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Satellos BioscienceFDocument history
Earnings documents stored for MSLE.
Investor releaseQuarter not tagged2026-08-13Satellos Reports Second Quarter 2026 Financial Results and Highlights Company Progress
GlobeNewswire
Satellos Reports Second Quarter 2026 Financial Results and Highlights Company Progress
Reported a reduction in muscle fat fraction by MRI along with increased total effort in all TRAILHEAD participants at month six, suggestive of muscle regeneration Continued favorable safety and tolerability profile, stable strength and improved quality of life reported in six-month follow-up data in TRAILHEAD Phase 2 adult DMD study Company remains on track to report clinical data from Phase 2 BASECAMP pediatric DMD study in Q4 2026 Strong financial position with $61.8 million in cash, cash equivalents and short-term investments as of June 30, 2026, expected to provide runway through 2027 SAT-3247 granted FDA Fast Track Designation for DMD TORONTO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL), a clinical-stage drug development company developing life-improving medicines to treat degenerative muscle diseases, today announced financial results for the second quarter ended June 30, 2026. The company also provided an update on the clinical development program for SAT-3247, an orally administered, small molecule drug candidate designed to restore muscle regeneration in people living with Duchenne muscular dystrophy (DMD) and potentially other muscle diseases. “Our progress in the second quarter demonstrates our commitment and ability to effectively deliver on our promises to the Duchenne community,” said Frank Gleeson, Satellos co-founder and CEO. “We received FDA Fast Track Designation for SAT-3247 for DMD. We advanced enrollment in our BASECAMP Phase 2 pediatric study with several patients currently in long-term follow-up. Finally, we reported interim data at month six from the TRAILHEAD Phase 2 adult study that we believe are consistent with muscle regeneration — results we believe will continue to mature in TRAILHEAD and translate to the pediatric population through the BASECAMP study. “We are anticipating several important catalysts for the remainder of this year. We expect to release clinical data from the BASECAMP pediatric trial in the fourth quarter, which will help to inform our continued development and regulatory strategies. We plan to share important updates from the TRAILHEAD study. In addition, we remain on track to submit an Investigational New Drug (IND) application to the FDA for facioscapulohumeral muscular dystrophy (FSHD) and launch a Phase 2 clinical trial.” Enrollment in BASECAMP (CL-201) Phase 2 pedi…Read full documentShow less
Reported a reduction in muscle fat fraction by MRI along with increased total effort in all TRAILHEAD participants at month six, suggestive of muscle regeneration Continued favorable safety and tolerability profile, stable strength and improved quality of life reported in six-month follow-up data in TRAILHEAD Phase 2 adult DMD study Company remains on track to report clinical data from Phase 2 BASECAMP pediatric DMD study in Q4 2026 Strong financial position with $61.8 million in cash, cash equivalents and short-term investments as of June 30, 2026, expected to provide runway through 2027 SAT-3247 granted FDA Fast Track Designation for DMD TORONTO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL), a clinical-stage drug development company developing life-improving medicines to treat degenerative muscle diseases, today announced financial results for the second quarter ended June 30, 2026. The company also provided an update on the clinical development program for SAT-3247, an orally administered, small molecule drug candidate designed to restore muscle regeneration in people living with Duchenne muscular dystrophy (DMD) and potentially other muscle diseases. “Our progress in the second quarter demonstrates our commitment and ability to effectively deliver on our promises to the Duchenne community,” said Frank Gleeson, Satellos co-founder and CEO. “We received FDA Fast Track Designation for SAT-3247 for DMD. We advanced enrollment in our BASECAMP Phase 2 pediatric study with several patients currently in long-term follow-up. Finally, we reported interim data at month six from the TRAILHEAD Phase 2 adult study that we believe are consistent with muscle regeneration — results we believe will continue to mature in TRAILHEAD and translate to the pediatric population through the BASECAMP study. “We are anticipating several important catalysts for the remainder of this year. We expect to release clinical data from the BASECAMP pediatric trial in the fourth quarter, which will help to inform our continued development and regulatory strategies. We plan to share important updates from the TRAILHEAD study. In addition, we remain on track to submit an Investigational New Drug (IND) application to the FDA for facioscapulohumeral muscular dystrophy (FSHD) and launch a Phase 2 clinical trial.” Enrollment in BASECAMP (CL-201) Phase 2 pediatric study advances The BASECAMP clinical trial is designed to evaluate SAT-3247 in 51 ambulatory boys with DMD aged 7, 8 or 9 years. Primary endpoints include safety, tolerability and dynamometry. Secondary endpoints will assess SAT-3247's impact on muscle quality, function and regeneration. The BASECAMP trial is actively enrolling and the company expects to report clinical data in the fourth quarter of 2026. TRAILHEAD (LT-001) Phase 2 adult study reports stabilization or improvement across multiple outcome measuresTRAILHEAD is a 12-month, open-label Phase 2 clinical trial designed to assess the long-term safety, tolerability, efficacy and sustained functional benefit of SAT-3247 in adults with DMD. In July, Satellos announced six-month follow-up data on four adult participants who completed the Phase 1b study (CL-101) and enrolled in TRAILHEAD, demonstrating stable strength, reduced muscle fat fraction, increased total effort and improved quality of life, with a favorable safety and tolerability profile. Satellos plans to enroll up to 20 participants in the U.S. and up to 10 participants in Australia for a total of up to 30 participants and intends to provide an update on the TRAILHEAD study in the fourth quarter of 2026. Second quarter 2026 financial results Cash Position: Satellos had cash, cash equivalents and short-term investments of $61.8 million as of June 30, 2026, compared with $27.7 million on December 31, 2025. The increase primarily reflects proceeds from an equity offering completed in February 2026, partially offset by cash used to fund ongoing operations. R&D Expenses: Research & Development expenses increased to $9.6 million for the quarter ended June 30, 2026, compared to $4.4 million for the quarter ended June 30, 2025, primarily due to increased costs associated with the TRAILHEAD and BASECAMP studies as well as chemistry and manufacturing control costs related to drug production to support the ongoing clinical trials. G&A Expenses: General and Administrative expenses increased to $2.5 million for the quarter ended June 30, 2026, as compared to $1.9 million for the quarter ended June 30, 2025, primarily due to increased headcount, professional fees associated with public company reporting obligations and costs associated with the Nasdaq listing. Net Loss: For the quarter ended June 30, 2026, the company reported a net loss of $11.7 million ($0.56 loss per share), compared to a net loss of $5.6 million ($0.39 loss per share) for the quarter ended June 30, 2025. Satellos' financial statements for the quarter ended June 30, 2026, and the related management's discussion and analysis (MD&A) are available on the Company website (satellos.com), EDGAR (sec.gov), and SEDAR+ (sedarplus.ca). ABOUT SAT-3247SAT-3247 is a proprietary, oral, small molecule drug candidate being developed by Satellos as a novel approach to regenerating skeletal muscle lost in Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases or injury conditions. SAT-3247 targets AAK1, a key protein identified by Satellos as capable of helping restore the body’s natural muscle repair and regeneration biology, a fundamental process that is disrupted in DMD and other degenerative conditions. By inhibiting AAK1, SAT-3247 treatment aims to re-establish a biochemical signal needed to support muscle regeneration. Satellos is advancing SAT-3247 as a potential treatment for DMD that is independent of dystrophin and applicable regardless of exon mutation status as either a stand-alone or adjunctive therapy, with ongoing Phase 2 clinical studies including BASECAMP, a global, randomized, placebo-controlled study in pediatric participants, and TRAILHEAD, an open-label study in adult participants. 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, an orally administered small molecule AAK1 inhibitor designed to address deficits in muscle repair and regeneration. SAT-3247 is being evaluated as a potential disease-modifying treatment, initially for Duchenne muscular dystrophy (DMD), in two Phase 2 clinical trials: BASECAMP in pediatric participants with DMD and TRAILHEAD in adults living with DMD. Satellos plans to submit an Investigational New Drug application and begin clinical research to investigate the use of SAT-3247 in individuals living with facioscapulohumeral muscular dystrophy (FSHD) in the second half of 2026 and has identified additional muscle diseases and injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and plans to pursue these opportunities in future clinical development. For more information, visit www.satellos.com and connect with Satellos on X, LinkedIn, Facebook and Instagram. NOTICE ON FORWARD-LOOKING STATEMENTSThis 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 DMD; anticipated benefits to patients from a small molecule treatment for DMD; the enrollment in, advancement and timing of results of SAT-3247 through clinical trials, including the BASECAMP and TRAILHEAD clinical trials; the pharmacodynamic properties and mechanism-of-action of SAT-3247; the potential of our approach in other degenerative muscle diseases and Satellos’ plans to pursue additional muscle diseases and injury conditions in future clinical development; SAT-3247's prospective impact on DMD patients, patients with other degenerative muscle disease or muscle injury or trauma, and on muscle regeneration generally, including whether results observed in the TRAILHEAD study will continue to mature or will translate to the pediatric population studied in BASECAMP; the anticipated timing for an Investigational New Drug submission to the U.S. Food and Drug Administration for SAT-3247 for evaluation in facioscapulohumeral muscular dystrophy and the anticipated timing for the launch of a related Phase 2 clinical trial; Satellos' technologies and drug development plans; and the company’s expectations regarding the sufficiency of its cash, cash equivalents and short-term investments to fund operations, including its expectation that its current cash resources will provide a runway through 2027. 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. These statements are based on assumptions and subject to risks and uncertainties. In making forward looking statements, the Company has relied on various assumptions, including but not limited to: its ability to obtain future funding on favorable terms, if at all; obtaining positive results in its clinical trials, its ability to obtain necessary regulatory approvals; its ability to arrange for the manufacturing of its product candidates and technologies; and general business, market and economic conditions. 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), 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 and uncertainties described in more detail in the “Risk Factors” section of Satellos' Annual Information Form dated March 27, 2026, and amended and restated short form base shelf prospectus dated August 11, 2026 (each of which is located on Satellos' SEDAR+ profile) and incorporated by reference in Satellos’ Form F-10 filed with the Securities and Exchange Commission on August 11, 2026, and in Satellos' public filings on EDGAR (sec.gov) and SEDAR+ (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. CONTACTSInvestors: Caitlin Lowie, Vice President, Investor Relations & Communications, [email protected] Media: Emily Williams, Senior Director, Communications, [email protected]
Investor releaseQuarter not tagged2026-08-13Satellos Bioscience: Q2 Earnings Snapshot
Associated Press
Satellos Bioscience: Q2 Earnings Snapshot
TORONTO (AP) — TORONTO (AP) — Satellos Bioscience Inc. (MSLE) on Thursday reported a loss of $11.7 million in its second quarter. On a per-share basis, the Toronto-based company said it had a loss of 56 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MSLE at https://www.zacks.com/ap/MSLE
Investor releaseQuarter not tagged2026-06-17Satellos Bioscience Announces Results of Annual Meeting of Shareholders
GlobeNewswire
Satellos Bioscience Announces Results of Annual Meeting of Shareholders
TORONTO, June 17, 2026 (GLOBE NEWSWIRE) -- Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL) (“Satellos” or the “Company”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, announced today the results of its Annual Meeting of Shareholders held June 17, 2026 (the “Meeting”). Satellos is pleased to announce that all the nominees listed in the management information circular dated May 14, 2026 (the “Circular”) were elected as directors. Shareholders present at the Meeting or represented by proxy totaled 55.3% of the issued and outstanding common shares of the Company. The results of the vote are detailed below: Satellos shareholders also voted in favor of the re-appointment of PricewaterhouseCoopers LLP as auditors of the Company. Please refer to Circular available on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov) for more details on the matters covered at the Meeting. Final voting results on all matters voted on at the Meeting will also be filed on SEDAR+ and EDGAR. ABOUT SATELLOS BIOSCIENCE INC. Satellos is a clinical-stage drug development company advancing SAT-3247, a first-of-its-kind, orally administered small molecule therapy designed to reset the body’s natural muscle repair and regeneration process in degenerative muscle diseases. SAT-3247 is being evaluated as a potential disease-modifying treatment, initially for DMD, in two Phase II clinical trials: BASECAMP in pediatrics and TRAILHEAD in adults. SAT-3247 targets AAK1, a protein that is a key regulator of the body’s natural muscle repair and regeneration biology, which Satellos discovered is disrupted in DMD and other degenerative conditions. By inhibiting AAK1, SAT-3247 is designed to re-establish a critical biochemical signal needed to guide this process, in a dystrophin-independent manner. This mechanistic feature offers SAT-3247 the potential for broad applicability as either a stand-alone treatment to potentially enhance muscle and function, or as adjunctive therapy alongside other approaches. Satellos has identified additional degenerative muscle diseases where enhancing muscle repair and regeneration may have therapeutic benefit and plans to pursue these opportunities in future clinical development. For more information, visit www.satellos.com. NOTICE ON FORWARD-LOOKING STATEMENTS This press release includes forward-looking informat…Read full documentShow less
TORONTO, June 17, 2026 (GLOBE NEWSWIRE) -- Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL) (“Satellos” or the “Company”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, announced today the results of its Annual Meeting of Shareholders held June 17, 2026 (the “Meeting”). Satellos is pleased to announce that all the nominees listed in the management information circular dated May 14, 2026 (the “Circular”) were elected as directors. Shareholders present at the Meeting or represented by proxy totaled 55.3% of the issued and outstanding common shares of the Company. The results of the vote are detailed below: Satellos shareholders also voted in favor of the re-appointment of PricewaterhouseCoopers LLP as auditors of the Company. Please refer to Circular available on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov) for more details on the matters covered at the Meeting. Final voting results on all matters voted on at the Meeting will also be filed on SEDAR+ and EDGAR. ABOUT SATELLOS BIOSCIENCE INC. Satellos is a clinical-stage drug development company advancing SAT-3247, a first-of-its-kind, orally administered small molecule therapy designed to reset the body’s natural muscle repair and regeneration process in degenerative muscle diseases. SAT-3247 is being evaluated as a potential disease-modifying treatment, initially for DMD, in two Phase II clinical trials: BASECAMP in pediatrics and TRAILHEAD in adults. SAT-3247 targets AAK1, a protein that is a key regulator of the body’s natural muscle repair and regeneration biology, which Satellos discovered is disrupted in DMD and other degenerative conditions. By inhibiting AAK1, SAT-3247 is designed to re-establish a critical biochemical signal needed to guide this process, in a dystrophin-independent manner. This mechanistic feature offers SAT-3247 the potential for broad applicability as either a stand-alone treatment to potentially enhance muscle and function, or as adjunctive therapy alongside other approaches. Satellos has identified additional degenerative muscle diseases where enhancing muscle repair and regeneration may have therapeutic benefit and plans to pursue these opportunities in future clinical development. 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 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 potential of our approach in other degenerative muscle diseases and our plans to pursue those opportunities. 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. These statements 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), 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 and uncertainties described in more detail in the “Risk Factors” section of Satellos’ Annual Information Form dated March 27, 2026 (which is located on Satellos’ profile at www.sedarplus.ca) and in Satellos’ public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). 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 CONTACTS Investors: Dan Ferry, LifeSci Advisors, [email protected]: Emily Williams, Senior Director of Communications, [email protected]
Investor releaseQuarter not tagged2026-05-15Satellos Reports First Quarter 2026 Financial Results and Highlights Company Progress
GlobeNewswire
Satellos Reports First Quarter 2026 Financial Results and Highlights Company Progress
Eleven clinical trial sites in BASECAMP currently active; remaining planned sites to be activated throughout Q2 2026 BASECAMP remains on track to complete enrollment in Q3 2026 The Company has initiated the TRAILHEAD study in the U.S. in adults aged 16-25 years. Current cash available of $69.9M (Cdn $97.5M) provides runway through 2027 TORONTO, May 15, 2026 (GLOBE NEWSWIRE) -- Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL) (“Satellos” or the “Company”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced financial results and corporate highlights for the first quarter ended March 31, 2026. “The first quarter of 2026 was a productive time for Satellos. We raised $57M, providing runway to meet all planned milestones through the end of 2027, uplisted to Nasdaq, and advanced the Phase 2 TRAILHEAD and BASECAMP studies,” said Frank Gleeson, MBA, Chief Executive Officer of Satellos. “We are excited by the progress we are making with BASECAMP enrollment and dosing across 11 active clinical sites to date. We expect the additional sites intended to complete BASECAMP to be activated in Q2. We remain on track to complete BASECAMP enrollment in Q3 2026, supported by the active and planned sites currently having identified more than 100% of potential participants for screening and potential enrollment in the coming months.” SAT-3247 CLINICAL PROGRESS SAT-3247 is an orally administered small-molecule therapy designed to enhance muscle regeneration by addressing deficits in muscle stem cell polarity in Duchenne and potentially other muscle diseases. BASECAMP (CL-201): Phase 2 Pediatric Study The BASECAMP study is evaluating SAT-3247 in 51 ambulatory boys with DMD aged 7, 8 or 9 years. Primary endpoints include safety, tolerability and dynamometry. Secondary endpoints will assess SAT-3247’s impact on muscle quality, function and regeneration. The BASECAMP trial is actively enrolling at 11 clinical centers. The Company anticipates activating additional clinical sites throughout Q2 2026. TRAILHEAD (LT-001): Phase 2 Adult Study TRAILHEAD is a 12-month, open-label Phase 2 study evaluating long-term safety, efficacy and sustained functional benefit of SAT-3247 in adults with DMD. After submitting TRAILHEAD to the FDA in early Q2 2026 and following the statutory review period, Satellos began to engag…Read full documentShow less
Eleven clinical trial sites in BASECAMP currently active; remaining planned sites to be activated throughout Q2 2026 BASECAMP remains on track to complete enrollment in Q3 2026 The Company has initiated the TRAILHEAD study in the U.S. in adults aged 16-25 years. Current cash available of $69.9M (Cdn $97.5M) provides runway through 2027 TORONTO, May 15, 2026 (GLOBE NEWSWIRE) -- Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL) (“Satellos” or the “Company”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced financial results and corporate highlights for the first quarter ended March 31, 2026. “The first quarter of 2026 was a productive time for Satellos. We raised $57M, providing runway to meet all planned milestones through the end of 2027, uplisted to Nasdaq, and advanced the Phase 2 TRAILHEAD and BASECAMP studies,” said Frank Gleeson, MBA, Chief Executive Officer of Satellos. “We are excited by the progress we are making with BASECAMP enrollment and dosing across 11 active clinical sites to date. We expect the additional sites intended to complete BASECAMP to be activated in Q2. We remain on track to complete BASECAMP enrollment in Q3 2026, supported by the active and planned sites currently having identified more than 100% of potential participants for screening and potential enrollment in the coming months.” SAT-3247 CLINICAL PROGRESS SAT-3247 is an orally administered small-molecule therapy designed to enhance muscle regeneration by addressing deficits in muscle stem cell polarity in Duchenne and potentially other muscle diseases. BASECAMP (CL-201): Phase 2 Pediatric Study The BASECAMP study is evaluating SAT-3247 in 51 ambulatory boys with DMD aged 7, 8 or 9 years. Primary endpoints include safety, tolerability and dynamometry. Secondary endpoints will assess SAT-3247’s impact on muscle quality, function and regeneration. The BASECAMP trial is actively enrolling at 11 clinical centers. The Company anticipates activating additional clinical sites throughout Q2 2026. TRAILHEAD (LT-001): Phase 2 Adult Study TRAILHEAD is a 12-month, open-label Phase 2 study evaluating long-term safety, efficacy and sustained functional benefit of SAT-3247 in adults with DMD. After submitting TRAILHEAD to the FDA in early Q2 2026 and following the statutory review period, Satellos began to engage with its planned clinical sites in the U.S. to identify participants with DMD aged 16 to 25 years. Four participants from the Company’s Phase 1b study (CL-101) enrolled in TRAILHEAD and restarted on SAT-3247 at various times in Q4 2025; they are expected to complete six months on drug at various times during Q2 2026 Satellos plans to enroll up to 30 individuals living with DMD aged ≥16 to 25 years in the U.S. and Australia The Company intends to provide updates from the TRAILHEAD study throughout 2026 FINANCIAL RESULTS Satellos had cash and cash equivalents and short-term investments of $69.9 million as of March 31, 2026, compared with $27.7 million on Dec. 31, 2025. The increase primarily reflects proceeds from an equity offering completed in February 2026, partially offset by cash used to fund ongoing operations. For the quarter ended March 31, 2026, Satellos reported a net loss of $9.8 million ($0.53 loss per share), compared to a net loss of $6.1 million ($0.44 loss per share) for the quarter ended March 31, 2025. The increase in net loss was primarily a result of increased Research and Development (“R&D”) expenses related to clinical activities associated with SAT-3247. General and Administrative (“G&A”) expenses also increased as compared to the prior period due to additional personnel and professional fees to support advancing operations and the Nasdaq listing. R&D expenses increased to $7.3 million for the quarter ended March 31, 2026, compared to $4.5 million for the quarter ended March 31, 2025. The increase in R&D expenses was primarily the result of costs associated with the TRAILHEAD and BASECAMP studies. G&A expenses increased to $2.7 million for the quarter ended March 31, 2026, as compared to $1.9 million for the quarter ended March 31, 2025. The increase in G&A expenses was primarily the result of increased headcount, professional fees associated with public company reporting obligations, and costs associated with the Nasdaq listing. Satellos’ financial statements for the quarter ended March. 31, 2026, and the related management’s discussion and analysis (MD&A) will be available on the Company website and SEDAR+ at www.sedarplus.ca. ABOUT SAT-3247 SAT-3247 is a proprietary, oral, small molecule drug candidate being developed by Satellos as a novel approach to regenerating skeletal muscle lost in Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD that is independent of dystrophin and applicable regardless of exon mutation status, with ongoing Phase 2 clinical studies, including TRAILHEAD, an open-label study in adult participants, and BASECAMP, a global, randomized, placebo-controlled study in pediatric participants. 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 therapy designed to address deficits in muscle repair and regeneration. SAT-3247 is being evaluated as a potential disease-modifying treatment, initially for DMD, in two Phase II clinical trials: BASECAMP in pediatrics and TRAILHEAD in adults. SAT-3247 targets AAK1, a key protein that Satellos has identified as capable of helping restore the body’s natural muscle repair and regeneration biology, a fundamental stem cell driven process that is disrupted in DMD and other degenerative conditions. By inhibiting AAK-1, SAT-3247 treatment aims to re-establish a biochemical signal needed to support muscle regeneration in a dystrophin-independent manner — with potential broad applicability as either a stand-alone or adjunctive therapy. Satellos has identified additional muscle diseases and injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and plans to pursue these opportunities in future clinical development. 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 expected runway; 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, including the BASECAMP clinical trial and the expected timing of enrollment and top-line data; the activation of additional clinical sites; expected participants in the TRAILHEAD study; the pharmacodynamic properties and mechanism-of-action of SAT-3247; the potential of our approach in other degenerative muscle diseases and our plans to pursue those opportunities; SAT-3247’s 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. These statements 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), 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 and uncertainties described in more detail in the “Risk Factors” section of Satellos’ Annual Information Form dated March 26, 2025 (which is located on Satellos’ profile at www.sedarplus.ca) and in Satellos’ public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). 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 CONTACTS Investors: Dan Ferry, LifeSci Advisors, [email protected] Media: Emily Williams, Senior Director of Communications, [email protected]
Investor releaseQuarter not tagged2026-05-15Satellos Bioscience: Q1 Earnings Snapshot
Associated Press
Satellos Bioscience: Q1 Earnings Snapshot
TORONTO (AP) — TORONTO (AP) — Satellos Bioscience Inc. (MSLE) on Friday reported a loss of $9.8 million in its first quarter. The Toronto-based company said it had a loss of 53 cents per share. The results fell short of Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 51 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MSLE at https://www.zacks.com/ap/MSLE
Investor releaseQuarter not tagged2026-03-27Satellos Bioscience: Q4 Earnings Snapshot
Associated Press Finance
Satellos Bioscience: Q4 Earnings Snapshot
TORONTO (AP) — TORONTO (AP) — Satellos Bioscience Inc. (MSLE) on Friday reported a loss of $7.3 million in its fourth quarter. On a per-share basis, the Toronto-based company said it had a loss of 47 cents. For the year, the company reported a loss of $24.9 million, or $1.70 per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MSLE at https://www.zacks.com/ap/MSLE
Investor releaseQuarter not tagged2026-03-27Satellos Reports 2025 Financial Results and Highlights Recent Company Progress
GlobeNewswire
Satellos Reports 2025 Financial Results and Highlights Recent Company Progress
Completed a US$57.2 million equity financing; commenced trading on the Nasdaq Global Market under the ticker “MSLE” on Feb. 6, 2026 Secured global regulatory clearances and initiated BASECAMP, a placebo-controlled Phase 2 clinical trial of SAT-3247 in boys aged 7 to less than 10 years living with Duchenne muscular dystrophy (“Duchenne” or “DMD”) Presented initial functional outcomes from 56 days of treatment in TRAILHEAD (follow-on trial to CL-101) at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, demonstrating that grip strength improvements observed in CL-101 were maintained or improved in TRAILHEAD over an aggregate period of 9 to 13 months Reported proteomic data from CL-101 (28-day Phase 1b trial in adults with DMD) at MDA, showing reductions in established biomarkers of muscle degeneration following SAT-3247 treatment Presented validation of a Regenerative Index (“RI”) biomarker at MDA, supporting its use to quantify muscle regeneration following SAT-3247 treatment and inform clinical interpretation; also presented new preclinical efficacy data in facioscapulohumeral muscular dystrophy (FSHD) Cash runway expected to extend through 2027 TORONTO, March 27, 2026 (GLOBE NEWSWIRE) -- Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL) (“ Satellos ” or the “ Company ”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced financial results and corporate highlights for the full year ended Dec. 31, 2025. “2025 was a defining year for Satellos, and we are excited by the progress we have made across our clinical programs, including the initiation of two Phase 2 trials in Duchenne: BASECAMP, a placebo-controlled pediatric study, and TRAILHEAD, an open-label adult study,” said Satellos CEO Frank Gleeson. “Continued data from TRAILHEAD, where we observed greater improvements in participants with higher baseline muscle mass, has increased our confidence as we advance BASECAMP. We look forward to meaningful clinical progress and updates in 2026 supporting the potential of SAT-3247 as a disease-modifying therapy.” SAT-3247 CLINICAL PROGRESS SAT-3247 is an oral, small-molecule tablet designed to restore muscle regeneration by addressing deficits in muscle stem cell polarity in Duchenne and potentially other muscle diseases. BASECAMP (CL-201): Phase 2 Pediatric S…Read full documentShow less
Completed a US$57.2 million equity financing; commenced trading on the Nasdaq Global Market under the ticker “MSLE” on Feb. 6, 2026 Secured global regulatory clearances and initiated BASECAMP, a placebo-controlled Phase 2 clinical trial of SAT-3247 in boys aged 7 to less than 10 years living with Duchenne muscular dystrophy (“Duchenne” or “DMD”) Presented initial functional outcomes from 56 days of treatment in TRAILHEAD (follow-on trial to CL-101) at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, demonstrating that grip strength improvements observed in CL-101 were maintained or improved in TRAILHEAD over an aggregate period of 9 to 13 months Reported proteomic data from CL-101 (28-day Phase 1b trial in adults with DMD) at MDA, showing reductions in established biomarkers of muscle degeneration following SAT-3247 treatment Presented validation of a Regenerative Index (“RI”) biomarker at MDA, supporting its use to quantify muscle regeneration following SAT-3247 treatment and inform clinical interpretation; also presented new preclinical efficacy data in facioscapulohumeral muscular dystrophy (FSHD) Cash runway expected to extend through 2027 TORONTO, March 27, 2026 (GLOBE NEWSWIRE) -- Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL) (“ Satellos ” or the “ Company ”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced financial results and corporate highlights for the full year ended Dec. 31, 2025. “2025 was a defining year for Satellos, and we are excited by the progress we have made across our clinical programs, including the initiation of two Phase 2 trials in Duchenne: BASECAMP, a placebo-controlled pediatric study, and TRAILHEAD, an open-label adult study,” said Satellos CEO Frank Gleeson. “Continued data from TRAILHEAD, where we observed greater improvements in participants with higher baseline muscle mass, has increased our confidence as we advance BASECAMP. We look forward to meaningful clinical progress and updates in 2026 supporting the potential of SAT-3247 as a disease-modifying therapy.” SAT-3247 CLINICAL PROGRESS SAT-3247 is an oral, small-molecule tablet designed to restore muscle regeneration by addressing deficits in muscle stem cell polarity in Duchenne and potentially other muscle diseases. BASECAMP (CL-201): Phase 2 Pediatric Study BASECAMP is a global, randomized, placebo-controlled Phase 2 clinical trial in DMD evaluating safety, biomarkers and treatment effect of SAT-3247 over three months in 51 ambulatory children aged 7 to under 10 years. Of note: First participant dosed Feb. 12, 2026, following regulatory clearance from the U.S. FDA and global regulators Enrollment anticipated to complete in the third quarter of 2026 with top-line data expected in the fourth quarter of 2026 At MDA, Satellos presented validation of a novel Regenerative Index (RI) methodology derived from established biomarkers of muscle regeneration supporting its potential as a biomarker for evaluating regenerative capacity and treatment effect on muscle; the RI, is included as an exploratory endpoint in the BASECAMP trial TRAILHEAD (LT-001): Phase 2 Adult Study TRAILHEAD is a 12-month, open-label Phase 2 study evaluating long-term safety, efficacy and sustained functional benefit of SAT-3247 in adults with DMD. Four patients who originally participated in CL-101 (the Company’s 28-day Phase 1b study) re-enrolled in TRAILHEAD for up to an additional 11 months of SAT-3247 treatment (up to 12 months total) The returning adult participants were re-dosed in Q4 2025, following gaps in dosing between 205 and 328 days since completion of CL-101 Safety and functional assessments were performed on all four returning patients following a further 56 days on drug in TRAILHEAD (84 days or approximately three months of combined treatment across CL-101 and TRAILHEAD). At MDA, interim observations included: Stabilization or continued increases in handgrip strength observed in CL-101 relative to baseline were maintained or improved in TRAILHEAD, representing an aggregate time interval of approximately 9 to 13 months across the four participants Additional functional assessments were added in the TRAILHEAD protocol to explore potential effects on larger muscle groups; overall stability with preliminary indications of improvement in elbow and shoulder strength were observed Across the multiple functional measurements assessed, greater improvements in strength were observed in participants with higher muscle mass at baseline as measured by creatinine levels FVC measurements were stable to greater for 3 of 4 returning patients from CL-101 through Day 56 in TRAILHEAD, with one of the four patients showing a meaningful, unexplained decline that did not correlate with results from other functional measures tested for the patient Satellos plans to enroll additional participants in Australia and to open TRAILHEAD in the U.S. with the aim of enrolling up to 30 individuals living with DMD aged ≥16 years, pending regulatory and site approvals Preclinical Research in FSHD At MDA, Satellos presented new preclinical data evaluating SAT-3247 in the FLEX DUX4 model of FSHD. Key findings included a significant enhancement of muscle strength across a 12-week dosing period. These data support the potential expansion of SAT-3247 beyond DMD into FSHD. CORPORATE ACHIEVEMENTS Feb. 9, 2026: Closed an equity offering of common shares and pre-funded warrants for gross proceeds of US$57.2 million, strengthening the Company’s balance sheet and supporting execution of its clinical development strategy. The Company’s common shares began trading on the Nasdaq Global Market under the ticker “MSLE” on Feb. 6, 2026. Jan. 29, 2026: Appointed Antoinette Paone, M.S., MBA, as Chief Development Officer and Head of Regulatory Affairs to lead global clinical development and regulatory strategy. Nov. 14, 2025: Appointed Mark Nawacki, MBA, CPA, to the Company’s Board of Directors, adding experience in corporate development, strategic transactions and the pharmaceutical industry. FINANCIAL RESULTS (in US$) Satellos had cash and cash equivalents and short-term investments of $27.7 million as of Dec. 31, 2025, compared with $48.5 million on Dec. 31, 2024. The decrease primarily reflects cash used to fund ongoing operations, particularly clinical trial costs and supporting operating activities. Subsequent to the year end, Satellos completed a public offering of common shares and pre-funded warrants providing $57.2 million in gross proceeds. For the year ended Dec. 31, 2025, Satellos reported a net loss of $24.9 million ($1.70 loss per basic and diluted common share), compared to a net loss of $20.6 million ($2.16 loss per basic and diluted common share) for the year ended Dec. 31, 2024. The increase in net loss for the year ended Dec. 31, 2025, compared with the year ended Dec. 31, 2024, was primarily a result of increased Research and Development (“R&D”) expenses related to clinical activities associated with SAT-3247. General and Administrative (“G&A”) expenses also increased as compared to the prior period due to additional personnel fees and professional fees to support advancing operations. R&D expenses increased to $18.4 million for the year ended Dec. 31, 2025, compared to $14.4 million for the year ended Dec. 31, 2024. The increase in R&D expenses was primarily the result of costs associated with the initiation of a Phase 2 clinical trial. G&A expenses increased to $8.0 million for the year ended Dec. 31, 2025, as compared to $6.0 million for the year ended Dec. 31, 2024. The increase in G&A expenses was primarily the result of salary and management fees related to increased headcount, and professional fees associated with public company reporting obligations. Satellos’ audited financial statements for the year ended Dec. 31, 2025 and 2024, and the related management’s discussion and analysis (MD&A) will be available on the Company website and SEDAR+ at www.sedarplus.ca. ABOUT SAT-3247 SAT-3247 is a proprietary, oral, small molecule drug candidate being developed by Satellos as a novel approach to regenerating skeletal muscle lost in Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD that is independent of dystrophin and applicable regardless of exon mutation status, with ongoing Phase 2 clinical studies, including TRAILHEAD, an open-label study in adult participants, and BASECAMP, a global, randomized, placebo-controlled study in pediatric participants. 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, a process 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 of SAT-3247 through clinical trials, including the BASECAMP clinical trial; the pharmacodynamic properties and mechanism-of-action of SAT-3247; the potential of our approach in other degenerative muscle diseases; SAT-3247’s prospective impact on Duchenne patients, patients with other degenerative muscle disease or muscle injury or trauma, and on muscle regeneration generally; Satellos’ technologies and drug development plans; and Satellos’ expected cash runway. 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. These statements 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), 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 and uncertainties described in more detail in the “Risk Factors” section of Satellos’ Annual Information Form and Form 40-F dated March 27, 2026 which is located in Satellos’ public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). 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. CONTACTS Investors: Liz Williams, CFO, [email protected] Media: Emily Williams, Senior Director of Communications, [email protected]
Investor releaseQuarter not tagged2026-03-27Satellos Bioscience Fiscal 2025 Net Loss Widens
MT Newswires
Satellos Bioscience Fiscal 2025 Net Loss Widens
Satellos Bioscience (MSCL.TO) said Friday that fiscal 2025 net loss widened on higher research expen

