On February 22, 2024 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 fourth quarter and full year 2023 financial results and corporate highlights (Filing, 3 mnth, DEC 31, Relay Therapeutics, 2024, FEB 22, 2024, View Source [SID1234640377]).
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"We made important progress across our portfolio during 2023, advancing multiple clinical programs and continuing to invest significantly in our research engine – the Dynamo platform," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "We are very pleased with the RLY-2608 data disclosed to-date and how its clinical profile continued to mature throughout last year. Our clinical team is focused on advancing this program in the near term in both a doublet and a triplet combination, and we look forward to sharing additional data in the second half of 2024. Our Dynamo platform continues to demonstrate precision and productivity with each target we’ve chosen to-date, and we are excited to disclose at least one new program that has come out of it later this year, which is being designed to have first-in-class potential."
Recent Corporate Highlights
PI3Kα
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RLY-2608 doublet
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Completed enrollment in initial dose expansion cohort of RLY-2608 600mg BID + fulvestrant in patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer
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Initiated two additional dose expansion cohorts of RLY-2608 in combination with fulvestrant – a second 600mg BID cohort as well as one at 400mg BID
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Published RLY-2608 preclinical profile and clinical proof-of-concept in Cancer Discovery (Discovery and Clinical Proof-of-Concept of RLY-2608, a First-in-Class Mutant-Selective Allosteric PI3Kα Inhibitor That Decouples Antitumor Activity from Hyperinsulinemia) with vignettes from two patients with advanced HR+ breast cancer with kinase or helical mutations, with no observed wildtype PI3Kα-related toxicities
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RLY-2608 triplet
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Initiated RLY-2608 + fulvestrant + ribociclib triplet combination in patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer
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RLY-5836
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Deprioritized further clinical development
Lirafugratinib (RLY-4008)
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Presented initial clinical data in patients with FGFR2-altered solid tumors at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper)
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As previously disclosed, the company will minimize resource allocation in 2024 to allow data to mature and inform future clinical development decisions
Anticipated 2024 Milestones
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RLY-2608
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RLY-2608 + fulvestrant data update in the second half of 2024
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RLY-2608 + fulvestrant + ribociclib initial safety data in the second half of 2024
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Lirafugratinib: tumor agnostic data and regulatory update in the second half of 2024
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Pre-clinical: disclose new program(s) in 2024
Fourth Quarter and Full Year 2023 Financial Results
Cash, Cash Equivalents and Investments: As of December 31, 2023, cash, cash equivalents and investments totaled $750.1 million compared to approximately $1 billion as of December 31, 2022. The company expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2026.
Revenue: There was no material revenue for the fourth quarter of 2023 or 2022. Revenue was $25.5 million for the full year 2023, as compared to $1.4 million for the full year 2022. The increase was primarily due to the recognition of previously received milestone payments under the company’s Collaboration and License Agreement with Genentech, Inc.
R&D Expenses: Research and development expenses were $77.5 million for the fourth quarter of 2023, as compared to $67.3 million for the fourth quarter of 2022. The increase was primarily due to additional clinical trial expenses and employee-related costs, which were offset by a decrease in other external research costs. Research and development expenses were $330.0 million for the full year 2023, as compared to $246.4 million for the full year 2022. The increase was primarily due to $50.0 million of additional external costs in connection with our clinical trials and $32.4 million of additional employee costs from increased headcount in our research and development functions, which includes $17.7 million of additional stock compensation expense.
G&A Expenses: General and administrative expenses were $16.8 million for the fourth quarter of 2023, as compared to $16.4 million for the fourth quarter of 2022. The increase was primarily due to additional stock compensation expense. General and administrative expenses were $75.0 million for the full year 2023, as compared to $66.0 million for the full year 2022. The increase was primarily due additional stock compensation expense.
Net Loss: Net loss was $83.5 million for the fourth quarter of 2023, or a net loss per share of $0.67, as compared to a net loss of $67.5 million for the fourth quarter of 2022, or a net loss per share of $0.56.
Net loss was $342.0 million for the full year 2023, or a net loss per share of $2.79, as compared to a net loss of $290.5 million for the full year 2022, or a net loss per share of $2.59.