FORWARD-LOOKING STATEMENTS
This prospectus and the information incorporated by reference in this prospectus contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. All statements, other than statements of historical fact, contained in this prospectus or incorporated by reference herein, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these words or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
The forward-looking statements in this prospectus and incorporated by reference herein include, among other things, statements about:
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the initiation, timing, progress, and results of our current and future nonclinical studies and clinical trials and our research and development programs, including our timing of when we will submit an investigational new drug application for our product candidates AK-OTOF, for otoferlin gene (OTOF)-mediated hearing loss, and AK-antiVEGF, for vestibular schwannoma, to the U.S. Food and Drug Administration;
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our estimates regarding expenses, future revenue, capital requirements, need for additional financing, and the period over which we believe that our existing cash, cash equivalents and investments will be sufficient to fund our operating expenses and capital expenditure requirements;
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our plans to develop and, if approved, subsequently commercialize our product candidates;
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the timing of and our ability to submit applications for, and obtain and maintain regulatory approvals for, our product candidates;
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our expectations regarding our regulatory strategy;
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our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents and marketable securities;
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the potential advantages of our product candidates;
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the rate and degree of market acceptance and clinical utility of our product candidates;
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our estimates regarding the potential addressable patient population for our product candidates;
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our commercialization, marketing and manufacturing capabilities and strategy;
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our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates;
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our intellectual property position;
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our ability to identify additional products, product candidates, or technologies with significant commercial potential that are consistent with our commercial objectives;
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the impact of government laws and regulations;
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our competitive position and expectations regarding developments and projections relating to our competitors and any competing therapies that are or become available;
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developments and expectations regarding developments and projections relating to our competitors and our industry;
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the impact of the COVID-19 pandemic on our business, results of operations, and financial condition;
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our ability to maintain and establish collaborations or obtain additional funding; and
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our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012.