On May 4, 2023 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 2023 financial results and corporate highlights (Press release, Relay Therapeutics, MAY 4, 2023, View Source [SID1234631051]).
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"We have made important progress so far in 2023 by continuing to advance our clinical and pre-clinical programs," said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. "At the AACR (Free AACR Whitepaper) Annual Meeting, we announced initial clinical data for RLY-2608, which showed that selectively inhibiting mutant PI3Kα avoided key common off-target toxicities. Of the eight patients with measurable breast cancer who received a dose at target exposure, one experienced a confirmed partial response after data cut-off and the other seven experienced a best overall response of stable disease; seven of these patients continue on treatment. Given the early but promising nature of these data, we are moving quickly to initiate dose expansion cohorts in the second half of the year."
Recent Corporate Highlights
RLY-4008 (FGFR2 inhibitor)
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Presented data at AACR (Free AACR Whitepaper) Annual Meeting 2023, which showed that food and esomeprazole did not have a clinically relevant effect on the pharmacokinetics (PK) of RLY-4008
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Full dose escalation data from the ReFocus trial accepted for presentation at 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2-6, 2023
Breast Cancer Portfolio
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RLY-2608 (pan-mutant and isoform-selective PI3Kα inhibitor)
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Presented initial clinical data from the first-in-human ReDiscover trial at the AACR (Free AACR Whitepaper) Annual Meeting, which support initial clinical proof of mechanism, demonstrating that RLY-2608 achieved selective target engagement at multiple predicted efficacious doses with a favorable initial safety and tolerability profile. The cut-off date for these data was March 9, 2023. Key highlights include:
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Multiple doses achieved sustained target exposure of approximately 80 percent or greater mutant PI3Kα inhibition
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No Grade 3 hyperglycemia, rash or diarrhea observed at target exposures
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Favorable initial safety profile at target exposures with mostly low-grade adverse events that were manageable and reversible
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Partial response in breast cancer patient with 12 prior lines of therapy, which was confirmed subsequent to the data cut-off date
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Initial anti-tumor activity in breast cancer patients observed across a range of doses
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Median treatment duration among the 27 patients with breast cancer was approximately 4 months, with 70 percent (19/27) still on treatment as of the cut-off date
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Dose exploration is ongoing to determine the recommended dose(s) for the dose expansion cohorts, which Relay Therapeutics anticipates initiating in the second half of 2023
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RLY-5836 (pan-mutant and isoform-selective PI3Kα inhibitor)
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In April 2023, initiated a first-in-human trial in patients with advanced solid tumors with a PIK3CA (PI3Kα) mutation
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RLY-2139 (CDK2 inhibitor)
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Selected development candidate; anticipate early 2024 clinical start, pending regulatory authorization
Anticipated Upcoming Milestones
RLY-4008
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Full dose escalation data to be presented at ASCO (Free ASCO Whitepaper) Annual Meeting
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Complete enrollment of pivotal cohort in the second half of 2023
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Data from non-CCA expansion cohorts in the second half of 2023
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Breast Cancer
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RLY-2608: initiation of expansion cohorts in the second half of 2023
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ERα degrader: development candidate nomination in 2023
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RLY-2139 (selective CDK2 inhibitor): clinical start in early 2024, pending regulatory authorization
First Quarter 2023 Financial Results
Cash, Cash Equivalents and Investments: As of March 31, 2023, cash, cash equivalents and investments totaled $937.8 million compared to approximately $1 billion as of December 31, 2022. Relay Therapeutics expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into 2025.
R&D Expenses: Research and development expenses were $82.8 million for the first quarter of 2023, as compared to $51.7 million for the first quarter of 2022. The increase was primarily due to $16.3 million of additional clinical trial expenses, $9.4 million of additional employee-related costs, which include $4.5 million of additional stock-based compensation expense, and $3.3 million of additional costs for preclinical programs and platform technologies.
G&A Expenses: General and administrative expenses were $19.6 million for the first quarter of 2023, as compared to $16.1 million for the first quarter of 2022. The increase was primarily due to additional employee-related costs, which include $3.6 million of additional stock-based compensation expense.
Net Loss: Net loss was $94.2 million for the first quarter of 2023, or a net loss per share of $0.78, as compared to a net loss of $62.0 million for the first quarter of 2022, or a net loss per share of $0.57.