Item 1A. Risk Factors
ITEM 1A.
RISK FACTORS
Our
business, financial condition or results of operations could be materially adversely affected by the risks set forth in Part I, “Item
1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 22, 2022 and
our Quarterly Report on Form 10-Q for the period ended March 31, 2022 filed with the SEC on May 12, 2022. There have been no material
changes from those risk factors, except for the additional risk factors set forth below. This Quarterly Report on Form 10-Q also contains
forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in
these forward-looking statements as a result of certain factors, including these risks. Additional risks not currently known or currently
material to us may also harm our business.
Unstable market and
economic conditions, including elevated and sustained inflation, may have serious adverse consequences on our business, financial condition
and stock price.
As has been widely reported,
we are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by
domestic and global monetary and fiscal policy, geopolitical instability, an ongoing military conflict between Russia and Ukraine, and
historically high domestic and global inflation. In particular, the conflict in Ukraine has exacerbated market disruptions, including
significant volatility in commodity prices, as well as supply chain interruptions, and has contributed to record inflation globally. The
U.S. Federal Reserve and other central banks may be unable to contain inflation through more restrictive monetary policy and inflation
may increase or continue for a prolonged period of time. Inflationary factors, such as increases in the cost of clinical supplies, interest
rates, overhead costs and transportation costs may adversely affect our operating results. We continue to monitor these events and the
potential impact on our business. Although we do not believe that inflation has had a material impact on our financial position or results
of operations to date, we may be adversely affected in the future due to domestic and global monetary and fiscal policy, supply chain
constraints, consequences associated with the coronavirus pandemic and the ongoing conflict
between Russia and Ukraine, and such factors may lead to increases in the cost of manufacturing our product candidates and delays in initiating
studies. In addition, global credit and financial markets have experienced extreme volatility and disruptions in the past several years
and the foregoing factors have led to and may continue to cause diminished liquidity and credit availability, declines in consumer confidence,
declines in economic growth, uncertainty about economic stability and increased inflation.
There can be no assurance
that further deterioration in credit and financial markets and confidence in economic conditions will not occur. Our general business
strategy may be adversely affected by any such economic downturn, volatile business environment or continued unpredictable and unstable
market conditions. If the current equity and credit markets deteriorate, or do not improve, it may make any necessary debt or equity financing
more difficult, more costly, and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could
have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay or abandon
clinical development plans. In addition, there is a risk that one or more of our current service providers, manufacturers and other partners
may not survive these difficult economic times, which could directly affect our ability to attain our operating goals.
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ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
No sales
or issuances of unregistered securities occurred that have not previously been disclosed in a Current Report on Form 8-K.
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4.
MINE SAFETY DISCLOSURES
Not applicable.
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