What changed in this filing

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Item 1A. Risk Factors

2026-06-10 compared with 2025-06-26 · 1258 added, 918 removed, 869 unchanged (71% 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

We have incurred significant losses and expect to continue to

incur losses for the foreseeable future.

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.

We have never been profitable.

We did not generate any revenue during the fiscal years ended March 31, 2026 and March 31, 2025.

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.

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.

In prior fiscal years we recorded revenue

from government contracts, however, 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.

Although we had cash and cash equivalents of approximately $5.5 million as of March 31, 2026, 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 expect to seek additional

capital through equity financings and other potential sources of funding;

however, there can be no assurance that such financing will

be available on acceptable terms, in sufficient amounts, or at all.

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 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.

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.

There is substantial

doubt about our ability to continue as a going concern.

The 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.

The Company’s

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

To date, we 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

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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.

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

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

Delays, interruptions or the cessation of production

by our third-party suppliers of important materials or delays in qualifying new materials, have 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, could 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

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 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 current Food Manufacturing

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 and

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

Practices, or cGMP in the manufacture of our product.

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

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

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

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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,

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.

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 and,

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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The base cartridge on which the Hemopurifier is constructed is sourced

from Medica S.p.A and we are dependent on the continued availability of these cartridges.

from Medica S.p.A.

and we are dependent on the continued availability of these cartridges.

We currently purchase the diatomaceous earth

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The GNA is sourced from Vector Laboratories, Inc.

and also is available from other suppliers;

however, Sigma Aldrich

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.

Although alternate suppliers exist regulatory review and approval would

be required before we could utilize a replacement source.

Any business interruption at any of these sources, including the interruption

resulting from the delays in qualifying and obtaining any necessary regulatory approvals of alternate suppliers, could 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 better tolerated;

are more adaptable to various modes of dosing;

are more adaptable and easier to integrate into existing standards of care;

are easier to administer;

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

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.

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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,

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

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

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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.

Our success depends in part on our ability to obtain, maintain, protect

and enforce intellectual property protection for our proprietary technologies and products.

We rely on a combination of patent,

trade secret, copyright and trademark laws, as well as confidentiality agreements, licensing agreements and other agreements, to establish

and protect our proprietary rights.

Our success also depends, in part, on our ability to avoid infringing patents issued to others.

we were judicially determined to be infringing on any third-party patent, we could be required to pay damages, alter our products or processes,

obtain licenses or cease sales of products or certain activities.

Our pending and future patent

applications may not result in issued patents, and any patents that are issued may not provide meaningful protection or commercial advantage,

may be challenged, narrowed, invalidated or circumvented by third parties, or may not prevent competitors from developing similar technologies.

In addition, patent protection in foreign jurisdictions may be less extensive than in the United States.

We also rely on unpatented trade

secrets, proprietary know-how and technological expertise.

Third parties may independently develop similar technology, obtain access to

our proprietary information, or disclose our confidential information.

We rely, in part, on confidentiality agreements with

our marketing partners, employees, advisors, vendors and consultants to protect our trade secrets and proprietary technological expertise.

These measures may not adequately protect our proprietary

If we are unable to adequately protect our intellectual property and proprietary technology, our business, financial condition

and results of operations could be materially adversely affected.

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.

We have in the past

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

If we fail to maintain effective internal controls

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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.

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

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.

The homeland security industry is growing rapidly with many competitors

that are trying to develop products or vaccines to protect against infectious disease.

Any one of our competitors could develop a more

effective product which would render our technology obsolete.

Further, our ability to achieve significant and sustained penetration of

our key target markets will depend upon our success in developing or acquiring technologies developed by other companies, either independently,

through joint ventures or through acquisitions.

If we fail to develop or acquire, and manufacture and sell, products that satisfy our

customers’ demands, or we fail to respond effectively to new product announcements by our competitors by quickly introducing competitive

products, then market acceptance of our products could be reduced and our business could be adversely affected.

Our products may not remain

competitive with products based on new technologies.

Companies are developing a wide range of therapies, medical devices,

immunotherapies, biologics, blood purification technologies and other treatment approaches that may compete with the Hemopurifier for

the patient populations and disease indications we seek to address.

Anyone of our competitors could develop a more effective product which

would render our technology obsolete.

Further, our ability to achieve commercial acceptance of the Hemopurifier depends upon our success

in developing or acquiring technologies developed by other companies, either independently, through joint ventures or through acquisitions.

If we fail to develop or acquire, and manufacture and sell, products that satisfy our customers’ demands, or we fail to respond

effectively to new product announcements by our competitors by quickly introducing competitive products, then market acceptance of our

products could be reduced and our business could be adversely affected.

Our products may not remain competitive with products based on

new technologies.

We are highly dependent on our key personnel,

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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,

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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We utilize, whenever appropriate, consultants in order to conserve cash and resources.

Although we believe that these employees and

consultants will be able to handle most of our additional administrative, research and development and business development in the near

term, we will nevertheless be required over the longer-term to hire highly skilled managerial, scientific and administrative personnel

Although we believe that these employees

and consultants will be able to handle most of our additional administrative, research and development and business development in the

near term, we will nevertheless be required over the longer-term to hire highly skilled managerial, scientific and administrative personnel

to fully implement our business plan and growth strategies.

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or abroad, we may have significant difficulty

doing so due to the high cost of living in the Southern California area and due to the costs incurred with transferring personnel to the

If we cannot attract and retain qualified staff and executives, we will be unable to develop our products and achieve regulatory

clearance, and our business could fail.

We plan to expand our operations, which

may strain our resources;

doing so due to the high cost of living in the Southern California area and due to the costs incurred with transferring personnel to

If we cannot attract and retain qualified personnel, our product development, clinical development and regulatory activities

could be delayed or adversely affected, which could materially harm our business, financial condition and results of operations.

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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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 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 have investigated whether

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

manage our growth initiatives, including our expansion of our clinical trials in Australia 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 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 have investigated whether the

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

cytokines, chemokines and other inflammatory molecules from recovered organs.

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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

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

imposing additional duties, obligations and liabilities on management and directors.

Due to these perceived risks, directors and management

are also becoming increasingly concerned with the availability of directors’ and officers’ liability insurance to pay on a

timely basis the costs incurred in defending such claims.

While we currently carry directors’ and officers’ liability insurance,

such insurance is expensive and could be difficult to maintain in the future.

If we are unable to continue or provide directors’

and officers’ liability insurance at affordable rates or at all, it may become increasingly more difficult to attract and retain

qualified outside directors to serve on our Board of Directors.

We may lose potential independent board members and management candidates

to other companies in the biotechnology field that have greater directors’ and officers’ liability insurance to insure them

from liability or to biotechnology companies that have revenues or have received greater funding to date which can offer greater compensation

The fees of directors are also rising in response to their increased duties, obligations and liabilities.

In addition, our products

could potentially be harmful to users, and we are exposed to claims of product liability including for injury or death.

We have limited

insurance and may not be able to afford robust coverage even as our products are introduced into the market.

As a company with limited

resources and potential exposures to management, we will have a more difficult time attracting and retaining management and outside independent

directors than a more established public or private company due to these enhanced duties, obligations and potential liabilities.

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

governance requirements and regulatory.

Due to these perceived risks, directors and management are also becoming increasingly concerned

with the availability of directors’ and officers’ liability insurance to pay on a timely basis the costs incurred in defending

While we currently carry directors’ and officers’ liability insurance, such insurance is expensive and could

be difficult to maintain in the future.

If we are unable to continue or provide directors’ and officers’ liability insurance

at affordable rates or at all, it may become increasingly more difficult to attract and retain qualified outside directors to serve on

our Board of Directors.

We may lose potential independent board members and management candidates to other companies in the biotechnology

field that have greater directors’ and officers’ liability insurance to insure them from liability or to biotechnology companies

that have revenues or have received greater funding to date which can offer greater compensation packages.

The fees of directors are

also rising in response to their increased duties, obligations and liabilities.

In addition, our products could potentially be harmful

to users, and we are exposed to claims of product liability including for injury or death.

We have limited insurance and may not be able

to afford robust coverage even as our products are introduced into the market.

As a company with limited resources and potential exposures

to management, we will have a more difficult time attracting and retaining management and independent directors than a more established

public or private company due to these enhanced duties, obligations and potential liabilities.

If we fail to comply with extensive regulations

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 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

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.

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

Despite the time and expense exerted, regulatory approval

is never guaranteed.

Despite the time and expense exerted, regulatory approval is never

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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Our business prospects depend

on our ability to complete studies, commence and complete our planned clinical trials, including our ongoing and planned studies in solid

tumors in cancer, obtain satisfactory results, obtain required regulatory approvals and successfully commercialize our Hemopurifier product

Completion of our clinical trials, announcement of results of the trials and our ability to obtain regulatory approvals could

be delayed for a variety of reasons, including:

on our ability to complete studies, commence and complete our planned clinical trials, including our ongoing clinical trial evaluating

the Hemopurifier in patients with solid tumors and any future clinical studies obtain satisfactory results, obtain required regulatory

approvals and successfully commercialize our Hemopurifier product candidate.

Completion of our clinical trials, announcement of results

of the trials and our ability to obtain regulatory approvals could be delayed for a variety of reasons, including:

failure to obtain required approvals to commence our planned clinical trials;

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the failure of our principal third-party investigators to perform our clinical trials on our anticipated schedules;

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.

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.

different interpretations of our pre-clinical and

clinical data, which could initially lead to inconclusive results;

difficulty identifying, screening and enrolling eligible patients.

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.

Any product for which we obtain

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foreign regulatory bodies.

In particular, we and our third-party suppliers may be required to comply with the FDA’s Quality System

Regulation, or QSR.

These FDA regulations cover the methods and documentation of the design, testing, production, control, quality assurance,

labeling, packaging, sterilization, storage and shipping of our products.

Compliance with applicable regulatory requirements is subject

to continual review and is monitored rigorously through periodic inspections by the FDA.

If we, or our manufacturers, fail to adhere to

QSR requirements in the United States, this could delay production of our products and lead to fines, difficulties in obtaining regulatory

clearances, recalls, enforcement actions, including injunctive relief or consent decrees, or other consequences, which could, in turn,

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

In particular, we and our third-party suppliers may be required to comply with the FDA’s Quality Management

System Regulation, or QMSR, which incorporates by reference ISO 13485:2016 and establishes quality management system requirements for

medical device manufacturers.

These requirements govern the methods and documentation of the design, testing, production, control, quality

assurance, labeling, packaging, sterilization, storage and shipping of our products.

Compliance with applicable regulatory requirements

is subject to continual review and is monitored rigorously through periodic inspections by the FDA.

If we, or our manufacturers, fail

to adhere to applicable quality system requirements in the United States, this could delay production of our products and lead to fines,

difficulties in obtaining regulatory clearances, recalls, enforcement actions, including injunctive relief or consent decrees, or other

consequences, which could, in turn, have a material adverse effect on our financial condition or results of operations.

In addition, the FDA assesses

compliance with the QSR through periodic announced and unannounced inspections of manufacturing and other facilities.

The failure by us

or one of our suppliers to comply with applicable statutes and regulations administered by the FDA, or the failure to timely and adequately

compliance with the QMSR through periodic announced and unannounced inspections of manufacturing and other facilities.

The failure by

us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA, or the failure to timely and adequately

respond to any adverse inspectional observations or product safety issues, could result in any of the following enforcement actions:

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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 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

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.

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 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

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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

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

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 clinical and operational requirements associated with administration of the Hemopurifier

may limit physician adoption, patient acceptance or commercial viability.

The required testing of the product candidate may make that

candidate no longer commercially viable.

The conduct of clinical trials, particularly those involving infectious agents, may be critiqued

by the FDA, a clinical trial site’s IRB, biosafety committees other oversight bodies, 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.

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.

Our business model calls for the partial or full outsourcing of

the clinical and other development, sales and marketing of our product candidates in order to reduce our capital and infrastructure costs

as a means of potentially improving our financial position.

Our business model calls for the partial or full outsourcing

of the clinical and other development, sales and marketing of our product candidates in order to reduce our capital and infrastructure

costs as a means of potentially improving our financial position.

Our success will depend on the performance of these outsourced providers.

If these providers fail to perform adequately, our development of product candidates may be delayed and any delay in the development of

our product candidates would have a material and adverse effect on our business prospects.

If these providers fail to perform adequately, our development of product candidates may be delayed and any delay in the development

of our product candidates would have a material and adverse effect on our business prospects.

We are and will be exposed to product liability

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.

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

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

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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We have not received, and may never receive,

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.

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:

regulatory approval to market the Hemopurifier in the United States, Australia or other jurisdictions.

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.

our clinical development activities in Australia are subject to oversight by the Therapeutic Goods Administration (“TGA”) and

applicable ethics review bodies, and we may seek future regulatory approvals in Australia and other foreign jurisdictions.

authorities outside the United States may impose different requirements, standards and review processes than those imposed by the FDA

and obtaining regulatory approval in one jurisdiction does not guarantee approval in another jurisdiction.

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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inadequate compliance with preclinical, clinical or other regulations;

failure to satisfy the requirements of foreign regulatory authorities, including the TGA, for marketing authorization or commercialization;

our failure to meet the FDA’s statistical requirements for approval;

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.

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,

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

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.

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.

The approval requirements for medical products

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viruses that are not addressed with an approved therapy.” We currently have an open FDA approved Expanded Access Protocol for the

treatment of Ebola infected patients in the United States and a corresponding HealthCanada approval in Canada.

treatment of Ebola infected patients in the United States and a corresponding Health Canada approval in Canada.

Based on our studies to

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

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

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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conducted in compliance with FDA regulations, or the FDA may take enforcement action.

The data collected from these clinical studies may

ultimately be used to support market clearance for these products.

Even if our clinical trials are completed as planned, the results of

these trials may not support our product candidate claims and the FDA may not agree with our conclusions regarding the trial results.

The data collected from these clinical studies

may ultimately be used to support market clearance for these products.

Even if our clinical trials are completed as planned, the results

of these trials may not support our product candidate claims and the FDA may not agree with our conclusions regarding the trial results.

Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and the later

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ultimately, our ability to commercialize our product candidates and generate revenues.

It is also possible that patients enrolled in clinical

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

legislative or FDA regulatory reforms

It is also possible that patients enrolled in

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

legislative or FDA or TGA 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

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and marketing of regulated products or the reimbursement thereof.

In addition, FDA regulations and guidance are often revised or reinterpreted

by the FDA in ways that may significantly affect our business and our products.

In addition, FDA and TGA regulations and guidance are often revised

or reinterpreted in ways that may significantly affect our business and our products.

Any new regulations or revisions or reinterpretations

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It is impossible to predict whether legislative

changes will be enacted or FDA regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be on

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.

changes will be enacted or FDA or TGA regulations, guidance or interpretations changed, and what the impact of such changes, if any, may

be on 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.

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

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

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

federal data privacy and security laws;

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”.

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”.

In the United States, federal,

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For example, the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information

Technology for Economic and Clinical Health Act, or HITECH, imposes specific requirements relating to the privacy, security, and transmission

Technology for Economic and Clinical Health Act, or HITECH, imposes specific requirements relating to privacy, security, and transmission

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 operations;

disruptions of our business

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 sub processors 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.

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

we may experience delays in developing and deploying remedial measures and patches 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

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:

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

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;

including class claims;

litigation, including class

indemnification obligations;

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monetary fund diversions;

diversion of management

diversion of management attention;

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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of the costs and fees associated with the medical procedures being performed or to compensate them for their patient care services.

our products under development be approved for commercialization by the FDA, any such products may not be considered cost-effective, reimbursement

may not be available in the United States or other countries, if approved, and reimbursement may not be sufficient to allow sales of our

future products, including the Hemopurifier, on a profitable basis.

The coverage decisions of third-party payors will be significantly

influenced by the assessment of our future products by health technology assessment bodies.

These assessments are outside our control

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,

our products under development be approved for commercialization by the FDA, any such products may not be considered cost-effective,

reimbursement may not be available in the United States or other countries, if approved, and reimbursement may not be sufficient to allow

sales of our future products, including the Hemopurifier, on a profitable basis.

The coverage decisions of third-party payors will be

significantly influenced by the assessment of our future products by health technology assessment bodies.

These assessments are outside

our control 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,

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 control healthcare

Government and third-party payors are increasingly seek to contain healthcare costs by limiting coverage, reducing reimbursement

rates and implementing other cost containment measures that may affect the adoption of new medical technologies.

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.

On June 17, 2021, the U.S.

Supreme Court

dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate”

was repealed by Congress.

Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which

among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year

The IRA also eliminates the "donut hole" under the Medicare Part D program beginning in 2025 by significantly lowering

the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.

It is unclear how any such challenges, and

the healthcare reform measures of the Biden administration will impact the ACA and our business.

The Budget Control Act of 2011, as amended

by subsequent legislation, further reduces Medicare’s payments to providers by two percent through fiscal year 2032These reductions

may reduce providers’ revenues or profits, which could affect their ability to purchase new technologies.

by subsequent legislation, reduces Medicare’s payments to providers by two percent through fiscal year 2032.

These reductions may

reduce providers’ revenues or profits, which could affect their ability to purchase new technologies.

Furthermore, the healthcare

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costs by imposing lower payment rates and negotiating reduced contract rates with service providers.

In July 2021, the Biden Administration

released an executive order, “Promoting Competition in the American Economy,” which contained provisions relating to prescription

On September 9, 2021, in response to this executive order, the U.S.

Department of Health and Human Services, or HHS, released a

Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential

legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles.

Further, the IRA, among other things (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics

covered under Medicare and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.

These provisions will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges.

and will continue to issue and update guidance as these programs are implemented.

It is currently unclear how the IRA will be implemented

but is likely to have a significant impact on the pharmaceutical industry.

In addition, in response to the Biden administration’s

October 2022 executive order, on February 14, 2023, HHS released a report outlining three new models for testing by the Center for Medicare

and Medicaid Innovation which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality

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

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.

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offset its post-change income or taxes may be limited.

If we achieve profitability and an ownership change occurs and our ability to use

our net operating loss carryforwards is materially limited, it would harm our future operating results by effectively increasing our future

tax obligations.

In addition, at the state level, there may be periods during which the use of net operating loss carryforwards is suspended

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.

If we achieve profitability and an ownership change occurs and our ability to

use our net operating loss carryforwards is materially limited, it would harm our future operating results by effectively increasing

our future tax obligations.

In addition, at the state level, there may be periods during which the use of net operating loss carryforwards

is suspended 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.

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.

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.

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.

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

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

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

We currently carry a limited

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

Our products may in the future be subject

to product recalls.

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

Companies are required to maintain certain records of recalls, even if they are not reportable to 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 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

competent authority.

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.

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.

The Breakthrough Devices Program

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designation or access to any other expedited program.

Access to an expedited program may also be withdrawn by the FDA if it believes that

the designation is no longer supported by data from our clinical development program.

Additionally, qualification for any expedited review

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

Access to an expedited program may also be withdrawn by the FDA if it believes

that the designation is no longer supported by data from our clinical development program.

Additionally, qualification for any expedited

review 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

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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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

licensors may have relied on third-party consultants or collaborators or on funds from third parties such that our licensors are not

the sole and exclusive owners of the patents we in-license.

If other third parties have ownership rights to our in-licensed patents,

they may be able to license such patents to our competitors, and our competitors could market competing products and technology.

could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

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

in the marketplace and introduce products to market.

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

in litigation or proceedings before the U.S.

Patent and Trademark Office or foreign patent offices where our applications are pending.

Patent and Trademark Office or foreign offices may deny or require significant narrowing of claims in our pending patent applications.

Patents issued as a result of the pending patent applications, if any, may not provide us with significant commercial protection or be

issued in a form that is advantageous to us.

Proceedings before the U.S.

Patent and Trademark Office or foreign offices could result in

adverse decisions as to the priority of our inventions and the narrowing or invalidation of claims in issued patents.

The laws of some

foreign countries may not protect our intellectual property rights to the same extent as the laws of the U.S., if at all.

patents may expire before we receive FDA approval to market our products in the United States or we receive approval to market our products

in a foreign country.

Although we believe that certain patent applications and/or other patents issued more recently will help protect

the proprietary nature of the Hemopurifier treatment technology, this protection may not be sufficient to protect us during the development

of that technology.

Our competitors may successfully

challenge and invalidate or render unenforceable our issued patents, including any patents that may issue in the future, which could prevent

or limit our ability to market our products and could limit our ability to stop competitors from marketing products that are substantially

equivalent to ours.

In addition, competitors may be able to design around our patents or develop products that provide outcomes that are

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

In addition, we may not have sufficient resources to litigate, enforce or defend our intellectual property rights.

in either the patent laws or their interpretation in the United States and other countries may diminish our ability to protect our inventions,

obtain, maintain, and enforce our intellectual property rights and, more generally, could affect the value of our intellectual property

or narrow the scope of our owned and licensed patents.

With respect to both in-licensed and owned intellectual property, we cannot predict

whether the patent applications we and our licensors are currently pursuing will issue as patents in any particular jurisdiction or whether

the claims of any issued patents will provide sufficient protection from competitors or other third parties.

Our pending and issued patent

claims for our Hemopurifier devices are not broad, and it is possible that a competitor may seek to make modifications to their product

in an effort to design around our patent claims and avoid infringement.

patent prosecution process is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce, or

license all necessary or desirable patent applications at a reasonable cost or in a timely manner.

It is also possible we will be unsuccessful

in our efforts to identify patentable aspects of our research and development output in time to obtain patent protection.

enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research

and development output, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers,

consultants, advisors, and other third parties, any of these parties may breach the agreements and disclose such output before a patent

application is filed, thereby jeopardizing our ability to seek patent protection.

In addition, our ability to obtain and maintain valid

and enforceable patents depends on whether the differences between our inventions and the prior art allow our inventions to be patentable

over the prior art.

Furthermore, publications of discoveries in the scientific literature often lag the actual discoveries, and patent

applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases

Therefore, we cannot be certain that we or our licensors were the first to make the inventions claimed in any of our owned

or licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such

position of biotechnology, medical device and life sciences companies generally is highly uncertain, involves complex legal and factual

questions, and has been the subject of much litigation in recent years.

As a result, the issuance, scope, validity, enforceability, and

commercial value of our patent rights are highly uncertain.

Our owned or in-licensed pending and future patent applications may not result

in patents being issued which protect our Hemopurifier devices and other product candidates or proprietary technologies that we may seek

to develop or which effectively prevent others from commercializing competitive technologies and product candidates.

the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted

after issuance.

Even if patent applications we license or own currently or in the future issue as patents, they may not issue in a form

that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide

us with any competitive advantage.

Any patents we own or in-license may be challenged, narrowed, circumvented, or invalidated by third

Consequently, we do not know whether our Hemopurifier devices and other proprietary technology will be protectable or remain

protected by valid and enforceable patents.

Our competitors or other third parties may be able to circumvent our patents by developing

similar or alternative technologies or products in a non-infringing manner which could materially adversely affect our business, financial

condition, results of operations and prospects.

of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, and our patents may be challenged in the courts

or patent offices in the United States and abroad.

We or our licensors may be subject to a third-party pre-issuance submission of prior

art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant and inter partes review,

or interference proceedings or other similar proceedings challenging our owned or licensed patent rights.

An adverse determination

in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, our owned or in-licensed

patent rights, allow third parties to commercialize versions of our products, product candidates and other proprietary technologies we

may develop and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without

infringing third-party patent rights.

Moreover, we, or one of our licensors, may have to participate in interference proceedings declared

by the USPTO to determine priority of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office,

that challenge our or our licensor’s priority of invention or other features of patentability with respect to our owned or in-licensed

patents and patent applications.

Such challenges may result in loss of patent rights, loss of exclusivity, or in patent claims being narrowed,

invalidated, or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical technology

and products, or limit the duration of the patent protection of our product candidates and other proprietary technologies we may develop.

Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual

outcome is favorable to us.

given the amount of time required for the commercialization, development, testing, and regulatory review of our products and product

candidates, patents protecting such products and product candidates might expire before or shortly after such products or product candidates

are fully commercialized.

Moreover, some of our owned and in-licensed patents and patent applications may in the future be co-owned with

third parties.

If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent

applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors

could market competing products and technology.

In addition, we may need the cooperation of any such co-owners of our patents in order

to enforce such patents against third parties, and such cooperation may not be provided to us.

Furthermore, our owned and in-licensed

patents may be subject to a reservation of rights by one or more third parties.

Any of the foregoing could have a material adverse effect

on our competitive position, business, financial conditions, results of operations, and prospects.

We may not be able

to protect our intellectual property and proprietary rights throughout the world.

prosecuting, and defending patents on our products, product candidates and other proprietary technologies we may develop in all countries

throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect our rights to the same extent

as the laws of the United States.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries

outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.

Competitors may use our technology in jurisdictions where we have not obtained patent protection to develop their own products and, further,

may export otherwise infringing products to territories where we have patent protection but enforcement is not as strong as that in the

United States.

These products may compete with our products, and our patents or other intellectual property rights may not be effective

or sufficient to prevent them from competing.

companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets,

and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for

us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary

rights generally.

In addition, some jurisdictions, such as Europe, Japan, and China, may have a higher standard for patentability than

in the United States, including for example the requirement of claims having literal support in the original patent filing and the limitation

on using supporting data that is not in the original patent filing.

Under those heightened patentability requirements, we may not be able

to obtain sufficient patent protection in certain jurisdictions even though the same or similar patent protection can be secured in United

States and other jurisdictions.

to enforce our intellectual property and proprietary rights in foreign jurisdictions could result in substantial costs and divert our

efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly,

could put our patent applications at risk of not issuing, and could provoke third parties to assert claims against us.

We may not prevail

in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

our efforts to enforce our intellectual property and proprietary rights around the world may be inadequate to obtain a significant commercial

advantage from the intellectual property we develop or license.

countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.

many countries limit the enforceability of patents against government agencies or government contractors.

In these countries, the patent

owner may have limited remedies, which could materially diminish the value of such patent.

If we or any of our licensors are forced to

grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our

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

Obtaining and maintaining

our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed

by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

maintenance fees, renewal fees, annuity fees, and various other government fees on patents and applications will be due to be paid to

the USPTO and various government patent agencies outside of the United States over the lifetime of our owned or licensed patents and

applications.

In certain circumstances, we rely on our licensing partners to pay these fees due to U.S.

patent agencies.

The USPTO and various non-United States government agencies require compliance with several procedural, documentary, fee payment, and

other similar provisions during the patent application process.

We are also dependent on our licensors to take the necessary action to

comply with these requirements with respect to our licensed intellectual property.

In some cases, an inadvertent lapse can be cured by

payment of a late fee or by other means in accordance with the applicable rules.

There are situations, however, in which non-compliance

can result in abandonment or lapse of the patent or patent application, resulting in a partial or complete loss of patent rights in the

relevant jurisdiction.

In such an event, potential competitors might be able to enter the market with similar or identical products or

technology, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Changes in U.S.

law could diminish the value of patents in general, thereby impairing our ability to protect our products.

in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding

the prosecution of patent applications and the enforcement or defense of issued patents.

Assuming other requirements for patentability

are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside

the United States, the first to file a patent application was entitled to the patent.

After March 2013, under the Leahy-Smith America

Invents Act (the America Invents Act) enacted in September 2011, the United States transitioned to a first inventor to file system in

which, assuming other requirements for patentability are met, the first inventor to file a patent application will be entitled to the

patent on an invention regardless of whether a third party was the first to invent the claimed invention.

A third party that files a patent

application in the USPTO after March 2013, but before we do could therefore be awarded a patent covering an invention of ours even if

we had made the invention before it was made by such third party.

This will require us to be cognizant going forward of the time from

invention to filing of a patent application.

Since patent applications in the United States and most other countries are confidential

for a period after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent

application related to our Hemopurifier devices and other proprietary technologies we may develop or (ii) invent any of the inventions

claimed in our or our licensor’s patents or patent applications.

Invents Act also includes a number of significant changes that affect the way patent applications will be prosecuted and also may affect

patent litigation.

These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures

to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review,

and derivation proceedings.

Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S.

federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient

for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in

a district court action.

Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would

not have been invalidated if first challenged by the third party as a defendant in a district court action.

Therefore, the America Invents

Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned or in-licensed patent applications

and the enforcement or defense of our owned or in-licensed issued patents, all which could have a material adverse effect on our business,

financial condition, results of operations, and prospects.

the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain.

Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights

of patent owners in certain situations.

This combination of events has created uncertainty with respect to the validity and enforceability

of patents, once obtained.

Depending on future actions by the U.S.

Congress, the federal courts, and the USPTO, the laws and regulations

governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our

ability to protect and enforce our intellectual property in the future.

Issued patents covering

our Hemopurifier devices and other proprietary technologies we may develop could be found invalid or unenforceable if challenged in court

or before administrative bodies in the United States or abroad.

or one of our licensors initiated legal proceedings against a third party to enforce a patent covering our Hemopurifier devices or other

proprietary technologies we may develop, the defendant could counterclaim that such patent is invalid or unenforceable.

In patent litigation

in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace.

Grounds for a validity challenge

could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement.

Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant

information from the USPTO, or made a misleading statement, during prosecution.

Third parties may raise claims challenging the validity

or enforceability of our owned or in-licensed patents before administrative bodies in the United States or abroad, even outside the context

of litigation.

Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings,

derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).

Such proceedings could result

in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our Hemopurifier devices and

other proprietary technologies we may develop.

The outcome following legal assertions of invalidity and unenforceability is unpredictable.

With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we or our licensing

partners and the patent examiner were unaware during prosecution.

If a third party were to prevail on a legal assertion of invalidity

or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates and other proprietary

technologies we may develop.

Such a loss of patent protection would have a material adverse impact on our business, financial condition,

results of operations, and prospects.

If we do not obtain

a Patent Term Extension (PTE) for our products or product candidates, our business may be materially harmed.

more of our owned or in-licensed U.S.

patents covers our Hemopurifier devices, and depending upon the timing, duration and specifics of

any FDA marketing approval of any other product candidate we may develop, our patents may be eligible for limited PTE under the Hatch-Waxman

The Hatch-Waxman Amendments permit a PTE of up to 5 years as compensation for patent term lost during the FDA regulatory review

A PTE cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent

may be extended, and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.

Similar patent term restoration provisions to compensate for commercialization delay caused by regulatory review are also available in

certain foreign jurisdictions, such as in Europe under Supplemental Protection Certificate (SPC).

Further, if the FDA determines that

our Hemopurifier devices does not represent the first permitted commercial marketing or use of the product, or the active ingredients,

we may fail to satisfy applicable requirements which could materially harm us and our operations.

We may be subject to

claims challenging the inventorship of our patents and other intellectual property.

our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in our owned or in-licensed

patents, trade secrets, or other intellectual property as an inventor or co-inventor.

For example, we or our licensors may have inventorship

disputes arise from conflicting obligations of consultants or others who are involved in developing our products or product candidates

and other proprietary technologies we may develop.

Litigation may be necessary to defend against these and other claims challenging inventorship

or our or our licensor’s ownership of our owned or in-licensed patents, trade secrets or other intellectual property.

licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights,

such as exclusive ownership of, or right to use, intellectual property that is important to our products, product candidates and other

proprietary technologies we may develop.

Even if we are successful in defending against such claims, litigation could result in substantial

costs and be a distraction to management and other employees.

Any of the foregoing could have a material adverse effect on our business,

financial condition, results of operations and prospects.

If we are unable to

protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

to seeking and maintaining patents for our Hemopurifier devices and other proprietary technologies we may develop, we also rely on trade

secrets and confidentiality agreements to protect our unpatented know-how, technology, and other proprietary information and to maintain

our competitive position.

With respect to our Hemopurifier devices, we consider trade secrets and know-how to be one of our important

sources of intellectual property.

Trade secrets and know-how can be difficult to protect.

In particular, our trade secrets and know-how

in connection with our Hemopurifier devices and other proprietary technology we may develop over time may be disseminated within the industry

through independent development, the publication of journal articles describing the methodology, and the movement of personnel with scientific

positions in academic and industry.

to protect these trade secrets and other proprietary technology, in part, by entering into non-disclosure and confidentiality agreements

with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract

manufacturers, consultants, advisors, and other third parties.

We also enter into confidentiality and invention or patent assignment agreements

with our employees and consultants.

We cannot guarantee we have entered into such agreements with each party that may have or have had

access to our trade secrets or proprietary technology and processes.

Despite these efforts, any of these parties may breach the agreements

and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time-consuming, and

the outcome is unpredictable.

In addition, some courts inside and outside the United States are less willing or unwilling to protect trade

If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we

would have no right to prevent them from using that technology or information to compete with us.

If any of our trade secrets were to

be disclosed to or independently developed by a competitor or other third party, our competitive position would be materially and adversely

be subject to claims that third parties have an ownership interest in our trade secrets.

For example, we may have disputes arise from

conflicting obligations of our employees, consultants or others who are involved in developing our products and product candidates.

may be necessary to defend against these and other claims challenging ownership of our trade secrets.

If we fail in defending any such

claims, in addition to paying monetary damages, it may lose valuable trade secret rights, such as exclusive ownership of, or right to

use, trade secrets that are important to a product candidate and other proprietary technologies we may develop.

Such an outcome could

have a material adverse effect on our business.

Even if we are successful in defending against such claims, litigation could result in

substantial costs and be a distraction to management and other employees.

We may be subject to

claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

common in the biotechnology, medical device and life sciences industries, we employ individuals who were previously employed at other

biotechnology or pharmaceutical companies, including our competitors or potential competitors.

Although we have no knowledge of any claims

against us, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or

other proprietary information of their former employers.

Litigation may be necessary to defend against these claims.

Even if we are successful

in defending against these claims, litigation could result in substantial costs and be a distraction to management.

To date, none of our

employees have been subject to such claim.

We may be at risk that

our former employees may wrongfully use or disclose our trade secrets.

to patent protection, we rely heavily upon know-how and trade secret protection, as well as non-disclosure agreements and invention assignment

agreements with our employees, consultants, and third parties, to protect our confidential and proprietary information, especially where

we do not believe patent protection is appropriate or obtainable.

In addition to contractual measures, we try to protect the confidential

nature of our proprietary information using physical and technological security measures.

Such measures may not, for example, in the case

of misappropriation of a trade secret by an employee, former employee, consultant, former consultant or third party with authorized access,

provide adequate protection for our proprietary information.

Our security measures may not prevent an employee or consultant from misappropriating

our trade secrets and providing them to a competitor, and recourse we take against such misconduct may not provide an adequate remedy

to protect our interests fully.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult,

expensive, and time-consuming, and the outcome is unpredictable.

In addition, trade secrets may be independently developed by others in

a manner that could prevent legal recourse by us.

If any of our confidential or proprietary information, such as our trade secrets, were

to be disclosed or misappropriated, or if any such information was independently developed by a competitor, our competitive position could

We may rely on licenses for new technology,

9 unchanged sentences

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.

If we are unable to protect our proprietary

technology and preserve our trade secrets, we will increase our vulnerability to competitors which could materially adversely impact our

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 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.

Although we have entered into

invention assignment agreements with our employees and with certain advisors, and we routinely enter into confidentiality agreements with

our contract partners, if those employees, advisors or contract partners develop inventions or processes independently that may relate

to products or technology under development by us, disputes may arise about the ownership of those inventions or processes.

Time-consuming

and costly litigation could be necessary to enforce and determine the scope of our rights under these agreements.

In addition, we may

be required to commence litigation to enforce such agreements if they are violated, and it is certainly possible that we will not have

adequate remedies for breaches of our confidentiality agreements as monetary damages may not be sufficient to compensate us.

unable to fund the costs of any such litigation to a satisfactory conclusion, which could leave us without recourse to enforce contracts

that protect our intellectual property rights.

Other companies may claim that our technology

infringes on their intellectual property or proprietary rights and commence legal proceedings against us which could be time-consuming

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

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.

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.

Third-party claims

of intellectual property infringement, induced intellectual property infringement, misappropriation or other violation against us or our

collaborators may prevent or delay the development and commercialization of our products, product candidates and other proprietary technologies

we may develop.

in which we are developing the Hemopurifier, including oncology, infectious disease, transplantation and other extracorporeal therapeutic

applications, are competitive and dynamic.

Due to significant research and development activities taking place in the fields of oncology,

infectious disease, extracellular vesicle biology, blood purification technologies and related therapeutic modalities the intellectual

property landscape is in flux, and it may remain uncertain in the future.

There may be significant intellectual property related litigation

and proceedings relating to our owned and in-licensed and other third-party intellectual property and proprietary rights in the future.

Our commercial

success depends in part on our and our collaborators’ ability to avoid infringing, inducing infringement, misappropriating and otherwise

violating the patents and other intellectual property rights of third parties.

There is a substantial amount of complex litigation involving

patents and other intellectual property rights in the biotechnology and biopharmaceutical industries, as well as administrative proceedings

for challenging patents, including interference, derivation and reexamination proceedings before the USPTO or oppositions and other comparable

proceedings in foreign jurisdictions.

As discussed above, recently, due to changes in U.S.

law referred to as patent reform, new procedures

including inter partes review and post-grant review have been implemented.

As stated above, this reform adds uncertainty to

the possibility of challenge to our patents in the future.

and foreign issued patents and pending patent applications owned by third parties exist in the fields of extracorporeal medical devices,

blood purification technologies, lectin-affinity technologies, oncology, infectious diseases, extracellular vesicle biology and related

therapeutic applications in which we are developing the Hemopurifier and other proprietary technologies.

As the biotechnology, medical

device and life sciences industries expand and more patents are issued, the risk increases that our product candidate may give rise to

claims of infringement of the patent rights of others.

We cannot assure you that our Hemopurifier and other proprietary technologies we

may develop will not infringe existing or future patents owned by third parties.

We may not be aware of patents that have already been

issued and that a third party, for example, a competitor in the fields in which we are commercializing or developing our products or product

candidates, might assert are infringed by our current or future product candidates, including claims to compositions, formulations, methods

of manufacture or methods of use or treatment that cover our product candidates.

It is also possible that patents owned by third parties

of which we are aware, but which we do not believe are relevant to our products, product candidates and other proprietary technologies

we may develop, could be found to be infringed by our products or product candidate.

In addition, because patent applications can take

many years to issue, there may be currently pending patent applications that may later result in issued patents that our products or product

candidate may infringe.

parties may currently have patents or obtain patents in the future and may claim that use of our technology or the manufacture, use or

sale of our product candidates infringes upon these patents.

In the event a third party claims we infringed their patents or that we are

otherwise employing their proprietary technology without authorization and initiates litigation against us, even if we believe such claims

are without merit, a court of competent jurisdiction could hold that such patents are valid, enforceable and infringed by our technology,

products or product candidates.

In this case, the holders of such patents may be able to block our ability to commercialize the applicable

product candidate or technology unless we obtain a license under the applicable patents, or until such patents expire or are finally determined

to be held invalid or unenforceable.

Such a license may not be available on commercially reasonable terms or at all.

Even if we are able

to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights granted to us might

be nonexclusive, which could result in our competitors gaining access to the same intellectual property.

If we are unable to obtain a

necessary license to a third-party patent on commercially reasonable terms, we may be unable to commercialize our products, product candidates

or technology or such commercialization efforts may be significantly delayed, which could in turn significantly harm our business.

of infringement claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of

management and other employee resources from our business, and may impact our reputation.

In the event of a successful claim of infringement

against us, we may be enjoined from further developing or commercializing our infringing products or technology.

In addition, we may have

to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from

third parties, pay royalties and/or redesign our infringing products or technology, which may be impossible or require substantial time

and monetary expenditure.

In that event, we would be unable to further develop and commercialize our product, product candidates or technology,

which could harm our business significantly.

Further, we cannot predict whether any required license would be available at all or whether

we would be available on commercially reasonable terms.

In the event we could not obtain a license, we may be unable to further develop

our product, product candidates and commercialize our product and product candidates, if approved, which could harm our business significantly.

Even if we are able to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights

granted to us might be nonexclusive, which could result in our competitors gaining access to the same intellectual property.

we could be prevented from commercializing a product or be forced to cease some aspect of our business operations such as the commercialization

of the Hemopurifier, if, as a result of actual or threatened patent infringement claims, we are unable to enter licenses on acceptable

in litigation defending us against third parties alleging infringement of patent and other intellectual property rights is very expensive,

particularly for a company of our size, and time-consuming.

Some of our competitors may be able to sustain the costs of litigation or

administrative proceedings more effectively than we can because of greater financial resources.

Patent litigation and other proceedings

may also absorb significant management time.

Uncertainties resulting from the initiation and continuation of patent litigation or other

proceedings could impair our ability to compete in the marketplace.

The occurrence of any of the foregoing could have a material adverse

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

In the ordinary course,

we have been and again may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which

could be expensive, time consuming, and unsuccessful.

or other third parties may infringe our patents or the patents of our licensing partners.

We have and may again be required to defend

against claims of infringement or otherwise engage in legal action to protect our intellectual property.

Any commercial success we may

achieve with the Hemopurifier may incentivize third parties to challenge or infringe our intellectual property.

In addition, our patents

or the patents of our licensing partners also may become involved in inventorship, priority or validity disputes.

To counter or defend

against these claims is expensive and time consuming.

In an infringement proceeding, a court may decide a patent owned or in-licensed

by us is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds our owned and

in-licensed patents do not cover the technology in question.

An adverse result in any litigation proceeding could put one or more of our

owned or in-licensed patents at risk of being invalidated or interpreted narrowly.

Furthermore, because of the substantial amount of discovery

required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised

by disclosure during this type of litigation.

if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant

expenses and could distract our personnel from their normal responsibilities.

In addition, there could be public announcements of the

results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results

to be negative, it could have a substantial adverse effect on the price of our common stock.

These litigation or proceedings could substantially

increase our operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution

We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately.

competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial

resources and more mature and developed intellectual property portfolios.

Uncertainties resulting from the initiation and continuation

of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

If our trademarks and

trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business

may be adversely affected.

Our registered

or unregistered trademarks or trade names have in the ordinary course of our business been challenged and may again be challenged by third

These trademarks and trade names may also be infringed, circumvented or may not be registered with the USPTO or determined to

be infringing on other marks.

During trademark registration proceedings, we may receive rejections of our applications by the USPTO or

in other foreign jurisdictions.

Although we are given an opportunity to respond to those rejections, we may be unable to overcome such

In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity

to oppose pending trademark applications and to seek to cancel registered trademarks.

Opposition or cancellation proceedings may be filed

against our trademarks, and our trademarks may not survive such proceedings.

Moreover, any name we have proposed to use with our product

or product candidates in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register

it, as a trademark.

Similar requirements exist in Europe.

The FDA typically conducts a review of proposed product names, including an

evaluation of potential for confusion with other product names.

Furthermore, in many countries, owning and maintaining a trademark registration

may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark.

not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners

or customers in our markets of interest.

At times, competitors or other third parties may adopt trade names or trademarks similar to ours,

thereby impeding our ability to build brand identity and possibly leading to market confusion.

In addition, we may be subject to potential

trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations

of our registered or unregistered trademarks or trade names or that allege we have infringed on their trademarks and trade names.

the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete

effectively and our business may be adversely affected.

Our efforts to enforce or protect our proprietary rights or to defend ourselves

in suits related to our trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could

result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations

and prospects.

Intellectual property

rights do not necessarily address all potential threats.

of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and

may not adequately protect our business or permit us to maintain our competitive advantage.

· others may be able to make products that

are similar to our products or product candidates or utilize similar technology but that are not covered by the claims of the patents

that we license or may own;

or our current or future licensors or collaborators, might not have been the first to make the inventions covered by the issued patent

or pending patent application that we license or may own in the future;

or our current or future licensors or collaborators, might not have been the first to file patent applications covering certain of our

or their inventions;

may independently develop similar or alternative technologies or duplicate any of our technology without infringing our owned or licensed

intellectual property rights;

is possible that our current or future pending owned or licensed patent applications will not lead to issued patents;

patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors or

other third parties;

competitors or other third parties might conduct research and development activities in countries where we do not have patent rights

and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

may not develop additional proprietary technologies that are patentable;

patents of others may harm our business;

may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent

covering such intellectual property.

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

Risks Related to U.S.

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to further develop our technology.

While we have previously had

we have previously had U.S.

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

The process of obtaining government

contracts is lengthy with the uncertainty that we will be successful in obtaining announced grants or contracts for therapeutics as a

medical device technology.

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.

of obtaining government contracts is lengthy with no assurance that we will successfully obtain grants or contracts relating to therapeutic

medical device technologies, including the Hemopurifier .

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.

Government agencies have special contracting

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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.

We may seek future funding opportunities

through contracts, grants or other arrangements with U.S.

Government agencies.

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

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 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 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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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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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

a letter, or Notice, from The Nasdaq Stock Market, or Nasdaq, that we were not in compliance with the $1.00 minimum bid price requirement

for continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2), or the Minimum Bid Price Requirement.

The Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), we have 180 calendar days to regain compliance with the

Minimum Bid Price Requirement by having the closing bid price of our common stock meet or exceed $1.00 per share for at least ten consecutive

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 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.

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.

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

There can be no assurance, 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 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.

If Nasdaq adopts proposed continued listing

standards requiring a minimum market value of listed securities of at least $5 million and we fail to satisfy such requirements, our common

stock could become subject to delisting proceedings, which could materially harm our business.

On January 13, 2026, Nasdaq filed

a proposed rule change with the Securities and Exchange Commission, or SEC, to adopt a new continued listing requirement applicable to

companies listed on the Nasdaq Global Market and the Nasdaq Capital Market requiring the maintenance of a minimum Market Value of Listed

Securities, or MVLS, of at least $5 million.

Under the proposal, a company that fails to maintain an MVLS of at least $5 million for 30

consecutive business days could become subject to suspension and delisting proceedings.

The proposal would apply to companies listed on

the Nasdaq Capital Market, including our company.

The proposed rule has not been approved by the SEC.

On April 28, 2026, the SEC instituted

proceedings to determine whether to approve or disapprove the proposal and solicited additional public comment regarding the proposed

As a result, there can be no assurance that the proposal will be adopted in its current form, modified form, or at all.

the proposal is approved and becomes effective, and if we fail to satisfy any applicable MVLS requirement, we could become subject to

Nasdaq deficiency, suspension or delisting proceedings.

Delisting of our common stock could materially and adversely affect the liquidity

and market price of our common stock, reduce analyst coverage and investor interest in our company, impair our ability to raise additional

capital, limit the number of investors willing to hold or acquire our securities and otherwise adversely affect our business, financial

condition and results of operations.

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.

The market price of our common stock is speculative

and may be volatile, which could result in securities litigation.

The trading price of our common

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announcements regarding our ongoing development of the Hemopurifier;

results regarding the progress of our clinical trials with the Hemopurifier;

results reported from our clinical trials with the Hemopurifier;

the initiation, progress, enrollment, results or discontinuation of clinical trials involving the Hemopurifier;

failure to meet the continued listing requirements of and maintain our listing on Nasdaq;

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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.

Currently, our common stock is subject to the SEC’s

“penny stock” rules promulgated under the Exchange Act and as a result, broker-dealers may find it difficult to effectuate

customer transactions and trading activity in our securities may be adversely affected.

For any transaction involving a penny stock, unless

exempt, the rules require:

that a broker or dealer approve a person’s account for transactions in penny stocks;

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.

Although our common stock is currently listed on the

Nasdaq Capital Market and is therefore generally exempt from the SEC’s penny stock rules, if our common stock were delisted from Nasdaq

and otherwise met the criteria for classification as a penny stock, transactions in our common stock could become subject to the SEC’s

penny stock rules, which could adversely affect the liquidity and market price of our common stock.

For any transaction involving a penny

stock, unless exempt, the rules require:

that a broker or dealer approves a person’s account for transactions in penny stocks;

furnish the investor a disclosure document describing the risks of investing in penny stocks;

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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 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 may be reluctant to follow an unproven clinical-stage 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

with limited operating history and no approved products.

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.

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;

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, 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.

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, 2026, the high and low closing

sale prices for a share of our common stock were $33.19 and $1.65, 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, 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

of restricted stock units to our independent directors under our 2020 Equity Incentive Plan made subsequent to March 31, 2025.

31, 2025, we had issued and outstanding 2,585,239 shares of common stock.

As a result, as of March 31, 2025 we had 57,023,811 shares of

common stock available for issuance to new investors or for use to satisfy indebtedness or pay service providers.

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.

We are entitled under our articles

of incorporation to issue up to 100,000,000 shares of common stock.

As of March 31, 2026, we have reserved for issuance 1,958,149 shares

of common stock for outstanding restricted stock units, stock options and warrants, excluding an aggregate of 87,260 issuances of restricted

stock units to our independent directors under our 2020 Equity Incentive Plan made subsequent to March 31, 2026.

As of March 31, 2026,

we had issued and outstanding 1,570,449 shares of common stock issued and outstanding and as of March 31, 2026 we had 96,471,402 shares

of common stock available for future issuances.

Subsequent to March 31, 2026, we issued additional shares of common stock, including under

our at-the-market offering program, and may continue to issue additional securities in the future.

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.

In addition, we may sell securities from time to

time under existing registration statements, including any shelf registration statement and related prospectus supplements, or under future

registration statements that we may file with the SEC.

Any such issuances, as well as the exercise, conversion or settlement of outstanding

warrants, stock options, restricted stock units or other equity awards, could result in substantial dilution to our existing stockholders

and could adversely affect the market price of our common stock.

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

8 unchanged sentences

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

43 unchanged sentences

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.

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

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

the power to adopt, amend or repeal the bylaws by a vote of not less than a majority of our directors.

8 unchanged sentences

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

13 unchanged sentences

In addition, if we are unable to continue to meet the legal, regulatory and other requirements

related to being a public company, we may not be able to maintain the quotation of our common stock on the Nasdaq Capital Market or on

any other senior market to which we may apply for listing, which would likely have a material adverse effect on the trading price of our

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.

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.

related to being a public company, we may not be able to maintain the quotation listing of our common stock on the Nasdaq Capital Market

or on any other senior market national securities exchange to which we may apply for listing, which would likely have a material adverse

effect on the trading price of our 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 is influenced, in part, by the research and reports that industry or securities analysts publish about us or our business.

coverage of our company 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