On November 3, 2022 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 2022 financial results and recent corporate highlights (Press release, Relay Therapeutics, NOV 3, 2022, View Source [SID1234622973]).

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"We continue to deliver on our execution focus for 2022 and the third quarter uniquely exemplified this," said Sanjiv Patel, M.D., Relay Therapeutics’ president and chief executive officer. "We presented interim data at the ESMO (Free ESMO Whitepaper) Congress that demonstrate an 88% overall response rate at the pivotal dose of RLY-4008 and further support our hypothesis that selective inhibition of FGFR2 can improve the treatment for patients with FGFR2-driven tumors. The interim data demonstrate the potential power of our Dynamo platform to build transformative therapies for patients. We continue to build momentum upon our achievements this year and we believe we have the team, platform and capital to deliver upon numerous milestones."

Recent Corporate Highlights

Continued to enroll patients across both dose escalation cohorts of the first-in-human trial for RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor, assessing it as a single agent for patients with unresectable or metastatic solid tumors with PI3Kα mutation and evaluating RLY-2608 in combination with fulvestrant for patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer.

Presented updated RLY-4008 data as of the August 1, 2022 cut-off date at ESMO (Free ESMO Whitepaper) Congress 2022, including key highlights:

15 out of 17 of the FGFRi-naïve FGFR2-fusion CCA efficacy evaluable patients at the pivotal dose experienced a partial response resulting in an 88% interim ORR (14 confirmed, 1 unconfirmed in an ongoing patient).

13 out of these 15 responders remain on treatment; 1 responder came off study to be resected with curative intent.

More broadly across all dose levels and schedules, 38 FGFRi-naïve FGFR2-fusion CCA patients were eligible for efficacy evaluation, of which 24 experienced a partial response resulting in a 63% interim ORR (22 confirmed, 2 unconfirmed).

Most treatment emergent adverse events were expected FGFR2 on-target, low-grade, monitorable, manageable and largely reversible.

There were no observed Grade 4 or 5 adverse events, and off-target toxicities of hyperphosphatemia and diarrhea continued to be clinically insignificant.

Raised $300 million of gross proceeds in an underwritten follow-on public offering.

Third Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2022, cash, cash equivalents and investments totaled approximately $1.1 billion compared to $958 million as of December 31, 2021. 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 $66.9 million for the third quarter of 2022, as compared to $45.0 million for the third quarter of 2021. The increase was primarily due to $11.9 million related to clinical trial expenses, $5.6 million of additional employee related costs, which includes $1.7 million in stock-based compensation, and $2.7 million related to preclinical programs and platform technologies.

G&A Expenses: General and administrative expenses were $16.1 million for third quarter of 2022, as compared to $14.7 million for the third quarter of 2021. The increase was primarily due to additional employee related costs.

Net Loss: Net loss was $84.2 million for the third quarter of 2022, or a net loss per share of $0.76, as compared to a net loss of $60.8 million for the third quarter of 2021, or a net loss per share of $0.66.