As a smaller reporting company, we are not required to provide disclosure pursuant to this item.
−Removed: However, in addition to other information set forth in this Quarterly Report, including the important information in the section entitled “Private Securities Litigation Reform Act,” you should carefully consider the “Risk Factors” discussed in our Annual Report on Form 10-K for the year ended December 31, 2019 for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report.
+Added: However, in addition to other information set forth in this Quarterly Report, including the important information in the section entitled “Private Securities Litigation Reform Act,” you should carefully consider the “Risk Factors” discussed in our Annual Report on Form 10-K for the year ended December 31, 2020 and in Exhibit 99.4 to our Current Report on Form 8-K, filed with the SEC on April 8, 2021 for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report.
Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition and/or operating results.
You should also consider the following risk factor:
−Removed: The COVID-19 pandemic may materially and adversely impact our business, including ongoing clinical trials.
−Removed: The outbreak of COVID-19 and government measures taken in response have had a significant impact on the global economy, with healthcare systems particularly affected.
−Removed: In response to the COVID-19 outbreak, public health measures have been implemented across much of the United States, Europe and Asia, including in the locations of our offices, clinical trial sites, and partners.
−Removed: Due to these public health measures, we are allowing employees who do not need to be physically present in the lab to perform their work at home.
−Removed: Our increased reliance on employees working from home may negatively impact productivity, or disrupt, delay or otherwise adversely impact our business.
−Removed: As a result of the COVID-19 outbreak and related public health measures, we have and may in the future experience disruptions that could materially and adversely impact our clinical trials, business, financial condition and results of operations.
−Removed: Potential disruptions include but are not limited to:
−Removed: delays or difficulties in enrolling patients in clinical trials and obtaining the results of completed clinical trials;
−Removed: increased rates of patients withdrawing from clinical trials following enrollment as a result of quarantine or concerns about COVID-19;
−Removed: diversion of healthcare resources away from the conduct of clinical trials;
−Removed: delays in prospective clinical trial collaborations with pharmaceutical companies and sponsors.
−Removed: interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;
−Removed: limitations on our ability to recruit and hire key personnel due to our inability to meet with candidates because of travel restrictions and
−Removed: limitations on employee resources that would otherwise be focused on the conduct of clinical trials and research as a result of focus addressing COVID-19 mitigation and loss of productivity from remote work.
−Removed: The COVID-19 pandemic continues to rapidly evolve.
−Removed: The extent to which the outbreak impacts our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the magnitude of the pandemic, the duration of social distancing in the United States and other countries, business closures or business disruptions, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.
−Removed: Beyond the direct effect of the pandemic, mitigation efforts have had broad economic effects.
−Removed: The extent of the scope and duration of these economic effects cannot currently be predicted, although they are likely to be significant for the near future.
−Removed: The economic impact of COVID-19 will affect us in a variety of ways, including without limitation making our stock price more volatile, making it more difficult to raise additional capital through offerings of equity or debt securities, and reducing the availability of bank loans.
−Removed: As a result, we may face difficulties raising capital and capital raising efforts may be on terms than are less favorable than would have been previously available.
−Removed: All of the effects of COVID-19 described herein are expected to apply to any future recurrences of COVID-19 and any other pandemics that may occur in the future.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.