What changed in this filing

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Item 1A. Risk Factors

2025-05-15 compared with 2024-11-14 · 58 added, 17 removed, 23 unchanged (77% of the section changed)

Other than set forth below,

there have been no material changes in our risk factors set forth in Part I, “Item 1A.

Risk Factors” in our 2023 Form 10-K.

The risk factor set forth below and risk factors disclosed in Part I, “Item 1A.

Risk Factors” in our 2023 Form 10-K could

materially adversely affect our business, financial condition, or results of operations.

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.

there have been no material changes in our risk factors set forth in “ Risk Factors in Part I , “ Item 1A ”.

in our 2024 Form 10-K.

The risk factor described therein and set forth below could materially adversely affect our business, financial

condition, or results of operations.

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 maintain compliance

with the continued listing requirements of The Nasdaq Capital Market.

Nasdaq Listing Rule 5550(b)(1)

requires companies listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $2.5 million for continued listing.

As of September 30, 2024, our stockholders’ equity was $4.9 million and there can be no assurance that we will be able to maintain

or increase our stockholders’ equity in the future.

To maintain continued listing

on The Nasdaq Capital Market, we must satisfy minimum financial and other requirements.

For example, Nasdaq Listing Rule 5550(b)(1) requires

companies listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $2.5 million for continued listing.

of March 31, 2025, our stockholders’ equity was $12.2 million and there can be no assurance that we will be able to maintain or

increase our stockholders’ equity in the future.

If our stockholders’ equity falls below $2.5 million, as a result of operating

8 unchanged sentences

allotted timeframe, Nasdaq may take steps to delist our Common Stock.

In addition, Nasdaq Listing

Rule 5550(a)(2) requires a minimum bid price of at least $1.00 per share, and Nasdaq 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 days.

Company is currently in compliance with this requirement, there can be no assurance that we will be able to maintain compliance.

in the past effected reverse stock splits of our Common Stock in order to regain or maintain compliance with this requirement (most recently

on July 5, 2024).

Nasdaq Listing Rule 5810(c)(3)(A)(iv) states that any listed company that fails to meet this requirement and has effected

a reverse stock split over the prior one-year period, or has effected one or more reverse stock splits over the prior two-year period

with a cumulative ratio of 250 shares or more to one, may not be eligible for an automatic 180-day grace compliance period and the Nasdaq

Listing Qualifications Department is obligated to immediately issue a delisting determination.

Therefore, if we were to fall out of compliance

with the minimum bid price requirement prior to July 5, 2025, we would not be able to effect a reverse stock split and would immediately

be issued a delisting determination.

Such a delisting would have

2 unchanged sentences

ability to obtain financing for the continuation of our operations.

We are actively monitoring our stockholders’ equity and will

consider any and all options available to us to maintain compliance with Nasdaq Listing Rule 5550(b)(1).

We actively monitor our stockholders’ equity and minimum

bid price and will consider any and all options available to us to maintain compliance with Nasdaq Listing Rules 5550(b)(1) and (a)(2).

Changes in U.S.

and international trade

policies may adversely impact our business and operating results.

From time to time, proposals

are made to significantly change existing trade agreements and relationships between the U.S.

and other countries.

In recent years, the

government has implemented substantial changes to U.S.

trade policies, including import restrictions, increased import tariffs and

changes in U.S.

participation in multilateral trade agreements.

Because some of our vendors, manufactures and suppliers are located in

other foreign countries, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in

the policies, laws, rules and regulations of the United States or foreign governments, as well as political unrest or unstable economic

conditions in foreign countries.

government has indicated its intent to adopt a new approach to trade policy and in some cases

to renegotiate, or potentially terminate, certain existing bilateral or multi-lateral trade agreements.

For example, in February 2025,

President Donald Trump signed executive orders imposing a 25% tariff on certain imports from Mexico and Canada, and in April 2025, up

to 145% tariffs on certain imports from China.

In April 2025, President Donald Trump also announced a plan for reciprocal tariffs and

there have been statements from the current administration regarding additional tariffs on certain industries, including the pharmaceutical

Our supply may in the future be subject to these tariffs, which could increase our manufacturing costs and could make our products,

if successfully developed and approved, less competitive than those of our competitors whose inputs are not subject to these tariffs.

We may otherwise experience supply disruptions or delays, and our suppliers may not continue to provide us with clinical supply in our

required quantities, to our required specifications and quality levels or at attractive prices.

Such disruption could have adverse effects

on the development of our product candidates and our business operations.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

5 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