Independent Safety Data Monitoring Committee Recommends Initiation of Cohort 3 at the Top Dose of 18 mg/kg in Entrada Therapeutics’ ELEVATE-44-201 Study

-- Company to receive ELEVATE-44-201 data from Cohort 1 open-label period by year-end 2026 --

-- ELEVATE-44-201 Cohort 2 enrollment complete with data expected in Q1 2027 --

BOSTON, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today announced that an independent Data Monitoring Committee (DMC), per study protocol, has reviewed all available safety and PK data from the eight participants enrolled in Cohort 2 of the double-blind, placebo-controlled, multiple ascending dose (MAD) portion of ELEVATE-44-201. The DMC recommended initiating Cohort 3 at the top dose of 18 mg/kg, an increase from 12 mg/kg in Cohort 2 and 6 mg/kg in Cohort 1. ELEVATE-44-201 is a Phase 1/2 MAD clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in participants with a confirmed mutation in the DMD gene amenable to exon 44 skipping.

“The independent Data Monitoring Committee’s recommendation to advance to Cohort 3 at the top dose of 18 mg/kg marks another important step in the clinical development of ENTR-601-44,” said Natarajan Sethuraman, PhD, President of Research and Development at Entrada Therapeutics. “This recommendation allows us to continue dose escalation in the ELEVATE-44-201 clinical study and deepen our understanding of ENTR-601-44’s safety, pharmacokinetic and pharmacodynamic profile, as dosing at 18 mg/kg could lead to meaningfully higher exposure, dystrophin production and functional benefit. We look forward to receiving data later this year from Cohort 1 participants after one year of treatment in the open-label period, followed by Cohort 2 data in the first quarter of 2027.”

About the ELEVATE-44-201 Phase 1/2 Study
ELEVATE-44-201 is a global, two-part, randomized, double-blind, placebo-controlled Phase 1/2 study evaluating the safety, tolerability and effectiveness of ENTR-601-44 in ambulatory participants aged four to 20 with Duchenne who are amenable to exon 44 skipping. The multiple ascending dose (MAD) Part A portion of the study is evaluating the safety, pharmacokinetics, pharmacodynamics and functional parameters following intravenous administration of ENTR-601-44 to study participants in three cohorts at sites in the U.K. and EU.

About ENTR-601-44
ENTR-601-44 is a proprietary Endosomal Escape Vehicle (EEV™)-conjugated oligonucleotide that has a sequence designed and optimized for people with a confirmed mutation in the DMD gene that is amenable to exon 44 skipping, which comprises approximately eight percent of the Duchenne patient population globally. ENTR-601-44 is designed to address the underlying cause of Duchenne, facilitating production of functional dystrophin from the endogenous (naturally occurring) DMD gene.

In December 2025, the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to ENTR-601-44.

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About Duchenne Muscular Dystrophy (DMD)
Duchenne muscular dystrophy (DMD) is a rare disease caused by mutations in the DMD gene, which encodes the dystrophin protein. These mutations lead to inadequate dystrophin production. Dystrophin is essential to maintaining the structural integrity and function of muscle cells. Lack of functional dystrophin leads to progressive loss of muscle strength, impacting mobility and causing heart or respiratory complications that contribute to high mortality rates. An estimated 41,000 people in the U.S. and Europe are living with DMD. Of those, approximately 11,500 are amenable to skipping of exon 44, 45, 50, or 51.

About Entrada Therapeutics
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

For more information about Entrada, please visit our website, www.entradatx.com, and follow us on LinkedIn.

Forward-Looking Statements

This press release contains express and implied 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 Entrada’s strategy, future operations, prospects and plans, objectives of management, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, expectations regarding Entrada’s ELEVATE-44-201 study, including the timing of receiving data later this year from Cohort 1 participants after one year of treatment in the open-label period, the timing of data from Cohort 2 expected in Q1 2027, the potential for dose escalation in the ELEVATE-44-201 study to deepen Entrada’s understanding of ENTR-601-44’s safety, pharmacokinetic and pharmacodynamic profile and functional benefits and the ability of the MAD Part A portion of the study to evaluate the safety, pharmacokinetics, pharmacodynamics and functional parameters of ENTR-601-44, expectations regarding ENTR-601-44, including the ability for dosing at 18 mg/kg to lead to meaningfully higher exposure, dystrophin production and functional benefit, and the potential for ENTR-601-44 to address the underlying cause of DMD, facilitating production of functional dystrophin from the endogenous (naturally occurring) DMD gene, the potential therapeutic benefits of Entrada’s EEV product candidates, including and the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the treatment of DMD and the partnered product candidate VX-670 for the potential treatment of DM1, the ability to continue to expand and develop additional therapeutic programs and modalities, including the potential treatment of neuromuscular and inherited retinal diseases, 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. Entrada 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 conduct of research activities and the initiation and completion of preclinical studies and clinical studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; whether Entrada’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Entrada’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-K and in subsequent filings Entrada may make with the SEC. In addition, the forward-looking statements included in this press release represent Entrada’s views as of the date of this press release. Entrada anticipates that subsequent events and developments will cause its views to change. However, while Entrada 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 Entrada’s views as of any date subsequent to the date of this press release.

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dsnow@entradatx.com

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