On August 8, 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 second quarter 2023 financial results and corporate highlights (Press release, Relay Therapeutics, AUG 8, 2023, View Source [SID1234633989]).

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"In the second quarter of 2023, we continued to advance our pipeline and progress our breast cancer portfolio," said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. "In July, we initiated the first RLY-2608 + fulvestrant dose expansion cohort. The additional RLY-2608 data supporting this decision, and the breadth of our breast cancer franchise, continue to drive our confidence that we are building a comprehensive solution for the more than 100,000 patients diagnosed with PI3Kα-mutated breast cancer in the U.S. each year."

RLY-2608 Update

In July 2023, initiated dose expansion cohort with RLY-2608 600mg BID + fulvestrant in patients with PI3Kα-mutant, HR+, HER2– locally advanced or metastatic breast cancer

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Selection of 600mg BID dose supported by updated data from 17 breast cancer patients treated with RLY-2608 600mg BID + fulvestrant (cut-off date of July 24, 2023)
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Interim clinical benefit rate (CBR) of 86 percent (6 of 7 CBR-evaluable patients) (CBR defined as the proportion of patients with stable disease, complete response, or partial response for at least 24 weeks)
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Fifteen of 17 patients remain on treatment as of the cut-off date
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One of five efficacy-evaluable patients with measurable disease achieved a confirmed partial response (PR) and remains on treatment as of the cut-off date (helical mutation)
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Interim safety data compelling for use in metastatic breast cancer combinations
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Overall, updated data strengthen the RLY-2608 profile and continue to support selective target engagement across doses and mutation types with favorable interim safety and tolerability data. As of the July 24th data cut-off, 43 total breast cancer patients had received RLY-2608 monotherapy (n=4) or RLY-2608 + fulvestrant (n=39)

Four of 24 efficacy-evaluable patients with measurable disease achieved PRs, including three confirmed (400mg BID mono with double mutation; 100mg BID combo with kinase mutation; 600mg BID combo with helical mutation) and one unconfirmed (800mg BID combo with helical mutation)
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The interim safety profile of RLY-2608 remains consistent with safety data previously reported at AACR (Free AACR Whitepaper)
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No adverse event-related discontinuations
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No Grade 3+ hyperglycemia or diarrhea
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Data from ongoing dose escalation arms could support decision to bring an additional dose into dose expansion in the future
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Next data update expected in 2024

Additional Recent Corporate Highlights

RLY-4008

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Presented full dose escalation data from the ReFocus study at 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Anticipated Upcoming Milestones

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RLY-4008
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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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RLY-2608
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Next data update expected in 2024
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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

Second Quarter 2023 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2023, cash, cash equivalents and investments totaled $871.6 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 the second half of 2025.

R&D Expenses: Research and development expenses were $88.2 million for the second quarter of 2023, as compared to $60.5 million for the second quarter of 2022. The increase was primarily due to $13.6 million of additional clinical trial expenses and $9.3 million of additional employee-related costs, which include $5.0 million of additional stock-based compensation expense.

G&A Expenses: General and administrative expenses were $20.1 million for the second quarter of 2023, as compared to $17.5 million for the second quarter of 2022. The increase was primarily due to additional employee-related costs, which include $3.3 million of additional stock-based compensation expense.

Net Loss: Net loss was $98.5 million for the second quarter of 2023, or a net loss per share of $0.81, as compared to a net loss of $76.8 million for the second quarter of 2022, or a net loss per share of $0.71.