What changed in this filing

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Item 1A. Risk Factors

2025-06-26 compared with 2024-06-27 · 813 added, 680 removed, 974 unchanged (61% of the section changed)

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price or value of our securities could be materially adversely affected and you may lose all or part of your investment.

Risks Relating to Our Financial Position and Need for Additional Capital

We have incurred significant losses and expect to continue to incur

losses for the foreseeable future.

never been profitable.

We have generated revenues during the fiscal years ended March 31, 2024 and March 31, 2023 in the amounts of $0

and $574,245, respectively, primarily from our contract with the NIH, which ended in September 2022.

We do not currently have any research

grants or contracts.

It is possible that we may not be able to enter into future government contracts.

Future profitability, if any, will

require the successful commercialization of our Hemopurifier technology or any other product that we develop or from additional government

contract or grant income we may obtain.

We may not be able to successfully commercialize the Hemopurifier or any other products, and even

if commercialization is successful, we may never be profitable.

While we currently have over $9.1 million in cash and cash equivalents

and have been carrying out certain expense reductions since November 2023, our planned additional expense reductions may not materialize

and/or our patient recruitment may occur more rapidly than expected along with the concomitant increases in expenses;

therefore there

is substantial doubt that our cash on hand will carry the company for 12 months beyond the filing date of the financial statements included

in this Annual Report.

Risks Relating to Our Financial Position and Need for Additional

We have incurred significant losses and expect to continue to

incur losses for the foreseeable future.

We have never been profitable.

We did not generate any revenue during the fiscal years ended March 31, 2025 and March 31, 2024.

In prior fiscal years we did record revenue

from government contracts.

We do not currently have any research grants or contracts.

It is possible that we may not be able to enter

into future government contracts.

Future profitability, if any, will require the successful commercialization of our Hemopurifier technology

or any other product that we develop or from additional government contract or grant income we may obtain.

We may not be able to successfully

commercialize the Hemopurifier or any other products, and even if commercialization is successful, we may never be profitable.

currently have over $5.5 million in cash and cash equivalents and have been carrying out certain expense reductions since November 2023,

our planned additional expense reductions may not materialize and/or our patient recruitment may occur more rapidly than expected along

with the concomitant increases in expenses;

therefore there is substantial doubt that our cash on hand will carry the company for 12 months

beyond the filing date of the financial statements included in this Annual Report.

We do plan to access the equity

markets for additional capital, however, there can be no assurance that we will be able to access such additional capital.

We will require additional financing to sustain our operations, achieve

our business objectives and satisfy our cash obligations, which may dilute the ownership of our existing stockholders.

We will require significant additional

financing for our operations and for expected additional future clinical trials in the United States, India and Australia, regulatory

clearances, and continued research and development activities for the Hemopurifier and other future products.

In addition, as we expand

our activities, our overhead costs to support personnel, laboratory materials and infrastructure will increase.

We may also choose to

raise additional funds in debt or equity financings if they are available to us on reasonable terms to increase our working capital and

to strengthen our financial position.

Any sale of additional equity or convertible debt securities could result in dilution of the equity

interests of our existing stockholders.

Additionally, new investors may require that we and certain of our stockholders enter into voting

arrangements that give them additional voting control or representation on our Board of Directors.

If required financing is unavailable

to us on reasonable terms, or at all, we may be unable to support our operations, including our research and development activities, which

would have a material adverse effect on our ability to commercialize our products or continue our business.

We will require additional financing to

sustain our operations, achieve our business objectives and satisfy our cash obligations, which may dilute the ownership of our existing

stockholders.

We will require significant

additional financing for our operations and for expected additional future clinical trials in the United States, India and Australia,

regulatory clearances, and continued research and development activities for the Hemopurifier and other future products.

as we expand our activities, our overhead costs to support personnel, laboratory materials and infrastructure will increase.

choose to raise additional funds in debt or equity financings if they are available to us on reasonable terms to increase our working

capital and to strengthen our financial position.

Any sale of additional equity or convertible debt securities could result in dilution

of the equity interests of our existing stockholders.

Additionally, new investors may require that we and certain of our stockholders

enter into voting arrangements that give them additional voting control or representation on our Board of Directors.

If required financing

is unavailable to us on reasonable terms, or at all, we may be unable to support our operations, including our research and development

activities, which would have a material adverse effect on our ability to commercialize our products or continue our business.

Our ability to raise additional

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expenses and cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.

We may not currently

or in the future be able to continue as a going concern.

financial statements in this Annual Report have been prepared on a going concern basis of accounting, which assumes that we will continue

as a going concern, and do not reflect any adjustments that might result if the Company is unable to continue as a going concern.

Company’s ability to continue as a going concern is dependent on our ability to generate revenues and raise capital.

have not generated sufficient revenues to provide cash flows that enable us to finance our operations internally.

In connection with an

evaluation conducted by our management during the preparation of the financial statements included in this Annual Report, management concluded

that there were conditions and events which raised substantial doubt as to the Company’s ability to continue as a going concern

within twelve months after the date of the issuance of the financial statements included in this Annual Report.

uncertainty regarding our ability to continue as a going concern could materially adversely affect our share price and our ability to

service our indebtedness, raise new capital or enter into commercial transactions.

To address these matters, we may take actions that

materially and adversely affect our business, including significant reductions in research, development, administrative and commercial

activities, reduction of our employee base, and ultimately curtailing or ceasing operations, any of which could materially adversely affect

our business, financial condition, results of operations and share price.

In addition, doubts about our ability to continue as a going

concern could impact our relationships with partners, vendors and other third parties and our ability to obtain, maintain or renew contracts

with them, or negatively impact our negotiating leverage with such parties, which could have a material adverse effect on our business,

financial condition and results of operations.

Furthermore, any loss of key personnel, employee attrition or material erosion of employee

morale arising out of doubts about our ability to operate as a going concern could have a material adverse effect on our ability to effectively

conduct our business and could impair our ability to execute our strategy and implement our business objectives, thereby having a material

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

Risks Related to Our Business Operations

Delays, interruptions or the cessation of production

by our third-party suppliers of important materials or delays in qualifying new materials, has and may continue to prevent or delay our

ability to manufacture our Hemopurifier.

Most of the raw materials used

in the process for manufacturing our Hemopurifier are available from more than one supplier.

However, there are materials within the manufacturing

and production process that come from single suppliers.

We do not have written contracts with all of our single source suppliers, and

at any time they could stop supplying our orders.

FDA review of a new supplier is required if these materials become unavailable from

our current suppliers.

In the recent past, we experienced an interruption in the manufacturing of our Hemopurifier as we sought to transition

to a new supplier of galanthus nivalis agglutinin, or GNA, used in the manufacture of our Hemopurifier.

We have not received the required

FDA approval of our IDE supplement for a new qualified supplier of the GNA and are working with the FDA to gain approval of this supplier.

Although we have resumed purchasing GNA from our prior supplier, it is possible that we could experience future disruptions from this

supplier as we work to qualify a second supplier.

FDA review of the new second supplier could take several additional months to obtain.

In addition, an uncorrected impurity,

a supplier’s variation in a raw material or testing, either unknown to us or incompatible with its manufacturing process, or any

other problem with our materials, testing or components, would prevent or delay the release of our Hemopurifiers for use in our clinical

For example, in late 2020, we identified during our device quality review procedures prior to product release that one of our

critical suppliers had produced a Hemopurifier component that was not produced to our specifications, although no affected Hemopurifiers

Delays, interruptions or the cessation of

production by our third-party suppliers of important materials or delays in qualifying new materials, has and may continue to prevent

or delay our ability to manufacture our Hemopurifier.

Most of the raw materials

used in the process for manufacturing our Hemopurifier are available from more than one supplier.

However, there are materials within

the manufacturing and production process that come from single suppliers.

We do not have written contracts with all of our single source

suppliers, and at any time they could stop supplying our orders.

FDA review of a new supplier is required if these materials become unavailable

from our current suppliers.

In the recent past, we experienced an interruption in the manufacturing of our Hemopurifier as we sought to

transition to a new supplier of galanthus nivalis agglutinin, or GNA, used in the manufacture of our Hemopurifier.

We have not received

the required FDA approval of our IDE supplement for a new qualified supplier of the GNA and are working with the FDA to gain approval

of this supplier.

Although we have resumed purchasing GNA from our prior supplier, it is possible that we could experience future disruptions

from this supplier as we work to qualify a second supplier.

FDA review of the new second supplier could take several additional months

In addition, an uncorrected

impurity, a supplier’s variation in a raw material or testing, either unknown to us or incompatible with its manufacturing process,

or any other problem with our materials, testing or components, could prevent or delay the release of our Hemopurifiers for use in our

clinical trials.

For example, in late 2020, we identified during our device quality review procedures prior to product release that one

of our critical suppliers had produced a Hemopurifier component that was not produced to our specifications, although no affected Hemopurifiers

were released into our inventory or to any clinical trial sites.

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could have an adverse effect upon our expenses, our product revenues and our ability to complete our clinical trials.

We only recently received approval

from the FDA for our IDE supplement to manufacture Hemopurifiers at our site in San Diego.

We received approval from

the FDA for our IDE supplement to manufacture Hemopurifiers at our site in San Diego.

The manufacturing of our Hemopurifier is difficult

To support our current clinical trial needs, we comply with and intend to continue to comply with cGMP in the manufacture

of our product.

Our ability to adequately manufacture and supply our Hemopurifier in a timely matter is dependent on the uninterrupted

and efficient operation of our facilities and those of third parties producing raw materials and supplies upon which we rely in our manufacturing.

To support our current clinical trial needs, we comply with and intend to continue to comply with current Food Manufacturing

Practices, or cGMP in the manufacture of our product.

Our ability to adequately manufacture and supply our Hemopurifier in a timely matter

is dependent on the uninterrupted and efficient operation of our facilities and those of third parties producing raw materials and supplies

upon which we rely in our manufacturing.

The manufacture of our products may also be impacted by:

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global viruses and pandemics.

Any future interruption in the

manufacture and supply of our Hemopurifier could delay shipments of our Hemopurifier for use in clinical trials in the United States,

Any future interruption in

the manufacture and supply of our Hemopurifier could delay shipments of our Hemopurifier for use in clinical trials in the United States,

Australia and India.

Our products are manufactured

with raw materials that are sourced from specialty suppliers with limited competitors and we may therefore be unable to access the materials

we need to manufacture our products.

Our products are

manufactured with raw materials that are sourced from specialty suppliers with limited competitors and we may therefore be unable to access

the materials we need to manufacture our products.

Specifically, the Hemopurifier

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however, Sigma Aldrich

is our only back up supplier at this time and we are in the process of working with the FDA to obtain regulatory approval for this supplier.

A business interruption at any of these sources, including the interruption resulting from the delay in obtaining FDA approval of our

new GNA supplier, has and may continue to have a material impact on our ability to manufacture the Hemopurifier.

is our only potential back up supplier at this time and we are in the process of working with the FDA to obtain regulatory approval for

this supplier.

A business interruption at any of these sources, including the interruption resulting from the delay in obtaining FDA approval

of our new GNA supplier, has and may continue to have a material impact on our ability to manufacture the Hemopurifier.

We face intense competition in the medical device industry .

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are less expensive than the products or product candidates we are developing.

Even if we are successful in developing

the Hemopurifier and obtain FDA and other regulatory approvals necessary for commercialization, our products may not compete effectively

with other successful products.

Researchers are continually learning more about diseases, which may lead to new technologies for treatment.

Our competitors may succeed in developing and marketing products that are either more effective than those that we may develop, alone

or with our collaborators, or that are marketed before any products we develop are marketed.

Our competitors include fully integrated

pharmaceutical companies and biotechnology companies as well as universities and public and private research institutions.

organizations competing with us have substantially greater capital resources, larger research and development staffs and facilities, greater

experience in product development and in obtaining regulatory approvals, and greater marketing capabilities than we do.

If our competitors

develop more effective pharmaceutical treatments for infectious disease or cancer, or bring those treatments to market before we can commercialize

the Hemopurifier for such uses, we may be unable to obtain any market traction for our products, or the diseases we seek to treat may

be substantially addressed by competing treatments.

If we are unable to successfully compete against larger companies in the pharmaceutical

industry, we may never generate significant revenue or be profitable.

We have limited experience in identifying and working with large-scale

contracts with medical device manufacturers;

manufacture of our devices must comply with good manufacturing practices in the United States.

Even if we are successful

in developing the Hemopurifier and obtain FDA and other regulatory approvals necessary for commercialization, our products may not compete

effectively with other successful products.

Researchers are continually learning more about diseases, which may lead to new technologies

for treatment.

Our competitors may succeed in developing and marketing products that are either more effective than those that we may

develop, alone or with our collaborators, or that are marketed before any products we develop are marketed.

Our competitors include fully

integrated pharmaceutical companies and biotechnology companies as well as universities and public and private research institutions.

Many of the organizations competing with us have substantially greater capital resources, larger research and development staffs and facilities,

greater experience in product development and in obtaining regulatory approvals, and greater marketing capabilities than we do.

competitors develop more effective pharmaceutical treatments for infectious disease or cancer, or bring those treatments to market before

we can commercialize the Hemopurifier for such uses, we may be unable to obtain any market traction for our products, or the diseases

we seek to treat may be substantially addressed by competing treatments.

If we are unable to successfully compete against larger companies

in the pharmaceutical industry, we may never generate significant revenue or be profitable.

We have limited experience in identifying

and working with large-scale contracts with medical device manufacturers;

manufacture of our devices must comply with good manufacturing

practices in the United States.

To achieve the levels of production

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revenue from product sales and we may never be profitable.

We have in the

past experienced a material weakness in our internal controls over financial reporting.

If we fail to maintain effective internal controls

and fail to remediate any future or present control deficiencies, our ability to produce accurate and timely financial statements could

be impaired, which could harm our operating results, our ability to operate our business and our reputation with investors, ultimately

leading to a decline in the price of our Common Stock.

a public company, we are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, the Sarbanes-Oxley

Act, and the rules and regulations of the applicable listing standards of Nasdaq.

In particular, Section 404 of the Sarbanes-Oxley Act

requires that we evaluate and determine the effectiveness of our internal controls over financial reporting.

It also requires our independent

registered public accounting firm to attest to our evaluation of our internal controls over financial reporting.

disclosed in Item 9A in our Annual Report on Form 10-K for the fiscal year ended March 31, 2024, management identified a material

weakness in the segregation of duties within our financial systems.

Specifically, user access controls were not sufficiently maintained

to properly restrict both user and privileged access to financial applications within our accounting software system to initiate, record

and approve entries.

We also noted that check stock was secured in an authorized signatory’s office.

During 2017 through 2020, the

Company incorrectly recorded accrued commission liability of approximately $404,000.

The Company reversed accrued commission liability

of approximately $404,000 during the year ended March 31, 2024 related to this error in accounting under U.S.

The Company originally

failed to correctly apply appropriate accounting principles in recording the transaction, and the error was not detected and corrected

in a timely manner, resulting in an adjustment to the financial statements.

Management has discussed with counsel appropriate measures

to record such potential commission liabilities in the future and will implement a quarterly review of all accruals.

The reversal of the

accrued commission liability into equity as of March 31, 2024 corrected the impact of the error.

that time, we have implemented several remediation measures, including enhanced user access controls, segregation of duties, relocation

of check stock to a secure, access-controlled area, and the implementation of a quarterly review process for all significant accruals.

Management has also consulted with legal counsel to clarify how potential commission liabilities should be recorded in the future.

reversal of the commission accrual into equity as of March 31, 2024 corrected the impact of the historical error.

of March 31, 2025, management has concluded that the previously identified material weakness has been remediated.

While we are committed

to maintaining a robust control environment, there can be no assurance that future material weaknesses will not be identified.

we have difficulty maintaining effective internal controls over financial reporting, or if we identify a material weakness in our

internal controls over financial reporting in the future, we may not detect errors on a timely basis, such that it could harm our

operating results, adversely affect our reputation, cause our stock price to decline, or result in inaccurate financial reporting or

material misstatements in our annual or interim financial statements.

We may be unable to maintain compliance with securities laws,

stock exchange listing requirements and debt instruments’ covenants regarding the timely filing of accurate periodic reports,

which could lead to investigations by Nasdaq, the SEC or other regulatory authorities or litigations with our creditors and/or

stockholders, hence requiring additional management attention and impairing our ability to operate our business.

Our liquidity,

access to capital markets and perceptions of our creditworthiness may be adversely affected.

We could be required to implement

expensive and time-consuming remedial measures.

Our independent registered public accounting firm may issue reports that are adverse

in the event it is not satisfied with the level at which our internal control over financial reporting is documented, designed, or

operating, or if it is not satisfied with our remediation of any identified material weaknesses.

Any failure to maintain effective

disclosure controls and internal control over financial reporting could have a material adverse effect on our business, financial

position, results of operations, and cash flows.

Our Hemopurifier technology may become obsolete.

Our Hemopurifier product may be

made unmarketable prior to commercialization by us by new scientific or technological developments by others with new treatment modalities

Our Hemopurifier product may

be made unmarketable prior to commercialization by us by new scientific or technological developments by others with new treatment modalities

that are more efficacious and/or more economical than our products.

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competitive with products based on new technologies.

We are highly dependent on our key personnel, and if we are not successful

in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

Our ability to compete in the

highly competitive biotechnology and medical device industries depends upon our ability to attract and retain highly qualified managerial,

We are highly dependent on our key personnel,

and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our

business strategy.

Our ability to compete in

the highly competitive biotechnology and medical device industries depends upon our ability to attract and retain highly qualified managerial,

scientific, and medical personnel.

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prospects, financial condition or results of operations.

We do not currently carry key

man life insurance policies on any of our key executive officers which would assist us in recouping our costs in the event of the loss

of those officers.

If any of our key officers were to leave us, it could make it impossible, if not cause substantial delays and costs,

to implement our long-term business objectives and growth.

We do not currently carry

key man life insurance policies on any of our key executive officers which would assist us in recouping our costs in the event of the

loss of those officers.

If any of our key officers were to leave us, it could make it impossible, if not cause substantial delays and

costs, to implement our long-term business objectives and growth.

Our inability to attract and retain qualified

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clearance, and our business could fail.

We plan to expand our operations, which may

strain our resources;

We plan to expand our operations, which

may strain our resources;

our inability to manage our growth could delay or derail implementation of our business objectives.

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systems, procedures and controls necessary to support our anticipated increased levels of operations and to coordinate our various corporate

functions, or that we will be able to properly manage, train, motivate and retain our anticipated increased employee base.

functions, or that we may not be able to properly manage, train, motivate and retain our anticipated increased employee base.

manage our growth initiatives, including our expansion of our clinical trials in India and potentially in other countries, we will be

unable to commercialize our products on a large-scale in a timely manner, if at all, and our business could fail.

We do not have any experience in the organ transplant market and

We have limited experience in the organ transplant market and

face competition from entities more familiar with this business and our efforts may not succeed.

We are investigating whether

We have investigated whether

the Hemopurifier, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses, exosomes, RNA molecules,

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This area is new to our product development and management

personnel, and we may not be successful in the organ transplant market where we do not have any experience.

Even if we are successful

in developing our Hemopurifier for the organ transplant market, we may not be able to compete effectively or generate significant revenues

personnel, and we may not be successful in the organ transplant market where we have limited experience.

Even if we are successful in

developing our Hemopurifier for the organ transplant market, we may not be able to compete effectively or generate significant revenues

in this new area.

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It is possible that, even if we

are successful in the organ transplant field, that the market will not accept our product, or that our product will generate significant

are successful in the organ transplant field, that the market will not accept our product, or that our product will not generate significant

revenues for us.

As a public company with limited financial resources undertaking

the launch of new medical technologies, we may have difficulty attracting and retaining executive management and directors.

The directors and management of

publicly traded corporations are increasingly concerned with the extent of their personal exposure to lawsuits and stockholder claims,

As a public company with limited financial

resources undertaking the launch of new medical technologies, we may have difficulty attracting and retaining executive management and

The directors and management

of publicly traded corporations are increasingly concerned with the extent of their personal exposure to lawsuits and stockholder claims,

as well as governmental and creditor claims which may be made against them, particularly in view of recent changes in securities laws

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and foreign regulatory agencies, the commercialization of our products could be delayed or prevented entirely.

Our Hemopurifier product is subject

to extensive government regulations related to development, testing, manufacturing and commercialization in the United States and other

The determination of when and whether a product is ready for large-scale purchase and potential use will be made by the U.S.

Government through consultation with a number of governmental agencies, including the FDA, the National Institutes of Health, the CDC

and the Department of Homeland Security.

Our Hemopurifier has not received required regulatory approval from the FDA, or any foreign regulatory

agencies, to be commercially marketed and sold.

The process of obtaining and complying with FDA and other governmental regulatory approvals

and regulations in the United States and in foreign countries is costly, time consuming, uncertain and subject to unanticipated delays.

Our Hemopurifier product is

subject to extensive government regulations related to development, testing, manufacturing and commercialization in the United States

and other countries.

The determination of when and whether a product is ready for large-scale purchase and potential use will be made

Government through consultation with a number of governmental agencies, including the FDA, the National Institutes of Health,

the CDC and the Department of Homeland Security.

Our Hemopurifier has not received required regulatory approval from the FDA, or any foreign

regulatory agencies, to be commercially marketed and sold.

The process of obtaining and complying with FDA and other governmental regulatory

approvals and regulations in the United States and in foreign countries is costly, time consuming, uncertain and subject to unanticipated

Obtaining such regulatory approvals, if any, can take several years.

Despite the time and expense exerted, regulatory approval is never

Despite the time and expense exerted, regulatory approval

is never guaranteed.

We also are subject to the following risks and obligations, among others:

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the FDA may change its approval policies and/or adopt new regulations.

Failure to comply with these or

other regulatory requirements of the FDA may subject us to administrative or judicially imposed sanctions, including:

Failure to comply with these

or other regulatory requirements of the FDA may subject us to administrative or judicially imposed sanctions, including:

warning letters;

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different interpretations of our pre-clinical and clinical data, which could initially lead to inconclusive results.

Our development costs will increase

if we have material delays in any clinical trial or if we need to perform more or larger clinical trials than planned.

If the delays are

significant, or if any of our product candidates do not prove to be safe or effective or do not receive required regulatory approvals,

our financial results and the commercial prospects for our product candidates will be harmed.

Furthermore, our inability to complete our

clinical trials in a timely manner could jeopardize our ability to obtain regulatory approval for our Hemopurifier or any other potential

product candidates.

If we or our suppliers fail to comply with ongoing

FDA or foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products could be

subject to restrictions or withdrawal from the market.

Our development costs will

increase if we have material delays in any clinical trial or if we need to perform more or larger clinical trials than planned.

delays are significant, or if any of our product candidates do not prove to be safe or effective or do not receive required regulatory

approvals, our financial results and the commercial prospects for our product candidates will be harmed.

Furthermore, our inability to

complete our clinical trials in a timely manner could jeopardize our ability to obtain regulatory approval for our Hemopurifier or any

other potential product candidates.

If we or our suppliers fail to comply with

ongoing FDA or foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products

could be subject to restrictions or withdrawal from the market.

Any product for which we obtain

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criminal prosecution.

Moreover, the FDA strictly regulates

the promotional claims that may be made about approved products.

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

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

However, companies may share truthful and not misleading information

that is otherwise consistent with a product’s FDA approved labeling.

The FDA and other agencies actively enforce the laws and regulations

prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to

significant civil, criminal and administrative penalties.

Any of these sanctions could have

a material adverse effect on our reputation, business, results of operations and financial condition.

Furthermore, our key component suppliers

may not currently be or may not continue to be in compliance with all applicable regulatory requirements, which could result in our failure

to produce our products on a timely basis and in the required quantities, if at all.

Moreover, the FDA strictly

regulates the promotional claims that may be made about approved products.

In particular, a product may not be promoted for uses that

are not approved by the FDA as reflected in the product’s approved labeling.

However, companies may share truthful and not misleading

information that is otherwise consistent with a product’s FDA approved labeling.

The FDA and other agencies actively enforce the

laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses

may be subject to significant civil, criminal and administrative penalties.

Any of these sanctions could

have a material adverse effect on our reputation, business, results of operations and financial condition.

Furthermore, our key component

suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements, which could result

in our failure to produce our products on a timely basis and in the required quantities, if at all.

If our products, or malfunction of our products,

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corrective actions or agency enforcement actions.

Under the FDA medical device reporting

regulations, medical device manufacturers are required to report to the FDA information that a device has or may have caused or contributed

to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction

of the device or one of our similar devices were to recur.

If we fail to report these events to the FDA within the required timeframes,

or at all, the FDA could take enforcement action against us.

Any such adverse event involving our products also could result in future

voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action.

corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time

and capital, distract management from operating our business, and may harm our reputation and financial results.

We outsource many of our operational and development

activities, and if any party to which we have outsourced certain essential functions fails to perform its obligations under agreements

with us, the development and commercialization of our Hemopurifier product candidate and any future product candidates that we may develop

could be delayed or terminated.

Under the FDA medical device

reporting regulations, medical device manufacturers are required to report to the FDA information that a device has or may have caused

or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury

if the malfunction of the device or one of our similar devices were to recur.

If we fail to report these events to the FDA within the

required timeframes, or at all, the FDA could take enforcement action against us.

Any such adverse event involving our products also could

result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement

Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication

of our time and capital, distract management from operating our business, and may harm our reputation and financial results.

We outsource many of our operational and

development activities, and if any party to which we have outsourced certain essential functions fails to perform its obligations under

agreements with us, the development and commercialization of our Hemopurifier product candidate and any future product candidates that

we may develop could be delayed or terminated.

We rely on third-party consultants

or other vendors to manage and implement much of the day-to-day conduct of our clinical trials and the manufacturing our Hemopurifier

or other vendors to manage and implement much of the day-to-day conduct of our clinical trials and the manufacturing of our Hemopurifier

product candidate.

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may harm our reputation.

If we or our manufacturers or

other third-party contractors fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to regulatory

actions, which could affect our ability to successfully develop, market and sell our Hemopurifier product candidate or any future product

candidates, if any, and could harm our reputation and lead to reduced or non-acceptance of our proposed product candidates by the market.

Even technical recommendations or evidence by the FDA through letters, site visits, and overall recommendations to academia or biotechnology

companies may make the manufacturing of a clinical product extremely labor intensive or expensive, making the product candidate no longer

viable to manufacture in a cost-efficient manner.

The mode of administration may make the product candidate not commercially viable.

required testing of the product candidate may make that candidate no longer commercially viable.

The conduct of clinical trials may be

critiqued by the FDA, or a clinical trial site’s IRB or Institutional Biosafety Committee, which may delay or make impossible clinical

testing of a product candidate.

The IRB for a clinical trial may stop a trial or deem a product candidate unsafe to continue testing.

If we or our manufacturers

or other third-party contractors fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to

regulatory actions, which could affect our ability to successfully develop, market and sell our Hemopurifier product candidate or any

future product candidates, if any, and could harm our reputation and lead to reduced or non-acceptance of our proposed product candidates

by the market.

Even technical recommendations or evidence by the FDA through letters, site visits, and overall recommendations to academia

or biotechnology companies may make the manufacturing of a clinical product extremely labor intensive or expensive, making the product

candidate no longer viable to manufacture in a cost-efficient manner.

The mode of administration may make the product candidate not commercially

The required testing of the product candidate may make that candidate no longer commercially viable.

The conduct of clinical trials

may be critiqued by the FDA, or a clinical trial site’s IRB or Institutional Biosafety Committee, which may delay or make impossible

clinical testing of a product candidate.

The IRB for a clinical trial may stop a trial or deem a product candidate unsafe to continue

This would have a material adverse effect on the value of the product candidate and our business prospects.

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our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties.

We do not have the required financial

and human resources to carry out on our own all the pre-clinical and clinical development for our Hemopurifier product candidate or any

other or future product candidates that we may develop, and do not have the capability and resources to market or sell our Hemopurifier

We do not have the required

financial and human resources to carry out on our own all the pre-clinical and clinical development for our Hemopurifier product candidate

or any other or future product candidates that we may develop, and do not have the capability and resources to market or sell our Hemopurifier

product candidate or any future product candidates that we may develop.

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risks, and clinical and preclinical liability risks, which could place a substantial financial burden upon us should we be sued.

Our business exposes us to potential

product liability and other liability risks that are inherent in the testing, manufacturing and marketing of medical devices.

be asserted against us.

A successful liability claim or series of claims brought against us could have a material adverse effect on our

Our business exposes us to

potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of medical devices.

Claims may be asserted against us.

A successful liability claim or series of claims brought against us could have a material adverse effect

on our business, financial condition and results of operations.

We may not be able to continue to obtain or maintain adequate product

liability insurance on acceptable terms, if at all, and such insurance may not provide adequate coverage against potential liabilities.

Claims or losses in excess of any product liability insurance coverage that we may obtain could have a material adverse effect on our

business, financial condition and results of operations.

We may not be able to continue to obtain or maintain adequate product liability

insurance on acceptable terms, if at all, and such insurance may not provide adequate coverage against potential liabilities.

losses in excess of any product liability insurance coverage that we may obtain could have a material adverse effect on our business,

financial condition and results of operations.

Our Hemopurifier product candidate

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approval from the FDA to market a medical device in the United States.

Before a new medical device can

be marketed in the United States, it must first receive a PMA or 510(k) clearance from the FDA, unless an exemption applies.

A PMA submission,

which is a higher standard than a 510(k) clearance, is used to demonstrate to the FDA that a new or modified device is safe and effective.

The 510(k) is used to demonstrate that a device is “substantially equivalent” to a predicate device, that is, one that has

been cleared by the FDA.

We expect that any product we seek regulatory approval for, including the Hemopurifier, will require a PMA.

FDA approval process involves, among other things, successfully completing clinical trials and filing for and obtaining a PMA.

process requires us to prove the safety and effectiveness of our products to the FDA’s satisfaction.

This process, which includes

preclinical studies and clinical trials, can take many years and requires the expenditure of substantial resources and may include post-marketing

surveillance to establish the safety and efficacy of the product.

Notwithstanding the effort and expense incurred, the process may never

result in the FDA granting a PMA.

Data obtained from preclinical studies and clinical trials are subject to varying interpretations that

could delay, limit or prevent regulatory approval.

Delays or rejections may also be encountered based upon changes in governmental policies

for medical devices during the period of product development.

The FDA can delay, limit or deny approval of a PMA application for many

reasons, including:

Before a new medical device

can be marketed in the United States, it must first receive a PMA or 510(k) clearance from the FDA, unless an exemption applies.

submission, which is a higher standard than a 510(k) clearance, is used to demonstrate to the FDA that a new or modified device is safe

and effective.

The 510(k) is used to demonstrate that a device is “substantially equivalent” to a predicate device, that is,

one that has been cleared by the FDA.

We expect that any product we seek regulatory approval for, including the Hemopurifier, will require

The FDA approval process involves, among other things, successfully completing clinical trials and filing for and obtaining a PMA.

The PMA process requires us to prove the safety and effectiveness of our products to the FDA’s satisfaction.

This process, which

includes preclinical studies and clinical trials, can take many years and requires the expenditure of substantial resources and may include

post-marketing surveillance to establish the safety and efficacy of the product.

Notwithstanding the effort and expense incurred, the

process may never result in the FDA granting a PMA.

Data obtained from preclinical studies and clinical trials are subject to varying

interpretations that could delay, limit or prevent regulatory approval.

Delays or rejections may also be encountered based upon changes

in governmental policies for medical devices during the period of product development.

The FDA can delay, limit or deny approval of a

PMA application for many reasons, including:

our inability to demonstrate safety or effectiveness of the Hemopurifier, or any other product we develop, to the FDA’s satisfaction;

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changes in the FDA’s approval policies, or the adoption of new regulations that require additional data or additional clinical trials.

Modifications to products that

are approved through a PMA application generally need FDA approval.

Similarly, some modifications made to products cleared through a 510(k)

may require a new 510(k).

Modifications to products

that are approved through a PMA application generally need FDA approval.

Similarly, some modifications made to products cleared through

a 510(k) may require a new 510(k).

The FDA’s 510(k) clearance process usually takes from three to 12 months, but may last longer.

of obtaining a PMA is much costlier and more uncertain than the 510(k) clearance process and generally takes from one to three years,

or even longer, from the time the application is submitted to the FDA until an approval is obtained.

Any of our products considered to

be a class III device, which are considered to pose the greatest risk and the approval of which is governed by the strictest guidelines,

The process of obtaining a PMA is much costlier and more uncertain than the 510(k) clearance process and generally takes from one to three

years, or even longer, from the time the application is submitted to the FDA until an approval is obtained.

Any of our products considered

to be a class III device, which are considered to pose the greatest risk and the approval of which is governed by the strictest guidelines,

will require the submission and approval of a PMA in order for us to market it in the United States.

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the future that could require the clearance of a 510(k).

Although we have received approval

to proceed with clinical trials of the Hemopurifier in the United States under the investigational device exemption, the current approval

from the FDA to proceed could be revoked, the study could be unsuccessful, or the FDA PMA approval may not be obtained or could be revoked.

Even if we obtain approval, the FDA or other regulatory authorities may require expensive or burdensome post-market testing or controls.

Any delay in, or failure to receive or maintain, clearance or approval for our future products could prevent us from generating revenue

from these products or achieving profitability.

Additionally, the FDA and other regulatory authorities have broad enforcement powers.

Regulatory enforcement or inquiries, or other increased scrutiny on us, could dissuade some physicians from using our products and adversely

affect our reputation and the perceived safety and efficacy of our products.

Although we have received

approval to proceed with clinical trials of the Hemopurifier in the United States under the investigational device exemption, the current

approval from the FDA to proceed could be revoked, the study could be unsuccessful, or the FDA PMA approval may not be obtained or could

Even if we obtain approval, the FDA or other regulatory authorities may require expensive or burdensome post-market testing

Any delay in, or failure to receive or maintain, clearance or approval for our future products could prevent us from generating

revenue from these products or achieving profitability.

Additionally, the FDA and other regulatory authorities have broad enforcement

Regulatory enforcement or inquiries, or other increased scrutiny on us, could dissuade some physicians from using our products

and adversely affect our reputation and the perceived safety and efficacy of our products.

The approval requirements for medical products

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date, the Hemopurifier can potentially clear many viruses that are pathogenic in humans, including HCV, HIV, Monkeypox and Ebola.

For example, in June 2020, the

FDA approved a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients

For example, in June 2020,

the FDA approved a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients

with SARS-CoV-2/COVID-19 in a New Feasibility Study.

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obtain regulatory approval for the Hemopurifier.

The results of our clinical trials may not support our product candidate

claims or may result in the discovery of adverse side effects.

The results of our clinical trials may not support our product

candidate claims or may result in the discovery of adverse side effects.

Any research and development,

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trials will experience adverse side effects that are not currently part of the product candidate’s profile.

legislative or FDA regulatory reforms may

make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute

legislative or FDA regulatory reforms

may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute

our products after approval is obtained.

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our product development efforts.

Our current and future business activities are

subject to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security

and other healthcare laws and regulations, which could expose us to significant penalties.

We are currently and will in the

future be subject to healthcare regulation and enforcement by the U.S.

federal government and the states in which we will conduct our

business if our product candidates are approved by the FDA and commercialized in the United States.

In addition to the FDA’s restrictions

on marketing of approved products, the U.S.

Our current and future business activities

are subject to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and

security and other healthcare laws and regulations, which could expose us to significant penalties.

We are currently and will

in the future be subject to healthcare regulation and enforcement by the U.S.

federal government and the states in which we will conduct

our business if our product candidates are approved by the FDA and commercialized in the United States.

In addition to the FDA’s

restrictions on marketing of approved products, the U.S.

healthcare laws and regulations that may affect our ability to operate include:

fraud and abuse laws, including the federal anti-kickback and false claims laws;

the federal fraud and abuse laws, including the federal anti-kickback and false claims laws;

federal data privacy and security laws;

and federal transparency

laws related to payments and/or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists

and chiropractors) and other healthcare professionals (such as physicians assistants and nurse practitioners) and teaching hospitals.

Many states have similar laws and regulations that may differ from each other and federal law in significant ways, thus complicating compliance

These laws may adversely affect our sales, marketing and other activities with respect to any product candidate for which we

receive approval to market in the United States by imposing administrative and compliance burdens on us.

Because of the breadth of these

laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities,

particularly any sales and marketing activities after a product candidate has been approved for marketing in the United States, could

be subject to legal challenge and enforcement actions.

If our operations are found to be in violation of any of the federal and state

laws described above or any other governmental regulations that apply to us, we may be subject to significant civil, criminal, and administrative

penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs,

additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations

of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely affect our ability

to operate our business and our results of operations.

We and the third parties with whom we work are

subject to stringent and changing U.S.

and foreign laws, rules, regulations and standards as well as policies, contracts and other obligations

related to data privacy and security.

Our actual or perceived failure to comply with such obligations, or such failure by the third parties

with whom we work, could lead to regulatory investigations or actions, fines and penalties, a disruption of our clinical trials or commercialization

of our products, private litigation, including class claims, and mass arbitration demands, harm to our reputation, or other adverse effects

on our business or prospects.

In the ordinary course of business,

we collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share,

or collectively, “Process” or “Processing” personal data and other Sensitive Information (as defined below), including

proprietary and confidential business data, trade secrets, and intellectual property that we collect in connection with clinical trials,

as necessary to operate our business, for legal and marketing purposes, and for other business-related purposes.

Our data Processing activities

may subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external

and internal privacy and security policies, representations, certifications, standards, publications, frameworks, contractual requirements

and other obligations related to data privacy and security collectively, “Data Protection Obligations”.

federal transparency laws related to payments and/or other transfers of value made to physicians (defined to include doctors, dentists,

optometrists, podiatrists and chiropractors) and other healthcare professionals (such as physicians assistants and nurse practitioners)

and teaching hospitals.

Many states have similar laws and regulations that may differ from each other and federal law in significant ways,

thus complicating compliance efforts.

These laws may adversely affect our sales, marketing and other activities with respect to any product

candidate for which we receive approval to market in the United States by imposing administrative and compliance burdens on us.

Because of the breadth of

these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business

activities, particularly any sales and marketing activities after a product candidate has been approved for marketing in the United States,

could be subject to legal challenge and enforcement actions.

If our operations are found to be in violation of any of the federal and

state laws described above or any other governmental regulations that apply to us, we may be subject to significant civil, criminal, and

administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare

programs, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to

resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely

affect our ability to operate our business and our results of operations.

We and the third parties with whom we work

are subject to stringent and changing U.S.

and foreign laws, rules, regulations and standards as well as policies, contracts and other

obligations related to data privacy and security.

Our actual or perceived failure to comply with such obligations, or such failure by

the third parties with whom we work, could lead to regulatory investigations or actions, fines and penalties, a disruption of our clinical

trials or commercialization of our products, private litigation, including class claims, and mass arbitration demands, harm to our reputation,

or other adverse effects on our business or prospects.

In the ordinary course of

business, we collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure, dispose of, transmit,

and share, or collectively, “Process” or “Processing” personal data and other Sensitive Information (as defined

below), including proprietary and confidential business data, trade secrets, and intellectual property that we collect in connection with

clinical trials, as necessary to operate our business, for legal and marketing purposes, and for other business-related purposes.

data Processing activities may subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance,

industry standards, external and internal privacy and security policies, representations, certifications, standards, publications, frameworks,

contractual requirements and other obligations related to data privacy and security collectively, “Data Protection Obligations”.

In the United States, federal,

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of individually identifiable health information.

In addition, over the past few

years, numerous U.S.

states—including California, Virginia, Colorado, Connecticut, and Utah—have enacted comprehensive privacy

laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording

In addition, over the past

few years, numerous U.S.

states—including California, Virginia, Colorado, Connecticut, and Utah—have enacted comprehensive

privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording

residents with certain rights concerning their personal data.

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and local levels, and we expect more states to pass similar laws in the future.

Outside the United States, an

increasing number of laws, regulations, and industry standards may govern data privacy and security.

Outside the United States,

an increasing number of laws, regulations, and industry standards may govern data privacy and security.

For example, the European Union’s

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individual litigants and activist groups.

We publish privacy policies and

may publish marketing materials and other statements, such as compliance with certain certifications or self-regulatory principles, regarding

data privacy and security.

If these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair,

or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators, or other adverse consequences.

In addition to data privacy and

security laws, we are contractually subject to industry standards adopted by industry groups and may become subject to such obligations

We publish privacy policies

and may publish marketing materials and other statements, such as compliance with certain certifications or self-regulatory principles,

regarding data privacy and security.

If these policies, materials or statements are found to be deficient, lacking in transparency, deceptive,

unfair, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators, or other adverse

consequences.

In addition to data privacy

and security laws, we are contractually subject to industry standards adopted by industry groups and may become subject to such obligations

in the future.

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such obligations may not be successful.

Data Protection Obligations, and

consumers’ data privacy expectations, are quickly changing, becoming increasingly stringent, and creating uncertainty.

Data Protection Obligations,

and consumers’ data privacy expectations, are quickly changing, becoming increasingly stringent, and creating uncertainty.

Additionally,

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business operations and compliance posture.

If we or third parties fail, or

are perceived to have failed, to address or comply with applicable Data Protection Obligations, it could:

If we or third parties fail,

or are perceived to have failed, to address or comply with applicable Data Protection Obligations, it could:

increase our compliance and

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an effort to comply, which could materially adversely affect our business operations and financial results.

Any of these events could have

a material adverse effect on our reputation, business, or financial condition, including but not limited to:

Any of these events could

have a material adverse effect on our reputation, business, or financial condition, including but not limited to:

loss of customers;

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or revision or restructuring of our operations.

If our information technology systems, or those

of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such

compromise, including but not limited to:

If our information technology systems, or

those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from

such compromise, including but not limited to:

regulatory investigations or actions;

fines and penalties;

disruptions of our business

disruptions of our

business operations;

reputational harm;

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and other adverse consequences.

In the ordinary course of our

business, we and third parties with whom we work may process proprietary, confidential and sensitive information, including personal data,

intellectual property, trade secrets, and proprietary business information owned or controlled by ourselves or other third parties, or

collectively, Sensitive Information.

We may use and share Sensitive Information with service providers and subprocessors and other third

parties with whom we work to help us operate our business.

If we or such third parties with who we work have experienced, or in the future

experience, any security incident(s) that result in any data loss;

In the ordinary course of

our business, we and third parties with whom we work may process proprietary, confidential and sensitive information, including personal

data, intellectual property, trade secrets, and proprietary business information owned or controlled by ourselves or other third parties,

or collectively, Sensitive Information.

We may use and share Sensitive Information with service providers and subprocessors and other

third parties with whom we work to help us operate our business.

If we or such third parties with who we work have experienced, or in

the future experience, any security incident(s) that result in any data loss;

deletion or destruction;

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payments due to, for example, applicable laws or regulations prohibiting such payments.

Remote work has become more common

and has increased risks to our information technology systems and data, as more of our employees utilize network connections, computers,

Remote work has become more

common and has increased risks to our information technology systems and data, as more of our employees utilize network connections, computers,

and devices outside our premises or network, including working at home, while in transit and in public locations.

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may be difficult to integrate companies into our information technology environment and security program.

In addition, our reliance on third-party

service providers could introduce new cybersecurity risks and vulnerabilities, including supply-chain attacks, and other threats to our

business operations.

We rely on third-parties and their technologies to operate critical business systems to process Sensitive Information

in a variety of contexts, including, without limitation, cloud-based infrastructure, data center facilities, encryption and authentication

technology, employee email, content delivery to customers, and other functions.

We also rely on third-party service providers to assist

with our clinical trials, provide other products or services, or otherwise to operate our business.

Our ability to monitor these third

parties’ information security practices is limited, and these third parties may not have adequate information security measures

In addition, our reliance

on third-party service providers could introduce new cybersecurity risks and vulnerabilities, including supply-chain attacks, and other

threats to our business operations.

We rely on third-parties and their technologies to operate critical business systems to process Sensitive

Information in a variety of contexts, including, without limitation, cloud-based infrastructure, data center facilities, encryption and

authentication technology, employee email, content delivery to customers, and other functions.

We also rely on third-party service providers

to assist with our clinical trials, provide other products or services, or otherwise to operate our business.

Our ability to monitor these

third parties’ information security practices is limited, and these third parties may not have adequate information security measures

If our third-party service providers experience a Security Breach or other interruption, we could experience adverse consequences.

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systems that support us and our services.

While we have implemented security

measures designed to protect against Security Breaches, these measures may not be effective.

We take steps designed to detect, mitigate,

and remediate vulnerabilities in our information technology systems, including our products, hardware and/or software, including that

of third parties upon which we rely.

While we have implemented

security measures designed to protect against Security Breaches, these measures may not be effective.

We take steps designed to detect,

mitigate, and remediate vulnerabilities in our information technology systems, including our products, hardware and/or software, including

that of third parties upon which we rely.

We may not, however, detect or remediate all such vulnerabilities including on a timely basis.

we may experience delays in developing and deploying remedial measures and patched designed to address any such identified vulnerabilities.

Further, we may experience delays in developing and deploying remedial measures and patched designed to address any such identified vulnerabilities.

Vulnerabilities could be exploited and result in a security incident.

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work to provide our services.

We may expend significant resources,

fundamentally change our business activities and practices, or modify our operations, including clinical trial activities, or information

technology in an effort to protect against Security Breaches and to mitigate, detect and remediate actual and potential vulnerabilities.

Applicable Data Protection Obligations may require us to implement specific security measures or use industry-standard or reasonable measures

to protect against Security Breaches.

Our security measures, or those of third parties with whom we work, may not be effective in protecting

against Security Breaches.

Applicable Data Protection Obligations

may require us to notify relevant stakeholders of Security Breaches, including affected individuals, customers, investors, partners, collaborators,

regulators, law enforcement agencies and others, or to implement other requirements, such as providing credit monitoring.

Such disclosures

and compliance with such requirements are costly, and the disclosures or the failure to comply with such requirements could lead to an

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

If we or a third party with whom we work experiences a

Security Breach or are perceived to have experienced a Security Breach, we may experience adverse consequences.

These consequences may

We may expend significant

resources, fundamentally change our business activities and practices, or modify our operations, including clinical trial activities,

or information technology in an effort to protect against Security Breaches and to mitigate, detect and remediate actual and potential

vulnerabilities.

Applicable Data Protection Obligations may require us to implement specific security measures or use industry-standard

or reasonable measures to protect against Security Breaches.

Our security measures, or those of third parties with whom we work, may not

be effective in protecting against Security Breaches.

Applicable Data Protection

Obligations may require us to notify relevant stakeholders of Security Breaches, including affected individuals, customers, investors,

partners, collaborators, regulators, law enforcement agencies and others, or to implement other requirements, such as providing credit

Such disclosures and compliance with such requirements are costly, and the disclosures or the failure to comply with such

requirements could lead to an adverse impact on our business, results of operations and financial condition.

If we or a third party with

whom we work experiences a Security Breach or are perceived to have experienced a Security Breach, we may experience adverse consequences.

These consequences may include:

government enforcement actions, for example, investigations, fines, penalties, audits, and inspections;

additional reporting

requirements and/or oversight;

additional reporting requirements and/or oversight;

restrictions on processing Sensitive Information, including personal data;

litigation, including class

including class claims;

indemnification obligations;

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monetary fund diversions;

diversion of management attention;

diversion of management

interruptions in our operations, including availability of data;

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and other similar harms.

Security Breaches or other interruptions

and attendant consequences may prevent or cause customers to stop using our services, deter new customers from using our services, and

negatively impact our ability to grow and operate our business.

Security Breaches

or other interruptions and attendant consequences may prevent or cause customers to stop using our services, deter new customers from

using our services, and negatively impact our ability to grow and operate our business.

Our contracts may not contain

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to protect us from liabilities or damages if we fail to comply with Data Protection Obligations related to information security or Security

Our insurance coverage may not

be adequate or otherwise protect us from or adequately mitigate liabilities or damages with respect to claims, costs, expenses, litigation,

Our insurance coverage may

not be adequate or otherwise protect us from or adequately mitigate liabilities or damages with respect to claims, costs, expenses, litigation,

fines, penalties, business loss, data loss, regulatory actions or other material adverse impact on our business, results of operations

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could have a material adverse impact on our business, results of operations and financial condition.

In addition to experiencing a

Security Breach, third parties may gather, collect, or infer Sensitive Information about us from public sources, data brokers, or other

In addition to experiencing

a Security Breach, third parties may gather, collect, or infer Sensitive Information about us from public sources, data brokers, or other

means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or

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and any such evaluations may not be conducted or have a favorable outcome.

If approved for use in the United

States, we expect that any products that we develop, including the Hemopurifier, will be purchased primarily by medical institutions,

If approved for use in the

United States, we expect that any products that we develop, including the Hemopurifier, will be purchased primarily by medical institutions,

which will in turn bill various third-party payors for the health care services provided to patients at their facility.

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our ability to market and sell our products.

Healthcare costs have risen significantly

over the past decade, and there have been and continue to be proposals by legislators, regulators and third-party payors to decrease costs.

Third-party payors are increasingly challenging the prices charged for medical products and services and instituting cost containment

measures to control or significantly influence the purchase of medical products and services.

For example, in the United States,

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

Healthcare costs have risen

significantly over the past decade, and there have been and continue to be proposals by legislators, regulators and third-party payors

to decrease costs.

Third-party payors are increasingly challenging the prices charged for medical products and services and instituting

cost containment measures to control or significantly influence the purchase of medical products and services.

For example, in the United

States, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively,

ACA, among other things, reduced and/or limited Medicare reimbursement to certain providers.

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It is unclear whether the models will be utilized in any health reform measures in the future.

Legislation could be adopted in

the future that limits payments for our products from governmental payors.

Legislation could be adopted

in the future that limits payments for our products from governmental payors.

In addition, commercial payors such as insurance companies,

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and certain other tax attributes to offset future taxable income or taxes may be limited.

Under current law, federal net

operating losses incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of

such federal net operating loss carryforwards in a taxable year is limited to 80% of taxable income in such year.

In addition, under Sections

382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an

“ownership change,” which is generally defined as a greater than 50% change in its equity ownership value over a three-year

Under current law, federal

net operating losses incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility

of such federal net operating loss carryforwards in a taxable year is limited to 80% of taxable income in such year.

In addition, under

Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes

an “ownership change,” which is generally defined as a greater than 50% change in its equity ownership value over a three-year

period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to

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or otherwise limited, which could accelerate or permanently increase state taxes owed.

Uncertainties in the interpretation and application

of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.

The tax regimes to which we are

subject or under which we operate are unsettled and may be subject to significant change.

Uncertainties in the interpretation and

application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.

The tax regimes to which we

are subject or under which we operate are unsettled and may be subject to significant change.

The issuance of additional guidance related

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of related uncertainty, these changes may adversely impact our business, financial condition, results of operations, and cash flows.

The amount of taxes we pay in

different jurisdictions depends on the application of the tax laws of various jurisdictions, including the United States, to our international

The amount of taxes we pay

in different jurisdictions depends on the application of the tax laws of various jurisdictions, including the United States, to our international

business activities, tax rates, new or revised tax laws, or interpretations of tax laws and policies, and our ability to operate our business

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in one or more jurisdictions.

The Tax Cuts and Jobs Act of 2017

eliminated the option to deduct research and development expenses for tax purposes in the year incurred and requires taxpayers to capitalize

and subsequently amortize such expenses over five years for research activities conducted in the United States and over 15 years for research

activities conducted outside the United States.

Although there have been legislative proposals to repeal or defer the capitalization requirement

to later years, there can be no assurance that the provision will be repealed or otherwise modified.

Future guidance from the Internal

Revenue Service and other tax authorities with respect to such legislation may affect us, and certain aspects of such legislation could

be repealed or modified in future legislation.

Our use of hazardous materials, chemicals and

viruses exposes us to potential liabilities for which we may not have adequate insurance.

Our research and development involves

the controlled use of hazardous materials, chemicals and viruses.

The primary hazardous materials include chemicals needed to construct

the Hemopurifier cartridges and the infected plasma samples used in preclinical testing of the Hemopurifier.

All other chemicals are fully

inventoried and reported to the appropriate authorities, such as the fire department, which inspects the facility on a regular basis.

We are subject to federal, state, local and foreign laws governing the use, manufacture, storage, handling and disposal of such materials.

Although we believe that our safety procedures for the use, manufacture, storage, handling and disposal of such materials comply with

the standards prescribed by federal, state, local and foreign regulations, we cannot completely eliminate the risk of accidental contamination

or injury from these materials.

The Tax Cuts and Jobs Act

of 2017 eliminated the option to deduct research and development expenses for tax purposes in the year incurred and requires taxpayers

to capitalize and subsequently amortize such expenses over five years for research activities conducted in the United States and over

15 years for research activities conducted outside the United States.

Although there have been legislative proposals to repeal or defer

the capitalization requirement to later years, there can be no assurance that the provision will be repealed or otherwise modified.

guidance from the Internal Revenue Service and other tax authorities with respect to such legislation may affect us, and certain aspects

of such legislation could be repealed or modified in future legislation.

Our use of hazardous materials, chemicals

and viruses exposes us to potential liabilities for which we may not have adequate insurance.

Our research and development

involves the controlled use of hazardous materials, chemicals and viruses.

The primary hazardous materials include chemicals needed to

construct the Hemopurifier cartridges and the infected plasma samples used in preclinical testing of the Hemopurifier.

All other chemicals

are fully inventoried and reported to the appropriate authorities, such as the fire department, which inspects the facility on a regular

We are subject to federal, state, local and foreign laws governing the use, manufacture, storage, handling and disposal of such

Although we believe that our safety procedures for the use, manufacture, storage, handling and disposal of such materials comply

with the standards prescribed by federal, state, local and foreign regulations, we cannot completely eliminate the risk of accidental

contamination or injury from these materials.

We have had no incidents or problems involving hazardous chemicals or biological samples.

of such an accident, we could be held liable for significant damages or fines.

We currently carry a limited amount

of insurance to protect us from bodily injury or property damages arising from hazardous materials.

Our product liability policy has a

$5,000,000 limit of liability.

For our facilities, our property policy provides $25,000 in coverage for contaminant clean-up or removal

and $100,000 in coverage for damages to the premises resulting from contamination.

Should we violate any regulations concerning the handling

or use of hazardous materials, or should any injuries or death result from our use or handling of hazardous materials, we could be the

subject of substantial lawsuits by governmental agencies or individuals.

We may not have adequate insurance to cover all or any of such

claims, if any.

If we were responsible to pay significant damages for violations or injuries, if any, we might be forced to cease operations

since such payments could deplete our available resources.

Our products may in the future be subject to

product recalls.

In the event of such an accident, we could be held liable for significant damages or fines.

We currently carry a limited

amount of insurance to protect us from bodily injury or property damages arising from hazardous materials.

Our product liability policy

has a $5,000,000 limit of liability.

For our facilities, our property policy provides $25,000 in coverage for contaminant clean-up or

removal and $100,000 in coverage for damages to the premises resulting from contamination.

Should we violate any regulations concerning

the handling or use of hazardous materials, or should any injuries or death result from our use or handling of hazardous materials, we

could be the subject of substantial lawsuits by governmental agencies or individuals.

We may not have adequate insurance to cover all

or any of such claims, if any.

If we were responsible to pay significant damages for violations or injuries, if any, we might be forced

to cease operations since such payments could deplete our available resources.

Our products may in the future be subject

to product recalls.

A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, including

a third-country authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.

The FDA and similar foreign governmental

authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design

or manufacture.

For the FDA, the authority to require a recall must be based on a finding that there is reasonable probability that the

device would cause serious injury or death.

In addition, foreign governmental bodies have the authority to require the recall of our products

in the event of material deficiencies or defects in design or manufacture.

Manufacturers may, under their own initiative, recall a product

if any material deficiency in a device is found.

The FDA requires that certain classifications of recalls be reported to the FDA within

ten working days after the recall is initiated.

A government-mandated or voluntary recall by us or one of our international distributors

could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing errors, design or labeling

defects or other deficiencies and issues.

Recalls of any of our products would divert managerial and financial resources and have an adverse

effect on our reputation, results of operations and financial condition, which could impair our ability to produce our products in a cost-effective

and timely manner in order to meet our customers’ demands.

We may also be subject to liability claims, be required to bear other

costs, or take other actions that may have a negative impact on our future sales and our ability to generate profits.

Companies are required

to maintain certain records of recalls, even if they are not reportable to the FDA or another third-country competent authority.

initiate voluntary recalls involving our products in the future that we determine do not require notification of the FDA or another third-country

The FDA and similar foreign

governmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or

defects in design or manufacture.

For the FDA, the authority to require a recall must be based on a finding that there is reasonable probability

that the device would cause serious injury or death.

In addition, foreign governmental bodies have the authority to require the recall

of our products in the event of material deficiencies or defects in design or manufacture.

Manufacturers may, under their own initiative,

recall a product if any material deficiency in a device is found.

The FDA requires that certain classifications of recalls be reported

to the FDA within ten working days after the recall is initiated.

A government-mandated or voluntary recall by us or one of our international

distributors could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing errors, design

or labeling defects or other deficiencies and issues.

Recalls of any of our products would divert managerial and financial resources and

have an adverse effect on our reputation, results of operations and financial condition, which could impair our ability to produce our

products in a cost-effective and timely manner in order to meet our customers’ demands.

We may also be subject to liability claims,

be required to bear other costs, or take other actions that may have a negative impact on our future sales and our ability to generate

Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA or another third-country

competent authority.

If the FDA disagrees with our determinations, they could require us to report those actions as recalls.

recall announcement could harm our reputation with customers and negatively affect our sales.

In addition, the FDA could take enforcement

action for failing to report recalls.

We are also required to follow detailed recordkeeping requirements for all firm-initiated medical

device corrections and removals.

Even though we have received breakthrough device

designation for the Hemopurifier for two independent indications, this designation may not expedite the development or review of the Hemopurifier

and does not provide assurance ultimately of PMA submission or approval by the FDA.

We may initiate voluntary recalls involving our products in the future that we determine do not require notification

of the FDA or another third-country competent authority.

If the FDA disagrees with our determinations, they could require us to report

those actions as recalls.

A future recall announcement could harm our reputation with customers and negatively affect our sales.

the FDA could take enforcement action for failing to report recalls.

We are also required to follow detailed recordkeeping requirements

for all firm-initiated medical device corrections and removals.

Even though we have received breakthrough

device designation for the Hemopurifier for two independent indications, this designation may not expedite the development or review of

the Hemopurifier and does not provide assurance ultimately of PMA submission or approval by the FDA.

The Breakthrough Devices Program

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procedure does not ensure that we will ultimately obtain regulatory approval for the product.

Our bylaws designate the Eighth Judicial District

Court of Clark County, Nevada, as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our

stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors,

officers, employees or agents.

Our bylaws require that, to the

fullest extent permitted by law, and unless the Company consents in writing to the selection of an alternative forum, the Eighth Judicial

Our bylaws designate the Eighth Judicial

District Court of Clark County, Nevada, as the sole and exclusive forum for certain types of actions and proceedings that may be initiated

by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our

directors, officers, employees or agents.

Our bylaws require that, to

the fullest extent permitted by law, and unless the Company consents in writing to the selection of an alternative forum, the Eighth Judicial

District Court of Clark County, Nevada, will, to the fullest extent permitted by law, be the sole and exclusive forum for each of the

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any action asserting a claim governed by the internal affairs doctrine, including, without limitation, any action to interpret, apply, enforce or determine the validity of our articles of incorporation or bylaws.

However, our bylaws provide that

the exclusive forum provisions do not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other

claim for which the federal courts have exclusive jurisdiction.

However, our bylaws provide

that the exclusive forum provisions do not apply to suits brought to enforce any liability or duty created by the Exchange Act or any

other claim for which the federal courts have exclusive jurisdiction.

We note that there is uncertainty as to whether a court would enforce

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licenses and ownership rights assigned from third parties for the development of specific uses for our Hemopurifier devices.

we are researching, developing and testing cancer-related applications for our devices under patents assigned from the London Health Science

Center Research, Inc.

Should any of our licenses be prematurely terminated for any reason, or if the patents and intellectual property

assigned to us or owned by such entities that we have licensed are challenged or defeated by third parties, our research efforts could

be materially and adversely affected.

Our licenses and patents assigned to us may not continue in force for as long as we require for

our research, development and testing of cancer treatments.

It is possible that, if our licenses terminate or the underlying patents and

intellectual property is challenged or defeated or the patents and intellectual property assigned to us is challenged or defeated, suitable

replacements may not be obtained or developed on terms acceptable to us, if at all.

There is also the related risk that we may not be

able to make the required payments under any patent license or assignment agreement, in which case we may lose to ability to use one or

more of the licensed or assigned patents.

We could become subject to intellectual property

litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, prevent us

from selling our commercially available products and/or reduce the margins we may realize from our products.

The medical devices industry is

characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights.

Whether a product

infringes a patent involves complex legal and factual issues, and the determination is often uncertain.

There may be existing patents

of which we are unaware that our products under development may inadvertently infringe.

The likelihood that patent infringement claims

may be brought against us increases as the number of participants in the infectious market increases and as we achieve more visibility

We are researching,

developing and testing cancer-related applications for our devices under patents assigned from the London Health Science Center Research,

Under the assignment agreement, we own the patents outright for the life of the patent, which expires in May 2029.

Under certain

circumstances, ownership of the patents may revert to the London Health Science Center Research, Inc.

if there is an uncured substantial

breach of the assignment agreement.

Should any of our licenses be prematurely terminated for any reason, or if the patents and intellectual

property assigned to us or owned by such entities that we have licensed are challenged or defeated by third parties, our research efforts

could be materially and adversely affected.

Our licenses and patents assigned to us may not continue in force for as long as we require

for our research, development and testing of cancer treatments.

It is possible that, if our licenses terminate or the underlying patents

and intellectual property is challenged or defeated or the patents and intellectual property assigned to us is challenged or defeated,

suitable replacements may not be obtained or developed on terms acceptable to us, if at all.

There is also the related risk that we may

not be able to make the required payments under any patent license or assignment agreement, in which case we may lose ability to use one

or more of the licensed or assigned patents.

We could become subject to intellectual

property litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, prevent

us from selling our commercially available products and/or reduce the margins we may realize from our products.

The medical devices industry

is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights.

product infringes a patent involves complex legal and factual issues, and the determination is often uncertain.

There may be existing

patents of which we are unaware that our products under development may inadvertently infringe.

The likelihood that patent infringement

claims may be brought against us increases as the number of participants in the infectious market increases and as we achieve more visibility

in the marketplace and introduce products to market.

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on our ability to protect our proprietary rights to the technologies incorporated in our products.

We currently have five issued U.S.

We currently have three issued U.S.

patents and two pending U.S.

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international patents.

Our issued patents begin to expire in August 2024, with the last of these patents expiring in 2031, although terminal

Our issued patents begin to expire in March 2027, with the last of these patents expiring in 2031, although terminal

disclaimers, patent term extension or patent term adjustment can shorten or lengthen the patent term.

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However, these may not adequately protect our rights or permit us to gain or keep any competitive advantage.

The issuance of a patent is not

conclusive as to its scope, validity or enforceability.

The issuance of a patent is

not conclusive as to its scope, validity or enforceability.

The scope, validity or enforceability of our issued patents can be challenged

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comparable to our products but that are not covered by our patents.

We have also entered into confidentiality

and assignment of intellectual property agreements with all of our employees, consultants and advisors directly involved in the development

of our technology as one of the ways we seek to protect our intellectual property and other proprietary technology.

However, these agreements

may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of

unauthorized use or disclosure or other breaches of the agreements.

In the event a competitor infringes

upon any of our patents or other intellectual property rights, enforcing our rights may be difficult, time consuming and expensive, and

would divert management’s attention from managing our business.

We have also entered into

confidentiality and assignment of intellectual property agreements with all of our employees, consultants and advisors directly involved

in the development of our technology as one of the ways we seek to protect our intellectual property and other proprietary technology.

However, these agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information

in the event of unauthorized use or disclosure or other breaches of the agreements.

In the event a competitor

infringes upon any of our patents or other intellectual property rights, enforcing our rights may be difficult, time consuming and expensive,

and would divert management’s attention from managing our business.

We may not be successful on the merits in any enforcement effort.

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development path, which could seriously harm our business, financial position and results of our operations.

New technology may lead to our competitors developing

superior products which would reduce demand for our products.

Research into technologies similar

to ours is proceeding at a rapid pace, and many private and public companies and research institutions are actively engaged in the development

of products similar to ours.

These new technologies may, if successfully developed, offer significant performance or price advantages

when compared with our technologies.

Our existing patents or our pending and proposed patent applications may not offer meaningful protection

if a competitor develops a novel product based on a new technology.

New technology may lead to our competitors

developing superior products which would reduce demand for our products.

Research into technologies

similar to ours is proceeding at a rapid pace, and many private and public companies and research institutions are actively engaged in

the development of products similar to ours.

These new technologies may, if successfully developed, offer significant performance or price

advantages when compared with our technologies.

Our existing patents or our pending and proposed patent applications may not offer meaningful

protection if a competitor develops a novel product based on a new technology.

If we are unable to protect our proprietary

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ability to remain in business.

Our ability to successfully commercialize

our products will depend on our ability to protect those products and our technology with domestic and foreign patents.

We will also need

to continue to preserve our trade secrets.

The issuance of a patent is not conclusive as to its validity or as to the enforceable scope

of the claims of the patent.

The patent positions of technology companies, including us, are uncertain and involve complex legal and factual

Our patents may not prevent other companies from developing similar products or products which produce benefits substantially

the same as our products, and other companies may be issued patents that may prevent the sale of our products or require us to pay significant

licensing fees in order to market our products.

From time to time, we may need

to obtain licenses to patents and other proprietary rights held by third parties in order to develop, manufacture and market our products.

If we are unable to timely obtain these licenses on commercially reasonable terms, our ability to commercially exploit such products may

be inhibited or prevented.

Our pending patent applications may not result in issued patents, patent protection may not be secured for

any particular technology, and our issued patents may not be valid or enforceable or provide us with meaningful protection.

If we are required to engage in expensive and

lengthy litigation to enforce our intellectual property rights, such litigation could be very costly and the results of such litigation

Our ability to successfully

commercialize our products will depend on our ability to protect those products and our technology with domestic and foreign patents.

We will also need to continue to preserve our trade secrets.

The issuance of a patent is not conclusive as to its validity or as to the

enforceable scope of the claims of the patent.

The patent positions of technology companies, including us, are uncertain and involve complex

legal and factual issues.

Our patents may not prevent other companies from developing similar products or products which produce benefits

substantially the same as our products, and other companies may be issued patents that may prevent the sale of our products or require

us to pay significant licensing fees in order to market our products.

From time to time, we may

need to obtain licenses to patents and other proprietary rights held by third parties in order to develop, manufacture and market our

If we are unable to timely obtain these licenses on commercially reasonable terms, our ability to commercially exploit such

products may be inhibited or prevented.

Our pending patent applications may not result in issued patents, patent protection may not be

secured for any particular technology, and our issued patents may not be valid or enforceable or provide us with meaningful protection.

If we are required to engage in expensive

and lengthy litigation to enforce our intellectual property rights, such litigation could be very costly and the results of such litigation

may not be satisfactory.

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and expensive and could result in our being prohibited from developing, marketing, selling or distributing our products.

Because of the complex and difficult

legal and factual questions that relate to patent positions in our industry, it is possible that our products or technology could be found

to infringe upon the intellectual property or proprietary rights of others.

Third parties may claim that our products or technology infringe

on their patents, copyrights, trademarks or other proprietary rights and demand that we cease development or marketing of those products

or technology or pay license fees.

We may not be able to avoid costly patent infringement litigation, which will divert the attention

of management away from the development of new products and the operation of our business.

We may not prevail in any such litigation.

If we are found to have infringed on a third-party’s intellectual property rights, we may be liable for money damages, encounter

significant delays in bringing products to market or be precluded from manufacturing particular products or using particular technology.

Other parties may challenge certain

of our foreign patent applications.

If any such parties are successful in opposing our foreign patent applications, we may not gain the

protection afforded by those patent applications in particular jurisdictions and may face additional proceedings with respect to similar

patents in other jurisdictions, as well as related patents.

The loss of patent protection in one jurisdiction may influence our ability

to maintain patent protection for the same technology in other jurisdictions.

Because of the complex and

difficult legal and factual questions that relate to patent positions in our industry, it is possible that our products or technology

could be found to infringe upon the intellectual property or proprietary rights of others.

Third parties may claim that our products or

technology infringe on their patents, copyrights, trademarks or other proprietary rights and demand that we cease development or marketing

of those products or technology or pay license fees.

We may not be able to avoid costly patent infringement litigation, which will divert

the attention of management away from the development of new products and the operation of our business.

We may not prevail in any such

If we are found to have infringed on a third-party’s intellectual property rights, we may be liable for money damages,

encounter significant delays in bringing products to market or be precluded from manufacturing particular products or using particular

Other parties may challenge

certain of our foreign patent applications.

If any such parties are successful in opposing our foreign patent applications, we may not

gain the protection afforded by those patent applications in particular jurisdictions and may face additional proceedings with respect

to similar patents in other jurisdictions, as well as related patents.

The loss of patent protection in one jurisdiction may influence

our ability to maintain patent protection for the same technology in other jurisdictions.

Risks Related to U.S.

Government Contracts

We may not obtain additional U.S.

contracts to further develop our technology.

While we have previously had U.S.

government contracts, we may not be successful in obtaining additional government grants or contracts.

We may not obtain U.S.

Government contracts

to further develop our technology.

While we have previously had

government contracts, we may not be successful in obtaining future government grants or contracts.

The process of obtaining government

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medical device technology.

Accordingly, although we have obtained government contracts in the past, we may not be awarded any additional

Accordingly, although we have obtained government contracts in the past, we may not be awarded any future U.S.

Government grants or contracts utilizing our Hemopurifier platform technology.

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a negative audit would be detrimental to

Our business plan to utilize the

Aethlon Hemopurifier technology may seek to involve contracts with the U.S.

Many government contracts, typically contain unfavorable

termination provisions and are subject to audit and modification by the government at its sole discretion, which would subject us to additional

risks should we obtain contracts with the U.S.

Our business plan to utilize

the Aethlon Hemopurifier technology may seek to involve contracts with the U.S.

Many government contracts, typically contain

unfavorable termination provisions and are subject to audit and modification by the government at its sole discretion, which would subject

us to additional risks should we obtain contracts with the U.S.

Government in the future.

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change certain terms and conditions in our contracts.

As a former and potential future

Government contractor, we are required to comply with applicable laws, regulations and standards relating to our accounting practices

and would be subject to periodic audits and reviews.

As a former and potential

Government contractor, we are required to comply with applicable laws, regulations and standards relating to our accounting

practices and would be subject to periodic audits and reviews.

As part of any such audit or review, the U.S.

Government may review the adequacy

of, and our compliance with, our internal control systems and policies, including those relating to our purchasing, property, estimating,

compensation and management information systems.

Government may review the

adequacy of, and our compliance with, our internal control systems and policies, including those relating to our purchasing, property,

estimating, compensation and management information systems.

Based on the results of its audits, the U.S.

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and other legal actions and liabilities.

Moreover, recent actions by the U.S.

Congress and executive agencies to reduce discretionary

spending, impose funding constraints, or shift policy priorities could limit the availability of government funding for programs that

might otherwise support the development or acquisition of our technology.

These developments could reduce the likelihood of future contract

opportunities or result in the modification, delay, or cancellation of existing or anticipated government solicitations involving our

As a potential future U.S.

Government contractor, we would be subject

to a number of procurement rules and regulations.

Government contractors must comply

with specific procurement regulations and other requirements.

These requirements, although customary in government contracts, would impact

our performance and compliance costs.

Government contractor, we would be

subject to a number of procurement rules and regulations.

Government contractors must

comply with specific procurement regulations and other requirements.

These requirements, although customary in government contracts, would

impact our performance and compliance costs.

In addition, current U.S.

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Risks Relating to Our Common Stock and Our Corporate Governance

If we are unable to regain compliance with the

listing requirements of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market, which could have a

material adverse effect on our financial condition and could make it more difficult for you to sell your shares.

Our common stock is listed on

the Nasdaq Capital Market and we are therefore subject to its continued listing requirements, including requirements with respect to the

market value of publicly held shares, market value of listed shares, minimum bid price per share (subject to a 180-day grace period, as

discussed below) and minimum stockholders' equity, among others, and requirements relating to board and committee independence.

fail to satisfy one or more of the requirements, we may be delisted from the Nasdaq Capital Market.

If we are unable to maintain compliance with

the listing requirements of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market, which could have

a material adverse effect on our financial condition and could make it more difficult for you to sell your shares.

Our common stock is listed

on the Nasdaq Capital Market and we are therefore subject to its continued listing requirements, including requirements with respect to

the market value of publicly held shares, market value of listed shares, minimum bid price per share (subject to a 180-day grace period,

as discussed below) and minimum stockholders’ equity, among others, and requirements relating to board and committee independence.

we fail to satisfy one or more of the requirements, we may be delisted from the Nasdaq Capital Market.

On June 27, 2024, we received

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business days.

On January 7, 2025, the Company

received a letter from Nasdaq (the “Extension Notice”) advising that the Company has been granted a 180-day extension, or

until June 23, 2025, to regain compliance with the Minimum Bid Price Requirement, in accordance with Nasdaq Listing Rule 5810(c)(3)(A).

If at any time prior to June 23, 2025, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum

of 10 consecutive trading days, the Company will regain compliance with the Minimum Bid Price Requirement.

On January 7, 2025, the Company

received a letter from Nasdaq (the “Extension Notice”) advising that the Company has been granted a 180-day extension, or

until June 23, 2025, to regain compliance with the Minimum Bid Price Requirement, in accordance with Nasdaq Listing Rule 5810(c)(3)(A).

If at any time prior to June 23, 2025, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum

of 10 consecutive trading days, the Company will regain compliance with the Minimum Bid Price Requirement.

Effective as of the close

of business on June 6, 2025 with an effective trading date of June 9, 2025 the Company effectuated a 1-for-8 reverse split to attempt

to maintain compliance with the $1.00 minimum bid requirement and to avoid, or at least mitigate, the likely adverse consequences of our

common stock being delisted from the Nasdaq Capital Market by producing the immediate effect of increasing the bid price of our common

On June 24, 2025, the Company

received notification that they had regained compliance with the Minimum Bid Price Requirement.

There can be no assurance,

however, that we will be able to regain compliance with the Minimum Bid Price Requirement.

Even if we do regain compliance, we may not

be able to maintain compliance with the continued listing requirements for the Nasdaq Capital Market or our common stock could be delisted

in the future.

In addition, we may be unable to meet other applicable listing requirements of the Nasdaq Capital Market, including maintaining

minimum levels of stockholders’ equity or market values of our common stock in which case, our common stock could be delisted notwithstanding

our ability to demonstrate compliance with the Minimum Bid Price Requirement.

Delisting from the Nasdaq Capital

Market may adversely affect our ability to raise additional financing through the public or private sale of equity securities, may significantly

affect the ability of investors to trade our securities and may negatively affect the value and liquidity of our common stock.

also could have other negative results, including the potential loss of employee confidence, the loss of institutional investors or interest

in business development opportunities.

Historically we have not paid dividends on our

common stock, and we do not anticipate paying any cash dividends in the foreseeable future.

however, that we will be able to continue to maintain compliance with the continued listing requirements for the Nasdaq Capital Market

and our common stock could be delisted in the future.

In addition, we may be unable to meet other applicable listing requirements of the

Nasdaq Capital Market, including maintaining minimum levels of stockholders’ equity or market values of our common stock in which

case, our common stock could be delisted notwithstanding our ability to demonstrate compliance with the Minimum Bid Price Requirement.

Delisting from the Nasdaq

Capital Market may adversely affect our ability to raise additional financing through the public or private sale of equity securities,

may significantly affect the ability of investors to trade our securities and may negatively affect the value and liquidity of our common

Delisting also could have other negative results, including the potential loss of employee confidence, the loss of institutional

investors or interest in business development opportunities.

Historically we have not paid dividends

on our common stock, and we do not anticipate paying any cash dividends in the foreseeable future.

We have never paid cash dividends

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will be the sole source of gain for our common stockholders in the foreseeable future.

Our stock price is speculative, and there is

a risk of litigation.

Our stock price is speculative, and there

is a risk of litigation.

The trading price of our common

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general market conditions;

social and geopolitical incidents and issues;

domestic or international terrorism and other factors;

the other factors described in this section.

Fluctuations in the price of our

common stock may expose us to the risk of securities class action lawsuits.

Although no such lawsuits are currently pending against us

and we are not aware that any such lawsuit is threatened to be filed in the future, future lawsuits are possible as a result of fluctuations

Fluctuations in the price

of our common stock may expose us to the risk of securities class action lawsuits.

Although no such lawsuits are currently pending against

us and we are not aware that any such lawsuit is threatened to be filed in the future, future lawsuits are possible as a result of fluctuations

in the price of our common stock.

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In addition, any settlement or adverse determination of such lawsuits could subject us to significant liability.

If at any time our common stock is subject to

the SEC’s penny stock rules, broker-dealers may experience difficulty in completing customer transactions and trading activity in

our securities may be adversely affected.

If at any time our common stock

is not listed on a national securities exchange or we have net tangible assets of $2,000,000 or less, or we have an average revenue of

less than $6,000,000 for the last three years, and our common stock has a market price per share of less than $5.00, transactions in our

common stock will be subject to the SEC’s “penny stock” rules.

If at any time our common stock is subject

to the SEC’s penny stock rules, broker-dealers may experience difficulty in completing customer transactions and trading activity

in our securities may be adversely affected.

If at any time our common

stock is not listed on a national securities exchange or we have net tangible assets of $2,000,000 or less, or we have an average revenue

of less than $6,000,000 for the last three years, and our common stock has a market price per share of less than $5.00, transactions in

our common stock will be subject to the SEC’s “penny stock” rules.

Currently, our common stock is subject to the SEC’s

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make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.

The broker or dealer must also

deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to the penny stock market, which,

in highlight form:

The broker or dealer must

also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to the penny stock market,

which, in highlight form:

sets forth the basis on which the broker or dealer made the suitability determination;

that the broker or dealer received a signed, written agreement from the investor prior to the transaction.

Generally, brokers may be less

willing to execute transactions in securities subject to the “penny stock” rules.

This may make it more difficult for investors

to dispose of our common stock and cause a decline in the market value of our stock.

Disclosure also has to be made

about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both

the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies available to an

investor in cases of fraud in penny stock transactions.

Generally, brokers may be

less willing to execute transactions in securities subject to the “penny stock” rules.

This may make it more difficult for

investors to dispose of our common stock and cause a decline in the market value of our stock.

Disclosure also has to be

made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable

to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies available

to an investor in cases of fraud in penny stock transactions.

Finally, monthly statements have to be sent disclosing recent price information

for the penny stock held in the account and information on the limited market in penny stocks.

Our common stock has had an unpredictable trading

volume which means you may not be able to sell our shares at or near trading prices or at all.

Trading in our common shares historically

has been volatile and often has been thin, meaning that the number of persons interested in purchasing our common shares at or near trading

prices at any given time may be relatively small or non-existent.

This situation is attributable to a number of factors, including the

fact that we are a small company which is relatively unknown to stock analysts, stock brokers, institutional investors and others in the

investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to

be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until

such time as we became more seasoned and viable.

As a consequence, there may be periods of several days or more when trading activity

in our shares is minimal, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally

support continuous sales without an adverse effect on share price.

A broader or more active public trading market for our common shares

may not develop or be sustained, and current trading levels may decrease.

The market price for our common stock is volatile;

Our common stock has had an unpredictable

trading volume which means you may not be able to sell our shares at or near trading prices or at all.

Trading in our common shares

historically has been volatile and often has been thin, meaning that the number of persons interested in purchasing our common shares

at or near trading prices at any given time may be relatively small or non-existent.

This situation is attributable to a number of factors,

including the fact that we are a small company which is relatively unknown to stock analysts, stock brokers, institutional investors and

others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons,

they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of

our shares until such time as we became more seasoned and viable.

As a consequence, there may be periods of several days or more when

trading activity in our shares is minimal, as compared to a seasoned issuer which has a large and steady volume of trading activity that

will generally support continuous sales without an adverse effect on share price.

A broader or more active public trading market for our

common shares may not develop or be sustained, and current trading levels may decrease.

The market price for our common stock is

you may not be able to sell our common stock at or above the price you have paid for it, which may result in losses to you.

The market for our common stock

is characterized by significant price volatility when compared to seasoned issuers, and we expect that our share price will continue to

be more volatile than a seasoned issuer for the indefinite future.

During the 52-week period ended March 31, 2024, the high and low closing

sale prices for a share of our common stock were $6.10 and $1.42, respectively.

The volatility in our share price is attributable to a

number of factors.

The market for our common

stock is characterized by significant price volatility when compared to seasoned issuers, and we expect that our share price will continue

to be more volatile than a seasoned issuer for the indefinite future.

During the 52-week period ended March 31, 2025, the high and low

closing sale prices for a share of our common stock were $14.08 and $2.08, respectively.

The volatility in our share price is attributable

to a number of factors.

First, as noted above, trading in our common stock often has been thin.

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with the stock of a seasoned issuer.

The following factors also may

add to the volatility in the price of our common stock:

The following factors also

may add to the volatility in the price of our common stock:

actual or anticipated variations in our quarterly or annual operating results;

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stock or convertible securities could be dilutive.

We are entitled under our articles

of incorporation to issue up to 60,000,000 shares of common stock.

As of March 31, 2024, we have reserved for issuance 124,028 of those

We are entitled under our

articles of incorporation to issue up to 60,000,000 shares of common stock.

As of March 31, 2025, we have reserved for issuance 319,518

shares of common stock for outstanding restricted stock units, stock options and warrants, excluding an aggregate of 71,432 issuances

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common stock available for issuance to new investors or for use to satisfy indebtedness or pay service providers.

On May 17, 2024, we closed a public

offering pursuant to which we sold an aggregate of:

(i) 2,450,000 shares of our common stock and accompanying Class A warrants to purchase

up to 2,450,000 shares of common stock and Class B warrants to purchase up to 2,450,000 shares of common stock, at a combined public offering

price of $0.58 per share and accompanying warrants;

and (ii) in lieu of common stock, pre-funded warrants to purchase 5,650,000 shares

of common stock and accompanying Class A warrants to purchase up to 5,650,000 shares of common stock and Class B warrants to purchase

up to 5,650,000 shares of common stock, at a combined public offering price of $0.579 per pre-funded warrant and accompanying warrants,

which is equal to the public offering price per share of common stock, and accompanying warrants less the $0.001 per share exercise price

of each such pre-funded warrant.

On March 24, 2022, we entered

into an At the Market Offering Agreement, or the 2022 ATM Agreement, with H.C.

Wainwright & Co., LLC, or Wainwright, which established

an at-the-market equity program pursuant to which we may offer and sell shares of our common stock from time to time as set forth in the

2022 ATM Agreement.

During the fiscal year ended March 31, 2024, we sold an aggregate of 296,056 shares under the 2022 ATM Agreement for

net proceeds of $1,322,383.

As of March 31, 2024, $5,302,617 of shares of common stock remained available for sale under the 2022 ATM

Our Board of Directors may generally

issue shares of common stock, restricted stock units or stock options or warrants to purchase those shares, without further approval by

our stockholders, based upon such factors as our Board of Directors may deem relevant at that time.

It is likely that we will be required

to issue a large amount of additional securities to raise capital to further our development.

It is also likely that we will be required

to issue a large amount of additional securities to directors, officers, employees and consultants as compensatory grants in connection

with their services, both in the form of stand-alone grants or under our stock plans.

Our officers and directors are entitled to indemnification from us

for liabilities under our articles of incorporation, which could be costly to us and may discourage the exercise of stockholder rights.

March 16, 2025, Aethlon Medical, Inc.

(the “Company”) entered into

an inducement offer to exercise existing Class A and Class B Warrants (the “Agreement”) with a certain accredited and institutional

holder (the “Holder”) of the Company’s outstanding Class A and Class B Warrants issued on May 17, 2024 (the “Existing

Pursuant to the Agreement, the Holder, upon exercise, will receive a new unregistered Common Stock Purchase Warrant

(“New Warrant”) pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (“Securities Act”), to purchase

up to a number of shares equal to 200% of the number of Warrant Shares issued pursuant to the exercise of Existing Warrants pursuant to

this Agreement (the “New Warrant Shares”), which New Warrant shall have an exercise price per share equal to $0.3736, subject

to adjustment as provided in the New Warrant, will be exercisable at any time on or after six (6) months from the date of issuance and

have a term of exercise of five and one-half (5.5) years from the date of issuance and a reduction of the exercise price of the Existing

Warrants to $0.3736 per share, representing the closing price on March 14, 2025, but only with respect to a cash exercise under the

Existing Warrants (as reduced from the current respective exercise price per share as set forth in the Existing Warrants).

closing took place on March 17, 2025.

Gross proceeds to the Company from the exercise of the Existing Warrants was $2,316,320, prior to

deducting closing costs and placement agent fees as further described below.

The Company intends to use the net proceeds from the offering

for working capital and general corporate purposes.

a result of the Holder exercising the Existing Warrants, the Company issued an aggregate of 6,200,000 shares of its common stock.

shares underlying the Existing Warrants have all been registered on Form S-1 registration statement (Registration Number 333-278188).

Company agreed to file a resale registration statement registering the shares underlying the Replacement Warrants (“Resale Registration

Statement”) within ninety (90) days of the date of the Agreement and to use commercially reasonable best efforts to cause the Resale

Registration Statement to be effective on or prior to the 150th calendar day after the date of the Agreement.

to the terms of the Agreement, the Company will be required to pay certain liquidated damages if the shares underlying the New Warrants

are not filed within the ninety (90) period, as more fully described in the Agreement.

Company further agreed that until sixty (60) days after the closing date of the warrant exercise, it will not (other than in connection

with limited enumerated exceptions) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares

of common stock or common stock equivalents or file any registration statement or any amendment or supplement (other than the registration

statement registering the shares underlying the Replacement Warrants).

connection with the transactions contemplated in the Agreement, the Company agreed to pay its placement agent, Maxim Group, LLC (the “Agent”)

the following compensation, (i) a cash fee equal to 6.0% of the gross proceeds received by the Company in the transactions contemplated

by the Agreement, and (ii) legal fees and out-of-pocket expenses of $15,000.

On May 17, 2024, we closed

a public offering pursuant to which we sold an aggregate of:

(i) 2,450,000 shares of our common stock and accompanying Class A warrants

to purchase up to 2,450,000 shares of common stock and Class B warrants to purchase up to 2,450,000 shares of common stock, at a combined

public offering price of $0.58 per share and accompanying warrants;

and (ii) in lieu of common stock, pre-funded warrants to purchase

5,650,000 shares of common stock and accompanying Class A warrants to purchase up to 5,650,000 shares of common stock and Class B warrants

to purchase up to 5,650,000 shares of common stock, at a combined public offering price of $0.579 per pre-funded warrant and accompanying

warrants, which is equal to the public offering price per share of common stock, and accompanying warrants less the $0.001 per share exercise

price of each such pre-funded warrant.

Our Board of Directors may

generally issue shares of common stock, restricted stock units or stock options or warrants to purchase those shares, without further

approval by our stockholders, based upon such factors as our Board of Directors may deem relevant at that time.

It is likely that we will

be required to issue a large amount of additional securities to raise capital to further our development.

It is also likely that we will

be required to issue a large amount of additional securities to directors, officers, employees and consultants as compensatory grants

in connection with their services, both in the form of stand-alone grants or under our stock plans.

Our officers and directors are entitled to indemnification from

us for liabilities under our articles of incorporation, which could be costly to us and may discourage the exercise of stockholder rights.

Our articles of incorporation

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benefit our company and stockholders.

Our bylaws and Nevada law may discourage, delay

or prevent a change of control of our company or changes in our management, would have the result of depressing the trading price of our

common stock.

Our bylaws and Nevada law may discourage,

delay or prevent a change of control of our company or changes in our management, would have the result of depressing the trading price

of our common stock.

Certain anti-takeover provisions

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the control shares.

Various provisions of our bylaws

may delay, defer or prevent a tender offer or takeover attempt of us that a stockholder might consider in his or her best interest.

bylaws may be adopted, amended or repealed by the affirmative vote of the holders of at least a majority of our outstanding shares of

capital stock entitled to vote for the election of directors, and except as provided by Nevada law, our Board of Directors shall have

Various provisions of our

bylaws may delay, defer or prevent a tender offer or takeover attempt of us that a stockholder might consider in his or her best interest.

Our bylaws may be adopted, amended or repealed by the affirmative vote of the holders of at least a majority of our outstanding shares

of capital stock entitled to vote for the election of directors, and except as provided by Nevada law, our Board of Directors shall have

the power to adopt, amend or repeal the bylaws by a vote of not less than a majority of our directors.

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company, thereby reducing the likelihood that you could receive a premium for your common stock in an acquisition.

We incur substantial costs as a result of being

a public company and our management expects to devote substantial time to public company compliance programs.

We incur substantial costs as a result of

being a public company and our management expects to devote substantial time to public company compliance programs.

As a public company, we incur

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common stock.

If securities or industry analysts do not publish

research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading

volume could decline.

The trading market for our common

stock will be influenced by the research and reports that industry or securities analysts publish about us or our business.

coverage by industry and financial analysts is currently limited.

Even if our analyst coverage increases, if one or more of the analysts

who cover us downgrade our stock, our stock price would likely decline.

If one or more of these analysts cease coverage of our company

or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price

or trading volume to decline.

If securities or industry analysts do not

publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price

and trading volume could decline.

The trading market for our

common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business.

research coverage by industry and financial analysts is currently limited.

Even if our analyst coverage increases, if one or more of the

analysts who cover us downgrade our stock, our stock price would likely decline.

If one or more of these analysts cease coverage of our

company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock

price or trading volume to decline.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors