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Item 1A. Risk Factors

2026-04-15 compared with 2025-04-11 · 754 added, 1618 removed, 325 unchanged (88% of the section changed)

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Related to Our Business

financial statements have been prepared on a going concern basis;

we must raise additional capital to fund our operations in order

We expect that we will need to raise additional capital to fund our operations in order

to continue as a going concern.

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or those of third-party providers.

Related to our Product Development and Regulatory Approval

we are unable to develop, obtain regulatory approval for and commercialize Isomyosamine, Supera-CBD, or other future product candidates,

or if we experience significant delays in doing so, our business will be materially harmed.

in pre-clinical studies and earlier clinical trials for our product candidates may not be indicative of the results that may be obtained

in later clinical trials, including our Phase 2 clinical trial for Isomyosamine, which may delay or prevent obtaining regulatory approval.

if we complete the necessary pre-clinical studies and clinical trials, we cannot predict when, or if, we will obtain regulatory approval

to commercialize a product candidate and the approval may be for a narrower indication than we seek.

Potential future public

health crises could have a material adverse impact the execution of our planned clinical trials.

product candidate for which we obtain marketing approval will be subject to extensive post-marketing regulatory requirements and

could be subject to post-marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply

with regulatory requirements or if it experiences unanticipated problems with our product candidates, when and if any of them are

development program for Supera-CBD, a synthetic analog of CBD, is uncertain and may not yield commercial results and is subject to

significant regulatory risks.

Related to Commercialization and Manufacturing

commercial success of our product candidates, including Isomyosamine and Supera-CBD, will depend upon their degree of market acceptance

by providers, patients, patient advocacy groups, third-party payors, and the general medical community.

pricing, insurance coverage, and reimbursement status of newly approved products is uncertain.

Failure to obtain or maintain adequate

coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease

our ability to generate product revenue.

third parties on which we depend to conduct our planned pre-clinical studies or clinical trials, do not perform as contractually

required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our development program could be delayed with

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

face significant competition in an environment of rapid pharmacological change and it is possible that our competitors may achieve

regulatory approval before us or develop therapies that are more advanced or effective than ours, which may harm our business, financial

condition and our ability to successfully market or commercialize Isomyosamine, Supera-CBD and our other product candidates.

manufacture of drugs is complex, and our third-party manufacturers may encounter difficulties in production.

If any of our third-party

manufacturers encounter such difficulties, our ability to provide supply of Isomyosamine, Supera-CBD or our other product candidates for

clinical trials, our ability to obtain marketing approval, or our ability to provide supply of our product candidates for patients,

if approved, could be delayed or stopped.

Related to Government Regulation

and future legislation may increase the difficulty and cost for us to commercialize and obtain marketing approval of our product

candidates and may affect the prices we may set.

FDA’s ability to review and approve new products may be hindered by a variety of factors, including budget and funding levels,

ability to hire and retain key personnel, statutory, regulatory and policy changes and global health concerns.

operations and relationships with future customers, providers and third-party payors will be subject to applicable anti-kickback,

fraud and abuse and other healthcare laws and regulations, which could expose us to penalties including criminal sanctions, civil

penalties, contractual damages, reputational harm and diminished profits and future earnings.

have recently shifted our business strategy from pharmaceutical development to laser-based computing for blockchain and high-performance

computing, and we may not successfully develop, validate or commercialize our new technology.

cryptocurrency and blockchain markets are highly volatile, and a sustained downturn in cryptocurrency prices or demand could materially

reduce the market for our laser-based computing products.

if we are successful in developing qc-LPU100 and LPU prototypes, competitors in the industry may achieve technological breakthroughs

that render our systems obsolete or inferior to other technology.

primary source for developing qc-LPU100 and LPU prototypes is through a licensing partnership, and therefore the Company is dependent

upon maintaining and increasing the number of licensing agreements and developing annual recurring revenues through those partnerships,

in order to continue to develop its business.

Related to Our Legacy Pharmaceutical Business

legacy pharmaceutical product candidates, Isomyosamine and Supera-CBD, are subject to extensive clinical development, regulatory

approval, and commercialization risks.

legacy pharmaceutical product candidate that obtains marketing approval would be subject to extensive post-marketing regulatory requirements,

and could be subject to restrictions or withdrawal from the market.

Company’s legacy Supera-CBD program, a synthetic analog of CBD, is in its earliest stages and subject to substantial uncertainty

and significant regulatory risks that could reduce the value of this asset.

commercial viability of our legacy pharmaceutical product candidates is dependent on market acceptance, pricing, reimbursement, and

competition, any of which could reduce the value of these assets.

Company’s legacy pharmaceutical operations are subject to healthcare laws and regulations, including anti-kickback, fraud and

abuse, and healthcare reform legislation, which could affect the value of these pharmaceutical assets.

legacy pharmaceutical operations involve the use of hazardous materials, and we are subject to environmental, health, and safety

laws and regulations.

Related to Our Intellectual Property

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jurisdictions could diminish the value of patents in general, thereby impairing our ability

to protect our product candidates.

to protect our laser-based computing technology and legacy pharmaceutical intellectual property.

Related to Our Preferred Stock

Series F Convertible Preferred Stock (the “Series F Preferred Stock”) and Series F-1 Convertible Preferred Stock

(“Series F-1 Preferred Stock”) provides for the payment of dividends in cash or in shares of our Common Stock.

such dividends in shares of Common Stock, it may result in dilution to existing investors.

of our Series F Preferred Stock, Series F-1 Preferred Stock and Series G Convertible Preferred Stock (“Series

G Preferred Stock”) are entitled to certain payments under the Certificate of Designation that may be paid in cash or

in shares of Common Stock depending on the circumstances.

If we make these payments in cash, it may require the expenditure of a

substantial portion of our cash resources.

If we make these payments in Common Stock, it may result in substantial dilution to the

holders of our Common Stock.

certificate of designation for the Series F Preferred Stock, Series F-1 Preferred Stock, Series G Preferred Stock and the warrants

issued concurrently therewith contain anti-dilution provisions that may result in the reduction of the conversion price of the

Series F Preferred Stock or the exercise price of such warrants in the future.

These features may result in an indeterminate number

of shares of Common Stock being issued upon conversion of the Series F Preferred Stock, Series F-1 Preferred Stock, Series G Preferred Stock or exercise of the warrants.

Series H Convertible Preferred Stock (the “Series H Preferred Stock”) and Series G Convertible Preferred Stock

(“Series G Preferred Stock”) provide for the payment of dividends in cash, in shares of our Common Stock or in

additional shares of Series G Preferred Stock, as applicable.

If we pay such dividends in shares of Common Stock, it may result in

dilution to existing investors.

Certain outstanding shares of preferred stock and common stock purchase warrants of the Company contain anti-dilution

provisions that may result in the reduction of the conversion price of the applicable preferred stock or the exercise price of such warrants

in the future.

These features may increase the number of shares of Common Stock being issuable upon conversion of such preferred stock

or upon the exercise of such warrants.

The Series H Certificate of Designations and Series H Purchase Agreement, as well as the Series G Certificate of

Designations and the Series G Purchase Agreement contain restrictive covenants and terms that may make it difficult to procure additional

financing and that may affect our financial condition and results of operations.

addition, we face other business, financial, operational and legal risks and uncertainties set forth under “Risk Factors”

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Related to our Business

financial statements have been prepared on a going concern basis;

we must raise additional capital to fund our operations in order to

continue as a going concern.

its report dated April 1, 2024, Morison Cogen LLP, our independent registered public accounting firm, expressed substantial doubt about

our ability to continue as a going concern as we have suffered recurring losses from operations and have insufficient liquidity to fund

our future operations.

If we are unable to improve our liquidity position, we may not be able to continue as a going concern.

The accompanying

consolidated financial statements do not include any adjustments that might result if we are unable to continue as a going concern and,

therefore, be required to realize our assets and discharge our liabilities other than in the normal course of business which could cause

investors to suffer the loss of all or a substantial portion of their investment.

As of December 31, 2024, we had approximately $8.5

million of cash and marketable securities.

In order to have sufficient cash to fund our operations in the future, we will need to raise

additional equity or debt capital and cannot provide any assurance that we will be successful in doing so.

If are unable to raise sufficient

capital to fund our operations, we may need to delay, reduce or eliminate certain research and development programs or other operations,

sell some or all of our assets or merge with another entity.

expect that we will need to raise additional funding before we can expect to become profitable from any potential future sales of our

product candidates.

This additional financing may not be available on acceptable terms or at all.

Failure to obtain this necessary capital

when needed may force us to delay, limit or terminate our product development efforts or other operations.

will require substantial future capital in order to complete planned and future pre-clinical and clinical development for Isomyosamine and

Supera-CBD and potentially commercialize these product candidates.

We expect increased spending levels in connection with our clinical

trials of our product candidates.

In addition, if we obtain marketing approval for any of our product candidates, we expect to incur

significant expenses related to commercial launch, product sales, medical affairs, regulatory, marketing, manufacturing and distribution.

expect that we will need to raise additional funding before we can expect to become profitable from our laser-based computing

business or any realization of value from our legacy pharmaceutical product candidates.

This additional financing may not be

available on acceptable terms or at all.

Failure to obtain this necessary capital when needed may force us to delay, limit or

terminate our product development efforts or other operations.

will require substantial future capital in order to fund the development, commercialization, and deployment of our laser-based

computing business, including the qc-LPU100 prototype, performance benchmarking, pilot testing, hardware certifications,

manufacturing, and scaling deployment clusters.

In addition, we hold legacy pharmaceutical assets, including Isomyosamine and

Supera-CBD, and may incur costs in connection with maintaining or disposing of those assets as part of any strategic alternatives we evaluate.

Furthermore, we expect to incur additional costs associated with operating as a public company.

Accordingly, we will need to obtain substantial

additional funding in connection with our continuing operations before any commercial revenue may occur.

Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations before any

commercial revenue may occur.

additional capital raised through the sale of equity or equity-backed securities may dilute our stockholders’ ownership percentages

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reduce or eliminate certain research and development programs or other operations, sell some or all of our assets or merge with another

have recently shifted our business strategy from pharmaceutical development to laser-based computing for blockchain and high-performance

computing, and we may not successfully develop, validate or commercialize our new technology.

have historically focused on pharmaceutical research and development of our Isomyosamine and Supera-CBD product candidates.

in September 2025, we redirected our strategy toward energy-efficient blockchain and cryptocurrency infrastructure using laser-based

However, the qc-LPU100 prototypes we are developing remain in early-stage development, have not completed performance validation

or regulatory certifications, and may not achieve the speed, efficiency, scalability, or energy-consumption improvements we anticipate.

the qc-LPU100 or future LPUs do not perform as expected, cannot be manufactured at commercial scale, or fail to gain adoption from AI,

DePin Token, or cryptocurrency infrastructure users, our business prospects and financial condition would be materially adversely affected.

Furthermore, our lack of operating history in the technology hardware, photonics, and blockchain markets increases the uncertainty of

our ability to execute this new strategy.

may require significant additional capital to develop the qc-LPU100, finance pilot deployments and other development efforts, and execute

our hardware commercialization plan, and we may be unable to obtain such capital on acceptable terms or at all.

shift to laser-based computing for blockchain, DePin Token infrastructure, and AI requires significant capital for prototype development,

performance benchmarking, pilot testing, hardware certifications, manufacturing and scaling deployment clusters.

Additional capital will

likely be needed to fund operations through prototype completion, including R&D efforts, beta-unit deployment, and early commercialization,

particularly given the volatility and cyclicality of the cryptocurrency sector.

or debt financing may be unavailable or may occur on dilutive or unfavorable terms.

Our ability to raise capital may be constrained by

our prior going-concern history and our strategic transition.

If we cannot secure additional financing, we may be forced to delay or

reduce prototype development, defer regulatory certifications, scale back commercialization efforts, or cease operations.

primary source for developing qc-LPU100 and LPU prototypes is through a licensing partnership, and therefore the Company is dependent

upon maintaining and increasing the number of licensing agreements and developing annual recurring revenues through those partnerships,

in order to continue to develop its business.

are in the early stages of shifting our business and recently began transitioning our products to LPU technology by licensing through

a channel partner.

There can be no certainty over the pace and scale of revenue growth generated from such relationship, which might

take longer than anticipated to generate material revenues.

In addition, we are dependent upon maintaining our existing partnership in

order to continue to develop our business and annual recurring revenues.

If revenues from our licensing relationship fail to develop,

take longer than expected to develop, or we fail to maintain existing or increase the number of our partnerships, the impact could adversely

affect its business, financial condition, and results of operations.

market price of our Common Stock has been and may continue to be subject to significant fluctuations and volatility, and the stockholders

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market price of our Common Stock has been and could continue to be subject to significant fluctuation following.

Market prices for securities

of life sciences and biopharmaceutical companies in particular have historically been volatile and have shown extreme price and volume

fluctuations that have often been unrelated or disproportionate to the operating performance of those companies.

Broad market and industry

factors, as well as general economic, political and market conditions such as recessions or interest rate changes, may seriously affect

the market price of our Common Stock, regardless of the actual operating performance of the combined company.

Some of the factors that

may cause the market price of our Common Stock to fluctuate include:

announcement of new products, new developments, services or technological innovations by us or our competitors;

Broad market and industry factors, as well as general economic,

political and market conditions such as recessions or interest rate changes, may seriously affect the market price of our Common Stock,

regardless of the actual operating performance of the combined company.

Some of the factors that may cause the market price of our Common

Stock to fluctuate include:

actions by competitors

or anticipated quarterly increases or decreases in revenue, gross margin or earnings, and changes in our business, operations or

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other events by the us or our competitors;

or trends in the life sciences and biopharmaceutical industries;

in the economic performance or market valuations of other life sciences and biopharmaceutical companies;

or trends in the quantum computing, cryptocurrency and blockchain industries;

in the economic performance or market valuations of quantum computing, cryptocurrency and blockchain companies;

market conditions or domestic or international macroeconomic and geopolitical factors unrelated to our performance or financial condition;

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and limitations in trading volumes of our Common Stock;

in the market prices and trading volumes of the life sciences and biopharmaceutical stocks;

in the market prices and trading volumes of the quantum computing, cryptocurrency and blockchain stocks;

ability to finance our business;

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be forced to delay, reduce or eliminate our product development programs or commercial development efforts.

are a clinical-stage pharmaceutical company with a limited operating history.

Pharmaceutical product development is a highly speculative

undertaking and involves a substantial degree of risk.

Our operations to date have been limited primarily to business planning, raising

capital and conducting research and development activities for our product candidates.

We have never generated any revenue from product

We have not obtained regulatory approvals for any of our product candidates and we have funded our operations to date through

proceeds from private placements of Common Stock and a line of credit from an affiliate of TNF’s founder.

have incurred net losses in each year since our inception.

We incurred net losses attributable to shareholders of $27,161,219 and $8,218,163

for the years ended December 31, 2024 and 2023, respectively.

We have incurred net losses in each year since our inception.

net losses attributable to shareholders of $11,627,122 and $23,359,334, for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025, we had an accumulated deficit of $144,122,732.

Substantially all our operating losses have resulted from costs incurred in connection with our research and development programs and

from general and administrative costs associated with our operations.

We expect to continue to incur significant expenses and operating

losses over the next several years and for the foreseeable future as we intend to continue to conduct research and development, clinical

testing, regulatory compliance activities, manufacturing activities, and, if any of our product candidates is approved, sales and marketing

activities that, together with anticipated general and administrative expenses, will likely result in the company incurring significant

losses for the foreseeable future.

Our prior losses, combined with expected future losses, have had and will continue to have an adverse

effect on our shareholders’ equity and working capital.

limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability.

predecessor, MyMD Florida, was formed in late 2014.

Our operations to date have been limited primarily to business planning, raising

capital and conducting research and development activities for our product candidates.

We have not yet demonstrated the ability to complete

clinical trials of our product candidates, obtain marketing approvals, manufacture a commercial-scale product or conduct sales and marketing

activities necessary for successful commercialization.

Consequently, predictions about our future success or viability are speculative

and no assurances can be given about our future performance.

concentration of the capital stock ownership with insiders of the Company will likely limit the ability of our stockholders to influence

corporate matters.

of the date of this Annual Report on Form 10-K, the executive officers, directors, five percent or greater stockholders, and the

respective affiliated entities of the Company, in the aggregate, beneficially owned more than 10% of the Company’s outstanding

Common Stock.

As a result, these stockholders, acting together, had, and continue to have, control over matters that require

approval by our stockholders, including the election of directors and approval of significant corporate transactions.

actions might be taken even if other stockholders oppose them.

This concentration of ownership might also have the effect of

delaying or preventing a corporate transaction that other stockholders may view as beneficial.

Substantially all our operating losses have resulted from costs

incurred in connection with our research and development efforts and from general and administrative costs associated with our operations.

We expect to continue to incur significant expenses and operating losses over the next several years as we develop our laser-based computing

technology, together with anticipated general and administrative expenses, will likely result in the company incurring significant losses

for the next several years.

Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect

on our shareholders’ equity and working capital.

limited operating history related to our laser-based computing technology may make it difficult to evaluate the success of our

business to date and to assess our future viability.

a result of our limited operating history related to our laser-based

computing technology , our ability to accurately forecast our future results of operations is limited and subject to a number

of uncertainties, including our ability to plan for and model future growth.

Our ability to generate revenues will largely be

dependent on our ability to develop and produce the qc-LPU100.

As a result, our scalable business model relating to our laser-based

computing technology has not been formed and our technical roadmap may not be realized as quickly as expected, or even at

The development of our scalable business model will likely require the incurrence of a substantially higher level of costs than

incurred to date, while our revenues will not substantially increase until our technology is developed, that requires a number of

technological advancements which may not occur on the currently anticipated timetable

As a result, our historical results relating to our laser-based

computing technology should not be considered indicative of our future performance.

Further, in future periods, our growth

could slow or decline for a number of reasons, including but not limited to increased competition, changes to technology, inability

to scale up our technology, a decrease in the growth of the overall market, or our failure, for any reason, to continue to take

advantage of growth opportunities.

We have also encountered, and will continue to encounter, risks and uncertainties

frequently experienced by growing companies in rapidly changing industries.

If our assumptions regarding these risks and uncertainties

and our future growth are incorrect or change, or if we do not address these risks successfully, our operating and financial results could

differ materially from our expectations, and our business could suffer.

Our success as a business ultimately relies upon fundamental research

and development breakthroughs in the coming years and decade.

There is no certainty these research and development milestones will be

achieved as quickly as expected, or even at all.

Our estimates of market opportunity and forecasts of market growth may

prove to be inaccurate.

Market opportunity estimates and growth forecasts, including those we have

generated, are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate.

The variables

that go into the calculation of our market opportunity are subject to change over time, and there is no guarantee that any particular

number or percentage of companies covered by our market opportunity estimates will purchase our products at all or generate any particular

level of revenue for us.

In addition, alternatives to quantum-class laser-based computing may present themselves and if they did, could

substantially reduce the market for quantum computing services.

Any expansion in our market depends on a number of factors, including

the cost, performance, and perceived value associated with quantum computing solutions.

The methodology and assumptions used to estimate market opportunities may

differ materially from the methodologies and assumptions previously used to estimate the total addressable market.

To estimate the size

of our market opportunities and our growth rates, we have relied on market reports by leading research and consulting firms.

These estimates

of the total addressable market and growth forecasts are subject to significant uncertainty, are based on assumptions and estimates that

may not prove to be accurate and are based on data published by third parties that we have not independently verified.

Advances in classical

computing may prove more robust for longer than currently anticipated.

This could adversely affect the timing of any quantum advantage

being achieved, if at all.

stockholders could attempt to influence changes within the Company, which could adversely affect our operations, financial condition

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largest stockholder maintains the ability to significantly influence all matters submitted to our stockholders for approval.

of April 4, 2025, our largest stockholder, PharmaCyte Biotech, Inc.

(“Pharmacyte”) beneficially owns approximately 88.64% of the

issued and outstanding Common Stock of the Company.

As a result, if Pharmacyte may be able to significantly influence all matters submitted

to the Company’s stockholders for approval, as well as the Company’s management and affairs.

For example, Pharmacyte could

significantly influence the election of directors or the approval of any merger, consolidation or sale of all or substantially all of

the Company’s assets.

This concentration of voting power could delay or prevent an acquisition of the Company on terms that other

must attract and retain highly skilled employees to succeed.

succeed, we must recruit, retain, manage and motivate qualified clinical, scientific, technical and management personnel, and we face

significant competition for experienced personnel.

If we do not succeed in attracting and retaining qualified personnel, particularly

at the management level, it could adversely affect our ability to execute our business plan, harm our results of operations and increase

our capabilities to successfully commercialize Isomyosamine, Supera-CBD and our other product candidates.

The competition for qualified personnel

in the biotechnology field is intense and as a result, we may be unable to continue to attract and retain qualified personnel necessary

for the development of our business or to recruit suitable replacement personnel.

of the other biotechnology companies that we compete against for qualified personnel have greater financial and other resources, different

risk profiles and a longer history in the industry than we do.

They also may provide more diverse opportunities and better chances for

career advancement.

Some of these characteristics may be more appealing to high-quality candidates than what we have to offer.

are unable to continue to attract and retain high-quality personnel, the rate and success at which we can discover and develop product

candidates and our business will be limited.

operate in a highly competitive industry.

face, and will continue to face, intense competition from large pharmaceutical companies, specialty pharmaceutical and biotechnology

companies as well as academic and research institutions pursuing research and development of technologies, drugs or other therapies that

would compete with our products or product candidates.

The pharmaceutical market is highly competitive, subject to rapid technological

change and significantly affected by existing rival drugs and medical procedures, new product introductions and the market activities

of other participants.

Our competitors may develop products more rapidly or more effectively than us.

If our competitors are more successful

in commercializing their products than us, their success could adversely affect our competitive position and harm our business prospects

and may also lead to the diversion of funding away from us and towards other companies.

we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur

costs that could harm our business.

are subject to numerous environmental, health, and safety laws and regulations, including those governing laboratory procedures and the

handling, use, storage, treatment and disposal of hazardous materials and wastes.

Our operations will involve the use of hazardous materials,

including chemicals and biological materials.

Our operations also may produce hazardous waste products.

We generally anticipate contracting

with third parties for the disposal of these materials and wastes.

We will not be able to eliminate the risk of contamination or injury

from these materials.

In the event of contamination or injury resulting from any use by us of hazardous materials, we could be held liable

for any resulting damages, and any liability could exceed our resources.

We also could incur significant costs associated with civil

or criminal fines and penalties for failure to comply with such laws and regulations.

we maintain workers’ compensation insurance to cover us for costs and expenses, we may incur due to injuries to our employees resulting

from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.

addition, we may incur substantial costs in order to comply with current or future environmental, health, and safety laws and regulations.

These current or future laws and regulations may impair our research, development or production efforts.

Our failure to comply with these

laws and regulations also may result in substantial fines, penalties or other sanctions.

As of April 12, 2026, our largest stockholder, PharmaCyte Biotech, Inc.

(“Pharmacyte”) beneficially owns more than 10% of the issued and outstanding Common Stock of the Company.

As a result, Pharmacyte

may be able to significantly influence all matters submitted to the Company’s stockholders for approval, as well as the Company’s

management and affairs.

For example, Pharmacyte could significantly influence the election of directors or the approval of any merger,

consolidation or sale of all or substantially all of the Company’s assets.

This concentration of voting power could delay or prevent

an acquisition of the Company on terms that other.

order to compete, we must attract, retain and motivate key associates, and the failure to do so could have an adverse effect on our business,

financial condition and results of operations.

depend on our executive officers and management team to run our business.

As we develop new business models and new ways of working,

we will need to develop suitable skill sets within our organization.

In addition, our future success depends on our continuing ability

to attract, develop, motivate and retain highly qualified and skilled employees that have highly technical set of skills.

market for such positions is highly competitive.

Qualified individuals are in high demand and we may incur significant costs to attract

and retain them.

Moreover, the loss of any of our senior management or other key employees or our inability to recruit and develop capable

managers could adversely affect our ability to execute our business plan and we may be unable to find adequate replacements.

We have a very limited workforce and are highly

dependent on a small number of individuals to execute our business strategy, which exposes us to significant operational risk.

As of December 31, 2025, we had only two full-time

employees and no part-time employees.

Our limited workforce means that we are highly dependent on a very small number of individuals to

manage all aspects of our business, including research and development, regulatory compliance, financial management, investor relations,

and strategic planning.

The loss, incapacity, or departure of any of these individuals could severely disrupt our operations and our ability

to execute our business strategy.

We rely heavily on third-party contractors and consultants for specialized functions, and any failure

to retain or effectively coordinate with these third parties could delay our product development or commercialization efforts.

staffing also limits our capacity to respond to unexpected challenges, pursue multiple strategic initiatives simultaneously, or scale

our operations rapidly if market conditions warrant.

If we are unable to attract and retain additional qualified personnel as our business

grows, or if our limited workforce is unable to effectively manage the demands of our business, our ability to achieve our strategic objectives

could be materially impaired.

quantum computing industry is competitive and we may not be successful in competing in this industry or establishing and maintaining

confidence in our long-term business prospects among current and future partners and customers.

our change in business strategy, we now operate in markets that are rapidly evolving and highly competitive.

We expect competition to

intensify as the marketplace continues to mature and new technologies and competitors enter.

Our current competitors include:

less-established

public and private companies focused on blockchain and cryptocurrency infrastructure through quantum-class laser-based computing;

or emerging entrants seeking to develop competing prototypes;

organizations funded by sovereign nations such as China, Russia, Canada, Australia and the United Kingdom, and those in the European

additional countries may decide to fund quantum computing programs in the future.

compete based on various factors, including technology, performance, brand recognition and reputation, scalability and reliability, data

governance and security.

Many of our competitors have substantially greater partner relationships, and financial, technical and other

resources than we do.

They may be able to respond more effectively than us to new or changing opportunities, technologies and standards.

In addition, many countries are focused on developing quantum computing solutions either in the private or public sector and may subsidize

quantum technology, which may make it difficult for us to compete.

Many of these competitors do not face the same challenges we do in

growing our business.

Additionally,

we must be able to achieve our objectives in a timely manner such that we don’t lose ground to competitors, including competing

technologies.

Because there are a large number of market participants, including certain sovereign nations, focused on developing quantum

computing technology, we must dedicate significant resources to achieving any technical objectives on the timelines established by our

management team.

Any failure to achieve objectives in a timely manner could adversely affect our business, operating results and financial

all of these reasons, competition may negatively impact our ability to maintain and grow consumption of our platform or put downward

pressure on our prices and gross margins, any of which could materially harm our reputation, business, results of operations, and financial

if we are successful in developing qc-LPU100 and LPU prototypes, competitors in the industry may achieve technological breakthroughs

that render our systems obsolete or inferior to other technology.

continued growth and success depend on our ability to innovate and develop LPU technology in a timely manner and effectively license

these products.

Without timely innovation and development, our technology could be rendered obsolete or less competitive by changing

customer preferences or because of the introduction of a competitor’s newer technologies.

We believe that many competing technologies

will require a technological breakthrough in one or more problems related to science, fundamental physics or manufacturing.

is uncertain whether such technological breakthroughs will occur in the next several years, that does not preclude the possibility that

such technological breakthroughs could eventually occur.

Any technological breakthroughs that render our technology obsolete or inferior

to other products could have a material adverse effect on our business, financial condition or results of operations.

quantum-class laser computing industry is in its early stages and volatile, and if it does not develop, if it develops slower than we

anticipate, if it encounters negative publicity or if quantum computing products and services generally do not achieve commercial adoption,

the growth of our business will be harmed.

nascent market for quantum-class laser computing technology is still rapidly evolving, characterized by rapidly changing technologies,

competitive pricing and competitive factors, evolving government regulation and industry standards, and changing customer demands and

Our success will depend to a substantial extent on the willingness of the industry to adopt LPU technology to in organizations,

government agencies, and other users of quantum computing offerings.

Negative publicity concerning the quantum computing industry as

a whole could limit market acceptance of our offerings.

If our clients and partners do not perceive the benefits of our technology and

services, or if they do not drive customer engagement, then our market may not develop at all, or it may develop more slowly than we

Similarly, individual and industry concerns or negative publicity regarding technophobic views in the context of quantum computing

could limit market acceptance of our quantum computing products and services.

If any of these events occur, our business, prospects,

financial condition and operating results could be harmed.

addition, our growth and future demand for our products is highly dependent upon the adoption by developers and customers of quantum

Technical failures at other quantum computing companies could limit acceptance of our services and technology.

Negative publicity

concerning the quantum computing industry as a whole could limit acceptance of our products and services.

While we believe that quantum-class

laser computing technology will solve many large-scale problems, it is possible that such problems may never be solvable by quantum computing

If any of these events occur, it could have a material adverse effect on our business, financial condition and results of

The cryptocurrency and blockchain markets are

highly volatile, and a sustained downturn in cryptocurrency prices or demand could materially reduce the market for our laser-based computing

Our laser-based computing products, including the

qc-LPU100, are primarily targeted at cryptocurrency infrastructure, DePin Token ecosystems, and blockchain applications.

The cryptocurrency

market has historically experienced extreme price volatility, including dramatic declines in the market prices of Bitcoin, Ethereum, and

other digital assets.

A sustained downturn in cryptocurrency prices could significantly reduce investment in cryptocurrency mining, blockchain

infrastructure, and related computational services, thereby decreasing demand for our products.

Additionally, the cryptocurrency industry

has experienced high-profile failures of exchanges, lending platforms, and other participants, which have eroded confidence in the industry.

Any reduction in the overall size, growth, or acceptance of the cryptocurrency and blockchain ecosystem, whether due to market conditions,

regulatory actions, security breaches, or loss of investor confidence, could materially limit our addressable market and adversely affect

our business, financial condition, and results of operations.

conditions in our industries or the global economy could limit our ability to grow our business and negatively affect our results of operations.

results of operations may vary based on the impact of changes in our industries or the global economy on us or our customers and potential

Negative conditions in the general economy both in the United States and abroad, including conditions resulting from changes

in gross domestic product growth, financial and credit market fluctuations, inflation, international trade relations, tariffs, public

health emergencies, political turmoil, natural catastrophes, warfare, and terrorist attacks on

the United States or elsewhere, could cause a decrease in business investments, including the progress on development of quantum technologies,

and negatively affect the growth of our business.

In addition, in challenging economic times, our current or potential future customers

may experience cash flow problems and as a result may modify, delay or cancel plans to purchase our products and services.

Additionally,

if our customers are not successful in generating sufficient revenue or are unable to secure financing, they may not be able to pay,

or may delay payment of, amounts they owe.

uncertain economic conditions may make it more difficult for us to raise funds through borrowings or sales of debt or equity securities.

We cannot predict the timing, location, strength or duration of any economic slowdown, instability or recovery, generally or within any

particular industry.

business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security or

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addition, we collect and store sensitive data, including intellectual property, research data, our proprietary business information and

that of our suppliers, technical information about our products, clinical trial plans and employee records.

that of our suppliers, technical information about our products, and employee records.

Similarly, our third-party

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could adversely affect our business.

Related to our Product Development and Regulatory Approval

regard to our Supera-CBD product candidate, we must conduct pre-clinical testing and prepare and submit an IND to the FDA.

to both our Isomyosamine and Supera-CBD product candidates, we must conduct all phases of clinical studies, which will likely take several

years and substantial expenses to complete, before we can submit an application for marketing approval to the FDA, and we may be required

to complete additional post-market or “Phase 4” studies after application or approval.

There is no guarantee that we will

complete such clinical development in a timely manner or at all or that we will obtain or maintain regulatory approval for either product

– IND review is conducted and feedback is delivered within 30 days of receipt of the initial application.

At the time, changes

to the study protocol may be requested in order to proceed with the proposed Phase 2 clinical trial.

Institutional

Review Board (IRB) – If the FDA requests changes to the protocol included in the initial application, an amendment must be

submitted to the IRB for an additional review.

This review may include changes to the protocol, informed consent form, surveys, and

other assessments planned over the course of the clinical trial.

– Clinical sites must follow specific COVID-19 guidelines.

Clinical trial activity must adhere to those guidelines which may

change over the course of the study.

For example, the protocol may need to be revised to accommodate for in-home visits (if necessary)

to maximize patient and research staff safety.

Initiation Visit (SIV) – Site initiation visits are scheduled around principal investigator (PI) availability.

Due to changing

clinic schedules, SIVs may need to be rescheduled to accommodate various PI demands.

Lab – Central labs are responsible for creating all the kits (supplies) required for patient visits.

Kits are created to execute

all aspects of screening through study completion.

Kits are developed based on specifications from core labs and third-party vendors

(as applicable).

All shipping and storing requirements need to be clearly articulated and lab manuals provided to make the kits.

The central lab is also responsible for building a database to store all the lab results.

Database – The overall database used for the study must be built around the schedule of assessments planned for each patient

over the course of the clinical trial.

This includes every assessment and data element collected.

The complexity of the Phase 2 trial

also requires development and testing of drug randomization across treatment groups to ensure blinding is maintained.

Thorough user-acceptability

testing (UAT) is required and is time-intensive.

– To maintain adequate blinding across treatment groups, new labels were created and applied to the active drug and placebo

Logistics and manufacturing need to work together to ensure capsules were not only filled appropriately, but also labelled

correctly to ensure the electronic database and randomization schemes maintain alignment over the course of the study.

drug development is a lengthy, expensive, and inherently uncertain process, and we may experience delays in completing, or ultimately

be unable to complete, the development and commercialization of our product candidates.

FDA must approve any new drug products before they can be marketed in the United States, and such approval is contingent upon the collection

of sufficient safety- and efficacy-data from preclinical and clinical studies.

We must complete preclinical development and conduct extensive

clinical trials to demonstrate the safety and efficacy of our product candidates for their respective targeted indications.

to Supera-CBD, we are still in the pre-clinical stage, and we are in relatively early clinical stages with regard to certain indications

for which Isomyosamine is being developed and in pre-clinical stages for others.

Clinical trials are expensive, difficult to design and implement,

and can take many years to complete, and their outcomes are inherently uncertain.

Failure can occur at any time during the clinical trial

Nonclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies have believed

their product candidates performed satisfactorily in nonclinical studies and clinical trials and, nonetheless, were denied marketing

approval for such candidates due to insufficient safety or efficacy data and/or other clinical-study deficiencies.

It is impossible to

predict whether we will be able to prove that either or both of our product candidates are safe and effective for any of the indications

for which they are, respectively, being developed and, accordingly, when they will be approved for commercialization in the United States

for any given indication, if ever.

completing the requisite preclinical testing, IND submission, internal review board (“IRB”) review, and any other applicable

early-development obligations, sponsors must conduct extensive clinical trials to demonstrate the safety and efficacy of the product

We have completed such early-stage preclinical testing and IND-submission for some, but not all, indications for which Isomyosamine

is being developed and are currently working towards completion of such pre-IND activities for Supera-CBD.

Even if the results of our

pre-clinical testing and clinical trials are favorable, we expect our product candidates to remain in clinical development for several

years before they may be considered for regulatory approval, and clinical development of either or both candidates for one or more targeted

indications may take significantly longer to complete and may never be successful.

Failures in connection with one or more clinical trials

can occur at any stage of testing.

that may prevent successful or timely completion of clinical development include:

in reaching a consensus with regulatory authorities on trial design;

in reaching agreement on acceptable terms with prospective contract research organization (“CRO”) and clinical trial

in opening clinical trial sites or obtaining required IRB or independent ethics committee approval at each clinical trial site;

or perceived lack of effectiveness of any product candidate during clinical trials;

of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions,

including those which cause confounding changes to the levels of other concomitant medications;

than expected rates of subject recruitment and enrollment rates in clinical trials;

in retaining subjects for the entire duration of applicable clinical studies (as study subjects may withdraw at any time due to adverse

side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;

or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing

of or changes in its manufacturing process or product candidate formulation;

in obtaining regulatory authorization s, such as INDs and any others that must be obtained, maintained, and/or satisfied to commence

a clinical trial, the imposition of “clinical holds” or delays requiring suspension 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;

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

regarding proper dosing;

or failure to supply products for use in clinical trials which conforms to regulatory specification , or otherwise do not comply with required manufacturing obligations, such as cGMPs;

results from ongoing pre-clinical studies and clinical trials;

of its CROs, or other third-party contractors to comply with all contractual requirements or to perform their services in a timely

or acceptable manner;

failure, or the failure of any individuals, entities, or organizations involved in one or more aspects of our clinical development

activities, to comply with all applicable FDA or other regulatory requirements relating to the conduct of clinical trials;

conflicts with participating clinicians and clinical institutions;

to design appropriate clinical trial protocols;

concerns and additional difficulties associated with cannabinoid products, generally;

data to support regulatory approval;

or unwillingness of medical investigators to follow its clinical protocols;

in maintaining contact with patients during or after treatment, which may result in incomplete data.

the result of any of the clinical trials for any of our current or future therapeutic candidates do not produce sufficiently

favorable results or are found to have been conducted in violation of the FDA’s or other regulatory body’s standards

governing such studies, our ability to request and obtain regulatory approval for the therapeutic candidate may be adversely

impacted, which could have a material adverse effect on our reputation, business, financial condition or results of

we are unable to develop, obtain regulatory approval for and commercialize Isomyosamine, Supera-CBD or other future product candidates, or

if we experience significant delays in doing so, our business will be materially harmed.

have invested a substantial amount of effort and financial resources in Isomyosamine and Supera-CBD.

We plan to initiate Phase 2 clinical trials

for treatment of diabetes, rheumatoid arthritis, aging and multiple sclerosis with Isomyosamine and IND-enabling pre-clinical studies of Supera-CBD

to enable submission of an Investigational New Drug (“IND”) application for a Phase 1 in healthy volunteers followed by clinical

trials in epilepsy, addiction and anxiety disorders.

In order to conduct human clinical trials, we are required obtain approval from

Institutional Review Boards (“IRBs”) or Ethics committees.

IRBs are independent committee organizations that operate in compliance

federal regulations (including but not limited to 21 C.F.R.

Parts 50 and 56, and 45 C.F.R.

Part 46) in order to help protect

the rights of research subjects under the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

IRBs provide expertise in examining research for its ethical implications, including research involving vulnerable populations, such

as pediatrics, critically ill, and cognitively impaired participants.

There is no guarantee that an IRB will approve our current product

candidates for human clinical trials.

Without IRB approval, the Company would not be able to perform clinical research on humans and

our products would not be able to move through the regulatory approval process.

ability to generate product revenue will depend heavily on the successful development and eventual commercialization of Isomyosamine, Supera-CBD

and our other product candidates, which may never occur.

We currently generate no revenue from sales of any product and we may never

be able to develop or commercialize a marketable product.

of our programs and product candidates will require further clinical and/or pre-clinical development, regulatory approval in multiple

jurisdictions, obtaining pre-clinical, clinical and commercial manufacturing supply, capacity and expertise, building of a commercial

organization, substantial investment and significant marketing efforts before we generate any revenue from product sales.

Isomyosamine and

Supera-CBD and our other product candidates must be authorized for marketing by the FDA and certain other foreign regulatory agencies

before we may commercialize any of our product candidates.

success of our product candidates depends on multiple factors, including:

completion of pre-clinical studies, including those compliant with Good Laboratory Practices (“GLP”) or GLP toxicology

studies, biodistribution studies and minimum effective dose studies in animals, and successful enrollment and completion of clinical

trials compliant with current Good Clinical Practices (“GCPs”);

INDs and Clinical Trial Authorizations (“CTAs”) that allow commencement of our planned clinical trials or future clinical

trials for our product candidates in relevant territories;

from IRBs or Ethics committees to conduct human clinical trials;

and maintaining relationships with contract research organizations (“CROs”), and clinical sites for the clinical development

of our product candidates;

clearance of products arriving from foreign countries, needed to perform clinical trials, through U.S.

of arrangements with third-party contract manufacturing organizations (“CMOs”) for key materials used in our manufacturing

processes and to establish backup sources for clinical and large-scale commercial supply;

results from our clinical programs that are supportive of safety and efficacy and provide an acceptable risk-benefit profile for

our product candidates in the intended patient populations;

of regulatory approvals from applicable regulatory authorities, including those necessary for pricing and reimbursement of our product

establishment

and maintenance of patent and trade secret protection and regulatory exclusivity for our product candidates;

launch of our product candidates, if and when approved, whether alone or in collaboration with others;

of our product candidates, if and when approved, by patients, patient advocacy groups, third-party payors and the general medical

effective competition against other therapies available in the market;

establishment

and maintenance of adequate reimbursement from third-party payors for our product candidates;

ability to acquire or in-license additional product candidates;

maintenance, enforcement and defense of intellectual property rights and claims;

of a continued acceptable safety profile of our product candidates following approval, including meeting any post-marketing commitments

or requirements imposed by or agreed to with applicable regulatory authorities;

factors surrounding the approval process, such as government shutdowns, political instability or global pandemics.

we do not succeed in one or more of these factors in a timely manner or at all, we could experience significant delays or an inability

to successfully commercialize our product candidates, which would materially harm our business.

If we do not receive regulatory approvals

for our product candidates, we may not be able to continue our operations.

may not have the resources to conduct clinical protocols sufficient to yield data suitable for publication in peer-reviewed journals

and our inability to do so in the future could have an adverse effect on marketing our products effectively.

order for our products targeted for use by hospital laboratory professionals and healthcare providers to be widely adopted, we would

have to conduct clinical protocols that are designed to yield data suitable for publication in peer-reviewed journals.

These studies

are often time-consuming, labor-intensive and expensive to execute.

We have previously and not had the resources to effectively implement

such clinical programs within our clinical development activities and may not be able to do so in the future.

In addition, if a protocol

is initiated, the results of such protocol may ultimately not support the anticipated positioning and benefit proposition for the product.

Either of these scenarios could hinder our ability to market our products, and revenue may decline.

in pre-clinical studies and earlier clinical trials for our product candidates may not be indicative of the results that may be obtained

in later clinical trials, including our Phase 2 clinical trial for Isomyosamine, which may delay or prevent obtaining regulatory approval.

development is expensive and can take many years to complete, and its outcome is inherently uncertain.

Failure can occur at any time

during the clinical trial process.

Success in pre-clinical studies and early clinical trials may not be predictive of results in later-stage

clinical trials, and successful results from early or small clinical trials may not be replicated or show as favorable an outcome in

later-stage or larger clinical trials, even if successful.

We will be required to demonstrate through adequate and well-controlled clinical

trials that our product candidates are safe and effective for their intended uses before we can seek regulatory approvals for their commercial

The conduct of Phase 2 and Phase 3 trials, and the submission of a New Drug Application (“NDA”) is a complicated process.

We have not previously conducted any clinical trials, and have limited experience in preparing, submitting and supporting regulatory

Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials and other requirements

in a way that leads to NDA submission and approval of any product candidate we are developing.

companies in the pharmaceutical industry have suffered significant setbacks in late-stage clinical trials after achieving positive results

in early-stage development, and there is a high failure rate for product candidates proceeding through clinical trials.

different methodologies, assumptions and applications we utilize to assess particular safety or efficacy parameters may yield different

statistical results.

Even if we believe the data collected from clinical trials of our product candidates are promising, this data may

not be sufficient to support approval by the FDA or foreign regulatory authorities.

Pre-clinical and clinical data can be interpreted

in different ways.

Accordingly, the FDA or foreign regulatory authorities could interpret this data in different ways from us or our

partners, which could delay, limit or prevent regulatory approval.

If our study data do not consistently or sufficiently demonstrate

the safety or efficacy of any of our product candidates, including Isomyosamine and Supera-CBD, to the satisfaction of the FDA or foreign regulatory

authorities, then the regulatory approvals for such product candidates could be significantly delayed as we work to meet approval requirements,

or, if we are not able to meet these requirements, such approvals could be withheld or withdrawn.

if we complete the necessary pre-clinical studies and clinical trials, we cannot predict when, or if, we will obtain regulatory approval

to commercialize a product candidate and the approval may be for a narrower indication than we seek.

to commercialization in the United States, Isomyosamine, Supera-CBD and our other product candidates must be approved by the FDA pursuant to

an NDA for their respective target indication(s).

The process of obtaining marketing approvals, both in the U.S.

and abroad, is expensive

and takes many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type,

complexity and novelty of the product candidates involved.

Failure to obtain marketing approval for a product candidate will prevent

us from commercializing the product candidate.

We have not received approval to market Isomyosamine, Supera-CBD or any of our other product

candidates from regulatory authorities in any jurisdiction.

We have limited experience in submitting and supporting the applications

necessary to gain marketing approvals, and, in the event regulatory authorities indicate that we may submit such applications, we may

be unable to do so as quickly and efficiently as desired.

Securing marketing approval requires the submission of extensive pre-clinical

and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s

safety and efficacy.

Securing marketing approval also requires the submission of information about the product manufacturing process

to, and inspection of manufacturing facilities by the regulatory authorities.

Our product candidates may not be effective, may be only

moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude

our obtaining marketing approval or prevent or limit commercial use.

Regulatory authorities have substantial discretion in the approval

process and may refuse to accept or file any application or may decide that our data is insufficient for approval and require additional

pre-clinical, clinical or other studies.

In addition, varying interpretations of the data obtained from pre-clinical and clinical testing

could delay, limit or prevent marketing approval of a product candidate.

of Isomyosamine, Supera-CBD or our other product candidates may be delayed or refused for many reasons, including:

FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

may be unable to demonstrate, to the satisfaction of the FDA or comparable foreign regulatory authorities, that our product candidates

are safe and effective for any of their proposed indications;

populations studied in clinical trials may not be sufficiently broad or representative to assure efficacy and safety in the populations

for which we seek approval;

results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory

authorities for approval;

may be unable to demonstrate that our product candidates’ clinical and other benefits outweigh their safety risks;

data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other

comparable submission in foreign jurisdictions or to obtain regulatory approval in the U.S.

or elsewhere;

facilities of third-party manufacturers with which we contract or procure certain service or raw materials, may not be adequate to

support approval of our product candidates;

approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering

our clinical data insufficient for approval.

if our product candidates meet their pre-specified safety and efficacy endpoints in clinical trials, the regulatory authorities may not

complete their review processes in a timely manner and may not consider such clinical trial results sufficient to grant, or we may

not be able to obtain regulatory approval.

Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends

non-approval or restrictions on approval.

In addition, we may experience delays or rejections based upon additional government regulation

from future legislation or administrative action, or changes in regulatory authority policy during the period of product development,

clinical trials and the review process.

authorities also may approve a product candidate for more limited indications than requested or they may impose significant limitations

in the form of narrow indications, warnings, contraindications or Risk Evaluation and Mitigation Strategies (“REMS”).

regulatory authorities may also grant approval subject to the performance of costly post-marketing clinical trials.

In addition, regulatory

authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization of our product candidates.

Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates and adversely affect our business,

financial condition, results of operations and prospects.

product candidate for which we obtain marketing approval will be subject to extensive post-marketing regulatory requirements and could

be subject to post-marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with

regulatory requirements or if it experiences unanticipated problems with our product candidates, when and if any of them are approved.

product candidates and the activities associated with their development and potential commercialization, including their testing, manufacturing,

recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by

the FDA and other U.S.

and international regulatory authorities.

These requirements include submissions of safety and other post-marketing

information and reports, registration and listing requirements, requirements relating to manufacturing, including cGMPs, quality control, quality assurance and corresponding maintenance of records and documents, including

periodic inspections by the FDA and other regulatory authorities and requirements regarding the distribution of samples to providers

and recordkeeping.

In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced

inspections by the FDA and other regulatory authorities for compliance with cGMPs.

FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy

of any approved product.

addition, later discovery of previously unknown adverse events or other problems with our product candidates, manufacturers or manufacturing

processes, or failure to comply with regulatory requirements, may yield various results, including:

on such product candidates, manufacturers or manufacturing processes;

on the labeling or marketing of a product;

on product distribution or use;

to conduct post-marketing studies or clinical trials;

or untitled letters;

of any approved product from the market;

to approve pending applications or supplements to approved applications that we submit;

of product candidates;

restitution or disgorgement of profits or revenues;

or withdrawal of marketing approvals;

to permit the import or export of our product candidates;

or the imposition of civil or criminal penalties.

FDA also closely regulates the post-approval marketing and promotion of drugs to ensure that they are marketed in a manner consistent

with the provisions of the approved labeling.

The FDA imposes stringent restrictions on manufacturers’ communications regarding

use of their products.

For example, under applicable FDA marketing regulations, prescription drug promotions must be consistent with

and not contrary to approved labeling, present a “fair balance” between the product’s risks and benefits, be truthful

and not false or misleading, and be sufficiently substantiated with appropriate documentary evidence, among numerous other requirements.

If we promote our products that are approved for marketing in the United States, if any, in a manner inconsistent with FDA-approved labeling

or otherwise not in compliance with FDA regulations, we may be subject to enforcement action.

Violations of the Federal Food, Drug, and

Cosmetic Act (“FD&C Act”) relating to the promotion of prescription drugs may lead to investigation or prosecution by

the DOJ or other applicable agencies and could give rise to ancillary violations of federal and state healthcare fraud and abuse laws,

as well as state consumer protection laws and similar laws in international jurisdictions.

Additionally, our marketing activities relating

to any products we may commercialize in the United States in the future may also be subject to enforcement by the FTC and/or state attorneys

general, and we may face consumer class-action liability if our marketing practices are actually or allegedly misleading or deceptive.

addition to the requirements applicable to approved drug products, we may also be subject to enforcement action in connection with any

promotion of an investigational new drug.

A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, may

not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation

or otherwise promote the therapeutic candidate.

Sponsors must strike the often-difficult balance of communicating sufficient information

about its product candidates to inform investors and engaging in valid scientific exchanges with the medical community without crossing

the often-difficult-to-ascertain line into “promotion,” which is not defined by regulation but is generally interpreted broadly

Accordingly, if FDA finds any of our communications regarding Isomyosamine or Supera-CBD to be promotional, we may be subject to a

wide range of enforcement actions, and our candidates’ prospects for regulatory approval may be adversely affected.

occurrence of any event or penalty described above could give rise to material reputational harm to our business and our current, and

any future, product candidates we may develop and may inhibit our ability to commercialize our product candidates and generate revenue

and could require us to expend significant time and resources in response.

The FDA’s and other regulatory authorities’ policies

may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or

if we are not able to maintain regulatory compliance, we may lose any marketing approval that we have obtained, and we may not achieve

or sustain profitability.

failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the

market and sell Isomyosamine, Supera-CBD or our other product candidates in other jurisdictions, we must obtain separate marketing approvals

and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries and can involve additional

The time and data required to obtain approval may differ substantially from that required to obtain FDA approval.

The regulatory

approval process outside the U.S.

generally includes all of the risks associated with obtaining FDA approval.

In addition, in many countries

outside the U.S., we must secure product reimbursement approvals before regulatory authorities will approve the product for sale in that

Failure to obtain foreign regulatory approvals or non-compliance with foreign regulatory requirements could result in significant

delays, difficulties and costs for us and could delay or prevent the introduction of our product candidates in certain countries.

we fail to comply with the regulatory requirements in international markets and receive applicable marketing approvals, our target market

will be reduced and our ability to realize the full market potential of our product candidates will be harmed and our business will be

adversely affected.

We may not obtain foreign regulatory approvals on a timely basis, if at all.

Our failure to obtain approval of any

of our product candidates by regulatory authorities in another country may significantly diminish the commercial prospects of that product

candidate and our business prospects could decline.

development program for Supera-CBD, a synthetic analog of CBD, is in its infancy and subject to substantial uncertainty and may not yield

commercial results and is subject to significant regulatory risks.

are only in the pre-clinical stage of development for Supera-CBD, which is essentially the earliest stage of a candidate’s development

process and must be followed by regulatory submissions (such as, an IND application and FDA’s acceptance thereof), IRB approval,

as well as the complex, onerous clinical-trial process (which must be conducted in accordance with FDA’s IND regulations), and

ultimately, NDA submission, the approval of which is not guaranteed.

There can be no assurance that our development program for Supera-CBD,

a synthetic analog of CBD, will be successful, or that any research and development and product testing efforts will result in commercially

saleable products, or that the market will accept or respond positively to products based on Supera-CBD.

Further, the success of our prospective Supera-CBD candidate, if any, is subject to a number of constantly-evolving

state and federal laws, regulations, and enforcement policies pertaining to the use of CBD.

Regulation of CBD .

The market for cannabinoids is heavily regulated.

Synthetic cannabinoids may be viewed as qualifying as controlled

substances under the federal Controlled Substances Act of 1970 (CSA) and may be subject to a high degree of regulation including, among

other things, certain registration, licensing, manufacturing, security, record keeping, reporting, import, export, inspection by DEA

clinical and non-clinical studies, insurance and other requirements administered by the U.S.

Drug Enforcement Administration (DEA) and/or

Regulation of CBD.

Individual states and local jurisdictions have also established controlled substance laws and regulations, which

may differ from U.S.

States have also developed CBD-specific laws and regulations that govern a wide range of CBD-related

activities, from cultivation to processing to marketing.

There is substantial variation among states’ CBD laws, and we will have

to devote substantial time, expenses, and resources toward compliance, and such laws are also subject to ongoing evolution and, thus,

must be actively monitored.

We or our business partners may be required to obtain separate state or country registrations, permits or

licenses in order to be able to develop produce, sell, store and transport cannabinoids.

is Complex and Costly .

Complying with laws and regulations relating to cannabinoids is evolving, complex and expensive, and may divert

management’s attention and resources from other aspects of our business.

Failure to maintain compliance with such laws and regulations

may result in regulatory action that could have a material adverse effect on our business, results of operations and financial condition.

The DEA, FDA or state agencies may seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to revoke those

registrations.

In certain circumstances, violations could lead to criminal proceedings.

Additionally, to the extent we are able to successfully commercialize any of our currently contemplated CBD products,

including Supera-CBD, the presence of CBD as an active or inactive ingredient may give rise to heightened regulatory scrutiny and greater

risk of consumer litigation, either of which could further restrict the permissible scope of our marketing claims about such products

or our ability to sell them in the U.S.

Because synthetic CBD products may be regulated as controlled substances in the U.S., to conduct clinical trials in the U.S.,

each of our research sites must submit a research protocol to the DEA and obtain and maintain a DEA researcher registration that will

allow those sites to handle and dispense products based on Supera-CBD and to obtain product from our manufacturer.

If the DEA delays

or denies the grant of a research registration to one or more research sites, the clinical trial could be significantly delayed, and

we could lose clinical trial sites.

public perception of cannabis-related businesses, misconceptions about the nature of our business or Supera-MD, and regulatory uncertainties

relating to the legality of cannabinoids could each have a material adverse effect on our business, financial condition, and results

of operations.

believe the cannabinoid industry is highly dependent upon consumer perception regarding the safety, efficacy, quality, and legality of

cannabinoids, whether naturally derived or synthetic.

Consumer perception of cannabinoid products can be significantly influenced by

scientific research or findings, regulatory investigations, litigation, media attention, and other publicity regarding the consumption

of CBD products.

There can be no assurance that future scientific research, findings, regulatory proceedings, litigation, media attention,

or other research findings or publicity will be favorable to the CBD market or Supera-CBD, in particular.

Our dependence upon consumer

perceptions with regard to Supera-CBD, particularly once it is approved for commercialization, if ever, means that adverse scientific

research reports, findings, regulatory proceedings, litigation, media attention, or other publicity relating to cannabinoid products,

generally, or any particular cannabinoid products or derivatives, in particular, regardless of merit or accuracy, could have a material

adverse effect on our business, the development of, or ultimate commercial demand for (if applicable), Supera-CBD.

Such adverse publicity

or other negative media attention could arise even if the adverse effects reportedly associated with such products resulted from consumers’

failure to consume such products appropriately or as directed.

Any adverse publicity or other similar occurrences affecting consumer

perception may have a material adverse impact on our reputation, perception of Supera-CBD, and our ability to obtain the necessary regulatory

approvals for Supera-CBD and its prospective commercial viability.

Related to Commercialization and Manufacturing

commercial success of our product candidates, including Isomyosamine and Supera-CBD, will depend upon their degree of market acceptance by

providers, patients, patient advocacy groups, third-party payors and the general medical community.

with the requisite approvals from the FDA and other regulatory authorities internationally, the commercial success of our product candidates

will depend, in part, on the acceptance of providers, patients and third-party payors of our product candidates, as medically necessary,

cost-effective and safe.

Any product that we commercialize may not gain acceptance by providers, patients, patient advocacy groups, third-party

payors and the general medical community.

If these products do not achieve an adequate level of acceptance, we may not generate significant

product revenue and may not become profitable.

The degree of market acceptance of Isomyosamine, Supera-CBD and our other product candidates,

if approved for commercial sale, will depend on several factors, including:

efficacy, durability and safety of such product candidates as demonstrated in clinical trials;

potential and perceived advantages of product candidates over alternative treatments;

cost of treatment relative to alternative treatments;

clinical indications for which the product candidate is approved by the FDA or the European Commission;

willingness of providers to prescribe new therapies;

willingness of the target patient population to try new therapies;

prevalence and severity of any side effects;

labeling or product insert requirements of the FDA or other regulatory authorities, including any limitations or warnings contained

in a product’s approved labeling;

strength of marketing and distribution support;

timing of market introduction of competitive products;

quality of our relationships with patient advocacy groups;

concerning our product candidates or competing products and treatments;

third-party payor coverage and adequate reimbursement.

if a potential product displays a favorable efficacy and safety profile in pre-clinical studies and clinical trials, market acceptance

of the product will not be fully known until after it is launched.

pricing, insurance coverage and reimbursement status of newly approved products is uncertain.

Failure to obtain or maintain adequate

coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our

ability to generate product revenue.

we are unable to establish or sustain coverage and adequate reimbursement for our product candidates from third-party payors, the adoption

of those product candidates and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market

or sell those product candidates, if approved.

expect that coverage and reimbursement by third-party payors will be essential for most patients to be able to afford these treatments.

Accordingly, sales of Isomyosamine, Supera-CBD and our other product candidates will depend substantially, both domestically and internationally,

on the extent to which the costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar

healthcare management organizations, or will be reimbursed by government authorities, private health coverage insurers and other third-party

Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing

sufficient to realize a sufficient return on our investment.

is significant uncertainty related to the insurance coverage and reimbursement of newly approved products.

In the U.S., third-party

payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining

the extent to which new drugs will be covered and reimbursed.

The Medicare program covers certain individuals aged 65 or older,

disabled or suffering from end-stage renal disease.

The Medicaid program, which varies from state to state, covers certain

individuals and families who have limited financial means.

The Medicare and Medicaid programs increasingly are used as models for

how third-party private payors and other governmental payors develop their coverage and reimbursement policies for drugs.

payor’s determination to provide coverage for a drug product, however, does not assure that other payors will also provide

coverage for the drug product.

Further, a payor’s decision to provide coverage for a drug product does not imply that an

adequate reimbursement rate will be approved.

addition to government and private payors, professional organizations such as the American Medical Association (“AMA”), can

influence decisions about coverage and reimbursement for new products by determining standards for care.

In addition, many private payors

contract with commercial vendors who sell software that provide guidelines that attempt to limit utilization of, and therefore reimbursement

for, certain products deemed to provide limited benefit to existing alternatives.

Such organizations may set guidelines that limit reimbursement

or utilization of our product candidates.

Even if favorable coverage and reimbursement status is attained for one or more product candidates

for which our collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented

in the future.

the U.S., international operations are generally subject to extensive governmental price controls and other market regulations, and we

believe the increasing emphasis on cost-containment initiatives in Europe, Canada and other countries has and will continue to put pressure

on the pricing and usage of therapeutics such as our product candidates.

In many countries, particularly the countries of the European

Union, the prices of medical products are subject to varying price control mechanisms as part of national health systems.

In these countries,

pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product.

To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness

of our product candidate to other available therapies.

In general, the prices of products under such systems are substantially lower

than in the U.S.

Other countries allow companies to fix their own prices for products but monitor and control company profits.

foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates.

Accordingly, in markets outside the U.S., the reimbursement for our product candidates may be reduced compared with the U.S.

be insufficient to generate commercially reasonable revenues and profits.

increasing efforts by governmental and third-party payors, in the U.S.

and internationally, to cap or reduce healthcare costs may cause

such organizations to limit both coverage and level of reimbursement for new products approved and, as a result, they may not cover or

provide adequate payment for our product candidates.

We expect to experience pricing pressures in connection with the sale of any of

our product candidates due to the trend toward managed healthcare, the increasing influence of certain third-party payors, such as health

maintenance organizations, and additional legislative changes.

The downward pressure on healthcare costs in general, particularly prescription

drugs and surgical procedures and other treatments, has become very intense.

As a result, increasingly high barriers are being erected

to the entry of new products into the healthcare market.

Recently there have been instances in which third-party payors have refused

to reimburse treatments for patients for whom the treatment is indicated in the FDA-approved product labeling.

Even if we are successful

in obtaining FDA approvals to commercialize our product candidates, we cannot guarantee that we will be able to secure reimbursement

for all patients for whom treatment with our product candidates is indicated.

third parties on which we depend to conduct our planned pre-clinical studies or clinical trials, do not perform as contractually required,

fail to satisfy regulatory or legal requirements or miss expected deadlines, our development program could be delayed with adverse effects

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

rely on third party CROs, CMOs, consultants and others to design, conduct, supervise and monitor key activities relating to, discovery,

manufacturing, pre-clinical studies and clinical trials of our product candidates, and we intend to do the same for future activities

relating to existing and future programs.

Because we rely on third parties and do not have the ability to conduct all required testing,

discovery, manufacturing, preclinical studies or clinical trials independently, we have less control over the timing, quality and other

aspects of discovery, manufacturing, pre-clinical studies and clinical trials than we would if we conducted them on our own.

These investigators,

CROs, CMOs and consultants are not our employees, and we have limited control over the amount of time and resources that they dedicate

to our programs.

These third parties may have contractual relationships with other entities, some of which may be our competitors, which

may draw time and resources from our programs.

The third parties we contract with might not be diligent or timely in conducting our discovery,

manufacturing, pre-clinical studies or clinical trials, resulting in discovery, manufacturing, pre-clinical studies or clinical trials

being delayed or unsuccessful, in whole or in part.

we cannot contract with acceptable third parties on commercially reasonable terms, or at all, or if these third parties do not carry

out their contractual duties, satisfy legal and regulatory requirements for the conduct of pre-clinical studies or clinical trials or

meet expected deadlines, our clinical development programs could be delayed and otherwise adversely affected.

In all events, we are responsible

for ensuring that each of our pre-clinical studies and clinical trials is conducted in accordance with the general investigational plan

and protocols for the trial, as well as in accordance with GLP, GCPs and other applicable laws, regulations and standards.

on third parties that we do not control does not relieve us of these responsibilities and requirements.

The FDA and other regulatory

authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and trial sites.

If we or any of these

third parties fails to comply with applicable GCPs, the clinical data generated in its clinical trials may be deemed unreliable and the

FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving its marketing

applications.

We cannot assure that upon inspection by a given regulatory authority, such regulatory authority will determine that any

of our clinical trials have complied with GCPs.

In addition, our clinical trials must be conducted with product produced in accordance

Our failure to comply with these regulations may require us to repeat clinical trials, which could delay or prevent the receipt

of regulatory approvals.

Any such event could have an adverse effect on our business, financial condition, results of operations and

face significant competition in an environment of rapid pharmacological change and it is possible that our competitors may achieve regulatory

approval before us or develop therapies that are more advanced or effective than ours, which may harm our business, financial condition

and our ability to successfully market or commercialize Isomyosamine, Supera-CBD and our other product candidates.

biotechnology and pharmaceutical industries are characterized by rapidly changing technologies, competition and a strong emphasis on

intellectual property.

We are aware of several companies focused on developing immunometabolic treatments in various indications as well

as several companies addressing other treatments for anti-aging, anxiety and depression.

We may also face competition from large and

specialty pharmaceutical and biotechnology companies, academic research institutions, government agencies and public and private research

institutions that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing

and commercialization.

companies are focused on developing treatments for immunometabolic dysregulation in treatment of autoimmune disorders.

of our potential competitors, alone or with their strategic partners, may have substantially greater financial, technical and other resources

than we do, such as larger research and development, clinical, marketing and manufacturing organizations.

Mergers and acquisitions in

the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors.

Our commercial opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective,

have fewer or less severe side effects, are more convenient or are less expensive than any product candidates that we may develop.

also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for our products, which

could result in our competitors establishing a strong market position before we are able to enter the market, if ever.

Additionally,

new or advanced technologies developed by our competitors may render our current or future product candidates uneconomical or obsolete,

and we may not be successful in marketing our product candidates against competitors.

manufacture of drugs is complex, and our third-party manufacturers may encounter difficulties in production.

If any of our third-party

manufacturers encounter such difficulties, our ability to provide supply of Isomyosamine, Supera-CBD or our other product candidates for clinical

trials, our ability to obtain marketing approval, or our ability to provide supply of our product candidates for patients, if approved,

could be delayed or stopped.

intend to establish manufacturing relationships with a limited number of suppliers to manufacture raw materials, the drug substance and

finished product of any product candidate for which we are responsible for pre-clinical or clinical development.

Each supplier may require

licenses to manufacture such components if such processes are not owned by the supplier or in the public domain.

As part of any marketing

approval, a manufacturer and its processes are required to be qualified by the FDA prior to regulatory approval.

If supply from the approved

vendor is interrupted, there could be a significant disruption in commercial supply.

An alternative vendor would need to be qualified

through an NDA supplement which could result in further delay.

The FDA or other regulatory agencies outside of the U.S.

may also require

additional studies if a new supplier is relied upon for commercial production.

Switching vendors may involve substantial costs and is

likely to result in a delay in our desired clinical and commercial timelines.

process of manufacturing drugs is complex, highly regulated and subject to multiple risks.

Manufacturing drugs is highly susceptible

to product loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error, inconsistency

in yields, variability in product characteristics and difficulties in scaling the production process.

Even minor deviations from normal

manufacturing processes could result in reduced production yields, product defects and other supply disruptions.

If microbial, viral

or other contaminations are discovered at the facilities of our manufacturers, such facilities may need to be closed for an extended

period of time to investigate and remedy the contamination, which could delay clinical trials and adversely harm our business.

if the FDA determines that our CMOs are not in compliance with FDA laws and regulations, including those governing cGMPs, the FDA may

deny NDA approval until the deficiencies are corrected or we replace the manufacturer in our NDA with a manufacturer that is in compliance.

In addition, approved products and the facilities at which they are manufactured are required to maintain ongoing compliance with extensive

FDA requirements and the requirements of other similar agencies, including ensuring that quality control and manufacturing procedures

conform to cGMP requirements.

As such, our CMOs are subject to continual review and periodic inspections to assess compliance with cGMPs.

Furthermore, although we do not have day-to-day control over the operations of our CMOs, we are responsible for ensuring compliance with

applicable laws and regulations, including cGMPs.

addition, there are risks associated with large scale manufacturing for clinical trials or commercial scale including, among others,

cost overruns, potential problems with process scale-up, process reproducibility, stability issues, compliance with good manufacturing

practices, lot consistency, and timely availability of raw materials.

Even if our collaborators obtain regulatory approval for any of

our product candidates, there is no assurance that manufacturers will be able to manufacture the approved product to specifications acceptable

to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch

of the product or to meet potential future demand.

If our manufacturers are unable to produce sufficient quantities for clinical trials

or for commercialization, commercialization efforts would be impaired, which would have an adverse effect on our business, financial

condition, results of operations and prospects.

Related to Our Legacy Pharmaceutical Business

legacy pharmaceutical product candidates, Isomyosamine and Supera-CBD, are subject to extensive clinical development, regulatory approval,

and commercialization risks that could reduce the value of these assets.

Pharmaceutical

product development is a highly speculative undertaking and involves a substantial degree of risk.

Clinical drug development is lengthy,

expensive, and inherently uncertain.

With regard to Isomyosamine, the Company has completed certain early-stage pre-clinical testing

and IND submission for some, but not all, targeted indications.

With regard to Supera-CBD, the Company remains in the pre-clinical stage,

which is the earliest stage of development.

Clinical trials are expensive, difficult to design and implement, and can take many years

to complete, and their outcomes are inherently uncertain.

Failure can occur at any time during the clinical trial process.

pre-clinical studies and earlier clinical trials is not predictive of results in later-stage clinical trials.

Many companies in the pharmaceutical

industry have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development,

and there is a high failure rate for product candidates proceeding through clinical trials.

These risks affect the value of the Company’s

pharmaceutical assets.

process of obtaining marketing approvals for pharmaceutical products, both in the U.S.

and abroad, is expensive and takes many years,

and there is no assurance that approval would be obtained.

The Company has limited experience in submitting and supporting regulatory

Regulatory authorities have substantial discretion in the approval process and may refuse to accept or file any application,

or may require additional pre-clinical, clinical, or other studies.

Approval may be for a narrower indication than sought, or may be

subject to significant limitations, including Risk Evaluation and Mitigation Strategies, post-marketing study requirements, or restricted

distribution.

These regulatory uncertainties reduce the value of these assets in connection with any strategic alternatives the Company

legacy pharmaceutical product candidate that obtains marketing approval would be subject to extensive post-marketing regulatory requirements,

and could be subject to restrictions or withdrawal from the market.

Company’s legacy product candidates and the activities associated with their development and potential commercialization, including

testing, manufacturing, recordkeeping, labeling, storage, approval, advertising, promotion, sale, and distribution, are subject to comprehensive

regulation by the FDA and other regulatory authorities.

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

and reports, registration and listing requirements, requirements relating to manufacturing in compliance with current Good Manufacturing

Practices, quality control, quality assurance, and corresponding maintenance of records and documents.

Discovery of previously unknown

adverse events or other problems with these product candidates, manufacturers, or manufacturing processes, or failure to comply with

regulatory requirements, could result in restrictions on such products, warning or untitled letters, withdrawal of products from the

market, refusal to approve pending applications, product recalls, fines, suspension or withdrawal of marketing approvals, product seizure,

or injunctions or the imposition of civil or criminal penalties.

These regulatory risks affect the value of the Company’s pharmaceutical

commercial viability of our legacy pharmaceutical product candidates is dependent on market acceptance, pricing, reimbursement, and competition,

any of which could reduce the value of these assets.

commercial viability of Isomyosamine, Supera-CBD, or any other legacy product candidate depends in part on the acceptance of providers,

patients, patient advocacy groups, third-party payors, and the general medical community.

Market acceptance depends on several factors,

including the efficacy, durability, and safety of such product candidates as demonstrated in clinical trials, the potential and perceived

advantages over alternative treatments, the cost of treatment, and the strength of marketing and distribution support.

Absent adequate

coverage and reimbursement from third-party payors, the commercial viability of these products would be adversely affected.

The pharmaceutical

market is highly competitive, subject to rapid technological change, and significantly affected by existing rival drugs.

may develop products more rapidly or more effectively, and their success could adversely affect the value of the Company’s legacy

pharmaceutical programs.

Company’s legacy pharmaceutical operations are subject to healthcare laws and regulations, including anti-kickback, fraud and abuse,

and healthcare reform legislation, which could affect the value of these pharmaceutical assets.

Company’s legacy pharmaceutical product candidates and any arrangements with healthcare providers, third-party payors, and customers

associated with them are subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the

business or financial arrangements through which such products could be marketed, sold, and distributed.

These include federal and state

anti-kickback statutes, false claims laws, physician transparency requirements, and patient data privacy and security regulations.

addition, healthcare reform legislation, including the Affordable Care Act and subsequent legislative and regulatory changes, has significantly

affected the pharmaceutical industry.

These laws may increase the difficulty and cost of commercializing pharmaceutical product candidates

and may affect the prices that could be set.

The FDA’s ability to review and approve new products may also be hindered by a variety

of factors, including budget and funding levels, ability to hire and retain key personnel, statutory, regulatory and policy changes,

and global health concerns.

These regulatory factors affect the value of the Company’s legacy pharmaceutical assets.

legacy pharmaceutical operations involve the use of hazardous materials, and we are subject to environmental, health, and safety laws

and regulations.

legacy pharmaceutical operations involve the use of hazardous materials, including chemicals and biological materials.

We are subject

to numerous environmental, health, and safety laws and regulations, including those governing laboratory procedures and the handling,

use, storage, treatment, and disposal of hazardous materials and wastes.

We generally anticipate contracting with third parties for the

disposal of these materials and wastes.

We will not be able to eliminate the risk of contamination or injury from these materials.

the event of contamination or injury resulting from any use by us of hazardous materials, we could be held liable for any resulting damages,

and any liability could exceed our resources.

Our failure to comply with applicable environmental, health, and safety laws and regulations

may result in substantial fines, penalties, or other sanctions.

Related to Government Regulation

could be adversely affected if healthcare reform measures substantially change the market for medical care or healthcare coverage in

March 23, 2010, former President Obama signed the “Patient Protection and Affordable Care Act” (P.L.

111-148) (the

“ACA”) and on March 30, 2010, he signed the “Health Care and Education Reconciliation Act” (P.L.

collectively commonly referred to as the “Healthcare Reform Law.” The Healthcare Reform Law included a number of new

rules regarding health insurance, the provision of healthcare, conditions to reimbursement for healthcare services provided to

Medicare and Medicaid patients, and other healthcare policy reforms.

Through the law-making process, substantial changes have been

and continue to be made to the current system for paying for healthcare in the U.S., including changes made to extend medical

benefits to certain Americans who lacked insurance coverage and to contain or reduce healthcare costs (such as by reducing or

conditioning reimbursement amounts for healthcare services and drugs, and imposing additional taxes, fees, and rebate obligations on

pharmaceutical and medical device companies).

This legislation was one of the most comprehensive and significant reforms ever

experienced by the U.S.

in the healthcare industry and has significantly changed the way healthcare is financed by both governmental

and private insurers.

This legislation has impacted the scope of healthcare insurance and incentives for consumers and insurance

companies, among others.

Additionally, the Healthcare Reform Law’s provisions were designed to encourage providers to find

cost savings in their clinical operations.

Pharmaceuticals represent a significant portion of the cost of providing care.

environment has caused changes in the purchasing habits of consumers and providers and resulted in specific attention to the pricing

negotiation, product selection and utilization review surrounding pharmaceuticals.

This attention may result in products we may

commercialize or promote in the future being chosen less frequently or the pricing being substantially lowered.

At this stage, it is

difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on us.

structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare,

Medicaid, and the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or

some combination of both, as well as other changes.

Restructuring the coverage of medical care in the U.S.

could impact the reimbursement

for prescribed drugs and pharmaceuticals, including any products that we may commercialize or promote in the future.

If reimbursement for any product we may commercialize or promote is substantially reduced or

otherwise adversely affected in the future, or rebate obligations associated with them are substantially increased, it could have a material

adverse effect on our reputation, business, financial condition or results of operations.

medical benefits to those who currently lack coverage will likely result in substantial costs to the U.S.

federal government, which may

force significant additional changes to the healthcare system in the U.S.

Much of the funding for expanded healthcare coverage may be

sought through cost savings.

While some of these savings may come from realizing greater efficiencies in delivering care, improving the

effectiveness of preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost

of care and increased enforcement activities.

Cost of care could be reduced further by decreasing the level of reimbursement for medical

services or products (including any product we may commercialize or promote in the future), or by restricting coverage (and, thereby,

utilization) of medical services or products.

In either case, a reduction in the utilization of, or reimbursement for any product which

we receive marketing approval in the future, could have a material adverse effect on our reputation, business, financial condition or

results of operations.

states and private entities initially mounted legal challenges to the Healthcare Reform Law, in particular, the ACA, and they continue

to litigate various aspects of the legislation.

In June 2012, the U.S.

Supreme Court generally upheld the provisions of the ACA at

issue as constitutional.

However, the U.S.

Supreme Court held that the legislation improperly required the states to expand their Medicaid

programs to cover more individuals.

As a result, states have a choice as to whether they will expand the number of individuals covered

by their respective state Medicaid programs.

Some states have not expanded their Medicaid programs and have chosen to develop other cost-saving

and coverage measures to provide care to currently uninsured individuals.

Many of these efforts to date have included the institution

of Medicaid-managed care programs.

The manner in which these cost-saving and coverage measures are implemented could have a material

adverse effect on our reputation, business, financial condition or results of operations.

the healthcare regulatory environment has seen significant changes in recent years and is still in flux.

Legislative initiatives to modify,

limit, replace, or repeal the ACA and judicial challenges have continued.

We cannot predict the impact on our business of future legislative

and legal challenges to the ACA or other aspects of the Healthcare Reform Law or other changes to the current laws and regulations.

financial impact of U.S.

healthcare reform legislation over the next few years will depend on a number of factors, including the policies

reflected in implementing regulations and guidance and changes in sales volumes for therapeutics affected by the legislation.

to time, legislation is drafted, introduced and passed in the U.S.

Congress that could significantly change the statutory provisions

governing coverage, reimbursement, and marketing of pharmaceutical products.

In addition, third-party payor coverage and reimbursement

policies are often revised or interpreted in ways that may significantly affect our business and our products.

his first administration, President Trump supported the repeal of all or portions of the ACA.

President Trump also issued an executive

order in which he stated that it is his administration’s policy to seek the prompt repeal of the ACA and in which he directed executive

departments and federal agencies to waive, defer, grant exemptions from, or delay the implementation of the provisions of the ACA to

the maximum extent permitted by law.

Congress has enacted legislation that repeals certain portions of the ACA, including but not limited

to the Tax Cuts and Jobs Act, passed in December 2017, which included a provision that eliminates the penalty under the ACA’s individual

mandate, effective January 1, 2019, as well as the Bipartisan Budget Act of 2018, passed in February 2018, which, among other things,

repealed the Independent Payment Advisory Board (which was established by the ACA and was intended to reduce the rate of growth in Medicare

Additionally,

in December 2018, a district court in Texas held that the individual mandate is unconstitutional and that the rest of the ACA is, therefore,

On appeal, the Fifth Circuit Court of Appeals affirmed the holding on the individual mandate but remanded the case back to the

lower court to reassess whether and how such holding affects the validity of the rest of the ACA.

The Fifth Circuit’s decision

on the individual mandate was appealed to the U.S.

Supreme Court.

On June 17, 2021, the Supreme Court held that the plaintiffs (comprised

of the state of Texas, as well as numerous other states and certain individuals) did not have standing to challenge the constitutionality

of the ACA’s individual mandate and, accordingly, vacated the Fifth Circuit’s decision and instructed the district court

to dismiss the case.

As a result, the ACA will remain in-effect in its current form for the foreseeable future;

however, we cannot predict

what additional challenges may arise in the future, the outcome thereof, or the impact any such actions may have on our business.

Biden administration also introduced various measures in 2021 focusing on healthcare and drug pricing, in particular.

on January 28, 2021, former President Biden issued an executive order that initiated a special enrollment period for purposes of

obtaining health insurance coverage through the ACA marketplace, which began on February 15, 2021, and remained open through August

The executive order also instructed certain governmental agencies to review and reconsider their existing policies and

rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that

include work requirements and policies that create unnecessary barriers to obtaining access to health insurance coverage through

Medicaid or the ACA.

the legislative front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part,

eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single

source drugs and innovator multiple source drugs, beginning January 1, 2024.

And, in July 2021, the Biden administration released an

executive order entitled, “Promoting Competition in the American Economy,” with multiple provisions aimed at

prescription drugs.

In response, on September 9, 2021, HHS released a “Comprehensive Plan for Addressing High Drug

Prices” that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that

Congress could pursue as well as potential administrative actions HHS can take to advance these principles.

And, in August 2022, the

Inflation Reduction Act (“IRA”) was signed into law, which will, among other things, allow U.S.

Department of Health and

Human Services (“HHS”) to negotiate the selling price of certain drugs and biologics that the Centers for Medicare &

Medicaid Services (“CMS”) reimburses under Medicare Part B and Part D, although only high-expenditure single-source

drugs that have been approved for at least 7 years (11 years for biologics) can be selected by CMS for negotiation, with the

negotiated price taking effect two years after the selection year.

The negotiated prices, which will first become effective in 2026,

will be capped at a statutory ceiling price.

Beginning in October 2023, the IRA also began penalizing drug manufacturers that

increase prices of Medicare Part B and Part D drugs at a rate greater than the rate of inflation.

The IRA permits the Secretary of

HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

Manufacturers that fail

to comply with the IRA may be subject to various penalties, including civil monetary penalties.

The IRA also extends enhanced

subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.

Additionally, in December, 2023, the Biden Administration announced further related initiatives under the IRA to

lower prescription costs and increase competition with help from HHS, the DOJ, and the FTC.

is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the

or the effect of any future legislation or regulation.

Furthermore, we cannot asses the impact that President Trump’s second term will have on healthcare programs and regulations or the pharmaceutical industry in general.

However, it is possible that such initiatives could have an adverse effect on our

ability to obtain approval and/or successfully commercialize products in the U.S.

in the future, as applicable.

are subject to inspection and market surveillance by the FDA to determine compliance with regulatory requirements.

If the FDA finds that

we have failed to comply, the agency can institute a wide variety of enforcement actions which may materially affect our business operations.

are subject to inspection and market surveillance by the FDA to determine compliance with regulatory requirements.

If the FDA finds that

we have failed to comply with one or more applicable requirements the agency can institute a wide variety of enforcement actions, ranging

from a public warning letter to more severe sanctions such as:

injunctions and civil penalties;

detention or seizure of our products;

issuance of public notices or warnings;

restrictions, partial suspension or total shutdown of production;

approval of a marketing application;

failure to comply with applicable requirements could lead to an enforcement action that may have an adverse effect on our financial condition

and results of operations.

FDA’s ability to review and approve new products may be hindered by a variety of factors, including budget and funding levels,

ability to hire and retain key personnel, statutory, regulatory and policy changes and global health concerns.

ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding

levels, statutory, regulatory and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of

user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions.

In addition, government funding

of other government agencies that fund research and development activities is subject to 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 business.

For example, over the last several years, including for

35 days beginning on December 22, 2018, the U.S.

government has shut down several times and certain regulatory agencies, such as the

FDA, have had to furlough critical employees and stop critical activities.

ability of the FDA and other government agencies to properly administer their functions is highly dependent on the levels of government

funding and the ability to fill key leadership appointments, among various factors.

Delays in filling or replacing key positions could

significantly impact the ability of the FDA and other agencies to fulfill their functions and could greatly impact healthcare and the

pharmaceutical industry.

Recently, the U.S.

Office of Management and Budget issued a memo that instructed agencies, including the FDA, to

implement reductions in the workforce.

If such reductions result in staffing cuts at the FDA, there may be delays in the review and approval

of drug candidates, which may delay our ability to market any current or future drug candidates.

operations and relationships with future customers, providers and third-party payors will be subject to applicable anti-kickback, fraud

and abuse and other healthcare laws and regulations, which could expose us to penalties including criminal sanctions, civil penalties,

contractual damages, reputational harm and diminished profits and future earnings.

providers and third-party payors will play a primary role in the recommendation and prescription of any product candidates for which

we obtain marketing approval.

Our future arrangements with providers, third-party payors and customers will subject us to broadly applicable

fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships

through which we market, sell and distribute any product candidates for which we obtain marketing approval.

under applicable U.S.

federal and state healthcare laws and regulations include the following:

federal Anti-Kickback Statute (“AKS”) prohibits, among other things, persons and entities from knowingly and willfully

soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either

the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made

under federal healthcare programs such as Medicare and Medicaid.

A person or entity does not need to have actual knowledge of the

AKS or specific intent to violate it in order to have committed a violation;

false claims laws, including the federal False Claims Act, imposes criminal and civil penalties, including through civil whistleblower

or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government,

claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money

to the federal government.

In addition, the government may assert that a claim including items or services resulting from a violation

of the AKS constitutes a false or fraudulent claim for purposes of the civil False Claims Act;

imposes criminal and civil liability for, among other things, knowingly and willfully executing or attempting to execute a scheme

to defraud any healthcare benefit program or making false statements relating to healthcare matters.

Similar to the AKS, a person

or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

federal Physician Payment Sunshine Act of 2010 (“PPSA”) requires applicable manufacturers of covered drugs, devices,

biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance

Program, with specific exceptions, to report payments and other transfers of value provided during the previous year to physicians,

as defined by such law, certain other healthcare providers starting in 2022 (for payments made in 2021), and teaching hospitals,

as well as certain ownership and investment interests held by such physicians and their immediate family, which includes annual data

collection and reporting obligations;

state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements

and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and

the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related

to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures.

to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve

substantial costs.

It is possible that governmental authorities will conclude that our business practices may not comply with current

or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations

are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant

civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of product candidates from government-funded healthcare

programs, such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm, diminished profits and future earnings,

and the curtailment or restructuring of our operations.

If any of the physicians or other healthcare providers or entities with whom

we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative

sanctions, including exclusions from government-funded healthcare programs.

internal computer systems, or those of its third-party vendors, collaborators, or other contractors may be subject to various federal

and state confidentiality and privacy laws in the United States and abroad and could sustain system failures, security breaches, or other

disruptions, any of which could have a material adverse effect on our business.

international, national, federal, provincial and state laws, including state privacy laws (such as the California Consumer Privacy Act),

state security breach notification and information security laws, and federal and state consumer protection laws govern the collection,

use, and disclosure of personal information.

In addition, most healthcare providers who may, in the future, prescribe and dispense our

products in the United States and research institutions in the United States with whom we may collaborate in the future are “covered

entities” subject to privacy and security requirements under HIPAA.

Among other things, HITECH makes HIPAA’s privacy and

security standards directly applicable to business associates, independent contractors, or agents of covered entities that receive or

obtain protected health information in connection with providing a service on behalf of a covered entity.

HITECH also created four new

tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and

gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal

HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

We, or the covered entities we engage

with, could be subject to a wide range of penalties and sanctions under HIPAA, including criminal penalties if the individually identifiable

health information maintained by a covered entity is disclosed in a manner that is not authorized or permitted by HIPAA.

Failure to comply

with applicable HIPAA requirements or other current and future privacy laws and regulations could result in governmental enforcement

actions (including the imposition of significant penalties), criminal and civil liability, and/or adverse publicity that negatively affects

our business.

we rely on our internal and third-party provided information technology systems and applications to support our operations and to maintain

and process company information including personal information, confidential business information and proprietary information.

information technology systems are subject to cybersecurity attacks, or are otherwise compromised, due to cyberattacks, human error or

malfeasance, system errors or otherwise, it may adversely impact our business, disrupt our operations, or lead to the loss, theft, destruction,

corruption, or compromise of our information or that of our collaborators, study subjects, or other third-party contractors, as applicable.

Such information technology or security events could also lead to legal liability, regulatory investigations or enforcement actions,

loss of business, negative media coverage, and reputational damage.

While we seek to protect our information technology systems from

these types of incidents, the healthcare sector continues to see a high frequency of cyberattacks and increasingly sophisticated threat

actors, and our systems and the information maintained within those systems remain potentially vulnerable to data security incidents.

On July 20, 2023, we experienced a cybersecurity incident.

A third-party forensic technology company’s investigation confirmed that

we were a victim of wire fraud due to a compromised electronic mail account.

As of the date of this filing, we have identified losses

totaling $78,198 related to this incident, net of amounts recovered.

Following the incident, we have taken measures to enhance our electronic

mail security and have modified our internal procedures to ensure the authenticity of payment instructions and we continue to evaluate

additional measures for improving cybersecurity.

Despite these prophylactic measures, the risk of such cyber-attacks against us or our

third-party providers and business partners remains a serious issue.

Cybersecurity incidents are pervasive, and the risks of cybercrime

are complex and continue to evolve.

of the above-described cyber or other security-related incidents may trigger notification obligations to affected individuals and government

agencies, legal claims or proceedings, and liability under foreign, federal, provincial and state laws that protect the privacy and security

of personal information.

Our proprietary and confidential information may also be accessed.

Any one of these events could cause our business

to be materially harmed and our results of operations may be adversely impacted.

Finally, as cyber threats continue to evolve, and privacy

and cybersecurity laws and regulations continue to develop, we may need to invest additional resources to implement new compliance measures,

strengthen our information security posture, or respond to cyber threats and incidents.

focus on blockchain and cryptocurrency infrastructure exposes us to regulatory, cybersecurity, and market risks that could materially

impact adoption of our technology.

intended deployment of LPUs for cryptocurrency mining, DePin Token infrastructure, decentralized computing, and AI applications subjects

us to evolving regulatory frameworks across multiple jurisdictions.

These include potential export controls under ITAR and the Export

Administration Regulations, FCC and UL hardware requirements, SEC and CFTC scrutiny regarding cryptocurrency activities, EU MiCA regulations,

and emerging standards for post-quantum cryptography.

changes affecting energy consumption, decentralized computing, or blockchain infrastructure could limit the market for our products or

impose compliance burdens.

Additionally, DePin Token networks and blockchain applications present cybersecurity, data-integrity, and

operational risks that may require substantial resources to mitigate.

Any adverse regulatory development, failure to achieve or maintain

required certifications, or inability to address cybersecurity risks could delay commercialization or reduce customer adoption of the

may be subject to governmental export and import controls that could impair our ability to compete in international markets due to licensing

requirements and subject us to liability if we are not in compliance with applicable laws.

we successfully finalize the qc-LPU100 prototypes, our technology and services may be subject to U.S.

export control and import laws

and regulations, including the U.S.

Export Administration Regulations, U.S.

Customs regulations, and various economic and trade sanctions

regulations administered by the U.S.

Treasury Department’s Office of Foreign Assets Control.

export control and economic sanctions

laws include restrictions or prohibitions on the sale or supply of certain products, technologies, and services to U.S.

Government embargoed

or sanctioned countries, governments, persons and entities.

In addition, certain technology may be subject to export licensing or approval

requirements.

Potential exports of our technology must be made in compliance with export control and sanctions laws and regulations.

If we fail to comply with these laws and regulations, we and certain of our employees could be subject to substantial civil or criminal

penalties, including the possible loss of export or import privileges, fines that may be imposed on us and responsible employees or managers

and, in extreme cases, the incarceration of responsible employees or managers.

addition, various countries regulate the import of certain encryption technology, including through import permit and license requirements

and have enacted laws that could limit our ability to distribute our products and technologies or could limit our end customers’

ability to implement our services in those countries.

Changes in our technologies or changes in applicable export or import laws and

regulations also may create delays in the introduction and sale of our products and technologies in international markets or, in some

cases, prevent the export or import of our technologies to certain countries, governments or persons altogether.

Any change in export

or import laws and regulations, shift in the enforcement or scope of existing laws and regulations, or change in the countries, governments,

persons or technologies targeted by such laws and regulations could also result in decreased use of our products and services or in our

decreased ability to export or sell our products and services to existing or potential customers.

Any decreased use of our products and

services or limitation on our ability to export or sell our products and services would likely adversely affect our business, financial

condition and results of operations.

countries in addition to the U.S.

also regulate the import and export of certain encryption and other technology, including

import and export licensing requirements, and have enacted laws that could limit our ability to license our technology.

Changes to our

technology or future changes in export and import regulations may create delays in the introduction of our LPU technology in international

markets or, in some cases, prevent the export or import of our technology to certain countries, governments, or persons altogether.

expect to incur significant costs in complying with these regulations.

Regulations related to quantum computing and LPU technology are

currently evolving and we face risks associated with changes to these regulations.

regulatory framework for artificial intelligence (“AI”) technologies is rapidly evolving as many federal, state and foreign

government bodies and agencies have introduced or are currently considering additional laws and regulations.

In addition, existing laws

and regulations may be interpreted in ways that would affect the use of AI in our business.

As a result, implementation standards and

enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws,

regulations, standards, or market perception of their requirements may have on our business and may not always be able to anticipate

how to respond to these laws or regulations.

Evolving related to artificial intelligence could affect demand for our laser-based computing

products and adversely

incorporate AI solutions into our platform technology, services, and features, and these applications are important in our operations.

The regulatory framework for AI technologies is rapidly evolving as many federal, state and foreign government bodies and agencies have

introduced or are currently considering additional laws and regulations.

In addition, existing laws and regulations may be interpreted

in ways that would affect the use of AI in our business.

As a result, implementation standards and enforcement practices are likely to

remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards, or market perception

of their requirements may have on our business and may not always be able to anticipate how to respond to these laws or regulations.

Our laser-based computing products, including the qc-LPU100, are designed to address computationally intensive workloads, including artificial

intelligence and machine learning applications.

As AI technologies become increasingly subject to regulation, the demand for computing

infrastructure that supports AI workloads, including our LPU systems, may be affected development, deployment, or technologies by customers

or the markets which products are deployed

existing legal regimes (e.g., relating to data privacy) regulate certain aspects of AI technologies, and new laws regulating AI technologies

recently entered into force in the United States and Europe.

In the United States, the former Biden administration issued a broad Executive

Order on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “2023 AI Order”), which sets

out principles intended to guide AI design and deployment for the public and private sectors and signals the increase in governmental

involvement and regulation over AI technologies.

Agencies such as the Department of Commerce and the FTC have issued proposed rules governing

the use and development of AI technologies.

Legislation related to AI technologies has also been introduced at the federal level and

is advancing at the state level.

Such additional regulations may impact our ability to develop, use, and commercialize AI technologies

offered by our service providers and within our products and services in the future.

This executive order was revoked by President Trump

on January 23, 2025.

Subsequently, on January 23, 2025, the President issued Executive Order on Removing Barriers to American Leadership

in Artificial Intelligence, which directed relevant agencies to develop an action plan to assure global dominance by the United States

in artificial intelligence, and to examine any actions taken in connection with the 2023 AI Order, which are incongruent with Trump’s

May 21, 2024, the European Union legislators approved the EU Artificial Intelligence Act (the “EU AI Act”), which establishes

a comprehensive, risk-based governance framework for artificial intelligence in the EU market.

The EU AI Act entered into force on August

2, 2024, and the majority of the substantive requirements will apply from August 2, 2026.

The EU AI Act, and developing interpretation

and application of the GDPR in respect of automated decision making, together with developing guidance and/or decisions in this area,

may affect our use of AI technologies and our ability to provide, improve or commercialize our business, require additional compliance

measures and changes to our operations and processes, result in increased compliance costs and potential increases in civil claims against

us, and could adversely affect our business, operations and financial condition.

is possible that further new laws and regulations will be adopted in the United States and in other non-U.S.

jurisdictions, or that existing

laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI technologies

for our business, or require us to change the way we use AI technologies in a manner that negatively affects the performance of our system

and business and the way in which we use AI technologies.

We may need to expend resources to adjust our system in certain jurisdictions

if the laws, regulations, or decisions are not consistent across jurisdictions.

Further, the cost to comply with such laws, regulations

or decisions and/or guidance interpreting existing laws, could be significant and would increase our operating expenses (such as by imposing

additional reporting obligations regarding our use of AI technologies).

Such an increase in operating expenses, as well as any actual

or perceived failure to comply with such laws and regulations, could materially and adversely affect our business, financial condition,

results of operations, and prospects.

Related to Our Intellectual Property

success largely depends on our ability to obtain, maintain and protect our intellectual property.

It is difficult and costly to protect

our proprietary rights and technology, and we may not be able to ensure their adequate protection.

commercial success will depend in large part on obtaining and maintaining patent, trademark, trade secret and other intellectual property

protection of our proprietary technologies and product candidates, which include Isomyosamine, Supera-CBD and the other product candidates

we have in development, their respective components, formulations, combination therapies, methods used to manufacture them and methods

of treatment, as well as successfully defending our patents and other intellectual property rights against third-party challenges.

ability to stop unauthorized third parties from making, using, selling, offering to sell, importing or otherwise commercializing our

product candidates is dependent upon the extent to which we have rights under valid and enforceable patents or trade secrets that cover

these activities.

If we are unable to secure and maintain patent protection for any product or technology we develop, or if the scope

of the patent protection secured is not sufficiently broad, our competitors could develop and commercialize products and technology similar

or identical to ours, and our ability to commercialize any product candidates we may develop may be adversely affected.

patenting process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications

at a reasonable cost or in a timely manner.

In addition, we may not pursue or obtain patent protection in all relevant markets.

also possible that we will fail to identify patentable aspects of our research and development activities before it is too late to obtain

patent protection.

Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent

applications, or to maintain the patents, covering technology that we may license from or license to third parties and may be reliant

on our licensors or licensees to do so.

Our pending and future patent applications may not result in issued patents.

Even if patent applications

we license or own currently or in the future issue as patents, they may not issue in a form that will provide us with adequate protection,

prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage.

that we hold or in-license may be challenged, narrowed, circumvented or invalidated by third parties.

Consequently, we do not know whether

any of our platform advances and product candidates will be protectable or remain protected by valid and enforceable patents.

our existing patents and any future patents we obtain may not provide an adequate scope of protection or otherwise may not be enforceable

to prevent others from using our technology or from developing competing products and technologies.

may not be able to adequately protect or enforce our intellectual property rights, which could harm our competitive position.

success and future revenue growth will depend, in part, on our ability to protect our intellectual property.

We will primarily rely on

patent, copyright, trademark and trade secret laws, as well as nondisclosure agreements and other methods, to protect our proprietary

technologies or processes.

It is possible that competitors or other unauthorized third parties may obtain, copy, use or disclose proprietary

technologies and processes, despite efforts by us to protect our proprietary technologies and processes.

While we hold rights in several

patents, there can be no assurances that any additional patents will be issued, or additional rights will be granted, to us.

new patents are issued, the claims allowed may not be sufficiently broad to adequately protect our technology and processes.

Our competitors

may also be able to develop similar technology independently or design around the patents to which we have rights.

TNF has 18 issued U.S.

patents, 69 issued foreign patents, one pending U.S.

patent applications, and five foreign patent applications

pending in such jurisdictions as Canada, China, Israel, and Japan, which if issued are expected to expire between 2036 and 2041.

we expect to obtain additional patents and in-licenses in the future, there is no guarantee that we will be able to successfully obtain

such patents or in-licenses in a timely manner or at all.

Further, any of our rights to existing patents, and any future patents issued

to us, may be challenged, invalidated or circumvented.

As such, any rights granted under these patents may not provide us with meaningful

Even if foreign patents are granted, effective enforcement in foreign countries may not be available.

If our patents or rights

to patents do not adequately protect our technology or processes, competitors may be able to offer products similar to our products.

potential strategy of obtaining rights to key technologies through in-licenses may not be successful.

future growth of our business may depend in part on our ability to in-license or otherwise acquire the rights to additional product candidates

and technologies.

We cannot assure that we will be able to in-license or acquire the rights to any product candidates or technologies

from third parties on acceptable terms or at all.

example, our agreements with certain of our third-party research partners provide that improvements developed in the course of our relationship

with a given partner may be owned solely by either us or our third-party research partner, or jointly between us and the third party.

If we determine that exclusive rights to such improvements owned solely by a research partner or other third party with whom we collaborate

are necessary to commercialize our drug candidates or maintain our competitive advantage, we may need to obtain an exclusive license

from such third party in order to use the improvements and continue developing, manufacturing or marketing our drug candidates.

not be able to obtain such a license on an exclusive basis, on commercially reasonable terms, or at all, which could prevent us from

commercializing our drug candidates or allow our competitors or others the opportunity to access technology that is important to our

We also may need the cooperation of any co-owners of our intellectual property in order to enforce such intellectual property

against third parties, and such cooperation may not be provided to us.

addition, the in-licensing and acquisition of these technologies is a highly competitive area, and a number of more established companies

are also pursuing strategies to license or acquire product candidates or technologies that we may consider attractive.

These established

companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization

capabilities.

In addition, companies that perceive us to be a competitor may be unwilling to license rights to us.

Furthermore, we may

be unable to identify suitable product candidates or technologies within our area of focus.

If we are unable to successfully obtain rights

to suitable product candidates or technologies, our business and prospects could be materially and adversely affected.

we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

addition to patent protection, we rely upon know-how and trade secret protection, as well as non-disclosure agreements and invention

assignment agreements with our employees, consultants and third parties, to protect our confidential and proprietary information, especially

where we do not believe patent protection is appropriate or obtainable.

is our policy to require our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to execute

confidentiality agreements upon the commencement of employment or consulting relationships with us.

These agreements provide that all

confidential information concerning our business or financial affairs developed or made known to the individual or entity during the

course of the party’s relationship with us is to be kept confidential and not disclosed to third parties, except in certain specified

circumstances.

In the case of employees, the agreements provide that all inventions conceived by the individual, and that are related

to our current or planned business or research and development or made during normal working hours, on our premises or using our equipment

or proprietary information (or as otherwise permitted by applicable law), are our exclusive property.

In the case of consultants and

other third parties, the agreements provide that all inventions conceived in connection with the services provided are our exclusive

However, we cannot guarantee that we have entered into such agreements with each party that may have or have had access to

our trade secrets or proprietary technology and processes.

We have also adopted policies and conduct training that provides guidance

on our expectations, and our advice for best practices in protecting our trade secrets.

Despite these efforts, 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.

addition to contractual measures, we try to protect the confidential nature of our proprietary information through other appropriate

precautions, such as physical and technological security measures.

However, trade secrets and know-how can be difficult to protect.

measures may not, for example, in the case of misappropriation of a trade secret by an employee or third party with authorized access,

provide adequate protection for our proprietary information.

Our security measures may not prevent an employee or consultant from misappropriating

our trade secrets and providing them to a competitor, and any recourse we might take against this type of misconduct may not provide

an adequate remedy to protect our interests fully.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret

can be difficult, expensive, and time-consuming, and the outcome is unpredictable.

In addition, trade secrets may be independently developed

by others in a manner that could prevent us from receiving legal recourse.

If any of our confidential or proprietary information, such

as our trade secrets, were to be disclosed or misappropriated, such as through a data breach, or if any of that information was independently

developed by a competitor, our competitive position could be harmed.

Additionally, certain trade secret and proprietary information may

be required to be disclosed in submissions to regulatory authorities.

If such authorities do not maintain the confidential basis of such

information or disclose it as part of the basis of regulatory approval, our competitive position could be adversely affected.

may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at other biotechnology

or pharmaceutical companies, including our competitors or potential competitors.

Although we have no knowledge of any claims against

us, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary

information of their former employers.

Litigation may be necessary to defend against these claims.

Even if we are successful in defending

against these claims, litigation could result in substantial costs and be a distraction to management.

To date, none of our employees

have been subject to such claims.

claims of intellectual property infringement may prevent, delay or otherwise interfere with our product discovery and development efforts.

commercial success depends in part on our ability to develop, manufacture, market and sell our product candidates and use our proprietary

technologies without infringing, misappropriating or otherwise violating the intellectual property or other proprietary rights of third

There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and

pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation, inter partes

review, post grant review, and reexamination proceedings before the United States Patent and Trademark Office (“USPTO”) or

oppositions and other comparable proceedings in foreign jurisdictions.

We may be exposed to, or threatened with, future litigation by

third parties having patent or other intellectual property rights alleging that our product candidates and/or proprietary technologies

infringe, misappropriate or otherwise violate their intellectual property rights.

We will primarily rely

on patent, copyright, trademark, and trade secret laws, as well as nondisclosure agreements and other methods, to protect our

proprietary technologies or processes.

It is possible that competitors or other unauthorized third parties may obtain, copy, use or

disclose proprietary technologies and processes, despite efforts by the us to protect our proprietary technologies and processes.

While we hold rights in several patents, there can be no assurances that any additional patents will be issued, or additional rights

will be granted, to us.

Even if new patents are issued, the claims allowed may not be sufficiently broad to adequately protect our

technology and processes.

Our competitors may also be able to develop similar technology independently or design around the patents

and other agreements under which we have rights.

the Company has 19 issued U.S.

patents, 70 foreign patents, and 4 foreign patent applications pending in such jurisdictions as Canada,

China, Israel, and Japan, which if issued are expected to expire between 2036 and 2041.

Although we expect to obtain additional patents

and in-licenses in the future, there is no guarantee that we will be able to successfully obtain such patents or in-licenses in a timely

manner or at all.

Further, any of our rights to existing patents, and any future patents issued to us, may be challenged, invalidated,

or circumvented.

As such, any rights granted under these patents may not provide us with meaningful protection.

Even if foreign patents

are granted, effective enforcement in foreign countries may not be available.

If our patents or rights to patents or under other agreements

do not adequately protect our technology or processes, competitors may be able to offer products similar to our products.

business depends on our exclusive global licensing agreement with LightSolver, and loss of access to this technology or disputes regarding

intellectual property could materially and adversely affect our operations.

core strategy relies on an exclusive global license with LightSolver Ltd.

to deploy their LPU technology, including the photonic methodologies

needed for the qc-LPU100.

We depend on LightSolver for certain intellectual property, know-how, improvements, and ongoing collaboration.

Any limitation, interruption, or termination of this license agreement would materially impair our ability to develop or commercialize

may also face risks relating to technology transfer, integration of LightSolver’s photonic systems into our hardware platforms,

failure to obtain new patents or extensions, and potential intellectual property disputes.

If we are unable to secure, maintain, or enforce

the intellectual property rights necessary to support our product roadmap, or if LightSolver is unable to meet its obligations or experiences

financial, developmental, or operational difficulties, our commercialization efforts could be delayed or rendered infeasible.

addition, although we are not currently experiencing any claims challenging our rights under our licensing and distribution arrangements,

we may in the future be subject to claims and/or disputes may arise regarding intellectual property subject to distribution and licensing

agreements, including:

scope of rights granted under existing and future license and distribution agreements and other interpretation-related issues;

extent to which our technology and processes infringe on intellectual property held by the counterparty that is not subject to the

distribution or licensing agreement;

sublicensing of patent and other rights under our existing relationship and any collaboration relationships we might enter into in

diligence obligations under license and distribution agreements and what activities satisfy those diligence obligations;

party rights to intellectual property that our activities (or those of our collaboration partner) are alleged to infringe or violate,

which might hinder or prevent our ability to develop, market, and otherwise commercialize such LPU technology and products;

parties who infringe or violate the intellectual property rights that we or our collaboration partner hold, which if not suitably

challenged could result in decreased market share and profitability of our collaboration arrangement.

Further, adverse

decisions in a dispute, such as by a court, arbitrator, or administrative agency, might also result in the invalidation of, narrowing

of the scope of, or other loss or diminishment of rights in the intellectual property that make it difficult or impossible to make

fair use of such rights to legally prevent further aspects of competition in certain markets as to certain products.

are generally also subject to all of the same risks with respect to protection of intellectual property that we license or have

rights to distribute, as we are for intellectual property that we own, which may be described elsewhere under “Risks Related

to Our Intellectual Property.” If we or our collaboration partner(s) fail to adequately protect this intellectual property,

our ability to commercialize our laser-based computing products or realize value from our legacy pharmaceutical assets could suffer.

Moreover, if disputes over intellectual property that we have licensed or have rights to distribute prevent or impair our ability to

maintain our current licensing or distribution arrangements on commercially acceptable terms, we may be unable to successfully

develop and commercialize our laser-based computing technology or realize value from our legacy pharmaceutical assets, which could have a material adverse effect on

our business, financial conditions, results of operations, and prospects.

may be necessary to defend against any claims or disputes challenging rights under such licensing and/or distribution arrangements, or

for infringing or violating the intellectual property rights of third parties.

If we fail in prosecuting or defending any such claims,

in addition to paying monetary damages, we may lose valuable intellectual property or distribution rights, such as exclusive ownership

of, or right to use or commercialize, valuable technology or intellectual property.

Such an outcome could have a material adverse effect

on our business.

Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction

to management and other employees.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively

block our ability to further develop and commercialize one or more products or services.

We may not be successful in obtaining or maintaining

necessary rights to the photonic systems or any related products and services, even through further acquisitions, in-licenses, and distribution

arrangements.

may infringe our patents or the patents of our licensors.

Although we are not currently involved in any litigation, if our licensing

partner initiated legal proceedings against a third party to enforce patent rights covering one of our products or services, the defendant

could counterclaim that the patent covering our product or service is invalid and/or unenforceable.

In patent litigation in the United

States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace.

Grounds for a validity challenge could be

an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement.

for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information

from the USPTO, or made a misleading statement, during prosecution.

There are USPTO administrative proceedings that competitors can seek

to use to challenge intellectual property rights covering the products we distribute, as well.

The outcome following legal assertions

of invalidity and unenforceability is unpredictable.

because of the substantial amount of discovery required in connection with litigation, there is a risk that confidential information

of our or our collaboration partner(s) could be compromised by disclosure during this type of litigation.

There could also be public

announcements of the results of hearings, motions, or other interim proceedings or developments.

If securities analysts or investors

perceive these results to be negative, it could have a material adverse effect on the price of our common stock.

may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information

of third parties, including potentially wrongfully use or disclosure of alleged trade secrets of their former employers.

claims of intellectual property infringement may prevent, delay or otherwise interfere with our business operations.

our business is transitioning away from pharmaceuticals, past activities regarding our product candidates and their development may be

accused of infringing, misappropriating or otherwise violating the intellectual property or other proprietary rights of third parties.

There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical

We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property

rights alleging that past activities with our product candidates and/or proprietary technologies infringe, misappropriate or otherwise

violate their intellectual property rights.

Numerous U.S.

and foreign issued patents and pending

patent applications that are owned by third parties exist in the fields in which we are developing our product candidates.

As the biotechnology

and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may give rise to claims

of infringement of the patent rights of others.

Moreover, it is not always clear to industry participants, including us, which patents

cover various types of drugs, products or their methods of use or manufacture.

Thus, because of the large number of patents issued and

patent applications filed in our field, third parties may allege they have patent rights encompassing our product candidates, technologies

and foreign issued patents and pending patent applications that are owned by

third parties exist in the fields in which we were developing our product candidates.

Moreover, it is not always clear to industry participants,

including us, which patents cover various types of drugs, products or their methods of use or manufacture.

Thus, because of the large

number of patents issued and patent applications filed in our field, third parties may allege they have patent rights encompassing our

product candidates, technologies or methods.

a third party claims that we infringe, misappropriate or otherwise violate its intellectual property rights, we may face a number of

issues, including, but not limited to:

and other intellectual property claims that, regardless of merit, may be expensive and time-consuming to litigate and may divert

our management’s attention from our core business;

damages for infringement, which we may have to pay if a court decides that the product candidate or technology at issue infringes

on or violates the third party’s rights, and, if the court finds that the infringement was willful, we could be ordered to

pay treble damages plus the patent owner’s attorneys’ fees;

court prohibiting us from developing, manufacturing, marketing, selling or importing our product candidates, or from using our proprietary

technologies, unless the third-party licenses its product rights or proprietary technology to us, which it is not required to do

and certain other countries, on commercially reasonable terms or at all;

a license is available from a third party, we may have to pay substantial royalties, upfront fees and other amounts, and/or grant

cross-licenses to intellectual property rights for our product candidates;

requirement that we redesign our product candidates or processes so they do not infringe, which may not be possible or may require

substantial monetary expenditures and time;

could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities

analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our Common

of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially

greater resources.

In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material

adverse effect on our ability to raise the funds necessary to continue our operations or could otherwise have a material adverse effect

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

● infringement

and other intellectual property claims that, regardless of merit, may be expensive and time-consuming

to litigate and may divert our management’s attention from our core business;

● substantial

damages for infringement, which we may have to pay if a court decides that the product candidate

or technology at issue infringes on or violates the third party’s rights, and, if the

court finds that the infringement was willful, we could be ordered to pay treble damages

plus the patent owner’s attorneys’ fees;

could be public announcements of the results of hearings, motions, or other interim proceedings

or developments, and if securities analysts or investors perceive these results to be negative,

it could have a substantial adverse effect on the price of our Common Stock.

addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on

our ability to raise the funds necessary to continue our operations or could otherwise have a material adverse effect on our business,

financial condition, results of operations and prospects.

parties may assert that we are employing their proprietary technology without authorization, including by enforcing its patents against

us by filing a patent infringement lawsuit against us.

In this regard, patents issued in the U.S.

by law enjoy a presumption of validity

that can be rebutted only with evidence that is “clear and convincing,” a heightened standard of proof.

may not have identified all patents, published applications or published literature that affect our business by blocking our ability

to commercialize our products, by preventing the patentability of one or more aspects of our products to us or our licensors, or by covering

the same or similar technologies that may affect our ability to market our products.

For example, we (or the licensor of a product to

us) may not have conducted a patent clearance search sufficient to identify potentially obstructing third party patent rights.

patent applications in the United States are maintained in confidence for up to 18 months after their filing.

In some cases, however,

patent applications remain confidential in the U.S.

Patent and Trademark Office (the “USPTO”), for the entire time prior

to issuance as a U.S.

Patent applications filed in countries outside of the United States are not typically published until at

least 18 months from their first filing date.

Similarly, publication of discoveries in scientific or patent literature often lags

behind actual discoveries.

We cannot be certain that we or our licensors were the first to invent, or the first to file, patent applications

covering our products.

We also may not know if our competitors filed patent applications for technology covered by our pending applications

or if we were the first to invent the technology that is the subject of our patent applications.

Competitors may have filed patent applications

or received patents and may obtain additional patents and proprietary rights that block or compete with our patents.

there may be third-party patents of which we are currently unaware with claims to materials, formulations, methods of manufacture or

methods for treatment related to the use or manufacture of our product candidates.

Because patent applications can take many years to

issue, there may be currently pending patent applications that may later result in issued patents that our product candidates may infringe.

In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents.

any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our product candidates,

or materials used in or formed during the manufacturing process, or any final product itself, the holders of those patents may be able

to block our ability to commercialize our product candidates unless we obtain a license under the applicable patents, or until those

patents were to expire or those patents are finally determined to be invalid or unenforceable.

Similarly, if any third-party patent were

held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including

combination therapy or patient selection methods, the holders of that patent may be able to block our ability to develop and commercialize

a product candidate unless we obtain a license or until such patent expires or is finally determined to be invalid or unenforceable.

In either case, a license may not be available on commercially reasonable terms, or at all, particularly if such patent is owned or controlled

by one of our primary competitors.

If we are unable to obtain a necessary license for a third-party patent on commercially reasonable

terms, or at all, our ability to commercialize our product candidates may be impaired or delayed, which could significantly harm our

Even if we obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed

In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could

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

making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further

develop and commercialize our product candidates.

Defense of these claims, regardless of their merit, would involve substantial litigation

expense and would be a substantial diversion of employee time and resources from our business.

In the event of a successful claim of

infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement,

obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require

substantial time and monetary expenditure.

We cannot predict whether any license of this nature would be available at all or whether

it would be available on commercially reasonable terms.

Furthermore, even in the absence of litigation, we may need to obtain licenses

from third parties to advance our research or allow commercialization of our product candidates and we may fail to obtain any of these

licenses at a reasonable cost or on reasonable terms, if at all.

In that event, we would be unable to further develop and commercialize

our product candidates, which could significantly harm our business.

may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming

and unsuccessful and could result in a finding that such patents are unenforceable or invalid.

may infringe our patents or the patents of our licensors.

To counter infringement or unauthorized use, we may be required to file infringement

claims, which can be expensive and time-consuming.

In addition, in an infringement proceeding, a court may decide that one or more of

our patents is not valid, is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that

our patents do not cover the technology in question.

patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous

grounds upon which a third party can assert invalidity or unenforceability of a patent.

Third parties may also raise similar claims before

administrative bodies in the U.S.

or abroad, even outside the context of litigation.

These types of mechanisms include re-examination,

post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions

(e.g., opposition proceedings).

These types of proceedings could result in revocation or amendment to our patents such that they no longer

cover our product candidates.

The outcome for any particular patent following legal assertions of invalidity and unenforceability is

unpredictable.

With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which

we, our patent counsel and the patent examiner were unaware during prosecution.

If a defendant were to prevail on a legal assertion of

invalidity and/or unenforceability, or if we are otherwise unable to adequately protect our rights, we would lose at least part, and

perhaps all, of the patent protection on our product candidates.

Defense of these types of claims, regardless of their merit, would involve

substantial litigation expense and would be a substantial diversion of employee resources from our business.

we may choose to challenge the patentability of claims in a third party’s U.S.

patent by requesting that the USPTO review the patent

claims in re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings

in foreign jurisdictions (e.g., opposition proceedings), or we may choose to challenge a third party’s patent in patent opposition

proceedings in the Canadian Intellectual Property Office (“CIPO”) the European Patent Office (“EPO”) or another

foreign patent office.

Even if successful, the costs of these opposition proceedings could be substantial, and may consume our time or

other resources.

If we fail to obtain a favorable result at the USPTO, CIPO, EPO or other patent office then we may be exposed to litigation

by a third party alleging that the patent may be infringed by our product candidates or proprietary technologies.

because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some

of our confidential information could be compromised by disclosure during this type of litigation.

In addition, there could be public

announcements of the results of hearings, motions or other interim proceedings or developments.

If securities analysts or investors perceive

these results to be negative, that perception could have a substantial adverse effect on the price of our Common Stock.

Any of the foregoing

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

have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.

currently have limited intellectual property rights outside the U.S.

Filing, prosecuting and defending patents on product candidates

in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside

can be less extensive than those in the U.S.

In addition, the laws of some foreign countries do not protect intellectual property

rights to the same extent as federal and state laws in the U.S.

For example, patents covering therapeutic methods of treating humans

are not available in many foreign countries.

Consequently, we may not be able to prevent third parties from practicing our inventions

in all countries outside the U.S., or from selling or importing products made using our inventions in and into the U.S.

or other jurisdictions.

Competitors may use our technologies in jurisdictions where we do not have or have not obtained patent protection to develop their own

products and, further, may export otherwise infringing products to territories where we have patent protection but where enforcement

is not as strong as that in the U.S.

These products may compete with our product candidates in jurisdictions where we do not have any

issued patents and our patent claims or other intellectual property rights may not be effective or sufficient to prevent them from competing.

companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

legal and political systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents,

trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make

it difficult for us to stop the infringement of our patents or marketing of competing products against third parties in violation of

our proprietary rights generally.

The initiation of proceedings by third parties to challenge the scope or validity of our patent rights

in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.

to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other

aspects of our business, could be impossible or impractical due to sanctions or trade disputes between countries, could put our patents

at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties

to assert claims against us.

We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may

not be commercially meaningful.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate

to obtain a significant commercial advantage from the intellectual property that we develop or license.

and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements

imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime

of the patent.

The USPTO and various foreign patent agencies also require compliance with a number of procedural, documentary, fee payment

and other provisions during the patent application process and following the issuance of a patent.

While an inadvertent lapse can in

many cases be cured by payment of a late fee or by other means in accordance with the applicable laws and rules, there are situations

in which noncompliance can result in irrevocable abandonment or lapse of the patent or patent application, resulting in partial or complete

loss of patent rights in the relevant jurisdiction.

Noncompliance events that could result in abandonment or lapse of a patent or patent

application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees

and failure to properly legalize and submit formal documents.

Were a noncompliance event to occur, our competitors might be able to enter

the market, which would have a material adverse effect on our business financial condition, results of operations and prospects.

in patent law in the U.S.

and in non-U.S.

jurisdictions could diminish the value of patents in general, thereby impairing our ability

to protect our product candidates.

is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.

and enforcing patents in the pharmaceutical industry involves both technological and legal complexity, and is therefore costly, time-consuming

and inherently uncertain.

or future patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications

and the enforcement or defense of our issued patents.

For example, in March 2013, under the Leahy-Smith America Invents Act (“America

Invents Act”), the U.S.

moved from a “first to invent” to a “first-inventor-to-file” patent system.

our “first-inventor-to-file” system, assuming the other requirements for patentability are met, the first inventor to file

a patent application generally will be entitled to a patent on the invention regardless of whether another inventor had made the invention

The America Invents Act includes a number of other significant changes to U.S.

patent law, including provisions that affect

the way patent applications are prosecuted, redefine prior art and establish a new post-grant review system.

The effects of these changes

continue to evolve as the USPTO continues to promulgate new regulations and procedures in connection with the America Invents Act and

many of the substantive changes to patent law, including the “first-inventor-to-file” provisions, only became effective in

In addition, the courts have yet to address many of these provisions and the applicability of the act and new regulations

on the specific patents discussed in this filing have not been determined and would need to be reviewed.

Moreover, the America Invents

Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the

enforcement or defense of our issued patents.

cases by the U.S.

Supreme Court have held that certain methods of treatment or diagnosis are not patent-eligible.

law regarding

patent-eligibility continues to evolve.

While we do not believe that any of our patents will be found invalid based on these changes

to US patent law, we cannot predict how future decisions by the courts, the U.S.

Congress or the USPTO may impact the value of our patents.

Any similar adverse changes in the patent laws of other jurisdictions could also have a material adverse effect on our business, financial

condition, results of operations and prospects.

terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

have a limited lifespan.

In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years

from its earliest U.S.

non-provisional filing date.

Various extensions may be available, but the life of a patent, and the protection

it affords, is limited.

Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open

to competition from competitive products, including generics.

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

review of new product candidates, patents protecting our product candidates might expire before or shortly after our or our partners

commercialize those candidates.

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

others from commercializing products similar or identical to ours.

we do not obtain patent term extension for any product candidates we may develop, our business may be materially harmed.

upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of our U.S.

patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, (the

“Hatch-Waxman Amendments”).

The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation

for patent term lost during clinical trials and the FDA regulatory review process.

A patent term extension cannot extend the remaining

term of a patent beyond a total of 14 years from the date of product approval, only one patent per product may be extended and only those

claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.

law concerning

patent term extensions and foreign equivalents continue to evolve.

Even if we were to seek a patent term extension, it may not be granted

because of, for example, the failure to exercise due diligence during the testing phase or regulatory review process, the failure to

apply within applicable deadlines, the failure to apply prior to expiration of relevant patents, or any other failure to satisfy applicable

requirements.

Moreover, the applicable time period of extension or the scope of patent protection afforded could be less than we request.

If we are unable to obtain patent term extension or term of any such extension is less than we request, our competitors may obtain approval

of competing products following our patent expiration sooner than expected, and our business, financial condition, results of operations

and prospects could be materially harmed.

Related to Our Preferred Stock

Holders of our Series F Preferred

Stock, Series F-1 Preferred Stock and Series G Preferred Stock are entitled to certain payments under the applicable Certificate of Designations

that may be paid in cash, in shares of Common Stock or in additional shares of Series G Preferred Stock depending on the circumstances.

of our Series H Preferred Stock and Series G Preferred Stock are entitled to certain payments under the applicable

Certificate of Designations that may be paid in cash, in shares of Common Stock or in additional shares of Series G Preferred Stock depending

on the circumstances.

If we make these payments in cash, it may require the expenditure of a substantial portion of our cash resources.

If we make these payments

in Common Stock, it may result in substantial dilution to the holders of our Common Stock.

the Series F Certificate of Designations and Series F-1 Certificate of Designations, we are required to redeem the shares of the shares

of the Series F Preferred Stock and Series F-1 Preferred Stock in equal monthly installments commencing July 1, 2023, and December 1,

2024, respectively.

Such holders are also entitled to receive dividends, payable in arrears monthly, and dividends payable on installment

dates shall be paid as part of the applicable installment amount.

Installment amounts are payable, at the Company’s election, in

shares of Common Stock or, subject to certain limitations, in cash.

Installment amounts paid in cash must be paid in the amount of 105%

of the applicable payment amount due.

ability to make payments due to the holders of our Series F Preferred Stock and Series F-1 Preferred Stock using shares of Common Stock

is subject to certain limitations set forth in the applicable Certificate of Designations.

If we are unable to make installment payments

in shares of Common Stock, we may be forced to make such payments in cash.

Additionally, the holders of the Series G Preferred Stock

are entitled to dividends of 10% per annum, compounded monthly, which are payable in arrears monthly, at the holder’s sole discretion,

in cash, or “in kind” in the form of additional Series G Preferred Stock, or a combination thereof.

If we do not have sufficient

cash resources to make these payments, we may need to raise additional equity or debt capital, and we cannot provide any assurance that

we will be successful in doing so.

If are unable to raise sufficient capital to meet our payment obligations, we may need to delay, reduce

or eliminate certain research and development programs or other operations, sell some or all of our assets or merge with another entity.

ability to make payments due to the holders of our Series F Preferred Stock, Series G Preferred Stock, Series F-1 Preferred Stock using

cash is also limited by the amount of cash we have on hand at the time such payments are due as well as certain provisions of the Delaware

General Corporation Law (the “DGCL”).

Further, we intend to make the installment payments due to holders of Series F Preferred

Stock and Series F-1 Preferred Stock in the form of Common Stock to the extent allowed under the applicable Certificate of Designation

and applicable law in order to preserve our cash resources.

The issuance of shares of Common Stock to the holders of our Series F Preferred

Stock and Series F-1 Preferred Stock with increase the number of shares of Common Stock outstanding and could result in substantial dilution

to the existing holders of our Common Stock.

Certificate of Designations for the Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock and the warrants

issued concurrently therewith contain anti-dilution provisions that may result in the reduction of the conversion price of the applicable

preferred stock or the exercise price of such warrants in the future.

These features may increase the number of shares of Common Stock

being issuable upon conversion of the Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock or upon the exercise

of the warrants.

Series F Certificate of Designations, Series F-1 Certificate of Designations and Series G Certificate of Designations and the warrants

issued concurrently therewith, contain anti-dilution provisions, which provisions require the lowering of the applicable conversion price

or exercise, as then in effect, to the purchase price of equity or equity-linked securities issued in subsequent offerings.

future, while any of our Series F Preferred Stock, Series F-1 Preferred Stock, Series G Preferred Stock, Series F Warrants, Series F-1

Warrants or Series G Warrants are outstanding, we issue securities for a consideration per share of Common Stock (the “New Issuance

Price”) that is less than the applicable conversion price of our preferred stock or the exercise price of the Series F Warrants,

Series F-1 Warrants or Series G Warrants, as then in effect, we will be required, subject to certain limitations and adjustments as provided

in the applicable Certificate of Designations or the applicable warrants, to reduce the conversion price or the exercise price to be

equal to the New Issuance Price, which will result in a greater number of shares of Common Stock being issuable upon conversion or exercise,

as applicable, which in turn will increase the dilutive effect of such conversion or exercise on existing holders of our Common Stock.

It is possible that we will not have a sufficient number of shares available to satisfy the conversion of the Series F Preferred Stock,

Series F-1 Preferred Stock or Series G Preferred Stock or the exercise of the Series F Warrants, Series F-1 Warrants or Series G Warrants

if we enter into a future transaction that reduces the applicable conversion price or exercise price.

If we do not have a sufficient

number of available shares for any such conversions or any such warrant exercises, we may need to seek stockholder approval to increase

the number of authorized shares of our Common Stock, which may not be possible and will be time-consuming and expensive.

The potential

for such additional issuances may depress the price of our Common Stock regardless of our business performance and may make it difficult

for us to raise additional equity capital while any of our Series F Preferred Stock, Series F-1 Preferred Stock, Series G Preferred Stock

or Series F Warrants, Series F-1 Warrants or Series G Warrants are outstanding.

the February 2023 SPA, the Series F-1 Purchase Agreement and Series G Purchase Agreement we are subject to certain restrictive covenants

that may make it difficult to procure additional financing.

February 2023 SPA, pursuant to which we issued the Series F Preferred Stock, contains, among others, the following restrictive covenants:

(i) until all of the Series F Warrants are exercised, we agreed not to enter into any variable rate transactions;

and (ii) until the

later of no shares of Series F Preferred Stock being outstanding and the maturity date of the Series F Preferred Stock, the opportunity

If we make these payments in Common Stock, it may result in substantial dilution to the holders of our Common Stock.

of our Series H Preferred Shares are entitled to receive dividends of 7% per annum, compounded each calendar quarter, which are payable

in arrears (i) on the first trading day of each quarter, commencing on October 1, 2025 (ii) upon any redemption or any required payment

upon any Triggering Event (as defined in the Series H Certificate of Designations.

The holders of the Series H Preferred Shares are also

entitled to receive a dividend make-whole payment.

Upon the occurrence and during the continuance of a Triggering Event (as defined in

the Series H Certificate of Designations), the Series H Preferred Shares accrue dividends at the rate of 15% per annum.

In connection

with a Triggering Event, each holder of the Series H Preferred Shares will be able to require us to redeem in cash any or all of the

holder’s Series H Preferred Shares at a premium set forth in the Series H Certificate of Designations.

If such Triggering Event

occurs, our financial condition and results of operations could be materially affected.

we do not have sufficient cash resources to make these payments, we may need to raise additional equity or debt capital, and we

cannot provide any assurance that we will be successful in doing so.

If are unable to raise sufficient capital to meet our payment

obligations, we may need to delay, reduce or eliminate certain research and development programs or other operations, sell some or

all of our assets or merge with another entity.

Our ability to make payments due to the holders of our Series H Preferred Shares

using cash is also limited by the amount of cash we have on hand at the time such payments are due as well as certain provisions of

the Delaware General Corporation Law (the “DGCL”).

Additionally, the holders of the Series G Preferred Stock are entitled to

dividends of 10% per annum, compounded monthly, which are payable in arrears monthly, at the holder’s sole discretion, in

cash, or “in kind” in the form of additional Series G Preferred Stock, or a combination thereof.

If we do not have

sufficient cash resources to make these payments, we may need to raise additional equity or debt capital, and we cannot provide any

assurance that we will be successful in doing so.

If are unable to raise sufficient capital to meet our payment obligations, we may

need to delay, reduce or eliminate certain research and development programs or other operations, sell some or all of our assets or

merge with another entity.

ability to make payments due to the holders of our Series H Preferred Stock and Series G Preferred Stock

using cash is also limited by the amount of cash we have on hand at the time such payments are due as well as certain provisions of

Certain outstanding shares of preferred stock and common stock purchase warrants of the Company

contain anti-dilution provisions that may result in the reduction of the conversion price of the applicable preferred stock or the exercise

price of such warrants in the future.

These features may increase the number of shares of Common Stock being issuable upon conversion

of such preferred stock or upon the exercise of such warrants.

The Series H Certificate of

Designations and Series G Certificate of Designations and the warrants issued concurrently therewith (as applicable, the

“Series G Warrants” or the “Series H Warrants”), as well as the warrants (as applicable, the “Series F

Warrants” or the “Series F-1 Warrants”) issued in connection with the issuance of the Company’s Series F

Convertible Preferred Stock, par value $0.001 per share (“Series F Preferred Stock”) and Series F-1 Convertible

Preferred Stock, par value $0.001 per share (“Series F-1 Preferred Stock”), contain anti-dilution provisions, which

provisions require the lowering of the applicable conversion price or exercise, as then in effect, to the purchase price of equity

or equity-linked securities issued in subsequent offerings.

If in the future, while any of our Series H Preferred Stock, Series G

Preferred Stock, Series H Warrants or Series F Warrants, Series F Warrants, and Series F-1 Warrants are outstanding, we issue

securities for a consideration per share of Common Stock (the “New Issuance Price”) that is less than the applicable

conversion price of our preferred stock or the exercise price of the warrants, as then in effect, we will be required, subject to

certain limitations and adjustments as provided in the applicable Certificate of Designations or the applicable warrants, to reduce

the conversion price or the exercise price to be equal to the New Issuance Price, which will result in a greater number of shares of

Common Stock being issuable upon conversion or exercise, as applicable, which in turn will increase the dilutive effect of such

conversion or exercise on existing holders of our Common Stock.

It is possible that we will not have a sufficient number of shares

available to satisfy the conversion of the Series H Preferred Stock or Series G Preferred Stock or the exercise of the Series H

Warrants, Series G Warrants or Series F Warrants, or Series F-1 Warrants if we enter into a future transaction that reduces the

applicable conversion price or exercise price.

If we do not have a sufficient number of available shares for any such conversions or

any such warrant exercises, we may need to seek stockholder approval to increase the number of authorized shares of our Common

Stock, which may not be possible and will be time-consuming and expensive.

The potential for such additional issuances may depress

the price of our Common Stock regardless of our business performance and may make it difficult for us to raise additional equity

capital while any of our Series H Preferred Stock, Series G Preferred Stock or Series G

Warrants, Series H Warrants, Series F Warrants, or Series F-1 Warrants are outstanding.

The Series H Certificate of Designations and Series G Certificate of Designations

contains restrictive covenants and terms that may make it difficult to procure additional financing and that may affect our financial

condition and results of operations.

The Series H Certificate of Designations and Series G Certificate of Designations

contains certain restrictive covenants including but not limited to, maintaining a Cash Minimum (as defined in the Series H Certificate

of Designations), restrictions on incurring any indebtedness until the date on which no Series H Preferred Shares or Series G Preferred

Stock are outstanding, subject to certain exceptions, restrictions on directly or indirectly, redeeming, repurchasing or declaring or

paying any cash dividend or distribution on any of our capital stock (other than as required by the applicable Certificate of Designations

and subject to certain exceptions as set forth therein), and restrictions on directly or indirectly, permitting any of our indebtedness

to mature or accelerate prior to the Maturity Date (as defined in the Series H Certificate of Designations).

Additionally, the Series

H Preferred Shares and Series G Preferred Stock also contains certain purchase rights (the “Purchase Rights”) permitting the

holders of the applicable preferred stock to acquire upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights

which such holder could have acquired if such holder had held the number of shares of Common Stock acquirable upon complete conversion

of all of its Series H Preferred Shares or shares of Series G Preferred Stock.

These restrictive covenants may limit our flexibility in

raising capital or incurring any indebtedness, which may have an adverse effect on our financial condition.

the Series H Purchase Agreement and Series G Purchase Agreement, we are subject to certain restrictive covenants that may make it difficult

to procure additional financing.

Series H Purchase Agreement contains, among others, the following restrictive covenants:

(A) unless Stockholder Approval is obtained,

the Company may not effect (i) any Dilutive Issuance (as defined in the Series H Certificate of Designations) or (ii) without the prior

written consent of the Required Holders (as defined in the Series H Certificate of Designations), issue or sell (or enter into any agreement

or publicly announce the intention to grant, issue or sell) securities containing any anti-dilution price-based adjustments, (B) until

ninety (90) days following the earlier of (x) the date on which this registration statement is declared effective or (y) the date on

which the selling stockholders may sell their Series H Conversion Shares or shares of Common Stock issuable upon exercise of the warrants issued in connection with the Series H Preferred Stock (the “Series H Warrants”) without restriction pursuant to Rule 144 under the Securities Act, we may not issue, offer, sell, grant any option or right

to purchase, or otherwise dispose of (or announce any issuance, offer, sale, grant of any option or right to purchase or other disposition

of) any equity security or any equity-linked or related security, (C) until all of the Series H Warrants are no longer outstanding, we

shall be prohibited from effecting or entering into an agreement to effect any subsequent placement involving a variable rate transaction,

and (D) until the later of (i) the Maturity Date (as defined in the Series H Certificate of Designations), and (ii) the date in which

no Series H Preferred Shares remain outstanding, the Company must provide the holders of the Series H Preferred Shares the opportunity

to participate in any subsequent securities offerings by us.

The Series F-1 Purchase Agreement, pursuant to which we issued the Series

F-1 Preferred Stock, contains, among others, the following restrictive covenants:

(i) until all of the Series F-1 Warrants are exercised,

The Series G Purchase Agreement, pursuant to which we issued the Series

G Preferred Stock, contains, among others, the following restrictive covenants:

(i) until all of the Series G Warrants are exercised,

we agreed not to enter into any variable rate transactions;

and (ii) until the later of no shares of Series F-1 Preferred Stock being

outstanding and the maturity date, the opportunity to participate in any subsequent securities offerings by us.

The Series G Purchase

Agreement, pursuant to which we issued the Series G Preferred Stock, contains, among others, the following restrictive covenants:

until all of the Series G Warrants are exercised, we agreed not to enter into any variable rate transactions;

and (ii) until the later

of no shares of Series G Preferred Stock being outstanding and the second anniversary of the Series G Closing Date, the opportunity to

participate in any subsequent securities offerings by us.

and (ii) until the later of no shares of Series G Preferred Stock being outstanding

and the second anniversary of the Series G Closing Date, the opportunity to participate in any subsequent securities offerings by us.

we require additional funding while these restrictive covenants remain in effect, we may be unable to effect a financing transaction

while remaining in compliance with the terms of the February 2023 SPA or Purchase Agreements, or we may be forced to seek a waiver from

the investors party to the February 2023 SPA and Purchase Agreements.

on terms acceptable to us, or at all, while also remaining in compliance with the terms of each purchase agreement, or we may be forced

to seek a waiver from the investors party to each purchase agreement, which such investors are not obligated to grant to us.

or availability for sale of a substantial number of shares of our Common Stock may cause the price of our Common Stock to decline.

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it more difficult for us to raise funds through future offerings of Common Stock or other securities.

Our stockholders and the

holders of our options and warrants may sell substantial amounts of our Common Stock in the public market.

In addition, we may be

required to issue shares of Common Stock to the holders of our Series F Preferred Stock, Series F-1 Preferred Stock or Series G

Preferred Stock upon conversion of such shares of our Series F Preferred Stock and the payment of the dividends thereunder in Common

Stock as a result of the full ratchet anti-dilution price protection in the Certificate of Designation if the effective Common Stock

purchase price in a subsequent offering is less than the then current conversion price, which in turn will

increase the number of shares of Common Stock available for sale.

See “Risk Factors—Risks Related to Our Series F Preferred Stock—

The Certificate of Designations for the Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock and the warrants

issued concurrently therewith contain anti-dilution provisions that may result in the reduction of the conversion price of the applicable

preferred stock or the exercise price of such warrants in the future.

These features may increase the number of shares of Common Stock

being issuable upon conversion of the Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock or upon the exercise

of the warrants.”

Our stockholders and the holders

of our options and warrants may sell substantial amounts of our Common Stock in the public market.

addition, the fact that our stockholders can sell substantial amounts of our Common Stock in the public market, whether or not sales

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development opportunities.

previously disclosed, on March 17, 2025, we received a written notice (the “Notice”) from the Listing Qualifications Department

of the Nasdaq Stock Market indicating that for the last 30 consecutive business days, the bid price for our Common Stock had closed below

the minimum $1.00 per share requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum

As previously disclosed, on

March 17, 2025, we received a written notice (the “Notice”) from the Listing Qualifications Department of the Nasdaq

Stock Market indicating that for the last 30 consecutive business days, the bid price for our Common Stock had closed below the

minimum $1.00 per share requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum

Bid Price Requirement”).

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15, 2025 (the “Compliance Period”), in which to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A).

as of 4:05 p.m.

Eastern Standard Time on February 14, 2024, we effected the Reverse Stock Split of our common stock at a ratio of one-for-thirty.

Simultaneously with the Reverse Stock Split, number of shares of our common stock authorized for issuance was reduced from 500,000,000

shares to 16,666,666 shares, and our authorized capital stock was reduced from 550,000,000 shares to 66,666,666 shares.

Our common stock

continued to be traded on the Nasdaq Capital Market under the symbol TNF and began trading on a split-adjusted basis at market open on

February 15, 2024.

On March 4, 2024, we were notified by Nasdaq that we had regained compliance with all Nasdaq listing requirements

and the matter was closed.

is no assurance that we will maintain compliance with such minimum listing requirements.

September 16, 2025, the Company received written notice from Nasdaq that Nasdaq determined the Company regained compliance with

Nasdaq Listing Rule 5550(a)(2), and considers the matter closed.

is no assurance that we will maintain compliance with minimum listing requirements in the future.

If our common stock were delisted from Nasdaq,

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In addition, we may be required to issue an indeterminate number of shares

of Common Stock to the holders of our Series F Preferred Stock, Series F-1 Preferred Stock, Series G Preferred Stock and related warrants

upon the conversion or exercise of either, as applicable.

See “Risk Factors—Risks Related to Our Preferred Stock— Holders

of our Series F Preferred Stock, Series F-1 Preferred Stock and Series G Preferred Stock are entitled to certain payments under the applicable

Certificate of Designations that may be paid in cash, in shares of Common Stock or in additional shares of Series G Preferred Stock depending

on the circumstances.

If we make these payments in cash, it may require the expenditure of a substantial portion of our cash resources.

If we make these payments in Common Stock, it may result in substantial dilution to the holders of our Common Stock..” and “Risk

Factors—Risks Related to Our Preferred Stock—The Certificate of Designations for the Series F Preferred Stock, Series F-1

Preferred Stock and Series G Preferred Stock and the warrants issued concurrently therewith contain anti-dilution provisions that may

result in the reduction of the conversion price of the applicable preferred stock or the exercise price of such warrants in the future.

These features may increase the number of shares of Common Stock being issuable upon conversion of the Series F Preferred Stock, Series

F-1 Preferred Stock and Series G Preferred Stock or upon the exercise of the warrants.”

of Common Stock to the holders of our Series H Preferred Stock, Series G Preferred Stock and related warrants upon the conversion or exercise

of either, as applicable.

See “Risk Factors—Risks Related to Our Preferred Stock— Holders of our Series H Preferred

Stock, and Series G Preferred Stock are entitled to certain payments under the applicable Certificate of Designations that may be paid

in cash, in shares of Common Stock or in additional shares of Series G Preferred Stock depending on the circumstances.

If we make these

payments in cash, it may require the expenditure of a substantial portion of our cash resources.

If we make these payments in Common Stock,

it may result in substantial dilution to the holders of our Common Stock.” and “Risk Factors—Risks Related to Our Preferred

Stock—The Certificate of Designations for the Series H Preferred Stock and Series G Preferred Stock and the warrants issued concurrently

therewith contain anti-dilution provisions that may result in the reduction of the conversion price of the applicable preferred stock

or the exercise price of such warrants in the future.

These features may increase the number of shares of Common Stock being issuable

upon conversion of the Series H Preferred Stock and Series G Preferred Stock or upon the exercise of the warrants.”

do not anticipate paying cash dividends on our Common Stock and, accordingly, stockholders must rely on stock appreciation for any return

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So long as any

shares of Series F Preferred Stock, Series F-1 Preferred Stock or Series G Preferred Stock are outstanding, as they are at this

shares of Series H Preferred Stock or Series G Preferred Stock are outstanding, as they are at this

time, we are not able to declare or pay any cash dividend or distribution on any of our capital stock (other than as required by the

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Common Stock could decline.

trading market for our Common Stock relies in part on the availability of research and reports that third-party industry or financial

analysts publish about us.

There are many large, publicly traded companies active in the life sciences and biopharmaceutical industries,

which may mean it will be less likely that we receive widespread analyst coverage.

Furthermore, if one or more of the analysts who do

cover the Company (if any) downgrades our stock, our stock price would likely decline.

If one or more of these analysts cease coverage

of the Company, we could lose visibility in the market, which in turn could cause our stock price to decline.

Additionally, if securities

analysts publish negative evaluations of competitors in the life sciences and biopharmaceutical industries, the comparative effect could

cause our stock price to decline.

trading market for our Common Stock relies in part on the availability of research and reports that third-party industry or

financial analysts publish about us.

There are many large, publicly traded companies active in the technology, blockchain, and

laser computing industries, which may mean it will be less likely that we receive widespread analyst coverage.

Furthermore, if one

or more of the analysts who do cover the Company (if any) downgrades our stock, our stock price would likely decline.

If one or more

of these analysts cease coverage of the Company, we could lose visibility in the market, which in turn could cause our stock price

Additionally, if securities analysts publish negative evaluations of competitors in the technology and

computing industries, the comparative effect could cause our stock price to decline.

Anti-takeover

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combining with us for a prescribed period of time.

have been subject to a number of securities litigations, and we may be subject to similar or other litigation in the future.

have been subject to a number of litigations as described elsewhere in this Annual Report on Form 10-K and in Note 8 to our consolidated

financial statements.

In connection with certain of these litigations, we have entered into settlements of claims for significant monetary

We may also be subject to judgements or enter into additional settlements of claims for significant monetary damages for the

securities litigations that we have yet to enter into settlement agreements.

Defending against the current litigations is or can be time-consuming,

expensive and cause diversion of our management’s attention.

We may be subject to securities litigation in the future.

that have experienced volatility in the market price of their stock have frequently been the objects of securities class action litigation.

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to cover any eventual liability.

market and economic conditions in one or more of our markets could impact our ability to grow our business.

the last few years in the U.S.

and globally, market and economic conditions have been challenging, particularly in light of public health

pandemics and, more recently, as a result of uncertainty concerning government shutdowns, debt ceilings, government funding and trade

Any negative impact on economic conditions and international markets, continued volatility or deterioration in the debt and equity

capital markets, heightened inflation, deflation or other adverse economic conditions may adversely affect our business, liquidity, financial

condition, cash flows and results of operations and could cause the market value of our common shares and/or debt securities to decline.

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