- Data from DELIVER and ACHIEVE Clinicals Trial to be Presented -

- Presentation on ACHIEVE Trial in DM1 and Company Symposium to Feature Data on the Use of Splicing Correction as a Prognostic Biomarker of Functional Outcomes in DM1 -

- Presentations Add Insights into the FORCE™ Platform’s Ability to Deliver Targeted Therapeutics to Muscle and the CNS -

WALTHAM, Mass., Feb. 14, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc . (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancing life-transforming therapeutics for people living with genetically driven diseases, today announced that the company will be presenting two oral and five poster presentations at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference being held March 16-19, 2025, in Dallas, TX, and virtually. The oral presentations include data from the ongoing DELIVER clinical trial in Duchenne muscular dystrophy (DMD) as well as the recent positive results from the ongoing ACHIEVE clinical trial in myotonic dystrophy type 1 (DM1) which will include a summary of data on the use of splicing correction as a prognostic biomarker of functional outcomes in DM1.

Oral Presentations:

Abstract Title : Safety and Efficacy from the Ongoing Phase 1/2 DELIVER Trial of DYNE-251 in Males with DMD Mutations Amenable to Exon 51 Skipping
Date and Time : Wednesday, March 19, at 8:30-8:45 a.m. CT
Presenter : Kevin Flanigan M.D., Director, Center for Gene Therapy, Abigail Wexner Research Institute of Nationwide Children’s Hospital in Columbus, Ohio and a Principal Investigator for the DELIVER Trial

Abstract Title : Safety and Efficacy of DYNE-101 in Adults with DM1: Phase 1/2 ACHIEVE Trial Data
Date and Time : Wednesday, March 19, at 12:30-12:45 p.m. CT
Presenter : James Lilleker M.D., Neurologist, UK, and principal investigator in the ACHIEVE trial

Poster Presentations:

Poster sessions are from 6:00 p.m. – 8:00 p.m. CT Sunday, March 16 through Tuesday, March 18 in the conference exhibit hall throughout the conference.

  • Safety and Efficacy from the Ongoing Phase 1/2 DELIVER Trial of DYNE-251 in Males with DMD Mutations Amenable to Exon 51 Skipping

  • Safety and Efficacy of DYNE-101 in Adults with DM1: Phase 1/2 ACHIEVE Trial Data

  • Characteristics of Patients with Myotonic Dystrophy Type 1 with Complex Care Needs: Results from the Real-World IMPaCT Study

  • The FORCE™ Platform Achieves Robust and Durable DUX4 Suppression and Improves Muscle Function in Facioscapulohumeral Muscular Dystrophy Mouse Model

  • The FORCE™ Platform Enables TfR1-mediated Delivery of Exon Skipping PMO to the CNS and Resolves Anxiety in a Mouse Model of DMD

The presentations will be available in the Scientific Publications & Presentations section of Dyne’s website.

Additionally, a symposium titled “Harnessing the FORCE™ Platform to Advance Targeted Therapies for Neuromuscular Diseases” will be held on March 18 at 12:00 p.m. CT. The symposium will detail key attributes of Dyne’s platform and data from its two lead clinical programs in DM1 and DMD, as well as a summary of data on the use of splicing correction as a prognostic biomarker of functional outcomes in DM1.

About Dyne Therapeutics
Dyne Therapeutics is focused on discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Dyne’s strategy, future operations, prospects and plans, objectives of management, the potential of the FORCE platform, the potential of DYNE-101 and DYNE-251, and the anticipated timelines for reporting additional data from the ACHIEVE and DELIVER clinical trials, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; the timing of and Dyne’s ability to enroll patients in clinical trials; whether results from preclinical studies and data from clinical trials will be predictive of the final results of the clinical trials or other trials; whether data from clinical trials will support submission for regulatory approvals; uncertainties as to the FDA’s and other regulatory authorities’ interpretation of the data from Dyne's clinical trials and acceptance of Dyne's clinical programs and as to the regulatory approval process for Dyne’s product candidates; whether Dyne’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Dyne’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-Q and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne’s views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Dyne’s views as of any date subsequent to the date of this press release.

Contacts:

Investors
Mia Tobias
[email protected]
781-317-0353

Media
Stacy Nartker
[email protected]
781-317-1938