SEC Filings

10-K
AVEXIS, INC. filed this Form 10-K on 02/28/2018
Entire Document
 

SPECIAL NOTE REGARDING FORWARD‑LOOKING STATEMENTS

This Annual Report on Form 10‑K (this “Annual Report”) contains forward‑looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. The forward‑looking statements are contained principally in Part I, Item 1: “Business,” Part I, Item 1A: “Risk Factors,” and Part 2, Item 7: “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but are also contained elsewhere in this Annual Report. In some cases, you can identify forward‑looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future. These statements speak only as of the date of this Annual Report and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward‑looking statements. We have based these forward‑looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward‑looking statements include, without limitation, statements about the following:

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the timing, progress and results of preclinical studies and clinical trials for AVXS‑101 and any other product candidates, 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 trials will become available and our research and development programs;

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the timing of and our ability to obtain and maintain regulatory approval of AVXS‑101;

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the proposed clinical development pathway for AVXS‑101, including the expected trial design for our current and proposed pivotal clinical trials, and the acceptability of the results of such trials for regulatory approval of AVXS‑101 by the FDA or comparable foreign regulatory authorities;

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the proposed timing of filing investigational new drug applications with the FDA in connection with gene therapies we are developing for Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 gene;

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our expectations regarding timing for meetings with regulatory agencies;

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our expectations regarding the size of the patient populations for our product candidates, if approved for commercial use;

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our manufacturing capabilities and strategy, including the scalability and commercial viability of our manufacturing methods and processes;

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our ability to successfully commercialize AVXS‑101;

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our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing;

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our ability to identify, license and develop new product candidates;

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our ability to identify, recruit and retain key personnel;

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our and our licensors’ ability to protect and enforce our intellectual property protection for AVXS‑101, and the scope of such protection;

·

our financial performance;

·

the development of and projections relating to our competitors or our industry;

 


 


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