Item 9A. Controls and Procedures
ITEM
9A.
Controls and Procedures.
Effectiveness
of Control Procedures
As
of December 31, 2023, 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, 2023, 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, 2023. 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). A material weakness is a deficiency, or combination of
deficiencies, such that there is a reasonable possibility that a material misstatement of
our annual or interim financial statements will not be prevented or detected on a timely basis.
Management
has concluded that we did maintain effective internal control over financial reporting as of December 31, 2023, 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.
None.
42
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
71
Chief
Executive Officer, President, and Director
Peter
W. Rodino III
72
Chief
Operating Officer, General Counsel & Secretary
William
M. Mitchell, M.D., Ph.D.
89
Chairman
of the Board and Director
Stewart
L. Appelrouth
70
Director
Nancy
Bryan
66
Director
Robert
Dickey IV
68
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.
43
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, is our Chief Executive Officer (since 2016), President (since 2015) and Executive
Vice Chairman (since 2008). He has also been one of our Directors since 2008. Mr. Equels was formerly the President and Managing Director
of the Equels Law Firm in Miami, Fla. For over a quarter century, he represented national governments, state governments and private companies
in banking, insurance, aviation, pharmaceutical and construction matters. He also was on numerous occasions the court-appointed receiver
to turn around distressed companies. 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 Master 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.
THOMAS
K. EQUELS, Esq. - Director Qualifications:
●
Leadership
Experience – Military, Owner and former President, Managing Director of Equels Law Firm, Court appointed receiver in numerous
industries;
●
Industry
Experience – as legal counsel, General Counsel, CFO and CEO; and
Biotech,
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, Microbiology & Immunology at Vanderbilt University School of Medicine and is a board certified physician. Dr. Mitchell
earned an M.D. from Vanderbilt University and a Ph.D. from Johns Hopkins University, where he served as a 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
viral pathogenesis, anti-viral drugs, immune responses to infection, cancer diagnostics, as well as other biomedical topics. Dr. Mitchell
has been active in 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, the International Academy of Pathology, the United States and Canadian Academy of Pathology, 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 was an independent member of the Board of Directors
for Chronix Biomedical and was 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;
44
●
Academic
and Industry Experience – Physician scientist with extensive investigative experience on viral and immunology, and cancer issues
relevant to our scientific business along with being a former independent Director of an entrepreneurial diagnostic company (Chronix
Biomedical) that is involved in next generation DNA sequencing for blood based cancer diagnosis (i.e.- the liquid biopsy).; 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. and, since March 2022, a partner at Citrin Cooperman Advisors, LLP, both Certified Public
Accountants. 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.
NANCY
K. BRYAN - was appointed as a director in March 2023. Ms. Bryan is an established leader with more than 35 years of experience
in the life sciences industry. She has served on executive leadership teams and played key roles in biopharmaceutical
companies’ successes, including marketing, sales, business development, financing, and communications. From 2013 to 2023, Ms.
Bryan served as President and CEO of BioFlorida Inc., an association supporting the advancement of life sciences in Florida. Prior
to joining BioFlorida, Ms. Bryan began her career with major pharmaceutical companies including Merck, GlaxoSmithKline and Bayer
Pharmaceuticals. She then went on to serve in a number of executive leadership positions in specialty pharmaceuticals and smaller,
start-up biotech companies, including Indevus Pharmaceuticals and NPS Pharmaceuticals. Throughout her career, Ms. Bryan helped
develop, launch, and commercialize many products including blockbusters (Zantac, Levitra), major biologics (Tysabri) and orphan
drugs for rare diseases (Valstar for bladder cancer, Supprelin LA for central precocious puberty), and helped establish franchises
in a wide variety of therapeutic areas, including Oncology, Anti-infectives, GI and Autoimmune (MS, CD). She has established a
successful track record with introducing strategic and tactical solutions to develop global markets as well as launch, grow and turn
around established and underperforming drugs, resulting in greater revenue, market share, profitability, and stockholder
value.
Ms.
Bryan holds a BA in Economics from the University of Virginia and an MBA from Columbia University, and her academic honors include Phi
Beta Kappa and Beta Gamma Sigma.
NANCY
K. BRYAN – Director Qualifications:
●
Leadership
Experience – President and CEO of BioFlorida; served on executive leadership teams and played a key role in biopharmaceutical
companies’ successes including marketing, sales, business development, financing initiatives and investor and PR communications;
and
●
Commercialization
Experience – 25 years of experience in Biopharmaceuticals in commercial positions of increasing responsibility involving primary
care, biologics and specialty markets; throughout her career, she has developed, launched and commercialized many products, major
biologics and orphan drugs for rare diseases and has established franchises in a wide variety of therapeutic areas including: Oncology,
Anti-infectives, GI and Autoimmune (MS,CD).
45
Information
about our Executive Officers
In
addition to Mr. Equels (discussed above), the following are our Executive Officers during fiscal 2023:
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.
ROBERT
DICKEY, IV has been our Chief Financial Officer since April 4, 2022. Mr. Dickey has more than 25 years of experience in 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. Mr. Dickey has served as Managing Director at Foresite Advisors
since March 2020 assuming responsibility for CFO advisory, financial analysis, capital raising, and transactional support/execution for
public offerings and M&A services at life science companies and was previously a Managing Director at Danforth Advisors from August
2018 to March 2020. Both Foresite Advisors and Danforth Advisors provide financial support and investment advisory services. Mr. Dickey
served as a member on the board of directors at Emmaus Life Sciences, a biopharmaceutical company, from July 2019 to August 2022; served
as a member on the board of directors at Sanuthera, Inc., a privately held medical device company, from 2013 to 2017, and was employed
as Chief Financial Officer of Motif Bio Plc., a NASDAQ and London AIM exchange-listed antibiotics company, from January 2017 to February
2018. 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, 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.
Audit
Committee and Audit Committee Expert
The
Audit Committee of our Board consists of Stewart L. Appelrouth (Chair) and Dr. Mitchell, both determined by the Board 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. On March 28, 2023, Ms. Bryan was appointed as an additional member
of the Audit Committee.
We
believe Dr. Mitchell, Ms. Bryan 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 (1) 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; (2)
select the independent registered public accounting firm, oversee the work of the independent registered public accounting firm, pre-approve
all auditing services of the independent registered public accounting firm and evaluate the independent registered public accounting
firm’s qualifications, independence and performance; (3) prepare the reports or statements as may be required by NYSE American
or the securities laws; (4) 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; (5) discuss the financial statements and
reports with management and the independent registered public accounting firm, including critical accounting policies and practices,
our disclosures in our Annual Report and any significant financial reporting that arose in the preparation of the audited financial statements;
and (6) oversee the Disclosure Control Committee. The Audit Committee is authorized to engage independent counsel and other advisors
as it deems necessary.
This
Audit Committee formally met twelve times in 2023 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”.
46
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 met one time in 2023.
Disclosure
Controls Committee
The
Disclosure Controls Committee (“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. The DCC is responsible
for (1) implementing, monitoring and evaluating our disclosure controls and procedures; (2) reviewing and evaluating our interactions
with the FDA and other similar regulatory bodies; and (3) reviewing with the Audit Committee our earnings and other press releases and
periodic reports and proxy statements that are to be filed with the SEC. Robert Dickey, our CFO, is the DCC’s Investor Relations
Coordinator and Chair. The other members of the DCC are Peter Rodino, our COO and General Counsel, Dr. William Mitchell, one of our Independent
Directors, Dr. David Strayer, Chief Scientific Officer, Diane Young, our Clinical Project Manager, Jodie Pelz, our Director of Finance,
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 2023.
Executive
Committee
In
February 2016, our Board formed the Executive Committee. On March 28, 2023, Ms. Bryan was appointed as an additional member of this 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 chair
of the Committee and is a member of the Committee along with three of our independent directors, Mr. Appelrouth, Dr. Mitchell and Ms.
Bryan. The full text of the Executive Committee Charter, as approved by the Board, is available on our website: www.aimimmuno.com in
the “Investor Relations” tab under “Corporate Governance”. The Committee did not meet in 2023.
Corporate
Governance and Nomination Committee
The
Corporate Governance and Nomination Committee consists of Dr. William M. Mitchell (Chair) and Director, and Mr. Stewart L. Appelrouth,
Director. On March 28, 2023, Ms. Nancy Bryan was appointed as an additional member of this committee. In 2023, the Corporate Governance
and Nomination Committee met two times. All committee members were in attendance for the meetings.
All
of the members of the Committee meet the independence standards contained within the NYSE American Company Guide and AIM’s Corporate
Governance Guidelines. The full text of the Corporate Governance and Nomination Committee Charter as well as the Corporate Governance
Guidelines, are available on our website: https://aimimmuno.com/corporate-governance/.
The
Corporate Governance and Nomination Committee is responsible for (1) assisting the Board in identifying, recommending, assessing, recruiting
and selecting candidates to serve as members of the Board, including in connection with filling vacancies; (2) assisting the Board in
developing criteria for identifying and selecting individuals for nomination to the Board; (3) advising the Board with respect to the
Board’s composition, procedures and committees; (4) reviewing, assessing and recommending appropriate Corporate Governance Guidelines;
(5) reviewing the charter of each committee of the Board and recommending to the Board the number, identity and responsibilities of each
committee; (6) reviewing our business practices as they relate to preserving our good reputation; (7) developing and recommending to
the Board procedures for succession planning for our executives and continuity of the Board; and (8) assessing the effectiveness of the
Board in meeting the long-terms interest of the stockholders. The Committee is authorized to retain search firms and other consultants
to assist it in identifying candidates and fulfilling its other duties.
Stockholders
who wish to suggest qualified candidates should write to the Corporate Secretary, AIM ImmunoTech Inc., 2117 SW Highway 484, Ocala, Florida
34473, stating in detail the qualifications of such persons for consideration by the Committee. Director candidates should demonstrate
the qualifications, experience and skills for Board members which are important to AIM’s business and its future, as outlined in
Proposal 1 below.
47
We
aspire to the highest standards of ethical conduct; reporting results with accuracy and transparency; and maintaining full compliance
with the laws, rules and regulations that govern our business. AIM’s Corporate Governance Guidelines embody many of our policies
and procedures which are at the foundation of our commitment to best practices. The guidelines are reviewed annually and revised if deemed
necessary, to continue to reflect best practices.
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.
Section
16(a) Beneficial Ownership Reporting Compliance
Under
federal securities laws, our directors and officers, and any beneficial owner of more than 10% of a class of our equity securities,
are required to report their ownership of the Company’s equity securities and any changes in such ownership in a timely
manner. We are required to disclose in this Report any delinquent filing of such reports and any failure to file such reports during
the fiscal year ended December 31, 2023. Based solely upon information provided by officers and directors and greater than 10%
owners, we are not aware of any filings not made on a timely basis, except for two Forms 4 filed on March 27, 2024, to report awards
of options to Thomas Equels and Peter Rodino on November 30, 2023.
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;
●
Robert
Dickey IV, Chief Financial Officer (“CFO”); and
●
Peter
Rodino, Chief Operating Officer (“COO”), General Counsel and Company Secretary (“CS”).
In
November 2020, we entered into an employment agreement with Thomas Equels, the agreement runs for five years with a base salary of $850,000.
Mr. Equels will be awarded a year-end target bonus of $350,000. In March 2021, subsequent to the fiscal year ended December 31, 2020,
we entered into employment agreements with Peter Rodino. The agreement runs for three years, respectively. Compensation is divided into
both short- and long-term compensation. Short-term (cash) compensation will consist of a base salary of $425,000. Mr. Rodino 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. Equels
and Mr. Rodino will be entitled to awards (“Event Awards”) equal to 3% for Mr. Equels and 1% for Mr. Rodino of the “Gross
Proceeds” from specific events such as acquisitions, 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. Equels and
Mr. Rodino also will each be entitled to an award (an “Acquisition Award”) equal to 3% for Mr. Equels and 1% for Mr. Rodino
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. On March 2022, the Company entered into
a consulting agreement with Foresite Advisors, LLC, a company wholly owned by Robert Dickey IV, for $375 an hour pursuant to which Mr.
Dickey serves as our Chief Financial Officer, effective April 4, 2022.
Governance
of Compensation Committee
The
Compensation Committee consists of the following three directors, each of whom is “independent” under applicable NYSE American
rules, a “Non-Employee Director” as defined in Rule 16b-3 under the Exchange Act, and an “Outside Director” as
defined under the U.S. Treasury regulations promulgated under Section 162(m) of the Internal Revenue Code of 1986, as amended (the “Internal
Revenue Code”): William Mitchell, M.D., Ph.D. (Chair) and Stewart L. Appelrouth. On March 28, 2023, Ms. Bryan was appointed as
an additional member of this committee.
48
The
Compensation Committee oversees implementation and administration of our compensation and employee benefits programs with the goal of
attracting, retaining and motivating executives and officers, as well as other employees, to improve their performance and our financial
performance. In that regard, the Compensation Committee (1) reviews and approves corporate goals and objectives relevant to compensation;
(2) evaluates the performance and compensation of our officers and executives and reviews the compensation of all other non-officer executives
that are considered highly paid; (3) reviews and approves employment agreements, severance agreements, change of control agreements,
deferred compensation agreements, perquisites and similar compensation arrangements of our executive officers; (4) makes recommendations
to the Board on the compensation of non-employee members of the Board; (5) administers our incentive and equity-based compensation plans,
including, approving the grant of equity awards under such plans, reviewing such plans and making recommendations to the Board regarding
the adoption, amendment or termination of such plans; (6) selects and determines the fees and scope of work of its compensation consultants;
and (7) reviews our compensation strategy to assure that it continues to advance our objectives and promote stockholder value. 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 four times in 2023 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 November 2022 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.
EXECUTIVE
COMPENSATION
The
following table provides information on the compensation during the fiscal years ended December 31, 2023 and 2022 of Thomas Equels, our
Chief Executive Officer, Peter Rodino our Chief Operating Officer, General Counsel and Secretary, Robert Dickey IV our Chief Financial
Officer.
Summary
Compensation Table
Name & Principal Position
Year
Salary / Fees
$ (2)
Bonus
$ (3) (6)
Stock Awards
$
Option
Awards
$
(1)
Non-Equity Incentive Plan Compensation
$
Change in Pension Valued and NQDC Earnings
$
All Other Compensation
$ (3)
Total
$
Thomas K Equels
2023
850,000
—
—
128,112
—
—
103,189
1,081,301
CEO & President (2)3
2022
850,000
300,000
—
111,556
—
—
90,472
1,352,028
Robert Dickey IV
2023
54,484
$ 10,000
—
—
—
—
—
64,484
CFO (2)4
2022
37,815
$ 10,000
—
—
—
—
—
47,815
Peter Rodino
COO, General Counsel
2023
425,000
—
—
42,704
—
—
59,940
527,644
& Secretary (2)5
2022
425,000
150,000
—
69,295
—
—
55,003
699,298
49
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 2023 and 2022 as well as reported separately in the “Compensation of Directors”
section (see below) for calendar year 2023.
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 2023 and
2022.
(3)
Mr. Equels’ All Other Compensations consists of:
2023
2022
Life & Disability Insurance
$ 41,073
$ 31,375
Healthcare Insurance
24,316
26,764
Car Expenses/Allowance
18,000
18,000
401(k) Matching Funds
19,800
14,333
Total
$ 103,189
$ 90,472
(4)
Mr. Dickey’s All Other Compensations consists of:
2023
2022
Life & Disability Insurance
$ —
$ —
Healthcare Insurance
—
—
Car Expenses/Allowance
—
—
401(k) Matching Funds
—
—
Total
$ —
$ —
(5)
Mr. Rodino’s All Other Compensations consists of:
2023
2022
Life & Disability Insurance
$ 2,524
$ 2,450
Healthcare Insurance
23,216
23,820
Car Expenses/Allowance
14,400
14,400
401(k) Matching Funds
19,800
14,333
Total
$ 59,940
$ 55,003
50
(6) All bonus compensation for 2023 was deferred to 2024.
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
—
—
190.08
6/6/2024
—
—
—
—
President and Chief
568
—
—
132.00
6/8/2025
—
—
—
—
Executive Officer
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
—
—
—
—
300,000
—
—
0.41
11/30/2032
—
—
—
—
—
300,000
—
0.47
11/30/2033
—
—
—
—
Total
1,254,711
300,000
—
—
—
—
—
Robert Dickey IV Chief financial Officer
50,000
—
—
0.70
03/03/2032
—
—
—
—
Total
50,000
—
—
—
—
—
—
Peter Rodino
284
—
—
68.64
6/21/2026
—
—
—
—
COO, General Counsel and Secretary
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
11/30/2031
—
—
—
—
50,000
—
—
0.70
03/03/2032
—
—
—
—
100,000
—
—
0.41
11/30/2032
—
—
—
—
—
100,000
0.47
11/30/2033
—
—
—
—
Total
344,616
100,000
—
—
—
—
—
51
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 immediate vesting of stock options. In the event of
permanent disability, the Company will provide an additional two years of base salary. On March 24, 2021, we entered into employment
agreements with Mr. Rodino 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 immediate vesting of stock options. In the event of permanent disability, the Company will
provide an additional two years of base salary. 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
2023, 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 immediate vesting of stock options. Each NEO has coverage of group life insurance,
along with accidental death and dismemberment benefits, consistent to the dollar value available to all eligible employees. The benefit
is equal to two times current salary or wage with a maximum limit of $300,000, plus any supplemental life insurance elected and paid
for by the NEO. For the period June 2010 and through December 2023, Mr. Equels is entitled to receive total death benefit coverage of
$3,000,000 pursuant to his employment agreement and payable by us.
Estimated
Payments Following Severance — Named Executive Officers (NEO)
Pursuant
to his employment agreement, Mr. Equels is entitled to severance benefits on certain types of employment terminations not related to
a change in control or termination not for cause. Mr. Rodino and Mr. Dickey are not covered by an employment severance agreement and
therefore would only receive severance as determined by the Compensation Committee in its discretion.
The
dollar amounts below assume that the termination occurred on January 2, 2024. The actual dollar amounts to be paid can only be determined
at the time of the NEO’s separation from us based on their prevailing compensation and employment agreements along with any determination
by the Compensation Committee in its discretion.
52
Name
Event
Cash
Severance ($)
Value of Stock Awards That Will Become
Vested (1) ($)
Continuation of
Medical
Benefits ($)
Additional
Life
Insurance ($)
Total ($)
Thomas K. Equels,
Involuntary (no cause)
$ 2,436,000
$ 128,112
—
—
$ 2,564,112
CEO & President
Termination (for cause)
—
—
—
—
—
Death or disability
$ 1,700,000
$ 128,112
—
—
$ 1,828,112
Termination by employee or retirement
—
$ 128,112
—
—
$ 128,112
Robert Dickey IV
Involuntary (no cause)
—
—
—
—
—
CFO
Termination (for cause)
—
—
—
—
—
Death or disability
—
—
—
—
—
Termination by employee or retirement
—
—
—
—
—
Peter Rodino
Involuntary (no cause)
$ 107,880
$ 42,704
—
—
$ 150,584
COO, General Counsel and
Termination (for cause)
—
—
—
—
—
Secretary
Death or disability
$ 850,000
$ 42,704
—
—
$ 892,704
Termination by employee or retirement
—
$ 42,704
—
—
$ 42,704
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 an 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 employment agreement).
The
dollar amounts in the chart below assume that change in control termination occurred on January 2, 2024, 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, 2023
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, 2023. The amounts assume a January 2, 2024, termination date regarding base pay and use of the
opening price of $0.44 on the NYSE American for our common stock at that date.
53
Name
Aggregate
Severance
Pay
($)
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
$4,340,000 ( 1)
—
—
—
$651,000 ( 4)
—
—
—
$ 4,991,000
Robert Dickey IV
—
—
—
—
—
—
—
—
—
Peter Rodino
—
—
—
—
—
—
—
—
—
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 2, 2024 ($0.48 per share) minus the weighted average per share exercise
price of $0.43 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 2, 2024 of $0.48 was used with an estimated exercise price of $0.48 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 an 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 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, 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 Agreement. However, benefit
distributions that are made due to a “separation from service” occurring while he 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
during such period shall be accumulated and paid to him 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.
54
Death
or Disability
A
NEO can be terminated for death or disability. “Disability” means the NEO’s inability effectively to carry out substantially
all of his 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 employment is terminated due
to his death or disability, we will pay him (or his estate as the case may be), at the time of such termination, his base salary, applicable
benefits, and immediate vesting of unvested stock options. In the event of permanent disability, we will provide an additional two years
of base salary.
Compensation
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, Stewart L. Appelrouth, Audit Committee Chair, and Nancy K. Byrn all 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 2022 or 2023.
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 2018 Equity Incentive Plans.
Director
Compensation – 2023 & 2022
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
2023
—
—
—
—
—
—
—
Executive
2022
—
—
—
—
—
—
—
Vice
Chairman
W.
Mitchell
2023
139,365
—
—
—
—
—
139,365
Chairman
of
2022
182,462
—
50,703
—
—
—
233,165
the
Board
S.
Appelrouth
2023
139,365
—
—
—
—
—
139,365
Director
2022
182,462
—
50,703
—
—
—
233,165
N.
Bryan
2023
93,750
—
—
—
—
—
93,750
Director
2022
—
—
—
—
—
—
—
In
March 2023, the Board reduced annual cash compensation from $182,462 to $125,000 to allow for additional Board members.
ITEM
12.
Security Ownership of Certain Beneficial Owners and Management
and Related Stockholder Matters.
The
following table sets forth as of March 24, 2024, 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
55
●
All
of our officers and directors as a group.
●
Total
number of shares of Common Stock at March 27, 2024 was 49,901,177.
Name and Address of
Beneficial Owner
Shares
Beneficially
Owned
% Of Shares
Beneficially
Owned
Thomas K. Equels, Executive Vice Chairman, Chief Executive Officer, President
1,971,166 (1)
*0.04 %
Peter W. Rodino III, Chief Operating Officer, General Counsel, Secretary
526,335 (2)
* %
William M. Mitchell, M.D., Chairman of the Board of Directors
306,001 (3)
* %
Stewart L. Appelrouth, Director
379,364 (4)
* %
Robert Dickey IV, Chief Financial Officer
50,000 (5)
* %
Nancy K. Bryan, Director
38,462
*
%
All directors and executive officers as a group (6 persons)
3,271,328
0. 065 %
*
Less than 1%
(1)
For Mr. Equels, shares beneficially owned include 1,254,711 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 344,617 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.
(3)For
Dr. Mitchell, shares beneficially owned include 229,589 shares issuable upon exercise of options and excludes no 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 139,599 shares issuable upon exercise of options and excludes no shares issuable upon
exercise of options not vested or not exercisable within the next 60 days.
(5)For
Mr. Dickey IV, shares beneficially owned include 50,000 shares issuable upon exercise of options.
56
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 compensation plans as of December 31, 2023:
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:
3,293,493
$ 4.03
1,210,286
Equity compensation plans not approved by security holders:
152,160
$ 8.03
—
Total
3,445,653
$ 4.21
1,210,286
57
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.
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, P.C. (“BDO”) for 2023 were $594,474 and total fees for 2022 were $545,000.
Amount
($)
2023
2022
Description
of Fees:
Audit
Fees
$ 560,984
$ 522,000
Tax
Fees
33,490
23,000
Total
$ 594,474
$ 545,000
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.
It
also includes 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).
Tax
Fees
Tax
fees include fees billed by BDO for professional services rendered for tax return preparation, compliance, advice and planning services.
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 2023 and 2022.
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.
58
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, 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. (incorporated by reference to Exhibit 3.7 to the Company’s annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2022).
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
Amended and Restated Rights Agreement, dated as of November 9, 2022, between the Company and American Stock Transfer & Trust Company LLC. (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form 8-A12B (No. 001-27072) filed November 14 2022 )
4.4
Amended and Restated Rights Agreement, dated as of February 9, 2023, between the Company and American Stock Transfer & Trust Company LLC. (incorporated by reference to Exhibit 1 to the Company’s Registration Statement on Form 8-A12B (No. 001-27072) filed February 10, 2023)
4.5
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).
4.6
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).
4.7
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).
59
4.8
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).
4.9
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).
4.10
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).
4.11
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).
4.12
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).
4.13
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).
4.14
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).
4.15
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).
4.16
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).
4.17
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).
4.18
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).
4.19
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).
4.20
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).
4.21
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).
4.22
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).
4.23
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).
4.24
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).
4.25
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.
60
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).
61
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).
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).
62
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 Warrant holders.- 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).
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).
63
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).
64
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).
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)) (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, 2021).
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)) (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, 2022).
10.80
March 1, 2022 Amendment to Clinical Trial Agreement with hVIVO Services Ltd dated September 27, 2021. (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, 2021).
65
10.81
March 3, 2022 Agreement of Sale and Purchase with Acellories, Inc for sale of 783 Jersey Avenue, New Brunswick, NJ building. (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, 2021).
10.82
March 8, 2022 Change order to Master Service Agreement with Pharmaceutics International Inc. as a Fill & Finish provider for Ampligen. (incorporated by reference to Exhibit 10.82 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2021).
10.83
April 7, 2022 Project Work Order with Amarex Clinical Research LLC.to manage Phase 2 clinical trial in advanced pancreatic cancer patients (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 Current Report on Form 8-K (No. 001-27072) filed April 12, 2022).
10.84
June 13, 2022 Project Work Order with Amarex Clinical Research LLC. for a Randomized Double Blind, Placebo Controlled study to Evaluate the Efficacy and Safety of Ampligen in Patients with Post Covid Conditions (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 Current Report on Form 8-K (No. 001-27072) filed June 17, 2022).
10.85
June 16, 2022 Lease agreement entered into with New Jersey Economic Development Authority for 5,210 square-foot R&D facility at the New Jersey Bioscience Center (incorporated by reference 10.1 to the Company’s Current Report on Form 8-K (No.001-27072) filed June 21, 2022).
10.86
June 27, 2022 First Amendment to Agreement of Sale and Purchase with Acellories, Inc. (incorporated by reference 10.86 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended June 30, 2022 filed August 15, 2022).
10.87
August 2, 2022 Second Amendment to Agreement of Sale and Purchase with Acellories, Inc. (incorporated by reference 10.87 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended June 30, 2022 filed August 15, 2022).
10.88
August 10, 2022 Termination agreement with Shenzhen Smoore Technology Limited (incorporated by reference 10.88 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended June 30, 2022 filed August 15, 2022).
10.89
October 5, 2022 Lease extension for Riverton office (incorporated by reference 10.4 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended September 30, 2022 filed November 14, 2022).
10.90
October 11, 2022 Material Transfer and Research Agreement with University of Pittsburgh (portions of this agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference 10.5 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended September 30, 2022 filed November 14, 2022).
10.91
October 21, 2022 Material Transfer and Research Agreement with University of Pittsburgh (portions of this agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference 10.6 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended September 30, 2022 filed November 14, 2022).
10.92
October 21, 2022 Fourth Amendment to Agreement of Sale and Purchase with Acellories, Inc)) (incorporated by reference 10.7 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended September 30, 2022 filed November 14, 2022).
66
10.93
December 5, 2022 Master Service Agreement between Sterling Pharma Solutions Limited and AIM ImmunoTech Inc. (incorporated by reference to Exhibit 10.93 to the Company’s annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2022).
10.94
January 13, 2023 Study Support Agreement with Erasmus University Medical Center Rotterdam (portions of this agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to Exhibit 10.94 to the Company’s annual report on Form 10-K (No.001-27072) for the year ended December 31, 2022).
10.95
January 13, 2023 Co-ordination Agreement with Erasmus University Medical Center Rotterdam and AstraZeneca BV (portions of this agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to Exhibit 10.95 to the Company’s annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2022).
10.96
March
1, 2023 Extension Agreement with Foresite Advisors LLC (incorporated by reference to Exhibit 10.96 to the Company’s annual report
on Form 10-K (No. 001-27072) for the year ended December 31, 2022).
10.97
April 4, 2023 Unrestricted Grant Agreement with Erasmus University Medical Center (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed April 7, 2023)
10.98
April 5, 2023 Independent Contractor Service Agreement with Casper H.J van Eijck (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K (No. 001-27072) filed April 7, 2023)
10.99
April 19, 2023 Equity Distribution Agreement with Maxim Group, LLC (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K (No. 001-27072) filed April 19, 2023)
10.100
Material Transfer and Research Agreement, dated as of May 22, 2023, with Japanese National Institute of Infectious Disease (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 Current Report on Form 8-K (No. 001-27072) filed May 30, 2023).
10.101
September 20, 2023 Amended and Restated Material Transfer and Research Agreement with Roswell Park Cancer Institute Corporation d/b/a Roswell Park Comprehensive Cancer Center (incorporated by reference to Exhibit 10.1 to the Company’s Current Report of Form 8-K (No. 001-27072) filed September 29, 2023).
10.102
February 16, 2024 Note Purchase Agreement with Streeterville Capital LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed February 20, 2024).
10.103
February 16, 2024 Promissory Note with Streeterville Capital LLC (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K (No. 001-27072) filed February 20, 2024).
10.104
Atlas Equity Purchase Agreement *
10.105
Atlas Registration Rights Agreement *
21.1
List of Subsidiaries*
23.1
Consent of BDO USA, P.C.*
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. *
97.1
Company Clawback Policy*
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.
67
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
29, 2024
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
29, 2024
Thomas
K. Equels
Director
of the Board
/s/
William Mitchell
Chairman
of the Board
March
29, 2024
William
Mitchell, M.D., Ph.D.
and
Director
/s/
Stewart L Appelrouth
Director
March
29, 2024
Stewart
L. Appelrouth
/s/
Robert Dickey IV E
Chief
Financial Officer
March
29, 2024
Robert
Dickey IV
/s/
Nancy Bryan E
Director
March
29, 2024
Nancy
Bryan
68
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Index
to Consolidated Financial Statements
Page
Report of Independent Registered Public Accounting Firm (BDO USA, P.C.; Miami, Florida ; PCAOB ID # 243 )
F-2
Consolidated Balance Sheets at December 31, 2023 and 2022
F-4
Consolidated
Statements of Operations and Comprehensive Loss for each of the years in the two-year period ended December 31, 2023
F-5
Consolidated Statements of Changes in Stockholders’ Equity for each of the years in the two-year period ended December 31, 2023
F-6
Consolidated Statements of Cash Flows for each of the years in the two-year period ended December 31, 2023
F-7
Notes to Consolidated Financial Statements
F-8
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, 2023
and 2022, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash
flows for each of the two years in the period ended December 31, 2023 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, 2023 and 2022, and the results of its operations and its
cash flows for each of the two years in the period ended December 31, 2023 , 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 critical audit matters 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.
F- 2
Research and Development Costs
As described in Note 8 to the consolidated financial statements, the Company entered into research, consulting and
supply agreements with third party service providers to perform research and development activities on therapeutics, including clinical
trials. The Company recorded research and development costs of approximately $10.9 million for the year ended December 31, 2023, and accrued
clinical trial expenses of approximately $0.8 million at December 31, 2023. The identification of research and development costs involves
reviewing open contracts and purchase orders, communicating with applicable company and third-party personnel to identify services that
have been performed, and corroborating the level of service performed and the associated cost incurred for the service when the Company
has not yet been invoiced or otherwise notified of actual expenses.
We identified the recognition of research and development costs as a critical
audit matter. The principal consideration for our determination was that performing procedures and evaluating audit evidence relating
to research and development costs involved a high degree of auditor effort required to address this matter.
The
primary procedures we performed to address this critical audit matter included:
●
Testing
research and development costs on a sample basis, which included tracing relevant information to certain underlying agreements, purchase
orders, and invoices received.
●
Confirming
certain research and development costs incurred for the fiscal year with third party service providers.
/s/
BDO USA, P.C.
We
have served as the Company’s auditor since 2021.
Miami,
Florida
March
29, 2024
F- 3
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Balance Sheets
December
31, 2023 and 2022
(in
thousands, except for share and per share amounts)
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$ 5,439
$ 27,053
Marketable investments
7,631
7,137
Funds receivable from New Jersey net operating loss
1,184
1,676
Prepaid expenses and other current assets
302
455
Total current assets
14,556
36,321
Property and equipment, net
127
195
Right of use asset, net
697
829
Patent and trademark rights, net
2,313
1,941
Other assets
1,688
1,202
Total assets
$ 19,381
$ 40,488
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 6,443
$ 377
Accrued expenses
1,986
806
Current portion of operating lease liability
223
178
Total current liabilities
8,652
1,361
Long-term liability:
Operating lease liability
495
659
Total liabilities
9,147
2,020
Commitments and contingencies (Notes 8, 10, 11, 16)
-
-
Stockholders’ equity:
Series A Junior Participating Preferred Stock, $ 0.001 par value, 4,000,000 and 250,000 shares authorized as of December 31, 2023 and 2022, respectively; issued and outstanding – none
—
—
Series B Convertible Preferred Stock, stated value $ 1,000 per share, 10,000 shares authorized; 689 and 696 issued and outstanding as of December 31, 2023 and 2022, respectively
689
696
Preferred Stock,
Value
Common Stock, $ 0.001
par value, authorized shares - 350,000,000 ;
issued and outstanding shares 49,102,484
and 48,084,287
(including 701,667
and 694,324
of unvested stock awards) as of December 31, 2023 and 2022, respectively
49
48
Additional paid-in capital
419,004
418,270
Accumulated deficit
( 409,508 )
( 380,546 )
Total stockholders’ equity
10,234
38,468
Total liabilities and stockholders’ equity
$ 19,381
$ 40,488
See
accompanying notes to consolidated financial statements.
F- 4
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Operations and Comprehensive Loss
(in
thousands, except share and per share data)
2023
2022
Years ended December 31,
2023
2022
Revenues:
Clinical treatment programs – US
$ 202
$ 141
Total Revenues
202
141
Costs and Expenses:
Production costs
42
—
Research and development
10,939
6,990
General and administrative
21,137
13,074
Total Costs and Expenses
32,118
20,064
Operating loss
( 31,916 )
( 19,923 )
Gain (loss) on investments
200
( 1,679 )
Interest and other income
1,069
629
Gain on sale of fixed assets
18
3
Redeemable warrants valuation adjustment
—
35
Gain from sale of income tax operating losses
1,667
1,490
Net Loss
$ ( 28,962 )
$ ( 19,445 )
Basic and diluted loss per share
$ ( 0.60 )
$ ( 0.40 )
Weighted average shares outstanding basic and diluted
48,585,404
48,047,288
See
accompanying notes to consolidated financial statements.
F- 5
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Changes in Stockholders’ Equity
(in
thousands except share data)
For
the Year Ended December 31, 2023
Series B
Common Stock
Common Stock .001
Additional Paid-in
Accumulated other Comprehensive
Accumulated
Total Stockholders’
Preferred
Shares
Par Value
Capital
Income (Loss)
Deficit
Equity
Balance December 31, 2022
$ 696
48,084,287
$ 48
$ 418,270
$ —
$ ( 380,546 )
$ 38,468
Common stock issuance, net of costs
—
1,017,399
1
484
—
—
485
Equity-based compensation
—
—
—
243
—
—
243
Series B preferred shares converted to common shares
( 7 )
798
—
7
—
—
—
Net comprehensive loss
—
—
—
—
—
( 28,962 )
( 28,962 )
Balance December 31, 2023
$ 689
49,102,484
$ 49
$ 419,004
$ —
$ ( 409,508 )
$ 10,234
For
the Year Ended December 31, 2022
Series B
Common
Stock
Common Stock .001
Additional Paid-in
Accumulated other Comprehensive
Accumulated
Total Stockholders’
Preferred
Shares
Par Value
Capital
Income (Loss)
Deficit
Equity
Balance December 31, 2021
$ 715
47,994,672
$ 48
$ 417,217
$ —
$ ( 361,101 )
$ 56,879
Balance
$ 715
47,994,672
$ 48
$ 417,217
$ —
$ ( 361,101 )
$ 56,879
Common stock issuance, net of costs
—
88,749
—
80
—
—
80
Equity-based compensation
—
—
—
954
—
—
954
Cashless warrant conversion
—
638
—
—
—
—
—
Series B preferred shares converted to common shares
( 19 )
228
—
19
—
—
—
Net comprehensive loss
—
—
—
—
—
( 19,445 )
( 19,445 )
Balance December 31, 2022
$ 696
48,084,287
$ 48
$ 418,270
$ —
$ ( 380,546 )
$ 38,468
Balance
$ 696
48,084,287
$ 48
$ 418,270
$ —
$ ( 380,546 )
$ 38,468
See
accompanying notes to consolidated financial statements.
F- 6
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Cash Flows
(in
thousands)
Years
ended December 31,
2023
2022
Cash flows from operating activities:
Net loss
$ ( 28,962 )
$ ( 19,445 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment
39
38
Redeemable warrants valuation adjustment
—
( 35 )
Gain on sale of fixed assets
( 18 )
—
Abandonment and expiration of patents and trademark rights
14
—
Amortization of patent and trademark rights
199
218
Non-cash lease expense
287
( 680 )
Loss from sale of income tax operating losses
—
197
Equity-based compensation
243
954
Loss (gain) on sale of marketable investments
( 200 )
1,679
Change in assets and liabilities:
Funds receivable from New Jersey operating loss sales
492
( 35 )
Prepaid expenses and other current assets
153
( 151 )
Lease liability
( 274 )
688
Other assets
( 486 )
( 83 )
Accounts payable
6,066
179
Accrued expenses
1,180
368
Net cash used in operating activities
( 21,267 )
( 16,108 )
Cash flows from investing activities:
Proceeds from sale of marketable investments
1,299
10,083
Purchase of marketable investments
( 1,593 )
( 2,724 )
Purchase of property and equipment
—
( 86 )
Proceeds from sale of property and equipment
47
3,900
Purchase of patent and trademark rights
( 585 )
( 185 )
Net cash (used in) provided by investing activities
( 832 )
10,988
Cash flows from financing activities:
Proceeds from sale of stock, net of issuance costs
485
80
Net cash provided by financing activities
485
80
Net decrease in cash and cash equivalents
( 21,614 )
( 5,040 )
Cash and cash equivalents at beginning of year
27,053
32,093
Cash and cash equivalents at end of year
$ 5,439
$ 27,053
Supplemental disclosures of non-cash investing and financing cash flow information:
Unrealized gain (loss) on marketable investments
$ 376
$ ( 928 )
Conversion of Series B preferred
$ 7
19
Operating lease liability arising from obtaining right of use asset
$ 73
$ 736
See
accompanying notes to consolidated financial statements.
F- 7
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(1)
Description of Business and
Basis of Presentation
Business
A IM
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 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 four areas:
●
Conducting
a randomized, controlled study to evaluate efficacy and safety of Ampligen compared to a control group to treat locally advanced
pancreatic cancer patients.
●
Evaluating
Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor responses
to check point inhibitors.
●
Exploring
Ampligen’s antiviral activities and potential use as a prophylactic or treatment for existing viruses, new viruses and mutated
viruses thereof.
●
Evaluating
Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and fatigue and/or Post-COVID
conditions of fatigue.
AIM
is prioritizing activities in an order related to the stage of development, with those clinical activities such as pancreatic cancer,
ME/CFS and Post-COVID conditions having priority over antiviral experimentation. AIM intends that priority clinical work be conducted
in trials authorized by the U.S. Food and Drug Administration (“FDA”) or European Medicines Agency (“EMA”), which
trials support a potential future NDA. However, the Company’s antiviral experimentation is designed to accumulate additional preliminary
data supporting its hypothesis that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced
immunity and cross-protection. Accordingly, the Company will conduct antiviral programs in those venues most readily available and able
to generate valid proof-of-concept data, including foreign venues.
Basis of Preparation and Consolidation
The accompanying consolidated
financial statements include the accounts of AIM ImmunoTech and all entities in which a controlling interest is held by the Company. All
significant intercompany balances and transactions have been eliminated in consolidation. The consolidated financial statements are prepared
in accordance with accounting principles generally accepted in the U.S. (“GAAP”).
(2)
Summary of Significant Accounting Policies
(a)
Cash and Cash Equivalents
Cash
includes bank deposits maintained at several financial institutions. The Company considers highly liquid
instruments with an original maturity of three months or less to be cash equivalents. At various times throughout the year
ended December 31, 2023, some accounts held at financial institutions were in excess of the federally insured limit of $ 250
thousand. The Company has not experienced any losses on these accounts and believes credit risk to be minimal.
(b)
Marketable Investment
The
Company’s marketable investments consist solely of mutual funds. We determine realized gains and losses for marketable investments
using the specific identification method and measure the fair value of our marketable investments using a market approach where identical
or comparable prices are available. If quoted market prices are not available, fair values of investments are determined using prices
from a pricing service, pricing models, quoted prices of investments with similar characteristics or discounted cash flow models.
F- 8
(c)
Property and Equipment, net
Schedule
of Property and Equipment
2023
2022
(in thousands) December 31,
2023
2022
Furniture, fixture and equipment
$ 1,448
$ 2,233
Less: accumulated depreciation
( 1,321 )
( 2,038 )
Property and equipment, net
$ 127
$ 195
Property
and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective
assets, ranging from three to ten years . Depreciation expense for the years ended December 31, 2023 and 2022 was $ 39,000
and $ 38,000 , respectively.
The
Company made a strategic shift on in-house manufacturing and recorded an impairment of the facility in the amount of $ 1,800,000 during
the year ended December 31, 2021. The Company sold the manufacturing facility on November 1, 2022.
(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, fair value of warrants, and contingency accruals.
(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 it 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.
F- 9
(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.
(h)
Recent Accounting Standards and Pronouncements
In
October 2023, the FASB issued ASU 2023-06, Disclosure Improvements. The standard requires additional or amended disclosure requirements
for a variety of transactions. The provisions most applicable to the Company include the method used in diluted earnings per share computation
for each dilutive security including interim periods, preferences in involuntary liquidation for preferred stock. This ASU becomes effective
dependent upon the SEC’s removal of related disclosures from Regulation S-X or S-K. Early adoption is permitted. The Company has
evaluated the impact of adoption of this ASU on its financial condition, results of operations and cash flows, and, as such, has determined
that the adoption of the new standard will not have a material effect on its financial statements.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) Improvements to Income Tax Disclosures. The amendments in
this Update require that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and
(2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items
is equal to or greater than 5 percent of the amount computed by multiplying pretax income [or loss] by the applicable statutory income
tax rate). Specifically, public business entities are required to disclose a tabular reconciliation, using both percentages and reporting
currency amounts. The amendments in this Update require that all entities disclose on an annual basis the following information about
income taxes paid: 1. The amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign
taxes 2. The amount of income taxes paid (net of refunds received) disaggregated by individual jurisdictions in which income taxes paid
(net of refunds received) is equal to or greater than 5 percent of total income taxes paid (net of refunds received). The amendments
in this Update require that all entities disclose the following information: 1. Income (or loss) from continuing operations before income
tax expense (or benefit) disaggregated between domestic and foreign 2. Income tax expense (or benefit) from continuing operations disaggregated
by federal (national), state, and foreign.
The
amendments in this Update eliminate the requirement for all entities to (1) disclose the nature and estimate of the range of the reasonably
possible change in the unrecognized tax benefits balance in the next 12 months or (2) make a statement that an estimate of the range
cannot be made. The amendments in this Update remove the requirement to disclose the cumulative amount of each type of temporary difference
when a deferred tax liability is not recognized because of the exceptions to comprehensive recognition of deferred taxes related to subsidiaries
and corporate joint ventures. The Company has evaluated the impact of adoption of this ASU on its financial condition, results of operations
and cash flows, and, as such, has determined that the adoption of the new standard will not have a material effect on its 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)
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 3,523,949 and 2,966,538 of stock options and warrants, are excluded from the calculation of diluted
net loss per share for the years ended December 31, 2023 and 2022, respectively, since their effect is antidilutive due to the net loss
of the Company.
(k)
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 decreases in the market price of a long-lived asset or group, a significant adverse change in the extent or manner in which
a long-lived asset (asset group) is being used or its physical condition, a significant adverse change in legal factors or in the business
climate that could affect the value of a long-lived asset (asset group), including an adverse action or assessment by a regulator, an
accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of a long-lived asset
(asset group), a current period operating or cash flow loss combined with a history of operating or cash flow losses or projection or
forecast that demonstrates continuing losses associated with the use of a long-lived asset (asset group) or a current expectation that,
more likely than not, a long-lived asset (asset group) will be sold or otherwise disposed of significantly before the end of its previously
estimated useful life.
When
assessing for impairment, 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, if 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.
(l) Lease accounting
The Company is a party to leases
for office space, lab facilities and other equipment. The Company determines if a contract contains a lease arrangement at the inception
of the contract. For leases in which the Company is the lessee, leases are classified as either finance or operating, with classification
affecting the pattern of expense recognition. The Company records right of use assets and operating lease liabilities for its operating leases,
which are initially recognized at the present value of future lease payments over the lease term. For leases that do not provide an implicit
rate, the Company utilizes an estimated incremental borrowing rate based on market observations existing at lease inception to calculate
the present value of future payments. The Company amortizes its right of use assets on a straight-line basis over the associated lease
term.
The lease term is defined as the
non-cancelable period of the lease, plus any options to extend or terminate the lease when it is reasonably certain that the Company will
exercise the option. 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 is recognized as variable lease expenses as incurred.
The Company has elected not to
recognize right of use assets and lease obligations for its short term leases, which are defined as leases with an initial term of 12 months
or less. Lease payments for short term leases are recognized on a straight-line basis over the lease term.
(m) Reclassifications
Certain prior year amounts have
been reclassified to conform with current year presentation. These changes did not have any effect on net income, stockholders’
equity, or cash flows.
(3)
Marketable Investments
Marketable
investments consist of mutual funds. At December 31, 2023 and 2022, it was determined that none of the marketable investments had an
other-than-temporary impairment. At December 31, 2023 and 2022, all securities were measured as Level 1 instruments of the fair value
measurements standard (See Note 15: Fair Value). As of December 31, 2023 and 2022, the Company held $ 7,631,000 and $ 7,137,000 , respectively,
in mutual funds.
Mutual
Funds classified as available for sale consisted of:
(in
thousands)
December
31, 2023
Schedule
of Available of Sale
Securities
Fair
Value
Short-Term Investments
Mutual Funds
$ 7,631
$ 7,631
Totals
$ 7,631
$ 7,631
F- 11
(in
thousands)
December
31, 2023
Schedule
of Equity Securities
Securities
Net gain recognized during the year on equity securities
$ 200
Less: Net gains and losses recognized during the year on equity securities sold during the year
( 176 )
Unrealized gains and losses recognized during the year on equity
securities still held at the end of the year
$ 376
Mutual
Funds classified as available for sale consisted of:
(in
thousands)
December
31, 2022
Securities
Fair Value
Short-Term Investments
Mutual Funds
$ 7,137
$ 7,137
Totals
$ 7,137
$ 7,137
(in
thousands)
December
31, 2022
Securities
Net losses recognized during the period on equity securities
$ ( 1,679 )
Less: Net gains and losses recognized during the period on equity securities sold during the year
( 751 )
Unrealized gains and losses recognized during the reporting period on equity securities still held at the end of the year
$ ( 928 )
(4)
Patents and Trademark Rights, Net
Patent and trademark rights consist of the following (in thousands):
Schedule
of Patent and Trademark Rights
December 31, 2023
December 31, 2022
Gross Carrying Value
Accumulated Amortization
Net Carrying Value
Gross Carrying Value
Accumulated Amortization
Net Carrying Value
Patents
$ 2,947
$ ( 750 )
$ 2,197
$ 2,389
$ ( 595 )
$ 1,794
Trademarks
229
( 113 )
116
216
( 69 )
147
Net amortizable patents and trademarks rights
$ 3,176
$ ( 863 )
$ 2,313
$ 2,605
$ ( 664 )
$ 1,941
The following table presents the changes in the patents and
trademark rights:
Schedule
of Changes in Patents, Trademark Rights
(in thousands)
December 31, 2022
$ 1,941
Acquisitions
585
Abandonments
( 14 )
Amortization
( 199 )
December 31, 2023
$ 2,313
Patents
and trademarks are stated at cost (primarily legal fees) and are amortized using the straight-line method of the estimated useful life
of 17 years and 10 years, respectively.
F- 12
Amortization
of patents and trademarks for each of the next five years is as follows (in thousands):
Schedule
of Amortization of Patents and Trademarks
Year Ending December 31,
2024
$ 241
2025
232
2026
230
2027
208
2028
189
Thereafter
1,213
Total
$ 2,313
(5)
Accrued Expenses
Accrued
expenses at December 31, 2023 and 2022 consist of the following:
Schedule
of Accrued Expenses
2023
2022
(in thousands) December 31,
2023
2022
Compensation
$ 414
$ 1
Professional fees
1,352
492
Clinical trial expenses
184
110
Other expenses
36
203
Total
$ 1,986
$ 806
(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 our authorized preferred stock, 4,000,000 shares have been designated as Series A Junior Participating
Preferred Stock and 10,000 shares have been designated as Series B Convertible Preferred Stock.
Series
A Junior Participating Preferred Stock
On
May 10, 2023, the Company filed a Certificate of Increase in Delaware, increasing the number of preferred stock designated as Series
A Junior Participating Preferred Stock to 4,000,000 from 250,000 shares.
Series
B Convertible Preferred Stock
The
Company has designated 10,000 shares of its preferred stock as Series B Convertible Preferred Stock (the “Preferred Stock”).
Each share of Preferred Stock has a par value of $ 0.01 per share and a stated value equal to $ 1,000 (the “Stated Value”).
The shares of Preferred Stock shall initially be issued and maintained in the form of securities held in book-entry form and the Depository
Trust Company or its nominee (“DTC”) shall initially be the sole registered holder of the shares of Preferred Stock.
Each
share of Preferred Stock shall be convertible, at any time and from time to time from and after the Original Issue Date at the option
of the Holder thereof or at any time and from time to time on or after the second anniversary of the Original Issue Date at the option
of the Corporation, into that number of shares of Common Stock (subject in each case to the limitations determined by dividing the Stated
Value of such share of Preferred Stock by the Conversion Price). The conversion price for the Preferred Stock shall be equal to $ 0.20 ,
subject to adjustment herein (the “Conversion Price”).
F- 13
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 redeemable 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 redeemable 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 year ended December 31, 2023, 7 shares of Series B Convertible Preferred Stock
were converted into common stock.
As
of December 31, 2023 and 2022, the Company had 689 and 696 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 does not carry voting Rights.
(b)
Common Stock and Equity Finances
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. As of December 31, 2023 and 2022, there were 49,102,484 and 48,084,287 shares
of Common Stock issued and outstanding, respectively.
Employee
Stock Purchase Plan (Not equity compensation)
On
July 7, 2020, the Board 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 (including subsequent plans, the “Employee Stock Purchase Plan”).
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 created successive new plans following the expiration of the July 7,
2020 plan. The latest plan was approved by the Board in January 2024 and expires in March 2024.
During
the year ended December 31, 2023, the Company issued a total of 419,285 shares of its Common Stock at a price ranging from $ 0.31 to $ 0.67
for total proceeds of approximately $ 150,500 as part of the employee stock purchase plan.
During
the year ended December 31, 2022, the Company issued a total of 86,817 shares of its Common Stock at prices ranging from $ 0.76 to $ 1.02
for total proceeds of $ 80,000 as part of the employee stock purchase plan.
Warrants
(Rights offering)
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, we issued 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 ended 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. No Warrants were exercised during the year ended December 31, 2023 and 2022. As of December 31, 2023 and 2022 there are
15,000 Warrants outstanding.
F- 14
Equity
Distribution Agreement
On
April 19, 2023, the Company entered into an Equity Distribution Agreement (the “EDA”) with Maxim Group LLC
(“Maxim”), pursuant to which the Company may sell, from time to time, shares of its common stock having an aggregate
offering price of up to $ 8,500,000
through Maxim, as agent (the “Offering”). Sales under the EDA were registered under the S-3 Shelf Registration
Statement. Under the terms of the EDA, Maxim will be entitled to a transaction fee at a fixed rate of 3.0 %
of the gross sales price of shares sold under the EDA. During the year ended December 31, 2023, the Company sold 598,114
shares under the EDA for total gross proceeds of approximately $ 344,000 ,
which includes a 3.0 %
fee to Maxim of $ 10,326 . Subsequent to the year ended December 31, 2023, the Company sold 699,568 shares under the EDA for total gross proceeds
of $ 316,392 , which includes a 3.0 % fee to Maxim of $ 9,492 .
Rights
Plan
On
May 12, 2023, the Company amended and restated its November 14, 2017 Rights Plan with American Stock Transfer & Trust Company as
Rights Agent (the “Rights Plan”).
(c)
Common Stock Options and Warrants
(i)
Stock Options
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.
The
Equity Incentive Plans of 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,
2023
2022
Risk-free interest rate
4.37 %
1.74 % - 3.88 %
Expected dividend yield
—
—
Expected life
10 years
10 years
Expected volatility
99.91 %
98.43 % - 107.18 %
Weighted average grant date fair value for options issued
$0.43 per option for 400,000 options
$0.51 per option for 850,000 options
F- 15
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 the Equity Plan of 2009 is summarized below. The plan expired on June
24, 2019:
Schedule
of Stock Option Activity
2023
2022
Option
Weighted
Average
Exercise
Option
Weighted
Average
Exercise
Shares
Price
Price
Shares
Price
Price
Outstanding, beginning of year
124,399
13.20 – 1,003.20
22.23
128,504
13.20 – 2,127.84
25.58
Granted
—
—
—
—
—
—
Forfeited
( 5,047 )
9.68 - 327.36
57.79
( 4,105 )
16.76 - 2,127.84
129.88
Exercised
—
—
—
—
—
—
Outstanding, end of year
119,352
13.20 - 2,127.84
20.72
124,399
13.20 - 1,003.20
22.23
Exercisable, end of year
119,352
13.20 - 2,127.84
124,399
13.20 - 1,003.20
Weighted average remaining contractual life (years)
4.06 years
5.98 years
Information
regarding the options approved by the Board of Directors under the Equity Plan of 2018 is summarized below:
Schedule
of Stock Option Activity
2023
2022
Option
Weighted
Average
Exercise
Option
Weighted
Average
Exercise
Shares
Price
Price
Shares
Price
Price
Outstanding, beginning of year
2,474,971
0.31 - 9.68
1.72
1,650,017
1.11 – 9.68
2.35
Granted
400,000
0.47 - 0.47
0.47
850,000
0.31 – 1.71
0.51
Forfeited
( 60,829 )
0.31 - 9.68
1.98
( 25,046 )
1.85 – 9.68
1.86
Exercised
—
—
—
—
—
—
Outstanding, end of year
2,814,142
0.31 - 9.68
1.54
2,474,971
0.31 – 9.68
1.72
Exercisable, end of year
2,397,474
0.31 - 327.36
4.71
1,916,637
0.41 – 9.68
2.22
Weighted average remaining contractual life (years)
7.96 years
9.65 years
Available for future grants
1,210,286
466,120
F- 16
Stock
option activity during the years ended December 31, 2023 and 2022 is as follows:
Vested
stock option activity for employees:
Schedule
of Vest Stock Option Activity
Number of
Weighted Average Exercise
Weighted
Average
Remaining
Contracted
Term
Aggregate Intrinsic
Options
Price
(Years)
Value
Outstanding December 31, 2021
1,498,798
$ 4.22
9.11
—
Granted
550,000
0.49
9.71
—
Forfeited
( 28,584 )
17.71
—
—
Expired
—
—
—
—
Outstanding December 31, 2022
2,020,214
$ 3.01
8.86
—
Granted
400,000
0.47
10.17
—
Forfeited
( 7,601 )
9.68
—
Expired
( 4,175 )
41.61
—
—
Outstanding December 31, 2023
2,408,438
$ 2.50
8.70
—
Vested and expected to vest at December 31, 2023
2,041,772
$ 1.90
6.73
—
Exercisable at December 31, 2023
2,041,772
$ 1.90
6.73
—
The
weighted-average grant-date fair value of employee options vested during the year ended December 31, 2023 was $ 184,000 for 424,999 options
at $ 0.43 per option and during year ended December 31, 2022 was $ 768,666 for 575,000 options at $ 1.34 per option.
Unvested
stock option activity for employees:
Schedule
of Unvested Stock Option Activity
Number of
Weighted Average Exercise
Average Remaining Contracted Term
Aggregate Intrinsic
Options
Price
(Years)
Value
Unvested December 31, 2021
412,500
$ 4.15
5.85
—
Granted
550,000
0.49
9.71
—
Vested
( 541,590 )
1.31
9.73
—
Forfeited
( 28,584 )
17.71
—
—
Unvested December 31, 2022
392,326
$ 0.80
8.86
—
Granted
400,000
0.47
10.17
—
Vested
( 413,884 )
1.90
6.73
—
Forfeited
( 7,601 )
9.68
—
—
Expired
( 4,175 )
41.61
—
—
Unvested December 31, 2023
366,666
$ 2.13
12.44
—
F- 17
Vested
stock option activity for non-employees:
Schedule
of Vest Stock Option Activity
Number of
Weighted Average Exercise
Weighted Average Remaining Contracted Term
Aggregate Intrinsic
Options
Price
(Years)
Value
Outstanding December 31, 2021
279,723
$ 6.12
7.93
—
Granted
300,000
0.54
9.68
—
Exercised
—
—
—
—
Forfeited
( 568 )
153.12
—
—
Outstanding December 31, 2022
579,155
$ 3.09
8.36
—
Granted
360,000
0.46
10.04
—
Exercised
—
—
—
—
Expired
( 653 )
145.24
—
—
Forfeited
( 53,447 )
1.31
—
—
Outstanding December 31, 2023
885,055
$ 2.02
9.23
—
Vested and expected to vest at December 31, 2023
550,055
$ 2.56
10.02
—
Exercisable at December 31, 2023
550,055
$ 2.56
10.02
—
The
weighted-average grant-date fair value of non-employee options vested during year 2023 was $ 90,000 for 191,666 options at $ 0.47 per option
and during the year 2022 was $ 247,166 for 229,053 options at $ 1.08 per option.
Unvested
stock option activity for non-employees:
Schedule
of Unvested Stock Option Activity
Number of
Weighted Average Exercise
Weighted
Average
Remaining
Contracted
Term
Aggregate Intrinsic
Options
Price
(Years)
Value
Unvested December 31, 2021
97,831
$ 3.89
7.82
—
Granted
300,000
0.54
9.68
—
Vested
( 229,053 )
0.82
—
—
Forfeited
( 1,989 )
—
—
—
Unvested December 31, 2022
166,789
$ 4.05
9.49
—
Granted
360,000
0.46
10.18
—
Vested
( 137,565 )
0.47
9.47
—
Expired
( 776 )
145.24
—
—
Forfeited
( 53,447 )
1.31
—
—
Unvested December 31, 2023
335,001
$ 1.83
10.70
—
Stock-based
compensation expense was approximately $ 243,000 and $ 954,000 for the years ended December 31, 2023 and 2022.
As
of December 31, 2023 and 2022, there was $ 294,000 and $ 217,000 , 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.
F- 18
(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. No warrants were granted in 2023 or 2022.
Information
regarding warrants outstanding and exercisable into shares of common stock is summarized below:
Schedule
of Warrants Outstanding and Exercisable
2023
2022
Warrant
Weighted
Average
Exercise
Warrant
Weighted
Average
Exercise
Shares
Price
Price
Shares
Price
Price
Outstanding, beginning of year
226,610
$ 0.99 - 132.00
$ 9.10
294,939
$ 0.99 – 469.92
$ 15.19
Granted
—
—
—
—
—
—
Expired
( 74,450 )
17.05
17.05
( 68,215 )
469.92
469.92
Exercised
—
—
—
( 114 )
8.80
8.80
Outstanding, end of year
152,160
$ 0.99 - 8.80
$ 8.03
226,610
$ 0.99 - 132.00
$ 9.10
Exercisable
152,160
$ 0.99 - 8.80
$ 8.03
226,610
$ 0.99 - 132.00
$ 9.10
Weighted average remaining contractual life
.75 years
.94 years
Years exercisable
2024
2023 - 2024
Stock
warrants are issued at the discretion of the Board. During the year ended December 31, 2023, there were no warrants issued or exercised.
During the year ended December 31, 2022, there were no warrants issued and 114 were exercised.
(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, 2023, were earned in the United States. All assets are maintained
in the United States of America.
(8)
Research, Consulting and Supply Agreements
The
Company has entered into research, consulting and supply agreements with third party service providers to perform research and development
activities on therapeutics, including clinical trials. The identification of research and development costs involves reviewing open contracts
and purchase orders, communicating with applicable company and third-party personnel to identify services that have been performed, and
corroborating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced
or otherwise notified of actual expenses. The Company expenses these research and development costs when incurred.
During the year ended December 31, 2023, research and development expenses
were comprised of: clinical studies ($ 6,014,000 ), manufacturing and engineering ($ 3,220,000 ), quality control ($ 1,271,000 ) and regulatory
($ 434,000 ).
During the year ended December 31, 2022, research and development expenses
were comprised of: clinical studies ($ 4,070,000 ), manufacturing and engineering ($ 1,241,000 ), quality control ($ 1,236,000 ) and regulatory
($ 443,000 ).
The
following summarizes the most substantial of our contracts relating to research, consulting, and supply costs for AIM as they related
to research and development costs during the year ended December 31, 2023.
F- 19
Amarex
Clinical Research LLC
Amarex
is the principal administrator of several of AIM’s largest clinical studies. AIM has multiple contracts with Amarex Clinical
Research LLC (“Amarex”). During the year ended December 31, 2023 and 2022, the Company incurred approximately $ 4,290,000
and $ 2,272,000 , respectively, related to these ongoing agreements:
●
Pancreatic
Cancer - In April 2022, AIM executed a work order with Amarex pursuant to which Amarex is managing a Phase 2 clinical trial in locally
advanced pancreatic cancer patients designated AMP-270. Per the work order, AIM anticipates that Amarex’s management of the
study will cost approximately $ 8,400,000 . This estimate includes pass-through costs of approximately $ 1,000,000 and excludes certain
third-party and investigator costs and escalations necessary for study completion. AIM anticipates that the study will take approximately
4.6 years to complete.
○
During
the year ended December 31, 2023, the Company incurred approximately $ 600,000 related to this agreement.
○
During the year ended December 31, 2022, the Company incurred approximately $ 1,691,000 related to this agreement.
●
Post-COVID
Conditions - In September 2022, AIM executed a work order with Amarex, pursuant to which Amarex is managing a Phase 2 trial in patients
with Post-COVID Conditions. AIM is sponsoring the study. AIM anticipates that the study will cost approximately $ 6,400,000 , which
includes pass through costs of approximately $ 125,000 , investigator costs estimated at about $ 4,400,000 , and excludes certain other
third-party costs and escalations. During 2023, the original work order increased to approximately $ 6,600,000 for the addition of
patient reported outcome (PRO) electronic questionnaires (devices/tablets for patients to complete); services associated with the
ePRO system and additional safety monitoring services as well as changes to study documentation (such as protocol amendments) which
resulted in additional IND submissions to FDA. This study was effectively concluded in 2023.
○
During
the year ended December 31, 2023, the Company incurred approximately $ 3,690,000 related to this agreement.
○
During the year ended December 31, 2022, the Company incurred approximately $ 581,000 related to this agreement.
Jubilant
HollisterStier
Jubilant
HollisterStier (“Jubilant”) is AIM’s authorized CMO for Ampligen for the approval in Argentina. In 2017, the Company
entered into an agreement with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for the Company. Since the
2017 engagement of Jubilant, two lots of Ampligen consisting of more than 16,000 units were manufactured and released in the year 2018.
The first lot was designated for human use in the United States 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. Jubilant
manufactured additional two lots of Ampligen in December 2019 and January 2020. In March 2023, the Company ordered an additional 27,900
vials from Jubilant at a cost of approximately $ 1,432,000 .
○
During
the year ended December 31, 2023, the Company incurred approximately $ 1,432,000 related to this agreement.
○
During the year ended December 31, 2022, the Company incurred approximately $ 79,000 related to this agreement.
Sterling
Pharma Solutions
In
2022, the Company entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”)
for the manufacture of the Company’s Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’s
Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen.
○
During
the year ended December 31, 2023, the Company incurred approximately $ 363,000 related to this agreement.
○
During the year ended December 31, 2022, the Company did not incur any expense related to this agreement.
Erasmus
In
December 2022, the Company entered into a joint clinical study agreement with Erasmus University Medical Center Rotterdam to conduct
a Phase II study: Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic
pancreatic ductal adenocarcinoma for therapy efficacy. This is a study in collaboration with AstraZeneca. AIM’s limited responsibilities
are limited to providing Ampligen. Additionally, AIM agreed to provide a grant of $ 200,000 for the study.
○
During
the year ended December 31, 2023, the Company incurred approximately $ 100,000 pursuant to the Grant Agreement.
○
During the year ended December 31, 2022, the Company did not incur any expense related to this agreement.
F- 20
Azenova
Sales International
In
October 2023, the Company entered into a consulting agreement with Azenova, LLC whereas Azenova will provide business development services
for AIM’s Ampligen product for solid tumors for a 12 month term that is extendable upon the agreement of the parties. In exchange
for its services, Azenova will receive a fixed monthly retainer of $ 30,000 per month in addition to 360,000 stock options that vest monthly.
○
During
the year ended December 31, 2023, the Company incurred approximately $ 75,000 related to this agreement.
○
During the year ended December 31, 2022, the Company did not incur any expense related to this agreement.
Alcami
In
September 2023, the Company entered into an agreement with Alcami Corporation to perform an extractables study for a primary packaging
component. The agreement called for fixed costs of approximately $ 30,000 upon completion of the study and issue of the final report,
along with solvent costs, and pass through items to be billed on a per activity basis. The final bill for the initial study was received
in December 2023.
○
During
the year ended December 31, 2023, the Company incurred approximately $ 65,000 of lab services from Alcami.
○
During the year ended December 31, 2022, the Company incurred approximately $ 18,000 of lab services from Alcami.
(9)
401(k) Plan
AIM
has a defined contribution plan, entitled the AIM ImmunoTech Employees 401(k) Plan and Trust Agreement (the “401(k) Plan”).
AIM’s full-time employees are eligible to participate in the 401(k) Plan following 61 days 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 us at a rate determined annually by the Board.
Each
participant immediately vests in his or her deferred salary contributions as well as the Company’s safe harbor contributions.
A 6 %
safe harbor matching contribution by us was reinstated effective January 1, 2021. For the year ended December 31, 2023 and 2022, the
Company’s matching contributions were approximately $ 162,000
and $ 122,000 ,
respectively
(10)
Employment Agreements
The
Company had contractual agreements with Named Executive Officers (“NEO”) in 2023, and 2022. The aggregate annual base compensation
for these NEO under their respective contractual agreements for 2023 and 2022 was $ 1,275,000 and $ 1,275,000 , 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. For the years ended December 31, 2023 and 2022, Officers’
bonuses were $ 450,000 , to be deferred and paid in 2024 and $ 450,000 , respectively.
In
2023, equity was granted as a form of compensation to these Officers.
a.
The
Company granted 300,000 ten-year options to purchase common stock with an exercise price of $ 0.47 per share to vest in one year to
Thomas K. Equels, Chief Executive Officer.
b.
The
Company granted 100,000 ten-year options to purchase common stock with an exercise price of $ 0.47 per share which vest in one year
to Peter Rodino, Chief Operating Officer and General Counsel.
The
Company recorded stock compensation expense of approximately $ 14,000 during the year ended December 31, 2023 with regard to these issuances
to Officers Equels and Rodino.
In
2022, equity was granted as a form of compensation to these Officers.
F- 21
c.
The
Company granted 300,000 ten-year options to purchase common stock with an exercise price of $ 0.41 per share to vest in one year to
Thomas K. Equels, Chief Executive Officer.
d.
The
Company granted 150,000 ten-year options to purchase common stock with exercise price of $ 0.41 to $ 0.70 per share which vest in one
year to Peter Rodino, Chief Operating Officer and General Counsel.
e.
The
Company granted 50,000 ten-year options to purchase common stock with an exercise price of $ 0.70 per share which vest in one year
to Ellen Lintal, former Chief Financial Officer.
The
Company recorded stock compensation expense of approximately $ 107,000 during the year ended December 31, 2023 with regard to these issuances
to Officers Equels, Rodino, and former Officer Lintal.
(11)
Leases
The
Company leases office and lab facilities and other equipment under non-cancellable operating leases with initial terms typically ranging
from 1 to 5 years, expiring at various dates during 2024 through 2027, and requiring monthly payments ranging from less than $ 1,000
to $ 17,000 . Certain leases include additional renewal options ranging from 1 to 5 years.
AIM
has classified all of its leases as operating leases.
As of December 31, 2023 and 2022, the balance of the right of use assets was $ 697,000 and $ 829,000 , respectively,
and the corresponding operating lease liability balance was $ 718,000 and $ 837,000 , respectively. Right of use assets are recorded net
of accumulated amortization of $ 363,000 and $ 158,000 as of December 31, 2023 and 2022, respectively.
AIM
recognized rent expense associated with these leases are follows:
Schedule of AIM
Recognized Rent Expense Associated with Operating Lease
2023
2022
Year ended December 31,
(in thousands)
2023
2022
Lease costs:
Operating lease costs
$ 288
$ 128
Short-term and variable lease costs
335
211
Total lease costs
$ 623
$ 339
Classification of lease costs
Research & development
$ 498
$ 220
General and administrative
125
119
Lease cost
125
119
Total lease costs
$ 623
$ 339
The Company’s leases have remaining lease terms between 3 and 44 months. As of December
31, 2023 and 2022, the weighted-average remaining term was 41 and 43 months, respectively.
The
Company’s weighted average incremental borrowing rate for its leases was 10 %
as of December 31, 2023 and 2022, respectively.
Future
minimum payments as of December 31, 2023, are as follows:
Schedule of Operating Lease Future Payments
Year Ending December 31, (in thousands)
2024
$ 279
2025
229
2026
200
2027
133
Thereafter
—
Less imputed interest
( 123 )
Total
$ 718
F- 22
(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, 2023,
the Company has approximately $ 166,300,000 of Federal net operating loss carryforwards (expiring in the years 2023 through 2038), and
$ 103,300,000 of Federal net operating loss carryforwards with no expiration date, both of which have been limited by Internal Revenue
Code Section 382, available to offset future federal taxable income. The Company has approximately $ 28,800,000 of New Jersey state net
operating loss carryforwards (expiring in 2044). The Company has approximately $ 82,500,000 of Florida state net operating loss carryforwards
with no expiration date to offset future Florida taxable income. The Company has approximately $ 3,600,000 of Belgium net operating loss
carryforwards with no expiration date to offset future taxable income In December 2023, the Company effectively sold $ 14,156,000 of its
New Jersey state net operating loss carryforward and $ 38,600 in R&D credits for the year 2022 for approximately $ 1,313,000 . 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, 2023 and 2022.
The
components of the net deferred tax assets and liabilities as of December 31, 2023 and 2022, which include the correction of an
immaterial deferred tax error of approximately $ 1.4
million in the stock compensation component and the corresponding valuation allowance for the same amount as of December 31, 2022,
consist of the following:
Schedule of Components of Net Deferred Tax Assets and Liabilities
2023
2022
(in thousands)
Deferred tax assets:
December 31,
2023
2022
Net operating losses
$ 25,114
$ 19,674
Research and Development costs
3,517
7,647
Amortization & depreciation
6,791
2,342
R&D credits
1,376
744
Other
137
77
Right of use asset
6
2
Stock compensation
1,479
1,472
Total deferred tax assets
38,420
31,958
Less: Valuation allowance
( 36,816 )
( 30,840 )
Deferred tax assets, net
$ 1,604
$ 1,118
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 Operations and
Comprehensive Loss. The Company’s deferred tax asset estimates the projected sale of 2023 and 2022 New Jersey state operating
losses to be sold in the subsequent year, respectively.
F- 23
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
$ ( 28,962 )
Federal Rate
( 6,082 )
21.0 %
State Taxes
( 2,244 )
7.75 %
Other Perms
( 83 )
0.29 %
RTP
( 8 )
0.03 %
Income Tax Income
( 479 )
1.65 %
State Rate Change
618
- 2.13 %
R&D
( 272 )
0.94 %
State NOL
—
0.00 %
NJ NOL True Up
1,123
- 3.88 %
Stock Compensation True Up
( 1,347 )
4.65 %
Fixed Assets True Up
925
- 3.19 %
Other
( 22 )
0.08 %
NOL Refund VA True Up
486
- 1.68 %
Valuation Allowance
7,385
- 25.50 %
Total
$ —
0.0 %
(13)
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.
(14)
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 2023 and 2022.
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, the Company does not have any agreements with third parties for the supply
of any of these materials or it is 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. The Company anticipates that additional
orders will be placed upon approved quotes and purchase orders provided by us to Jubilant. On December 22, 2020, it 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 the Company’s
existing fill and finish capacity. If the Company is unable to place adequate acceptable purchase orders with Jubilant or Pii in the
future at acceptable prices upon acceptable terms, it will need to find another manufacturer. The costs and availability of products
and materials the Company 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 the Company will be able to obtain such products and materials on terms acceptable to it or at all.
Currently,
the Alferon N Injection manufacturing process is on hold and there is no definitive timetable to restart production. If the Company is
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, its 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.
(15)
Fair Value
The
Company complies with the provisions of FASB ASC 820 “Fair Value Measurements” for its financial and non-financial assets
and liabilities. ASC 820 defines fair value, establishes a framework for measuring fair value and expands disclosure for each major asset
and liability category measured at fair value on either a recurring or nonrecurring basis.
F- 24
The
Company accounts for certain assets and liabilities at fair value. The hierarchy below lists three levels of fair value based on the
extent to which inputs used in measuring fair value are observable in the market. AIM categorizes each of its fair value measurements
in one of these three levels based on the lowest level input that is significant to the fair value measurement in its entirety. These
levels are:
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 September 30, 2023, the Company has classified the warrants with cash
settlement features 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.
The
table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy
as (in thousands):
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis
As of December 31, 2023
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$ 4,805
$ 4,805
$ —
$ —
Marketable investments
$ 7,631
$ 7,631
$ —
$ —
As of December 31, 2022
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$ 25,180
$ 25,180
$ —
$ —
Marketable investments
$ 7,137
$ 7,137
$ —
$ —
The
Company’s cash balances are representative of their fair values as these balances are comprised of deposits available on demand.
For certain instruments, including funds receivable from New Jersey net operating loss, accounts payable and accrued expenses, it was
estimated that the carrying values approximated the fair value due to the short-term maturities of these instruments (Level 1).
The
Company also has certain redeemable warrants with a cash settlement feature in the occurrence of a Fundamental Transaction. The fair
value of the redeemable warrants (“Redeemable Warrants”) related to the Company’s March 2019 common stock and warrant
issuance, are calculated using a Monte Carlo Simulation (Level 3).
The
Company recomputes the fair value of the Redeemable 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.
F- 25
The
Company utilized the following assumptions to estimate the fair value of the March 2019 Warrants:
Schedule
of Assumptions to Estimate Fair Value of Warrants
December 31,
December 31,
2023
2022
Underlying price per share
$ 0.44
$ 0.31
Exercise price per share
$ 8.80
$ 8.80
Risk-free interest rate
5.47 %
4.67 %
Expected holding period
.19
1.19
Expected volatility
80 %
70 %
Expected dividend yield
—
—
Warrants measurement input
—
—
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.
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.
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(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 $ 0
at December 31, 2023 and 2022.
(16) Contingencies
Because litigation is inherently
unpredictable, assessing contingencies related to litigation is a complex process involving highly subjective judgment about potential
outcomes of future events. When evaluating litigation contingencies, the Company may be unable to provide a meaningful estimate due to
a number of factors, including the procedural status of the matter in question, the availability of appellate remedies, insurance coverage
related to the claim or claims in question, the presence of complex or novel legal theories, and the ongoing discovery and development
of information important to the matter. In addition, damage amounts claimed in litigation against the Company may be unsupported, exaggerated,
or unrelated to possible outcomes, and as such are not meaningful indicators of the Company’s potential liability or financial exposure.
Accordingly, the Company reviews the adequacy of accruals and disclosures each quarter in consultation with legal counsel, and it assesses
the probability and range of possible losses associated with contingencies for potential accrual in the condensed consolidated
financial statements. However, the ultimate resolution of litigated claims may differ from the Company current estimates.
In the normal course of business,
there are various claims in process, matters in litigation, and other contingencies, certain of which are covered by insurance policies.
When a loss is probable, we record an accrual based on the reasonably estimable loss or range of loss. We do not record liabilities for
reasonably possible loss contingencies but do disclose a range of reasonably possible losses if they are material and we are able to estimate
such a range. If we cannot provide a range of reasonably possible losses, we explain the factors that prevent us from determining such
a range. Historically, adjustments to our estimates have not been material. While it is not possible to predict the outcome of these suits,
legal proceedings, and claims with certainty, management is of the opinion that adequate provision for potential losses associated with
these matters has been made in the financial statements and that the ultimate resolution of any one of these matters will not have a material
adverse effect on the Company’s financial position and results of operations. A significant increase in the number of these claims,
or one or more successful claims resulting in greater liabilities than the Company currently anticipates, could materially and adversely
affect the Company’s business, financial condition, results of operations, and cash flows.
(17)
Subsequent Events
On
February 16, 2024, the Company entered into a Note Purchase Agreement with an unrelated party raising $ 2,500,000
in net proceeds from the sale of an unsecured promissory Note.
On March 28, 2024, the Company entered into a purchase agreement and a
registration rights agreement with an unrelated party, pursuant to which this party committed to purchase up to $ 15,000,000 of common
stock of the Company for a period of 24 months from the date of the agreement.
In
March 2024, the Company sold 204,547 and 38,462 shares of its common stock at prices of $ 0.33 and $ 0.39 per share, respectively, under
the Employees and Directors Purchase Plan.
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