What changed in this filing

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Item 9A. Controls and Procedures

2023-05-02 compared with 2022-03-31 · 850 added, 165 removed, 116 unchanged (90% of the section changed)

4 unchanged sentences

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, 2021, our disclosure controls and procedures were not effective

due to the newly identified 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.

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.

Report on Internal Control over Financial Reporting

1 unchanged sentence

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

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

2 unchanged sentences

set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework.

material weakness described below, our management concluded that as of December 31, 2021, our internal control over financial

reporting was not effective.

the continuing material weakness described below, our management concluded that as of December 31, 2022, our internal control over

financial reporting was not effective.

of Material Weakness

connection with the audit of our financial statements as of and for the year ended December 31, 2021, 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.

This material weakness resulted in adjustments to our warrant valuations.

We have evaluated and implemented

additional procedures in order to remediate this material weakness, i ncluding 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.

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.

In response to this material

weakness, we continue to take 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.

Changes in Internal Control over Financial

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 quarter ended December 31, 2021 that materially affected, or are reasonably likely to materially affect, our internal

control over financial reporting.

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.

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.

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

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.

in Internal Control over Financial Reporting

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.

on Effectiveness of Controls

15 unchanged sentences

Directors, Executive Officers and Corporate Governance.

have adopted a code of business conduct and ethics, which we refer to as the Code of Ethics.

Our Code of Ethics is designed to meet the

requirements of Section 406 of Regulation S-K and the rules promulgated thereunder.

We will promptly disclose on our website (i) the

nature of any amendment to this Code of Ethics that applies to any covered person, and (ii) the nature of any waiver, including an implicit

waiver, from a provision of this Code of Ethics that is granted to one of the covered persons.

The Code of Ethics is available on our

website at www.qualigeninc.com under the Investors section of the website.

However, the information contained on or accessed through

our website does not constitute part of this Annual Report, and references to our website address in this Annual Report are inactive

textual references only.

other information required by this item will be set forth in the sections of our proxy statement for the 2022 annual meeting

of stockholders (the “Proxy Statement”) titled “Board of Directors and Corporate Governance –The Board

of Directors in General,” “Executive Officers,” and “Board of Directors and Corporate Governance – Committees

of the Board of Directors – Audit Committee” (or similarly titled sections), or an amendment to this Annual Report on

Form 10-K (this “Annual Report”), and is incorporated herein by reference.

The Proxy Statement will be filed with

the SEC not later than 120 days after the close of our fiscal year ended December 31, 2021.

Board of Directors

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.

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.

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.

Position with the Company

Director Since

Michael Poirier

Chairman and Chief Executive Officer

Amy Broidrick

President, Chief Strategy Officer and Director

Richard David

Sidney Emery, Jr.

Matthew Korenberg

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.

Poirier holds a B.A.

from Providence College and attended the University of Zürich, Switzerland, School of Law.

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.

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

From 2016 to July 2020, Ms.

Broidrick served as Senior Vice President, Global Head of Corporate Development of Viking Therapeutics,

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.

Searle & Company.

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.

David, MD FACS .

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.

obtained his undergraduate education at Stanford University and his medical degree at Thomas Jefferson University in Philadelphia.

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.

David is a fellow of the

American College of Surgeons.

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.

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

MTSC), a leading global supplier of mechanical testing systems and high-performance industrial position sensors.

Emery served on the Board of Directors of Allete, Inc.

ALE), a Minnesota-based utilities and energy company, from 2006 to

Emery chairs the University of St.

Thomas School of Engineering Board of Governors.

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).

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.

Korenberg has served as President and Chief Operating Officer of Ligand Pharmaceuticals Incorporated (Nasdaq:

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.

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.

where he spent two

years working with healthcare companies in the biotechnology and pharmaceutical sectors and industrial companies.

Korenberg holds

in Finance and Accounting from the University of Michigan.

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

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.

Kruger received

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.

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.

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.

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.

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.

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.

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.

of the Board of Directors

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 .

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.”

following table sets forth information about our current executive officers.

with the Company

and Chief Executive Officer

and Chief Strategy Officer

Financial Officer, Vice President of Finance

Medical Officer and Senior Vice President

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

the biographies of Mr.

Poirier and Ms.

Broidrick, please see “Board of Directors - The Board of Directors in General”.

Lotz | Chief Financial Officer, Vice President of Finance.

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

Lotz holds a B.S.

in Business Administration from Colorado State University.

Tariq Arshad, MD, MBA |

Chief Medical Officer and Senior Vice President.

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,

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.

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

degree from George Washington University.

Section 16(a) Reports

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.

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.

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).

Executive Compensation.

information required by this item will be set forth in the section of our Proxy Statement titled “Executive and Director

Compensation” (or a similarly titled section), or in an amendment to this Annual Report, and is incorporated herein by reference.

AND DIRECTOR COMPENSATION

Compensation Table (2022 and 2021)

following table sets forth the compensation paid to or earned by our named executive officers for the periods presented.

Name and Principal Position

Option Awards (1)

All Other Compensation (2)

Michael Poirier, Chairman and Chief Executive Officer

Amy Broidrick, President and Chief Strategy Officer

Tariq Arshad, Chief Medical Officer and Senior Vice President (3)

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

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.

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.

Arshad joined Qualigen in May 2021.

Employment Agreements

Agreement with Michael Poirier

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.

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.

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.

Agreement with Amy Broidrick

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.

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.

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,

Broidrick’s base salary was reduced to $360,000.

following definitions are used in each of the Employment Agreements described above:

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

(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.

Reason” means the occurrence of any of the following circumstances, without the employee’s express consent:

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.

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.

Incentive Plan

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.

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:

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;

subject to awards granted under the 2020 Plan that are subsequently forfeited or repurchased

by us at the original issue price;

subject to awards granted under the 2020 Plan that otherwise terminate without shares being

surrendered, canceled, or exchanged for cash or a different award (or combination thereof);

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.

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.

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.

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

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.

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.

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.

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.

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 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 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

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.

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.

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.

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.

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.

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

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.

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.

Participant generally will not recognize income upon the grant of a stock appreciation right or a restricted stock unit.

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.

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.

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.

Equity Awards at December 31, 2022

following table presents the outstanding stock options and compensatory warrants held by each of the named executive officers as of December

There were no direct stock awards, restricted stock units or stock appreciation rights outstanding at December 31, 2022.

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

Unexercisable

Michael Poirier

Amy Broidrick

underlying the stock option vest over three years in three equal annual installments from

the date of grant.

underlying the stock option vest over three years in three equal annual installments from

the vesting commencement date of May 17, 2021.

Versus Performance (PVP)

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.

versus Performance Table - Compensation Definitions

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

date fair value of stock awards granted during the year

value of stock awards that are unvested as of the end of the year, or vested during the year

Versus Performance Table

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:

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.

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:

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

Average Non-PEO NEO

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%.

of Information Presented in the Pay versus Performance Table

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.

Actually Paid and Cumulative Total Stockholder Return

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.

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.

Actually Paid and Net Loss

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.

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).

2022 , our non-employee directors received $35,000 in cash for their services.

Committee chair received additional cash compensation of $15,000 and the other Board committee chairs received additional cash compensation

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

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.

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

All other compensation (2)

Richard David

Sidney Emery, Jr.

Matthew Korenberg

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

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

(2) Represents

amounts paid for consulting services.

or Offsetting Against Compensatory Securities

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.

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.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

information required by this item will be set forth in the sections of our Proxy Statement titled “Equity Compensation

Plans” and “Ownership of the Company – Security Ownership of Certain Beneficial Owners and Management” (or similarly

titled sections), or in an amendment to this Annual Report, and is incorporated herein by reference.

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;

each stockholder known by us to own beneficially more than 5% of our common stock.

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.

percentage of beneficial ownership of our common stock is calculated based on an aggregate of 5,052,463 shares outstanding as of April

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.

Beneficial Owner

Number of Shares

Beneficially Owned

Percentage of

Beneficially Owned

Five Percent Stockholders

Alpha Capital Anstalt (1)

Executive Officers, Directors and Director Nominees

Michael Poirier (2)

Amy Broidrick (3)

Tariq Arshad (4)

Richard David (5)

Sidney Emery, Jr.

Matthew Korenberg (7)

Kurt Kruger (8)

Ira Ritter (9)

All current executive officers and directors as a group (9 persons)(10)

Represents beneficial ownership of less than 1% of the shares of common stock.

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.

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.

23,334 shares of common stock exercisable within 60 days under outstanding stock options.

13,334 shares of common stock exercisable within 60 days under outstanding stock options.

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.

3,334 shares of common stock exercisable within 60 days under outstanding stock options.

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.

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.

Compensation Plan Information

following table presents information regarding securities authorized for issuance under equity compensation plans as of December 31,

Plan Category

Number of Securities

to be Issued upon

Options, Warrants and Rights

Weighted-Average

Exercise Price of Outstanding

Options, Warrants and Rights

Number of Securities

Remaining Available

for Future Issuance

Compensation Plans

(excluding securities

Equity compensation plans approved by stockholders

Equity compensation plans not approved by stockholders (1)

of shares of common stock issuable upon the exercise of compensatory warrants granted to

service providers.

Certain Relationships and Related Transactions, and Director Independence.

information required by this item will be set forth in the sections of our Proxy Statement titled “Board of Directors

and Corporate Governance – Certain Relationships and Related Party Transactions” and “- Director Independence”

(or similarly titled sections), or in an amendment to this Annual Report, and is incorporated herein by reference.

Relationships and Related Party Transactions

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.

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.

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.

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.

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.

Principal Accounting Fees and Services.

information required by this item will be set forth in the section of our Proxy Statement titled “Relationship with Independent

Registered Public Accounting Firm – Fees and Services of Baker Tilly US, LLP” (or a similarly titled section), or

in an amendment to this Annual Report, and is incorporated herein by reference.

Tilly US, LLP (“Baker Tilly”) serves as the Company’s independent registered public accounting firm and has served

in that capacity since June 2018.

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.

and Services of Baker Tilly US, LLP

following table sets forth the aggregate fees billed to the Company by Baker Tilly for the years ended December 31, 2022 and 2021:

Audit Fees(1)

Audit-Related Fees

All Other Fees

fees consisted of fees for audit work performed in the audit of financial statements, as

well as fees for quarterly reviews and registration statements.

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

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.

the years ended December 31, 2022 and 2021, all audit services and the corresponding fees were approved by our Audit Committee.

Exhibits and Financial Statement Schedules

4 unchanged sentences

Consolidated Balance Sheets as of December 31, 2022 and December 31, 2021

Consolidated Statements of Operations for the Year Ended December 31, 2021 and Nine Months Ended December 31, 2020

Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the Year Ended December 31, 2021 and Nine Months Ended December 31, 2020

Consolidated Statements of Cash Flows for the Year Ended December 31, 2021 and Nine Months Ended December 31, 2020

Consolidated Statements of Operations and Comprehensive Loss for the Year Ended December 31, 2022 and Year Ended December 31, 2021

Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the Year Ended December 31, 2022 and Year Ended December 31, 2021

Consolidated Statements of Cash Flows for the Year Ended December 31, 2022 and Year Ended December 31, 2021

Notes to Consolidated Financial Statements

3 unchanged sentences

See EXHIBIT INDEX

Agreement and Plan of Merger, among Ritter Pharmaceuticals, Inc., RPG28 Merger Sub, Inc.

and Qualigen, Inc., dated January 15, 2020

Amendment No.

1 to Agreement and Plan of Merger among Ritter Pharmaceuticals, Inc., RPG28 Merger Sub, Inc.

and Qualigen, Inc., dated February 1, 2020

Amendment No.

2 to Agreement and Plan of Merger among Ritter Pharmaceuticals, Inc., RPG28 Merger Sub, Inc.

and Qualigen, Inc., dated March 26, 2020

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.

Amended and Restated Certificate of Incorporation of Ritter Pharmaceuticals, Inc.

Certificate of Amendment to the Amended and Restated Certificate of Incorporation

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 20, 2020

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]

and Restated Certificate of Incorporation of Ritter Pharmaceuticals, Inc.

of Amendment to the Amended and Restated Certificate of Incorporation

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

of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020 [reverse stock split]

Certificate of Merger, filed with the Delaware Secretary of State on May 22, 2020

Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020

Amended and Restated Bylaws of the Company, as of August 10, 2021

Certificate of Designation of Preferences, Rights and Limitations of Series Alpha Preferred Stock of Qualigen, filed with the Delaware Secretary of State on May 22, 2020

Warrant Agency Agreement between Ritter Pharmaceuticals, Inc.

and Corporate Stock Transfer, Inc.

and Form of Warrant Certificate

First Amendment to Warrant Agency Agreement between Ritter Pharmaceuticals, Inc.

and Corporate Stock Transfer, Inc.

Second Amendment to Warrant Agency Agreement between the Company and Equiniti Group plc, dated November 9, 2020

and Restated Bylaws of the Company, as of August 10, 2021

Certificate of Amendment to the Amended and Restated Certificate of Incorporation, as amended.

Warrant, issued by the Company in favor of Alpha Capital Anstalt, dated May 22, 2020

Form of Warrant, issued by the Company in favor of GreenBlock Capital LLC and its designees, dated May 22, 2020 [post-Merger]

Common Stock Purchase Warrant for 1,920,768 shares in favor of Alpha Capital Anstalt, dated July 10, 2020

Pre-Funded Common Stock Purchase Warrant for 1,920,768 shares in favor of Alpha Capital Anstalt, dated July 10, 2020

Common Stock Purchase Warrant for 1,287,829 shares in favor of Alpha Capital Anstalt, dated August 4, 2020

Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated July 10, 2020

Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated August 4, 2020

“Two-Year” Common Stock Purchase Warrant for 1,348,314 shares in favor of Alpha Capital Anstalt, dated December 18, 2020

“Deferred” Common Stock Purchase Warrant for 842,696 shares in favor of Alpha Capital Anstalt, dated December 18, 2020

“Prefunded” Common Stock Purchase Warrant for 1,000,000 shares in favor of Alpha Capital Anstalt, dated December 18, 2020

Form of liability classified Warrant to Purchase Common Stock (“exploding warrant”)

Form of “service provider” (non-”exploding”) compensatory equity classified Warrant

“Deferred” Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated December 18, 2020

of liability classified Warrant to Purchase Common Stock

of “service provider” compensatory equity classified Warrant

Description of Common Stock

Amended and Restated Common Stock Purchase Warrant to GreenBlock Capital LLC, dated April 25, 2022

and Restated Common Stock Purchase Warrant to Christopher Nelson, dated April 25, 2022

Stock Purchase Warrant for 2,500,000 shares in favor of Alpha Capital Anstalt, dated December 22, 2022

Executive Employment Agreement, by and between Qualigen, Inc.

2 unchanged sentences

and Christopher Lotz, dated as of February 1, 2017 and as amended on January 9, 2018

Executive Employment Agreement, by and between Qualigen, Inc.

and Shishir Sinha, dated as of February 1, 2017 and as amended on January 9, 2018

2015 Equity Incentive Plan

Amendment to 2015 Equity Incentive Plan

Second Amendment to 2015 Equity Incentive Plan

Third Amendment to 2015 Equity Incentive Plan

Form of Notice of Grant of Stock Option under the 2015 Equity Incentive Plan

Executive Employment Agreement dated December 10, 2021 with Amy Broidrick

Stock Equity Incentive Plan

Standard template of Stock Option Agreement for use under 2020 Stock Incentive Plan

Amended and Restated Common Stock Purchase Agreement, between Ritter Pharmaceuticals, Inc.

and Aspire Capital Fund, LLC, dated July 23, 2019

Form of Agreement to Exchange Warrants

Consulting Agreement, by and between Qualigen, Inc.

and GreenBlock Capital LLC, dated as of August 22, 2018

Amendment to Consulting Agreement, by and between Qualigen, Inc.

and GreenBlock Capital LLC, dated as of March 6, 2020

Amendment No.

2 to Consulting Agreement, between Qualigen, Inc.

and GreenBlock Capital LLC, dated as of May 3, 2020

Securities Purchase Agreement, between Qualigen, Inc.

and Alpha Capital Anstalt, dated May 20, 2020

Notice of Grant of Stock Option / Stock Option Agreement, between the Company and Andrew J.

Ritter, dated as of May 18, 2020

Notice of Grant of Stock Option / Stock Option Agreement, between the Company and Ira E.

Ritter, dated as of May 18, 2020

Notice of Grant of Stock Option / Stock Option Agreement, between the Company and John Beck, dated as of May 18, 2020

Consulting Agreement, between the Company and Andrew J.

Ritter, dated as of May 22, 2020

Consulting Agreement, between the Company and Stonehenge Partners, LLC, dated as of May 22, 2020

Consulting Agreement, between the Company and CFB Financial, Inc., dated as of May 22, 2020

Form of Indemnification Agreement – Qualigen, Inc.

Letter agreement amending M&A Advisory Agreement between the Company and A.G.P./Alliance Global Partners dated May 20, 2020

Exclusive Agreement, by and between Qualigen, Inc.

template of Stock Option Agreement for use under 2020 Stock Incentive Plan

of Indemnification Agreement – Qualigen, Inc.

Agreement (QN-24), by and between Qualigen, Inc.

and University of Louisville Research Foundation, Inc.

dated as of June 8,

Exclusive License Agreement, between the Company and University of Louisville Research Foundation, Inc.

dated as of June 9, 2020

Exclusive License Agreement between the Company and University of Louisville Research Foundation, Inc., dated as of July 17, 2020

License Agreement between Qualigen, Inc.

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

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

Exclusive License Agreement between the Company and University of Louisville Research Foundation (RAS), Inc., dated as of July 17, 2020

Amendment 1 to the Exclusive License Agreement (RAS), by and between Qualigen, Inc.

and University of Louisville Research Foundation, Inc., dated March 16, 2021

Agreement between Qualigen, Inc.

and Advanced Cancer Therapeutics, LLC dated December 17, 2018

Novation Agreement among the Company, Qualigen, Inc.

Agreement among the Company, Qualigen, Inc.

and Advanced Cancer Therapeutics, LLC dated July 29, 2020

Distribution and Development Agreement, dated May 1, 2016, by and between Sekisui Diagnostics, LLC and its Affiliates, and Qualigen, Inc.

and its Affiliates

Letter of Intent, dated March 16, 2018, by and between Sekisui Diagnostics, LLC and Qualigen, Inc.

Amendment to Distribution and Development Agreement, dated April 2, 2018, by and between Sekisui Diagnostics, LLC and Qualigen, Inc.

Amendment to Letter of Intent, dated December 6, 2019, by and between Sekisui Diagnostics, LLC and Qualigen, Inc.

Amended and Restated Letter of Intent, dated August 22, 2018, by and between Sekisui Diagnostics, LLC and Qualigen, Inc.

Letter agreement (for payment date extension) between the Company and Sekisui Diagnostics, LLC dated June 23,2020

Securities Purchase Agreement between the Company and Alpha Capital Anstalt, dated July 8, 2020 [corrected]

Placement Agency Agreement between the Company and A.G.P./Alliance Global Partners, dated July 8, 2020

Securities Purchase Agreement between the Company and Alpha Capital Anstalt, dated August 2, 2020

Placement Agency Agreement between the Company and A.G.P./Alliance Global Partners, dated August 2, 2020

Technology Transfer Agreement dated as of October 7, 2020 between Qualigen, Inc.

Transfer Agreement dated as of October 7, 2020 between Qualigen, Inc.

and Yi Xin Zhen Duan Jishu (Suzhou) Ltd.

Securities Purchase Agreement between the Company and Alpha Capital Anstalt, dated December 16, 2020

Placement Agency Agreement between Qualigen Therapeutics, Inc.

and A.G.P./Alliance Global Partners, dated December 15, 2020

Agreement among the Company, Qualigen, Inc.

4 unchanged sentences

dated March 1, 2021

to Distribution and Development Agreement between Sekisui Diagnostics, LLC and Qualigen, Inc., dated as of July 1, 2021 [signed August

offer letter from the Company to Tariq Arshad, dated April 22, 2021

to Distribution and Development Agreement between Sekisui Diagnostics, LLC and Qualigen, Inc., dated as of July 1, 2021 [signed August

to Technology Transfer Agreement between Yi Xin Zhen Duan Jishu (Suzhou) Ltd.

1 unchanged sentence

to 2020 Stock Incentive Plan (approved by the Board of Directors on April 27, 2021 and by the Stockholders on August 9, 2021)

of) Securities Purchase Agreement, dated November 29, 2021.

Agency Agreement between Qualigen Therapeutics, Inc.

and A.G.P./Alliance Global Partners, dated November 29, 2021.

and Amendment between Qualigen Therapeutics, Inc.

and Alpha Capital Anstalt, dated November 29, 2021.

Employment Agreement dated December 10, 2021 with Amy Broidrick

Amendment to Lease with Bond Ranch LP dated December 15, 2021

Agreement with UCL Business Limited dated January 13, 2022

Code of Business Conduct and Ethics

First Deed of Variation to License Agreement with UCL Business Limited dated March 30, 2022

B Preferred Share Purchase Agreement between the Company and NanoSynex Ltd.

dated April 29, 2022

Purchase Agreement between the Company and Alpha Capital Anstalt dated April 29, 2022

Agreement for the Operational and Technological Funding of NanoSynex between Qualigen Therapeutics, Inc.

and NanoSynex Ltd., dated

Therapeutics, Inc.

2022 Employee Stock Purchase Plan

2 to the 2020 Stock Incentive Plan of Qualigen Therapeutics, Inc.

1 to the 2022 Employee Stock Purchase Plan of Qualigen Therapeutics, Inc.

Purchase Agreement, dated December 21, 2022, by and between Qualigen Therapeutics, Inc.

and Alpha Capital Anstalt

Senior Convertible Debenture Due December 22, 2025

Rights Agreement, dated December 22, 2022, by and between Qualigen Therapeutics, Inc.

and Alpha Capital Anstalt

Letter to Michael P.

Poirier, dated January 13, 2023, regarding compensatory changes

Letter to Amy Broidrick, dated January 13, 2023, regarding compensatory changes

Letter to Tariq Arshad, dated January 13, 2023, regarding compensatory changes

of Business Conduct and Ethics

of the Registrant

22 unchanged sentences

Form 10-K Summary

Not applicable.

to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Annual Report

1 unchanged sentence

Therapeutics, Inc.

of the Board, Chief Executive Officer and President

March 31, 2022

of the Board, Chief Executive Officer

ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Michael S.

9 unchanged sentences

of the Registrant and in the capacities and on the dates indicated.

of the Board, Chief Executive Officer and President

of the Board, Chief Executive Officer

Executive Officer)

2 unchanged sentences

Financial and Accounting Officer)

March 31, 2022

President, Chief Strategy and Operating Officer

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures