Item 1A. Risk Factors
ITEM 1A. RISK FACTORS
Unstable market and economic conditions
and potential disruptions in the credit markets may adversely affect our business, including the availability and cost of short-term funds
for liquidity requirements and our ability to meet long-term commitments, which could adversely affect our results of operations, cash
flows and financial condition.
If internally generated funds
are not available from operations, we may be required to rely on the banking and credit markets to meet our financial commitments and
short-term liquidity needs. Our access to funds under our revolving credit facility or pursuant to arrangements with other financial institutions
is dependent on the financial institution’s ability to meet funding commitments. Financial institutions may not be able to meet
their funding commitments if they experience shortages of capital and liquidity or if they experience high volumes of borrowing requests
from other borrowers within a short period of time.
In addition, the global credit
and financial markets have recently experienced extreme volatility and disruptions, including severely diminished liquidity and credit
availability, declines in consumer confidence, declines in economic growth, inflationary pressure and interest rate changes and uncertainty
about economic stability. More recently, the closures of Silicon Valley Bank, Signature Bank and First Republic Bank and
their placement into receivership with the Federal Deposit Insurance Corporation (FDIC) created bank-specific and broader financial institution
liquidity risk and concerns. Although the Department of the Treasury, the Federal Reserve and the FDIC jointly released a statement that
depositors at Silicon Valley Bank and Signature Bank would have access to their funds, even those in excess of the
standard FDIC insurance limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions
or the broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term
working capital needs, and create additional market and economic uncertainty. There can be no assurance that future credit and financial
market instability and a deterioration in confidence in economic conditions will not occur. Our general business strategy may be adversely
affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market
conditions. If the equity and credit markets deteriorate, or if adverse developments are experienced by financial institutions, it may
cause short-term liquidity risk and also 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, financial institutions, manufacturers and other partners may be adversely affected
by the foregoing risks, which could directly affect our ability to attain our operating goals on schedule and on budget.
Our failure to meet the continued listing requirements of Nasdaq
Stock Market (“Nasdaq”) could result in a de-listing of our common stock.
If
we fail to maintain the continued listing requirements of Nasdaq, including maintaining the minimum closing bid price requirement of $1.00
per share, Nasdaq will take steps to de-list our common stock. As a result of several factors, including but not limited to recent market
sentiment concerning our industry, the ongoing COVID-19 epidemic and its effects on the global marketplace, recent volatility in the financial
markets generally due to the expectation of a tightening in monetary policy by the U.S. Federal Reserve and other geopolitical events,
the per share price of our common stock has declined below the minimum bid price threshold required for continued listing. Were we to
be delisted from Nasdaq, such a de-listing would likely have a negative effect on the price of our common stock and would impair your
ability to sell or purchase our common stock when you wish to do so, as well as adversely affect our ability to issue additional securities
and obtain additional financing in the future.
48
On
November 9, 2022, we received a deficiency notice from Nasdaq (the “Deficiency Notice”) informing us that our common
stock had failed to comply with the $1.00 minimum bid price required for continued listing under Nasdaq Listing Rule 5550(a)(1)
(“Rule 5550(a)(1)”) based upon the closing bid price of our common stock for the 30 consecutive business days prior to
the date of the Deficiency Notice. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been given 180 calendar days
from September 9, 2022, or until May 8, 2023, to regain compliance with Rule 5550(a)(1). Thus, if at any time before May 8, 2023 the
bid price of our common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, Nasdaq will provide
us with written confirmation that we have regained compliance.
As of May 8, 2023, as we had
not yet regained compliance with Rule 5550(a)(1). As a result, prior to May 8, 2023, we had submitted to Nasdaq our plan to regain compliance,
including our method for rectifying our present deficiency regarding the minimum bid price requirement. To qualify, we are required to
meet the continued listing requirement for market value of publicly held shares and all other Nasdaq initial listing standards, except
for the minimum bid price requirement. On May 9, 2023, Nasdaq granted the Company’s request for an Additional Grace Period, or through
November 6, 2023, to regain compliance.
Nonetheless,
following the additional 180-day extension period, in the event of a de-listing or threatened de-listing, we would take actions to restore
our compliance with Nasdaq Rules, but we can provide no assurances that the listing of our common stock would be restored, that our common
stock will remain above the Nasdaq minimum bid price requirement or that we otherwise will remain in compliance with the Nasdaq Rules.
ITEM 2. RECENT SALES OF UNREGISTERED EQUITY SECURITIES
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not Applicable.
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