On May 5, 2025 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported first quarter 2025 financial results and corporate updates (Press release, Relay Therapeutics, MAY 5, 2025, View Source [SID1234652518]).
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"2025 is a year of execution across a range of high value clinical programs," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "The ongoing changes to our cost base are designed to enable a full funding of key initiatives including generating topline data from the ReDiscover-2 trial and clinical proof-of-concept data in vascular malformations."
Strategic Cost Reductions Implemented to Extend Runway into 2029 and to Fully Fund Key Value Drivers
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These reductions help extend operating runway into 2029 and are aimed at funding key objectives, including:
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Completion of ReDiscover-2 Phase 3 trial of RLY-2608 + fulvestrant in metastatic breast cancer well past topline data readout and additional breast cancer clinical trials
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Execution of RLY-2608 Phase 1 vascular malformations trial through clinical proof-of-concept data
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Advance Fabry and NRAS program to Investigational New Drug application (IND) readiness
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Advance one research-stage program
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Specific cost reductions include:
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Over the past year, focused the research portfolio and platform on the highest value areas resulting in a reduction in the research run rate spend by approximately 80%
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Reduced research-stage programs from four to one
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Recent reduction in force by approximately 70 people
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Executed a global out-license of RLY-4008 with Elevar Therapeutics, Inc. (Elevar) with potential for downstream economics
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Phased the timing of entry into the clinic for Fabry and NRAS targeted programs
RLY-2608 Highlights
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Breast Cancer
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Initiation of Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer remains on track for mid-2025
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Abstract accepted to ASCO (Free ASCO Whitepaper) for update of Phase 1b ReDiscover trial of RLY-2608 + fulvestrant
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Focus of the abstract is updated 600mg BID (fasted) doublet data with median follow-up now greater than 12 months
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Poster Title: Updated efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trial
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Date/Time: Monday, June 2, 10:00-1:00 p.m. ET (9:00-12:00 p.m. CT)
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Continued advancement of the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib or ribociclib
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Planning continues for development of next-generation endocrine therapy combinations with RLY-2608
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Vascular Malformations
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Initiation of Phase 1 vascular malformations clinical trial in the first quarter of 2025
First Quarter 2025 Financial Results
Cash, Cash Equivalents and Investments: As of March 31, 2025, cash, cash equivalents and investments totaled $710.3 million, as compared to $781.3 million as of December 31, 2024. 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 $7.7 million for the first quarter of 2025, as compared to $10.0 million for the first quarter of 2024. The revenue recognized in the first quarter of 2025 was due to completion of all performance obligations under the company’s Exclusive License Agreement with Elevar. The revenue recognized in the first quarter of 2024 was due to a milestone achieved under the Collaboration and License Agreement with Genentech, Inc.
R&D Expenses: Research and development expenses were $73.8 million for the first quarter of 2025, as compared to $82.4 million for the first quarter of 2024. The decrease was primarily due to the series of strategic choices made to streamline the research organization throughout 2024.
G&A Expenses: General and administrative expenses were $18.7 million for the first quarter of 2025, as compared to $19.8 million for the first quarter of 2024. The decrease was primarily due to a decrease in stock compensation expense, partially offset by costs to obtain the agreement with Elevar, which were expensed commensurate with the timing of revenue recognized.
Net Loss: Net loss was $77.1 million for the first quarter of 2025, or a net loss per share of $0.46, as compared to a net loss of $81.4 million for the first quarter of 2024, or a net loss per share of $0.62.