Earnings release
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NEWS RELEASE Satellos Reports Third Quarter 2025 Results and Announces Appointment of Mark Nawacki to Board of Directors 2025-11-14 Appointed Mark Nawacki, seasoned M&A expert, co-founder, president & former CEO of Searchlight Pharma, to Board of Directors Completed IND submission to the U.S. FDA and global regulatory lings to advance a Phase 2 clinical trial of SAT-3247 in children with Duchenne muscular dystrophy (DMD) Dosed rst patient in open-label, long-term follow-up study (LT-001) of SAT-3247 in adults with DMD Ended the third quarter of 2025 with cash balance of $48.2 million ($34.6 million in $U.S.) 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 its nancial results for the third quarter ended September 30, 2025, and other corporate and clinical updates. “The second half of 2025 represents another important milestone for Satellos as we advance toward initiating the global Phase 2 pediatric study of SAT-3247 and continue to generate meaningful data in adults with Duchenne,” said Wildon Farwell, M.D., Satellos chief medical o cer. “With multiple regulatory submissions completed and our long-term adult clinical study LT-001 now underway, our focus is rmly on clinical execution for these patients.” As Satellos advances its clinical programs and matures as an organization, the Company is also taking steps to ensure alignment with its long-term value strategy. This includes maintaining a strong and independent Board of Directors with the experience to guide the next phases of development and growth. 1
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“We are pleased to strengthen our strategic leadership with the addition of Mark Nawacki to the Board of Directors,” said Frank Gleeson, co-founder and chief executive o cer of Satellos. “Mark’s extensive experience founding and developing organizations through disciplined growth, acquisitions, and licensing will add valuable perspective as we prepare for the next stage of SAT-3247 development and Satellos’ continued growth.” CORPORATE UPDATE In November 2025, Satellos appointed Mark Nawacki, co-founder, president and former CEO of Searchlight Pharma, to its Board of Directors. Mr. Nawacki brings more than two decades of experience across pharmaceuticals, corporate development, and mergers and acquisitions. He co-founded Searchlight Pharma in 2015 and served as President and CEO from its inception till May 2024, guiding the organization’s expansion through acquisitions, in- licensing, and commercial growth into one of the three largest specialty pharmaceutical businesses in Canada. Searchlight was acquired by Apotex in June 2024, and Mark continues to lead Searchlight, now the innovative, branded division of Apotex, as President. His earlier career includes senior corporate development roles at Paladin Labs and board positions with healthcare companies. Mr. Nawacki’s transactional and leadership experience will support Satellos as it advances SAT-3247 through clinical development and provides perspectives on organizational growth. SAT-3247 CLINICAL PROGRESS In September 2025, Satellos announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial of SAT-3247 in ambulatory children with Duchenne muscular dystrophy (Duchenne or DMD). Parallel global regulatory lings were submitted in the United Kingdom, Europe, Serbia and Australia, with reviews progressing as expected. On November 13, 2025, Satellos submitted a regulatory ling to Health Canada. The Company continues to expect to enroll the rst patient into the Phase 2 study by the end of calendar 2025. Additionally, Satellos presented new data at the 30 Annual Congress of the World Muscle Society that demonstrated tolerability and initial e cacy of SAT-3247 in adults with DMD. Phase 1b participants demonstrated a 118.6% mean improvement in maximum grip strength in the dominant hand and 97.9% in the non-dominant hand. Phase 1b participants also exhibited a 5.8% mean improvement in respiratory function as measured by predicted forced vital capacity (FVC). The rst patient was dosed in the long-term follow-up, open-label study (LT-001) of SAT-3247 in adult males with DMD. th 2
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The study will assess longer-term safety, changes in muscle composition by MRI, and functional outcomes in participants. Initial results from patients returning from the Phase 1b trial are anticipated following a further two months of drug treatment for a total of three months. Satellos currently expects to report these data and ndings during calendar Q1 2026. Satellos plans to enroll additional patients beyond those returning from the previously reported study and such plans include expansion of LT-001 into the United States. FINANCIAL RESULTS (in $U.S.) Satellos had cash and cash equivalents and short-term investments of $34.6 million as of September 30, 2025, compared with $48.5 million at Dec. 31, 2024. The decrease in funds available is due to the net loss in the current year period, as well as increased deposits related to the planned Phase 2 clinical trial. For the three-months ended September 30, 2025, Satellos reported a net loss of $5.8 million ($0.03 loss per share), compared to a net loss of $6.6 million ($0.06 loss per share) for the three-months ended September 30, 2024. The decrease in net loss for the three-month period ended September 30, 2025, compared with the same periods in 2024 was primarily a result of an impairment of $2.9 million to fully write down the remaining carrying value of an intangible asset recognized in the three months ended September 30, 2024. This decrease was partially o set by increased research and development (R&D) and general and administrative (G&A) expenses. R&D expenses increased to $4.0 million for the three-months ended September 30, 2025, compared to $2.4 million for the three-months ended September 30, 2024. The increase in R&D expenses was the result of increased clinical costs associated with ongoing and planned clinical trials, partially o set by decreased CMC activities related to the process development and manufacturing of SAT-3247 for clinical use in the prior year period and preclinical costs due to IND enabling studies conducted to support the clinical regulatory lings for SAT-3247 as we prepared to initiate Phase 1 clinical development in Q3 2024. G&A expenses increased to $2.0 million for the three-months ended September 30, 2025, as compared to $1.3 million for the three-months ended September 30, 2024. The increase in general and administrative expenses in the current year period is primarily the result of increased salary and professional fees related to changes in headcount to support expanded operations and non-cash stock-based compensation expense due to new grants issued in the current period. The Satellos consolidated interim nancial statements for the three- and six-months ended June 30, 2025, and the related management discussion and analysis will be available on SEDAR+ at www.sedarplus.ca. 3
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ABOUT SAT-3247 SAT-3247 is a proprietary, oral, small molecule drug being developed by Satellos as a novel treatment to regenerate skeletal muscle that is lost in Duchenne muscular dystrophy and other degenerative or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD, independent of dystrophin and regardless of exon mutation status. 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 rst-of-its-kind, orally administered small molecule drug designed to address de cits in muscle repair and regeneration. SAT-3247 targets AAK1, a key protein that Satellos has identi ed as capable of replacing the signal normally provided by dystrophin in muscle stem cells to e ect repair and regeneration. By restoring this missing dystrophin signal in DMD, SAT-3247 enables muscle stem cells to divide properly and more e ciently, promoting natural muscle repair and regeneration. SAT-3247 is currently in clinical development as a potential disease-modifying treatment initially for DMD. Satellos also is leveraging its proprietary discovery platform MyoReGenX™ to identify additional muscle diseases or injury conditions where restoring muscle repair and regeneration may have therapeutic bene t 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, the advancement SAT-3247 through regulatory approvals and clinical trials; the expected timing of enrolling the rst patient into the Phase 2 study, the timing of data related to the LT-001 long term follow up study, our plans to enroll additional patients in LT-001 and open the study in the United States, 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 identi ed 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 4
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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 di er materially as a result of known and unknown risk factors and uncertainties a ecting 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 in ation 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’ pro le at www.sedarplus.ca). Although Satellos has attempted to identify important factors that could cause actual actions, events or results to di er materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to di er 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. Investors: Liz Williams, CFO, ir@satellos.com Media: Emily Williams, Senior Director of Communications, media@satellos.com Clinical Trial Info: medicalinfo@satellos.com Source: Satellos Bioscience Inc. 5