On November 2, 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 third quarter 2023 financial results and corporate highlights (Press release, Relay Therapeutics, NOV 2, 2023, View Source [SID1234636790]).

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"We have made important progress expanding the number of patients we have the potential to help with our clinical programs," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "We presented data at the Triple Meeting demonstrating the potential of lirafugratinib in patients with many types of FGFR2-altered tumors, and we are working to initiate RLY-2608 triplet combinations this year with the goal of being able to treat patients with earlier stage breast cancer. We have focused our clinical development and execution to extend our cash runway into the second half of 2026 with the goal of having the resources to execute these programs, and we are continuing to advance them as quickly as possible."

Recent Corporate Highlights

RLY-4008 (lirafugratinib)

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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), which demonstrated activity across several sub-groups, including in patients with FGFR2-fusion tumors and in patients with FGFR2-altered HR+/HER2- breast cancer. The cut-off date for these data was August 23, 2023. Key highlights include:
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FGFR2 fusions: Nine of 26 patients experienced a confirmed partial response (PR) (35% overall response rate (ORR)), with 63 percent of responders experiencing a duration of response of at least 6 months
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HR+/HER2- breast cancer, all FGFR2 alterations: Four of 10 patients achieved PRs (40% ORR), with all responders having a duration of response of at least 6 months, and the longest duration of response 72 weeks and ongoing as of the data cut-off

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Patients were very heavily pre-treated (median of 6 prior lines of therapy) with prior targeted therapies (100%), prior chemotherapy/ADC (93%), prior endocrine therapy (79%) and prior CDK4/6 (71%)
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FGFR2 amplifications: Eight of 34 patients experienced a PR (24% ORR), with 43 percent of responders experiencing a duration of response of at least 6 months
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Completed enrollment in the pivotal expansion cohort in patients with FGFR2-fusion cholangiocarcinoma (CCA) who have not previously received an FGFR inhibitor
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Paused near-term commercial readiness activities for CCA to align with the broader tumor agnostic opportunity being pursued
RLY-2608

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Announced plans to initiate RLY-2608 + fulvestrant + CDK4/6 triplet combinations in patients with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast cancer by the end of 2023
Pre-Clinical

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Paused further development efforts on RLY-2139 (CDK2 inhibitor)
Anticipated Upcoming Milestones

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Lirafugratinib: report additional tumor agnostic clinical data and regulatory update in 2024
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PI3Kα: next data update expected in 2024
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Pre-clinical: disclose new program(s) in 2024

Third Quarter 2023 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2023, cash, cash equivalents and investments totaled $810.6 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 2026.

Revenue: Revenue was $25.2 million for the third quarter of 2023, as compared to $0.3 million for the third quarter of 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 $81.5 million for the third quarter of 2023, as compared to $66.9 million for the third quarter of 2022. The increase was primarily due to $8.2 million of additional clinical trial expenses and $7.4 million of additional employee-related costs, which include $4.5 million of additional stock compensation expense.

G&A Expenses: General and administrative expenses were $18.5 million for the third quarter of 2023, as compared to $16.1 million for the third quarter of 2022. The increase was primarily due to additional stock compensation expense.

Net Loss: Net loss was $65.7 million for the third quarter of 2023, or a net loss per share of $0.54, as compared to a net loss of $84.2 million for the third quarter of 2022, or a net loss per share of $0.76.