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Item 1A. Risk Factors

2025-03-28 compared with 2024-04-01 · 283 added, 112 removed, 1501 unchanged (21% of the section changed)

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

business is subject to numerous risks and uncertainties that you should consider before investing in our company.

You should carefully

consider all of the risks described more fully in the section titled “Risk Factors” in this Annual Report on page 19, before

deciding to invest in our common stock.

If any of these risks actually occurs, our business, financial condition and results of operations

would likely be materially adversely affected.

factors that could cause actual results or events to differ materially, but are not limited to, the following:

Related to Our Intellectual Property

depend on rights to Ketamir-2 that are or will be licensed to us.

may not be able to adequately protect our product candidates or our proprietary technology in the marketplace.

third parties claim that our intellectual property, products, processes, or anything else used by us infringes upon their intellectual

property, our operating profits could be adversely affected.

have been granted a license to the right to develop Ketamir-2 in the United States in human and pet application, but we have not been

granted a license to the rights to patents covering Ketamir-2 in foreign jurisdictions.

Related to Our Operations and Financial Condition

are an early development-stage company with no revenues and our financial condition raises substantial doubt as to our ability to continue

as a going concern.

we have a limited operating history, you may not be able to accurately evaluate our operations.

will need to raise additional financing for the continuation of our operations.

operating results may fluctuate, which could have a negative impact on our ability to grow our client base, establish sustainable revenues

and succeed overall.

have yet to achieve a profit and will not achieve a profit in the near future, if at all.

of our executive officers are not employed by us on a full-time basis.

of interest may arise between us and MIRALOGX.

Relating to Our Business and Our Industry

future success will largely depend on the success of Ketamir-2 and MIRA-55 and any future product candidates, which development will

require significant capital resources and years of clinical development effort.

are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.

We may not successfully

integrate with SKNY following our potential upcoming acquisition

of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.

have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement

capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future.

will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing

our growth and executing our growth strategy.

expect to face intense competition, often from companies with greater resources and experience than we have.

have significant and increasing liquidity needs and may require additional funding.

Related to Development and Regulatory Approval of Our Product Candidates

trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination.

of clinical trials are open to differing interpretations.

failure by us to comply with existing regulations could harm our reputation and operating results.

regulatory approval processes with the FDA are lengthy and inherently unpredictable.

is a high rate of failure for drug candidates proceeding through clinical trials.

Related to Our Reliance Upon Third Parties

rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates.

existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect

our ability to develop and commercialize our product candidates.

Relating to the Ownership of Our Common Stock

of the speculative nature of an investment in our company, you may lose your entire investment.

of our founding stockholders, plus our existing officers and directors, control a substantial interest in us and thus may influence certain

actions requiring stockholder vote

Related to Our Operations and Financial Condition

are an early development-stage company with no revenues.

As such, our losses from operations and negative cash flows as of December 31,

2023 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity

2024 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings.

a very early development-stage enterprise that is focused on the development of a pre-clinical pharmaceutical product, we have generated

no revenue and have an accumulated deficit of $29.1 million through December 31, 2024, and $21.3 million through December 31, 2023.

have concluded that substantial doubt exists about our ability to continue as a going concern for the 12 months following

the issuance of the financial statements included in this Annual Report on Form 10-K.

As of the issuance date of these financial statements,

we believe that we have sufficient resources available to support our development activities and business operations and timely satisfy

our obligations as they come due into the fourth quarter of 2024.

We do not have sufficient cash and cash equivalents as of the date

of filing this Annual Report on Form 10-K to support our operations for at least the 12 months following the issuance of the financial

have concluded that substantial doubt exists about our ability to continue as a going concern for the 12 months following the issuance

of the financial statements included in this Annual Report on Form 10-K.

As of the issuance date of these financial statements, we believe

that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations

as they come due into the third quarter of 2025.

We do not have sufficient cash and cash equivalents as of the date of filing this Annual

Report on Form 10-K to support our operations for at least the 12 months following the issuance of the financial statements.

alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional

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that raise substantial doubt about our ability to continue as a going concern.

If none of these alternatives are available,

or if available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business

operations for at least the 12 months following the date the financial statements are issued.

The failure to obtain sufficient capital

on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability

to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be

materially adversely affected.

In addition, the perception that we may not be able to continue as a going concern may

cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.

If none of these alternatives are available, or if available,

are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for

at least the 12 months following the date the financial statements are issued.

The failure to obtain sufficient capital on acceptable

terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our

business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely

In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with

us due to concerns about our ability to meet our contractual obligations.

Additionally,

we filed a shelf registration statement with the SEC to facilitate the issuance of our common stock and entered into an At The Market

Offering Agreement with Rodman & Renshaw LLC, under which we may offer and sell shares of our Common Stock.

The maximum amount eligible

to be sold under the ATM Agreement is $75 million.

However, although we have received net proceeds of $3.6 million during 2024 from the

ATM, there are no assurances that we will be successful in raising any additional capital from the ATM.

report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2024

contains an explanatory paragraph relating to our ability to continue as a going concern .

auditor’s opinion on our audited financial statements for the year ended December 31, 2023 includes an explanatory paragraph stating

that we have incurred recurring losses from operations that raise substantial doubt about our ability to continue as a going concern.

While we believe that we will be able to obtain the capital we need to continue our operations, there can be no assurances that we will

be successful in these efforts or will be able to resolve our liquidity issues or eliminate our operating losses.

If we are unable to

obtain sufficient funding, we would need to significantly reduce our operating plans and curtail some or all of our development efforts.

Accordingly, our business, prospects, financial condition, and results of operations will be materially and adversely affected, and we

may be unable to continue as a going concern.

If we seek additional financing to fund our business activities in the future

and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources

may be unwilling to provide additional funding on commercially reasonable terms or at all.

The auditor’s opinion on our audited financial statements for the

year ended December 31, 2024 includes an explanatory paragraph stating that we have no revenue and incurred recurring losses from operations

and cash used in operations that raise substantial doubt about our ability to continue as a going concern.

While we believe that we will

be able to obtain the capital we need to continue our operations, there can be no assurances that we will be successful in these efforts

or will be able to resolve our liquidity issues or eliminate our operating losses.

If we are unable to obtain sufficient funding, we would

need to significantly reduce our operating plans and curtail some or all of our development efforts.

Accordingly, our business, prospects,

financial condition, and results of operations will be materially and adversely affected, and we may be unable to continue as a going

If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability

to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable

terms or at all.

may not be successful in the integration of our potential acquisition of SKNY.

discussed earlier in this Annual Report of Form 10-K, we have entered into a binding letter of intent to acquire SKNY.

Integrating SKNY’s

business, processes, and operations presents new risks to the business that must be managed carefully.

If not, it could have a material

impact on operations and cause results to differ significantly from expectations.

Ac quisitions

involve a number of risks and difficulties, including:

(i) expansion into new markets and business ventures;

(ii) the requirement

to understand local business practices;

(iii) the diversion of management’s attention to the assimilation of acquired operations

and personnel;

(iv) being bound by client or vendor contracts with unfavorable terms;

and (v) potential adverse effects on

a company’s operating results for various reasons, including, but not limited to, the following items:

(a) the inability to

achieve financial targets;

(b) the inability to achieve certain operating goals and synergies;

or acquired contracts or activities;

(d) costs incurred to service any acquisition debt;

and (e) the amortization or impairment

of intangible assets.

the multiple risks and difficulties associated with any acquisition, there can be no assurance that we will be successful in achieving

our expected strategic, operating, and financial goals for any such acquisition.

we have a limited operating history, you may not be able to accurately evaluate our operations.

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For the year ended December 31, 2024, we reported a net operating

cash outflow of $4.5 million and a net cash inflow from investing activities of $8.8 million.

For the year ended December 31, 2022,

we reported a net operating cash outflow of $5.6 million and a net cash inflow from investing activities of $3.1 million.

cash outflow of $5.6 million and a net cash inflow from financing activities of $3.8 million.

For the year ended December 31, 2023, we

reported a net operating cash outflow of $4.5 million and a net cash inflow from financing activities of $8.8 million.

and development, and general and administrative expenses, and cash used for operations will continue to be significant and may increase

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timing of FDA approval, if any;

DEA continuing to classify Ketamir-2 and MIRA1a as a substance not subject to CSA;

DEA granting the classification of MIRA-55 as a substance not subject to CSA;

DEA continuing to classify Ketamir-2 as a substance not subject to CSA;

DEA continuing to classify MIRA-55 as a substance not subject to CSA;

timing and amount of revenue from sales of our products, or revenue from grants or other sources;

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of our executive officers will not be employed by us on a full-time basis.

Aminov, our Chairman and Chief Executive Officer, will not be employed by our company on full-time basis.

As provided in his respective

employment agreement with our company, Mr.

Aminov is expected to devote approximately fifty percent (50%) of his business time to the

affairs of our company.

Because this officer will not work full time for our company, instances may occur where he may not be immediately

available to provide solutions to problems or address concerns that arise in the course of us conducting our business and thus adversely

affect our business.

In addition, he can become subject to conflicts of interest because he devotes part of his working time to other

business endeavors and has responsibilities to other entities.

Although such officer is aware of his duty and accountability to our company

and to applicable laws and policies relating to corporate opportunity and conflicts of interest, such conflicts of interest may include

deciding how much time to devote to our affairs, as well as what business opportunities should be presented to us.

Aminov, our Chief Executive Officer and Chairman of our board of directors, is not employed by our company on a full-time basis.

to be provided in his employment agreement with our company, he works on a part-time and as-needed basis.

Because he does not work full

time for our company, instances may occur where he may not be immediately available to provide solutions to problems or address concerns

that arise in the course of us conducting our business and thus adversely affect our business.

In addition, he can become subject to

conflicts of interest because he devotes part of his working time to other business endeavors and may have responsibilities to other

Aminov is aware of his duties and accountability to our company and to applicable laws and policies relating to

corporate opportunity and conflicts of interest, such conflicts of interest may include deciding how much time to devote to our affairs,

as well as what business opportunities should be presented to us.

Yanez, our Chief Financial Officer, is not employed by our company on a full-time basis.

As intended to be provided in her employment

agreement with our company, she works on a part-time and as-needed basis.

Because she does not work full time for our company, instances

may occur where she may not be immediately available to provide solutions to problems or address concerns that arise in the course of

us conducting our business and thus adversely affect our business.

In addition, she can become subject to conflicts of interest because

she devotes part of her working time to other business endeavors and may have responsibilities to other entities.

Although Mrs.

is aware of her duties and accountability to our company and to applicable laws and policies relating to corporate opportunity and conflicts

of interest, such conflicts of interest may include deciding how much time to devote to our affairs, as well as what business opportunities

should be presented to us.

Relating to Our Business and Our Industry

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will require significant capital resources and years of clinical development effort.

currently have no drug products on the market, and all of our drug development projects are in a pre-clinical stage of development.

business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory approval, and commercialization

of our product candidates, principally Ketamir-2 and MIRA-55.

Investors need to be aware that substantial additional investments including

pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required before we are permitted to

undertake clinical studies and market and commercialize our product candidates, if ever.

It may be several years before we can commence

clinical trials, if ever.

Any clinical trial will be subject to extensive and rigorous review and regulation by numerous government authorities

in the United States and other jurisdictions where we intend, if approved, to market our product candidates.

Before obtaining regulatory

approvals for any of our product candidates, we must demonstrate through pre-clinical testing and clinical trials that the product candidate

is safe and effective for its specific application.

This process can take many years and may include post- marketing studies and surveillance,

which would require the expenditure of substantial resources.

Of the large number of drugs in development for approval in the United

States (and the rest of the world), only a small percentage will successfully complete the FDA regulatory approval financing to fund

our planned research, development, and clinical programs, we cannot assure you that any of our product candidates will be successfully

developed or commercialized.

currently have no drug products on the market, and all of our drug development projects are in a pre-clinical stage of development or

moving into clinical stages.

Our business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory

approval, and commercialization of our product candidates, principally Ketamir-2 and MIRA-55.

Investors need to be aware that substantial

additional investments including pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required

before we are permitted to undertake clinical studies and market and commercialize our product candidates, if ever.

It may be several

years before we can commence clinical trials, if ever.

Any clinical trial will be subject to extensive and rigorous review and regulation

by numerous government authorities in the United States and other jurisdictions where we intend, if approved, to market our product candidates.

Before obtaining regulatory approvals for any of our product candidates, we must demonstrate through pre-clinical testing and clinical

trials that the product candidate is safe and effective for its specific application.

This process can take many years and may include

post- marketing studies and surveillance, which would require the expenditure of substantial resources.

Of the large number of drugs

in development for approval in the United States (and the rest of the world), only a small percentage will successfully complete the

FDA regulatory approval financing to fund our planned research, development, and clinical programs, we cannot assure you that any of

our product candidates will be successfully developed or commercialized.

may be unable to formulate or scale up any or all of our product candidates.

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of global tensions may increase uncertainty of our future operations.

global tensions arising from the Palestine-Israel war and the war in Ukraine may result in disruptions in the broader global

economic environment.

The uncertain nature, magnitude, and duration of hostilities stemming from

such conflicts, including the potential effects of sanctions and countersanctions, or retaliatory cyber-attacks on the world economy

and markets, have contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic factors

that affect our business and operations, such as pre-clinical study issues, manufacturer delays or shipping delays.

global tensions arising from the Palestine-Israel war and the war in Ukraine may result in disruptions in the broader global economic

The uncertain nature, magnitude, and duration of hostilities stemming from such conflicts, including the potential effects

of sanctions and countersanctions, or retaliatory cyber-attacks on the world economy and markets, have contributed to increased market

volatility and uncertainty, which could have an adverse impact on macroeconomic factors that affect our business and operations, such

as pre-clinical study issues, manufacturer delays or shipping delays.

the conflict between Palestine and Israel could impact future business decisions to locate potential clinical trials in Israel.

It is not possible to predict the short and long-term implications of military conflicts or wars or geopolitical tensions which could

include further sanctions, uncertainty about economic and political stability, increases in inflation rate and energy prices, cyber-attacks,

not possible to predict the short and long-term implications of military conflicts or wars or geopolitical tensions which could include

further sanctions, uncertainty about economic and political stability, increases in inflation rate and energy prices, cyber-attacks,

supply chain challenges and adverse effects on currency exchange rates and financial markets.

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positive results from future pre-clinical testing of our product candidates and potential future clinical trials may not necessarily

be predictive of the results from Phase 1, Phase 2 or Phase 3 clinical trials.

be predictive of the results from Phase I, Phase II or Phase III clinical trials.

In addition, our interpretation of results derived from

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Furthermore, certain product candidates may perform satisfactorily

in pre-clinical studies and clinical trials, but nonetheless fail to obtain FDA approval or appropriate approvals by the appropriate

regulatory authorities in other countries.

If we fail to produce positive results in our clinical trials for our product candidates,

the development timeline and regulatory approval and commercialization prospects for them and as a result our business and financial

prospects, would be materially adversely affected.

in pre-clinical studies and clinical trials but nonetheless fail to obtain FDA approval or appropriate approvals by the appropriate regulatory

authorities in other countries.

If we fail to produce positive results in our clinical trials for our product candidates, the development

timeline and regulatory approval and commercialization prospects for them and as a result our business and financial prospects would

be materially adversely affected.

have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement

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with third parties, our product revenues may suffer.

we later determine it is in our best interest to develop a sales force we may be unable to effectively train and equip our sales force,

therefore our ability to successfully commercialize our products may be harmed.

we later determine if it is in our best interest to develop a sales force, we may be unable to effectively train and equip our sales

force, therefore our ability to successfully commercialize our products may be harmed.

will be required to expend significant time and resources to train our sales force to be credible, persuasive and compliant with applicable

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depends on a number of factors, including the indication statement and warnings required by regulatory authorities in the product label.

Market acceptance can also be influenced by continued demonstration of efficacy and safety in commercial use, physicians’ willingness

Market acceptance can also be influenced by continued demonstrations of efficacy and safety in commercial use, physicians’ willingness

to prescribe the product, reimbursement from third-party payers such as government health care programs and private third-party payers,

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Patients may not use our products if coverage is not provided,

or reimbursement is inadequate to cover a significant portion of its cost.

or reimbursement is inadequate to cover a significant portion of their cost.

addition, the market for our products will depend significantly on access to third-party payers’ drug formularies or lists of medications

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Specifically, the import and export process require the issuance of import

and export licenses by the relevant controlled substance authority in both the importing and exporting country.

and export licenses by the relevant controlled substance authority in both the importing and exporting countries.

We may not be granted,

or if granted, maintain such licenses from the authorities in certain countries.

Even if we obtain the relevant licenses, shipments

of Ketamir-2 and MIRA-55 and our product candidates may be held up in transit, which could cause significant delays and may lead to product

Even if we obtain the relevant licenses, shipments of

Ketamir-2 and MIRA-55 and our product candidates may be held up in transit, which could cause significant delays and may lead to product

batches being stored outside required temperature ranges.

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change its position.

We have filed the necessary requirements with the DEA to review MIRA-55, however, there can be

no assurance that the DEA will conclude that MIRA-55 is not a controlled substance or listed chemical.

We have filed the necessary requirements with the DEA to review MIRA-55, however, there can be no assurance that

the DEA will conclude that MIRA-55 is not a controlled substance or listed chemical.

manufacture of our product candidates is complex and uncertain, and until we develop a validated manufacturing process, we may encounter

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and scale-up process of MIRA1a, the intended MIRA1a compound was in fact synthesized as MIRA-55.

our contract manufacturing organizations (“CMOs”) or contract development and manufacturing

organization (“CDMOs”) may be unable to successfully increase the manufacturing scale for our product candidates in

a timely or cost-effective manner and may experience delays due to limited manufacturing capacity.

In addition, quality issues may arise

during manufacturing activities.

If our CMOs or CDMOs are unable to successfully manufacture our product candidates in sufficient quantity

in a timely manner or produce active drug substances that do not meet our quality specifications, our planned pre-clinical or clinical

trials may be delayed or modified.

our contract manufacturing organizations (“CMOs”) or contract development and manufacturing organization (“CDMOs”)

may be unable to successfully increase the manufacturing scale for our product candidates in a timely or cost-effective manner and may

experience delays due to limited manufacturing capacity.

In addition, quality issues may arise during manufacturing activities.

CMOs or CDMOs are unable to successfully manufacture our product candidates in sufficient quantity in a timely manner or produce active

drug substances that do not meet our quality specifications, our planned pre-clinical or clinical trials may be delayed or modified.

may fail to expand our manufacturing capability in time to meet market demand for our products and product candidates, and the FDA may

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market and maintain profitability.

Unfavorable global economic

and geopolitical conditions could adversely affect our business, financial condition, stock price, and results of operations.

could be adversely affected by unstable economic and political conditions within the United States and foreign jurisdictions, including

as a result of an economic downturn and geopolitical events, such as changes in U.S.

federal policy that affect the geopolitical landscape.

Changes to policy implemented by the U.S.

Congress, the Trump administration or any new administration have impacted and may in the future

impact, among other things, the U.S.

and global economy, international trade relations, unemployment, immigration, healthcare, taxation,

regulatory environment, inflation and other areas.

For example, during the prior Trump administration, increased tariffs were

implemented on goods imported into the U.S., particularly from China, Canada, and Mexico.

On February 1, 2025, the U.S.

imposed a 25%

tariff on imports from Canada and Mexico, which were subsequently suspended for a period of one month, and a 10% additional tariff on

imports from China.

Historically, tariffs have led to increased trade and political tensions, between not only the U.S.

and China, but

also between the U.S.

and other countries in the international community.

In response to tariffs, other countries have implemented retaliatory

tariffs on U.S.

Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange

and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions

and the stability of global financial markets.

Any changes in political, trade, regulatory, and economic conditions, including U.S.

policies, could have a material adverse effect on our financial condition or results of operations.

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

credit and financial markets have also generally experienced extreme volatility and disruptions (including as a result of actual or perceived

changes in interest rates, inflation and macroeconomic uncertainties), which has included severely diminished liquidity and credit availability,

declines in consumer confidence, declines in economic growth, high inflation, uncertainty about economic stability, global supply chain

disruptions, and increases in unemployment rates.

The financial markets and the global economy may also be adversely affected by military

conflict, including the ongoing conflicts between Russia and Ukraine, and Israel and Hamas, terrorism, or other geopolitical events.

imposed by the United States and other countries in response to such conflicts, including the one in Ukraine, may also continue to adversely

impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate

market and economic instability.

There can be no assurance that further deterioration in credit and financial markets and confidence in

economic conditions will not occur.

A severe or prolonged economic downturn could result in a variety of risks to our business.

current inflationary trends in the global economy may impact salaries and wages, costs of goods and transportation expenses, among other

things, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures may create

market and economic instability.

We cannot anticipate all of the ways in which the foregoing, and the current economic climate and financial

market conditions generally, could adversely impact our business.

may acquire other companies which could divert our management’s attention, result in additional dilution to our shareholders and

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If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations and technologies

successfully, effectively manage the combined business following the acquisition or realize anticipated cost savings or synergies.

also may not achieve the anticipated benefits from the acquired business due to a number of factors, including:

successfully, or effectively manage the combined business following the acquisition or realize anticipated cost savings or synergies.

We also may not achieve the anticipated benefits from the acquired business due to a number of factors, including:

of acquisition-related costs;

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or termination of a trial by a regulatory agency, such as the FDA, before or after a trial is commenced;

in applicable regulatory policies and regulation, including changes to requirements imposed on the extent, nature, or timing of studies;

in applicable regulatory policies and regulations, including changes to requirements imposed on the extent, nature, or timing of

or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites;

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The active pharmaceutical

ingredient (or API) content shown in INDs can vary from one IND to another – hence it is not necessarily possible to extrapolate

results from studies with one product and predict efficacy of safety with another product containing a similar API and different source.

Whilst the principal synthetic cannabinoid component may be similar, the APIs may differ in terms of minor cannabinoid content, impurity

profiles or degradant profiles.

While we are encouraged by the results of clinical trials by others (where they exist), there can be

no assurance that any pre-clinical study or clinical trial will result in in commercially viable drugs or treatments.

ingredient (or API) content shown in INDs can vary from one IND to another - hence it is not necessarily possible to extrapolate results

from studies with one product and predict efficacy of safety with another product containing a similar API and different source.

the principal synthetic cannabinoid component may be similar, the APIs may differ in terms of minor cannabinoid content, impurity profiles

or degradant profiles.

While we are encouraged by the results of clinical trials by others (where they exist), there can be no assurance

that any pre-clinical study or clinical trial will result in in commercially viable drugs or treatments.

trials are expensive, time consuming and difficult to design and implement.

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for which we may receive regulatory approval.

plan to conduct clinical trials at sites outside the United States.

The FDA may not accept data from trials conducted in such locations,

and the conduct of trials outside the United States could subject us to additional delays and expense.

plan to conduct one or more clinical trials with one or more trial sites that are located outside the United States.

The acceptance by

the FDA or other regulatory authorities of study data from clinical trials conducted outside their jurisdiction may be subject to certain

conditions or may not be accepted at all.

In cases where data from foreign clinical trials are intended to serve as the sole basis for

marketing 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 GCP 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 .

addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data

as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCP requirements

and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary.

Many foreign regulatory authorities

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 comparable 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 could be costly and time-consuming, and which may

result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.

clinical trials outside the United States also exposes us to additional risks, including risks associated with:

additional foreign regulatory requirements;

foreign exchange fluctuations;

compliance with foreign manufacturing, customs, shipment and storage requirements;

cultural differences in medical practice and clinical research;

diminished protection of intellectual property in some countries;

interruptions or delays in our trials resulting from geopolitical events, such as war or terrorism.

regulatory approval processes with the FDA are lengthy and inherently unpredictable.

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actions requiring stockholder vote.

founding stockholders, which include the Bay Shore Trust, and MIRALOGX, collectively

own in excess of 30% of our issued and outstanding common stock.

Our officers and

directors also own shares of our common stock.

Therefore, these entities and individuals could influence the outcome of matters requiring

stockholder approval, including the election of directors and approval of significant corporate transactions.

founding stockholders, which include the Bay Shore Trust, and MIRALOGX, collectively own in excess of 27% of our issued and outstanding

common stock, as well as outstanding warrants.

Our officers and directors also own shares of our common stock.

Therefore, these entities

and individuals could influence the outcome of matters requiring stockholder approval, including the election of directors and approval

of significant corporate transactions.

of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress

22 unchanged sentences

To comply with these requirements, we may need

to hire more employees in the future or engage outside consultants, which will increase its costs and expenses.

to hire more employees in the future or engage outside consultants, which will increase our costs and expenses.

addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for

233 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