Announcement • Sep 08

Dyne Therapeutics Presents Additional One-Year Clinical Data from Phase 1/2 Achieve Trial of Z-Basivarsen (Dyne-101) for Myotonic Dystrophy Type 1

Dyne Therapeutics, Inc. announced that it will present additional one-year clinical data from the Phase 1/2 ACHIEVE trial of zeleciment basivarsen (z-basivarsen, also known as DYNE-101) for DM1 at the 31st Annual International Congress of the World Muscle Society (WMS) being held September 29, 2026, through October 3, 2026, virtually and in Hiroshima, Japan, as well as the 2026 Annual Meeting of the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) being held September 29, 2026, through October 2, 2026, virtually and in Orlando, Florida. These presentations will both include: Data at 6 and 12 months from a pooled dose group (N=25-26), comprised of participants initially enrolled in the 3.4 mg/kg Fourth Quarter, 5.4 mg/kg Eighth Quarter and 6.8 mg/kg Eighth Quarter cohorts of the multiple ascending dose (MAD) portion of the ACHIEVE trial, including participants originally assigned to placebo in these cohorts. Data at 12 months from a cohort of participants (N=41-46) from the ongoing END-DM1 natural history study who were propensity-matched to the ACHIEVE pooled dose group. Updated safety data from ACHIEVE MAD participants. Dyne will also provide the average baseline value for video hand opening time (vHOT) in the registrational expansion cohort (REC) of the ACHIEVE trial (n=71), which remains blinded to treatment assignment. Topline data from the ACHIEVE REC are planned for First Quarter 2027. The new data from ACHIEVE will be included in the oral presentation below: Oral Presentation Title: Long-term functional improvement with zeleciment basivarsen in the phase 1/2 ACHIEVE trial. Presentation Date and Time: Wednesday, September 30, 12:30-12:45 p.m. JST (Tuesday, September 29, 11:30-11:45 p.m. ET). The slides from this presentation will be available in the Scientific Publications & Presentations section of Dyne’s website. Additional encore presentations at WMS include: Poster Presentation Title: HARMONIA study design: A global phase 3 trial assessing the efficacy and safety of z-basivarsen in myotonic dystrophy type 1 (DM1). Poster Session Date and Time: Friday, October 2, 3:45-4:45 p.m. JST. Poster Presentation Title: Zeleciment rostudirsen increased dystrophin protein levels and demonstrated functional improvement in clinical measures in the DELIVER trial. Poster Session Date and Time: Wednesday, September 30, 5:15-6:15 p.m. JST. Poster Presentation Title: FORZETTO, a phase 3 study of z-rostudirsen in ambulatory males with DMD mutations amenable to exon 51 skipping. Poster Session Date and Time: Wednesday, September 30, 5:15-6:15 p.m. JST. The new data from ACHIEVE will be included in the poster presentation below: Poster Presentation Title: Zeleciment basivarsen targets the underlying cause of myotonic dystrophy type 1 to enable functional improvement in the Phase 1/2 ACHIEVE trial. Z-basivarsen is an investigational therapeutic being evaluated in the fully enrolled global Phase 1/2 ACHIEVE clinical trial and the global confirmatory Phase 3 HARMONIA clinical trial for people living with DM1. Z-basivarsen consists of an antisense oligonucleotide (ASO) conjugated to an antigen-binding fragment (Fab) that binds to the transferrin receptor 1 (TfR1) to enable delivery to muscle and the central nervous system. It is designed to deliver functional improvement in individuals living with DM1 by reducing toxic nuclear DMPK RNA to release splicing proteins and allow normal mRNA processing. Z-basivarsen has been granted Breakthrough Therapy, Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA), as well as Orphan Drug designation from the European Medicines Agency (EMA) and the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of DM1.

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