Item 9A. Controls and Procedures
Item
9A. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of
our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2023,
the end of the year covered by this Annual Report. Based on this evaluation, our principal executive officer and principal financial
officer concluded that, as of December 31, 2023, our disclosure controls and procedures were effective. We believe that a disclosure
controls system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the disclosure controls
system are met, and no evaluation of disclosure controls can provide absolute assurance that all disclosure control issues, if any, within
a company have been detected.
Management’s
Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f)
and 15d-15(f) under the Exchange Act. Internal control over financial reporting is a process designed under the supervision and with
the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes
in accordance with accounting principles generally accepted in the United States of America.
As
of December 31, 2023, our management assessed the effectiveness of our internal control over financial reporting using the criteria set
forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework. Based on the
continuing material weakness described below, our management concluded that as of December 31, 2023, our internal control over financial
reporting was not effective.
Description
of Material Weaknesses
In connection
with the audit of our financial statements as of and for the year ended December 31, 2023, we identified material weaknesses related to a lack of sufficient number of personnel within our accounting function
to adequately segregate duties, and we have not designed and implemented effective Information Technology General Controls (“ITGC”)
related to access controls to financial accounting systems.
We lack the resources to employ
additional personnel to help mitigate these material weaknesses and we foresee that these material weaknesses will not be remediated until we
receive additional funding to support our accounting department.
Remediation
of Material Weakness
We cannot assure you that these
or other measures will fully remediate the material weakness in a timely manner. Notwithstanding the identified material weakness, our
management believes that the consolidated financial statements included in this report fairly represent in all material respects our financial
condition, results of operations and cash flows at and for the periods presented in accordance with U.S. GAAP.
62
Changes
in Internal Control over Financial Reporting
Other
than as described above, there were no changes in our internal control over financial reporting identified in management’s evaluation
pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the year ended December 31, 2023 that materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
Limitation
on Effectiveness of Controls
In
designing and evaluating our controls and procedures, management recognized that any controls and procedures, no matter how well designed
and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. No evaluation of internal
control can provide absolute assurance that all internal control issues and instances of fraud, if any, within a company are detected.
In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. There are inherent limitations to the effectiveness of any system of disclosure controls
and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. In addition,
the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be
no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may
become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because
of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Item
9B. Other Information.
None.
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
None.
63
PART
III
Item
10. Directors, Executive Officers and Corporate Governance.
The
Board of Directors
Our
board of directors currently consists of six members, each of whose current term of office as a director expires at the 2024 annual meeting
of stockholders. Biographical information with respect to our directors is provided below.
Our
directors hold office for one year or until their respective successors have been duly elected or until their death, resignation or removal.
Our amended and restated bylaws provide that the authorized number of directors comprising our board of directors will be fixed, from
time to time, by a majority of the total number of directors.
There
are no family relationships among any of our directors or executive officers. There is no arrangement or understanding between any director
and any other person pursuant to which the director was selected.
Name
Position with the Company
Age
Director Since
Michael Poirier
Chairman and Chief Executive Officer
68
2020
Richard David
Director
64
2020
Sidney Emery, Jr.
Director
77
2020
Matthew Korenberg
Director
49
2020
Kurt Kruger
Director
68
2020
Ira Ritter
Director
75
2008
Michael
S. Poirier . Mr. Poirier founded the Qualigen business in 1996 and is its Chairman and Chief Executive Officer. Before founding Qualigen,
Mr. Poirier had relevant operating, marketing and sales positions with Ashirus Technologies, Inc., EnSys, Inc., Sanofi Pasteur and Abbott
Laboratories, Inc. Before working at Abbott, Mr. Poirier served as an officer in the United States Navy, assigned to the US Atlantic
Fleet. Mr. Poirier holds a B.A. from Providence College and attended the University of Zürich, Switzerland, School of Law.
Mr.
Poirier’s commitment to our strategic goals, his long experience leading our company and his deep knowledge of its technologies
and business contributed to our board of directors’ conclusion that he should serve as a director of our company.
Richard
A. David, MD FACS . Dr. David serves as Chief Medical Officer for the Los Angeles Division of Genesis Healthcare Partners, the largest
urology group in Southern California. He also serves as medical director for Genesis’ Advanced Prostate Cancer Center of Excellence.
In addition, Dr. David serves as Clinical Professor of Urology for the David Geffen School of Medicine at UCLA. Dr. David obtained his
undergraduate education at Stanford University and his medical degree at Thomas Jefferson University in Philadelphia. He also holds a
Master’s degree in Medical Management (MMM) from the Marshall School of Business at the University of Southern California. He trained
in general surgery and completed his urology residency at UCLA Medical Center in Los Angeles. Dr. David is a fellow of the American College
of Surgeons.
Dr.
David’s experience as an executive of a large healthcare organization, including his background as a medical doctor, contributed
to our board of directors’ conclusion that he should serve as a director of our company.
Sidney
W. Emery, Jr. Mr. Emery is a seasoned executive in manufacturing, distribution and supply chain management. He served as Chairman
and Chief Executive Officer of MTS Systems Corporation (Nasdaq-GS: MTSC), a leading global supplier of mechanical testing systems and
high-performance industrial position sensors. Mr. Emery served on the Board of Directors of Allete, Inc. (NYSE: ALE), a Minnesota-based
utilities and energy company, from 2006 to 2018. Mr. Emery chairs the University of St. Thomas College of Engineering Board of Governors.
Mr. Emery holds a PhD in Industrial Engineering from Stanford University and a B.S. in Engineering from the US Naval Academy.
Mr.
Emery’s extensive board service with and executive leadership of major companies contributed to our board of directors’ conclusion
that he should serve as a director of our company.
Matthew
E. Korenberg . Mr. Korenberg has served as President and Chief Operating Officer of Ligand Pharmaceuticals Incorporated (Nasdaq: LGND),
a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines,
since November 2022, and before that as Executive Vice President, Finance and Chief Financial Officer of Ligand Pharmaceuticals Incorporated
since August 2015. Before joining Ligand, commencing in September 2013, Mr. Korenberg was the founder, Chief Executive Officer and a
director of NeuroCircuit Therapeutics, a company focused on developing drugs to treat genetic disorders of the brain with an initial
focus on Down syndrome. Before founding NeuroCircuit Therapeutics, Mr. Korenberg was a Managing Director and member of the healthcare
investment banking team at Goldman Sachs from July 1999 through August 2013. During his 14 year tenure at Goldman Sachs, Mr. Korenberg
was focused on advising and financing companies in the biotechnology and pharmaceutical sectors and was based in New York, London and
San Francisco. Before Goldman Sachs, Mr. Korenberg was a healthcare investment banker at Dillon, Read & Co. Inc. where he spent two
years working with healthcare companies in the biotechnology and pharmaceutical sectors and industrial companies. Mr. Korenberg holds
a B.B.A. in Finance and Accounting from the University of Michigan.
64
Mr.
Korenberg’s financial and accounting expertise, his experience as chief financial officer of a large public biopharmaceutical company
and his investment banking background contributed to our board of directors’ conclusion that he should serve as a director of our
company.
Kurt
H. Kruger . Mr. Kruger has enjoyed a 30-year career in medical technology. His deep involvement in the field has ranged from product
design and development as a biomedical engineer to raising capital for, and following, publicly traded medical product companies as an
equities research analyst. As a marketing manager at Guidant, now a part of Boston Scientific, he developed the launch plans for the
first-ever implantable defibrillator. As a securities analyst he led Hambrecht & Quist’s efforts in providing venture funds
for, and then taking public, Ventritex, which was later acquired by St. Jude Medical/Abbott. After H&Q, Mr. Kruger worked as an analyst
for Montgomery Securities and Bank of America. Across 20 years of research work, Mr. Kruger has overseen the IPOs of over 30 medical
products companies. Later he headed up the Life Sciences banking effort for WR Hambrecht & Co. Mr. Kruger received a Sc.B. degree
in Biomedical Engineering from Brown University; a Master’s degree in Bioengineering from the University of Michigan; and a business
degree (S.M.) from the Sloan School at the Massachusetts Institute of Technology (MIT). He also completed the premedical post-baccalaureate
program at Columbia University.
Mr.
Kruger’s long experience in investment banking and securities analysis with a life sciences focus contributed to our board of directors’
conclusion that he should serve as a director of our company.
Ira
E. Ritter. Mr. Ritter served as Co-Founder, Chief Strategic Officer and Executive Chairman of the Company during its Ritter Pharmaceuticals,
Inc. phase, from its inception in 2004 through the formation of the Ritter Pharmaceuticals, Inc. corporate entity in 2008 and served
in those positions with Ritter Pharmaceuticals, Inc. from 2008 until the May 22, 2020 reverse recapitalization transaction (the “Reverse
Recapitalization Transaction”) in which Ritter Pharmaceuticals, Inc. changed its name to Qualigen Therapeutics, Inc. Mr. Ritter
has extensive experience creating and building diverse business enterprises and since 1987 through Andela Corporation, of which he is
the CEO, has provided corporate management, strategic planning and financial consulting for a wide range of market segments including;
health product related national distribution and private label production, television and publishing. He assisted taking Ritter Pharmaceuticals,
Inc. public on Nasdaq and Martin Lawrence Art Galleries public on the New York Stock Exchange. Since 2010, Mr. Ritter has also acted
as a managing partner of Stonehenge Partners, LLC. Mr. Ritter has a long history of public service that includes appointments by three
Governors to several State of California Commissions including eight years as Commissioner on the California Prison Industry Authority.
Mr.
Ritter’s experience as an entrepreneur and chairman of a publicly traded development-phase therapeutics company contributed to
our board of directors’ conclusion that he should serve as a director of our company. Mr. Ritter continued his service on our board
of directors, by agreement in connection with the Reverse Recapitalization Transaction, as the designated legacy member from the pre-Reverse
Recapitalization Transaction public-company board of directors.
Committees
of the Board of Directors
Our
board of directors has established an Audit Committee, a Compensation Committee and a Nominating and Corporate Governance Committee.
Each committee operates under a charter. Copies of each committee’s charter are posted on the Investor Relations section of our
website, which is located at www.qlgntx.com .
Audit
Committee . The current members of our Audit Committee are Mr. Kruger (Chair), Mr. Emery, and Mr. Korenberg, each of whom was
determined by our board of directors to be independent under Rule 10A-3 under the Exchange Act and the continued listing requirements
of Nasdaq, and to satisfy the other continued listing requirements of Nasdaq for audit committee membership. The Company has identified
Matthew Korenberg as an “audit committee financial expert” as such term is defined in Item 407(d)(5) of SEC Regulation S-K,
and has determined that he has the requisite level of financial sophistication required by the continued listing requirements of Nasdaq;
this identification does not constitute a determination that other members of the Audit Committee would not also be able to qualify as
an “audit committee financial expert.”
65
EXECUTIVE
OFFICERS
The
following table sets forth information about our current executive officers.
Name
Age
Position with the Company
Michael Poirier
68
Chairman and Chief Executive Officer
Christopher Lotz
59
Chief Financial Officer, Vice President of Finance
Officers
serve at the discretion of the board of directors. There are no family relationships among any of our directors or executive officers.
There is no arrangement or understanding between any executive officer and any other person pursuant to which the executive officer was
selected.
For
the biography of Mr. Poirier, please see “Board of Directors” above.
Christopher
L. Lotz | Chief Financial Officer, Vice President of Finance. Mr. Lotz joined Qualigen, Inc. as Director of Finance in 2002 and was
promoted to his current role of Chief Financial Officer, Vice President of Finance in 2003. He became an officer of the Company at the
time of the Reverse Recapitalization Transaction in 2020. Before joining Qualigen, Inc. Mr. Lotz spent the previous 15 years serving
in financial leadership positions with Bexcom, an Asian-based software developer, California Furniture Collections, Inc., a custom furniture
manufacturer, and Group Publishing, Inc., an educational media publisher. Mr. Lotz holds a B.S. in Business Administration from Colorado
State University.
Delinquent
Section 16(a) Reports
Section
16(a) of the Exchange Act requires the Company’s officers and directors, and persons who own more than 10% of our common stock,
to file reports of securities ownership and changes in such ownership with the SEC. Officers, directors, and greater than 10% stockholders
also are required by SEC rules to furnish the Company with copies of all Section 16(a) forms they file.
Based
solely on the Company’s review of Forms 3, 4 and 5 filed by such persons and information provided by the Company’s directors
and officers, the Company believes that during the year ended December 31, 2023, all Section 16(a) filing requirements applicable to
such persons were met in a timely manner.
Item
11. Executive Compensation.
Summary
Compensation Table (2023 and 2022)
The
following table sets forth the compensation paid to or earned by our named executive officers for the periods presented.
Name and Principal Position
“Year”
Salary
($)
Bonus
($)
Option Awards (1)
($)
All Other Compensation (2)
($)
Total
($)
Michael Poirier, Chairman and Chief Executive Officer
2023
512,635
118,174
—
1,889
632,698
2022
575,000
—
145,274
8,180
728,454
Tariq Arshad, Former Chief
Medical Officer and Senior Vice President (3)
2023
356,615
101,231
—
5,326
463,172
2022
400,000
—
39,512
138
439,650
Amy Broidrick, Former President, Chief Strategy and Operating Officer (4)
2023
194,017
—
—
371,454
565,470
2022
450,000
—
50,359
7,642
508,001
(1) The
amounts reported in this column reflect the aggregate grant date fair value of the option
awards granted during 2022, computed in accordance with Financial Accounting Standards
Board Accounting Standards Codification Topic 718 for stock-based compensation transactions
(“ASC 718”). Such grant date fair values do not take into account any estimated
forfeitures related to service-based vesting conditions. Assumptions used in the calculation
of these amounts are included in the notes to our consolidated financial statements included
in this Annual Report. These amounts do not reflect the actual economic value that may be
realized by the executive officers upon the exercise of the stock options or the sale of
the common stock underlying such stock options. There were no option awards granted during 2023.
(2) The amounts reported in this column represent
401(k) matching contributions and life insurance premiums paid by us for Mr. Poirier and Dr. Arshad, and $1,316 in 401(k) matching contributions and life insurance premiums paid by us for Ms. Broidrick,
and $370,138 in severance compensation for Ms. Broidrick.
(3) Dr.
Arshad resigned from his role as Chief Medical Officer and Senior Vice President effective
February 25, 2024.
(4) Ms. Broidrick resigned from her role as President, Chief
Strategy and Operating Officer and as a Director effective June 16, 2023. The 2023 “Salary” for Ms. Broidrick includes
amounts we paid through June 16, 2023. The 2023 “All Other Compensation” for Ms. Broidrick includes $370,138 of severance compensation.
66
Executive
Employment Agreements
Employment
Agreement with Michael Poirier
Mr.
Poirier is party to an Executive Employment Agreement dated February 1, 2017, as amended January 9, 2018 (the “Poirier
Employment Agreement”). The Poirier Employment Agreement had an initial three-year term and is now automatically renewed for successive
one-year periods unless either party gives notice of nonrenewal at least 90 days before the end of such a one-year period.
Under
the terms of the Poirier Employment Agreement, Mr. Poirier is entitled to an annual base salary of at least $315,000, is eligible to
participate in the Company’s bonus plans, benefit programs and medical benefits, is eligible for certain event-based bonuses (including
for “Liquidity Event” acquisition transactions), and is entitled to four weeks of vacation per year. If Mr. Poirier’s
employment is terminated without Cause or he resigns for Good Reason (as such terms are defined in the Poirier Employment Agreement),
and he provides a general release to the Company, he will be entitled to one year of salary continuation plus the cost of COBRA coverage
continuation for such one year period. In May 2021, our board of directors and its compensation committee increased Mr. Poirier’s
annual base salary to $575,000. On January 13, 2023, the Company’s board of directors, as part of certain cost-cutting measures,
approved a temporary 20% reduction to the base salaries of all executive officers of the Company. Accordingly, on January 16, 2023, Mr.
Poirier’s base salary was reduced to $460,000; it was subsequently restored in August 2023.
Employment
Agreement with Christopher Lotz
Mr.
Lotz is party to an Executive Employment Agreement dated February 1, 2017, as amended January 9, 2018 (the “Lotz
Employment Agreement”). The Lotz Employment Agreement had an initial three-year term and is now automatically renewed for successive
one-year periods unless either party gives notice of nonrenewal at least 90 days before the end of such a one-year period.
Under
the terms of the Lotz Employment Agreement, Mr. Lotz is entitled to an annual base salary of at least $225,000, is eligible to participate
in the Company’s bonus plans, benefit programs and medical benefits, is eligible for certain event-based bonuses (including for
“Liquidity Event” acquisition transactions), and is entitled to four weeks of vacation per year. If Mr. Lotz’s employment
is terminated without Cause or he resigns for Good Reason (as such terms are defined in the Lotz Employment Agreement), and he provides
a general release to the Company, he will be entitled to 180 days of salary continuation plus the cost of COBRA coverage continuation
for such 180 day period. In May 2021, our board of directors and its compensation committee increased Mr. Lotz’s annual base salary
to $300,000. On January 13, 2023, the Company’s board of directors, as part of certain cost-cutting measures, approved a temporary
20% reduction to the base salaries of all executive officers of the Company. Accordingly, on January 16, 2023, Mr. Lotz’s base
salary was reduced to $240,000; it was subsequently restored in August 2023.
Offer
Letter with Tariq Arshad
Under
the terms of his hire offer letter with the Company, dated May 17, 2021, Dr. Arshad was entitled to an annual base salary of at
least $400,000. He received a cash signing bonus of $25,000 when he joined the Company, was eligible to receive annual cash bonuses
equal to an amount up to 40% of his annualized base salary, and is entitled to four weeks of vacation per year. Under the terms of
his hire offer letter, if Dr. Arshad’s employment is terminated without Cause or he resigns for Good Reason, and he provides a
general release to the Company, he will be entitled to 180 days of salary continuation plus the cost of COBRA coverage continuation
for such 180 day period.
On
February 25, 2024, Dr. Arshad resigned from his position as the Company’s Chief Medical Officer and Senior Vice President. He
did not assert that the resignation was for Good Reason and he did not provide a general release to the Company.
Employment Agreement with Amy Broidrick
Ms. Broidrick was party to an Executive
Employment Agreement with Qualigen, Inc., a former wholly-owned subsidiary of the Company, dated December 10, 2021. On May 16, 2023,
Ms. Broidrick resigned from all officer and director positions with the Company and its subsidiaries, which became effective June
16, 2023 (the “Separation Date”). Ms. Broidrick’s departure was not related to any disagreement with the Company
on any matter relating to the Company’s operations, policies, or practices. In connection with her termination of employment,
on June 20, 2023, Qualigen, Inc, entered into a separation agreement and general release with Ms. Broidrick, which became effective
after a 7 day revocation period following Ms. Broidrick’s signing of it, on June 24, 2023. Under the terms of the Separation
Agreement, Qualigen, Inc. was obligated to provide Ms. Broidrick severance in the form of continued salary pay at the rate then in
effect on the Separation Date ($360,000 per annum) for a period of 12 months following the Separation Date, subject to applicable
withholding, and payment or reimbursement for the cost of COBRA continuation medical and dental insurance coverage for 12 months
following the Separation Date, less any required taxes or withholdings. Upon the July 20, 2023 closing of our sale of Qualigen,
Inc., Chembio (as the new parent company of Qualigen, Inc.) undertook the remaining severance liability to Ms. Broidrick.
Stock
Incentive Plan
The
material terms of our 2020 Stock Equity Incentive Plan (as amended, the “2020 Plan”) are outlined below. This summary is
qualified in its entirety by reference to the complete text of the 2020 Plan, which is incorporated herein by reference.
Authorized
Shares . We have reserved an aggregate of 755,702 shares of our common stock for issuance under the 2020 Plan. The number of shares
is subject to adjustment in the event of any recapitalization, stock split, reclassification, stock dividend or other change in our capitalization.
In addition, the following shares of our common stock will be available for grant and issuance under the 2020 Plan:
● shares
subject to stock options or stock appreciation rights (“SARs”), granted under
the 2020 Plan that cease to be subject to the stock option or SAR for any reason other than
exercise of the stock option or SAR;
● shares
subject to awards granted under the 2020 Plan that are subsequently forfeited or repurchased
by us at the original issue price;
67
● shares
subject to awards granted under the 2020 Plan that otherwise terminate without shares being
issued;
● shares
surrendered, canceled, or exchanged for cash or a different award (or combination thereof);
and
● shares
subject to awards under the 2020 Plan that are used to pay the exercise price of an award
or withheld to satisfy the tax withholding obligations related to any award.
Plan
Administration . The 2020 Plan will be administered by our Compensation Committee or by our board of directors acting in place of
our Compensation Committee. Our Compensation Committee will have the authority to construe and interpret the 2020 Plan, grant awards
and make all other determinations necessary or advisable for the administration of the 2020 Plan.
Awards
and Eligible Participants . The 2020 Plan authorizes the award of stock options, stock appreciation rights, restricted stock unit,
performance awards and stock bonuses. The 2020 Plan provides for the grant of awards to our employees, directors, consultants and independent
contractor service providers, subject to certain exceptions. No non-employee director may be granted awards under the 2020 Plan in any
calendar year that, taken together with any cash fees paid by us to such non-employee director during such calendar year, exceed $5,000,000
(calculating the value of any award based on the grant date fair value determined in accordance with GAAP). No more than 98,000,000 shares
of our common stock will be issued under the 2020 Plan pursuant to the exercise of incentive stock options.
Stock
Options . The 2020 Plan permits us to grant incentive stock options and non-qualified stock options. The exercise price of stock options
will be determined by our Compensation Committee, and may not be less than 100% of the fair market value of our common stock on the date
of grant. Our Compensation Committee has the authority to reprice any outstanding stock option (by reducing the exercise price, or canceling
the stock option in exchange for cash or another equity award) under the 2020 Plan without the approval of our stockholders. Stock options
may vest based on the passage of time or the achievement of performance conditions in the discretion of our compensation committee. Our
Compensation Committee may provide for stock options to be exercised only as they vest or to be immediately exercisable with any shares
issued on exercise being subject to our right of repurchase that lapses as the shares vest. The maximum term of stock options granted
under the 2020 Plan is 10 years.
Stock
Appreciation Rights . SARs provide for a payment to the holder, in cash or shares of our common stock, based upon the difference between
the fair market value of our common stock on the date of exercise and the stated exercise price on the date of grant, up to a maximum
amount of cash or number of shares. SARs may vest based on the passage of time or the achievement of performance conditions in the discretion
of our Compensation Committee. Our Compensation Committee has the authority to reprice any outstanding SAR (by reducing the exercise
price, or canceling the SAR in exchange for cash or another equity award) under the 2020 Plan without the approval of our stockholders.
Restricted
Stock Awards . A restricted stock award represents the issuance to the holder of shares of our common stock, subject to the forfeiture
of those shares in the event of failure to achieve certain performance conditions or termination of employment. The purchase price, if
any, for the shares will be determined by our Compensation Committee. Unless otherwise determined by the administrator at the time of
award, vesting will cease on the date the holder no longer provides services to us and unvested shares will be forfeited to us or can
be repurchased by us.
Restricted
Stock Units . Restricted stock units (“RSUs”) represent the right on the part of the holder to receive shares of our common
stock at a specified date in the future, subject to forfeiture of that right in the event of failure to achieve certain performance conditions
or termination of employment. If a RSU has not been forfeited, then, on the specified date, we will deliver to the holder of the RSU
shares of our common stock, cash or a combination of cash and shares of our common stock, as previously determined by the Compensation
Committee at the time of the award.
Performance
Awards . Performance awards cover a number of shares of our common stock that may be settled upon achievement of performance conditions
as provided in the 2020 Plan in cash or by issuance of the underlying common stock. These awards are subject to forfeiture before settlement
in the event of failure to achieve certain performance conditions or termination of employment.
Stock
Bonuses . Stock bonuses may be granted as additional compensation for past or future service or performance and, therefore, no payment
will be required from a participant for any shares awarded under a stock bonus. Unless otherwise determined by our Compensation Committee
at the time of award, vesting will cease on the date the holder no longer provides services to us and unvested shares will be forfeited
to us.
68
Change-in-Control .
If we are party to a merger or consolidation, sale of all or substantially all our assets or similar change-in-control transaction, outstanding
awards, including any vesting provisions, may be assumed or substituted by the successor company. In the alternative, the successor company
may issue, in place of outstanding shares held by a 2020 Plan participant, substantially similar shares or other property subject to
repurchase obligations no less favorable to the participant. Outstanding awards that are not assumed, substituted or cashed out will
accelerate in full and expire immediately before the transaction, and awards will be exercisable for a period of time determined by the
administrator.
Amendment;
Termination . The 2020 Plan will terminate 10 years from April 8, 2020, unless it is terminated earlier by our board of directors.
Our board of directors may amend, suspend or terminate the 2020 Plan at any time, subject to compliance with applicable law.
Federal
Income Tax Summary . The following is a brief summary of the principal federal income tax consequences to us and to an eligible person
(who is a citizen or resident of the United States for U.S. federal income tax purposes) (a “Participant”) of awards that
may be granted under the 2020 Plan. The summary is not intended to be exhaustive and, among other things, does not describe state, local
or foreign tax consequences. The federal income tax consequences of an eligible person’s award under the 2020 Plan are complex,
are subject to change and differ from person to person. Each person should consult with his or her own tax adviser as to his or her own
particular situation.
This
discussion is based on the Code, Treasury Regulations promulgated under the Code, Internal Revenue Service rulings, judicial decisions
and administrative rulings as of the date of this proxy statement, all of which are subject to change or differing interpretations, including
changes and interpretations with retroactive effect. No assurance can be given that the tax treatment described herein will remain unchanged
at the time that awards under the 2020 Plan are made.
A
Participant will not recognize income upon the grant of an option or at any time prior to the exercise of the option. At the time the
participant exercises a non-qualified option, he or she will recognize compensation taxable as ordinary income in an amount equal to
the excess of the fair market value of the common stock on the date the option is exercised over the price paid for the common stock,
and we will then be entitled to a corresponding deduction.
A
Participant who exercises an incentive stock option will not be taxed at the time he or she exercises his or her options or a portion
thereof. Instead, he or she will be taxed at the time he or she sells the common stock purchased pursuant to the option. The Participant
will be taxed on the excess of the amount for which he or she sells the stock over the price he or she had paid for the stock. If the
Participant does not sell the stock prior to two years from the date of grant of the option and one year from the date the stock is transferred
to him or her upon exercise, the gain will be capital gain and we will not get a corresponding deduction. If the Participant sells the
stock at a gain prior to that time, the difference between the amount the Participant paid for the stock and the lesser of the fair market
value on the date of the exercise or the amount for which the stock is sold, will be taxed as ordinary income and we will be entitled
to a corresponding deduction. If the Participant sells the stock for less than the amount he or she paid for the stock prior to the one
or two year periods indicated, no amount will be taxed as ordinary income and the loss will be taxed as a capital loss.
A
Participant generally will not recognize income upon the grant of a stock appreciation right or a restricted stock unit. At the time
a Participant receives shares or cash payment under any such award, he or she generally will recognize compensation taxable as ordinary
income in an amount equal to the cash or the fair market value of the common stock received, less any amount paid for the stock, and
we will then be entitled to a corresponding deduction. Upon a subsequent sale of the shares received under the stock appreciation right
or restricted stock unit, if any, the difference between the amount realized on the sale and the Participant’s tax basis (the amount
previously included in income) is generally taxable as a capital gain or loss, which will be short-term or long-term depending on the
Participant’s holding time of such shares.
The
taxation of restricted stock is dependent on the actions taken by the Participant. Generally, absent an election to be taxed currently
under Section 83(b) of the Code, or an 83(b) election, there will be no federal income tax consequences to the Participant upon the grant
of a restricted stock award. At the lapse of the restrictions or satisfaction of the conditions on the restricted stock, the Participant
will recognize ordinary income equal to the fair market value of our common stock at that time. If the Participant makes an 83(b) election
within 30 days of the date of grant, he or she will recognize ordinary income equal to the fair market value of our common stock at the
time of grant, determined without regard to the applicable restrictions. If an 83(b) election is made, no additional income will be recognized
by the Participant upon the lapse of the restrictions or satisfaction of the conditions on the restricted stock award. We generally should
be entitled to a deduction equal to the amount of ordinary income recognized by the Participant, at the same time as the ordinary income
is recognized by the Participant. Upon a subsequent sale of the formerly restricted stock, the difference between the amount realized
on the sale and the Participant’s tax basis (the amount previously included in income) is generally taxable as a capital gain or
loss, which will be short-term or long-term depending on the Participant’s holding time of such shares.
The
tax consequences to Participants who receive performance-based awards depend on the particular type of award issued. Our ability to take
a deduction for such awards similarly depends on the terms of the awards and the limitations of Section 162(m) of the Code, if applicable.
Section 162(m) of the Code currently imposes a $1 million limit on the amount that a public company may deduct for compensation paid
to an employee who is chief executive officer, chief financial officer, or another “covered employee” (as defined by Section
162(m)), or was such an employee beginning in any year after 2017. The Compensation Committee retains the discretion to establish the
compensation paid or intended to be paid or awarded to the executive officers as the Compensation Committee may determine is in the best
interest of us and our stockholders, and without regard to any limitation provided in Section 162(m). This discretion is an important
feature of the Compensation Committee’s compensation practices because it provides the Compensation Committee with sufficient flexibility
to respond to specific circumstances facing us.
69
Outstanding
Equity Awards at December 31, 2023
The
following table presents the outstanding stock options and compensatory warrants held by each of the named executive officers as of December
31, 2023. There were no direct stock awards, restricted stock units or stock appreciation rights outstanding at December 31, 2023. All
pre-2020 “option” awards shown were initially issued as Qualigen, Inc. Series C Warrants, and became warrants exercisable
instead for our common stock (at an adjusted exercise price) upon the Reverse Recapitalization Transaction. The share numbers and exercise
prices in the table below reflect the reverse stock split, which was effected by the Company on November 23, 2022 (the “Reverse
Stock Split”).
Equity Awards
Name
Grant
Date
Number of
Securities
Underlying
Unexercised
Awards
(#)
Exercisable
Number of
Securities
Underlying
Unexercised
Awards
(#)
Unexercisable
Exercise
Price
($)
Expiration
Date
Michael Poirier
7/11/2022
12,500
25,000 (1)
5.14
7/11/2032
6/5/2020
100,000
—
51.30
6/5/2030
9/22/2016
1,443
—
25.41
9/22/2026
3/3/2015
2,214
—
25.41
3/2/2025
8/2/2014
2,984
—
20.66
8/2/2024
1/31/2014
2,214
—
20.66
1/31/2024
Tariq Arshad
7/11/2022
3,400
6,800 (1)
5.14
7/11/2032
12/8/2021
20,000
10,000 (2)
12.40
5/17/2031
5/17/2021
6,667
3,333 (1)
18.00
5/17/2031
Amy Broidrick
7/11/2022
—
13,000 (3)
5.14
7/11/2032
12/8/2021
—
30,000 (3)
12.40
12/8/2031
12/7/2020
—
15,000 (3)
35.20
12/7/2030
8/27/2020
—
5,000 (3)
47.00
8/27/2030
(1) Shares
underlying the stock option vest over three years in three equal annual installments from
the date of grant.
(2) Shares
underlying the stock option vest over three years in three equal annual installments from
the vesting commencement date of May 17, 2021.
(3) Following Ms. Broidrick’s termination of employment on June 16, 2023, she did not exercise any vested stock options, and all of her
equity awards were subsequently forfeited.
Pay
Versus Performance (PVP)
In
accordance with the SEC’s disclosure requirements regarding pay versus performance, or PVP, this section presents the
SEC-defined “Compensation Actually Paid,” or CAP of our principal executive officer (“PEO”) and named
executive officers (“NEOs”) for each of the fiscal years ended December 31, 2023, 2022, and 2021, and our financial
performance. Also as required by the SEC, this section compares CAP to various measures used to gauge performance at the Company for
each such fiscal year.
Pay
versus Performance Table - Compensation Definitions
Salary,
Bonus, Stock Awards, and All Other Compensation are each calculated in the same manner for purposes of both CAP and Summary Compensation
Table, or SCT values. The primary difference between the calculation of CAP and SCT total compensation is the calculation of the value
of “Stock Awards,” with the table below describing the differences in how these awards are valued for purposes of SCT total
and CAP:
SCT
Total
CAP
Stock
Awards
Grant
date fair value of stock awards granted during the year
Fair
value of stock awards that are unvested as of the end of the year, or vested during the year
70
Pay
Versus Performance Table
In
accordance with the SEC’s new PVP rules, the following table sets forth information concerning the compensation of our NEOs for
each of the fiscal years ended December 31, 2023, 2022, and 2021, and our financial performance for each such fiscal year:
Year
Summary Compensation Table Total for PEO
Compensation Actually Paid to PEO
Average Summary Compensation Table Total for non-PEO Named Executive Officers
Average Compensation Actually Paid to non-PEO Named Executive Officers
Value of Initial Fixed $100 Investment Based On Total Shareholder Return
Net Loss Attributable to Qualigen Therapeutics, Inc. (millions)
2023
$ 632,698
$ 612,865
$ 514,321
$ 488,856
$ 1.83
$ (13.4 )
2022
728,454
262,274
473,826
121,235
4.29
(18.6 )
2021
742,279
(753,431 )
811,499
609,691
38.21
(17.9 )
The principal executive officer (“PEO”) in 2023, 2022, and 2021
was Michael Poirier, our Chairman and Chief Executive Officer. The Non-PEO NEOs in 2023, 2022, and 2021 were Amy Broidrick, who was our
President, Chief Strategy and Operating Officer, and Tariq Arshad, who was our Chief Medical Officer and Senior Vice President. The CAP
was calculated beginning with the NEOs SCT total. The following amounts were deducted from and added to the applicable SCT total compensation:
SCT Total
Stock awards deducted from SCT
Increase for fair value of awards granted during the year that remain unvested as of year end
Decrease in fair value from prior year-end to current year-end for awards granted in prior years and unvested as of year end
Decrease in fair value from prior year-end to current year vesting date for awards granted in prior years
Total CAP
(A)
(B)
(C )
(D)
(E )
A-B+C+D+E
PEO
2023
$ 632,698
$ -
$ -
$ (13,650 )
$ (6,183 )
$ 612,865
2022
728,454
(145,274 )
31,387
(218,695 )
(133,598 )
262,274
2021
742,279
-
-
(1,236,534 )
(259,176 )
(753,431 )
Average Non-PEO NEO
2023
$ 514,321
$ -
$ -
$ (23,708 )
$ (1,757 )
$ 488,856
2022
473,826
(44,936 )
9,709
(218,541 )
(98,823 )
121,235
2021
811,499
(363,370 )
314,858
(104,300 )
(48,997 )
609,691
The
fair value of stock options reported for CAP purposes in columns (B), (C), (D) and (E) above was estimated using a Black-Scholes option
pricing model for the purposes of this PVP calculation in accordance with SEC rules. This model uses both historical data and current
market data to estimate the fair value of options and requires several assumptions. The assumptions used in estimating fair value for
awards granted during 2022 were as follows: volatility 102%, expected life 5.99 years, expected dividend yield 0%, risk-free rate 3.04%.
The assumptions used in estimating fair value for awards granted during 2021 and prior were as follows: volatility 102%, expected life
5.99 years, expected dividend yield 0%, risk-free rate 0.42% - 1.43%. There were no awards granted in 2023.
Analysis
of Information Presented in the Pay versus Performance Table
Our executive compensation program
reflects a variable pay-for-performance philosophy. While we utilize several performance measures to align executive compensation with
Company performance, all of those Company measures are not presented in the Pay versus Performance table. Moreover, we generally seek
to incentivize long-term performance, and therefore we do not specifically align our performance measures with compensation that is actually
paid (as computed in accordance with SEC rules) for a particular year. Further, we do not have the right to (without the executive’s
consent) reduce an executive’s salary for a particular year to an amount lower than is provided for in any employment agreement
with the executive which covers such year. In accordance with SEC rules, we provide the following narrative disclosure:
Compensation
Actually Paid and Cumulative Total Stockholder Return
Compensation actually paid to our PEO increased from ($753,431) in 2021
to $262,274 in 2022, and further increased to $612,865 in 2023. Average compensation actually paid to our named executive officers other
than our PEO decreased from $609,691 in 2021 to $121,235 in 2022, and increased to $488,856 in 2023. Over the same period, the value of
an investment of $100 in our common stock on the last trading day of 2020 decreased by $61.79 to $38.21 during 2021, further decreased
by $33.92 to $4.29 during 2022, and further decreased by $2.46 during 2023, for a total decrease over 2021, 2022, and 2023 of $98.17.
71
Compensation
Actually Paid and Net Loss
Compensation actually paid to our PEO increased from ($753,431) in 2021
to $262,274 in 2022, and further increased to $612,865 in 2023. Average compensation actually paid to our named executive officers other
than our PEO decreased from $609,691 in 2021 to $121,235 in 2022, and increased to $488,856 in 2023. Over the same period, our net loss
increased by $0.7 million during 2022 (from a net loss in 2021 of $17.9 million to a net loss in 2022 of $18.6 million), and decreased
by $5.2 million during 2023 (from a net loss in 2022 of $18.6 million to a net loss in 2023 of $13.4 million).
Compensation
of Directors
For
2023 , our non-employee directors were eligible to receive $35,000 in annual cash compensation.
The Audit Committee chair was eligible to receive additional annual cash compensation of $15,000 and the other Board committee chairs
were eligible to receive additional annual cash compensation of $10,000. Each non-chair member of each Board committee was eligible to
receive additional annual cash compensation of $7,500 (Audit Committee) and $5,000 (other Committees). On January 13, 2023, the Company’s
board of directors, as part of certain cost-cutting measures, approved a temporary 20% reduction to the compensation of all directors
of the Company effective January 1, 2023. On August 1, 2023 the Company’s board of directors approved the reinstatement of the
compensation of all directors of the Company to the above amounts effective August 1, 2023. Non-employee directors did not receive stock
option grants during 2023. The amounts in the table below represent fees actually paid in cash during 2023 and include some fees earned in 2022.
Compensation
paid to Mr. Poirier and Ms. Broidrick is presented as part of the “Summary Compensation Table” above, rather than here.
Our employee directors do not receive compensation for their service as directors.
Name of Director
Fees Paid in
Cash ($)
Option
Awards
($)
All other compensation
($)
Total
($)
Richard David
40,000
—
—
40,000
Sidney Emery, Jr.
46,000
—
—
46,000
Matthew Korenberg
42,000
—
—
42,000
Kurt Kruger
40,000
—
—
40,000
Ira Ritter
16,333
—
—
16,333
As of December 31, 2023, all non-employee directors had been paid for compensation earned through July 31, 2023.
Hedging
or Offsetting Against Compensatory Securities
We
have adopted a policy that our employees (including officers) and directors shall not purchase securities or other financial instruments,
or otherwise engage in transactions, that hedge or offset, or are designed to hedge or offset, any decrease in the market value of equity
securities granted as compensation to, or held directly or indirectly by, those persons.
We have adopted a formal claw-back policy for the recovery of incentive-based
executive compensation erroneously awarded to executive officers based on misstated financial reporting measures.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The
following table sets forth certain information regarding the beneficial ownership of our common stock as of March 25, 2024 by:
●
our named executive officers;
●
our directors;
●
all of our current directors and executive officers as a group;
and
●
each stockholder known by us to own beneficially more than
5% of our common stock.
Beneficial
ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities.
Shares of common stock that may be acquired by an individual or group within 60 days after March 25, 2024, pursuant to the exercise of
options or warrants, are deemed to be outstanding for the purpose of computing the percentage ownership of such individual or group,
but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person shown in the table. The
percentage of beneficial ownership of our common stock is calculated based on an aggregate of 6,307,371 shares outstanding as of March
25, 2024.
72
Except
as indicated in the footnotes to this table, we believe that the stockholders named in this table have sole voting and investment power
with respect to all shares of common stock shown to be beneficially owned by them, based on information provided to us by such stockholders.
Unless otherwise indicated, the address for each director and executive officer listed is: c/o Qualigen Therapeutics, Inc., 5857 Owens
Avenue, Suite 300, Carlsbad, California 92008 USA.
Beneficial Owner
Number of Shares
Beneficially Owned
Percentage of
Common Stock
Beneficially Owned
Five Percent Stockholders
Alpha Capital Anstalt (1)
700,041
9.99 %
Executive Officers, Directors and Director Nominees
Michael Poirier (2)
142,376
2.2 %
Christopher Lotz (3)
72,353
1.1 %
Richard David (4)
7,219
*%
Sidney Emery, Jr. (5)
8,302
*%
Matthew Korenberg (6)
6,334
*%
Kurt Kruger (7)
9,019
*%
Ira Ritter (8)
6,738
*%
All current executive officers and directors as a group (7 persons) (9)
252,341
3.9 %
*
Represents beneficial ownership of less than 1% of the shares of common stock.
(1) Includes
shares of common stock issuable upon the exercise of warrants or conversion of its convertible
debentures; Alpha Capital Anstalt would not be permitted to convert or exercise all or any
portion of its warrants or debentures to the extent that such conversion or exercise would
result in Alpha Capital Anstalt (and its affiliates) beneficially owning more than 9.99%
of the number of shares of Company common stock outstanding immediately after giving effect
to the issuance of shares of common stock issuable upon conversion/exercise. Konrad Ackermann
has voting and investment power over the shares held by Alpha Capital Anstalt.
(2) Includes
112,500 shares of common stock exercisable within 60 days under outstanding stock options
and 8,855 shares of common stock exercisable within 60 days under outstanding warrants.
(3) Includes
63,333 shares of common stock exercisable within 60 days under outstanding stock options
and 7,766 shares of common stock exercisable within 60 days under outstanding warrants.
(4) Includes 6,334 shares of common stock exercisable within 60 days under
outstanding stock options and 885 shares of common stock exercisable within 60 days under outstanding warrants.
(5) Includes 6,334 shares of common stock exercisable within 60 days under
outstanding stock options.
(6) Includes
6,334 shares of common stock exercisable within 60 days under outstanding stock options.
(7) Includes 6,334 shares of common stock exercisable within 60 days under
outstanding stock options and 885 shares of common stock exercisable within 60 days under outstanding warrants.
(8) Includes 6,334 shares of common stock exercisable within 60 days under
outstanding stock options. Also includes shares of common stock held in a retirement plan trust of which Ira Ritter and his spouse are
trustees; and also includes shares beneficially owned by Stonehenge Partners. As a managing partner of Stonehenge Partners, Ira Ritter
may be deemed the beneficial owner of these shares.
(9) Includes 207,503 shares of common stock exercisable within 60 days under
outstanding stock options and 18,391 shares of common stock exercisable within 60 days under outstanding warrants.
73
Equity
Compensation Plan Information
The
following table presents information regarding securities authorized for issuance under equity compensation plans as of December 31,
2023:
Plan Category
Number of Securities
to be Issued upon
Exercise of
Outstanding
Options, Warrants and Rights
Weighted-Average
Exercise Price 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 stockholders
398,924
$ 35.21
356,791
Equity compensation plans not approved by stockholders (1)
119,046
$ 10.35
—
Total
517,970
$ 29.50
356,791
(1) Consists
of shares of common stock issuable upon the exercise of compensatory warrants granted to
service providers.
Item
13. Certain Relationships and Related Transactions, and Director Independence.
Certain
Relationships and Related Party Transactions
Our
Audit Committee is responsible for reviewing, approving and overseeing any transaction between the Company and its directors, director
nominees, executive officers, greater than 5% beneficial owners, and each of their respective immediate family members, where the amount
involved exceeds the lesser of (i) $120,000 and (ii) 1% of the average of our total assets at year-end for the prior two fiscal years.
Since January 1, 2021, there have been no such transactions except as described below.
On
May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. (“NanoSynex”) from Alpha a related party, in exchange for 350,000 reverse split adjusted shares of the Company’s
common stock and a prefunded warrant to purchase 331,464 reverse split adjusted shares of the Company’s common stock at an exercise
price of $0.001 per share. These warrants were subsequently exercised on September 13, 2022.
On
December 21 and 22, 2022, we entered into a Securities Purchase Agreement with Alpha and in exchange for $3,000,000 in cash (less $50,000
for expense reimbursement) issued to Alpha the 2022 Debenture, plus 2,500,000 common stock warrants exercisable (from June 22, 2023 through
June 22, 2028) at $1.65 per share. Commencing June 1, 2023 and continuing on the first day of each month thereafter until the earlier
of (i) December 22, 2025 and (ii) the full redemption of the 2022 Debenture (each such date, a “Monthly Redemption Date”),
we must redeem $110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under the 2022 Debenture (the
“Monthly Redemption Amount”). The Monthly Redemption Amount must be paid in cash; provided that after the first two monthly
redemptions, we may (if the Equity Conditions, as defined in the 2022 Debenture, are then satisfied or have been waived) elect to pay
all or a portion of a Monthly Redemption Amount in shares of our common stock, based on a conversion price equal to the lesser of (i)
the then applicable conversion price of the 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined in the 2022 Debenture)
for the five consecutive trading days ending on the trading day that is immediately prior to the applicable Monthly Redemption Date.
The
2022 Debenture accrues interest at the rate of 8% per annum, which began accruing on December 1, 2023, and will be payable on a quarterly
basis. Interest may be paid in cash or shares of common stock or a combination thereof at our option; provided that the Equity Conditions
have been satisfied.
The
2022 Debenture is convertible into our common stock at any time at the holder’s option; the conversion price was originally $1.32.
Other
than the Monthly Redemption Amounts, the 2022 Debenture does not call for scheduled payments of principal before the scheduled maturity
date.
Both
the 2022 Debenture and the accompanying warrants provide for “ratchet” antidilution adjustments to their conversion price
and exercise price.
74
Both
the 2022 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon
61 days’ notice to the Company.
On
December 5, 2023, we and Alpha entered into an Amendment No. 1 with regard to Securities Purchase Agreement, under which the conversion
price of the 2022 Debenture and the exercise price of the associated warrants were reduced to $0.73 per share, in exchange for Alpha
permitting us to make certain Monthly Redemption Amount payments in the form of our stock rather than in cash even though the Equity
Conditions were not satisfied (which would otherwise have prevented payment in the form of stock). In addition, such Amendment revised
certain provisions of the 2,500,000 common stock warrants to (i) limit the circumstances which would trigger a potential adjustment to
the exercise price of the 2,500,000 common stock warrants and (ii) clarify the treatment of the 2,500,000 common stock warrants upon
a “Fundamental Transaction.” (The purpose of these revisions was to remove the terms that caused the 2,500,000 common stock
warrants to be liability-classified under U.S. GAAP).
The
new $0.73 per share conversion/exercise price triggered a “ratchet” antidilution adjustment in the Company’s outstanding
“exploding” “Series C Warrants,” resulting in such Series C Warrants becoming exercisable for 455,623 common
shares (at an exercise price of $0.73 per share), as opposed to the 251,971 common shares into which such outstanding Series C Warrants
would have been exercisable (at $1.32 per share) pre-adjustment. Finally, the $0.73 per share price triggered a “ratchet”
antidilution adjustment in the exercise price of other outstanding Company common stock warrants, including 7,084 warrants held by Alpha
and 67,620 warrants held by other persons, all of which were previously exercisable at $1.32 per share.
In
February 26 and 27, 2024, we entered into a Securities Purchase Agreement with Alpha and in exchange for $500,000 in cash (less $25,000
for expense reimbursement) issued to Alpha an 8% Convertible Debenture with a face amount of $550,000 due on December 31, 2024 (the “2024
Debenture”), plus 900,016 5-year common stock warrants exercisable at $0.26 per share. In addition, per this Securities Purchase
Agreement Alpha obtained an option to purchase additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate
of $1,100,000 (and with a proportional number of accompanying common stock warrants of like tenor, up to a total of 1,800,032 additional
warrants), which would (if and when Alpha exercises such option) provide us up to an additional $1.0 million in cash proceeds (less expense
reimbursement, and not including any possible cash proceeds from any future exercise of the additional warrants). This option is valid through July 1, 2024.
The
2024 Debenture has a maturity date of December 31, 2024 and is convertible, at any time, and from time to time, at Alpha’s option,
into shares of our common stock, at $0.6111 per share. The 2024 Debenture does not call for scheduled payments of principal or interest
before the scheduled maturity date. Interest on the 2024 Debenture accrues on its outstanding principal balance at the rate of 8% per
annum.
Both
the 2024 Debenture and the accompanying warrants provide for “ratchet” antidilution adjustments to their conversion price/exercise
price.
Both
the 2024 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon
61 days’ notice to the Company.
We
granted Alpha “piggyback” registration rights for the common shares underlying the 2024 Debenture and the accompanying warrants.
The
$0.26 exercise price of the warrants issued with the 2024 Debenture triggered a “ratchet” antidilution adjustment in the
2022 Debenture, resulting in the then current $1,198,922 principal amount thereof becoming convertible into 4,611,238 shares of Company
common stock (as opposed to the 1,642,359 shares into which such outstanding principal amount were convertible pre-adjustment). Also,
the $0.26 exercise price of the warrants issued with the 2024 Debenture triggered a “ratchet” antidilution adjustment in
the Company’s outstanding “exploding” “Series C Warrants,” resulting in such Series C Warrants becoming
exercisable for 1,279,261 common shares (at an exercise price of $0.26 per share), as opposed to the 455,623 common shares into which
such outstanding Series C Warrants would have been exercisable (at $0.73 per share) pre-adjustment. Finally, the $0.26 exercise price
of the warrant triggered a “ratchet” antidilution adjustment in the exercise price of other outstanding Company common stock
warrants, including 2,507,048 warrants held by Alpha and 67,620 warrants held by other persons, all of which were previously exercisable
at $0.73 per share.
In
connection with her termination of employment, on June 20, 2023, Qualigen, Inc., a former wholly-owned subsidiary of the Company,
signed a separation agreement and general release (the “Separation Agreement”) with Amy Broidrick, which became
effective on June 24, 2023.
Under
the terms of the Separation Agreement, Qualigen, Inc. provided Ms. Broidrick with (i) $16,637 in cash compensation, less applicable withholdings
for federal and state income and employment taxes, which represented Ms. Broidrick’s accrued but unpaid salary and vacation pay
through the Separation Date, and reimbursement of certain expenses incurred by Ms. Broidrick, (ii) severance in the form of continued
salary pay to Ms. Broidrick at the rate then in effect on the Separation Date ($360,000 per annum) for a period of 12 months following
the Separation Date, subject to applicable withholding, and (iii) payment or reimbursement for the cost of COBRA continuation medical
and dental insurance coverage for 12 months following the Separation Date, less any required taxes or withholdings. In addition, Ms.
Broidrick is entitled to any rights or benefits under Qualigen Inc.’s employee benefit plans, to the extent earned and vested,
and had three months from the Separation Date to exercise any vested stock options. Ms. Broidrick did not exercise any vested stock options.
75
Director
Independence
Under
Nasdaq’s continued listing requirements, a majority of a listed company’s board of directors must be comprised of independent
directors, subject to certain exceptions. In addition, Nasdaq’s continued listing requirements require that, subject to certain
exceptions, each member of a listed company’s audit, compensation and governance and nominating committees must be independent.
Audit Committee members must also satisfy the independence criteria set forth in Rule 10A-3 under the Exchange Act. Under Nasdaq’s
continued listing requirements, a director will only qualify as an “independent director” if, in the opinion of that company’s
board of directors, such person does not have a relationship that would interfere with the exercise of independent judgment in carrying
out the responsibilities of a director.
Based
upon information requested from and provided by each director concerning their background, employment and affiliations, including family
relationships, our board of directors determined that each of Messrs. David, Emery, Korenberg, Kruger and Ritter are independent under
the applicable rules and regulations of Nasdaq. In making such determinations, the board of directors considered the relationships that
each such non-employee director has with our company and all other facts and circumstances the board of directors deemed relevant in
determining their independence.
Item
14. Principal Accounting Fees and Services.
Baker
Tilly US, LLP (“Baker Tilly”) serves as the Company’s independent registered public accounting firm and has served
in that capacity since June 2018.
The
Audit Committee considered the independence of Baker Tilly and whether the audit services Baker Tilly provided to the Company are compatible
with maintaining that independence. The Audit Committee has adopted procedures by which the Audit Committee must approve in advance all
services provided by and fees paid to the Company’s independent registered public accounting firm. The advance approval requirement
was not waived in any instance during 2023 or 2022.
Fees
and Services of Baker Tilly US, LLP
The
following table sets forth the aggregate fees billed to the Company by Baker Tilly for the years ended December 31, 2023 and 2022:
2023
2022
Audit Fees(1)
$ 495,955
$ 411,362
Audit-Related Fees
—
—
Tax Fees (2)
18,789
35,050
All Other Fees
—
—
Total
$ 514,744
$ 446,412
(1) Audit
fees consisted of fees for audit work performed in the audit of financial statements, as
well as fees for quarterly reviews and registration statements.
(2) These
fees were incurred for professional services rendered in connection with tax compliance,
tax advice, and tax planning. These services included income tax compliance and related tax
services.
The
Audit Committee has adopted a formal policy on auditor independence requiring the advance approval by the Audit Committee of all audit
and non-audit services provided by our independent registered public accounting firm. In determining whether to approve any services
by our independent registered public accounting firm, the Audit Committee reviews the services and the estimated fees, and considers
whether approval of the proposed services will have a detrimental impact on the auditor’s independence. On an annual basis, our
management reports to the Audit Committee all audit services performed during the previous 12 months and all fees billed by our independent
registered public accounting firm for such services.
For
the years ended December 31, 2023 and 2022, all audit services and the corresponding fees were approved by our Audit Committee.
76
PART
IV
Item
15. Exhibits and Financial Statement Schedules
(a)
The following documents are filed as part of this Annual Report:
1. Financial
Statements. The following documents are included in Part II, Item 8 of this Annual Report and are incorporated by reference
herein:
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID 23)
33
Financial
Statements:
Consolidated Balance Sheets as of December 31, 2023 and December 31, 2022
35
Consolidated Statements of Operations and Comprehensive Loss for the Year Ended December 31, 2023 and Year Ended December 31, 2022
36
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the Year Ended December 31, 2023 and Year Ended December 31, 2022
37
Consolidated Statements of Cash Flows for the Year Ended December 31, 2023 and Year Ended December 31, 2022
38
Notes to Consolidated Financial Statements
39
2.
Financial Statement Schedules. Financial statement schedules have been omitted because they are not required or are not applicable,
or the required information is shown in the consolidated financial statements or notes thereto.
3.
Exhibits. See EXHIBIT INDEX
77
EXHIBIT
INDEX
Exhibit
No.
Description
Form
File
No.
Exhibit
Filing
Date
2.1
Stock Purchase Agreement dated July 20, 2023 with Chembio Diagnostics, Inc., Biosynex, S.A. and Qualigen, Inc.
8-K
001-37428
2.1
7/26/2023
3.1
Amended and Restated Certificate of Incorporation of Ritter Pharmaceuticals, Inc.
8-K
001-37428
3.1
7/1/2015
3.2
Certificate of Amendment to the Amended and Restated Certificate of Incorporation
8-K
001-37428
3.1
9/15/2017
3.3
Certificate of Amendment to the Amended and Restated Certificate of Incorporation
8-K
001-37428
3.1
3/22/2018
3.4
Certificate of Designation of Preferences, Rights and Limitations of Series Alpha Preferred Stock of the Company, filed with the Delaware Secretary of State on May 29, 2020
8-K
001-37428
3.1
5/29/2020
3.5
Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020 [reverse stock split]
8-K
001-37428
3.2
5/29/2020
3.6
Certificate of Merger, filed with the Delaware Secretary of State on May 22, 2020
8-K
001-37428
3.3
5/29/2020
3.7
Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020
8-K
001-37428
3.4
5/29/2020
3.8
Amended and Restated Bylaws of the Company, as of August 10, 2021
8-K
001-37428
3.1
8/13/2021
3.9
Certificate of Amendment to the Amended and Restated Certificate of Incorporation, filed with the Delaware Secretary of State on November 21, 2022
8-K
001-37428
3.1
11/22/2022
4.1
Warrant, issued by the Company in favor of Alpha Capital Anstalt, dated May 22, 2020
8-K
001-37428
10.13
5/29/2020
4.2
Form of Warrant, issued by the Company in favor of GreenBlock Capital LLC and its designees, dated May 22, 2020 [post-Merger]
8-K
001-37428
10.10
5/29/2020
4.3
Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated July 10, 2020
8-K
001-37428
10.2
7/10/2020
4.4
Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated August 4, 2020
8-K
001-37428
10.3
8/4/2020
4.5
“Two-Year” Common Stock Purchase Warrant for 1,348,314 shares in favor of Alpha Capital Anstalt, dated December 18, 2020
8-K
001-37428
10.3
12/18/2020
4.6
“Deferred” Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated December 18, 2020
8-K
001-37428
10.4
12/18/2020
78
4.7
Form of liability classified Warrant to Purchase Common Stock
10-K
001-37428
4.13
3/31/2021
4.8
Form of “service provider” compensatory equity classified Warrant
10-K
001-37428
4.14
3/31/2021
4.9
Description of Common Stock
10-K/A
001-37428
4.9
7/7/2023
4.10
Amended and Restated Common Stock Purchase Warrant to GreenBlock Capital LLC, dated April 25, 2022
10-Q
001-37428
4.15
5/13/2022
4.11
Amended and Restated Common Stock Purchase Warrant to Christopher Nelson, dated April 25, 2022
10-Q
001-37428
4.16
5/13/2022
4.12
Common Stock Purchase Warrant for 2,500,000 shares in favor of Alpha Capital Anstalt, dated December 22, 2022
8-K
001-37428
4.1
12/22/2022
10.1+
Executive Employment Agreement, by and between Qualigen, Inc. and Michael Poirier, dated as of February 1, 2017 and as amended on January 9, 2018
8-K
001-37428
10.1
5/29/2020
10.2+
Executive Employment Agreement, by and between Qualigen, Inc. and Christopher Lotz, dated as of February 1, 2017 and as amended on January 9, 2018
8-K
001-37428
10.2
5/29/2020
10.4+
2020 Stock Equity Incentive Plan
8-K
001-37428
10.20
5/29/2020
10.5+
Standard template of Stock Option Agreement for use under 2020 Stock Incentive Plan
8-K
001-37428
10.1
6/11/2020
10.10
Exclusive License Agreement (RAS) between the Company and University of Louisville Research Foundation, Inc., dated as of July 17, 2020
8-K
001-37428
10.4
8/4/2020
10.11
Amendment 1 to the Exclusive License Agreement (RAS), by and between Qualigen, Inc. and University of Louisville Research Foundation, Inc., dated March 16, 2021
10-K
001-37428
10.11
5/2/2023
10.15
Novation Agreement (RAS) among the Company, Qualigen, Inc. and University of Louisville Research Foundation, Inc. dated January 30, 2021
10-Q
001-37428
10.1
5/14/2021
10.17+
Hire offer letter from the Company to Tariq Arshad, dated April 22, 2021
10-Q
001-37428
10.1
8/16/2021
10.20
License Agreement with UCL Business Limited dated January 12, 2022
10-K
001-37428
10.55
3/31/2022
10.21
First Deed of Variation to License Agreement with UCL Business Limited dated March 30, 2022
10-K
001-37428
10.21
5/2/2023
10.22
Series B Preferred Share Purchase Agreement between the Company and NanoSynex Ltd. dated April 29, 2022
10-Q
001-37428
10.1
5/13/2022
10.23
Share Purchase Agreement between the Company and Alpha Capital Anstalt dated April 29, 2022
10-Q
001-37428
10.2
5/13/2022
79
10.24
Master Agreement for the Operational and Technological Funding of NanoSynex between Qualigen Therapeutics, Inc. and NanoSynex Ltd., dated May 26, 2022
8-K
001-37428
10.1
6/2/2022
10.25+
Qualigen Therapeutics, Inc. 2022 Employee Stock Purchase Plan
10-Q
001-37428
10.1
11/14/2022
10.26+
Amendment No. 2 to the 2020 Stock Incentive Plan of Qualigen Therapeutics, Inc.
8-K
001-37428
10.1
11/22/2022
10.27+
Amendment No. 1 to the 2022 Employee Stock Purchase Plan of Qualigen Therapeutics, Inc.
8-K
001-37428
10.2
11/22/2022
10.28
Securities Purchase Agreement, dated December 21, 2022, by and between Qualigen Therapeutics, Inc. and Alpha Capital Anstalt
8-K
001-37428
10.1
12/22/2022
10.29
8% Senior Convertible Debenture Due December 22, 2025 in favor of Alpha Capital Anstalt
8-K
001-37428
10.2
12/22/2022
10.30
Registration Rights Agreement, dated December 22, 2022, by and between Qualigen Therapeutics, Inc. and Alpha Capital Anstalt
8-K
001-37428
10.3
12/22/2022
10.31+
Letter to Michael Poirier, dated January 13, 2023, regarding compensatory changes
10-K
001-37428
10.31
5/2/2023
10.32+
Letter to Amy Broidrick, dated January 13, 2023, regarding compensatory changes
10-K
001-37428
10.32
5/2/2023
10.33+
Letter to Tariq Arshad, dated January 13, 2023, regarding compensatory changes
10-K
001-37428
10.33
5/2/2023
10.34
Amendment No. 1 with regard to Securities Purchase Agreement dated December 5, 2023 with Alpha Capital Anstalt
8-K
001-37428
10.1
12/7/2023
10.35
Amendment and Settlement Agreement dated July 19, 2023 with NanoSynex, Ltd.
8-K
001-37428
10.1
7/26/2023
10.36+
Separation Agreement and General Release dated June 20, 2023 with Amy Broidrick
10-Q
001-37428
10.1
8/14/2023
14.1
Code of Business Conduct and Ethics
8-K
001-37428
14.1
5/29/2020
21.1*
Subsidiaries of the Registrant
23.1*
Consent of Baker Tilly US, LLP, independent registered public accounting firm
24.1
Power of Attorney (included on signature page)
80
31.1
Certificate of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certificate of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1
Certificate of principal executive officer and principal financial officer pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.1*
Clawback Policy
101.INS#
Inline
XBRL Instance Document.
101.SCH#
Inline
XBRL Taxonomy Extension Schema Document.
101.CAL#
Inline
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF#
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB#
Inline
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE#
Inline
XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
*
Filed or furnished herewith.
**
Schedules have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedules will be furnished to the SEC
upon request.
+
Indicates management contract or compensatory plan or arrangement.
#
XBRL (Extensible Business Reporting Language) information is furnished and not filed herewith, is not a part of a registration statement
or Prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of section 18 of the
Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections.
Item
16. Form 10-K Summary
Not
applicable.
81
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Annual Report
to be signed on its behalf by the undersigned, thereunto duly authorized.
Qualigen
Therapeutics, Inc.
By:
/s/
Michael S. Poirier
Name:
Michael
S. Poirier
Title:
Chief
Executive Officer (Principal Executive Officer)
Date:
April 5, 2024
By:
/s/
Christopher L. Lotz
Name:
Christopher
L. Lotz
Title:
Vice
President of Finance, Chief Financial Officer (Principal Financial Officer and Chief Accounting Officer)
Date:
April 5, 2024
POWER
OF ATTORNEY
KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Michael S. Poirier and
Christopher L. Lotz, and each of them individually, his true and lawful attorneys-in-fact and agents, with full power of substitution
and resubstitution, for him and in his name, place, and stead, in any and all capacities, to sign any and all amendments to this Annual
Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every
act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do
in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or his substitute or substitutes,
may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, this Annual Report has been signed below by the following persons on behalf
of the Registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/
Michael S. Poirier
Chairman
of the Board, Chief Executive Officer
April 5, 2024
Michael
S. Poirier
(Principal
Executive Officer)
/s/
Christopher L. Lotz
Vice
President of Finance, Chief Financial Officer
April 5, 2024
Christopher
L. Lotz
(Principal
Financial and Accounting Officer)
/s/
Richard A. David
Director
April 5, 2024
Richard
A. David
/s/
Sidney W. Emery, Jr.
Director
April 5, 2024
Sidney
W. Emery, Jr.
/s/
Matthew E. Korenberg
Director
April 5, 2024
Matthew
E. Korenberg
/s/
Kurt H. Kruger
Director
April 5, 2024
Kurt
H. Kruger
/s/
Ira E. Ritter
Director
April 5, 2024
Ira
E. Ritter
82