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Item 1A. Risk Factors

2026-03-30 compared with 2025-03-27 · 983 added, 1331 removed, 68 unchanged (97% of the section changed)

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filings with the SEC, before making an investment decision regarding our common stock.

We will require additional capital to finance our operations to continue as a going concern, which may not be available to us on acceptable terms, if at all.

As a result, we may not complete the development and commercialization of our product candidates or develop new product candidates and have substantial doubt about our ability to continue as a going concern.

Our ability to successfully engage with, and satisfactorily respond to, requests for information from the FDA in the future.

We have incurred losses since inception and anticipate that we will continue to incur losses for the foreseeable future.

We are not currently profitable, and we may never achieve or sustain profitability.

We will require additional capital to fund our operations and if we fail to obtain necessary financing, we will not be able to complete the development and commercialization of our product candidates.

We are significantly dependent on the success of our DN-TNF product platform and Natural Killer Cell Priming Platform (INKmune), CORDStrom, and our product candidates based on these platforms.

We need to attract and retain highly skilled personnel;

we may be unable to effectively manage growth with our limited resources.

We depend upon our senior management and key consultants and their loss or unavailability could put us at a competitive disadvantage.

The biotechnology and immunotherapy industries are characterized by rapid technological developments and a high degree of competition.

We may be unable to compete with more substantial enterprises.

We can provide no assurance that our clinical product candidates will obtain regulatory approval or that the results of clinical studies will be favorable.

Drug discovery and development is a complex, time-consuming and expensive process with a high rate of failure.

We may face legal claims;

legal disputes are expensive, and we may not be able to afford the costs.

We can provide no assurance of the successful and timely development of new products.

We must comply with significant government regulations.

We rely upon patents to protect our technology.

We may be unable to protect our intellectual property rights.

The price of our common stock may be volatile.

The market prices for our common stock may be adversely impacted by future events.

A limited public trading market may cause volatility in the price of our common stock.

Our Rights Agreement contains anti-takeover provisions that could discourage, delay or prevent a change in control, which may cause our stock price to decline.

is a Substantial Doubt About Our Ability to Continue as a Going Concern.

Have a History of Losses and May Never Achieve or Sustain Profitability.

Limitations on Capital Raising Due to Low Public Float.

We face intense competition in the markets targeted by our product candidates.

Many competitors have substantially greater resources, and all of our product candidates are expected to face strong competition from existing and future drugs.

We are substantially dependent on the success of CORDStrom, and we may never obtain regulatory approval.

Even if we commercialize our product candidates, pricing, reimbursement and healthcare regulations could limit their market success.

If we cannot keep pace with rapid technological changes or compete effectively, we may not operate profitably.

Clinical drug development is lengthy, expensive, and inherently uncertain, and our product candidates may never receive regulatory approval.

If clinical trials fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, we may incur additional costs, experience delays, or be unable to commercialize our product candidates.

If our product candidates are approved and later found to be less effective than expected or to cause previously unidentified side effects, our business could be materially harmed.

Dependence on Key Personnel.

Product liability claims could result in substantial costs, divert resources, and limit the development or commercialization of our product candidates.

We and our contract manufacturers are subject to extensive regulatory requirements with respect to the manufacture of our product candidates, and any failure to comply with these requirements could materially harm our business and operations.

We rely on third parties to conduct and support clinical trials for our product candidates, and any failure by these parties to meet their obligations could materially delay or impair our development programs and regulatory approvals.

Global economic uncertainty and financial market volatility caused by political instability, changes in international trade relationships and conflicts, such as the conflict between Russia and Ukraine and the recent military conflict in the Middle East involving Iran, could make it more difficult for us to access financing and could adversely affect our business and operations.

Cybersecurity Incidents and Other Technological Disruptions Could Negatively Affect Our Business and Customer Relationships

We depend on obtaining certain patents and protecting our proprietary rights.

If we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would be negatively affected.

Our stock price may be volatile.

Anti-takeover provisions in our stockholder rights plan could make a third-party acquisition more difficult.

You should carefully consider

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RISKS RELATED TO OUR BUSINESS

There is doubt about our ability to continue

as a going concern.

There is a Substantial Doubt About Our Ability to Continue as a

Going Concern

As of December 31, 2025, the

Company had an accumulated deficit of $209,037,000.

Losses have principally occurred as a result of the substantial resources required

for research and development of the Company’s product candidates which included the general and administrative expenses associated

with its organization and product development as well as the lack of sources of revenues until such time as the Company’s products

are commercialized.

These factors raise substantial doubt about the Company’s ability to continue as a going concern for the 12

months from the issuance date of these financial statements.

These financial statements do not include any adjustments to reflect the

possible future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result

from the outcome of these uncertainties.

Management intends to pursue additional funding and implement its strategic plan to allow the

opportunity for the Company to continue as a going concern, however, there cannot be any assurance that we will be successful in doing

The opinion of our independent registered public accounts on our audited financial statements for the year ended December 31, 2024,

contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.

There is no assurance that

we will be successful in raising the additional funds needed to fund our business plan.

If we are not able to raise sufficient capital

in the near future, our continued operations will be in jeopardy and we may be forced to cease operations and sell or otherwise transfer

all or substantially all of our remaining assets.

We face intense competition in the markets

targeted by our lead product candidates.

Many of our competitors have substantially greater resources than we do, and we expect that all

of our product candidates under development will face intense competition from existing or future drugs.

We expect that our product

candidates under development, if approved, will face intense competition from existing and future drugs marketed by large companies.

competitors may successfully market products that compete with our products, successfully identify drug candidates or develop products

earlier than we do, or develop products that are more effective, have fewer side effects or cost less than our products, if any.

Additionally, if a competitor

receives FDA approval before we do for a drug that is similar to one of our product candidates, FDA approval for our product candidate

may be precluded or delayed due to periods of non-patent exclusivity and/or the listing with the FDA by the competitor of patents covering

its newly-approved drug product.

Periods of non-patent exclusivity for new versions of existing drugs such as our current product candidates

can extend up to three and one-half years.

See the section entitled “Government Regulation.”

These competitive factors

could require us to conduct substantial new research and development activities to establish new product targets, which would be costly

and time-consuming.

These activities would adversely affect our ability to commercialize products and achieve revenue and profits.

Competition and technological change may

make our product candidates and technologies less attractive or obsolete.

We compete with established

pharmaceutical and biotechnology companies that are pursuing other forms of treatment for the same indications we are pursuing and that

have greater financial and other resources.

Other companies may succeed in developing products earlier than us, obtaining FDA approval

for products more rapidly, or developing products that are more effective than our product candidates.

Research and development by others

may render our technology or product candidates obsolete or noncompetitive or result in treatments or cures superior to any therapy we

We face competition from companies that internally develop competing technology or acquire competing technology from universities

and other research institutions.

As these companies develop their technologies, they may develop competitive positions that may prevent,

make futile, or limit our product commercialization efforts, which would result in a decrease in the revenue we would be able to derive

from the sale of any products.

These losses primarily reflect the substantial resources devoted to research and development

of our product candidates, along with general and administrative expenses, and the absence of revenues until commercialization of our

These factors raise substantial

doubt about our ability to continue as a going concern for the 12 months following the issuance of these financial statements.

The financial

statements do not include adjustments that might result if we are unable to continue as a going concern, including the possible impact

on the recoverability and classification of assets or the amounts and classifications of liabilities.

Management intends to pursue

additional funding and implement its strategic plan to support continuation of the Company, but there can be no assurance that these efforts

will be successful.

The opinion of our independent registered public accounting firm on our audited financial statements for the year

ended December 31, 2025, includes an explanatory paragraph regarding this substantial doubt.

We Have a History of Losses and May Never Achieve or Sustain Profitability

We have incurred losses since our inception in September 2015 and are

not currently profitable.

We reported net losses of $45.9 million and $42.1 million for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025, we had cash and cash equivalents of $24.8 million.

We expect to continue incurring significant losses

for the foreseeable future as we advance the research, development, and regulatory approval of our product candidates.

The costs of clinical

development increase substantially at each phase, and the total expenses to achieve marketing approval for any product candidate, even

in a single jurisdiction, will be substantial.

Due to the inherent risks and uncertainties of pharmaceutical product development, we cannot

predict when, or if, we will generate revenue or achieve profitability.

Our ability to achieve and sustain profitability

depends on, among other factors, our success in developing, obtaining regulatory approval for, and commercializing our product candidates,

alone or through collaborations, as well as our ability to control costs.

If we are unable to achieve or sustain profitability, or if

revenues from approved products are insufficient, our business, financial condition, and the value of our common stock will be materially

and adversely affected.

Limitations on Capital Raising Due to Low Public Float

Our ability to raise additional capital, including

through sales of common stock under our ATM Program, may be limited if the public float of our common stock remains below $75.0 million.

Under SEC rules, if the aggregate market value of our common stock held by non-affiliates (public float) is less than $75.0 million at

the time we file an Annual Report—or in some cases, earlier—the amount we can raise through primary public offerings using

shelf registration statements is limited to one-third of our public float in any 12-month period.

However, the SEC has recently published

a Corporate Finance Interpretation stating that the Staff will not object if a company continue offering and selling the full amount of

securities covered by any prospectus supplement filed prior to its Section 10(a)(3) update (such as filing of an annual report on Form

10-K) , without being limited to one-third of its public float in any 12-month period, even when such company will not meet the public

float requirement of Instruction I.B.1 of Form S-3 at the time it files its annual report.

As of December 31, 2025, our public float was

approximately $36.8 million and the amount of securities we would be able to sell under our Form S-3 would be reduced;

however, as we

have an effective Form S-3 registration statement, we were eligible to offer and sell securities in reliance on General Instruction I.B.1,

and we filed a prospectus supplement for the offering of the common stock under our ATM program prior to the date of this Annual Report,

we believe, based on the SEC’s Corporate Finance Interpretation, that we will be able to continue using our existing ATM without the aforementioned

We face intense competition in the markets targeted by our product

Many competitors have substantially greater resources, and all of our product candidates are expected to face strong competition

from existing and future drugs.

If approved, our product candidates may compete

with drugs marketed by large pharmaceutical and biotechnology companies.

Competitors could market products more effectively, identify

drug candidates or develop products faster, or produce therapies that are more effective, safer, or lower cost than ours.

If a competitor obtains FDA approval before us

for a similar drug, approval of our product candidate may be delayed or precluded due to periods of non-patent exclusivity or patent listings

by the competitor.

These competitive pressures may require substantial

additional research and development to establish new product targets, increasing costs and timelines, and could adversely affect our ability

to commercialize products and achieve revenue and profits.

Competition and Technological Change Could

Reduce the Attractiveness of Our Product Candidates

We face intense competition from established pharmaceutical

and biotechnology companies pursuing treatments for the same indications as our product candidates.

Many competitors have substantially

greater financial, research, and regulatory resources, and may succeed in developing products more quickly, obtaining FDA approvals sooner,

or creating therapies that are more effective than ours.

Research and development by others could render

our technologies or product candidates obsolete or noncompetitive.

Competitors may also acquire or internally develop technologies that

limit or prevent our commercialization efforts, reducing potential revenues.

Even if we successfully develop and obtain regulatory

approval for our product candidates, there can be no assurance that physicians, patients, or payors will adopt our products as a preferred

Approval of competing products before ours could further complicate our regulatory path or market acceptance.

The pharmaceutical and biotechnology industry is

complex, diverse, and rapidly changing.

Factors such as competition, intellectual property disputes, market acceptance, and evolving regulations

make it difficult to predict revenues or profitability with certainty.

We are substantially dependent on the

success of CORDStrom, and we may never obtain regulatory approval.

Our future success is highly

dependent on our ability to obtain regulatory approval for CORDStrom for the treatment of recessive dystrophic epidermolysis bullosa (“RDEB”).

Although we believe the clinical data generated to date support the potential therapeutic benefit of CORDStrom, regulatory authorities

may interpret the data differently or determine that the evidence is insufficient to support approval.

Regulatory agencies may require

additional preclinical studies or clinical trials, impose limitations on the indicated patient population, or determine that the benefit-risk

profile does not support approval.

As a result, we may experience significant delays in the development and review process, incur substantial

additional costs, or ultimately be unable to obtain regulatory approval for CORDStrom.

Failure to obtain approval would materially and

adversely affect our business, financial condition and results of operations.

Global economic

uncertainty and financial market volatility caused by political instability, changes in international trade relationships and conflicts,

such as the conflict between Russia and Ukraine and the recent military conflict in the Middle East involving Iran, could make it more

difficult for us to access financing and could adversely affect our business and operations.

ability to access capital markets and raise additional funds depends in large part on investor confidence and market valuations of our

The market value and liquidity of our common stock are subject to significant fluctuations based on factors beyond our control,

including changes in general economic conditions, interest rate environments, inflationary pressures, investor sentiment toward biotechnology

and early-stage issuers, and overall equity market volatility.

Periods of macroeconomic weakness or recession, rising interest rates,

tightening credit markets, or risk-off investor behavior may limit the availability of equity or debt financing on acceptable terms, or

A decline in the market price of our securities could also impair our ability to raise capital without substantial dilution to

existing shareholders.

addition, geopolitical developments and international conflicts, such as instability or war in the Middle East, the ongoing conflict between

Russia and Ukraine, or a deterioration in relations between the United States and China, may contribute to global uncertainty, disrupt

financial and commodity markets, and adversely affect investor risk appetite.

Resulting government actions, including the imposition of

sanctions, export controls, tariffs, or other trade restrictions, could disrupt global supply chains and trade flows, further exacerbating

inflationary or recessionary pressures.

Such events may impair our ability to source key raw materials, reagents, or specialized components

required for our research and development programs and clinical manufacturing activities, potentially leading to increased costs, delays

in development timelines, or operational interruptions.

market instability or geopolitical tension could also constrain venture capital and institutional investment into the life sciences sector

more broadly, reduce valuations for comparable companies, and limit opportunities for strategic partnerships or follow-on financings.

If we are unable to obtain additional capital when needed, or only on unfavorable terms, we may be forced to delay, scale back, or discontinue

one or more of our product development programs, which could materially and adversely affect our business, financial condition, and prospects.

Even if we commercialize our product candidates, pricing, reimbursement,

and healthcare regulations could limit their market success.

The commercial success of our products will depend

largely on coverage and reimbursement by government programs (such as Medicare and Medicaid), private insurers, and other third-party

payors, both in the U.S.

If reimbursement is unavailable, limited, or insufficient, we may be unable to successfully commercialize

our products or achieve a meaningful return on investment.

Third-party coverage and reimbursement policies

for newly approved drugs are uncertain and vary significantly across countries.

Some jurisdictions require pricing approval before marketing,

and ongoing governmental price controls may apply even after initial approval.

Consequently, we could face delays in product launches

or limitations on revenues, which may hinder our ability to recoup development and commercialization costs.

We are subject to extensive government regulations.

The manufacture and sale of human therapeutic products

and abroad are governed by numerous laws and regulations.

These requirements include approval of manufacturing facilities,

controlled preclinical and clinical testing, submission of extensive data on safety and efficacy, compliance with current Good Manufacturing

Practices (cGMP) during production and storage, and oversight of marketing activities, including advertising and labeling.

The products we are developing require substantial

investment, development, and testing before commercialization.

Obtaining regulatory approvals is costly and time-consuming, and there

is no assurance that any product will prove safe and effective or receive the necessary approvals.

Investors should be aware that our

business is subject to significant regulatory risks, delays, and expenses inherent in the development and commercialization of therapeutic

If we cannot keep pace with rapid technological changes or compete

effectively, we may not operate profitably.

We operate in a rapidly evolving field with intense

competition from established pharmaceutical and biotechnology companies, smaller companies, and academic or governmental institutions.

Many competitors have greater financial resources, expertise in research, development, manufacturing, regulatory approvals, and marketing,

as well as ongoing product pipelines.

They also compete for qualified scientific and management personnel.

Competition will be based on product efficacy and

safety, regulatory approvals, supply, marketing and sales capabilities, pricing, reimbursement, and patent protection.

There is no assurance

that our competitors will not develop more effective or affordable products, secure earlier approvals, or achieve earlier commercialization.

Even as we seek to expand our technological capabilities, research by others may render our products less competitive, obsolete, or inferior

to alternative therapies.

We may request priority review, but the FDA may not grant it,

and even if granted, it may not accelerate approval.

We may seek priority review for our product candidate

if the FDA determines it offers a major advance in treatment or addresses a condition with no adequate therapy.

Priority review sets a

goal of six months for FDA action rather than the standard ten-month review.

However, the FDA has broad discretion in granting this designation,

and our product candidate may not receive it.

Even if granted, priority review does not guarantee faster approval or confer any advantage

in the ultimate regulatory decision.

If we are unable to obtain accelerated approval or other expedited

regulatory designations, development and commercialization of our product candidates may be delayed or more costly.

We may seek accelerated approval

for our product candidates under FDA or comparable non-U.S.

regulatory pathways intended for therapies addressing serious or life-threatening

Such pathways often rely on surrogate or intermediate clinical endpoints reasonably likely to predict clinical benefit, and

approval may be contingent on conducting confirmatory post-approval studies.

If these studies fail to confirm clinical benefit, regulatory

authorities may withdraw approval.

There can be no assurance

that any of our product candidates will be accepted by the marketplace as readily as these or other competing treatments.

if our competitors’ products are approved before ours, it could be more difficult for us to obtain approval from the FDA.

our products are successfully developed and approved for use by all governing regulatory bodies, there can be no assurance that physicians

and patients will accept our product(s) as a treatment of choice.

Furthermore, the pharmaceutical

research industry is diverse, complex, and rapidly changing.

By its nature, the business risks associated therewith are numerous and significant.

The effects of competition, intellectual property disputes, market acceptance, and FDA regulations preclude us from forecasting revenues

or income with certainty or even confidence.

have incurred losses since inception and anticipate that we will continue to incur losses for the foreseeable future.

We are not currently

profitable, and we may never achieve or sustain profitability.

We were formed in September

2015 and have only a limited operating history and have incurred losses since our formation.

We continue to incur significant development

and other expenses related to our ongoing operations.

As a result, we are not and have never been profitable and have incurred losses

in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern.

We reported a net loss

of $42.1 million and $30.0 million for the years ended December 31, 2024 and 2023, respectively.

As of December 31, 2024 and 2023, we

had cash and cash equivalents of $20.9 million and $35.8 million, respectively.

We expect to continue to incur significant losses for the foreseeable

future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our

product candidates and now that we are no longer an emerging growth company, as defined in Section 2(a) of the Securities Act of 1933,

As a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the Dodd-Frank

Act, as well as rules adopted, and to be adopted, by the SEC and The Nasdaq Stock Market LLC.

We also expect that compliance with the

auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and increased disclosure requirements will increase our legal

and financial compliance costs.

The size of our future net losses will depend, in part, on the rate of future growth of our expenses and

our ability to generate revenues, if any.

The costs of advancing product candidates into each clinical phase tend to increase substantially

over the duration of the clinical development process.

Therefore, the total costs to advance any of our product candidates to marketing

approval in even a single jurisdiction will be substantial.

Because of the numerous risks and uncertainties associated with pharmaceutical

product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to

begin generating revenue from the commercialization of any products or achieve or maintain profitability.

The costs of advancing product

candidates into each clinical phase tend to increase substantially over the duration of the clinical development process.

Therefore, the

total costs to advance any of our product candidates to marketing approval in even a single jurisdiction will be substantial.

of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing

or amount of increased expenses or when, or if, we will be able to begin generating revenue from the commercialization of any products

or achieve or maintain profitability.

our ability to successfully develop, commercialize and license any product candidates and generate product revenue is subject to substantial

additional risks and uncertainties.

As a result, we expect to continue to incur net losses and negative cash flows for the foreseeable

These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity

and working capital.

The amount of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability

to generate revenues.

If we are unable to develop and commercialize one or more product candidates, either alone or through collaborations,

or if revenues from any product that receives marketing approval are insufficient, we will not achieve profitability.

Even if we do achieve

profitability, we may not be able to sustain profitability or meet outside expectations for our profitability.

If we are unable to achieve

or sustain profitability or to meet outside expectations for our profitability, the value of our common stock will be materially and adversely

Even if we are able to commercialize any

product candidate that we develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement

practices or healthcare reform initiatives that could harm our business.

The commercial success of

our product candidates will depend substantially, both domestically and abroad, 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 reimbursed by government

health administration authorities (such as Medicare and Medicaid), private health coverage insurers and other third-party payors.

If reimbursement

is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates.

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

to realize a meaningful return on our investment.

There is significant uncertainty

related to third-party payor coverage and reimbursement of newly approved drugs.

Marketing approvals, pricing and reimbursement for new

drug products vary widely from country to country.

Some countries require approval of the sale price of a drug before it can be marketed.

In many countries, the pricing review period begins after marketing or product licensing approval is granted.

In some non-U.S.

prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted.

we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay commercial

launch of the product, possibly for lengthy time periods, which may negatively impact the revenues we are able to generate from the sale

of the product in that country.

Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates,

even if our product candidates obtain marketing approval.

We are subject to various government regulations.

The manufacture and sale of

human therapeutic products in the U.S.

and foreign jurisdictions are governed by a variety of statutes and regulations.

These laws require

approval of manufacturing facilities, controlled research and testing of products and government review and approval of a submission containing

manufacturing, preclinical and clinical data in order to obtain marketing approval based on establishing the safety and efficacy of the

product for each use sought, including adherence to current cGMP during production and storage, and control of marketing activities, including

advertising and labeling.

The products we are currently

developing will require significant development, preclinical and clinical testing and investment of substantial funds prior to its commercialization.

The process of obtaining required approvals can be costly and time-consuming, and there can be no assurance that we develop successfully

this product or any future products, or that this product or any future products we develop will prove to be safe and effective in clinical

trials or receive applicable regulatory approvals.

Potential investors and shareholders should be aware of the risks, problems, delays,

expenses and difficulties which we may encounter in view of the extensive regulatory environment which controls our business.

If we are unable to keep up with rapid technological

changes in our field or compete effectively, we will be unable to operate profitably.

We are engaged in a rapidly

changing field.

Other products and therapies that will compete directly with the products that we are seeking to develop and market currently

exist or are being developed.

Competition from fully integrated pharmaceutical companies and more established biotechnology companies

is intense and is expected to increase.

Most of these companies have significantly greater financial resources and expertise in discovery

and development, manufacturing, preclinical and clinical testing, obtaining regulatory approvals and marketing than us.

Smaller companies

may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical and established

biopharmaceutical or biotechnology companies.

Many of these competitors have significant products that have been approved or are in development

and operate large, well-funded discovery and development programs.

Academic institutions, governmental agencies and other public and private

research organizations also conduct research, seek patent protection and establish collaborative arrangements for therapeutic products

and clinical development and marketing.

These companies and institutions compete with us in recruiting and retaining highly qualified

scientific and management personnel.

In addition to the above factors, we will face competition based on product efficacy and safety,

the timing and scope of regulatory approvals, availability of supply, marketing and sales capability, reimbursement coverage, price and

patent position.

There is no assurance that our competitors will not develop more effective or more affordable products, or achieve earlier

patent protection or product commercialization, than our own.

Other companies may succeed

in developing products earlier than ourselves, obtaining FDA and European Medicines Agency (“EMA”) approvals for such products

more rapidly than we will, or in developing products that are more effective than products we propose to develop.

While we will seek to

expand our technological capabilities in order to remain competitive, there can be no assurance that research and development by others

will not render our technology or products obsolete or non-competitive or result in treatments or cures superior to any therapy we develop,

or that any therapy we develop will be preferred to any existing or newly developed technologies.

We may request priority review for our product

candidate in the future.

The FDA may not grant priority review for our product candidate.

Moreover, even if the FDA designates such product

for priority review, that designation may not lead to a faster regulatory review or approval process and, in any event, would not assure

FDA approval.

We may be eligible for priority

review designation for our product candidate if the FDA determines such product candidate offers major advances in treatment or provides

a treatment where no adequate therapy exists.

A priority review designation means that the goal for the FDA is to take action on an application

in six months, rather than the standard review period of ten months.

The FDA has broad discretion with respect to whether or not to grant

priority review status to a product candidate, so even if we believe a particular product candidate is eligible for such designation or

status, the FDA may decide not to grant it.

Thus, while the FDA has granted priority review to other oncology disease products, our product

candidate, should we determine to seek priority review, may not receive similar designation.

Moreover, even if our product candidate is

designated for priority review, such a designation does not necessarily mean a faster regulatory review process or necessarily confer

any advantage with respect to approval compared to conventional FDA procedures.

Receiving priority review from the FDA does not guarantee

approval within an accelerated timeline or thereafter.

We believe we may in some instances be able

to secure approval from the FDA or comparable non-U.S.

regulatory authorities to use accelerated development pathways.

If we are unable

to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate,

which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals.

We anticipate that we may

seek an accelerated approval pathway for our product candidates.

Under the accelerated approval provisions in the Federal Food, Drug,

and Cosmetic Act, or FDCA, and the FDA’s implementing regulations, the FDA may grant accelerated approval to a product designed

to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination

that the product has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical

The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given

disease, such as irreversible morbidity or mortality.

For the purposes of accelerated approval, a surrogate endpoint is a marker, such

as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not

itself a measure of clinical benefit.

An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect

on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other

clinical benefit.

The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may

not be a direct therapeutic advantage but is a clinically important improvement from a patient and public health perspective.

accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval

confirmatory studies to verify and describe the drug’s clinical benefit.

If such post-approval studies fail to confirm the drug’s

clinical benefit, the FDA may withdraw its approval of the drug.

Prior to seeking such accelerated

approval, we will seek feedback from the FDA and will otherwise evaluate our ability to seek and receive such accelerated approval.

can be no assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit a New Drug Application,

or NDA, for accelerated approval or any other form of expedited development, review or approval.

Similarly, there can be no assurance

that after subsequent FDA feedback we will continue to pursue or apply for accelerated approval or any other form of expedited development,

review or approval, even if we initially decide to do so.

Furthermore, if we decide to submit an application for accelerated approval

or under another expedited regulatory designation (e.g., breakthrough therapy designation), there can be no assurance that such submission

or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all.

FDA or other non-U.S.

authorities could also require us to conduct further studies prior to considering our application or granting approval

A failure to obtain accelerated approval or any other form of expedited development, review or approval for our product candidate

would result in a longer time period to commercialization of such product candidate, could increase the cost of development of such product

candidate and could harm our competitive position in the marketplace.

Clinical drug development involves a lengthy

and expensive process with an uncertain outcome.

We may incur additional costs or experience delays in completing, or ultimately be unable

to complete the development and commercialization of our product candidate.

Our product candidates are

in early clinical development.

Therefore, the risk of failure of our product candidates is high.

It is impossible to predict when or if

our product candidates will prove effective or safe in humans or will receive regulatory approval.

Before obtaining marketing approval

from regulatory authorities for the sale of any product candidate, we must complete preclinical development and then conduct extensive

clinical trials to demonstrate the safety and efficacy of our product candidate in humans.

Clinical testing is expensive, difficult to

design and implement, can take many years to complete and is uncertain as to outcome.

A failure of one or more clinical trials can occur

at any stage of testing.

The clinical development of our product candidates is susceptible to the risk of failure inherent at any stage

of drug development, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence

of severe or medically or commercially unacceptable adverse events, failure to comply with protocols or applicable regulatory requirements

and determination by the FDA or any comparable non-U.S.

regulatory authority that a drug product is not safe or effective for its intended

It is possible that even if our product candidate has a beneficial effect, that effect will not be detected during clinical evaluation

as a result of one or more of a variety of factors, including the size, duration, design, measurements, conduct or analysis of our clinical

Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect of a product candidate

that is greater than the actual positive effect, if any.

Similarly, in our clinical trials we may fail to detect toxicity of, or intolerability

caused by our product candidates, or mistakenly believe that our product candidates are toxic or not well tolerated when that is not in

fact the case.

Success in early development

does not mean that later development will be successful because, for example, drug candidates in later-stage clinical trials may fail

to demonstrate sufficient safety and efficacy despite having progressed through initial clinical trials.

The design of a clinical trial

can determine whether its results will support approval of a product;

however, flaws in the design of a clinical trial may not become

apparent until the clinical trial is well advanced or completed.

In addition, preclinical and clinical data are often susceptible to varying

interpretations and analyses.

Many companies that believed their product candidates performed satisfactorily in preclinical studies and

clinical trials have nonetheless failed to obtain marketing approval for the product candidates.

Even if we believe that the results of

clinical trials for our product candidate warrant marketing approval, the FDA or comparable non-U.S.

regulatory authorities may disagree

and may not grant marketing approval of our product candidate.

In some instances, there can

be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous

factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes

in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants.

Any clinical trials that we

may conduct may not demonstrate the efficacy and safety necessary to obtain regulatory approval to market our product candidate.

The results of

preclinical studies and early-stage clinical trials may not be predictive of future results.

Initial success in clinical trials may not

be indicative of results obtained when these trials are completed or in later-stage trials.

The results of preclinical

studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not

be predictive of the results of the later-stage clinical trials.

In addition, initial success in clinical trials may not be indicative

of results obtained when such trials are completed.

In particular, the small number of patients in our planned early clinical trials may

make the results of these trials less predictive of the outcome of later clinical trials.

For example, even if successful, the results

of our initial clinical trials for XPro may not be predictive of the results of further clinical trials of this drug candidate or any

of our other drug candidates.

Moreover, preclinical and clinical data often are susceptible to varying interpretations and analyses, and

many companies that have believed their drug candidates performed satisfactorily in preclinical studies and clinical trials nonetheless

have failed to obtain marketing approval of their products.

Our future clinical trials may not ultimately be successful or support further

clinical development of any of our drug candidates.

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

A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even

after achieving encouraging results in earlier studies.

Any such setbacks in our clinical development could materially harm our business,

results of operations, financial condition and prospects.

Interim top-line

and preliminary data from our planned clinical trials that we announce or publish from time to time may change as more patient data become

available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may

publish interim top-line or preliminary data from our planned clinical trials.

Interim data from clinical trials that we may complete

are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient

data becomes available.

Preliminary or top-line data also remain subject to audit and verification procedures that may result in the final

data being materially different from the preliminary data we previously published.

As a result, interim and preliminary data should be

viewed with caution until the final data is available.

Adverse differences between preliminary or interim data and final data could significantly

harm our reputation and business prospects.

If clinical trials of our product candidates

fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S.

regulators, we may incur additional costs

or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

We are not permitted to commercialize,

market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA.

Comparable non-U.S.

regulatory authorities, such as the EMA, impose similar restrictions.

We may never receive such approvals.

We must complete extensive

preclinical development and clinical trials to demonstrate the safety and efficacy of our product candidate in humans before we will be

able to obtain these approvals.

Clinical testing is expensive,

difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome.

We have not previously submitted

an NDA to the FDA or similar drug approval filings to comparable non-U.S.

regulatory authorities for any product candidate.

Any inability to successfully

complete preclinical and clinical development could result in additional costs to us and impair our ability to generate revenues from

product sales, regulatory and commercialization milestones and royalties.

In addition, if (1) we are required to conduct additional clinical

trials or other testing of our product candidate beyond the trials and testing than we contemplate, (2) we are unable to successfully

complete clinical trials of our product candidate or other testing, (3) the results of these trials or tests are unfavorable, uncertain

or are only modestly favorable, or (4) there are unacceptable safety concerns associated with our product candidate, we, in addition to

incurring additional costs, may:

be delayed in obtaining marketing approval for our product candidate;

not obtain marketing approval at all;

obtain approval for indications or patient populations that are not as broad as we intended or desired;

obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed warnings;

be subject to additional post-marketing testing or other requirements;

be required to remove the product from the market after obtaining marketing approval.

If we experience any of a number of possible

unforeseen events in connection with clinical trials of any of our product candidates, potential marketing approval or commercialization

of that product candidate could be delayed or prevented.

We may experience numerous

unforeseen events during, or as a result of, clinical trials that could delay or prevent marketing approval of any of our product candidates,

clinical trials of our product candidate may produce unfavorable or inconclusive results;

we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

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

data safety monitoring committees may recommend suspension, termination or a clinical hold for various reasons, including concerns about patient safety;

regulators or institutional review boards, or IRBs, may suspend or terminate the trial or impose a clinical hold for various reasons, including noncompliance with regulatory requirements or concerns about patient safety;

patients with serious, life-threatening diseases included in our clinical trials may die or suffer other adverse medical events for reasons that may not be related to our product candidate;

participating patients may be subject to unacceptable health risks;

patients may not complete clinical trials due to safety issues, side effects, or other reasons;

changes in regulatory requirements and guidance may occur, which require us to amend clinical trial protocols to reflect these changes;

our third-party contractors, including those manufacturing our product candidate or components or ingredients thereof or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner or at all;

regulators or IRBs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

we may experience delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

patients who enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the patients from the clinical trial, increase the needed enrollment size for the clinical trial or extend the clinical trial’s duration;

we may have to suspend or terminate clinical trials of our product candidate for various reasons, including a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of a product candidate;

the FDA or comparable non-U.S.

regulatory authorities may disagree with our clinical trial design or our interpretation of data from preclinical studies and clinical trials;

the FDA or comparable non-U.S.

regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies;

the supply or quality of raw materials or manufactured product candidate or other materials necessary to conduct clinical trials of our product candidate may be insufficient, inadequate, delayed, or not available at an acceptable cost, or we may experience interruptions in supply;

the approval policies or regulations of the FDA or comparable non-U.S.

regulatory authorities may significantly change in a manner rendering our clinical data insufficient to obtain marketing approval.

Product development costs

for us will increase if we experience delays in testing or pursuing marketing approvals and we may be required to obtain additional funds

to complete clinical trials and prepare for possible commercialization of our product candidates.

We do not know whether any preclinical

tests or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all.

preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our

product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize

our product candidates and may harm our business and results of operations.

In addition, many of the factors that cause, or lead to, clinical

trial delays may ultimately lead to the denial of marketing approval of our product candidates.

If we experience delays or difficulties

in the enrollment of patients in clinical trials, we may not achieve our clinical development on our anticipated timeline, or at all,

and our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate

or continue clinical trials for CORDStrom, INKmune our DN-TNF product platform or any other product candidate if we are unable to locate

and enroll a sufficient number of eligible patients to participate in clinical trials.

Patient enrollment is a significant factor in the

timing of clinical trials, and is affected by many factors, including:

the size and nature of the patient population;

the severity of the disease under investigation;

the proximity of patients to clinical sites;

the eligibility criteria for the trial;

the design of the clinical trial;

efforts to facilitate timely enrollment;

competing clinical trials;

clinicians’ and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.

Our inability to enroll a

sufficient number of patients for our clinical trials could result in significant delays or may require us to abandon one or more clinical

trials altogether.

Enrollment delays in our clinical trials may result in increased development costs for our product candidates, delay

or halt the development of and approval processes for our product candidates and jeopardize our ability to achieve our clinical development

timeline and goals, including the dates by which we will commence, complete and receive results from clinical trials.

Enrollment delays

may also delay or jeopardize our ability to commence sales and generate revenues from our product candidates.

Any of the foregoing could

cause the value of the Company to decline and limit our ability to obtain additional financing, if needed.

We will need to obtain FDA approval of any

proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.

A pharmaceutical product cannot

be marketed in the U.S.

or other countries until we have completed rigorous and extensive regulatory review processes, including approval

of a brand name.

Any brand names we intend to use for our product candidates will require approval from the FDA regardless of whether

we have secured a formal trademark registration from the U.S.

Patent and Trademark Office, or the USPTO.

The FDA typically conducts a

review of proposed product brand names, including an evaluation of potential for confusion with other product names.

The FDA may also

object to a product brand name if it believes the name inappropriately implies medical claims.

If the FDA objects to any of our proposed

product brand names, we may be required to adopt an alternative brand name for our product candidates.

If we adopt an alternative brand

name, we will lose the benefit of our existing trademark applications for such product candidate and may be required to expend significant

additional resources in an effort to identify a suitable product brand name that would qualify under applicable trademark laws, not infringe

the existing rights of third parties and be acceptable to the FDA.

We may be unable to build a successful brand identity for a new trademark

in a timely manner or at all, which would limit our ability to commercialize our product candidates.

We may fail to comply with regulatory requirements .

Our success will be dependent

upon our ability, and our collaborative partners’ abilities, to maintain compliance with regulatory requirements, including cGMP,

and safety reporting obligations.

The failure to comply with applicable regulatory requirements can result in, among other things, fines,

injunctions, civil penalties, total or partial suspension of regulatory approvals, refusal to approve pending applications, recalls or

seizures of products, operating and production restrictions and criminal prosecutions.

Even if our product candidates receive marketing

approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical

community necessary for commercial success and the market opportunity for the product candidates may be smaller than we estimate.

We have never commercialized

Even if CORDStrom, INKmune, our DN-TNF product platform (INB03 or XPro), or any other product candidate we develop is approved

by the appropriate regulatory authorities for marketing and sale, it may nonetheless fail to gain sufficient market acceptance by physicians,

patients, third-party payors and others in the medical community.

For example, physicians are often reluctant to switch their patients

from existing therapies even when new and potentially more effective or convenient treatments enter the market.

Further, patients often

acclimate to the therapy that they are currently taking and do not want to switch unless their physicians recommend switching products

or they are required to switch therapies due to lack of reimbursement for existing therapies.

Efforts to educate the medical

community and third-party payors on the benefits of our product candidate may require significant resources and may not be successful.

If our product candidate is approved but does not achieve an adequate level of market acceptance, we may not generate significant revenues

and we may not become profitable.

The degree of market acceptance of INmune or any other product candidate we develop, if approved for

commercial sale, will depend on a number of factors, including:

the efficacy and safety of the product;

the potential advantages of the product compared to alternative treatments;

the prevalence and severity of any side effects;

the clinical indications for which the product is approved;

whether the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy;

limitations or warnings, including distribution or use restrictions, contained in the product’s approved labeling;

our ability to offer the product for sale at competitive prices;

our ability to establish and maintain pricing sufficient to realize a meaningful return on our investment;

the product’s convenience and ease of administration compared to alternative treatments;

the willingness of the target patient population to try, and of physicians to prescribe, the product;

the strength of sales, marketing and distribution support;

the approval of other new products for the same indications;

changes in the standard of care for the targeted indications for the product;

the timing of market introduction of our approved products as well as competitive products and other therapies;

availability and amount of reimbursement from government payors, managed care plans and other third-party payors;

adverse publicity about the product or favorable publicity about competitive products;

potential product liability claims.

The potential market opportunities

for our product candidate are difficult to estimate precisely.

Our estimates of the potential market opportunities are predicated on many

assumptions, including industry knowledge and publications, third-party research reports and other surveys.

While we believe that our

internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are

inherently uncertain and the reasonableness of these assumptions has not been assessed by an independent source.

If any of the assumptions

prove to be inaccurate, the actual markets for our product candidate could be smaller than our estimates of the potential market opportunities.

Even if we obtain regulatory approvals for

CORDStrom, INKmune and/or any product from our DN-TNF platform those approvals and ongoing regulation of our products may limit how we

manufacture and market our products, which could prevent us from realizing the full benefit of our efforts.

If we obtain regulatory approvals,

CORDStrom, INKmune and/or the DN-TNF product platform, and the manufacturing facilities used for its production will be subject to continual

review, including periodic inspections, by the FDA and other United States and foreign regulatory authorities.

In addition, regulatory

authorities may impose significant restrictions on the indicated uses or marketing of INKmune or other products that we may develop.

and other factors may significantly restrict our ability to successfully commercialize INKmune.

We and many of our vendors

and suppliers will be required to comply with current Good Manufacturing Practices, or GMP, which include requirements relating to quality

control and quality assurance as well as to the corresponding maintenance of records and documentation.

Furthermore, any manufacturing

facilities will need to be approved by regulatory agencies before these facilities can be used to manufacture, and they will also be subject

to additional regulatory inspections.

Any material changes we may make to our manufacturing process may require approval by the FDA and

state or foreign regulatory authorities.

Failure to comply with FDA or other applicable regulatory requirements may result in criminal

prosecution, civil penalties, recall or seizure of products, partial or total suspension of production or withdrawal of a product from

We must also report adverse

events that occur when our products are used.

The discovery of previously unknown problems with CORDStrom, INKmune, the DN-TNF product

platform or manufacturing facilities used to manufacture CORDStrom, INKmune, or the DN-TNF product platform may result in restrictions

or sanctions on our products or manufacturing facilities, including withdrawal of our products from the market.

Regulatory agencies may

also require us to reformulate our products, conduct additional clinical trials, make changes in the labeling of our product or obtain

re-approvals.

This may cause our reputation in the marketplace to suffer or subject us to lawsuits, including class action suits.

If our product candidates receive marketing

approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects

that were not previously identified, our ability to market the drugs could be compromised.

Clinical trials of our product

candidates will be conducted in carefully defined subsets of patients who have agreed to enter into clinical trials.

Consequently, it

is possible that our clinical trials may indicate an apparent positive effect of a product candidate that is greater than the actual positive

effect, if any, or alternatively fail to identify undesirable side effects.

If, following approval of our product candidate, we, or others,

discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified,

any of the following adverse events could occur:

regulatory authorities may withdraw their approval of the drug or seize the drug;

we may be required to recall the drug or change the way the drug is administered;

additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular drug;

we may be subject to fines, injunctions or the imposition of civil or criminal penalties;

regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;

we may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients;

we could be sued and held liable for harm caused to patients;

the drug may become less competitive;

our reputation may suffer.

Any of these events could

have a material and adverse effect on our operations and business.

Any product candidate for which we obtain

marketing approval, along with the manufacturing processes, qualification testing, post-approval clinical data, labeling and promotional

activities for such product, will be subject to continual and additional requirements of the FDA and other regulatory authorities.

These requirements include

submissions of safety and other post-marketing information, reports, registration and listing requirements, good manufacturing practices,

or GMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents, and recordkeeping.

Even if marketing approval of our product candidate is granted, the approval may be subject to limitations on the indicated uses for which

the product may be marketed or to conditions of approval or contain requirements for costly post-marketing testing and surveillance to

monitor the safety or efficacy of the product.

The FDA closely regulates the post-approval marketing and promotion of pharmaceutical products

to ensure such products are marketed only for the approved indications and in accordance with the provisions of the approved labeling.

In addition, later discovery

of previously unknown problems with our products, manufacturing processes, or failure to comply with regulatory requirements, may lead

to various adverse results, including:

restrictions on such products, manufacturers or manufacturing processes;

restrictions on the labeling or marketing of a product;

restrictions on product distribution or use;

requirements to conduct post-marketing clinical trials;

requirements to institute a risk evaluation mitigation strategy, or REMS, to monitor safety of the product post-approval;

warning letters issued by the FDA or other regulatory authorities;

withdrawal of the products from the market;

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

recall of products, fines, restitution or disgorgement of profits or revenue;

suspension, revocation or withdrawal of marketing approvals;

refusal to permit the import or export of our products;

injunctions or the imposition of civil or criminal penalties.

We currently have no marketing and sales

organization and have no experience in marketing products.

If we are unable to establish marketing and sales capabilities or enter into

agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.

We currently have no sales,

marketing or distribution capabilities and have no experience as a company in marketing products.

If we develop internal sales, marketing

and distribution organization, this will require significant capital expenditures, management resources and time, and we would have to

compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.

If we are unable or decide

not to establish internal sales, marketing and distribution capabilities, we expect to pursue collaborative arrangements regarding the

sales, marketing and distribution of our products.

However, we may not be able to establish or maintain such collaborative arrangements,

or if we are able to do so, their sales forces may not be successful in marketing our products.

Any revenue we receive would depend upon

the efforts of such third parties, which may not be successful.

We may have little or no control over the sales, marketing and distribution

efforts of such third parties and our revenue from product sales may be lower than if we had commercialized our product candidates ourselves.

We also face competition in our search for third parties to assist us with the sales, marketing and distribution efforts of our product

There can be no assurance that we will be able to develop internal sales, marketing distribution capabilities or establish

or maintain relationships with third-party collaborators to commercialize any product in the United States or overseas.

We face substantial competition from other

pharmaceutical and biotechnology companies and our operating results may suffer if we fail to compete effectively.

that we will pursue, be granted, or successfully achieve accelerated or expedited approval.

Regulatory authorities could require additional

preclinical studies or clinical trials, delay acceptance of our submissions, or impose other conditions that could increase development

costs, extend timelines, and harm our competitive position.

Clinical drug development is lengthy, expensive, and inherently

uncertain, and our product candidates may never receive regulatory approval.

Our product candidates are in early stages of development,

and the risk of failure is high.

Before obtaining marketing approval, we must complete preclinical studies and extensive clinical trials

to demonstrate safety and efficacy.

Clinical development is time-consuming, costly, and uncertain, and a failure can occur at any stage.

Product candidates may fail to demonstrate efficacy, may cause unacceptable adverse events, may not perform consistently across patient

populations, or may fail to meet regulatory requirements.

Even if a product candidate shows promising results in early studies, those

results may not be replicated in later-stage trials.

Clinical trial outcomes can be affected by numerous

factors, including trial design, patient selection, protocol adherence, statistical analysis, and variability across trial sites.

and clinical data are subject to differing interpretations, and regulatory authorities may disagree with our conclusions regarding safety

As a result, we may incur substantial additional costs, experience significant delays, or be unable to obtain marketing approval

for our product candidates, which would materially harm our business and prospects.

Preclinical and early-stage clinical trial

results may not predict later results, and interim or preliminary data may change materially.

Results from preclinical studies or early-stage

clinical trials may not be predictive of outcomes in later-stage trials or final results.

Initial success in a clinical trial, particularly

in small early trials, may not indicate success in larger or later-stage studies.

Preclinical and clinical data are subject to varying

interpretations, and many drug candidates that initially appeared promising have failed to achieve marketing approval.

Any setbacks in

our clinical development could materially harm our business, financial condition, results of operations, and prospects.

Interim or top-line data from ongoing trials may

differ materially from final results.

Such preliminary data are subject to audit, verification, and changes as additional patient data

become available.

Adverse differences between early data and final results could negatively affect our reputation, investor perception,

and business prospects.

If clinical trials fail to demonstrate safety and efficacy to

the satisfaction of regulatory authorities, we may incur additional costs, experience delays, or be unable to commercialize our product

We cannot market or sell any product candidate

in the United States without FDA approval, nor in other jurisdictions without comparable regulatory authorizations.

Clinical testing is

expensive, time-consuming, complex, and inherently uncertain.

We have not previously submitted an NDA or equivalent application to any

regulatory authority, and there is no guarantee that we will obtain marketing approval for any product candidate.

Failure to successfully complete preclinical or

clinical development, or unfavorable trial outcomes, could delay or prevent approval, result in narrower indications or restrictive labeling,

require additional post-marketing studies, or lead to withdrawal from the market.

Any of these outcomes could materially increase costs,

delay revenue generation, and harm our business, financial condition, and results of operations.

Unforeseen events in clinical trials could delay or prevent marketing

approval of our product candidates.

We may experience a variety of challenges during

clinical trials that could adversely affect the development and approval of our product candidates.

These include unfavorable or inconclusive

trial results, slower-than-expected patient enrollment or higher dropout rates, safety concerns or adverse events among participants,

failure of third-party contractors to meet regulatory or contractual obligations, supply interruptions, or changes in regulatory requirements.

Regulators or institutional review boards may also impose suspensions, terminations, or clinical holds, or disagree with our trial design,

interpretation of data, or manufacturing processes.

Delays or failures in clinical trials could increase

our development costs, require us to secure additional funding, shorten periods of potential market exclusivity, allow competitors to

enter the market first, and impair our ability to successfully commercialize our product candidates.

Many of the factors that delay or

complicate clinical trials may ultimately contribute to the denial of marketing approval.

Regulatory Approval of Product Brand Names

Any pharmaceutical product we develop cannot be

marketed in the U.S.

or other countries until it completes rigorous regulatory review processes, including approval of a brand name.

proposed brand names for our product candidates require FDA approval, regardless of whether we have obtained a trademark registration

from the U.S.

Patent and Trademark Office (USPTO).

The FDA evaluates proposed brand names for potential

confusion with existing products and may object if a name inappropriately implies medical claims.

If the FDA objects to a proposed brand

name, we may need to select an alternative name, which could result in the loss of benefits associated with our existing trademark applications

and require additional resources to secure a suitable replacement.

Failure to obtain timely approval of an acceptable brand name could

limit our ability to establish brand recognition and commercialize our product candidates effectively.

Risk of Noncompliance with Regulatory Requirements

Our success depends on our ability, and that of

our collaborators, to comply with regulatory requirements, including current Good Manufacturing Practices (cGMP) and safety reporting

Failure to comply could lead to fines, civil or criminal penalties, injunctions, suspension or revocation of regulatory approvals,

denial of pending applications, product recalls or seizures, and restrictions on operations or production, any of which could materially

harm our business, financial condition, and prospects.

Even if our product candidates are approved, they may fail to

achieve sufficient market acceptance, which could limit revenue and affect our business.

We have never commercialized a product.

CORDStrom or any other product candidate is approved, physicians, patients, third-party payors, and others in the medical community may

be reluctant to adopt new therapies.

Educating the medical community and securing reimbursement may require significant resources and

may not be successful.

The degree of market acceptance will depend on

factors such as the efficacy and safety of the product, advantages over alternative treatments, side effect profile, approved indications,

pricing, convenience of administration, sales and marketing support, competitive products, changes in standard of care, reimbursement

availability, publicity, and potential product liability claims.

In addition, our estimates of potential market size are inherently uncertain

and based on assumptions that may prove inaccurate, which could result in actual market opportunities being smaller than expected.

to achieve adequate market acceptance could materially and adversely affect our business, financial condition, and results of operations.

Even if we obtain regulatory approvals for CORDStrom or any product,

ongoing regulation may limit our ability to manufacture and commercialize these products.

Approved products and the

facilities used to manufacture them will remain subject to continuous review and inspections by the FDA and other U.S.

and foreign regulatory

Regulatory agencies may impose restrictions on the indicated uses, labeling, marketing, or manufacturing processes of these

products, and any material changes to manufacturing may require prior regulatory approval.

We are required to comply

with current Good Manufacturing Practices (“cGMP”) and maintain quality control, quality assurance, and documentation standards.

Discovery of previously unknown safety issues, manufacturing problems, or noncompliance with regulatory requirements could result in product

recalls, withdrawal from the market, fines, civil or criminal penalties, additional clinical trials, labeling changes, or other sanctions.

Such events could materially harm our ability to commercialize our products, affect our reputation, and subject us to lawsuits, including

class action claims.

If our product candidates are approved and later found to be

less effective than expected or to cause previously unidentified side effects, our business could be materially harmed.

Clinical trials are conducted in limited patient

populations under controlled conditions, and results may not fully predict effectiveness or safety in the broader population.

approval, a product is discovered to be less effective or to cause adverse effects, we could face regulatory actions such as withdrawal

of approval, recalls, restrictions on marketing or manufacturing, labeling changes (including “black box” warnings), or additional

post-marketing requirements.

We could also face civil or criminal liability,

reputational harm, loss of market share, reduced competitiveness, and decreased revenues.

Any of these outcomes could materially and adversely

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

Even if we obtain marketing approval for a product candidate,

we will remain subject to extensive ongoing regulatory requirements, and failure to comply could materially harm our business.

Any approved product, its

manufacturing processes, labeling, promotional activities, and post-approval clinical data will be subject to continuing regulation by

the FDA and other authorities.

These requirements include safety reporting, post-marketing studies, registration and listing obligations,

adherence to good manufacturing practices (“GMP”), quality control and assurance, and recordkeeping.

Approvals may also be

limited to specific indications or include conditions that require costly post-marketing testing or surveillance.

Later discovery of previously

unknown safety or efficacy issues, or failure to comply with regulatory obligations, could result in restrictions on manufacturing or

distribution, labeling or marketing limitations, requirements for additional clinical trials or a Risk Evaluation and Mitigation Strategy

(REMS), warning letters, fines, product recalls, withdrawal or suspension of approvals, import/export prohibitions, injunctions, or civil

or criminal penalties.

Any of these actions could materially and adversely affect our ability to commercialize a product candidate and

harm our business, financial condition, and results of operations.

We currently have no marketing or sales

organization, and our inability to establish these capabilities or collaborate with third parties could limit our product revenue.

We have no experience in marketing

or selling pharmaceutical products, and building internal sales, marketing, and distribution capabilities would require substantial capital,

management attention, and time.

Recruiting, training, and retaining qualified personnel is competitive, and we may be unable to establish

an effective commercial organization.

If we rely on third parties

to market and sell our products, our revenue will depend on their efforts, which may not be successful.

We may have limited control over

their activities, and competition for third-party collaborators may limit our ability to secure or maintain such relationships.

to develop internal capabilities or establish successful third-party arrangements could materially and adversely affect our ability to

generate revenue from our product candidates.

We face substantial competition from other pharmaceutical and

biotechnology companies and our operating results may suffer if we fail to compete effectively.

The development and commercialization

of new drug products is highly competitive.

We expect that we will face significant competition from major pharmaceutical companies, specialty

pharmaceutical companies and biotechnology companies worldwide with respect to our DN-TNF product platform, INKmune and any other of our

product candidates that we may seek to develop or commercialize in the future.

Specifically, due to the large unmet medical need, global

demographics and relatively attractive reimbursement dynamics, the oncology market is fiercely competitive and there are a number of large

pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of product candidates

for the treatment of cancer.

Our competitors may succeed in developing, acquiring or licensing technologies and drug products that are

more effective, have fewer or more tolerable side effects or are less costly than any product candidates that we are currently developing

or that we may develop, which could render our product candidates obsolete and noncompetitive.

We rely on key personnel and, if we are

unable to retain or motivate key personnel or hire qualified personnel, we may not be able to grow effectively.

We are dependent on certain

members of our management, the loss of services of one or more of whom could materially adversely affect us.

In particular, our success

depends to a significant extent upon the continued services of Dr.

Tesi, our President and CEO.

Tesi has overseen INmune

Bio since inception and provides leadership for our growth and operations strategy as well as being an inventor of our patents.

we have entered into an employment agreement with Dr.

Tesi, if he were to nevertheless terminate his employment with us, the loss of the

services of Dr.

Tesi, would have a material adverse effect on our growth, revenues, and prospective business.

We are also highly dependent

on the other principal members of our management and scientific team.

We are not aware of any present intention of any of our key personnel

to leave our company or to retire.

The loss of any of our key personnel, or the inability to attract and retain qualified personnel, may

significantly delay or prevent the achievement of our research, development or business objectives and could materially adversely affect

our business, financial condition and results of operations.

Our ability to manage growth

effectively will require us to continue to implement and improve our management systems and to recruit and train new employees.

can be no assurance that we will be able to successfully attract and retain skilled and experienced personnel.

Product liability lawsuits against us could

divert our resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop.

We face an inherent risk of

product liability claims as a result of the clinical testing of our product candidate despite obtaining appropriate informed consent from

our clinical trial participants.

We will face an even greater risk if we commercially sell any product that we may develop.

we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during clinical testing, manufacturing,

marketing or sale.

Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure

to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties.

Claims could also be asserted under

state consumer protection acts.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial

liabilities or be required to limit commercialization of our product candidate.

Regardless of the merits or eventual outcome, liability

claims may result in:

decreased demand for our product candidate or products that we may develop;

injury to our reputation and significant negative media attention;

withdrawal of clinical trial participants;

significant costs to defend resulting litigation;

substantial monetary awards to trial participants or patients;

loss of revenue;

reduced resources of our management to pursue our business strategy;

the inability to commercialize any products that we may develop.

We expect to face significant competition from major pharmaceutical companies, specialty pharmaceutical

companies, and biotechnology companies worldwide with respect to any product candidates we may develop or commercialize.

Dependence on Key Personnel

Our success depends largely on the continued service

and performance of our principal members of management and scientific staff.

The loss of any of these individuals could materially impede

our ability to achieve our business objectives.

In addition, our ability to attract, retain, and

motivate qualified scientific, technical, and commercial personnel is critical to our growth and operational success.

Competition for

experienced professionals in the biotechnology, pharmaceutical, and healthcare industries—as well as at universities and research

institutions—is intense.

We may be unable to hire or retain personnel on terms acceptable to us, which could adversely affect our

research, development, and commercialization efforts.

We also rely on a significant number of consultants

to support the execution of our business objectives.

Any disruption in these relationships could negatively impact our operations.

During August 2025, Raymond J.

Tesi, Ph.D., retired

as our President and Chief Executive Officer.

David Moss, previously our Chief Financial Officer, succeeded Dr.

Tesi as President and

CEO and joined our Board of Directors.

Product liability claims could result in substantial costs, divert

resources, and limit the development or commercialization of our product candidates.

We face inherent risks of

product liability claims as a result of clinical testing of our product candidates, and these risks would increase if we commercialize

any products.

Claims could be based on alleged defects in design or manufacturing, failure to warn of risks, negligence, strict liability,

breach of warranties, or violations of consumer protection laws.

Any such claims, even if without merit or successfully defended, could

result in costly litigation, adverse publicity, injury to our reputation, withdrawal of trial participants, loss of revenue, or reduced

managerial resources, and could limit or delay commercialization.

Although we plan to maintain

general liability insurance, this insurance may not fully cover potential liabilities that we may incur.

The cost of any product liability

litigation or other proceeding, even if resolved in our favor, could be substantial.

In addition, insurance coverage is becoming increasingly

If we are unable to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against

potential product liability claims, it could prevent or inhibit the development and commercial production and sale of our product candidate,

which could adversely affect our business, financial condition, results of operations and prospects.

We will need to increase the size and capabilities

of our organization, and we may experience difficulties in managing this growth.

To execute our business plan,

we will need to rapidly add other management, accounting, regulatory, manufacturing and scientific staff.

We currently have 13 full-time

employees in the United States, 9 full-time employees in the United Kingdom and retain the services of additional personnel on an independent

contractor basis.

We will need to attract, retain and motivate a significant number of new additional managerial, operational, sales,

marketing, financial, and other personnel, as well as highly skilled scientific and medical personnel, and to expand our capabilities

to successfully pursue our research, development, manufacturing and commercialization efforts and secure collaborations to market and

distribute our products.

This growth may strain our existing managerial, operational, financial and other resources.

We also intend to

add personnel in our research and development and manufacturing departments as we expand our clinical trial and research capabilities.

Any inability to attract and retain qualified employees to enable our planned growth and establish additional capabilities or our failure

to manage our growth effectively could delay or curtail our product development and commercialization efforts and harm our business.

We are subject to a multitude of manufacturing risks, any of which

could substantially increase our costs and limit supply of our drug candidates.

The process of manufacturing

our drug candidates is complex, highly regulated and subject to several risks.

For example, the process of manufacturing our drug candidates

is extremely susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, or

vendor or operator error.

Even minor deviations from normal manufacturing processes for any of our drug candidates could result in reduced

production yields, product defects and other supply disruptions.

If microbial, viral, or other contaminations are discovered in our drug

candidates or in the manufacturing facilities in which our drug candidates are made, such manufacturing facilities may need to be closed

for an extended period of time to investigate and remedy the contamination.

In addition, the manufacturing facilities in which our drug

candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, epidemics, pandemics, power

failures and numerous other factors.

In addition, any adverse developments

affecting manufacturing operations of our drug candidates may result in shipment delays, inventory shortages, lot failures, withdrawals

or recalls, or other interruptions in the supply of our drug candidates.

We also may need to take inventory write-offs and incur other

charges and expenses for drug candidates that fail to meet specifications, undertake costly remediation efforts, or seek costlier manufacturing

alternatives.

We and our contract manufacturers are subject to significant regulation

with respect to manufacturing our drug candidates.

The manufacturing facilities on which we rely may not continue to meet regulatory requirements.

All entities involved in the

preparation of therapeutics for clinical trials or commercial sale, including our existing contract manufacturers for our drug candidates,

are subject to extensive regulation.

Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical

trials must be manufactured in accordance with cGMP.

These regulations govern manufacturing processes and procedures and the implementation

and operation of quality systems to control and assure the quality of investigational products and products approved for sale.

of production processes can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of our drug

candidates that may not be detectable in final product testing.

We or our contract manufacturers must supply all necessary documentation

in support of an NDA or marketing authorization application, or MAA, on a timely basis and must adhere to GLP and cGMP regulations enforced

by the FDA, EMA or comparable foreign authorities through their facilities inspection program.

Some of our contract manufacturers may

not have produced a commercially approved pharmaceutical product and therefore may not have obtained the requisite regulatory authority

approvals to do so.

The facilities and quality systems of some or all of our third-party contractors must pass a pre-approval inspection

for compliance with the applicable regulations as a condition of regulatory approval of our drug candidates or any of our other potential

In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation

of our drug candidates or any of our other potential products or the associated quality systems for compliance with the regulations applicable

to the activities being conducted.

Although we oversee the contract manufacturers, we cannot control the manufacturing process of, and

are completely dependent on, our contract manufacturing partners for compliance with the regulatory requirements.

If these facilities

do not pass a pre-approval plant inspection, regulatory approval of the products may not be granted or may be substantially delayed until

any violations are corrected to the satisfaction of the regulatory authority, if ever.

The regulatory authorities

also may, at any time following approval of a product for sale, audit the manufacturing facilities of our third-party contractors.

any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications

or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial

measures that may be costly or time consuming for us or a third party to implement, and that may include the temporary or permanent suspension

of a clinical trial or commercial sales or the temporary or permanent closure of a facility.

Any such remedial measures imposed upon us

or third parties with whom we contract could materially harm our business, financial condition and results of operations.

If we or any of our third-party manufacturers fail

to maintain regulatory compliance, the FDA, EMA or comparable foreign authorities can impose regulatory sanctions including, among other

things, refusal to approve a pending application for a drug candidate, withdrawal of an approval, or suspension of production.

our business, financial condition and results of operations may be materially and adversely affected.

Additionally, if supply from one manufacturer is

interrupted, an alternative manufacturer would need to be qualified through an NDA supplement or MAA variation, or equivalent foreign

regulatory filing, which could result in further delay.

The regulatory agencies may also require additional studies or trials if a new

manufacturer is relied upon for commercial production.

Switching manufacturers may involve substantial costs and is likely to result in

a delay in our desired clinical and commercial timelines.

These factors could cause us to incur higher costs

and could cause the delay or termination of clinical trials, regulatory submissions, required approvals, or commercialization of our drug

Furthermore, if our suppliers fail to meet contractual requirements and we are unable to secure one or more replacement suppliers

capable of production at a substantially equivalent cost, our clinical trials may be delayed, or we could lose potential revenue.

If we or our third-party manufacturers use

hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.

Our research and development

activities involve the controlled use of potentially hazardous substances, including chemical and biological materials, by us and any

third-party manufacturers.

We and such manufacturers will be subject to federal, state and local laws and regulations in the United States

governing the use, manufacture, storage, handling and disposal of medical and hazardous materials.

Although we will seek to ensure that

our procedures for using, storing and disposing of these materials comply with legally prescribed standards, we cannot completely eliminate

the risk of contamination or injury resulting from medical or hazardous materials.

As a result of any such contamination or injury, we

may incur liability or local, city, state or federal authorities may curtail the use of these materials and interrupt our business operations.

In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources.

We do not have any insurance for liabilities arising from medical or hazardous materials.

Compliance with applicable environmental laws

and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts,

which could harm our business, prospects, financial condition or results of operations.

We plan to rely on third parties to conduct

clinical trials for our product candidates.

Any failure by a third party to meet its obligations with respect to the clinical development

of our product candidate may delay or impair our ability to obtain regulatory approval for our product candidates.

We plan to rely on contract

research organizations to conduct clinical trials relating to our product candidates.

Our reliance on third parties to conduct clinical

trials could, depending on the actions of such third parties, jeopardize the validity of the clinical data generated and adversely affect

our ability to obtain marketing approval from the FDA or other applicable regulatory authorities.

Such clinical trial arrangements

will provide us with information rights with respect to the clinical data, including access to and the ability to use and reference the

data, including for our own regulatory filings, resulting from the clinical trials.

If investigators or institutions breach their obligations

with respect to the clinical trials of our product candidate, or if the data proves to be inadequate, then our ability to design and conduct

any future clinical trials may be adversely affected.

Our reliance on these third

parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities.

For example, we will design our clinical trials and will remain responsible for ensuring that each of our clinical trials is conducted

in accordance with the general investigational plan and protocols for the trial.

Moreover, the FDA requires us to comply with standards,

commonly referred to as good clinical practices, or GCPs, for conducting, recording and reporting the results of clinical trials to assure

that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are

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

are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database,

ClinicalTrials.gov, within specified timeframes.

Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Furthermore, these third parties

may also have relationships with other entities, some of which may be our competitors.

If these third parties do not successfully carry

out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our

stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidate and will

not be able to, or may be delayed in our efforts to, successfully commercialize our product candidate.

We also expect to rely on

other third parties to store and distribute drug supplies for our clinical trials.

Any performance failure on the part of our distributors

could delay clinical development or marketing approval of our product candidate or commercialization of our products, producing additional

losses and depriving us of potential product revenue.

Current and future legislation may increase

the difficulty and cost of commercializing our drug candidates and may affect the prices we may obtain if our drug candidates are approved

for commercialization.

and some foreign

jurisdictions, there have been a number of adopted and proposed legislative and regulatory changes regarding the healthcare system that

could prevent or delay regulatory approval of our drug candidates, restrict or regulate post-marketing activities and affect our ability

to profitably sell any of our drug candidates for which we obtain regulatory approval.

In the U.S., the Medicare

Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare covers and pays for pharmaceutical

Cost reduction initiatives and other provisions of this legislation could limit the coverage and reimbursement rate that we

receive for any of our approved products.

While the MMA only applies to drug benefits for Medicare beneficiaries, private payors often

follow Medicare coverage policy and payment limitations in setting their own reimbursement rates.

Therefore, any reduction in reimbursement

that results from the MMA may result in a similar reduction in payments from private payors.

In March 2010, the Patient

Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, collectively the PPACA, was

The PPACA was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance

remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose

new taxes and fees on the health industry and impose additional health policy reforms.

The PPACA increased manufacturers’ rebate

liability under the Medicaid Drug Rebate Program by increasing the minimum rebate amount for both branded and generic drugs and revised

the definition of “average manufacturer price,” or AMP, which may also increase the amount of Medicaid drug rebates manufacturers

are required to pay to states.

The legislation also expanded Medicaid drug rebates and created an alternative rebate formula for certain

new formulations of certain existing products that is intended to increase the rebates due on those drugs.

The Centers for Medicare &

Medicaid Services, or CMS, which administers the Medicaid Drug Rebate Program, also has proposed to expand Medicaid rebates to the utilization

that occurs in the territories of the U.S., such as Puerto Rico and the Virgin Islands.

Further, beginning in 2011, the PPACA imposed

a significant annual fee on companies that manufacture or import branded prescription drug products and required manufacturers to provide

a discount, equal to 70% off, effective as of 2019, the negotiated price of prescriptions filled by beneficiaries in the Medicare Part

D coverage gap, referred to as the “donut hole.” Legislative and regulatory proposals have been introduced at both the state

and federal level to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

Moreover, payment methodologies

may be subject to changes in healthcare legislation and regulatory initiatives.

For example, CMS may develop new payment and delivery

models, such as bundled payment models.

In addition, recently there has been heightened governmental scrutiny over the manner in which

manufacturers set prices for their marketed products, which has resulted in several U.S.

Congressional inquiries and proposed and enacted

federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription

drugs under government payor programs, and review the relationship between pricing and manufacturer patient programs.

We also expect that

additional U.S.

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

government will pay for healthcare products and services, which could result in reduced demand for our drug candidates, if approved for

commercialization.

In Europe, the United Kingdom

withdrew from the European Union on January 31, 2020, and entered into a transition period that expired on December 31, 2020.

A significant

portion of the previous regulatory framework in the United Kingdom was derived from the regulations of the European Union.

United Kingdom’s Medicines and Healthcare products Regulatory Agency, or MHRA, and the European Medicines Agency, or EMA, released

guidance explaining the new regulatory framework.

We cannot predict the consequences or impact that the new regulatory framework will

have on our future operations, if any, in these jurisdictions.

In addition, on August 16,

2022, President Biden signed into law the Inflation Reduction Act of 2022, which, among other things, includes policies that are designed

to have a direct impact on drug prices and reduce drug spending by the federal government, which shall take effect in 2023.

Inflation Reduction Act, Congress authorized Medicare beginning in 2026 to negotiate lower prices for certain costly single-source drug

and biologic products that do not have competing generics or biosimilars.

This provision is limited in terms of the number of pharmaceuticals

whose prices can be negotiated in any given year and it only applies to drug products that have been approved for at least 9 years and

biologics that have been licensed for 13 years.

Drugs and biologics that have been approved for a single rare disease or condition are

categorically excluded from price negotiation.

Further, the new legislation provides that if pharmaceutical companies raise prices in

Medicare faster than the rate of inflation, they must pay rebates back to the government for the difference.

The new law also caps Medicare

out-of-pocket drug costs at an estimated $4,000 a year in 2024 and, thereafter beginning in 2025, at $2,000 a year.

Government regulations could impact

our ability to price our products

and international governmental

regulations that mandate price controls or limitations on patient access to our drugs under development, create coverage criteria or establish

prices paid by government entities or programs for our potential products could impact our business, and our future results could be adversely

affected by changes in such regulations or policies.

In addition to the recent expansion of price controls in the U.S.

in the IRA, the

adoption of restrictive coverage policies and price controls in new jurisdictions, more restrictive controls in existing jurisdictions

or the failure to obtain or maintain timely or adequate coverage and pricing could also adversely impact future revenue.

We expect pricing

pressures and other cost containment measures for drugs and vaccines will continue globally.

In the U.S., pharmaceutical

product pricing is subject to government and public scrutiny and calls for reform, and many of our products are subject to increasing

pricing pressures as a result.

We expect to see continued focus by the U.S.

Congress and the Biden Administration on regulating pricing

and access to medicine.

For example, in August 2022, the drug pricing provisions of the IRA were signed into law, which, among other things,

require manufacturers of certain drugs to engage in price negotiations with Medicare which will permit the CMS to set a maximum fair price

for selected drugs, impose rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replace

the Part D coverage gap discount program with a new discounting program.

The drug pricing provisions of the IRA began to be implemented

in 2022 and implementation efforts are expected to continue over the next several years.

In August 2023, the Biden Administration unveiled

the first round of medicines subject to the Medicare Drug Pricing Negotiation Program.

Health plans may also require rebates in addition

to the maximum fair price for preferred placement on a Medicare plan formulary.

The Medicare Drug Price Negotiation Program is currently

subject to legal challenges and therefore, the outcome of the 340B Program remains uncertain.

Payors may promote generic

drugs and biosimilars more aggressively to generate savings and attempt to stimulate additional price competition.

In addition, we expect

that consolidation and integration among pharmacy chains, wholesalers and PBMs will increase pricing pressures in the industry.

have implemented, and others are considering, patient access constraints or cost cutting under state regulated programs including the

Medicaid program.

State legislatures also have continued to focus on addressing drug costs, generally by increasing price transparency

or attempting to limit drug price increases for state regulated insurance.

Measures to regulate prices or payment for pharmaceutical products,

including legislation on drug importation, such as Florida’s drug importation program which was recently approved by the FDA, could

adversely affect our business.

We may encounter similar regulatory

and legislative issues in other countries in which we may operate.

In certain markets, such as in EU member states, the U.K., Japan, China,

Canada and South Korea, governments have significant power as large single payors to regulate prices, access criteria, or impose other

means of cost control, particularly as a result of recent global financing pressures.

general liability insurance, it may not fully cover potential claims, and insurance coverage is increasingly costly.

If we are unable

to obtain or maintain adequate insurance at reasonable cost, we could face significant financial exposure, which could materially and

adversely affect our business, financial condition, results of operations, and prospects.

We will need to expand our organization and may encounter challenges

in managing this growth.

To execute our business plan, we will need to hire

additional management, scientific, regulatory, manufacturing, and operational personnel, as well as expand our capabilities to support

research, development, clinical trials, and potential commercialization.

Recruiting and retaining highly skilled employees, particularly

in scientific and medical roles, is competitive and may be difficult.

If we are unable to attract and retain qualified

personnel, effectively manage our organizational growth, or build the necessary operational and technical capabilities, our product development,

regulatory submissions, and commercialization efforts could be delayed or impaired, which could materially harm our business, financial

condition, and results of operations.

Our manufacturing processes are complex and subject to numerous

risks that could increase costs and limit the supply of our drug candidates.

The production of our drug

candidates is highly regulated and susceptible to disruptions from contamination, equipment failures, operator error, labor shortages,

natural disasters, epidemics, pandemics, power outages, or other operational factors.

Even minor deviations from standard procedures could

reduce yields, cause product defects, or necessitate costly remediation, lot failures, or recalls.

Any interruption in manufacturing

could delay clinical trials, regulatory submissions, or commercialization, result in inventory write-offs, increase costs, and materially

and adversely affect our ability to supply our drug candidates and achieve anticipated revenues.

We and our contract manufacturers

are subject to extensive regulatory requirements with respect to the manufacture of our product candidates, and any failure to comply

with these requirements could materially harm our business.

All materials used in clinical

trials or for commercial sale must be manufactured in accordance with current Good Manufacturing Practices (“cGMP”) and other

applicable regulatory standards.

If we fail to maintain cGMP compliance, experience quality control issues, or do not pass inspections

by the FDA, EMA, or other regulatory authorities, approval of our product candidates could be delayed, suspended, or denied, or previously

granted approvals could be withdrawn.

Regulatory authorities may

also audit or inspect these facilities at any time following approval.

Any deficiencies identified could require costly or time-consuming

remedial actions, including suspension of clinical trials or commercial production.

Any interruption in supply, inability to secure compliant

manufacturers, or delays in regulatory approvals could materially and adversely affect our development timelines, commercialization prospects,

and financial results.

Risk Related to Hazardous and Biological Materials

Our research and development activities involve

the use of potentially hazardous chemical and biological materials by us and our third-party manufacturers.

Federal, state, and local

laws regulate the handling, storage, use, and disposal of such materials.

Despite implementing safety procedures, we cannot eliminate

the risk of contamination, injury, or legal violations.

Accidents could result in liability for damages, fines, or restrictions on our

operations, and we currently have no insurance coverage for such liabilities.

Compliance with environmental and safety regulations is

costly, and changes in such regulations could impair our research, development, or production efforts, adversely affecting our business,

financial condition, and results of operations.

We rely on third parties to conduct and support clinical trials

for our product candidates, and any failure by these parties to meet their obligations could materially delay or impair our development

programs and regulatory approvals.

We engage contract research organizations, investigators,

and other third parties to conduct our clinical trials, manage data, and provide related services.

While we maintain oversight and retain

responsibility for trial design and compliance with regulatory requirements, including good clinical practice (“GCP”) standards,

our reliance on these third parties reduces our direct control over certain aspects of trial execution.

If these third parties fail to

perform as expected, do not comply with regulatory requirements, or generate incomplete or unreliable data, our ability to obtain or maintain

marketing approval could be delayed or compromised.

We also rely on third parties to manufacture, store,

and distribute drug supplies for our clinical trials.

Any failure by these parties could disrupt trial timelines, increase costs, or adversely

affect the validity of clinical results, which could materially and adversely impact our ability to commercialize our product candidates

and achieve anticipated revenues.

Current and future healthcare reform measures

and pricing regulations may increase the difficulty and cost of commercializing our product candidates and may materially reduce the prices

we may obtain and the revenues we may generate if any of our product candidates are approved.

In the United States and certain

foreign jurisdictions, there have been and continue to be significant legislative and regulatory changes affecting the healthcare system,

including initiatives intended to control healthcare costs, reduce pharmaceutical pricing, increase transparency, and impose additional

manufacturer obligations.

Federal healthcare reform laws, including the Patient Protection and Affordable Care Act, as amended, expanded

manufacturers’ rebate obligations, increased financial liabilities for branded drug manufacturers, and enhanced government oversight

of pricing and reimbursement.

Private payors frequently adopt policies consistent with government reimbursement limitations, which may

further constrain pricing, coverage, and reimbursement for any approved products.

More recently, the Inflation

Reduction Act of 2022 introduced substantial changes to the Medicare program, including authorizing government price negotiation for certain

high-expenditure products, imposing inflation-based rebate obligations, redesigning the Medicare Part D benefit structure in a manner

that increases manufacturer financial responsibility, and capping beneficiary out-of-pocket costs.

Although certain provisions apply only

after a product has been marketed for a specified period and meets statutory criteria, these measures may increase pricing pressure across

the pharmaceutical market and materially reduce the prices we may be able to charge.

In addition, federal and state governments continue

to consider and implement further healthcare reform and drug pricing initiatives, and payment methodologies may evolve in ways that reduce

reimbursement levels or increase compliance costs.

Outside the United States,

many countries, including those in the European Union and the United Kingdom, impose governmental price controls, reimbursement restrictions,

and market access requirements that may delay commercialization or limit pricing flexibility.

The long-term impact of these and future

healthcare reform measures is uncertain.

If any of our product candidates are approved, existing and future pricing and reimbursement

reforms could materially reduce demand, lower realized prices, increase our financial and compliance obligations, and adversely affect

our ability to generate revenues or achieve profitability.

Further, the current administration has issued executive orders focused on decreasing prescription drug prices,

including directing the Secretary of HHS to establish a mechanism through which American patients can buy drugs directly from manufacturers

who sell at a most-favored-nation price and directing the U.S.

Trade Representative and Secretary of Commerce to take action to ensure

foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the U.S.

In November 2025, CMS announced a voluntary initiative called the GENEROUS Model (GENErating cost Reductions fOr U.S.

Medicaid Model)

to introduce the option of most-favored-nation pricing to the Medicaid program, whereby a drug manufacturer may voluntarily offer supplemental

rebates to participating state Medicaid programs for a manufacturer’s covered outpatient drugs.

Government agreements with pharmaceutical

companies and other measures that use most-favored-nation pricing targets for prescription drugs or that increase generic and biosimilar

drug entry sooner than expected can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover

R&D costs, ability to attract potential investors and potential buyers in the future, or the pricing of our approved product in the

and in foreign countries.

The regulatory approval processes of the

FDA, EMA, and other comparable foreign regulatory authorities are complex, time-consuming and inherently unpredictable.

If we are not

able to obtain, or if there are delays in obtaining, required regulatory approvals for CORDStrom, we may not be able to commercialize,

or may be delayed in commercializing, CORDStrom, and our ability to generate revenue will be materially impaired .

The process of obtaining regulatory approvals in the United States, the EU, and other jurisdictions is complex,

expensive and typically takes many years following commencement of clinical trials, 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.

We cannot commercialize

CORDStrom in the United States without first obtaining regulatory approval from the FDA.

Similarly, we cannot commercialize CORDStrom

outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities.

Before obtaining regulatory

approvals for the commercial sale of CORDStrom, we must demonstrate through complex and expensive preclinical studies and clinical trials

that CORDStrom is both safe and effective for each targeted indication.

Securing regulatory approval also requires the submission of information

about the drug manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authorities.

CORDStrom 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.

The FDA, EMA, and comparable foreign regulatory authorities

have discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval

and require additional preclinical, clinical or other data.

CORDStrom could be delayed in receiving, or fail to receive, regulatory approval

for many reasons, including:

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

of our clinical trials;

we may be unable to demonstrate to the satisfaction of the FDA, EMA, or comparable foreign regulatory authorities

that CORDStrom is safe and effective for its proposed indication;

the results of clinical trials may not meet the level of statistical

significance required by the FDA, EMA, or comparable foreign regulatory authorities for approval;

serious and unexpected drug-related

side effects may be experienced by participants in our clinical trials or by individuals using drugs similar to CORDStrom;

we may be unable

to demonstrate that CORDStrom’s clinical and other benefits outweigh its safety risks;

the FDA, EMA or comparable foreign regulatory

authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

the data collected from clinical

trials of CORDStrom may not be acceptable or sufficient to support the submission of a BLA or other submission or to obtain regulatory

approval in the United States or elsewhere, and we may be required to conduct additional clinical trials;

the FDA, EMA, or the applicable

foreign regulatory authority may disagree regarding the formulation, labeling and/or the specifications of CORDStrom;

the FDA, EMA, or

comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with

which we contract for clinical and commercial supplies;

and the approval policies or regulations of the FDA, EMA, or comparable foreign

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

Thus, the approval

requirements for CORDStrom are likely to vary by jurisdiction such that success in one jurisdiction is not necessarily predictive of success

Further, the FDA and comparable foreign regulatory authorities may undergo leadership changes, change their policies, issue

additional regulations or revise existing regulations, or take other actions, which may impact our clinical development plans or prevent

or delay approval of our product candidates under development on a timely basis.

Such policy or regulatory changes could impose additional

requirements upon us that could delay our ability to obtain approvals and increase the costs of compliance.

Of the large number of drugs in development, only a small percentage successfully complete the FDA, EMA, or foreign

regulatory approval processes and are commercialized.

The lengthy approval process as well as the unpredictability of future clinical

trial results may result in our failing to obtain regulatory approval to market CORDStrom, which would significantly harm our business,

results of operations and prospects.

If we were to obtain approval, regulatory authorities may approve CORDStrom for fewer or more limited indications

than we request, including failing to approve the most commercially promising indications, may grant approval contingent on the performance

of costly post-marketing clinical trials, or may approve CORDStrom with a label that does not include the labeling claims necessary or

desirable for the successful commercialization of CORDStrom.

If we are not able to obtain, or if there are delays in obtaining, required

regulatory approvals for CORDStrom, we may not be able to commercialize, or may be delayed in commercializing, CORDStrom and our ability

to generate revenue could be materially impaired.

Deterioration in general economic conditions

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Our business and results of

operations could be adversely affected by changes in national or global economic conditions.

These conditions include but are not limited

to inflation, rising interest rates, availability of capital markets, energy availability and costs, the negative impacts caused

by pandemics and public health crises, negative impacts resulting from the military conflict between Russia and the Ukraine, and the effects

of governmental initiatives to manage economic conditions.

Impacts of such conditions could be passed on to our business in the form of

higher costs for labor and materials, higher investigator fees, possible reductions in pharmaceutical industry-wide spending on research

and development and acquisitions and higher costs of capital.

Public health threats could have an

adverse effect on our operations and financial results.

Public health threats, such

as the novel coronavirus (COVID-19), influenza and other highly communicable diseases or viruses could adversely impact our operations

and disrupt our ongoing or planned research and development activities.

We cannot presently predict the scope and severity of any potential

future business shutdowns or disruptions, but if we or any of the third parties with whom we engage, including the suppliers, clinical

trial sites, regulators and other third parties with whom we conduct business, were to experience shutdowns or other business disruptions,

our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively impacted.

operations may be adversely affected by unfavorable national or global economic conditions, including inflationary pressures, elevated

interest rates, volatility in capital markets, reduced access to financing, disruptions in supply chains, labor shortages, geopolitical

instability, and other macroeconomic developments.

Although inflation rates have fluctuated in recent years, sustained or renewed inflationary

pressures could increase our operating costs, including costs for clinical trial services, manufacturing, raw materials, logistics, and

Adverse economic conditions

may also reduce the availability of capital or increase our cost of capital, which could impair our ability to raise additional funds

on acceptable terms, if at all.

In addition, economic uncertainty or government actions taken to address economic conditions could result

in reduced investment, research and development spending, strategic transactions, or partnership activity within the biotechnology and

pharmaceutical industries.

Any of these factors could increase our costs, delay our development programs, limit our access to financing,

or otherwise materially and adversely affect our business, financial condition, and results of operations.

Public health emergencies or other widespread health events could

adversely affect our operations and financial results.

Public health emergencies,

including pandemics, epidemics, or other outbreaks of highly communicable diseases, could disrupt our business operations and delay or

impair our research and development activities.

Such events may result in clinical site closures, reduced patient enrollment or retention,

supply chain disruptions, travel restrictions, workforce shortages, delays in regulatory review, or other operational interruptions affecting

us or the third parties on whom we rely.

Because we depend on third-party

clinical trial sites, contract research organizations, manufacturers, suppliers, and regulatory authorities in multiple jurisdictions,

any future public health emergency affecting these parties could materially disrupt our development timelines and increase our costs.

The scope, duration, and impact of any future health-related disruptions are uncertain and could materially and adversely affect our business,

financial condition, and results of operations.

We are exposed to risks related to currency

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rates have had and could have in the future a significant effect on our operating results when our operating results are translated into

Our employees,

principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance

with regulatory standards and requirements and insider trading, which could cause significant liability for us and harm our reputation.

Our employees, principal investigators, consultants, and collaborators

may engage in misconduct or fail to comply with regulatory requirements, which could result in liability and harm our reputation.

We are exposed to the risk

of fraud or other misconduct by our employees, principal investigators, consultants and collaborators, including intentional failures

to comply with FDA or Office of Inspector General regulations or similar regulations of comparable non-U.S.

regulatory authorities, provide

accurate information to the FDA or comparable non-U.S.

regulatory authorities, comply with manufacturing standards we have established,

comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced

by comparable non-U.S.

regulatory authorities, report financial information or data accurately or disclose unauthorized activities to

Misconduct by these parties could also involve the improper use of information obtained in the course of clinical trials, which could

result in regulatory sanctions and serious harm to our reputation.

It is not always possible to identify and deter misconduct, and the

precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in

protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws,

standards or regulations.

Such actions could have a significant impact on our business and results of operations, including the imposition

of significant fines or other sanctions.

A cybersecurity incident and other technological

disruptions could negatively affect our business and our relationships with customers.

We use technology in substantially

all aspects of our business operations.

The widespread use of technology, including mobile devices, cloud computing, and the internet,

gives rise to cybersecurity risks, including security breach, espionage, system disruption, theft and inadvertent release of information.

Our business involves the storage and transmission of numerous classes of sensitive and/or confidential information and intellectual property,

including information relating to suppliers, private information about employees, and financial and strategic information about us and

our business partners.

If we fail to effectively assess and identify cybersecurity risks associated with the use of technology in our

business operations, we may become increasingly vulnerable to such risks.

Additionally, while we have implemented measures to prevent

security breaches and cyber incidents, our preventative measures and incident response efforts may not be entirely effective.

destruction, loss, misappropriation, or release of sensitive and/or confidential information or intellectual property, or interference

with our information technology systems or the technology systems of third parties on which we rely, could result in business disruption,

negative publicity, brand damage, violation of privacy laws, loss of customers, potential liability and competitive disadvantage.

Use of social media platforms presents

We believe that our potential

patient population is active on social media.

Social media practices in the pharmaceutical and biotechnology industries are evolving,

which creates uncertainty and risk of noncompliance with regulations applicable to our business.

For example, patients may use social

media platforms to comment on the effectiveness of, or adverse experiences with, a product candidate, which could result in reporting

In addition, there is a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments

about us or our product candidates on any social networking website.

In addition, our employees or third parties with whom we contract,

such as our CROs or CMOs, may knowingly or inadvertently make use of social media in a manner that may give rise to liability, lead to

the loss of trade secrets or other intellectual property or result in public exposure of personal information of our employees, clinical

trial patients, customers and others or information regarding our product candidates or clinical trials.

Any of these events could have

a material adverse effect on our business, prospects, operating results and financial condition and could adversely affect the price of

our common shares.

that these parties may engage in improper or illegal activities, including violations of FDA or other regulatory standards, healthcare

fraud and abuse laws, manufacturing procedures, clinical trial protocols, or financial reporting requirements.

Misconduct could also involve

the improper use or disclosure of confidential or proprietary information.

Although we maintain policies

and controls designed to prevent and detect misconduct, it is not always possible to identify or deter all improper activities.

misconduct could result in regulatory sanctions, fines, civil or criminal liability, or damage to our reputation, and could materially

and adversely affect our business, financial condition, and results of operations.

Cybersecurity Incidents and Other Technological Disruptions Could

Negatively Affect Our Business and Customer Relationships

We rely on technology in substantially all aspects

of our business operations.

The widespread use of technology, including mobile devices, cloud computing, and the internet, exposes us

to cybersecurity risks, such as security breaches, espionage, system disruptions, theft, and inadvertent disclosure of information.

Our business involves the storage and transmission

of sensitive and/or confidential information and intellectual property, including data relating to suppliers, private employee information,

and financial and strategic information about us and our business partners.

If we fail to adequately assess and manage cybersecurity risks,

we may become increasingly vulnerable to such threats.

Although we have implemented measures to prevent

security breaches and cyber incidents, these measures and our incident response efforts may not be entirely effective.

Theft, destruction,

loss, misappropriation, or unauthorized disclosure of sensitive or confidential information, or interference with our information technology

systems—or the systems of third parties on which we rely—could result in business disruption, negative publicity, reputational

harm, violations of privacy laws, loss of customers, potential liability, and competitive disadvantage.

Use of Social Media Platforms Presents New Risks

We believe that our potential patient population

is active on social media.

Social media practices in the pharmaceutical and biotechnology industries are evolving, creating uncertainty

and risks of noncompliance with applicable regulations.

For example, patients may post comments regarding the effectiveness of, or adverse

experiences with, a product candidate, which could trigger reporting obligations.

There is also a risk that sensitive information

could be disclosed inappropriately, or that negative or inaccurate posts about us or our product candidates may appear on social media.

In addition, our employees or third parties with whom we contract, including contract research organizations (“CROs”) or contract

manufacturing organizations (“CMOs”), could knowingly or inadvertently use social media in a manner that exposes us to liability,

compromises trade secrets or other intellectual property, or publicly discloses personal information of employees, clinical trial patients,

customers, or information regarding our product candidates or clinical trials.

Any of these events could materially harm our business,

prospects, operating results, and financial condition, and could adversely affect the price of our common shares.

The use or anticipated use of artificial

intelligence, or AI, technologies, including generative AI, by us or third parties, may increase or create new operational risks .

AI technologies offer numerous potential benefits, such as creating or increasing operational efficiencies, and

we expect the use of AI and generative AI by us, third parties on our behalf, and other market actors, including our competitors, to increase.

However, the deployment of such technologies also poses certain risks, including that the models may be flawed, misused or otherwise function

in an unexpected manner; the data sets on which the models are trained may be insufficient, of poor quality, lack transparency, or

contain biased information; and inappropriate or controversial data practices by data scientists, engineers, and end-users could

impair results.

The use of AI could also present risks and challenges related to cybersecurity, data privacy, IT, confidentiality, regulatory,

legal, operational, competitive, reputational and intellectual property risks.

The speed at which the technology is being adopted, and

the uncertainty regarding the scope and details of laws, regulations or standards governing its use, and in particular the scope and form

of risk assessments that must be undertaken by developers or deployers of AI systems deemed to represent a high-risk to human safety,

combined with the growing interest by various legislatures and regulators to address the development and deployment of AI technologies

in a manner which may not be consistent across jurisdictions, increases these risks.

If AI-based outputs are deficient or inaccurate,

or if AI technologies are otherwise misused, we could be subjected to potential legal liability and brand or reputational harm.

Our competitors

may also adopt AI or generative AI more quickly or more effectively than we do, which could affect our market position.

Furthermore, use

of AI-based software may lead to the release of confidential information which may impact our ability to realize the benefits of our intellectual

Additionally, government and supranational regulation related to AI is evolving and could increase the burden

and cost of compliance, including through requirements related to transparency, accountability, risk management, human oversight, and

data governance.

The EU’s Artificial Intelligence Act, or AI Act, started coming into force in August 2024, with important parts

of the new law scheduled to come into effect in August 2026.

In the United States, the regulatory environment is complex and uncertain.

Over the past year, states have advanced, and in some cases passed, dozens of laws focusing on AI governance and regulation, including

deployment of AI in healthcare settings.

At the federal level, the current administration endorsed a federal moratorium on the enforcement

of state AI laws.

So far, these efforts have not been successful at curtailing state action on AI regulation, contributing to a complicated

legislative patchwork.

In addition, there is continued uncertainty regarding the application of existing federal and state legal frameworks

to uses and development of AI, and legal norms and market standards regarding AI continue to evolve.

For example, the FDA issued guidance

on the use of AI in medical devices, requiring detailed risk management and review processes to obtain approvals.

If we develop or use

AI systems that are governed by the these laws or regulations, we will need to meet higher standards of data quality, transparency, and

human oversight, and we would need to adhere to specific and potentially burdensome and costly ethical, accountability, and administrative

requirements.

The rapid evolution of AI will require the application of significant resources to help ensure that AI is implemented in

accordance with applicable law and regulation and in a socially responsible manner.

The use of certain AI technologies can also give rise

to intellectual property risks.

The use of AI tools by our vendors also exposes us to risk.

the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely

affect our business.

2017, the U.S.

Congress and the Trump administration made substantial changes to U.S.

policies, which included comprehensive corporate

and individual tax reform.

In addition, the Trump administration called for significant changes to U.S.

trade, healthcare, immigration

and government regulatory policy.

With the transition to the Biden administration in early 2021, changes to U.S.

policy occurred and since

the start of the Trump Administration in 2025, U.S.

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

Changes to U.S.

policy implemented by the U.S.

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

future impact, among other things, the U.S.

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

taxation, the U.S.

regulatory environment, inflation and other areas.

For example, in September 2025, President Trump announced plans

to impose 100% tariffs on imported branded or patented pharmaceuticals, unless the importing company is building U.S.

manufacturing capacity.

It is not yet clear whether these tariffs would apply to the importation of active pharmaceutical ingredients and possibly bulk drug products

that are intended for use in clinical trials and not for commercial sale, which could increase the costs of materials for our clinical

Any direct tariffs, if imposed on pharmaceutical products, may result in increased costs for raw materials and contract manufacturing

services, reduced ability to source critical contract manufacturing organizations, and a delay in our development timelines.

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

Until we know what policy

changes are made, whether those policy changes are challenged and subsequently upheld by the court system and how those changes impact

our business and the business of our competitors over the long term, we will not know if, overall, we will benefit from them or be negatively

affected by them.

Disruptions at the FDA, the SEC and other government agencies

could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed

or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions, which could negatively

impact our business and our timelines.

The ability of the FDA to review and approve

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

and accept the payment of user fees, shifting policy priorities as a result of changes in the presidential administration and political

appointees tasked to oversee the agency, and statutory, regulatory, leadership, and policy changes.

Average review times at the agency

have fluctuated in recent years as a result.

In addition, government funding of the SEC, and other government agencies on which our operations

may rely is subject to the impacts of political events, which are inherently fluid and unpredictable.

Disruptions at the FDA and other federal agencies,

including substantial leadership departures, personnel cuts, and policy changes, may also slow the time necessary for new drugs to be

reviewed and/or approved, which would harm our business.

Changes and cuts in FDA staffing also could result in delays in the FDA’s

responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory

requirements in a timely fashion or at all.

For example, over the last several years, the

government has shut down several times, including from October 1, 2025 through November 12, 2025, and from January 31, 2025 through

February 3, 2026.

In some circumstances, certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA,

SEC and other government employees and stop critical activities.

If a prolonged government shutdown occurs, it could significantly impact

the ability of the FDA and the SEC to timely review and process our submissions, which could have a material adverse effect on our business

and our timelines.

Since the change in the U.S.

presidential administration

in 2025, there is uncertainty as to how and to what extent the current administration will continue to seek to modify or revise the requirements

and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain

This uncertainty could present new challenges and/or opportunities as we navigate development and approval of our product candidates.

Additionally, the current administration could issue or promulgate executive orders, regulations, policies or guidance that adversely

affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates.

Risks Related to our Intellectual Property

We depend on obtaining certain patents and

protecting our proprietary rights.

Our success will depend, in

part, on our ability to obtain patents, maintain trade secret protection and operate without infringing on the proprietary rights of third

parties or having third parties circumvent our rights.

We have filed and are actively pursuing a patent application for our product candidates.

The patent positions of biotechnology, biopharmaceutical and pharmaceutical companies can be highly uncertain and involve complex legal

and factual questions.

Thus, there can be no assurance that our patent application will result in the issuance of a patent, that we will

develop additional proprietary products that are patentable, that any patents issued to us will provide us with any competitive advantages

or will not be challenged by any third parties, that the patents of others will not impede our ability to do business or that third parties

will not be able to circumvent our patents.

Furthermore, there can be no assurance that others will not independently develop similar

products, duplicate any of our products not under patent protection, or, if patents are issued to us, design around the patented products

we developed or will develop.

We may be required to obtain

licenses from third parties to avoid infringing patents or other proprietary rights.

No assurance can be given that any licenses required

under any such patents or proprietary rights would be made available, if at all, on terms we find acceptable.

If we do not obtain such

licenses, we could encounter delays in the introduction of products or could find that the development, manufacture or sale of products

requiring such licenses could be prohibited.

A number of pharmaceutical,

biopharmaceutical and biotechnology companies and research and academic institutions have developed technologies, filed patent applications

or received patents on various technologies that may be related to or affect our business.

Some of these technologies, applications or

patents may conflict with our technologies or patent applications.

Such conflict could limit the scope of the patents, if any, that we

may be able to obtain or result in the denial of our patent applications.

In addition, if patents that cover our activities are issued

to other companies, there can be no assurance that we would be able to obtain licenses to these patents at a reasonable cost or be able

to develop or obtain alternative technology.

If we do not obtain such licenses, we could encounter delays in the introduction of products,

or could find that the development, manufacture or sale of products requiring such licenses could be prohibited.

In addition, we could

incur substantial costs in defending ourselves in suits brought against us on patents it might infringe or in filing suits against others

to have such patents declared invalid.

Much of our know-how and technology

We depend on obtaining certain patents and protecting our proprietary

Our success depends in part on our ability to obtain

and maintain patents, protect trade secrets, and operate without infringing the proprietary rights of others.

We have filed and are actively

pursuing patent applications for our product candidates, but the patent positions of biotechnology, biopharmaceutical, and pharmaceutical

companies are inherently uncertain and involve complex legal and factual questions.

There can be no assurance that any patent application

will result in the issuance of a patent, that patents issued to us will provide a competitive advantage, that patents issued to others

will not impede our business, or that third parties will not circumvent any patents we obtain.

Others may independently develop similar

products or duplicate products not under patent protection, or design around our patents.

We may need to obtain licenses from third parties

to avoid infringing their patents or proprietary rights.

There can be no assurance that such licenses would be available on acceptable

terms, or at all.

Failure to obtain necessary licenses could delay or prevent the development, manufacture, or commercialization of our

product candidates.

A number of companies, academic institutions, and

research organizations have filed patents or developed technologies that may relate to or affect our business.

Conflicts with these existing

or future patents could limit the scope of patents we may obtain or result in the denial of our patent applications.

If we cannot obtain

required licenses or develop alternative technologies, product development or commercialization may be delayed or prohibited.

incur substantial costs defending against patent infringement claims or in challenging the validity of patents held by others.

Much of our proprietary know-how and technology

may not be patentable.

To protect our rights, we plan to require employees, consultants, advisors and collaborators to enter into confidentiality

There can be no assurance, however, that these agreements will provide meaningful protection for our trade secrets, know-how

or other proprietary information in the event of any unauthorized use or disclosure.

Further, our business may be adversely affected by

competitors who independently develop competing technologies, especially if we obtain no, or only narrow, patent protection.

If we fail to protect our intellectual property

rights, our ability to pursue the development of our technologies and products would be negatively affected.

Our success will depend, in

part, on our ability to obtain patents and maintain adequate protection of our technologies and products.

If we do not adequately protect

our intellectual property, competitors may be able to use our technologies to produce and market drugs in direct competition with us and

erode our competitive advantage.

Some foreign countries lack rules and methods for defending intellectual property rights and do not protect

proprietary rights to the same extent as the United States.

Many companies have had difficulty protecting their proprietary rights in

these foreign countries.

We may not be able to prevent misappropriation of our proprietary rights.

We have received, and are

currently seeking, patent protection for numerous compounds and methods of treating diseases.

However, the patent process is subject to

numerous risks and uncertainties, and there can be no assurance that we will be successful in protecting our products by obtaining and

defending patents.

These risks and uncertainties include the following:

patents that may be issued or licensed may be challenged, invalidated,

or circumvented, or otherwise may not provide any competitive advantage;

our competitors, many of which have substantially greater resources

than us and many of which have made significant investments in competing technologies, may seek, or may already have obtained, patents

that will limit, interfere with, or eliminate our ability to make, use, and sell our potential products either in the United States or

in international markets;

there may be significant pressure on the United States government and other international governmental bodies

to limit the scope of patent protection both inside and outside the United States for treatments that prove successful as a matter of

public policy regarding worldwide health concerns;

countries other than the United States may have less restrictive patent laws than those

upheld by United States courts, allowing foreign competitors the ability to exploit these laws to create, develop, and market competing

Moreover, any patents issued

to us may not provide us with meaningful protection, or others may challenge, circumvent or narrow our patents.

Third parties may also

independently develop products similar to our products, duplicate our unpatented products or design around any patents on products we

Additionally, extensive time is required for development, testing and regulatory review of a potential product.

While extensions

of patent term due to regulatory delays may be available, it is possible that, before any of our product candidates can be commercialized,

any related patent, even with an extension, may expire or remain in force for only a short period following commercialization, thereby

reducing any advantages of the patent.

In addition, the United States

Patent and Trademark Office (the “USPTO”) and patent offices in other jurisdictions have often required that patent applications

concerning pharmaceutical and/or biotechnology-related inventions be limited or narrowed substantially to cover only the specific innovations

exemplified in the patent application, thereby limiting the scope of protection against competitive challenges.

Thus, even if we or our

licensors are able to obtain patents, the patents may be substantially narrower than anticipated.

Our success depends on patent

applications that are licensed exclusively to us and other patents to which we may obtain assignment or licenses.

We may not be aware,

however, of all patents, published applications or published literature that may affect our business either by blocking our ability to

commercialize our product candidates, by preventing the patentability of our product candidates to us or our licensors, or by covering

the same or similar technologies that may invalidate our patents, limit the scope of our future patent claims or adversely affect our

ability to market our product candidates.

In addition to patents, we

rely on a combination of trade secrets, confidentiality, nondisclosure and other contractual provisions, and security measures to protect

our confidential and proprietary information.

These measures may not adequately protect our trade secrets or other proprietary information.

If they do not adequately protect our rights, third parties could use our technology, and we could lose any competitive advantage we may

In addition, others may independently develop similar proprietary information or techniques or otherwise gain access to our trade

secrets, which could impair any competitive advantage we may have.

Patent protection and other

intellectual property protection is crucial to the success of our business and prospects, and there is a substantial risk that such protections

will prove inadequate.

By working with research collaborators

patent rights may be jointly owned by different parties.

of our licensors may have relied on third-party consultants or collaborators such that our licensors are not the sole and exclusive owners

of the patents we in-licensed.

If other third parties have ownership rights to our in-licensed patents, the license granted to us for

such jointly owned patents may not be valid.

Absent an agreement, each joint owner can independently sell, license, or otherwise exploit

the jointly owned patent without the approval of the other joint owner(s) and without having to account to each other for their revenues.

Without the cooperation of all joint owners, none can grant an exclusive license to a third party.

Further, a jointly owned patent cannot

be enforced unless all of the owners join in the lawsuit.

If a co-owner refuses to participate, the lawsuit cannot proceed.

our in-licensed patents from Xencor show joint ownership between Xencor and a third party.

Xencor provided representations and warrants

as to its ability to grant the rights provided in the license.

In addition, Xencor is required to indemnify us as to any breach of its

representations, warranties and covenants made in the agreement.

our rights to current or future in-licensed patents and patent applications may be dependent, in part, on inter-institutional or other

operating agreements between the joint owners of such in-licensed patents and patent applications.

If one or more of such joint owners

breaches such inter-institutional or operating agreements, our rights to such in-licensed patents and patent applications may be adversely

Any of these events could have a material adverse effect on our competitive position, business, financial conditions, results

of operations, and prospects.

Intellectual property discovered through

government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements

and a preference for U.S.-based companies.

Compliance with such regulations may limit our exclusive rights and limit our ability to contract

with non-U.S.

manufacturers.

in-licensed patents (i.e.

those from the University of Pittsburgh) were supported through the use of U.S.

government funding.

to the Bayh-Dole Act of 1980, the U.S.

government has certain rights in inventions developed with government funding.

rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.

government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive

licenses to any of these inventions to a third party if it determines that:

(1) adequate steps have not been taken to commercialize the

(2) government action is necessary to meet public health or safety needs;

or (3) government action is necessary to meet requirements

for public use under federal regulations (also referred to as march-in rights).

government exercised its march-in rights in

our current or future intellectual property rights that are generated through the use of U.S.

government funding or grants, we could be

forced to license or sublicense intellectual property developed by us or that we license on terms unfavorable to us, and there can be

no assurance that we would receive compensation from the U.S.

government for the exercise of such rights.

government also has

the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to file

an application to register the intellectual property within specified time limits.

Intellectual property generated under a government

funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources.

In addition, the U.S.

government requires that any products embodying any of these inventions or produced through the use of any of these

inventions be manufactured substantially in the United States.

This preference for U.S.

industry may be waived by the federal agency that

provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been

made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States

or that under the circumstances domestic manufacture is not commercially feasible.

This preference for U.S.

industry may limit our ability

to contract with non-U.S.

product manufacturers for products covered by such intellectual property.

To protect our rights, we require employees, consultants, advisors, and collaborators to enter into confidentiality

and nondisclosure agreements.

However, these agreements may not provide meaningful protection in the event of unauthorized use or disclosure.

Competitors may independently develop competing technologies, particularly if patent protection is narrow or unavailable, which could

erode our competitive advantage and harm our business prospects.

If we fail to protect our intellectual property rights, our ability

to pursue the development of our technologies and products would be negatively affected.

Our success depends in part on our ability to obtain

and maintain adequate protection of our technologies and products.

If we fail to adequately protect our intellectual property, competitors

may be able to use our technologies to develop and market products that compete directly with us, eroding our competitive advantage.

foreign countries lack robust rules or enforcement mechanisms for intellectual property, which may make it difficult to protect our proprietary

rights internationally.

We have received, and are seeking, patent protection

for numerous compounds and methods of treating diseases.

However, the patent process involves substantial risks and uncertainties.

that are issued or licensed may be challenged, invalidated, circumvented, or otherwise fail to provide a meaningful competitive advantage.

Competitors—many with greater resources—may obtain patents that limit or block our ability to make, use, or sell our products,

both domestically and abroad.

Additionally, governments may impose limits on patent scope for successful treatments as a matter of public

Even if patents are granted, they may be narrower

than expected due to limitations imposed by the United States Patent and Trademark Office or foreign patent offices.

Third parties may

independently develop similar products, duplicate unpatented aspects of our technologies, or design around our patents.

Regulatory delays

may shorten the effective period of patent protection, reducing any competitive advantage.

Furthermore, we may not be aware of all existing

patents, published applications, or literature that could prevent the patentability of our products or limit the scope of our patent claims.

Beyond patents, we rely on trade secrets, confidentiality

agreements, nondisclosure provisions, and other contractual and security measures to protect proprietary information.

These measures may

not fully prevent unauthorized use of our technology or disclosure of our proprietary information.

Others may independently develop similar

technologies or gain access to our trade secrets, which could diminish our competitive advantage.

There can be no assurance that our patents, licenses,

or other intellectual property protections will provide meaningful protection, and failure to adequately protect our intellectual property

could materially harm our business, prospects, and competitive position.

with research collaborators patent rights may be jointly owned by different parties .

Some of our in-licensed patents may be jointly

owned by multiple parties, including licensors, collaborators, or third-party consultants.

If a third party holds ownership rights in

patents we have licensed, the validity of our license could be uncertain.

Absent an agreement among all joint owners, each owner may independently

sell, license, or exploit the patent without the consent of the others, and without accounting for revenues.

Moreover, an enforcement

action cannot proceed unless all joint owners participate in the lawsuit.

Certain patents we license from Xencor, Inc.

jointly owned with third parties.

Xencor has provided representations and warranties regarding its rights to grant licenses and is required

to indemnify us against breaches of these representations, warranties, and covenants.

Our rights to current and future in-licensed patents

may also depend on inter-institutional or operating agreements among joint owners.

If any joint owner breaches such agreements, our rights

to these patents and patent applications could be adversely affected.

Any of these events could materially harm our competitive position,

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

Risks related to government-funded intellectual property.

Some of our in-licensed patents, including certain

rights from the University of Pittsburgh, were developed with U.S.

government funding and are therefore subject to federal regulations

under the Bayh-Dole Act of 1980.

These regulations grant the U.S.

government certain rights, including a non-exclusive, irrevocable license

to use the inventions for governmental purposes, and the ability, under specific circumstances, to require us to grant licenses to third

parties (referred to as “march-in rights”) if:

Adequate steps have not been taken to commercialize the invention;

Government action is necessary to address public health or safety

Government action is necessary to meet public use requirements

under federal regulations.

government may also take title to inventions

if disclosure or patent filing requirements are not met.

If the government exercised its march-in rights, we could be required to license

or sublicense such intellectual property on terms unfavorable to us, without assurance of compensation.

Additionally, government-funded inventions are

generally required to be manufactured substantially in the United States.

While waivers are possible under limited circumstances, this

manufacturing preference” could limit our ability to contract with non-U.S.

manufacturers for products covered by these

Compliance with these regulations may also require substantial administrative effort and resources.

We license our patents from others.

owners do not properly maintain or enforce the intellectual property underlying such licenses, our competitive position and business prospects

could be harmed.

If such owners do not properly

maintain or enforce the intellectual property underlying such licenses, our competitive position and business prospects could be harmed.

Our licensors may also seek to terminate our license.

We are a party to a number of licenses that give us rights to third-party

We rely on licenses from third parties for certain

intellectual property that is necessary or useful to our business.

To this end, we are dependent on our licenses with Xencor, Inc., Immune

Ventures, LLC, the University of Pittsburgh and GOSH.

Our success will depend in part on the ability of our licensors to obtain, maintain

and enforce our licensed intellectual property.

Our licensors may not successfully prosecute any applications for or maintain intellectual

property to which we have licenses, may determine not to pursue litigation against other companies that are infringing such intellectual

property, or may pursue such litigation less aggressively than we would.

Without protection for the intellectual property we license,

other companies might be able to offer similar products for sale, which could adversely affect our competitive business position and harm

our business prospects.

If we lose any of our right to use third-party intellectual property, it could adversely affect our ability to

commercialize our technologies, products or services, as well as harm our competitive business position and our business prospects.

Our licensors include Xencor, Inc., Immune Ventures, LLC, the University

of Pittsburgh, and GOSH.

Our business depends, in part, on the ability of

these licensors to obtain, maintain, and enforce the intellectual property underlying our licenses.

If a licensor fails to adequately

prosecute, maintain, or enforce its intellectual property, or decides not to pursue litigation against infringers—or does so less

aggressively than we would—our competitive position could be harmed.

Additionally, if any licensor terminates a license

or otherwise limits our rights, we could lose the ability to use important technologies or products, which could adversely affect our

commercialization efforts, competitiveness, and overall business prospects.

We are dependent on our licensing agreement

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it, which would harm our business.

Our officers and Chairman of the Board own

the company that we license our INKmune patent from.

On October 29, 2015, we entered

into an exclusive license agreement with Immune Ventures, LLC (Immune Ventures).

The license agreement relates to our natural killer program,

Immune Ventures is owned by our RJ Tesi, our CEO and Chairman of the Board of Directors, David Moss, our Chief Financial Officer

and Treasurer and Mark Lowdell, our Chief Scientific Officer.

Because our officers and directors also own Immune Ventures there may be

an inherent conflict of interest which could result in unanticipated actions that adversely affect us.

Changes in U.S.

patent law could diminish

the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other

biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.

Obtaining and enforcing

patents in the biopharmaceutical industry involves both technological and legal complexity and is costly, time-consuming and inherently

For example, on September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law.

The Leahy-Smith

Act included a number of significant changes to U.S.

patent law, including provisions that affect the way patent applications will be

prosecuted and that may also affect patent litigation.

In particular, under the Leahy-Smith Act, the United States transitioned in March

2013 to a “first to file” system in which the first inventor to file a patent application is typically entitled to the patent.

Third parties are allowed to submit prior art before the issuance of a patent by the USPTO, and may become involved in post-grant proceedings,

including opposition, derivation, reexamination, inter partes review or interference proceedings challenging our patent rights or the

patent rights of others.

An adverse determination in any such submission, proceeding or litigation could reduce the scope or enforceability

of, or invalidate, our patent rights, which could adversely affect our competitive position.

In addition, the U.S.

Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances

or weakening the rights of patent owners in certain situations.

In addition to increasing uncertainty with regard to our ability to obtain

patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.

on decisions by the U.S.

Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable

ways that would weaken our ability to obtain new patents or to enforce patents that we might obtain in the future.

Similarly, changes in patent

law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the

relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents

that we have licensed or that we may obtain in the future.

For example, the complexity and uncertainty of European patent laws have also

increased in recent years.

In Europe, in June 2023, a new unitary patent system was introduced, which will significantly impact European

patents, including those granted before the introduction of the system.

Under the unitary patent system, after a European patent is granted,

the patent proprietor can request unitary effect, thereby getting a European patent with unitary Effect, or a Unitary Patent.

Patent is subject to the jurisdiction of the Unitary Patent Court, or the UPC.

As the UPC is a new court system, there is no precedent

for the court, increasing the uncertainty of any litigation.

Patents granted before the implementation of the UPC will have the option

of opting out of the jurisdiction of the UPC and remaining as national patents in the UPC countries.

Patents that remain under the jurisdiction

of the UPC may be potentially vulnerable to a single UPC-based revocation challenge that, if successful, could invalidate the patent in

all countries who are signatories to the UPC.

We cannot predict with certainty the long-term effects of the new unitary patent system.

Potential conflict of interest with our INKmune license.

On October 29, 2015, we entered into an exclusive

license agreement with Immune Ventures, LLC (“Immune Ventures”) for our natural killer cell program, INKmune.

Immune Ventures

is owned by our Chief Executive Officer and Treasurer, David Moss, our Chief Scientific Officer, Mark Lowdell, and our former CEO and

former Chairman of the Board, RJ Tesi.

Because our officers and former officers also own

Immune Ventures, this relationship creates a potential conflict of interest.

Such a conflict could result in decisions or actions that

are not fully aligned with the interests of our company or stockholders and could adversely affect us.

Changes in patent laws could diminish the value of our intellectual

property and impair our ability to protect our products.

Our success depends heavily on intellectual property,

particularly patents.

Obtaining and enforcing patents in the biopharmaceutical industry is costly, complex, time-consuming, and uncertain.

In the U.S., the Leahy-Smith America Invents Act

(2011) transitioned the U.S.

to a “first-to-file” system, allowing third parties to submit prior art and participate in post-grant

proceedings, including oppositions, inter partes reviews, and reexaminations.

Adverse outcomes in any such proceedings could reduce the

scope, enforceability, or validity of our patents.

Additionally, U.S.

Supreme Court decisions in recent years have narrowed patent protections

or weakened patent owner rights, creating further uncertainty regarding the value and enforceability of patents.

Changes in patent laws or enforcement in other

countries could similarly weaken our patent protection.

In Europe, the unitary patent system introduced in June 2023 allows patent holders

to obtain a single European patent with unitary effect under the Unitary Patent Court (UPC).

As the UPC is a new court system with no

established precedent, patents under its jurisdiction could be challenged and potentially invalidated across multiple countries.

can opt out to remain national patents, but the long-term effects of the new system remain uncertain.

Any of these changes could impair our ability to

obtain, maintain, or enforce patents, reduce the value of our intellectual property, and adversely affect our competitive position.

Risks Related to our Common Stock

We do not intend to pay dividends for the

foreseeable future.

We have paid no dividends

on our common stock to date, and we do not anticipate paying any dividends to holders of our common stock in the foreseeable future.

our future dividend policy will be based on the operating results and capital needs of the business, we anticipate that we will retain

any earnings to finance our future expansion and for the implementation of our business plan.

As an investor, you should take note of

the fact that a lack of a dividend can further affect the market value of our common stock and could significantly affect the value of

any investment in our Company.

We are subject to the reporting requirements

of federal securities laws, which can be expensive and may divert resources from other projects, thus impairing our ability grow.

We are a public reporting

company and, accordingly, subject to the information and reporting requirements of the Exchange Act and other federal securities laws,

including compliance with the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”).

The costs of preparing and filing annual

and quarterly reports, proxy statements and other information with the SEC and furnishing audited reports to stockholders would cause

our expenses to be higher than they would be if we remained privately held.

It may be time consuming,

difficult and costly for us to develop and implement the internal controls and reporting procedures required by the Sarbanes-Oxley Act.

We may need to hire additional financial reporting, internal controls and other finance personnel in order to develop and implement appropriate

internal controls and reporting procedures.

We may fail to qualify

for continued listing on The NASDAQ Capital Market which could make it more difficult for investors to sell their shares.

Our common stock is listed

on The NASDAQ Global Market (“NASDAQ”).

As a NASDAQ listed company, we are required to satisfy the continued listing requirements

of NASDAQ for inclusion in the Capital Market to maintain such listing, including, among other things, the maintenance of a minimum closing

bid price of $1.00 per share and stockholders’ equity of at least $2.5 million.

There can be no assurance that we will be able to maintain

compliance with the continued listing requirements or that o ur

common stock will not be delisted from NASDAQ in the future.

If our common stock is delisted by NASDAQ, we could face significant material

adverse consequences, including:

limited availability of market quotations for our securities;

liquidity with respect to our securities;

determination that our shares are a “penny stock,” which will require brokers trading in our shares to adhere to more stringent

rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares;

limited amount of news and analyst coverage for our company;

decreased ability to issue additional securities or obtain additional financing in the future.

do not intend to pay dividends in the foreseeable future.

We have not paid dividends on our common stock

to date and do not expect to do so in the foreseeable future.

Any future dividend decisions will depend on our operating results, financial

condition, and capital requirements.

We currently intend to retain any earnings to fund business growth and implement our strategic plan.

As a result, investors should be aware that the absence of dividends may affect the market value of our common stock and the overall return

on any investment in the Company.

Compliance with federal securities laws and reporting requirements

is costly and may divert resources from growth initiatives.

As a public company, we are subject to the reporting

and disclosure obligations of the Securities Exchange Act of 1934 (the “Exchange Act”) and other federal securities laws,

including the Sarbanes-Oxley Act of 2002.

Preparing and filing annual and quarterly reports, proxy statements, and other required disclosures

with the SEC, as well as providing audited financial statements to stockholders, increases our operating expenses compared to private

Developing, implementing, and maintaining the internal

controls and reporting procedures required under the Sarbanes-Oxley Act may be time-consuming, complex, and costly.

We may also need to

hire additional personnel with expertise in financial reporting and internal controls to ensure compliance, which could further divert

resources from other growth initiatives.

Our stock price may be volatile.

16 unchanged sentences

In addition, the securities

markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance of

particular companies.

markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance

of particular companies.

These market fluctuations may also materially and adversely affect the market price of our Common Stock.

You may have difficulty trading and obtaining

quotations for our common stock.

Our securities are not actively

traded, and the bid and asked prices for our common stock may fluctuate widely.

As a result, investors may find it difficult to dispose

of, or to obtain accurate quotations of the price of, our securities.

This severely limits the liquidity of the common stock and would

likely reduce the market price of our common stock and hamper our ability to raise additional capital.

There is a limited market for our

Accordingly, investors may therefore bear the economic risk of an investment in our securities for an indefinite period of

Additional stock offerings in the future

may dilute your percentage ownership of our company.

Given our plans and expectations

that we may need additional capital and personnel, we may need to issue additional shares of common stock or securities convertible or

exercisable for shares of common stock, including convertible preferred stock, convertible notes, stock options or warrants.

of additional securities in the future will dilute the percentage ownership of then current stockholders.

Our internal control over financial reporting may not

meet the standards required by Section 404 of the Sarbanes-Oxley Act, and failure to achieve and maintain effective internal control

over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act, could have a material adverse effect on our business

and share price.

Our management is currently required to report on the effectiveness of our internal control over financial

However, as a smaller reporting company and a non-accelerated filer, our independent registered public accounting firm will

not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 for as long as

we are not deemed an “accelerated filer” or “large accelerated filer.” The rules governing the standards that

must be met for our management to assess our internal control over financial reporting are complex and require significant documentation,

testing and possible remediation.

In connection with

the implementation of the necessary procedures and practices related to internal control over financial reporting, we may identify deficiencies

or material weaknesses that we may not be able to remediate in time to meet the deadline imposed by the Sarbanes-Oxley Act for compliance

with the requirements of Section 404.

In addition, we may encounter problems or delays in completing the implementation of any requested

improvements and receiving a favorable attestation in connection with the attestation provided by our independent registered public accounting

Failure to achieve and maintain an effective internal control environment could have a material adverse effect on our business,

financial condition and results of operations and could limit our ability to report our financial results accurately and in a timely manner.

Anti-takeover provisions in our stockholder

rights plan could make a third-party acquisition of us difficult.

We have a stockholder rights

plan that may have the effect of discouraging unsolicited takeover proposals.

Specifically, the rights issued under the stockholder rights

plan could cause significant dilution to a person or group that attempts to acquire us on terms not approved in advance by our board of

The rights plan is not intended to prevent a takeover, and we believe it will enable all our stockholders to realize the full

potential value of their investment in the Company and protect the Company and its stockholders from efforts to obtain control of the

Company that are inconsistent with the best interests of the Company and its stockholders.

The rights under the plan will expire on December

30, 2025, subject to a possible earlier expiration to the extent provided in the stockholder rights plan, unless extended.

Sales of our common

shares by our employees, including our executive officers, could cause the trading price of our common shares to fall or prevent it from

increasing for numerous reasons, and sales by such persons could be viewed negatively by other investors.

In accordance with the guidelines

specified under Rule 10b5-1 under the Exchange Act, as amended, equivalent legislation in applicable jurisdictions, and our policies regarding

equity transactions, a number of our employees, including executive officers, may adopt share trading plans pursuant to which they have

arranged to sell common shares from time to time in the future.

Generally, sales of common shares, including sales under such plans, by

our executive officers and directors require public filings.

Sales of our common shares by such persons could cause the price of our common

shares to fall or prevent it from increasing.

If sales by employees, executive officers, or directors cause a substantial number of our

common shares to become available for purchase in the public market, the price of our common shares could fall or may not increase.

sales by such personnel could be viewed negatively by holders and potential purchasers of our common shares.

You may have difficulty trading and obtaining quotations for

our common stock.

Our securities are not actively traded, and the

bid and asked prices for our common stock may fluctuate significantly.

As a result, investors may experience difficulty selling their

shares or obtaining accurate quotations for the price of our securities.

This limited trading activity reduces liquidity, may adversely

affect the market price of our common stock, and could hamper our ability to raise additional capital.

Given the limited market for our

securities, investors may bear the economic risk of an investment in our shares for an indefinite period of time.

Additional stock offerings in the future may dilute your ownership

interest in our company.

To support our growth plans and capital requirements,

we may need to issue additional shares of common stock or securities convertible or exercisable for common stock, including convertible

preferred stock, convertible notes, stock options, or warrants.

Any future issuance of such securities would dilute the ownership percentage

of current stockholders.

Our internal control over financial reporting may not meet the

standards required by Section 404 of the Sarbanes-Oxley Act, and failure to achieve or maintain effective internal controls could adversely

affect our business and stock price.

Management is required to assess and report on

the effectiveness of our internal control over financial reporting.

As a smaller reporting company and a non-accelerated filer, our independent

registered public accounting firm is not required to attest to the effectiveness of our internal controls under Section 404 for as long

as we do not qualify as an “accelerated filer” or “large accelerated filer.” The standards for assessing internal

controls are complex and require substantial documentation, testing, and, if necessary, remediation.

In implementing the necessary procedures, we may

identify deficiencies or material weaknesses that we cannot remediate in time to meet Section 404 deadlines.

We may also face delays in

completing improvements or obtaining a favorable attestation from our independent registered public accounting firm.

Failure to establish

and maintain effective internal controls could materially harm our business, financial condition, and results of operations, and could

impair our ability to report financial results accurately and on a timely basis.

Anti-takeover provisions in our stockholder rights plan could

make a third-party acquisition more difficult.

We have a stockholder rights plan designed to discourage

unsolicited takeover proposals.

The rights issued under this plan could result in significant dilution to any person or group attempting

to acquire the Company on terms not pre-approved by our board of directors.

The plan is not intended to prevent a takeover

We believe it helps stockholders realize the full potential value of their investment and protects the Company and its stockholders

from attempts to gain control in ways inconsistent with their best interests.

The rights under the plan are set to expire on

December 30, 2026, unless extended or otherwise modified as permitted under the terms of the plan.

Sales of our common stock by employees,

including executive officers, could cause the trading price of our common stock to decline and may be viewed negatively by investors.

Some of our employees, including executive officers, may adopt trading

plans under Rule 10b5-1 of the Exchange Act, equivalent laws in other jurisdictions, or our internal equity policies, allowing them to

sell common stock at predetermined times.

Sales of common stock, including under these plans, generally require public filings.

Such sales could increase the number of shares available in the public

market, which may cause the trading price of our common stock to decline or prevent it from rising.

In addition, sales by employees, executive

officers, or directors could be perceived negatively by existing or potential investors, potentially affecting the market price of our

common stock.

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