CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement and the accompanying prospectus may contain, the documents incorporated by reference herein may contain and management may make certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, may be forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expects,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes.
Forward-looking statements include, but are not limited to, statements about:
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our anticipated 2024 key milestones;
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our preliminary, unaudited estimates of cash, cash equivalents and marketable securities as of December 31, 2023;
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the safety and efficacy of, and the ability of our preclinical studies and clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;
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our ability to utilize our proprietary drug discovery platform to develop a pipeline of product candidates to address muscle disorders;
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the timing, progress and results of preclinical studies and clinical trials for EDG-5506, EDG-7500, product candidates from our EDG-003 cardiometabolic discovery program and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become available, potential registrational studies or cohorts and our research and development programs;
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the timing, scope and likelihood of domestic and foreign regulatory filings and approvals, including timing of U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) applications of EDG-5506, EDG-7500, product candidates from our EDG-003 cardiometabolic discovery program and any other future product candidates;
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our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies;
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our manufacturing, commercialization, operations and marketing capabilities, relationships with other businesses and other business strategies, systems and relationships;
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our business strategy and plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy;
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the need to hire additional personnel and our ability to attract and retain such personnel;
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the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting and our expectations regarding the implementation of newborn screening for muscular dystrophy;
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our expectations regarding the approval and use of our product candidates in combination with other drugs
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our competitive position and the success of competing product candidates and therapies that are or may become available;
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our estimates of the number of patients that we will enroll in our clinical trials;
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the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidates;
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our ability to obtain and maintain regulatory approval of our product candidates;
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our plans relating to the further development of our product candidates, including additional indications we may pursue;