On February 23, 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 fourth quarter and full year 2022 financial results and corporate highlights (Press release, Relay Therapeutics, FEB 23, 2023, View Source [SID1234627627]).

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"We successfully executed against our strategy in 2022, advancing multiple clinical and pre-clinical programs and continuing to demonstrate the power of our Dynamo platform," said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. "We reported additional RLY-4008 interim data showing an overall response rate of 63% across all doses and 88% at the pivotal dose, building on the previously reported early data and supporting our belief that limiting off-target effects and toxicity can allow us to improve efficacy. We also expanded our breast cancer portfolio, continuing clinical development of RLY-2608 and announcing three new programs. With a robust pipeline and cash in hand to fund us into 2025, we are excited to continue to execute on our plans and deliver against our milestones this year, as we work toward our goal of bringing life-changing therapies to patients."

2022 Corporate Highlights

RLY-4008 (FGFR2 inhibitor)

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Presented additional interim data from patients with FGFRi-naïve FGFR2-fusion cholangiocarcinoma (CCA) at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022. Key highlights included:
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All doses – 63% interim overall response rate (ORR): across all dose levels and schedules, 24 of 38 efficacy-evaluable patients experienced a partial response (22 confirmed, 2 unconfirmed)
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Pivotal dose (70 mg once daily) – 88% ORR: 15 of 17 efficacy-evaluable patients experienced a partial response (14 confirmed, 1 unconfirmed in an ongoing patient)
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13 out of these 15 responders remain on treatment; 1 responder came off study to be resected with curative intent

Most treatment emergent adverse events were expected FGFR2 on-target, low-grade, monitorable, manageable and largely reversible
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There were no observed Grade 4 or 5 adverse events, and off-target toxicities of hyperphosphatemia and diarrhea continued to be clinically insignificant
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Based on discussions with the U.S. Food and Drug Administration, moved forward with a single-arm pivotal trial design for patients with pan-FGFR (FGFRi) treatment-naïve FGFR2-fusion CCA at 70 mg once daily to potentially support accelerated approval
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Anticipate completing enrollment in pivotal cohort in the second half of 2023

Breast Cancer Portfolio

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RLY-2608 (pan-mutant and isoform-selective PI3Kα inhibitor)
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Monotherapy: Following December 2021 initiation of the first-in-human trial, continued to enroll dose escalation portion of trial assessing RLY-2608 as a single agent in patients with unresectable or metastatic solid tumors with PI3Kα mutation
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Combination: In April 2022, initiated dose escalation portion of a fulvestrant combination arm in patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer
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Anticipate disclosing initial clinical data from both dose escalation portions in the first half of 2023
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In June 2022, disclosed three new programs:
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Selective CDK2 inhibitor, anticipated clinical start in early 2024
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ERα degrader, development candidate nomination in 2023
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RLY-5836 (chemically distinct pan mutant-PI3Kα inhibitor), expected to enter the clinic in the second quarter of 2023

Corporate Highlights

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Appointed Sekar Kathiresan, M.D., CEO of Verve Therapeutics, to Board of Directors
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Raised $300.0 million of gross proceeds in an underwritten follow-on public offering

2023 Anticipated Milestones

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RLY-4008
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Full dose escalation data in the first half of 2023
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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: initial clinical data from dose escalation portions of monotherapy and combination arms of trial in the first half of 2023
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RLY-5836: clinical start in the second quarter of 2023
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ERα degrader: development candidate nomination in 2023
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Selective CDK2 inhibitor: clinical start in early 2024

Fourth Quarter and Full Year 2022 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2022, cash, cash equivalents and investments totaled approximately $1 billion compared to $958.1 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 $67.3 million for the fourth quarter of 2022, as compared to $51.9 million for the fourth quarter of 2021. The increase was primarily due to $6.8 million of additional clinical trial expenses and $6.3 million of additional employee related costs, which includes $3.1 million of additional stock-based compensation expense. Research and development expenses were $246.4 million for the full year 2022, as compared to $172.7 million for the full year 2021. The increase was primarily due to $32.7 million of additional clinical trial expenses, $24.7 million of additional employee related costs, which includes $5.7 million of additional stock-based compensation expense, and $10.8 million of additional preclinical programs and platform technologies.

G&A Expenses: General and administrative expenses were $16.4 million for the fourth quarter of 2022, as compared to $15.5 million for the fourth quarter of 2021. The increase was primarily due to additional employee related costs, which includes $0.5 million of additional stock-based compensation expense. General and administrative expenses were $66.0 million for the full year 2022, as compared to $57.4 million for the full year 2021. The increase was primarily due to additional employee related costs, which includes $1.9 million of additional stock-based compensation expense.

Net Loss: Net loss was $67.5 million for the fourth quarter of 2022, or a net loss per share of $0.56, as compared to a net loss of $67.5 million for the fourth quarter of 2021, or a net loss per share of $0.64. Net loss was $290.5 million for the full year 2022, or a net loss per share of $2.59, as compared to a net loss of $363.9 million for the full year 2021, or a net loss per share of $3.82. Net loss for the full year 2021 included one-time expenses of $134.9 million associated with the acquisition of ZebiAI Therapeutics, Inc.