On August 7, 2025 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing life-changing therapies for patients living with cancer and genetic disease, reported second quarter 2025 financial results and corporate updates (Press release, Relay Therapeutics, AUG 7, 2025, View Source [SID1234654997]).
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"It is an exciting time for Relay as we have initiated our Phase 3 ReDiscover-2 Trial, studying RLY-2608 + fulvestrant versus capivasertib + fulvestrant in HR+/HER2- breast cancer patients," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "The interim data from our Phase 1 trial have remained consistent with previously announced data, showing what we believe are the potential benefits of RLY-2608 compared to historical standard of care data for both safety and efficacy. It is our company’s top priority to enroll patients and execute this trial, and hopefully deliver a novel medicine in the post-CDK4/6 breast cancer setting where there is a large unmet medical need."
RLY-2608 Highlights
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Presented updated interim clinical data from the open-label Phase 1b study for RLY-2608 + fulvestrant at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, showing data consistent with previous disclosures:
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10.3-month median progression-free survival (PFS) and 39% objective response rate (ORR) across all patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer
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For 2L patients
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11.0-month median PFS in second line
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median PFS was 18.4 months for patients with kinase mutations and 8.5 months for patients with non-kinase mutations
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42% confirmed ORR across 2L patients with measurable disease
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Safety profile remained strong with mostly low-grade treatment-related adverse events
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12.5-month median follow-up
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Breast Cancer Clinical Trial Execution
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Initiated Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
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Continued advancement of the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib or ribociclib
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Vascular Malformations Clinical Trial
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Continued execution of ongoing Phase 1 vascular malformations clinical trial
Second Quarter 2025 Financial Results
Cash, Cash Equivalents and Investments: As of June 30, 2025, cash, cash equivalents and investments totaled $656.8 million, as compared to $710.4 million as of March 31, 2025. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.
Revenue: Revenue was $0.7 million for the second quarter of 2025, as compared to $0 for the second quarter of 2024.
R&D Expenses: Research and development expenses were $63.9 million for the second quarter of 2025, as compared to $92.0 million for the second quarter of 2024. The decrease of $28.1 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024 and 2025, as well as cost avoidance on continued development of lirafugratinib after execution of the license agreement with Elevar Therapeutics, Inc. in December 2024.
G&A Expenses: General and administrative expenses were $13.6 million for the second quarter of 2025, as compared to $20.1 million for the second quarter of 2024. The decrease of $6.5 million was primarily due to a decrease in stock compensation expense, as well as other employee compensation costs.
Net Loss: Net loss was $70.4 million for the second quarter of 2025, or a net loss per share of $0.41, as compared to a net loss of $92.2 million for the second quarter of 2024, or a net loss per share of $0.69.