What changed in this filing

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Item 9A. Controls and Procedures

2022-03-31 compared with 2021-03-31 · 1732 added, 1911 removed, 584 unchanged (86% of the section changed)

2 unchanged sentences

of Control Procedures

of December 31, 2020, the end of the period covered by this report, we carried out an evaluation under the supervision and with

the participation of our Management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness

of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) promulgated

under the Exchange Act.

Our disclosure controls and procedures are intended to ensure that the information we are required to

disclose in the reports that we file or submit under the Securities Exchange Act is (i) recorded, processed, summarized and reported

within the time periods specified in the Securities Exchange Commission’s rules and forms and (ii) accumulated and communicated

to our management, including the Chief Executive Officer and Chief Financial Officer, as the principal executive and financial

officers, respectively, to allow final decisions regarding required disclosures.

Based on that evaluation, our Chief Executive

Officer and Chief Financial Officer concluded that the controls and procedures were effective as of December 31, 2020 to ensure

that material information was accumulated and communicated to our management, including our Chief Executive Officer and Chief

Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

Our management has concluded that the

financial statements included in this Form 10-K present fairly, in all material respects our financial position, results of operations

and cash flows for the periods presented in conformity with accounting principles generally accepted in the United States of America.

of December 31, 2021, the end of the period covered by this report, we carried out an evaluation under the supervision and with the participation

of our Management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation

of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act.

Our disclosure

controls and procedures are intended to ensure that the information we are required to disclose in the reports that we file or submit

under the Securities Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the Securities

Exchange Commission’s rules and forms and (ii) accumulated and communicated to our management, including the Chief Executive Officer

and Chief Financial Officer, as the principal executive and financial officers, respectively, to allow final decisions regarding required

Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that the controls and procedures

were effective as of December 31, 2021 to ensure that material information was accumulated and communicated to our management, including

our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

management has concluded that the financial statements included in this Form 10-K present fairly, in all material respects our financial

position, results of operations and cash flows for the periods presented in conformity with accounting principles generally accepted

in the United States of America.

in Internal Control over Financial Reporting

made no changes in our internal control over financial reporting during the last fiscal quarter that have materially affected,

or are reasonably likely to materially affect, our internal control over financial reporting (as defined in Rules 13a-15(f) and

15d-15(f) under the Exchange Act).

Management’s

made no changes in our internal control over financial reporting during the last fiscal quarter that have materially affected, or are

reasonably likely to materially affect, our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under

the Exchange Act).

Report on Internal Control over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is

defined in Rules 13a-15(f) or 15d-15(f), under the Exchange Act.

Internal control over financial reporting is a process designed

by, or under the supervision of, our principal executive and principal financial officers and affected by our Board of Directors,

Management and other personnel, and to provide reasonable assurance regarding the reliability of financial reporting and the preparation

of financial statements for external purposes in accordance with generally accepted accounting principles.

A company’s internal

control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in

reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;

(ii) provide reasonable assurance

that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted

accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations

of management and directors of the Company;

and (iii) provide reasonable assurance regarding prevention or timely detection of

unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect on its financial

Management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined

in Rules 13a-15(f) or 15d-15(f), under the Exchange Act.

Internal control over financial reporting is a process designed by, or under

the supervision of, our principal executive and principal financial officers and affected by our Board of Directors, Management and other

personnel, and to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements

for external purposes in accordance with generally accepted accounting principles.

A company’s internal control over financial

reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately

and fairly reflect the transactions and dispositions of our assets;

(ii) provide reasonable assurance that transactions are recorded

as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts

and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company;

(iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s

assets that could have a material effect on its financial statements.

of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections

of any evaluation of effectiveness to future periods are subject to risk that controls may become inadequate because of changes

in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Also, projections of

any evaluation of effectiveness to future periods are subject to risk that controls may become inadequate because of changes in conditions,

or that the degree of compliance with the policies or procedures may deteriorate.

has assessed the effectiveness of our internal control over financial reporting as of December 31, 2021.

In making this assessment,

Management used the criteria set forth in the framework in 2013 established by the Committee of Sponsoring Organizations of the

Treadway Commission Internal Control—Integrated Framework, (COSO).

Based on this assessment, Management has not identified

any material weaknesses as of December 31, 2020.

A material weakness is a control deficiency, or combination of control deficiencies,

that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will

not be prevented or detected.

In making this assessment, Management

used the criteria set forth in the framework in 2013 established by the Committee of Sponsoring Organizations of the Treadway Commission

Internal Control—Integrated Framework, (COSO).

Based on this assessment, Management has not identified any material weaknesses

as of December 31, 2021.

A material weakness is a control deficiency, or combination of control deficiencies, that results in more than

a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected.

has concluded that we did maintain effective internal control over financial reporting as of December 31, 2021, based on the criteria

set forth in “Internal Control—Integrated Framework”

issued by the COSO.

Directors and Executive Officers and Corporate

set forth in “Internal Control—Integrated Framework” issued by the COSO.

Regarding Foreign Jurisdictions that Prevent Inspections.

Not Applicable.

Directors and Executive Officers and Corporate Governance.

following sets forth biographical information about each of our Directors and Executive Officers as of the date of this report:

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Financial Officer

Director has been elected to serve until the next annual meeting of stockholders, or until his earlier resignation, removal from

office, death or incapacity.

Each Executive Officer serves at the discretion of the Board of Directors, subject to rights, if

any, under contracts of employment.

believe our Board Members represent a desirable diversity of backgrounds, skills, education and experiences, and they all share

the personal attributes of dedication to be effective directors.

In recommending Board candidates, Corporate Governance and Nomination

Committee considers a candidate’s:

(1) general understanding of elements relevant to the success of a publicly traded company

in the current business environment;

Director has been elected to serve until the next annual meeting of stockholders, or until their earlier resignation, removal from office,

death or incapacity.

Each Executive Officer serves at the discretion of the Board of Directors, subject to rights, if any, under contracts

of employment.

believe our Board Members represent a desirable diversity of backgrounds, skills, education and experiences, and they all share the personal

attributes of dedication to be effective directors.

In recommending Board candidates, Corporate Governance and Nomination Committee considers

a candidate’s:

(1) general understanding of elements relevant to the success of a publicly traded company in the current business

(2) understanding of our business;

and (3) diversity in educational and professional background.

The Committee also gives consideration to a candidate’s judgment, competence, dedication and anticipated participation in

Board activities along with experience, geographic location and special talents or personal attributes.

The following are qualifications,

experience and skills for Board members which are important to our business and its future:

The Committee also gives

consideration to a candidate’s judgment, competence, dedication and anticipated participation in Board activities along with experience,

geographic location and special talents or personal attributes.

The following are qualifications, experience and skills for Board members

which are important to our business and its future:

We seek directors who have demonstrated strong leadership qualities.

Such leaders bring diverse perspectives and

broad business insight to our Company.

The relevant leadership experience that we seek includes a past or current leadership role

in a large or entrepreneurial company, a senior faculty position at a prominent educational institution or a past elected or appointed

senior government position.

Such leaders bring diverse perspectives and broad

business insight to our Company.

The relevant leadership experience that we seek includes a past or current leadership role in a large

or entrepreneurial company, a senior faculty position at a prominent educational institution or a past elected or appointed senior government

or Academic Experience :

We seek directors who have relevant industry experience, both with respect to the disease areas where

we are developing new therapies as well as with the economic and competitive dynamics of pharmaceutical markets, including those

in which our drugs will be prescribed.

We seek directors who have relevant industry experience, both with respect to the disease areas where we

are developing new therapies as well as with the economic and competitive dynamics of pharmaceutical markets, including those in which

our drugs will be prescribed.

Legal or Regulatory Experience :

Given the highly technical and specialized nature of biotechnology, we desire that certain

of our directors have advanced degrees, as well as drug development experience.

Since we are subject to substantial regulatory

oversight, both here and abroad by the FDA and other agencies, we also desire directors who have legal or regulatory experience.

Given the highly technical and specialized nature of biotechnology, we desire that certain of our

directors have advanced degrees, as well as drug development experience.

Since we are subject to substantial regulatory oversight, both

here and abroad by the FDA and other agencies, we also desire directors who have legal or regulatory experience.

We believe that our directors should possess an understanding of finance and related reporting processes, particularly

given the complex budgets and long timelines associated with drug development programs.

EQUELS, has been a Director and serves as our Executive Vice Chairman (since 2008), Chief Executive Officer (since 2016)

and President (since 2015).

Equels was the owner of and former President and Managing Director of the Equels Law Firm headquartered

in Miami, Florida that focused on litigation.

EQUELS, has been a Director and serves as our Executive Vice Chairman (since 2008), Chief Executive Officer (since 2016) and President

(since 2015).

Equels was the owner of and former President and Managing Director of the Equels Law Firm headquartered in Miami, Florida

that focused on litigation.

For over a quarter century, Mr.

Equels represented national and state governments

as well as companies in the banking, insurance, aviation, pharmaceutical and construction industries.

Equels received his

Juris Doctor degree with high honors from Florida State University.

He received his Bachelor of Science, summa cum laude, from

Troy University and also obtained his Masters’

Equels represented national and state governments as well as companies in

the banking, insurance, aviation, pharmaceutical and construction industries.

Equels received his Juris Doctor degree with high honors

from Florida State University.

He received his Bachelor of Science, summa cum laude, from Troy University and also obtained his Masters’

of Science Degree from Troy University.

Equels began his professional

career as a military pilot.

He served in Vietnam and was awarded two Distinguished Flying Crosses, the Bronze Star, the Purple

Heart, and fifteen Air Medals.

Equels began his professional career as a military pilot.

He served in Vietnam and was awarded

two Distinguished Flying Crosses, the Bronze Star, the Purple Heart, and fifteen Air Medals.

In 2012, he was Knighted by Pope Benedict.

- Director Qualifications:

Experience –

Military, Owner and former President, Managing Director of Equels Law Firm, Court appointed receiver in

numerous industries;

Experience –legal counsel, General Counsel, CFO and CEO to us;

Legal or Regulatory Experience - Law degree with over 25 years as a practicing attorney specializing in litigation, development

of clinical trials, creating intellectual property concepts, and established plan to finance drug development.

EQUELS – Director Qualifications:

Experience – Military;

Owner and former President;

Managing Director of Equels Law

Firm, Court-appointed receiver in numerous industries;

Experience – legal counsel, General Counsel, CFO and CEO to us;

● Scientific,

Legal or Regulatory Experience – Law degree with over 25 years as a practicing attorney

specializing in litigation, development of clinical trials, creating intellectual property

concepts, and established plan to finance drug development.

MITCHELL, M.D., Ph.D., has been a Director since July 1998 and Chairman of the Board since February 2016.

is a Professor of Pathology at Vanderbilt University School of Medicine and is a board certified physician.

Mitchell earned

from Vanderbilt and a Ph.D.

from Johns Hopkins University, where he served as House Officer in Internal Medicine, followed

by a Fellowship at its School of Medicine.

Mitchell has published over 200 papers, reviews and abstracts that relate to viruses,

anti-viral drugs, immune responses to HIV infection, and other biomedical topics.

Mitchell has worked for and with many professional

societies that have included the American Society of Investigative Pathology, the International Society for Antiviral Research,

the American Society of Clinical Oncology, the American Society of Biochemistry and Molecular Biology, the American Chemical Society,

and the American Society of Microbiology.

Mitchell is a Professor

of Pathology at Vanderbilt University School of Medicine and is a board-certified physician.

Mitchell earned a M.D.

from Vanderbilt

from Johns Hopkins University, where he served as House Officer in Internal Medicine, followed by a Fellowship at its School

Mitchell has published over 200 papers, reviews and abstracts that relate to viruses, anti-viral drugs, immune responses

to HIV infection, and other biomedical topics.

Mitchell has worked for and with many professional societies that have included the

American Society of Investigative Pathology, the International Society for Antiviral Research, the American Society of Clinical Oncology,

the American Society of Biochemistry and Molecular Biology, the American Chemical Society, and the American Society of Microbiology.

Mitchell is a member of the American Medical Association.

He has served on numerous

government review committees, among them the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health,

including the initial AIDS and Related Research Review Group.

Mitchell previously served as one of our Directors from 1987

He has served on numerous government review committees, among them the

Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, including the initial AIDS and Related Research

Review Group.

Mitchell previously served as one of our Directors from 1987 to 1989.

MITCHELL, M.D., Ph.D.

– Director Qualifications:

Experience –

Professor at Vanderbilt University School of Medicine.

He is a member of the Board of Directors for Chronix

Biomedical and is Chairman of its Medical Advisory Board.

Additionally, he has served on multiple governmental review committees

of the National Institutes of Health, Centers for Disease Control and Prevention and for the European Union, including key

roles as Chairman;

and Industry Experience –

Well published medical researcher with extensive investigative experience on virus and immunology

issues relevant to our scientific business along with being a Director of an entrepreneurial diagnostic company (Chronix Biomedical)

that is involved in next generation DNA sequencing for medical diagnostics;

Experience – Professor at Vanderbilt University School of Medicine.

He is a member

of the Board of Directors for Chronix Biomedical and is Chairman of its Medical Advisory

Additionally, he has served on multiple governmental review committees of the National

Institutes of Health, Centers for Disease Control and Prevention and for the European Union,

including key roles as Chairman;

and Industry Experience – Well published medical researcher with extensive investigative

experience on virus and immunology issues relevant to our scientific business along with

being a Director of an entrepreneurial diagnostic company (Chronix Biomedical) that is involved

in next generation DNA sequencing for medical diagnostics;

● Scientific,

Legal or Regulatory Experience – M.D., Ph.D.

and professor at a top ranked school of medicine, and inventor of record on numerous

and international patents who is experienced in regulatory affairs through filings with the FDA.

and professor at a top ranked school of

medicine, and inventor of record on numerous U.S.

and international patents who is experienced

in regulatory affairs through filings with the FDA.

APPELROUTH, CPA was appointed as a director and head of the Audit Committee in August 2016 and is a certified public accountant

and partner at Appelrouth Farah & Co., P.A., Certified Public Accountants and Advisors.

Appelrouth is also a certified

forensic accountant and possesses 40 years of experience in Accounting and Consulting.

He is a member of or has affiliations with

the AICPA, American College of Forensic Examiners, Association of Certified Fraud Examiners, past member of the Florida

Bar Grievance Committee, Florida Institute of Certified Public Accountants and InfraGard Member, a national information sharing

program between the Federal Bureau of Investigation and the private sector.

Appelrouth graduated from Florida State University in 1975 and received his Master’s Degree in Finance from Florida International

Appelrouth is also a certified forensic

accountant and possesses 40 years of experience in Accounting and Consulting.

He is a member of or has affiliations with the AICPA, American

College of Forensic Examiners, Association of Certified Fraud Examiners, past member of the Florida Bar Grievance Committee, Florida

Institute of Certified Public Accountants and InfraGard Member, a national information sharing program between the Federal Bureau of

Investigation and the private sector.

Appelrouth graduated from Florida State University in 1975 and received his Master’s Degree in Finance from Florida International

University in 1980.

The Board has determined Mr.

Appelrouth to be an Independent Director as required under Section 803(2) of

Appelrouth to be an Independent Director as required under Section 803(2) of the NYSE:

American Company Guide and Rule 10A-3 under the Exchange Act.

APPELROUTH – Director Qualifications:

Experience –has served in leadership positions on numerous Boards and other organizations;

Experience –

Partner at certified public accounting and advisory firm;

Certified Public Accountant and Certified Fraud

Experience –

FINRA Arbitrator.

Expert –

over 40 years of accounting and audit experience.

Experience –has served in leadership positions on numerous Boards and other organizations;

Experience – Partner at certified public accounting and advisory firm;

Certified Public

Accountant and Certified Fraud Examiner;

Experience – FINRA Arbitrator.

Expert – over 40 years of accounting and audit experience.

about our Executive Officers

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On September 30, 2016, Mr.

Rodino resigned as a member of our Board to

permit him to serve us in a new capacity.

Rodino resigned as a member of our Board to permit

him to serve us in a new capacity.

Effective October 1, 2016, we retained Mr.

Rodino as our Executive Director for Governmental

Relations, and as our General Counsel and, as of October 16, 2019, Mr.

Rodino as our Executive Director for Governmental Relations,

and as our General Counsel and, as of October 16, 2019, Mr.

Rodino assumed the role of Chief Operating Officer.

Rodino has been our Secretary since November 2016.

Rodino has been our

Secretary since November 2016.

Rodino has broad legal, financial, and executive experience.

to being President of Rodino Consulting LLC and managing partner at several law firms during his many years as a practicing attorney,

he served as Chairman and CEO of Crossroads Health Plan, the first major Health Maintenance Organization in New Jersey.

has had experience as an investment executive in the securities industry and acted as trustee in numerous Chapter 11 complex corporate

reorganizations.

Previously, as founder and president of Rodino Consulting, Mr.

Rodino provided business and government relations

consulting services to smaller companies with a focus on helping them develop business plans, implement marketing strategies and

acquire investment capital.

In addition to being President of Rodino

Consulting LLC and managing partner at several law firms during his many years as a practicing attorney, he served as Chairman and CEO

of Crossroads Health Plan, the first major Health Maintenance Organization in New Jersey.

He also has had experience as an investment

executive in the securities industry and acted as trustee in numerous Chapter 11 complex corporate reorganizations.

Previously, as founder

and president of Rodino Consulting, Mr.

Rodino provided business and government relations consulting services to smaller companies with

a focus on helping them develop business plans, implement marketing strategies and acquire investment capital.

Rodino holds a B.S.

in Business Administration from Georgetown University and a J.D.

Seton Hall University.

degree from Seton Hall University.

LINTAL has been our Chief Financial Officer since September 16, 2019.

Lintal has more than two decades of prior public

company and non-profit experience.

Lintal has more than two decades of prior public company

and non-profit experience.

She earned a Bachelor of Science degree in Accounting from Elmira College.

Lintal served

for several years as a Chief Financial Officer and SVP of Finance & Control for an international non-profit Organization and

public accounting experience at Corning Inc, Carlisle Companies and AGY where she led the organizational focus on financial management,

strategic planning and mergers and acquisitions.

Lintal served for several

years as a Chief Financial Officer and SVP of Finance & Control for an international non-profit Organization and public accounting

experience at Corning Inc, Carlisle Companies and AGY where she led the organizational focus on financial management, strategic planning

and mergers and acquisitions.

Prior to joining the Company Mrs.

Lintal was the CFO for the National Wild Turkey

Federation, an international non-profit organization.

Lintal was the CFO for the National Wild Turkey Federation, an international

non-profit organization.

DICKEY IV, who will become our Chief Financial Officer effective April 4, 2022, has more than 25 years of experience of C-suite financial

leadership for life science and medical device companies, both private and public, ranging from preclinical development to commercial

operations and across a variety of disease areas and medical technologies.

Earlier in his career, Mr.

Dickey spent 18 years in investment

banking, primarily at Lehman Brothers, with a background split between mergers and acquisitions and capital markets transactions.

Dickey was a senior vice president of the Company from 2008 until 2013.

Throughout his career he has demonstrated C-level (CFO, COO and

CEO) and Board level experience in public, private, revenue stage and development stage life sciences and medical device companies, and

has played a leading role in two start-ups.

His prior career as an investment banker included 14 years at Lehman Brothers.

is experienced in all stages of the business lifecycle, including start-up, high-growth and turnarounds, and in building businesses and

achieving an exit.

He also has international experience, He has expertise in public and private financings, M&A, partnering/licensing

transactions, project management and Chapter 11 reorganizations, as well as interacting with Boards, VC’s, shareholders and Wall

Dickey has an MBA from The Wharton School and an AB from Princeton University.

STRAYER, M.D.

has acted as our Medical Director and Chief Scientific Officer since 1986.

He has served as Professor of

Medicine at the Medical College of Pennsylvania and Hahnemann University.

Strayer is Board Certified in Medical Oncology and

Internal Medicine with research interests in the fields of cancer and immune system disorders.

He has served as principal investigator

in studies funded by the Leukemia Society of America, the American Cancer Society, and the National Institutes of Health.

Strayer attended the School of Medicine at the University of California at Los Angeles where he received his M.D.

He has served as Professor of Medicine

at the Medical College of Pennsylvania and Hahnemann University.

Strayer is Board Certified in Medical Oncology and Internal Medicine

with research interests in the fields of cancer and immune system disorders.

He has served as principal investigator in studies funded

by the Leukemia Society of America, the American Cancer Society, and the National Institutes of Health.

Strayer attended the School

of Medicine at the University of California at Los Angeles where he received his M.D.

Committee and Audit Committee Expert

3 unchanged sentences

are determined by the Board of Directors to be Independent Directors as required under Section 803(2) of the NYSE:

American Company

Guide and Rule 10A-3 under the Exchange Act.

American Company Guide

and Rule 10A-3 under the Exchange Act.

The Board has determined that Mr.

Appelrouth qualifies as an “audit committee

financial expert”

as that term is defined by Section 803B(2) of the NYSE:

American Company Guide and the rules and regulations

Appelrouth qualifies as an “audit committee financial

expert” as that term is defined by Section 803B(2) of the NYSE:

American Company Guide and the rules and regulations of the SEC.

Mitchell and Mr.

Appelrouth to be independent of management and free of any relationship that would interfere with

their exercise of independent judgment as members of this Committee.

The principal functions of the Audit Committee are to (i)

assist the Board in fulfilling its oversight responsibility relating to the annual independent audit of our consolidated financial

statements and management’s assessment of internal control over financial reporting, the engagement of the independent registered

public accounting firm and the evaluation of the independent registered public accounting firm’s qualifications, independence

and performance;

(ii) prepare the reports or statements as may be required by NYSE American or the securities laws;

the Board in fulfilling its oversight responsibility relating to the integrity of our financial statements and financial reporting

process and our system of internal accounting and financial controls;

(iv) discuss the financial statements and reports with management,

including any significant adjustments, management judgments and estimates, new accounting policies and disagreements with management;

and (v) review disclosures by our independent registered public accounting firm concerning relationships with us and the performance

of our independent accountants.

Audit Committee formally met five times in 2020 with all committee members in attendance.

Our General Counsel and Chief Financial

Officer support the Audit Committee in its work.

The full text of the Audit Committee’s Charter, as approved by the Board,

is available on our website:

www.aimimmuno.com in the “Investor Relations”

tab under “Corporate Governance”.

Advisory Board (“SAB”)

SAB was established to leverage its member’s scientific and pharmaceutical expertise and advice to advance our drug development

programs by providing guidance on steering us forward and capitalizing on business opportunities as well as interactions with

Appelrouth to be independent of management and free of any relationship that would interfere with their

exercise of independent judgment as members of this Committee.

The principal functions of the Audit Committee are to (i) assist the Board

in fulfilling its oversight responsibility relating to the annual independent audit of our consolidated financial statements and management’s

assessment of internal control over financial reporting, the engagement of the independent registered public accounting firm and the

evaluation of the independent registered public accounting firm’s qualifications, independence and performance;

(ii) prepare the

reports or statements as may be required by NYSE American or the securities laws;

(iii) assist the Board in fulfilling its oversight

responsibility relating to the integrity of our financial statements and financial reporting process and our system of internal accounting

and financial controls;

(iv) discuss the financial statements and reports with management, including any significant adjustments, management

judgments and estimates, new accounting policies and disagreements with management;

and (v) review disclosures by our independent registered

public accounting firm concerning relationships with us and the performance of our independent accountants.

Audit Committee formally met four times in 2021 with all committee members in attendance.

Our General Counsel and Chief Financial Officer

support the Audit Committee in its work.

The full text of the Audit Committee’s Charter, as approved by the Board, is available

on our website:

http://www.aimimmuno.com in the “Investor Relations” tab under “Corporate Governance”.

Advisory Board (“SAB”)

SAB was established to leverage its member’s scientific and pharmaceutical expertise and advice to advance our drug development

programs by providing guidance on steering us forward and capitalizing on business opportunities as well as interactions with the FDA.

It is responsible for:

(i) reviewing all submissions made by us to the FDA and other regulators to ensure that the submissions

fully, accurately, and timely describe the status of any clinical trials, tests, or other studies or analyses of drug safety and

efficacy undertaken by us, and any agreements, protocols, or guidance provided by relevant regulatory agencies;

and (ii) monitoring

and supervising our relationship with the FDA.

The SAB shall have free and open access to our scientific and executive personnel,

including the Chief Scientific Officer and the members of our Board of Directors.

The SAB is comprised of William Mitchell, M.D.,

Chairman, and Ronald Brus, M.D., W.

Neal Burnette, M.D., Christopher Nicodemus, M.D., and Philip Ransom Roane, Ph.D.

The SAB reports to the independent directors of the Company and closely interacts with the Disclosure Controls Committee.

The SAB met two times in 2020.

Controls Committee (“DCC”)

(i) reviewing all submissions made by us to the FDA and other regulators to ensure that the submissions fully,

accurately, and timely describe the status of any clinical trials, tests, or other studies or analyses of drug safety and efficacy undertaken

by us, and any agreements, protocols, or guidance provided by relevant regulatory agencies;

and (ii) monitoring and supervising our relationship

with the FDA.

The SAB shall have free and open access to our scientific and executive personnel, including the Chief Scientific Officer

and the members of our Board of Directors.

The SAB is comprised of William Mitchell, M.D., Chairman, and Ronald Brus, M.D., W.

Neal Burnette,

M.D., Christopher Nicodemus, M.D., and Philip Ransom Roane, Ph.D.

all of whom are members.

The SAB reports to the independent directors

of the Company and closely interacts with the Disclosure Controls Committee.

The SAB met three times in 2021.

Controls Committee (“DCC”)

DCC reports to the Audit Committee and is responsible for procedures and guidelines on managing disclosure information.

of the DCC is to make certain that information required to be publicly disclosed is properly accumulated, recorded, summarized

and communicated to the Board and management.

This process is intended to allow for timely decisions regarding communications

and disclosures and to help ensure that we comply with related SEC rules and regulations.

Lintal is the DCC’s Investor

Relations Coordinator and Chairperson.

The other members of the DCC are Peter Rodino, our General Counsel, William Mitchell, one

of our Independent Directors, Dr.

David Strayer, Medical Director and Chief Scientific Officer, Julie Mierau, our Controller,

and Ann Marie Coverly, Director of HR and Administration serving as the Deputy Investor Relations Coordinator.

The full text of

the DCC’s Charter, as approved by the Board, is available on our website:

www.aimimmuno.com in the “Investor Relations”

tab under “Corporate Governance”.

The DCC actively met on numerous occasions in 2020.

The purpose of

the DCC is to make certain that information required to be publicly disclosed is properly accumulated, recorded, summarized and communicated

to the Board and management.

This process is intended to allow for timely decisions regarding communications and disclosures and to help

ensure that we comply with related SEC rules and regulations.

Lintal is the DCC’s Investor Relations Coordinator and Chairperson.

The other members of the DCC are Peter Rodino, our General Counsel;

William Mitchell, one of our Independent Directors;

David Strayer,

Medical Director and Chief Scientific Officer;

Jodie Pelz, our Controller;

and Ann Marie Coverly, Director of HR and Administration serving

as the Deputy Investor Relations Coordinator.

The full text of the DCC’s Charter, as approved by the Board, is available on our

www.aimimmuno.com in the “Investor Relations” tab under “Corporate Governance.” The DCC actively met

on numerous occasions in 2021.

February 2016, our Board formed the Executive Committee.

The Executive Committee reports to the Board and its purpose is to aid

the Board in handling matters which, in the opinion of the Chairman of the Board, should not be postponed until the next scheduled

meeting of the Board.

Equels, our Chief Executive Officer is the chairman of the Committee, along with two of our independent

directors, Mr.

Appelrouth and Dr.

The full text of the Executive Committee Charter, as approved by the Board, is available

on our website:

www.aimimmuno.com in the “Investor Relations”

tab under “Corporate Governance”.

The Committee

did not meet in 2020.

Board of Directors adopted a revision to the 2003 Code of Ethics and business conduct for officers, directors, employees, agents

and consultants.

The principal amendments included broadening the Code’s application to our agents and consultants, adoption

of a regulatory compliance policy and adoption of a policy for protection and use of Company computer technology for business

purposes only.

On an annual basis, this Code is reviewed and signed by each Officer, Director, employee and strategic consultant

with none of the amendments constituting a waiver of provision of the Code of Ethics on behalf of our Chief Executive Officer,

Chief Financial Officer, or persons performing similar functions.

may obtain a copy of this Code by visiting our web site at www.aimimmuno.com (Investor Relations / Corporate Governance) or by

The Executive Committee reports to the Board and its purpose is to aid the Board

in handling matters which, in the opinion of the Chairman of the Board, should not be postponed until the next scheduled meeting of the

Equels, our Chief Executive Officer, is the chairman of the Committee, along with two of our independent directors, Mr.

The full text of the Executive Committee Charter, as approved by the Board, is available on our website at www.aimimmuno.com

in the “Investor Relations” tab under “Corporate Governance”.

The Committee did not meet in 2021.

Board of Directors adopted a revision to the 2003 Code of Ethics and business conduct for officers, directors, employees, agents and

The principal amendments included broadening the Code’s application to our agents and consultants, adoption of a regulatory

compliance policy and adoption of a policy for protection and use of Company computer technology for business purposes only.

basis, this Code is reviewed and signed by each Officer, Director, employee and strategic consultant with none of the amendments constituting

a waiver of provision of the Code of Ethics on behalf of our Chief Executive Officer, Chief Financial Officer, or persons performing

similar functions.

may obtain a copy of this Code by visiting our website at www.aimimmuno.com (Investor Relations / Corporate Governance) or by

written request to our office at 2117 SW Highway 484, Ocala, FL 34473.

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DISCUSSION AND ANALYSIS

discussion and analysis describes our executive compensation philosophy, process, plans and practices as they relate to our “Named

Executive Officers”

(“NEO”) listed below and gives the context for understanding and evaluating the more specific

compensation information contained in the narratives, tables and related disclosures that follow.

For the purposes of discussion

and analysis, the following NEOs are included in the narratives, tables and related disclosures that follow:

Equels, Chief Executive Officer (“CEO”) and President.

Lintal, Chief Financial Officer (“CFO”);

Rodino, Chief Operating Officer (“COO”), General Counsel and Company Secretary (“CS”).

March 2021, subsequent to the fiscal year ended December 31, 2020, we entered into employment agreements with Peter Rodino

and Ellen Lintal.

discussion and analysis describes our executive compensation philosophy, process, plans and practices as they relate to our “Named

Executive Officers” (“NEO”) listed below and gives the context for understanding and evaluating the more specific compensation

information contained in the narratives, tables and related disclosures that follow.

For the purposes of discussion and analysis, the

following NEOs are included in the narratives, tables and related disclosures that follow:

Equels, Chief Executive Officer (“CEO”) and President;

Lintal, Chief Financial Officer (“CFO”);

Rodino, Chief Operating Officer (“COO”), General Counsel and Company Secretary

March 2021, subsequent to the fiscal year ended December 31, 2020, we entered into employment agreements with Peter Rodino and Ellen

The agreements run for three years and one year, respectively.

Compensation is divided into both short- and

long-term compensation.

Compensation is divided into both short- and long-term compensation.

Short term (cash) compensation will consist of a base salary of $425,000 and $350,000, respectively.

Rodino and Ms.

Lintal will be awarded a year-end target bonus based on performance and goals established by the

Compensation Committee.

Long term compensation will be provided by 100,000 non-qualified yearly stock options with one-year

vesting commencing on November 30, 2021.

Lintal will be

awarded a year-end target bonus based on performance and goals established by the Compensation Committee.

Long term compensation will

be provided by 100,000 non-qualified yearly stock options with one-year vesting commencing on November 30, 2021.

In addition, Mr.

Lintal shall each be entitled to awards (“Event Awards”) equal to 1% of the “Gross Proceeds” from specific

events such as licensing agreements or “therapeutic indication” (each, an “Event”).

Gross Proceeds means those

cash amounts paid to us by the other parties for licensing agreements, therapeutic acquisitions or any other one time cash generating

Therapeutic indications are for example target organ specific pathologically defined cancer indications, vaccine enhancers, broad

spectrum antiviral indications, or medical entities associated with persistent severe fatigue.

Rodino and Ms.

Lintal shall each be entitled to awards

(“Event Awards”) equal to 1% of the “Gross Proceeds”

from specific events such as licensing

agreements or “therapeutic indication”

(each, an “Event”).

Gross Proceeds means those cash amounts

paid to us by the other parties for licensing agreements, therapeutic acquisitions or any other one time cash generating

Therapeutic indications are for example target organ specific pathologically defined cancer indications, vaccine

enhancers, broad spectrum antiviral indications, or medical entities associated with persistent severe fatigue.

Lintal also will each be entitled to an award (an “Acquisition Award”) equal to 1% of the Gross Proceeds,

upon the sale of our Company or substantially all of its assets (an “Acquisition”).

An Event Award or Acquisition

Award shall be paid in cash within 90 days of our receipt of the Gross Proceeds.

Lintal also will each

be entitled to an award (an “Acquisition Award”) equal to 1% of the Gross Proceeds, upon the sale of our Company or substantially

all of its assets (an “Acquisition”).

An Event Award or Acquisition Award shall be paid in cash within 90 days of our receipt

of the Gross Proceeds.

of Compensation Committee

Compensation Committee consists of the following two directors, each of whom is “independent”

under applicable NYSE

American rules, a “Non-Employee Director”

as defined in Rule 16b-3 under the Exchange Act, and an “Outside Director”

as defined under the U.S.

Treasury regulations promulgated under Section 162(m) of the Internal Revenue Code of 1986, as amended

(the “Internal Revenue Code”):

Compensation Committee consists of the following two directors, each of whom is “independent” under applicable NYSE American

rules, a “Non-Employee Director” as defined in Rule 16b-3 under the Exchange Act, and an “Outside Director” as

defined under the U.S.

Treasury regulations promulgated under Section 162(m) of the Internal Revenue Code of 1986, as amended (the “Internal

Revenue Code”):

William Mitchell, M.D.

(Chair) and Stewart L.

The Compensation Committee

makes recommendations concerning salaries and compensation for senior management and other highly paid professionals or consultants

The full text of the Compensation Committee’s Charter, as approved by the Board, is available on our website:

www.aimimmuno.com

in the “Investor Relations”

tab under “Corporate Governance”.

Committee formally met six times in 2020 and all committee members were in attendance for the meetings.

The Compensation Committee makes recommendations

concerning salaries and compensation for senior management and other highly paid professionals or consultants to us.

The full text of

the Compensation Committee’s Charter, as approved by the Board, is available on our website:

www.aimimmuno.com in the “Investor

Relations” tab under “Corporate Governance”.

Committee formally met three times in 2021 and all committee members were in attendance for the meetings.

Our General Counsel, Chief

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of Stockholder Advisory Vote on Executive Compensation

the October 7, 2020 Annual Meeting of Stockholders, the Stockholders approved the annual, non-binding advisory vote on Executive

the October 2021 Annual Meeting of Stockholders, the Stockholders did not approve the annual, non-binding advisory vote on Executive

Compensation.

and Philosophy of Executive Compensation

primary objectives of the Compensation Committee of our Board of Directors with respect to Executive compensation are to attract

and retain the most talented and dedicated Executives possible, to tie annual and long-term cash and stock incentives to achievement

of measurable performance objectives, and to align Executives’

incentives with stockholder value creation.

To achieve these

objectives, the Compensation Committee expects to implement and maintain compensation plans that tie a substantial portion of

Executives’

overall compensation to key strategic financial and operational goals such as the establishment and maintenance

of key strategic relationships, the development of our products, the identification and advancement of additional products and

the performance of our common stock price.

The Compensation Committee evaluates individual Executive performance with the goal

of setting compensation at levels the Committee believes are comparable with Executives in other companies of similar size and

stage of development operating in the biotechnology industry while taking into account our relative performance, our own strategic

goals, governmental regulations and the results of Stockholder Advisory Votes regarding executive compensation.

following table provides information on the compensation during the fiscal years ended December 31, 2020 and 2019 of Thomas Equels,

our Chief Executive Officer, Ellen Lintal, our Chief Financial Officer, and Peter Rodino, who, during 2018 was our General Counsel

and Secretary, constituting the Company’s Named Executive Officers, based on the year ended 2020 for each fiscal year.

primary objectives of the Compensation Committee of our Board of Directors with respect to Executive compensation are to attract and

retain the most talented and dedicated Executives possible, to tie annual and long-term cash and stock incentives to achievement of measurable

performance objectives, and to align Executives’ incentives with stockholder value creation.

To achieve these objectives, the Compensation

Committee expects to implement and maintain compensation plans that tie a substantial portion of Executives’ overall compensation

to key strategic financial and operational goals such as the establishment and maintenance of key strategic relationships, the development

of our products, the identification and advancement of additional products and the performance of our common stock price.

The Compensation

Committee evaluates individual Executive performance with the goal of setting compensation at levels the Committee believes are comparable

with Executives in other companies of similar size and stage of development operating in the biotechnology industry while taking into

account our relative performance, our own strategic goals, governmental regulations and the results of Stockholder Advisory Votes regarding

executive compensation.

following table provides information on the compensation during the fiscal years ended December 31, 2021 and 2019 of Thomas Equels, our

Chief Executive Officer, Ellen Lintal, our Chief Financial Officer, and Peter Rodino, who, during 2018 was our General Counsel and Secretary,

constituting the Company’s Named Executive Officers, based on the year ended 2020 for each fiscal year.

Compensation Table

Name & Principal Position

Salary / Fees

Stock Awards $

Option Awards

Non-Equity Incentive Plan Compensation $

Change in Pension Valued and NQDC Earnings

All Other Compensation $

Incentive Plan

Thomas K Equels

CEO & President (2)3

COO, General Counsel & Secretary (5)

COO, General Counsel

& Secretary (5)

option awards were valued using the Black-Scholes method.

Named Executive Officers, who are also Directors that receive compensation for their services as a Director, the Salary/Fees

and Option Awards columns include compensation that was received by them for their role as a member of the Board of Directors.

As is required by Regulation S-K, Item 402(c), compensation for services as a Director have been reported within the “Summary

Compensation Table”

(above) for fiscal years of 2020 and 2019 as well as reported separately in the “Compensation

of Directors”

section (see below) for calendar year 2020.

stated in Thomas Equels’

prior employment contract, he is entitled to 5% of Ampligen sales.

In the years 2019 and 2018,

a bonus of 5% of Ampligen sales totaled $37,425 and was accrued.

Equels’

was paid $44,100, representing the

2020 sales bonus of $6,675 and the previous years accrued sales bonuses of $37,425.

Pursuant to his current employment

agreement, Mr.

Equels is entitled to 3% of the “Gross Proceeds”

(as defined in the employment agreement) for

“significant events”

(as described in the employment agreement) There were no payments during 2020.

Equels’

All Other Compensations consists of:

Named Executive Officers, who are also Directors that receive compensation for their services

as a Director, the Salary/Fees and Option Awards columns include compensation that was received

by them for their role as a member of the Board of Directors.

As is required by Regulation

S-K, Item 402(c), compensation for services as a Director have been reported within the “Summary

Compensation Table” (above) for fiscal years of 2021 and 2020 as well as reported separately

in the “Compensation of Directors” section (see below) for calendar year 2021.

to his current employment agreement, Mr.

Equels is entitled to 3% of the “Gross Proceeds” (as defined in the employment agreement)

for “significant events” (as described in the employment agreement) There were no payments during 2021 and 2020.

Equels’ All Other Compensations consists of:

Life & Disability Insurance

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401(k) Matching Funds

Lintal’s All Other Compensations consists of:

Life & Disability Insurance

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401(k) Matching Funds

Rodino’s All Other Compensations consists of:

Life & Disability Insurance

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401(k) Matching Funds

Outstanding Equity Awards at

Equity Awards at

Fiscal Year End

Option Awards

Number of Securities Underlying Unexercised Options (#) Exercisable

Number of Securities Underlying Unexercised Options (#) Unexercisable

Equity Incentive Plan Awards:

Number of Securities Underlying Unexercised Unearned Options (#)

Options Exercise Price ($)

Option Expiration Date

Number of Shares or Units of Stock that Have Not Vested (#)

Market Value of Shares or Units of Stock that Have Not Vested ($)

Equity Incentive Plan Awards:

Number of Unearned Shares, Units or Other Rights that Have Not Vested (#)

Equity Incentive Plan Awards:

Market or Payout Value of Unearned Shares, Units or Other Rights that Have Not Vested ($)

Unexercisable

Thomas K Equels

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of December 31, 2020, we had an employment agreement with Mr.

Equels which entitled him to his base salary, applicable benefits

otherwise due and payable through the last day of the month in which disability occurs and for an additional two year period.

All of his unvested options vest too.

Equels which entitled him to his base salary, applicable benefits otherwise

due and payable through the last day of the month in which disability occurs and for an additional two year period.

All of his unvested

options vest too.

On March 24, 2021, we entered into employment agreements with Mr.

Rodino and Ms.

which entitled them to their base salary, applicable benefits otherwise due and payable through the last day of the month in which

disability occurs and for an additional two year period.

All of each NEO’s unvested options vest too.

In addition, each

NEO has the same short and long-term disability coverage which is available to all eligible employees.

The coverage for short-term

disability provides up to six months of full salary continuation up to 60% of weekly pay, less other income, with a $1,500 weekly

maximum limit.

The coverage for group long-term disability provides coverage at the exhaustion of short-term disability benefits

of full salary continuation up to 60% of monthly pay, less other income, with a $10,000 monthly maximum limit.

The maximum benefit

period for the group long-term disability coverage is 60 months for those age 60 and younger at the time of the claim with the

coverage period proportionately reduced with the advanced age of the eligible employee to a minimum coverage period of 12 months

for those of 69 years old and older as of the date of the claim.

For the period June 2010 through December 2020, Mr.

entitled to receive total disability coverage of $400,000 pursuant to his employment agreement and payable by us.

Lintal which entitled them to their

base salary, applicable benefits otherwise due and payable through the last day of the month in which disability occurs and for an additional

two year period.

All of each NEO’s unvested options vest too.

In addition, each NEO has the same short and long-term disability

coverage which is available to all eligible employees.

The coverage for short-term disability provides up to six months of full salary

continuation up to 60% of weekly pay, less other income, with a $1,500 weekly maximum limit.

The coverage for group long-term disability

provides coverage at the exhaustion of short-term disability benefits of full salary continuation up to 60% of monthly pay, less other

income, with a $10,000 monthly maximum limit.

The maximum benefit period for the group long-term disability coverage is 60 months for

those age 60 and younger at the time of the claim with the coverage period proportionately reduced with the advanced age of the eligible

employee to a minimum coverage period of 12 months for those of 69 years old and older as of the date of the claim.

For the period June

2010 through December 2021, Mr.

Equels was entitled to receive total disability coverage of $400,000 pursuant to his employment agreement

and payable by us.

to their employment agreements, the NEOS are entitled to their base salary and applicable benefits otherwise due and payable through

the last day of the month in which death occurs and for an additional two year period.

In addition, all of their unvested options

Each NEO, has coverage of group life insurance, along with accidental death and dismemberment benefits, consistent to the

dollar value available to all eligible employees.

The benefit is equal to two times current salary or wage with a maximum limit

of $300,000, plus any supplemental life insurance elected and paid for by the NEO.

For the period June 2010 and through December

Equels is entitled to receive total death benefit coverage of $3,000,000 pursuant to his employment agreement and payable

Payments Following Severance —

Named Executive Officers (NEO)

In addition, all of their unvested options vest.

Each NEO, has coverage of group life insurance, along with accidental death and dismemberment benefits, consistent to the dollar value

available to all eligible employees.

The benefit is equal to two times current salary or wage with a maximum limit of $300,000, plus

any supplemental life insurance elected and paid for by the NEO.

For the period June 2010 and through December 2021, Mr.

Equels is entitled

to receive total death benefit coverage of $3,000,000 pursuant to his employment agreement and payable by us.

Payments Following Severance — Named Executive Officers (NEO)

to his employment agreement, Mr.

Equels is entitled to severance benefits on certain types of employment terminations not related

to a change in control or termination not for cause.

Equels is entitled to severance benefits on certain types of employment terminations not related to

a change in control or termination not for cause.

Rodino and Ms.

Lintal are not covered by an employment severance agreement

and therefore would only receive severance as determined by the Compensation Committee in its discretion.

Lintal are not covered by an employment severance agreement and

therefore would only receive severance as determined by the Compensation Committee in its discretion.

dollar amounts below assume that the termination occurred on January 1, 2022.

The actual dollar amounts to be paid can only be

determined at the time of the NEO’s separation from us based on their prevailing compensation and employment agreements

along with any determination by the Compensation Committee in its discretion.

The actual dollar amounts to be paid can only be determined

at the time of the NEO’s separation from us based on their prevailing compensation and employment agreements along with any determination

by the Compensation Committee in its discretion.

Value of Stock

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Termination by employee or retirement

of stock options contractually required per the employee’s respective employment agreement or arrangement to be granted

during each calendar year of the term under our 2018 Equity Incentive Plan.

The stock options have a ten-year term and an

exercise price equal to the closing market price of our common stock on the date of grant.

The value was obtained using the

Black-Scholes-Merton pricing model for stock-based compensation in accordance with FASB ASC 718.

of stock options contractually required per the employee’s respective employment agreement

or arrangement to be granted during each calendar year of the term under our 2018 Equity

Incentive Plan.

The stock options have a ten-year term and an exercise price equal to the

closing market price of our common stock on the date of grant.

The value was obtained using

the Black-Scholes-Merton pricing model for stock-based compensation in accordance with FASB

on Termination in Connection with a Change in Control of Named Executive Officers

to their employment agreements, each NEO is entitled to severance benefits on certain types of employment terminations related

to a change in control.

In such event, the term of their employment agreements would automatically be extended for three additional

years, except where such change in control occurs as a result of certain “significant events”

(as described in his

or her employment agreement).

dollar amounts in the chart below assume that change in control termination occurred on January 1, 2021, based on the employment

agreements that existed at that time.

The actual dollar amounts to be paid can only be determined at the time of the NEO’s

separation from us based on their prevailing compensation and employment agreements along with any determination by the Compensation

Committee in its discretion.

Benefits on Termination Following a Change in Control —

December 31, 2020

to their employment agreements, each NEO is entitled to severance benefits on certain types of employment terminations related to a change

In such event, the term of their employment agreements would automatically be extended for three additional years, except

where such change in control occurs as a result of certain “significant events” (as described in his or her employment agreement).

dollar amounts in the chart below assume that change in control termination occurred on January 1, 2022, based on the employment agreements

that existed at that time.

The actual dollar amounts to be paid can only be determined at the time of the NEO’s separation from

us based on their prevailing compensation and employment agreements along with any determination by the Compensation Committee in its

Benefits on Termination Following a Change in Control — December 31, 2021

following table shows potential payments to the NEO if employment terminates following a change in control under contracts, agreements,

plans or arrangements at December 31, 2021.

The amounts assume a January 4, 2021 termination date regarding base pay and use of

the opening price of $1.79 on the NYSE American for our common stock at that date.

The amounts assume a January 3, 2022 termination date regarding base pay and use of the opening

price of $0.97 on the NYSE American for our common stock at that date.

Severance Pay

Stock (4) (5) ($)

Award (5) ($)

$ 6,076,000 (1)

$ 1,988,119 (4)

amount represents the Base Salary and benefits for the remaining current term of the NEO’s employment agreement plus

a three-year extension in the term upon the occurrence of a termination from a change in control.

The employment agreement

amount represents the Base Salary and benefits for the remaining current term of the NEO’s

employment agreement plus a three-year extension in the term upon the occurrence of a termination

from a change in control.

The employment agreement with Mr.

Equels has a term through December

This amount excludes the following payments as they cannot be calculated

unless and until certain events occur:

Equels is entitled to 3% of the “Gross Proceeds”

(as defined in the

employment agreement) for “significant events”

(as described in his employment agreement) and 3% of the Gross

Proceeds from any sale of our company or substantially all of our assets.

amount represents the payout of all outstanding performance-vesting share units (“PVSU”) awarded on a change in

control at the target payout level with each award then pro-rated based on the time elapsed for the applicable three-year

performance period.

amount is the intrinsic value [fair market value] on January 1, 2018 ($0.18 per share) minus the per share exercise price

of $0.30 of all unvested stock options for each NEO, including Stock Appreciation Rights (“SAR”).

Any option with

an exercise price of greater than fair market value was assumed to be cancelled for no consideration and, therefore, had no

intrinsic value.

amount represents the options to be issued annually for the remaining term of the NEO’s employment agreement plus a

three-year extension in the occurrence of termination from a change in control.

For the purpose of this schedule, a NYSE American

closing price at January 4, 2021of $1.79 was used with an estimated exercise price of $0.30 for Mr.

The value was

obtained using the Black-Scholes-Merton pricing model for stock-based compensation in accordance with FASB ASC 718.

purchase rights represented by the Option not then vested shall, upon a change in control, shall become vested.

This amount excludes the following payments as they cannot be calculated unless

and until certain events occur:

Equels is entitled to 3% of the “Gross Proceeds”

(as defined in the employment agreement) for “significant events” (as described

in his employment agreement) and 3% of the Gross Proceeds from any sale of our Company

or substantially all of our assets.

amount represents the payout of all outstanding performance-vesting share units (“PVSU”)

awarded on a change in control at the target payout level with each award then pro-rated

based on the time elapsed for the applicable three-year performance period.

amount is the intrinsic value [fair market value] on January 3, 2022 ($1.03 per share) minus

the weighted average per share exercise price of $3.54 of all unvested stock options for

each NEO, including Stock Appreciation Rights (“SAR”).

Any option with an exercise

price of greater than fair market value was assumed to be cancelled for no consideration

and, therefore, had no intrinsic value.

amount represents the options to be issued annually for the remaining term of the NEO’s

employment agreement plus a three-year extension in the occurrence of termination from a

change in control.

For the purpose of this schedule, a NYSE American closing price at January

3, 2022 of $1.03 was used with an estimated exercise price of $1.03 for Mr.

was obtained using the Black-Scholes-Merton pricing model for stock-based compensation in

accordance with FASB ASC 718.

purchase rights represented by the Option not then vested shall, upon a change in control,

shall become vested.

Post-Employment

5 unchanged sentences

of our NEOs can be terminated for cause.

For each NEO “Cause”

means willful engaging by any NEO in illegal conduct,

gross misconduct or gross violation of our Code of Ethics and Business Conduct for Officers, which is demonstrably and materially

injurious to our company.

Equel’s agreement provides that he shall not be deemed to have been terminated for Cause unless

and until we initiate a process by delivery to him a copy of a resolution duly adopted by the affirmative vote of not less than

a majority of the directors of the Board specifying the grounds for termination.

For each NEO “Cause” means willful engaging by any NEO in illegal conduct, gross

misconduct or gross violation of our Code of Ethics and Business Conduct for Officers, which is demonstrably and materially injurious

to our Company.

Equels’ agreement provides that he shall not be deemed to have been terminated for Cause unless and

until we initiate a process by delivery to him a copy of a resolution duly adopted by the affirmative vote of not less than a majority

of the directors of the Board specifying the grounds for termination.

After reasonable notice to Mr.

Equels and an

opportunity for him to be heard, the issues shall be adjudicated by a retired Florida judge or a Florida certified mediator mutually

acceptable to the Board of Directors and Mr.

Equels and an opportunity for him

to be heard, the issues shall be adjudicated by a retired Florida judge or a Florida certified mediator mutually acceptable to the Board

of Directors and Mr.

Termination requires a finding that Mr.

Equels was guilty of intentional

and material misconduct according to the standards set forth above, and specifying the particulars thereof in detail supported

by legally admissible evidence and utilizing the legal standard of beyond reasonable doubt.

In the event that an NEO’s employment

is terminated for Cause, we shall pay such NEO, at the time of such termination, only the compensation and benefits otherwise

due and payable to him or her through the last day of his actual employment by us.

Equels was guilty of intentional and material misconduct according

to the standards set forth above, and specifying the particulars thereof in detail supported by legally admissible evidence and utilizing

the legal standard of beyond reasonable doubt.

In the event that an NEO’s employment is terminated for Cause, we shall pay such

NEO, at the time of such termination, only the compensation and benefits otherwise due and payable to him or her through the last day

of his actual employment by us.

without Cause

the event that an NEO is terminated at any time without “Cause”, we shall pay to him or her, at the time of such termination,

the compensation and benefits otherwise due and payable through the last day of the then current term of his or her Agreement.

However, benefit distributions that are made due to a “separation from service”

occurring while he or she is a Named

Executive Officer shall not be made during the first six months following separation from service.

Rather, any distribution which

would otherwise be paid to him or her during such period shall be accumulated and paid to him or her in a lump sum on the first

day of the seventh month following the “separation from service”.

All subsequent distributions shall be paid in the

manner specified.

benefit distributions that are made due to a “separation from service” occurring while he or she is a Named Executive Officer

shall not be made during the first six months following separation from service.

Rather, any distribution which would otherwise be paid

to him or her during such period shall be accumulated and paid to him or her in a lump sum on the first day of the seventh month following

the “separation from service”.

All subsequent distributions shall be paid in the manner specified.

or Disability

NEO can be terminated for death or disability.

“Disability”

means the NEO’s inability effectively to carry out

substantially all of his or her duties by reason of any medically determinable physical or mental impairment which can be expected

to result in death or which has lasted or can be expected to last for a continuous period of not less than 12 months.

his or her employment is terminated due to his or her death or disability, we will pay him or her (or their estate as the case

may be), at the time of such termination, his or her base salary, applicable benefits, and immediate vesting of unvested stock

In the event of permanent disability, we will provide an additional two years of base salary.

“Disability” means the NEO’s inability effectively to carry out substantially

all of his or her duties by reason of any medically determinable physical or mental impairment which can be expected to result in death

or which has lasted or can be expected to last for a continuous period of not less than 12 months.

In the event his or her employment

is terminated due to his or her death or disability, we will pay him or her (or their estate as the case may be), at the time of such

termination, his or her base salary, applicable benefits, and immediate vesting of unvested stock options.

In the event of permanent

disability, we will provide an additional two years of base salary.

Compensation, Audit and Corporate Governance and Nomination Committees, consist of Dr.

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Governance and Nomination Committee Chair, and Stewart L.

Appelrouth, Audit Committee Chair, both of whom are independent Board

of Director members.

reimburse Directors for travel expenses incurred in connection with attending board, committee, stockholder and special meetings

along with other Company business-related expenses.

We do not provide retirement benefits or other perquisites to non-employee

Directors under any current program.

Appelrouth, Audit Committee Chair, both of whom are independent Board of Director

reimburse Directors for travel expenses incurred in connection with attending board, committee, stockholder and special meetings along

with other Company business-related expenses.

We do not provide retirement benefits or other perquisites to non-employee Directors under

any current program.

was no cost of living increase granted in 2020 or 2021.

Directors’

fees were being deferred beginning in August 2018.

cash became available, they were paid their deferred fees in 2019.

Directors have been granted options to purchase common stock under our Stock Option Plans and/or Warrants to purchase common stock.

We believe such compensation and payments are necessary in order for us to attract and retain qualified outside directors.

shares for stock compensation were issued under the 2009 and 2018 Equity Incentive Plans.

Compensation –

believe such compensation and payments are necessary in order for us to attract and retain qualified outside directors.

Options shares

for stock compensation were issued under the 2009 and 2018 Equity Incentive Plans.

Compensation – 2021 & 2020

Name and Title of Director

Fees Earned or Paid in

Non-Equity Incentive Plan Compensation $

Change in Pension Value & Nonqualified Deferred Compensation Earnings $

All Other Compensation As Director $

Executive Vice Chairman

Incentive Plan

As Director $

Vice Chairman

Chairman of the Board

Appelrouth Director (1)

Director of the Company.

Beginning August 16, 2018, the independent directors are deferring payment of 100% of their director’s

fees until cash is available.

During 2019 cash became available and the directors were paid their deferred compensation.

Security Ownership of Certain Beneficial Owners

and Management and Related Stockholder Matters.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

following table sets forth as of March 25, 2022, the number and percentage of outstanding shares of Common Stock beneficially

person, individually or as a group, known to us to be deemed the beneficial owners of five percent or more of our issued and

outstanding Common Stock;

person, individually or as a group, known to us to be deemed the beneficial owners of five

percent or more of our issued and outstanding Common Stock;

of our Directors and the Named Executives Officers;

1 unchanged sentence

number of shares of Common Stock at March 25, 2022 was 47,994,672.

Name and Address of

Shares Beneficially

Beneficial Owner

Beneficially Owned

and Address of Beneficial Owner

Equels, Executive Vice Chairman, Chief Executive Officer, President*

2 unchanged sentences

Appelrouth, Director*

Ellen Lintal, Chief Financial Officer*

All directors and executive officers as a group (5 persons)

** Less than 1%

Equels, shares beneficially owned include 55,678 shares issuable upon exercise of options and excludes 601,222 shares

issuable upon exercise of options not vested or not exercisable within the next 60 days.

Rodino, shares beneficially owned include 19,339 shares issuable upon exercise of options and excludes 75,569 shares issuable

upon exercise of options not vested or not exercisable within the next 60 days.

Mitchell, shares beneficially owned include 29,328 shares issuable upon exercise of options and excludes 50,742 shares

issuable upon exercise of options not vested or not exercisable within the next 60 days.

Also includes 190 shares of common stock

owned by his spouse and 194 shares owned by family trusts.

Appelrouth, shares beneficially owned include 28,473 shares issuable upon exercise of options and excludes 50,742 shares

Lintal, Chief Financial Officer*

directors and executive officers as a group(5 persons)

Equels, shares beneficially owned include

656,888 shares issuable upon exercise of options and excludes 300,000 shares issuable upon exercise of options not vested or not

exercisable within the next 60 days.

Rodino, shares beneficially owned include 94,902 shares issuable upon exercise of options and excludes 150,000 shares

issuable upon exercise of options not vested or not exercisable within the next 60 days.

Lintal, shares beneficially owned include 23 shares issuable upon exercise of options and excludes 75,000 shares issuable

Mitchell, shares beneficially owned include 80,062 shares issuable upon exercise of options and excludes 100,000

shares issuable upon exercise of options not vested or not exercisable within the next 60 days.

Also includes 190 shares of common

stock owned by his spouse and 190 shares owned by family trusts.

Appelrouth, shares beneficially owned include 79,209 shares issuable upon exercise of options and excludes 100,000 shares issuable

upon exercise of options not vested or not exercisable within the next 60 days.

following table gives information about our Common Stock that may be issued upon the exercise of options, warrants and rights

under all of our equity compensation plans as of December 31, 2020:

Lintal, shares beneficially owned include

75,023 shares issuable upon exercise of options and excludes 150,000 shares issuable upon exercise of options not vested or not

exercisable within the next 60 days.

following table gives information about our Common Stock that may be issued upon the exercise of options, warrants and rights under all

of our equity com pensation plans as of December 31, 2021:

Plan Category

Securities to be

available for

1 unchanged sentence

Equity compensation plans approved by security holders:

Equity compensation plans not approved by security holders:

Certain Relationships and Related Transactions,

and Director Independence.

Equity compensation plans not approved by security

Certain Relationships and Related Transactions, and Director Independence.

Approval or Ratification of Transactions with Related Persons

policy is to require that any transaction with a related party required to be reported under applicable SEC rules, other than

compensation related matters and waivers of our code of business conduct and ethics, be reviewed and approved or ratified by a

majority of independent, disinterested Directors.

We have adopted procedures in which the Audit Committee shall conduct an appropriate

review of all related party transactions for potential conflict of interest situations on an annual and case-by-case basis with

the approval of this Committee required for all such transactions.

have employment agreements with certain of our executive officers and have granted such Officers and Directors options and warrants

to purchase our Common Stock, as discussed under the headings, Item 11.

“Executive Compensation”, and Item 12.

“Security

Ownership of Certain Beneficial Owners and Management”, as noted above.

policy is to require that any transaction with a related party required to be reported under applicable SEC rules, other than compensation

related matters and waivers of our code of business conduct and ethics, be reviewed and approved or ratified by a majority of independent,

disinterested Directors.

We have adopted procedures in which the Audit Committee shall conduct an appropriate review of all related party

transactions for potential conflict of interest situations on an annual and case-by-case basis with the approval of this Committee required

for all such transactions.

have employment agreements with certain of our executive officers and have granted such Officers and Directors options and warrants to

purchase our Common Stock, as discussed under the headings, Item 11.

“Executive Compensation”, and Item 12.

Ownership of Certain Beneficial Owners and Management”, as noted above.

Principal Accountant Fees and Services.

All audit and professional services are approved

in advance by the Audit Committee to assure such services do not impair the auditor’s independence from us.

The total fees

by BDO USA, LLP (“BDO”) and Morrison, Brown, Argiz & Farra LLC (“MBAF”) for 2020 were $52,500 and

$301,000, respectively.

Total fees by MBAF for 2019 were $391,000.

The following table shows the aggregate fees for professional

services rendered during the year ended December 31, 2020 and 2019.

To be updated

audit and professional services are approved in advance by the Audit Committee to assure such services do not impair the auditor’s

independence from us.

The total fees by BDO USA, LLP (“BDO”) for 2021 were $485,000 and total 2020 were $353,500.

Description of Fees:

1 unchanged sentence

All Other Fees

fees include the audit of our annual financial statements and the review of our financial statements included in our quarterly

reports and services in connection with statutory and regulatory filings.

fees include the audit of our annual financial statements and the review of our financial statements included in our quarterly reports

and services in connection with statutory and regulatory filings.

Audit-Related

the fees for assurance and related services that were reasonably related to the performance of the audit or review of our financial

Audit-related fees include professional services related to the Company’s filing of SEC Form S-3 and S-8 (i.e.,

stock shelf offering procedures).

Audit Committee has determined that BDO’s rendering of these audit-related services and all other fees were compatible with

maintaining auditor’s independence.

The Board of Directors considered BDO to be well qualified to serve as our independent

public accountants.

the fees for assurance and related services that were reasonably related to the performance of the audit or review of our financial statements.

Audit-related fees include professional services related to the Company’s filing of SEC Form S-3 and S-8 (i.e., stock shelf offering

Audit Committee has determined that BDO’s rendering of these audit-related services and all other fees were compatible with maintaining

auditor’s independence.

The Board of Directors considered BDO to be well qualified to serve as our independent public accountants.

The Committee also pre-approved the charges for services performed in 2020 and 2019.

Audit Committee pre-approves all auditing and accounting services and the terms thereof (which may include providing comfort letters

in connection with securities underwriting) and non-audit services (other than non-audit services prohibited under Section 10A(g)

of the Exchange Act or the applicable rules of the SEC or the Public Company Accounting Oversight Board) to be provided to us

by the independent auditor;

provided, however, the pre-approval requirement is waived with respect to the provisions of non-audit

services for us if the “de minimus”

provisions of Section 10A (i)(1)(B) of the Exchange Act are satisfied.

This authority

to pre-approve non-audit services may be delegated to one or more members of the Audit Committee, who shall present all decisions

to pre-approve an activity to the full Audit Committee at its first meeting following such decision.

and Financial Statement Schedules.

in connection with securities underwriting) and non-audit services (other than non-audit services prohibited under Section 10A(g) of

the Exchange Act or the applicable rules of the SEC or the Public Company Accounting Oversight Board) to be provided to us by the independent

provided, however, the pre-approval requirement is waived with respect to the provisions of non-audit services for us if the

“de minimus” provisions of Section 10A (i)(1)(B) of the Exchange Act are satisfied.

This authority to pre-approve non-audit

services may be delegated to one or more members of the Audit Committee, who shall present all decisions to pre-approve an activity to

the full Audit Committee at its first meeting following such decision.

Exhibits and Financial Statement Schedules.

Statements and Schedules - See index to financial statements on page F-1 of this Annual Report.

All other schedules called for

under regulation S-X are not submitted because they are not applicable or not required, or because the required information is

included in the financial statements or notes thereto.

All other schedules called for under

regulation S-X are not submitted because they are not applicable or not required, or because the required information is included in

the financial statements or notes thereto.

- See exhibit index below.

and Restated Certificate of Incorporation of the Company, as amended, along with Certificates of Designations.

Amendment to Certificate of Incorporation.

Certificate of Designation of Preference, Rights and Limitations of Series B Convertible Preferred Stock.

Amended and Restated By-Laws of Registrant.

certificate representing our Common Stock.

and Restated Certificate of Incorporation of the Company, as amended, along with Certificates of Designations (incorporated by reference

to exhibits of the Company’s Registration Statement on Form S-1 (No.

33-93314) filed November 2, 1995).

Amendment to Certificate of Incorporation (incorporated by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A (No.

001-13441) filed September 16, 2011).

Amendment to Certificate of Incorporation (incorporated by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A (No.

000-27072) filed June 27, 2016).

Amendment to Certificate of Incorporation (incorporated by reference to exhibit 3.11 to the Company’s Current report on Form 8-K (No.

001-27072) filed June 5, 2019).

Amendment to Certificate of Incorporation (incorporated by reference to exhibit 3.11 to the Company’s Current report on Form 8-K (No.

001-27072) filed August 23, 2019).

Certificate of Designation of Preference, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to exhibit 3.5 to the Amendment to the Company’s Registration Statement on Form S-1/A (No.

333-229051) filed February 6, 2019).

Amended and Restated By-Laws of Registrant (incorporated by reference to exhibit 3.1 to the Company’s Current report on Form 8-K (No.

000-27072) filed June 10, 2016).

certificate representing our Common Stock (incorporated by reference to exhibits of the Company’s Registration Statement on

Form S-1 (No.

33-93314) filed November 2, 1995).

Amended and Restated Rights Agreement, dated as of November 14, 2017, between the Company and American Stock Transfer & Trust Company LLC.

The Amended and Restated Right Agreement includes the Form of Certificate of Designation, Preferences and Rights of the Series A Junior Participating Preferred Stock, the Form of Rights Certificate and the Summary of the Right to Purchase Preferred Stock.

Form of Indenture filed with Form S-3 Universal Shelf Registration Statement.

Form of Warrant pursuant to August 30, 2016 Securities Purchase Agreement.

Form of Warrant pursuant to February 1, 2017 Securities Purchase Agreement.

Form of Series A Warrant-June 2017.

Form of Series B Warrant-June 2017.

Form of New Series A Warrant-August 2017.

Form of New Series B Warrant-August 2017.

Form of Warrant issued to Purchaser of facility.

Form of Class A Warrant- April 2018.

Form of Class B Warrant- April 2018.

001-27072) filed November 14, 2017).

Form of Indenture filed with Form S-3 Universal Shelf Registration Statement (incorporated by reference to exhibit 4.4 to the Company’s Form S-3 Registration Statement (No.

333- 262280) filed January 21, 2022).

Form of Warrant pursuant to August 30, 2016 Securities Purchase Agreement (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No.

000-270720 filed September 1, 2016).

Form of Warrant pursuant to February 1, 2017 Securities Purchase Agreement (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No.

000-27072) filed February 3, 2017).

Form of Series A Warrant-June 2017 (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No.

000-27072) filed June 1, 2017).

Form of Series B Warrant-June 2017(incorporated by reference to exhibit 4.2 to the Company’s Current report on Form 8-K (No.

000-27072) filed June 1, 2017).

Form of New Series A Warrant-August 2017 (incorporated by reference to exhibit 4.1 the Company’s Current report on Form 8-K (No.

000-27072) filed August 23, 2017).

Form of New Series B Warrant-August 2017 (incorporated by reference to exhibit 4.2 the Company’s Current report on Form 8-K (No.

000-27072) filed August 23, 2017).

Form of Warrant issued to Purchaser of facility (incorporated by reference to exhibit 4.8 to the Company’s Annual report on Form 10-K (No.

000-27072) for the year ended December 31, 2017).

Form of Class A Warrant- April 2018 (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No.

001-27072) filed April 20, 2018).

Form of Class B Warrant- April 2018 (incorporated by reference to exhibit 4.2 to the Company’s Current report on Form 8-K (No.

001-27072) filed April 20, 2018).

September 28, 2018 Secured Convertible Promissory Note from the Company to Iliad Research and Trading, L.P.

Rights Offering Form of Non-Transferable Subscription Rights Certificate.

Rights Offering Form of Warrant Agreement.

Rights Offering Form of Warrant Certificate.

Rights Offering Warrant Agency Agreement with American Stock Transfer & Trust.

AGP Offering-Form of Pre-Funded Warrant.

AGP Offering-Form of Warrant.

AGP Offering-Form of Representative’s Warrant.

(incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No.

001-27072) filed October 4, 2018).

Rights Offering Form of Non-Transferable Subscription Rights Certificate (incorporated by reference to exhibit 4.14 to the Company’s Registration Statement on Form S-1/A (No.

333-229051) filed February 6, 2019).

Rights Offering Form of Warrant Agreement (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K filed February 27, 2019 and is hereby incorporated by reference).

Rights Offering Form of Warrant Certificate (incorporated by reference to exhibit 4.15 to the Company’s Registration Statement on Form S-1/A (No.

333-229051) filed February 6, 2019).

Rights Offering Warrant Agency Agreement with American Stock Transfer & Trust (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No.001-27072) filed March 8, 2019).

AGP Offering-Form of Pre-Funded Warrant (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No.

001-27072) filed September 27, 2019).

AGP Offering-Form of Warrant (incorporated by reference to exhibit 4.2 to the Company’s Current report on Form 8-K (No.

001-27072) filed September 27, 2019).

AGP Offering-Form of Representative’s Warrant (incorporated by reference to exhibit 4.20 to the Company’s Registration Statement on Form S-1/A (No.

333-233657) filed September 24, 2019).

March 2019 Amendment to September 28, 2018 Secured Convertible Promissory Note from the Company to Iliad Research and Trading, L.P.

December 5, 2019 Secured Promissory Note with Atlas Sciences, LLC.

(incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

001-27072) filed March 15, 2019).

December 5, 2019 Secured Promissory Note with Atlas Sciences, LLC (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No.001-27072) filed December 11, 2019).

Description of Common Stock.*

Form of Confidentiality,

Invention and Non-Compete Agreement.

Form of Clinical

Research Agreement.

Employee Wage or Hours Reduction Program.

Supply Agreement with Hollister-Stier Laboratories LLC dated December 5, 2005.

Amendment to Supply Agreement with Hollister-Stier Laboratories LLC dated February 25, 2010.

Vendor Agreement with Bio Ridge Pharma, LLC dated August 15, 2011.

Vendor Agreement with Armada Healthcare, LLC dated August 15, 2011.

Amendment to Supply Agreement with Hollister-Stier Laboratories LLC executed September 9, 2011.

Equity Distribution Agreement, dated July 23, 2012, with Maxim Group LLC (18)

Vendor Agreement extension with Bio Ridge Pharma, LLC dated August 14, 2012.

Vendor Agreement extension with Armada Healthcare, LLC dated August 14, 2012.

Vendor Agreement extension with Armada Healthcare, LLC dated July 19, 2013.

Vendor Agreement extension with Bio Ridge Pharma, LLC dated July 19, 2013.

of Confidentiality, Invention and Non-Compete Agreement (incorporated by reference to exhibits of the Company’s Registration

Statement on Form S-1 (No.

33-93314) filed November 2, 1995).

of Clinical Research Agreement (incorporated by reference to exhibits of the Company’s Registration Statement on Form S-1 (No.

33-93314) filed November 2, 1995.

Supply Agreement with HollisterStier Laboratories LLC dated December 5, 2005 (incorporated by reference to exhibit 10.46 to the Company’s Annual report on Form 10-K (No.

001-13441) for the year ended December 31, 2005).

Amendment to Supply Agreement with HollisterStier Laboratories LLC dated February 25, 2010 (incorporated by reference to exhibit 10.68 to the Company’s Annual report on Form 10-K (No.

001-13441) for the year ended December 31, 2009).

Vendor Agreement with Armada Healthcare, LLC dated August 15, 2011 (incorporated by reference exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No.

001-131) for the period ended September 30, 2011).

Amendment to Supply Agreement with HollisterStier Laboratories LLC executed September 9, 2011 (incorporated by reference to exhibit 10.22 to the Company’s Annual report on Form 10-K (No.

001-13441) for the year ended December 31, 2011).

Vendor Agreement extension with Armada Healthcare, LLC dated August 14, 2012 (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

000-27072) filed August 15, 2012).

Vendor Agreement extension with Armada Healthcare, LLC dated July 19, 2013 (incorporated by reference to exhibit 10.22 to the Company’s Annual report on Form 10-K (No.

000-27072) for the year ended December 31, 2013).

Vendor Agreement extension with Bio Ridge Pharma, LLC and Armada Healthcare, LLC dated August 8, 2014.

(incorporated by reference to exhibit 10.24 to the Company’s Annual report on Form 10-K (No.

000-27072) for the year ended December 31, 2014).

Sales, Marketing, Distribution, and Supply Agreement with Emerge Health Pty Ltd.

dated March 9, 2015.(Confidential Treatment granted with respect to portions of the Agreement) (20)

August 4, 2015 Amendment to Equity Distribution Agreement between the registrant and Maxim Group LLC.

Vendor Agreement extension with Armada Healthcare, LLC dated July 29, 2015.

Vendor Agreement extension with Bio Ridge Pharma, LLC dated July 29, 2013.

dated March 9, 2015.

(Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.25 to the Company’s Annual report on Form 10-K (No.

000-27072) for the year ended December 31, 2014).

Vendor Agreement extension with Armada Healthcare, LLC dated July 29, 2015 (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended June 30, 2015).

Early Access Agreement with Impatients N.V.

dated August 3, 2015.(Confidential Treatment granted with respect to portions of the Agreement) (25)

dated August 3, 2015.(Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.

001-13441) for the period ended September 30, 2015).

Sales, Marketing, Distribution, and Supply Agreement with Emerge Health Pty Ltd.

dated August 6, 2015.

(Confidential Treatment granted with respect to portions of the Agreement) (25)

(Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.4 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended June 30, 2015).

Addendum to Early Access Agreement with Impatients N.V.

dated October 16, 2015.(Confidential Treatment granted with respect to portions of the Agreement) (25)

November 23, 2015 Thomas K.

Equels Employment Agreement Waiver.

Equity Distribution Agreement, dated December 15, 2015 with Chardan Capital Markets, LLC.

Termination of Chardan Equity Distribution Agreement.

2016 Senior Executive Deferred Cash Performance Award Plan.

2016 Voluntary Incentive Stock Award Plan.

Amended and Restated 2016 Senior Executive Deferred Cash Performance Award Plan.

Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with Scientific Products Pharmaceutical Co.

LTD dated March 3, 2016 (Confidential Treatment granted with respect to portions of the Agreement).

Agreement between Avrio Biopharmaceuticals (“Avrio”) and the Company dated July 20, 2016 (Confidential Treatment granted with respect to portions of the Agreement).

Licensing Agreement dated April 13, 2016 with Lonza Sales AG (Confidential Treatment granted with respect to portions of the Agreement).

Form of Securities Purchase Agreement entered into on August 30, 2016.

dated October 16, 2015.

(Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No.

001-13441) for the period ended September 30, 2015).

2016 Senior Executive Deferred Cash Performance Award Plan (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

000-27072) filed February 4, 2016).

2016 Voluntary Incentive Stock Award Plan (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No.

000-27072) filed February 4, 2016).

Amended and Restated 2016 Senior Executive Deferred Cash Performance Award Plan (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

000-27072) filed March 1, 2016).

Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with Scientific Products Pharmaceutical Co.

LTD dated March 3, 2016 (Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended March 31, 2016).

Agreement between Avrio Biopharmaceuticals (“Avrio”) and the Company dated July 20, 2016 (Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.000-27072) for the period ended June 30, 2016).

Licensing Agreement dated April 13, 2016 with Lonza Sales AG (Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.2 to the Company’s report Form 10-Q/A (No.

000-27072) for the period ended March 31, 2016).

Form of Securities Purchase Agreement entered into on August 30, 2016 (incorporated by reference to exhibit 10.1 to the Company’s Current report Form 8-K (No.

000-27072) filed September 1, 2016).

Amended and Restated Early Access Agreement with Impatients N.V.

dated May 20, 2016.

(Confidential Treatment granted with respect to portions of the Agreement) (37)

(Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.1 to the Company’s report Form 8-K/A (No.

000-27072) filed May 8, 2017).

December 13, 2016 Amendment No.

1 to Amended and Restated Early Access Agreement with Impatients N.V.

(incorporated by reference to exhibit 10.45 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2017).

June 28, 2017 Amendment No.

2 to Amended and Restated Early Access Agreement with Impatients N.V.

(incorporated by reference to exhibit 10.46 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2017).

February 14, 2018 Amendment No.

3 to Amended and Restated Early Access Agreement with Impatients N.V.

(incorporated by reference to exhibit 10.47 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2017).

March 26, 2018 Amendment No.

4 to Amended and Restated Early Access Agreement with Impatients N.V.

Form of Securities Purchase Agreement entered into on February 1, 2017.

August 2017 Form of Employee Pay Reduction Plan.

August 2017Form of Executive Compensation Deferral Plan.

August 2017 Form of Directors’

Compensation Deferral Plan.

(incorporated by reference to exhibit 10.48 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2017).

Form of Securities Purchase Agreement entered into on February 1, 2017 (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

000-27072) filed February 3, 2017).

August 2017 Form of Employee Pay Reduction Plan (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

000-27072) filed August 29, 2017).

August 2017 Form of Executive Compensation Deferral Plan (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No.

000-27072) filed August 29, 2017).

August 2017 Form of Directors’ Compensation Deferral Plan (incorporated by reference to exhibit 10.3 to the Company’s Current report on Form 8-K (No.

000-27072) filed August 29, 2017).

Form of August 2017 Agreement between the Company and the Warrant holders .

Form of June 2017 Agreement between the Company and the Warrant holders.

Mortgage and Security Agreement with SW Partners LLC dated May 12, 2017.

Promissory Note with SW Partners LLC dated May 12, 2017.

September 11, 2017 Purchase and Sale Agreement- 5 Jules Lane.

January 8, 2018 Purchase and Sale Agreement- 783 Jersey Lane.

Lease Agreement for 783 Jersey Lane.

Form of Stock Purchase Agreement entered into on March 21, 2018.

Form of Securities Purchase Agreement entered into on May 24, 2018.

2018 Equity Incentive Plan.

(incorporated by reference to exhibit 10.1 the Company’s Current report on Form 8-K (No.

000-27072) filed August 23, 2017).

Form of June 2017 Agreement between the Company and the Warrant holders (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

000-27072) filed June 1, 2017).

Mortgage and Security Agreement with SW Partners LLC dated May 12, 2017 (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended March 31, 2017).

Promissory Note with SW Partners LLC dated May 12, 2017 (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended March 31, 2017).

September 11, 2017 Purchase and Sale Agreement- 5 Jules Lane (incorporated by reference to exhibit 10.57 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2017).

January 8, 2018 Purchase and Sale Agreement- 783 Jersey Lane (incorporated by reference to exhibit 10.58 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2017).

Lease Agreement for 783 Jersey Lane (incorporated by reference to exhibit 10.59 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2017).

Form of Stock Purchase Agreement entered into on March 21, 2018 (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

001-27072) filed March 22, 2018).

Form of Securities Purchase Agreement entered into on May 24, 2018 (incorporated by reference to exhibit 10.55 to the Company’s Registration Statement on Form S-1 (No.

333-226057) filed July 2, 2018).

2018 Equity Incentive Plan (filed with the Securities and Exchange Commission as Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A (No.

001-27072) filed on August 3, 2018).

September 28, 2018 Securities Purchase Agreement with Iliad Research and Trading, L.P.

(incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

001-27072) filed October 4, 2018).

September 28, 2018 Security Agreement with Iliad Research and Trading, L.P.

October 9, 2018, Clinical Trial Agreement with Roswell Park Comprehensive Cancer Center.

October 8, 2018, Restated First Amendment to Purchase and Sale Agreement.

October 9, 2018, Restated Bill of Sale for the Restated First Amendment and Sale Agreement.

Form of Agreement between the Company and the Warrantholders.- May 2, 2019.

Termination of August 4, 2015 Equity Distribution Agreement between the registrant and Maxim Group LLC.

July 19, 2019 Equity Distribution Agreement between the registrant and Maxim Group LLC.

(incorporated by reference to exhibit 10.3 to the Company’s Current report on Form 8-K (No.

001-27072) filed October 4, 2018).

October 9, 2018, Clinical Trial Agreement with Roswell Park Comprehensive Cancer Center (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended September 30, 2018).

October 8, 2018, Restated First Amendment to Purchase and Sale Agreement (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended September 30, 2018).

October 9, 2018, Restated Bill of Sale for the Restated First Amendment and Sale Agreement (incorporated by reference to exhibit 10.3 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended September 30, 2018).

Form of Agreement between the Company and the Warrantholders.- May 2, 2019 (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

001-27072) filed May 2, 2019).

Note Purchase Agreement dated August 5, 2019 with Chicago Venture Partners, L.P.

(incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.

001-27072) for the period ended June 30, 2019).

Secured Promissory Note dated August 5, 2019 issued to Chicago Venture Partners, L.P.

(incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No.

001-27072) for the period ended June 30, 2019).

Security Agreement dated August 5, 2019 with Chicago Venture Partners, L.P.

Salary Reduction and Restricted Stock Award Memo (August 2019).

Form of Restricted Stock Award.

December 5, 2019 Note Purchase Agreement with Atlas Sciences, LLC.

December 5, 2019 Security Agreement with Atlas Sciences, LLC.

March 20, 2020 Amendment to 2017 Material Transfer and Research Agreement with Roswell Park Cancer Institute.

1, 2020 Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited.

April 21, 2020 Mutual Confidentiality Agreement with UMN Pharma Inc., National Institute of Infectious Diseases, and Shionogi & Co., Ltd.(65)

(incorporated by reference to exhibit 10.3 to the Company’s Quarterly report on Form 10-Q (No.

001-27072) for the period ended June 30, 2019).

Salary Reduction and Restricted Stock Award Memo (August 2019) (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

001-27072) filed August 26, 2019).

Form of Restricted Stock Award (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No.

001-27072) filed August 26, 2019).

December 5, 2019 Note Purchase Agreement with Atlas Sciences, LLC (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.001-27072) filed December 11, 2019).

December 5, 2019 Security Agreement with Atlas Sciences, LLC (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No.001-27072) filed December 11, 2019).

March 20, 2020 Amendment to 2017 Material Transfer and Research Agreement with Roswell Park Cancer Institute (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

001-27072) filed March 26, 2020).

April 1, 2020 Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

)001-27072) filed April 6, 2020).

April 21, 2020 Mutual Confidentiality Agreement with UMN Pharma Inc., National Institute of Infectious Diseases, and Shionogi & Co., Ltd (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

001-27072) filed April 27, 2020).

June 1, 2020, Material Transfer and Research Agreement with the University of Rochester.

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10))(66)

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended June 30, 2020).

June 23, 2020, Specialized Services Agreement with Utah State University.

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10))(66)

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended June 30, 2020).

July 1, 2020, Material Transfer and Research Agreement with the Japanese National Institute of Infectious Diseases and Shionogi & Co., Ltd.

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10))(66)

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.3 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended June 30, 2020).

July 6, 2020, Clinical Trial Agreement with Roswell Park Comprehensive Cancer Center.

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10))(66)

6, 2020, Project Work Order with Amarex Clinical Research LLC.

(Portions of this Agreement have been redacted in compliance

with Regulation S-K Item 601(b)(10))(66)

10, 2020 employment agreement with Thomas K.

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.5 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended June 30, 2020).

August 6, 2020, Project Work Order with Amarex Clinical Research LLC.

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.5 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended June 30, 2020).

November 10, 2020 employment agreement with Thomas K.

(incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended September 30, 2020).

December 22, 2020 Master Service Agreement with Pharmaceutics International Inc.

as a Fill & Finish provider for Ampligen.*

as a Fill & Finish provider for Ampligen (incorporated by reference to exhibit 10.75 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2020).

January 11, 2021 Sponsor Agreement with Centre for Human Drug Research.

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) *

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.76 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2020).

November 29, 2020, Material Transfer and Research Agreement with Leyden Laboratories, B.V.

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10))*

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.77 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2020).

December 30, 2020 Amendment to Project Work Order with Amarex Clinical Research LLC.

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10))*

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.78 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2020).

December 23, 2020 Amendment to Master Service Agreement with Pharmaceutics International Inc.

as a Fill & Finish provider for Ampligen (incorporated by reference to exhibit 10.79 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2020).

March 24, 2021 employment agreement with Peter Rodino (incorporated by reference to exhibit 10.80 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2020).

March 24, 2021 employment agreement with Ellen Lintal (incorporated by reference to exhibit 10.81 to the Company’s Annual report on Form 10-K (No.

001-27072) for the year ended December 31, 2020).

April 1, 2021 extension of April 1, 2020 Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited.

(incorporated by reference to exhibit 10.3 to the Company’s Quarterly report on Form 10-Q (No.

001-27072) for the period ended March 31, 2021).

Material Transfer And Research Agreement with the University of Cagliari Dipartimento di Scienze della Vita e dell’Ambiente executed on April 5, 2021 (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.4 to the Company’s Quarterly report on Form 10-Q (No.

001-27072) for the period ended March 31, 2021).

Material Transfer and Research agreement with Roswell Park Comprehensive Cancer Center executed on April 14, 2021 (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No.

001-27072) for the period ended March 31, 2021).

April 19, 2021 Purchase and Sale Agreement with Phoenix Equipment Corporation, Branford Auctions, LLC and Perry Videx LLC (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.

001-27072) for the period ended March 31, 2021).

May 12, 2021 Amendment to the Renewed Sales, Marketing, Distribution and Supply Agreement with GP Pharm.

(Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.5 to the Company’s Quarterly report on Form 10-Q (No.

001-27072) for the period ended March 31, 2021).

May 21, 2021 extension of April 1, 2020 Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No.

001-27072) for the period ended June 30, 2021).

July 8, 2021 Reservation and Start-Up Agreement with hVIVO Services Limited (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (No.

000-27072) for the period ended June 30, 2021 filed August 16, 2021)

September 27, 2021 Clinical Trial Agreement with hVIVO Services Limited (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No.

000-27072) for the period ended September 30, 2021)

1, 2022 Consulting Agreement with Foresite Advisors, LLC pursuant to which Robert Dickey

IV will serve as the Company’s Chief Financial Officer (Portions of this agreement

have been redacted in compliance with Regulation S-K Item 601(b)(10))*

24, 2022 Consulting Agreement with Ellen Lintal (Portions of this agreement have been redacted in compliance with Regulation

S-K Item 601(b)(10))

March 1, 2022 Amendment to Clinical Trial Agreement with hVIVO Services Ltd dated September 27, 2021.*

March 3, 2022 Agreement of Sale and Purchase with Acellories, Inc for sale of 783 Jersey Avenue, New Brunswick, NJ building.

March 8, 2022 Change order to Master Service Agreement with Pharmaceutics International Inc.

as a Fill & Finish provider for Ampligen.*

March 24, 2021 employment agreement with Peter Rodino.*

March 24, 2021 employment agreement with Ellen Lintal.*

16, 2021 Letter from MBAF (65)

January 16, 2021 Letter from MBAF (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.

001-27072) filed APRIL 27, 2020).

List of Subsidiaries*

Consent of BDO USA, LLP.*

Consent of Morrison, Brown, Argiz & Farra, LLC.*

Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer.

Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer.

Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer.

Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer.

following materials from AIM’

Annual Report on Form 10-K for the year ended December 31, 2019, formatted in eXtensible

Business Reporting Language (“XBRL”):

Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer.

Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer.

Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer.

Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer.

following materials from AIM’ Annual Report on Form 10-K for the year ended December 31, 2019, formatted in eXtensible Business

Reporting Language (“XBRL”):

(i) the Condensed Consolidated Statements of Income;

(ii) the Condensed

Consolidated Balance Sheets;

(ii) the Condensed Consolidated Balance

(iii) the Condensed Consolidated Statements of Cash Flows;

and (iv) Notes to Condensed Consolidated

Financial Statements.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed March 15,

2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Registration Statement on Form S-1 (No.

filed November 2, 1995 and is hereby incorporated by reference.

with the Securities and Exchange Commission as Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A

filed on September 16, 2011 and is hereby incorporated by reference.

with the Securities and Exchange Commission as Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A

filed on June 27, 2016 and is hereby incorporated by reference.

with the Securities and Exchange Commission on November 14, 2017 as an exhibit to the Company’s Registration Statement

on Form 8-A12B (No.

0-27072) and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Form S-3 Registration Statement (No.

on June 25, 2015 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s annual report on Form 10-K (No.

for the year ended December 31, 2008 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q (No.

for the period ended June 30, 2010 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s annual report on Form 10-K (No.

for the year ended December 31, 2005 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Annual Report on Form 10-K (No.

for the year ended December 31, 2009 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

dated May 28, 2010 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q (No.

for the period ended March 31, 2011 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q (No.

for the period ended September 30, 2011 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed September 23, 2011 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed December 12, 2011 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Annual Report on Form 10-K (No.

for the year ended December 31, 2011 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed August 15, 2012 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed July 23, 2012 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s annual report on Form 10-K (No.

for the year ended December 31, 2013 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s annual report on Form 10-K (No.

for the year ended December 31, 2014 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s annual report on Form 10-K (No.

for the year ended December 31, 2017 and is hereby incorporated by reference left blank.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed June 23, 2015 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed August 4, 2015 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q (No.

for the period ended June 30, 2015 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q (No.

for the period ended September 30, 2015 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed November 23, 2015 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed December 15, 2015 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed January 14, 2016 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed February 4, 2016 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K (No.

filed March 1, 2016 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s amended quarterly report on Form 10-Q/A (No.

000-27072) for the period ended September 30, 2011 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q for the period

ended March 31, 2016 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed June 10,

2016 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q for the period

ended June 30, 2016 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q/A for the period

ended March 31, 2016 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed September

1, 2016 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K/A filed May 8,

2017 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed February

3, 2017 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed August 29,

2017 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed August 23,

2017 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed June 1,

2017 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q (No.

for the period ended March 31, 2017 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed March 22,

2018 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed April 20,

2018 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed May 6, 2018

and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q (No.

for the period ended September 30, 2018 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Registration Statement on Form S-1 (No.

filed July 2, 2018 and is hereby incorporated by reference.

with the Securities and Exchange Commission as Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A

filed on August 3, 2018 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed October

4, 2018 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed March 8,

2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Registration Statement on Form S-1/A (No.

333-229051) filed February 6, 2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed June 5,

2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed August 23,

2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed May 2, 2019

and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed July 22,

2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q (No.

for the period ended June 30, 2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed August 26,

2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed September

27, 2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Registration Statement on Form S-1/A (No.

333-233657) filed September 24, 2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed December

11, 2018 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed February

27, 2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed December

11, 2019 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed March 26,

2020 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed April 6,

2020 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed April 27,

2020 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q (No.

for the period ended June 30, 2020 and is hereby incorporated by reference.

with the Securities and Exchange Commission as an exhibit to the Company’s quarterly report on Form 10-Q (No.

for the period ended September 30, 2020 and is hereby incorporated by reference.

and (iv) Notes to Condensed Consolidated Financial Statements.

Financial Statement Schedules

schedules have been omitted because either they are not required, are not applicable or the information is otherwise set forth

in the financial statements and related notes thereto.

to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report

to be signed on its behalf by the undersigned, thereunto duly authorized.

schedules have been omitted because either they are not required, are not applicable or the information is otherwise set forth in the

financial statements and related notes thereto.

Form 10-K Summary

to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed

on its behalf by the undersigned, thereunto duly authorized.

IMMUNOTECH INC.

Executive Officer

to the requirements of Section 13 or 15(d) of the Securities Exchange of 1934, as amended, this report has been signed below by

the following persons on behalf of this Registrant and in the capacities and on the dates indicated.

to the requirements of Section 13 or 15(d) of the Securities Exchange of 1934, as amended, this report has been signed below by the following

persons on behalf of this Registrant and in the capacities and on the dates indicated.

Thomas K Equels

3 unchanged sentences

Stewart L Appelrouth

Ellen M Lintal

Ellen M Lintal E

Financial Officer

2 unchanged sentences

to Consolidated Financial Statements

of Independent Registered Public Accounting Firms

Report of Independent Registered Public Accounting Firm (BDO USA, LLP;

Miami, Florida;

PCAOB ID # 243 )

Consolidated Balance Sheets at December 31, 2021 and 2020

Consolidated Statements of Comprehensive Loss for each of the years in the two-year period ended December 31, 2021

Consolidated Statements of Changes in Stockholders’

Equity for each of the years in the two-year period ended December 31, 2020

Consolidated Statements of Changes in Stockholders’ Equity for each of the years in the two-year period ended December 31, 2021

Consolidated Statements of Cash Flows for each of the years in the two-year period ended December 31, 2021

4 unchanged sentences

on the Consolidated Financial Statements

have audited the accompanying consolidated balance sheet of AIM ImmunoTech Inc.

(the “Company”) as of December 31,

2020, the related consolidated statement of operations and comprehensive loss, stockholders’

equity, and cash flows for

the year ended December 31, 2020 and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the

Company at December 31, 2020, and the results of its operations and its cash flows for the year ended December 31, 2020 ,

in conformity with accounting principles generally accepted in the United States of America.

consolidated financial statements are the responsibility of the Company’s management.

Our responsibility is to express an

opinion on the Company’s consolidated financial statements based on our audit.

We are a public accounting firm registered

with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with

respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities

and Exchange Commission and the PCAOB.

conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit

to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether

due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over

financial reporting.

As part of our audit we are required to obtain an understanding of internal control over financial reporting

but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.

have audited the accompanying consolidated balance sheets of AIM ImmunoTech Inc.

(the “Company”) as of December 31, 2021

and 2020, the related consolidated statements of comprehensive loss, changes in stockholders’ equity, and cash flows for

each of the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company

at December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the years then ended , in

conformity with accounting principles generally accepted in the United States of America.

consolidated financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion

on the Company’s consolidated financial statements based on our audits.

We are a public accounting firm registered with the Public

Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company

in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission

and the PCAOB.

conducted our audits in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain

reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing

an opinion on the effectiveness of the Company’s internal control over financial reporting.

Accordingly, we express no such opinion.

audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether

audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether

due to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis,

evidence regarding the amounts and disclosures in the consolidated financial statements.

Our audit also included evaluating the

accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the

consolidated financial statements.

We believe that our audit provides a reasonable basis for our opinion.

critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements

that was communicated or required to be communicated to the audit committee and that:

(1) relates to accounts or disclosures that

are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements,

taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical

audit matter or on the accounts or disclosures to which it relates.

Such procedures included examining, on a test basis, evidence

regarding the amounts and disclosures in the consolidated financial statements.

Our audits also included evaluating the accounting principles

used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

We believe that our audits provide a reasonable basis for our opinion.

critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that

was communicated or required to be communicated to the audit committee and that:

(1) relates to accounts or disclosures that are material

to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication

of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we

are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts

or disclosures to which it relates.

of the fair value of redeemable warrants

discussed in Note 18 to the consolidated financial statements, the Company has certain redeemable warrants issued in conjunction

with offerings that contain a cash settlement feature upon the occurrence of a Fundamental Transaction.

The Company calculates

the fair value of the redeemable warrants at the end of each quarterly reporting period using a Monte Carlo Simulation, which

includes subjective assumptions.

Subsequent changes in the fair value of the redeemable warrants are recorded in the consolidated

statement of operations and comprehensive loss.

discussed in Note 16 to the consolidated financial statements, the Company has certain redeemable warrants issued in conjunction with

offerings that contain a cash settlement feature upon the occurrence of a Fundamental Transaction.

The Company calculates the fair value

of the redeemable warrants at the end of each quarterly reporting period using a Monte Carlo Simulation, which includes subjective assumptions.

Subsequent changes in the fair value of the redeemable warrants are recorded in the consolidated statement of comprehensive

As of December 31, 2021, the fair value of the redeemable warrants was approximately $35,000.

$180 thousand.

identified the calculation of the fair value of the redeemable warrants as a critical audit matter.

Specifically, there was a

high degree of management subjectivity and judgment in selecting the assumptions used in the Monte Carlo Simulation, including

the expected probability of a Fundamental Transaction and the expected stock price volatility.

Auditing these elements involved

especially subjective auditor judgment due to the nature and extent of audit effort required to address these matters, including

the use of personnel with specialized skill and knowledge to evaluate the Company’s Monte Carlo Simulation.

Specifically, there was a high degree

of management subjectivity and judgment in selecting the assumptions used in the Monte Carlo Simulation, including the expected probability

of a Fundamental Transaction and the expected stock price volatility.

Auditing these elements involved especially subjective auditor

judgment due to the nature and extent of audit effort required to address these matters, including the use of personnel with specialized

skill and knowledge to evaluate the Company’s Monte Carlo Simulation.

primary procedures we performed to address this critical audit matter included:

management’s process for developing the fair value estimate and evaluating the significant assumptions used to calculate

the fair value of the redeemable warrants, including the probability of a Fundamental Transaction and testing the accuracy

and completeness of data used by management to estimate the fair value of the redeemable warrants, including considering evidence

obtained in other areas of the audit to determine if contradictory evidence existed.

personnel with specialized skills and knowledge in valuation to assist in evaluating (i) the appropriateness of the Monte

Carlo Simulation model, and (ii) the expected stock price volatility range that was independently developed in consideration

of daily historical stock price volatility information.

have served as the Company’s auditor since 2021.

Report of Independent Registered Public Accounting

of Directors and Stockholders of AIM ImmunoTech Inc.

on the Financial Statement

have audited the accompanying balance sheet of AIM ImmunoTech Inc.

(the “Company”) as of December 31, 2019, and the

related statement of operations, stockholders’

equity and cashflows for the year in the period ended December 31, 2019,

and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial statements

present fairly, in all material respects, the financial position of the Company as of December 31, 2019, and the results of its

operations and its cash flows for the year in the period ended December 31, 2019, in conformity with accounting principles generally

accepted in the United States of America.

financial statements are the responsibility of the entity’s management.

Our responsibility is to express an opinion on these

financial statements based on our audit.

We are a public accounting firm registered with the Public Company Accounting Oversight

Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit

to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial

As part of our audit we are required to obtain an understanding of internal control over financial reporting but not

for the purpose of expressing an opinion on the effectiveness of the entity’s internal control over financial reporting.

Accordingly, we express no such opinion.

audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to

error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence

regarding the amounts and disclosures in the financial statements.

Our audit also included evaluating the accounting principles

used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audits provide a reasonable basis for our opinion.

Morrison, Brown, Argiz & Farra, LLC

have served as the Company’s auditor since 2018.

management’s process for developing the fair value estimate and evaluating the significant

assumptions used to calculate the fair value of the redeemable warrants, including the probability

of a Fundamental Transaction and testing the accuracy and completeness of data used by management

to estimate the fair value of the redeemable warrants, including considering evidence obtained

in other areas of the audit to determine if contradictory evidence existed.

personnel with specialized skills and knowledge in valuation to assist in evaluating (i)

the appropriateness of the Monte Carlo Simulation model, and (ii) the expected stock price

volatility range that was independently developed in consideration of daily historical stock

price volatility information.

have served as the Company’s auditor since 2021.

IMMUNOTECH INC.

7 unchanged sentences

Funds receivable from New Jersey net operating loss

Accounts receivable, net

Accounts receivable

Prepaid expenses and other current assets

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Marketable securities, long term

LIABILITIES AND STOCKHOLDERS’

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

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Operating lease liability

Notes payable

Financing obligation arising from sale leaseback transaction (Note 17)

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Commitments and contingencies (Notes 8, 10, 11, 13, and 17)

Stockholders’

Series B Convertible Preferred Stock, stated value $1,000 per share, 732 shares designated, 778 shares issued and outstanding

Stockholders’ equity:

Series B Convertible Preferred Stock, stated value $ 1,000 per share, issued and outstanding 715 and 732 , respectively

Common Stock, par value $ 0.001 per share, authorized 350,000,000 shares;

3 unchanged sentences

Accumulated deficit

Total stockholders’

Total liabilities and stockholders’

Total stockholders’ equity

Total liabilities and stockholders’ equity

accompanying notes to consolidated financial statements.

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General and administrative

Impairment of other assets

Impairment of assets

Total Costs and Expenses

Operating loss

Interest and other income

Gain (loss) on investments

Interest expense and other finance costs

Settlement of litigation/Insurance Claim

Extinguishment of debt

Fair value of convertible note adjustment

Extinguishment of financing obligation and note payable

Gain on sale of fixed assets

Redeemable warrants valuation adjustment

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Other comprehensive loss

Unrealized loss on marketable securities

Reclassification adjustment for realized investment loss

Change in unrealized loss on marketable securities available for sale

Net comprehensive loss

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AND SUBSIDIARIES

Statements of Changes in Stockholders’

Statements of Changes in Stockholders’ Equity

thousands except share data)

Comprehensive

Stockholders’

December 31, 2018

Stock issuance, net of costs

note origination shares

based compensation

issued to pay accounts payable

B preferred shares issued, net of offering costs

B preferred shares converted to Common shares

comprehensive loss

December 31, 2019

Stock issuance, net of costs

issued to pay accounts payable

B preferred shares converted to Common shares

comprehensive loss

December 31, 2020

Stockholders’

Income (Loss)

Balance December 31, 2019 2018

$ ( 327,574 )

Shares issued for:

Common Stock issuance, net of costs

Warrant modification

Equity based compensation

Shares issued to pay accounts payable

Series B preferred shares converted to Common shares

Net comprehensive loss

Balance December 31, 2020

Shares issued for:

Common Stock issuance, net of costs

Shares issued for:

Common stock issuance, net of costs

Equity-based compensation

Shares issued to pay accounts payable

Series B preferred shares converted to Common shares

Net comprehensive loss

Balance December 31, 2021

$ ( 361,101 )

accompanying notes to consolidated financial statements.

2 unchanged sentences

Statements of Cash Flows

ended December 31,

Years ended December 31,

Cash flows from operating activities:

2 unchanged sentences

Redeemable warrants valuation adjustment

of patents and trademarks

Fair value of convertible note adjustment

for bad debt recovery

Abandonment of patents and trademarks

Gain on sale of fixed assets

Allowance for bad debt recovery

Warrant modification

Extinguishment of convertible note

Extinguishment of financing obligation and note payable

Amortization of patent, trademark rights

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Inventory write-off

Impairment of other assets

Impairment of plant property equipment and other assets

Gain from sale of income tax operating losses

Equity-based compensation

Realized gain (loss) on sale of marketable securities

Amortization of finance and debt issuance costs

Change in assets and liabilities:

Accounts receivables

Funds receivable from New Jersey net operating loss

Accounts receivable

Funds receivable from New Jersey operating loss sales

Prepaid expenses and other current assets and other non current assets

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Proceeds from sale of marketable securities

Purchase of short-term marketable securities

Purchase of marketable securities

Purchase of property and equipment

Proceeds from sales of property and equipment

Purchase of patent and trademark rights

2 unchanged sentences

Financing obligation payments

Proceeds from note payable, net of issuance costs

Payoff of note payable

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Net cash provided by financing activities

Net increase in cash and cash equivalents

Net (decrease) increase in cash and cash equivalents

Cash and cash equivalents at beginning of period

2 unchanged sentences

Stock issued to settle accounts payable

Conversion of note payable in shares

Conversion of Series B preferred

Operating Lease –

Right of Use Assets

Operating Lease - Right of Use Assets

accompanying notes to consolidated financial statements.

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ImmunoTech Inc.

and its subsidiaries (collectively, “AIM”

or the “Company”) are an immuno-pharma company

headquartered in Ocala, Florida and focused on the research and development of therapeutics to treat multiple types of cancers,

various viruses and immune-deficiency disorders.

The Company has established a strong foundation of laboratory, pre-clinical and

clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense

system of the human body and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

flagship products include Ampligen®

(rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules,

and Alferon N Injection®

(Interferon Alfa-N3).

A first-in-class drug is also known as a new molecular entity that contains

an active moiety.

Ampligen has not been approved by the FDA or marketed in the US.

the outbreak of SARS-CoV-2, the novel virus that causes COVID-19, the Company has been actively engaged in determining whether

Ampligen could be an effective treatment for this virus or could be part of a vaccine.

The Company believes that Ampligen has

the potential to be both an early-onset treatment for and prophylaxis against SARS-CoV-2.

Ampligen also has potential as a COVID-19

vaccine strategy that combines Ampligen as an immune enhancer seeking to boost the efficacy of the vaccine and also convey cross-reactivity

and cross-protection against future mutations.

The Company believes that prior studies of Ampligen in SARS-CoV-1 animal experimentation

may predict similar protective effects against the new virus.

in April 2020, the Company entered into confidentiality and non-disclosure agreements with numerous companies for the potential

outsourcing of the production of polymer, enzyme, placebo as well as Ampligen and one Contract Research Organization which may

also assist with the planning, presentation and filing of documents with the FDA.

These confidentiality and non-disclosure agreements

are only the initial step in forging relationships with these entities to obtain contract manufacturers and research partners.

No assurance can be given as to how many of these, initial explorations, if any, will result in definitive arrangements or, with

regard to potential research partners, what research arrangements will develop and thereafter prove fruitful.

represents an RNA being developed for globally important cancers, viral diseases and disorders of the immune system.

has in the clinic demonstrated the potential for standalone efficacy in a number of solid tumors.

The Company has also seen success

in increasing survival rates and efficacy in the treatment of animal tumors when Ampligen is used in combination with checkpoint

blockade therapies.

This success in the field of immuno-oncology has guided our focus toward the potential use of Ampligen as

a combinational therapy for the treatment of a variety of solid tumor types.

There are currently multiple Ampligen clinical trials

testing Ampligen in humans —

both underway and planned —

at major cancer research centers.

Ampligen was used as a

monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in

the Netherlands at Erasmus Medical Center.

In September, AIM reported receipt of statistically significantly results of positive

survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy.

AIM will work with its Contract Research Organization, Amarex Clinical Research LLC, to seek FDA “fast-track”

possibly even FDA “breakthrough”

designations and to obtain authorization to conduct a follow-up pancreatic cancer

Phase 2/3 clinical trial with sites in the Netherlands at Erasmus MC under Prof.

van Eijck, and also at major cancer research

centers in the United States.

is also being evaluated for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

AIM is currently sponsoring

an expanded access program for ME/CFS patients in the U.S.

In August 2016, the Company received approval of our NDA from Administracion

Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of Ampligen in the Argentine Republic for

the treatment of severe CFS.

With regulatory approval in Argentina, Ampligen is the world’s only approved therapeutic for

On June 10, 2020, the Company received import clearance from ANMAT to import the first shipment of commercial grade vials

of Ampligen to Argentina.

The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the

product and release tests before granting final approval to begin commercial sales.

AIM has supplied GP Pharm with the Ampligen

required for testing and ANMAT release.

Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen in

The Company continues to pursue our Ampligen New Drug Application, or NDA, for the treatment of CFS with the FDA.

N Injection is approved for a category of sexually transmitted diseases infection and patients that are intolerant to recombinant

and its subsidiaries (collectively, “AIM”, “Company”, “we” or “us”) are

an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple

types of cancers, viral diseases and immune-deficiency disorders.

We have established a strong foundation of laboratory, pre-clinical

and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system

of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

flagship products are Ampligen (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon

N Injection (Interferon Alfa-N3).

Ampligen has not been approved by the FDA or marketed in the United States.

Ampligen is approved for

commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (“CFS”).

Company’s primary present business focus involves Ampligen.

Ampligen is a double-stranded RNA (“dsRNA”) molecule being

developed for globally important cancers, viral diseases and disorders of the immune system.

currently is proceeding primarily in three areas:

plus Standard of Care (“SOC”) to treat pancreatic cancer patients, and in other

cancers, as a potential therapeutic that modifies the tumor microenvironment with the goal

of increasing anti-tumor responses to check point inhibitors and with SOC.

Ampligen’s antiviral activities and potential use as a prophylactic or treatment for

existing viruses, mutations thereof or new viruses.

as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”)

and what we refer to as Post-COVID-19 Cognitive Impairment.

some two years after COVID-19 first appeared, the world has a number of vaccines and some promising therapeutics.

AIM’s quest to

prove the antiviral activities of Ampligen continues.

If Ampligen has the broad-spectrum antiviral properties that the Company believes

that it has, it could be a very valuable tool in treating variants of existing viral diseases, including COVID-19, or novel ones that

arise in the future.

Unlike most developing therapeutics which attack the virus, Ampligen works differently.

AIM believes that it activates

antiviral immune system pathways that fight not just a particular virus or viral variant, but other similar viruses as well.

N Injection is approved in Argentina for a category of sexually transmitted disease infections and patients that are not responsive or

are intolerant to recombinant interferon.

Alferon N Injection is the only natural-source, multi-species alpha interferon currently approved

for sale in the United States for the intralesional treatment of refractory (i.e., resistant to other treatment) or recurring external

condylomata acuminata/genital warts in patients 18 years of age or older.

Certain types of human papilloma viruses cause genital warts.

AIM also has approval from ANMAT for the treatment of refractory patients that failed or were intolerant to treatment with recombinant

interferon in Argentina.

Alferon is the only natural-source, multi-species alpha interferon currently approved for sale in the

for the intralesional treatment of refractory (resistant to other treatment) or recurring external condylomata acuminata/genital

warts (GW) in patients 18 years of age or older.

Certain types of human papilloma viruses cause GW.

AIM also has approval from

ANMAT for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon in Argentina.

Company operates a 30,000 sq.

facility in New Brunswick, NJ, where it conducts testing and has produced limited quantities

of active pharmaceutical ingredients (“API”) for its products.

The Company has reviewed its operations at the facility

and believes that some of the equipment most likely should be upgraded to realize greater efficiencies, when and if it requires

more API than is currently in storage.

The Company is also exploring engaging a Contract Manufacturing Organization (“CMO”)

to produce API.

While the Company believes it has sufficient API to meet its current needs, is also continually exploring new

efficiencies so as to maximize its ability to fulfill future obligations.

consolidated financial statements include the financial statements of AIM ImmunoTech Inc.

and its wholly-owned subsidiaries, which

are incorporated in Delaware and are dormant.

The Company’s foreign subsidiary, Hemispherx Biopharma Europe N.V./S.A., was

established in Belgium in 1998.

All significant intercompany balances and transactions have been eliminated in consolidation.

of Significant Accounting Policies

Company recently announced the sale of its 30,000

facility at 783 Jersey

Ave, New Brunswick, N.J., where it conducts testing and has produced limited quantities of active pharmaceutical ingredients (“API”)

for its products.

While the Company believes it has sufficient API to meet its current needs, it is also continually exploring new opportunities

to maximize its ability to fulfill future needs.

AIM’s current and active production plan is to shift to the utilization of Contract

Manufacturing Organizations (“CMO”), while maintaining on-site teams for Quality Control (QC), Quality Assurance (QA), Research

& Development (R&D), bench and small-batch manufacturing.

(See Note 2c Property and Equipment, net)

(2) Summary of Significant Accounting Policies

Cash and Cash Equivalents

and Cash Equivalents consist of cash and money market accounts and total $38,501,000 and $1,470,000 at December 31, 2020 and 2019,

respectively.

and Cash Equivalents consist of cash and money market accounts and total $ 32,093,000 and $ 38,501,000 at December 31, 2021 and 2020, respectively.

Marketable Securities

securities consist of mutual funds and debt securities.

The Company’s securities are stated at fair value.

The Company records

changes in fair value of mutual funds in results of operations and the changes in fair value of debt securities in other comprehensive

income, gains and losses are determined by the specific identification method.

Property and Equipment, net

Schedule of Property and Equipment

(in thousands)

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and equipment are recorded at cost.

Depreciation and amortization are computed using the straight-line method over the estimated

useful lives of the respective assets, ranging from three to thirty-nine years.

Depreciation and amortization are computed using the straight-line method over the estimated useful

lives of the respective assets, ranging from three to thirty-nine years.

Depreciation expense for the years ending December 31, 2021

and December 31, 2020 was $ 659,000 and $ 665,000 , respectively.

During the fourth quarter of 2021, the Company

made a strategic shift on in-house manufacturing.

In accordance with its accounting policy discussed in item (l) within this footnote,

the Company recorded an impairment of the facility in the amount of $ 1,779,000 for the year ending December 31, 2021.

(See Note 16 Fair

Value and Note 18 Subsequent Events).

Patent and Trademark Rights, net

and trademarks are stated at cost (primarily legal fees) and are amortized using the straight line method over the established

useful life of 17 years.

The Company reviews its patents and trademark rights periodically to determine whether they have continuing

value or their value has become impaired.

Such review includes an analysis of the patent and trademark’s ultimate revenue

and profitability potential.

Management’s review addresses whether each patent continues to fit into the Company’s

strategic business plans.

and trademarks are stated at cost (primarily legal fees) and are amortized using the straight line method over the established useful

life of 17 years .

The Company reviews its patents and trademark rights periodically to determine whether they have continuing value or

their value has become impaired.

Such review includes an analysis of the patent and trademark’s ultimate revenue and profitability potential.

Management’s review addresses whether each patent continues to fit into the Company’s strategic business plans.

Use of Estimates

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

requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure

(“GAAP”) of contingent assets and liabilities at the date of the financial statements and the reported amounts of

revenues and expenses for the reporting period.

Actual results could differ from those estimates, and those differences may be

Accounts requiring the use of significant estimates include valuation allowances for inventory, determination of other-than-temporary

impairment on securities, valuation of deferred taxes, patent and trademark valuations, stock-based compensation calculations,

building valuation, fair value of warrants, convertible note payable and contingency accruals.

preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires

management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure (“GAAP”)

of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the

reporting period.

Actual results could differ from those estimates, and those differences may be material.

Accounts requiring the use

of significant estimates include determination of other-than-temporary impairment on securities, valuation of deferred taxes, patent

and trademark valuations, stock-based compensation calculations, building valuation, fair value of warrants, and contingency accruals.

of the Novel Coronavirus

January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain

of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community

as the virus spreads globally beyond its point of origin.

In March 2020, the WHO classified the COVID-19 outbreak as a pandemic,

based on the rapid increase in exposure globally.

January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus

originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally

beyond its point of origin.

In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure

full impact of the COVID-19 outbreak continues to evolve as of the date of this report.

As such, it is uncertain as to the full

magnitude that the pandemic will have on the Company’s financial condition, liquidity, and future results of operations.

As such, it is uncertain as to the full magnitude

that the pandemic will have on the Company’s financial condition, liquidity, and future results of operations.

is actively monitoring the global situation on its financial condition, liquidity, operations, scientific collaborations, suppliers,

1 unchanged sentence

Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, the Company

is not able to estimate the effects of the COVID-19 outbreak on its results of operations, financial condition, or liquidity for

fiscal year 2021.

the Company cannot estimate the length or gravity of the impact of the COVID-19 outbreak at this time, if the pandemic continues,

it may have a material adverse effect on the Company’s results of future operations, financial position, and liquidity for

the fiscal year 2021.

is not able to estimate the effects of the COVID-19 outbreak on its results of operations, financial condition, or liquidity for fiscal

the Company cannot estimate the length or gravity of the impact of the COVID-19 outbreak at this time, if the pandemic continues, it

may have a material adverse effect on the Company’s results of future operations, financial position, and liquidity for the fiscal

Aid, Relief and Economic Security Act

March 27, 2020, the U.S.

Government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was

signed into law.

Government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was signed

The CARES Act includes various income and payroll tax provisions.

The Company has analyzed the tax provisions

of the CARES Act and determined they have no significant financial impact to the consolidated financial statements.

has no intention of taking advantage of other benefits but will continue to evaluate the impact on the Company’s financial

January 1, 2018, the Company adopted Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers,

using the modified retrospective method and there was no impact to financial position and results of operations as a result of

the adoption.

This standard applies to all contracts with customers, except for contracts that are within the scope of other standards,

such as leases, insurance, collaboration arrangements and financial instruments.

Under Topic 606, an entity recognizes revenue

when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity

expects to receive in exchange for those goods or services.

To determine revenue recognition for arrangements that an entity determines

are within the scope of Topic 606, the entity performs the following five steps:

(i) identify the contract(s) with a customer;

The Company has analyzed the tax provisions of the CARES

Act and determined they have no significant financial impact to the consolidated financial statements.

The Company has no intention of

taking advantage of other benefits.

The Company accounts for

revenue in accordance with Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers (“Topic 606”),

Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects

the consideration which the entity expects to receive in exchange for those goods or services.

To determine revenue recognition for arrangements

that an entity determines are within the scope of Topic 606, the entity performs the following five steps:

(i) identify the contract(s)

with a customer;

(ii) identify the performance obligations in the contract;

(iii) determine the transaction price;

(iv) allocate the transaction

price to the performance obligations in the contract;

(iv) allocate the

transaction price to the performance obligations in the contract;

and (v) recognize revenue when (or as) the entity satisfies a performance

1 unchanged sentence

it is entitled to in exchange for the goods or services it transfers to the customer.

At contract inception, once the contract

is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and

determines those that are performance obligations, and assesses whether each promised good or service is distinct.

then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when

(or as) the performance obligation is satisfied.

Overall, adoption of the new standard did not result in an adjustment to amounts

previously reported in our consolidated financial statements and there were no other significant changes impacting the timing

or measurement of our revenue or our business processes and controls.

from the sale of Ampligen under cost recovery clinical treatment protocols approved by the FDA is recognized when the product

At contract inception, once the contract is determined

to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that

are performance obligations, and assesses whether each promised good or service is distinct.

The Company then recognizes as revenue the

amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is

from the sale of Ampligen under cost recovery clinical treatment protocols approved by the FDA is recognized when the product is shipped.

The Company has no other obligation associated with its products once shipment has been accepted by the customer.

from the sale Ampligen under the EAP is recognized as the product is distributed and administered to patients involved in the

cost recovery program.

from the sale Ampligen under the EAP is recognized as the product is distributed and administered to patients involved in the cost recovery

Accounting for Income Taxes

income tax assets and liabilities are determined based on differences between the financial statement reporting and tax bases

of assets and liabilities and are measured using the enacted tax rates and laws in effect when the differences are expected to

The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits

which are not expected to be realized.

The effect on deferred income tax assets and liabilities of a change in tax rates is recognized

in the period that such tax rate changes are enacted.

The Company applies

the provisions of FASB ASC 740-10 Uncertainty in Income Taxes.

As a result of the implementation, there has been no material change

to the Company’s tax positions as they have not paid any corporate income taxes due to operating losses.

income tax assets and liabilities are determined based on differences between the financial statement reporting and tax bases of assets

and liabilities and are measured using the enacted tax rates and laws in effect when the differences are expected to reverse.

The measurement

of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized.

The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes

Company applies the provisions of FASB ASC 740-10 Uncertainty in Income Taxes.

As a result of the implementation, there has been no material

change to the Company’s tax positions as they have not paid any corporate income taxes due to operating losses.

With the exception of

net operating losses generated in New Jersey, all tax benefits will likely not be recognized due to the substantial net operating

loss carryforwards which will most likely not be realized prior to expiration.

With no tax due for the foreseeable future,

the Company has determined that a policy to determine the accounting for interest or penalties related to the payment of tax is

not necessary at this time.

Immaterial Revision of

Previously Reported Amounts

During the preparation

of the consolidated financial statements as of and for the period ended December 31, 2020, Management noted an error in the Company’s

previously issued Consolidated Financial Statements.

The error in the amount of approximately $535,000 related to the Company’s

accounting for income taxes that resulted in a deferred tax benefit associated with the sale of net operating losses.

In evaluating

whether the previously issued Consolidated Financial Statements were materially misstated, the Company applied the guidance of

ASC 250, Accounting Changes and Error Corrections, SEC Staff Accounting Bulletin (“SAB”) Topic 1.M, Assessing Materiality

and SAB Topic 1.N, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial

Statements and concluded that the effect of the errors on prior period financial statements was immaterial.

The cumulative

effect of adjustments required to correct the misstatements in the Consolidated Financial Statements years prior to 2019 are reflected

in the revised opening accumulated deficit balance as of January 1, 2019.

The cumulative effect of those adjustments on all

periods reduced previously reported accumulated deficit by approximately $406,000.

As a result, certain amounts presented in

the Company’s Consolidated Balance Sheet and Consolidated Statement of Operations have been revised from the amounts previously

reported to correct this error which include an adjustment to decrease Accumulated deficit in the amount of approximately $406,000,

increase Other assets in the amount of approximately $535,000, increase Gain from the sale of income tax operating losses of approximately

$129,000, decrease Net loss in the amount of approximately $129,000 and increase Basic and diluted loss per share of $(0.04).

net operating losses generated in New Jersey, all tax benefits will likely not be recognized due to the substantial net operating loss

carryforwards which will most likely not be realized prior to expiration.

With no tax due for the foreseeable future, the Company has

determined that a policy to determine the accounting for interest or penalties related to the payment of tax is not necessary at this

Recent Accounting Standards and Pronouncements

February 2016, the FASB issued ASU 2016-02 - Leases, which amends the existing accounting standards for lease accounting,

including requiring lessees to recognize most leases on their balance sheets and making targeted changes to lessor accounting.

ASU 2016-02 will be effective for annual reporting periods beginning after December 15, 2018, and early adoption of is permitted

as of the standard’s issuance date.

ASU 2016-02 allows a modified retrospective transition approach for all leases existing

at, or entered into after, the date of initial application, with an option to use certain transition relief.

The Company evaluated

the effects and the adoption of this guidance will have on the consolidated financial statements.

(See Note 12 :

June 2016, the FASB issued ASU 2016-13, Financial Instruments - Measurement of Credit Losses on Financial Instruments, and

subsequent amendments to the guidance, ASU 2018-19 in November 2018 and ASU 2020-02 in February 2020.

The standard significantly

changes how entities will measure credit losses for most financial assets and certain other instruments that are not measured

at fair value through net income.

The standard will replace today’s “incurred loss”

approach with an “expected

model for instruments measured at amortized cost.

For available-for-sale debt securities, entities will be required

to record allowances rather than reduce the carrying amount, as they do today under the other-than-temporary impairment model.

It also simplifies the accounting model for purchased credit-impaired debt securities and loans.

The amendment will affect loans,

debt securities, trade receivables, net investments in leases, off balance sheet credit exposures, reinsurance receivables, and

any other financial assets not excluded from the scope that have the contractual right to receive cash.

ASU 2018-19 clarifies

that receivables arising from operating leases are accounted for using lease guidance and not as financial instruments.

June 2016, the FASB issued ASU 2016-13, Financial Instruments - Measurement of Credit Losses on Financial Instruments, and subsequent

amendments to the guidance, ASU 2018-19 in November 2018 and ASU 2020-02 in February 2020.

The standard significantly changes how entities

will measure credit losses for most financial assets and certain other instruments that are not measured at fair value through net income.

The standard will replace today’s “incurred loss” approach with an “expected loss” model for instruments

measured at amortized cost.

For available-for-sale debt securities, entities will be required to record allowances rather than reduce

the carrying amount, as they do today under the other-than-temporary impairment model.

It also simplifies the accounting model for purchased

credit-impaired debt securities and loans.

The amendment will affect loans, debt securities, trade receivables, net investments in leases,

off balance sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the

contractual right to receive cash.

ASU 2018-19 clarifies that receivables arising from operating leases are accounted for using lease

guidance and not as financial instruments.

The amendments should be applied on either a prospective transition or modified-retrospective

approach depending on the subtopic.

This ASU will be effective for us beginning the first day of our 2023 fiscal year.

Early adoption

is permitted.

We are evaluating the impact of adoption of this ASU on our financial condition, results of operations and cash flows,

and, as such, we are not able to estimate the effect the adoption of the new standard will have on our financial statements.

August 2020, the FASB issued ASU 2020-06, “Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and

Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2020-06”) .

ASU 2020-06 reduces the number

of models used to account for convertible instruments, amends diluted EPS calculations for convertible instruments, and amends the requirements

for a contract (or embedded derivative) that is potentially settled in an entity’s own shares to be classified in equity.

The amendments

should be applied on either a prospective transition or modified-retrospective approach depending on the subtopic.

This ASU will

be effective for us beginning the first day of our 2023 fiscal year.

Early adoption is permitted.

We are evaluating the impact

of adoption of this ASU on our financial condition, results of operations and cash flows, and, as such, we are not able to estimate

the effect the adoption of the new standard will have on our financial statements.

recent accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact on the

Company’s present or future financial statements.

add certain disclosure requirements to increase transparency and decision-usefulness about a convertible instrument’s terms and features.

Under the amendment, the Company must use the if-converted method for including convertible instruments in diluted EPS as opposed to

the treasury stock method.

ASU 2020-06 is effective for annual reporting periods beginning after December 15, 2023.

Early adoption is

allowed under the standard with either a modified retrospective or full retrospective method.

The Company early adopted ASU 2020-06 on

January 1, 2021 using the modified retrospective method.

As a result of Management’s evaluation, the adoption of ASU 2020-06 did

not have a material impact on the consolidated financial statements.

December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740):

Simplifying the Accounting for Income Taxes (“ASU 2019-12”),

which eliminates certain exceptions to the existing guidance for income taxes related to the approach for intra-period tax allocations,

the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences.

This ASU also simplifies the accounting for income taxes by clarifying and amending existing guidance related to the effects of enacted

changes in tax laws or rates in the effective tax rate computation, the recognition of franchise tax and the evaluation of a step-up

in the tax basis of goodwill, among other clarifications.

ASU 2019-12, which the Company adopted during the first quarter of 2021, did

not have a material effect on the Company’s consolidated financial statements.

recent accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact on the Company’s

present or future financial statements.

Stock-Based Compensation

Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, “Compensation –

Compensation”, which requires recognition of compensation expense related to stock-based compensation awards over the period

during which an employee is required to provide service for the award.

Compensation expense is equal to the fair value of the

award at the date of grant, net of estimated forfeitures.

Accounts Receivable, net

Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, “Compensation – Stock Compensation”,

which requires recognition of compensation expense related to stock-based compensation awards over the period during which an employee

is required to provide service for the award.

Compensation expense is equal to the fair value of the award at the date of grant, net

of estimated forfeitures.

Accounts Receivable

Concentration

of credit risk, with respect to accounts receivable, is limited due to the Company’s credit evaluation process.

does not require collateral on its receivables.

The Company’s receivables were $34,000 and $44,000, net of $30,000 allowance

for doubtful accounts, as of December 31, 2020 and 2019, respectively.

of credit risk, with respect to accounts receivable, is limited due to the Company’s credit evaluation process.

The Company does

not require collateral on its receivables.

The Company’s receivables were zero and $ 34,000 , as of December 31, 2021, and 2020,

respectively.

Common Stock Per Share Calculation

and diluted net loss per share is computed using the weighted average number of shares of Common Stock outstanding during the

Equivalent Common shares, consisting of 548,374, and 8,351,113 of stock options and warrants, are excluded from the calculation

of diluted net loss per share for the years ended December 31, 2020 and 2019, respectively, since their effect is antidilutive

due to the net loss of the Company.

and diluted net loss per share is computed using the weighted average number of shares of Common Stock outstanding during the period.

Equivalent Common shares, consisting of 2,150,163 and 548,374 of stock options and warrants, are excluded from the calculation of diluted

net loss per share for the years ended December 31, 2021 and 2020, respectively, since their effect is antidilutive due to the net loss

of the Company.

Long-Lived Assets

Company assesses long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of

the assets or the asset grouping may not be recoverable.

Factors that the Company considers in deciding when to perform an impairment

review include significant under-performance of a business or product line in relation to expectations, significant negative industry

or economic trends, and significant changes or planned changes in its use of the assets.

The Company measures the recoverability

of assets that it will continue to use in its operations by comparing the carrying value of the asset grouping to our estimate

of the related total future undiscounted net cash flows.

If an asset grouping’s carrying value is not recoverable through

the related undiscounted cash flows, the asset grouping is considered to be impaired.

Company measures the impairment by comparing the difference between the asset grouping’s carrying value and its fair value.

Long-lived assets are considered a non-financial asset and are recorded at fair value only if an impairment charge is recognized.

Impairments are determined for groups of assets related to the lowest level of identifiable independent cash flows.

makes subjective judgments in determining the independent cash flows that can be related to specific asset groupings.

as the Company reviews its manufacturing process and other manufacturing planning decisions, the useful lives of assets are

shorter than the Company had originally estimated, it accelerates the rate of depreciation over the assets’

useful lives.

(3) Inventories

Company uses the lower of first-in, first-out (“FIFO”) cost or net realizable value method of accounting for inventory.

sales of Alferon in the U.S.

will not resume until new batches of commercial filled and finished product are produced and released

by the Food and Drug Administration (“FDA”).

While the facility is approved by the FDA under the Biologics License

Application (“BLA”) for Alferon, this status will need to be reaffirmed by an FDA pre-approval inspection.

also will need the FDA’s approval to release commercial product once it has submitted satisfactory stability and quality

release data.

Currently, the manufacturing process is on hold and there is no definitive timetable to have the facility back online.

The Company estimates it will need approximately $10,000,000 to commence the manufacturing process.

Due to the Company extending

the timeline of Alferon production to an excess of one year, the Company reclassified Alferon work in process inventory of $1,095,000

to other assets within our balance sheet as of December 31, 2019.

on the Company’s current oncology and growing projects related to COVID-19 and ability to ready the manufacturing plant

to utilize the current Alferon work in process in a timely manner prior to expiration of the WIP the Company concluded to write

off the value of the Alferon as of December 31, 2020 and included within Research and Development expenses on the Consolidated

Statement of Comprehensive Loss.

(4) Marketable

Company assesses long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets

or the asset grouping may not be recoverable.

Factors that the Company considers in deciding when to perform an impairment review include

significant under-performance of a business or product line in relation to expectations, significant negative industry or economic trends,

and significant changes or planned changes in its use of the assets.

The Company measures the recoverability of assets that it will continue

to use in its operations by comparing the carrying value of the asset grouping to our estimate of the related total future undiscounted

net cash flows.

If an asset grouping’s carrying value is not recoverable through the related undiscounted cash flows, the asset

grouping is considered to be impaired.

Company measures the impairment by comparing the difference between the asset grouping’s carrying value and its fair value.

assets are considered a non-financial asset and are recorded at fair value only if an impairment charge is recognized.

Impairments are

determined for groups of assets related to the lowest level of identifiable independent cash flows.

The Company makes subjective judgments

in determining the independent cash flows that can be related to specific asset groupings.

In addition, as the Company reviews its manufacturing

process and other manufacturing planning decisions, the useful lives of assets are shorter than the Company had originally estimated,

it accelerates the rate of depreciation over the assets’ new, shorter useful lives.

Marketable Securities

securities consist of mutual funds and debt securities.

1 unchanged sentence

securities had an other-than-temporary impairment.

At December 31, 2020 and December 31, 2019, all securities were measured as

Level 1 instruments of the fair value measurements standard (See Note 18:

As of December 31, 2020 and December 31,

2019 the Company held $15,877,000 and $7,308,000 in debt and equity securities respectively.

As of December 31, 2019 there were

no debt securities.

At December 31, 2021 and December 31, 2020, all securities were measured as Level

1 instruments of the fair value measurements standard (See Note 16:

As of December 31, 2021, and December 31, 2020, the

Company held $ 16,175,000 and

$ 15,877,000 in

mutual funds and debt and equity securities, respectively.

Funds classified as available for sale consisted of:

Schedule of Available for Sale

December 31, 2021

(in thousands)

of Equity Securities

December 31, 2021

Net losses recognized during the period on

equity securities

Net gains and losses recognized during the period

on equity securities sold during the period

Unrealized gains and losses recognized during the reporting

period on equity securities still held at the reporting date

Securities classified as available for sale consisted of:

Gains /(Losses)

Schedule of Available for Sale

Marketable Securities

5 unchanged sentences

12 Months or More

Gains (Losses)

Treasury notes

1 unchanged sentence

Corporate bonds

gain and loss recognized during 2020 and 2019 respectively was $1,000 and $3,000.

Trademark Rights, net

realized gain recognized during 2021 was $ 11,000 and gross realized (loss) of $ 1,000 during 2020.

Patents, Trademark Rights ,

of Patents, Trademark Rights

December 31, 2019

1 unchanged sentence

December 31, 2021

and trademarks are stated at cost (primarily legal fees) and are amortized using the straight-line method of the estimated useful

life of 17 years.

During the years ended December 31, 2020, the Company decided not to pursue certain patents in various

countries for strategic reasons and recorded abandonment charges which are included in research and development.

and trademarks are stated at cost and are amortized using the straight-line method of the estimated useful life of 17 years.

years ended December 31, 2020, the Company decided not to pursue certain patents in various countries for strategic reasons and recorded

abandonment charges which are included in research and development.

of patents and trademarks for each of the next five years is as follows:

Schedule of Amortization of Patents and Trademarks

Year Ending December 31,

(5) Accrued Expenses

expenses at December 31, 2021 and 2020 consist of the following:

Schedule of Accrued Expenses

(in thousands)

2 unchanged sentences

Other expenses

(7) Stockholders’

Stockholders’ Equity

Preferred Stock

Company is authorized to issue 5,000,000 shares of $0.01 par value preferred stock with such designations, rights and preferences

as may be determined by the Board of Directors.

Of our authorized preferred stock, 250,000 shares have been designated as Series

A Junior Participating Preferred Stock and 8,000 shares have been designated as Series B Convertible Preferred Stock.

B Convertible Preferred Stock has a stated value $1,000 per share.

Company is authorized to issue 5,000,000 shares of $ 0.01 par value preferred stock with such designations, rights and preferences as

may be determined by the Board of Directors.

Of our authorized preferred stock, 250,000 shares have been designated as Series A Junior

Participating Preferred Stock and 8,000 shares have been designated as Series B Convertible Preferred Stock.

The Series B Convertible

Preferred Stock has a stated value $ 1,000 per share.

Company is authorized to issue 8,000 Series B Convertible Preferred Stock, no par value, stated value $ 1,000 per share.

December 31, 2020, and December 31, 2019, the Company had 732 and 778 shares of Series B Convertible Preferred Stock outstanding,

respectively.

As of December

31, 2021, and December 31, 2020, the Company had 715 and 732 shares of Series B Convertible Preferred Stock outstanding, respectively.

Holders shall be entitled to receive, and the Company shall pay, dividends on shares of Series B Preferred Stock equal (on an as-if-converted-to-Common-Stock

basis) to and in the same form as dividend actually paid on shares of Common Stock when as and if such dividends are paid on shares of

the Common Stock.

Each such Preferred Share is convertible into 114 shares of common stock.

to a registration statement relating to a rights offering declared effective by the SEC on February 14, 2019, AIM distributed

to its holders of common stock and to holders of certain options and warrants as of February 14, 2019, at no charge, one non-transferable

subscription right for each share of common stock held or deemed held on the record date.

Each right entitled the holder to purchase

one unit, at a subscription price of $1,000 per unit, consisting of one share of Series B Convertible Preferred Stock with a face

value of $1,000 (and immediately convertible into common stock at an assumed conversion price of $8.80) and 114 warrants with

an assumed exercise price of $8.80.

Upon any liquidation, dissolution or winding-up

of the Company, whether voluntary or involuntary, the Holders shall be entitled to receive out of the assets, whether capital or surplus

of the Company the same amount that a holder of Common Stock would receive if the Preferred Stock was fully converted.

The Series B Convertible

Preferred Stock shall no voting Rights.

to a registration statement relating to a rights offering declared effective by the SEC on February 14, 2019, AIM distributed to its

holders of common stock and to holders of certain options and warrants as of February 14, 2019, at no charge, one non-transferable subscription

right for each share of common stock held or deemed held on the record date.

Each right entitled the holder to purchase one unit, at

a subscription price of $ 1,000 per unit, consisting of one share of Series B Convertible Preferred Stock with a face value of $ 1,000

(and immediately convertible into common stock at an assumed conversion price of $ 8.80 ) and 114 warrants with an assumed exercise price

The warrants are exercisable for five years after the date of issuance.

The net proceeds realized

from the rights offering were approximately $4,700,000.

During the twelve months ending December 31, 2020, 46 shares of Series

B Convertible Preferred Stock were converted into common stock.

The net proceeds realized from the rights offering

were approximately $ 4,700,000 .

During the twelve months ending December 31, 2021, 17 shares of Series B Convertible Preferred Stock were

converted into common stock.

Company has authorized shares of 350,000,000 with specific limitations and restrictions on the usage of 8,000,000 of the 350,000,000

authorized shares.

June 2019, the Company effected a 44-to-1 reverse stock split of the outstanding shares, in order to become compliant with the

NYSE regulations.

This did not affect the number of authorized shares.

All references herein to shares of common stock, options,

warrants and preferred stock have been adjusted to give effect to this reverse stock split.

July 7, 2020, the board of directors approved up to $500,000 for all directors, officers and employees to buy company shares from

the Company at the market price.

As of August 31, 2020, the Company has issued 10,730 shares of its common stock at a price of

$2.33 for a total of $25,000.

This plan expired September 10,2020.

September 4, 2020, the board of directors approved up to $500,000 for all directors, officers and employees to buy company shares

from the Company at the market price.

As of October 31, 2020, the Company has issued 12,316 shares of its common stock at a price

of $2.03 for a total of $25,000.

This plan expired November 1,2020.

November 5, 2020, the board of directors approved up to $500,000 for all directors, officers and employees to buy company shares

from the Company at the market price.

As of December 31, 2020, the Company has issued 14,435 shares of its common stock at a price

of $1.72 for a total of $25,000.

This plan expired January 2, 2021.

June 11, 2019, the board of directors approved up to $500,000 for all directors, officers and employees to buy company shares

July 7, 2020, the board of directors approved a plan pursuant to which all directors, officers, and employees could purchase from the

Company up to an aggregate of $ 500,000 worth of shares at the market price.

Pursuant to NYSE American rules, this plan was effective

for a sixty-day period commencing upon the date that the NYSE American approved the Company’s Supplemental Listing Application.

The Company issued 10,730 shares of its common stock at a price of $ 2.33 for a total of $ 25,000 under this plan.

When this plan expired,

the board of directors approved subsequent similar $ 500,000 plans for all directors, officers and employees to buy Company shares

from the Company at the market price.

As of June 28, 2019, the Company has issued 67,767 shares of its common stock at prices

between $4.03 and $4.37 for a total of $274,000.

This plan expired August 19, 2019.

September 27, 2019, the Company closed a public offering underwritten by A.G.P./Alliance Global Partners, LLC (the “Offering”)

Subsequent plans were approved by the board of directors upon the expiration of prior plans.

latest plan was approved by the board of directors on September 14, 2021.

the fiscal year ended December 31, 2020, the Company issued a total of 27,501 shares of its common stock at prices ranging from $ 1.72

to $ 2.03 for a total of $ 50,000 .

the twelve months ended December 31, 2021, the Company issued a total of 132,238 shares of its common stock at prices ranging from $ 1.16

to $ 2.35 for a total of $ 205,000 .

September 27, 2019, the Company closed a public offering underwritten by A.G.P./Alliance Global Partners, LLC (the “Offering”)

of (i) 1,740,550 shares of Common Stock;

(ii) pre-funded warrants exercisable for 7,148,310 shares of Common Stock (the “Pre-funded

Warrants”), and (iii) warrants to purchase up to an aggregate of 8,888,860 shares of Common Stock (the “Warrants”).

In conjunction with the Offering, a Representative’s Warrant to purchase up to an aggregate of 266,665 shares of common

stock (the “Representative’s Warrant”).

The shares of Common Stock and Warrants were sold at a combined Offering

price of $0.90, less underwriting discounts and commissions.

Each Warrant sold with the shares of Common Stock represents the

right to purchase one share of Common Stock at an exercise price of $0.99 per share.

The Pre-Funded Warrants and Warrants were

sold at a combined Offering price of $0.899, less underwriting discounts and commissions.

The Pre-Funded Warrants were sold to

purchasers whose purchase of shares of Common Stock in the Offering would otherwise result in the purchaser, together with its

affiliates and certain related parties, beneficially owning more than 4.99% of the Company’s outstanding Common Stock immediately

following the consummation of the Offering, in lieu of shares of Common Stock.

Each Pre-Funded Warrant represents the right to

purchase one share of Common Stock at an exercise price of $0.001 per share.

The Pre-Funded Warrants are exercisable immediately

and may be exercised at any time until the Pre-Funded Warrants are exercised in full.

A registration statement on Form S-1, relating

to the Offering was filed with the SEC and was declared effective on September 25, 2019, the net proceeds were approximately $7,200,000.

During the year ending December 31, 2020, 1,870,000 of the Pre-funded Warrants were exercised and 7,687,860

Warrants were exercised.

In addition, on March 25, 2020, the Representative’s Warrant was amended to permit

exercise of such warrant to commence on March 30, 2020.

These warrants were exercised on March 31, 2020 and an aggregate of 266,665

shares were issued upon exercise of this warrant for gross proceeds of approximately $264,000 and a $46,000 expense for the warrant

modification.

April 20, 2018, the Company entered into Securities Purchase Agreements (the “Purchase Agreements”) with certain investors

(the “Investors”) for the sale by the Company of an aggregate of 150,000 shares (the “Common Shares”)

of the Company’s Common Stock, par value $0.001 per share (the “Common Stock”), at a purchase price of $17.16

Concurrently with the sale of the Common Shares, pursuant to the Purchase Agreements the Company also sold 150,000

warrants, 50% of which are Class A Warrants and 50% of which are Class B Warrants (collectively, the “Warrants”).

The Company received gross proceeds from the sale of the Warrants solely to the extent such Warrants are exercised for cash.

classes of Warrants will not be exercisable until six months after issuance and will have an exercise price of $17.16 per share,

subject to adjustments as provided under the terms of the Warrants.

The Class A Warrants and Class B Warrants will expire, respectively,

two and five years after the date on which they are first exercisable.

The closing of the sales of these securities under the

Purchase Agreements took place on April 24, 2018.

The Company received net proceeds from the transactions of $2,343,820 after

deducting certain fees due to the placement agent and the Company’s transaction expenses.

May 2, 2019, the Company entered into an agreement with the holders of the August 23, 2017 and April 20, 2018 respectively.

The warrant exercise price was reduced to $6.60 and 103,410 warrants were exercised, reducing the liability attributed to the

warrants by approximately $404,000, and the Company realized about $682,000 in net proceeds, resulting in an addition to

stockholders’

equity of approximately $1,086,000.

November 27, 2017, the Company reactivated its equity distribution agreement (the “EDA”) with Maxim Group LLC (“Maxim”).

During the year ended December 31, 2019, the Company sold an aggregate of 49,463 shares under the EDA for proceeds of $827,000

net of $25,000 in commissions.

July 19, 2019, the Company entered into a new Equity Distribution Agreement (the “2019 EDA”) with Maxim, pursuant

to which it could sell from time to time, shares of its Common Stock through Maxim, as agent (the “Offering”).

2019 EDA replaced the EDA with Maxim.

(ii) pre-funded warrants exercisable for 7,148,310 shares of Common Stock (the “Pre-funded

Warrants”), and (iii) warrants to purchase up to an aggregate of 8,888,860 shares of Common Stock (the “Warrants”).

In conjunction with the Offering, a Representative’s Warrant to purchase up to an aggregate of 266,665 shares of common stock (the

“Representative’s Warrant”).

The shares of Common Stock and Warrants were sold at a combined Offering price of $ 0.90 ,

less underwriting discounts and commissions.

Each Warrant sold with the shares of Common Stock represents the right to purchase one share

of Common Stock at an exercise price of $ 0.99 per share.

The Pre-Funded Warrants and Warrants were sold at a combined Offering price

of $ 0.899 , less underwriting discounts and commissions.

The Pre-Funded Warrants were sold to purchasers whose purchase of shares of Common

Stock in the Offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially

owning more than 4.99% of the Company’s outstanding Common Stock immediately following the consummation of the Offering, in lieu

of shares of Common Stock.

Each Pre-Funded Warrant represents the right to purchase one share of Common Stock at an exercise price of

$0.001 per share.

The Pre-Funded Warrants are exercisable immediately and may be exercised at any time until the Pre-Funded Warrants

are exercised in full.

A registration statement on Form S-1, relating to the Offering was filed with the SEC and was declared effective

on September 25, 2019, the net proceeds were approximately $ 7,200,000 .

During the year ending December 31, 2020, 1,870,000 of the Pre-funded

Warrants were exercised and 8,873,960 Warrants were exercised.

In addition, on March 25, 2020, the Representative’s Warrant was

amended to permit exercise of such warrant to commence on March 30, 2020.

These warrants were exercised on March 31, 2020 and an aggregate

of 266,665 shares were issued upon exercise of this warrant for gross proceeds of approximately $ 264,000 and a $ 46,000 expense for the

warrant modification.

As of December 31, 2021, there are 15,000 Warrants outstanding.

July 19, 2019, the Company entered into a new Equity Distribution Agreement (the “2019 EDA”) with Maxim Group LLC (“Maxim”),

pursuant to which it could sell, from time to time, shares of its Common Stock through Maxim, as agent (the “Offering”).

The 2019 EDA replaced a prior EDA with Maxim.

For the year ended December 31, 2020, the Company sold 20,444,807 shares under the 2019

EDA for total gross proceeds of $ 53,936,615 , which includes a 3.5 % fee to Maxim of $ 1,888,727 .

2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory

Stock Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance

Stock Awards, (vii) Performance Cash Awards, and (viii) Other Stock Awards.

Initially, a maximum of 7,000,000 shares of Common

Stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan.

Unless sooner terminated, the

2018 Equity Incentive Plan will continue in effect for a period of 10 years from its effective date.

On October 17, 2018, the

Board of Directors issued 26,324 options to the officers and directors at the exercise price of $9.68 expiring in 10 years, and

on November 14, 2018, the Board of Directors issued 23 options to each employee, officer and director at the exercise price of

$9.68 expiring in ten years.

On January 28, 2019, 27,570 options were issued to each of these officers with an exercise price

of $9.68 for a period of ten years with a vesting period of one year.

In August 2020, 400,000 options were issued to each of these

officers with an exercise price range of $2.77 to $3.07 for a period of ten years with a vesting period of one year.

December 2020, 675,000 options were issued to employees with an exercise price range of $1.85 to $1.96 for a period of ten years

with a vesting period of one year.

During the period ended December 31, 2021,

the Company sold 5,665,731 shares under the 2019 EDA for total gross proceeds of $ 13,301,526 , which includes a 3.5 % fee to Maxim of $ 465,533 .

The 2019 EDA was terminated in early February 2021.

2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory Stock

Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance Stock Awards,

(vii) Performance Cash Awards, and (viii) Other Stock Awards.

Initially, a maximum of 7,000,000 shares of Common Stock is reserved for

potential issuance pursuant to awards under the 2018 Equity Incentive Plan.

Unless sooner terminated, the 2018 Equity Incentive Plan

will continue in effect for a period of 10 years from its effective date.

On October 17, 2018, the Board of Directors issued 26,324 options

to the officers and directors at the exercise price of $ 9.68 expiring in 10 years, and on November 14, 2018, the Board of Directors issued

23 options to each employee, officer and director at the exercise price of $ 9.68 expiring in ten years .

On January 28, 2019, 27,570 options

were issued to each of these officers with an exercise price of $ 9.68 for a period of ten years with a vesting period of one year .

August 2020, 400,000 options were issued to each of these officers with an exercise price range of $ 2.77 to $ 3.07 for a period of ten

years with a vesting period of one year .

During fourth quarter of 2021, 613,512 options were issued to employees with an exercise price

range of $ 1.11 to $ 1.71 for a period of ten years with a vesting period of one year .

During December 2020, 675,000 options were issued

to employees with an exercise price range of $ 1.85 to $ 1.96 for a period of ten years with a vesting period of one year .

of December 31, 2021, and 2020, there were 47,994,672 and 42,154,371 shares outstanding, respectively.

2 unchanged sentences

Stock Options

Equity Incentive Plan of 2009, effective June 24, 2009, as amended, authorizes the grant of non-qualified and incentive stock

options, stock appreciation rights, restricted stock and other stock awards.

A maximum of 22,000,000 shares of common stock is

reserved for potential issuance pursuant to awards under the Equity Incentive Plan of 2009.

Unless sooner terminated, the Equity

Incentive Plan of 2009 will continue in effect for a period of 10 years from its effective date.

2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory

Stock Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance

Stock Awards, (vii) Performance Cash Awards, and (viii) Other Stock Awards.

Initially, a maximum of 7,000,000 shares of common

stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan.

Unless sooner terminated, the

2018 Equity Incentive Plan will continue in effect for a period of 10 years from its effective date.

On October 17, 2018, the

Board of Directors issued 26,234 options to the officers and directors at the exercise price of $9.68 expiring in 10 years, and

on November 14, 2018, the Board of Directors issued 23 options to each employee, officer and director at the exercise price of

$9.68 expiring in ten years.

On January 28, 2019, 27,570 options were issued to each of these officers with an exercise price

of $9.68 for a period of ten years with a vesting period of one year.

Equity Incentive Plan of 2009, effective June 24, 2009, as amended, authorizes the grant of non-qualified and incentive stock options,

stock appreciation rights, restricted stock and other stock awards.

A maximum of 22,000,000 shares of common stock is reserved for potential

issuance pursuant to awards under the Equity Incentive Plan of 2009.

Unless sooner terminated, the Equity Incentive Plan of 2009 will

continue in effect for a period of 10 years from its effective date.

2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory Stock

Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance Stock Awards,

(vii) Performance Cash Awards, and (viii) Other Stock Awards.

Initially, a maximum of 7,000,000 shares of common stock is reserved for

potential issuance pursuant to awards under the 2018 Equity Incentive Plan.

Unless sooner terminated, the 2018 Equity Incentive Plan

will continue in effect for a period of 10 years from its effective date.

On October 17, 2018, the Board of Directors issued 26,234 options

to the officers and directors at the exercise price of $ 9.68 expiring in 10 years, and on November 14, 2018, the Board of Directors issued

23 options to each employee, officer and director at the exercise price of $ 9.68 expiring in ten years.

On January 28, 2019, 27,570 options

were issued to each of these officers with an exercise price of $ 9.68 for a period of ten years with a vesting period of one year.

Equity Incentive Plans of 2009 and 2018 are administered by the Board of Directors.

The Plans provide for awards to be made to

such Officers, other key employees, non-employee Directors, consultants and advisors of the Company and its subsidiaries as the

Board may select.

options awarded under the Plans may be exercisable at such times (not later than 10 years after the date of grant) and at such

exercise prices (not less than fair market value at the date of grant) as the Board may determine.

The Board may provide for options

to become immediately exercisable upon a “change in control”, which is defined in the Plans to occur upon any of the

following events:

(a) the acquisition by any person or group, as beneficial owner, of 20% or more of the outstanding shares or

the voting power of the outstanding securities of the Company;

(b) either a majority of the Directors of the Company at the annual

stockholders meeting has been nominated other than by or at the direction of the incumbent Directors of the Board, or the incumbent

Directors cease to constitute a majority of the Company’s Board;

other business combination pursuant to which the outstanding common stock of the Company no longer represents more than 50% of

the combined entity after the transaction;

(d) the Company’s stockholders approve a plan of complete liquidation or an agreement

for the sale or disposition of all or substantially all of the Company’s assets;

or (e) any other event or circumstance

determined by the Company’s Board to affect control of the Company and designated by resolution of the Board as a change

The Plans provide for awards to be made to such Officers,

other key employees, non-employee Directors, consultants and advisors of the Company and its subsidiaries as the Board may select.

options awarded under the Plans may be exercisable at such times (not later than 10 years after the date of grant) and at such exercise

prices (not less than fair market value at the date of grant) as the Board may determine.

The Board may provide for options to become

immediately exercisable upon a “change in control”, which is defined in the Plans to occur upon any of the following events:

(a) the acquisition by any person or group, as beneficial owner, of 20% or more of the outstanding shares or the voting power of the

outstanding securities of the Company;

(b) either a majority of the Directors of the Company at the annual stockholders meeting has been

nominated other than by or at the direction of the incumbent Directors of the Board, or the incumbent Directors cease to constitute a

majority of the Company’s Board;

which the outstanding common stock of the Company no longer represents more than 50% of the combined entity after the transaction;

the Company’s stockholders approve a plan of complete liquidation or an agreement for the sale or disposition of all or substantially

all of the Company’s assets;

or (e) any other event or circumstance determined by the Company’s Board to affect control of

the Company and designated by resolution of the Board as a change in control.

fair value of each option award is estimated on the date of grant using a Black-Scholes-Merton pricing option valuation model.

Expected volatility is based on the historical volatility of the price of the Company’s stock.

The risk-free interest rate

is based on U.S.

volatility is based on the historical volatility of the price of the Company’s stock.

The risk-free interest rate is based on U.S.

Treasury issues with a term equal to the expected life of the option and equity warrant.

The Company uses historical

data to estimate expected dividend yield, life and forfeiture rates.

The expected life of the options and equity warrants was

estimated based on historical option and equity warrant holders’

behavior and represents the period of time that options

and equity warrants are expected to be outstanding.

The fair values of the options and equity warrants granted were estimated

based on the following weighted average assumptions:

Year Ended December 31,

Risk-free interest rate

0.3% - 0.46 %

Expected dividend yield

Expected life

Expected volatility

115.24% - 116.79 %

Weighted average grant date fair value for options and equity warrants issued

The Company uses historical data to estimate

expected dividend yield, life and forfeiture rates.

The expected life of the options and equity warrants was estimated based on historical

option and equity warrant holders’ behavior and represents the period of time that options and equity warrants are expected to be outstanding.

The fair values of the options granted were estimated based on the following weighted average assumptions:

Schedule of Options and Equity Estimated Based on Weighted Average Assumptions

Ended December 31,

interest rate

dividend yield

average grant date fair value for options issued

per option for 613,512 options

4 unchanged sentences

The plan expired June 24, 2019:

Schedule of Stock Option Activity

Outstanding, beginning of year

13.20 –

13.20 – 2,127.84

13.20 –

13.20 - 2,127.84

16.76 - 1056.00

9.68 – 380.16

Outstanding, end of year

3 unchanged sentences

13.20 - 2,127.84

13.20 –

13.20 – 2,127.84

Weighted average remaining contractual life (years)

regarding the options approved by the Board of Directors under the Equity Plan of 2018 is summarized below:

Schedule of Stock Option Activity

Outstanding, beginning of year

5 unchanged sentences

option activity for employees

of Stock Option Activity

Outstanding December 31, 2019

3 unchanged sentences

Exercisable at December 31, 2021

weighted-average grant-date fair value of employee options granted during the year 2020 was $2,110,250 for 925,000 options at

$2.28 per option and during year 2019 was $267,000 for 27,570 options at $9.68 per option.

weighted-average grant-date fair value of employee options granted during the year 2021 was $ 801,000 for 500,000 options at $ 1.60 per

option and during year 2020 was $ 2,110,250 for 925,000 options at $ 2.28 per option.

stock option activity for employees:

of Unvested Stock Option Activity

Unvested December 31, 2019

2 unchanged sentences

option activity for non-employees during the year:

of Stock Option Activity

Outstanding December 31, 2019

3 unchanged sentences

Exercisable at December 31, 2021

weighted-average grant-date fair value of non-employee options granted during year 2020 was $277,000 for 100,000 options at $2.77

per option and during the year 2019 was $113,000 for 11,697 options at $9.68 per option.

weighted-average grant-date fair value of non-employee options granted during year 2021 was $ 181,161 for 109,154 options at $ 1.66 per

option and during the year 2019 was $ 277,000 for 1000,000 options at $ 2.77 per option.

stock option activity for non-employees:

of Unvested Stock Option Activity

Unvested December 31, 2019

1 unchanged sentence

Unvested December 31, 2021

compensation expense was approximately $1,036,000 and $853,000 for the years ended December 31, 2020, and 2019 resulting in an

increase in general and administrative expenses and loss per share of $0.03 and $0.23, respectively.

of December 31, 2020, and 2019, there was $1,599,000 and $696,000, respectively, of unrecognized stock-based compensation cost

related to options granted under the Equity Incentive Plans.

Stock-based compensation related to options granted under the Equity

Incentive Plans will be recorded over the vesting period which is typically one year or upon reaching agreed upon company and/or

individual performance milestones being met which is indefinite.

compensation expense was approximately $ 1,568,000 and $ 1,036,000 for the years ended December 31, 2021, and 2020 resulting in an increase

in general and administrative expenses and loss per share of $0.03 and $0.03, respectively.

of December 31, 2021, and 2020, there was $ 779,000 and $ 1,599,000 , respectively, of unrecognized stock-based compensation cost related

to options granted under the Equity Incentive Plans.

Stock-based compensation related to options granted under the Equity Incentive Plans

will be recorded over the vesting period which is typically one year or upon reaching agreed upon Company and/or individual performance

milestones being met which is indefinite.

Stock Warrants

1 unchanged sentence

fair value of each warrant award is estimated on the date of grant using a Black-Scholes-Merton pricing option valuation model.

Expected volatility is based on the historical volatility of the price of the Company’s stock.

The risk-free interest rate

is based on U.S.

volatility is based on the historical volatility of the price of the Company’s stock.

The risk-free interest rate is based on U.S.

Treasury issues with a term equal to the expected life of the warrant.

The Company uses historical data to estimate

expected dividend yield, life and forfeiture rates.

The expected life of the warrants was estimated based on historical option

holder’s behavior and represents the period of time that options are expected to be outstanding.

There were 16,907,471

granted in 2019 at $0.99 - $8.80 per warrant.

No warrants were granted in 2020.

The Company uses historical data to estimate expected dividend

yield, life and forfeiture rates.

The expected life of the warrants was estimated based on historical option holder’s behavior

and represents the period of time that options are expected to be outstanding.

There were 16,907,471 granted in 2019 at $ 0.99 - $ 8.80

No warrants were granted in 2021 or 2020.

regarding warrants outstanding and exercisable into shares of common stock is summarized below:

Weighted Average Exercise Price

of Warrants Outstanding and Exercisable

Outstanding, beginning of year

$ .909 –

$ 0.99 – 469.92

17.16 – 84.48

( 9,826,661 )

Outstanding, end of year

1 unchanged sentence

$ 0.99 – 469.92

$ 0.90 –

$ 0.99 - 469.92

$ 0.99 – 469.92

Weighted average remaining contractual life

1 unchanged sentence

warrants are issued at the discretion of the Board.

In 2020 there were no warrants issued and in 2019, there were 16,907,471 warrants

issued at a weighted average price of $1.23.

9,826,661 warrants were exercised in 2020 and 7,030,582 were exercised

and Related Information

Company operates in one segment, which performs research and development activities related to Ampligen and other drugs under

The Company’s revenues for the two-year period ended December 31, 2020, were earned in the United States and

All assets are maintained in the United States of America.

In 2021 and 2020 there were no warrants issued and 568 warrants were exercised in

2021 and 9,826,661 were exercised in 2020.

Segment and Related Information

Company operates in one segment, which performs research and development activities related to Ampligen and other drugs under development.

The Company’s revenues for the two-year period ended December 31, 2021, were earned in the United States and overseas.

are maintained in the United States of America.

(8) Research,

Consulting and Supply Agreements

2016, the Company entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V.

(“myTomorrows”),

a Netherlands based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”)

related to ME/CFS.

Pursuant to the agreement, myTomorrows, as the exclusive service provider and distributor in the Territory,

is performing EAP activities.

HollisterStier (Jubilant) is AIM’s authorized CMO for Ampligen for the approval in Argentina.

In 2017, the Company entered

into a purchase order with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen®

for the Company.

the 2017 engagement of Jubilant, four lots of Ampligen consisting of more than 16,000 units have been manufactured and released

in year 2018.

The first lot was designated for human use in the US in the cost recovery CFS program and for expanded oncology

clinical trials.

The second lot has been designated for these programs in addition to commercial distribution in Argentina for

the treatment of CFS.

We paid Jubilant $320,000 in 2017 and $1,078,000 in 2018 for a total of $1,398,000 to date for these services.

In 2019, the Company entered into a purchase order with Jubilant pursuant to which Jubilant will manufacture two additional batches

of Ampligen for the Company.

Two commercial size batches will be filled and finished for human use in early 2020.

paid Jubilant $383,320 in 2019 to date for these services.

production of additional polymer (Ampligen intermediates) took place in 2019 at the Company’s New Brunswick facility.

2016, the Company entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V.

(“myTomorrows”),

a Netherlands based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related

Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in the Territory, is performing

EAP activities.

The agreement was automatically extended for a period of 12 months on May 20, 2021, and will automatically extend for

an additional period of 12 months on May 20, 2022.

HollisterStier (Jubilant) is AIM’s authorized CMO for Ampligen for the approval in Argentina.

In 2017, the Company entered into

a purchase order with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for the Company.

Since the 2017 engagement

of Jubilant, four lots of Ampligen consisting of more than 16,000 units have been manufactured and released in year 2018.

The first lot

was designated for human use in the US in the cost recovery CFS program and for expanded oncology clinical trials.

The second lot has

been designated for these programs in addition to commercial distribution in Argentina for the treatment of CFS.

production of additional polymer (Ampligen intermediates) took place in 2019 at the Company’s New Brunswick facility.

Additionally,

two lots of Ampligen were manufactured in December 2019 and January 2020 at Jubilant.

The current manufactured lots of Ampligen

have been fully tested and released for commercial product launch in Argentina and for clinical trials.

The current manufactured lots of Ampligen have

been fully tested and released for commercial product launch in Argentina and for clinical trials.

August 2020, we contracted Amarex Clinical Research LLC (“Amarex”) to act as our Clinical Research Organization and provide

regulatory support with regard to a possible clinical trial testing Ampligen’s potential as a COVID-19 prophylaxis via intranasal

delivery, and for the development of Ampligen as a therapy for pancreatic cancer.

For the year ended December 31, 2021, and

for the year ended December 31, 2020 the Company

has incurred an expense and paid Amarex approximately $ 437,000

and $ 205,000 ,

respectively.

December 2020, AIM added Pharmaceutics International Inc.

(“Pii”) as a “Fill & Finish”

enhance the Company’s capacity to produce the drug Ampligen.

This addition amplifies AIM’s manufacturing capability

by providing redundancy and cost savings.

The contracts augment AIM’s existing fill and finish capacity.

to in the Master Services Agreement, the terms of each of AIM’s projects with Pii will be negotiated separately and defined

in individual Service Contracts.

Company has a defined contribution plan, entitled the AIM ImmunoTech Employees 401(k) Plan and Trust Agreement (the “401(k)

Plan”).

(“Pii”) as a “Fill & Finish” provider to enhance

the Company’s capacity to produce the drug Ampligen.

This addition amplifies AIM’s manufacturing capability by providing

redundancy and cost savings.

The contracts augment AIM’s existing fill and finish capacity.

As agreed to in the Master Services

Agreement, the terms of each of AIM’s projects with Pii will be negotiated separately and defined in individual Service Contracts.

As of December 31, 2021, the Company has incurred an expense and paid Pii approximately $ 249,000 .

January 2021, the Company entered into a Sponsor Agreement with the Centre for Human Drug Research (“CHDR”) for a Phase 1

clinical study to assess the safety, tolerability, and biological activity of Ampligen as a potential intranasal therapy.

As of December

31, 2021, the Company has incurred an expense and paid CHDR approximately $ 1,010,000 .

The balance of the agreement is approximately $ 58,000 .

April 2021, the Company approved a proposal from Polysciences Inc.

(“Polysciences”) for the manufacture of our Poly I and

Poly C12U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce

the polymer precursors to the drug Ampligen.

We are working with Polysciences to negotiate and finalize both a Service Agreement and

a Quality Agreement.

For the year ended December 31, 2021 the

Company has incurred an expense

and paid Polysciences approximately $ 250,000 .

July 2021, the Company executed a Reservation and Start-Up Agreement (the “Agreement”) with hVIVO Services Limited (“hVIVO”),

and subsequently signed a clinical trial agreement (“CTA”) in September.

As of December 3, 2021, the Company has incurred

an expense and paid hVIVO approximately $ 2,340,000

for services incurred in 2021.

In March 2022, the Company announced that it had officially withdrawn its application from the Medicines and Healthcare Regulatory Agency

and terminated its agreement with hVIVO and incurred a cancelation fee of $ 61,000

to be paid in the first quarter

Company has a defined contribution plan, entitled the AIM ImmunoTech Employees 401(k) Plan and Trust Agreement (the “401(k) Plan”).

Full time employees of the Company are eligible to participate in the 401(k) Plan following one year of employment.

Subject to certain limitations imposed by federal tax laws, participants are eligible to contribute up to 15% of their salary

(including bonuses and/or commissions) per annum.

Participants’

contributions to the 401(k) Plan may be matched by the Company

at a rate determined annually by the Board of Directors.

participant immediately vests in his or her deferred salary contributions, while Company contributions will vest over one year.

A 6% Company matching contribution was established, effective as of January 1, 2010 through December 31, 2015.

As of January 1,

2016, the matching has been terminated.

For 2020 and 2019, the Company made no contributions towards the 401(k) Plan in these

(11) Royalties,

License and Employment Agreements

Company had contractual agreements with Named Executive Officers, exclusive of Mr.

Pascale, who retired in September 2019, (“Officers”)

in 2020, and 2019.

The aggregate annual base compensation for these Officers under their respective contractual agreements for

2020, and 2019 was $ 850,000, and $750,000, respectively.

In addition, certain of these Officers were entitled to receive performance

bonuses of up to 25% or 20% of their respective annual base salary, at the sole discretion of the Compensation Committee of the

Board of Directors.

In 2020 and 2019, Officers’

bonuses were $913,500 and $0 respectively.

Subject to certain

limitations imposed by federal tax laws, participants are eligible to contribute up to 15 % of their salary (including bonuses and/or

commissions) per annum.

Participants’ contributions to the 401(k) Plan may be matched by the Company at a rate determined annually by

the Board of Directors.

Each participant immediately

vests in his or her deferred salary contributions, while Company contributions will vest over one year.

A 6 % Company matching contribution

was reinstated effective January 1, 2021.

For the period ending December 31, 2021 the Company made $ 139,000 in contributions and for

the period ending December 31, 2020 zero contributions were made

Employment Agreements

Company had contractual agreements with Named Executive Officers, (“NEO”) in 2021, and 2020.

The aggregate annual base compensation

for these NEO under their respective contractual agreements for 2021, and 2020 was $ 1,625,000 , and $ 850,000 , respectively.

certain of these Officers were entitled to receive performance bonuses of up to 25 % or 20 % of their respective annual base salary, at

the sole discretion of the Compensation Committee of the Board of Directors.

In 2021 and 2020, Officers’ bonuses were $ 550,000

and $ 913,500 respectively.

2021, equity was granted as a form of compensation to these Officers.

The Company granted 300,000 ten-year options to purchase

common stock with exercise prices of $3.05 per share to vest in a year to Thomas K.

Equels, Chief Executive Officer.

The Company granted 300,000 ten-year options to purchase

common stock with exercise prices of $1.96 per share to vest in a year to Thomas K.

Company granted 300,000 ten -year options to purchase common stock with exercise prices of

$ 1.71 per share to vest in a year to Thomas K.

Equels, Chief Executive Officer.

The Company granted 75,000 ten-year options to purchase common

stock with exercise prices of $1.85 per share which vest in one year to Peter Rodino, Chief Operating Officer and General

The Company granted 75,000 ten-year options to purchase common

stock with exercise prices of $1.85 per share which vest in one year to Ellen Lintal, Chief Financial Officer.

Company granted 100,000 ten -year options to purchase common stock with exercise prices of

$ 1.44 per share which vest in one year to Peter Rodino, Chief Operating Officer and General

Company granted 100,000 ten -year options to purchase common stock with exercise prices of

$ 1.44 per share which vest in one year to Ellen Lintal, Chief Financial Officer.

Company recorded stock compensation expense of approximately $ 105,000 during the year ended December 31, 2021.

with regard to these issuances.

2020, equity was granted as a form of compensation to these Officers.

Company granted 9,685 ten-year options to purchase common stock with exercise prices of $9.68 per share to vest in a year

Company granted 300,000 ten -year options to purchase common stock with exercise prices of

$ 3.05 per share to vest in a year to Thomas K.

Equels, Chief Executive Officer.

Company granted 4,520 ten-year options to purchase common stock with exercise prices of $9.68 per share which vest in one

year to Peter Rodino, Chief Operating Officer and General Counsel.

Company granted to Thomas K.

Equels, Chief Executive Officer, 97,500 shares of Restricted Stock Awards with an exercise price

ranging from $0.40 to $0.55 per share which vest in 6 months, for 25% cut in salary.

Company granted to Peter Rodino, Chief Operating Officer General Counsel, 45,500 Restricted Stock Awards with an exercise

price ranging from $0.40 to $0.55 per share which vest in 6 months, for 25% cut in salary.

Company granted to Ellen M.

Lintal, Chief Financial Officer, 22,528 shares of Restricted Stock Awards with an exercise price

ranging from $0.40 to $0.55 per share which vest in 6 months, for 25% cut in salary.

Company recorded stock compensation expense of approximately $433,000 and $118,000 during the years ended December 31,

2020 and 2019 respectively with regard to these issuances.

February 2016, the FASB established Topic 842, Leases, by issuing ASU No.

2016-02, which requires lessees to recognize leases

on-balance sheet and disclose key information about leasing arrangements.

Topic 842 was subsequently amended by ASU No.

Land Easement Practical Expedient for Transition to Topic 842;

2018-10, Codification Improvements to Topic 842, Leases;

2018-11, Targeted Improvements;

2018-20, Narrow-Scope Improvements for Lessors.

The new standard establishes

a right-of-use model (ROU) that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases

with a term longer than 12 months.

Leases will be classified as finance or operating, with classification affecting the pattern

and classification of expense recognition in the income statement.

new standard was effective for the Company on January 1, 2019, with early adoption permitted.

A modified retrospective transition

approach was required, applying the new standard to all leases existing at the date of initial application.

An entity may choose

to use either (1) its effective date or (2) the beginning of the earliest comparative period presented in the financial statements

as its date of initial application.

If an entity chooses the second option, the transition requirements for existing leases also

apply to leases entered into between the date of initial application and the effective date.

The entity must also recast its comparative

period financial statements and provide the disclosures required by the new standard for the comparative periods.

adopted the new standard on January 1, 2019 and used the effective date as the date of initial application.

new standard provides several optional practical expedients in transition.

The Company elected the ‘package of practical

expedients’, which permits it not to reassess under the new standard our prior conclusions about lease identification, lease

classification and initial direct costs.

The Company elected all the new standard’s available transition practical expedients

other than the use-of hindsight.

new standard also provides practical expedients for an entity’s ongoing accounting.

The Company elected the short-term lease

recognition exemption for all leases that qualify.

This means, for those leases that qualify, it will not recognize ROU assets

or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those

assets in transition.

The Company also elected the practical expedient to not separate lease and non-lease components for leases

of office equipment.

standard had a material effect on the Company’s financial statements.

The most significant effect related to the

recognition of new ROU assets and lease liabilities on the balance sheet for real estate and equipment operating leases and providing

significant new disclosures about the Company’s leasing activities.

Company entered into a Lease Agreement for a term of five years commencing on September 14, 2020 with Fraser Advanced Information

Systems, pursuant to which the Company agreed to lease two Sharp copiers.

Company granted 300,000 ten -year options to purchase common stock with exercise prices of

$ 1.96 per share to vest in a year to Thomas K.

Equels, Chief Executive Officer.

Company granted 75,000 ten -year options to purchase common stock with exercise prices of

$ 1.85 per share which vest in one year to Peter Rodino, Chief Operating Officer and General

Company granted 75,000 ten -year options to purchase common stock with exercise prices of

$ 1.85 per share which vest in one year to Ellen Lintal, Chief Financial Officer.

Company recorded stock compensation expense of approximately $ 374,000 during the years ended December 31, 2020 with regard to these issuances.

Company leases office and storage space, and other equipment under non-cancellable operating leases with initial terms typically ranging

from 1 to 5 years.

At contract inception, the Company reviews the facts and circumstances of the arrangement to determine if the contract

is or contains a lease.

The Company follows the guidance in Topic 842 “ Leases ” to evaluate whether the contract has

an identified asset;

if the Company has the right to obtain substantially all economic benefits from the asset;

and if the Company has

the right to direct the use of the underlying asset.

When determining if a contract has an identified asset, the Company considers both

explicit and implicit assets, and whether the supplier has the right to substitute the asset.

When determining if the Company has the

right to direct the use of an underlying asset, the Company considers if it has the right to direct how and for what purpose the asset

is used throughout the period of use and if it controls the decision-making rights over the asset.

Company’s lease terms may include options to extend or terminate the lease.

The Company exercises judgment to determine the term

of those leases when extension or termination options are present and include such options in the calculation of the lease term when

it is reasonably certain that it will exercise those options.

Company has elected to include both lease and non-lease components in the determination of lease payments.

Payments made to a lessor

for items such as taxes, insurance, common area maintenance, or other costs commonly referred to as executory costs, are also included

in lease payments if they are fixed.

The fixed portion of these payments are included in the calculation of the lease liability, while

any variable portion would be recognized as variable lease expenses, when incurred.

Variable payments made to third parties for these,

or similar costs, such as utilities, are not included in the calculation of lease payments.

lease commencement, lease-related assets and liabilities are measured at the present value of future lease payments over the lease term.

As most of the Company’s leases do not provide an implicit rate, the Company exercises judgment in determining the incremental

borrowing rate based on the information available when the lease commences to measure the present value of future payments.

leases are included in other assets, current operating lease obligations, and operating lease obligations (less current portion) on the

Company’s consolidated balance sheet.

Short term leases with an initial term of 12 months or less are not presented on the balance

sheet with expense recognized as incurred.

Company entered into a Lease Agreement for a term of five years commencing on September 14, 2020 pursuant to which the Company agreed

to lease two Sharp copiers.

The base of $ 1,415 per month.

June 13, 2018, the Company entered into a Lease Agreement for a term of six years commencing on July 1, 2018 with SML FL Holdings

LLC, pursuant to which the Company agreed to lease approximately 3,000 rentable square feet.

The base rent increases by 3% each

year, and ranges from $2,100 per month for the first year to $2,785 per month for the sixth year.

May 1, 2019, the Company entered into a Lease Agreement for a term of three years commencing on May 1, 2019 with 604 Associates

LLC, pursuant to which the Company agreed to lease approximately 3,000 rentable square feet.

The base rent is $1,500 per month

for the term of the lease.

expected lease term includes both contractual lease periods and, when applicable, cancelable option periods when it is reasonably

certain that the Company would exercise such options.

The Company’s leases have remaining lease terms between 6 months and

As of December 31, 2020, the weighted-average remaining term is 1.92 years.

Company has determined that the incremental borrowing rate is 10% as of December 31, 2020 based upon the recently completed financing

transaction in December 2019.

June 13, 2018, the Company entered into a Lease Agreement for a term of six years commencing on July 1, 2018 pursuant to which the Company

agreed to lease approximately 3,000 rentable square feet.

The base rent increases by 3 % each year, and ranges from $ 2,100 per month for

the first year to $ 2,785 per month for the sixth year.

May 1, 2019, the Company entered into a Lease Agreement for a term of three years commencing on May 1, 2019 , pursuant to which the Company

agreed to lease approximately 3,000 rentable square feet.

The base rent is $ 1,500 per month for the term of the lease.

On October 4,

2021, the Company executed a request to renew the lease for a one-year term as defined in the Lease Agreement.

expected lease term includes both contractual lease periods and, when applicable, cancelable option periods when it is reasonably certain

that the Company would exercise such options.

The Company’s leases have remaining lease terms between 4

As of December 31, 2021,

and 2020, the weighted-average remaining term is 2.72 and 1.92 years, respectively.

Company has determined that the incremental borrowing rate is 10 %

as of December 31, 2021, and 2020, respectively, based upon the recently completed financing transaction in December

Schedule of Operating lease Future Payments

Year Ending December 31,

Less imputed interest

of December 31, 2020, the balance of the right of use assets was $179,000 and the corresponding lease liability balance was $179,000.

The total rent expense for the years ended December 31, 2020 and 2019 amounted to approximately $53,000 and $59,000, respectively.

The total short term rent expense for the years ended December 31, 2020 and 2019 amounted to approximately $34,000 and $23,000,

As of December 31, 2021,

and 2020, the balance of the right of use assets was $ 149,000 and $ 179,000 , respectively, and the corresponding lease liability balance

was $ 149,000 and $ 179,000 , respectively.

The total rent expense for the years ended December 31, 2021, and 2020 amounted to approximately

$ 67,000 and $ 53,000 ,

respectively.

Taxes (FASB ASC 740 Income Taxes)

Company’s applies the provisions of FASB ASC 740-10 Uncertainty in Income Taxes.

As a result of the implementation,

there has been no material change to the Company’s tax positions as they have not paid any corporate income taxes due to

operating losses.

With the exception of net operating losses and research and development credits generated in New Jersey, all

tax benefits will likely not be recognized due to the substantial net operating loss carryforwards which will most likely not

be realized prior to expiration.

of December 31, 2020, the Company has approximately $180.8M of Federal net operating loss carryforwards (expiring in the years

2021 through 2038) and $33.7M of Federal net operating loss with no expiration date available to offset future federal taxable

The Company also has approximately $13.1M of New Jersey state net operating loss carryforwards (expiring in 2041) available

to offset future state taxable income and net operating loss carryforwards in Belgium of approximately $2.8M with no expiration.

In December 2020, the Company effectively sold $10,000,000 of its New Jersey state net operating loss carryforward for

the year 2019 for approximately $1,090,000.

In December 2019, the Company effectively sold $8,000,000 of its New Jersey state

net operating loss carryforward for the year 2018 for approximately $776,000.

Total rent expense for short term leases for the years ended December 31, 2021, and 2020 amounted to approximately $ 12,000

and 11,000 , respectively.

(12) Income Taxes (FASB ASC 740 Income Taxes)

Company applies the provisions of FASB ASC 740-10 Uncertainty in Income Taxes.

As a result of the implementation, there has been no material

change to the Company’s tax positions as they have not paid any corporate income taxes due to operating losses.

With the exception of

net operating losses and research and development credits generated in New Jersey, all tax benefits will likely not be recognized due

to the substantial net operating loss carryforwards which will most likely not be realized prior to expiration.

of December 31, 2021, the Company has approximately $ 237.6 M

of Federal net operating loss carryforwards (expiring in the years 2022 through 2038), the use of which has been limited by IRC Section

382 and $ 56.4 M

of Federal net operating loss with no expiration date available to offset future federal taxable income.

The Company has approximately

of New Jersey state net operating loss carryforwards ( expiring

The Company has approximately

of Florida state net operating loss carryforwards with no expiration date to offset future Florida taxable income.

The Company has approximately

of Belgium net operating loss carryforwards with no expiration date to offset future taxable income.

In December 2021, the Company effectively

sold $ 19,600,000

of its New Jersey state net operating

loss carryforward for the year 2020 for approximately $ 1,641,000 .

In December 2020, the Company effectively

sold $ 10,000,000

of its New Jersey state net operating

loss carryforward for the year 2019 for approximately $ 1,090,000 .

utilization of certain state net operating loss carryforwards may be subject to annual limitations.

With no tax due for the foreseeable

future, the Company has determined that a policy to determine the accounting for interest or penalties related to the payment

of tax is not necessary at this time.

the Tax Reform Act of 1986, the utilization of a corporation’s net operating loss carryforward is limited following a greater

than 50% change in ownership.

Due to the Company’s prior and current equity transactions, the Company’s net operating

loss carryforwards may be subject to an annual limitation generally determined by multiplying the value of the Company on the

date of the ownership change by the federal long-term tax-exempt rate.

Any unused annual limitation may be carried forward to

future years for the balance of the net operating loss carryforward period.

income taxes reflect the net tax effects of temporary differences between carrying amounts of assets and liabilities for financial

reporting purposes and the carrying amounts used for income tax purposes.

In assessing the realizability of deferred tax assets,

Management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized.

The realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which temporary

differences representing net future deductible amounts become deductible.

With the exception of net operating losses generated

in New Jersey which can be surrendered for 80% of their values, due to the uncertainty of the Company’s ability to realize

the benefit of the deferred tax asset, the remainder of our deferred tax assets are fully offset by a valuation allowance at December

31, 2020 and 2019.

future, the Company has determined that a policy to determine the accounting for interest or penalties related to the payment of tax

is not necessary at this time.

the Tax Reform Act of 1986, the utilization of a corporation’s net operating loss carryforward is limited following a greater than 50%

change in ownership.

As noted above, due to the Company’s prior and current equity transactions, some of the Company’s net operating

loss carryforwards are subject to an annual limitation generally determined by multiplying the value of the Company on the date of the

ownership change by the federal long-term tax-exempt rate.

Any unused annual limitation may be carried forward to future years for the

balance of the net operating loss carryforward period.

income taxes reflect the net tax effects of temporary differences between carrying amounts of assets and liabilities for financial reporting

purposes and the carrying amounts used for income tax purposes.

In assessing the realizability of deferred tax assets, Management considers

whether it is more likely than not that some portion or all of the deferred tax assets will not be realized.

The realization of deferred

tax assets is dependent upon the generation of future taxable income during the periods in which temporary differences representing net

future deductible amounts become deductible.

With the exception of net operating losses generated in New Jersey which can be surrendered

for 80% of their value, due to the uncertainty of the Company’s ability to realize the benefit of the deferred tax asset, the remainder

of our deferred tax assets are fully offset by a valuation allowance at December 31, 2021 and 2020.

components of the net deferred tax assets and liabilities as of December 31, 2021 and 2020 consist of the following:

Schedule of Components of Net Deferred Tax Assets and Liabilities

(in thousands)

1 unchanged sentence

Net operating losses

Research and Development costs

Amortization & depreciation

7 unchanged sentences

tax assets are included within other assets in the accompanying Consolidated Balance Sheets.

The benefits of deferred tax assets

are included within the gain from sale of income tax operating losses in the accompanying Consolidated Statements of Comprehensive

(14) Convertible

September 28, 2018, the Company entered into a $3,170,000 10% Secured Convertible Promissory Note (the “IR Note”)

with Iliad Research and Trading, L.P.

(the “Holder”), which was issued to the Holder in conjunction with 500,000 shares

of common stock (the “Origination Shares”).

The Company collected $3,000,000 in cash from the Holder during September

2018 and the remainder $170,000 was retained by the Holder for the Holder’s legal fees of $20,000 for the issuance of the

IR Note and the Original Issue Discount of $150,000.

The Company incurred $210,000 in third-party fees directly attributed to

the issuance of the IR Note.

The Company promised to pay the principal amount, together with guaranteed interest at the annual

rate of 10%, with principal and accrued interest on the IR Note due and payable on September 28, 2019, unless converted under

terms and provisions as set forth within the IR Note.

The IR Note provides the Holder with the right to convert, at any time,

all or any part of the outstanding principal and accrued but unpaid interest into shares of the Company’s common stock at

a conversion price of $0.30 per share.

In addition, beginning on March 28, 2019, the IR Note also provides the Holder with the

right to redeem all or any portion of the IR Note (“Redemption Amount”).

The payments of each Redemption Amount may

be made, at the option of the Company, in cash, by converting such Redemption Amount into shares of common stock (“Redemption

Conversion Shares”), or a combination thereof.

The number of Redemption Conversion Shares equals the portion of the applicable

Redemption Amount being converted divided by the lesser of $0.30 or 80% of the lowest Volume Weighted Average Price (“VWAP”)

during the ten (10) trading days immediately preceding the applicable measurement date (the “Market Price”).

Agreement requires the Company to reserve at least 8,900,000 shares of common stock from its authorized and unissued common stock

to provide for all issuances of common stock under the IR Note.

However, the IR Note provides that the aggregate number shares

of common stock issued to the Holder under the IR Note and Purchase Agreement shall not exceed 19.99% of the total number of shares

of common stock outstanding as of the closing date unless the Company has obtained stockholder approval of the issuance.

The Origination

Shares were to be returned to the Company in the event that the Company could provide within 30 days of the closing of the transaction

certain requested assets as security for repayment of the IR Note.

The security was not provided so the Origination Shares remained

with the Holder.

Company determined the IR Note should be recorded at fair value with subsequent changes in fair value recorded in earnings.

conclusion is based on the redemption conversion feature, which allows the Holder to trigger the redemption of the IR Note for

cash or conversion of the IR Note for common shares prior to its maturity date at a price of the lesser of $0.30 per share or

the Market Price as defined within the IR Note.

The choice of cash redemption or conversion of the IR Note for common shares is

at the option of the Company.

This feature may require the Company to issue a variable number of common shares to settle the IR

Note which was determined to have a predominantly fixed monetary value at inception.

March 13, 2019, the Company amended the Purchase Agreement pursuant to which it issued the Convertible IR Note (the “Amendment”).

The Amendment extends the maturity of the IR Note to September 28, 2020.

In addition, the redemption conversion rates were revised

to a price to be determined by mutual agreement between the Company and the Holder.

In the event that the Company and the Holder

are unable to reach a mutually agreeable price, the Company will be required to pay the applicable redemption amount in cash.

The maximum amount of the IR Note the Lender will be able to redeem in any given calendar month is $300,000.

Company evaluated the Amendment in accordance with ASC 470, Debt (“ASC 470”) and determined the Amendment is

considered an extinguishment of the existing debt and issuance of net debt.

As a result, the Company derecognized the liability

and recorded a loss on the extinguishment of debt of $345,000 in 2019 which was equal to the difference between the reacquisition

price of the debt and the net carrying amount (amount due at maturity, adjusted for unamortized discounts) of the extinguished

Subsequently, the amended note was recorded in accordance with ASC 480 at the fair value that the note was issued with changes

in fair value recorded through earnings at each reporting period.

were a series of debt conversions during 2019 which partially converted $1,400,000 of the $3,408,000 convertible debt, as amended,

into stockholders’

equity, adding approximately $1,400,000 to stockholders’

The number of shares issued in

these conversions were 204,246 shares.

In October 2019 and November 2019 respectively, the lender redeemed $300,000 pursuant to

the terms of the modification.

In connection with the IR Note, the Company recorded a gain equal to $127,000 for the year-end

December 31, 2019.

Note Payable.

expense associated with the IR Note was $0 for the year ended December 31, 2020, and $224,000 for the year ended December 31,

August 5, 2019, the Company issued a Secured Promissory Note (the “CV Note”) with Chicago Venture Partners, L.P.

“CV”).

The Note has an original principal amount of $2,635,000, bears interest at a rate of 10% per annum and will

mature in 24 months, unless earlier paid in accordance with its terms.

The Company received proceeds of $1,900,000 after an original

issue discount and payment of Lender’s legal fees.

Pursuant to a Security Agreement between the Company and the Lender,

repayment of the Note is secured by substantially all of our assets other than its intellectual property.

The benefits of deferred tax assets are

included within the gain from sale of income tax operating losses in the accompanying Consolidated Statements of Comprehensive Loss.

The Company’s deferred tax asset estimates the projected sale of 2021 and 2020 New Jersey state operating losses to be sold

in the subsequent year, respectively.

Reconciliation

between the effective tax rate on income from continuing operations and the statutory tax rate is as follows (in thousands):

of Effective Tax Rate and Statutory Tax Rate

Pre Tax Book Loss

Valuation Allowance

August 5, 2019, the Company issued a Secured Promissory Note (the “CV Note”) with Chicago Venture Partners, L.P.

The Note has an original principal amount of $ 2,635,000 , bears interest at a rate of 10 % per annum and will mature in 24 months, unless

earlier paid in accordance with its terms.

The Company received proceeds of $ 1,900,000 after an original issue discount and payment of

Lender’s legal fees.

Pursuant to a Security Agreement between the Company and the Lender, repayment of the Note is secured by substantially

all of our assets other than its intellectual property.

the quarter ending June 30, 2020, the Holder made redemptions of $ 650,000 reducing the principal to $ 1,985,000 .

On May 29, 2020,

the Company paid off the outstanding CV note consisting of principal of $1,985,000, and accrued interest payable of $220,000.

The net payment of $1,795,000, less the write off of the origination discount of $369,000 and issuance costs of $6,000, resulted

in a gain on extinguishment of $66,000.

expense associated with the CV Note was approximately $116,000, for the year ended December 31, 2020 and was approximately $241,000,

for the year ended December 31, 2019, which included approximately $127,000 associated with the amortization of applicable discounts

to the CV Note.

December 5, 2019, the Company issued a secured Promissory Note (the “AS Note”) to Atlas Sciences L.P.

(“AS”).

The AS Note has an original principal amount of $2,175,000, bears interest at a rate of 10% per annum and will mature in 24 months,

unless earlier paid in accordance with its term.

In conjunction with the AS Note, the Company utilized $1,650,000 of the net proceeds

from the AS Note to pay off in full its obligation to Iliad, an entity with affiliations to AS, pursuant to the IR Note (see Note

Company evaluated the IR Note transaction in accordance with ASC 470, Debt (“ASC 470”) and determined the exchange

is considered an extinguishment of the existing debt and issuance of new debt.

As a result, the Company derecognized the liability

and recorded a loss on the extinguishment of debt of $250,000 which was equal to the difference between the reacquisition price

of the debt and the net carrying amount (amount due at maturity, adjusted for unamortized discounts) of the extinguished debt.

Subsequently, the AS Note was recorded in accordance with ASC 470 whereby the Company recorded a liability equal to the proceeds

received on December 5, 2019.

June 19, 2020, the Company paid off the outstanding AS note which consisted of original principal of $2,175,000, and accrued

interest payable of $122,000 less origination discount of $376,000 and issuance costs of $7,000, with a net note payable of $1,838,000,

On May 29, 2020, the

Company paid off the outstanding CV note consisting of principal of $ 1,985,000 , and accrued interest payable of $ 220,000 .

The net payment

of $ 1,795,000 , less the write off of the origination discount of $ 369,000 and issuance costs of $ 6,000 , resulted in a gain on extinguishment

of $ 66,000 .

Interest expense associated with the CV Note was approximately $ 116,000 , for the year ended December 31, 2020.

December 5, 2019, the Company issued a secured Promissory Note (the “AS Note”) to Atlas Sciences L.P.

The AS Note has an original principal amount of $ 2,175,000 ,

bears interest at a rate of 10 %

per annum and will mature in 24

months, unless earlier paid in

accordance with its term.

On June 19, 2020, the Company paid off the outstanding AS note which consisted of original principal of $ 2,175,000 ,

and accrued interest payable of $ 122,000

less origination discount of $ 376,000

and issuance costs of $ 7,000 ,

with a net note payable of $ 1,838,000 ,

including a gain on extinguishment of $ 76,000 .

expense associated with AS Note for the period ending December 31, 2020 was $106,000, and was approximately $37,000 for the year

ended December 31, 2019.

Relationships and Related Transactions

Company has an employment agreement with its Chief Executive Officer and has granted its executive officers and directors options

and warrants to purchase its common stock.

Please see details of these Employment Agreements in Note 11 - Royalties, License and

Employment Agreements.

set forth in Section 3(c)(ii) of his prior employment agreement, Mr.

Equels earned $8,000 and $7,000 for 5% of the Ampligen cost

recovery sales in 2020 and 2019, respectively.

Interest expense associated with AS Note for the period ending December 31, 2020 was approximately $ 106,000.

Certain Relationships and Related Transactions

Company has an employment agreement with its NEOs and has granted its NEOs and directors options to purchase its common stock.

see details of these Employment Agreements in Note 10 - Employment Agreements.

set forth in Section 5 of Mr.

Equels employment agreement, Mr.

Equels is entitled to reimbursement for the premiums for a $ 3,000,000

life insurance policy.

As of December 31, 2021, Mr.

Equels was due $ 19,420 for 2022 premiums.

(15) Concentrations

of Credit Risk

instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash, cash equivalents,

investments and accounts receivable.

The Company places its cash with high-quality financial institutions and, at times, such

amounts in non-interest-bearing accounts may be in excess of Federal Deposit Insurance Corporation insurance limits.

no credit-based sales for 2020 and 2019.

instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash, cash equivalents, investments

and accounts receivable.

The Company places its cash with high-quality financial institutions and, at times, such amounts in non-interest-bearing

accounts may be in excess of Federal Deposit Insurance Corporation insurance limits.

There were no credit-based sales for 2021 and 2020.

are a limited number of suppliers in the United States and abroad available to provide the raw and packaging materials/reagents for use

in manufacturing Ampligen and Alferon N Injection.

At present, we do not have any agreements with third parties for the supply of any

of these materials or we are relying on a limited source of reagent suppliers necessary for the manufacture of Alferon N Injection.

HollisterStier LLC has manufactured batches of Ampligen for us pursuant to purchase orders.

We anticipate that additional orders will

be placed upon approved quotes and purchase orders provided by us to Jubilant.

On December 22, 2020, we added Pharmaceutics International

(“Pii”) as a “Fill & Finish” provider to enhance our capacity to produce the drug Ampligen.

This addition

amplifies our manufacturing capability by providing redundancy and cost savings.

The contracts augment our existing fill and finish capacity.

If we are unable to place adequate acceptable purchase orders with Jubilant or Pii in the future at acceptable prices upon acceptable

terms, we will need to find another manufacturer.

The costs and availability of products and materials we would need for the production

of Ampligen are subject to fluctuation depending on a variety of factors beyond our control, including competitive factors, changes in

technology, ownership of intellectual property, FDA and other governmental regulations.

There can be no assurance that we will be able

to obtain such products and materials on terms acceptable to us or at all.

the Alferon N Injection manufacturing process is on hold and there is no definitive timetable to restart production.

If we are unable

to acquire FDA approvals related to the manufacturing process and/or final product of new Alferon N Injection inventory or contract with

a CMO, our operations most likely will be materially and/or adversely affected.

In light of these contingencies, there can be no assurances

that the approved Alferon N Injection product will be returned to production on a timely basis, if at all, or that if and when it is

again made commercially available, it will return to prior sales levels.

Company is required under U.S.

GAAP to disclose information about the fair value of all the Company’s financial instruments,

whether or not these instruments are measured at fair value on the Company’s consolidated balance sheets.

GAAP to disclose information about the fair value of all the Company’s financial instruments, whether

or not these instruments are measured at fair value on the Company’s consolidated balance sheets.

Company estimates that the fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate

their carrying values due to the short-term maturities of these items.

The Company also has certain warrants with a cash settlement

feature in the occurrence of a Fundamental Transaction.

The fair value of the redeemable warrants (“Warrants”) related

to the Company’s August 2016, February 2017, June 2017, August 2017, April 2018, and March 2019 common stock and warrant

issuance, are calculated using a Monte Carlo Simulation.

While the Monte Carlo Simulation is one of a number of possible pricing

models, the Company has determined it to be industry accepted and fairly presented the fair value of the Warrants.

As an additional

factor to determine the fair value of the Put’s liability, the occurrence probability of a Fundamental Transaction event

was factored into the valuation.

The Company also has certain warrants with a cash settlement feature

in the occurrence of a Fundamental Transaction.

The fair value of the redeemable warrants (“Warrants”) related to the Company’s

February 2017, June 2017, August 2017, April 2018, and March 2019 common stock and warrant issuance, are calculated using a Monte Carlo

While the Monte Carlo Simulation is one of a number of possible pricing models, the Company has determined it to be industry

accepted and fairly presented the fair value of the Warrants.

As an additional factor to determine the fair value of the Put’s liability,

the occurrence probability of a Fundamental Transaction event was factored into the valuation.

Company recomputes the fair value of the Warrants at the issuance date and the end of each quarterly reporting period.

computation includes subjective input assumptions that are consistently applied each period.

If the Company were to alter its

assumptions or the numbers input based on such assumptions, the resulting fair value could be materially different.

Company utilized the following assumptions to estimate the fair value of the August 2016 Warrants:

Underlying price per share

Exercise price per share

Risk-free interest rate

Expected holding period

Expected volatility

Expected dividend yield

Such value computation

includes subjective input assumptions that are consistently applied each period.

If the Company were to alter its assumptions or the

numbers input based on such assumptions, the resulting fair value could be materially different.

Company utilized the following assumptions to estimate the fair value of the February 2017 Warrants:

Schedule of Assumptions to Estimate Fair Value of Warrants

Underlying price per share

3 unchanged sentences

Risk-free interest rate

0.22 %- 0.23 %

Expected holding period

30 unchanged sentences

significant assumptions using the Monte Carlo Simulation approach for valuation of the Warrants are:

(i) Risk-Free

Interest Rate .

The risk-free interest rates for the Warrants are based on U.S.

Treasury constant maturities for periods

commensurate with the remaining expected holding periods of the warrants.

constant maturities for periods commensurate with the remaining expected holding periods

of the warrants.

(ii) Expected

Holding Period .

The expected holding period represents the period of time that the Warrants are expected to be outstanding

until they are exercised.

The Company utilizes the remaining contractual term of the Warrants at each valuation date as the

expected holding period.

Expected stock volatility is based on daily observations of the Company’s historical stock values for

a period commensurate with the remaining expected holding period on the last day of the period for which the computation is

The expected holding period represents the period of time that the Warrants

are expected to be outstanding until they are exercised.

The Company utilizes the remaining

contractual term of the Warrants at each valuation date as the expected holding period.

(iii) Expected

Expected stock volatility is based on daily observations of the Company’s

historical stock values for a period commensurate with the remaining expected holding period

on the last day of the period for which the computation is made.

(iv) Expected

Dividend Yield .

Expected dividend yield is based on the Company’s anticipated dividend payments over the remaining

expected holding period.

As the Company has never issued dividends, the expected dividend yield is 0% and this assumption

will be continued in future calculations unless the Company changes its dividend policy.

Expected dividend yield is based on the Company’s anticipated dividend

payments over the remaining expected holding period.

As the Company has never issued dividends,

the expected dividend yield is 0 % and this assumption will be continued in future calculations

unless the Company changes its dividend policy.

Probability of a Fundamental Transaction.

The possibility of the occurrence of a Fundamental Transaction triggering a

Put right is extremely remote.

As discussed above, a Put right would only arise if a Fundamental Transaction 1) is an all

cash transaction;

(2) results in the Company going private;

or (3) is a transaction involving a person or entity not traded

on a national securities exchange.

The Company believes such an occurrence is highly unlikely because:

Company only has one product that is FDA approved but is currently not available for commercial sales.

Company will have to perform additional clinical trials for FDA approval of its flagship product.

and market conditions continue to include a global market recession, adding risk to any transaction.

The possibility of the occurrence of a Fundamental

Transaction triggering a Put right is extremely remote.

As discussed above, a Put right would

only arise if a Fundamental Transaction 1) is an all cash transaction;

(2) results in the

Company going private;

or (3) is a transaction involving a person or entity not traded on

a national securities exchange.

The Company believes such an occurrence is highly unlikely

Company only has one product that is FDA approved but is currently not available for commercial

Company will have to perform additional clinical trials for FDA approval of its flagship

and market conditions continue to include uncertainty, adding risk to any transaction.

capital for a potential buyer in a cash transaction continues to be limited.

nature of a life sciences company is heavily dependent on future funding and high fixed costs, including Research & Development.

Company has minimal revenues streams which are insufficient to meet the funding needs for the cost of operations or construction

at their manufacturing facility;

Company’s Rights Agreement and Executive Agreements make it less attractive to a potential buyer.

the above factors utilized in analysis of the likelihood of the Put’s potential Liability, the Company estimated the range

of probabilities related to a Put right being triggered as:

nature of a life sciences company is heavily dependent on future funding and high fixed costs,

including Research & Development.

Company has minimal revenues streams which are insufficient to meet the funding needs for

the cost of operations or construction at their manufacturing facility;

Company’s Rights Agreement and Executive Agreements make it less attractive to a potential

the above factors utilized in analysis of the likelihood of the Put’s potential Liability, the Company estimated the range of probabilities

related to a Put right being triggered as:

Schedule of Range of Probabilities

Range of Probability

Monte Carlo Simulation has incorporated a 5.0 % probability of a Fundamental Transaction to date for the life of the securities.

(vi) Expected

Timing of Announcement of a Fundamental Transaction.

As the Company has no specific expectation of a Fundamental Transaction,

for reasons elucidated above, the Company utilized a discrete uniform probability distribution over the Expected Holding Period

to model in the potential announcement of a Fundamental Transaction occurring during the Expected Holding Period.

As the Company has no specific expectation

of a Fundamental Transaction, for reasons elucidated above, the Company utilized a discrete

uniform probability distribution over the Expected Holding Period to model in the potential

announcement of a Fundamental Transaction occurring during the Expected Holding Period.

(vii) Expected

100 Day Volatility at Announcement of a Fundamental Transaction .

An estimate of future volatility is necessary as there

is no mechanism for directly measuring future stock price movements.

Daily observations of the Company’s historical

stock values for the 100 days immediately prior to the Warrants’

grant dates, with a floor of 100%, were utilized as

a proxy for the future volatility.

An estimate of future

volatility is necessary as there is no mechanism for directly measuring future stock price

Daily observations of the Company’s historical stock values for the 100

days immediately prior to the Warrants’ grant dates, with a floor of 100 %, were utilized

as a proxy for the future volatility.

(viii) Expected

Risk-Free Interest Rate at Announcement of a Fundamental Transaction .

The Company utilized a risk-free interest rate corresponding

to the forward U.S.

Treasury rate for the period equal to the time between the date forecast for the public announcement of

a Fundamental Transaction and the Warrant expiration date for each simulation.

The Company utilized

a risk-free interest rate corresponding to the forward U.S.

Treasury rate for the period

equal to the time between the date forecast for the public announcement of a Fundamental

Transaction and the Warrant expiration date for each simulation.

(ix) Expected

Time Between Announcement and Consummation of a Fundamental Transaction.

The expected time between the announcement and

the consummation of a Fundamental Transaction is based on the Company’s experience with the due diligence process performed

by acquirers and is estimated to be six months.

The Monte Carlo Simulation approach incorporates this additional period to

reflect the delay Warrant Holders would experience in receiving the proceeds of the Put.

the assumptions remain consistent from period to period (e.g., utilizing historical stock prices), the numbers input change from

period to period (e.g., the actual historical prices input for the relevant period).

The carrying amount and estimated fair value

of the above Warrants was approximately $180,000 and $57,000 at December 31, 2020 and 2019, respectively.

time between the announcement and the consummation of a Fundamental Transaction is based

on the Company’s experience with the due diligence process performed by acquirers and

is estimated to be six months.

The Monte Carlo Simulation approach incorporates this additional

period to reflect the delay Warrant Holders would experience in receiving the proceeds of

the assumptions remain consistent from period to period (e.g., utilizing historical stock prices), the numbers input change from period

to period (e.g., the actual historical prices input for the relevant period).

The carrying amount and estimated fair value of the above

Warrants was approximately $ 35,000 and $ 180,000 at December 31, 2021 and 2020, respectively.

Company applies FASB ASC 820 (formerly Statement No.

157 Fair Value Measurements ) that defines fair value, establishes

a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements.

The guidance does not impose any new requirements around which assets and liabilities are to be measured at fair value, and instead

applies to asset and liability balances required or permitted to be measured at fair value under existing accounting pronouncements.

The Company measures its warrant liability for those warrants with a cash settlement feature at fair value.

157 Fair Value Measurements ) that defines fair value, establishes a framework

for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements.

does not impose any new requirements around which assets and liabilities are to be measured at fair value, and instead applies to asset

and liability balances required or permitted to be measured at fair value under existing accounting pronouncements.

The Company measures

its warrant liability for those warrants with a cash settlement feature at fair value.

ASC 820-10-35-37 (formerly SFAS No.

2 unchanged sentences

Classification is based on the lowest level of inputs that is significant to the fair value measurement.

The valuation hierarchy contains three levels:

Quoted prices are available in active markets for identical assets or liabilities at the reporting date.

this includes debt and equity securities that are traded in an active market.

Observable inputs other than Level 1 prices such as quote prices for similar assets or liabilities;

quoted prices

in markets that are not active;

or other inputs that are observable or can be corroborated by observable market data for substantially

the full term of the assets or liabilities.

Generally, this includes debt and equity securities that are not traded in an

active market.

Unobservable inputs that are supported by little or no market activity and that are significant to the fair value

of the assets or liabilities.

Level 3 assets and liabilities include financial instruments whose value is determined using

pricing models, discounted cash flow methodologies, or other valuation techniques, as well as instruments for which the determination

of fair value requires significant management judgment or estimation.

As of December 2020, the Company has classified the

warrants with cash settlement features and a convertible note payable as Level 3.

Management evaluates a variety of inputs

and then estimates fair value based on those inputs.

As discussed above, the Company utilized the Monte Carlo Simulation Model

in valuing the warrants and the convertible note.

valuation hierarchy contains three levels:

1 – Quoted prices are available in active markets for identical assets or liabilities

at the reporting date.

Generally, this includes debt and equity securities that are traded

in an active market.

2 – Observable inputs other than Level 1 prices such as quote prices for similar assets

or liabilities;

quoted prices in markets that are not active;

or other inputs that are observable

or can be corroborated by observable market data for substantially the full term of the assets

or liabilities.

Generally, this includes debt and equity securities that are not traded in

an active market.

3 – Unobservable inputs that are supported by little or no market activity and that

are significant to the fair value of the assets or liabilities.

Level 3 assets and liabilities

include financial instruments whose value is determined using pricing models, discounted

cash flow methodologies, or other valuation techniques, as well as instruments for which

the determination of fair value requires significant management judgment or estimation.

of December 2021, the Company has classified the warrants with cash settlement features and

a convertible note payable as Level 3.

Management evaluates a variety of inputs and then

estimates fair value based on those inputs.

As discussed above, the Company utilized the

Monte Carlo Simulation Model in valuing the warrants and the convertible note.

table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy

Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis

(in thousands)

7 unchanged sentences

changes in Level 3 Liabilities measured at fair value on a recurring basis are summarized as follows (in thousands):

of Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis

Redeemable warrants:

2 unchanged sentences

Balance at December 31, 2021

Obligation Arising from Sale Leaseback Transaction

table below presents the balances of assets and liabilities measured at fair value on a nonrecurring basis by level within the hierarchy

of Assets and Liabilities Measured at Fair Value on a NonRecurring Basis

(in thousands)

As of December 31, 2021

Total Gains (Losses)

Long lived assets held and used (a)

accordance with Subtopic 360-10, long-lived assets held and used with a carrying amount of

$ 5,700,000 were written down to their fair value of $ 3,900,000 , resulting in an impairment

charge of $ 1,800,000 , which is included in earnings for the period.

Financing Obligation Arising from Sale Leaseback Transaction

March 16, 2018, the Company sold land and a building for $ 4,080,000 and concurrently entered into an agreement to lease the property

back for ten years at $408,000 per year for two years through March 31, 2020.

The lease payments will increase 2.5% per year for

the next three years through March 31, 2023 and the lease payments will increase 3% for the remaining five years through March

The sale of the property includes an option to repurchase the property at fair value which does not permanently transfer

all the risks and rewards of ownership to the buyer.

The option to repurchase the property also would be at a higher price than

the sales price and is considered likely based upon the Company’s plans going forward.

Because the sale of the property

includes the option to repurchase the property and includes the above attributes, the transaction was accounted for as a financing

transaction whereby the Company debited cash for the amount of cash received and credited financing obligation.

The Company will

continue to report the property as an asset and the property will continue to be depreciated.

If the option is exercised, the

cash payment by the seller-lessee is to pay off the financing obligation.

As part of the sale of this building, warrants were

provided to the buyer for the purchase of up to 3,225,806 shares of Company common stock for a period of five years at an exercise

price of $0.3875 per share, 125% of the closing price of the common stock on the NYSE American on the date of execution of the

letter of intent for the purchase.

The warrants cannot be exercised to the extent that any exercise would result in the purchaser

owning in excess of 4.99% of the Company’s issued and outstanding shares of common stock.

Property and equipment in “Note 7 Stockholders’

Equity”

above are the property and equipment involved in this

Depreciation on the building will continue until a sale has been recognized.

minimum payments required under the Financing Obligation and the balance of the Finance Obligation as of December 31, 2020, are

During the Year:

(amount in thousands)

Total of Payments

Less Deferred Issuance Costs

Less Discount on Debt Instrument

Less Imputed Interest

Total Balance

Less Current Portion

Long Term Portion

expense relating to this financing agreement was $61,000 for the year ended December 31, 2020 an $67,000 for the year ended December

January 2021, the Company entered into a sponsorship agreement with the Centre for Human Drug Research (“CHDR”) for

a proposed clinical study on the safety of the Company’s drug Ampligen as an intranasal therapy.

CHDR, an independent institute

located in Leiden in the Netherlands, will conduct and manage the proposed clinical study, titled “A Phase I, Randomized,

Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly

I:Poly C12U) in Healthy Subjects.”

The Company is funding the clinical study at a cost of approximately $980,000.

February 2021, the Company completed its At-The-Market (ATM) facility and closed the ATM’s Equity Distribution Agreement

(EDA) with Maxim Group LLC.

February 2021, the Company received formal notification from the European Commission (“EC”) that the European Medicines

Agency (“EMA”) has designated Ampligen as an Orphan Medicinal Product (“OMP”) for treatment of pancreatic

Medications that have an OMP designation by the EMA, once commercially approved in the European Union (“EU”),

receive benefits including up to ten years of protection from market competition from similar medicines with similar active component

and indication for use that are not shown to be clinically superior.

March 2021, the Company entered into employment agreements with Peter Rodino and Ellen Lintal.

The agreements run for three years

and one year, respectively.

Compensation is divided into both short- and long-term compensation.

Short term (cash) compensation

will consist of a base salary of $425,000 and $350,000, respectively.

Rodino and Ms.

Lintal will be awarded a year-end target

bonus based on performance and goals established by the Compensation Committee.

Long term compensation will be provided by 100,000

non-qualified yearly stock options with one-year vesting commencing on November 30, 2021.

In addition, Mr.

Rodino and Ms.

shall each be entitled to awards (“Event Awards”) equal to 1% of the “Gross Proceeds”

from specific

events such as licensing agreements or “therapeutic indication”

(each, an “Event”).

Gross Proceeds means

those cash amounts paid to the Company by the other parties for licensing agreements, therapeutic acquisitions or any other one

time cash generating event.

Therapeutic indications are for example target organ specific pathologically defined cancer indications,

vaccine enhancers, broad spectrum antiviral indications, or medical entities associated with persistent severe fatigue.

Lintal also will each be entitled to an award (an “Acquisition Award”) equal to 1% of the Gross Proceeds,

upon the sale of the Company or substantially all of its assets (an “Acquisition”).

An Event Award or Acquisition

Award shall be paid in cash within 90 days of our receipt of the Gross Proceeds.

The lease payments will increase 2.5% per year for the

next three years through March 31, 2023, and the lease payments will increase 3% for the remaining five years through March 31, 2028 .

As part of the sale of this building, warrants were provided to the buyer for the purchase of up to 73,314 shares of Company common stock

for a period of five years at an exercise price of $ 17.05 per share, 125 % of the closing price of the common stock on the NYSE American

on the date of execution of the letter of intent for the purchase.

The sale of the property includes an option to repurchase the property

based on a contractual formula which does not permanently transfer all the risks and rewards of ownership to the buyer.

Because the sale

of the property includes the option to repurchase the property and includes the above attributes, the transaction was accounted for as

a financing transaction whereby the Company recorded the cash received and a financing obligation.

The warrants cannot be exercised to

the extent that any exercise would result in the purchaser owning in excess of 4.99% of our issued and outstanding shares of common stock.

May 13, 2021, the Company completed its repurchase of the property for cash of $ 4,732,637 .

The repurchase resulted in the related liability

recorded upon sale being extinguished on the date of the repurchase.

A loss on the extinguishment was recorded based on the difference

between the carrying value of the financing obligation including unamortized debt discount and the amount exchanged to extinguish the

the period ended December 31, 2021, the loss on extinguishment was $ 2,701,460 .

Interest expense relating to this financing agreement

was $ 19,000 for the period ended December 31, 2021, and $ 61,000 for the period ended December 31, 2020.

(18) Subsequent

January 21, 2022, the Company filed a universal shelf registration statement with the Securities and Exchange Commission registering

Company securities of up to $ 100 million.

The registration statement was declared effective on February 4, 2022.

March 1, 2022, after review and approval by the Board of Directors, the Company entered into a consulting agreement with Foresite Advisors,

LLC, a company wholly owned by Robert Dickey IV, pursuant to which Mr.

Dickey will serve as the Company’s new Chief Financial Officer

effective April 4, 2022.

The initial term of the agreement is for one year.

Pursuant to the consulting agreement, Mr.

Dickey will be

compensated at $ 375 per hour.

determining whether to proceed with a Human Challenge Trial (“HCT”) with hVIVO Services Ltd at their quarantine facility

to test Ampligen as a potential intranasal antiviral therapy using a human rhinovirus HRV (common cold virus) and influenza,

the Medicines and Healthcare Regulatory Agency (“MHRA”), the agency that reviews the study protocol, issued Grounds for

Non-Acceptance and requested additional data before moving forward.

As the request would require the Company to first conduct an animal

experiment that it believes would take approximately six months to complete, it determined that continuing with the HCT application process

would not be a prudent use of Company resources, so terminated the agreement with hVIVO and officially notified the MHRA of its decision

to withdraw the application.

As the MHRA’s Grounds for Non-Acceptance had already been issued, the withdrawal was technically recognized

as a rejection of the proposed study.

March 3, 2022, the Company entered into an Agreement of Sale and Purchase with Acellories, Inc.

as purchaser pursuant to which the Company

will sell its property located at 783 Jersey Ave., New Brunswick, NJ.

Pursuant to the agreement, the purchaser will purchase the property

for $ 3.9 million.

Among other things, the purchaser has a 45 day right of due diligence and has the right to terminate the agreement

within that period.

(see Note 2 Summary of Significant Accounting Policies).

March 3, 2022, the Company’s Board of Directors, at the recommendation of the Compensation Committee, awarded options to purchase

50,000 shares of Company Common Stock to both of our independent directors, Mr.

Appelrouth and Dr.

Mitchell, and to certain other members

of management, including Peter Rodino, our COO;

Ellen Lintal, our CFO;

and Robert Dickey IV, our incoming CFO.

The options vest one year

after issuance and have an exercise price of $ 0.70 , the closing price of the Company’s Common Stock on the day prior to issuance.

CEO Thomas K.

Equels, at his recommendation, did not request or receive any such options under the March 3 decision.

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 9A. Controls and Procedures