Item 1A. Risk Factors
Item 1A Risk Factors.
There have been no material changes from the risk factors previously disclosed in the Company’s most recent Quarterly Report on Form 10-Q as filed with the SEC on August 12, 2021.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This quarterly report contains express or implied forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements and opinions contained in this quarterly report are based upon information available to our management as of the date of this quarterly report and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements contained in this quarterly report include, but are not limited to, statements about:
● the success, cost and timing of our product development activities and clinical trials;
● the timing, scope or likelihood of regulatory filings and approvals, including timing of Investigational New Drug Application and Biological License Application filings for our current and future product candidates, and final U.S. Food and Drug Administration, European Medicines Agency, United Kingdom Medicines and Healthcare products Regulatory Agency or other foreign regulatory authority approval of our current and future product candidates;
● our ability to develop and advance our current and future product candidates and programs into, and successfully complete, clinical trials;
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● our ability to establish future or maintain current collaborations or strategic relationships or obtain additional funding;
● the rate and degree of market acceptance and clinical utility of our current and future product candidates;
● the ability and willingness of our third-party collaborators to continue research and development activities relating to our product candidates;
● our and our collaborators’ ability to obtain, maintain, defend and enforce our intellectual property protection for our product candidates, and the scope of such protection;
● our manufacturing, commercialization and marketing capabilities and strategy;
● future agreements with third parties in connection with the commercialization of our product candidates and any other approved products;
● regulatory developments in the United States and foreign countries;
● competitive companies, technologies and our industry and the success of competing therapies that are or may become available;
● our ability to attract and retain key scientific or management personnel;
● our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;
● the accuracy of our estimates of our annual total addressable markets, future revenue, expenses, capital requirements and needs for additional financing;
● our expectations about market trends;
● our ability to overcome the challenges posed by the COVID-19 pandemic to the conduct of our business; and
● our expectations regarding the period during which we qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, as amended.
If our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should read this quarterly report and the documents that we reference in this quarterly report with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements in this quarterly report by these cautionary statements.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.