What changed in this filing

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Item 1A. Risk Factors

2026-03-31 compared with 2025-04-15 · 224 added, 216 removed, 3578 unchanged (11% of the section changed)

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programs to identify new product candidates require substantial technical, financial and human resources.

If we are unable to

identify suitable additional candidates for preclinical and clinical development, our opportunities to successfully develop and

commercialize therapeutic products will be limited.

If we are unable to identify

suitable additional candidates for preclinical and clinical development, our opportunities to successfully develop and commercialize

therapeutic products will be limited.

regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive, and inherently unpredictable,

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Drugs designated as breakthrough therapies

by the FDA may also be eligible for fast-track designation (under a separate request), priority review, or accelerated approval,

if supported by clinical data at the time the NDA is submitted to the FDA.

FDA encourages a Breakthrough Therapy designation request

to be submitted, and received by FDA, no later than the end-of-phase-2 meetings.

Even if granted, accelerated approval status does

not guarantee an accelerated review or marketing approval by the FDA.

by the FDA may also be eligible for fast-track designation (under a separate request), priority review, or accelerated approval, if supported

by clinical data at the time the NDA is submitted to the FDA.

FDA encourages a Breakthrough Therapy designation request to be submitted,

and received by FDA, no later than the end-of-phase-2 meetings.

Even if granted, accelerated approval status does not guarantee an accelerated

review or marketing approval by the FDA.

as a Breakthrough Therapy is within the discretion of the FDA both at the time of the submission of such a request, and during FDA’s

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potential of our product candidates.

will strive, in conjunction with our wholly-owned subsidiary Enviro Therapeutics, to co-develop companion biomarkers with all drugs in

its portfolio and to evaluate whether a companion diagnostic test will be required for any of our product candidates.

will strive to develop companion biomarkers for all drugs in

our portfolio and to evaluate whether a companion diagnostic test will be required for any of our product candidates.

In general, the

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Also, to the extent other approved diagnostics are able to broaden their labeling claims

to include our approved drug products, if any, we may be forced to abandon any of our companion diagnostic development plans or

we may not be able to compete effectively upon approval, which could adversely impact our ability to generate revenue from the sale of

our to be approved products, if any, and our business operations.

to include our approved drug products, if any, we may be forced to abandon any of our companion diagnostic development plans or we may

not be able to compete effectively upon approval, which could adversely impact our ability to generate revenue from the sale of our to

be approved products, if any, and our business operations.

may rely on third parties for the design, development, and manufacture of companion diagnostic tests for our product candidates that

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delay or rejection could prevent us from commercializing our current in-development products or any future product candidates.

will rely on third-party contract manufacturing organizations, or CMOs, for the production of clinical supply of our drug therapy

candidates and intend to rely on CMOs for the production of commercial supply our drug therapies, if approved.

Our dependence on CMOs

may impair the development and commercialization of the drug, which would adversely impact our business and financial position.

will rely on third-party contract manufacturing organizations, or CMOs, for the production of clinical supply of our drug therapy candidates

and intend to rely on CMOs for the production of commercial supply our drug therapies, if approved.

Our dependence on CMOs may impair

the development and commercialization of the drug, which would adversely impact our business and financial position.

have limited personnel with experience in manufacturing, and we do not own facilities for manufacturing.

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intend to continue to rely on third parties to conduct, supervise and monitor our clinical trials.

If those third parties do

not successfully carry out their contractual duties, or if they perform in an unsatisfactory manner, it may harm our business.

If those third parties do not successfully

carry out their contractual duties, or if they perform in an unsatisfactory manner, it may harm our business.

rely, and will continue to rely, on CROs, CRO-contracted vendors and clinical trial sites to ensure the proper and timely conduct of

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our exclusive licensing rights may be terminated.

these third-party licensors also own equity with certain

anti-dilution and participation rights.

agreements with Cedars-Sinai Medical Center and Tracon Pharmaceuticals, Inc.

are contingent on our ability to make payments and meet

commercialization goals, which we may not be able to meet based on innumerable factors.

If we do not make such payments or meet such

milestones, our exclusive licensing rights to our intellectual property may be terminated.

Even if we meet certain milestones, we may

not be able to make the required payments, which may cause us to breach such agreements.

to the Enviro-Cedars license agreements, Enviro would also issue to Cedars shares of Enviro’s common stock equal to, in the aggregate

between the two Enviro-Cedars license agreements, 2.0% of Enviro’s outstanding equity on a fully diluted basis.

Cedars also has

certain anti-dilution protections, whereby Enviro shall issue to Cedars, without consideration, additional shares necessary to ensure

that Cedars maintains at least 2.0% of the equity issued and outstanding on a fully diluted basis until the earlier of (i) Enviro’s

initial public offering or (ii) Enviro having raised at least $20,000,000 in capital.

Cedars shall also have a right to participate in

any private offering of Enviro’s equity securities and purchase for cash that number of securities issued to maintain Cedars’

pro rata ownership in Enviro on a fully diluted basis.

a license and supply agreement between Enviro and Tracon Pharmaceuticals, Inc., Enviro issued Tracon equity ownership in Enviro equal

to a number of shares of restricted common stock of Enviro equal to 7% on a fully diluted and converted basis of all common and preferred

shares of Enviro.

Until such time as Tracon has received all of the Cash Consideration (as defined in the Enviro-Tracon license agreement),

Enviro or its successor in interest, shall issue to Tracon, without further consideration, any additional common stock of Enviro, or

such successor in interest, necessary so that Tracon maintains ownership of shares of Enviro, or such successor in interest, equal to

7% on a fully diluted and converted basis of all common and preferred shares of Enviro (or its successor).

Cash Consideration under the

Enviro-Tracon license agreement consists of an upfront fee of $100,000, an additional $500,000 upon it’s or its successor’s

completion of one or more financings through the sale of equity (or debt convertible to equity) in an amount of $10,000,000, and an additional

$500,000 within 10 days of it’s or its successor’s completion of one or more financings through the sale of equity (or debt

convertible to equity) in an amount of $22,000,000.

the Company is not able to raise funds sufficient to terminate these anti-dilution rights granted to Cedars and Tracon, then investors

in the Company’s securities could experience severe dilution in proportion to Cedars and Tracon.

The presence of these anti-dilution

rights granted to Cedars and Tracon may also discourage third-party investors from investing in the Company’s securities.

agreements with Cedars-Sinai Medical Center and Tracon Pharmaceuticals, Inc., which

were originally between each of Cedars-Sinai and Tracon and our subsidiary, Enviro Therapeutics, Inc., and which were assumed by the

Company effective April 17, 2025 pursuant to a novation agreement, are contingent on our ability to make payments and meet commercialization

goals, which we may not be able to meet based on innumerable factors.

If we do not make such payments or meet such milestones, our exclusive

licensing rights to our intellectual property may be terminated.

Even if we meet certain milestones, we may not be able to make the required

payments, which may cause us to breach such agreements.

we are unable to obtain and maintain patent and other intellectual property protection for our technology, or for any our current in-development

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Patent and Trademark Office, or USPTO, or

become involved in opposition, derivation, reexamination, inter partes review, or interference proceedings, in the United

States or elsewhere, challenging our patent rights or the patent rights of others.

become involved in opposition, derivation, reexamination, inter partes review, or interference proceedings, in the United States

or elsewhere, challenging our patent rights or the patent rights of others.

An adverse determination in any such submission, proceeding,

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For example, we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved

in derivation, revocation, reexamination, post-grant review, or PGR, inter partes review, or IPR, interference proceedings,

and equivalent proceedings in foreign jurisdictions, such as opposition proceedings challenging any patents that we may own or in-license.

in derivation, revocation, reexamination, post-grant review, or PGR, inter partes review, or IPR, interference proceedings, and

equivalent proceedings in foreign jurisdictions, such as opposition proceedings challenging any patents that we may own or in-license.

Such submissions may also be made prior to a patent’s issuance, precluding the granting of a patent based on one of our owned or

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civil and criminal false claims laws, including the federal False Claims Act, which impose criminal and civil penalties, including

through civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly

presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment

that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal

through civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting,

or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are

false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government;

federal civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined

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may not perform their obligations as expected;

collaborators may not pursue

development and commercialization of product candidates that achieve regulatory approval or may elect not to continue or renew development

or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding,

or external factors, such as an acquisition, that divert resources or create competing priorities;

collaborators

may not pursue development and commercialization of product candidates that achieve regulatory approval or may elect not to continue

or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic

focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

collaborators

may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product

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we may maintain about California residents.

The California Privacy Rights Act of 2020 (CPRA), effective

January 1, 2023, further expanded the CCPA in California by adding additional consumer rights and obligations for businesses.

the CPRA established the California Privacy Protection Agency, which is tasked with CRPA implementation and enforcement, among other responsibilities.

Other states have enacted data privacy laws.

For example, Virginia passed the Consumer Data Protection Act, and Colorado passed the Colorado

Privacy Act, both of which became effective in 2023.

In addition, data privacy and security laws have been proposed at the federal, state,

and local levels in recent years, which could further complicate compliance efforts.

The California Privacy Rights Act of 2020 (CPRA), effective January 1, 2023, further expanded

the CCPA in California by adding additional consumer rights and obligations for businesses.

In addition, the CPRA established the California

Privacy Protection Agency, which is tasked with CRPA implementation and enforcement, among other responsibilities.

Other states have

enacted data privacy laws.

For example, Virginia passed the Consumer Data Protection Act, and Colorado passed the Colorado Privacy Act,

both of which became effective in 2023.

In addition, data privacy and security laws have been proposed at the federal, state, and local

levels in recent years, which could further complicate compliance efforts.

the United States, an increasing number of laws, regulations, and industry standards apply to data privacy and security.

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restricted stock and/or restricted stocks to our independent directors and consultants.

We cannot predict the effect, if any, that

market sales of shares of our common stock or the availability of shares of our common stock for sale will have on the market price of

our common stock prevailing from time to time.

Sales of substantial amounts of shares of our common stock in the public market, or the

perception that those sales will occur, could cause the market price of our common stock to decline.

We cannot predict the effect, if any, that market

sales of shares of our common stock or the availability of shares of our common stock for sale will have on the market price of our common

stock prevailing from time to time.

Sales of substantial amounts of shares of our common stock in the public market, or the perception

that those sales will occur, could cause the market price of our common stock to decline.

shares are registered on Form S-8 and will be available for sale in the public market subject to vesting arrangements and exercise of

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his control of a majority of our voting stock and exercises significant voting power.

Yu, our Chairman, and CEO, has the right to exercise voting rights with respect to an aggregate of 5,341,837 shares of common

stock, which represents approximately 36.00% of the voting power of our outstanding capital stock.

Yu, our Chairman, and CEO, has the right to exercise voting rights with respect to an aggregate of 5,341,837 shares of common stock,

which represents approximately 36.00% of the voting power of our outstanding capital stock.

As a result, Dr.

ability to substantially control the outcome of matters submitted to our stockholders for approval, including the election of directors

and any merger, consolidation, or sale of all or substantially all of our assets.

This could delay, defer, or prevent a change of control,

merger, consolidation, or sale of all or substantially all of our assets that our other stockholders support, or conversely this concentrated

Yu has the ability

to substantially control the outcome of matters submitted to our stockholders for approval, including the election of directors and any

merger, consolidation, or sale of all or substantially all of our assets.

This could delay, defer, or prevent a change of control, merger,

consolidation, or sale of all or substantially all of our assets that our other stockholders support, or conversely this concentrated

control could result in the consummation of such a transaction that our other stockholders do not support.

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from influencing significant corporate decisions and matters submitted to stockholders for approval.

of the date of this Annual Report, our executive officers, directors, and current beneficial owners of 5% or more of our capital stock

and their respective affiliates hold, in the aggregate, beneficially own [48.68]% of our outstanding common stock, based on 14,349,306

shares of our common stock outstanding as of April 11, 2025.

As a result, these persons, acting together, would be able to

significantly influence all matters requiring stockholder approval, including the election and removal of directors, any merger, consolidation,

or sale of all or substantially all of our assets, or other significant corporate transactions.

In addition, these persons, acting together,

may have the ability to control the management and affairs of our Company.

Accordingly, this concentration of ownership may harm the

market price of our common stock by:

delaying, deferring, or preventing

a change in control;

entrenching our management and/or the board of directors;

impeding a merger, consolidation, takeover, or other

business combination involving us;

discouraging a potential acquirer from making a tender

offer or otherwise attempting to obtain control of us.

of the date of this Annual Report, our executive officers, directors, and current beneficial owners of 5% or more of our capital

stock and their respective affiliates hold, in the aggregate, beneficially own 37.2% of our outstanding common stock, based on

21,411,198 shares of our common stock outstanding as of March 31, 2026.

As a result, these persons, acting together, would

be able to significantly influence all matters requiring stockholder approval, including the election and removal of directors, any

merger, consolidation, or sale of all or substantially all of our assets, or other significant corporate transactions.

these persons, acting together, may have the ability to control the management and affairs of our Company.

Accordingly, this

concentration of ownership may harm the market price of our common stock by:

deferring, or preventing a change in control;

our management and/or the board of directors;

a merger, consolidation, takeover, or other business combination involving us;

a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

addition, some of these persons or entities may have interests different than yours.

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Among other things, these provisions:

allow the authorized number of our

directors to be changed only by resolution of our board of directors;

limit the manner in which stockholders can remove directors

from the board of directors;

establish advance notice requirements for stockholder

proposals that can be acted on at stockholder meetings and nominations to our board of directors;

require that stockholder actions must be effected at

a duly called stockholder meeting and prohibit actions by our stockholders by written consent;

limit who may call stockholder meetings;

authorize our board of directors to issue preferred

stock without stockholder approval, which could be used to institute a stockholder rights plan, or so-called “poison pill,”

that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not

been approved by our board of directors;

require the approval of the holders of at least 66

2/3% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws.

the authorized number of our directors to be changed only by resolution of our board of directors;

the manner in which stockholders can remove directors from the board of directors;

advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of

that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written

who may call stockholder meetings;

our board of directors to issue preferred stock without stockholder approval, which could be used to institute a stockholder rights

plan, or so-called “poison pill,” that would work to dilute the stock ownership of a potential hostile acquirer, effectively

preventing acquisitions that have not been approved by our board of directors;

the approval of the holders of at least 66 2/3% of the votes that all our stockholders would be entitled to cast to amend or repeal

certain provisions of our charter or bylaws.

because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, or

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brought under the Securities Act or the Exchange Act, the Court of Chancery of the State of Delaware is the exclusive forum for:

any derivative action or proceeding

brought on our behalf;

any action asserting a breach of fiduciary duty;

any action asserting a claim against us arising pursuant

to any provision of the DGCL or our certificate of incorporation or bylaws;

any action or proceeding to interpret, apply, enforce,

or determine the validity of our certificate of incorporation, or our bylaws;

any action asserting a claim against us or any of our

directors, officers, employees, or agents that is governed by the internal-affairs doctrine.

derivative action or proceeding brought on our behalf;

action asserting a breach of fiduciary duty;

action asserting a claim against us arising pursuant to any provision of the DGCL or our certificate of incorporation or bylaws;

action or proceeding to interpret, apply, enforce, or determine the validity of our certificate of incorporation, or our bylaws;

action asserting a claim against us or any of our directors, officers, employees, or agents that is governed by the internal-affairs

person purchasing or otherwise acquiring or holding any interest in shares of our capital stock is deemed to have received notice of

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In addition to the factors discussed under this “Item1A Risk Factors” section and elsewhere in this Annul Report, these factors

the commencement,

enrollment, or results of our planned and future clinical trials;

the loss of any of our

key research, development, or management personnel;

regulatory or legal changes

or developments in the United States and other countries or in the status of our regulatory approvals;

the success of competitive

products or technologies;

the emergence of new competitors

or new technologies;

our ability to develop

and market new and enhanced products on a timely basis;

adverse actions taken by

regulatory agencies with respect to our clinical trials or manufacturers;

changes or developments

in laws or regulations applicable to our current in-development products or any future product candidates;

changes to our relationships

with collaborators, manufacturers, or suppliers;

the results of our testing

and clinical trials;

disruption to our operations

or those of other sources critical to our operations;

unanticipated safety, tolerability,

or efficacy concerns;

announcements by us or

our competitors of acquisitions, new products, significant contracts, commercial relationships or capital commitments;

other announcements concerning

our competitors or the pharmaceutical industry in general;

actual or anticipated fluctuations

in our operating results or those of our competitors;

changes in financial estimates

or recommendations by securities analysts;

potential acquisitions;

the results of our efforts

to discover, develop, acquire, or in-license additional product candidates;

commencement of, or our

involvement in, litigation;

dilutive issuances of our

stock or the stock of our subsidiaries, or the incurrence of additional debt;

changes in our board of

directors or management;

adoption of new or different

accounting standards;

the trading volume of our

common stock on NYSE American;

sales of our common stock

by us, our executive officers and directors or our stockholders or the anticipation that such sales may occur in the future;

general economic, political,

and market conditions and overall fluctuations in the financial markets in the United States or the United Kingdom (including those

relating to macroeconomic events, such as the COVID-19 pandemic and the wars between Russia and Ukraine and Israel and Hamas);

stock market price and

volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;

general economic conditions

and slow or negative growth of related markets;

investors’ general

perception of us and our business.

commencement, enrollment, or results of our planned and future clinical trials;

loss of any of our key research, development, or management personnel;

or legal changes or developments in the United States and other countries or in the status of our regulatory approvals;

success of competitive products or technologies;

emergence of new competitors or new technologies;

ability to develop and market new and enhanced products on a timely basis;

actions taken by regulatory agencies with respect to our clinical trials or manufacturers;

or developments in laws or regulations applicable to our current in-development products or any future product candidates;

to our relationships with collaborators, manufacturers, or suppliers;

results of our testing and clinical trials;

to our operations or those of other sources critical to our operations;

unanticipated

safety, tolerability, or efficacy concerns;

announcements

by us or our competitors of acquisitions, new products, significant contracts, commercial relationships or capital commitments;

announcements concerning our competitors or the pharmaceutical industry in general;

or anticipated fluctuations in our operating results or those of our competitors;

in financial estimates or recommendations by securities analysts;

acquisitions;

results of our efforts to discover, develop, acquire, or in-license additional product candidates;

of, or our involvement in, litigation;

issuances of our stock or the stock of our subsidiaries, or the incurrence of additional debt;

in our board of directors or management;

of new or different accounting standards;

trading volume of our common stock on NYSE American;

of our common stock by us, our executive officers and directors or our stockholders or the anticipation that such sales may occur

in the future;

economic, political, and market conditions and overall fluctuations in the financial markets in the United States or the United Kingdom

(including those relating to macroeconomic events, such as wars in the Middle East and between Russia and Ukraine);

market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;

economic conditions and slow or negative growth of related markets;

general perception of us and our business.

and other market and industry factors may cause the market price and demand for our common stock to fluctuate substantially, regardless

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issuer, or a majority-owned subsidiary of a parent that is not a smaller reporting company and that:

Had a public float of less than

$250 million as of the last business day of its most recently completed fiscal quarter, computed by multiplying the aggregate number

of worldwide number of shares of its voting and non-voting common equity held by non-affiliates by the price at which the common

equity was last sold, or the average of the bid and asked prices of common equity, in the principal market for the common equity;

In the case of an initial registration statement under

the Securities Act or the Exchange Act for shares of its common equity, had a public float of less than $250 million as of a date

within 30 days of the date of the filing of the registration statement, computed by multiplying the aggregate worldwide number of

such shares held by non-affiliates before the registration plus, in the case of a Securities Act registration statement, the number

of such shares included in the registration statement by the estimated offering price of the shares;

In the case of an issuer who had annual revenue of

less than $100 million during the most recently completed fiscal year for which audit financial statements are available, had a public

float as calculated under paragraph (1) or (2) of this definition that was either zero or less than $700 million.

a public float of less than $250 million as of the last business day of its most recently completed fiscal quarter, computed by multiplying

the aggregate number of worldwide number of shares of its voting and non-voting common equity held by non-affiliates by the price

at which the common equity was last sold, or the average of the bid and asked prices of common equity, in the principal market for

the common equity;

the case of an initial registration statement under the Securities Act or the Exchange Act for shares of its common equity, had a

public float of less than $250 million as of a date within 30 days of the date of the filing of the registration statement, computed

by multiplying the aggregate worldwide number of such shares held by non-affiliates before the registration plus, in the case of

a Securities Act registration statement, the number of such shares included in the registration statement by the estimated offering

price of the shares;

the case of an issuer who had annual revenue of less than $100 million during the most recently completed fiscal year for which audit

financial statements are available, had a public float as calculated under paragraph (1) or (2) of this definition that was either

zero or less than $700 million.

a “smaller reporting company” we are not required and may not include a Compensation Discussion and Analysis section in our

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all continued listing requirements of NYSE American from which we would not be exempt, including minimum stock price requirements.

Changes in funding for or disruption at the

FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations

could hinder their ability to hire and retain key leadership and other personnel, delay the review and approval of regulatory submissions,

limit the development or implementation of regulatory programs, prevent new products and services from being developed or commercialized

in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business

may rely, which could negatively impact our business

Federal agencies in the United States, including the

FDA and the SEC, operate pursuant to annual appropriations and other political and budgetary processes, and may from time to time be subject

to continuing resolutions, funding lapses, or other fiscal constraints.

Without appropriation of sufficient funding to federal agencies,

our business operations related to our product development activities for the U.S.

market could be impacted.

The ability of the FDA to review and approve new products

can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel

and accept the payment of user fees, and statutory, regulatory and policy changes.

Average review times at the agency have fluctuated

in recent years and may continue to fluctuate as a results of these factor as a result.

In addition, government funding of the SEC and

other government agencies on which our operations may rely, including those that fund research and development activities, is subject

to the political process, which is inherently fluid and unpredictable.

For example, the Trump administration has issued executive orders

seeking to greatly reduce the size of the federal workforce, including through layoffs and severance packages offered to employees of

federal agencies within the executive branch and independent agencies, including the FDA.

Any such reduction in personnel may result in

longer review times by the FDA and other agencies.

Disruptions at the FDA and other agencies may also

slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely

affect our business.

For example, over the last several years, the U.S.

government has shut down several times, most recently in October

1, 2025 through November 12, 2025, and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees

and stop critical activities.

If a prolonged government shutdown occurs again, or if global health concerns or shortages in resources

prevent the FDA or other regulatory authorities from conducting their regulatory inspections, reviews or other regulatory activities,

including formal or informal interactions with product developers, it could significantly impact the ability of the FDA to timely review

and process our regulatory submissions, which could have a material adverse effect on our business.

Further, future government shutdowns

could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations

or delay the review or effectiveness of required regulatory or securities filings.

Congress, the Trump administration,

or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.

With the start of the Trump Administration in 2025,

policy changes have been implemented at a rapid pace and additional changes are likely.

Changes to U.S.

policy implemented by the

Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the

and global economy, international trade relations, unemployment, immigration, healthcare, taxation, the U.S.

regulatory environment,

inflation and other areas.

Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect

our business.

Until we know what policy changes are made, whether those policy changes are challenged and subsequently upheld by the court

system and how those changes impact our business and the business of our competitors over the long term, we will not know if, overall,

we will benefit from them or be negatively affected by them.

and potential future changes to U.S.

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could have adverse effects on our relationship with that third party and relationships with other existing or new partners, harming our

are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by

geopolitical instability due to the ongoing military conflicts between Russia and Ukraine, as well as Israel and Hamas.

and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the start of the

military conflict between Russia and Ukraine, as well as Israel in Hamas.

In February 2022, Russia launched a full-scale military invasion

And armed conflict began between Israel in Hamas in October 2023.

Although the length and impact of the ongoing military

conflicts is highly unpredictable, the conflict in Ukraine and the conflict in the Middle East could lead to market disruptions, including

significant volatility in commodity prices, credit and capital markets.

Additionally, Russia’s prior annexation of Crimea, recognition

of two separatist republics in the Donetsk and Luhansk regions of Ukraine, subsequent military interventions in Ukraine, and attempted

annexation of four oblasts in Ukraine have led to sanctions and other penalties being levied by the United States, European Union and

other countries against Russia, Belarus, the Crimea Region of Ukraine, the so-called Donetsk People’s Republic, and the so-called

Luhansk People’s Republic, including agreement to remove certain Russian financial institutions from the Society for Worldwide

Interbank Financial Telecommunication (SWIFT) payment system.

Additional potential sanctions and penalties have also been proposed and/or

Russian military actions and the resulting sanctions could adversely affect the global economy and financial markets and

lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds.

Any of the abovementioned factors could affect our business, prospects, financial condition, and operating results.

The extent and duration

of the military action, sanctions and resulting market disruptions are impossible to predict, but could be substantial.

Any such disruptions

may also magnify the impact of other risks described in this Annual Report.

markets may experience periods of disruption, instability and economic uncertainty.

Such market conditions may materially and adversely

affect the debt and equity capital markets, which may have a negative impact on our business and operations.

time to time, capital markets may experience periods of disruption, instability and economic uncertainty.

Such periods may result in,

among other things, write-offs, the re-pricing of credit risk, the failure of financial institutions or worsening general economic conditions,

any of which could materially and adversely impact the broader financial and credit markets and reduce the availability of debt and equity

capital for the market as a whole and, as a result, negatively affect our ability to access capital.

Global financial markets have experienced

heightened volatility in recent years.

In addition, social and political tensions in the U.S.

and around the world may contribute to

increased market volatility, may have long-term effects on the U.S.

and worldwide financial markets, and may cause economic uncertainties

or deterioration in the U.S.

and worldwide.

There can be no assurance these market conditions will not occur or worsen in the future,

including economic and political events in or affecting the world’s major economies, such as the ongoing war between Russia

and Ukraine and continued conflicts and political unrest in the Middle East and South America.

Sanctions imposed by the U.S.

and other countries in connection with hostilities between Russia

and Ukraine, the war in Iran, conflicts in the Middle East, and the tensions between China and Taiwan have caused additional financial

market volatility and affected the global economy.

Concerns over future inflation volatility, economic recession, as well as interest

rate volatility and fluctuations in oil and gas prices resulting from global production and demand levels, as well as geopolitical tension,

have exacerbated market volatility.

In addition, social unrest, changes regarding immigration and work permit policies and other political

and security concerns may not abate, which may cause the debt and equity capital markets and our business to be adversely affected both

within and outside of regions experiencing ongoing conflicts.

Market uncertainty and volatility have also been magnified as a result

of uncertainties regarding actual and potential shifts in U.S.

and foreign trade, economic and other policies, including with respect

to treaties and tariffs.

volatility in the capital markets may make it difficult to raise equity capital or obtain debt financing, the results of which could cause

a material adverse effect on our business, financial condition and/or results of operations.

If we are unable to raise additional capital,

we will not be able to fund our ongoing clinical trials and further develop our business.

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