Satellos Bioscience Announces Q1 2024 Financial Results and Operational Highlights
- Conducted preclinical toxicology studies and GMP manufacturing of SAT-3247
- On track to initiate Phase 1 first-in-human clinical trials mid-2024
- Cash balance of
- Invited to present at PPMD 30th annual conference to be held
“We are excited about progress made during the first quarter as we get closer to initiating Phase 1 clinical development with SAT-3247, our novel oral drug to treat Duchenne muscular dystrophy and other degenerative muscle conditions,” said
PROGRAM AND BUSINESS UPDATE:
Highlights for the quarter ended
Advanced SAT-3247
During Q1, 2024, the Company engaged a contract research organization (“CRO”) to design and implement its planned Phase 1a clinical trial for SAT-3247, initiated requisite GLP toxicology studies in two species with SAT-3247, made kilogram quantities of SAT-3247 at the contract manufacturing organization it selected as its manufacturing partner, and carried out GMP manufacturing and tablet formulation of SAT-3247. The Company continues to be on track to initiate a Phase 1a clinical trial in mid-2024 to evaluate the safety and pharmacokinetic (“PK”) properties of SAT-3247 in healthy human volunteers.
Also during the first quarter of 2024, Satellos further refined its clinical development plan to incorporate an additional Phase 1b clinical trial in healthy human volunteers, planned for early 2025, intended to demonstrate SAT-3247’s pharmacodynamic (“PD”) properties, which, if successful, may provide preliminary proof of concept evidence for the potential of SAT-3247’s mechanism-of-action (“MOA”) to have an effect in humans. The Company continues with its intention to conduct a Phase 1b/2a clinical trial in Duchenne patients in 2025, which is in the planning stages.
On
Subsequent to the quarter end, the Company received Orphan Drug status from the
Satellos is pleased to announce today that it has been invited to present at Parent Project Muscular Dystrophy (“PPMD”)’s Annual Conference scheduled for
Financial Results
Satellos had cash and cash equivalents and short-term investments of
For the three months ended
Research and development expenses increased by approximately
General and administrative expenses increased by approximately
Satellos’ condensed consolidated interim financial statements for the three months ended
About
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 MyoReGenXTM, 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
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; 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20240514430572/en/
Investors:
Business Development:
Media:
Source: