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Item 5. Market for Registrant’s Common Equity

2021-06-24 compared with 2020-06-25 · 453 added, 515 removed, 92 unchanged (91% of the section changed)

MARKET FOR REGISTRANT’S

COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER

MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

Our common stock is

traded on the Nasdaq Capital Market under the trading symbol “AEMD.”

On July 7, 2015, The Nasdaq Stock Market LLC approved

our application for listing our common stock on the Nasdaq Capital Market under the symbol “AEMD,”

and we commenced

trading on the Nasdaq Capital Market on July 13, 2015.

Previously, our common stock was quoted on the OTCQB Marketplace under the

trading symbol “AEMD.”

Our common stock is traded

on the Nasdaq Capital Market under the trading symbol “AEMD.”

On July 7, 2015, The Nasdaq Stock Market LLC approved our application

for listing our common stock on the Nasdaq Capital Market under the symbol “AEMD,”

and we commenced trading on the Nasdaq

Capital Market on July 13, 2015.

Previously, our common stock was quoted on the OTCQB Marketplace under the trading symbol “AEMD.”

Holders of Record

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record holders of our common stock at June 21, 2021.

The number of registered stockholders includes any beneficial owners of

common shares held in street name.

The number of registered stockholders includes any beneficial owners of common shares

held in street name.

Dividend Policy

We have not paid any

dividends on our common stock to date and do not anticipate that we will pay dividends in the foreseeable future.

Any payment of

cash dividends on our common stock in the future will be dependent upon the amount of funds legally available, our earnings, if

any, our financial condition, our anticipated capital requirements and other factors that the board of directors may think are

However, we currently intend for the foreseeable future to follow a policy of retaining all of our earnings, if any,

to finance the development and expansion of our business and, therefore, do not expect to pay any dividends on our common stock

in the foreseeable future.

We have not paid any dividends

on our common stock to date and do not anticipate that we will pay dividends in the foreseeable future.

Any payment of cash dividends

on our common stock in the future will be dependent upon the amount of funds legally available, our earnings, if any, our financial condition,

our anticipated capital requirements and other factors that the board of directors may think are relevant.

However, we currently intend

for the foreseeable future to follow a policy of retaining all of our earnings, if any, to finance the development and expansion of our

business and, therefore, do not expect to pay any dividends on our common stock in the foreseeable future.

Recent Sales of Unregistered Securities

Other than as previously

disclosed in our past Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, the Company did not have any sales of unregistered

securities for the period covered by this Annual Report.

Securities Authorized for Issuance Under Equity Compensation

Information about our equity compensation

plans is incorporated herein by reference to Item 12 of Part III of this Annual Report.

The Company did not have any

sales of unregistered securities for the period covered by this Annual Report.

Securities Authorized for Issuance Under Equity

Compensation Plans

Information about our equity

compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report.

SELECTED FINANCIAL DATA

As a Smaller Reporting

Company, we are not required to furnish information under this Item 6.

MANAGEMENT’S DISCUSSION

AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion

and analysis should be read in conjunction with the consolidated Financial Statements and Notes thereto appearing elsewhere in

this Annual Report.

As a Smaller Reporting Company,

we are not required to furnish information under this Item 6.

MANAGEMENT’S DISCUSSION AND ANALYSIS

OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and

analysis should be read in conjunction with the consolidated Financial Statements and Notes thereto appearing elsewhere in this Annual

We are a medical technology

company focused on developing products to diagnose and treat life and organ threatening diseases.

The Aethlon Hemopurifier is a

clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections.

In cancer, the Hemopurifier®

is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis

and inhibit the benefit of leading cancer therapies.

Food and Drug Administration, or FDA, has designated the Hemopurifier

as a “Breakthrough Device”

The Aethlon Hemopurifier is a clinical-stage

immunotherapeutic device designed to combat cancer and life-threatening viral infections.

In cancer, the Hemopurifier is designed to deplete

the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit

of leading cancer therapies.

Food and Drug Administration, or FDA, has designated the Hemopurifier as a “Breakthrough Device”

for two independent indications:

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We believe the Hemopurifier

can be a substantial advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes

that promote the growth and spread of tumors through multiple mechanisms.

We are currently preparing for the initiation of clinical

trials in patients with advanced and metastatic cancers.

We are initially focused on the treatment of solid tumors, including head

and neck cancer, gastrointestinal cancers and other cancers.

On October 4,

2019, the FDA approved our Investigational Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS,

of the Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda).

endpoint for the EFS, which will enroll 10-12 subjects at a single center, will be safety, with secondary endpoints including measures

of exosome clearance and characterization, as well as response and survival rates.

This study, which will be conducted at the UPMC

Hillman Cancer Center in Pittsburgh, PA, has been approved by the Institutional Review Board, or IRB, and is in the process of

We also believe the

Hemopurifier can be part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses

that are not addressed with an already approved treatment.

In small-scale or early feasibility human studies, the Hemopurifier

has been used to treat individuals infected with HIV, hepatitis-C, and Ebola.

can be a substantial advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote

the growth and spread of tumors through multiple mechanisms.

We are currently preparing for the initiation of clinical trials in patients

with advanced and metastatic cancers.

We are initially focused on the treatment of solid tumors, including head and neck cancer, gastrointestinal

cancers and other cancers.

As we advance our clinical trials, we are in close contact with our clinical sites to navigate and assess the

impact of the COVID-19 global pandemic on our clinical trials and current timelines.

On October 4, 2019, the FDA

approved our Investigational Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS, of the Hemopurifier

in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda).

The primary endpoint for the EFS,

which will enroll 10-12 subjects at a single center, will be safety, with secondary endpoints including measures of exosome clearance

and characterization, as well as response and survival rates.

This study is being conducted at the UPMC Hillman Cancer Center in Pittsburgh,

PA, is in the process of recruiting and treating patients.

We also believe the Hemopurifier

can be part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed

with an already approved treatment.

In small-scale or early feasibility human studies, the Hemopurifier has been used to treat individuals

infected with human immunodeficiency virus, or HIV, hepatitis-C, and Ebola.

Additionally, in-vitro ,

the Hemopurifier has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes

simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu

virus, and the reconstructed Spanish flu virus of 1918.

In several cases, these validations were conducted in collaboration with

leading government or non-government research institutes.

On June 17, 2020,

the FDA approved a supplement to the Company’s open IDE for the Company’s 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.

study’s plan is 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, orICU 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.

We are also the majority

owner of Exosome Sciences, Inc., or ESI, a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening

the Hemopurifier has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex

virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, and the

reconstructed Spanish flu virus of 1918.

In several cases, these validations were conducted in collaboration with leading government or

non-government research institutes.

On June 17, 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.

That study’s plan is 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 (NCT # 04595903).

The initial sites for this

trial, Hoag Memorial Hospital Presbyterian in Newport Beach, CA and Hoag Hospital –

Irvine in Irvine, CA and Loma Linda Hospital

in Loma Linda, CA, have completed clinical trial agreements, and have received IRB approval in the case of the Hoag hospitals, and are

preparing to open for patient enrollment.

Under Single Patient Emergency Use regulations, the Company has also treated two patients with

COVID-19 with the Hemopurifier.

We are also the majority owner

of Exosome Sciences, Inc., or ESI, a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening

Included among ESI’s activities is the advancement of a TauSome™

biomarker candidate to diagnose chronic

traumatic encephalopathy, or CTE, in the living.

ESI previously documented TauSome levels in former NFL players to be nine times

higher than same age-group control subjects.

Through ESI, we are also developing exosome based biomarkers in patients with, or

at risk for, a number of cancers.

biomarker candidate to diagnose chronic traumatic

encephalopathy, or CTE, in the living.

ESI previously documented TauSome levels in former NFL players to be nine times higher than same

age-group control subjects.

Through ESI, we are also developing exosome based biomarkers in patients with, or at risk for, a number of

We consolidate ESI’s activities in our consolidated financial statements.

Successful outcomes of human trials will

also be required by the regulatory agencies of certain foreign countries where we plan to sell the Hemopurifier.

Some of our patents

may expire before FDA approval or approval in a foreign country, if any, is obtained.

However, we believe that certain patent applications

and/or other patents issued more recently will help protect the proprietary nature of the Hemopurifier treatment technology.

Successful outcomes of human

trials will also be required by the regulatory agencies of certain foreign countries where we plan to sell the Hemopurifier.

patents may expire before FDA approval or approval in a foreign country, if any, is obtained.

However, we believe that certain patent

applications and/or other patents issued more recently will help protect the proprietary nature of the Hemopurifier treatment technology.

We were formed on March 10,

Our executive offices are located at 9635 Granite Ridge Drive, Suite 100, San Diego, California 92123.

Our telephone

number is (858) 459-7800.

Our telephone number is (858)

Our website address is www.aethlonmedical.com.

Our common stock is listed on the Nasdaq

Capital Market under the symbol “AEMD.”

Our common stock is listed on the Nasdaq Capital

Market under the symbol “AEMD.”

COVID-19 Update

In March 2020, the World Health Organization

declared COVID-19 a pandemic.

The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains

and created significant volatility and disruption of financial markets.

We are monitoring closely the impact of

the COVID-19 global pandemic on our business and have taken steps designed to protect the health and safety of our employees while

continuing our operations, including clinical trials.

In March 2020, the World Health

Organization declared COVID-19 a global pandemic.

The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply

chains and created significant volatility and disruption of financial markets.

We are monitoring closely

the impact of the COVID-19 global pandemic on our business and have taken steps designed to protect the health and safety of our employees

while continuing our operations, including clinical trials.

Given the level of uncertainty regarding the duration and impact of the COVID-19

pandemic on capital markets and the U.S.

economy, we are unable to assess the impact of the worldwide spread of SARS-CoV-2 and

the resulting COVID-19 pandemic on our future access to capital.

Further, while we have not experienced significant disruptions

to our manufacturing supply chain, business, results of operations, financial condition, clinical trials, or preclinical research

to date, we are unable to assess the potential impact this pandemic could have on our manufacturing supply chain, business, results

of operations, financial condition, clinical trials, or preclinical research in the future.

As we continue to actively advance our clinical

trials, we remain in close contact with our clinical sites and are assessing the impact of COVID-19 on our trials, expected timelines

and costs on an ongoing basis.

We will assess any potential delays in our ability to timely ship clinical trial materials, including

internationally, due to transportation interruptions.

The extent of the impact of COVID-19 on our operational and financial performance

will depend on certain developments, including the duration and spread of the outbreak, impact on our clinical trials, employees

economy, we are unable to assess the impact of the worldwide spread of SARS-CoV-2 and the resulting

COVID-19 pandemic on our future access to capital.

Further, while we have not experienced significant disruptions to our manufacturing

supply chain, business, results of operations, financial condition, clinical trials, or preclinical research to date, we are unable to

assess the potential impact this pandemic could have on our manufacturing supply chain, business, results of operations, financial condition,

clinical trials, or preclinical research in the future.

As we continue to actively

advance our clinical trials, we remain in close contact with our clinical sites and are assessing the impact of COVID-19 on our trials,

expected timelines and costs on an ongoing basis.

We will assess any potential delays in our ability to timely ship clinical trial materials,

including internationally, due to transportation interruptions.

The extent of the impact of COVID-19 on our operational and financial

performance will depend on certain developments, including the duration and spread of the outbreak, impact on our clinical trials, employees

and vendors, all of which are uncertain and cannot be predicted.

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Government Contract Revenues

We recorded government contract revenue

in the fiscal years ended March 31, 2020 and 2019.

We recorded government contract

revenue in the fiscal years ended March 31, 2021 and 2020.

This revenue resulted from work performed under our government contracts with

the NIH as follows:

the NIH and our subaward with the University of Pittsburgh as follows:

Ended 3/31/21

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Phase 2 Melanoma Cancer Contract

Phase 1 Melanoma Cancer Contract

Breast Cancer Grant

Subaward with University of Pittsburgh

Total Government Contract and Grant Revenue

We have entered into the following three contracts/grants with

the NCI, part of the NIH over the past two years:

Phase 2 Melanoma Cancer Contract

On September 12, 2019,

the NCI awarded to us an SBIR Phase II Award Contract, for NIH/NCI Topic 359, entitled “A Device Prototype for Isolation

of Melanoma Exosomes for Diagnostics and Treatment Monitoring”, or the Award Contract.

The Award Contract amount is $1,860,561

and runs for the period from September 16, 2019 through September 15, 2021.

The work to be performed

pursuant to this Award Contract will focus on melanoma exosomes.

This work follows from our completion of a Phase I contract for

the Topic 359 solicitation that ran from September 2017 through June 2018, as described below.

Following on the Phase I work, the

deliverables in the Phase II program involve the design and testing of a pre-commercial prototype of a more advanced version of

the exosome isolation platform.

During the fiscal year

ended March 31, 2020, we recognized $620,187 in government contract revenue under this contract as a result of the work involved

completing the first three milestones in the project as reported in the kick-off presentation to the NCI and the first and second

quarterly reports.

The kick-off presentation covered the Company's organization and project status, recent achievements, the status

of the field, the status of commercial and academic competitors, where the proposed project was positioned against the state of

the art, the IP landscape, a refresher on the proposed technology, the detailed plan for the first budget period of the contract

and technical risks and alternative approaches.

The first and second quarterly reports covered a summary of technical objectives,

a description of activities accomplished in the quarter, an analysis of experimental data, comments regarding the timeliness of

performance, and a brief explanation of activities to be pursued in the following quarter.

We have recognized revenue

under the following three government contracts/grants over the past two years:

Phase 2 Melanoma Cancer Contract

We entered into a contract

with NCI in September 2017.

This award was under the NIH’s SBIR program.

The title of the award was “SBIR Topic 359

Phase 1 Device Strategy for Selective Isolation of Oncosomes and Non-Malignant Exosomes.”

The award from NIH was a firm,

fixed-price contract with potential total payments to us of $299,250 over the course of nine months.

Fixed price contracts

require the achievement of multiple, incremental milestones to receive the full award during each period of the contract.

NIH also had the unilateral right to require us to perform additional work under an option period for an additional fixed amount

Under the terms of the contract, we were required to perform certain incremental work toward the achievement of specific

milestones against which we invoiced the government for fixed payment amounts.

The Phase 1 Melanoma Cancer Contract was completed

in June 2018.

In the fiscal year

ended March 31, 2019, we performed work under the contract covering the remainder of the technical objectives of the contract (Aim

To validate the Hemopurifier as a device for capture and recovery of melanoma exosomes from plasma, and Aim 2:

To validate a

method of melanoma exosome isolation consisting of the Hemopurifier followed by mab-based immunocapture to select out the tumor-derived

exosomes from non-malignant exosomes, and Aim 3:

To evaluate the functional integrity of melanoma exosomes purified by the Hemopurifier

and immunocapture isolation steps).

As a result we invoiced NIH for $149,625 during the fiscal year ended March 31, 2019.

Cancer Contract is now completed.

On September 12, 2019, the

National Cancer Institute, or NCI, part of the National Institutes of Health, or NIH, awarded to us an SBIR Phase II Award Contract, for

NIH/NCI Topic 359, entitled “A Device Prototype for Isolation of Melanoma Exosomes for Diagnostics and Treatment Monitoring”,

or the Award Contract.

The Award Contract amount is $1,860,561 and runs for the period from September 16, 2019 through September 15, 2021.

The work to be performed pursuant

to this Award Contract focuses on melanoma exosomes.

This work follows from our completion of a phase I contract for the Topic 359 solicitation

that ran from September 2017 through June 2018.

Following on the phase I work, the deliverables in the phase II program involve the design

and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.

During the fiscal year ended

March 31, 2021, we completed the milestones relevant to the first nine months of the fiscal year.

As a result, we recorded $436,427 of

government contract revenue on the Phase 2 Melanoma Cancer Contract in the fiscal year ended March 31, 2021.

revenue recognized during the current period relating to this grant, a total of $117,849 was invoiced to the NCI during the three months

ended December 31, 2020 and we recorded $318,578 which had previously been recognized as deferred revenue.

During the three month period

ended March 31, 2021, we did not complete all of the milestones relevant to that time period, as a result, we recorded $114,849 as deferred

revenue related to the Phase 2 Melanoma Cancer Contract.

Breast Cancer Grant

In September 2018,

the NCI awarded us a government grant (number 1R43CA232977-01).

The title of this Small Business Innovation Research, or SBIR,

Phase I grant is “The Hemopurifier Device for Targeted Removal of Breast Cancer Exosomes from the Blood Circulation.”

This NCI Phase I grant

period originally ran from September 14, 2018 through August 31, 2019.

In August 2019, we applied for and received a no cost, twelve

month extension on this grant, so the expiration date was extended to August 31, 2020.

The total amount of the firm grant is $298,444.

The grant calls for two subcontractors to work with us.

Those subcontractors are University of Pittsburgh and Massachusetts General

During the fiscal year

ended March 31, 2020, we recognized $30,000 in government contract revenue under this grant as a result of the work involved in

one of the three technical objectives of the contract (Aim 2.

“Elution of a population of breast cancer exosomes from Hemopurifier

cartridges that bear the signatures of malignancy based on expression of CSPG4 and HER2, for triple-negative or HER2-overexpressing

cancers, respectively”).

We also invoiced the NCI for an additional $100,000 during the fiscal year ended March 31, 2020

in order to pay our subcontractors under the contract.

As we did not complete any additional technical objectives beyond Aim 2

noted above during the period, we recorded this $100,000 as deferred revenue as of March 31, 2020.

During the fiscal year

ended March 31, 2019, we recognized $80,000 in government contract revenue under this grant as a result of the work involved in

completing one of the three technical objectives of the contract (Aim 1.

“To evaluate Hemopurifier-mediated capture of breast

cancer exosomes”).

In the fiscal year ended March

31, 2021, we completed and submitted the final reports applicable to this NCI grant (number 1R43CA232977-01).

The title of this Small

Business Innovation Research, or SBIR, Phase I grant is “The Hemopurifier Device for Targeted Removal of Breast Cancer Exosomes

from the Blood Circulation,”

or the Breast Cancer Grant.

This NCI Phase I grant period

originally ran from September 14, 2018 through August 31, 2019.

In August 2019, we applied for and received a no cost, twelve month extension

on this grant;

through August 31, 2020.

The total amount of the firm grant was $298,444.

The grant called for two subcontractors to work

Those subcontractors were University of Pittsburgh and Massachusetts General Hospital.

During the fiscal year ended

March 31, 2021, we recorded the remaining $188,444 of revenue related to the Breast Cancer Grant, as we achieved two of the three milestones

related to the Breast Cancer Grant.

We concluded in our final report to the SBIR that our pre-clinical results demonstrated that our work

under the grant provided support that the Hemopurifier has the capacity to clear exosomes from breast cancer patients.

That amount previously

was recorded as deferred revenue.

As of March 31, 2021, we received

all of the funds allocated to the Breast Cancer Grant and have submitted the final reports applicable to this grant.

Subaward with University of Pittsburgh

In 2020, we entered into a

cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting

Exosomes to Improve Responses to Immune Therapy in HNNCC.”

Our share of the award is $256,750.

We recorded $34,233 of revenue related

to this subaward in the fiscal year ended March 31, 2021.

Operating Costs and Expenses

Consolidated operating

expenses were $6,580,175 for the fiscal year ended March 31, 2020, compared to $6,228,642 for the fiscal year ended March 31, 2019,

an increase of $351,533.

The $351,533 increase was due to increases in professional fees of $536,977 and general and administrative

expense of $595,073, which were partially offset by a decrease of $780,517 in payroll and related expenses.

The $536,977 increase

in fiscal year ended March 21, 2020 in our professional fees was primarily arose from increases of $693,609 in legal fees and $110,829

in accounting fees, which were partially offset by decreases of $123,480 in investor relations expenses and $121,986 in scientific

consulting fees.

The $595,073 increase

in fiscal year ended March 21, 2020 in our general and administrative expenses primarily arose from increases of $316,232 in our

clinical trial expenses, $197,542 in subcontracting and other costs related to our government contracts, and $87,102 in laboratory

The $780,517 decrease

in fiscal year ended March 21, 2020 in our payroll and related expenses was due to a combination of a decrease in our stock-based

compensation of $475,003 and a decrease of $305,514 in cash-based compensation, primarily due to the termination of consulting

and severance payments to our former Chief Executive Office and former president.

Consolidated operating expenses

were $8,549,023 for the fiscal year ended March 31, 2021, compared to $6,580,175 for the fiscal year ended March 31, 2020, an increase

of $1,968,848.

The $1,968,848 increase was due to increases in payroll and related expenses of $1,152,342 and in general and administrative

expense of $907,867, which were partially offset by a decrease of $91,361 in professional fees.

The $1,152,342 increase in

fiscal year ended March 31, 2021 in our payroll and related expenses was due to an increase in cash-based compensation of $1,216,919,

which was partially offset by a decrease in our stock-based compensation of $64,577.

Approximately $444,729 of the increase in cash-based

compensation related to an accrual for severance payments to our former Chief Executive Officer.

The $907,867 increase in fiscal

year ended March 31, 2021 in our general and administrative expenses primarily arose from increases of $460,817 in our clinical trial

expenses and $469,304 in laboratory supplies.

The $91,361 decrease in fiscal

year ended March 31, 2021 in our professional fees primarily arose from decreases of $295,022 in legal fees and $116,536 in accounting

fees, which were partially offset by increases of $179,457 in scientific consulting fees, $94,548 in recruiting fees and $58,966 in contract

Other Expense

In the fiscal year

ended March 31, 2020, we recognized other expenses of $450,053, compared to $220,487 of other expense in the fiscal year ended

March 31, 2019.

The following table breaks out the various components of our other expense over the fiscal years ended March 31,

2020 and 2019:

In the fiscal year ended March

31, 2021, we recognized other expenses of $1,580, compared to $450,053 of other expense in the fiscal year ended March 31, 2020.

The following

table breaks out the various components of our other expense over the fiscal years ended March 31, 2021 and 2020:

Components of Other Expense

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Loss on Debt Extinguishment

During the fiscal year

ended March 31, 2020, we reduced the conversion price on our outstanding convertible notes from $45.00 per share to $10.20 per

The modification of the convertible notes was evaluated under ASC 470-50-40 and the instruments were determined to be substantially

different, and the transaction qualified for extinguishment accounting.

Under the extinguishment accounting we recorded a loss

on debt extinguishment of $447,011.

During the fiscal year ended

March 31, 2020, we reduced the conversion price on our outstanding convertible notes from $45.00 per share to $10.20 per share.

The modification

of the convertible notes was evaluated under ASC 470-50-40 and the instruments were determined to be substantially different, and the

transaction qualified for extinguishment accounting.

Under the extinguishment accounting we recorded a loss on debt extinguishment of

There was no comparable loss on debt extinguishment in the fiscal year ended March 31, 2021.

Gain on Common Stock for Warrant Cancellation

During the fiscal year

ended March 31, 2020, we agreed with seven accredited investors to issue an aggregate of 3,992 shares of our common stock to these

investors in exchange for the cancellation of outstanding warrants then held by the investors to purchase an aggregate of 39,900

shares of our common stock.

We measured the fair value of the shares issued and the fair value of the warrants exchanged for those

shares and recorded a gain of $51,190 on those exchanges based on the changes in fair value between the instruments exchanged.

During the fiscal year ended

March 31, 2020, we agreed with seven accredited investors to issue an aggregate of 3,992 shares of our common stock to these investors

in exchange for the cancellation of outstanding warrants then held by the investors to purchase an aggregate of 39,900 shares of our common

We measured the fair value of the shares issued and the fair value of the warrants exchanged for those shares and recorded a gain

of $51,190 on those exchanges based on the changes in fair value between the instruments exchanged.

There was no comparable gain on common

stock for warrant cancellation in the fiscal year ended March 31, 2021.

Interest and Other Debt Expenses

Our interest and other

debt expense decreased by $166,255 in the fiscal year ended March 31, 2020, from the fiscal year ended March 31, 2019.

The following

table breaks out the various components of our interest expense over the fiscal years ended March 31, 2020 and 2019:

Our interest and other debt

expense decreased by $52,652 in the fiscal year ended March 31, 2021, from the fiscal year ended March 31, 2020.

The following table breaks

out the various components of our interest expense over the fiscal years ended March 31, 2021 and 2020:

Components of Interest Expense and Other Debt

3 unchanged sentences

Total interest and other debt expenses

As noted in the above

table, the factors in the $166,255 overall decrease in fiscal year ended March 21, 2020 in interest and other debt expenses were

a $90,861 decrease in the amortization of note discounts and a $75,394 decrease in interest expense in fiscal year ended March

As a result of the

above factors, our net loss before noncontrolling interests increased to $6,380,041 for the fiscal year ended March 31, 2020, from

$6,219,504 for the fiscal year ended March 31, 2019.

As noted in the above table,

the factors in the $52,652 overall decrease in fiscal year ended March 21, 2021 in interest and other debt expenses were a $30,287 decrease

in the amortization of note discounts and a $22,365 decrease in interest expense in fiscal year ended March 31, 2021 as the result of

paying off our convertible notes.

As a result of the above factors,

our net loss before noncontrolling interests increased to $7,891,499 for the fiscal year ended March 31, 2021, from $6,380,041 for the

fiscal year ended March 31, 2020.

Liquidity and Capital Resources

At March 31, 2021, we had

a cash balance of $9,861,575 and working capital of $8,976,512.

This compares to a cash balance of $9,604,780 and working capital of $8,973,393

at March 31, 2020.

we had a cash balance of $9,604,780 and working capital of $8,973,393.

This compares to a cash balance of $3,828,074 and working

capital of $2,214,230 at March 31, 2019.

We expect our existing cash as of March 31, 2020 to be sufficient to fund the Company’s

operations for at least twelve months from the issuance date of this Form 10-K.

Our primary sources

of capital during the fiscal year ended March 31, 2020 were our public offering in December 2019, or the December 2019 Public

Offering, and our registered direct offering and related private placement in January 2020, as well as from at the market sales

of our common stock under our Common Stock Sales Agreement with H.C.

Wainwright LLC, or Wainwright, and exercises of certain of

the warrants from the December 2019 Public Offering.

The cash raised from those activities is noted below.

As a result of the

COVID-19 pandemic and actions taken to slow its spread, the global credit and financial markets have experienced extreme volatility,

including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases

in unemployment rates and uncertainty about economic stability.

There can be no assurance that further deterioration in credit

and financial markets and confidence in economic conditions will not occur.

If equity and credit markets deteriorate, it may make

any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive.

Any of these actions could materially

harm our business, results of operations and future prospects.

December 2019 Public Offering

On December 13, 2019,

we entered into an underwriting agreement with Wainwright as representative of the several underwriters named therein, relating

to the public offering, issuance and sale of 3,333,334 shares of common stock (which includes pre-funded warrants to purchase shares

of common stock in lieu thereof), and common warrants to purchase up to an aggregate of 3,333,334 shares of common stock at a public

offering price of $1.50 per share.

Each share of common stock (or pre-funded warrant in lieu thereof) was sold together with a

common warrant to purchase one share of common stock.

The common warrants have an exercise price of $1.50 per share, were immediately

exercisable, and will expire five years from the date of issuance.

The offering closed on December 17, 2019.

The gross proceeds

of the December 2019 Public Offering were approximately $5 million, prior to deducting underwriting discounts and commissions and

estimated offering expenses and excluding the exercise of any common warrants and the underwriter's option to purchase additional

The net proceeds from the December 2019 Public Offering were $4,091,437.

Subsequent to the completion

of the December 2019 Public Offering and prior to March 31, 2020, all of the holders of pre-funded warrants exercised their pre-funded

warrants in full.

In the event of a Fundamental

Transaction, defined in the common warrants issued in the December 2019 Public Offering as a transfer of ownership of the Company

within our control, the holders of the unexercised common stock warrants exercisable for $1.50 per share, are entitled to receive

cash consideration equal to a Black-Scholes valuation, as defined in the warrant.

If such Fundamental Transaction is not within

our control, the warrant holders would only be entitled to receive the same form of consideration (and in the same proportion)

as the holders of our common stock, hence these warrants are classified as a component of permanent equity.

January 2020 Registered Direct Offering and Private Placement

On January 16, 2020,

we engaged Wainwright to act as our exclusive placement agent in connection with the private placement

and a concurrent registered direct offering, referred to together, as the Offering, of an aggregate of 1,885,378 shares of our

common stock, at a purchase price per share of $2.00 per share, for aggregate gross proceeds to us of approximately $3.77 million,

before deducting fees payable to Wainwright and other estimated offering expenses payable by us.

We also entered into a securities

purchase agreement with certain institutional investors, pursuant to which we agreed to sell and issue to the investors warrants,

or the Purchase Warrants, to purchase up to an aggregate of 942,689 shares of our common stock.

We agreed to pay Wainwright a cash

fee of 6.0% of the aggregate gross proceeds in the Offering, excluding the proceeds, if any, from the exercise of the warrants.

We paid Wainwright an additional 1.0% of the aggregate gross proceeds in the Offering as a management fee and also paid Wainwright

an additional $70,000 for certain expenses in connection with the Offering.

In addition, Wainwright received placement agent warrants

on substantially the same terms as the investor warrants in an amount equal to 3.0% of the aggregate number of shares sold in the

offering, or 56,561 shares of common stock, at an exercise price of $2.50 per share and a term expiring on January 17, 2025.

On January 22, 2020,

the Company closed the Offering and issued the warrants to the investors.

The warrants are exercisable immediately at an exercise

price of $2.75 per share and will expire five and one-half years from the issuance date.

The net proceeds from

the Offering were $3,364,878.

Common Stock Sales Agreement with H.C.

On June 28, 2016, we

entered into a Common Stock Sales Agreement, or the Agreement, with Wainwright, which established an at-the-market equity program

pursuant to which we may offer and sell shares of our common stock from time to time as set forth in the Agreement.

The Agreement

provides for the sale of shares of our common stock having an aggregate offering price of up to $12,500,000).

On March 30, 2020, we executed Amendment

We expect our existing cash as of March 31, 2021 to be sufficient to fund the Company’s operations for at least

twelve months from the issuance date of this Form 10-K.

The primary source of our

increase in cash during the fiscal year ended March 31, 2021 resulted from our Common Stock Sales Agreement with H.C.

Co., LLC, or Wainwright, entered into originally in 2016.

The cash raised from that activity is described below:

Common Stock Sales Agreement with Wainwright

On June 28, 2016, we entered

into a Common Stock Sales Agreement, or the 2016 Agreement, with Wainwright, which established an at-the-market equity program pursuant

to which we may offer and sell shares of our common stock from time to time as set forth in the 2016 Agreement.

The 2016 Agreement provided

for the sale of shares of our common stock having an aggregate offering price of up to $12,500,000.

On March 30, 2020, we executed

Amendment No.

2 to the 2016 Agreement with Wainwright, effective as of the same date.

The amendment provides that references in the Agreement

to the registration statement shall refer to the registration statement on Form S-3 (File No.

333-237269), originally filed with

the SEC on March 19, 2020, declared effective by the SEC on March 30, 2020.

Subject to the terms

and conditions set forth in the Agreement Wainwright agreed to use its commercially reasonable efforts consistent with its normal

trading and sales practices to sell the shares under the Agreement from time to time, based upon our instructions.

We have provided

Wainwright with customary indemnification rights, and Wainwright is entitled to a commission at a fixed rate equal to three percent

of the gross proceeds per share sold.

In addition, we agreed to pay certain expenses incurred by Wainwright in connection with

the Agreement, including up to $50,000 of the fees and disbursements of their counsel.

The Agreement will terminate upon the sale

of all of the shares under the Agreement, unless terminated earlier by either party as permitted under the Agreement.

Sales of the Shares,

if any, under the Agreement will be made in transactions that are deemed to be “at the market offerings”

in Rule 415 under the Securities Act, including sales made by means of ordinary brokers’

transactions, including on the Nasdaq

Capital Market, at market prices or as otherwise agreed with Wainwright.

The amendment provides that references in the 2016

Agreement to the registration statement shall refer to the registration statement on Form S-3 (File No.

333-237269), originally filed

with the SEC on March 19, 2020, declared effective by the SEC on March 30, 2020.

Subject to the terms and conditions

set forth in the 2016 Agreement, Wainwright agreed to use its commercially reasonable efforts consistent with its normal trading and sales

practices to sell the shares under the 2016 Agreement from time to time, based upon our instructions.

We provided Wainwright with customary

indemnification rights under the 2016 Agreement, and Wainwright is entitled to a commission at a fixed rate equal to three percent of

the gross proceeds per share sold.

In addition, we agreed to pay certain expenses incurred by Wainwright in connection with the 2016 Agreement,

including up to $50,000 of the fees and disbursements of their counsel.

The 2016 Agreement will terminate upon the sale of all of the

shares under the 2016 Agreement, unless terminated earlier by either party as permitted under the 2016 Agreement.

As of March 31, 2021, no further

sales will be made under the 2016 Agreement.

On March 22, 2021, we entered

into an At the Market Offering Agreement, or the Offering Agreement, with Wainwright as sales agent, pursuant to which we may offer and

sell shares of our common stock, from time to time as set forth in the Offering Agreement.

offering was registered under the Securities Act of 1933, as amended, or Securities Act ,

pursuant to our shelf registration statement on Form S-3 (Registration Statement No.

333-237269), as previously filed with

the SEC and declared effective on March 30, 2020.

We filed a prospectus supplement, dated March 22, 2021, with the SEC in connection with

the offer and sale of the shares of common stock, pursuant to which we may offer and sell shares

of common stock having an aggregate offering price of up to $5,080,000 from time to time.

Subject to the terms and conditions

set forth in the Offering Agreement, Wainwright agreed to use its commercially reasonable efforts consistent with its normal trading and

sales practices to sell the shares under the Offering Agreement from time to time, based upon our instructions.

We provided Wainwright

with customary indemnification rights under the Offering Agreement, and Wainwright is entitled to a commission at a fixed rate equal to

three percent of the gross proceeds per share sold.

In addition, we agreed to reimburse Wainwright for certain specified expenses in connection

with entering into the Offering Agreement.

The Offering Agreement will terminate upon the written termination by either party as permitted

Sales of the shares, if any,

under the 2016 Agreement and the Offering Agreement will be made in transactions that are deemed to be “at the market offerings”

as defined in Rule 415 under the Securities Act, including sales made by means of ordinary brokers’

transactions, including on the

Nasdaq Capital Market, at market prices or as otherwise agreed with Wainwright.

We have no obligation to sell any of the shares, and,

at any time, we may suspend offers under the Agreement or terminate the Agreement.

In the fiscal year

ended March 31, 2020, we raised aggregate net proceeds of $896,031, net of $27,896 in commissions to Wainwright and $5,929 in

other offering expenses, under the Agreement through the sale of 161,149 shares at an average price of $5.56 per share of net

Warrant Exercises

In fiscal year ended

March 31, 2020, investors that participated in the December 2019 Public Offering exercised 2,700,000 warrants for aggregate cash

proceeds to us of $3,807,162.

at any time, we may suspend offers under the 2016 Agreement and the Offering Agreement or terminate the Agreement.

In the fiscal year ended March

31, 2021, we raised aggregate net proceeds of $7,260,869, net of $224,825 in commissions to Wainwright and $8,472 in other offering expenses,

under the 2016 Agreement through the sale of 2,685,600 shares at an average price of $2.70 per share of net proceeds.

Future capital requirements

will depend upon many factors, including progress with pre-clinical testing and clinical trials, the number and breadth of our clinical

programs, the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary

rights, the time and costs involved in obtaining regulatory approvals, competing technological and market developments, as well as our

ability to establish collaborative arrangements, effective commercialization, marketing activities and other arrangements.

continue to incur increasing negative cash flows and net losses for the foreseeable future.

As a result of the COVID-19

pandemic and actions taken to slow its spread, the global credit and financial markets have experienced extreme volatility, including

diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment

rates and uncertainty about economic stability.

There can be no assurance that further deterioration in credit and financial markets and

confidence in economic conditions will not occur.

If equity and credit markets deteriorate, it may make any necessary debt or equity financing

more difficult to obtain, more costly and/or more dilutive.

Any of these actions could materially harm our business, results of operations

and future prospects.

Cash flows from operating,

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Financing activities

Net increase (decrease) in cash

Net increase in cash

Net Cash Used in Operating Activities

We used cash in our

operating activities due to our losses from operations.

Net cash used in operating activities was approximately $5,198,000 in fiscal

2020, compared to net cash used in operating activities of approximately $4,293,000 in fiscal 2019, an increase of approximately

The primary factors in this $905,000 increase in cash used in operations were a $475,000 decrease in stock-based compensation,

a $407,000 decrease in accounts payable and a $282,000 increase in accounts receivable, which were partially offset by a $447,000

increase in loss on extinguishment of debt.

We used cash in our operating

activities due to our losses from operations.

Net cash used in operating activities was approximately $6,765,000 in fiscal 2021, compared

to net cash used in operating activities of approximately $5,198,000 in fiscal 2020, an increase of approximately $1,567,000.

factors in this $1,567,000 increase in cash used in operations was a $1,511,000 increase in our net loss.

Net Cash Used in Investing Activities

During the fiscal year

ended March 31, 2020, we purchased approximately $152,000 of equipment.

During the fiscal year ended March 31, 2019, we did not

purchase any equipment.

During the fiscal years ended

March 31, 2121 and 2020, we purchased approximately $60,000 and $152,000 of equipment, respectively.

Net Cash from Financing Activities

Net cash generated

from financing activities increased to approximately $11,126,000 in the fiscal year ended March 31, 2020, from approximately $1,147,000

Net cash generated from financing

activities decreased from approximately $11,126,000 in the fiscal year ended March 31, 2020 to approximately $7,128,000 in the fiscal

year ended March 31, 2021.

In the fiscal year ended March

In fiscal 2020, we raised approximately $12,160,000 from the issuance of common stock,

compared to approximately $1,341,000 raised from the issuance of common stock in fiscal year ended March 31, 2019.

We used approximately

$993,000 to pay off our convertible notes in the fiscal year ended March 31, 2020.

We used approximately $41,000 to pay for the

tax withholding on restricted stock units in fiscal 2020, compared to paying approximately $194,000 in fiscal 2019.

31, 2021, we raised approximately $7,261,000 from the issuance of common stock, which was partially offset by the use of approximately

$133,000 to pay for the tax withholding on the issuance of restricted stock units.

In the fiscal year ended March 31, 2020, we raised

approximately $12,160,000 from the issuance of common stock.

We used approximately $993,000 to pay off our convertible notes in the fiscal

year ended March 31, 2020 and we also used approximately $41,000 to pay for the tax withholding on restricted stock units issued in the

fiscal year ended March 31, 2020.

Recent Events

Management Update

In June 2020, Thomas L.

Taccini joined

our management team as Vice President, Manufacturing and Product Development.

Taccini has over 35 years of experience in leading

teams in engineering, product development, project management, quality systems and regulatory affairs for multiple different classes

of medical devices.

On April 3, 2020,

pursuant to the terms of the Company’s 2012 Non-Employee Directors Compensation Program, as modified on August 9, 2016,

or the Directors Plan, the Compensation Committee of the Board granted restricted stock units, or RSUs, under the Company’s

2010 Stock Incentive Plan, or the 2010 Plan, to each non-employee director of the Company.

The Director’s Plan provides

for a grant of $35,000 worth of RSUs at the beginning of each fiscal year, priced at the average for the closing prices for the

five days preceding and including the date of grant, or $1.41 per share as of April 3, 2020.

Each eligible director was granted

an RSU in the amount of 23,893 shares under the 2010 Plan, as the number of available shares under the 2010 Plan was not sufficient

for each director’s full grant.

The RSU’s are subject to vesting in four equal quarterly installments on June 30,

September 30, December 31, 2020, and March 31, 2021, subject to the recipient's continued service with the Company on each such

vesting date.

Each eligible director will receive the remaining portion of the annual RSU grants, or 929 RSU’s, contingent

upon stockholder approval at the 2020 annual meeting of the Company’s stockholders, of a new 2020 Equity Incentive Plan.

IDE Supplement

On June 17, 2020,

the FDA approved a supplement to the Company’s open IDE for the Company’s 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.

That study’s plan is 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 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.

On April 1, 2021, pursuant

to the terms of the Company’s 2012 Non-Employee Directors Compensation Program, as amended, or the Directors Plan, the Compensation

Committee of the Board granted RSUs under the Company’s 2020 Equity Incentive Plan, or the 2020 Plan, to each non-employee director

of the Company.

The Director’s Plan provides for a grant of $50,000 worth of RSUs at the beginning of each fiscal year, priced at

the average for the closing prices for the five days preceding and including the date of grant, or $2.06 per share as of April 1, 2021.

Each eligible director was granted an RSU in the amount of 24,295 shares under the 2020 Plan.

The RSU’s are subject to vesting in

four equal quarterly installments on June 30, September 30, December 31, 2021, and March 31, 2022, subject to the recipient's continued

service with the Company on each such vesting date.

Sales Under ATM Facility

In June 2020, we raised

aggregate net proceeds of $7,260,869, net of $224,825 in commissions to Wainwright and $8,472 in other offering expenses, under

the Agreement described above through the sale of 2,685,600 shares at an average price of $2.70 per share of net proceeds.

COVID-19 Update

In March 2020, the

World Health Organization declared COVID-19 a pandemic.

The COVID-19 pandemic has negatively impacted the global economy, disrupted

global supply chains and created significant volatility and disruption of financial markets.

We are monitoring closely the impact of

the COVID-19 global pandemic on our business and have taken steps designed to protect the health and safety of our employees while

continuing our operations, including clinical trials.

Given the level of uncertainty regarding the duration and impact of the COVID-19

pandemic on capital markets and the U.S.

economy, we are unable to assess the impact of the worldwide spread of SARS-CoV-2 and

the resulting COVID-19 pandemic on our future access to capital.

Further, while we have not experienced significant disruptions

to our manufacturing supply chain, business, results of operations, financial condition, clinical trials, or preclinical research

to date, we are unable to assess the potential impact this pandemic could have on our manufacturing supply chain, business, results

of operations, financial condition, clinical trials, or preclinical research in the future.

As we continue to actively

advance our clinical trials, we remain in close contact with our clinical sites and are assessing the impact of COVID-19 on our

trials, expected timelines and costs on an ongoing basis.

We will assess any potential delays in our ability to timely ship clinical

trial materials, including internationally, due to transportation interruptions.

The extent of the impact of COVID-19 on our operational

and financial performance will depend on certain developments, including the duration and spread of the outbreak, impact on our

clinical trials, employees and vendors, all of which are uncertain and cannot be predicted.

Given these uncertainties, we cannot

reasonably estimate the related impact to our business, operating results and financial condition, if any.

In June 2021, we raised aggregate

net proceeds of $4,947,785, net of $126,922 in commissions to Wainwright and $2,154 in other offering expenses, under the Offering Agreement

described above through the sale of 626,000 shares of our common stock at an average purchase price of $8.11 per share of gross proceeds.

Registered Direct Financing

In June 2021, we sold an aggregate

of 1,380,555 shares of our common stock at a purchase price per share of $9.00, for aggregate gross proceeds to us of approximately $12.425

million, before deducting fees payable to Maxim Group LLC, the placement agent and other offering expenses.

These shares were sold pursuant

to a securities purchase agreement entered into by the Company with certain institutional investors, The shares of common stock were issued

in this offering pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the SEC on March 19,

2020, and was declared effective on March 30, 2020 (File No.

333-237269) (the “Registration Statement”) and a prospectus supplement

Warrant Exercises

In June 2021, pursuant to

the exercise of outstanding warrants held by institutional investors, we issued 531,167 shares of our common stock and received proceeds

in the amount of $820,938.

Also in June 2021, pursuant

to the exercise on a cashless, net exercise basis, of 874,664 outstanding warrants, we issued 675,554 shares of our common stock.

difference of 199,110 outstanding warrants were cancelled in connection with the exercise.

Critical Accounting Policies

Use of Estimates

The preparation of

consolidated financial statements in conformity with accounting principles generally accepted in the United States of America,

or GAAP, requires us to make a number of estimates and assumptions that affect the reported amounts of assets and liabilities and

disclosure of contingent assets and liabilities at the date of the financial statements.

Such estimates and assumptions affect

the reported amounts of expenses during the reporting period.

On an ongoing basis, we evaluate estimates and assumptions based

upon historical experience and various other factors and circumstances.

We believe our estimates and assumptions are reasonable

in the circumstances;

however, actual results may differ from these estimates under different future conditions.

We believe that

the estimates and assumptions that are most important to the portrayal of our financial condition and results of operations, in

that they require the most difficult, subjective or complex judgments, form the basis for the accounting policies deemed to be

most critical to us.

These critical accounting estimates relate to revenue recognition, stock purchase warrants issued with notes

payable, beneficial conversion feature of convertible notes payable, impairment of intangible assets and long lived assets, stock

compensation, deferred tax asset valuation allowance, and contingencies.

The preparation of consolidated

financial statements in conformity with accounting principles generally accepted in the United States of America, or GAAP, requires us

to make a number of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent

assets and liabilities at the date of the financial statements.

Such estimates and assumptions affect the reported amounts of expenses

during the reporting period.

On an ongoing basis, we evaluate estimates and assumptions based upon historical experience and various other

factors and circumstances.

We believe our estimates and assumptions are reasonable in the circumstances;

however, actual results may differ

from these estimates under different future conditions.

We believe that the estimates and assumptions that are most important to the portrayal

of our financial condition and results of operations, in that they require the most difficult, subjective or complex judgments, form the

basis for the accounting policies deemed to be most critical to us.

These critical accounting estimates relate to revenue recognition,

stock purchase warrants issued with notes payable, beneficial conversion feature of convertible notes payable, impairment of intangible

assets and long lived assets, stock compensation, deferred tax asset valuation allowance, and contingencies.

Revenue Recognition

Our revenues consist

entirely of amounts earned under contracts and grants with the National Institutes of Health, or NIH.

During the fiscal years

ended March 31, 2020 and 2019, we recognized revenues totaling $650,187 and $229,625, respectively, under such contracts.

concluded that these agreements are not within the scope of ASC Topic, 606, Revenue from Contracts with Customers, or Topic 606,

as the NIH grants and contracts do not meet the definition of a “customer”

Our revenues consist entirely

of amounts earned under contracts and grants with the National Institutes of Health, or NIH.

During the fiscal years ended March 31, 2021

and 2020, we recognized revenues totaling $659,104 and $650,187, respectively, under such contracts.

We have concluded that these agreements

are not within the scope of ASC Topic, 606, Revenue from Contracts with Customers, or Topic 606, as the NIH grants and contracts do not

meet the definition of a “customer”

as defined by Topic 606.

Prior to the effective

date of ASC Topic 606, which for the Company was April 1, 2018, we accounted for our grant/contract revenues under the Milestone

Method as prescribed by the legacy guidance of ASC 605-28, Revenue Recognition –

Prior to the effective date of ASC Topic 606, which for the Company

was April 1, 2018, we accounted for our grant/contract revenues under the Milestone Method as prescribed by the legacy guidance of ASC

605-28, Revenue Recognition –

Milestone Method, or the Milestone Method.

In the absence of other applicable guidance under US GAAP, effective April 1, 2018, we elected to continue to use the Milestone

Method by analogy to recognize revenue under these grants/contracts.

In the absence of other applicable guidance under US GAAP,

effective April 1, 2018, we elected to continue to use the Milestone Method by analogy to recognize revenue under these grants/contracts.

Common Stock Warrants

We often grant warrants

to purchase our common stock in connection with financing transactions.

When such warrants are classified as equity, we measure

the relative estimated fair value of such warrants which represents a discount from the face amount of the notes payable.

discounts are amortized to interest expense over the term of the notes.

We analyze such warrants for classification as either equity

or derivative liabilities and value them based on binomial lattice models.

We often grant warrants to

purchase our common stock in connection with financing transactions.

When such warrants are classified as equity, we measure the relative

estimated fair value of such warrants which represents a discount from the face amount of the notes payable.

Such discounts are amortized

to interest expense over the term of the notes.

We analyze such warrants for classification as either equity or derivative liabilities

and value them based on binomial lattice models.

Share-based Compensation

We account for share-based

compensation awards using the fair-value method and record such expense based on the grant date fair value in the consolidated

financial statements over the requisite service period.

compensation awards using the fair-value method and record such expense based on the grant date fair value in the consolidated financial

statements over the requisite service period.

Derivative Instruments

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Our policy is to settle instruments indexed to our common shares on a first-in-first-out basis.

The classification

of a derivative instrument is reassessed at each reporting date.

If the classification changes as a result of events during a reporting

period, the instrument is reclassified as of the date of the event that caused the reclassification.

There is no limit on the number

of times a contract may be reclassified.

Instruments classified

as derivative liabilities are remeasured each reporting period (or upon reclassification) and the change in fair value is recorded

on our consolidated statement of operations in other expense (income).

The classification of a derivative

instrument is reassessed at each reporting date.

If the classification changes as a result of events during a reporting period, the instrument

is reclassified as of the date of the event that caused the reclassification.

There is no limit on the number of times a contract may

be reclassified.

Instruments classified as

derivative liabilities are remeasured each reporting period (or upon reclassification) and the change in fair value is recorded on our

consolidated statement of operations in other expense (income).

We had no derivative instruments at March 31, 2021 or March 31, 2020.

Deferred tax assets

are recognized for the future tax consequences attributable to the difference between the consolidated financial statements and

their respective tax basis.

Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying

amounts of assets and liabilities for financial reporting purposes and the amounts reported for income tax purposes, and (b) tax

credit carryforwards.

We record a valuation allowance for deferred tax assets when, based on our best estimate of taxable income

(if any) in the foreseeable future, it is more likely than not that some portion of the deferred tax assets may not be realized.

Deferred tax assets are recognized

for the future tax consequences attributable to the difference between the consolidated financial statements and their respective tax

Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities

for financial reporting purposes and the amounts reported for income tax purposes, and (b) tax credit carryforwards.

We record a valuation

allowance for deferred tax assets when, based on our best estimate of taxable income (if any) in the foreseeable future, it is more likely

than not that some portion of the deferred tax assets may not be realized.

Off-Balance Sheet Arrangements

We have not entered

into any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial

condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital

resources that is material to investors.

We have not entered into any

off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes

in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material

to investors.

Convertible Notes Payable and Warrants

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convertible notes in the amount of $992,591.

There were no convertible notes outstanding as of March 31, 2020.

There were no convertible notes outstanding as of March 31, 2021 or 2020.

Restricted Stock Unit Grants to Non-Employee

In 2012, as amended

on August 9, 2016, our Board of Directors established the Directors Plan, to provide for cash and equity compensation for persons

serving as non-employee directors of the Company.

Under this program, each new director receives either stock options or a grant

of restricted stock unites, or RSUs, as well as an annual grant of RSUs at the beginning of each fiscal year.

In 2012, as amended through

October 30, 2020, our Board of Directors established the Non-Employee Directors Compensation Program, to provide for cash and equity compensation

for persons serving as non-employee directors of the Company.

Under this program, each new director receives either stock options or a

grant of restricted stock units, or RSUs, as well as an annual grant of RSUs at the beginning of each fiscal year.

The RSUs are subject

to vesting and represent the right to be issued on a future date shares of our common stock for upon vesting.

In April 2019, pursuant

to the Directors Plan, we issued RSUs with a value of $35,000, in accordance with the terms of the plan, to each of our non-employee

directors, as the stock-based compensation element of their overall directors’

compensation, for the fiscal year ended March

Those grants were based on the closing price of our common stock on the grant date, or $14.25 per share, resulting in

2,456 RSUs being issued to each of our five non-employee directors, for a total of 12,280 RSUs.

All of the RSUs were subject to

vesting in equal quarterly installments on June 30, 2019, September 30, 2019, December 31, 2019 and March 31, 2020.

During the fiscal year

ended March 31, 2020, 12,280 vested RSUs held by our outside directors were exchanged into the same number of shares of our common

As four of our five independent directors elected to return 40% of their RSUs in exchange for cash in order to pay their

withholding taxes on the share issuances, 3,926 of the RSUs were cancelled and we paid $11,230 in cash to those independent directors.

In addition, during

the fiscal year ended March 31, 2020, 8,793 vested RSUs then held by our executive officers were exchanged into the same number

of shares of our common stock.

As our executives elected to net settle a portion of their RSU’s in exchange for the Company

paying the related withholding taxes on the share issuance, 4,657 of the RSUs were cancelled and we issued a net 4,136 shares to

our executives.

Common Stock for Warrant Cancellation

During the fiscal year

ended March 31, 2020, we agreed with seven accredited investors to issue an aggregate of 3,992 shares of our common stock to these

investors in exchange for the cancellation of outstanding warrants then held by the investors to purchase an aggregate of 39,900

to vesting and represent the right to be issued on a future date shares of our common stock upon vesting.

On April 3, 2020, pursuant

to the terms of the Company’s Non-Employee Directors Compensation Program, the Compensation Committee of the Board of Directors

granted RSUs to each non-employee director of the Company.

The Non-Employee Directors Compensation Program provided for a grant of RSUs

with a grant date fair value of $35,000, priced at the average of the closing prices for the five trading days ending on the date of grant,

which was $1.41 per share, so that the total number of RSUs to be granted to each non-employee director for fiscal year 2020 would be

24,822 shares of our common stock.

We measured the fair value of the shares issued and the fair value of the warrants exchanged for those

shares and recorded a gain of $51,190 on those exchanges based on the changes in fair value between the instruments exchanged.

QUANTITATIVE AND QUALITATIVE

DISCLOSURES ABOUT MARKET RISK

As a Smaller Reporting

Company, we are not required to furnish information under this Item 7A.

FINANCIAL STATEMENTS

On April 3, 2020, each eligible director was granted an RSU for 23,893 shares under the

Company’s 2010 Stock Plan, or the 2010 Plan, as the number of shares that remained available for grant under the 2010 Plan was not

sufficient for each director’s full RSU grant.

The Compensation Committee also granted to each eligible director a contingent grant

under our 2020 Equity Incentive Plan, or the 2020 Plan, for the remaining portion of the annual RSU grants, or 929 RSU’s to each

eligible director, contingent upon stockholder approval of the 2020 Plan at the Company’s 2020 Annual Meeting of Stockholders, or

the Annual Meeting.

These grants are subject to vesting as follows:

50% of the RSUs subject to the grants will vest on December 31, 2020

and 50% of the RSUs will vest on March 31, 2021, subject in each case to the continuous service of each director, through such vesting

dates, as well as approval of the 2020 Plan by the stockholders at the Annual Meeting, which was obtained at the Annual Meeting.

In June 2020, 29,866 vested

RSUs held by our non-employee directors were exchanged into the same number of shares of our common stock.

All five non-employee directors

elected to return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting

in 11,947 of the vested RSUs being cancelled in exchange for $24,251 in aggregate cash proceeds to those independent directors.

In September 2020, 29,866

vested RSUs held by our non-employee directors were exchanged into the same number of shares of our common stock.

All five non-employee

directors elected to return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances,

resulting in 11,947 of the vested RSUs being cancelled in exchange for $16,128 in aggregate cash proceeds to those independent directors.

Also in September 2020, our

stockholders approved the 2020 Plan at the Annual Meeting, at which point the grants of 929 RSUs to each of our eligible independent directors

for a total of 4,645 RSUs were considered effective and no longer contingent as of that date.

In December 2020, 32,189 vested

RSUs held by our non-employee directors were exchanged into the same number of shares of our common stock.

All five non-employee directors

elected to return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting

in 12,876 of the vested RSUs being cancelled in exchange for $31,802 in aggregate cash proceeds to those independent directors.

In March 2021, 32,189 vested

RSUs held by our non-employee directors were exchanged into the same number of shares of our common stock.

All five directors elected

to return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting in

12,875 of the vested RSUs being cancelled in exchange for $26,136 in aggregate cash proceeds to those independent directors.

There were no vested RSUs outstanding as of March

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a Smaller Reporting Company,

we are not required to furnish information under this Item 7A.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

The consolidated financial

statements listed in the accompanying Index to Financial Statements are attached hereto and filed as a part of this Report under

CHANGES IN AND DISAGREEMENTS

WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

statements listed in the accompanying Index to Financial Statements are attached hereto and filed as a part of this Report under Item

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING

AND FINANCIAL DISCLOSURE

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 5. Market for Registrant’s Common Equity