What changed in this filing

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Item 1A. Risk Factors

2025-03-28 compared with 2024-02-20 · 70 added, 59 removed, 388 unchanged (25% of the section changed)

5 unchanged sentences

We cannot assure you that any of the events discussed below will not occur.

These events could have a material and

adverse impact on our business, financial condition, results of operations and prospects.

If that were to happen, the trading price of

our common stock could decline, and you could lose all or part of your investment.

These events could have a material

and adverse impact on our business, financial condition, results of operations and prospects.

If that were to happen, the trading price

of our common stock could decline, and you could lose all or part of your investment.

Related to Liquidity, the Company’s Business and Industry

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may not have adequate funds to implement our business plan .

we have received capital from our parent company to meet our working capital and financing needs in the past, additional financing

may be required in order to meet our current and projected cash requirements for operations.

We cannot be assured that we will

secure all or any of the funding we anticipate.

If our entire original capital is fully expended and additional costs cannot be funded

from borrowings or capital from other sources, then our financial condition, results of operations and business performance would be

materially adversely affected.

We cannot assure you that we will have adequate capital or financing to conduct our business or

we have received capital from our parent company to meet our working capital and financing needs in the past, and have successfully

completed our IPO, additional financing may be required in order to meet our current and projected cash requirements for operations.

We cannot be assured that we will secure all or any of the funding we anticipate.

If our entire original capital is fully expended

and additional costs cannot be funded from borrowings or capital from other sources, then our financial condition, results of

operations and business performance would be materially adversely affected.

We cannot assure you that we will have adequate capital

or financing to conduct our business or to grow.

ability to resell and/or license our products will depend upon successful clinical trials.

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Even if later stage clinical trials are successful, regulatory authorities may disagree with our

view of the data or require additional studies and may fail to approve or delay approval of our product candidates or may grant

marketing approval that is more restricted than anticipated, including indications for a narrower patient population than expected and

the imposition of safety monitoring or educational requirements or risk evaluation and mitigation strategies.

In addition, if another

company is the first to file for marketing approval of a competing drug candidate, that company may ultimately receive marketing exclusivity

for its drug candidate, thereby reducing the value of our product.

view of the data or require additional studies and may fail to approve or delay approval of our product candidates or may grant marketing

approval that is more restricted than anticipated, including indications for a narrower patient population than expected and the imposition

of safety monitoring or educational requirements or risk evaluation and mitigation strategies.

In addition, if another company is the

first to file for marketing approval of a competing drug candidate, that company may ultimately receive marketing exclusivity for its

drug candidate, thereby reducing the value of our product.

face significant competition from other biopharmaceutical and consumer product companies.

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vendors may or could have access to our confidential information, making such systems vulnerable.

Data breaches of our information

technology systems, or those of our third party vendors, may pose a risk that sensitive data may be exposed to unauthorized persons or

to the public.

For example, the loss of clinical trial data from completed or ongoing clinical trials or preclinical studies could result

in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

While we believe

that we have taken appropriate security measures to protect our data and information technology systems and have been informed

by our third party vendors that they have as well, there can be no assurance that our efforts will prevent breakdowns or breaches in

our systems, or those of our third party vendors, that could materially adversely affect our business and financial condition.

Data breaches of our information technology

systems, or those of our third party vendors, may pose a risk that sensitive data may be exposed to unauthorized persons or to the public.

For example, the loss of clinical trial data from completed or ongoing clinical trials or preclinical studies could result in delays

in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

While we believe that we have

taken appropriate security measures to protect our data and information technology systems and have been informed by our third party

vendors that they have as well, there can be no assurance that our efforts will prevent breakdowns or breaches in our systems, or those

of our third party vendors, that could materially adversely affect our business and financial condition.

we are unable to obtain U.S.

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intellectual property rights may not be sufficiently broad or otherwise may not provide us a significant competitive advantage.

In addition, the steps that we have taken to maintain and protect our intellectual property may not prevent it from being challenged,

invalidated, circumvented or designed-around, particularly in countries where intellectual property rights are not highly developed or

In some circumstances, enforcement may not be available to us because an infringer has a dominant intellectual property position

or for other business reasons, or countries may require compulsory licensing of our intellectual property.

the steps that we have taken to maintain and protect our intellectual property may not prevent it from being challenged, invalidated,

circumvented or designed-around, particularly in countries where intellectual property rights are not highly developed or protected.

In some circumstances, enforcement may not be available to us because an infringer has a dominant intellectual property position or for

other business reasons, or countries may require compulsory licensing of our intellectual property.

Our failure to obtain or maintain

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secrets and proprietary information, and in such case, we could not assert any trade secret rights against such party.

a claim that a party illegally obtained and is using our trade secrets is difficult, expensive and time-consuming, and the outcome is

unpredictable.

Enforcing a claim

that a party illegally obtained and is using our trade secrets is difficult, expensive and time-consuming, and the outcome is unpredictable.

In addition, courts outside the U.S.

may be less willing to protect trade secrets.

Costly and time-consuming litigation

could be necessary to seek to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret

protection could materially adversely affect our business and financial condition.

Costly and time-consuming litigation could be necessary

to seek to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could

materially adversely affect our business and financial condition.

Related to Ownership of Our Securities

1 unchanged sentence

trading price of our common stock is likely to be volatile.

Our stock has a relatively small public

float, and the concentrated ownership of our common stock among our executive officers

and directors, and greater than 5% stockholders.

As a result of our small public float, our common stock may be less liquid and have

greater stock price volatility than the common stock of companies with broader public ownership.

Our stock has a relatively small public float, and the concentrated ownership

of our common stock among our executive officers and directors, and greater than 5% stockholders.

As a result of our small public float,

our common stock may be less liquid and have greater stock price volatility than the common stock of companies with broader public ownership.

stock price could be subject to wide fluctuations in response to a variety of other factors, which include:

we achieve our anticipated corporate objectives;

in financial or operational estimates or projections;

of the lock-up agreement or other restrictions on the ability of our stockholders and other security holders to sell shares after

this offering;

economic or political conditions in the United States or elsewhere.

addition, the stock market in general has recently experienced extreme price and volume fluctuations that have often been unrelated or

disproportionate to the operating performance of these companies.

Such rapid and substantial price volatility, including any stock run-up,

may be unrelated to our actual or expected operating performance and financial condition or prospects, making it difficult for prospective

investors to assess the rapidly changing value of our stock.

This volatility may prevent you from being able to sell your securities

at or above the price you paid for your securities upon our initial public offering.

of our common stock by our stockholders, executives, and directors;

and limitations in trading volumes of our shares of common stock;

ability to obtain financing to conduct and complete research and development activities;

ability to attract new customers;

in the development status of the drugs we acquire;

to meet external expectations or management guidance;

in our capital structure or dividend policy or future issuances of securities;

cash position;

announcements

and events surrounding financing efforts, including debt and equity securities;

announcements

of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

in general economic, political and market conditions in or any of the regions in which we conduct our business;

in industry conditions or perceptions;

in valuations of similar companies or groups of companies;

research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

and additions of key personnel;

and litigations related to intellectual property rights, proprietary rights, and contractual obligations;

in applicable laws, rules, regulations, or accounting practices and other dynamics;

events or factors, many of which may be out of our control.

addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences

a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial condition

and results of operations.

If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that,

even if unsuccessful, could be costly to defend and a distraction to management.

do not anticipate paying any dividends in the foreseeable future.

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be designated into series pursuant to authority granted by our certificate of incorporation, and on approval from our Board.

The Board, without any action by our stockholders, may designate and issue shares in such classes or series as the Board deems appropriate and establish the rights, preferences and privileges of such shares, including dividends, liquidation

and voting rights.

The rights of holders of other classes or series of stock that may be issued could be superior to the rights of holders

of our common stock.

The designation and issuance of shares of capital stock having preferential rights could adversely affect other

rights appurtenant to shares of our common stock.

without any action by our stockholders, may designate and issue shares in such classes or series as the Board deems appropriate and establish

the rights, preferences and privileges of such shares, including dividends, liquidation and voting rights.

The rights of holders of other

classes or series of stock that may be issued could be superior to the rights of holders of our common stock.

The designation and issuance

of shares of capital stock having preferential rights could adversely affect other rights appurtenant to shares of our common stock.

are an “emerging growth company” under the federal securities laws and we cannot be certain if the reduced disclosure requirements

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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-K

Item 1A. Risk Factors