On November 10, 2021 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 2021 financial results (Press release, Relay Therapeutics, NOV 10, 2021, View Source [SID1234595104]).
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"It’s been a very productive year at Relay Therapeutics. We have delivered on all of our key goals set out at our IPO in July 2020 and have proven our ability to effectively advance our clinical trials, having recently disclosed interim clinical data for RLY-4008. Not only do the clinical data validate our Dynamo platform and approach, but they also suggest RLY-4008 is a highly selective FGFR2 inhibitor that has the potential to address a significant unmet medical need," said Sanjiv Patel, M.D., president and chief executive officer. "Our other programs continue to progress, with RLY-2608, the first of our PI3Kα franchise, on path to begin a first-in-human study in the first half of 2022. We will continue to focus on execution for the remainder of 2021 and into 2022, and are confident our recent financing will provide the capital needed to push multiple programs through the clinic while maintaining a robust preclinical pipeline."
Recent Corporate Highlights
Presented interim clinical data for RLY-4008 in a first-in-human trial in patients with FGFR2-altered cholangiocarcinoma and other solid tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets Conference on October 8, 2021 that suggest RLY-4008 is a highly selective FGFR2 inhibitor demonstrating robust inhibition of FGFR2 regardless of alteration or tumor type while not being limited by off-target toxicities
Announced the Company anticipates selecting a once daily recommended Phase 2 dose and initiating expansion cohorts prior to the end of 2021
Shared preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets Conference on October 7, 2021 that support RLY-2608 as the first known allosteric pan-mutant selective inhibitor of PI3Kα
Additional preclinical data for RLY-2608 in combination with standard of care medicines, fulvestrant (estrogen receptor inhibitor) and/or abemaciclib (CDK 4/6 inhibitor), will be presented at the San Antonio Breast Cancer Symposium
Presentation Title: RLY-2608: the first allosteric mutant- and isoform-selective inhibitor of PI3Kα, is efficacious as a single agent and drives regressions in combination with standard of care therapies in PIK3CA mutant breast cancer models
Presentation Time: Poster Session 5, December 10, 2021, 7:00 a.m. – 8:30 a.m. CT
Successfully raised $402 million of gross proceeds in an underwritten follow-on public offering
Third Quarter 2021 Financial Results
Cash, Cash Equivalents and Investments: As of September 30, 2021, cash, cash equivalents and investments totaled approximately $616.5 million, which excludes the gross proceeds of $402 million from the Company’s recent public offering, compared to $678.1 million as of December 31, 2020. The Company expects its current cash and cash equivalents, together with the net proceeds from its recent public offering, will be sufficient to fund its current operating plan at least into 2025.
R&D Expenses: Research and development expenses were $45.0 million for the third quarter of 2021, as compared to $24.4 million for the third quarter of 2020. The increase of $20.6 million was primarily due to $8.9 million related to pre-clinical development candidates and $9.6 million of additional employee related costs and expenses attributable to clinical development activities.
G&A Expenses: General and administrative expenses were $14.7 million for the third quarter of 2021, as compared to $12.2 million for the third quarter of 2020. The increase of $2.5 million was primarily due to $1.3 million of increased personnel costs and $0.7 million of other general and administrative expenses.
Net Loss: Net loss was $60.8 million for the third quarter of 2021, or a net loss per share of $0.66, as compared to a net loss of $36.1 million for the third quarter of 2020, or a net loss per share of $3.00.