What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2023-06-28 compared with 2022-06-28 · 631 added, 606 removed, 1007 unchanged (55% of the section changed)

15 unchanged sentences

We have never been profitable.

We have generated revenues during the fiscal years ended March 31, 2022 and March 31, 2021, in the amounts of $294,165, and $659,104,

respectively, primarily from our contracts with the NIH.

Our revenues, from research grants, continue to be insufficient to cover our

cost of operations.

It is possible that we may not be able to enter into future government contracts beyond our current contract with

the NIH that ends in September 2022.

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

other products that may emerge from our potential diagnostic products or from additional government contract or grant income.

be able to successfully commercialize the Hemopurifier or any other products, and even if commercialization is successful, we may never

be 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.

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,

1 unchanged sentence

We will require significant

additional financing for our operations and for expected additional future clinical trials in the U.S., 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.

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

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

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

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

capital and to strengthen our financial position.

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

of the equity interests of our existing stockholders.

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

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

If required financing

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

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

Our ability to raise additional

funds may be adversely impacted by our ability to remain listed on Nasdaq, the potential worsening global economic conditions and disruptions

to and volatility in the credit and financial markets in the United States, including due to bank

failures, actual or perceived changes in interest rates and economic inflation , and worldwide resulting from macroeconomic factors.

Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased

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

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.

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

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.

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:

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

our ability to comply with new regulatory requirements, including our ability to comply with cGMP;

natural disasters;

changes in forecasts of future demand for product components;

potential facility contamination by microorganisms or viruses;

updating of manufacturing specifications;

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;

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

of this product.

The GNA is sourced from Vector Laboratories, Inc.

and also is available from other suppliers;

however, Sigma Aldrich

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

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

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

We face intense competition in the medical device industry .

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 neurodegenerative diseases 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

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;

5 unchanged sentences

Even if we are successful

in developing the Hemopurifier and potential diagnostic products, and obtain FDA and other regulatory approvals necessary for commercializing

them, 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

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.

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

1 unchanged sentence

manufacture of our devices must comply with good manufacturing

practices in the U.S.

practices in the United States.

To achieve the levels of production

1 unchanged sentence

with contract manufacturers which comply with good manufacturing practice standards and other standards prescribed by various federal,

state and local regulatory agencies in the U.S.

and any other country of use.

We have limited experience coordinating and overseeing the

manufacture of medical device products on a large-scale.

state and local regulatory agencies in the United States and any other country of use.

We have limited experience coordinating and overseeing

the manufacture of medical device products on a large-scale.

It is possible that manufacturing and control problems will arise as we attempt

24 unchanged sentences

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

our Chief Medical Officer, Steven LaRosa, M.D., and our Chief Business Officer, Guy Cipriani.

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

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.

Our inability to attract and retain qualified

1 unchanged sentence

We have 15 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 could fail.

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

1 unchanged sentence

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.

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.

This 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

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.

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.

As a public company with limited financial resources undertaking

27 unchanged sentences

Our Hemopurifier product is

subject to extensive government regulations related to development, testing, manufacturing and commercialization in the U.S.

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 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 U.S.

and in foreign countries is costly, time consuming, uncertain

and subject to unanticipated delays.

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.

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 guaranteed.

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

14 unchanged sentences

clinical trials could jeopardize our ability to obtain regulatory approval.

Our business prospects will

depend on our ability to complete studies, clinical trials, including our ongoing Early Feasibility trial in 10 to 12 patients in head

and neck cancer and our study in Covid-19 patients, 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:

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;

25 unchanged sentences

If we, or our manufacturers, fail to adhere to

QSR requirements in the U.S., this could delay production of our products and lead to fines, difficulties in obtaining regulatory clearances,

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

adverse effect on our financial condition or results of operations.

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

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

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

In addition, the FDA assesses

5 unchanged sentences

unanticipated expenditures to address or defend such actions;

notifications or repair, replacement, refunds, recall,

detention or seizure of our products;

customer notifications or repair, replacement, refunds, recall, detention or seizure of our products;

operating restrictions or partial suspension or total shutdown of production;

12 unchanged sentences

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

The COVID-19 pandemic could also potentially affect the business

of the FDA and comparable authorities in other countries, which could result in delays in meetings related to planned clinical trials

and ultimately of reviews and approvals of our product candidates.

Any of these sanctions could

3 unchanged sentences

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

Delays, interruptions or the cessation of

production by our third-party suppliers of important materials or delays in qualifying new materials, may prevent or delay our ability

to manufacture or process our Hemopurifier.

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 may be required if

these materials become unavailable from our current suppliers.

Although there may be other suppliers that have equivalent materials that

would be available to us, FDA review of any alternate suppliers, if required, could take several months or more to obtain, if able to

be obtained at all.

Any delay, interruption or cessation of production by our third-party suppliers of important materials, or any delay

in qualifying new materials, if necessary, would prevent or delay our ability to manufacture our Hemopurifiers.

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 were released into our inventory or to any clinical

trial sites, we believe we have resolved this issue both with that initial supplier and with an additional supplier and that our current

Hemopurifier inventory combined with expected near term production runs from raw materials on hand will be sufficient for the conduct

of our current ongoing clinical trials, but it is possible that the need for our Hemopurifiers could increase and exceed our production.

Any such delays could limit our ability to meet demand for the Hemopurifier and delay our ongoing clinical trials, which would 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.

The manufacture of our products may be impacted

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

our ability to comply with new regulatory requirements, including our ability to comply with cGMP;

natural disasters;

changes in forecasts of future demand for product components;

potential facility contamination by microorganisms or viruses;

updating of manufacturing specifications;

product quality success rates and yields;

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

If efficient manufacture and

supply of our Hemopurifier is interrupted, we may experience delayed shipments or supply constraints.

If we are at any time unable to

provide an uninterrupted supply of our products for our clinical trials, our ongoing clinical trials may be delayed, which could materially

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

If our products, or malfunction of our products,

25 unchanged sentences

by our management team, but all other activities are the responsibility of third-party vendors.

It is possible that the ongoing COVID-19

pandemic might constrain the ability of needed third-party vendors to provide services that we require.

If a clinical research organization

62 unchanged sentences

in the testing, manufacturing, marketing and sale of medical products.

We have recently obtained general clinical trial liability insurance

We have obtained general clinical trial liability insurance coverage.

However, our insurance coverage may not be adequate or available.

We may not be able to secure product liability insurance coverage

on acceptable terms or at reasonable costs when needed.

Any product recall or lawsuit seeking significant monetary damages may have a

material effect on our business and financial condition.

We may not be able to secure product liability insurance coverage on

acceptable terms or at reasonable costs when needed.

Any product recall or lawsuit seeking significant monetary damages may have a material

effect on our business and financial condition.

Any liability for mandatory damages could exceed the amount of our coverage.

Moreover, a product recall could generate substantial negative publicity about our products and business and inhibit or prevent commercialization

a product recall could generate substantial negative publicity about our products and business and inhibit or prevent commercialization

of other future product candidates.

2 unchanged sentences

Before a new medical device

can be marketed in the U.S., 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:

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

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

and effective.

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

one that has been cleared by the FDA.

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

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

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

This process, which

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

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

Notwithstanding the effort and expense incurred, the

process may never result in the FDA granting a PMA.

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

interpretations that could delay, limit or prevent regulatory approval.

Delays or rejections may also be encountered based upon changes

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

The FDA can delay, limit or deny approval of a

PMA application for many reasons, including:

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

13 unchanged sentences

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 U.S.

We also may design new products in the future

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

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

We also may design new products in

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 U.S.

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.

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

10 unchanged sentences

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

treatment of Ebola infected patients in the U.S.

and a corresponding HealthCanada approval in Canada.

Based on our studies to date, the

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

Additionally, in June 2020,

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

Based on our studies to

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

For example, in June 2020,

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

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

This study is designed to enroll up to 40 subjects

at up to 20 centers in the U.S.

Subjects will have established laboratory diagnosis of COVID-19, be admitted to an intensive care unit,

or ICU, and will have acute lung injury and/or severe or life threatening disease, among other criteria.

Endpoints for this study, in

addition to safety, will include reduction in circulating virus as well as clinical outcomes.

However, we have a very limited

supply of Hemopurifiers and therefore any use in this pandemic will be only investigational in a very small number of patients, even if

it appears that the device can help those patients.

Thus, we may not be able to demonstrate the effectiveness of our treatment countermeasures

through controlled human efficacy studies.

Additionally, a change in government policies could impair our ability to obtain regulatory

approval for the Hemopurifier.

This study was designed to enroll up to 40

subjects at up to 20 centers in the United States.

Subjects had to have an established laboratory diagnosis of COVID-19, be admitted to

an intensive care unit, or ICU, and have had acute lung injury and/or severe or life threatening disease, among other criteria.

to lack of COVID-19 patients in the ICUs of our trial sites, we terminated this study in 2022.

As a result of the termination

of our COVID-19 study due to lack of patients in the ICUs, we were unable to demonstrate the effectiveness of our treatment countermeasures

through controlled human efficacy studies in this U.S.

Additionally, a change in government policies could impair our ability to

obtain regulatory approval for the Hemopurifier.

The results of our clinical trials may not

2 unchanged sentences

pre-clinical testing and clinical trial activities involving our Hemopurifier and any additional products that we may develop are subject

to extensive regulation and review by numerous governmental authorities both in the U.S.

Clinical studies must be conducted

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

The data collected from these clinical studies may ultimately

be used to support market clearance for these products.

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

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

Success in pre-clinical

studies and early clinical trials does not ensure that later clinical trials will be successful, and the later trials may not replicate

the results of prior trials and pre-clinical studies.

The clinical trial process may fail to demonstrate that our product candidates are

safe and effective for the proposed indicated uses, which could cause us to abandon a product candidate and may delay development of others.

Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, our ability to commercialize

our product candidates and generate revenues.

It is also possible that patients enrolled in clinical trials will experience adverse side

effects that are not currently part of the product candidate’s profile.

legislative or FDA regulatory reforms

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.

to extensive regulation and review by numerous governmental authorities both in the United States and abroad.

Clinical studies must be

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

The data collected from these clinical studies may

ultimately be used to support market clearance for these products.

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

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

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

trials may not replicate the results of prior trials and pre-clinical studies.

The clinical trial process may fail to demonstrate that

our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product candidate and

may delay development of others.

Any delay or termination of our clinical trials will delay the filing of our product submissions and,

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

It is also possible that patients enrolled in clinical

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

legislative or FDA regulatory reforms 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

38 unchanged sentences

We are subject to stringent and changing

and foreign laws, 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 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.

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 information, including proprietary

and confidential business data, trade secrets, intellectual property, information 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, and contractual obligations

to third parties related to privacy, information security and Processing (collectively, “Data Protection Obligations”).

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”).

In the United States, federal,

state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data

privacy laws, and consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act).

For example, the federal Health Insurance

Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical

Health Act (“HITECH”), imposes specific requirements relating to the privacy, security, and transmission of individually identifiable

health information.

In addition, the California Consumer Privacy Act of 2018, CCPA, imposes obligations on covered businesses, including

giving California residents expanded rights to access and require deletion of their personal information, opt-out of certain personal

information sharing, and receive detailed information about how their personal information is used.

The CCPA also provides for statutory

fines for noncompliance(up to $7,500 per violation).

Although there are limited exemptions for clinical trial data under the CCPA, the

CCPA could increase compliance costs and potential liability with respect to other personal data we may maintain about California residents.

In addition, it is anticipated that the California Privacy Rights Act of 2020 (“CPRA”), effective January 1, 2023, will expand

The CPRA establishes a new California Privacy Protection Agency to implement and enforce the CPRA, which could increase the

risk of enforcement.

Other states, including Colorado, Connecticut, Utah and Virginia, have enacted data privacy laws which become effective

in 2023 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.

The enactment of such laws could have potentially conflicting requirements that would make compliance

challenging and expose us to additional liability.

privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping

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

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

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,

1 unchanged sentence

For example, the European Union’s

General Data Protection Regulation, or EU GDPR and the United Kingdom’s GDPR (“UK GDPR”) impose strict requirements

for processing personal data..

The GDPR requires covered businesses to, among other requirements, provide detailed disclosures, contractually

commit to data protection measures in our contracts, maintain adequate data security measures, notify regulators and affected individuals

of certain data breaches and meet extensive privacy governance and documentation requirements.

Companies that violate the GDPR can face

private litigation, restrictions on data processing, and fines of up to the greater of 20 million Euros or 4% of their worldwide annual

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.

Certain jurisdictions have

enacted data localization laws and cross-border personal data transfer laws, which could make it more difficult to transfer information

across jurisdictions (such as transferring or receiving personal data that originates in the EU or in other foreign jurisdictions).

mechanisms that facilitate cross-border personal data transfers may change or be invalidated and recent legal challenges and increasingly

strict interpretive guidance have created significant uncertainty about what measures would suffice to make such transfers lawful.

example, absent appropriate safeguards or other circumstances, the EU GDPR generally restricts the transfer of personal data to countries

outside of the European Economic Area (“EEA”) that the European Commission does not consider to provide an adequate level

of data privacy and security, such as the United States.

The European Commission released a set of “Standard Contractual Clauses”

(“SCCs”) that are designed to be a valid mechanism to facilitate personal data transfers out of the EEA to these jurisdictions.

Currently, these SCCs are a valid mechanism to transfer personal data outside of the EEA, but there exists some uncertainty regarding

whether the SCCs will remain a valid mechanism.

Additionally, the SCCs impose additional compliance burdens, such as conducting transfer

impact assessments to determine whether additional security measures are necessary to protect the at-issue personal data.

the UK similarly restricts personal data transfers outside of those jurisdictions to countries such as the United States that do not provide

an adequate level of personal data protection, and certain countries outside Europe have also passed or are considering laws requiring

local data residency or otherwise impeding the transfer of personal data across borders, any of which could increase the cost and complexity

of doing business.

If we cannot implement a valid

compliance mechanism for cross-border data transfers, we may face increased exposure to regulatory actions, substantial fines, and injunctions

against processing or transferring personal data from Europe or other foreign jurisdictions.

The inability to import personal data to

the United States could significantly and negatively impact our business operations, including by limiting our ability to conduct clinical

trial activities;

limiting our ability to collaborate with parties that are subject to such cross-border data transfer or localization

or requiring us to increase our personal data processing capabilities and infrastructure in foreign jurisdictions at significant

General Data Protection Regulation, or EU GDPR, and the United Kingdom’s GDPR, or UK GDPR, or collectively GDPR, Australia’s

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

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

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

to transfer personal data from Europe and other jurisdictions to the United States or other countries due to data localization requirements

or limitations on cross-border data flows.

Europe and other jurisdictions have enacted laws requiring data to be localized or limiting

the transfer of personal data to other countries.

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

31 unchanged sentences

interruptions

or stoppages in our business operations including, as relevant, clinical trials;

interruptions or stoppages of data collection needed

to train our algorithms;

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

limited ability to develop or commercialize

our products;

or stoppages in our business operations including, as relevant, clinical trials inability to process personal data or to operate in certain

jurisdictions;

limited ability to develop or commercialize our products;

expenditure of time and resources to defend any claim or inquiry;

adverse publicity;

or revision or restructuring of our

or revision or restructuring of our operations.

If our information technology systems or

data, or those maintained on our behalf, are or were compromised we could experience adverse consequences resulting from such compromise,

including but not limited to:

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

compromise, including but not limited to:

regulatory investigations or actions;

fines and penalties;

disruptions of our business operations;

disruptions of our business

reputational harm;

2 unchanged sentences

In the ordinary course of

our business, we 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;

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;

deletion or destruction;

unauthorized access to;

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.

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.

Cyberattacks, malicious internet-based

1 unchanged sentence

These threats are becoming increasingly difficult to detect.

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

states, and nation-state-supported actors.

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 cyber-attacks, that could materially disrupt our systems and operations,

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

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

10 unchanged sentences

example, applicable laws or regulations prohibiting such payments.

Similarly, 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

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.

Additionally, future

or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities,

as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies.

Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and it

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.

Any of the previously identified

or similar threats could cause a security incident or other interruption.

A security incident or other interruption could result in unauthorized,

unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive

A security incident or other interruption could disrupt our ability (and that of third parties upon whom we rely) to provide

our services.

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

5 unchanged sentences

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 Incidents.

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 incidents, there can be no assurance that these measures will be effective.

may be unable in the future to detect vulnerabilities in our information technology systems (including our products) because such threats

and techniques change frequently, are often sophisticated in nature, and may not be detected until after a security incident has occurred.

Despite our efforts to identify and address vulnerabilities, if any, in our information technology systems (including our products), our

efforts may not be successful.

Further, we may experience delays in developing and deploying remedial measures designed to address any

such identified vulnerabilities.

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

3 unchanged sentences

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 incident or are perceived to have experienced a security incident, we may experience

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.

12 unchanged sentences

and other similar harms.

Security incidents 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.

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

2 unchanged sentences

We cannot be sure that our

insurance coverage, if any, 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.

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

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

market position.

Should our products be approved for commercialization,

7 unchanged sentences

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

may not be available in the U.S.

or other countries, if approved, and reimbursement may not be sufficient to allow sales of our future

products, including the Hemopurifier, on a profitable basis.

The coverage decisions of third-party payors will be significantly influenced

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

These assessments are outside our control and any such

evaluations may not be conducted or have a favorable outcome.

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

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

The coverage decisions of third-party payors will be significantly

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

These assessments are outside our control

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

If approved for use in the

U.S., 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.

Payors may include the

Centers for Medicare & Medicaid Services, or CMS, which administers the Medicare program and works in partnership with state governments

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.

Payors may include

the Centers for Medicare & Medicaid Services, or CMS, which administers the Medicare program and works in partnership with state governments

to administer Medicaid, other government programs and private insurance plans.

23 unchanged sentences

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

For example, in the U.S.,

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

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.

However, on December 14, 2018, a Texas U.S.

District Court Judge ruled that the Affordable Care Act is unconstitutional in its entirety because the “individual mandate”

was repealed by Congress as part of the Tax Cuts and Jobs Act of 2017.

Additionally, on June 17, 2021, the U.S.

Supreme Court dismissed

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

On June 17, 2021, the U.S.

Supreme Court

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

was repealed by Congress.

Thus, the ACA will remain in effect in its current form.

Further, prior to the U.S.

Supreme Court ruling, on

January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health

insurance coverage through the ACA marketplace, which began on February 15, 2021 and remained open through August 15, 2021.

The executive

order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare,

including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that

create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

It is possible that the ACA

will be subject to judicial or Congressional challenges in the future.

It is unclear how any such challenges and litigation, and the healthcare

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

The Budget Control Act of 2011, as amended by subsequent

legislation, further reduces Medicare’s payments to providers by two percent through fiscal year 2031.

However, COVID-19 relief

legislation suspended the two percent Medicare sequester from May 1, 2020 through March 31, 2022.

Under current legislation, the actual

reduction in Medicare payments will vary from 1% in 2022 to up to 3% in the final fiscal year of this sequester.

These reductions may

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

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

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

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

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

It is unclear how any such challenges, and

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

The Budget Control Act of 2011, as amended

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

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

Furthermore, the healthcare

industry in the U.S.

has experienced a trend toward cost containment as government and private insurers seek to control healthcare costs

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

industry in the United States has experienced a trend toward cost containment as government and private insurers seek to control healthcare

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

In July 2021, the Biden Administration

4 unchanged sentences

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

No legislation or administrative actions have been finalized to implement these principles.

In addition, Congress is considering drug

pricing as part of other reform initiatives.

Furthermore, the healthcare industry in the U.S.

has experienced a trend toward cost containment

as government and private insurers seek to control healthcare costs by imposing lower payment rates and negotiating reduced contract rates

with service providers.

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

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

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

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

It is currently unclear how the IRA will be implemented

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

In addition, in response to the Biden administration’s

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

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

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

Legislation could be adopted

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

In addition, Congress is considering additional health reform

It is also possible that additional governmental action is taken in response to the COVID-19 pandemic.

In addition, commercial

payors such as insurance companies, could adopt similar policies that limit reimbursement for medical device manufacturers’ products.

Therefore, it is possible that our product or the procedures or patient care performed using our product will not be reimbursed at a cost-effective

We face similar risks relating to adverse changes in reimbursement procedures and policies in other countries where we may market

our products.

Reimbursement and healthcare payment systems vary significantly among international markets.

Our inability to obtain international

reimbursement approval, or any adverse changes in the reimbursement policies of foreign payors, could negatively affect our ability to

sell our products and have a material adverse effect on our business and financial condition.

In addition, commercial payors such as insurance companies,

could adopt similar policies that limit reimbursement for medical device manufacturers’ products.

Therefore, it is possible that

our product or the procedures or patient care performed using our product will not be reimbursed at a cost-effective level.

We face similar

risks relating to adverse changes in reimbursement procedures and policies in other countries where we may market our products.

Reimbursement

and healthcare payment systems vary significantly among international markets.

Our inability to obtain international reimbursement approval,

or any adverse changes in the reimbursement policies of foreign payors, could negatively affect our ability to sell our products and have

a material adverse effect on our business and financial condition.

Our ability to use net operating loss carryforwards

2 unchanged sentences

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 in tax years beginning after December 31, 2020, 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

We believe we have not experienced an ownership change in the past three years, however, we could experience ownership changes

in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control.

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

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.

The issuance of additional guidance related

to existing or future tax laws, or changes to tax laws or regulations proposed or implemented by the current or a future U.S.

administration, Congress, or taxing authorities in other jurisdictions, including jurisdictions outside of the United States, could materially

affect our tax obligations and effective tax rate.

To the extent that such changes have a negative impact on us, including as a result

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

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

in a manner consistent with our corporate structure and intercompany arrangements.

The taxing authorities of the jurisdictions in which

we operate may challenge our methodologies for pricing intercompany transactions pursuant to our intercompany arrangements or disagree

with our determinations as to the income and expenses attributable to specific jurisdictions.

If such a challenge or disagreement were

to occur, and our position was not sustained, we could be required to pay additional taxes, interest, and penalties, which could result

in one-time tax charges, higher effective tax rates, reduced cash flows, and lower overall profitability of our operations.

Our financial

statements could fail to reflect adequate reserves to cover such a contingency.

Similarly, a taxing authority could assert that we are

subject to tax in a jurisdiction where we believe we have not established a taxable connection, often referred to as a “permanent

establishment” under international tax treaties, and such an assertion, if successful, could increase our expected tax liability

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

13 unchanged sentences

We currently carry a limited

amount of insurance to protect us from damages arising from hazardous materials.

Our product liability policy has a $5,000,000 limit of

liability that would cover certain releases of hazardous substances away from our facilities.

For our facilities, our property policy

provides $25,000 in coverage for contaminant clean-up or removal and $50,000 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.

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.

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

31 unchanged sentences

for all firm-initiated medical device corrections and removals.

Our business is subject to risks arising

from the recent COVID-19 pandemic.

The ongoing COVID-19 worldwide

pandemic has presented substantial public health and economic challenges and is affecting our employees, patients, communities and business

operations, as well as the U.S.

and global economy and financial markets.

International and U.S.

authorities in impacted regions have been taking actions in an effort to slow the spread of COVID-19.

In response, we have implemented

a hybrid work from home policy for all non-laboratory employees, following the guidelines or directives issued by federal, state and local

government agencies in the U.S.

To date, we do not currently

anticipate any interruptions in supply.

In addition, while we are continuing with our clinical trials, we expect that COVID-19 precautions

may directly or indirectly impact the timeline for the trials.

As the COVID-19 pandemic continues to spread around the globe, we may experience

disruptions that could severely impact our business, clinical trials and manufacturing and supply chains, including:

further delays or difficulties in enrolling patients in our clinical trials;

delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures, which may impact the integrity of subject data and clinical study endpoints;

interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;

delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials and interruption in global shipping that may affect the transport of clinical trial materials;

limitations on employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

delays in receiving feedback or approvals from the FDA or other regulatory authorities with respect to future clinical trials or regulatory submissions;

changes in local regulations as part of a response to COVID-19 which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;

refusal of the FDA to accept data from clinical trials in affected geographies;

difficulties launching or commercializing products, including due to reduced access to doctors as a result of social distancing protocols.

In addition, the spread of

COVID-19 has had and may continue to impact the trading price of shares of our common stock and could further negatively impact our ability

to raise additional capital on a timely basis or at all.

The COVID-19 pandemic continues

to rapidly evolve.

The extent to which COVID-19 may impact our business, including our clinical trials, manufacturing and supply chains

and financial condition will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as

the continued geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing in the United

States and other countries, continued business closures or business disruptions and the effectiveness of actions taken in the United States

and other countries to contain and treat the disease.

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

of this product.

The Galanthus nivalis agglutinin, or GNA, is sourced from Vector Laboratories, Inc.

and also is available from other

however, Sigma Aldrich is the only approved back up supplier at this time.

A business interruption at any of these sources,

including interruption resulting from the coronavirus pandemic, could have a material impact on our ability to manufacture the Hemopurifier.

Even though we have received breakthrough

88 unchanged sentences

We currently have five issued U.S.

patents and five pending U.S.

patents and four pending U.S.

patent applications.

We also have 43 issued foreign patents and have applied for four additional foreign

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

and international patents.

17 unchanged sentences

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

patents may expire before we receive FDA approval to market our products in the U.S.

or we receive approval to market our products in

a foreign country.

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

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

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

in a foreign country.

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

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

of that technology.

93 unchanged sentences

contracts to further develop our technology.

We may not be successful in

obtaining additional government grants or contracts.

The process of obtaining government contracts is lengthy with the uncertainty that

we will be successful in obtaining announced grants or contracts for therapeutics as a medical device technology.

Accordingly, although

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

Government grants or contracts utilizing

our Hemopurifier platform technology.

While we have previously had

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

The process of obtaining government

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

medical device technology.

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

Government grants or contracts utilizing our Hemopurifier platform technology.

Government agencies have special contracting

2 unchanged sentences

Our business plan to utilize

the Aethlon Hemopurifier technology is likely to continue 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 subjects

us to additional risks.

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.

These risks include the ability of the U.S.

4 unchanged sentences

change certain terms and conditions in our contracts.

Government contractor,

we are required to comply with applicable laws, regulations and standards relating to our accounting practices and would be subject to

periodic audits and reviews.

As a former and potential

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

practices and would be subject to periodic audits and reviews.

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

Government may review the adequacy of, and our compliance with,

our internal control systems and policies, including those relating to our purchasing, property, estimating, compensation and management

information systems.

Government may review the

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

estimating, compensation and management information systems.

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

Government may adjust our contract-related costs and fees, including

allocated indirect costs.

In addition, if an audit or review uncovers any improper or illegal activity, we would possibly be subject to

civil and criminal penalties and administrative sanctions, including termination of our contracts, forfeiture of profits, suspension of

payments, fines and suspension or prohibition from doing business with the U.S.

We could also suffer serious harm to our reputation

if allegations of impropriety were made against us.

Although we have not had any government audits and reviews to date, future audits

and reviews could cause adverse effects.

Government may adjust our contract-related

costs and fees, including allocated indirect costs.

In addition, if an audit or review uncovers any improper or illegal activity, we would

possibly be subject to civil and criminal penalties and administrative sanctions, including termination of our contracts, forfeiture of

profits, suspension of payments, fines and suspension or prohibition from doing business with the U.S.

We could also suffer

serious harm to our reputation if allegations of impropriety were made against us.

Although we have not had any government audits and

reviews to date, future audits and reviews could cause adverse effects.

In addition, under U.S.

Government purchasing regulations, some of our costs, including most

financing costs, amortization of intangible assets, portions of our research and development costs, and some marketing expenses, would

possibly not be reimbursable or allowed under such contracts.

Further, as a U.S.

Government contractor, we would be subject to an increased

risk of investigations, criminal prosecution, civil fraud, whistleblower lawsuits and other legal actions and liabilities.

Government contractor, we are subject to a number of

procurement rules and regulations.

Government purchasing regulations, some

of our costs, including most financing costs, amortization of intangible assets, portions of our research and development costs, and some

marketing expenses, would possibly not be reimbursable or allowed under such contracts.

Further, as a former and potential future U.S.

Government contractor, we would be subject to an increased risk of investigations, criminal prosecution, civil fraud, whistleblower lawsuits

and other legal actions and liabilities.

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, impact

our performance and compliance costs.

These requirements, although customary in government contracts, would

impact our performance and compliance costs.

In addition, current U.S.

Government budgetary constraints could lead to changes in the procurement

environment, including the Department of Defense’s recent initiative focused on efficiencies, affordability and cost growth and

other changes to its procurement practices.

If and to the extent such changes occur, they could impact our results of operations and liquidity,

and could affect whether and, if so, how we pursue certain opportunities and the terms under which we are able to do so.

environment, including the Department of Defense’s initiative focused on efficiencies, affordability and cost growth and other changes

to its procurement practices.

If and to the extent such changes occur, they could affect whether and, if so, how we pursue certain opportunities

and the terms under which we are able to do so.

In addition, failure to comply

7 unchanged sentences

of costs, and foreign corruption.

The termination of our government contract as a result of any of these acts could have a negative impact

on our results of operations and financial condition and could have a negative impact on our reputation and ability to procure other government

contracts in the future.

The termination of any government contract we may obtain as a result of any of these acts could have

a negative impact on our results of operations and financial condition and could have a negative impact on our reputation and ability

to procure other government contracts in the future.

Risks Relating to Our Common Stock and Our Corporate Governance

Our failure to meet the continued listing

requirements of The Nasdaq Capital Market could result in a de-listing of our common stock.

If we fail to satisfy the

continued listing requirements of The Nasdaq Capital Market, or Nasdaq, such as the minimum stockholders’ equity requirement or

the minimum closing bid price requirement, Nasdaq may take steps to de-list our common stock.

For example, in May 2019 we received a letter

from Nasdaq indicating that Nasdaq had determined that we had failed to comply with the minimum bid price requirement of Nasdaq Listing

Rule 5550(a)(2).

Nasdaq Listing Rule 5550(a)(2) requires that companies listed on the Nasdaq Capital Market maintain a minimum closing

bid price of at least $1.00 per share.

In July 2019, we received another letter from Nasdaq indicating that Nasdaq has determined

that we have failed to comply with the minimum stockholder’s equity requirement of Nasdaq Listing Rule 5550(b)(1).

Nasdaq Listing

Rule 5550(b)(1) requires that companies listed on the Nasdaq Capital Market maintain a minimum of $2,500,000 in stockholder’s equity.

If we fail to maintain compliance with these, or any other of the continued listing requirements of The Nasdaq Capital Market, Nasdaq

may take steps to de-list our common stock.

Such a de-listing would likely have a negative effect on the price of our common stock and

would impair your ability to sell or purchase our common stock when you wish to do so.

In the event of a de-listing, we would take actions

to restore our compliance with Nasdaq’s listing requirements, but any such action taken by us may not be successful.

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

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.

There can be no assurance,

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

Even if we do regain compliance, we may not

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

in the future.

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

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

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

Delisting from the Nasdaq

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

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

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

32 unchanged sentences

general market conditions;

domestic or international terrorism and other factors, including the effects of the ongoing COVID-19 pandemic;

domestic or international terrorism and other factors;

the other factors described in this section.

83 unchanged sentences

actual or anticipated variations in our quarterly or annual operating results;

announcements regarding our clinical trials and the development of the Hemopurifier;

acceptance of our proprietary technology as a viable

method of augmenting the immune response of clearing viruses and toxins from human blood;

government regulations, announcements of significant

acquisitions, strategic partnerships or joint ventures;

our capital commitments and additions or departures of our key personnel.

of these factors are beyond our control and may decrease the market price of our common shares regardless of our operating performance.

We cannot make any predictions or projections as to what the prevailing market price for our common shares will be at any time, including

as to whether our common shares will sustain their current market prices, or as to what effect the sale of shares or the availability

of common shares for sale at any time will have on the prevailing market price.

announcements regarding our clinical trials and the development and manufacture of our Hemopurifier;

acceptance of our proprietary technology

as a viable method of augmenting the immune response of clearing viruses and toxins from human blood;

government regulations, announcements

of significant acquisitions, strategic partnerships or joint ventures;

our capital commitments and additions or departures of our key

Many of these factors are beyond our control and may decrease the market price of our common shares regardless of our operating

We cannot make any predictions or projections as to what the prevailing market price for our common shares will be at any

time, including as to whether our common shares will sustain their current market prices, or as to what effect the sale of shares or the

availability of common shares for sale at any time will have on the prevailing market price.

Our issuance of additional shares of common

2 unchanged sentences

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

We have reserved for issuance 2,243,838 of those shares of

common stock for outstanding restricted stock units, stock options and warrants, excluding an aggregate of 181,464 contingent issuances

of restricted stock units and options made subsequent to March 31, 2022, which are subject to approval by the stockholders of the Company

at the 2022 annual meeting of stockholders of an increase in the number of shares of common stock authorized for issuance under our 2020

Equity Incentive Plan.

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, 2022 we had 12,336,999 shares of common stock available for issuance to new investors or for use to satisfy indebtedness or pay service

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.

On March 24, 2022, we entered

3 unchanged sentences

2022 ATM Agreement.

The 2022 ATM Agreement provides for the sale of shares of our common stock having an aggregate offering price of up

to $15,000,000.

As of March 31, 2022, we had not sold any shares under the 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

113 unchanged sentences

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