What changed in this filing

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Item 1A. Risk Factors

2025-11-13 compared with 2025-08-14 · 21 added, 58 removed, 10 unchanged (89% of the section changed)

Other than set forth below,

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

Other than set forth below, 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.

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.

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 June 30, 2025, our stockholders’ equity was $10.1 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 losses

or for other reasons, or if we are unable to demonstrate to Nasdaq’s satisfaction that we subsequently regained compliance with

this requirement, Nasdaq will notify us of such non-compliance.

If we receive such notice from Nasdaq, in accordance with the Nasdaq Listing

Rules, we will have 45 calendar days from the date of the notification to submit a plan to regain compliance with Nasdaq Listing Rule

If our compliance plan is accepted, we may be granted up to 180 calendar days from the date of the initial notification to

evidence compliance.

If our compliance plan is not accepted or we are otherwise unable to evidence compliance within Nasdaq’s 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).

Such a delisting would have

an adverse effect on the market liquidity of our securities, decrease the market price of our securities, result in the potential loss

of confidence by investors, suppliers, customers and employees and fewer business development opportunities, and adversely affect our

ability to obtain financing for the continuation of our operations.

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).

We may not be able to maintain compliance with the continued listing requirements of The Nasdaq Capital Market.

To maintain continued listing on The Nasdaq Capital Market, we must satisfy minimum financial and other requirements.

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.

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

We have 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).

Such a delisting would have an adverse effect on the market liquidity of our securities, decrease the market price of our securities, result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities, and adversely affect our ability to obtain financing for the continuation of our operations.

We actively monitor our minimum bid price and will consider any and all options available to us to maintain compliance with Nasdaq Listing Rule 5550(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 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

In recent years, the U.S.

government has implemented substantial changes to U.S.

trade policies, including import restrictions, increased import tariffs and

changes in 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 adopted a new approach to trade policy and, in some cases, entered into new trade

Our supply may in the future be subject to increased import 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 such 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.

Because some of our vendors, manufactures and suppliers are located in 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 adopted a new approach to trade policy and, in some cases, entered into new trade agreements.

Our supply may in the future be subject to increased import 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 such 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

No sales or issuances of unregistered

securities occurred that have not previously been disclosed in a Current Report on Form 8-K.

No sales or issuances of unregistered securities occurred that have not previously been disclosed in a Current Report on Form 8-K.

DEFAULTS UPON SENIOR SECURITIES

2 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