FORWARD-LOOKING STATEMENTS
Certain statements and information in this MD&A contain “forward-looking information” and “forward-looking statements”, within the meaning of applicable Canadian securities laws and Section 27A of the US Securities Act of 1933, as amended, and Section 21E of the US Securities Exchange Act of 1934, as amended, pursuant to the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, as amended (collectively herein referred to as “forward-looking statements”). These statements relate to future events or future performance and reflect the Company’s expectations and assumptions regarding the growth, results of operations, performance and business prospects and opportunities of the Company. These forward-looking statements are made as of the date of this MD&A or, in the case of documents incorporated by reference herein, as of the date of such documents. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “expectation”, “anticipates”, “believes”, “intends”, “intention”, “estimates”, “predicts”, “continues”, “potential”, “targeted”, “plans”, “possible”, “goal”, “seek”, “project”, “future”, “likely” and similar expressions, or statements that events, conditions or results “will”, “may”, “could”, “would” or “should” occur or be achieved. Any forward-looking statements or statements of “belief”, including the statements made under “Risks and Uncertainties”, represent the Company’s estimates only as of the date of this MD&A and the documents incorporated by reference herein, respectively, and should not be relied upon as representing the Company’s estimates as of any subsequent date. Forward-looking statements are necessarily based on estimates and assumptions made by Satellos in light of its experience and perception of historical trends, current conditions and expected future developments, as well as factors that Satellos believes are appropriate. Forward-looking statements in this MD&A include, but are not limited to, statements relating to:
| · | our belief that the Company will be successful in raising additional capital; |
| · | the expected research and development timelines, therapeutic benefits, effectiveness and safety of our product candidates; |
| · | our belief that the Company's products and research and development efforts are targeting diseases and conditions with significant unmet medical treatment needs; |
| · | our belief that the Company has made, and will continue to make, progress towards the achievement of certain milestones or objectives; |
| · | our expectation with respect to meeting milestones and the minimum amount of funds the Company expects to need to raise in order to achieve such milestones and garner additional funding; |
| · | the initiation, timing, cost, progress, outcomes, resource needs and success of our research and development activities, plans and programs; |
| · | our expectations regarding our ability to design, test and patent novel drug products suitable for advancement into clinical trials and the anticipated timelines surrounding such clinical trials; |
| · | our belief that we will not receive substantive comments on our Investigational New Drug (“IND”) or equivalent applications; |
| · | our expectations that the Notch pathway and AAK1 drug target (both as further described herein) represent drug development opportunities similar or superior to modulation of the EGFR (Epidermal Growth Factor Receptor) signaling pathway; |
| · | our intentions of developing inhibitors to AAK1 (as defined herein) (including but not limited to SAT-3247 and SAT-3153) and in showing that such potential inhibitors have desirable effects in relevant models of Duchenne muscular dystrophy ("Duchenne" or “DMD”) and in other indications, such as other degenerative muscle diseases, muscle injury or trauma, or muscle regeneration generally; |
| · | our expectations that we will identify predictive biomarkers which will translate into or be useful in conducting human clinical trials; |
| · | our belief that the results of the Company’s research and development activities, preclinical studies, safety studies or clinical trials have the potential to be commercially competitive with research and development activities, preclinical studies, safety studies or clinical trials conducted by other parties; |
| · | discoveries we have made in muscle stem cell regulation having the potential to represent insights into a potential root cause of degenerative muscle disorders which has previously not been recognized and which may be therapeutically relevant in the treatment of degenerative muscle disorders; |
| · | our belief that the Company’s technology can be commercialized, and that such commercialization could be done as effectively or more effectively than other technologies to treat degenerative muscle disorders and conditions or other medical disorders or conditions, or at all; |
| · | our ability to discover, optimize, select and advance into clinical development therapeutic drug development candidates in a timely, cost-efficient and effective manner, or at all; |
| · | our ability to translate our discoveries in muscle stem cell regulation into safe and therapeutically effective drug products and the broad applicability of such products; |
| · | our ability to enter into research and/or commercial development collaborations or partnerships to successfully and profitably advance our drug development candidates; |
| · | our ability and that of our partners (if any) to advance identified drug development candidates into, and successfully complete, clinical trials; |
| · | our intention to identify and nominate one or more back-up product candidates and the potential benefits of having such back-ups; |
| · | our plans to utilize and deploy MyoReGenXTM in our programs and our continued relationship with OHRI (as defined herein); |
| · | the ability of our products to effectively and safely treat Duchenne and other degenerative muscle disorders and conditions or other medical disorders or conditions and the applicability of our products to other disorders and conditions; |
| · | our expectations regarding future enrolment into clinical trials and the timing of future enrolment into clinical trials for our product candidates; |
| · | our belief that our approach may reduce the risk, time and cost of developing therapeutics by avoiding some of the uncertainty associated with certain research and preclinical stages of drug development; |
| · | our ability to establish and maintain relationships with collaborators with acceptable preclinical and/or clinical research and development capability, and regulatory and commercialization expertise to enable the development and future commercialization of our technology or products, and the benefits to be derived from such collaborative efforts; |
| · | our ability to enter into agreements or partnerships with pharmaceutical or biotechnology companies that have research and clinical development and/or sales and marketing capabilities and the expected benefits that could be derived therefrom; |
| · | our ability to generate and protect our intellectual property; |
| · | our ability to operate our business without infringing upon the intellectual property rights of others; |
| · | our ability to engage third party services with specialized domain expertise for the drafting and submitting of regulatory applications to conduct clinical trials in humans; |
| · | our ability to establish suitable Chemistry, Manufacturing and Controls and Good Manufacturing practices protocols; |
| · | the manufacturing capacity of third-party manufacturers for our product candidates; |
| · | our expectations regarding federal, provincial and foreign regulatory requirements; |
| · | the timing of, and the costs of obtaining and maintaining, regulatory approvals in the United States, Australia, Europe, Serbia and other jurisdictions; |
| · | the rate and degree of market acceptance and clinical utility of our future products, if any; |
| · | existing and future corporate alliances and licensing transactions with third parties, and the receipt and timing of any payments to be made by us or to us pursuant to such arrangements; |
| · | the implementation and execution of our commercial and operational strategy; |
| · | our ability to engage and retain the consultants or employees required to grow our business; |
| · | the potential revenue that may be generated from our products, pricing and reimbursement of the patient cost of our drug products by insurers or national health systems, as the case may be, in those jurisdictions where the Company intends to sell its drug products and our ability to achieve profitability; |
| · | developments relating to our competitors and our industry, including the success of competing therapies that are or become available; |
| · | the potential growth of the market and demand for our products as well as the estimated pricing and subsequent revenue generation of any potential therapeutics we discover; |
| · | our belief that any discoveries by the Rudnicki Lab (as defined below) have the potential to have a positive impact on Satellos and our work; |
| · | our future financial performance, including projected expenditures, future revenue, capital requirements and our needs for additional financing; |
| · | our belief that our existing cash and cash equivalents and short-term investments will be sufficient to finance our operations through 2027; |
| · | our anticipated filing of regulatory documents to initiate a Phase 2 clinical trial in FSHD (as defined |
herein) in the United States and Canada in the second half of 2026;
| · | our ability to maintain our listings on the Toronto Stock Exchange (the “TSX”) and the Nasdaq Global Market (“Nasdaq”) and the continued liquidity and trading market for our Common Shares; |
| · | the potential impact of tariffs, trade policy changes, and geopolitical conditions on our operations and ability to conduct business; and |
| · | general business and economic conditions and the evolving regulatory landscape. |
Such forward-looking statements reflect our current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Satellos as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance, achievements, prospects or opportunities to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. In making the forward-looking statements included in this MD&A, the Company has made various material assumptions, including, but not limited to:
| · | obtaining positive results from our research and development activities, including clinical trials; |
| · | our ability to obtain regulatory approvals; |
| · | assumptions regarding general business, market, economic and regulatory conditions; |
| · | assumptions regarding the cost and timing of each study; |
| · | the Company’s ability to successfully advance its preclinical and clinical development programs and execute its plans substantially as currently envisioned; |
| · | the Company’s ability to identify and advance suitable product candidates; |
| · | assumptions related to the pricing and reimbursement of its drug products in jurisdictions in which the Company intends to sell its drug products; |
| · | the Company’s current positive relationships with third parties will be maintained and the potential to develop new partnerships; |
| · | the Company’s ability to continue to use existing licenses for the development of our product(s); |
| · | the availability (and sources) of financing on reasonable terms; |
| · | future expenditures to be incurred by the Company, including research and development and operating costs; |
| · | the Company’s ability to attract and retain skilled consultants and employees; |
| · | assumptions regarding market competition, market capture and pricing; |
| · | the products and technology offered by the Company’s competitors; and |
| · | the Company’s ability to protect patents and proprietary rights. |
In evaluating forward-looking statements, current and prospective shareholders should specifically consider various factors, including the risks outlined under the headings “Market Risk – Currency Risk”, “Liquidity Risk”, “Credit Risk” and “Risks and Uncertainties” in this MD&A and the risks outlined in the Company’s annual information form for the year ended December 31, 2025 dated March 27, 2026 (the “AIF”) and the Company’s amended and restated short form base shelf prospectus dated August 11, 2026 (the “Base Shelf Prospectus”) and incorporated by reference in our Form F-10 filed with the Securities and Exchange Commission, and declared effective on August 11, 2026 (the “Registration Statement”). Certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to:
| · | risks related to the early stage of our products; |
| · | uncertainties related to preclinical product development activities and clinical trial outcomes; |
| · | uncertainties related to current economic conditions; |
| · | risks related to rapid technological change; |
| · | uncertainties related to forecasts and timing of clinical trials and regulatory approval; |
| · | competition in the market for therapeutic products, including those to treat Duchenne and related diseases; |
| · | risks related to potential product liability claims; |
| · | availability of financing and access to capital and the risks associated with the Company’s ability to continue as a going concern; |
| · | market acceptance and commercialization of products; |
| · | the availability, costs and supply of materials; |
| · | risks related to the effective management of our growth; |
| · | risks related to the reliance on partnerships and licensing agreements; |
| · | risks related to our reliance on key personnel; |
| · | risks related to the regulatory approval process for the manufacture and sale of therapeutic products; |
| · | risks related to the reimbursement process in various jurisdictions where the Company plans to sell its drug products; and |
| · | our ability to secure and protect our intellectual property. |
The Company cautions that the foregoing list of important factors and assumptions is not exhaustive. Although the Company has attempted to identify on a reasonable basis important factors and assumptions related to forward-looking statements, there can be no assurance that forward-looking statements will prove to be accurate, as events or circumstances or other factors could cause actual results to differ materially from those estimated or projected and expressed in, or implied by, these forward-looking statements. Other than as specifically required by law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made, or to reflect the occurrence of unanticipated events, whether as a result of new information, future events or results or otherwise. Accordingly, readers should not place undue reliance on forward-looking statements.
