SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (Annual Report) contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “intends”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
• the ability of our preclinical studies and planned clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;
• our ability to utilize our proprietary drug discovery platform to develop a pipeline of product candidates to address muscle disorders;
• the timing, progress and results of preclinical studies and clinical trials for EDG-5506, product candidates in our EDG-5440 and EDG-002 programs, 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, and our research and development programs;
• the timing, scope and likelihood of regulatory filings and approvals, including timing of INDs and final FDA approval of EDG-5506, product candidates in our EDG-5440 and EDG-002 programs and any other future product candidates;
• the timing, scope or likelihood of foreign regulatory filings and approvals;
• our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies;
• our manufacturing, commercialization, and marketing capabilities and strategy;
• our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy;
• the need to hire additional personnel and our ability to attract and retain such personnel;
• 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;
• our expectations regarding the approval and use of our product candidates in combination with other drugs;
• our competitive position and the success of competing therapies that are or may become available;
• our estimates of the number of patients that we will enroll in our clinical trials;
• the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidates;
• 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;
• existing regulations and regulatory developments in the United States, Europe and other jurisdictions;
• our expectations regarding the impact of the COVID-19 pandemic on our business;
• our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering EDG-5506, product candidates in our EDG-5440 and EDG-002 programs, and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;
• our continued reliance on third parties to conduct additional preclinical studies and planned clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials;
• our relationships with patient advocacy groups, key opinion leaders, regulators, the research community and payors;
• our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;
• the pricing and reimbursement of EDG-5506, product candidates in our EDG-5440 and EDG-002 programs, and other product candidates we may develop, if approved;
• the rate and degree of market acceptance and clinical utility of EDG-5506, product candidates in our EDG-5440 and EDG-002 programs, and other product candidates we may develop;
• our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
• our financial performance;
• the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements;
• the impact of laws and regulations; and
• our expectations regarding the period during which we will qualify as an emerging growth company under The Jumpstart Our Business Startups Act of 2012 and a smaller reporting company under the Securities Exchange Act of 1934, as amended.
We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Annual Report and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Annual Report. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.
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