{"url_path":"/sec/rlay/8-k/2026-04-27/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-04-27","source_url":"https://www.sec.gov/Archives/edgar/data/1812364/0001193125-26-179404-index.html","accession_number":"0001193125-26-179404","cik":"0001812364","ticker":"RLAY","issuer_name":"Relay Therapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1812364/0001193125-26-179404-index.html","primary_entity_key":"0001812364","primary_entity_name":"Relay Therapeutics, Inc."},"word_count":1163,"has_tables":true,"body_markdown":"## Item 8.01 Other Events.\n\nOn April 27, 2026, the Company announced clinical data from the zovegalisib, fulvestrant and atirmociclib triplet combination arm of the Phase 1/2 ReDiscover trial as well as the Company's plans to move zovegalisib plus atirmociclib into Phase 3 development for 1L patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer.\n\n \n\nTriplet Clinical Data\n\n \n\nZovegalisib is currently being evaluated in the ReDiscover trial, an ongoing first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of zovegalisib in combination with fulvestrant and CDK inhibitors in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer. These data are from the zovegalisib plus atirmociclib plus fulvestrant dose finding portion of the trial.\n\n \n\nAs of the April 13, 2026 data cut-off date (the \"Data Cut-Off Date\"), 69 total patients were enrolled, with 62 patients at or below the potential Phase 3 dose and 34 patients with measurable disease evaluable for response. All patients had previously received a CDK4/6 inhibitor and at least one prior endocrine therapy in the advanced setting and could have received a PI3K pathway inhibitor. These heavily pre-treated patients had received a median of two prior therapies (21% received three or more prior therapies) in the metastatic setting with 63% having visceral disease, 29% having received chemotherapy, and 47% being pre-diabetic. The median follow-up was 7.4 months.\n\n \n\nEarly safety and tolerability data for zovegalisib in combination with atirmociclib and fulvestrant (N=62) reinforce the potential of this regimen moving forward in 1L endocrine sensitive patients. As of the Data Cut-Off Date:\n\n \n\n•\nOnly two patients (3%) discontinued zovegalisib and six patients (10%) dose reduced zovegalisib due to treatment-related adverse events (\"TRAEs\");\n\n•\nAdverse events were consistent with those previously reported by each molecule;\n\no\nGrade 3 hyperglycemia was 0% despite 47% of patients being pre-diabetic;\n\n•\nOverall grade 3+ TRAE rate in these median third-line patients is 40%;\n\no\nNeutropenia accounts for the majority of the grade 3+ events;\n\no\nNo instance of febrile neutropenia was observed.\n\n \n\nAs of the Data Cut-Off Date, 34 patients had measurable disease to be evaluated for response:\n\n \n\n•\nObjective response rate (\"ORR\") was 44% (15/34) and was also 44% in both kinase and non-kinase patients;\n\no\nORR in these heavily pre-treated patients has approached that of current standard of care doublets in 1L patients, ranging from 53% to 55% ORR;\n\no\nNearly all patients experienced tumor reduction (85%, 29/34);\n\n•\n48 of 62 patients (77%) remain on study as of the Data Cut-Off Date, with a median follow-up of 7.4 months;\n\no\nThe data are not yet mature enough to estimate median progression-free survival.\n\n \n\n \n\n \n\n \n\n \n\n \n\nPharmacokinetic analyses demonstrated that atirmociclib increased the exposure of zovegalisib by about two and half-fold (regardless of atirmociclib dose), while zovegalisib had no impact on atirmociclib exposure. Subject to regulatory feedback, the potential Phase 3 dose of zovegalisib will be 150mg twice daily (BID), which maintains average concentration of zovegalisib just below IC90 throughout the dosing interval.\n\n \n\nPreliminary Phase 3 Development Plans\n\n \n\nThe planned study, subject to regulatory feedback, is a randomized Phase 3 trial evaluating zovegalisib in combination with atirmociclib and aromatase inhibitor (\"AI\") in 1L endocrine sensitive patients with PIK3CA-mutated, HR+/HER2- advanced or metastatic breast cancer.\n\n \n\n•\nPopulation: 1L endocrine sensitive patients with HR-positive, HER2-negative advanced or metastatic breast cancer harboring a PIK3CA mutation\n\n•\nExperimental arm: Zovegalisib plus atirmociclib plus AI\n\n•\nControl arm: CDK4/6 inhibitor (investigator’s choice) plus AI\n\n•\nKey endpoints: Median progression-free survival (primary) and overall survival (secondary)\n\n \n\nPursuant to the terms of a clinical trial supply agreement, Pfizer, Inc. (\"Pfizer\") has agreed to supply atirmociclib for the experimental arm in combination with zovegalisib and the palbociclib portion of the control arm for use in the planned study. The Company will sponsor, fully operationalize and fund the planned Phase 3 trial.\n\n \n\nCautionary Note Regarding Forward Looking Statements\n\n \n\nThis Current Report on Form 8-K and certain materials furnished or filed herewith contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the Company's strategy, business plans and focus; the progress and timing of the clinical development of the programs across the Company's portfolio, including the timing of initiation of a frontline Phase 3 clinical trial for zovegalisib in combination with atirmociclib and AI; the timing of clinical data readouts for zovegalisib; the expected therapeutic benefits and potential efficacy and tolerability of zovegalisib, both as a monotherapy and in combination with other agents, including the combination of zovegalisib and atirmociclib, and its other programs; the clinical data for zovegalisib; the interactions with regulatory authorities and any related approvals; the potential commercialization and market opportunity for zovegalisib; and the expected strategic benefits under the Company's clinical trial supply agreement with Pfizer. The words “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.\n\nAny forward-looking statements in this Current Report on Form 8-K are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of global economic uncertainty, geopolitical instability and conflicts, or public health epidemics or outbreaks of an infectious disease on countries or regions in which the Company has operations or does business, as well as on the timing and anticipated results of its clinical trials, strategy, future operations and profitability; significant political, trade or regulatory developments, such as tariffs, beyond the Company's control; the delay or pause of any current or planned clinical trials or the development of the Company's drug candidates; the risk that the preliminary or interim results of its preclinical or clinical trials may not be predictive of future or final results in connection with future clinical trials of its product candidates and that interim and early clinical data may change as more patient data become available and are subject to audit and verification procedures; the Company's ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of its planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the Company's most recent Annual Report on Form 10-K, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements."}