What changed in this filing

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Item 1A. Risk Factors

2022-11-10 compared with 2022-08-11 · 42 added, 44 removed, 6 unchanged (93% of the section changed)

business, financial condition or results of operations could be materially adversely affected by the risks set forth in Part I, “Item

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.

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

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.

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,

our Quarterly Report on Form 10-Q for the period ended March 31, 2022 filed with the SEC on May 12, 2022 and our Quarterly Report on

Form 10-Q for the period ended June 30, 2022 filed with the SEC on August 11, 2022.

There have been no material changes from those risk

factors, except for the additional risk factor 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.

We may not be able

to regain compliance with the continued listing requirements of The Nasdaq Capital Market.

February 25, 2022, we received written notice (the “ First Notification Letter ”) from the Listings Qualifications Department

of The Nasdaq Stock Market LLC (“ Nasdaq ”) notifying us that we were not in compliance with the minimum bid price requirements

set forth in Nasdaq Listing Rule 5550(a)(2) (the “ Minimum Bid Price Rule ”) for continued listing on The Nasdaq Capital

The Minimum Bid Price Rule requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A)

provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business

Based on the closing bid price of our common stock for the 30 consecutive business days prior to the date of the First Notification

Letter, we no longer met the minimum bid price requirement.

The First Notification Letter stated that the Company had 180 days, or until

August 24, 2022, to demonstrate its compliance with the Minimum Bid Price Rule.

August 25, 2022, we received a second written notice (the “ Second Notification Letter ” and, together with the First

Notification Letter, the “ Notification Letters ”) from Nasdaq advising that we had been granted an additional 180 calendar

days, or to February 20, 2023, to regain compliance with the Minimum Bid Price Rule, in accordance with Nasdaq Listing Rule 5810(c)(3)(A).

According to the Second Notification Letter, if at any time before that date 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 notify us that we have achieved compliance with the Minimum Bid Price

The Notification Letters

do not impact our listing on The Nasdaq Capital Market or trading of our common stock at this time.

In the event that we do not regain

compliance by February 20, 2022, Nasdaq will provide notice that our common stock will be subject to delisting.

We would then be entitled

to appeal that determination to a Nasdaq hearings panel.

There can be no assurance that we will be able to regain compliance with the

Minimum Bid Price Rule.

However, if we fail to regain compliance with the Minimum Bid Price Rule or fail to maintain compliance with

all other applicable continued listing requirements and Nasdaq determines to delist our common stock, the delisting could adversely impact

us by, among other things, reducing the liquidity and market price of our common stock;

reducing the number of investors willing to hold

or acquire our common stock;

limiting our ability to issue additional securities in the future;

and limiting our ability to fund our

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

4 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