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, 2022,
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, 2022, our disclosure controls and procedures were not effective due to the continuing
material weakness described below. 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, 2022, 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, 2022, our internal control over
financial reporting was not effective.
Description
of Material Weakness
As previously
described in our annual report on Form 10-K for the year ended December 31, 2021, in connection with the audit of our financial
statements as of and for the year ended December 31, 2021 (the “2021 audit”), our management and registered independent
public accounting firm identified a material weakness in
our internal control over financial reporting related to the lack of accounting department resources and/or policies and procedures
to ensure recording and disclosure of items in compliance with U.S. GAAP. This material weakness resulted in adjustments to our
warrant valuations in connection with the 2021 audit. In response to the material weakness, we took a number of remediation steps to
enhance our internal controls, including implementing additional procedures and utilizing external consulting resources with
experience and expertise in U.S. GAAP and public company accounting and reporting requirements to assist management with its
accounting and reporting of complex and/or non-recurring transactions and related disclosures. However, in connection with the audit
of our financial statements as of and for the year ended December 31, 2022 (the “2022 audit”), our management determined
that that the material weakness identified in connection with the 2021 audit has not been fully remediated and resulted in
adjustments to the accounting treatment related to convertible debt, the business combination and goodwill impairment during the
2022 audit, which resulted in the late filing of this Annual Report.
Remediation
of Material Weakness
As described above, following the 2021 audit, we evaluated and implemented
additional procedures in order to remediate this material weakness, including utilizing external consulting resources with experience
and expertise in U.S. GAAP and public company accounting and reporting requirements to assist management with its accounting and reporting
of complex and/or non-recurring transactions and related disclosures. However, due, in part, to a number of unfortunate staffing adjustments
and departures at the consulting firms we utilized, these changes have not completely remediated the material weakness identified and
reported. We intend to continue to take steps to enhance our internal controls, including implementing additional internal procedures
and utilizing well-established external consulting resources with experience and expertise in U.S. GAAP and public company accounting
and reporting requirements.
However, 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 indicated
adjustments having been made) 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.
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, 2022 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.
71
PART
III
Item
10. Directors, Executive Officers and Corporate Governance.
The
Board of Directors
Our
board of directors currently consists of seven members, each of whose current term of office as a director expires at the 2023 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
67
2020
Amy Broidrick
President, Chief Strategy Officer and Director
64
2020
Richard David
Director
63
2020
Sidney Emery, Jr.
Director
76
2020
Matthew Korenberg
Director
48
2020
Kurt Kruger
Director
67
2020
Ira Ritter
Director
74
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.
Amy
S. Broidrick . Ms. Broidrick has served as our President, Chief Strategy and Operating Officer since February 2023. She previously
served as our President and Chief Strategy Officer since December 2021, and Executive Vice President/Chief Strategy Officer since December
2020. From 2016 to July 2020, Ms. Broidrick served as Senior Vice President, Global Head of Corporate Development of Viking Therapeutics,
Inc. (Nasdaq: VKTX), a clinical-stage biopharmaceutical company. Before that, she was Vice President, Head of Global Marketing Excellence
and Business Innovation with EMD Serono (part of Merck KGaA). Earlier, she was Vice President, Head of Marketing and Commercialization
at Arena Pharmaceuticals, Inc., and had significant roles and responsibilities at Merck & Co., Inc. and G.D. Searle & Company.
Ms.
Broidrick’s executive experience with large and smaller public companies in the therapeutics industry contributed to our board
of directors’ conclusion that she 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.
72
Sidney
W. Emery, Jr. Mr. Emery acquired Supply Chain Services in 2010 and, as its Chief Executive Officer, grew it into a premier
provider of automatic identification and data capture and factory automation solutions before selling the business to Sole Source
Capital LLC in May 2020. Before Supply Chain Services, 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 School 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. He served for 10 years in the US Navy
(including on gunboats in Vietnam).
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.
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 showed perspicuity leading Hambrecht & Quist in providing venture
funds for, and then taking public, Ventritex, which was later acquired by St. Jude Medical. After Hambrecht & Quist, 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, including leadership of 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 our predecessor, Ritter Pharmaceuticals,
Inc., from its inception in 2004 through the formation of Ritter Pharmaceuticals, Inc. 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.
73
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.qualigeninc.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.”
EXECUTIVE
OFFICERS
The
following table sets forth information about our current executive officers.
Name
Age
Position
with the Company
Michael
Poirier
67
Chairman
and Chief Executive Officer
Amy
Broidrick
64
President
and Chief Strategy Officer
Christopher
Lotz
58
Chief
Financial Officer, Vice President of Finance
Tariq
Arshad
53
Chief
Medical Officer and Senior Vice President
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.
74
For
the biographies of Mr. Poirier and Ms. Broidrick, please see “Board of Directors - The Board of Directors in General”.
Christopher
L. Lotz | Chief Financial Officer, Vice President of Finance. Mr. Lotz joined Qualigen as Director of Finance in 2002 and was
promoted to his current role of Chief Financial Officer, Vice President of Finance in 2003. Before joining
Qualigen, 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.
Tariq Arshad, MD, MBA |
Chief Medical Officer and Senior Vice President. Dr. Arshad brings more than 20 years of biotech
and pharmaceutical experience to Qualigen. He is an oncologist with expertise in both early and late-stage clinical development at several
leading and emergent biopharmaceutical companies. Prior to joining Qualigen in May 2021, Dr. Arshad was Global Head of Medical
Affairs and Clinical Research with Becton Dickinson Biosciences in San Jose, California from 2019-2021,
where he led a team of MDs and PHDs driving scientific strategy for a cutting-edge immuno-oncology focused portfolio. From 2018-2019,
Dr. Arshad served as Head of Medical Affairs, Immunology, Global Markets for Sanofi Genyzyme, and Chief Medical Officer, Head of
Clinical Research and Medical Affairs for Humanigen, Inc. from 2016-2018. Prior to that, he held leadership positions with XOMA Corporation,
Genentech, Inc., Merck & Co., Inc., and Pfizer Inc. Dr. Arshad holds a M.B.B.S (Bachelor of
Medicine, Bachelor of Surgery) from University of Punjab, MD from Educational Commission for Foreign Medical Graduates (ECFMG), and a
M.B.A. degree from George Washington 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, 2022, all Section 16(a) filing requirements applicable to
such persons were met in a timely manner, except as described below.
Each
of Michael Poirier, Amy Broidrick, Christopher Lotz, Shishir Sinha, Wajdi Abdul-Ahad, Tariq Arshad, Richard David, Sidney Emery, Jr.,
Matthew Korenberg, Kurt Kruger and Ira Ritter filed one late Form 4 report with respect to a grant of stock options that each of them
received on July 11, 2022 as follows: Michael Poirier (37,000 options), Amy Broidrick (130,000 options), Christopher Lotz (100,000 options),
Shishir Sinha (100,000 options), Wajdi Abdul-Ahad (80,000 options), Tariq Arshad (102,000 options), Richard David (40,000 options), Sidney
Emery (40,000 options), Jr., Matthew Korenberg (40,000 options), Kurt Kruger (40,000 options) and Ira Ritter (40,000 options).
Item
11. Executive Compensation.
EXECUTIVE
AND DIRECTOR COMPENSATION
Summary
Compensation Table (2022 and 2021)
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
2022
575,000
—
145,274
8,180
728,454
2021
517,788
218,740
—
5,751
742,279
Amy Broidrick, President and Chief Strategy Officer
2022
450,000
—
50,359
7,642
508,001
2021
403,077
155,000
296,170
4,055
858,302
Tariq Arshad, Chief Medical Officer and Senior Vice President (3)
2022
400,000
—
39,512
138
439,650
2021
253,846
80,212
430,569
69
764,696
(1) The
amounts reported in this column reflect the aggregate grant date fair value of the option
awards granted during 2022 and 2021, computed in accordance with Financial Accounting Standard
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.
75
(2)
Represents
life insurance premiums paid by us for each named executive officer in addition to 401(k)
matching contributions paid by us for Mr. Poirier and Ms. Broidrick.
(3) Dr.
Arshad joined Qualigen in May 2021.
Executive
Employment Agreements
Employment
Agreement with Michael Poirier
Mr.
Poirier, is party to an Executive Employment Agreement with Qualigen 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.
Employment
Agreement with Amy Broidrick
Upon
her promotion to the position of President and Chief Strategy Officer in December 2021, Ms. Broidrick is party to an Executive
Employment Agreement with Qualigen dated December 10, 2021 (the “Broidrick Employment Agreement”). The Broidrick
Employment Agreement had an initial term expiring on April 30, 2022 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 Broidrick Employment Agreement, Ms. Broidrick is entitled to an annual base salary of at least $450,000, is
eligible to participate in the Company’s bonus plans, benefit programs and medical benefits, is eligible for certain
event-based bonuses, and is entitled to four weeks of vacation per year. If Ms. Broidrick’s employment is terminated without
Cause or she resigns for Good Reason (as such terms are defined in the Broidrick Employment Agreement), and she provides a general
release to the Company, she will be entitled to one year of salary continuation plus the cost of COBRA coverage continuation for
such one year period. 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,
Ms. Broidrick’s base salary was reduced to $360,000.
The
following definitions are used in each of the Employment Agreements described above:
“Cause”
means any of the following: (i) a material breach by the employee of any of the trade secret/proprietary information, confidential information
of intellectual property ownership sections of the Employment Agreement; (ii) a material breach by the employee of any other provision
of the Employment Agreement, if such material breach (if susceptible to cure) has continued uncured for a period of at least 15 days
following delivery by Qualigen to the employee of written notice of such material breach; (iii) fraud, dishonesty or other breach of
trust whereby the employee obtains personal gain or benefit at the expense of or to the detriment of Qualigen or any of Qualigen’s
subsidiaries or affiliates; (iv) a conviction of or plea of nolo contendere or similar plea by the employee of any felony; (v) a conviction
of or plea of nolo contendere or similar plea by of any other crime involving theft, misappropriation of property, dishonesty or moral
turpitude; (vi) a willful and material violation of applicable law by the employee in connection with the performance of his/her duties
under the Employment Agreement; (vii) chronic or repeated substance abuse by the employee, or any other use by the employee of alcohol,
drugs or illegal substances in such a manner as to interfere with the performance of his/her material duties hereunder; or (viii) failure
to comply with the lawful directions of Qualigen’s board of directors which are otherwise consistent with the terms of this Agreement,
which failure has continued for a period of at least 10 days after delivery by Qualigen to the employee of written demand by Qualigen’s
board of directors.
76
“Good
Reason” means the occurrence of any of the following circumstances, without the employee’s express consent: the employee
resigns due to (i) a material reduction of the employee’s title or authority, (ii) a material reduction in the employee’s
salary or benefits (other than a reduction that generally applies to the officers at the employee’s level in Qualigen or, as applicable,
after a transaction in which Qualigen or substantially all its assets is acquired, in the successor entity at that time), (iii) any material
breach of this Agreement by Qualigen which is not cured within 30 days after written notice by the employee; or (iv) a change of the
principal non-temporary location in which the employee is required to perform the employee’s services to any location exceeding
35 miles from Carlsbad, California. In no event shall a resignation be considered to be with Good Reason unless the resignation occurs
after but within 30 days after the initiation of the item of Good Reason.
The
foregoing description of the employment agreements does not purport to be complete and is qualified in its entirety by reference to the
employment agreements.
Offer Letter with Tariq Arshad
Under the terms of his offer letter
with the Company, dated May 17, 2021, Dr. Arshad is 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, is 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 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 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. Arshad’s annual base salary was reduced to $320,000.
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 filed as an exhibit to the Original Report and
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;
● 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.
77
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.
78
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.
79
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 $1 million limit on the amount that a public company may deduct for compensation paid
to an employee who is chief executive officer, chief financial officer, or another “covered employee” (as defined by Section
162(m)), or was such an employee beginning in any year after 2017. The Compensation Committee retains the discretion to establish the
compensation paid or intended to be paid or awarded to the executive officers as the Compensation Committee may determine is in the best
interest of us and our stockholders, and without regard to any limitation provided in Section 162(m). This discretion is an important
feature of the Compensation Committee’s compensation practices because it provides the Compensation Committee with sufficient flexibility
to respond to specific circumstances facing us.
Outstanding
Equity Awards at December 31, 2022
The
following table presents the outstanding stock options and compensatory warrants held by each of the named executive officers as of December
31, 2022. There were no direct stock awards, restricted stock units or stock appreciation rights outstanding at December 31, 2022. All
pre-2020 “option” awards shown were initially issued as Qualigen, Inc. Series C Warrants, and became warrants exercisable
instead for our common stock (at an adjusted exercise price) upon the Reverse Recapitalization Transaction. The share numbers and exercise
prices in the table below reflect the reverse stock split, which was effected by the Company on November 23, 2022 (the “Reverse
Stock Split”).
Equity Awards
Name
Grant
Date
Number of
Securities
Underlying
Unexercised
Awards
(#)
Exercisable
Number of
Securities
Underlying
Unexercised
Awards
(#)
Unexercisable
Exercise
Price
($)
Expiration
Date
Michael Poirier
7/11/2022
—
37,500 (1)
5.14
7/11/2032
6/5/2020
66,667
33,333 (1)
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
770
—
20.66
8/2/2024
8/2/2014
2,214
—
20.66
8/2/2024
1/31/2014
2,214
—
20.66
1/31/2024
Amy Broidrick
7/11/2022
—
13,000 (1)
5.14
7/11/2032
12/8/2021
10,000
20,000 (1)
12.40
12/8/2031
12/7/2020
10,000
5,000 (1)
35.20
12/7/2030
8/27/2020
3,333
1,666 (1)
47.00
8/27/2030
Tariq Arshad
7/11/2022
—
10,200 (1)
5.14
7/11/2032
12/8/2021
10,000
20,000 (2)
12.40
5/17/2031
5/17/2021
3,333
6,666 (1)
18.00
5/17/2031
(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.
80
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 PEO and NEOs for each of the fiscal years ended December 31, 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
Pa y
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, 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)
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 )
81
The principal executive officer
(“PEO”) in 2022 and 2021 is Michael Poirier, our Chairman and Chief Executive Officer. The Non-PEO NEOs in 2022 and 2021 are
Amy Broidrick, our President, Chief Strategy and Operating Officer and Tariq Arshad, 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
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
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 103%, 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%.
Analysis
of Information Presented in the Pay versus Performance Table
The
Company’s executive compensation program reflects a variable pay-for-performance philosophy. While the Company utilizes 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, the Company generally seeks to incentivize long-term performance, and therefore does not specifically
align the Company’s performance measures with compensation that is actually paid (as computed in accordance with SEC rules) for
a particular year. In accordance with SEC rules, the Company is providing the following narrative disclosure regarding the relationships
between information presented in the Pay versus Performance table.
Compensation
Actually Paid and Cumulative Total Stockholder Return
During
2021 and 2022, compensation actually paid to our PEO increased from ($753,431) in 2021 to $262,274 in 2022 for Mr. Poirier, and average
compensation actually paid to our named executive officers other than our PEO decreased from $609,691 in 2021 to $121,235 in 2022. 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, and further decreased by $34.12 to $4.09 during 2022, for a total decrease over 2021 and 2022 of $95.91.
Compensation
Actually Paid and Net Loss
During
2021 and 2022, compensation actually paid to our PEO increased from ($753,431) in 2021 to $262,274 in 2022 for Mr. Poirier, and average
compensation actually paid to our named executive officers other than our PEO decreased from $609,691 in 2021 to $121,235 in 2022. Over
the same period, our net loss decreased by $1.6 million during 2021 (from a net loss in 2020 of $19.5 million to a net loss in 2021 of
$17.9 million), and 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).
Compensation
of Directors
For
2022 , our non-employee directors received $35,000 in cash for their services. The Audit
Committee chair received additional cash compensation of $15,000 and the other Board committee chairs received additional cash compensation
of $10,000. Each non-chair member of each Board committee received additional cash compensation of $7,500 (Audit Committee) and $5,000
(other Committees). Non-employee directors each received a grant of 4,000 stock options (adjusted for the Reverse Stock Split) during
2022.
On January 13, 2023, the Company’s
board of directors, as part of certain cost-cutting measures, approved a temporary 20% reduction to the compensation of all directors
of the Company effective January 1, 2023.
Compensation
paid to Mr. Poirier and to Ms. Broidrick is presented as part of the “Summary Compensation Table” above, rather than here.
Our employee directors do not receive compensation for their service as directors.
Name of Director
Fees Earned and
Paid in Cash
($)
Option
Awards (1)
($)
All other compensation (2)
($)
Total
($)
Richard David
54,167
15,496
—
69,663
Sidney Emery, Jr.
62,292
15,496
—
77,788
Matthew Korenberg
56,875
15,496
—
72,371
Kurt Kruger
54,167
15,496
—
69,663
Ira Ritter
—
15,496
80,000
95,496
(1) The
amounts reported in this column reflects the aggregate grant date fair value of the option
awards granted during the year ending December 31, 2022, computed in accordance with 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 our Annual
Report on Form 10-K filed with the Securities and Exchange Commission on April 17, 2023.
These amounts do not reflect the actual economic value that may be realized by the directors
upon the exercise of the stock options or the sale of the common stock underlying such stock
options.
(2) Represents
amounts paid for consulting services.
82
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
also intend to adopt a formal claw-back policy for the recovery of incentive-based executive compensation erroneously awarded to executive
officers based on misstated financial reporting measures once Nasdaq’s listing standards become effective.
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 April 28, 2023 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 April 28, 2023, 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 5,052,463 shares outstanding as of April
28, 2023.
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., 2042 Corte Del Nogal, Carlsbad, California 92011 USA.
83
Beneficial Owner
Number of Shares
Beneficially Owned
Percentage of
Common Stock
Beneficially Owned
Five Percent Stockholders
Alpha Capital Anstalt (1)
555,155
9.99 %
Executive Officers, Directors and Director Nominees
Michael Poirier (2)
96,543
1.9 %
Amy Broidrick (3)
26,784
*%
Tariq Arshad (4)
13,334
*%
Richard David (5)
4,219
*%
Sidney Emery, Jr. (6)
5,302
*%
Matthew Korenberg (7)
3,334
*%
Kurt Kruger (8)
6,019
*%
Ira Ritter (9)
3,738
*%
All current executive officers and directors as a group (9 persons)(10)
208,293
4.0 %
*
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; Alpha Capital Anstalt would
not be permitted to convert or exercise all or any portion of its warrants 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 Qualigen 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
66,667 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
23,334 shares of common stock exercisable within 60 days under outstanding stock options.
(4) Includes
13,334 shares of common stock exercisable within 60 days under outstanding stock options.
(5) Includes
3,334 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.
(6) Includes
3,334 shares of common stock exercisable within 60 days under outstanding stock options.
(7) Includes
3,334 shares of common stock exercisable within 60 days under outstanding stock options.
(8) Includes
3,334 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.
(9) Includes
3,334 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.
(10) Includes
160,005 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.
Equity
Compensation Plan Information
The
following table presents information regarding securities authorized for issuance under equity compensation plans as of December 31,
2022:
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
608,012
$ 35.02
147,690
Equity compensation plans not approved by stockholders (1)
179,046
$ 9.12
—
Total
787,058
$ 29.13
2,809,157
(1) Consists
of shares of common stock issuable upon the exercise of compensatory warrants granted to
service providers.
84
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
Capital Anstalt (“Alpha Capital”), 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 22, 2022, the Company issued to Alpha Capital, an 8% Senior Convertible Debenture (the “Debenture”) in the
aggregate principal amount of $3,300,000 for a purchase price of $3,000,000 pursuant to the terms of a Securities Purchase
Agreement, dated December 21, 2022. The Debenture is convertible, at any time, and from time to time, at Alpha’s option, into
shares of common stock of the Company, at a price equal to $1.32 per share, subject to adjustment as described in the Debenture and
other terms and conditions described in the Debenture, including the Company’s receipt of the requisite stockholder approvals.
Additionally, on December 22, 2022, the Company issued to Alpha Capital a liability classified warrant to purchase 2,500,000 shares
of the Company’s common stock (see Note 10-Warrant Liabilities to the consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K). The exercise price of the warrant is $1.65 (equal to 125% of
the conversion price of the Debenture on the closing date). The warrant may be exercised by Alpha Capital, in whole or in part, at
any time on or after June 22, 2023 and before June 22, 2028, subject to certain terms conditions described in the warrant, including
the Company’s receipt of the necessary stockholder approvals.
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 and Kruger 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 2022 or 2021.
85
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, 2022 and 2021:
2022
2021
Audit Fees(1)
$ 411,362
$ 267,020
Audit-Related Fees
—
—
Tax Fees (2)
35,050
25,175
All Other Fees
—
—
Total
$ 446,412
$ 292,195
(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, 2022 and 2021, all audit services and the corresponding fees were approved by our Audit Committee.
86
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)
38
Financial
Statements:
Consolidated Balance Sheets as of December 31, 2022 and December 31, 2021
41
Consolidated Statements of Operations and Comprehensive Loss for the Year Ended December 31, 2022 and Year Ended December 31, 2021
42
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the Year Ended December 31, 2022 and Year Ended December 31, 2021
43
Consolidated Statements of Cash Flows for the Year Ended December 31, 2022 and Year Ended December 31, 2021
44
Notes to Consolidated Financial Statements
45
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
87
EXHIBIT
INDEX
Exhibit
No.
Description
Form
File
No.
Exhibit
Filing
Date
2.1
Contingent Value Rights Agreement, dated May 22, 2020, among the Company, John Beck in the capacity of CVR Holders’ Representative and Andrew J. Ritter in his capacity as a consultant to the Company.
8-K
001-37428
2.4
5/29/2020
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, as amended.
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
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
001-37428
4.7
3/31/2020
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
10.3+
Executive Employment Agreement dated December 10, 2021 with Amy Broidrick
10-K
001-37428
10.53
3/31/2022
88
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
10.6+
Form
of Indemnification Agreement – Qualigen, Inc.
8-K
001-37428
10.21
5/29/2020
10.7
Exclusive
Agreement (QN-24), by and between Qualigen, Inc. and University of Louisville Research Foundation, Inc. dated as of June 8,
2018
S-4/A
001-37428
10.58
3/13/2020
10.8*
Amendment 1 to the Exclusive License Agreement (QN-247), by and between Qualigen, Inc. and University of Louisville Research Foundation, Inc., dated March 16, 2021
10.9*
Amendment 2 to the Exclusive License Agreement (QN-247), by and between Qualigen, Inc. and University of Louisville Research Foundation, Inc., dated January 17, 2023
10.10*
Exclusive License Agreement between the Company and University of Louisville Research Foundation (RAS), Inc., dated as of July 17, 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
10.12
License
Agreement between Qualigen, Inc. and Advanced Cancer Therapeutics, LLC dated December 17, 2018
S-4/A
001-37428
10.59
3/13/2020
10.13
Novation
Agreement among the Company, Qualigen, Inc. and Advanced Cancer Therapeutics, LLC dated July 29, 2020
10-K
001-37428
10.31
3/31/2021
10.14
Technology
Transfer Agreement dated as of October 7, 2020 between Qualigen, Inc. and Yi Xin Zhen Duan Jishu (Suzhou) Ltd.
8-K
001-37428
10.1
10/9/2020
10.15
Novation
Agreement 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
10.16
Novation
Agreement among the Company, Qualigen, Inc. and University of Louisville Research Foundation, Inc. dated March 1, 2021
10-Q
001-37428
10.2
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
10.18
Amendment
to Technology Transfer Agreement between Yi Xin Zhen Duan Jishu (Suzhou) Ltd. and Qualigen, Inc., dated August 5, 2021
10-Q
001-37428
10.2
11/15/2021
10.19
Amendment
to 2020 Stock Incentive Plan (approved by the Board of Directors on April 27, 2021 and by the Stockholders on August 9, 2021)
10-Q
001-37428
10.3
11/15/2021
10.20
Second
Amendment to Lease with Bond Ranch LP dated December 15, 2021
10-K
001-37428
10.54
3/31/2022
10.21*
First Deed of Variation to License Agreement with UCL Business Limited dated March 30, 2022
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
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
89
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
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 P. Poirier, dated January 13, 2023, regarding compensatory changes
10.32+*
Letter to Amy Broidrick, dated January 13, 2023, regarding compensatory changes
10.33+*
Letter to Tariq Arshad, dated January 13, 2023, regarding compensatory changes
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)
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.
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.
90
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
Michael
S. Poirier
Chairman
of the Board, Chief Executive Officer
Date:
May 2, 2023
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
May 2, 2023
Michael
S. Poirier
(Principal
Executive Officer)
/s/
Christopher L. Lotz
Vice
President of Finance, Chief Financial Officer
May 2, 2023
Christopher
L. Lotz
(Principal
Financial and Accounting Officer)
/s/
Amy S. Broidrick
President, Chief Strategy and Operating Officer
May 2, 2023
Amy
S. Broidrick
/s/
Richard A. David
Director
May 2, 2023
Richard
A. David
/s/
Sidney W. Emery, Jr.
Director
May 2, 2023
Sidney
W. Emery, Jr.
/s/
Matthew E. Korenberg
Director
May 2, 2023
Matthew
E. Korenberg
/s/
Kurt H. Kruger
Director
May 2, 2023
Kurt
H. Kruger
/s/
Ira E. Ritter
Director
May 2, 2023
Ira
E. Ritter
91