UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39385 RELAY THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-3923475 (State or other jurisdi ...

Exhibit 99.1 Relay Therapeutics Reports First Quarter 2025 Financial Results and Corporate Updates Cash runway extended into 2029 Initiation of Phase 3 ReDiscover-2 trial on track for mid-2025 Initiated Phase 1 RLY-2608 vascular malformations clinical trial in Q1 Extended cash runway expected to fully fund the Company meaningfully past topline data for ReDiscover-2 trial and through clinical proof-of-concept data in Vascular Malformations Approximately $710 million in cash, cash equivalents and investments ...

Cash runway extended into 2029 Initiation of Phase 3 ReDiscover-2 trial on track for mid-2025 Initiated Phase 1 RLY-2608 vascular malformations clinical trial in Q1 Extended cash runway expected to fully fund the Company meaningfully past topline data for ReDiscover-2 trial and through clinical proof-of-concept data in Vascular Malformations Approximately $710 million in cash, cash equivalents and investments at end of Q1 2025 CAMBRIDGE, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nas ...

CAMBRIDGE, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, will report first quarter 2025 financial results and corporate highlights after the U.S. financial markets close on Monday, May 5, 2025. About Relay Therapeutics Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicine company transforming the dru ...

Group 1 - The core point of the article is the upheaval in Relay Therapeutics' pipeline, particularly the outlicensing of the FGFR2 inhibitor lirafugratinib to Elevar [1] - The author emphasizes the importance of understanding the science behind biotech investments and aims to educate investors to avoid pitfalls in this sector [1] Group 2 - The article does not provide any specific financial data or performance metrics related to Relay Therapeutics or the broader biotech industry [1]

Core Viewpoint - Relay Therapeutics, Inc. (RLAY) has experienced a significant decline of 31.1% over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to improved earnings expectations from Wall Street analysts [1]. Group 1: Stock Performance and Technical Indicators - RLAY's stock has been under heavy selling pressure, leading to an RSI reading of 26.89, indicating it is oversold [5]. - The Relative Strength Index (RSI) is a momentum oscillator that helps identify oversold conditions when the reading falls below 30 [2]. - Stocks oscillate between overbought and oversold states, and an oversold condition may present entry opportunities for investors anticipating a rebound [3]. Group 2: Earnings Estimates and Analyst Consensus - There is a strong consensus among sell-side analysts that RLAY will report better earnings than previously predicted, with a 14.1% increase in the consensus EPS estimate over the last 30 days [6]. - RLAY holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a near-term turnaround [7].

Clinical Development Risks - The company has never successfully completed any large-scale, pivotal clinical trials, which poses a significant risk to the development of its product candidates [203]. - The company may face delays in obtaining marketing approval for its product candidates, which could result in not obtaining approval at all or only for narrower indications than desired [204]. - Clinical testing is described as expensive and uncertain, with the potential for significant setbacks during the process [218]. - The company may incur additional costs or experience delays in completing the development and commercialization of its product candidates due to unforeseen events [207]. - Enrollment in clinical trials may be hindered by competition and specific eligibility criteria, potentially delaying regulatory approvals [211]. - The company may need to conduct additional clinical trials or testing if initial results are not positive, which could further delay marketing approval [204]. - Positive data from early studies may not predict later success, and many companies have faced setbacks in late-stage trials despite initial positive results [217]. - The company may face challenges in developing companion diagnostics, which are necessary for certain product candidates to ensure safe and effective use [213]. - Significant adverse events in clinical trials could hinder patient recruitment and lead to trial abandonment, impacting business prospects [220]. - The company announced three preclinical programs in June 2024 focused on vascular malformations, Fabry disease, and NRAS, but timelines for clinical development are uncertain [223]. Financial and Operational Challenges - The company incurred net losses of $337.7 million, $342.0 million, and $290.5 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $1.7 billion as of December 31, 2024 [284]. - The company has no products approved for commercial sale and has not generated any revenue from product sales, with no expectation of revenue generation in the near future [288]. - The company anticipates continued significant operating losses due to ongoing research and development expenses, as well as general and administrative costs [285]. - The company expects to incur substantial additional funding needs to support ongoing operations and product development, particularly as it seeks marketing approval for its product candidates [291]. - The company may face significant fluctuations in quarterly operating results due to various factors, including clinical trial outcomes and regulatory approvals [286]. - The company has incurred significant operating losses since inception, primarily due to research and development costs [285]. Competition and Market Dynamics - The company faces substantial competition in the biopharmaceutical industry, with competitors having significantly greater financial resources and expertise in R&D, manufacturing, and regulatory approvals [240]. - Key competitive factors include the efficacy, safety, convenience, and pricing of the company's product candidates compared to currently approved therapies and new therapies [241]. - The commercial opportunity may be reduced if competitors develop safer, more effective, or less expensive products, or if they obtain regulatory approval more rapidly [243]. - The total addressable market for the company's product candidates may be smaller than estimated, affecting revenue and profitability [236]. Regulatory and Compliance Issues - Regulatory approval for novel product candidates may be more expensive and time-consuming, potentially delaying commercialization [229]. - The company must ensure that clinical trials comply with Good Clinical Practices (GCPs) to avoid unreliable data that could hinder regulatory approval [253]. - The company is subject to ongoing regulatory obligations post-approval, which may include costly post-marketing studies and could result in significant additional expenses if safety issues arise [347]. - The FDA's policies and regulations may change, which could delay or prevent regulatory approval of the company's product candidates, adversely affecting its business and profitability [349]. - Compliance with data collection regulations in Europe and other jurisdictions is critical, as failure to adhere to these requirements could have a material adverse effect on the company's operations and financial results [351]. Intellectual Property Risks - The company’s ability to commercialize products may be impaired if it fails to adequately protect its intellectual property [281]. - The company may need to relinquish valuable rights to intellectual property or future revenue streams if it raises funds through collaborations or licensing arrangements [297]. - The company faces risks related to patent protection, including potential loss of exclusivity and inability to stop competitors from using similar technologies [317]. - The company's patent portfolio may not provide sufficient protection against competitors designing around its claims, which could negatively impact commercialization efforts [318]. - Intellectual property litigation is costly and time-consuming, potentially diverting resources from core business activities [330]. Strategic Partnerships and Collaborations - The company has entered into collaborations, such as the Elevar Agreement for lirafugratinib, but faces risks if these collaborations do not succeed [268]. - The company may need to seek additional licenses or collaborations to fund product development, facing significant competition in this area [272]. - Any delays or failures in collaborations could result in the company not receiving expected milestone or royalty payments, affecting development timelines [270]. External Economic and Political Factors - Economic uncertainty, including rising interest rates and inflation, may increase business costs and impact the ability to raise necessary capital [301]. - Political and trade developments, such as tariffs imposed by the U.S., could negatively impact markets and lead to weaker macroeconomic conditions [303]. - The closures of Silicon Valley Bank and Signature Bank in 2023 created liquidity risks that could affect the company's access to working capital [301]. Healthcare and Market Regulations - The company must ensure compliance with healthcare laws and regulations, which could involve substantial costs and risks of penalties [374]. - The Inflation Reduction Act of 2022 includes a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, which may impact the company's revenue prospects [389]. - Recent federal legislation may allow the reimportation of drugs from foreign countries, which could adversely affect the prices received for the company's products [392]. Human Resources and Management - The company faces risks related to the retention of key executives and experienced personnel, which are critical for achieving research and development objectives [396]. - The company may face challenges in recruiting and retaining qualified personnel due to competition from larger firms [242]. - The company relies on consultants and advisors for its strategy, and their availability may be limited due to commitments to other entities [397].

Exhibit 99.1 Relay Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Updates Initiation of Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant anticipated in the middle of 2025 in PI3Kα- mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer Presented interim data for RLY-2608 + fulvestrant showing 11.4-month median PFS in 2L patients with PI3Kα-mutated, HR+/HER2- advanced breast cancer Continued progression of other front-line breast cancer regimens, including i ...

Core Insights - Relay Therapeutics is advancing its RLY-2608 breast cancer program, with a Phase 3 trial (ReDiscover-2) expected to start in mid-2025, focusing on patients with PI3Kα mutations who have been pre-treated with CDK4/6 inhibitors [1][5][2] - The interim data for RLY-2608 combined with fulvestrant shows a median progression-free survival (PFS) of 11.4 months in second-line patients with PI3Kα mutations [1][11] - The company reported approximately $781.3 million in cash, cash equivalents, and investments as of December 31, 2024, which is expected to fund operations into the second half of 2027 [7][19] Clinical Development - The ReDiscover-2 trial will be a randomized, open-label, multicenter study evaluating the safety and efficacy of RLY-2608 + fulvestrant against capivasertib + fulvestrant in advanced breast cancer patients [5] - Key inclusion criteria for the trial include prior treatment with a CDK4/6 inhibitor and frontline endocrine therapy for over six months [5] - The primary endpoint is progression-free survival, with overall survival as a key secondary endpoint [5] Financial Performance - Relay Therapeutics reported no revenue for Q4 2024, with total revenue for the full year at $10 million, down from $25.5 million in 2023, primarily due to timing of milestones [8] - Research and development expenses decreased to $68.1 million in Q4 2024 from $77.5 million in Q4 2023, and total R&D expenses for 2024 were $319.1 million compared to $330 million in 2023 [9] - The net loss for Q4 2024 was $76 million, or $0.45 per share, an improvement from a net loss of $83.5 million, or $0.67 per share, in Q4 2023 [12] Future Outlook - The company plans to continue advancing its clinical programs, including the initiation of the RLY-2608 + fulvestrant Phase 3 trial and exploring additional triplet combinations for earlier treatment settings [2][11] - Upcoming milestones include additional Phase 1b data for RLY-2608 and the initiation of clinical trials for vascular malformations in Q1 2025 [11]

Company Overview - 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 aims to develop life-changing therapies, particularly in targeted oncology and genetic disease indications [2] - Relay Therapeutics utilizes its proprietary Dynamo® platform, which integrates various computational and experimental approaches to target previously challenging protein targets [2] Upcoming Events - Management will participate in two fireside chats, which will be webcast live and accessible through the company's website [1] - The events include participation in TD Cowen's 45th Annual Health Care Conference on March 5, 2025, and Barclays 27th Annual Global Healthcare Conference on March 11, 2025 [3]