Satellos Reports Second Quarter 2025 Results and Highlights Upcoming Clinical Milestones

Executive Summary

• Satellos Bioscience reported positive Phase 1b clinical data for its lead drug candidate SAT-3247 in adults with Duchenne muscular dystrophy (DMD), demonstrating safety, tolerability, and an approximate doubling of grip strength after 28 days of treatment.
• The company announced its financial results for the second quarter ended June 30, 2025, reporting a net loss of $5.6 million and a cash balance of $38.2 million ($52.1 million CAD).
• Satellos is on track to initiate a long-term follow-up Phase 1b study in adults in Q3 2025 and plans to submit regulatory applications (IND/CTA) for a global Phase 2 pediatric trial in Q3 2025.

Key Details

• Clinical Data (SAT-3247 Phase 1b):
  • Study involved five adult male patients with DMD (ages 20–27) treated for 28 days.
  • Safety: The drug demonstrated a clean safety profile and was well-tolerated.
  • Efficacy: Grip strength (measured by MyoGrip) approximately doubled across all participants, increasing from ~2 kg to 4 kg.
  • Respiratory Function: Patients showed an approximate average increase in force-vital capacity of 5%.
  • Stability: Participants remained stable in other exploratory measurement areas.
  • Pharmacokinetics: Expected pharmacokinetic profile was met, despite all patients being on steroids.
• Clinical Development Pipeline:
  • Adult Follow-up (SAT-3247-LT-001): Approval received to initiate in Q3 2025; will provide 11 additional months of treatment to assess durability of functional responses, long-term safety, and muscle composition via MRI. Interim 3-month results expected prior to year-end. Protocol to be expanded to include additional patients.
  • Pediatric Phase 2: Plans to submit IND application to FDA and CTAs in other countries in Q3 2025 for a global, randomized, placebo-controlled, proof-of-concept trial in pediatric patients with DMD. The trial will assess safety, pediatric pharmacokinetics, optimal dose, biologic effects, and functional efficacy.
• Financial Results (Q2 2025):
  • Cash Position: $38.2 million in cash and cash equivalents and short-term investments as of June 30, 2025 (down from $48.5 million at Dec. 31, 2024).
  • Net Loss: $5.6 million ($0.03 loss per share) for the three months ended June 30, 2025, compared to a net loss of $4.4 million ($0.04 loss per share) in the same period of 2024.
  • R&D Expenses: Increased to $4.4 million (from $3.6 million in Q2 2024) due to increased clinical costs for ongoing/planned trials, partially offset by decreased CMC and preclinical costs.
  • G&A Expenses: Increased to $1.9 million (from $1.3 million in Q2 2024) primarily due to increased salary, professional fees, and non-cash stock-based compensation.
• Corporate Updates:
  • Appointed Dr. Wildon Farwell as Chief Medical Officer (CMO).

Notable Quotes

• “We are excited by the clean safety profile and promising functional improvements with SAT-3247 in our Phase 1a/1b study,” said Satellos Co-Founder and Chief Executive Officer Frank Gleeson. “The consistency between our clinical and preclinical findings continues to point to the transformative potential of SAT-3247 as a novel treatment for degenerative muscle conditions broadly.”