• SAT-3247 treatment improved muscle repair and regeneration in canine model of DMD
•  SAT-3247 treatment also improved muscle force in this canine model of DMD
•  Satellos remains on track to initiate a Phase 1 clinical trial in Q3 2024

TORONTO / Jul 02, 2024 / Business Wire / Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSX: MSCL, OTCQB: MSCLF), a public biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, today announced preliminary results from a single case study of SAT-3247 treatment in a canine model of Duchenne muscular dystrophy (DMD or Duchenne). This model represents a severe dystrophy that closely reflects disease progression observed in people with DMD. SAT-3247 is in development as a novel regenerative medicine approach to treating DMD. These data were presented at the Parent Project Muscular Dystrophy (PPMD) 30th Annual Conference this past weekend.

"We are encouraged by these initial data showing treatment with SAT-3247 improved regeneration and muscle force in a canine model of Duchenne," said Frank Gleeson, Co-founder and CEO of Satellos Bioscience. "As Satellos' first results in a large animal study, we are pleased that these findings continue to validate the improvement in muscle repair and regeneration that we have consistently seen in the mdx mouse model. This pilot study offers further support that SAT-3247 treatment may be capable of restoring muscle repair and regeneration that is impaired in people living with Duchenne."

After treatment with SAT-3247 the animals showed an increase in Regenerative Index (RI), a measure of the number of newly regenerated muscle fibers versus the number of damaged and dying muscle fibers.

“Increases in the Regenerative Index suggest that muscle repair and regeneration is occurring,” commented Phil Lambert, Ph.D., Chief Scientific Officer of Satellos Bioscience. “While preliminary, these results further build and support our understanding of the unique mechanism of action of SAT-3247. We continue to work diligently to advance this novel small molecule drug candidate into a first-in-human clinical trial this quarter.”

The highlighted results released at the PPMD conference and available on the Company’s website here are from one of two dystrophic animals in a pilot study in which each animal was treated for four months with a daily oral dose of SAT-3247. A summary of the results for the single case study animal reported is as follows:

• After four months of SAT-3247 treatment, skeletal muscle displayed an approximate four hundred and fifty percent (450%) increase in Regenerative Index; and
• After two months of SAT-3247 treatment, skeletal muscle displayed up to a one hundred percent (100%) increase in muscle force.

About SAT-3247

SAT-3247 is designed as a once-daily, oral small molecule drug that targets the root cause of muscle loss in degenerative diseases, initially in Duchenne. SAT-3247 presents a novel mechanism of action to restore impaired muscle regeneration caused by the absence of functional dystrophin.

About Duchenne Muscular Dystrophy

Duchenne muscular dystrophy is an inherited disease caused by mutations in the dystrophin gene that no longer allow the dystrophin protein to function properly. Consequently, as discovered by Satellos, muscle repair and regeneration are impaired. Satellos designed SAT-3247 to restore the process of muscle repair and regeneration by regulating a dystrophin-independent pathway with the goal of increasing muscle function. SAT-3247 is intended to work as a standalone therapeutic without regard to a patient’s genetic mutation or ambulatory status. Our approach has the potential to complement approaches designed to restore dystrophin production.

About Satellos Bioscience Inc.

Satellos is a publicly traded biotechnology company dedicated to developing life-improving medicines to treat degenerative muscle diseases. Satellos has incorporated breakthrough research in muscle stem cell polarity into a proprietary discovery platform, called MyoReGenX™, to identify degenerative muscle diseases where deficits in this process affect muscle regeneration and are amenable to therapeutic intervention. With this platform, Satellos is building a pipeline of novel therapeutics to correct muscle stem cell polarity and promote the body’s innate muscle repair and regeneration process. The Company’s lead program is an oral, small molecule drug candidate in development as a potential disease-modifying treatment for Duchenne muscular dystrophy. Satellos is headquartered in Toronto, Ontario. 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 anticipated benefits to patients from a small molecule treatment for Duchenne; the advancement of our lead drug candidate into clinical trials; our belief that assessing regenerative status in skeletal muscle could potentially provide a meaningful way to predict functional outcomes in future clinical trial,, the pharmacodynamic properties and mechanism-of-action of our lead drug candidate; the potential of our approach in other degenerative muscle diseases or in muscle injury or trauma; the general benefits of modulating stem cell polarity by administering small molecule drugs; its/their prospective impact on Duchenne patients, patients with other degenerative muscle disease or muscle injury or trauma, and on muscle regeneration generally; the utility of regenerating muscle by modulating polarity; adoption of Satellos’ approach by the medical community; 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”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “anticipate”, “potential”, “prospective” , “assert” or any variations (including negative or plural variations) of such words and phrases, or state 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, 2024 (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.