Satellos Announces IND Submission to the U.S. FDA and Global Regulatory Filings to Advance a Phase 2 Clinical Trial of SAT-3247 in Children with Duchenne Muscular Dystrophy

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TORONTO--(BUSINESS WIRE)--Sep 22, 2025--

Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) (“Satellos” or the “Company”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), along with parallel regulatory filings in the United Kingdom, Europe, Serbia and Australia, to initiate a Phase 2 clinical trial of SAT-3247 in ambulatory children with Duchenne muscular dystrophy (Duchenne or DMD).

The planned Phase 2 trial will enroll children with Duchenne in the U.S., following FDA approval, and globally, following country health authority approvals. The three-month randomized, placebo-controlled study will assess safety and tolerability as well as key measures of strength, function, biomarkers, and muscle health. A nine-month open-label extension for this study is also being planned.

“Filing our Phase 2 clinical trial submissions in the US and globally marks a major milestone for Satellos in advancing SAT-3247’s potential to treat Duchenne in a novel way,” said Satellos Co-Founder and CEO Frank Gleeson. “Current therapies do not address the fundamental challenge in Duchenne, which we have identified — the body’s impaired muscle-repair process. With SAT-3247, our goal is to re-boot that regenerative cycle with the potential to restore muscle, improve functional outcomes and truly change lives.”

SAT-3247 is an oral small-molecule therapy designed to restore the body’s ability to regenerate muscle, a process that is impaired in Duchenne. In a recently completed Phase 1b study in five adults with Duchenne, SAT-3247 was safe and well tolerated and the pharmacokinetics of SAT-3247 in adults with Duchenne mirrored that of healthy volunteers. Importantly, efficacy was explored, and an approximate doubling of grip strength was observed over 28 days along with a 5% improvement in force vital capacity (lung function). Satellos has initiated an 11-month extension study in Australia to evaluate long-term safety and efficacy among individuals who participated in the Phase 1b trial. Further expansions of this trial are planned.

CORPORATE UPDATE

Satellos is also pleased to announce that since its last reporting period, it has received investor support through the exercise of 1,737,500 share purchase warrants (“ Warrants ”) for gross proceeds of C$1,042,500. The Warrants were issued pursuant to a financing that closed on Sept. 13, 2022, pursuant to which an aggregate of 4,375,000 Warrants were issued. As disclosed in Satellos’ Q2 2025 financial statements, a total of 911,000 Warrants had been previously exercised. The remaining 1,726,500 Warrants expired as of Sept. 13, 2025, pursuant to the expiry date.

ABOUT SAT-3247

SAT-3247 is a proprietary, oral, small molecule drug being developed by Satellos as a novel treatment to regenerate skeletal muscle that is lost in Duchenne muscular dystrophy and other degenerative or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD, independent of dystrophin and regardless of exon mutation status.

ABOUT SATELLOS BIOSCIENCE INC.

Satellos is a clinical-stage drug development company focused on restoring natural muscle repair and regeneration in degenerative muscle diseases. Through its research, Satellos has developed SAT-3247, a first-of-its-kind, orally administered small molecule drug designed to address deficits in muscle repair and regeneration. SAT-3247 targets AAK1, a key protein that Satellos has identified as capable of replacing the signal normally provided by dystrophin in muscle stem cells to effect repair and regeneration. By restoring this missing dystrophin signal in DMD, SAT-3247 enables muscle stem cells to divide properly and more efficiently, promoting natural muscle repair and regeneration. SAT-3247 is currently in clinical development as a potential disease-modifying treatment initially for DMD. Satellos also is leveraging its proprietary discovery platform MyoReGenX™ to identify additional muscle diseases or injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and represent future clinical development opportunities. For more information, visit www.satellos.com.

NOTICE ON FORWARD-LOOKING STATEMENTS

This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Satellos and its business, which may include, but are not limited to, statements regarding the potential for SAT-3247 to represent a disease modifying approach to the therapeutic treatment of people living with Duchenne; anticipated benefits to patients from a small molecule treatment for Duchenne; the advancement SAT-3247 through clinical trials and the expected timing and design of such trials; the pharmacodynamic properties and mechanism-of-action of SAT-3247; the potential of our approach in other degenerative muscle diseases; its/their prospective impact on Duchenne patients, patients with other degenerative muscle disease or muscle injury or trauma, and on muscle regeneration generally; and Satellos’ technologies and drug development plans. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, occurrences or developments, are “forward-looking information or statements.” Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “believe”, “plan”, “expect”, “intend”, “estimate”, “anticipate”, “potential”, “prospective”, “assert” or any variations (including negative or plural variations) of such words and phrases, or statements that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, risks relating to the pharmaceutical and bioscience industry (including the risks associated with preclinical and clinical trials and regulatory approvals), and the research and development of therapeutics, the results of preclinical and clinical trials, general market conditions and equity markets, economic factors and management’s ability to manage and to operate the business of the Company generally, including inflation and the costs of operating a biopharma business, and those risks listed in the “Risk Factors” section of Satellos’ Annual Information Form dated March 26, 2025 (which is located on Satellos’ profile at www.sedarplus.ca ). Although Satellos has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Satellos does not undertake any obligation to publicly update or revise any forward-looking statement, whether resulting from new information, future events, or otherwise.

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CONTACT: Investors:Liz Williams, CFO,[email protected]

Media: Emily Williams, Senior Director of Communications,[email protected]

Clinical Trial Info:[email protected]

KEYWORD: AUSTRALIA NORTH AMERICA CANADA EUROPE UNITED STATES UNITED KINGDOM SERBIA AUSTRALIA/OCEANIA

INDUSTRY KEYWORD: SCIENCE STEM CELLS BIOTECHNOLOGY RESEARCH PHARMACEUTICAL HEALTH FDA CLINICAL TRIALS

SOURCE: Satellos Bioscience Inc.

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PUB: 09/22/2025 07:00 AM/DISC: 09/22/2025 06:59 AM

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