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Item 1A. Risk Factors

2025-11-25 compared with 2024-12-23 · 447 added, 393 removed, 1091 unchanged (44% of the section changed)

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· We have a very limited relevant operating history upon which an evaluation of our performance and prospects

We may never be able to successfully develop marketable products or generate any revenue.

If we cannot generate sufficient

revenues, we may suspend or cease operations;

· Our research and development plans will require substantial additional future funding;

We may be unable

to raise capital when needed, which would force us to delay, reduce or eliminate our research and development activities;

· We will need additional funding and may be unable to raise additional capital when needed, which would

force us to delay, reduce or eliminate our research and development activities;

· Even if our products are approved, we may not be able to generate significant revenues from or successfully

commercialize them, which will adversely affect our financial results and financial condition and we will have to delay or terminate some

or all of our research and development plans which may force us to cease operations;

· Our research and development plans require substantial additional future funding which could impact our

operations and financial condition;

· We may be unable to raise additional capital when needed, which would force us to delay, reduce or eliminate

our research and development activities;

· The marketing approval process is burdensome and may not be successful;

· If we or any companion diagnostic collaborator of ours are unable to timely develop and obtain regulatory

approval for companion diagnostic tests for our drug candidates, we may not realize the commercial potential of our drug candidates;

· The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy,

· The regulatory approval processes of the FDA, EMA and comparable foreign regulatory authorities are lengthy,

time-consuming and inherently unpredictable, which could lead to our inability to generate product revenue;

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· We may be unable to maintain any benefits associated with orphan drug designation, including market exclusivity;

· If we fail to demonstrate efficacy in our non-clinical studies and clinical trials our future business

prospects, financial condition and operating results will be materially adversely affected;

· We may fail to demonstrate efficacy in our non-clinical studies and clinical trials;

· If a particular product candidate causes undesirable side effects, then we may be unable to receive regulatory

approval of or commercialize such product candidate;

· Wea re highly dependent on our key personnel and if we are not successful in attracting and retaining

· Treatment of neurodegenerative and central nervous system, or CNS, disorders, is a field that has seen

very limited success in product development;

· The use of any of our products in clinical trials may expose us to liability claims, causing our business

· We are highly dependent on our key personnel and if we are not successful in attracting and retaining

highly qualified personnel, we may not be able to successfully implement our business strategy;

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· We may not be able to develop, market or generate sales of our products to the extent anticipated;

business may fail and investors could lose all their investment in our Company;

· None of our potential drug compounds may reach the commercial market and our business may fail;

· Material modifications in the methods of product candidate manufacturing may result in additional costs

· Our technologies and future products may be rendered undesirable or obsolete if our competitors succeed

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change our understanding of the potential scope and utility of our potential products;

· We have advanced our research and development efforts on the treatment of neurodegenerative and central

nervous system, or CNS, disorders, a field that has seen very limited success in product development;

· Our reliance on third parties may result in delays in completing, or a failure to complete, non-clinical

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other collaboration opportunities, our ability to research and develop our potential drug compounds may be limited;

· The use of any of our products in clinical trials may expose us to liability claims, causing our business

· If we are unable to safeguard against security breaches with respect to our information systems, our business

may be adversely affected;

· Continuing regulatory obligations and ongoing regulatory review may result in additional expense.

compounds could be subject to restrictions on marketing or withdrawal from the market, and we may be subject to penalties when and if

any of them are approved;

· Changes in funding for the FDA, the SEC and other government agencies could prevent these agencies from

performing normal functions on which the operations of our business may rely, which could negatively affect our business;

· We receive Australian government research and development income tax incentive refunds.

Loss of access

to such incentives could have a negative effect on our future cash flows and the funding of future research and development projects;

· Operating our business internationally carries various risks which could materially adversely affect our

· Our business could be affected by litigation, government investigations and enforcement actions;

· Loss of access to Australian government research and development income tax incentive refunds could have

a negative effect on our future cash flows and the funding of future research and development projects;

· Our ability to use our net operating loss carryforwards and tax credit carryforwards may be subject to

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contractual damages, reputational harm and diminished profits and future earnings, among other penalties;

· We expect current and future legislation affecting the pharmaceutical industry, including drug pricing

reform, to impact our business generally, which could adversely affect our business operations;

· Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved,

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may cause our stock price to fall;

A decline in our stock price could affect our ability to raise further working capital and adversely

affect our operations.

Raising funds at lower prices would severely dilute existing or future investors;

· Our stock price has been volatile and may be volatile in the future and our common stock may become the

target of a “short squeeze”;

· If we fail to maintain an effective system of internal control over financial reporting, we may not be

able to accurately report our financial results or prevent fraud.

Our disclosure controls and procedures may not prevent or detect all

errors or acts of fraud.

As a result, stockholders could lose confidence in our financial and other public reporting, which would harm

our business and the trading price of our common stock;

· Patent terms may be inadequate to protect our competitive position on our product candidates.

unable to obtain and maintain sufficient intellectual property protection for our product candidates, our competitors could develop and

commercialize product candidates similar or identical to ours, and our ability to successfully commercialize our product candidates may

· If we fail to comply with our obligations in intellectual property licensing agreements or experience

disruptions to our business relationships with our licensors, we could lose important intellectual property rights.

If we are unable to

protect the confidentiality of our trade secrets, our business would be harmed;

· Our stock price has been volatile at times in the past and may be volatile in the future and our common

stock may become the target of a “short squeeze”;

· If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates,

our competitors could develop and commercialize product candidates similar or identical to ours, and our ability to successfully commercialize

our product candidates may be impaired;

· Intellectual property infringement claims may adversely affect our development and commercialization efforts;

· We may be subject to claims that our employees, consultants or independent contractors have wrongfully

used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets

of their former employers;

used or disclosed confidential information of third parties;

· We may become involved in lawsuits to protect or enforce our patents or other intellectual property;

Obtaining and maintaining our patent protection

depends on compliance with various requirements imposed by governmental patent agencies.

Changes in patent law could impair our ability

to protect our product candidates;

· Obtaining and maintaining our patent protection depends on compliance with various requirements imposed

by governmental patent agencies.

Changes in patent law could impair our ability to protect our product candidates;

· We may fail to protect our intellectual property rights or the confidentiality of our trade secrets.

in patent law could diminish the value of our patents and patent applications in general.

In addition to other information in this Annual Report

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of operations.

We are an early clinical stage pharmaceutical

research and development company and may never be able to successfully develop marketable products or generate any revenue.

very limited relevant operating history upon which an evaluation of our performance and prospects can be made.

There is no assurance that

our future operations will result in profits.

We are a clinical stage pharmaceutical research

and development company and may never be able to successfully develop marketable products or generate any revenue.

We have a very limited

relevant operating history upon which an evaluation of our future performance and prospects can be made.

There is no assurance that our

future operations will result in profits.

If we cannot generate sufficient revenues, we may suspend or cease operations.

We are an early clinical stage company and have not

generated any revenues to date and have no operating history.

Moreover, we cannot be certain that our research and development efforts

will be successful or, if successful, that our potential drug compounds will ever be approved for sale to pharmaceutical companies or

generate commercial revenues.

We have no relevant operating history upon which an evaluation of our performance and prospects can be made.

We are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen capital

requirements, failure of potential drug compounds either in non-clinical testing or in clinical trials, failure to establish business

relationships and competitive disadvantages against larger and more established companies.

If we fail to become profitable, we may suspend

or cease operations.

We will need additional funding and may be unable

to raise additional capital when needed, which would force us to delay, reduce or eliminate our research and development activities.

To date, we have funded our operations primarily through

private placement of our equity securities, through issuances of shares under the Purchase Agreement with Lincoln Park Capital Fund, LLC

(“Lincoln Park”) pursuant to which the Company may direct Lincoln Park to purchase shares of common stock registered under

an effective registration statement, or, historically, through draws under our “at-the-market offering” in connection with

the Amended and Restated Sales Agreement with Cantor Fitzgerald & Co.

and SVB Leerink LLC (the “Sales Agents”), pursuant

to which we could offer and sell shares of common stock registered under an effective registration statement from time to time through

the Sales Agents.

The Company terminated the Sales Agreement in July 2024.

We will need to raise additional funding and the current economic

conditions may have a negative impact on our ability to raise additional needed capital on terms that are favorable to our Company or

We are a clinical stage company and have not generated

any revenues to date.

Moreover, we cannot be certain that our research and development efforts will be successful or, if successful, that

our potential drug compounds will ever be approved for sale to pharmaceutical companies or generate commercial revenues.

We have a very

limited relevant operating history upon which an evaluation of our performance and prospects can be made.

We are subject to all of the

business risks associated with a pre-revenue company, including, but not limited to, risks of unforeseen capital requirements, failure

of potential drug compounds either in non-clinical testing or in clinical trials, failure to establish business relationships and competitive

disadvantages against larger and more established companies.

If we fail to become profitable, we may suspend or cease operations.

We may be unable to raise additional capital

when needed, which would force us to delay, reduce or eliminate our research and development activities.

To date, we have funded our operations primarily through issuances of shares

at-the-market sales agreements pursuant to which we offer and sell shares of common stock registered under an effective registration statement

from time to time through a sales agent and, historically, also through a Purchase Agreement with Lincoln Park Capital Fund, LLC (“Lincoln

Park”) pursuant to which the Company could direct Lincoln Park to purchase shares of common stock registered under an effective

registration.

The Company will need to file a prospectus supplement in order to access funds under the 2023 Purchase Agreement and the

2023 Purchase Agreement will expire on February 3, 2026.

We will need to raise additional funding, and the

current economic conditions may have a negative impact on our ability to raise additional needed capital on terms that are favorable to

our Company or at all.

We may not be able to generate significant revenues for several years, if at all.

Until we can generate significant revenues,

if ever, we expect to satisfy our future cash needs through equity or debt financing.

We cannot be certain that additional funding will

be available on acceptable terms, or at all.

If adequate funds are not available, we may be required to delay, reduce the scope of, or

eliminate one or more of our research and development activities.

Risks Related to our Business

Until we can generate significant

revenues, if ever, we expect to satisfy our future cash needs through equity or convertible debt financing.

We cannot be certain that

additional funding will be available on acceptable terms, or at all.

If adequate funds are not available, we may be required to delay,

reduce the scope of, or eliminate one or more of our research and development activities.

A decline in the price of our common stock could

affect our ability to raise further working capital and adversely impact our operations and would severely dilute existing or future investors

if we were to raise funds at lower prices.

A prolonged decline in the price of our common stock

could result in a reduction in our ability to raise capital.

Because our operations have been financed through the sale of equity securities,

a decline in the price of our common stock could be especially detrimental to our continued operations.

Any reduction in our ability to

raise equity capital in the future would force us to reallocate funds from other planned uses and would have a significant negative effect

on our business plans and operations, including our ability to develop new products and continue our current operations.

price declines, we may be forced to sell equity securities at such lower prices resulting in significant dilution to existing investors.

We believe the following factors could cause the market price of our common stock to continue to fluctuate widely and could cause our

common stock to trade lower:

actual or anticipated variations in our quarterly operating results;

announcements of new services, products, acquisitions or strategic relationships by us or our competitors;

the outcome of our clinical trials, which are inherently

unpredictable;

changes in accounting treatments or principles;

changes in earnings estimates by securities analysts and in analyst recommendations;

general political, economic, regulatory and market conditions.

The market price for our common stock may also be

affected by our ability to meet or exceed expectations of analysts or investors.

Any failure to meet these expectations, even if minor,

could materially adversely affect the market price of our common stock.

Risks Related to the Discovery and Development

of Our Current and Future Product Candidates

The marketing approval process for pharmaceutical

products is a lengthy, complex and highly regulated process and we cannot predict the outcome of any interactions with the regulatory

authorities or when we will receive marketing approval, if at all.

The regulatory approval processes of the EMA, the FDA, and other comparable

foreign authorities are lengthy, time-consuming and inherently unpredictable, and the approval process can vary significantly depending

on the regulatory authority.

Relevant health authorities may, at the time of the filing of the application for a marketing authorization,

or later during their review, impose requirements that can evolve over time, including requiring additional clinical trials, and such

authorities may delay or refuse to grant approval.

On November 14, 2025, we announced that the CHMP of the EMA has rendered a negative

trend vote following an oral explanation of our MAA.

The CHMP is expected to adopt a formal opinion on the MAA at its December meeting.

We plan to seek a re-examination of the MAA upon its formal adoption.

However, we cannot predict the outcome of any interactions with

the regulatory authorities and when we will receive a marketing approval, if at all.

In recent years, health authorities have become increasingly

focused on product safety and on the risk/benefit profile of pharmaceutical products, which could lead to more burdensome and costly approval

processes and negatively affect our ability to obtain regulatory approval for products under development.

For example, the FDA and the

EMA have been implementing strict requirements for approval, particularly in terms of the volume of data needed to demonstrate a product’s

efficacy and safety.

Obtaining and maintaining regulatory approval

of blarcamesine or any future product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory

approval of those product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of blarcamesine

and any future product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval

in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on

the regulatory approval process in others.

Approval procedures vary among jurisdictions and can involve requirements and administrative

review periods different from each other, including additional preclinical studies or clinical trials, as clinical trials conducted in

one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.

In many jurisdictions outside the U.S., including

Canada, and certain jurisdictions in the EU, a product candidate must be approved for reimbursement before it can be approved for sale

in that jurisdiction.

In some cases, the price that we intend to charge for our products is also subject to approval.

Regulatory authorities in jurisdictions outside of

have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions and

such regulatory requirements can vary widely from country to country.

Obtaining other regulatory approvals and compliance with other regulatory

requirements could result in significant delays, difficulties and costs for us and could require additional preclinical studies or clinical

trials, which could be costly and time-consuming and could delay or prevent the introduction of our products in certain countries.

foreign regulatory approval process involves all of the risks associated with FDA approval.

We do not have experience in obtaining regulatory

approval in international markets or within the United States.

If we fail to comply with the regulatory requirements in international

or domestic markets and/or obtain and maintain applicable marketing approvals, our target market will be reduced and our ability to realize

the full market potential of blarcamesine or any future product candidates will be harmed.

Even if we are able to develop our potential

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the possibility that non-clinical testing or clinical trials may show that our potential drug compounds are ineffective and/or cause harmful side effects;

regulators may not authorize us to commence or continue a clinical trial or may impose a clinical hold or may limit the conduct of a clinical trial through the imposition of a partial clinical hold;

regulators may not authorize us to commence or continue a clinical trial or may impose a clinical hold or may limit the conduct of a clinical trial through the imposition of a clinical hold;

the number of patients required for clinical trials for our drug candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, participants may drop out of these clinical trials at a higher rate than we anticipate or the duration of these clinical trials may be longer than we anticipate;

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substantial additional future funding which could impact our operations and financial condition.

It will take several years before we can develop potentially

It may take several years before we can develop potentially

marketable products, if at all.

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Any of these uncertain events can

significantly change our cash requirements as they determine such one-time events as the receipt or payment of major milestones and other

Additional funds may be required to support our operations

and if we are unable to obtain them on favorable terms, we may be required to cease or reduce certain further research and development

programs of our drug product platform, sell some or all our intellectual property, merge with another entity or scale back operations.

significantly change our cash requirements as they may involve one-time events such as the receipt or payment of major milestones and

other payments.

Additional funds will be required to support our operations,

including commercialization of our product candidates, and if we are unable to obtain them on favorable terms, we may be required to cease

or reduce certain further research and development and commercialization programs of our drug product platform, sell some or all our intellectual

property, merge with another entity or scale back operations.

If we or any companion diagnostic collaborator

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Companion diagnostics are subject to regulation by

the FDA and comparable foreign regulatory authorities as medical devices and will likely require separate regulatory approval prior to

commercialization.

the FDA, EMA and comparable foreign regulatory authorities as medical devices and will likely require separate regulatory approval prior

to commercialization.

If we or third parties are unable to successfully develop companion diagnostics for our drug candidates, or experience

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these drug candidates may not receive marketing approval if their safe and effective use depends on a companion diagnostic;

we may not realize the full commercial potential of these drug candidates that receive marketing approval if, among other reasons, we are unable to appropriately identify patients or types of tumors targeted by these drug candidates.

Even if our drug candidates and any associated companion

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candidates may be perceived negatively compared to alternative treatments that do not require the use of companion diagnostics, either

due to the additional cost of the companion diagnostic or the need to complete additional prior to administering our drug candidates.

due to the additional cost of the companion diagnostic or the need to complete additional [testing?] prior to administering our drug candidates.

If any of these events were to occur, our business

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The regulatory approval processes of the FDA,

and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, which could lead to our inability

EMA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, which could lead to our inability

to generate product revenue.

The time required to obtain approval by the FDA and

comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials and

depends upon numerous factors, including the type, complexity and novelty of the product candidates involved.

The time required to obtain approval by the FDA, EMA

and comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials

and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved.

Seeking foreign regulatory

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Even if we eventually complete clinical testing and receive approval of any regulatory

filing for our product candidates, the FDA and comparable foreign regulatory authorities may approve our product candidates for a more

limited indication or a narrower patient population than we originally requested.

If we fail to comply with regulatory requirements in

international markets or to obtain and maintain required approvals, our target market will be reduced and our ability to realize the full

market potential of our product candidates will be harmed.

filing for our product candidates, the FDA, EMA and comparable foreign regulatory authorities may approve our product candidates for a

more limited indication or a narrower patient population than we originally requested.

If we fail to comply with regulatory requirements

in international markets or to obtain and maintain required approvals, our target market will be reduced and our ability to realize the

full market potential of our product candidates will be harmed.

Applications for our product candidates could fail

to receive regulatory approval for many reasons, including but not limited to the following:

· the FDA or comparable international regulatory authorities may disagree with the design, implementation

· the FDA, EMA or comparable international regulatory authorities may disagree with the design, implementation

or results of our clinical trials;

· the FDA or comparable international regulatory authorities may determine that our product candidates are

not safe and effective, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics

· the FDA, EMA or comparable international regulatory authorities may determine that our product candidates

are not safe and effective, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics

that preclude our obtaining marketing approval or prevent or limit commercial use;

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efficacy and potency and safety in the full population for which we seek approval;

· the FDA or comparable international regulatory authorities may disagree with our interpretation of data

from preclinical studies or clinical trials;

· the FDA, EMA or comparable international regulatory authorities may disagree with our interpretation of

data from preclinical studies or clinical trials;

· the data collected from clinical trials of our product candidates may not be sufficient to support the

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States or elsewhere;

· we may be unable to demonstrate to the FDA or comparable international regulatory authorities that a product

candidate’s risk-benefit ratio for its proposed indication is acceptable;

· we may be unable to demonstrate to the FDA, EMA or comparable international regulatory authorities that

a product candidate’s risk-benefit ratio for its proposed indication is acceptable;

· the FDA or comparable international regulatory authorities may fail to approve the manufacturing processes,

test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

· the approval policies or regulations of the FDA or international foreign regulatory authorities may significantly

change in a manner rendering our clinical data insufficient for approval.

· the approval policies or regulations of the FDA, EMA or international foreign regulatory authorities may

significantly change in a manner rendering our clinical data insufficient for approval.

In order to market any product candidates outside

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All but one of our clinical

trials to date have been conducted outside the United States, and the FDA and other foreign regulatory authorities may not accept data

from such trials.

The acceptance of study data from

clinical trials conducted outside the United States by the FDA may be subject to certain conditions or may not be accepted at all.

cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the United States, the

FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United States

population and United States medical practice;

(ii) the trials were performed by clinical investigators of recognized competence and pursuant

to good clinical practice regulations;

and (iii) the data may be considered valid without the need for an on-site inspection by the FDA,

or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate

trials to date have been conducted outside the United States, and the FDA, EMA and other foreign regulatory authorities may not accept

data from such trials.

The acceptance of study

data from clinical trials conducted outside the United States by the FDA may be subject to certain conditions or may not be accepted at

In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the United States,

the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United

States population and United States medical practice;

(ii) the trials were performed by clinical investigators of recognized competence

and pursuant to good clinical practice regulations;

and (iii) the data may be considered valid without the need for an on-site inspection

by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection

or other appropriate means.

Many foreign regulatory bodies have similar approval requirements.

In addition, such foreign trials would be subject to the applicable

local laws of the foreign jurisdictions where the trials are conducted.

There can be no assurance that the FDA or any other foreign regulatory

authority will accept data from trials conducted outside of the United States or the applicable jurisdiction.

If the FDA or any comparable

foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming

and delay aspects of our business plan, and which may result in our product candidates not receiving approval or clearance for commercialization

In addition, such foreign trials would

be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted.

There can be no assurance that the

FDA , EMA or any other foreign regulatory authority will accept data from trials conducted outside

of the United States or the applicable jurisdiction.

If the FDA , EMA or any comparable foreign regulatory

authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay

aspects of our business plan, and which may result in our product candidates not receiving approval or clearance for commercialization

in the applicable jurisdiction.

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Additionally, even if Priority Review is granted for one of our compounds, the FDA

does not always meet its six-month PDUFA goal date for Priority Review and the review process is often extended by FDA requests for additional

information or clarification.

does not always meet its six-month Prescription Drug User Fee Act (PDUFA) goal date for Priority Review and the review process is often

extended by FDA requests for additional information or clarification.

We may seek Breakthrough Therapy designation for one

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and 10-12 years is not unusual for certain compounds.

If any of our future clinical development potential

drug compounds become the subject of problems, our ability to sustain our development programs will become critically compromised.

example, efficacy or safety concerns may arise, whether or not justified, that could lead to the suspension or termination of our clinical

Examples of problems that could arise include, among others:

If any of our future clinical development potential drug compounds become

the subject of problems, our ability to sustain our development programs will become critically compromised.

For example, efficacy or

safety concerns may arise, whether or not justified, that could lead to the suspension or termination of our clinical programs.

of problems that could arise include, among others:

efficacy or safety concerns with the potential drug compounds, even if not justified;

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events may significantly harm our business and financial prospects.

Even if we receive regulatory approval for one

or more compounds, we will be subject to continuing regulatory obligations and ongoing regulatory review, which may result in significant

additional expense.

Additionally, our compounds, if approved, could be subject to labeling and other restrictions on marketing or withdrawal

from the market, and we may be subject to penalties, if we fail to comply with regulatory requirements or if we experience unanticipated

problems with our compounds, when and if any of them are approved.

Following potential approval of any our compounds,

the FDA may impose significant restrictions on a drug’s indicated uses or marketing or require potentially costly and time-consuming

post-approval studies, post-market surveillance or clinical trials to monitor the safety and efficacy of the drug.

The FDA may also require

a Risk Evaluation and Mitigation Strategy (“REMS”) as a condition of approval of one or more of our compounds, which could

include requirements for a medication guide, physician communication plans or additional elements to ensure safe use of the drug.

REMS elements may include restricted distribution methods, patient registries and other risk minimization tools.

In addition, if the FDA, EMA or a comparable foreign

regulatory authority approves one or more of our compounds, the manufacturing processes, labeling, packaging, distribution, adverse event

reporting, storage, advertising, promotion, import, export and recordkeeping for the approved drug will be subject to additional and potentially

extensive ongoing regulatory requirements.

These requirements include submissions of safety and other post-marketing information and reports,

establishment registration, as well as continued compliance with cGMPs and GCP requirements for any clinical trials that we conduct post-approval.

Later discovery of previously unknown problems with our products, including adverse events of unanticipated severity or frequency, or

with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among

other things:

restrictions on the marketing or manufacturing of our products, withdrawal of the product from the market or voluntary or mandatory product recalls;

fines, restitutions, disgorgement of profits or revenues, warning letters, untitled letters or holds on clinical trials;

restrictions on product distribution or use, or requirements to conduct post-marketing studies or clinical trials;

product seizure or detention, or refusal to permit the import or export of our products;

injunctions or the imposition of civil or criminal penalties;

refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of approvals.

The occurrence of any event or penalty described above

may limit our ability to commercialize our compounds and generate revenue and could require us to expend significant time and resources

in response or generate negative publicity.

If any of our compounds are approved, our product

labeling, advertising and promotion will also be subject to regulatory requirements and ongoing regulatory review.

The FDA strictly regulates

the promotional claims that may be made about drug products.

In particular, a drug may not be promoted for uses that are not approved

by the FDA as reflected in the drug’s approved labeling.

If we receive marketing approval for a compound, physicians may nevertheless

lawfully prescribe it to their patients in a manner that is inconsistent with the approved label.

While the FDA recently clarified that

mere knowledge that a physician is prescribing an approved drug for off-label use is not sufficient to constitute unlawful off-label promotion,

if we are found to have actively promoted such off-label uses, we may become subject to significant liability under the Federal Food,

Drug, and Cosmetic Act (FDCA).

The federal government has levied large civil and criminal fines against companies for alleged improper

promotion and has enjoined several companies from engaging in off-label promotion.

Additionally, promotion for off-label uses could result

in significant liability under the False Claims Act.

The FDA has also requested that companies enter into consent decrees or permanent

injunctions under which specified promotional conduct is changed or curtailed.

The FDA’s and other regulatory authorities’

policies are subject to change at any time, and additional government regulations may be enacted that could prevent, limit or delay regulatory

approval of our compounds.

If we are unable to timely adapt to changes in existing requirements or the adoption of new requirements or

policies, or if we are not able to maintain regulatory compliance post-marketing, we may lose any marketing approval that we may have

obtained, and we may not achieve or sustain profitability.

Finally, we cannot predict the likelihood, nature

or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United

States or abroad.

It is difficult to predict how any such legislative, administrative or executive actions will be implemented, and the

extent to which they will impact the FDA’s ability to exercise its regulatory authority.

If these legislative or executive actions

impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business

may be negatively impacted.

Material modifications in the methods of product

candidate manufacturing may result in additional costs or delay.

As product candidates progress from preclinical studies

to late-stage clinical trials to marketing approval and commercialization, it is common that various aspects of the development program,

such as manufacturing methods, materials and processes, are altered along the way in an effort to optimize yield, manufacturing batch

size, minimize costs and achieve consistent purity, identity, potency, quality and results.

Such changes carry the risk that they will

not achieve these intended objectives.

Any of these changes could cause our product candidates to perform differently and could affect

planned or other clinical trials conducted with product candidates produced using the modified manufacturing methods, materials, and processes.

This could delay completion of clinical trials and could require non-clinical or clinical bridging and comparability studies, which could

increase costs, delay approval of our product candidates and jeopardize our ability to commercialize our product candidates, if approved.

We have advanced our research and development

efforts on the treatment of neurodegenerative and central nervous system, or CNS, disorders, a field that has seen very limited success

in product development.

We have advanced our research

and development efforts on addressing neurodegenerative, neurodevelopmental and CNS disorders.

Collectively, efforts by pharmaceutical

companies in the field of neurodegenerative, neurodevelopmental and CNS disorders have seen very limited successes in product

The development of neurodegenerative and CNS therapies presents unique challenges, including an imperfect understanding of

the biology, the presence of the blood brain barrier that can restrict the flow of drugs to the brain, a frequent lack of translatability

of preclinical study results in subsequent clinical trials and dose selection, and the product candidate having an effect that may be

too small to be detected using the outcome measures selected in clinical trials or if the outcomes measured do not reach statistical significance.

The use of any of our products in clinical trials

may expose us to liability claims, which may cost us significant amounts of money to defend against or pay out, causing our business to

The nature of our business exposes us to potential

liability risks inherent in the testing, manufacturing and marketing of our products.

We currently have one drug compound in clinical

however, when any of our products enter clinical trials or become marketed products, they could potentially harm people or allegedly

harm people possibly subjecting us to costly and damaging product liability claims.

Some of the patients who participate in clinical trials

are already ill when they enter a trial or may intentionally or unintentionally fail to meet the exclusion criteria.

The waivers we obtain

may not be enforceable and may not protect us from liability or the costs of product liability litigation.

Although we intend to obtain

product liability insurance, which we believe is adequate, we are subject to the risk that our insurance will not be sufficient to cover

The insurance costs along with the defense or payment of liabilities above the amount of coverage could cost us significant

amounts of money and management distraction from other elements of the business, causing our business to suffer.

Risks Related to our Business

We are highly dependent on our key personnel,

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our business.

We will need to establish relationships with leading

scientists and research institutions.

We believe that such relationships are pivotal to establishing products using our technologies as

a standard of care for various indications.

Additionally, although in discussion, there is no assurance that our current research partners

will continue to work with us or that we will be able to attract additional research partners.

If we are not able to establish scientific

relationships to assist in our research and development, we may not be able to successfully develop our potential drug compounds.

happens, our business will be adversely affected.

While we have established relationships with leading scientists and research

institutions, we will need to continue to establish these relationships.

We believe that such relationships are pivotal to establishing

products using our technologies as a standard of care for various indications.

Additionally, although in discussion, there is no assurance

that our current research partners will continue to work with us or that we will be able to attract additional research partners.

are not able to maintain our existing scientific relationships and establish new scientific relationships to assist in our research and

development, we may not be able to successfully develop our potential drug compounds.

If this happens, our business will be adversely

We may not be able to develop, market or generate

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If this happens, our business will be adversely affected.

Material modifications in the methods of product

candidate manufacturing may result in additional costs or delay.

As product candidates progress from preclinical studies

to late-stage clinical trials to marketing approval and commercialization, it is common that various aspects of the development program,

such as manufacturing methods, materials and processes, are altered along the way in an effort to optimize yield, manufacturing batch

size, minimize costs and achieve consistent purity, identity, potency, quality and results.

Such changes carry the risk that they will

not achieve these intended objectives.

Any of these changes could cause our product candidates to perform differently and could affect

planned or other clinical trials conducted with product candidates produced using the modified manufacturing methods, materials, and processes.

This could delay completion of clinical trials and could require non-clinical or clinical bridging and comparability studies, which could

increase costs, delay approval of our product candidates and jeopardize our ability to commercialize our product candidates, if approved.

If our competitors succeed in developing products

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of patients should be treated with the targeted therapy.

We have advanced our research and development

efforts on the treatment of neurodegenerative and central nervous system, or CNS, disorders, a field that has seen very limited success

in product development.

We have advanced our research

and development efforts on addressing neurodegenerative, neurodevelopmental and CNS disorders.

Collectively, efforts by pharmaceutical

companies in the field of neurodegenerative, neurodevelopmental and CNS disorders have seen very limited successes in product

The development of neurodegenerative and CNS therapies presents unique challenges, including an imperfect understanding of

the biology, the presence of the blood brain barrier that can restrict the flow of drugs to the brain, a frequent lack of translatability

of preclinical study results in subsequent clinical trials and dose selection, and the product candidate having an effect that may be

too small to be detected using the outcome measures selected in clinical trials or if the outcomes measured do not reach statistical significance.

Our reliance on third parties, such as university

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and clinical trials.

If we engage these organizations to help us with our non-clinical and clinical programs, many important aspects of

If we engage these organizations to help us with our non-clinical and clinical programs,

many important aspects of

this process have been and will be out of our direct control.

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may be limited in our ability to develop new products.

The use of any of our products in clinical trials

may expose us to liability claims, which may cost us significant amounts of money to defend against or pay out, causing our business to

The nature of our business exposes us to potential

liability risks inherent in the testing, manufacturing and marketing of our products.

We currently have one drug compound in clinical

however, when any of our products enter clinical trials or become marketed products, they could potentially harm people or allegedly

harm people possibly subjecting us to costly and damaging product liability claims.

Some of the patients who participate in clinical trials

are already ill when they enter a trial or may intentionally or unintentionally fail to meet the exclusion criteria.

The waivers we obtain

may not be enforceable and may not protect us from liability or the costs of product liability litigation.

Although we intend to obtain

product liability insurance, which we believe is adequate, we are subject to the risk that our insurance will not be sufficient to cover

The insurance costs along with the defense or payment of liabilities above the amount of coverage could cost us significant

amounts of money and management distraction from other elements of the business, causing our business to suffer.

If our information systems or data, or those

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misappropriation, loss or other unauthorized disclosure of confidential or personally identifiable information as a result of a cyber-security

breach or other act, however, a cyber-security breach or other act and/or disruption to our information technology systems could have

breach or other act;

however, a cyber-security breach or other act and/or disruption to our information technology systems could have

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

Even if we receive regulatory approval for one

or more compounds, we will be subject to continuing regulatory obligations and ongoing regulatory review, which may result in significant

additional expense.

Additionally, our compounds, if approved, could be subject to labeling and other restrictions on marketing or withdrawal

from the market, and we may be subject to penalties, if we fail to comply with regulatory requirements or if we experience unanticipated

problems with our compounds, when and if any of them are approved.

Following potential approval of any our compounds,

the FDA may impose significant restrictions on a drug’s indicated uses or marketing or require potentially costly and time-consuming

post-approval studies, post-market surveillance or clinical trials to monitor the safety and efficacy of the drug.

The FDA may also require

a Risk Evaluation and Mitigation Strategy (“REMS”) as a condition of approval of one or more of our compounds, which could

include requirements for a medication guide, physician communication plans or additional elements to ensure safe use of the drug.

REMS elements may include restricted distribution methods, patient registries and other risk minimization tools.

In addition, if the FDA or a comparable foreign regulatory

authority approves one or more of our compounds, the manufacturing processes, labeling, packaging, distribution, adverse event reporting,

storage, advertising, promotion, import, export and recordkeeping for the approved drug will be subject to additional and potentially

extensive ongoing regulatory requirements.

These requirements include submissions of safety and other post-marketing information and reports,

establishment registration, as well as continued compliance with cGMPs and GCP requirements for any clinical trials that we conduct post-approval.

Later discovery of previously unknown problems with our products, including adverse events of unanticipated severity or frequency, or

with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among

other things:

restrictions on the marketing or manufacturing of our products, withdrawal of the product from the market or voluntary or mandatory product recalls;

fines, restitutions, disgorgement of profits or revenues, warning letters, untitled letters or holds on clinical trials;

restrictions on product distribution or use, or requirements to conduct post-marketing studies or clinical trials;

product seizure or detention, or refusal to permit the import or export of our products;

injunctions or the imposition of civil or criminal penalties;

refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of approvals.

The occurrence of any event or penalty described above

may limit our ability to commercialize our compounds and generate revenue and could require us to expend significant time and resources

in response or generate negative publicity.

If any of our compounds are approved, our product

labeling, advertising and promotion will also be subject to regulatory requirements and ongoing regulatory review.

The FDA strictly regulates

the promotional claims that may be made about drug products.

In particular, a drug may not be promoted for uses that are not approved

by the FDA as reflected in the drug’s approved labeling.

If we receive marketing approval for a compound, physicians may nevertheless

lawfully prescribe it to their patients in a manner that is inconsistent with the approved label.

While the FDA recently clarified that

mere knowledge that a physician is prescribing an approved drug for off-label use is not sufficient to constitute unlawful off-label promotion,

if we are found to have actively promoted such off-label uses, we may become subject to significant liability under the FDCA.

government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies

from engaging in off-label promotion.

Additionally, promotion for off-label uses could result in significant liability under the False

The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional

conduct is changed or curtailed.

The FDA’s and other regulatory authorities’

policies are subject to change at any time, and additional government regulations may be enacted that could prevent, limit or delay regulatory

approval of our compounds.

If we are unable to timely adapt to changes in existing requirements or the adoption of new requirements or

policies, or if we are not able to maintain regulatory compliance post-marketing, we may lose any marketing approval that we may have

obtained, and we may not achieve or sustain profitability.

Finally, we cannot predict the likelihood, nature

or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United

States or abroad.

It is difficult to predict how any such legislative, administrative or executive actions will be implemented, and the

extent to which they will impact the FDA’s ability to exercise its regulatory authority.

If these legislative or executive actions

impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business

may be negatively impacted.

Changes in funding for the FDA, the SEC and

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the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also

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

Disruptions at the FDA and other agencies may

also slow the time necessary for new drugs 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 and certain regulatory agencies, such

as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities.

government has shut down several times, including the

longest government shutdown that began on October 1, 2025 and ended November 13, 2025, and certain regulatory agencies, such as the

FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities.

If a prolonged

government shutdown occurs, 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.

government shutdown occurs, 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.

Our business could be affected by litigation,

government investigations and enforcement actions.

We currently operate in a number of jurisdictions

in a highly regulated industry and we could be subject to litigation, government investigation and enforcement actions on a variety of

matters in the United States or foreign jurisdictions, including, without limitation, intellectual property, regulatory, product liability,

environmental, whistleblower, false claims, privacy, anti-kickback, anti-bribery, securities, commercial, employment and other claims

and legal proceedings which may arise from conducting our business.

In the ordinary course as a public company, the SEC and other U.S.

and foreign regulatory and governmental agencies have initiated and may in the future initiate requests, comments and/or investigations

regarding legal, regulatory and compliance matters of the Company.

We have cooperated, and will in the future cooperate, on any such matters

with such regulatory and governmental agencies, and such matters could require us to expend significant time, attention and resources.

Any determination that our operations or activities are not in compliance with existing laws or regulations could result in the imposition

of fines, civil and criminal penalties, equitable remedies, including disgorgement, injunctive relief and/or other sanctions against us,

and remediation of any such findings could have an adverse effect on our business operations.

Legal proceedings, government investigations and enforcement

actions can be expensive and time-consuming.

An adverse outcome resulting from any such proceedings, investigations or enforcement actions

could result in significant damages, awards, fines, penalties, exclusion from the federal healthcare programs, healthcare debarment, injunctive

relief, product recalls, reputational damage and modifications of our business practices, which could have a material adverse effect on

our business and results of operations.

Even if such a proceeding, investigation or enforcement action is ultimately decided in our favor,

the investigation and defense thereof could require substantial financial and management resources.

Changes in U.S.

and international trade policies

may adversely impact our business and operating results.

government has made statements and taken

actions that have led to certain changes and may lead to additional changes to U.S.

and international trade policies.

For example, President

Trump has imposed or signaled to impose a series of tariffs on certain products manufactured outside the United States, including

pharmaceutical products and raw materials and components for pharmaceutical products, and it is unknown whether and to what extent additional tariffs (or

other new laws or regulations) will be adopted, or the effect that any such actions would have on us or our industry.

Such unfavorable

government policies on international trade, such as export controls, capital controls or tariffs, may affect the import and export

of materials and products used in our drug development.

For example, we have already faced increased costs associated with our imports

of drug products due to newly imposed tariffs on Canada.

These policies may also affect the demand for our product candidates, the competitive

position of our product candidates, and clinical manufacturing and future commercial activities.

If any new tariffs, export controls,

legislation and/or regulations are implemented, or if existing trade agreements are renegotiated or if the U.S.

government takes retaliatory

trade actions due to the ongoing trade tensions, such changes could have an adverse effect on our business, financial condition and results

of operations.

We receive Australian government research

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a negative effect on our future cash flows.

Additionally, although the

Company believes that it has complied with all the relevant conditions of eligibility under the program for all periods claimed, the ATO

has the right to review the Company’s qualifying programs and related expenditures for a period of four years.

If such a review

were to occur, the ATO may have different interpretations of certain eligibility requirements.

If the ATO disagreed with the Company’s

assessments and any related subsequent appeals, it could require adjustment to and repayment of current or previous years’ claims

already received.

Additionally, if the Company was unable to demonstrate a reasonably arguable position taken on such claims, the ATO

could also assess penalties and interest on any such adjustments.

A variety of risks are associated with operating

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state taxes owed.

We conducted a Section 382 study during the year ended

September 30, 2021 and determined that, during the year ended September 30, 2015, there was a change in ownership which resulted in $25.8

million of federal NOLs being subject to an annual limitation.

During the year ended September 30, 2021, we reduced our federal NOLs by

$12.1 million and our research and development tax credit carryforwards by $0.8 million, which are the amount of tax assets that will

expire unutilized pursuant to the Section 382 study.

This resulted in a reduction of $2.5 million of NOLs and $0.8 million of research

and development credits and a corresponding reduction in the valuation allowance of $3.3 million, which was recorded in the 2021 fiscal

Subsequent ownership changes in future years could trigger additional limitations of our NOLs.

During the year ended September 30,

2024 and 2023, we determined that there were no changes in ownership pursuant to Section 382.

The Company conducts a Section 382 study annually

and has reduced its federal NOLs by $12.1 million and its Research and Development tax credit carryforwards by $0.8 million, which are

the amount of tax assets that will expire unutilized pursuant to Section 382.

Subsequent ownership changes in future years could trigger

additional limitations of the Company’s NOLs .

During the year ended September 30, 2025, the

Company determined that there were no changes in ownership pursuant to Section 382.

We are subject to healthcare laws and regulations

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actions HHS can take to advance these principles.

In addition, the IRA, among other things, (1) directs HHS to negotiate the price of

certain single-source drugs and biologics covered under Medicare and (2) imposes rebates under Medicare Part B and Medicare Part D to

penalize price increases that outpace inflation.

These provisions will take effect progressively starting in fiscal year 2023, although

they may be subject to legal challenges.

It is currently unclear how the IRA will be implemented but is likely to have a significant impact

on the pharmaceutical industry.

If any of our products are subject to such negotiation, we may lose a significant amount of the revenues

expected during the full life cycle of these products.

Further, the Biden administration released an additional executive order on October

14, 2022, directing HHS to submit a report within 90 days on how the Center for Medicare and Medicaid Innovation can be further leveraged

to test new models for lowering drug costs for Medicare and Medicaid beneficiaries.

We expect that additional U.S.

federal healthcare

reform measures will be adopted in the future, any of which could limit the amounts that the U.S.

federal government will pay for healthcare

products and services, which could result in reduced demand for our product candidates or additional pricing pressures.

In addition, the Inflation Reduction Act of 2022 (“IRA”),

among other things,

(1) directs HHS to negotiate the price of certain single-source drugs and biologics covered under Medicare and (2) imposes rebates under

Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.

These provisions will take effect progressively

starting in fiscal year 2023, although they may be subject to legal challenges.

It is currently unclear how the IRA will be implemented

but is likely to have a significant impact on the pharmaceutical industry.

If any of our products are subject to such negotiation, we

may lose a significant amount of the revenues expected during the full life cycle of these products.

In addition, the current administration

is pursuing other measures to reduce the cost of drugs in the United States.

For example, on July 4, 2025, the 2025 Reconciliation Act,

which reduces funding to federal healthcare programs and imposes additional requirements to be eligible for healthcare, was signed into

Additionally, in April 2025, an executive order was signed directing the Secretary of HHS to take appropriate steps to, among other

things, modify certain provisions of the Medicare Drug Price Negotiation Program, develop and implement a payment model to reduce the

price of high-cost prescription drugs and biological products covered by Medicare, accelerate approval of generic and biosimilar products,

and facilitate the ability of states to import pharmaceuticals from other countries, and in May 2025, an executive order was signed, among

other things, directing the Secretary of HHS to propose rules that impose “most-favored-nation” pricing and take other measures

to reduce the cost of prescription drugs.

It is currently unclear whether and to what extent these measures will be implemented and what

impact any such implementation would have on our business.

Further, there can be no assurance that the current administration or future

administrations will not pursue different or additional measures, such as those intended to more closely align U.S.

drug prices with international

drug prices (often referred to as “reference” or “international price index” drug pricing).

Future price controls

or other changes in pricing regulation or negative publicity related to the pricing of pharmaceutical drugs could restrict the amount

that we are able to charge for our drug products, which could render our product candidates, if approved, commercially unviable and materially

adversely affect our ability to raise additional capital on acceptable terms.

The coverage and reimbursement status of newly

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Risks Related to our Common Stock

A decline in the price of our common stock could

affect our ability to raise further working capital and adversely impact our operations and would severely dilute existing or future investors

if we were to raise funds at lower prices.

A prolonged decline in the price of our common stock

could result in a reduction in our ability to raise capital.

Because our operations have been financed through the sale of equity securities,

a decline in the price of our common stock could be especially detrimental to our continued operations.

Any reduction in our ability to

raise equity capital in the future would force us to reallocate funds from other planned uses and would have a significant negative effect

on our business plans and operations, including our ability to develop new products and continue our current operations.

price declines, there can be no assurance that we can raise additional capital or generate funds from operations sufficient to meet our

We believe the following factors could cause the market price of our common stock to continue to fluctuate widely and could

cause our common stock to trade at a price below the price at which you purchase your shares of common stock:

actual or anticipated variations in our quarterly operating results;

announcements of new services, products, acquisitions or strategic relationships by us or our competitors;

changes in accounting treatments or principles;

changes in earnings estimates by securities analysts and in analyst recommendations;

general political, economic, regulatory and market conditions.

The market price for our common stock may also be

affected by our ability to meet or exceed expectations of analysts or investors.

Any failure to meet these expectations, even if minor,

could materially adversely affect the market price of our common stock.

If we issue additional shares of common stock

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developments concerning our collaborations or partners;

the impact of the COVID-19 outbreak and its effect on us;

the perception of the biotechnology or pharmaceutical industries by the public, legislatures, regulators and the investment community;

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shares in those companies at an inflated rate face the risk of losing a significant portion of their original investment as the price

per share has declined steadily as interest in those stocks have abated.

per share has declined steadily as interest in those stocks has abated.

There can be no assurance that we will not in the future be a

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is significantly disconnected from our underlying value.

If we fail to maintain an effective system of

internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud.

stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of

our common stock.

Pursuant to Section 404 of the Sarbanes-Oxley Act,

our management is required to report upon the effectiveness of our internal control over financial reporting.

We cannot assure you that

there will not be material weaknesses or significant deficiencies in our internal control over financial reporting in the future.

failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition,

results of operations or cash flows.

If we are unable to conclude that our internal control over financial reporting is effective, or

if our independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal

control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports, the market

price of our common stock could decline, and we could be subject to sanctions or investigations by the Nasdaq Stock Market, the SEC or

other regulatory authorities.

Failure to remedy any material weakness in our internal control over financial reporting, or to implement

or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

Our disclosure controls and procedures may not

prevent or detect all errors or acts of fraud.

We are subject to the periodic reporting requirements

of the Exchange Act.

We designed our disclosure controls and procedures to reasonably assure that information we must disclose in reports

we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported

within the time periods specified in the rules and forms of the SEC.

We believe that any disclosure controls and procedures or internal

controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives

of the control system are met.

These inherent limitations include the realities that judgments in decision-making can be faulty, and that

breakdowns can occur because of simple error or mistake.

For example, our directors or executive officers could inadvertently fail to

disclose a new relationship or arrangement causing us to fail to make a required related party transaction disclosure.

Additionally, controls

can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls.

Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

Risks Related to our Intellectual Property

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We seek to protect our proprietary position by filing patent applications in the United States

and abroad related to our product candidates or by in-licensing intellectual property.

and abroad related to our product candidates and/or by in-licensing intellectual property.

patents related to ANAVEX ® 2-73

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and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or, in some

cases, not at all.

Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our patents or

pending patent applications, or that we were the first to file for patent protection of such inventions.

As a result, the issuance, scope,

validity, enforceability and/or commercial value of our patent rights are highly uncertain.

Our pending and future patent applications

may not result in patents being issued that protect our product candidates, in whole or in part, or which could effectively prevent others

from commercializing competitive product candidates.

Even if our patent applications issue as patents, they may not issue in a form that

will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive

Our competitors may be able to circumvent our patents by developing similar or alternative product candidates in a non-infringing

cases, not at all until issuance.

we cannot know with certainty whether we were the first to make the inventions claimed in

our patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

As a result, the

issuance, scope, validity, enforceability and/or commercial value of our patent rights are highly uncertain.

Our pending and future patent

applications may not result in patents being issued that protect our product candidates, in whole or in part, or which could effectively

prevent others from commercializing competitive product candidates.

Even if our patent applications issue as patents, they may not issue

in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with

any competitive advantage.

Our competitors may be able to circumvent our patents by developing similar or alternative product candidates

in a non-infringing manner.

Moreover, we may be subject to a third-party pre-issuance

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collaborating with us to license, develop or commercialize current or future product candidates.

In addition, the issuance of a patent is not conclusive

as to its inventorship, scope, validity and/or enforceability, and our patents may be challenged in the courts or patent offices in the

United States and abroad.

Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed,

invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar

or identical product candidates, or limit the duration of the patent protection of our product candidates.

Given the amount of time required

for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or

shortly after such candidates are commercialized.

As a result, our patent portfolio may not provide us with sufficient rights to exclude

others from commercializing drugs similar or identical to ours.

We hold ownership or exclusive rights to twenty-two

patents, twenty-three U.S.

patent applications, and various PCT or ex-U.S.

patent applications relating to our drug candidates, methods

associated therewith, and to our research programs.

Neither patents nor patent applications ensure the protection of our intellectual

property for a number of reasons, including the following:

In addition, while U.S.

patents have a presumption

of validity, our patents may be challenged in the courts or patent offices in the United States and abroad.

Such challenges may result

in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part,

which could limit our ability to stop others from using or commercializing similar or identical product candidates, or limit the duration

of the patent protection of our product candidates.

Given the amount of time required for the development, testing and regulatory review

of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing drugs similar or identical

We hold ownership or exclusive rights to thirty (30)

patents, seventeen (17) pending U.S.

patent applications, and numerous PCT and ex-U.S.

patents and patent applications relating to

our drug candidates, methods associated therewith, and to our research programs.

Neither patents nor patent applications necessarily ensure

the protection of our intellectual property for a number of reasons, including the following:

Competitors may interfere with our patenting process in a variety of ways.

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If we receive a patent of narrow scope, then it may be possible for competitors to design products that do not infringe our patent(s).

We are seeking patent protection for a number of indications, combination products and drug regimens.

We have patents covering, and are seeking patent protection for a number of indications, combination products and drug regimens.

The lack of patent protection in global markets for a specific end product or indication may inhibit our ability to advance our compounds and may make us less attractive to potential partners.

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Redesigning our potential drug compounds so that they do not infringe on other patents may not be possible or could require substantial funds and time.

It is also unclear whether our trade secrets are adequately

While we use reasonable efforts to protect our trade secrets, our employees or consultants may unintentionally or willfully

disclose our information to competitors.

Enforcing a claim that someone illegally obtained and is using our trade secrets, like patent

litigation, is expensive and time consuming, and the outcome is unpredictable.

In addition, courts outside the United States are sometimes

less willing to protect trade secrets.

Our competitors may independently develop equivalent knowledge, methods and know-how.

While we use reasonable efforts to protect our trade

secrets, our employees or consultants may unintentionally or willfully disclose our information to competitors.

Enforcing a claim that

someone illegally obtained and is using our trade secrets, like patent litigation, is expensive and time consuming, and the outcome is

unpredictable.

In addition, courts outside the United States are sometimes less willing to protect trade secrets.

Our competitors may

independently develop equivalent knowledge, methods and know-how.

We may also support and collaborate in research conducted

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information and techniques.

For example, any of these parties may breach the agreements and disclose our proprietary information, including

any of these parties may breach the agreements and disclose our proprietary information, including

our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

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Since patent applications in the United States and most other countries are confidential for a period of time after filing

or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our

or until issuance,

we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our

product candidates or (ii) invent any of the inventions claimed in our or our licensor’s patents or patent applications.

21 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-K

Item 1A. Risk Factors