Item 9A. Controls and Procedures
ITEM
9A. Controls
and Procedures.
Effectiveness
of Control Procedures
As
of December 31, 2024, 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, 2024, 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).
43
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, 2024. 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, 2024, based on the criteria
set forth in “Internal Control—Integrated Framework” issued by the COSO.
This report does not include an attestation report of our independent registered
public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by
our independent registered public accounting firm pursuant to rules of the SEC that permits us to provide only management’s report
in this report.
ITEM
9B. Other
Information.
We
received no tice from the NYSE American about our potential delisting and we have submitted a Plan that has been accepted by the NYSE
American to regain compliance and fund our continued operations. Please see Item 7. Management’s Discussion and Analysis of Financial
Condition and Results of Operations; Liquidity and Capital Resources; Potential Delisting from the NYSE American, above.
ITEM
9C. Disclosure
Regarding Foreign Jurisdictions that Prevent Inspections.
None.
44
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, M.S., J.D.
72
Chief
Executive Officer, President and Director
Nancy
Bryan, MBA
67
Director
William
M. Mitchell, M.D., Ph.D.
90
Chair
of the Board and Director
Ted
D. Kellner
78
Director
David
Chemerow, MBA
73
Director
Peter
W. Rodino III, Esq.
73
Chief
Operating Officer, General Counsel and Secretary
Robert
Dickey IV, MBA
69
Chief
Financial Officer
Each
Director has been elected to serve until the next annual meeting of stockholders, or until their earlier resignation, removal from office,
death or incapacity. Each Executive Officer serves at the discretion of the Board of Directors, subject to rights, if any, under contracts
of employment.
We
believe our Board Members represent a desirable diversity of backgrounds, skills, education and experiences, and they all share the personal
attributes of dedication to be effective directors. In recommending Board candidates, Corporate Governance and Nomination Committee considers
a candidate’s: (1) general understanding of elements relevant to the success of a publicly traded company in the current business
environment; (2) understanding of our business; and (3) diversity in educational and professional background. The Committee also gives
consideration to a candidate’s judgment, competence, dedication and anticipated participation in Board activities along with experience,
geographic location and special talents or personal attributes. The following are qualifications, experience and skills for Board members
which are important to our business and its future:
45
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, M.S., J.D. is our Chief Executive Officer (since 2016), President (since 2015) and Executive Vice Chair (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, M.S., J.D. - 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.
NANCY
K. BRYAN, MBA was appointed as a director of the Company 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 May 2013 to December 2023, Ms. Bryan
served as the 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, 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, Urology and Autoimmune (MS, CD). She has established a successful track record 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.
46
NANCY
K. BRYAN, MBA – 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
●
Industry/Commercialization
Experience – 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).
WILLIAM
M. MITCHELL, M.D., Ph.D. has been a director since July 1998 and Chair of the Board since February 2016. Dr. Mitchell has served
as a Professor of Pathology, Microbiology & Immunology, at Vanderbilt University School of Medicine since 1966 and is a board-certified
physician. Dr. Mitchell earned an M.D. from Vanderbilt and a Ph.D. from Johns Hopkins University, where he served as House Officer in
Internal Medicine, followed by a Fellowship at its School of Medicine. Dr. Mitchell has published over 250 papers, reviews and abstracts
that relate to viruses, anti-viral drugs, immune responses to viral infection, detection in blood of cancer DNA (i.e., the liquid biopsy),
and other biomedical topics. Dr. Mitchell has worked for and with many professional societies that have included the American Society
of Investigative Pathology, the International Society for Antiviral Research, the American Society of Clinical Oncology, the American
Society of Biochemistry and Molecular Biology, the American Chemical Society, and the American Society of Microbiology. Dr. Mitchell
is a member of the American Medical Association. He has served on numerous government review committees, among them the Centers for Disease
Control and Prevention (CDC) and the National Institutes of Health, including the initial AIDS and Related Research Review Group. Dr.
Mitchell previously served as one of the Company’s 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;
●
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.
TED
D. KELLNER was elected as a Director of the Company in December 2024. Mr. Kellner is a Chartered Financial Analyst with 50 years
of investment experience and currently manages his personal and family investments after retiring in 2017 from his career as a portfolio
manager at Fiduciary Management, Inc., an investment management firm that he founded in 1980. Fiduciary Management, Inc. currently manages
approximately $15 billion in assets, pension and profit-sharing trusts, Taft-Hartley and public funds, endowments and personal trusts
throughout the United States. He is also the Chairman of Fiduciary Real Estate Development Inc., a business founded by Mr. Kellner in
1984 that owns and manages over $2.3 billion in multi-family residential units. Mr. Kellner previously served as a director of Metavante
Technologies, Inc., a then publicly-traded company that provided banking and payments technologies to financial services firms, from
2007 to 2009, and Marshall & Ilsley Corporation, a then publicly-traded bank and financial holding company, from 2000 to 2011. He
also served as a director of each of the American Family Mutual Insurance Company from 2001 to 2018, and currently serves on the board
of the Kelben Foundation, a family foundation focused on education and health programs. Mr. Kellner holds a BBA in Finance, Investments,
and Banking from the University of Wisconsin.
TED
D. KELLNER - Director Qualifications:
●
Leadership
Experience – Executive and founder of Fiduciary Management, Inc. and Board of Directors Chairman and founder of Fiduciary Real
Estate Development Inc. Extensive experience serving as an independent Board Member on three public company Boards, including participation
on Executive, Compensation, Finance, and Investment committees. Additionally, he has served as a Board Member for several private
company and non-profit organizations; and
●
Finance
Experience – Over 50 years of experience with financial analysis both as an executive and investor, executing strategic plans,
overseeing day-to-day financial management, and identifying investment monetization opportunities.
DAVID
CHEMEROW, MBA was appointed as a Director of the Company in February 2025. Mr. Chemerow brings more than 40 years of finance, accounting
and operations leadership experience across multiple industries. He previously served as the Chief Financial Officer and Treasurer, and
prior to that as Chief Revenue Officer, of Comscore, Inc., an American-based global media measurement and analytics company. Prior to
his tenure at Comscore, Mr. Chemerow served as the Chief Operating Officer and Chief Financial Officer of Rentrak Corporation through
its merger with Comscore, Inc. in January 2016. Prior to 2009, Mr. Chemerow held senior executive roles leveraging his financial, business
and operational expertise across multiple companies. Mr. Chemerow earned an AB in mathematics from Dartmouth College in 1973 and an MBA from the Amos Tuck School of Business
Administration at Dartmouth College in 1975.
47
DAVID
CHEMEROW, MBA – Director Qualifications
● Leadership
Experience – Held senior executive roles leveraging his financial, business and operational
expertise across multiple companies. Currently serves on the Board of Directors for Dunham’s
Athleisure Corporation and on the Advisory Board of Huntington Outdoor, LLC, Also serves
on the Board of non-profit theater, The Martha’s Vineyard Playhouse, and is President
of the Board of the Pilot Hill Farm Association. Previously served as a member of the Board
of Directors of RiceBran Technologies, Inc. and served 15 years as a Board member of Playboy
Enterprises.
● Finance
Experience - More than 40 years of finance, accounting and operations leadership experience across multiple industries. Served as the
Chief Financial Officer and Treasurer, and prior to that as Chief Revenue Officer, of Comscore, Inc., an American-based global media
measurement and analytics company. Served as the Chief Operating Officer and Chief Financial Officer of Rentrak Corporation through its
merger with Comscore, Inc.
Information
about our Executive Officers
In
addition to Mr. Equels (discussed above), the following are our Executive Officers:
PETER
W. RODINO, III, Esq. was a director of the Company from July 2013 until September 30, 2016, when Mr. Rodino resigned as a member
of our Board to permit him to serve the Company 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, MBA has been our Chief Financial Officer since April 4, 2022. Mr. Dickey was a senior vice president of the Company from 2008
until 2013. 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.
Mr. Dickey serves as a member on the board of directors of AngioGenex, SFA Therapeutics and GSNO Therapeutics. 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. 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 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. Mr. Dickey has an MBA from The Wharton School and an AB from Princeton University.
Audit
Committee
The Audit Committee of our Board
consists of Ms. Bryan (Chair), Dr. Mitchell, Mr. Kellner and Mr. Chemerow, all of whom have been 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 Ms. Bryan and Mr. Chemerow each 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. Messrs. Kellner and Chemerow were appointed
to the Audit Committee on March 13, 2025.
We
believe all of the foregoing 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.
48
This
Audit Committee formally met six times in 2024 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”.
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 did not meet in 2024.
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, Medical 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 2024.
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
and on March 13, 2025, Mr. Kellner 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 our two independent directors, 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 2024.
Compensation
Committee
The
Compensation Committee consists of Nancy Bryan (Chair), William Mitchell, M.D., Ph.D., Ted Kellner and David Chemerow. Messrs.
Keller and Chemerow were appointed to this committee on March 13, 2025. Each of these committee members 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”).
49
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 2024 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.
Corporate
Governance and Nomination Committee
The
Corporate Governance and Nomination Committee consists of Dr. William M. Mitchell (Chair) and Director, and Nancy K. Bryan, Director.
In 2024, 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.
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.
50
Insider
Trading Policy
Our
Insider Trading Policy is contained in our Code of Ethics (see above) which, inter alia, governs the purchase, sale and other dispositions
of ours securities by directors, officers and employees and our affiliates, as well as their immediate family members and other persons
living in their households. The Insider Trading Policy is reasonably designed to promote compliance with insider trading laws, rules
and regulations and any listing standards applicable to us. The Insider Trading Policy prohibits covered persons from directly or indirectly
purchasing or selling our securities while in possession of material non-public information concerning us.
Equity
Grant Practices
Although
we have not adopted a formal policy pertaining to the timing of stock option grants to our named executive officers, it is our practice
no t to time the grant of equity awards, including stock options, in relation to the release of material non-public information (“MNPI”).
Similarly, the Company does no t time the disclosure of MNPI for the purpose of affecting the value of executive compensation. In addition,
our Compensation Committee generally approves the grant of equity awards for our executive officers, including each of the named executive
officers.
Limitation
on Liability and Indemnification of Directors and Officers
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling us,
we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act
and is therefore unenforceable.
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, 2024. 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 a Form 4 filed on January 21, 2025, to report Thomas Equels purchase of shares.
51
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; and
● 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 but automatically renews
for additional five-year periods unless terminated in writing prior to the end of the then current term. Compensation is divided into
both short- and long-term compensation. Short-term (cash) compensation consists of a base salary of $850,000. Mr. Equels will be awarded
a year-end target bonus based on performance and goals established by the Compensation Committee of up to $350,000. Long term compensation
will be provided by 100,000 non-qualified yearly stock options with one-year vesting commencing on November 30, 2021. In March 2021,
we entered into employment agreements with Peter Rodino. The agreement runs for three years but automatically renews for additional three-year
periods unless terminated in writing prior to the end of the then current term. The Agreement renewed. Compensation is divided into both
short- and long-term compensation. Short-term (cash) compensation consists 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.
52
Mr.
Equels employment agreement was amended in August 2024 and further amended in September 2024. The first amendment revised short term
compensation during the one-year period ending August 12, 2025. The Employee’s Short-term compensation consists of a base salary
of $750,000 and shares of the Company’s common stock, $.001 par value, valued at $100,000, such value equal to 100% of the closing
price of the Company’s common stock on the NYSE American on the trading date immediately preceding August 12, 2024. The second
amendment further revised short term compensation during the one year period ending September 11, 2025. The Employee’s short-term
compensation consists of a base salary of $650,000 and shares of the Company’s common stock, $.001 par value, valued at $100,000,
such value equal to 100% of the closing price of the Company’s common stock on the NYSE American on the trading date immediately
preceding September 11, 2024.
Mr.
Rodino’s employment agreement was amended in August 2024 and further amended in September 2024. The first amendment revised short
term compensation during the one-year period ending August 12, 2025. The Employee’s Short-term compensation consists of a base
salary of $375,000 and shares of the Company’s common stock, $.001 par value, valued at $50,000, such value equal to 100% of the
closing price of the Company’s common stock on the NYSE American on the trading date immediately preceding August 12, 2024.
Results
of Stockholder Advisory Vote on Executive Compensation
At
the December 2024 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 the 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, 2024 and 2023 of Thomas Equels, our
Chief Executive Officer, Peter Rodino our Chief Operating Officer, General Counsel and Secretary, Robert Dickey IV our Chief Financial
Officer.
53
Summary
Compensation Table
Name & Principal Position
Year
Salary / Fees $ (2)
Bonus
$(6)
Stock Awards $ (2)
Option
Awards
$ (1)
Non-Equity Incentive Plan Compensation $
Non-qualified Deferred Compensation Earnings $
All Other Compensation $ (3)
Total $
Thomas K Equels
2024
783,333
—
200,000
—
—
—
106,392
1,089,725
CEO & President
2023
850,000
350,000
—
128,112
—
—
103,189
1,431,301
(2)3
Robert Dickey IV
2024
49,549
—
—
—
—
—
—
49,549
CFO (2)4
2023
54,484
$ 10,000
—
—
—
—
—
64,484
Peter Rodino
COO, General Counsel
2024
408,333
—
50,000
—
—
—
63,016
521.349
& Secretary (2)5
2023
425,000
150,000
—
42,704
—
—
59,940
677,644
Notes:
(1) All
option awards were valued using the Black-Scholes method. The options for 2024 were deferred
to a later date and not issued as of December 31, 2024.
(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 2024 and 2023 as well as reported separately
in the “Compensation of Directors” section (see below) for calendar year 2024.
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 2024 and 2023.
Pursuant
to his current employment agreement, Mr. Rodino is entitled to 1% of the “Gross Proceeds” (as defined in the employment agreement)
for “significant events” (as described in the employment agreement) There were no payments during 2024 and 2023.
As
part of our cash conservation strategy, we issued common stock as a substitute for cash salaries to certain Named Executive Officers.
For the year ended December 31, 2024, stock issued as payroll totaled $250,000, which is included in the overall equity-based
compensation expense. There was no stock issued as payroll for the year ended December 31, 2023.
(3)
Mr.
Equels’ All Other Compensations consists of:
2024
2023
Life & Disability Insurance
$ 41,073
$
41,073
Healthcare Insurance
26,619
24,316
Car Expenses/Allowance
18,000
18,000
401(k) Matching Funds
20,700
19,800
Total
$ 106,392
$
103,189
(4)
Mr.
Dickey’s All Other Compensations consists of:
2024
2023
Life & Disability Insurance
$ —
$ —
Healthcare Insurance
—
—
Car Expenses/Allowance
—
—
401(k) Matching Funds
—
—
Total
$ —
$ —
(5)
Mr.
Rodino’s All Other Compensations consists of:
2024
2023
Life & Disability Insurance
$ 2,524
$ 2,524
Healthcare Insurance
25,392
23,216
Car Expenses/Allowance
14,400
14,400
401(k) Matching Funds
20,700
19,800
Total
$ 63,016
$ 59,940
(6) All bonus compensation for 2023 was deferred to 2024 and subsequently paid in 2024. In last year’s table, Mr.
Equels’ $350,000 bonus was not included for 2023 because it was accrued and not paid until 2024. This was disclosed in the footnotes
to the table. As it was earned in 2023, it is now reported in 2023. The executive officers voluntarily waived all 2024 bonus compensation
in support of the company’s cash conservation efforts.
54
Outstanding Equity Awards at Fiscal Year End
Option Awards
Stock Awards
Name
Number of Securities Underlying Unexercised Options (#) Exercisable
Number of Securities Underlying Unexercised Options (#) Unexercisable
Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#)
Options Exercise Price ($)
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
—
—
—
—
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
1,554,143
—
—
—
—
—
—
Robert Dickey IV
50,000
—
—
0.70
03/03/2032
—
—
—
—
Chief Financial Officer
Total
50,000
—
—
—
—
—
—
Peter Rodino
285
—
—
68.65
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
444,617
—
—
—
—
—
—
55
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
2024, 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 2024, Mr. Equels is entitled to receive total death benefit coverage of
$3,000,000 pursuant to his employment agreement and payable by us.
Estimated
Payments Following Severance — Named Executive Officers (NEO)
Pursuant
to his employment agreement, Mr. Equels is entitled to severance benefits on certain types of employment terminations not related to
a change in control or termination not for cause. Mr. Rodino and Mr. Dickey are not covered by an employment severance agreement and
therefore would only receive severance as determined by the Compensation Committee in its discretion.
The
dollar amounts below assume that the termination occurred on January 2, 2025. The actual dollar amounts to be paid can only be determined
at the time of the NEO’s separation from us based on their prevailing compensation and employment agreements along with any determination
by the Compensation Committee in its discretion.
Name
Event
Cash
Severance
($)
Value of Stock
Awards That
Will Become
Vested (1) ($)
Continuation of
Medical Benefits
($)
Additional
Life
Insurance
($)
Total
($)
Thomas K. Equels,
Involuntary (no cause)
$ 1,218,000
—
—
—
$ 1,218,000
CEO & President
Termination (for cause)
—
—
—
—
—
Death or disability
$ 1,700,000
—
—
—
$ 1,700,000
Termination by employee or retirement
—
—
—
—
—
Robert Dickey IV
Involuntary (no cause)
—
—
—
—
—
CFO
Termination (for cause)
—
—
—
—
—
Death or disability
—
—
—
—
—
Termination by employee or retirement
—
—
—
—
—
Peter Rodino
Involuntary (no cause)
$ 1,186,680
—
—
—
$ 1,186,680
COO, General Counsel and
Termination (for cause)
—
—
—
—
—
Secretary
Death or disability
$ 850,000
—
—
—
$ 850,000
Termination by employee or retirement
—
—
—
—
—
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 issuance for the 2024 options were deferred to a later date. 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.
56
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, 2025, 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, 2024
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, 2024. The amounts assume a January 2, 2025, termination date regarding base pay and use of the
opening price of $0.22 on the NYSE American for our common stock at that date.
Name
Aggregate Severance Pay ($)
PVSU Acceleration (2) ($)
Early Vesting of Restricted Stock (4) (5) ($)
Early Vesting of Stock Options and SARs (3) ($)
Acceleration and Vesting of Supplemental Award (5) ($)
Welfare Benefits Continuation ($)
Outplacement Assistance ($)
Parachute Tax Gross-up Payment ($)
Total ($)
Thomas K. Equels
$ 3,472,000 (1)
—
—
—
$ 234,077 (4)
—
—
—
$ 3,706,077
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, 2025 ($0.22 per share) minus
the weighted average per share exercise price of $0.20 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 $0.22 was used with an estimated exercise price of $0.22 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.
57
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.
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 Non-Employee Directors
We
reimburse non-employee 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 2024 or 2023.
During
2023, Dr. Mitchell and Stewart Appelrouth each received $139,365 in director compensation, and Ms. Bryan, who became a Director in
March 2023, received $93,750 in director compensation. During 2024, each of the foregoing Directors received $109,375 in director
compensation. Since November 2024, non-employee director compensation has taken the form of stock in lieu of cash. The value of the
stock received by Mr. Appelrouth was $12,153 and Dr. Mitchell and Ms. Bryan each received stock valued at $15,625. Since becoming a
Director on December 19, 2024, replacing Mr. Appelrouth, Mr. Kellner has declined to take any compensation.
We
believe such compensation and payments are necessary in order for us to attract and retain qualified outside directors.
Policies
and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information
From
time to time, we grant equity awards, including stock options, to our employees, including our named executive officers. Also, non-employee
directors periodically receive annual grants of stock option awards. None were issued in 2024. We do not otherwise maintain any written
policies on the timing of awards of stock options, stock appreciation rights, or similar instruments with option-like features. The Compensation
Committee considers whether there is any material nonpublic information (“MNPI”) about our company when determining the timing
of stock option grants and does not seek to time the award of stock options in relation to our public disclosure of MNPI. We have not
timed the release of MNPI for the purpose of affecting the value of executive compensation.
Director
Compensation – 2024 & 2023
Name and Title of Director
Year
Fees Earned or Paid in Cash $
Stock Award $
Option Award $
Non-Equity Incentive Plan Compensation $
Non-qualified Deferred Compensation Earnings $
All Other Compensation As Director $
Total $
T. Equels
2024
—
—
—
—
—
—
—
Executive
2023
—
—
—
—
—
—
—
Vice Chairman
W. Mitchell
2024
109,375
15,625
—
—
—
—
125,000
Chairman of
2023
139,365
—
—
—
—
—
139,365
the Board
S. Appelrouth
2024
109,375
12,153
—
—
—
—
121,528
Director
2023
139,365
—
—
—
—
—
139,365
N. Bryan
2024
109,375
15,625
—
—
—
—
125,000
Director
2023
93,750
—
—
—
—
—
93,750
T. Kellner
2024
—
—
—
—
—
—
—
Director
2023
—
—
—
—
—
—
—
In
March 2023, the Board reduced annual cash compensation from $182,462 to $125,000 to allow for additional Board members.
58
Pay
Versus Performance
Year
Summary Compensation Table Total for PEO (1)
Compensation Actually Paid to PEO (1) (2) (3)
Average Summary Compensation Table Total for Non-PEO NEOs (1)
Average Compensation Actually Paid to Non-PEO NEOs (1) (2)
Value of Initial Fixed $100 Investment Based On Total Shareholder Return (4)
Net Income (Loss)(5)
2024
$ 1,089,725
$ 1,067,109
$ 285,935
$ 282,166
$ 21.52
$ (17,320,000 )
2023
$ 1,431,301
$ 1,458,539
$ 369,860
$ 375,160
$ 47.83
$ (28,962,000 )
2022
$ 1,352,028
$ 1,235,379
$ 332,113
$ 288,864
$ 33.70
$ (19,445,000
(1)
The
PEO and the non-PEO NEOs for each year are as follows:
2024
and 2023: Thomas Equels, PEO; Robert Dickey and Peter Rodino, NEOs.
2022:
Thomas K. Equels, PEO. Ellen Lintal was our PFO until April 3, 2022, and her compensation for 2022 (including her consulting fees)
has been included in the “Summary Compensation Table” and “Compensation Actually Paid.” Robert Dickey became
our PFO to replace Ellen Lintal on April 4, 2022, and his compensation from that date through year-end has been included in the “Summary
Compensation Table” and “Compensation Actually Paid.” Peter Rodino served as the other NEO for the entire year.
(2)
The
dollar amounts reported in the “Compensation Actually Paid to PEO” column represent the amount of “compensation
actually paid” to the PEO, as computed in accordance with SEC rules. The dollar amounts do not reflect the actual amount of
compensation earned by or paid to the PEO during the applicable year. In accordance with SEC rules, the following adjustments were
made to total compensation to determine the compensation actually paid to the PEO:
Year
Summary Compensation Table Total for PEO
Less: Summary Compensation Table Reported Value of Equity Awards(a)
Plus: Equity Award Adjustments(b)
Equals: Compensation Actually Paid to PEO
2024
$ 1,089,725
$ (200,000 )
$ 177,384
$ 1,067,109
2023
$ 1,431,301
$ (128,112 )
$ 155,350
$ 1,458,539
2022
$ 1,352,028
$ (111,556 )
$ (5,093 )
$ 1,235,379
(a)
Represents
the aggregate grant-date fair value of equity awards as reported in the “Option Awards” columns in the “Summary
Compensation Table” for the applicable year.
(b)
The
equity award adjustments for each applicable year were as set forth in the table below. The valuation assumptions used to calculate
fair values did not materially differ from those disclosed at the time of grant. The amounts deducted or added in calculating the
equity award adjustments are as follows:
59
Year
Year End Fair Value of Outstanding and Unvested Equity Awards Granted in the Covered Year
Year over Year Change in Fair Value of Outstanding and Unvested Equity Awards Granted in Prior Years
Vesting Date Fair Value of Equity Awards Granted in the Covered Year that Vested in the Covered Year
Change in Fair Value of Equity Awards Granted in Prior Years that Vested in the Covered Year (From Prior Year End to Vesting Date)
Fair Value at the End of the Prior Year of Equity Awards that Failed to Vest in the Covered Year
Value of Dividend Equivalents Accrued or other Earnings Paid on Stock Awards not Otherwise Reflected in Fair Value
Total Equity Award Adjustments
2024
$ —
$ —
$ 200,000
$ (22,616 )
$ —
$ —
$ 177,384
2023
$ 108,555
$ —
$ 9,869
$ 36,926
$ —
$ —
$ 155,350
2022
$ 79,433
$ —
$ 7,221
$ (91,747 )
$ —
$ —
$ (5,093 )
The
dollar amounts reported in the “Average Compensation Actually Paid to Non-PEO NEOs” column represent the average amount of
“compensation actually paid” to the NEOs as a group (excluding the PEO), as computed in accordance with SEC rules. The dollar
amounts do not reflect the actual amount of compensation earned by or paid to the NEOs (excluding the PEO) during the applicable year.
In accordance with the SEC rules, the following adjustments were made to average total compensation for the NEOs as a group (excluding
the PEO) or each year to determine the compensation actually paid:
Year
Average Reported Summary Compensation Table Total for Non-PEO NEOs
Less: Summary Compensation Table Average Reported Value of Equity Awards
Plus: Average Equity Award Adjustments(x)
Equals: Average Compensation Actually Paid to Non-PEO NEOs
2024
$ 285,935
$ (25,000 )
$ 21,231
$ 282,166
2023
$ 369,860
$ (21,352 )
$ 26,652
$ 375,160
2022
$ 332,113
$ (33,802 )
$ (9,447 )
$ 288,864
(x)
The
amounts deducted or added in calculating the total average equity award adjustments are as follows (figures in columns other than
“Total Average Equity Award Adjustments” are rounded to the nearest dollar):
60
Year
Average
Year End Fair Value of Outstanding and Unvested Equity Awards Granted in the Covered Year
Year
over Year Average Change in Fair Value of Outstanding and Unvested Equity Awards Granted in Prior Years
Vesting
Date Fair Value of Equity Awards Granted in the Covered Year that Vested in the Covered Year
Change
in Fair Value of Equity Awards Granted in Prior Years that Vested in the Covered Year (From Prior Year End to Vesting Date)
Fair
Value at the End of the Prior Year of Equity Awards that Failed to Vest in the Covered Year
Average
Value of Dividend Equivalents Accrued or other Earnings Paid on Stock Awards not Otherwise Reflected in Fair Value
Total
Average Equity Award Adjustments
2024
$
—
$
—
$
25,000
$
(3,769
)
$
—
$
—
$
21,231
2023
$
18,092
$
—
$
1,645
$
6,915
$
—
$
—
$
26,652
2022
$
10,430
$
—
$
8,826
$
(28,703
)
$
—
$
—
$
(9,447
)
(3)
In
calculating the “compensation actually paid” amounts reflected in these columns, the fair value or change in fair value,
as applicable, of the equity award adjustments included in such calculations was computed in accordance with FASB ASC Topic 718.
The valuation assumptions used to calculate such fair values did not materially differ from those disclosed at the time of grant.
(4)
The
values disclosed in this TSR column represent the re-measurement period value at December 31, 2024, 2023, and 2022 with an initial
investment of $100 in the Company’s shares.
(5)
Represents
the amount of net income (loss) reflected in the Company’s audited GAAP financial statements for each applicable fiscal year.
The Company’s net comprehensive loss for the years ended December 31, 2024, 2023, and 2022 was approximately $17,320,000, $28,962,000,
and $19,445,000 respectively.
One
objective of the “Pay Versus Performance Table” is to illustrate how performance-based features in our executive compensation
program operate to index pay to performance. As further explained below, we believe that the table reflects an alignment of compensation
actually paid with the decline in the Company’s performance.
Compensation
Actually Paid versus Company Total Shareholder Return
As
outlined in the table, increases in the compensation actually paid values for our PEO and non-PEO NEOs from 2022 to 2024 are directionally
aligned with the changes in our total shareholder return over this same period. The decrease in compensation from 2022 to 2024 is primarily
a result of the PEO and an NEO not receiving a bonus in 2024 when compared to the previous two years of 2023 and 2022. In 2024, the PEO
and non-PEO NEOs agreed to voluntarily forego the cash bonuses for 2024 for which they are entitled to pursuant to their employment agreements
to conserve cash for the Company, which primarily resulted in a reduction in their compensation actually paid. Additionally, the PEO
and non-PEO NEO did not receive stock awards for 2024. These reductions were offset by the change in type of salary that they received.
The PEO and non-PEO NEO reduced their cash compensation within their salary in 2024 for an annual period and receiving common stock the
for the total amount of the reduction, which was valued equal to 100% of the closing price of our common stock on the trading date immediately
preceding the date of issuance of the shares in accordance with the compensation arrangements. As a portion of their annual salary for
the 2024-2025 period was received in common stock in 2024. Due to this net change the compensation actually paid decrease and was aligned
with the total shareholder return decreased. Our compensation programs are structured based on short-term and long-term compensation
for the NEOs. As we have been primarily focused on conserving cash in the short-term, these compensation arrangements to reduce cash
compensation met our short-term needs. Long-term compensation is provided by non-qualified yearly stock options within yearly vesting.
The ultimate value of these equity awards, and the resulting impact on compensation actually paid, aligns with our total shareholder
return performance. In 2024, the PEO and non-PEO NEOs were not awarded their yearly stock options. While the overall total shareholder
return performance has declined, compensation actually paid decreased as a result of the structuring of the compensation arrangements.
Compensation
Actually Paid versus Company Net Income
As outlined in the table, decreases in the compensation actually paid values for our PEO and non-PEO NEOs occurred
from 2022 to 2024, while the net loss decreased for the same period. The decrease in compensation actually paid from 2022 to 2024 is primarily
the result of the structuring of the compensation arrangements for the PEO and non-PEO NEOs. In 2024, the PEO and non-PEO NEOs agreed
to voluntarily forego the cash bonuses for 2024 for which they are entitled to pursuant to their employment agreements to conserve cash
for the Company. As such, there was a reduction in their compensation actually paid, which would not align with the decrease in the net
loss. As we have been primarily focused on the clinical and regulatory development of Ampligen and, accordingly, we have not historically
used net income (loss) as a performance measurement in our executive compensation. As a pre-commercial stage company, our performance
is attributable to the successful execution of our regulatory, clinical, research and commercial goals. Therefore, while the Board monitors
our net income (loss), we do not currently believe there is a meaningful relationship between our net loss and compensation actually paid
to our NEOs during the periods presented.
ITEM
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The
following table sets forth as of March 24, 2025 , 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
61
● All
of our officers and directors as a group.
● Total
number of shares of Common Stock at March 24, 2025
was 72,290,030.
Name and Address of
Shares Beneficially
% Of Shares
Beneficial Owner
Owned
Beneficially Owned
Thomas K. Equels, Executive Vice Chairman, Chief Executive Officer, President
3,412,172 (1)
4.72 %
Peter W. Rodino III, Chief Operating Officer, General Counsel, Secretary
845,879 (2)
1.17 %
William M. Mitchell, M.D., Chairman of the Board of Directors
554,746 (3)
* %
Ted D. Kellner, Director
1,583,000 (4)
2.19 %
Nancy K. Bryan, Director
291,882
* %
David Chemerow, Director
64,189
* %
Robert Dickey IV, Chief Financial Officer
50,000 (5)
* %
All 5% stockholders, directors and executive officers as a group (7 persons)
6,801,868
9.41 %
*
Less than 1%
(1)
For
Mr. Equels, shares beneficially owned include 1,554,143 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.
(2)
For
Mr. Rodino, shares beneficially owned include 444,617 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.
(3)
For
Dr. Mitchell, shares beneficially owned include 229,494 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. Kellner, shares beneficially owned indirectly include 1,582,000 shares owned by
family and other trusts and annuities and a profit sharing/money purchase plan.
(5)
For
Mr. Dickey IV, shares beneficially owned include 50,000 shares issuable upon exercise of options.
Equity
Compensation Plan Information
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, 2024.
Plan Category
Number of securities to be issued upon exercise of outstanding options, warrants and rights
Weighted average exercise price of outstanding options, warrants and rights
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)
(a)
(b)
(c)
Equity compensation plans approved by security holders:
3,292,593
$ 1.54
487,050
Equity compensation plans not approved by security holders:
—
—
—
Total
3,292,593
$ 1.54
487,050
62
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.
Other
than compensation arrangements for our executive officers and directors which are described elsewhere in this filing, see “Executive
and Director Compensation,” there were no transactions occurring since January 1, 2022 to which we were a party and in which:
●
the amount involved exceeded $120,000 (or, if less, 1% of the average of our total assets at either December 31, 2023, and 2022); and
●
any director, executive officer, holder of 5% or more of any class of our outstanding capital stock, or any member of the immediate family
of, or entities affiliated with, any of the foregoing persons, had, or will have, a direct or indirect material interest.
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 2024 were $ 799,600 and total fees for 2023 were $697,474.
Amount ($)
2024
2023
Description of Fees:
Audit Fees
$ 761,300
$ 663,984
Tax Fees
38,300
33,490
Total
$ 799,600
$ 697,474
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 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 2024 and 2023.
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 a decision.
63
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)
Amendment to Certificate of Incorporation (incorporated by reference to Exhibit 3(i).1 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended September 30, 2024).
3.2(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).
3.3
Amended and Restated By-Laws of Registrant (incorporated by reference to Exhibit 3.1(ii) to the Company’s Current Report on Form 8-K (No. 001-27072) filed August 1, 2024).
4.1
Specimen certificate representing our Common Stock (incorporated by reference to Exhibit 4.1 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended September 30, 2024).
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 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).
4.7
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).
4.8
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).
4.9
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).
4.10
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).
4.11
Description of Common Stock.*
64
4.12
Third Amended and Restated Rights Agreement, dated May 12, 2023 between AIM ImmunoTech Inc. (formerly, Hemispherx Biopharma, Inc.) and American Stock Transfer & Trust Company, LLC. (incorporated by reference to Exhibit 4.6 to Amendment No. 3 to the Company’s Registration Statement on Form 8-A12B (No. 001-27072) filed May 15, 2023).
4.13
Form of Warrant Agency Agreement between AIM and Equiniti Trust Company, LLC (incorporated by reference to Exhibit 4.28 to the Company’s Registration Statement on Form S-1/A, Amendment No. 1 (No. 333-0284443) filed February 3, 2025).
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
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).
10.3
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).
10.4
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).
10.5
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).
10.6
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).
10.7
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).
10.8
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).
10.9
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).
10.10
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).
10.11
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).
65
10.12
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).
10.13
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).
10.14
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).
10.15
March 20, 2020 Amendment to 2017 Material Transfer and Research Agreement with Roswell Park Cancer Institute (incorporated by reference to Exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed March 26, 2020).
10.16
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).
10.17
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).
10.18
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).
10.19
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).
10.20
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).
10.21
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).
10.22
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).
10.23
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).
66
10.24
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).
10.25
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).
10.26
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).
10.27
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).
10.28
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).
10.29
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).
10.30
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).
10.31
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).
10.32
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).
10.33
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).
10.34
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).
67
10.35
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).
10.36
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).
10.37
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).
10.38
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)
10.39
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)
10.40
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)
10.41
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).
10.42
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).
10.43
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).
10.44
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).
10.45
Atlas Equity Purchase Agreement (incorporated by reference to Exhibit 10.104 to the Company’s annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2023) filed April 1, 2024.
10.46
Atlas Registration Rights Agreement (incorporated by reference to Exhibit 10.104 to the Company’s annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2023) filed April 1, 2024.
10.47
October 4, 2023 Lease extension for Riverton office (incorporated by reference to Exhibit 10.106 to the Company’s Registration Statement on Form S-1 (No. 333-278839) filed April 19, 2024).
10.48
March 15, 2024 Addendum 1 to Lease for Ocala office (incorporated by reference to Exhibit 10.107 to the Company’s Registration Statement on Form S-1 (No. 333-278839) filed April 19, 2024).
68
10.49
Form of Securities Purchase Agreement, dated as of May 31, 2024, by and among the Company and a Purchaser (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed June 3, 2024).
10.50
August 12, 2024 Amendment to Employment Agreement for Thomas K Equels (incorporated by reference to Exhibit 10.4 to the Company’s Quarterly report on form 10-Q (No. 001-27072) for period ended June 30, 2024).
10.51
August 12, 2024 Amendment to Employment Agreement for Peter W Rodino III (incorporated by reference to Exhibit 10.5 to the Company’s Quarterly report on form 10-Q (No. 001-27072) for period ended June 30, 2024).
10.52
September 11, 2024 Amendment to Employment Agreement for Thomas K Equels (incorporated by reference to Exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed September 12, 2024).
10.53
September 11, 2024 Amendment to Employment Agreement for Peter W. Rodino III (incorporated by reference to Exhibit 10.2 to the Company’s Current report on Form 8-K (No. 001-27072) filed September 12, 2024).
10.54
September 30, 2024 Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed October 1, 2024).
10.55
September 30, 2024 Placement Agency Agreement with Maxim Group LLC (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed October 1, 2024).
10.56
October 1, 2024 Class C Common Stock Purchase Warrant with Armistice Capital Master Fund Ltd (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed October 1, 2024).
10.57
October 1, 2024 Class D Common Stock Purchase Warrant with Armistice Capital Master Fund Ltd (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K (No. 001-27072) filed October 1, 2024).
10.58
September 19, 2024 Lease extension for Riverton office (incorporated by reference to Exhibit 10.15 to the Company’s Quarterly Report on Form 10-Q (No. 001-27072) filed November 14, 2024).
10.59
Class A/B Common Stock Purchase Warrant with Armistice (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K (No. 011-27072) filed June 3, 2024).
10.60
Class C Common Stock purchase warrant with Armistice (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed on October 1, 2024).
10.61
Class D Common Stock Purchase Warrant with Armistice incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K (No. 001-27072) filed on October 1, 2024).
10.62
Form of Lock-up Agreement (incorporated by reference to Exhibit 10.119 to the Company’s Registration Statement on Form S-1/A, Amendment No. 1 (No. 333-0284443) filed February 3, 2025).
21.1
List of Subsidiaries*
69
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 (incorporated by reference to Exhibit 97.1 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2023).
101
The
following materials from AIM’ Annual Report on Form 10-K for the year ended December 31, 2024, formatted in eXtensible Business
Reporting Language (“XBRL”): (i) the Consolidated Statements of Income; (ii) the Consolidated Balance
Sheets; (iii) the Consolidated Statements of Cash Flows; and (iv) Notes to Consolidated Financial Statements.
*
Filed
herewith
**
Certain
confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because
the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.
(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.
70
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
27, 2025
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
27, 2025
Thomas
K. Equels
Director
of the Board
/s/
William Mitchell
Chairman
of the Board
March
27, 2025
William
Mitchell
and
Director
/s/
Robert Dickey IV
Chief
Financial Officer
March
27, 2025
Robert
Dickey IV
/s/
Nancy Bryan
Director
March
27, 2025
Nancy
Bryan
/s/
Ted D. Kellner
Director
March 27, 2025
Ted D. Kellner
/s/
David Chemerow
Director
March 27, 2025
David Chemerow
71
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, 2024 and 2023
F-4
Consolidated Statements of Operations for each of the years in the two-year period ended December 31, 2024
F-5
Consolidated
Statements of Changes in Stockholders’ (Deficit) Equity for each of the years in the two-year period ended December 31,
2024
F-6
Consolidated Statements of Cash Flows for each of the years in the two-year period ended December 31, 2024
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, 2024
and 2023, the related consolidated statements of operations, stockholders’ (deficit) equity, and cash flows for each of the two
years in the period ended December 31, 2024, 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, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December
31, 2024, in conformity with accounting principles generally accepted in the United States of America.
Going
Concern Uncertainty
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 1 to the consolidated financial statements, the Company has suffered recurring losses from operations and has a net capital deficiency
that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are
also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of
this uncertainty.
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 Matters
The
critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements
that were communicated or required to be communicated to the audit committee and that: (1) relate 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 matters below, providing separate opinions on the critical audit matters or on the
accounts or disclosures to which they relate.
Research
and Development Costs
As
described in Notes 5 and 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 $6.2 million for the year ended December 31, 2024, and accrued clinical trial
expenses of approximately $0.1 million at December 31, 2024. 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.
F- 2
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.
Classification
of Class A & B Common Warrants
As
described in Note 7 to the financial statements, the Company entered into a securities purchase agreement to complete an offering with
a single accredited investor (the “Purchaser”), pursuant to which the Company will issue to the Purchaser, (i) in a registered
direct offering, 5,640,958 shares of the Company’s common stock, par value $0.001 per share and (ii) in a concurrent
private placement, the Company will issue to the Purchaser Class A common warrants to purchase an aggregate of up to 5,640,958 shares
of its common stock (the “A Warrants”) at an exercise price of $0.363 per share and Class B common warrants to purchase
an aggregate of up to 5,640,958 shares of its common stock (the “B “Warrants” and, along with the A Warrants,
the “Class A & B Common Warrants”) at an exercise price of $0.363 per share.
We
identified the evaluation of the financial statement classification for the Class A & B Common Warrants as a critical audit mater.
The principal consideration for our determination was that performing procedures and evaluating audit evidence relating to the existence
of accounting complexities related to certain provisions of the warrant agreement, including volatility. Auditing these elements involved
especially complex auditor judgment due to the terms of the applicable agreement, including the extent of expertise needed.
The
primary procedures we performed to address this critical audit matter included:
● Evaluating
the appropriateness of management’s conclusions through the review of: (i) the relevant
terms of the warrant agreement, (ii) the completeness and accuracy of the Company’s
technical accounting analysis, and (iii) the appropriateness of application of the relevant
accounting literature.
● Utilizing
firm personnel with expertise in the relevant technical accounting to assist in: (i) evaluating
relevant terms of the warrant agreement in relation to the appropriate accounting literature,
and (ii) assessing the appropriateness of conclusions reached by the Company.
Valuation
of Common Warrants
In
addition to the Class A & B Common Warrants described above, and as described in Note 7 to the financial statements, Company entered
into a Purchase Agreement with the Selling Stockholder as Purchaser, pursuant to which the Company issued to the Selling Stockholder,
(i) in a registered direct offering, 4,653,036 shares of Common Stock (“Shares”) and (ii) in the concurrent Private Placement,
Class C and Class D Warrants, each to purchase an aggregate of up to 4,653,036 Shares (the “Common Warrant Shares”) each
with an exercise price of $0.28. The Class C and Class D Warrants together, hereinafter the “Common Warrants”. The purchase
price for Shares in the registered direct offering was $0.27 per Share.
We
identified the valuation of the Class A & B Common Warrants, and Class C & D Common Warrants (the “Common Warrants”)
as a critical audit matter. The principal consideration for our determination was that performing procedures and evaluating audit evidence
relating to the valuation of the Common Warrants involved a high degree of auditor effort to address this matter.
The
primary procedures we performed to address this critical audit matter included:
● Testing
the accuracy of the source data used by management in the valuation by comparing it to the
securities purchase agreement and share price;
● Utilizing
personnel with specialized knowledge and skills in valuation to assist in: (i) assessing
the appropriateness of the methodology used in estimating the fair value of the common warrants;
(ii) evaluating the reasonableness of the fair value and assumptions used to calculate the
fair value of the common warrants, including the volatility; and (iii) testing the mathematical
accuracy of the Company’s model.
/s/
BDO USA, P.C.
We
have served as the Company’s auditor since 2021.
Miami,
Florida
March
27, 2025
F- 3
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Balance Sheets
December
31, 2024 and 2023
(in
thousands, except for share and per share amounts)
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$ 1,701
$ 5,439
Marketable securities
2,276
7,631
Funds receivable from New Jersey net operating loss
—
1,184
Prepaid expenses and other current assets
199
302
Total current assets
4,176
14,556
Property and equipment, net
108
127
Right of use asset, net
618
697
Patent and trademark rights, net
2,594
2,313
Other assets
1,112
1,688
Total assets
$ 8,608
$ 19,381
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY
Current liabilities:
Accounts payable
$ 6,383
$ 6,443
Accrued expenses
606
1,986
Current portion of operating lease liability
239
223
Current portion of note payable, net
2,307
—
Total current liabilities
9,535
8,652
Long-term liability:
Operating lease liability
395
495
Total liabilities
9,930
9,147
Commitments and contingencies (Notes 7, 8, 10, 16)
-
-
Stockholders’ (deficit) equity:
Series A Junior Participating Preferred Stock, $ 0.001 par value, 4,000,000 shares authorized as of December 31, 2024 and 2023; issued and outstanding – none
—
—
Series B Convertible Preferred Stock, stated value $ 1,000 per share, 10,000 shares authorized; no shares and 689 issued and outstanding as of December 31, 2024 and 2023, respectively
—
689
Preferred Stock, Value
—
689
Common Stock, $ 0.001 par value, authorized shares - 350,000,000 ; issued and outstanding shares 65,526,320 and 49,102,484 as of December 31, 2024 and 2023, respectively
66
49
Additional paid-in capital
425,440
419,004
Accumulated deficit
( 426,828 )
( 409,508 )
Total stockholders’ (deficit) equity
( 1,322 )
10,234
Total liabilities and stockholders’ (deficit)
equity
$ 8,608
$ 19,381
See
accompanying notes to consolidated financial statements.
F- 4
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Operations
(in
thousands, except share and per share data)
2024
2023
Years ended December 31,
2024
2023
Revenues:
Clinical treatment programs – US
$ 170
$ 202
Total Revenues
170
202
Costs and Expenses:
Production costs
31
42
Research and development
6,197
10,939
General and administrative
13,714
21,137
Total Costs and Expenses
19,942
32,118
Operating loss
( 19,772 )
( 31,916 )
(Loss) gain on investments
( 93 )
200
Interest and other income
5,192
1,069
Interest expense
( 585 )
—
Gain on sale of fixed assets
—
18
(Loss) on warrant issuance
( 458 )
—
(Loss) gain from sale of income tax operating losses
( 1,604 )
1,667
Net Loss
$ ( 17,320 )
$ ( 28,962 )
Basic and diluted loss per share
$ ( 0.31 )
$ ( 0.60 )
Weighted average shares outstanding basic and diluted
56,016,870
48,585,404
See
accompanying notes to consolidated financial statements.
F- 5
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Changes in Stockholders’ (Deficit) Equity
(in
thousands except share data)
For
the Year Ended December 31, 2024
Series B
Preferred
Common
Stock
Shares
Common
Stock .001
Par Value
Additional
Paid-in
Capital
Accumulated
Deficit
Total
Stockholders’
Equity
Balance December 31, 2023
$ 689
49,102,484
$ 49
$ 419,004
$ ( 409,508 )
$ 10,234
Common stock issuance, net of costs
—
2,551,010
4
888
—
892
Cashless exercise of warrants
—
3,272
—
—
—
—
Issuance of warrants
—
10,293,994
9
3,752
—
3,761
Equity-based compensation
—
1,465,969
2
684
—
686
Repayment of Debt with Shares
—
2,109,591
2
423
—
425
Series B preferred shares expired
( 689 )
—
—
689
—
—
Net loss
—
—
—
—
( 17,320 )
( 17,320 )
Balance December 31, 2024
$ —
65,526,320
$ 66
$ 425,440
$ ( 426,828 )
$ ( 1,322 )
For
the Year Ended December 31, 2023
Series B
Preferred
Common
Stock
Shares
Common
Stock .001
Par Value
Additional
Paid-in
Capital
Accumulated
Deficit
Total
Stockholders’
Equity
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
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 loss
—
—
—
—
( 28,962 )
( 28,962 )
Balance December 31, 2023
$ 689
49,102,484
$ 49
$ 419,004
$ ( 409,508 )
$ 10,234
Balance
$ 689
49,102,484
$ 49
$ 419,004
$ ( 409,508 )
$ 10,234
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,
2024
2023
Cash flows from operating activities:
Net loss
$ ( 17,320 )
$ ( 28,962 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment
37
39
Gain on sale of fixed assets
—
( 18 )
Abandonment and expiration of patents and trademark rights
48
14
Amortization of patent and trademark rights
209
199
Non-cash lease expense
304
287
Amortization of financial obligation
301
—
Equity-based compensation
686
243
Loss (gain) on sale of marketable securities
93
( 200 )
Loss on fair value of warrants
458
—
Change in assets and liabilities:
Funds receivable from New Jersey operating loss sales
1,184
492
Prepaid expenses and other current assets
103
153
Lease liability
( 309 )
( 274 )
Other assets
576
( 486 )
Accounts payable
( 60 )
6,066
Accrued expenses
( 1,198 )
1,180
Net cash used in operating activities
( 14,888 )
( 21,267 )
Cash flows from investing activities:
Proceeds from sale of marketable investments
5,623
1,299
Purchase of marketable investments
( 361 )
( 1,593 )
Purchase of property and equipment
( 18 )
—
Proceeds from sale of property and equipment
—
47
Purchase of patent and trademark rights
( 538 )
( 585 )
Net cash provided by (used in) by investing activities
4,706
( 832 )
Cash flows from financing activities:
Proceeds from sale of stock, net of issuance costs
892
485
Repayment of debt obligation
( 251 )
—
Proceeds from note payable, net of issuance costs
2,500
—
Proceeds from issuance of equity warrants
3,303
—
Net cash provided by financing activities
6,444
485
Net decrease in cash and cash equivalents
( 3,738 )
( 21,614 )
Cash and cash equivalents at beginning of year
5,439
27,053
Cash and cash equivalents at end of year
$ 1,701
$ 5,439
Supplemental disclosures of non-cash investing and financing cash flow information:
Unrealized gain on marketable investments
$ 570
$ 376
Conversion of Series B preferred
$ 689
$ 7
Repayment of debt obligation with shares
$ 243
$ —
Operating lease liability arising from obtaining right of use asset
$ 31
$ 73
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
AIM
ImmunoTech Inc. and its subsidiaries (collectively, “AIM”, “Company”, “we” or “us”) are
an immuno-pharma company headquartered in Ocala, Florida, 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) and Alferon N Injection (Interferon alfa). Ampligen is a double-stranded RNA (“dsRNA”)
molecule being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has not been approved
by the FDA or marketed in the United States but is approved for commercial sale in the Argentine Republic for the treatment of severe
Chronic Fatigue Syndrome (“CFS”).
The
Company is currently proceeding primarily in four areas:
● Conducting
clinical trials to evaluate the efficacy and safety of Ampligen for the treatment of pancreatic
cancer.
● Evaluating
Ampligen across multiple cancers as a potential therapy that modifies the tumor microenvironment
with the goal of increasing anti-tumor responses to checkpoint 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 the Post-COVID condition of fatigue.
● Evaluating Ampligen as a vaccine adjuvant in the combination of Ampligen and AstraZeneca’s FluMist as an intranasal
vaccine for influenza, including avian influenza.
The
Company 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. The Company intends that priority clinical work
be conducted in trials authorized by the FDA or European Medicines Agency (“EMA”), which trials support a potential future
NDA. However, AIM’s antiviral experimentation is designed to accumulate additional preliminary data supporting their hypothesis
that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced immunity and cross-protection.
Accordingly, AIM will conduct antiviral programs in those venues most readily available and able to generate valid proof-of-concept data,
including foreign venues.
We
have recently announced that we have engaged Amarex Clinical Research (“Amarex”), our Clinical Research Organization, with
the application and eventual management of a follow-up Investigational New Drug (“IND”) application for the study of a potential
avian influenza combination therapy of our Ampligen and AstraZeneca’s FluMist, a nasal spray vaccine that helps prevent seasonal
influenza. We are seeking collaborative grants from government and industry to defray the cost of the study. In addition, we recently
announced that the Erasmus Medical Center Safety Committee grants approval to proceed with a Phase 2 Study of Ampligen and Imfinzi as
a potential combination therapy for late-stage pancreatic cancer.
AIM’s
business plan requires one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen and its Active Pharmaceutical
Ingredients (APIs). This includes utilizing Jubilant HollisterStier and Sterling for the manufacture of Ampligen and our Poly I and Poly
C12U polynucleotides, respectively.
In
the opinion of management, all adjustments necessary for a fair presentation of its consolidated financial statements have been included.
Such adjustments consist of normal recurring items. Interim results are not necessarily indicative of results for a full year.
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”).
F- 8
Liquidity
and Going Concern
The
accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern.
The going concern basis of presentation assumes that the Company will continue in operation one year after the date these financial statements
are issued and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business.
Pursuant
to the requirements of the Financial Accounting Standards Board’s (the “FASB”) Accounting Standards Codification (“ASC”)
Topic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, management must evaluate whether
there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue
as a going concern for one year from the date these financial statements are issued. This evaluation does not take into consideration
the potential mitigating effect of management’s plans that have not been fully implemented or are not within control of the Company
as of the date the financial statements are issued. When substantial doubt about the Company’s ability to continue as a going concern
exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt. The mitigating
effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented
within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will
mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern
within one year after the date that the financial statements are issued. .
The
Company’s principal source of liquidity is its cash and cash equivalents, marketable securities, and proceeds from financing activities
to provide the necessary funding to meet our obligations as they become due. The Company has suffered losses from operations and net
cash used on operating activities for the year ended December 31, 2024, and has a working capital deficit as of December 31, 2024. Additionally,
the Company’s stockholders’ equity was below the minimum requirements for continued listing on the New York Stock Exchange
American (“NYSE American”). These conditions raise substantial doubt regarding the Company’s ability to continue as
a going concern for a period of at least one year from the date of issuance of these consolidated financial statements. Management evaluated
the conditions, and the significance of these conditions related to the Company’s ability to meet its obligations. If the Company is unable to implement sufficient mitigation efforts,
the Company may be forced to limit its business activities or be unable to continue as a going concern, which would have a material adverse
effect on its results of operations and financial condition.
(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, 2024, some accounts
held at financial institutions were in excess of the federally insured limit of $ 250,000 . The Company has not experienced any losses
on these accounts and believes credit risk to be minimal.
(b)
Marketable Securities
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.
(c)
Property and Equipment, net
Schedule
of Property and Equipment
2024
2023
(in thousands)
December 31,
2024
2023
Furniture, fixture and equipment
$ 1,466
$ 1,448
Less: accumulated depreciation
( 1,358 )
( 1,321 )
Property and equipment, net
$ 108
$ 127
F- 9
Property
and equipment are recorded at cost. Depreciation and amortization are computed using the straight-line method over the estimated useful
lives of the respective assets, ranging from three to ten years. Depreciation expense for the year ended December 31, 2024 and December
31, 2023 was $ 37,000 and $ 39,000 , respectively.
(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.
(g)
Accounting for Income Taxes
Deferred
income tax assets and liabilities are determined based on differences between the financial statement reporting and tax bases of assets
and liabilities and are measured using the enacted tax rates and laws in effect when the differences are expected to reverse. The measurement
of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized.
The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes
are enacted.
The
Company applies the provisions of FASB ASC 740-10 Uncertainty in Income Taxes. As a result of the implementation, there has been no material
change to the Company’s tax positions as they have not paid any corporate income taxes due to operating losses. With the exception
of net operating losses generated in New Jersey, all tax benefits will likely not be recognized due to the substantial net operating
loss carryforwards which will most likely not be realized prior to expiration. With no tax due for the foreseeable future, the Company
has determined that a policy to determine the accounting for interest or penalties related to the payment of tax is not necessary at
this time.
F- 10
(h)
Recent Accounting Standards and Pronouncements
The
Financial Accounting Standards Board (“FASB”) issues Accounting Standards Updates (“ASUs”) to improve U.S. General
Accounting Principles (“U.S. GAAP”). The Company has reviewed the recently issued ASUs and their applicability to its operations.
During
the fiscal year ended December 31, 2024, the Company adopted the following ASUs:
In November
2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
2023-07, Segment Reporting—Improvements to Reportable Segment Disclosures, which
improves segment disclosure requirements, primarily through enhanced disclosure requirements for
significant segment expenses. The improved disclosure requirements apply to all public entities that are required to
report segment information, including those with only one reportable segment. The Company adopted the guidance in the
fiscal year beginning January 1, 2024 and there was no impact on the Company’s reportable segments identified. Refer to additional
required disclosures in Note 17.
In
March 2024, the FASB issued ASU 2024-01, Compensation – Stock Compensation. This update clarifies the scope of share-based
compensation guidance in ASC 718 regarding profits interest awards. The adoption of this standard did not have a material impact on the
Company’s financial position or results of operations.
In
March 2024, the FASB issued ASU 2024-02, Codification Improvements-Amendments to Remove References to the Concepts Standards. This
update removes outdated references to the FASB’s Conceptual Framework across multiple topics. The adoption of this standard did
not impact the Company’s 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.
(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 20,587,988 and 3,523,949 of stock options and warrants, are excluded from the calculation of
diluted net loss per share for the years ended December 31, 2024 and 2023, 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.
F- 11
(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)
Segment Reporting
The Company manages the business
activities on a consolidated basis and operates in one reportable segment, which is the research and development of potential therapeutics
for cancers, viruses and autoimmune disorders. As the Company has one reportable segment, research and development, and general and
administrative expenses are equal to consolidated results. Financial results for the Company’s reportable segment have been
prepared using a management approach, which is consistent with the basis and manner in which financial information is evaluated by the
Company’s Chief Operating Decision Maker (“CODM”) in allocating resources and in assessing performance. The Company’s
CODM is the Chief Executive Officer. Actual financial results used by the CODM to assess performance and allocate resources, as well as
strategic decisions related to headcount and other expenditures, are reviewed on a consolidated basis.
(3) Marketable Securities
Marketable
securities consist of mutual funds. At December 31, 2024 and December 31, 2023, it was determined that none of the marketable securities
had an other-than-temporary impairment. At December 31, 2024 and December 31, 2023, all securities were measured as Level 1 instruments
of the fair value measurements standard (See Note 15: Fair Value ). At December 31, 2024, and December 31, 2023 the Company held
$ 2,276,000 and $ 7,631,000 respectively, in mutual funds.
Mutual
Funds classified as available for sale consisted of $ 2,276,000 at December 31, 2024. The net loss recognized for the year ended December
31, 2024 on equity securities was ($ 93,000 ). The net losses recognized for the year ended December 31, 2024 on equity securities sold
during the period were ($ 663,000 ). The unrealized gains recognized for the year ended December 31, 2024 on equity securities still held
was $ 570,000 .
Mutual
Funds classified as available for sale consisted of $ 7,631,000 at December 31, 2023. The net gain recognized for the year ended December
31, 2023 on equity securities was $ 200,000 . The net losses recognized for the year ended December 31, 2023 on equity securities sold
during the period were ($ 176,000 ). The unrealized gain recognized during the year ended December 31, 2023 on equity securities still
held was $ 376,000 .
(4) Patents and Trademark Rights, Net
Patent
and trademark rights consist of the following (in thousands):
Schedule
of Patent and Trademark Rights
December 31, 2024
December 31, 2023
Gross Carrying Value
Accumulated Amortization
Net Carrying Value
Gross Carrying Value
Accumulated Amortization
Net Carrying Value
Patents
$ 3,434
$ ( 939 )
$ 2,495
$ 2,947
$ ( 750 )
$ 2,197
Trademarks
232
( 133 )
99
229
( 113 )
116
Net amortizable patents and trademarks rights
$ 3,666
$ ( 1,072 )
$ 2,594
$ 3,176
$ ( 863 )
$ 2,313
F- 12
Patent
and trademark rights acquisitions, abandonments and amortization:
Schedule
of Changes in Patents, Trademark Rights
December 31, 2023
$ 2,313
Acquisitions
538
Abandonments and expirations
( 48 )
Amortization
( 209 )
December 31, 2024
$ 2,594
Patents
and trademarks are stated at cost (primarily legal fees) and are amortized using the straight-line method over an estimated useful life
of 17 years for patents and 10 years for trademarks. The weighted remaining average amortization period is approximately 12 years for
patents and 6 years for trademarks, respectively. The company expenses annuity costs related to its trademarks and patents.
Amortization
of patents and trademarks for each of the next five years and thereafter is as follows (in thousands):
Schedule
of Amortization of Patents and Trademarks
Year Ending December 31,
2025
$ 283
2026
278
2027
249
2028
229
2029
211
Thereafter
1,344
Total
$ 2,594
(5) Accrued Expenses
Accrued
expenses at December 31, 2024 and 2023 consist of the following:
Schedule
of Accrued Expenses
2024
2023
(in thousands)
December 31,
2024
2023
Compensation
$ 1
$ 414
Professional fees
416
1,352
Clinical trial expenses
145
184
Interest
11
—
Other expenses
33
36
Total
$ 606
$ 1,986
(6) Unsecured Promissory Note
On
February 16, 2024, the Company (“Borrower”) entered into a Note Purchase Agreement with Streeterville Capital LLC (“Streeterville”
or the “Lender”). Under the terms of the agreement, Streeterville paid the Company $ 2,500,000 in exchange for an unsecured
promissory Note with an Original Issue Discount of $ 781,250 . The Company will pay $ 3,301,250 consisting of the principal amount of the
Note, together with the original issue discount and $ 20,000 of lender transaction fees, no later than February 16, 2026. The stated interest
rate of the note is 10 %. There was no debt at December 31, 2023.
Schedule of Long Term Debt
Debt schedule at December 31, 2024 (in thousands)
Long-term debt
$ 2,807
Unamortized Original issue discount
( 489 )
Unamortized Financing fees
( 11 )
Unamortized discount and
debt issuance costs
2,307
Less current portion of long-term debt, net
( 2,307 )
Long-term debt, net
$ —
F- 13
Future maturities for long-term debt as of December 31, 2024 were as follows:
(in thousands)
Schedule of Maturities of Long-Term Debt
Fiscal years ending December 31:
2025
$ 2,807
Total
$ 2,807
Interest
expense related to long-term debt was $ 292,000 at December 31, 2024. Amortization expenses related to long-term debt was $ 302,000 at
December 31, 2024. This consisted of $ 293,000 in original issue discount and $ 9,000 for loan fee amortization. Future maturities of long-term
debt at December 31, 2024 were $ 2,807,000 for fiscal years ending December 31, 2025.
Current
portion of long-term debt of approximately $ 2,807,000 is net of the current portion of debt discount of approximately $ 489,000 and the
current portion of debt origination costs of approximately $ 11,000 as of December 31, 2024.
The
agreement allows the Lender to redeem up to $250,000 per calendar month beginning in August 2024, upon providing written notice to Borrower.
The Note further contains triggering events which can be remedied by the Lender requiring the Borrower to correct the triggering event,
increasing the outstanding balance by applying the triggering effect, or making the Note immediately due and payable.
(7) 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. As of December 31, 2024, there were no Series A Junior Participating
Preferred Stock outstanding.
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”).
Pursuant
to a registration statement relating to a rights offering (the “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 . As of December 31, 2024, 689 shares of Series B Convertible
Preferred Stock had expired, and none were converted prior to expiration.
F- 14
(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, 2024, and December 31, 2023, there were 65,526,320 and 49,102,484
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 on March 6, 2025 and expires in May 2025.
During
the year ended December 31, 2024, the Company issued a total of 395,713 shares of its common stock at a price ranging from $ 0.18 to $ 0.41
for total proceeds of approximately $ 131,000 as part of the employee stock purchase plan.
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.
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”).
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.
During
the year ended December 31, 2024, 205,000 warrants were exercised, and 5,830,028 warrants expired unexercised. No warrants were exercised
during the year ended December 31, 2023. At December 31, 2024 there were no warrants outstanding and December 31, 2023 there were 15,000
warrants outstanding.
F- 15
Equity
Distribution Agreement
On
April 19, 2023, we entered into an Equity Distribution Agreement (the “EDA”), with Maxim, pursuant to which we may sell from
time to time, shares of our common stock having an aggregate offering price of up to $ 8.5 million through Maxim, as agent. The amount
was subsequently reduced from $ 8.5 million to $ 3.1 million. Sales under the EDA were registered under the S-3 Shelf Registration Statement.
Under the terms of the Distribution Agreement, Maxim is entitled to a transaction fee at a fixed rate of 3.0 % of the gross sales price
of shares sold under the EDA. For the year ended December 31, 2024, we sold 1,395,612 shares under the EDA for total gross proceeds of
approximately $ 649,916 , which includes a 3.0 % fee to Maxim of $ 19,497 . During the year ended December 31, 2023, we 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 December
31, 2024, the Company has sold 1,119,106 shares under the EDA for total gross proceeds of approximately $ 259,800 , which includes a 3.0 %
fee to Maxim of approximately $ 7,800 .
Equity
Purchase Agreement
On
March 28, 2024, the Company entered into a purchase agreement and a registration rights agreement with Atlas Sciences, LLC (“Atlas”),
pursuant to which Atlas 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 purchase agreement. No assurance can be given as to the actual amount that will be raised pursuant to the purchase agreement.
Under
the terms of the purchase agreement, the Company, at its sole discretion, shall have the right to issue Put shares to the Investor at
95 % of the Market Price of the shares on the day of trade. Sales under the purchase agreement are limited to a daily maximum of the lessor
of: $ 500,000 , the Median Daily Trading volume, and a beneficial ownership limitation of 4.99 % and a maximum of 19.99 % of the outstanding
shares at the time of the purchase agreement. In April 2024, the Company filed a registration statement with the SEC on Form S-1 registering
a total of 9,975,000 shares for resale pursuant to the Atlas Agreements, consisting of 9,636,400 shares that can be sold by the Company
to Atlas and 338,600 shares that were issued to Atlas as Commitment Shares. The registration statement was declared effective on May
1, 2024. As of December 31, 2024, a total of 759,685 shares have been issued pursuant to the purchase agreement for a total of approximately
$ 128,000 after clearing costs. Subsequent to December 31, 2024, a total of 3,082,961 shares have
been issued pursuant to the purchase agreement for a total of approximately $ 398,000 after clearing costs.
Securities
Purchase Agreement
On
May 31, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering
(the “Transactions”) with a single accredited investor (the “Purchaser”), pursuant to which, on June 3, 2024,
the Company issued to the Purchaser, (i) in a registered direct offering, 5,640,958 shares of the Company’s common stock (the “Shares”),
par value $ 0.001 per share (“common stock”) and (ii) in a concurrent private placement, the Company issued to the Purchaser
Class A common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “A Warrants”) at an exercise
price of $ 0.363 per share and Class B common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “B
“Warrants” and, along with the A Warrants, the “Common Warrants”) at an exercise price of $ 0.363 per share. The
A Warrants and B Warrants are not exercisable for six months after the issuance date and expire, respectively, 24 months and five years
and six months after the issuance date. The Common Warrants and the shares of common stock issuable upon the exercise of such warrants
are offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities
Act and Rule 506(b) promulgated thereunder.
The
Shares were offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective
on February 4, 2022 (as amended from time to time, the “Registration Statement”).
Pursuant
to the terms of the Purchase Agreement, subject to certain exceptions, the Company could not issue any equity securities for 60 days
following the issuance date, provided that the Company was able to utilize its at-the-market offering program with the Placement Agent
after 30 days. Additionally, the Company cannot enter into a variable rate transaction (other than the ATM program with the Placement
Agent) for 120 days after the issuance date. In addition, the Company’s executive officers and each of the Company’s directors
have entered into lock-up agreements with the Company pursuant to which each of them has agreed not to, for a period of 90 days from
the closing of the Transactions, offer, sell, transfer or otherwise dispose of the Company’s securities, subject to certain exceptions.
The
exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock dividend
or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants. If a Fundamental
Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted for the Company,
and may exercise every right and power that the Company may exercise and will assume all of its obligations under the Common Warrants
with the same effect as if such successor entity had been named in the warrant itself. Common Warrant Holders will have additional rights
defined in the Common Warrants. The Common Warrants are exercisable on a “cashless” basis only if there is not a current
registration statement permitting public resale. In this regard, the Company filed a registration statement to register the resale of
the Common Warrant Shares providing for the resale of the Shares issued and issuable upon exercise of the Common Warrants. That registration
statement was declared effective by the SEC on July 11, 2024. The Company has agreed to use commercially reasonable efforts to cause
such registration statement to keep such registration statement effective at all times until no Purchaser owns any Warrants or Warrant
Shares issuable upon exercise thereof.
F- 16
Maxim
Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts” basis,
in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement Agency Agreement”),
by and between the Company and the Placement Agent. Pursuant to the Placement Agency Agreement, the Placement Agent was paid a cash fee
of 8 % of the aggregate gross proceeds paid to the Company for the securities sold in the Transactions and reimbursement of certain out-of-pocket
expenses.
The
Company evaluated the Common Warrants under the guidance of ASC 480 – Distinguishing Liabilities from Equity and determined that
they were in scope under the guidance as freestanding financial instruments but did not meet the criteria for liability classification
and are classified as equity within the consolidated financial statements. Proceeds allocated to such warrants totaled approximately
$ 2.5 million. For the year ended December 31,2024, no Common Warrants were exercised, and all remain outstanding on December 31, 2024
related to this agreement.
On
September 30, 2024, the Company entered into a Purchase Agreement with the Selling Stockholder as Purchaser, pursuant to which we
issued to the Selling Stockholder, (i) in a registered direct offering, 4,653,036 shares
of our Common Stock (“Shares”) and (ii) in the concurrent Private Placement, Class C and Class D Warrants, each to
purchase an aggregate of up to 4,653,036
Shares (the “ Common Warrant
Shares”) each with an exercise price of $ 0.28 .
The Class C and Class D Warrants together, hereinafter the “Common Warrants”. The purchase price for Shares in the
registered direct offering was $ 0.27 per
Share.
The
Company received aggregate gross proceeds from the Transactions of approximately $ 1.26
million, before deducting fees to the Placement Agent and other estimated offering expenses payable by us. The Shares were offered
by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective on
February 4, 2022. The Common Warrants and the Common Warrant Shares issued in the Private Placement were not registered under the
Securities Act. Rather the Common Warrants and the Common Warrant Shares were issued pursuant to the exemption from registration
provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. The Class C Warrants and the Class D
Warrants are not exercisable until December 3, 2024, and will expire, respectively, 24 months and five years and six months after
that date.
(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:
F- 17
During
the year ended December 31, 2023, we issued a total of 400,000 options under the 2018 Equity Incentive Plan, effective September 12,
2018, which will continue in effect for a period of 10 years from its effective date.
During
the year ended December 31, 2024, we did not issue any options under the 2018 Equity Incentive Plan, However, pursuant to employment
agreements for certain executives, 400,000 options were deferred to assure that a sufficient number of shares are available under the
2018 Equity Incentive Plan should they be needed, in the Company opinion, to focus on the Company’s financial resources to further
its Ampligen R&D Activities, This deferral is in effect until the Company no longer needs the shares underlying the options reserved
from the shares available for issuance under the Plan, or the Company agrees otherwise. During this deferral, the shares underlying the
options are still deemed reserved under the Plan.
Schedule of Options and Equity Estimated Based on Weighted Average Assumptions
Year Ended December 31,
2024
2023
Risk-free interest rate
—
4.37 %
Expected dividend yield
—
—
Expected life
—
10 years
Expected volatility
—
99.91 %
Weighted average grant date fair value for options issued
—
$0.43 per option for 400,000 options
The
exercise price of all stock options and equity warrants granted was equal to or greater than the fair market value of the underlying
common stock on the date of the grant.
Information
regarding the options approved by the Board of Directors under the Equity Plan of 2009 is summarized below. The plan expired on June
24, 2019:
Schedule
of Stock Option Activity
2024
2023
Shares
Option
Price
Weighted
Average
Exercise
Price
Shares
Option
Price
Weighted
Average
Exercise
Price
Outstanding, beginning of year
119,352
$ 13.20 - 2,127.84
$ 20.72
124,399
$ 13.20 – 1,003.20
$ 22.23
Granted
—
—
—
—
—
—
Forfeited
—
—
—
( 5,047 )
9.68 - 327.36
57.79
Expired
( 901 )
190
$ 356.36
—
—
—
Outstanding, end of year
118,451
$ 13.20 - 2,127.84
$ 18.17
119,352
$ 13.20 - 2,127.84
$ 20.72
Exercisable, end of year
118,451
$ 13.20 - 2,127.84
$ 18.17
119,352
$ 13.20 - 2,127.84
Weighted average remaining contractual life (years)
3.08 years
4.06 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
2024
2023
Shares
Option
Price
Weighted
Average
Exercise
Price
Shares
Option
Price
Weighted
Average
Exercise
Price
Outstanding, beginning of year
2,814,142
$ 0.31 - 9.68
$ 1.54
2,474,971
$ 0.31 - 9.68
$ 1.72
Granted
—
—
—
400,000
0.47 - 0.47
0.47
Forfeited
—
—
—
( 60,829 )
0.31 - 9.68
1.98
Outstanding, end of year
2,814,142
$ 0.31 - 9.68
$ 1.54
2,814,142
$ 0.31 - 9.68
$ 1.54
Exercisable, end of year
2,814,142
$ 0.31 - 9.68
$ 1.54
2,397,474
$ 0.31 - 327.36
4.71
Weighted average remaining contractual life (years)
6.96 years
7.96 years
Available for future grants
487,050
1,210,286
F- 18
Stock
option activity during the years ended December 31, 2024 and 2023 is as follows:
Vested
stock option activity for employees:
Schedule
of Vested Stock Option Activity
Number of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contracted
Term
(Years)
Aggregate
Intrinsic
Value
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
—
Granted
—
—
—
—
Forfeited
—
—
—
Expired
( 806 )
—
—
—
Outstanding December 31, 2024
2,407,632
$ 2.42
8.70
—
Vested and expected to vest at December 31, 2024
2,407,632
$ 2.42
8.70
—
Exercisable at December 31, 2024
2,407,632
$ 1.61
7.26
—
The
weighted-average grant-date fair value of employee options vested during the year ended December 31, 2024 was approximately $ 172,000
for 366,667 options at $ 0.47 per option and during year ended December 31, 2023 was approximately $ 184,000 for 424,999 options at $ 0.43
per option.
Unvested
stock option activity for employees:
Schedule
of Unvested Stock Option Activity
Number of
Options
Weighted
Average
Exercise
Price
Average
Remaining
Contracted
Term
(Years)
Aggregate
Intrinsic
Value
Unvested December 31, 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
—
Granted
—
—
—
—
Vested
( 365,860 )
0.47
7.26
—
Forfeited
—
—
—
—
Expired
( 806 )
—
—
—
Unvested December 31, 2024
—
$ —
—
—
F- 19
Vested
stock option activity for non-employees:
Schedule
of Vested Stock Option Activity
Number
of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contracted
Term
(Years)
Aggregate
Intrinsic
Value
Outstanding December 31, 2022
579,155
$ 3.09
8.36
—
Granted
360,000
0.46
10.04
—
Expired
( 653 )
145.24
—
—
Forfeited
( 53,447 )
1.31
—
—
Outstanding December 31, 2023
885,055
$ 2.02
9.23
—
Granted
—
—
—
—
Exercised
—
—
—
—
Expired
( 95 )
—
—
—
Forfeited
—
—
—
—
Outstanding December 31, 2024
884,960
$ 1.88
9.23
—
Vested and expected to vest at December 31, 2024
884,960
$ 1.88
9.23
—
Exercisable at December 31, 2024
884,960
$ 1.62
9.51
—
The
weighted-average grant-date fair value of non-employee options vested during year 2024 was approximately $ 131,000 for 285,000 options
at $ 0.46 per option and during the year 2023 was approximately $ 90,000 for 191,666 options at $ 0.47 per option.
Unvested
stock option activity for non-employees:
Schedule
of Unvested Stock Option Activity
Number of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contracted
Term
(Years)
Aggregate
Intrinsic
Value
Unvested December 31, 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
—
Granted
—
—
—
—
Vested
( 334,906 )
0.46
10.18
—
Expired
( 95 )
—
—
—
Forfeited
—
—
—
—
Unvested December 31, 2024
—
—
—
—
F- 20
Stock-based
compensation expense was approximately $ 686,000 and $ 243,000 for the years ended December 31, 2024 and 2023.
As
of December 31, 2024 all stock-based compensation cost related to options granted under the Equity Incentive Plans had been recognized.
As of December 31, 2023, there was $ 294,000 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 is recorded over the vesting period,
which is typically one year or upon reaching the agreed upon Company and/or individual performance milestones being met which is indefinite.
(ii)
Stock Warrants
Stock
warrants are issued as needed by the Board of Directors and have no formal plan.
The
fair value of each warrant award is estimated on the date of grant using a Black-Scholes-Merton pricing option valuation model. Expected
volatility is based on the historical volatility of the price of the Company’s stock. The risk-free interest rate is based on U.S.
Treasury issues with a term equal to the expected life of the warrant. The Company uses historical data to estimate expected dividend
yield, life and forfeiture rates. The expected life of the warrants was estimated based on historical option holder’s behavior
and represents the period of time that options are expected to be outstanding. No warrants were granted in 2023.
Information
regarding warrants outstanding and exercisable into shares of common stock is summarized below:
Schedule
of Warrants Outstanding and Exercisable
2024
2023
Shares
Warrant
Price
Weighted
Average
Exercise
Price
Shares
Warrant
Price
Weighted
Average
Exercise
Price
Outstanding, beginning of year
152,160
$ 0.99 - 8.80
$ 8.03
226,610
$ 0.99 - 132.00
$ 9.10
Granted
20,587,988
0.28 - 0.363
0.33
—
—
—
Expired
( 147,501 )
0.99 - 8.80
8.03
( 74,450 )
17.05
17.05
Exercised
( 4,659 )
8.80
8.80
—
—
—
Outstanding, end of year
20,587,988
$ 0.28 - 0.363
$ 0.33
152,160
$ 0.99 - 8.80
$ 8.03
Exercisable
11,281,916
$ 0.363
$ 0.363
152,160
$ 0.99 - 8.80
$ 8.03
Weighted average remaining contractual life
3.75 years
.75 years
Years exercisable
2025
2024
Stock
warrants are issued at the discretion of the Board. During the year ended December 31, 2024, there were 20,587,988
warrants issued, 4,659
warrants were exercised and 147,501 warrants expired. During the year ended December 31, 2023, there were no warrants issued or exercised.
(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, 2024, research and development expenses were comprised of: clinical studies ($ 2,627,000 ), manufacturing and
engineering ($ 1,116,000 ), quality control ($ 1,721,000 ) and regulatory ($ 733,000 ).
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 ).
F- 21
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 for the year ended December 31, 2024.
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 years ended December 31, 2024 and 2023, the Company incurred approximately $ 1,047,800 and
$ 4,290,000 , 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, 2024, the Company incurred approximately $ 458,800 related to
this agreement.
○ During
the year ended December 31, 2023, the Company incurred approximately $ 600,000 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 completed in 2023, although certain activities are still ongoing.
○ During
the year ended December 31, 2024, the Company incurred approximately $ 455,000 related to
this agreement.
○ During
the year ended December 31, 2023, the Company incurred approximately $ 3,690,000 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 December 2023, Jubilant completed manufacturing of
9,042 vials of Ampligen for clinical use.
○ During
the year ended December 31, 2024, the Company incurred approximately $ 1,200 related to this
agreement.
F- 22
○ During
the year ended December 31, 2023, the Company incurred approximately $ 1,432,000 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, 2024, the Company incurred approximately $ 498,300 related to
this agreement.
○ During
the year ended December 31, 2023, the Company incurred approximately $ 363,000 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, in April 2023 AIM agreed to provide to Erasmus MC an unrestricted grant of $ 200,000
for immune monitoring in pancreatic cancer patients.
○ During
the year ended December 31, 2024, the Company incurred approximately $ 104,300 related to
this agreement.
○ During
the year ended December 31, 2023, the Company incurred approximately $ 100,000 related to
this agreement.
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. In August 2024, an agreement was made to reduce the fixed monthly retainer fee to $ 10,000 . This agreement was further adjusted to solely include specific services performed.
On
December 6, 2023, the Company issued to Azenova, LLC, an option to purchase up to three hundred and sixty thousand ( 360,000 ) shares of
our “Common Stock” at a price equal to $ 0.46 per share. This Option was awarded pursuant to the Consulting Agreement dated
October 16, 2023 between the Company and Azenova, LLC. On December 6, 2023, 180,000 options were transferred to Jeffrey Southerton and
180,000 options were transferred to Stacy J. Evans; both transfers with an exercise price of $ 0.46 .
The
offers, sales and issuances of securities described above was deemed to be exempt from registration under the Securities Act in reliance
on either Section 4(a)(2) in that the issuance of securities to the accredited investors did not involve a public offering, or Rule 701
in that the transactions were under compensatory benefit plans and contracts relating to compensation as provided under Rule 701.
○ During
the year ended December 31, 2024, the Company incurred approximately $ 255,000 related to
this agreement.
○ During
the year ended December 31, 2023, the Company incurred approximately $ 75,500 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, 2024, the Company incurred approximately $ 14,000 of lab services
from Alcami.
F- 23
○ During
the year ended December 31, 2023, the Company incurred approximately $ 64,500 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, 2024 and 2023, the
Company’s matching contributions were approximately $ 167,000 and $ 162,000 , respectively
(10) Employment/Consulting Agreements
The
Company had contractual agreements with certain Named Executive Officers (“NEO”) in 2024 and 2023. The aggregate annual
base compensation which includes bonuses and stock issuances for these NEO under their respective contractual agreements for 2024
(which takes into account amendments to these agreements effected in September 2024 ), and 2023 was $ 1,491,215
and $ 1,839,484 ,
respectively. As part of the Company’s cash conservation strategy, certain NEOs were issued common stock
in 2024 as a substitute for cash salaries. For the year ended December 31, 2024, stock issued as payroll totaled $ 250,000 ,
which is included in the overall equity-based compensation expense. There was no stock issued as payroll for the year ended
December 31, 2023. In addition, certain 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 December 31, 2024 and 2023, there were no performance bonuses paid out. For the year ended December 31, 2023, Officers’
bonuses were $ 450,000
and were deferred and paid in 2024. An additional $ 50,000 was awarded retroactively in 2024 for 2023. For the year ended December 31, 2024, Officers’ bonuses were electively waived by the
Officers.
In
2024, the Company reserved equity compensation for later issuance to these Officers.
a. The
Company reserved 300,000 ten-year options to be issued at a later date for Thomas K. Equels,
Chief Executive Officer.
b. The
Company reserved 100,000 ten-year options to be issued at a later date for Peter Rodino,
Chief Operating Officer and General Counsel.
The
Company recorded stock compensation expense of approximately $ 156,600 during the year ended December 31, 2024 with regard to the 2023
issuances to Officers Equels and Rodino. The Company did not record stock compensation expense for the 2024 reserved options.
In
2023, equity was granted as a form of compensation to these Officers.
c. 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.
d. 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.
(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 2025 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.
At
December 31, 2024 and December 31, 2023, the balance of the right of use assets was $ 618,000 and $ 697,000 , respectively, and the corresponding
operating lease liability balance was $ 634,000 and $ 718,000 , respectively. Right of use assets are recorded net of accumulated amortization
of $ 428,000 and $ 363,000 as of December 31, 2024 and December 31, 2023, respectively.
F- 24
AIM
recognized rent expense associated with these leases are follows:
Schedule of AIM
Recognized Rent Expense Associated with Operating Lease
2024
2023
Year ended December 31,
(in thousands)
2024
2023
Lease costs:
Operating lease costs
$ 304
$ 288
Short-term and variable lease costs
283
335
Total lease costs
$ 587
$ 623
Classification of lease costs
Research & development
$ 446
$ 498
General and administrative
141
125
Lease cost
141
125
Total lease costs
$ 587
$ 623
The
Company’s leases have remaining lease terms between 3 and 31 months. At December 31, 2024, the weighted-average remaining term
was 29 months. At December 31, 2023, the weighted-average remaining term was 41 months. The Company’s weighted average incremental
borrowing rate for its leases was 10.3 % at December 31, 2024 and 10 % at December 31, 2023.
Future
minimum payments as of December 31, 2024, are as follows:
Schedule of Operating Lease Future Payments
Year Ending December 31, (in thousands)
2025
$ 293
2026
254
2027
159
2028
—
Thereafter
—
Less imputed interest
( 72 )
Total
$ 634
(12) 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, 2024, and December 31, 2023, respectively, the Company has approximately $ 117,194,000 of Federal net operating loss carryforwards
(expiring in the years 2024 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
$ 41,700,000 of New Jersey state net operating loss carryforwards (expiring in 2044). The Company has approximately $ 96,365,000 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 company has fully utilized the maximum $ 20,000,000 allowance in proceeds received for the sale
of New Jersey net operating loss carryforwards and R&D credits as of December 31, 2023. 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.
F- 25
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. As of December 31, 2024, the tax years after 2020 remain subject
to examination by major tax jurisdictions.
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, 2024 and 2023.
The
components of the net deferred tax assets and liabilities as of December 31, 2024 and 2023, consist of the following:
Schedule of Components of Net Deferred Tax Assets and Liabilities
2024
2023
(in thousands)
Deferred tax assets:
December 31,
2024
2023
Net operating losses
$ 29,001
$ 25,114
Research and Development costs
3,914
3,517
Stock Compensation
1,515
1,479
R&D credits
2,829
1,376
Other
41
137
Amortization & Depreciation
5,575
6,791
Right of use asset
4
6
Total deferred tax assets
42,879
38,420
Less: Valuation allowance
( 42,879 )
( 36,816 )
Deferred tax assets, net
$ —
$ 1,604
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 2023 net deferred tax asset estimates the projected sale of 2023 New Jersey state operating losses to be sold
in the subsequent year. After further analysis, it was determined that the New Jersey state operating loss sales proceeds reached the
maximum $ 20 million allowed after the 2022 sale and a full valuation allowance was recorded in 2024 against all deferred tax assets.
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
$ ( 17,320 )
Federal Rate
( 3,637 )
21.0 %
State Taxes
( 1,321 )
7.63 %
Other Perms
1
- 0.01 %
RTP
396
- 2.29 %
Income Tax Income
459
- 2.65 %
State Rate Change
149
- 0.86 %
162(m)
126
- 0.73 %
R&D credits
( 969 )
5.59 %
Mark to Market
( 163 )
0.94 %
R&D credit addback
261
- 1.51
%
Loss on Fair Value Warrants
131
- 0.76 %
Other
108
- 0.62 %
Valuation Allowance
4,459
- 25.75 %
Total
$ —
- 0.0 %
The Company files
tax returns in the U.S., Florida and New Jersey. As of December 31, 2024, tax years for 2023, 2022, and 2021 are still subject
to examination by the tax authorities. The Company is no longer subject to U.S. federal or state examinations by tax authorities for years before
2021.
F- 26
(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/Consulting Agreements.
(14) Concentrations of Risk
Financial
instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash, cash equivalents
and investments. 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 2024 and 2023.
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.
F- 27
(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.
The
fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate their carrying values due to
the short-term maturities of these items and are considered a Level 1 instrument of the fair value measurements standard. The Company
also has certain warrants with a cash settlement feature in the occurrence of a Fundamental Transaction. The fair value of the Class
A and Class B warrants (“June 2024 Warrants”) related to the Company’s June 2024 common stock and warrant issuance,
are calculated using a Monte Carlo Simulation. The fair value of the Class C and Class D warrants (“October 2024 Warrants”)
related to the Company’s October 2024 common stock and warrant issuance, are calculated using a Monte Carlo Simulation.
The
Company also had certain redeemable warrants in the Rights Offering with a cash settlement feature in the occurrence of a Fundamental
Transaction. No Fundamental Transaction occurred. In March 2024, 205,000 of these warrants converted on a cashless basis and 5,830,028
expired.
The
Company estimated the fair value of the June 2024 Warrants using the Black-Scholes Model, which uses multiple inputs including the Company’s
stock price, the exercise price of the warrant, volatility of the Company’s stock price, the risk-free interest rate and the expected
term of the warrants.
The
Company utilized the following assumptions to estimate the fair value of the Class A Warrants:
Schedule
of Assumptions to Estimate Fair Value of Warrants
December 31,
2024
Underlying price per share
$ 0.350
Exercise price per share
$ 0.363
Risk-free interest rate
4.42 %
Expected holding period
5.5 years
Expected volatility
110 %
Expected dividend yield
—
Warrants measurement input
—
The
Company utilized the following assumptions to estimate the fair value of the Class B Warrants:
December 31,
2024
Underlying price per share
$ 0.350
Exercise price per share
$ 0.363
Risk-free interest rate
4.82 %
Expected holding period
2 years
Expected volatility
89 %
Expected dividend yield
—
Warrants measurement input
—
F- 28
The
Company utilized the following assumptions to estimate the fair value of the Class C Warrants:
December 31,
2024
Underlying price per share
$ 0.26
Exercise price per share
$ 0.28
Risk-free interest rate
3.6 %
Expected holding period
2 years
Expected volatility
82 %
Expected dividend yield
—
Warrants measurement input
—
The
Company utilized the following assumptions to estimate the fair value of the Class D Warrants:
December 31,
2024
Underlying price per share
$ 0.26
Exercise price per share
$ 0.28
Risk-free interest rate
3.5 %
Expected holding period
5.5 years
Expected volatility
91 %
Expected dividend yield
—
The
significant assumptions using the Monte Carlo Simulation approach for valuation of the Warrants are:
(i) Risk-Free
Interest Rate . The risk-free interest rates for the Warrants are based on U.S. Treasury
constant maturities for periods commensurate with the remaining expected holding periods
of the warrants.
(ii) Expected
Holding Period . The expected holding period represents the period of time that the Warrants
are expected to be outstanding until they are exercised. The Company utilizes the remaining
contractual term of the Warrants at each valuation date as the expected holding period.
(iii) Expected
Volatility . Expected stock volatility is based on daily observations of the Company’s
historical stock values for a period commensurate with the remaining expected holding period
on the last day of the period for which the computation is made.
(iv) Expected
Dividend Yield . The 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. Put rights 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 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. The
nature of a life sciences company is heavily dependent on future funding and high fixed costs,
including Research & Development.
5. 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
6. The
Company’s Rights Agreement and Executive Agreements make it less attractive to a potential
buyer.
F- 29
With
the above factors utilized in analysis of the likelihood of the Put’s potential Liability, the Company estimated the range of probabilities
related to a Put right being triggered as:
Schedule of Range of Probabilities
Range of Probability
Probability
Low
0.5 %
Medium
1.0 %
High
5.0 %
The
Monte Carlo Simulation has incorporated a 5.0 % probability of a Fundamental Transaction to date for the life of the securities.
(vi) Expected
Timing of Announcement of a Fundamental Transaction. As the Company has no specific expectation
of a Fundamental Transaction, for reasons elucidated above, the Company utilized a discrete
uniform probability distribution over the Expected Holding Period to model in the potential
announcement of a Fundamental Transaction occurring during the Expected Holding Period.
(vii) Expected
100 Day Volatility at Announcement of a Fundamental Transaction . An estimate of future
volatility is necessary as there is no mechanism for directly measuring future stock price
movements. Daily observations of the Company’s historical stock values for the 100
days immediately prior to the Warrants’ grant dates, with a floor of 100 %, were utilized
as a proxy for future volatility estimates.
(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 actual historical prices input
for the relevant period input change.
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 December 31, 2024, 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.
F- 30
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, 2024
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$ 51
$ 51
$ —
$ —
Marketable securities
$ 2,276
$ 2,276
$ —
$ —
As of December 31, 2023
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$ 4,805
$ 4,805
$ —
$ —
Marketable securities
$ 7,631
$ 7,631
$ —
$ —
(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 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) Segment and Related Information
The C ompany
follows ASC 280, Segment Reporting, which establishes standards for the way public enterprises report information about operating
segments in annual financial statements and requires that those enterprises report selected information about operating segments in financial
statements issued to shareholders. The Company’s Chief Operating Decision Maker (“CODM”), its CEO, assesses performance
and allocates resources based on company-wide financial information. The Company has determined that it operates in a single reportable
segment and the strategic purpose of all operating activities is to support that one segment. The CODM does not generally evaluate the
Company’s performance using asset or historical cash flow information. The measure of performance used by the CODM to evaluate the Company’s
performance is consolidated net loss. Since the Company operates in one operating segment, which
performs research and development activities related to Ampligen and other drugs under development, all required financial segment information
can be found in the financial statements. Significant expenses that are used to evaluate performance are each separately presented in
the statements of income. The Company does not distinguish between markets or segments for the purpose of internal reporting.
The
Company’s revenues for the two-year period ended December 31, 2024, were earned in the United States. All assets are maintained
in the United States of America.
(18) Subsequent
Events
On
February 26, 2025, the NYSE American accepted the Company’s plan to regain compliance with the minimum stockholders’ equity
requirements of Sections 1003(a)(ii) and 1003(a)(iii) of the American Company Guide. AIM has until June 11, 2026 to regain compliance
with the NYSE’s Continued Listings Standards. The plan includes a number of ways to raise capital. As Part of the Plan, the Company
will be holding a special meeting of stockholders solely for the purpose of authorizing a reverse split of our outstanding shares. The
proxy statement for that meeting has been filed with the SEC and is available on the SEC’s website. The Company believes that effecting
a reverse split will assist it with raising capital it needs to continue its business and avoiding an automatic delisting if the stock
price drops to $ 0.10 per share.
F- 31