Item 9A. Controls and Procedures
ITEM
9A. Controls
and Procedures.
Effectiveness
of Control Procedures
As
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
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, 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. 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.
Changes
in Internal Control over Financial Reporting
We
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
Report on Internal Control over Financial Reporting
Our
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 statements.
Because
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.
Management
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, 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.
Management
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.
ITEM
9B. Other
Information.
None.
ITEM 9C.
Disclosure
Regarding Foreign Jurisdictions that Prevent Inspections.
Not Applicable.
38
PART
III
ITEM 10.
Directors and Executive Officers and Corporate Governance.
The
following sets forth biographical information about each of our Directors and Executive Officers as of the date of this report:
Name
Age
Position
Thomas
K. Equels, Esq
69
Chief
Executive Officer, President, and Director
Peter
W. Rodino III
70
Chief
Operating Officer, General Counsel & Secretary
William
M. Mitchell, M.D., Ph.D.
87
Chairman
of the Board and Director
Stewart
L. Appelrouth
68
Director
Ellen
M. Lintal
62
Chief
Financial Officer
Each
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.
We
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; (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:
Leadership
Experience : 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.
Industry
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.
Scientific,
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.
Finance
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.
THOMAS
K. EQUELS, has been a Director and serves as our Executive Vice Chairman (since 2008), Chief Executive Officer (since 2016) and President
(since 2015). Mr. 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. Mr. 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. Mr. 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.
39
THOMAS
K. EQUELS – Director Qualifications:
● Leadership
Experience – Military; Owner and former President; Managing Director of Equels Law
Firm, Court-appointed receiver in numerous industries;
● Industry
Experience – legal counsel, General Counsel, CFO and CEO to us; and
● 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.
WILLIAM
M. MITCHELL, M.D., Ph.D., has been a Director since July 1998 and Chairman of the Board since February 2016. Dr. Mitchell is a Professor
of Pathology at Vanderbilt University School of Medicine and is a board-certified physician. Dr. Mitchell earned a M.D. 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. Dr. 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. Dr. 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.
Dr. 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. Dr. Mitchell previously served as one of our Directors from 1987 to 1989.
WILLIAM
M. MITCHELL, M.D., Ph.D. – Director Qualifications:
● Leadership
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;
● Academic
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; and
● Scientific,
Legal or Regulatory Experience – M.D., Ph.D. 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.
STEWART
L. 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. Mr. 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.
Mr.
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 the NYSE:
American Company Guide and Rule 10A-3 under the Exchange Act.
STEWART
L. APPELROUTH – Director Qualifications:
● Leadership
Experience –has served in leadership positions on numerous Boards and other organizations;
● Industry
Experience – Partner at certified public accounting and advisory firm; Certified Public
Accountant and Certified Fraud Examiner;
● Regulatory
Experience – FINRA Arbitrator.
● Financial
Expert – over 40 years of accounting and audit experience.
Information
about our Executive Officers
In
addition to Mr. Equels (discussed above), the following are (or were) our Executive Officers during fiscal 2020:
PETER
W. RODINO III has been a Director since July 2013. On September 30, 2016, Mr. 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 assumed the role of Chief Operating Officer. Mr. Rodino has been our
Secretary since November 2016. Mr. Rodino has broad legal, financial, and executive experience. 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. Mr. Rodino holds a B.S.
in Business Administration from Georgetown University and a J.D. degree from Seton Hall University.
40
ELLEN
M. LINTAL has been our Chief Financial Officer since September 16, 2019. Ms. 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. Mrs. 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.
ROBERT
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. Mr.
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. Mr. Dickey
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
Street. Dickey has an MBA from The Wharton School and an AB from Princeton University.
DAVID
R. 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. Dr. 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. Dr. Strayer attended the School
of Medicine at the University of California at Los Angeles where he received his M.D. in 1972.
Audit
Committee and Audit Committee Expert
The
Audit Committee of our Board of Directors consists of William Mitchell, M.D. and Stewart L. Appelrouth. Dr. Mitchell and Mr. Appelrouth
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. 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 of the SEC.
We
believe Dr. 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; (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.
This
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”.
41
Scientific
Advisory Board (“SAB”)
The
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. 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.
Disclosure
Controls Committee (“DCC”)
The
DCC reports to the Audit Committee and is responsible for procedures and guidelines on managing disclosure information. 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. Ellen M. 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; 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
website: www.aimimmuno.com in the “Investor Relations” tab under “Corporate Governance.” The DCC actively met
on numerous occasions in 2021.
Executive
Committee
In
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. Mr. Equels, our Chief Executive Officer, is the chairman of the Committee, along with two of our independent directors, Mr. Appelrouth
and Dr. Mitchell. 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.
Code
of Ethics
Our
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.
You
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.
ITEM 11.
Executive Compensation.
COMPENSATION
DISCUSSION AND ANALYSIS
This
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:
● Thomas
K. Equels, Chief Executive Officer (“CEO”) and President;
● Ellen
M. Lintal, Chief Financial Officer (“CFO”); and
● Peter
Rodino, Chief Operating Officer (“COO”), General Counsel and Company Secretary
(“CS”).
42
In
March 2021, subsequent to the fiscal year ended December 31, 2020, we 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. Mr. 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. 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
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. Mr. Rodino and Ms. 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.
Governance
of Compensation Committee
The
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”): Dr. William Mitchell, M.D. (Chair) and Stewart L. Appelrouth. 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”.
This
Committee formally met three times in 2021 and all committee members were in attendance for the meetings. Our General Counsel, Chief
Financial Officer and Director of Human Resources support the Compensation Committee in its work.
Results
of Stockholder Advisory Vote on Executive Compensation
At
the October 2021 Annual Meeting of Stockholders, the Stockholders did not approve the annual, non-binding advisory vote on Executive
Compensation.
Objectives
and Philosophy of Executive Compensation
The
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.
43
EXECUTIVE
COMPENSATION
The
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.
Summary
Compensation Table
Name & Principal Position
Year
Salary /
Fees $ (2)
Bonus
$
Stock
Awards
$
Option
Awards
$ (1)
Non-Equity
Incentive Plan
Compensation
$
Change in
Pension
Valued
and
NQDC
Earnings
$
All Other
Compensation
$
Total $ (1)
Thomas K Equels
2021
850,000
352,500
—
473,038
—
—
86,106
1,761,644
CEO & President (2)3
2020
806,599
652,000
—
1,139,267
—
—
65,509
2,663,375
Ellen Lintal
2021
350,000
102,500
—
132,346
—
—
49,893
634,739
CFO (4)
2020
239,583
177,000
—
111,616
—
—
25,403
553,602
Peter Rodino
COO, General Counsel
2021
425,000
102,500
—
132,346
—
—
57,949
717,795
& Secretary (5)
2020
394,792
244,500
—
111,616
—
—
42,570
793,478
Notes:
(1) All
option awards were valued using the Black-Scholes method.
(2) For
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.
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 2021 and 2020.
(3)
Mr.
Equels’ All Other Compensations consists of:
2021
2020
Life & Disability Insurance
$ 22,037
$ 27,131
Healthcare Insurance
26,479
20,378
Car Expenses/Allowance
18,000
18,000
401(k) Matching Funds
19,500
—
Total
$ 86,016
$ 65,509
(4)
Ms.
Lintal’s All Other Compensations consists of:
2021
2020
Life & Disability Insurance
$ 3,014
$ 2,383
Healthcare Insurance
12,978
8,620
Car Expenses/Allowance
14,400
14,400
401(k) Matching Funds
19,500
—
Total
$ 49,893
$ 25,403
(5)
Mr.
Rodino’s All Other Compensations consists of:
2021
2020
Life & Disability Insurance
$ 2,521
$ 2,542
Healthcare Insurance
21,528
25,629
Car Expenses/Allowance
14,400
14,400
401(k) Matching Funds
19,500
—
Total
$ 57,949
$ 42,570
44
Outstanding
Equity Awards at
Fiscal Year End
Option
Awards
Stock
Awards
Name
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
($)
Thomas K Equels
568
—
—
216.48
6/24/2021
—
—
—
—
President and Chief
189
—
—
153.12
6/6/2022
—
—
—
—
Executive Officer
568
—
—
163.68
6/11/2022
—
—
—
—
568
—
—
163.68
6/6/2023
—
—
—
—
284
—
—
132.00
8/2/2023
—
—
—
—
568
—
—
190.08
6/6/2024
—
—
—
—
568
—
—
132.00
6/8/2025
—
—
—
—
568
—
—
73.92
6/8/2026
—
—
—
—
6,818
—
—
24.64
6/8/2027
—
—
—
—
323
—
—
21.56
6/15/2027
—
—
—
—
323
—
—
21.56
6/30/2027
—
—
—
—
412
—
—
21.12
7/15/2027
—
—
—
—
472
—
—
18.48
7/31/2027
—
—
—
—
485
—
—
18.04
8/15/2027
—
—
—
—
556
—
—
15.84
8/31/2027
—
—
—
—
8,446
—
—
16.28
2/13/2028
—
—
—
—
2,841
—
—
16.72
4/12/2028
—
—
—
—
6,818
—
—
13.20
5/16/2028
—
—
—
—
5,682
—
—
13.20
5/16/2028
—
—
—
—
3,666
—
—
13.64
7/18/2028
—
—
—
—
6,457
—
—
9.68
10/17/2028
—
—
—
—
23
—
—
9.68
11/14/2028
—
—
—
—
9,685
—
—
9.68
1/28/2029
—
—
—
—
300,000
—
—
3.05
8/12/2030
—
—
—
—
300,000
—
—
1.96
11/11/2030
—
—
—
—
—
300,000
1.71
11/11/2031
—
—
—
—
Total
656,888
300,000
—
—
—
—
—
Ellen Lintal
23
—
—
9.68
11/14/2029
—
—
—
—
Chief Financial Officer
75,000
75,000
—
1.85
12/9/2030
—
—
—
—
100,000
1.44
11/30/2031
—
—
—
—
Total
75,023
100,000
—
—
—
—
—
Peter Rodino
285
—
—
132.00
8/2/2023
—
—
—
—
COO, General Counsel and Secretary
285
—
—
68.65
6/21/2026
—
—
—
—
151
—
—
21.56
6/15/2027
—
—
—
—
151
—
—
21.56
6/30/2027
—
—
—
—
192
—
—
21.12
7/15/2027
—
—
—
—
220
—
—
18.48
7/31/2027
—
—
—
—
226
—
—
18.04
8/15/2027
—
—
—
—
259
—
—
15.84
8/31/2027
—
—
—
—
3,941
—
—
16.28
2/13/2028
—
—
—
—
2,273
—
—
16.72
4/12/2028
—
—
—
—
2,652
—
—
13.20
5/16/2028
—
—
—
—
1,711
—
—
13.64
7/18/2028
—
—
—
—
3,013
—
—
9.68
10/17/2028
—
—
—
—
23
—
—
9.68
11/14/2028
—
—
—
—
4,520
—
—
9.68
1/28/2029
—
—
—
—
75,000
—
—
1.85
12/9/2030
—
—
—
—
—
100,000
1.44
11/30/2021
—
—
—
—
Total
94,902
100,000
—
—
—
—
—
45
Payments
on Disability
As
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. On March 24, 2021, we entered into employment agreements with Mr. Rodino and Ms. 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.
Payments
on Death
Pursuant
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 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 $3,000,000 pursuant to his employment agreement and payable by us.
Estimated
Payments Following Severance — Named Executive Officers (NEO)
Pursuant
to his employment agreement, Mr. Equels is entitled to severance benefits on certain types of employment terminations not related to
a change in control or termination not for cause. Mr. Rodino and Ms. Lintal are not covered by an employment severance agreement and
therefore would only receive severance as determined by the Compensation Committee in its discretion.
46
The
dollar amounts below assume that the termination occurred on January 1, 2022. The actual dollar amounts to be paid can only be determined
at the time of the NEO’s separation from us based on their prevailing compensation and employment agreements along with any determination
by the Compensation Committee in its discretion.
Name
Event
Cash
Severance
($)
Value of Stock
Awards That
Will Become
Vested (1) ($)
Continuation of
Medical Benefits
($)
Additional
Life
Insurance
($)
Total
($)
Thomas K. Equels,
Involuntary (no cause)
$ 4,872,000
$ 473,038
—
—
$ 5,345,038
CEO & President
Termination (for cause)
—
—
—
—
—
Death or disability
$ 1,736,000
$ 473,038
—
—
$ 2,209,038
Termination by employee or retirement
—
$ 473,038
—
—
$ 473,038
Ellen Lintal
Involuntary (no cause)
$ 92,880
$ 132,346
—
—
$ 225,226
CFO
Termination (for cause)
—
—
—
—
—
Death or disability
$ 728,800
$ 132,346
—
—
$ 861,146
Termination by employee or retirement
—
$ 132,346
—
—
$ 132,346
Peter Rodino
Involuntary (no cause)
$ 1,186,000
$ 132,346
—
—
$ 1,319,026
COO, General Counsel and
Termination (for cause)
—
—
—
—
—
Secretary
Death or disability
$ 878,800
$ 132,346
—
—
$ 1,011,146
Termination by employee or retirement
—
$ 132,346
—
—
$ 132,346
Notes:
(1) Consists
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.
Payments
on Termination in Connection with a Change in Control of Named Executive Officers
Pursuant
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).
The
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
discretion.
Estimated
Benefits on Termination Following a Change in Control — December 31, 2021
The
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 3, 2022 termination date regarding base pay and use of the opening
price of $0.97 on the NYSE American for our common stock at that date.
Name
Aggregate
Severance Pay
($)
PVSU
Acceleration
(2) ($)
Early
Vesting
of
Restricted
Stock (4) (5) ($)
Early
Vesting
of Stock
Options
and SARs
(3) ($)
Acceleration
and
Vesting of
Supplemental
Award (5) ($)
Welfare
Benefits
Continuation
($)
Outplacement
Assistance
($)
Parachute
Tax
Gross-up
Payment
($)
Total
($)
Thomas K. Equels
$ 6,076,000 (1)
—
—
—
$ 1,988,119 (4)
—
—
—
$ 8,064,119
Ellen Lintal
—
—
—
—
—
—
—
—
—
Peter Rodino
—
—
—
—
—
—
—
—
—
47
Notes:
(1) This
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
31, 2025. This amount excludes the following payments as they cannot be calculated unless
and until certain events occur: Mr. 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.
(2) This
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.
(3) This
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.
(4) This
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. Equels. The value
was obtained using the Black-Scholes-Merton pricing model for stock-based compensation in
accordance with FASB ASC 718.
(5) Any
purchase rights represented by the Option not then vested shall, upon a change in control,
shall become vested.
Post-Employment
Compensation
The
following is a description of post-employment compensation payable to the respective NEO. If a NEO does not have a specific benefit,
they will not be mentioned in the subsection. In such event, the NEO does not have any such benefits upon termination unless otherwise
required by law.
Termination
for Cause
All
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. Mr. 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. 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.
Termination
without Cause
In
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.
Death
or Disability
An
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. 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.
48
Compensation
of Directors
Our
Compensation, Audit and Corporate Governance and Nomination Committees, consist of Dr. William M. Mitchell, Compensation and Corporate
Governance and Nomination Committee Chair, and Stewart L. Appelrouth, Audit Committee Chair, both of whom are independent Board of Director
members.
We
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.
There
was no cost of living increase granted in 2020 or 2021.
All
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. Options shares
for stock compensation were issued under the 2009 and 2018 Equity Incentive Plans.
Director
Compensation – 2021 & 2020
Name and Title of Director
Year
Fees
Earned or
Paid in
Cash $
Stock
Award
$
Option
Award $
Non-Equity
Incentive Plan
Compensation
$
Change in
Pension
Value &
Nonqualified
Deferred
Compensation
Earnings $
All Other
Compensation
As Director $
Total $
T. Equels
2021
—
—
—
—
—
—
—
Executive
2020
—
—
—
—
—
—
—
Vice Chairman
W. Mitchell
2021
182,462
—
78,673
—
—
—
261,135
Chairman of the Board
2020
182,462
—
112,158
—
—
—
294,620
S. Appelrouth
2021
182,462
—
78,673
—
—
—
261,135
Director
2020
182,462
—
112,158
—
—
—
294,620
ITEM
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The
following table sets forth as of March 25, 2022, the number and percentage of outstanding shares of Common Stock beneficially
owned by:
● Each
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;
● Each
of our Directors and the Named Executives Officers; and
● All
of our officers and directors as a group.
● Total
number of shares of Common Stock at March 25, 2022 was 47,994,672.
49
Shares
%
Of Shares
Name
and Address of Beneficial Owner
Beneficially
Owned
Beneficially
Owned
Thomas
K. Equels, Executive Vice Chairman, Chief Executive Officer, President*
957,677 (1)
**0.02 %
Peter
W. Rodino III, Chief Operating Officer, General Counsel, Secretary*
153,193 (2)
** %
William
M. Mitchell, M.D., Chairman of the Board of Directors*
156,474 (3)
** %
Stewart
L. Appelrouth, Director*
241,126 (4)
** %
Ellen
Lintal, Chief Financial Officer*
97,915 (5)
** %
All
directors and executive officers as a group(5 persons)
1,606,385
0.034 %
**
Less than 1%
(1)
Fo r Mr. 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.
(2)
For Mr. 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.
(3)
For Dr. 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.
(4)
For Mr. 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.
(5)
For Ms. 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.
The
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
Number of
Securities
to be
issued upon
exercise of
outstanding
options,
warrants and
rights
Weighted
Average
Exercise
Price
Per Share
Number of
securities
Remaining
available for
future issuance
under equity
compensation
plans
(excluding
securities
reflected
in
column) (a)
(a)
(c)
Equity compensation plans approved by security holders:
1,773,974
$ 4.033
307,834
Equity compensation plans not approved by security
holders:
294,939
$ 15.19
—
Total
2,068,913
$ 5.62
307,834
50
ITEM
13. Certain Relationships and Related Transactions, and Director Independence.
Review,
Approval or Ratification of Transactions with Related Persons
Our
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.
We
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.
ITEM
14. Principal Accountant Fees and Services. To be updated
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”) for 2021 were $485,000 and total 2020 were $353,500.
Amount ($)
2021
2020
Description of Fees:
Audit Fees
$ 370,000
$ 260,000
Audit-Related Fees
42,000
93,500
Tax Fees
73,000
—
All Other Fees
—
—
Total
$ 485,000
$ 353,500
Audit
Fees
Audit
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
Fees
Represents
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
procedures).
The
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.
The
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.
51
PART
IV
ITEM
15. Exhibits and Financial Statement Schedules.
Financial
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.
(i) Exhibits
- See exhibit index below.
Exhibit
No.
Description
3.1(i)
Amended
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).
3.2(i)
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).
3.3(i)
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).
3.4(i)
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).
3.5(i)
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).
3.6(i)
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).
3.7(ii)
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).
4.1
Specimen
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).
4.2
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 (incorporated by reference to exhibit 1 to the Company’s Registration Statement on Form 8-A12B (No. 001-27072) filed November 14, 2017).
4.3
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).
4.4
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).
4.5
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).
4.6
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).
4.7
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).
4.8
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).
4.9
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).
4.10
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).
4.11
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).
4.12
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).
4.13
September 28, 2018 Secured Convertible Promissory Note from the Company to Iliad Research and Trading, L.P. (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No. 001-27072) filed October 4, 2018).
4.14
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).
4.15
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).
52
4.16
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).
4.17
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).
4.18
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).
4.19
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).
4.20
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).
4.21
March 2019 Amendment to September 28, 2018 Secured Convertible Promissory Note from the Company to 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 March 15, 2019).
4.22
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).
4.23
Description of Common Stock.*
10.1
Form
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).
10.2
Form
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.
10.3
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).
10.4
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).
10.5
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).
10.6
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).
10.7
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).
10.8
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).
10.9
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).
10.10
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) (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).
10.11
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).
10.12
Early Access Agreement with Impatients N.V. 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).
10.13
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) (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).
10.14
Addendum to Early Access Agreement with Impatients N.V. 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).
10.15
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).
10.16
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).
10.17
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).
10.18
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).
10.19
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).
10.20
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).
53
10.21
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).
10.22
Amended and Restated Early Access Agreement with Impatients N.V. dated May 20, 2016. (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).
10.23
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).
10.24
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).
10.25
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).
10.26
March 26, 2018 Amendment No. 4 to Amended and Restated Early Access Agreement with Impatients N.V. (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).
10.27
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).
10.28
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).
10.29
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).
10.30
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).
10.31
Form of August 2017 Agreement between the Company and the Warrant holders . (incorporated by reference to exhibit 10.1 the Company’s Current report on Form 8-K (No. 000-27072) filed August 23, 2017).
10.32
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).
10.33
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).
10.34
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).
10.35
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).
10.36
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).
10.37
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).
10.38
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).
10.39
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).
10.40
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).
10.41
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).
10.42
September 28, 2018 Security Agreement with Iliad Research and Trading, L.P. (incorporated by reference to exhibit 10.3 to the Company’s Current report on Form 8-K (No. 001-27072) filed October 4, 2018).
10.43
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).
10.44
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).
10.45
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).
10.46
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).
10.47
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).
10.48
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).
54
10.49
Security Agreement dated August 5, 2019 with Chicago Venture Partners, L.P. (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).
10.50
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).
10.51
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).
10.52
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).
10.53
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).
10.54
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).
10.55
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).
10.56
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).
10.57
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)) (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).
10.58
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)) (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).
10.59
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)) (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).
10.60
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)) (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).
10.61
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).
10.62
November 10, 2020 employment agreement with Thomas K. Equels. (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).
10.63
December 22, 2020 Master Service Agreement with Pharmaceutics International Inc. 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).
10.64
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)) (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).
10.65
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)) (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).
10.66
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)) (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).
10.67
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).
10.68
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).
10.69
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).
10.70
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).
10.71
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).
10.72
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).
55
10.73
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).
10.74
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).
10.75
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).
10.76
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)
10.77
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)
10.78
March
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))*
10.79
March
24, 2022 Consulting Agreement with Ellen Lintal (Portions of this agreement have been redacted in compliance with Regulation
S-K Item 601(b)(10))
10.80
March 1, 2022 Amendment to Clinical Trial Agreement with hVIVO Services Ltd dated September 27, 2021.*
10.81
March 3, 2022 Agreement of Sale and Purchase with Acellories, Inc for sale of 783 Jersey Avenue, New Brunswick, NJ building. *
10.82
March 8, 2022 Change order to Master Service Agreement with Pharmaceutics International Inc. as a Fill & Finish provider for Ampligen.*
16.1
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).
21.1
List of Subsidiaries*
23.1
Consent of BDO USA, LLP.*
31.1
Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer. *
31.2
Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer. *
32.1
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer. *
32.2
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer. *
101
The
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; (iii) the Condensed Consolidated Statements of Cash Flows; and (iv) Notes to Condensed Consolidated Financial Statements.
*
Filed
herewith.
(b)
Financial Statement Schedules
All
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.
Item
16. Form 10-K Summary
None.
56
SIGNATURES
Pursuant
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.
AIM
IMMUNOTECH INC.
By:
/s/
Thomas K. Equels
Thomas
K. Equels
Chief
Executive Officer
March
31, 2022
Pursuant
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.
/s/
Thomas K Equels
Chief
Executive Officer & President,
March
31, 2022
Thomas
K. Equels
Director
of the Board
/s/
William Mitchell
Chairman
of the Board
March
31, 2022
William
Mitchell, M.D., Ph.D.
and
Director
/s/
Stewart L Appelrouth
Director
March
31, 2022
Stewart
L. Appelrouth
/s/
Ellen M Lintal E
Chief
Financial Officer
March
31, 2022
Ellen
M Lintal
57
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Index
to Consolidated Financial Statements
Page
Report of Independent Registered Public Accounting Firm (BDO USA, LLP; Miami, Florida; PCAOB ID # 243 )
F-2
Consolidated Balance Sheets at December 31, 2021 and 2020
F-3
Consolidated Statements of Comprehensive Loss for each of the years in the two-year period ended December 31, 2021
F-4
Consolidated Statements of Changes in Stockholders’ Equity for each of the years in the two-year period ended December 31, 2021
F-5
Consolidated Statements of Cash Flows for each of the years in the two-year period ended December 31, 2021
F-6
Notes to Consolidated Financial Statements
F-7
F- 1
Report
of Independent Registered Public Accounting Firm
Stockholders
and Board of Directors
AIM
ImmunoTech Inc.
Ocala,
Florida
Opinion
on the Consolidated Financial Statements
We
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.
Basis
for Opinion
These
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.
We
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. As part
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.
Our
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 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
The
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.
Calculation
of the fair value of redeemable warrants
As
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
loss. As of December 31, 2021, the fair value of the redeemable warrants was approximately $35,000.
We
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.
The
primary procedures we performed to address this critical audit matter included:
● Testing
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.
● Utilizing
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.
/s/
BDO USA, LLP
We
have served as the Company’s auditor since 2021.
Miami,
Florida
March
31, 2022
F- 2
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Balance Sheets
December
31, 2021 and 2020
(in
thousands, except for share and per share amounts)
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
$ 32,093
$ 38,501
Marketable securities
16,175
501
Funds receivable from New Jersey net operating loss
1,641
1,090
Accounts receivable
—
34
Prepaid expenses and other current assets
304
184
Total current assets
50,213
40,310
Property and equipment, net
4,047
6,473
Right of use asset, net
149
179
Patent and trademark rights, net
1,974
1,498
Marketable securities, long term
—
15,376
Other assets
1,316
748
Total assets
$ 57,699
$ 64,584
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 198
$ 383
Accrued expenses
438
442
Current portion of operating lease liability
37
47
Current portion of financing obligation
—
230
Total current liabilities
673
1,102
Long-term liabilities:
Operating lease liability
112
132
Financing obligation arising from sale leaseback transaction (Note 17)
—
1,876
Redeemable warrants
35
180
Commitments and contingencies (Notes 8, 10, 11, 13, and 17)
-
Stockholders’ equity:
Series B Convertible Preferred Stock, stated value $ 1,000 per share, issued and outstanding 715 and 732 , respectively
715
732
Common Stock, par value $ 0.001 per share, authorized 350,000,000 shares; issued and outstanding 47,994,672 and 42,154,371 , respectively
48
42
Additional paid-in capital
417,217
402,541
Accumulated other comprehensive loss
—
( 47 )
Accumulated deficit
( 361,101 )
( 341,974 )
Total stockholders’ equity
56,879
61,294
Total liabilities and stockholders’ equity
$ 57,699
$ 64,584
See
accompanying notes to consolidated financial statements.
F- 3
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Comprehensive Loss
(in
thousands, except share and per share data)
2021
2020
Years ended December 31,
2021
2020
Revenues:
Clinical treatment programs - US
$ 135
$ 144
Clinical treatment programs - Europe
—
19
Total Revenues
135
163
Costs and Expenses:
Production costs
850
806
Research and development
7,672
5,720
General and administrative
8,672
8,654
Impairment of assets
1,779
135
Total Costs and Expenses
18,973
15,315
Operating loss
( 18,838 )
( 15,152 )
Gain (loss) on investments
( 201 )
219
Interest expense and other finance costs
( 67 )
( 672 )
Extinguishment of financing obligation and note payable
( 2,701 )
142
Gain on sale of fixed assets
216
—
Redeemable warrants valuation adjustment
145
( 123 )
Gain from sale of income tax operating losses
2,319
1,186
Net Loss
( 19,127 )
( 14,400 )
Other comprehensive loss
Reclassification adjustment for realized investment loss
376
—
Change in unrealized loss on marketable securities available for sale
( 329 )
( 47 )
Net comprehensive loss
$ ( 19,080 )
$ ( 14,447 )
Basic and diluted loss per share
$ ( 0.40 )
$ ( 0.45 )
Weighted average shares outstanding basic and diluted
47,339,975
31,842,799
See
accompanying notes to consolidated financial statements.
F- 4
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Changes in Stockholders’ Equity
(in
thousands except share data)
Accumulated
Series B
Common
Common
Additional
other
Total
Preferred
Stock
Stock .001
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Shares
Par Value
Capital
Income (Loss)
Deficit
Equity
Balance December 31, 2019 2018
778
10,386,754
$ 10
$ 340,228
$ —
$ ( 327,574 )
$ 13,442
Shares issued for:
Common Stock issuance, net of costs
—
—
31,761,210
32
61,216
—
—
61,248
Warrant modification
—
—
—
46
—
—
46
Equity based compensation
—
—
—
1,036
—
—
1,036
Shares issued to pay accounts payable
—
6,407
—
15
—
—
15
Series B preferred shares converted to Common shares
( 46 )
—
—
—
—
—
( 46 )
Net comprehensive loss
—
—
—
—
( 47 )
( 14,400 )
( 14,447 )
Balance December 31, 2020
732
42,154,371
42
402,541
( 47 )
( 341,974 )
61,294
Shares issued for:
Common Stock issuance, net of costs
—
—
5,790,301
6
13,036
—
—
13,042
Shares issued for: Common stock issuance, net of costs
—
5,790,301
6
13,036
—
—
13,042
Equity-based compensation
—
—
—
1,568
—
—
1,568
Shares issued to pay accounts payable
—
50,000
—
55
—
—
55
Series B preferred shares converted to Common shares
( 17 )
—
—
17
—
—
—
Net comprehensive loss
—
—
—
—
47
( 19,127 )
( 19,080 )
Balance December 31, 2021
715
47,994,672
$ 48
$ 417,217
$ —
$ ( 361,101 )
$ 56,879
See
accompanying notes to consolidated financial statements.
F- 5
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Cash Flows
(in
thousands)
2021
2020
Years ended December 31,
2021
2020
Cash flows from operating activities:
Net loss
$ ( 19,127 )
$ ( 14,400 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment
659
665
Redeemable warrants valuation adjustment
( 145 )
123
Abandonment of patents and trademarks
—
158
Gain on sale of fixed assets
( 216 )
—
Allowance for bad debt recovery
—
( 30 )
Warrant modification
—
46
Extinguishment of financing obligation and note payable
2,701
142
Amortization of patent, trademark rights
116
68
Changes in ROU assets
30
( 27 )
Inventory write-off
—
1,095
Impairment of plant property equipment and other assets
1,779
135
Gain from sale of income tax operating losses
( 2,319 )
( 96 )
Equity-based compensation
1,568
1,036
Realized gain (loss) on sale of marketable securities
47
—
Amortization of finance and debt issuance costs
47
112
Change in assets and liabilities:
Accounts receivable
34
40
Funds receivable from New Jersey operating loss sales
( 551 )
( 314 )
Prepaid expenses and other current assets and other non current assets
1,631
671
Lease liability
( 30 )
27
Accounts payable
( 185 )
( 89 )
Accrued interest expense
—
231
Accrued expenses
( 4 )
39
Net cash used in operating activities
( 13,965 )
( 10,368 )
Cash flows from investing activities:
Proceeds from sale of marketable securities
22,292
10,044
Purchase of marketable securities
( 22,535 )
( 18,613 )
Purchase of property and equipment
( 41 )
( 22 )
Proceeds from sales of property and equipment
245
—
Purchase of patent and trademark rights
( 592 )
( 573 )
Net cash used in investing activities
( 631 )
( 9,164 )
Cash flows from financing activities:
Financing obligation payments
( 122 )
( 355 )
Payoff of note payable
( 4,732 )
( 4,330 )
Proceeds from sale of stock, net of issuance costs
13,042
61,248
Net cash provided by financing activities
8,188
56,563
Net (decrease) increase in cash and cash equivalents
( 6,408 )
37,031
Cash and cash equivalents at beginning of period
38,501
1,470
Cash and cash equivalents at end of period
$ 32,093
$ 38,501
Supplemental disclosures of non-cash investing and financing cash flow information:
Stock issued to settle accounts payable
$ 55
$ 15
Conversion of Series B preferred
$ 17
46
Operating Lease - Right of Use Assets
$ 18
$ 66
See
accompanying notes to consolidated financial statements.
F- 6
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(1) Business
AIM
ImmunoTech Inc. 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.
AIM’s
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”).
The
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.
AIM
currently is proceeding primarily in three areas:
● Ampligen
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.
● Exploring
Ampligen’s antiviral activities and potential use as a prophylactic or treatment for
existing viruses, mutations thereof or new viruses.
● Ampligen
as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”)
and what we refer to as Post-COVID-19 Cognitive Impairment.
Today,
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.
Alferon
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.
The
Company recently announced the sale of its 30,000
sq. ft. 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
(a)
Cash and Cash Equivalents
Cash
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.
F- 7
(b)
Marketable Securities
Marketable
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.
(c)
Property and Equipment, net
Schedule of Property and Equipment
2021
2020
(in thousands)
December 31,
2021
2020
Land, buildings and improvements
$ 3,900
$ 10,547
Furniture, fixtures, and equipment
2,353
5,136
Total property and equipment
6,253
15,683
Less: accumulated depreciation and amortization
( 2,206 )
( 9,210 )
Property and equipment, net
$ 4,047
$ 6,473
Property
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 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).
(d)
Patent and Trademark Rights, net
Patents
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.
(e)
Use of Estimates
The
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.
Impact
of the Novel Coronavirus
On
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.
F- 8
The
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.
Management
is actively monitoring the global situation on its financial condition, liquidity, operations, scientific collaborations, suppliers,
industry, and workforce. 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 2022.
Although
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 2022.
Coronavirus
Aid, Relief and Economic Security Act
On
March 27, 2020, the U.S. Government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was signed
into law. 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. The Company has no intention of
taking advantage of other benefits.
(f)
Revenue
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; and (v) recognize revenue when (or as) the entity satisfies a performance
obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration
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. 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
satisfied
Revenue
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.
Revenue
from the sale Ampligen under the EAP is recognized as the product is distributed and administered to patients involved in the cost recovery
program.
(g)
Accounting for Income Taxes
Deferred
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
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. 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.
F- 9
(h)
Recent Accounting Standards and Pronouncements
In
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.
In
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
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.
In
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.
Other
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.
(i)
Stock-Based Compensation
The
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.
F- 10
(j)
Accounts Receivable
Concentration
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.
(k)
Common Stock Per Share Calculation
Basic
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.
(l)
Long-Lived Assets
The
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.
The
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. 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.
(3)
Marketable Securities
Marketable
securities consist of mutual funds and debt securities. At December 31, 2021 and 2020, it was determined that none of the marketable
securities had an other-than-temporary impairment. 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: Fair Value). 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.
Mutual
Funds classified as available for sale consisted of:
Schedule of Available for Sale
December 31, 2021
(in thousands)
Securities
Fair
Value
Short-Term
Investments
Mutual Funds
$ 16,175
$ 16,175
Totals
$ 16,175
$ 16,175
Schedule
of Equity Securities
Securities
December 31, 2021
(in
thousands)
Net losses recognized during the period on
equity securities
$ ( 88 )
Less: 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
$ ( 88 )
Debt
Securities classified as available for sale consisted of:
Schedule of Available for Sale
December
31, 2020
(in
thousands)
Securities
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
(Losses)
Fair
Value
Marketable Securities
U.S. Treasury notes
$ 5,746
$ —
$ ( 47 )
$ 5,699
$ 5,699
U.S. Government mortgage backed securities
4,890
—
( 52 )
4,838
4,838
Corporate bonds
5,288
52
—
5,340
5,340
Totals
$ 15,924
$ 52
$ ( 99 )
$ 15,877
$ 15,877
F- 11
December
31, 2020
(in thousands)
Less than 12 Months
12 Months or More
Total
Securities
Fair Value
Gross
Unrealized
Gains (Losses)
Fair Value
Gross
Unrealized
Gains (Losses)
Fair Value
Gross
Unrealized
Gains (Losses)
U.S. Treasury notes
$ 501
$ —
$ 5,245
$ ( 47 )
$ 5,699
$ ( 47 )
U.S. Government mortgage backed securities
—
—
4,890
( 52 )
4,838
( 52 )
Corporate bonds
—
—
5,288
52
5,340
52
Totals
$ 501
$ —
$ 15,423
$ ( 47 )
$ 15,877
$ ( 47 )
Gross
realized gain recognized during 2021 was $ 11,000 and gross realized (loss) of $ 1,000 during 2020.
(4)
Patents, Trademark Rights ,
Schedule
of Patents, Trademark Rights
December 31, 2019
$ 1,151
Acquisitions
573
Abandonments
( 158 )
Amortization
( 68 )
December 31, 2020
$ 1,498
Acquisitions
592
Amortization
( 116 )
December 31, 2021
$ 1,974
Patents
and trademarks are stated at cost 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.
Amortization
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,
2022
$ 75
2023
149
2024
174
2025
195
2026
231
Thereafter
1,150
Total
$ 1,974
F- 12
(5) Accrued Expenses
Accrued
expenses at December 31, 2021 and 2020 consist of the following:
Schedule of Accrued Expenses
2021
2020
(in thousands)
December 31,
2021
2020
Compensation
$ 1
$ 2
Professional fees
169
124
Clinical trial expenses
61
—
Other expenses
207
316
Accrued
expenses
$ 438
$ 442
(6)
Stockholders’ Equity
(a)
Preferred Stock
The
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.
The
Company is authorized to issue 8,000 Series B Convertible Preferred Stock, no par value, stated value $ 1,000 per share. 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. 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.
Pursuant
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 . 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, 2021, 17 shares of Series B Convertible Preferred Stock were
converted into common stock.
(b)
Common Stock
The
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.
On
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. Subsequent plans were approved by the board of directors upon the expiration of prior plans. The
latest plan was approved by the board of directors on September 14, 2021.
During
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 .
During
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 .
F- 13
On
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 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.
On
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 . 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.
The
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 . 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 .
As
of December 31, 2021, and 2020, there were 47,994,672 and 42,154,371 shares outstanding, respectively.
(c)
Equity Financings
See
(b) above
(d)
Common Stock Options and Warrants
(i)
Stock Options
The
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.
The
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.
F- 14
The
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.
Stock
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; (c) the Company’s stockholders approve a merger or 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 in control.
The
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.
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 granted were estimated based on the following weighted average assumptions:
Schedule of Options and Equity Estimated Based on Weighted Average Assumptions
Year
Ended December 31,
2021
2020
Risk-free
interest rate
0.66 %
- 1.23 %
0.3 %
- 0.46 %
Expected
dividend yield
—
—
Expected
life
5
years
5
years
Expected
volatility
108.08 %
- 108.46 %
115.24 %
- 116.79 %
Weighted
average grant date fair value for options issued
$1.61
per option for 613,512 options
$2.28
per option for 1,025,000 options
The
exercise price of all stock options and equity warrants granted was equal to or greater than the fair market value of the underlying
common stock on the date of the grant.
Information
regarding the options approved by the Board of Directors under Equity Plan of 2009 is summarized below. The plan expired June 24, 2019:
Schedule of Stock Option Activity
2021
2020
Shares
Option
Price
Weighted
Average
Exercise
Price
Shares
Option
Price
Weighted
Average
Exercise
Price
Outstanding, beginning of year
129,680
13.20 – 2,127.84
23.05
132,615
13.20 - 2,127.84
31.65
Granted
—
—
—
—
—
Forfeited
( 1,176 )
16.76 - 1056.00
289.62
( 2,935 )
9.68 – 380.16
82.38
Exercised
—
—
—
—
—
—
Outstanding, end of year
128,504
13.20 - 2,127.84
25.58
129,680
13.20 - 2,127.84
23.05
Exercisable, end of year
126,393
13.20 - 2,127.84
98,138
13.20 – 2,127.84
Weighted average remaining contractual life (years)
5.9 years
5.6
years
F- 15
Information
regarding the options approved by the Board of Directors under the Equity Plan of 2018 is summarized below:
Schedule of Stock Option Activity
2021
2020
Shares
Option
Price
Weighted
Average
Exercise
Price
Shares
Option
Price
Weighted
Average
Exercise
Price
Outstanding, beginning of year
1,086,549
1.85 - 9.68
2.75
61,806
9.68
9.68
Granted
613,512
1.11 – 1.71
1.67
1,025,000
1.85 – 3.07
2.33
Forfeited
( 50,044 )
1.85 – 8.50
1.86
( 257 )
9.68 – 16.72
2.75
Exercised
—
—
—
—
—
—
Outstanding, end of year
1,650,017
1.11 – 9.68
2.35
1,086,549
1.85 – 9.68
2.75
Exercisable, end of year
1,141,798
1.11 – 9.68
2.35
243,750
1.85 – 9.68
2.75
Weighted average remaining contractual life (years)
9.12 years
9.4
years
Available for future grants
344,322
28,268
Stock
option activity during the years ended December 31, 2021 and 2020 is as follows:
Stock
option activity for employees
Schedule
of Stock Option Activity
Number of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contracted
Term
(Years)
Aggregate
Intrinsic
Value
Outstanding December 31, 2019
127,747
$ 29.61
6.41
—
Granted
925,000
2.28
9.78
—
Forfeited
( 2,483 )
19.50
—
—
Expired
( 569 )
348.48
—
—
Outstanding December 31, 2020
1,049,695
$ 5.38
9.28
—
Granted
500,000
1.60
9.11
—
Forfeited
( 50,897 )
—
Expired
—
—
—
—
Outstanding December 31, 2021
1,498,798
$ 4.22
9.11
—
Vested and expected to vest at December 31, 2021
1,498,798
$ 4.22
9.11
—
Exercisable at December 31, 2021
1,086,298
$ 3.52
7.96
—
The
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.
F- 16
Unvested
stock option activity for employees:
Schedule
of Unvested Stock Option Activity
Number of
Options
Weighted
Average
Exercise
Price
Average
Remaining
Contracted
Term
(Years)
Aggregate
Intrinsic
Value
Unvested December 31, 2019
30,100
$ 23.79
7.48
—
Granted
925,000
2.28
9.78
—
Vested
( 226,254 )
3.93
7.53
—
Forfeited
—
—
—
—
Unvested December 31, 2020
728,846
$ 3.71
9.61
—
Granted
449,102
1.60
9.11
—
Vested
( 765,448 )
2.24
8.36
—
Forfeited
—
—
—
—
Unvested December 31, 2021
412,500
$ 4.15
5.85
—
Stock
option activity for non-employees during the year:
Schedule
of Stock Option Activity
Number
of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contracted
Term
(Years)
Aggregate
Intrinsic
Value
Outstanding December 31, 2019
66,675
$ 12.80
5.59
—
Granted
100,000
2.77
—
—
Exercised
—
—
—
—
Forfeited
( 142 )
104.29
—
—
Outstanding December 31, 2020
166,533
$ 11.03
6.88
—
Granted
113,512
1.64
9.92
—
Exercised
—
—
—
—
Forfeited
( 322 )
965.93
—
—
Outstanding December 31, 2021
279,723
$ 6.12
7.93
—
Vested and expected to vest at December 31, 2021
279,723
$ 6.12
7.93
—
Exercisable at December 31, 2021
181,892
$ 7.11
7.53
—
The
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.
Unvested
stock option activity for non-employees:
Schedule
of Unvested Stock Option Activity
Number of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contracted
Term
(Years)
Aggregate
Intrinsic
Value
Unvested December 31, 2019
25,566
$ 12.80
5.59
—
Granted
100,000
2.77
9.58
—
Vested
( 59,364 )
5.95
—
—
Forfeited
—
—
—
—
Unvested December 31, 2020
66,202
$ 7.24
6.13
—
Granted
113,512
1.64
9.92
—
Vested
( 81,883 )
3.48
—
—
Forfeited
—
—
—
—
Unvested December 31, 2021
97,831
$ 3.89
7.82
—
F- 17
Stock-based
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.
As
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.
(ii)
Stock Warrants
Stock
warrants are issued as needed by the Board of Directors and have no formal plan.
The
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.
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 2021 or 2020.
Information
regarding warrants outstanding and exercisable into shares of common stock is summarized below:
Schedule
of Warrants Outstanding and Exercisable
2021
2020
Shares
Warrant
Price
Weighted
Average
Exercise
Price
Shares
Warrant
Price
Weighted
Average
Exercise
Price
Outstanding, beginning of year
375,100
$ 0.99 – 469.92
$ 116.38
10,201,761
$ 0.99 – 469.92
$ 1.54
Granted
—
—
—
—
—
—
Expired
( 79,593 )
17.16 – 84.48
20.85
—
—
—
Exercised
( 568 )
8.80
8.80
( 9,826,661 )
0.90 - 8.80
0.97
Outstanding, end of year
294,939
$ 0.99 - 469.92
$ 15.19
375,100
$ 0.99 – 469.92
$ 116.38
Exercisable
294,939
$ 0.99 - 469.92
$ 15.19
375,100
$ 0.99 – 469.92
$ 116.38
Weighted average remaining contractual life
4.75 years
5.75 years
Years exercisable
2022 - 2025
2021 - 2024
Stock
warrants are issued at the discretion of the Board. In 2021 and 2020 there were no warrants issued and 568 warrants were exercised in
2021 and 9,826,661 were exercised in 2020.
(7)
Segment and Related Information
The
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. All assets
are maintained in the United States of America.
(8) Research,
Consulting and Supply Agreements
In
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 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.
Jubilant
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.
F- 18
The
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.
In
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.
In
December 2020, AIM added Pharmaceutics International Inc. (“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 .
In
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 .
In
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 .
In
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
2022.
(9)
401(k) Plan
The
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.
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
(10)
Employment Agreements
The
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. 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 2021 and 2020, Officers’ bonuses were $ 550,000
and $ 913,500 respectively.
In
2021, equity was granted as a form of compensation to these Officers.
F- 19
a. The
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.
b. The
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
Counsel.
c. The
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.
The
Company recorded stock compensation expense of approximately $ 105,000 during the year ended December 31, 2021. with regard to these issuances.
In
2020, equity was granted as a form of compensation to these Officers.
d. 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.
e. 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. Equels, Chief Executive Officer.
f. 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
Counsel.
g. 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.
The
Company recorded stock compensation expense of approximately $ 374,000 during the years ended December 31, 2020 with regard to these issuances.
(11) Leases
The
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.
The
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.
The
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.
At
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.
F- 20
Operating
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.
The
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.
On
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.
On
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.
The
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
months and 4
years. As of December 31, 2021,
and 2020, the weighted-average remaining term is 2.72 and 1.92 years, respectively.
The
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
2019.
Schedule of Operating lease Future Payments
Year Ending December 31,
2022
$ 60
2023
53
2024
34
2025
16
Thereafter
—
Less imputed interest
( 14 )
Total
$ 149
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. 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)
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. 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.
As
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
$ 22.7 M
of New Jersey state net operating loss carryforwards ( expiring
in 2041 ). The Company has approximately
$ 41.9 M
of Florida state net operating loss carryforwards with no expiration date to offset future Florida taxable income. The Company has approximately
$ 2.8 M
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 .
F- 21
The
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.
Under
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.
Deferred
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.
The
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
2021
2020
(in thousands)
Deferred tax assets:
December 31,
2021
2020
Net operating losses
$ 15,988
$ 9,742
Research and Development costs
7,077
Amortization & depreciation
1,108
150
R&D credits
82
—
Other
54
—
Stock compensation
708
271
Total deferred tax assets
25,016
10,163
Deferred tax liabilities:
Research and development costs
—
( 94 )
Deferred tax assets, net
25,016
10,069
Less: Valuation allowance
( 23,711 )
( 9,437 )
Deferred tax assets, net
1,305
632
Deferred
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 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.
F- 22
Rate
Reconciliation
Reconciliation
between the effective tax rate on income from continuing operations and the statutory tax rate is as follows (in thousands):
Schedule
of Effective Tax Rate and Statutory Tax Rate
Pre Tax Book Loss
$ ( 19,127 )
Federal Rate
( 4,017 )
21.00 %
State Taxes
( 105 )
0.60 %
RTP
54
- 0.28 %
Valuation Allowance
4,068
- 21.32 %
Total
—
0.00 %
(13)
Note Payable
On
August 5, 2019, the Company issued a Secured Promissory Note (the “CV Note”) with Chicago Venture Partners, L.P. (the “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.
During
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 . Interest expense associated with the CV Note was approximately $ 116,000 , for the year ended December 31, 2020.
On
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. 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 .
Interest expense associated with AS Note for the period ending December 31, 2020 was approximately $ 106,000.
(14)
Certain Relationships and Related Transactions
The
Company has an employment agreement with its NEOs and has granted its NEOs and directors options to purchase its common stock. Please
see details of these Employment Agreements in Note 10 - Employment Agreements.
As
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 Risk
Financial
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.
There
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. Jubilant
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
Inc. (“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.
F- 23
Currently,
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.
(16)
Fair Value
The
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.
The
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
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 recomputes the fair value of the Warrants at the issuance date and the end of each quarterly reporting period. 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.
The
Company utilized the following assumptions to estimate the fair value of the February 2017 Warrants:
Schedule of Assumptions to Estimate Fair Value of Warrants
December 31,
December 31,
2021
2020
Underlying price per share
$ 0.92
$ 1.79
Exercise price per share
$ 30.25 -$ 33.00
$ 30.25 -$ 33.00
Risk-free interest rate
0.22 %- 0.23 %
0.126 %
Expected holding period
0.58 - 0.60
1.58 - 1.60
Expected volatility
45 %
160 %
Expected dividend yield
—
—
The
Company utilized the following assumptions to estimate the fair value of the June 2017 Warrants:
December 31,
December 31,
2021
2020
Underlying price per share
$ 0.92
$ 1.79
Exercise price per share
$ 27.50
$ 27.50
Risk-free interest rate
0.15 %
0.11 %
Expected holding period
0.42
1.42
Expected volatility
50 %
175 %
Expected dividend yield
—
—
F- 24
The
Company utilized the following assumptions to estimate the fair value of the August 2017 Warrants:
December 31,
December 31,
2021
2020
Underlying price per share
$ 0.92
$ 1.79
Exercise price per share
$ 19.80
$ 19.80
Risk-free interest rate
0.06 %
0.11 %
Expected holding period
0.18
1.18
Expected volatility
65 %
165 %
Expected dividend yield
—
—
The
Company utilized the following assumptions to estimate the fair value of the April 2018 Warrants:
December 31,
December 31,
2021
2020
Underlying price per share
$ 0.92
$ 1.79
Exercise price per share
$ 17.16
$ 17.16
Risk-free interest rate
0.67 %
0.16 %
Expected holding period
1.81
2.81
Expected volatility
120 %
130 %
Expected dividend yield
—
—
The
Company utilized the following assumptions to estimate the fair value of the March 2019 Warrants:
December 31,
December 31,
2021
2020
Underlying price per share
$ 0.92
$ 1.79
Exercise price per share
$ 8.80
$ 8.80
Risk-free interest rate
0.78 %
0.19 %
Expected holding period
2.19
3.19
Expected volatility
125 %
125 %
Expected dividend yield
—
—
The
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.
(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.
(iii) Expected
Volatility . 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.
(v) Expected
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:
1. The
Company only has one product that is FDA approved but is currently not available for commercial
sales.
2. The
Company will have to perform additional clinical trials for FDA approval of its flagship
product.
3. Industry
and market conditions continue to include uncertainty, adding risk to any transaction.
4. Available
capital for a potential buyer in a cash transaction continues to be limited.
5. The
nature of a life sciences company is heavily dependent on future funding and high fixed costs,
including Research & Development.
6. The
Company has minimal revenues streams which are insufficient to meet the funding needs for
the cost of operations or construction at their manufacturing facility; and
7. The
Company’s Rights Agreement and Executive Agreements make it less attractive to a potential
buyer.
F- 25
With
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
Probability
Low
0.5 %
Medium
1.0 %
High
5.0 %
The
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.
(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.
(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.
(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.
While
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.
The
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.
FASB
ASC 820-10-35-37 (formerly SFAS No. 157) establishes a valuation hierarchy based on the transparency of inputs used in the valuation
of an asset or liability. Classification is based on the lowest level of inputs that is significant to the fair value measurement. The
valuation hierarchy contains three levels:
1. Level
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. Level
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. Level
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. As
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.
F- 26
The
table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy
as:
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis
(in thousands)
As of December 31, 2021
Total
Level 1
Level 2
Level 3
Assets:
Marketable securities
$ 16,175
$ 16,175
$ —
$ —
Liabilities:
Redeemable warrants
$ 35
—
—
$ 35
(in thousands)
As of December 31, 2020
Total
Level 1
Level 2
Level 3
Assets:
Marketable securities
$ 15,877
$ 15,877
$ —
$ —
Liabilities:
Redeemable warrant
$ 180
—
—
$ 180
The
changes in Level 3 Liabilities measured at fair value on a recurring basis are summarized as follows (in thousands):
Schedule
of Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis
Redeemable warrants:
Balance at December 31, 2020
$ 180
Fair value adjustments
( 145 )
Balance at December 31, 2021
$ 35
The
table below presents the balances of assets and liabilities measured at fair value on a nonrecurring basis by level within the hierarchy
as:
Schedule
of Assets and Liabilities Measured at Fair Value on a NonRecurring Basis
(in thousands)
As of December 31, 2021
Total
Level 1
Level 2
Level 3
Total Gains (Losses)
Assets:
Long lived assets held and used (a)
$ 3,900
$ —
$ —
$ 3,900
$ 1,800
(a) In
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.
(17)
Financing Obligation Arising from Sale Leaseback Transaction
On
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 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.
F- 27
On
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
debt.
For
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
Events
On
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.
On
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.
In
determining whether to proceed with a Human Challenge Trial (“HCT”) with hVIVO Services Ltd at their quarantine facility
in the U.K. 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.
On
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).
On
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.
F- 28