Satellos Bioscience Inc Stock Price, News & Analysis

Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) announced its Q2 2024 financial results and operational highlights. Key points include:

• Updated canine DMD model data showing 195% improvement in muscle force over baseline at four months
• Receipt of Orphan Drug and Rare Pediatric Disease designations from US FDA for SAT-3247
• On track to initiate Phase 1 clinical trial with SAT-3247 in Q3 2024
• Cash balance of $27.7 million as of June 30, 2024
• Net loss of $6.0 million ($0.05 per share) for Q2 2024
• Increased R&D expenses to $4.9 million, up from $1.6 million in Q2 2023
• General and administrative expenses increased to $1.8 million from $1.5 million in Q2 2023

Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) has received Rare Pediatric Disease Designation from the U.S. FDA for SAT-3247, its potential treatment for Duchenne muscular dystrophy (DMD). This follows the earlier Orphan Drug Designation for the same drug. SAT-3247 is a first-in-class oral small molecule designed to restore muscle regeneration and repair, regardless of dystrophin or exon mutation status.

Key points:

• DMD is a rare genetic disorder causing progressive muscle degeneration
• Rare Pediatric Disease Designation may lead to a priority review voucher
• Orphan Drug Designation offers potential 7-year market exclusivity and other benefits
• Phase 1 clinical trial of SAT-3247 is anticipated in Q3 2024

Satellos Bioscience has submitted a clinical research proposal to Australia's Human Research Ethics Committee (HREC) on July 10, 2024, to start a Phase 1 trial for SAT-3247, an oral drug aimed at regenerating skeletal muscle in Duchenne muscular dystrophy (DMD) and other conditions. Expected to begin in Q3 2024, the trial will enroll healthy volunteers to assess safety and pharmacokinetics. Following successful preclinical and toxicology studies, this milestone marks Satellos' transition to a clinical-stage company. SAT-3247 could move to trials with DMD patients by early 2025, pending regulatory approvals.

Satellos Bioscience has announced promising preliminary results from a single case study of their SAT-3247 treatment in a canine model of Duchenne muscular dystrophy (DMD). The study reported a significant improvement in muscle repair and regeneration, with a 450% increase in the Regenerative Index after four months of treatment and up to a 100% increase in muscle force after two months. These findings were presented at the Parent Project Muscular Dystrophy (PPMD) 30th Annual Conference. Satellos plans to initiate Phase 1 clinical trials in Q3 2024.

Satellos Bioscience (TSX: MSCL, OTCQB: MSCLF) announced that CEO Frank Gleeson will be participating in a panel discussion at the Parent Project Muscular Dystrophy (PPMD) 30th Annual Conference in Orlando, Florida, from June 27-29, 2024. This event underscores the company's ongoing commitment to developing innovative treatments for Duchenne muscular dystrophy. Gleeson highlighted Satellos' progress, supported by a programmatic investment from PPMD in 2021, towards creating an oral drug candidate aimed at improving treatment options for Duchenne patients. The company plans to submit a regulatory package in July 2024 to begin a Phase 1 clinical trial of SAT-3247, evaluating its safety and pharmacokinetics in healthy volunteers in Q3 2024.

Satellos Bioscience has announced the creation of a Clinical Advisory Board (CAB) to aid in the development of SAT-3247, an oral small molecule drug for Duchenne Muscular Dystrophy (DMD). The company, listed on TSX as MSCL and OTCQB as MSCLF, expects to start first-in-human clinical trials mid-year for SAT-3247. The CAB comprises distinguished experts like Jordan Dubow, Ronald Cohn, Richard Finkel, Nicholas Johnson, Hanns Lochmüller, Francesco Muntoni, and Perry Shieh. This development marks a significant step for Satellos in becoming a clinical-stage drug development company focused on muscle diseases.

Satellos Bioscience, a biotech company developing small molecule therapeutics for muscle diseases, announced the results of its Annual and Special Meeting of Shareholders held on May 14, 2024. All nominees listed in the Circular dated April 10, 2024, were elected as directors with over 99% of votes cast. Shareholders approved a potential reverse stock split in the range of 1-for-5 to 1-for-20, re-appointment of MNP LLP as auditors, a new Equity Incentive Plan, an advanced notice bylaw, and amendments to existing bylaws. 54.43% of common shares were represented at the meeting. The detailed voting results are available on Sedar+.

Satellos Bioscience announced its Q1 2024 financial and operational results.

Key highlights include preclinical advancements and GMP manufacturing for SAT-3247, with Phase 1 clinical trials on track to start mid-2024.

The company reported a cash balance of $33.2 million as of March 31, 2024, down from $39.6 million at the end of 2023.

Net loss for Q1 2024 was $6.9 million, significantly higher than the $1.7 million loss in Q1 2023, due to increased R&D and G&A expenses.

Satellos also received Orphan Drug status from the FDA for SAT-3247 and plans to present at the PPMD conference in June 2024.