Relay Therapeutics(RLAY) - 2025 Q2 - Quarterly Results

Executive Summary & Corporate Updates Q2 2025 Key Highlights 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] - Presented updated data at ASCO showing consistency with prior data[1] 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 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] - 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] - 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] Clinical Program Updates RLY-2608 Clinical Development 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) 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] 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] Breast Cancer Clinical Trial Execution 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] - Continued advancement of the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib or ribociclib[4] Vascular Malformations Clinical Trial 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] Financial Results Second Quarter 2025 Financial Performance 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 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] - The decrease in G&A expenses was primarily due to a decrease in stock compensation expense and other employee compensation costs[7] - Current cash, cash equivalents, and investments are expected to fund operating expenses and capital expenditure requirements into 2029[5] Condensed Consolidated Statements of Operations and Comprehensive Loss 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 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] Company Information About Relay Therapeutics 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] - Utilizes the Dynamo® platform, integrating computational and experimental approaches to drug intractable protein targets[8] - 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] - Pipeline includes late-stage research programs for NRAS-driven solid tumors and Fabry disease[8] Legal & Contact Information Cautionary Note Regarding Forward-Looking Statements 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] - 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] - 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] Contact Information Provides contact details for investor relations and media inquiries - Investor Contact: Pete Rahmer (prahmer@relaytx.com)[12] - Media Contact: Dan Budwick, 1AB (dan@1abmedia.com, 973-271-6085)[12]