Relay Therapeutics Discloses Anticipated Registrational Path for RLY-4008 in Cholangiocarcinoma and Growing Breast Cancer Franchise at Virtual Analyst and Investor Event

End-of-phase 1 meeting with the U.S. Food and Drug Administration (FDA) resulted in alignment on the design of a single arm trial for pan-FGFR (FGFRi) treatment-naïve FGFR2-fusion cholangiocarcinoma (CCA) to potentially support accelerated approval

Interim data from the once daily (QD) dosing schedule shared with the FDA demonstrated confirmed partial responses in eight out of thirteen (62%) FGFRi-naïve FGFR2-fusion CCA patients, including all four of the patients treated at the registrational trial dose of 70 mg QD

Relay Therapeutics discloses three new programs as part of a growing HR+/HER2- breast cancer franchise: selective CDK2 inhibitor, ERα degrader, and chemically distinct pan mutant-PI3Kα (RLY-5836)

Relay Therapeutics continues to expect its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into 2025

CAMBRIDGE, Mass., June 27, 2022 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY) a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, will announce today the anticipated registrational path for RLY-4008 and three new programs within a growing HR+/HER2- breast cancer franchise at a virtual analyst and investor event from 8:00 a.m. to 9:00 a.m. ET.

“2022 has proven to be an extremely productive year so far for Relay Therapeutics and we’re looking forward to sharing updates across our portfolio today,” said Sanjiv Patel, M.D., Relay Therapeutics’ president and chief executive officer. “We are excited to be announcing the anticipated registrational path for RLY-4008 and the maturation of the data to support that pathway. In addition, building on the foundation of our PI3Kα franchise, we will outline a broad commitment to developing comprehensive treatment options for breast cancer patients. We believe our platform and approach have the potential to address some of the hardest-to-treat diseases and are excited to do just that in the coming years.”

RLY-4008 Regulatory and Clinical Data Update

Relay Therapeutics conducted an end-of-phase 1 meeting with the FDA to discuss next steps for the clinical development of RLY-4008. Based on discussions with the FDA, the Company has decided to move forward with a single arm trial design for FGFRi-naïve FGFR2-fusion CCA at 70 mg once daily to potentially support accelerated approval. The Company also intends to add additional supportive CCA cohorts to an NDA submission, including frontline, FGFRi-experienced and FGFR2 mutation and amplification patients that could potentially facilitate a line and alteration agnostic label if the submission is approved.