[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported a net loss for Q2 and the first six months of 2025, experiencing a decrease in total assets while maintaining a strong liquidity position [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $113,941 | $124,287 | | Investments | $542,834 | $657,036 | | Total current assets | $680,392 | $809,204 | | Total assets | $728,841 | $871,296 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $32,525 | $50,729 | | Total liabilities | $63,183 | $93,504 | | Total stockholders' equity | $665,658 | $777,792 | | Total liabilities and stockholders' equity | $728,841 | $871,296 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations (in thousands) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $677 | $0 | $8,355 | $10,007 | | Research and development expenses | $63,897 | $91,992 | $137,706 | $174,395 | | General and administrative expenses | $13,627 | $20,139 | $32,366 | $39,938 | | Loss from operations | $(76,847) | $(100,757) | $(161,717) | $(191,120) | | Net loss | $(70,375) | $(92,212) | $(147,440) | $(173,599) | | Net loss per share, basic and diluted | $(0.41) | $(0.69) | $(0.87) | $(1.32) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(128,471) | $(116,156) | | Net cash provided by investing activities | $117,611 | $56,081 | | Net cash provided by financing activities | $653 | $50,464 | | Net decrease in cash, cash equivalents, and restricted cash | $(10,207) | $(9,611) | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage precision medicine company with a lead product candidate, RLY-2608, in clinical development, having incurred net operating losses since inception, with an accumulated deficit of **$1.9 billion** as of June 30, 2025[31](index=31&type=chunk)[35](index=35&type=chunk) - The Genentech collaboration agreement was terminated effective January 7, 2025, resulting in **no further milestone payments** and **$0 revenue** from this agreement in the first six months of 2025, compared to **$10.0 million** in the same period of 2024[69](index=69&type=chunk)[71](index=71&type=chunk) - In December 2024, the company entered into an exclusive license agreement with Elevar Therapeutics for lirafugratinib (RLY-4008), recognizing **$8.4 million** in revenue from this agreement for the six months ended June 30, 2025[72](index=72&type=chunk)[75](index=75&type=chunk) - During Q2 2025, the company underwent restructuring, including terminating approximately **70 employees**, ending its lease at 399 Binney Street, and executing a new lease at One Kendall Square, leading to a **$2.3 million** intangible asset impairment and write-off for assembled workforce[80](index=80&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the advancement of lead product candidate RLY-2608, highlighting decreased operating expenses due to strategic streamlining and a strong financial position expected to fund operations into 2029 - The company's lead product candidate, RLY-2608, is an allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, with updated interim data from the ReDiscover Trial showing a **10.3-month median progression-free survival (PFS)** overall in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer[97](index=97&type=chunk)[99](index=99&type=chunk) - The company believes its existing cash, cash equivalents, and investments of **$656.8 million** as of June 30, 2025, will be sufficient to fund its operating expenses and capital expenditure requirements into **2029**[113](index=113&type=chunk)[162](index=162&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Comparison of Operations for the Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | License and other revenue | $677 | $0 | $677 | | Research and development expenses | $63,897 | $91,992 | $(28,095) | | General and administrative expenses | $13,627 | $20,139 | $(6,512) | | Net loss | $(70,375) | $(92,212) | $21,837 | - The **$28.1 million decrease** in R&D expenses for Q2 2025 compared to Q2 2024 was primarily due to strategic choices to streamline the research organization and cost avoidance on lirafugratinib development following the Elevar Agreement[134](index=134&type=chunk) Comparison of Operations for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | License and other revenue | $8,355 | $10,007 | $(1,652) | | Research and development expenses | $137,706 | $174,395 | $(36,689) | | General and administrative expenses | $32,366 | $39,938 | $(7,572) | | Net loss | $(147,440) | $(173,599) | $26,159 | - For the first six months of 2025, revenue of **$8.4 million** was recognized from the Elevar Agreement, while in the same period of 2024, **$10.0 million** was recognized from the now-terminated Genentech Agreement[139](index=139&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$656.8 million** in cash, cash equivalents, and investments[144](index=144&type=chunk) - Recent financing activities include a new 'at-the-market' (ATM) sales agreement for up to **$250.0 million** established in August 2024, though no shares have been sold under it as of June 30, 2025, with a prior ATM agreement terminated in August 2024[104](index=104&type=chunk)[149](index=149&type=chunk)[151](index=151&type=chunk) - In January 2024, the company received **$29.8 million** in net proceeds from a private placement of **2,500,000 shares** of common stock[105](index=105&type=chunk)[152](index=152&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its investment portfolio, with a hypothetical 100 basis point adverse movement not expected to have a material impact, and foreign currency risk considered immaterial - The company's primary market risk is interest rate sensitivity on its cash and investment portfolio, which as of June 30, 2025, consisted of money market funds, U.S. treasury bills, and U.S. agency securities[174](index=174&type=chunk) - Foreign currency exchange risk is minimal as operations are located in the United States and expenses are generally denominated in U.S. dollars[176](index=176&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The company's CEO and CFO concluded that as of June 30, 2025, the disclosure controls and procedures were **effective** at a reasonable assurance level[178](index=178&type=chunk) - There were **no changes** in internal control over financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[179](index=179&type=chunk) [PART II. OTHER INFORMATION](index=42&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a derivative lawsuit alleging excessive director and officer compensation and breach of fiduciary duty, with the outcome currently unpredictable - A derivative complaint was filed against certain directors and officers on December 18, 2024, alleging **excessive board member compensation** for the years 2021-2023[182](index=182&type=chunk) - The claims include breach of fiduciary duty, unjust enrichment, and waste of corporate assets, with the company unable to predict the outcome or potential loss related to this matter[182](index=182&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company faces numerous risks, including those related to its limited operating history, product candidate development, reliance on third parties, funding, intellectual property, and market factors [Risks Related to Our Product Candidates](index=42&type=section&id=Risks%20Related%20to%20Our%20Product%20Candidates) - The company has never successfully completed any large-scale, pivotal clinical trials and faces a lengthy, expensive, and uncertain product development process[184](index=184&type=chunk)[185](index=185&type=chunk) - Positive data from early clinical studies are not necessarily predictive of later trial results, and the company may not be able to replicate positive data[198](index=198&type=chunk) - Developing product candidates in combination with other therapies, such as RLY-2608 with fulvestrant and CDK4/6 inhibitors, exposes the company to additional risks, including potential for exacerbated adverse events and dependency on the approval and availability of the other therapies[202](index=202&type=chunk)[207](index=207&type=chunk) [Risks Related to Our Reliance on Third Parties](index=55&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) - The company relies on third parties like CROs to conduct clinical trials, and their failure to perform successfully or comply with regulations could harm the company's ability to obtain regulatory approval[231](index=231&type=chunk)[235](index=235&type=chunk) - Reliance on third-party manufacturers (CMOs) for product candidates creates risks related to supply sufficiency, cost, quality, and regulatory compliance, as the company does not own manufacturing facilities[242](index=242&type=chunk)[243](index=243&type=chunk) - Sourcing active pharmaceutical ingredients (API) and starting materials from single-source suppliers poses a significant risk to development and commercialization if these suppliers fail to deliver[250](index=250&type=chunk) [Risks Related to Our Financial Position and Ability to Raise Additional Capital](index=66&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Ability%20to%20Raise%20Additional%20Capital) - The company has a limited operating history, has incurred significant operating losses since inception (an accumulated deficit of **$1.9 billion** as of June 30, 2025), and anticipates continued losses for the foreseeable future[270](index=270&type=chunk)[271](index=271&type=chunk) - The company will need to raise substantial additional funding to support its development programs and commercialization efforts, with failure to do so potentially forcing delays, reductions, or elimination of programs[278](index=278&type=chunk) [Risks Related to Our Intellectual Property](index=74&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's success depends on its ability to obtain and maintain patent protection for its technology and products, recognizing that the patent position of biotech companies is highly uncertain and involves complex legal questions[293](index=293&type=chunk)[297](index=297&type=chunk) - Much of the company's R&D has been performed under the DESRES Agreement, leading to joint ownership of some work product, and disputes over this intellectual property could impair the company's ability to protect its product candidates[294](index=294&type=chunk)[296](index=296&type=chunk) - The company relies on trade secrets and know-how, and an inability to protect the confidentiality of this information could harm its business and competitive position[310](index=310&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=117&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[435](index=435&type=chunk) [Other Information](index=118&type=section&id=Item%205.%20Other%20Information) Brian Adams resigned as Chief Legal Officer and Secretary, effective August 8, 2025, with his departure not resulting from any disagreement with the company - Brian Adams, Chief Legal Officer and Secretary, resigned effective August 8, 2025, with his departure not the result of any dispute or disagreement with the company[438](index=438&type=chunk) [Exhibits](index=119&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, a lease amendment, and officer certifications - Key exhibits filed include an Amended and Restated Non-Employee Director Compensation Policy, a Third Amendment to a lease, and CEO/CFO certifications pursuant to the Sarbanes-Oxley Act[440](index=440&type=chunk)

[Executive Summary & Corporate Updates](index=1&type=section&id=Executive%20Summary%20%26%20Corporate%20Updates) [Q2 2025 Key Highlights](index=1&type=section&id=Q2%202025%20Key%20Highlights) Relay Therapeutics reported its Q2 2025 financial results and corporate updates, highlighting the initiation of the Phase 3 ReDiscover-2 trial for RLY-2608 and consistent updated data from the Phase 1 trial presented at ASCO, alongside a cash position of approximately $657 million - Initiated Phase 3 ReDiscover-2 trial in Q2[1](index=1&type=chunk) - Presented updated data at ASCO showing consistency with prior data[1](index=1&type=chunk) Key Clinical and Financial Highlights | Metric | Value | | :----- | :---- | | Median PFS (PI3Kα-mutated, HR+/HER2- mBC) | 10.3 months | | ORR (PI3Kα-mutated, HR+/HER2- mBC) | 39% | | Cash, Cash Equivalents and Investments (end of Q2 2025) | ~$657 million | [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Sanjiv Patel emphasized the excitement around initiating the Phase 3 ReDiscover-2 Trial for RLY-2608 + fulvestrant in HR+/HER2- breast cancer, noting the consistent interim Phase 1 data for safety and efficacy, and stated that patient enrollment and trial execution are top priorities to address the unmet medical need in post-CDK4/6 breast cancer - Initiated Phase 3 ReDiscover-2 Trial for RLY-2608 + fulvestrant in HR+/HER2- breast cancer patients[3](index=3&type=chunk) - Interim data from Phase 1 trial remained consistent, showing potential benefits of RLY-2608 for safety and efficacy compared to historical standard of care[3](index=3&type=chunk) - Company's top priority is to enroll patients and execute this trial to deliver a novel medicine in the post-CDK4/6 breast cancer setting[3](index=3&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) [RLY-2608 Clinical Development](index=1&type=section&id=RLY-2608%20Clinical%20Development) Relay Therapeutics provided detailed updates on its RLY-2608 clinical development, including consistent Phase 1b data presented at ASCO, the initiation of the Phase 3 ReDiscover-2 trial for breast cancer, and continued progress in the vascular malformations clinical trial [Phase 1b Data (ASCO Presentation)](index=1&type=section&id=Phase%201b%20Data%20(ASCO%20Presentation)) Updated interim clinical data from the open-label Phase 1b study for RLY-2608 + fulvestrant, presented at ASCO, showed consistent efficacy and a strong safety profile, with a median PFS of 10.3 months and an ORR of 39% across all PI3Kα-mutated, HR+/HER2- metastatic breast cancer patients - Updated interim clinical data from the open-label Phase 1b study for RLY-2608 + fulvestrant presented at ASCO was consistent with previous disclosures[4](index=4&type=chunk) RLY-2608 Phase 1b Clinical Data | Metric | All Patients (PI3Kα-mutated, HR+/HER2- mBC) | 2L Patients | | :----- | :------------------------------------------ | :---------- | | Median PFS | 10.3 months | 11.0 months | | ORR | 39% | 42% (confirmed, measurable disease) | | Median PFS (2L, kinase mutations) | N/A | 18.4 months | | Median PFS (2L, non-kinase mutations) | N/A | 8.5 months | | Median Follow-up | 12.5 months | N/A | - Safety profile remained strong with mostly low-grade treatment-related adverse events[4](index=4&type=chunk) [Breast Cancer Clinical Trial Execution](index=1&type=section&id=Breast%20Cancer%20Clinical%20Trial%20Execution) The company initiated the Phase 3 ReDiscover-2 trial for RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer and continued advancing ongoing triplet cohorts with atirmociclib or ribociclib - Initiated Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer[4](index=4&type=chunk) - Continued advancement of the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib or ribociclib[4](index=4&type=chunk) [Vascular Malformations Clinical Trial](index=1&type=section&id=Vascular%20Malformations%20Clinical%20Trial) Relay Therapeutics continued the execution of its ongoing Phase 1 vascular malformations clinical trial - Continued execution of ongoing Phase 1 vascular malformations clinical trial[4](index=4&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Performance) Relay Therapeutics reported a net loss of **$70.4 million** for Q2 2025, an improvement from **$92.2 million** in Q2 2024, driven by reduced R&D and G&A expenses, with the company's cash position standing at **$656.8 million**, projected to fund operations into 2029 [Key Financial Metrics](index=2&type=section&id=Key%20Financial%20Metrics) The company saw a significant decrease in R&D and G&A expenses in Q2 2025 compared to Q2 2024, leading to a reduced net loss and improved EPS, with revenue increasing from $0 to **$0.7 million**, and cash, cash equivalents, and investments decreasing from **$710.4 million** to **$656.8 million** quarter-over-quarter Q2 2025 Key Financial Metrics | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY, in millions) | | :----- | :-------------------- | :-------------------- | :------------------------ | | Cash, Cash Equivalents and Investments (period end) | $656.8 | N/A | -$53.6 (vs Q1 2025) | | Revenue | $0.7 | $0 | +$0.7 | | R&D Expenses | $63.9 | $92.0 | -$28.1 | | G&A Expenses | $13.6 | $20.1 | -$6.5 | | Net Loss | $70.4 | $92.2 | -$21.8 | | Net Loss Per Share | $0.41 | $0.69 | -$0.28 | - The decrease in R&D expenses was primarily due to strategic choices to streamline the research organization and cost avoidance on lirafugratinib development[6](index=6&type=chunk) - The decrease in G&A expenses was primarily due to a decrease in stock compensation expense and other employee compensation costs[7](index=7&type=chunk) - Current cash, cash equivalents, and investments are expected to fund operating expenses and capital expenditure requirements into 2029[5](index=5&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The detailed income statement shows a significant reduction in total operating expenses for both the three and six months ended June 30, 2025, compared to the prior year, contributing to a lower net loss, with license and other revenue increasing for the quarter but decreasing year-to-date Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | License and other revenue | $677 | $— | $8,355 | $10,007 | | Total revenue | $677 | $— | $8,355 | $10,007 | | Research and development expenses | $63,897 | $91,992 | $137,706 | $174,395 | | Change in fair value of contingent consideration liability | $— | $(11,374) | $— | $(13,206) | | General and administrative expenses | $13,627 | $20,139 | $32,366 | $39,938 | | Total operating expenses | $77,524 | $100,757 | $170,072 | $201,127 | | Loss from operations | $(76,847) | $(100,757) | $(161,717) | $(191,120) | | Interest income | $7,105 | $8,547 | $14,918 | $17,498 | | Net loss | $(70,375) | $(92,212) | $(147,440) | $(173,599) | | Net loss per share, basic and diluted | $(0.41) | $(0.69) | $(0.87) | $(1.32) | | Weighted average shares of common stock, basic and diluted | 171,264,622 | 132,821,826 | 170,254,500 | 131,832,420 | [Selected Condensed Consolidated Balance Sheet Data](index=5&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data) The balance sheet data shows a decrease in cash, cash equivalents, and investments, as well as total assets, working capital, and total liabilities from December 31, 2024, to June 30, 2025, with total stockholders' equity also decreasing Selected Condensed Consolidated Balance Sheet Data | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash, cash equivalents and investments | $656,775 | $781,323 | | Working capital (1) | $647,867 | $758,475 | | Total assets | $728,841 | $871,296 | | Total liabilities | $63,183 | $93,504 | | Total stockholders' equity | $665,658 | $777,792 | | Restricted cash | $2,258 | $2,119 | - Working capital is defined as current assets less current liabilities[15](index=15&type=chunk) [Company Information](index=2&type=section&id=Company%20Information) [About Relay Therapeutics](index=2&type=section&id=About%20Relay%20Therapeutics) Relay Therapeutics is a clinical-stage, small molecule precision medicine company focused on developing life-changing therapies for cancer and genetic diseases, leveraging its Dynamo® platform to drug challenging protein targets, with RLY-2608 as its lead clinical asset in Phase 3 for breast cancer and also being investigated for vascular malformations - Relay Therapeutics is a clinical-stage, small molecule precision medicine company developing therapies for cancer and genetic disease[8](index=8&type=chunk) - Utilizes the Dynamo® platform, integrating computational and experimental approaches to drug intractable protein targets[8](index=8&type=chunk) - RLY-2608 is the lead clinical asset, a pan-mutant selective PI3Kα inhibitor, in Phase 3 for HR+/HER2- metastatic breast cancer and Phase 1 for PI3Kα-driven vascular malformations[8](index=8&type=chunk) - Pipeline includes late-stage research programs for NRAS-driven solid tumors and Fabry disease[8](index=8&type=chunk) [Legal & Contact Information](index=2&type=section&id=Legal%20%26%20Contact%20Information) [Cautionary Note Regarding Forward-Looking Statements](index=2&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section provides a standard disclaimer regarding forward-looking statements, outlining various risks and uncertainties that could cause actual results to differ materially from projections, including those related to restructuring activities, clinical trial timing and outcomes, regulatory interactions, intellectual property, and global economic factors - Contains forward-looking statements regarding strategy, clinical development, therapeutic benefits, financial projections, and use of capital[9](index=9&type=chunk) - Statements are subject to risks and uncertainties, including those related to restructuring costs, clinical trial delays or outcomes, safety and efficacy demonstration, regulatory approvals, and intellectual property[11](index=11&type=chunk) - Risks are described in greater detail in the company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q[11](index=11&type=chunk) [Contact Information](index=3&type=section&id=Contact%20Information) Provides contact details for investor relations and media inquiries - Investor Contact: Pete Rahmer (prahmer@relaytx.com)[12](index=12&type=chunk) - Media Contact: Dan Budwick, 1AB (dan@1abmedia.com, 973-271-6085)[12](index=12&type=chunk)

Core Insights - Relay Therapeutics has initiated the Phase 3 ReDiscover-2 trial for RLY-2608 in HR+/HER2- metastatic breast cancer, aiming to address a significant unmet medical need [3][7] - The company reported a median progression-free survival (PFS) of 10.3 months and an objective response rate (ORR) of 39% in patients with PI3Kα mutations [1][7] - Financial results for Q2 2025 show cash and investments of approximately $657 million, with a net loss of $70.4 million [2][5][8] Clinical Development - The Phase 3 ReDiscover-2 trial compares RLY-2608 plus fulvestrant against capivasertib plus fulvestrant in HR+/HER2- breast cancer patients [3][7] - Interim data from the Phase 1 trial indicates a median PFS of 11.0 months for second-line patients, with a 42% confirmed ORR [7] - The safety profile of RLY-2608 remains strong, primarily showing low-grade treatment-related adverse events [7] Financial Performance - As of June 30, 2025, cash, cash equivalents, and investments totaled $656.8 million, down from $710.4 million at the end of Q1 2025 [5][16] - Revenue for Q2 2025 was reported at $0.7 million, an increase from $0 in Q2 2024 [5][15] - Research and development expenses decreased to $63.9 million in Q2 2025 from $92.0 million in Q2 2024, attributed to strategic streamlining [6][8] Operational Highlights - General and administrative expenses were reduced to $13.6 million in Q2 2025 from $20.1 million in Q2 2024, mainly due to lower stock compensation expenses [8] - The net loss for Q2 2025 was $70.4 million, or $0.41 per share, compared to a net loss of $92.2 million, or $0.69 per share, in Q2 2024 [8][15] - The company expects its current cash resources to fund operations into 2029 [5]

Core Insights - The article emphasizes the importance of understanding the science behind biotech investments to avoid pitfalls in the industry [1]. Group 1 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies [1]. - The mission is to educate investors on the scientific aspects of biotech businesses to facilitate informed decision-making [1].

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]