Mr. Frank Gleeson reports

SATELLOS CHANGES PRIMARY EFFICACY ENDPOINT IN BASECAMP PHASE 2 PEDIATRIC TRIAL TO MRI-MEASURED FAT FRACTION FOLLOWING FDA FEEDBACK

Satellos Bioscience Inc., following feedback from the U.S. Food and Drug Administration (FDA), has selected change in vastus lateralis fat fraction measured by magnetic resonance imaging (MRI) as the primary efficacy end point in the Basecamp phase 2 clinical study in boys ages seven, eight or nine with Duchenne muscular dystrophy (DMD). Change in MRI-measured (magnetic resonance imaging) fat fraction will replace dynamometry as the study's primary efficacy end point. Forazapadin is an investigational oral, small molecule designed to enhance the body's natural ability to repair and regenerate muscle. Early clinical data in DMD have demonstrated a favourable safety and tolerability profile and encouraging signs of biological and functional activity.

"Our goal is clear: if Basecamp delivers supportive results, we intend to move rapidly toward a potential accelerated approval pathway for forazapadin," said Frank Gleeson, co-founder and chief executive officer of Satellos. "We are delighted with our recent interactions with the FDA, which have helped sharpen our clinical and regulatory strategy and given us greater clarity on the evidence that could support a path to accelerated approval. With the Basecamp readout approaching, our focus is on rigorous execution, continued engagement with the FDA and moving with urgency toward our ultimate goal of bringing forazapadin to patients living with Duchenne."

Fat fraction is an objective MRI measure of muscle composition that quantifies the proportion of fat within muscle tissue. In DMD, fat progressively replaces healthy muscle; rising fat fraction is therefore associated with disease progression, while a reduction may represent muscle regeneration and healing. Natural history studies in boys living with DMD have demonstrated a consistent increase in fat fraction over time.

"We believe that change in MRI-measured muscle fat fraction of the vastus lateralis has the potential to serve as a surrogate endpoint reasonably likely to predict clinical benefit from forazapadin during Basecamp's 12-week placebo-controlled period and randomized active treatment period," said Wildon Farwell, MD, chief medical officer of Satellos. "It is an objective measure of muscle composition that has been associated with disease progression and loss of ambulation in boys living with Duchenne. Importantly, we have also observed encouraging clinical evidence on this measure in Trailhead, where adults treated with forazapadin demonstrated an improvement in muscle fat fraction of the biceps brachii over five months. Together, these data give us increased confidence in muscle fat fraction as a measure of forazapadin's biological activity in Basecamp and as a proposed surrogate endpoint to support a potential accelerated approval pathway."

Data from the company's open-label phase 2 Trailhead study in adults with DMD demonstrated a mean 3.7-percentage-point reduction in MRI-measured muscle fat fraction of the biceps brachii, from 49.7 per cent at baseline to 46.0 per cent at day 140, indicating improved muscle composition. Additional Trailhead data demonstrated increased total effort, stable strength, lower creatine kinase levels and a safety and tolerability profile consistent with previously reported data.

Conference call information

Satellos management will host a conference call and audio webcast to discuss the phase 2 Basecamp trial today, Nov. 6, 2026, at 8 a.m. ET. A live webcast of the conference call and accompanying slides will be available on the events and presentations page of the investors section of the company website. A replay will be available following the presentation.

Conference call details

Domestic:  1-877-269-7751

International:  1-201-389-0908

About Basecamp

Basecamp is a global, phase 2, randomized, double-blind, placebo-controlled proof-of-concept study evaluating forazapadin in 53 ambulatory boys with DMD ages seven, eight or nine years. The study includes an initial 12-week randomized, double-blind, placebo-controlled treatment period, followed by a 36-week active-treatment period in which all participants receive forazapadin. The primary objectives are to evaluate the safety and tolerability of forazapadin and its effect on muscle composition as measured by MRI fat fraction. Secondary and exploratory end points include assessments of muscle quality, functional outcomes and biomarkers of muscle regeneration, including Satellos's proprietary Regenerative Index.

About forazapadin

Forazapadin is a proprietary oral small-molecule drug candidate being developed by Satellos to enhance skeletal muscle repair and regeneration in degenerative muscle diseases and injury conditions. Forazapadin targets AAK1, a key protein identified by Satellos as a regulator of the muscle stem cell process that supports muscle repair and regeneration, which is disrupted in DMD, facioscapulohumeral muscular dystrophy (FSHD) and other degenerative conditions. By inhibiting AAK1, forazapadin is designed to restore a biochemical signal involved in supporting muscle regeneration. Satellos is advancing forazapadin as a potential dystrophin-independent treatment for DMD that may be applicable regardless of exon mutation status, either as a stand-alone or adjunctive therapy. Continuing phase 2 studies include Basecamp, a global randomized, placebo-controlled study in pediatric participants, and Trailhead, an open-label study in adult participants. An investigational new drug (IND) application to initiate clinical research into forazapadin for the treatment of FSHD has also been cleared.

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 forazapadin, an orally administered small molecule AAK1 inhibitor designed to address deficits in muscle repair and regeneration. Forazapadin is being evaluated as a potential disease-modifying treatment for DMD in two phase 2 clinical trials, Basecamp in pediatric participants with DMD and Trailhead in adults living with DMD. An IND application to initiate clinical research into forazapadin for the treatment of FSHD has also been cleared. The company has identified additional muscle diseases and injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and plans to pursue these opportunities in future clinical development.

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