What changed in this filing

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Item 1A. Risk Factors

2026-03-31 compared with 2025-03-28 · 229 added, 232 removed, 1552 unchanged (23% of the section changed)

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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.

are an early development-stage company with no revenues.

report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025

contains an explanatory paragraph relating 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.

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

have yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all.

of interest may arise between us and MIRALOGX.

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

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.

product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate

revenue from new products

product liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the

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

employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

or regulatory reform of the health care system in the U.S.

may affect our ability to profitably sell our products, if approved.

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

Related to Development and Regulatory Approval of Our Product Candidates

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of clinical trials are open to differing interpretations.

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

trials of synthetic cannabinoid drug candidates and ketamine analogs are novel with very limited or non-existing history;

we face a significant

risk that the trials will not result in commercially viable drugs and treatments.

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

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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.

depend on a limited number of suppliers for materials and components required to manufacture our product candidates.

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

Related to Our Intellectual Property

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

have no patent protection for MIRA-55, which could adversely impact MIRA-55’s potential competitive position.

Related to SKNY and SKNY-1

has yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all.

does not own rights to SKNY-1

of interest may arise between SKNY and MIRALOGX.

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 the speculative nature of investment risk, 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.

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

the market price of our common stock.

we fail to maintain compliance with Nasdaq Listing Rules, our shares may be delisted from Nasdaq, which would result in a limited trading

market for our shares and make obtaining future debt or equity financing more difficult for the us.

Related to Our Operations and Financial Condition

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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.

However, although we have received net proceeds of $6.7 million for the year ended

December 31, 2025 and $3.6 million for the year ended December 31, 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, 2025

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

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.

auditor’s opinion on our audited financial statements for the year ended December 31, 2025 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 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.

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

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us to favorably resolve such disputes.

Aminov, the Chief Executive Officer of the Company, is also the son-in-law of Jonnie Williams, the owner of MIRALOGX.

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

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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.

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

Weichselbaum 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.

Relating to Our Business and Our Industry

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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.

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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FDA may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product

we are unable to obtain regulatory approval for Ketamir-2 and MIRA-55 within the timeline we anticipate, we will not be able to execute

our business strategy effectively and our ability to substantially grow our revenues will be limited, which would have a material adverse

impact on our long-term business, results of operations, financial condition, and prospects.

we are unable to obtain regulatory approval for Ketamir-2, MIRA-55 and SKNY-1 within the timeline we anticipate, we will not be able

to execute our business strategy effectively and our ability to substantially grow our revenues will be limited, which would have a material

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

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

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Our ability to successfully commercialize our product candidates will depend on, among other things, our ability

complete pre-clinical and other nonclinical studies and clinical trials in a manner that allows us to progress our studies;

complete pre-clinical and other nonclinical studies and clinical trials in a manner that allows us to progress our product candidates;

IND acceptance and regulatory approvals from the FDA;

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

In addition, our interpretation of results derived from

clinical data or our conclusions based on our pre-clinical data may prove inaccurate.

Frequently, pharmaceutical and biotechnology companies

have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical testing and early phase clinical

trials, and we cannot be certain that we will not face similar setbacks.

These setbacks may be caused by the fact that pre-clinical and

clinical data can be susceptible to varying interpretations and analyses.

In addition, our interpretation of results derived

from clinical data or our conclusions based on our pre-clinical data may prove inaccurate.

Frequently, pharmaceutical and biotechnology

companies have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical testing and early phase

clinical trials, and we cannot be certain that we will not face similar setbacks.

These setbacks may be caused by the fact that pre-clinical

and clinical data can be susceptible to varying interpretations and analyses.

Furthermore, certain product candidates may perform satisfactorily

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with third parties, our product revenues may suffer.

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

laws in marketing Ketamir-2 and MIRA-55 or our other product candidates to physicians for their approved uses.

In addition, we must continue

to train our sales force to ensure that a consistent and appropriate message about Ketamir-2 and MIRA-55 or our other product candidates

are being delivered to our potential customers.

If we are unable to effectively train our sales force and equip them with effective materials,

including medical and sales literature, to help them inform and educate potential customers about the benefits of Ketamir-2 and MIRA-55

and our product candidates and its proper administration, our efforts to successfully commercialize Ketamir-2 and MIRA-55 and our product

candidates could be jeopardized, which would negatively impact our ability to generate product revenues.

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.

management and personnel, systems, and facilities currently in place may not be adequate to support our business plan and future growth.

As a result, we may need to further expand certain areas of our organization.

need to effectively manage our operations, growth and various projects requires that we:

to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures;

and retain enough talented employees;

our clinical trials effectively;

our external manufacturing operations with contract research organizations effectively and in a cost-effective manner;

our development efforts effectively while carrying out our contractual obligations to contractors and other third parties;

addition, we may utilize the services of part-time outside consultants and contractors to perform several tasks for us, including tasks

related to compliance programs, clinical trial management, regulatory affairs, formulation development and other drug development functions.

Our growth strategy may entail expanding our use of consultants and contractors to implement these and other tasks going forward.

we are not able to effectively expand our organization by hiring new employees and expanding our use of consultants and contractors,

we may be unable to successfully implement the tasks necessary to effectively execute on our planned research, development, manufacturing,

and commercialization activities and, accordingly, may not achieve our research, development and commercialization goals.

product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate

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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.

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

business 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

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,

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, the U.S.

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.

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.

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.

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.

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

trade 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 by them.

global 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.

Sanctions 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.

addition, 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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of the foregoing could have a material adverse effect on our business, results of operations and financial condition.

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

are subject to extensive regulation by U.S.

federal and state governments in each of the markets where we have product candidates progressing

through the approval process.

must also adhere to all regulatory requirements including FDA’s Good Laboratory Practice, Good Clinical Practice, and current Good

Manufacturing Practices requirements (“cGMP”) pharmacovigilance requirements, advertising, and promotion restrictions, reporting

and recordkeeping requirements.

If we or our suppliers fail to comply with applicable regulations, including FDA pre-or post-approval

cGMP requirements, then FDA could sanction us.

Even if a drug is FDA-approved, regulatory authorities may impose significant restrictions

on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials.

and MIRA-55, and any of our product candidates that may be approved in the U.S.

in the future, will be subject to ongoing regulatory

requirements for manufacturing, labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping

and submission of safety and other post-market information, including both federal and state requirements in the U.S.

In addition, manufacturers

and manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and

manufacturing procedures conform to GMP.

As such, we, and our contract manufacturers (in the event contract manufacturers are appointed

in the future) are subject to continual review and periodic inspections to assess compliance with GMP.

Accordingly, we and others with

whom we work must continue to spend time, money, and effort in all areas of regulatory compliance, including manufacturing, production,

quality control and quality assurance.

We will also be required to report certain adverse reactions and production problems, if any,

to the FDA, and to comply with requirements concerning advertising and promotion for our products.

Promotional communications with respect

to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the

product’s approved label.

a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency,

or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of the product,

it may impose restrictions on that product or us, including requiring withdrawal of the product from the market.

If we fail to comply

with applicable regulatory requirements, a regulatory agency or enforcement authority may:

untitled or warning letters;

to enjoin our activities;

civil or criminal penalties;

regulatory approval;

any of our ongoing clinical trials;

to approve pending applications or supplements to approved applications submitted by us;

restrictions on our operations, including by requiring us to enter into a Corporate Integrity Agreement or closing our contract manufacturers’

facilities, if any;

or detain products or require a product recall.

addition, any government investigation of alleged violations of law could require us to expend significant time and resources in response

and could generate negative publicity.

Any failure to comply with ongoing regulatory requirements may significantly and adversely affect

our ability to commercialize and generate revenue from our product candidates.

If regulatory sanctions are applied or if regulatory approval

is withdrawn, the value of our business and our operating results may be adversely affected.

action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses,

divert our management’s attention from the operation of our business and damage our reputation.

We expend significant resources

on compliance efforts and such expenses are unpredictable and might adversely affect our results.

Changing laws, regulations and standards

might also create uncertainty, higher expenses and increase insurance costs.

As a result, we intend to invest all reasonably necessary

resources to comply with evolving standards, and this investment might result in increased management and administrative expenses and

a diversion of management time and attention from revenue-generating activities to compliance activities.

are subject to federal and state healthcare laws and regulations and implementation of or changes to such healthcare laws and regulations

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customers and cause them to turn to our competitors for future needs.

maintain our cash at financial institutions, at times in balances that exceed federally insured limits.

The failure of financial institutions

could adversely affect our ability to pay operational expenses or make other payments.

cash held in non-interest-bearing and interest-bearing accounts can at times exceed the Federal Deposit Insurance Corporation (“FDIC”)

insurance limits.

If such banking institutions were to fail, we could lose all or a portion of those amounts held in excess of such insurance

In addition, even if account holders are ultimately made whole with respect to a future bank failure, account holders’

access to their accounts and assets held in their accounts may be substantially delayed.

Any material loss that we may experience in

the future or inability for a material time period to access our cash and cash equivalents could have an adverse effect on our ability

to pay our operational expenses or make other payments, which could adversely affect our business.

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

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price levels and third-party reimbursement for MIRA-55, any of which would materially affect our business.

Related to SKNY and SKNY-1

has yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all.

has not yet produced any revenues or profit and may not for many years, if at all.

SKNY’s ability to generate revenue is dependent

on the receipt of regulatory approval of SKNY’s product candidates, which will take years to achieve and may not be obtained.

therefore cannot assure you SKNY will be able to ever generate sufficient revenue to pay for SKNY’s expenses or achieve profitability.

SKNY’s ability to continue as a going concern in the future is dependent upon raising capital from financing transactions and keeping

operating expenses below SKNY’s revenue levels in order to achieve positive cash flows, none of which can be assured.

does not own rights to SKNY-1.

of SKNY’s rights in SKNY-1 are granted to it under a license (“License”) from MIRALOGIX LLC, a Florida corporation

(“Licensor”), so SKNY does not have an ownership interest in SKNY-1.

The License give SKNY the right to make, use and sell

SKNY-1 only in the US, Canada, and Mexico.

The Licensor retained the rights to SKNY-1 everywhere outside of the US, Canada and Mexico.

If SKNY breaches the License or if the Licensor goes bankrupt, SKNY could lose its rights to SKNY-1 and all of such rights would revert

back to the Licensor.

Further, Licensor will control the process of applying for and obtaining any patents or other intellectual property

rights in SKNY-1, all at the expense of SKNY.

All of such patents and intellectual rights will be owned by Licensor, subject to SKNY’s

rights under the License.

Furthermore, SKNY has no control over the patent prosecution strategy, which is fully managed by the Licensor.

rights to SKNY-1 are subject to royalties.

entered into an exclusive licensing agreement with MIRALOGIX LLC, a Florida corporation (“MIRALOGIX”) for the licensing by

MIRALOGX to SKNY the commercial rights of SKNY-1, or M308 (the “SKNY-1 Licensing Agreement”) in the United States, Mexico

Under the SKNY-1 Licensing Agreement SKNY will owe MIRALOGX a royalty of 8% on all revenue it receives from SKNY-1, with

a minimum annual royalty of $250,000 that begins in the first year that there is any revenue from SKNY-1.

This $250,000 will be owed

even if in any later year there is no revenue from SKNY-1 or if the 8% royalty rate on actual revenues yields less than $250,000.

failure to pay minimum royalties in any year would be a breach of the SKNY-1 Licensing Agreement and such breach would let the Licensor

terminate SKNY’s rights to SKNY-1.

of interest may arise between SKNY and MIRALOGX.

is the license of SKNY’s rights to SKNY-1.

MIRALOGX is a separate intellectual property development company owned by the Bay Shore

The Bay Shore Trust is also SKNY’s largest stockholder.

MIRALOGX is 100% owned by the Bay Shore Trust.

SKNY’s relationship

with MIRALOGX and the Bay Shore Trust may create, or may create the appearance of, conflicts of interest when SKNY is faced with decisions

that benefit MIRALOGIX but do not benefit other holders of MIRA Common Stock.

Furthermore, in light of the license agreement that SKNY

has with MIRALOGX, if a dispute were to arise between MIRALOGX and MIRA relating to SKNY’s past or future relationship with MIRALOGX

or with respect to intellectual property matters, there could be a conflict of interest that may make it more difficult for SKNY to resolve

such disputes on terms that are acceptable to SKNY.

product candidates, if approved, may not achieve the expected market acceptance and, consequently, limit SKNY’s ability to generate

when product development is successful and regulatory approval has been obtained, SKNY’s ability to generate sufficient revenue

depends on the acceptance of its products by physicians and patients.

There is no assurance that SKNY’s product candidates will

achieve the expected level of market acceptance and revenue if and when they obtain the requisite regulatory approvals.

The market acceptance

of any product 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 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, the price of the product, the nature of any post-approval risk management activities mandated by regulatory authorities, competition,

and marketing and distribution support.

Further, an ineffective or inefficient distribution model at launch may lead to the inability

to fulfill demand, and consequently a loss of revenue.

Any factors preventing or limiting the market acceptance of SKNY’s products

could have a material adverse effect on SKNY’s business, results of operations and financial condition.

expects to face intense competition, often from companies with greater resources and experience than it has.

for SKNY’s product candidates will likely be dependent on a number of social, political, legislative, and economic factors that

are beyond its control.

While we believe that there will be a demand for such drugs, and that the demand will grow, there is no assurance

that such demand will happen, that we will benefit from any demand or that its business, in fact, will ever generate revenues from its

drug development programs or become profitable.

emerging markets for product candidates like SKNY’s and related medical research and development is and will likely remain competitive.

The development and commercialization of drugs and medicines is highly competitive.

SKNY competes with a variety of multinational pharmaceutical

companies and specialized biotechnology companies, as well as products and processes being developed by universities and other research

institutions.

Many of SKNY’s competitors have developed, are developing, or will develop drugs and processes which may be competitive

with SKNY’s drug candidates.

Competitive therapeutic treatments include those that have already been approved by medicines regulators

and accepted by the medical community and any new treatments that may enter the market.

For some of SKNY’s drug development programs

/ areas of therapeutic interest, other treatment options are currently available, under development, and may become commercially available

in the future.

If any of SKNY’s product candidates are approved for the diseases and conditions SKNY is currently pursuing, they

may compete with a range of medicines or therapeutic treatments that are either in development, will be developed in the future or currently

companies may have a competitive advantage over SKNY due to their size and experiences, financial resources, and institutional networks.

Many of SKNY’s competitors may have significantly greater financial, technical, and human resources than SKNY does.

factors, SKNY’s competitors may have an advantage in marketing their approved drugs and may obtain regulatory approval of their

drug candidates before SKNY is able to, which may limit its ability to develop or commercialize SKNY’s drug candidates.

competitors may also develop drugs / medicines that are safer, more effective, more widely used and less expensive than SKNY’s.

These advantages could materially impact SKNY’s ability to develop and, if approved, commercialize SKNY’s product candidates

successfully.

Furthermore, some of these competitors may make acquisitions or establish collaborative relationships among themselves

or with third parties to increase their ability to rapidly gain market share.

as generic versions of drug products enter the market, the price for such medicines may be expected to decline rapidly and substantially.

Even if SKNY-1 is the first to obtain FDA approval of one of its product candidates, the future potential approval of generics could

adversely affect the price SKNY is able to charge, and the profitability of SKNY’s product(s) will likely decline.

and acquisitions in the pharmaceutical and biotechnology industries may result in more resources being concentrated among a smaller number

of SKNY’s competitors.

Smaller and other early-stage companies may also prove to be significant competitors, particularly through

collaborative arrangements with large and established companies.

companies may compete with SKNY in recruiting and retaining qualified scientific, management and commercial personnel, utilizing contract

manufacturing facilities or contract research organizations (CROs), or establishing clinical trial sites and subject registration for

clinical trials, as well as in acquiring technologies complementary to SKNY’s research projects.

are dependent on SKNY’s current and future product candidates, some of which may not receive regulatory approval or be successfully

commercialized.

ability to progress SKNY’s plan will depend on SKNY’s ability to clinically develop, gain regulatory approval for and ultimately

commercialize SKNY’s product candidates.

SKNY’s ability to successfully commercialize SKNY’s product candidates will

depend on, among other things, SKNY’s ability to:

complete pre-clinical and other nonclinical studies and clinical trials in a manner that allows us to progress SKNY’s studies;

IND acceptance and regulatory approvals from the FDA;

through a validated process, in manufacturing facilities inspected and approved by regulatory authorities, including the FDA, sufficiently

large quantities of product candidates to permit successful commercialization;

reimbursement from payers such as government health care programs and insurance companies and achieve commercially attractive levels

acceptance of SKNY’s product candidates from physicians, health care payers, patients, and the medical community;

positive publicity surrounding SKNY’s product candidates;

SKNY’s spending as costs and expenses increase due to clinical trials and commercialization;

and enforce sufficient intellectual property rights for SKNY’s product candidates.

failure or delay with respect to any of the factors above could have a material adverse effect on SKNY’s business, results of operations

and financial condition.

Relating to the Ownership of our Common Stock

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What changed 10-K

Item 1A. Risk Factors