Satellos Appoints Antoinette Paone as Chief Development Officer and Head of Regulatory Affairs

Key Terms

clinical-stage medical

Clinical-stage describes a drug, therapy, or company whose product is being tested in human trials but has not yet received regulatory approval. For investors, it signals that the project has moved beyond lab work into real-world testing—meaning higher potential reward if trials succeed but also clear risks from trial setbacks, costs, and regulatory delay; think of it like a prototype car on public road tests that could either prove its value or reveal problems that stop it from reaching production.

regulatory affairs regulatory

Regulatory affairs is the team and processes that secure and maintain government approvals, permits, and ongoing compliance for a company’s products, such as drugs, medical devices, or financial offerings. Think of them as the navigator and permit office that prepares submission paperwork, answers regulator questions, and monitors safety and labeling after launch. Their work matters to investors because regulatory timing, costs, and approval risk directly affect a product’s ability to reach markets and generate revenue.

clinical development medical

Clinical development is the process of testing a medical treatment in people to prove it is safe and works, moving from small early safety checks to larger trials that measure benefit and side effects. For investors it matters because each successful step reduces uncertainty and brings a product closer to regulatory approval and sales—like moving a prototype through road tests before mass production—while failures or delays can dramatically cut expected value.

ipo financial

An initial public offering (IPO) is the process by which a private company sells its shares to the public for the first time, making its ownership available on the stock market. This allows the company to raise money from a wide range of investors to fund growth or other goals. For investors, an IPO offers a chance to buy into a company early in its public journey, potentially benefiting if the company grows in value.

cmc technical

Chemistry, Manufacturing, and Controls (CMC) describes the technical documentation and processes that show how a drug or medical product is made, tested for consistent quality, and kept stable from batch to batch. Investors care because strong CMC means a product can be manufactured reliably at scale and meet regulatory standards—similar to proving a recipe can be cooked the same way in any kitchen before restaurants expand—affecting approval, production costs, and potential revenue.

duchenne muscular dystrophy medical

A rare, inherited condition that progressively weakens muscles, Duchenne muscular dystrophy causes the body’s muscle fibers to break down over time, often leading to severe disability. For investors, it matters because the small, well-defined patient population, high unmet medical need and complex regulatory and pricing dynamics mean successes or failures in clinical trials, approvals, or therapies can have outsized effects on a company’s valuation and future revenue prospects.

Experienced industry leader brings extensive expertise in leading breakthrough therapies through clinical development to marketing approval

TORONTO--(BUSINESS WIRE)-- Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) (“Satellos” or the “Company”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced the appointment of Antoinette Paone as Chief Development Officer (“CDO”) and Head of Regulatory Affairs. Ms. Paone brings extensive experience leading regulatory strategy from clinical development through approval, including her work on Kalydeco and Orkambi at Vertex Pharmaceuticals (Nasdaq: VRTX). She joins Satellos from Generation Bio (Nasdaq: GBIO), where she most recently served as Chief Operating Officer.

“Bringing Ms. Paone on board to the executive team is incredibly exciting given her track record of charting the path to regulatory approval for breakthrough medicines,” said Frank Gleeson, Satellos co-founder and CEO. “With our two clinical studies in DMD advancing in adult and pediatric populations, the possibility of pursuing regulatory approval for SAT-3247 in the future is beginning to come into view. The appointment of Ms. Paone is not only timely, but also reflects our confidence in our expanding set of clinical data.”

At Generation Bio, Ms. Paone led the company’s growth from start-up to a development-ready organization, shaping key business functions, including regulatory strategy, quality, CMC, technical operations, and program management. She was also part of the executive team responsible for a series of equity financings over four years, including a successful IPO and a strategic partnership with Moderna. Prior to Generation Bio, she spent more than a decade at Vertex, most recently as Vice President, Head of North American Regulatory Affairs Strategy, where she led regulatory efforts for multiple novel small molecule cystic fibrosis therapies, including Kalydeco and Orkambi. Earlier in her career, she held roles at Merck & Co. and Millenium Pharmaceuticals, Inc. Ms. Paone holds an MBA from Bentley College, an MS in Organic Chemistry from Yale University, and a BS in Chemistry from Fordham University.

“I feel so fortunate to join Satellos in its bold mission to change what is possible in the treatment of Duchenne muscular dystrophy and other serious and life-limiting muscle diseases with great unmet need,” said Ms. Paone. “Having long-been focused during my career on bringing transformative medicines to people living with devastating diseases, I am eager to bring my perspective to Satellos as we work together to cultivate a roadmap for success.”

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 SAT-3247, a first-of-its-kind, orally administered small molecule drug designed to address deficits in muscle repair and regeneration. SAT-3247 targets AAK1, a key protein that Satellos has identified as capable of helping restore muscle stem cell signaling that is disrupted in DMD. By addressing the loss of dystrophin-dependent cues, SAT-3247 may re-establish the signals that support effective muscle regeneration. SAT-3247 is currently in clinical development as a potential disease-modifying treatment, initially for DMD. Satellos is also working to identify additional muscle diseases or injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and represent future clinical development opportunities. 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 possibility of pursuing regulatory approval for SAT-3247, the potential for SAT-3247 to represent a disease modifying approach to the therapeutic treatment of people living with Duchenne; anticipated benefits to patients from a small molecule treatment for Duchenne; the advancement SAT-3247 through clinical trials; the pharmacodynamic properties and mechanism-of-action of SAT-3247; the potential of our approach in other degenerative muscle diseases; its/their prospective impact on Duchenne patients, patients with other degenerative muscle disease or muscle injury or trauma, and on muscle regeneration generally; 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”, “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, 2025 (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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260129951231/en/

Investors: Liz Williams, CFO, ir@satellos.com

Media: Emily Williams, Senior Director of Communications, media@satellos.com

Source: Satellos Bioscience Inc.