Item 1A. Risk Factors
Item 1A. Risk Factors.
Our Annual Report on Form 10-K for
the fiscal year ended December 31, 2019, filed with the SEC on February 14, 2020 (the “Annual Report”), includes
a detailed discussion of our risk factors under the heading “PART I, Item 1A – Risk Factors.” You should
carefully consider the risk factors discussed in our Annual Report, as well as other information in this quarterly report. Any
of these risks could cause our business, financial condition, results of operations and future growth prospects to suffer. We are
not aware of any material changes from the risk factors previously disclosed.
Our business and operations may be materially
and adversely affected by the recent coronavirus outbreak.
In December 2019, a novel strain of
coronavirus was reported to have surfaced in Wuhan, China and has since spread to other parts of the world, including the United
States and Europe. In March 2020, the World Health Organization declared the outbreak a pandemic. The coronavirus pandemic
is affecting the United States and global economies. If the outbreak continues to spread, it may affect our operations and those
of third parties on which we rely in a number of ways, including causing disruptions in the supply of our product candidate, the
pending regulatory approval process and the conduct of current and planned preclinical and clinical studies. We may need to limit
operations or implement limitations and may experience limitations in employee resources. There are risks that the coronavirus
may be more difficult to contain if the outbreak reaches a larger population or broader geography, in which case the risks described
herein could be elevated significantly. The extent to which the coronavirus impacts our results will depend on future developments,
including, without limitation, new information that may emerge concerning the severity of the coronavirus and the actions to contain
the coronavirus or treat its impact, all of which are highly uncertain and cannot be predicted.
Additionally, while the duration of and
the potential economic impact caused by the coronavirus pandemic are difficult to assess or predict, the impact of the coronavirus
on the global financial markets may reduce our ability to access capital, which could negatively impact our short-term and long-term
liquidity and our ability to complete our regulatory submissions and clinical studies on a timely basis, or at all. For instance,
our regulatory submissions may be temporarily delayed or paused, and the operations of our contracted third parties may be significantly
delayed as well. The ultimate impact of the coronavirus pandemic is highly uncertain and subject to change. We do not yet know
the full extent of potential delays or impacts on our business, financing or preclinical and clinical trial activities or the global
economy as a whole. However, these effects could have a material impact on our liquidity, capital resources, operations and business
and those of the third parties on which we rely.
Natural disasters, epidemic or pandemic
disease outbreaks, trade wars, political unrest or other events could disrupt our business or operations or those of our development
partners, manufacturers, regulators or other third parties with whom we conduct business now or in the future.
A wide variety of events beyond our control,
including natural disasters, epidemic or pandemic disease outbreaks (such as the recent novel coronavirus outbreak), trade wars,
political unrest or other events, could disrupt our business or operations or those of our manufacturers, regulatory authorities,
or other third parties with whom we conduct business. These events may cause businesses and government agencies to be shut down,
supply chains to be interrupted, slowed, or rendered inoperable, and individuals to become ill, quarantined, or otherwise unable
to work and/or travel due to health reasons or governmental restrictions. For example, many states recently ordered most businesses
closed, mandating work-from-home arrangements where feasible, in response to the coronavirus pandemic. These limitations could
negatively affect our business operations and continuity, and could negatively impact our development timelines and ability to
timely perform basic business functions, including, without limitation, making SEC filings and preparing financial reports. If
our operations or those of third parties with whom we conduct business are impaired or curtailed as a result of these events, the
development and commercialization of our products and product candidate could be impaired or halted, which could have a material
adverse impact on our business.
Item 2. Recent Sales of Unregistered
Securities.
None
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Item 3. Default Upon Senior Securities.
None.
Item 4. Mine Safety Disclosure.
Not applicable.
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.