What changed in this filing

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Item 1A. Risk Factors

2024-06-27 compared with 2023-06-28 · 885 added, 869 removed, 769 unchanged (70% 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.

We have never been profitable.

We have generated revenues during the fiscal years ended March 31, 2023 and March 31, 2022 in the amounts of $574,245 and $294,165, respectively,

primarily from our contract with the NIH, which ended in September 2022.

Our revenues, from research grants, continue to be insufficient

to cover our cost of operations.

Risks Relating to Our Financial Position and Need for Additional Capital

We have incurred significant losses and expect to continue to incur

losses for the foreseeable future.

never been profitable.

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

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

We do not currently have any research

grants or contracts.

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

Future profitability,

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

government contract or grant income we may obtain.

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

and even if commercialization is successful, we may never be profitable.

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.

Future profitability, if any, will

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

contract or grant income we may obtain.

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

if commercialization is successful, we may never be profitable.

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

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

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

therefore there

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

in this Annual Report.

We do plan to access the equity

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

We will require additional financing to sustain our operations, achieve

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

We will require significant additional

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

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

In addition, as we expand

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

We may also choose to

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

to strengthen our financial position.

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

interests of our existing stockholders.

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

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

If required financing is unavailable

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

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

Our ability to raise additional

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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.

Currently, we are experiencing an interruption in the manufacturing of our Hemopurifier as we transition to

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

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 proposal to approve a new qualified supplier of the GNA and are working with the FDA to gain approval of this supplier.

Although we have completed the manufacture of 112 Hemopurifiers, which have passed our quality control measures, we cannot ship the cartridges

for domestic use until we have FDA approval of our new GNA supplier.

FDA review of the new 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, would 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

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

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

supplier as we work to qualify a second supplier.

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

In addition, an uncorrected impurity,

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

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

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

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

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

Our current inventory of Hemopurifiers expired on September 30, 2022.

Any further delay in achieving the required FDA approvals for our new supplier will limit our ability to meet any demand for the Hemopurifier

in the United States and delay our clinical trials in the United States, which could have a material adverse impact on our business, results

of operations and financial condition.

Any such future supplier issues could have a material adverse impact

on our business, results of operations and financial condition.

Difficulties in manufacturing our Hemopurifier

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

We currently outsource most

of the manufacturing of our Hemopurifier.

The manufacturing of our Hemopurifier is difficult and complex.

To support our current clinical

trial needs, we comply with and intend to continue to comply with cGMP in the manufacture of our product.

Our ability to adequately manufacture

and supply our Hemopurifier in a timely matter is dependent on the uninterrupted and efficient operation of our facilities and those of

third parties producing raw materials and supplies upon which we rely in our manufacturing.

We currently are experiencing an interruption

in our Hemopurifier manufacturing due to delays in obtaining necessary regulatory approval of a new manufacturer of GNA.

The manufacture

of our products may also be impacted by:

We only recently received approval

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

The manufacturing of our Hemopurifier is difficult

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

of our product.

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

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

The manufacture of our products may also be impacted by:

availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier;

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product quality success rates and yields;

global viruses and pandemics, including the current COVID-19 pandemic.

The current interruption in

the manufacture and supply of our Hemopurifier has and may continue to delay shipments of our Hemopurifier for use in clinical trials

in the United States.

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 contains three critical components with limited supplier numbers.

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.

We currently purchase the diatomaceous

earth from Janus Scientific Inc., our distributor;

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.

Specifically, the Hemopurifier

contains three critical components with limited supplier numbers.

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.

We currently purchase the diatomaceous earth

from Janus Scientific Inc., our distributor;

however, the product is manufactured by Imerys Minerals Ltd., which is the only supplier

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We face intense competition in the medical device industry .

We compete with numerous

and foreign companies in the medical device industry, and many of our competitors have greater financial, personnel, operational

and research and development resources than we do.

We believe that because the field of exosome research is burgeoning, multiple competitors

are or will be developing competing technologies to address exosomes in cancer.

Progress is constant in the treatment and prevention

of viral diseases, so the opportunities for the Hemopurifier may be reduced there as well.

Diagnostic technology may be developed that

can supplant diagnostics we are developing for viruses and cancer.

Our commercial opportunities will be reduced or eliminated if our

competitors develop and market products for any of the diseases we target that:

We compete with numerous U.S.

and foreign companies in the medical device industry, and many of our competitors have greater financial, personnel, operational and research

and development resources than we do.

We believe that because the field of exosome research is burgeoning, multiple competitors are or

will be developing competing technologies to address exosomes in cancer.

Progress is constant in the treatment and prevention of viral

diseases, so the opportunities for the Hemopurifier may be reduced there as well.

Diagnostic technology may be developed that can supplant

diagnostics we are developing for viruses and cancer.

Our commercial opportunities will be reduced or eliminated if our competitors develop

and market products for any of the diseases we target that:

are more effective;

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

Even if we are successful

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

effectively with other successful products.

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

for treatment.

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

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

Our competitors include fully

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

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

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

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

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

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

If we are unable to successfully compete against larger companies

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

We have limited experience in identifying

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

manufacture of our devices must comply with good manufacturing

practices in the United States.

Even if we are successful in developing

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

with other successful products.

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

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

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

Our competitors include fully integrated

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

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

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

If our competitors

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

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

be substantially addressed by competing treatments.

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

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

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

contracts with medical device manufacturers;

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

To achieve the levels of production

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Our Hemopurifier technology may become obsolete.

Our Hemopurifier product may

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

Our Hemopurifier product may be

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

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

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competitive with products based on new technologies.

Our success is dependent in part on our

executive officers.

Our success depends to a critical

extent on the continued services of our Chief Executive Officer, Charles J.

Fisher, Jr., M.D., our Chief Financial Officer, James B.

our Chief Medical Officer, Steven LaRosa, M.D., our Chief Scientific Officer, Lee D.

Arnold, Ph.D., and our Chief Business Officer, Guy

If any of these key executive officers were to leave us, we would be forced to expend significant time and money in the pursuit

of a replacement, which would result in both a delay in the implementation of our business plan and the diversion of limited working capital.

The unique knowledge and expertise of these individuals would be difficult to replace within the biotechnology field.

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

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

Our ability to compete in the

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

scientific, and medical personnel.

We are highly dependent on our management, scientific, and medical personnel.

The loss of the services

of any of our executive officers or other key employees and our inability to find suitable replacements could potentially harm our business,

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.

Our inability to attract and retain qualified

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We have 14 full-time employees.

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 to fully implement our business

plan and growth strategies.

Due to the specialized scientific nature of our business, we are highly dependent upon our ability to attract

and retain qualified scientific, technical and managerial personnel.

Competition for these individuals, especially in San Diego, California,

where many biotechnology companies are located, is intense and we may not be able to attract, assimilate or retain additional highly qualified

personnel in the future.

We may not be able to engage the services of qualified personnel at competitive prices or at all, particularly

given the risks of employment attributable to our limited financial resources and lack of an established track record.

Also, if we are

required to attract personnel from other parts of the U.S.

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 area.

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

We plan to expand our operations, which

may strain our resources;

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

to fully implement our business plan and growth strategies.

Due to the specialized scientific nature of our business, we are highly dependent

upon our ability to attract and retain qualified scientific, technical and managerial personnel.

Competition for these individuals, especially

in San Diego, California, where many biotechnology companies are located, is intense and we may not be able to attract, assimilate or

retain additional highly qualified personnel in the future.

We may not be able to engage the services of qualified personnel at competitive

prices or at all, particularly given the risks of employment attributable to our limited financial resources and lack of an established

track record.

Also, if we are required to attract personnel from other parts of the U.S.

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;

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

We will need to significantly expand our operations to implement our

longer-term business plan and growth strategies.

We will also be required to manage multiple relationships with various strategic partners,

technology licensors, customers, manufacturers and suppliers, consultants and other third parties.

This expansion and these expanded relationships

will require us to significantly improve or replace our existing managerial, operational and financial systems, procedures and controls;

We will need to significantly

expand our operations to implement our longer-term business plan and growth strategies.

We will also be required to manage multiple relationships

with various strategic partners, technology licensors, customers, manufacturers and suppliers, consultants and other third parties.

expansion and these expanded relationships will require us to significantly improve or replace our existing managerial, operational and

financial systems, procedures and controls;

to improve the coordination between our various corporate functions;

and to manage, train, motivate and maintain a growing employee base.

The time and costs to effectuate these steps may place a significant strain on our management personnel, systems and resources, particularly

given the limited amount of financial resources and skilled employees that may be available at the time.

We may not be able to institute,

in a timely manner or at all, the improvements to our managerial, operational and financial systems, procedures and controls necessary

to support our anticipated increased levels of operations and to coordinate our various corporate functions, or that we will be able to

properly manage, train, motivate and retain our anticipated increased employee base.

If we cannot 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 may enter new business areas, such as the organ transplant

market or diagnostics.

We do not have any experience in these areas.

We would likely face competition from entities more familiar with

these businesses and our efforts may not succeed.

In the future, we may expand

our operations into business areas, such as the organ transplant market which we currently are exploring, where we do not have any experience.

These areas would be new to our product development and management personnel, and we may not be successful in these new areas.

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

significant revenues in this new area.

Many companies of all sizes, including major pharmaceutical companies, specialized biotechnology

companies, and traditional healthcare providers, are engaged in redesigning organ transplant care and diagnostic medicine.

operating in these potential new business areas may have substantially greater financial and other resources, larger research and development

staff, and more experience in these business areas.

It is possible that, even if we are successful in these new areas, that the market

will not accept our product, or that our product will generate significant revenues for us.

and to manage, train,

motivate and maintain a growing employee base.

The time and costs to effectuate these steps may place a significant strain on our management

personnel, systems and resources, particularly given the limited amount of financial resources and skilled employees that may be available

We may not be able to institute, in a timely manner or at all, the improvements to our managerial, operational and financial

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

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

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

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

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

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

We are investigating 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.

This area is new to our product development and management

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

Even if we are successful

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

in this new area.

Many companies of all sizes, including major pharmaceutical companies, specialized biotechnology companies, and traditional

healthcare providers, are engaged in redesigning organ transplant care.

Competitors operating in this area may have substantially greater

financial and other resources, larger research and development staff, and more experience in this area.

It is possible that, even if we

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

revenues for us.

As a public company with limited financial resources undertaking

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

The directors and management

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

The directors and management of

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

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

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

such insurance is expensive and difficult to obtain.

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 outside independent directors than a more established public

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

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.

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 Centers for Disease Control and Prevention and the Department of Homeland Security.

Our Hemopurifier has not received required regulatory

approval from the FDA, or any foreign regulatory agencies, to be commercially marketed and sold.

The process of obtaining and complying

with FDA and other governmental regulatory approvals and regulations in the United States and in foreign countries is costly, time consuming,

uncertain and subject to unanticipated delays.

Our Hemopurifier product is subject

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

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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total or partial suspension of productions.

Delays in successfully completing our planned

clinical trials could jeopardize our ability to obtain regulatory approval.

Delays in successfully commencing or completing

our planned clinical trials could jeopardize our ability to obtain regulatory approval and sustain our operations.

Our business prospects depend

on our ability to complete studies, clinical trials, including our ongoing and planned studies in COVID-19 patients and solid tumors in

cancer, 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:

slow patient enrollment;

serious adverse events related to our medical device candidates;

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:

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

slow patient enrollment in our planned clinical trials;

serious adverse events related to our Hemopurifier;

unsatisfactory results of any clinical trial;

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

delays resulting from the coronavirus pandemic.

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.

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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criminal prosecution.

Moreover, the FDA strictly

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

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

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

However, companies may share truthful and not misleading

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

The FDA and other agencies actively enforce the

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

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

Any of these sanctions could

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

Furthermore, our key component

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

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

Moreover, the FDA strictly regulates

the promotional claims that may be made about approved products.

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

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

However, companies may share truthful and not misleading information

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

The FDA and other agencies actively enforce the laws and regulations

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

significant civil, criminal and administrative penalties.

Any of these sanctions could have

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

Furthermore, our key component suppliers

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

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

If our products, or malfunction of our products,

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corrective actions or agency enforcement actions.

Under the FDA medical device

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

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

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

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

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

Any such adverse event involving our products also could

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

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 lead 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 the dedication of our time

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

We outsource many of our operational and development

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

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

could be delayed or terminated.

We rely on third-party consultants

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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 Institutional Review Board or Institutional Biosafety Committee, which may

delay or make impossible clinical testing of a product candidate.

The Institutional Review Board 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.

If we or our manufacturers or

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

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

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

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

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

viable to manufacture in a cost-efficient manner.

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

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

The conduct of clinical trials may be

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

testing of a product candidate.

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

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

We will need to outsource and rely on third

parties for the clinical development and manufacturing, sales and marketing of our Hemopurifier or any future product candidates that

we may develop, and 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 manufacture, 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 and manufacturing, 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.

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

parties for the clinical development, sales and marketing of our Hemopurifier or any future product candidates that we may develop, and

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

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 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.

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.

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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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:

Before a new medical device can

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

A PMA submission,

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

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

been cleared by the FDA.

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

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

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

This process, which includes

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

surveillance to establish the safety and efficacy of the product.

Notwithstanding the effort and expense incurred, the process may never

result in the FDA granting a PMA.

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

could delay, limit or prevent regulatory approval.

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

for medical devices during the period of product development.

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

reasons, including:

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

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

Modifications to products

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

Similarly, some modifications made to products cleared through

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

Modifications to products that

are approved through a PMA application generally need FDA approval.

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

may require a new 510(k).

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

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.

The approval requirements for medical products used to fight

bioterrorism and pandemics are still evolving, and any products we develop for such uses may not meet these requirements.

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

used to fight bioterrorism and pandemics are still evolving, and any products we develop for such uses may not meet these requirements.

We are advancing product candidates

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

For example, in June 2020,

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

For example, in June 2020, the

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

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

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obtain regulatory approval for the Hemopurifier.

The results of our clinical trials may not

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

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

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

Any research and development,

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

legislative or FDA regulatory reforms may make it more

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

after approval is obtained.

legislative or FDA regulatory reforms may

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

our products after approval is obtained.

From time to time, legislation

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our product development efforts.

Our current and future business activities

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

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

We are currently and will

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

federal government and the states in which we will conduct

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

In addition to the FDA’s

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

Our current and future business activities are

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

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

We are currently and will in the

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

federal government and the states in which we will conduct our

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

In addition to the FDA’s restrictions

on marketing of approved products, the U.S.

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

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 are subject to stringent and changing

and foreign laws, rules, regulations and standards as well as policies, contracts and other obligations related to data privacy and

Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions, fines and

penalties, a disruption of our clinical trials or commercialization of our products, private litigation, 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 (collectively, “Process” or “Processing”) personal information 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,

and contractual requirements and other obligations related to privacy, information security and Processing (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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of individually identifiable health information.

In addition, the California Consumer Privacy Act of 2018, CCPA, applies to personal information

of consumers, business representatives, and employees, and requires covered businesses to provide specific disclosures in privacy notices

and honor requests of California residents to exercise certain privacy rights.

The CCPA also provides for civil penalties for noncompliance

(up to $7,500 per violation) and allows private litigants affected by certain data breaches to recover significant statutory damages.

Although there are limited exemptions for clinical trial data under the CCPA, the CCPA increases compliance costs and potential liability

with respect to other personal data we maintain about California residents.

In addition, the California Privacy Rights Act of 2020, or

CPRA, expands the CCPA’s requirements, including by adding a new right for individuals to correct their personal information and

establishing a new regulatory agency to implement and enforce the law.

Other states, including Colorado, Connecticut, Utah and Virginia,

have enacted data privacy laws and similar laws are being considered in other states and at the federal level, reflecting a trend toward

more stringent privacy legislation in the United States.

While these states, like the CCPA, also exempt some data processing in the context

of clinical trials, the enactment of such laws and others could have potentially conflicting requirements that would make compliance challenging

and expose us to additional liability.

Outside the United States,

an increasing number of laws, regulations, and industry standards apply to data privacy and security.

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.

As applicable, such rights may include the right to access, correct, or

delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated

decision-making.

The exercise of these rights may impact our business and ability to provide our products and services.

Certain states

also impose stricter requirements for processing certain personal data, including sensitive information, such as conducting data privacy

impact assessments.

These state laws allow for statutory fines for noncompliance.

For example, the California Consumer Privacy Act of

2018, or CCPA, applies to personal data of consumers, business representatives, and employees who are California residents, and requires

covered businesses to provide specific disclosures in privacy notices and honor requests of California residents to exercise certain privacy

The CCPA also provides for fines of up to $7,500 per intentional violation and allows private litigants affected by certain data

breaches to recover significant statutory damages.

The CCPA and other comprehensive U.S.

state privacy laws exempt some data Processing

in the context of clinical trials, but these developments may further complicate compliance efforts, and increase legal risk and compliance

costs for us, the third parties with whom we work.

Similar laws are being considered in several other states, as well as at the federal

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.

For example, the European Union’s

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Privacy Act, and India’s Information Technology Act and supplementary rules impose strict requirements for Processing personal data.

Companies that violate the GDPR can face private litigation related to processing of personal data brought by classes of data subjects

For example, under GDPR, companies can face private litigation related to Processing of personal data brought by classes of data subjects

or consumer protection organizations authorized at law to represent their interests, temporary or definitive restrictions on data Processing

and other corrective actions, and fines of up to the greater of 20 million Euros under the EU GDPR / 17.5 million pounds streamline under

or other corrective actions, and fines of up to the greater of 20 million Euros under the EU GDPR / 17.5 million pounds streamline under

the UK GDPR or 4% of their worldwide annual revenue, whichever is greater.

GDPR litigation risk may increase as a result of a recent decision

of the EU’s highest court finding that a consumer protection association may bring representative actions alleging violations of

the GDPR even without a mandate to do so from any specific individuals and whether or not specific individuals’ data protection

rights have been violated.

In addition, we may be unable

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In particular, the European Economic Area, or EEA, and the United Kingdom, or UK, have

significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it believes are inadequate.

Other jurisdictions may adopt similarly stringent interpretations of their data localization and cross-border data transfer laws.

there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States in compliance

with law, such as the EEA and UK’s standard contractual clauses, these mechanisms are subject to legal challenges, and there is

no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States.

If there is no lawful

manner for us to transfer personal data from the EEA, the UK, or other jurisdictions to the United States, or if the requirements for

a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation

of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions at significant

expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners,

vendors and other third parties, and injunctions against our processing or transferring of personal data necessary to operate our business.

Some European regulators have ordered certain companies to suspend or permanently cease certain transfers of personal data to recipients

outside Europe for allegedly violating the EU GDPR’s cross-border data transfer limitations.

Additionally, companies that transfer

personal data to recipients outside of the EEA and/or UK to other jurisdictions, particularly to the United States, are subject to increased

scrutiny from regulators 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.

Data Protection Obligations

are quickly changing in an increasingly stringent fashion, creating some uncertainty as to the effective future legal framework.

significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it generally believes

are inadequate.

Other jurisdictions may adopt similarly stringent interpretations of their data localization and cross-border data transfer

Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the United States

in compliance with law, such as the EEA’s standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum,

and the EU-U.S.

Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who

self-certify compliance and participate in the Framework) these mechanisms are subject to legal challenges, and there is no assurance

that we can satisfy or rely on these measures to lawfully transfer personal data to the United States.

If there is no lawful manner for

us to transfer personal data from the EEA, the UK, or other jurisdictions to the United States, or if the requirements for a legally-compliant

transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations,

the need to relocate part of or all of our business or data processing activities to other jurisdictions at significant expense, increased

exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners, vendors and other

third parties, and injunctions against our processing or transferring of personal data necessary to operate our business.

Some European

regulators have ordered certain companies to suspend or permanently cease certain transfers of personal data out of Europe for allegedly

violating the EU GDPR’s cross-border data transfer limitations.

Additionally, companies that transfer personal data to recipients

outside of the EEA and/or UK to other jurisdictions, particularly to the United States, are subject to increased scrutiny from regulators

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

in the future.

We are also bound by other contractual obligations related to data privacy and security, and our efforts to comply with

such obligations may not be successful.

Data Protection Obligations, and

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

Additionally,

these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions.

Preparing for and complying with these obligations requires significant resources and may necessitate changes to our information technologies,

systems, and practices and to those of any third parties that process personal data on our behalf.

Preparing for and complying with these obligations requires us to devote significant resources and may necessitate changes to our services,

information technologies, systems, and practices and to those of any third parties that process personal data on our behalf.

Although we endeavor to comply

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Moreover, despite our

efforts, our personnel or third parties upon whom we rely may fail to comply with such obligations, which could negatively impact our

efforts, our personnel or third parties with whom we work may fail to comply with such obligations, which could negatively impact our

business operations and compliance posture.

For example, any failure by a third-party processor to comply with applicable law, regulations,

or contractual obligations could result in adverse effects, including inability to or interruption in our ability to operate our business

and proceedings against us by governmental entities or others.

If we fail, or are perceived

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

increase our compliance and operational costs;

us to regulatory scrutiny, actions, fines and penalties;

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

operational costs;

expose us to regulatory scrutiny, actions, fines and penalties;

result in reputational harm;

interrupt or stop our clinical trials;

litigation and liability;

interrupt or stop our

clinical trials;

result in litigation and liability;

result in an inability to process personal data or to operate in certain jurisdictions;

harm our business operations

or financial results or otherwise result in a material harm to our business, or other material adverse impact on our business, results

of operations and financial condition.

Additionally, given that Data Protection Obligations impose complex and burdensome obligations

and that there is substantial uncertainty over the interpretation and application of these obligations, we may be required to incur material

costs, divert management attention, and change our business operations, including our clinical trials, in 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:

harm our business operations or financial results or otherwise result in a material harm to our business, or other material adverse impact

on our business, results of operations and financial condition.

Additionally, given that Data Protection Obligations impose complex and

burdensome obligations and that there is substantial uncertainty over the interpretation and application of these obligations, we may

be required to incur material costs, divert management attention, and change our business operations, including our clinical trials, in

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:

loss of customers;

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or revision or restructuring of our operations.

If our information technology systems or

data, or those of third parties upon which we rely, are or were compromised we could experience adverse consequences resulting from such

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:

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and other adverse consequences.

In the ordinary course of

our business, we and third parties upon which we rely 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 upon whom we rely to help us operate our business.

If we, our service providers, partners, or other relevant third parties

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

In the ordinary course of our

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

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

collectively, Sensitive Information.

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

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

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

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

deletion or destruction;

loss, unauthorized acquisition, disclosure, or exposure of, Sensitive Information, or compromise related to the security, confidentiality,

integrity of our (or their) information technology, software, services, communications or data (any, a “Security Breach”),

it may result in a material adverse impact on our business, results of operations and financial condition, including the diversion of

funds to address the breach, and interruptions, delays, or outages in our operations and development programs.

unauthorized access to;

loss, unauthorized

acquisition, disclosure, or exposure of, Sensitive Information, or other compromise related to the security, confidentiality, integrity

of our, or their, information technology, software, services, communications or data, or collection, a Security Breach, it may result

in an adverse impact on our business.

Cyberattacks, malicious internet-based

activity and online and offline fraud are prevalent and continue to increase.

These threats are becoming increasingly difficult to detect.

These threats come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,”

organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported

Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors

for geopolitical reasons and in conjunction with military conflicts and defense activities.

During times of war and other major conflicts,

we and the third parties upon which we rely may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks,

that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our goods and services.

We and the third parties upon

which we rely may be subject to a variety of evolving threats, including but not limited to social-engineering attacks (including through

phishing attacks), supply-chain attacks, loss of data or other information technology assets, adware, software bugs, malicious code (such

as viruses and worms), employee theft or misuse, denial-of-service attacks (such as credential stuffing) and ransomware attacks.

also be the subject of phishing attacks, viruses, malware (including as a result of advanced persistent threat intrusions), server malfunction,

software or hardware failures, loss of data or other computer assets, telecommunications failures, earthquakes, fires, floods, or other

similar issues.

activity and online and offline fraud are prevalent, continue to rise, and are increasingly difficult to detect.

These threats come from

a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized criminal

threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors.

now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical

reasons and in conjunction with military conflicts and defense activities.

During times of war and other major conflicts, we and the third

parties with whom we work may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially

disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our goods and services.

We and the third parties with

whom we work are subject to a variety of evolving threats, including but not limited to social-engineering attacks, including through

deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks, supply-chain attacks, loss of data or

other information technology assets, adware, software bugs, malicious code, such as viruses and worms, employee theft or misuse, denial-of-service

attacks, such as credential stuffing, and ransomware attacks.

We may also be the subject of viruses, malware, including as a result of

advanced persistent threat intrusions, server malfunction, software or hardware failures, loss of data or other computer assets, adware,

attacks enhanced or facilitated by AI, telecommunications failures, earthquakes, fires, floods, or other similar threats.

Ransomware attacks, including

by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe,

and can lead to significant interruptions in our operations, loss of data and income, reputational harm, and diversion of funds.

payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such 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,

and can lead to significant interruptions in our operations, loss of Sensitive Information and income, reputational harm, and diversion

Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such

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,

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.

We rely on third-party service

providers and 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 place.

If our third-party service

providers experience a Security Breach or other interruption, we could experience adverse consequences.

While we may be entitled to damages

if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient

to cover our damages, or we may be unable to recover such award.

In addition, supply-chain attacks have increased in frequency and severity,

and we cannot guarantee that third parties and infrastructure in our supply chain or our third-party partners’ supply chains have

not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our information

technology systems (including our services) or the third-party information technology systems that support us and our services.

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.

While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations

to us, any award may be insufficient to cover our damages, or we may be unable to recover such award.

In addition, supply-chain attacks

have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our

third-party partners’ supply chains have not been compromised or that they do not contain exploitable defects or bugs that could

result in a breach of or disruption to our information technology systems (including our services) or the third-party information technology

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.

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

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

Vulnerabilities could be exploited and result in a security incident.

Any of the previously identified

or similar threats could cause a Security Breach or other interruption and disrupt our ability (and that of third parties upon whom we

rely) to provide our services.

We may be required to 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 (as defined above) may require us to implement specific security measures

or use industry-standard or reasonable measures to protect against Security Breaches.

There can be no assurances that our security measures,

or those of third parties upon whom we rely, will be effective in protecting against Security Breaches.

While we have implemented

security measures designed to protect against Security Breaches, there can be no assurance that these measures will be effective.

steps to detect and remediate vulnerabilities in our information technology systems (including our products), but we may not be able to

detect and remediate all vulnerabilities because the threats and techniques used to exploit vulnerabilities change frequently and are

often sophisticated in nature.

Therefore, such vulnerabilities could be exploited but may not be detected until after a Security Breach

has occurred.

These vulnerabilities pose material risks to our business.

Further, we may experience delays in developing and deploying

remedial measures designed to address any such identified vulnerabilities.

Applicable Data Protection

Obligations (as defined above) may require us to notify relevant stakeholders of Security Breaches, including affected individuals, partners,

collaborators, regulators, law enforcement agencies and others.

Such disclosures are costly, and the disclosures or the failure to comply

with such requirements could lead to a material adverse impact on our business, results of operations and financial condition.

a third party upon whom we rely) experience a Security Breach or are perceived to have experienced a Security Breach, we may experience

adverse consequences.

These consequences may include:

government enforcement actions (for example, investigations, fines, penalties, audits,

and inspections);

additional reporting requirements and/or oversight;

restrictions on processing Sensitive Information (including personal

litigation (including class claims);

or similar threats could cause a Security Breach or other interruption and disrupt our ability and that of third parties with whom we

work to provide our services.

We may expend significant resources,

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

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

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

to protect against Security Breaches.

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

against Security Breaches.

Applicable Data Protection Obligations

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

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

Such disclosures

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

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

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

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

These consequences may

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

additional reporting

requirements and/or oversight;

restrictions on processing Sensitive Information, including personal data;

litigation, including class

indemnification obligations;

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monetary fund diversions;

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 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.

There can be no assurances

that any limitations or exclusions of liability in our contracts would be adequate or would otherwise protect us from liabilities or damages

if we fail to comply with Data Protection Obligations related to information security or Security Breaches.

We cannot be sure that our

insurance coverage will 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 and financial condition arising out of our Processing operations, privacy and security practices, or Security Breaches

that we may experience.

The successful assertion of one or more large claims against us that exceeds our available insurance coverage,

or results in changes to our insurance policies (including premium increases or the imposition of large excess or deductible or co-insurance

requirements), 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

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

limitations of liability, and even where they do, any such limitations or exclusions of liability in our contracts may not be adequate

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,

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

and financial condition arising out of our Processing operations, privacy and security practices, or Security Breaches that we may experience.

In addition, such coverage may not continue to be available on commercially reasonable terms or at all or be sufficient coverage to pay

future claims.

The successful assertion of one or more large claims against us that exceeds our available insurance coverage, or results

in changes to our insurance policies, including premium increases or the imposition of large excess or deductible or co-insurance requirements,

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

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

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

If approved for use in the

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

If approved for use in the United

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

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

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by many private payors for any products that we develop.

Should any of our potential products, including

the Hemopurifier, be approved for commercialization, certain health reform measures and adverse changes in reimbursement policies and

procedures may impact 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,

Should our Hemopurifier or any future products,

be approved for commercialization, certain health reform measures and adverse changes in reimbursement policies and procedures may impact

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,

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

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

Legislation could be adopted

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

Legislation could be adopted in

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

In addition, commercial payors such as insurance companies,

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

Under current law, federal

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

of such federal net operating losses is limited to 80% of taxable income.

It is uncertain if and to what extent various states will conform

to federal tax laws.

In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions

of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change in

its equity ownership value over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards

and other pre-change tax attributes to 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.

Under current law, federal net

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

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

In addition, under Sections

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

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

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

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.

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.

Effective January 1, 2022,

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

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

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.

We currently carry a limited

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

Our product liability policy

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

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

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

Should we violate any regulations concerning

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

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

We may not have adequate insurance to cover all

or any of such claims, if any.

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

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

Our products may in the future be subject

to product recalls.

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

We currently carry a limited amount

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

Our product liability policy has a

$5,000,000 limit of liability.

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

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

Should we violate any regulations concerning the handling

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

subject of substantial lawsuits by governmental agencies or individuals.

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

claims, if any.

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

since such payments could deplete our available resources.

Our products may in the future be subject to

product recalls.

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

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

The FDA and similar foreign

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

defects in design or manufacture.

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

that the device would cause serious injury or death.

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

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

Manufacturers may, under their own initiative,

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

The FDA requires that certain classifications of recalls be reported

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

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

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

or labeling defects or other deficiencies and issues.

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

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

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

We may also be subject to liability claims,

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

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

Our bylaws designate the Eighth Judicial

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

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

directors, officers, employees or agents.

Our bylaws require that, to

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

Our bylaws designate the Eighth Judicial District

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

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

officers, employees or agents.

Our bylaws require that, to the

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

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

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

However, our bylaws provide

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

other claim for which the federal courts have exclusive jurisdiction.

However, our bylaws provide that

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

claim for which the federal courts have exclusive jurisdiction.

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

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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

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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We currently have five issued U.S.

patents and four pending U.S.

patents and two pending U.S.

patent applications.

We also have 32 issued foreign patents and have applied for nine additional foreign

and international patents.

Our issued patents begin to expire in 2024, with the last of these patents expiring in 2036, although terminal

We also have 24 issued foreign patents and have applied for 15 additional foreign and

international patents.

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

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

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

The issuance of a patent is

not conclusive as to its scope, validity or enforceability.

The issuance of a patent is not

conclusive as to its scope, validity or enforceability.

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

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

We have also entered into

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

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

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

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

In the event a competitor

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

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

We have also entered into confidentiality

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

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

However, these agreements

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

unauthorized use or disclosure or other breaches of the agreements.

In the event a competitor infringes

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

would divert management’s attention from managing our business.

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

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

New technology may lead to our competitors

developing superior products which would reduce demand for our products.

Research into technologies

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

the development of products similar to ours.

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

advantages when compared with our technologies.

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

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

New technology may lead to our competitors developing

superior products which would reduce demand for our products.

Research into technologies similar

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

of products similar to ours.

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

when compared with our technologies.

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

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

If we are unable to protect our proprietary

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ability to remain in business.

Our ability to successfully

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

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

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

enforceable scope of the claims of the patent.

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

legal and factual 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

Our ability to successfully commercialize

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

We will also need

to continue to preserve our trade secrets.

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

of the claims of the patent.

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

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

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

licensing fees in order to market our products.

From time to time, we may need

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

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

be inhibited or prevented.

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

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

If we are required to engage in expensive and

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

may not be satisfactory.

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

Because of the complex and

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

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

Third parties may claim that our products or

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

of those products or technology or pay license fees.

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

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

We may not prevail in any such

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.

Because of the complex and difficult

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

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

Third parties may claim that our products or technology infringe

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

or technology or pay license fees.

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

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

We may not prevail in any such litigation.

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

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

Other parties may challenge certain

of our foreign patent applications.

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

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

patents in other jurisdictions, as well as related patents.

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

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

Risks Related to U.S.

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contracts to further develop our technology.

While we have previously had

While we have previously had U.S.

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

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a negative audit would be detrimental to

Our business plan to utilize

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

Many government contracts, typically contain

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

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

Our business plan to utilize the

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

Many government contracts, typically contain unfavorable

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

risks should we obtain contracts with the U.S.

Government in the future.

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change certain terms and conditions in our contracts.

As a former and potential

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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Risks Relating to Our Common Stock and Our Corporate Governance

If we are unable to regain compliance with

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

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

Our common stock is listed

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

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

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

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

On October 25, 2022, we received

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

If we are unable to regain compliance with the

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

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

Our common stock is listed on

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

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

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

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

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 had 180 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

We subsequently requested an extension of time to regain compliance with the Nasdaq Listing Rule 5550(a)(2) and submitted to Nasdaq

a plan to regain compliance.

On April 25, 2023, Nasdaq informed us that the request for extension was granted.

As a result of the extension,

we have until October 23, 2023 to provide evidence that we have regained compliance with Nasdaq Listing Rule 5550(a)(2), by trading at

or above $1.00 per share for ten consecutive trading dates prior to that date.

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.

There can be no assurance,

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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.

Delisting from the Nasdaq Capital

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

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

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

in business development opportunities.

Historically we have not paid dividends on our

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

We have never paid cash dividends

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will be the sole source of gain for our common stockholders in the foreseeable future.

Our stock price is speculative, and there

is a risk of litigation.

Our stock price is speculative, and there is

a risk of litigation.

The trading price of our common

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the other factors described in this section.

Fluctuations in the price

of our common stock may expose us to the risk of securities class action lawsuits.

Although no such lawsuits are currently pending against

us and we are not aware that any such lawsuit is threatened to be filed in the future, future lawsuits are possible as a result of fluctuations

Fluctuations in the price of our

common stock may expose us to the risk of securities class action lawsuits.

Although no such lawsuits are currently pending against us

and we are not aware that any such lawsuit is threatened to be filed in the future, future lawsuits are possible as a result of fluctuations

in the price of our common stock.

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In addition, any settlement or adverse determination of such lawsuits could subject us to significant liability.

If at any time our common stock is subject

to the SEC’s penny stock rules, broker-dealers may experience difficulty in completing customer transactions and trading activity

in our securities may be adversely affected.

If at any time our common

stock is not listed on a national securities exchange or we have net tangible assets of $2,000,000 or less, or we have an average revenue

of less than $6,000,000 for the last three years, and our common stock has a market price per share of less than $5.00, transactions in

our common stock will be subject to the SEC’s “penny stock” rules.

If at any time our common stock is subject to

the SEC’s penny stock rules, broker-dealers may experience difficulty in completing customer transactions and trading activity in

our securities may be adversely affected.

If at any time our common stock

is not listed on a national securities exchange or we have net tangible assets of $2,000,000 or less, or we have an average revenue of

less than $6,000,000 for the last three years, and our common stock has a market price per share of less than $5.00, transactions in our

common stock will be subject to the SEC’s “penny stock” rules.

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

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make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.

The broker or dealer must

also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to the penny stock market,

which, in highlight form:

The broker or dealer must also

deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to the penny stock market, which,

in highlight form:

sets forth the basis on which the broker or dealer made the suitability determination;

that the broker or dealer received a signed, written agreement from the investor prior to the transaction.

Generally, brokers may be

less willing to execute transactions in securities subject to the “penny stock” rules.

This may make it more difficult for

investors to dispose of our common stock and cause a decline in the market value of our stock.

Disclosure also has to be

made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable

to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies available

to an investor in cases of fraud in penny stock transactions.

Generally, brokers may be less

willing to execute transactions in securities subject to the “penny stock” rules.

This may make it more difficult for investors

to dispose of our common stock and cause a decline in the market value of our stock.

Disclosure also has to be made

about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both

the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies available to an

investor in cases of fraud in penny stock transactions.

Finally, monthly statements have to be sent disclosing recent price information

for the penny stock held in the account and information on the limited market in penny stocks.

Our common stock has had an unpredictable

trading volume which means you may not be able to sell our shares at or near trading prices or at all.

Trading in our common shares

historically has been volatile and often has been thin, meaning that the number of persons interested in purchasing our common shares

at or near trading prices at any given time may be relatively small or non-existent.

This situation is attributable to a number of factors,

including the fact that we are a small company which is relatively unknown to stock analysts, stock brokers, institutional investors and

others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons,

they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of

our shares until such time as we became more seasoned and viable.

As a consequence, there may be periods of several days or more when

trading activity in our shares is minimal, as compared to a seasoned issuer which has a large and steady volume of trading activity that

will generally support continuous sales without an adverse effect on share price.

A broader or more active public trading market for our

common shares may not develop or be sustained, and current trading levels may decrease.

The market price for our common stock is

Our common stock has had an unpredictable trading

volume which means you may not be able to sell our shares at or near trading prices or at all.

Trading in our common shares historically

has been volatile and often has been thin, meaning that the number of persons interested in purchasing our common shares at or near trading

prices at any given time may be relatively small or non-existent.

This situation is attributable to a number of factors, including the

fact that we are a small company which is relatively unknown to stock analysts, stock brokers, institutional investors and others in the

investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to

be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until

such time as we became more seasoned and viable.

As a consequence, there may be periods of several days or more when trading activity

in our shares is minimal, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally

support continuous sales without an adverse effect on share price.

A broader or more active public trading market for our common shares

may not develop or be sustained, and current trading levels may decrease.

The market price for our common stock is volatile;

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, 2023, the high and low

closing sale prices for a share of our common stock were $1.99 and $0.25, 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, 2024, the high and low closing

sale prices for a share of our common stock were $6.10 and $1.42, respectively.

The volatility in our share price is attributable to a

number of factors.

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, 2023, we have reserved for issuance 2,045,006

of those shares of common stock for outstanding restricted stock units, stock options and warrants, excluding an aggregate of 348,837

issuances of restricted stock units to our independent directors under our 2020 Equity Incentive Plan made subsequent to March 31, 2023.

As of March 31, 2023, we had issued and outstanding 22,992,466 shares of common stock.

As a result, as of March 31, 2023 we had 34,962,528

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

We are entitled under our articles

of incorporation to issue up to 60,000,000 shares of common stock.

As of March 31, 2024, we have reserved for issuance 124,028 of those

shares of common stock for outstanding restricted stock units, stock options and warrants, excluding an aggregate of 131,576 issuances

of restricted stock units to our independent directors under our 2020 Equity Incentive Plan made subsequent to March 31, 2024.

31, 2024, we had issued and outstanding 2,629,725 shares of common stock.

As a result, as of March 31, 2024 we had 57,246,247 shares of

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

On May 17, 2024, we closed a public

offering pursuant to which we sold an aggregate of:

(i) 2,450,000 shares of our common stock and accompanying Class A warrants to purchase

up to 2,450,000 shares of common stock and Class B warrants to purchase up to 2,450,000 shares of common stock, at a combined public offering

price of $0.58 per share and accompanying warrants;

and (ii) in lieu of common stock, pre-funded warrants to purchase 5,650,000 shares

of common stock and accompanying Class A warrants to purchase up to 5,650,000 shares of common stock and Class B warrants to purchase

up to 5,650,000 shares of common stock, at a combined public offering price of $0.579 per pre-funded warrant and accompanying warrants,

which is equal to the public offering price per share of common stock, and accompanying warrants less the $0.001 per share exercise price

of each such pre-funded warrant.

On March 24, 2022, we entered

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2022 ATM Agreement.

Through March 31, 2023, we sold an aggregate of 7,480,836 shares under the 2022 ATM Agreement for net proceeds of

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.

During the fiscal year ended March 31, 2024, we sold an aggregate of 296,056 shares under the 2022 ATM Agreement for

net proceeds of $1,322,383.

As of March 31, 2024, $5,302,617 of shares of common stock remained available for sale under the 2022 ATM

Our Board of Directors may generally

issue shares of common stock, restricted stock units or stock options or warrants to purchase those shares, without further approval by

our stockholders, based upon such factors as our Board of Directors may deem relevant at that time.

It is likely that we will be required

to issue a large amount of additional securities to raise capital to further our development.

It is also likely that we will be required

to issue a large amount of additional securities to directors, officers, employees and consultants as compensatory grants in connection

with their services, both in the form of stand-alone grants or under our stock plans.

Our officers and directors are entitled to indemnification from us

for liabilities under our articles of incorporation, which could be costly to us and may discourage the exercise of stockholder rights.

Our articles of incorporation

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benefit our company and stockholders.

Our bylaws and Nevada law may discourage,

delay or prevent a change of control of our company or changes in our management, would have the result of depressing the trading price

of our common stock.

Our bylaws and Nevada law may discourage, delay

or prevent a change of control of our company or changes in our management, would have the result of depressing the trading price of our

common stock.

Certain anti-takeover provisions

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the control shares.

Various provisions of our

bylaws may delay, defer or prevent a tender offer or takeover attempt of us that a stockholder might consider in his or her best interest.

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

16 unchanged sentences

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.

UNRESOLVED STAFF COMMENTS

If securities or industry analysts do not publish

research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading

volume could decline.

The trading market for our common

stock will be influenced by the research and reports that industry or securities analysts publish about us or our business.

coverage by industry and financial analysts is currently limited.

Even if our analyst coverage increases, if one or more of the analysts

who cover us downgrade our stock, our stock price would likely decline.

If one or more of these analysts cease coverage of our company

or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price

or trading volume to decline.

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