Editas Medicine, Inc. 8-KCurrent Reports (8-K / ad hoc)

Financial Statements

Item 8.01 Other Events. On October 8, 2026, the Company announced that it has received approval to initiate the Phase 1/2 Strive™ clinical trial of EDIT-401 in patients with heterozygous familial hypercholesterolemia in Australia. The trial has received Human Research Ethics Committee approval and completed the Clinical Trial Notification process with Australia’s Therapeutic Goods Administration and has also been submitted for review in New Zealand. If approved in New Zealand, patients in both countries will be eligible to enroll in the Strive trial. EDIT-401 is an experimental, potentially best-in-class in vivo gene editing medicine for the treatment of hyperlipidemia. Utilizing Editas’ differentiated upregulation approach, EDIT-401 is designed to directly edit the LDL receptor (“LDLR”) gene to increase LDLR protein expression and reduce LDL-cholesterol (“LDL-C”) levels. In preclinical studies, EDIT-401 demonstrated approximately 90 percent or greater mean reduction in multiple atherogenic lipoproteins, including LDL-C, lipoprotein(a) (Lp(a)), an independent risk factor for atherosclerotic cardiovascular disease (“ASCVD”), and apolipoprotein B (ApoB), a key measure of total plaque-causing cholesterol particles and predictive measure for ASCVD, in non-human primates. New preclinical data also demonstrated an LDL-C reduction of approximately 90 percent was maintained over 10 months in an ongoing study in non-human primates. The Strive trial is designed to evaluate the safety, tolerability, and efficacy of a single dose of EDIT-401. The trial is designed in two parts: Part 1 is a single ascending dose, dose-finding, open-label trial. Part 2 will be a single-dose randomized, placebo-controlled expansion study. The Company has selected five clinical trial sites across Australia and New Zealand. The Company expects to report initial safety and tolerability data in the first quarter of 2027. The Company plans to complete enrollment in Part 1, the dose-finding portion of the Phase 1/2 trial of EDIT-401, with topline safety and efficacy data results available later in 2027. Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’