like Novartis' EPIC trials [30][32] - **Patient Population**: There is a significant opportunity in treating patients with PIK3CA mutations, with an estimated 170,000 patients across various types of vascular malformations [36][40] Regulatory and Market Considerations - **Regulatory Guidance**: The company is cautious about providing timelines for data release, emphasizing the importance of robust and interpretable data [36][37] - **Market Potential**: The company believes that any patient with PIK3CA mutated disease should respond to their selective inhibitor, indicating a broad market potential [39][40] Additional Insights - **Patient Selection**: The company is considering the implications of different mutational burdens and genetic factors in their trial designs [38][39] - **Testing Accessibility**: There is a significant amount of testing for PI3K alpha mutations in relevant patient populations, which may facilitate quicker treatment decisions [40] This summary encapsulates the key points discussed during the Relay Therapeutics conference call, highlighting the company's strategic focus, clinical data, competitive landscape, and future opportunities in the oncology space.

Summary of Relay Therapeutics FY Conference Call Company Overview - **Company**: Relay Therapeutics (NasdaqGM: RLAY) - **Focus**: Development of targeted therapies, particularly in oncology and vascular malformations Key Points on Portfolio and Development Priorities - **RLY-2608**: First PI3K mutant selective inhibitor in clinical trials with three ongoing trials - Pivotal trial for hormone receptor positive, HER2 negative breast cancer initiated in summer 2025 - Trials include combinations with RIBO, PALBO, and abemaciclib [5][6] - **Financial Position**: Company has sufficient cash to operate until 2029 with multiple upcoming catalysts [5] Clinical Profile and Competitive Positioning - **Efficacy vs. Safety**: RLY-2608 shows improved safety and tolerability compared to capivasertib, leading to longer treatment durations and better progression-free survival (PFS) rates [6][7] - PFS for RLY-2608 in second line setting is in double digits, significantly higher than capivasertib's 5.5 months [7] - **Market Dynamics**: Capivasertib has captured significant market share despite lower PFS due to its safety profile, generating $800 million annually [9] - **Comparative Data**: RLY-2608 has a confirmed objective response rate of 39%, outperforming competitors like the Scorpion Lilly molecule, which reported a 20% response rate [11][12] Strategic Considerations - **Post-CDK4/6 Market**: The company emphasizes the importance of the post-CDK4/6 market, which is expected to grow as CDK4/6 inhibitors gain traction in earlier treatment settings [15][16] - **Triplet Combinations**: Ongoing research into triplet combinations with fulvestrant and CDK inhibitors, focusing on dose optimization and patient selection [19][20] Expansion into Vascular Malformations - **Rationale for Development**: Similar to oncology, targeting PI3K mutations in vascular malformations is expected to yield significant benefits [28] - **Market Opportunity**: Estimated 170,000 patients in the U.S. with PI3K mutant vascular malformations, with potential for a multi-billion dollar market [39][41] - **Regulatory Path**: Following alpelisib's unusual regulatory approval, Relay plans to use similar endpoints for their trials [44][45] Enrollment and Market Research - **Patient Enrollment**: Positive feedback on enrollment pace in clinical trials for vascular malformations, despite the nascent nature of the disease setting [36][37] - **Current Treatment Landscape**: Limited use of existing therapies like alpelisib and sirolimus, with many patients unable to tolerate long-term treatment [42][43] Conclusion - Relay Therapeutics is positioned to leverage its innovative RLY-2608 in both oncology and vascular malformations, with a strong focus on safety, efficacy, and market potential. The company is optimistic about its clinical trials and the commercial opportunities that lie ahead.

Financial Performance - The company reported net losses of $221.6 million and $261.7 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $2.0 billion as of September 30, 2025[108]. - For the three months ended September 30, 2025, the company reported a net loss of $74.1 million, a decrease of $14.0 million compared to a net loss of $88.1 million for the same period in 2024[129]. - The company recognized $8.4 million in revenue during the nine months ended September 30, 2025, compared to $10.0 million in the same period of 2024, a decrease of $1.6 million[137]. - Other income, net, was $20.5 million for the nine months ended September 30, 2025, compared to $25.8 million in 2024, a decrease of $5.3 million due to changes in investment amounts and interest rate fluctuations[142]. - The company has not generated any revenue from product sales since its inception and does not expect to do so for several years[144]. - For the nine months ended September 30, 2024, the company reported a net loss of $261.7 million, with cash used in operating activities amounting to $191.2 million[153]. Cash and Financing - The company has cash, cash equivalents, and investments totaling $596.4 million as of September 30, 2025, which are expected to fund operations into 2029[113]. - Cash used in operating activities for the nine months ended September 30, 2025, was $190.6 million, slightly lower than $191.2 million in 2024[151]. - The company generated $269.4 million in net cash from financing activities for the nine months ended September 30, 2024, mainly from private placements and stock option exercises[157]. - The company anticipates needing additional financing to support ongoing operations and drug development efforts[111]. - The company may need to raise substantial additional funds to achieve its business objectives, with potential dilution of ownership interests if equity is sold[162]. Research and Development - The lead product candidate, RLY-2608, demonstrated a median progression-free survival (PFS) of 10.3 months overall and 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer[100]. - The company initiated a global Phase 3 registrational study, the ReDiscover-2 Trial, in the second quarter of 2025 to evaluate RLY-2608 plus fulvestrant in advanced breast cancer patients[100]. - The company incurred significant operating losses primarily due to research and development activities, licensing, and general administrative costs[108]. - The company expects to continue incurring significant expenses related to clinical trials and commercialization efforts for its product candidates[109]. - Research and development expenses for the three months ended September 30, 2025, were $68.3 million, down from $76.6 million in 2024, reflecting a decrease of $8.4 million due to strategic choices made to streamline operations[132]. - Total research and development expenses for the nine months ended September 30, 2025, were $206.0 million, down from $251.0 million in 2024, a decrease of $45.0 million attributed to strategic operational changes[139]. Administrative Expenses - General and administrative expenses decreased to $12.1 million for the three months ended September 30, 2025, from $19.8 million in 2024, a reduction of $7.6 million primarily due to lower stock compensation expenses[134]. - There were no material changes to the company's contractual obligations and commitments during the three months ended September 30, 2025[164]. - The company has no outstanding debt as of September 30, 2025, thus not exposed to interest rate risk related to debt[170]. Foreign Currency and Hedging - Foreign currency transaction gains and losses have not been material, with a 10% change in exchange rates estimated to have no significant effect on financial results[171]. - The company is evaluating the potential for a hedging program for foreign currency transactions as it expands international operations[171]. Licensing and Agreements - The company entered into an exclusive global licensing agreement with Elevar Therapeutics, receiving $5.0 million upfront and eligible for up to $495.0 million in milestone payments[102]. - The company entered into the Elevar Agreement in December 2024, receiving $5.0 million in upfront consideration and $3.4 million for the transfer of materials as of September 30, 2025[145]. Stock Sales - The company has not sold any shares under the 2024 Sales Agreement, which allows for gross proceeds of up to $250.0 million[104].

Financial Performance - As of September 30, 2025, Relay Therapeutics reported cash, cash equivalents, and investments totaling $596.4 million, down from $781.3 million as of December 31, 2024[7]. - Research and development expenses for Q3 2025 were $68.3 million, a decrease of $8.4 million compared to $76.6 million in Q3 2024, primarily due to strategic streamlining[8]. - General and administrative expenses decreased to $12.1 million in Q3 2025 from $19.8 million in Q3 2024, reflecting a reduction in stock compensation and employee costs[9]. - The net loss for Q3 2025 was $74.1 million, or $0.43 per share, compared to a net loss of $88.1 million, or $0.63 per share, in Q3 2024[9]. - Total revenue for the nine months ended September 30, 2025, was $8.4 million, down from $10.0 million for the same period in 2024[16]. - Relay Therapeutics' total assets as of September 30, 2025, were $670.0 million, down from $871.3 million as of December 31, 2024[18]. Future Outlook - The company expects its current cash resources to be sufficient to fund operating expenses and capital expenditures into 2029[7]. Clinical Development - Relay Therapeutics is advancing its RLY-2608 clinical trials in PI3Kα-mutated breast cancer and vascular malformations[1]. - The ongoing Phase 3 ReDiscover-2 trial of RLY-2608 in advanced breast cancer continues to progress[11]. Corporate Governance - The company appointed Lonnel Coats and Habib Dable to its Board of Directors, bringing extensive commercialization expertise[3].

Core Insights - Relay Therapeutics continues to focus on the clinical execution of RLY-2608 trials for PI3Kα-mutated breast cancer and vascular malformations, with positive progress reported [2][8] - The company appointed Lonnel Coats and Habib Dable to its Board of Directors, bringing extensive experience in biotech commercialization and late-stage development [3][4][5] - As of September 30, 2025, the company reported approximately $596 million in cash, cash equivalents, and investments, a decrease from $781 million at the end of 2024, but sufficient to fund operations into 2029 [9][18] Clinical Trials - The Phase 3 ReDiscover-2 trial of RLY-2608 combined with fulvestrant is ongoing for advanced breast cancer patients [8] - The Phase 1/2 ReDiscover trial is advancing triplet cohorts with RLY-2608, fulvestrant, and various CDK inhibitors [8] - The Phase 1/2 ReInspire clinical trial for vascular malformations is also in progress [8] Financial Performance - Research and development expenses for Q3 2025 were $68.3 million, down from $76.6 million in Q3 2024, attributed to strategic streamlining [10] - General and administrative expenses decreased to $12.1 million in Q3 2025 from $19.8 million in Q3 2024, mainly due to reduced stock compensation and employee costs [11] - The net loss for Q3 2025 was $74.1 million, or $0.43 per share, compared to a net loss of $88.1 million, or $0.63 per share, in Q3 2024 [11]

Group 1 - 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 upcoming fireside chats in November, which will be webcast live and available for replay for 30 days [1] - Relay's lead clinical asset, RLY-2608, is the first pan-mutant selective PI3Kα inhibitor in clinical development, currently in a Phase 3 trial for HR+/HER2- metastatic breast cancer [2] Group 2 - Relay's Dynamo platform utilizes advanced computational and experimental methods to target previously challenging protein targets [2] - The company is also exploring RLY-2608 for PI3Kα-driven vascular malformations and has late-stage research programs for NRAS-driven solid tumors and Fabry disease [2] - Upcoming events include Guggenheim's Healthcare Innovation Conference on November 10, 2025, and Jefferies Global Healthcare Conference on November 19, 2025 [3]

Core Insights - Relay Therapeutics is set to report its third quarter 2025 financial results and corporate highlights on November 6, 2025, after U.S. market close [1] Company Overview - Relay Therapeutics is a clinical-stage precision medicine company focused on developing therapies for cancer and genetic diseases [2] - The company utilizes its Dynamo® platform, which combines advanced computational and experimental technologies to target previously challenging protein targets [2] - Relay's lead clinical asset, RLY-2608, is the first pan-mutant selective PI3Kα inhibitor in clinical development, currently undergoing a Phase 3 trial for HR+/HER2- metastatic breast cancer [2] - RLY-2608 is also being explored for PI3Kα-driven vascular malformations, with additional late-stage research programs targeting NRAS-driven solid tumors and Fabry disease [2]

Group 1 - Relay Therapeutics, Inc. (RLAY) shares have increased by 37.4% over the past four weeks, closing at $7.31, with a mean price target of $13.6 indicating a potential upside of 86.1% [1] - The average of 10 short-term price targets ranges from a low of $4.00 to a high of $19.00, with a standard deviation of $4.22, suggesting variability in analyst estimates [2] - Analysts have shown increasing optimism regarding RLAY's earnings prospects, with a positive trend in earnings estimate revisions correlating with potential stock price movements [4][11] Group 2 - The Zacks Consensus Estimate for RLAY's current year earnings has increased by 2% over the last 30 days, indicating a positive outlook [12] - RLAY holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting strong potential for upside [13] - While consensus price targets may not be reliable for predicting exact gains, they can provide a directional guide for price movement [14]

Core Insights - Momentum investing focuses on following a stock's recent price trends, with the aim of buying high and selling higher, capitalizing on established price movements [1] - Relay Therapeutics, Inc. (RLAY) currently holds a Momentum Style Score of B, indicating a favorable position in momentum investing [3][12] - The Zacks Rank for Relay Therapeutics is 2 (Buy), suggesting strong potential for outperformance in the market [4][12] Price Performance - RLAY shares have increased by 5.7% over the past week, while the Zacks Medical - Drugs industry remained flat during the same period [6] - Over the last month, RLAY's price change is 42.2%, significantly outperforming the industry's 0.47% [6] - In the past quarter, RLAY shares have risen by 102.19%, and they are up 22.39% over the last year, compared to the S&P 500's increases of 7.9% and 19.67%, respectively [7] Trading Volume - RLAY's average 20-day trading volume is 1,878,524 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - In the last two months, one earnings estimate for RLAY has increased, while none have decreased, leading to a consensus estimate improvement from -$1.62 to -$1.59 [10] - For the next fiscal year, one estimate has moved upwards with no downward revisions, indicating positive earnings momentum [10]

Industry Overview - The global cancer treatment market is undergoing a transformative phase due to rising cancer incidence and rapid scientific advancements, with the U.S. projected to report 2.04 million new cancer cases and over 618,000 deaths in 2025 [1] - An aging population and lifestyle-related risks are increasing global cancer prevalence, leading to higher oncology spending by healthcare systems [1] Innovation in Cancer Treatment - Advances in immunotherapies, targeted drugs, and personalized vaccines are expanding treatment options beyond traditional chemotherapy and radiation [2] - Immune-based approaches, such as checkpoint inhibitors and CAR-T therapies, enhance the body's defenses against tumors, while targeted therapies focus on specific genetic mutations to improve precision and reduce side effects [2] - Emerging technologies like genomic sequencing, AI, and machine learning are accelerating biomarker discovery and improving early detection, contributing to better survival rates and quality of life across many cancer types [3] Pharmaceutical Investment - Major pharmaceutical companies, including Novartis, AstraZeneca, Johnson & Johnson, Pfizer, AbbVie, Merck, Bristol Myers Squibb, and Eli Lilly, are aggressively investing in new oncology pipelines, including antibody-drug conjugates and next-generation immuno-oncology agents [4] - Smaller biotech firms are key sources of innovation, driving collaborations, licensing deals, and acquisitions as larger companies seek novel assets [4] Investment Opportunities - The oncology segment is positioned as one of the most attractive and resilient areas for long-term investors due to continued innovation and favorable reimbursement trends [5] - Stocks such as Relay Therapeutics, Fate Therapeutics, and Verastem Oncology are highlighted as potential investment opportunities in the rising cancer treatment trend [6] Company Highlights - **Relay Therapeutics** is developing RLY-2608, a mutant-selective PI3Kα inhibitor, showing potential benefits in clinical studies for advanced breast cancer [7][8] - **Fate Therapeutics** focuses on universal, off-the-shelf cell products and is co-developing FT825/ONO-8250, a CAR T-cell product candidate, with promising safety profiles in early studies [9][10][11] - **Verastem Oncology** received FDA approval for its combination regimen of avutometinib and defactinib for treating KRAS mutant recurrent low-grade serous ovarian cancer, generating $2.1 million in sales shortly after launch [12][13]