What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2023-05-15 compared with 2023-02-14 · 58 added, 21 removed, 14 unchanged (85% of the section changed)

Our failure to meet

the continued listing requirements of Nasdaq Stock Market (“Nasdaq”) could result in a de-listing of our common stock.

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

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.

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.

we fail to maintain the continued listing requirements of Nasdaq, including maintaining the minimum closing bid price requirement of $1.00

8 unchanged sentences

and obtain additional financing in the future.

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.

If we do not regain compliance

with Rule 5550(a)(1) by May 8, 2023, we may be afforded a second 180 calendar day period to regain compliance.

To qualify, we would be

required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for

the Nasdaq, except for the minimum bid price requirement.

In addition, we would be required to notify Nasdaq of our intent and plan to

cure the deficiency during the second compliance period.

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.

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.

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.

RECENT SALES OF UNREGISTERED EQUITY SECURITIES

3 unchanged sentences

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.

What changed 10-Q

Item 1A. Risk Factors