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Item 9A. Controls and Procedures

2022-03-31 compared with 2020-03-31 · 249 added, 1167 removed, 32 unchanged (98% of the section changed)

1 unchanged sentence

of Disclosure Controls and Procedures

management, with the participation of our chief executive officer (our principal executive officer) and chief financial officer

(our principal financial officer), evaluated the effectiveness of our disclosures controls and procedures, as defined in Rules

13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended (the “Exchange Act”), as of December 31, 2019.

The term “disclosure controls and procedures,”

as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act,

means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company

in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time

periods specified in the SEC’s rules and forms.

Disclosure controls and procedures include, without limitation, controls

and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits

under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and

principal financial officers, as appropriate, to allow timely decisions regarding required disclosure.

recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of

achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible

controls and procedures.

Based on the evaluation of our disclosure controls and procedures as of December 31, 2019, our principal

executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were

effective at a reasonable assurance level.

Management’s

Annual Report on Internal Control Over Financial Reporting

control over financial reporting refers to the process designed by, or under the supervision of, our chief executive officer and

chief financial officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance

regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance

with generally accepted accounting principles.

Internal control over financial reporting includes those policies and procedures

(1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions

of our assets;

(2) provide a reasonable assurance that transactions are recorded as necessary to permit preparation of financial

statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made

in accordance with authorizations of our management and directors;

and (3) provide reasonable assurance regarding prevention or

timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect

on the financial statements.

control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its

inherent limitation.

Internal control over financial reporting is a process that involves human diligence and compliance and is

subject to lapses in judgement and breakdowns resulting from human failures.

Internal control over financial reporting also can

be circumvented by collusion or improper management override.

Because of such limitations, there is a risk that material misstatements

may not be prevented or detected on a timely basis by internal control over financial reporting.

However, these inherent limitations

are known features of the financial reporting process.

Therefore, it is possible to design into the process safeguards to reduce,

though not eliminate, this risk.

is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined

in Rule 13a-15(f) under the Exchange Act.

Under the supervision and with the participation of our management, including our chief

executive officer and chief financial officer, we conducted an evaluation of the effectiveness of our internal control over financial

Management has used the framework set forth in the report entitled “Internal Control –

Integrated Framework”

published by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of our internal

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,

2021, 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.

Report on Internal Control over Financial Reporting

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.

of December 31, 2021, 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.

material weakness described below, our management concluded that as of December 31, 2021, 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.

Based on its evaluation, management has concluded that our internal control over financial reporting

was effective as of December 31, 2019, the end of our most recent fiscal year.

in Internal Control over Financial Reporting

regularly review our system of internal control over financial reporting and make changes to our processes and systems to improve

controls and increase efficiency, while ensuring that we maintain an effective internal control environment.

Changes may include

such activities as implementing new, more efficient systems, consolidating activities, and migrating processes.

There were no

changes in our internal control over financial reporting that occurred during our last fiscal quarter that have materially affected,

or are reasonably likely to materially affect, our internal control over financial reporting.

on Effectiveness of Controls

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.

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.

of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Other Information.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Directors, Executive Officers and Corporate Governance.

required by this item will be contained in our Definitive Proxy Statement for our 2020 Annual Meeting of Stockholders,

to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2019.

information is incorporated herein by reference.

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.

Executive Compensation.

required by this item will be contained in our Definitive Proxy Statement for our 2020 Annual Meeting of Stockholders,

to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2019.

information is incorporated herein by reference.

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.

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

required by this item will be contained in our Definitive Proxy Statement for our 2020 Annual Meeting of Stockholders,

to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2019.

information is incorporated herein by reference.

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.

Certain Relationships and Related Transactions, and Director Independence.

required by this item will be contained in our Definitive Proxy Statement for our 2020 Annual Meeting of Stockholders,

to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2019.

information is incorporated herein by reference.

Principal Accountant Fees and Services

required by this item will be contained in our Definitive Proxy Statement for our 2020 Annual Meeting of Stockholders,

to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2019.

information is incorporated herein by reference.

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.

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.

Exhibits and Financial Statement Schedules

The following documents are filed as part of this Annual Report:

Financial Statements.

following financial statements of Ritter Pharmaceuticals, Inc., together with the report thereon of Mayer Hoffman McCann P.C.,

an independent registered public accounting firm, are included in this Annual Report on Form 10-K:

of Independent Registered Public Accounting Firm

Sheets as of December 31, 2019 and 2018

of Operations and Comprehensive Loss for the years ended December 31, 2019 and 2018

of Changes in Stockholders’

Equity for the years ended December 31, 2019 and 2018

of Cash Flows for the years ended December 31, 2019 and 2018

to Financial Statements

The following documents are included in Part II, Item 8 of this Annual Report and are incorporated by reference

Report of Independent Registered Public Accounting Firm (PCAOB ID 23 )

Consolidated Balance Sheets as of December 31, 2021 and December 31, 2020

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

Notes to Consolidated Financial Statements

Financial Statement Schedules.

schedules have been omitted because they are not required or because the required information is given in the Financial Statements

or Notes thereto set forth under Item 8 above.

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

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.

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 by and among Ritter Pharmaceuticals, Inc., RPG28 Merger Sub, Inc.

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

and Qualigen, Inc., dated February 1, 2020

and Restated Certificate of Incorporation of Ritter Pharmaceuticals, Inc.

of Amendment to the Amended and Restated Certificate of Incorporation

and Restated Bylaws of Ritter Pharmaceuticals, Inc.

of Designation of Series A Convertible Preferred Stock

of Designation of Series B Convertible Preferred Stock

of Designation of Series C Convertible Preferred Stock

of Common Stock Certificate of Ritter Pharmaceuticals, Inc.

of Common Stock Purchase Warrant

of Representative’s Warrant Agreement

Agency Agreement by and between Ritter Pharmaceuticals, Inc.

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]

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

Amendment to Warrant Agency Agreement by and between Ritter Pharmaceuticals, Inc.

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

and Corporate Stock Transfer, Inc.

Rights Agreement, by and among Ritter Pharmaceuticals, Inc.

and the Purchasers signatory thereto, dated October 30, 2018

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

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

“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

Description of Common Stock

Compensation Plan

Executive Employment Agreement, by and between Qualigen, Inc.

and Michael Poirier, dated as of February 1, 2017 and as amended on January 9, 2018

Executive Employment Agreement, by and between Qualigen, Inc.

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

to 2015 Equity Incentive Plan

Amendment to 2015 Equity Incentive Plan

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

Form of Performance Restricted Stock Unit Award Agreement

Option Agreement, dated September 25, 2013, by and between Ritter Pharmaceuticals, Inc.

and Andrew J.

Option Agreement, dated December 2, 2014, by and between Ritter Pharmaceuticals, Inc.

and Andrew J.

Option Agreement, dated December 2, 2014, by and between Ritter Pharmaceuticals, Inc.

and Andrew J.

Option Agreement, dated September 25, 2013, by and between Ritter Pharmaceuticals, Inc.

Option Agreement, dated December 2, 2014, by and between Ritter Pharmaceuticals, Inc.

and Development Agreement & License, dated November 30, 2010, by and among Kolu Pohaku Technologies, LLC, Kolu Pohaku

Management, LLC and Ritter Pharmaceuticals, Inc.

1 to Research and Development Agreement & License, dated July 6, 2011, by and among Kolu Pohaku Technologies, LLC,

Kolu Pohaku Management, LLC and Ritter Pharmaceuticals, Inc.

2 to Research and Development Agreement & License, dated September 30, 2011, by and among Kolu Pohaku Technologies,

LLC, Kolu Pohaku Management, LLC and Ritter Pharmaceuticals, Inc.

3 to Research and Development Agreement & License, dated February 6, 2012, by and among Kolu Pohaku Technologies,

LLC, Kolu Pohaku Management, LLC and Ritter Pharmaceuticals, Inc.

4 to Research and Development Agreement & License, dated November 4, 2013, by and among Kolu Pohaku Technologies,

LLC, Kolu Pohaku Management, LLC and Ritter Pharmaceuticals, Inc.

and Call Option Agreement, dated November 30, 2010, by and between Kolu Pohaku Technologies, LLC and Ritter Pharmaceuticals,

of Indemnification Agreement between Ritter Pharmaceuticals, Inc.

and each of its directors and executive officers

Supply and Operation Agreement, dated December 16, 2009, by and among Ritter Pharmaceuticals, Inc.

and Ricerche Sperimentali

Montale SpA and Inalco SpA

1 to the Clinical Supply and Cooperation Agreement, dated September 25, 2010, by and among Ritter Pharmaceuticals, Inc.

Ricerche Sperimentali Montale SpA and Inalco SpA

and Restated Offer Letter, by and between Ritter Pharmaceuticals, Inc.

and Andrew J.

Letter, by and between Ritter Pharmaceuticals, Inc.

Severance & Change in Control Agreement, by and between Ritter Pharmaceuticals, Inc.

and Andrew J.

Severance & Change in Control Agreement, by and between Ritter Pharmaceuticals, Inc.

Agreement, dated July 9, 2015, between the Company and Century Park

of Agreement, dated October 20, 2015 between Ritter Pharmaceuticals, Inc.

and Chord Advisors, LLC

and Restated Master Services Agreement, dated May 1, 2018, by and between Ritter Pharmaceuticals, Inc.

and Medpace, Inc.

Letter with John W.

Beck, dated May 23, 2018

Executive Severance and Change in Control Agreement, by and between Ritter Pharmaceuticals, Inc.

Beck, effective May 24, 2018

Purchase Agreement, by and among Ritter Pharmaceuticals, Inc.

and the Purchasers signatory thereto, dated October 30, 2018

of Common Stock Purchase Warrant

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

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

2020 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

Amendment to Employment Salary Terms, by and between Ritter Pharmaceuticals, Inc.

and Andrew Ritter dated October 15, 2019

Amendment to Employment Salary Terms, by and between Ritter Pharmaceuticals, Inc.

and John Beck, dated October 15, 2019

Amendment to Employment Salary Terms, by and between Ritter Pharmaceuticals, Inc.

and Ira Ritter, dated October 15, 2019

Sales Agreement, by and between Ritter Pharmaceuticals, Inc.

and A.G.P./Alliance Global Partners

Form of Irrevocable Consent and Waiver of Restriction on Dilutive Issuances

Form of Agreement to Exchange Warrants

of Mayer Hoffman McCann P.C., independent registered public accounting firm

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.

and University of Louisville Research Foundation, Inc.

dated as of June 8, 2018

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.

and Advanced Cancer Therapeutics, LLC dated December 17, 2018

Novation 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.

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.

and University of Louisville Research Foundation, Inc.

dated January 30, 2021

Agreement among the Company, Qualigen, Inc.

and University of Louisville Research Foundation, Inc.

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.

and Qualigen, Inc., dated August 5, 2021

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

of the Registrant

of Baker Tilly US, LLP, independent registered public accounting firm

of Attorney (included on signature page)

of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley

of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley

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 principal financial officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act

of principal executive officer and principal financial officer pursuant to 18 U.S.C.

1 unchanged sentence

906 of the Sarbanes-Oxley Act of 2002.

Instance Document.

Taxonomy Extension Schema Document.

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Taxonomy Extension Definition Linkbase Document.

Taxonomy Extension Label Linkbase Document.

Taxonomy Extension Presentation Linkbase Document.

Filed herewith.

XBRL Instance Document.

XBRL Taxonomy Extension Schema Document.

XBRL Taxonomy Extension Calculation Linkbase Document.

XBRL Taxonomy Extension Definition Linkbase Document.

XBRL Taxonomy Extension Label Linkbase Document.

XBRL Taxonomy Extension Presentation Linkbase Document.

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.

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.

Form 10-K Summary

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

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

to be signed on its behalf by the undersigned, thereunto duly authorized.

PHARMACEUTICALS, INC.

Financial Officer and Principal Accounting Officer

Therapeutics, Inc.

of the Board, Chief Executive Officer and President

March 31, 2022

ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Andrew J.

Ritter, Ira E.

Ritter and John W.

Beck, jointly and severally, his attorneys-in-fact, each with the power of substitution, for him in any and

all capacities, to sign any amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other

documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each

of said attorneys-in-fact, or his substitute or substitutes, may do or cause to be done by virtue hereof.

to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf

of the registrant on March 31, 2020 in the capacities indicated.

Executive Officer and Director

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

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.

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.

of the Board, Chief Executive Officer and President

Executive Officer)

Financial Officer

Financial Officer and Principal Accounting Officer)

Chairman, Chief Strategic Officer

TO FINANCIAL STATEMENTS

of Independent Registered Public Accounting Firm

Sheets as of December 31, 2019 and 2018

of Operations and Comprehensive Loss for the years ended December 31, 2019 and 2018

of Changes in Stockholders’

Equity for the years ended December 31, 2019 and 2018

of Cash Flows for the years ended December 31, 2019 and 2018

to Financial Statements

OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

the Board of Directors and Stockholders of Ritter Pharmaceuticals, Inc.

on the Financial Statements

have audited the accompanying balance sheets of Ritter Pharmaceuticals, Inc.

(the “Company”) as of December 31, 2019

and 2018, and the related statements of operations and comprehensive loss, changes in stockholders’

equity, and cash flows

for each of the two years in the period ended December 31, 2019, and the related notes (collectively referred to as the “financial

statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position

of the Company as of December 31, 2019 and 2018, and the results of its operations and its cash flows for each of the two years

in the period ended December 31, 2019, in conformity with accounting principles generally accepted in the United States of America.

Concern Uncertainty

accompanying financial statements have been prepared assuming that the Company will continue as a going concern.

in Note 2 to the financial statements, the Company has incurred recurring operating losses and is dependent on additional financing

to fund operations.

These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

Management’s plans in regard to these matters are described in Note 2 to the financial statements.

The financial statements

do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the

amounts and classification of liabilities that may result from the outcome of this uncertainty.

financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on

the Company’s financial statements based on our audits.

We are a public accounting firm registered with the Public Company

Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company

in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission

and the PCAOB.

conducted our audits in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audits

to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial

As part of our audits we are required to obtain an understanding of internal control over financial reporting but not

for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.

Accordingly, we express no such opinion.

audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to

error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence

regarding the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles

used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audits provide a reasonable basis for our opinion.

have served as the Company's auditor since 2014.

Angeles, California

PHARMACEUTICALS, INC.

and cash equivalents

interest receivable

in marketable securities

expenses and other current assets

current assets

and equipment, net

AND STOCKHOLDERS’

current liabilities

Stockholders’

A preferred stock, $0.001 par value;

9,500 shares authorized;

0 and 4,080 shares issued and outstanding as of December

31, 2019 and 2018, respectively

B preferred stock, $0.001 par value;

6,000 shares authorized;

1,850 and 5,608 shares issued and outstanding as of December

31, 2019 and 2018, respectively

C preferred stock, $0.001 par value;

1,880 shares authorized;

240 and 1,880 shares issued and outstanding as of December 31,

2019 and 2018, respectively

stock, $0.001 par value;

225,000,000 shares authorized;

19,108,331 and 6,036,562 shares issued and outstanding as of December

31, 2019 and 2018, respectively

paid-in capital

other comprehensive loss

(80,333,164 )

(70,200,145 )

stockholders’

Liabilities and Stockholders’

accompanying notes are an integral part of these financial statements.

PHARMACEUTICALS, INC.

OF OPERATIONS AND COMPREHENSIVE LOSS

For the Year Ended

Operating costs and expenses:

Research and development (a)

General and administrative

Total operating costs

Operating loss

(10,844,185 )

(17,889,369 )

Other income:

Interest income

Settlement of accounts

Total other income

$ (10,133,019 )

$ (16,868,711 )

Other comprehensive gain (loss):

Unrealized gain (loss)

on debt securities

Comprehensive loss

$ (10,132,096 )

$ (16,869,634 )

(10,133,019 )

(16,868,711 )

Deemed dividend of preferred stock

Net loss applicable to common stockholders

$ (10,133,019 )

$ (19,406,555 )

Net loss per common share –

Weighted average common shares outstanding

basic and diluted

comparative presentation purposes, settlement of accounts payable of $893,823 for the year ended December 31, 2018 was

reclassified out of research and development and into settlement of accounts payable under other income.

accompanying notes are an integral part of these financial statements.

PHARMACEUTICALS, INC.

OF CHANGES IN STOCKHOLDERS’

Preferred Stock

Comprehensive

Stockholders’

at December 31, 2017

$ (53,331,434 )

to shareholders for fractional shares

of Series B preferred shares upon closing of private placement

and offering costs of private placement

dividend of preferred stock

of Series A preferred shares into common stock

of Series B preferred shares into common stock

in unrealized loss on investment in marketable debt securities

(16,868,711 )

at December 31, 2018

$ (70,200,145 )

fractional adjustment

of common shares from ATM Agreement

issuance costs of ATM Agreement

of Series A preferred shares into common stock

of Series B preferred shares into common stock

of Series C preferred shares into common stock

in unrealized loss on available-for-sale securities

(10,133,019 )

at December 31, 2019

$ (80,333,164 )

accompanying notes are an integral part of these financial statements.

PHARMACEUTICALS, INC.

OF CASH FLOWS

the Years Ended December 31,

flows from operating activities

$ (10,133,019 )

$ (16,868,711 )

to reconcile net loss to net cash used in operating activities:

of right-of-use assets

of accounts payable

of discount on available-for-sale debt securities

in unrealized gain (loss) on investment in marketable debt securities

in operating assets and liabilities:

interest receivable

expenses and other current assets

cash and cash equivalents used in operating activities

(14,516,690 )

(13,332,927 )

flows from investing activities

of property and equipment

of investment in marketable securities

of investments in marketable debt securities

cash and cash equivalents provided by (used in) investing activities

flows from financing activities

from the issuance of preferred shares upon closing of private placement

and issuance costs of private placement

from the issuance of shares from ATM Agreement

issuance costs of ATM Agreement

to shareholders for fractional shares

cash and cash equivalents provided by financing activities

decrease in cash and cash equivalents

(14,819,712 )

and cash equivalents at beginning of year

and cash equivalents at end of year

disclosure of cash flow activities:

paid for taxes

disclosure of non-cash investing and financing activities:

dividend on preferred stock

of preferred stock to common stock

of Series A preferred stock to Series C preferred stock

assets obtained in exchange for lease liabilities

liabilities arising from obtaining right-of-use assets

accompanying notes are an integral part of these financial statements.

PHARMACEUTICALS, INC.

TO FINANCIAL STATEMENTS

ORGANIZATION AND PRINCIPAL ACTIVITIES

its inception, Ritter Pharmaceuticals, Inc.

(“Ritter”

or the “Company”) has focused on the development of therapeutic products that modulate the gut microbiome

to treat gastrointestinal diseases.

The Company’s only product candidate, RP-G28, is an orally administered, high

purity galacto-oligosaccharide (“GOS”), for the treatment of lactose intolerance (“LI”), a condition

that affects millions of people worldwide.

RP-G28 is designed to selectively stimulate the growth of lactose-metabolizing bacteria

in the colon, thereby effectively adapting the gut microbiome to assist in digesting lactose (the sugar found in milk) that reaches

the large intestine.

was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural Sciences, LLC.

Its first prototype

LI product, Lactagen™, was an alternative LI treatment method with a mechanism of action similar to RP-G28.

In 2004, clinical

testing was conducted with Lactagen, which included a 61-subject double-blind placebo controlled clinical trial.

The results were

published in the Federation of American Societies for Experimental Biology in May 2005.

early 2008, the Company initiated a prescription drug development program by developing RP-G28, an improved, second-generation

version of Lactagen, based on the belief that if it was successful in gaining approval from the U.S.

Food and Drug Administration

(“FDA”), it would be able to make stronger claims of both efficacy and safety, garner more medical community support

and reach a wider market in the effort to treat LI.

November 2010, Ritter was awarded a grant from the United States government’s Health Care Bill program, the Qualifying Therapeutic

Discovery Project, to help fund the development of RP-G28.

This grant program provides support for innovative projects that are

determined by the U.S.

Department of Health and Human Services to have reasonable potential to result in new therapies that treat

areas of unmet medical need and/or prevent, detect or treat chronic or acute diseases and conditions.

November 2011, the Company completed a Phase 2a clinical trial of RP-G28.

Positive trends were seen when the entire per protocol

study population was analyzed, including some statistically significant subgroup.

The combined data demonstrated proof of concept

and suggested that RP-G28 administration produced a positive therapeutic effect.

RP-G28 was also well tolerated with no significant

study-drug related adverse effects.

October 2016, the Company completed a Phase 2b multi-center, randomized, double-blind, placebo-controlled, parallel group trial

Topline results of the trial were announced in March 2017.

Results showed a clinically meaningful benefit to subjects

in the reduction of LI symptoms across a variety of outcome measures.

The majority of analyses showed positive outcome measures

and the robustness of the data point to a clear drug effect.

Treatment patients not only reported meaningful reduced symptoms,

but also 30 days after taking the treatment, patients reported adequate relief from LI symptoms and satisfaction with the results

of the treatment, with RP-G28 preventing or treating their LI symptoms.

Greater milk and dairy product consumption was also reported

2017, the Company held an End-of-Phase 2 meeting with the FDA’s Division of Gastroenterology and Inborn Errors Products.

The purpose of the meeting was to obtain the FDA’s feedback on its Phase 3 program.

The Company reached general consensus

with the FDA on certain elements of its Phase 3 program and clear guidance and recommendations on many necessary components of

its Phase 3 program;

including the clinical, non-clinical, and chemistry, manufacturing and controls (“CMC”) requirements

needed to support a new drug application (“NDA”) submission.

June 2018, the Company initiated the first pivotal Phase 3 clinical trial of RP-G28.

Called “Liberatus”, this study

was to determine the efficacy, safety and tolerability of RP-G28 to treat LI when compared to placebo.

The study was a multicenter,

randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States.

Trial enrollment exceeded expectations,

concluding with approximately 557 subjects randomized.

More than 30 U.S.

sites participated in the study.

The protocol design

included a 2-week screening period that included one week of study drug administration, a randomized 30-day study drug treatment

period and a 90-day “real world experience”

period to assess study drug response and durability of effect after treatment

as patients consumed their normal diets including dairy products.

The primary endpoint of the study was the mean change in LI

symptom composite score 30-days post-treatment compared to baseline.

Secondary endpoints were to examine the safety, tolerability

and meaningfulness of treatment benefit with RP-G28 and the durability of effect of treatment with RP-G28 on reduction of LI symptoms

after real-world lactose exposure.

The study utilized the prior validated symptom assessment measure and patient questionnaires

to capture relevant outcomes.

In addition, risk-based data review was used to monitor and assess potential protocol deviations

and site quality indicators.

Company completed enrollment of the Liberatus Phase 3 clinical trial of RP-G28 in March 2019 and last patient visit in July 2019.

In September 2019, the Company announced that its Phase 3 clinical trial of RP-G28 for LI failed to demonstrate statistical significance

in its pre-specified primary and secondary endpoints.

7, 2019, the Company announced publicly that it had engaged AGP as a financial advisor to explore and evaluate potential strategic

alternatives, as it continued to analyze the results of the trial to better understand the data and clinical outcome to assess

a path forward for RP-G28.

All further development efforts for RP-G28 have been suspended, until such time as the Company determines

a path forward.

January 15, 2020, Ritter entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Qualigen Inc.

(“Qualigen”), pursuant to which a wholly owned Company Merger Sub will merge with and into Qualigen, with Qualigen

surviving as a wholly owned subsidiary of Ritter Pharmaceuticals, Inc.

the merger is consummated, the combined company does not intend to continue the clinical development of RP-G28.

Pursuant to the

terms of the Merger Agreement, at the Effective Time (as defined in the Merger Agreement), Ritter and John Beck, the Company’s

Chief Financial Officer, acting as the initial contingent value right (“CVR”) holders’

representative and in

his capacity as a consultant to Ritter, will enter into a Contingent Value Rights Agreement (the “CVR Agreement”),

pursuant to which, each stockholder of record as of immediately prior to the Effective Time (after giving effect to the exercise

of any outstanding stock options or warrants and the conversion of any outstanding preferred stock, but not to be adjusted for

any reverse split to be effected in connection with the merger) will receive one CVR for each share of capital stock held by such

stockholder, entitling the holder to receive the net proceeds, if any, from any sale, license, transfer, spin-off or other monetizing

event of all or any part of our current business or all or any part of our intellectual property or technology (a “Legacy

Monetization”) that is entered into during the period beginning on the date the Merger Agreement was signed and ending on

the third anniversary of the closing date of the merger.

Under the CVR Agreement, the combined company agreed to commit up to

$350,000 (subject to reduction pursuant to the terms of the Merger Agreement) for certain expenses to be incurred by us in pursuing

and closing any Legacy Monetization.

The CVRs will not be transferable by the holders of CVRs (“CVR Holders”), except

in certain limited circumstances, will not be certificated or evidenced by any instrument, will not accrue interest and will not

be registered with the Securities and Exchange Commission (the “SEC”) or listed for trading on any exchange.

will terminate on the tenth anniversary of the Effective Time (the “CVR Termination Date”).

No payments with respect

to the CVRs will be payable in respect of any Legacy Monetization proceeds actually received after the CVR Termination Date by

From and after the CVR Termination Date, any further proceeds received by us arising from any Legacy Monetization will be

retained by Ritter and will not be distributed to the CVR Holders.

Company may not be successful in completing the merger.

If the merger is not completed, Ritter may seek to pursue the development

and commercialization of RP-G28 as either a prescription drug, OTC product or dietary supplement for the consumer healthcare industry,

which would, in any case, require significant additional funding.

If Ritter is unable to obtain funding for the development of

RP-G28, whether through potential collaborative, partnering or other strategic arrangements or otherwise, it will likely be required

to cease operations

Company currently operates in one business segment focusing on the potential future development and commercialization of

The Company is not organized by market and is managed and operated as one business.

A single management team reports to

the chief operating decision maker, the Chief Executive Officer.

The Company does not currently operate any separate lines of

business or separate business entities.

BASIS OF PRESENTATION

The accompanying

financial statements have been prepared in accordance with GAAP and include all adjustments necessary for the fair presentation

of the Company’s financial position for the periods presented.

Concern and Liquidity

The accompanying financial statements

have been prepared assuming the Company will continue as a going concern, which contemplates, among other things, the realization

of assets and satisfaction of liabilities in the normal course of business.

The Company has not generated any product revenue

and has not achieved profitable operations.

The Company had net losses of approximately $10.1 million and $16.9 million for the

years ended December 31, 2019 and 2018, respectively, and had net cash used in operating activities of approximately $14.5 million

and $13.3 million, for the years ended December 31, 2019 and 2018, respectively.

At December 31, 2019, the Company had working

capital of approximately $0.5 million, an accumulated deficit of approximately $80.3 million, cash and cash equivalents of approximately

$1.7 million.

There is no assurance that profitable operations will ever be achieved, and, if achieved, could be sustained on

a continuing basis.

In addition, development activities, clinical and pre-clinical testing, and commercialization of the Company’s

products will require significant financing.

If the Plan of Merger is not successful, the Company may close down operations and

operate as a shell company if the Company cannot raise the cash to continue operations.

These matters, among others, raise substantial

doubt about the Company’s ability to continue as a going concern.

inception, the operations of the Company have been funded through the sale of common shares, preferred shares, warrants and convertible

Management cannot be certain that additional funding will be available on acceptable terms, or at all.

To the extent that

the Company raises additional funds by issuing equity securities, the Company’s stockholders may experience significant

Any debt financing, if available, may involve restrictive covenants that could impact the Company’s ability to

conduct business.

If the Company is not able to raise additional capital when required or on acceptable terms, the Company may

have to (i) significantly delay, scale back or discontinue the development and/or commercialization of one or more product candidates;

(ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less

favorable than might otherwise be available;

or (iii) relinquish or otherwise dispose of rights to technologies, product candidates

or products that the Company would otherwise seek to develop or commercialize.

financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect

the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial

statements and the reported amounts of revenues and expenses during the reporting period.

Actual results could differ from those

estimates and such differences may be material to the financial statements.

The more significant estimates and assumptions by

management include among others;

the valuation allowance of deferred tax assets resulting from net operating losses and the valuation

of options on the Company’s common stock.

and Cash Equivalents

consists of amounts held in financial institutions and consists of immediately available fund balances.

The funds are maintained

at stable financial institutions, generally at amounts in excess of federally insured limits.

Cash equivalents include money market

funds and held-to-maturity securities with a maturity date of 90 days or less.

As of December 31, 2019, cash and cash equivalents

consisted of bank deposits, cash and investments in money market funds.

in Marketable Securities

Investment in marketable securities is held

in a custodial account at a financial institution and managed by the Company’s capital advisors based on the Company’s

investment guidelines.

All of the Company’s investments in marketable securities are classified as available-for-sale debt

securities and are carried at fair value.

Interest on these securities, as well as the amortization of discounts and premiums,

is included in interest income in the Statements of Operations and comprehensive loss.

The unrealized gains and losses on these

securities are excluded from earnings and reported in other comprehensive loss until realized, except when it considers declines

in value to be other than temporary.

Other than temporary impairment losses related to credit losses are considered to be realized

When available-for-sale debt securities are sold, the cost of the securities is specifically identified and is used to

determine the realized gain or loss.

Securities classified as current assets have maturity dates of less than or equal to one year

from the balance sheet date.

and Equipment

and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method (see Note

Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts

and any resulting gain or loss is credited or charged to income.

Maintenance and repairs are charged to expense as incurred while

expenditures for refurbishments and improvements that significantly add to the productive capacity or extend the useful life of

an asset are capitalized.

of Long-Lived Assets

Company periodically assesses the impairment of long-lived assets in accordance with Accounting Standards Codification (“ASC”)

Topic 360, Property Plant and Equipment.

When indicators of impairment are present, the Company evaluates the carrying

value of these assets in relation to the operating performance of the business and future undiscounted cash flows expected to

result from the use of these assets.

No such impairments have been recognized during the years ended December 31, 2019 or 2018.

Trial and Pre-Clinical Study Accruals

Company makes estimates of accrued expenses as of each balance sheet date in its financial statements based on the facts and circumstances

known to it at that time.

Accrued expenses for pre-clinical studies and clinical trials are based on estimates of costs incurred

and fees that may be associated with services provided by contract research organizations, clinical trial investigational sites,

and other related vendors.

Payments under certain contracts with such parties depend on factors such as successful enrollment

of patients, site initiation and the completion of milestones.

In accruing service fees, management estimates the time period

over which services will be performed and the level of effort to be expended in each period.

If possible, the Company obtains

information regarding unbilled services directly from these service providers.

However, the Company may be required to estimate

these services based on other information available to it.

If the Company underestimates or overestimates the activity or fees

associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary

in future periods.

Historically, estimated accrued liabilities have approximated actual expense incurred.

Subsequent changes in

estimates may result in a material change in the Company’s accruals.

and Development

Company expenses the cost of research and development as incurred.

Research and development expenses comprise costs incurred in

performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and pre-clinical

materials as well as other contracted services, license fees, and other external costs.

Nonrefundable advance payments for goods

and services that will be used in future research and development activities are expensed when the activity is performed or when

the goods have been received, rather than when payment is made, in accordance with ASC Topic 730, Research and Development .

Company has no historical data to support a probable future economic benefit for the arising patent applications, filing and prosecution

Therefore, patent costs are expensed as incurred.

Should the Company experience a legal cost to defend a patent in the

future, that cost would be capitalized only when it is part of the cost of retaining and obtaining the future economic benefit

of the patent.

Costs related to an unsuccessful outcome would be expensed.

compensation cost for stock awards issued to employees, members of the Company’s board of directors and non-employees, is

measured at the grant date based on the fair value of the award and is recognized as expense over the required service period,

which is generally equal to the vesting period.

Stock-based compensation is recognized only for those awards that are ultimately

expected to vest.

Common stock, stock options or warrants issued to non-employees, including consultants and members of the Company’s

Scientific Advisory Board as consideration for goods or services received by the Company, are accounted for based on the fair

value of the equity instruments issued unless the fair value consideration received can be more reliably measured.

The fair value

of stock options is determined using the Black-Scholes option-pricing model.

The fair value of any options issued to non-employees

is recorded as expense over the vesting period.

See Note 8 for further information.

Value Measurements

fair value of the Company’s financial instruments reflects the amounts that it estimates it would receive in connection

with the sale of an asset or pay in connection with the transfer of a liability in an orderly transaction between market participants

at the measurement date (exit price).

The Company discloses and recognizes the fair value of its assets and liabilities using

a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value.

The hierarchy gives the highest priority

to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements)

and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements).

The guidance establishes three levels of the fair value hierarchy as follows:

1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability

to access at the measurement date;

2 - Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs

in markets that are not considered to be active;

3 - Inputs that are unobservable.

and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant

to the fair value measurement.

The Company’s assessment of the significance of a particular input to the fair value measurement

in its entirety requires management to make judgments and consider factors specific to the asset or liability.

Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period.

There were no transfers

within the hierarchy during the year ended December 31, 2019.

summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows:

Value Measurements Using

and money market fund

debt securities

uses a market approach for determining the fair value of all its Level 1 money market funds and marketable securities.

its money market funds, the Company values the funds at $1 stable net asset value, which is the market pricing convention for

identical assets that the Company has the ability to access.

investments were classified as available-for-sale debt securities.

At December 31, 2019, the balance in the Company’s

accumulated other comprehensive loss was comprised primarily of activity related to the Company’s available-for-sale

debt securities and some activity related to held-to-maturity debt securities.

Realized gains and losses are included in

earnings The Company had no available-for-sale or held-to-maturity debt securities as of December 31,

Preferred Stock

Company follows authoritative accounting guidance to distinguish liabilities from equity when assessing the classification and

measurement of preferred stock.

Preferred shares subject to mandatory redemptions are considered liabilities and measured at fair

Conditionally redeemable preferred shares are considered temporary equity.

All other preferred shares are considered as

stockholders’

for Income Taxes

tax assets and liabilities are recognized for the expected future consequences of events that have been reflected in the financial

Deferred tax assets and liabilities are determined based on the differences between the book and tax basis of assets

and liabilities and operating loss carryforwards, using tax rates expected to be in effect for the years in which the differences

are expected to reverse.

Such differences arise primarily from stock-based compensation and net operating loss carryforwards.

The Company records a valuation allowance to reduce deferred income tax assets when it is more likely than not that some portion

or all of the deferred tax asset will not be realized.

Prior to September 15, 2008, the Company was a limited liability company

and the Company’s tax losses and credits generally flowed directly to the members.

Loss Per Share

Company determines basic net loss per share and diluted net loss per share in accordance with the provisions of ASC 260, “Earnings

per Share.”

Basic net loss per share was calculated by dividing net loss by the weighted-average common shares outstanding

during the period.

Diluted net loss per share was calculated by dividing net loss by the weighted-average common shares outstanding

during the period using the treasury stock method or the two-class method, whichever is more dilutive.

The potentially dilutive

stock options issued under the 2015 Stock Plan (described in Note 8), Series A, Series B and Series C Convertible Preferred Stock

(described in Note 6) and warrants on the Company’s common stock (described in Notes 6 and 7) were not considered in the

computation of diluted net loss per share because they would be anti-dilutive.

Comprehensive

Income (Loss)

Comprehensive

income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner

The Company is required to record all components of comprehensive loss in the financial statements in the period in which

they are recognized.

Net income (loss) and other comprehensive loss, including foreign currency translation adjustments and unrealized

gains and losses on investments are reported, net of their related tax effect, to arrive at a comprehensive loss.

For the years

ended December 31, 2019 and 2018, comprehensive loss comprised of unrealized losses on investments in available-for-sale debt

securities and held-to-maturity debt securities.

Accounting Pronouncements

June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)

2016-13, Financial Instruments –

Credit Losses (Topic 326):

Measurement of Credit Losses on Financial Instruments ,

an amendment that modifies the measurement recognition of credit losses for most financial assets and certain other instruments.

The amendment updates the guidance for measuring and recording credit losses on financial assets measured at amortized cost by

replacing the “incurred loss”

model with an “expected loss”

Accordingly, these financial assets

will be presented at the net amount expected to be collected.

The amendment also requires that credit losses related to available-for-sale

debt securities be recorded as an allowance through net income rather than reducing the carrying amount under the current, other-than-temporary-impairment

The FASB also issued subsequent amendments to the initial guidance:

ASU 2018-19, ASU 2019-04, and ASU 2019-05 (collectively,

“Topic 326”).

Topic 326 requires measurement and recognition of expected credit losses for financial assets held.

The effective date and transition methodology for the amendments in Topic 326 are the same as in ASU 2016-13.

is effective for public business entities that are SEC filers.

The amendments in ASU No.

2016-13 are effective for fiscal years

beginning after December 15, 2019, including interim periods within those fiscal years.

For all other public business entities,

the amendments in this ASU are effective for fiscal years beginning after December 15, 2020, including interim periods within

those fiscal years.

The Company does not expect the adoption of this guidance will have a material impact on its financial statements.

August 2018, the FASB issued ASU No.

2018-13, “Fair Value Measurement (Topic 820):

Disclosure Framework —

to the Disclosure Requirements for Fair Value Measurement”

, an amendment to the accounting guidance on fair value measurements.

The guidance modifies the disclosure requirements on fair value measurements, including the removal of disclosures of the amount

of and reasons for transfers between Level 1 of the fair value hierarchy, the policy for timing of transfers between levels, and

the valuation processes for Level 3 fair value measurements.

The guidance also adds certain disclosure requirements related to

Level 3 fair value measurements.

The guidance is effective for fiscal years, and interim periods within those fiscal years, beginning

after December 15, 2019.

The Company does not expect the adoption of this guidance will have a material impact on its financial

December 2019, the FASB issued ASU No.

2019-12, “

Income Taxes (Topic 740):

Simplifying the Accounting for Income Taxes ,”

which is intended to simplify various aspects related to accounting for income taxes.

The ASU 2019-12 removes certain exceptions

to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application.

ASU 2019-12 is effective for the Company beginning after December 15, 2021.

The Company is evaluating the impact of the adoption

of ASU 2019-12 on its financial statements, but does not expect such adoption to have a material impact.

accounting standard updates effective after December 31, 2019 are not expected to have a material impact on the Company’s

financial statements.

Adopted Accounting Pronouncements

2016, the FASB issued ASU No.

2016-02, Leases (Topic 842) .

Under this guidance, an entity is required to recognize right-of-use

(“ROU”) assets and corresponding lease liabilities on its balance sheets and disclose key information about leasing

arrangements.

In July 2018, the FASB issued ASU No.

2018-11, Leases (Topic 842) Targeted Improvements , which provides for

an alternative transition method by allowing companies to continue to use the legacy guidance in Topic 840, Leases, including

its disclosure requirements, in the comparative periods presented in the year of adoption of the new leases standard and recognize

a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption rather than the earliest

period presented.

elected the available package of practical expedients ,

but not the hindsight practical expedient, and adopted this guidance as of January 1, 2019.

The standard had a material impact on the

Company’s balance sheets, but did not have an impact on its statements of operations and comprehensive loss.

The most significant

impact was the recognition of a ROU asset and lease liability for the Company’s sole operating lease—the Company had

no finance leases.

Adoption of the standard did not require the Company to restate previously reported results as it elected to

apply a modified retrospective approach at the beginning of the period of adoption rather than at the beginning of the earliest

comparative period presented.

June 2018, the FASB issued ASU No.

2018-07, Improvements to Nonemployee Share-Based Payment Accounting , which expands the

scope of Topic 718 Compensation—Stock Compensation , to include share-based payments issued to nonemployees for goods

Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned.

2018-07 supersedes Subtopic 505-50 Equity—Equity-Based Payments to Non-Employees .

The amendments implemented

2018-07 are effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal

The Company adopted ASU 2018-07 on January 1, 2019 and it did not have a material effect on its results of operations, financial

position or cash flows.

PROPERTY AND EQUIPMENT

and equipment consists of the following:

property and equipment

and equipment, net

expense of approximately $6,100 and $5,700 was recognized for each of the years ended December 31, 2019 and 2018, respectively,

and is classified in general and administrative expense in the accompanying Statements of Operations and Comprehensive Loss.

COMMITMENTS AND CONTINGENCIES

Services Agreement

Ritter entered into an Amended and Restated Master Services Agreement (“Service Agreement”) with a clinical research

organization (“CRO”), pursuant to which the CRO agreed to perform certain services related to the management and execution

of certain clinical trials involving RP-G28.

The Services Agreement supersedes the Master Service Agreement, dated August 30,

2016, that Ritter entered into with the CRO.

The precise services to be performed by the CRO under the Services Agreement will

be mutually agreed upon by the parties in writing and set forth in one or more task orders.

Ritter is not obligated to purchase

any minimum or specific volume or dollar amount of services under the Services Agreement.

term of the Services Agreement is four years from the effective date of the Service Agreement unless earlier terminated.

may terminate the Services Agreement or any task without cause immediately upon giving the CRO notice of such termination.

CRO may, with advance notice to Ritter, terminate a task order if Ritter has materially defaulted on its obligations under the

Services Agreement or any task order and has not cured such material default, as described in the Services Agreement.

Supply and Cooperation Agreement with Ricerche Sperimentali Montale SpA (“RSM”)

terms of the Supply Agreement with RSM on July 22, 2015, Ritter is required to pay RSM $400,000 within 10 days following FDA approval

of an NDA for the first product owned or controlled by Ritter using Improved GOS as its active pharmaceutical ingredient.

Letter Amendments

October 15, 2019, Ritter entered into amendments to the respective employment offer letters of Andrew J.

Ritter, its Chief Executive

Officer, John W.

Beck, its Chief Financial Officer, and Ira E.

Ritter, its Chief Strategic Officer (the “Offer Letter Amendments”).

Pursuant to the terms of the Offer Letter Amendments, each of Ritter’s executive officers agreed to defer a portion of his

annual base salary (the “Deferred Amounts”), as set forth below, until such time as the board of directors, in its

sole discretion, decides to pay the Deferred Amounts (or any portion of the Deferred Amounts) to the executive officers, if ever.

of Executive Officer

Deferred Amount

July 9, 2015, the Company entered into a lease with a California limited partnership, pursuant to which the Company leased

approximately 2,780 square feet of office space in Los Angeles, California for its headquarters.

The lease provides for a

term of sixty-one (61) months, commencing on October 1, 2015.

The Company paid no rent for the first month of the term and

paid base rent of $9,174 per month for months 2 through 13 of the term, with increasing base rent for each twelve-month

period thereafter under the term of the lease to a maximum of $10,325 per month for months 50 through 61.

The base rent

payments do not include the Company’s proportionate share of any operating expenses, including real estate taxes.

Company has the option to extend the term of the lease for one five-year term, provided that the rent would be subject to

market adjustment at the beginning of the renewal term.

Rent expense, recognized on a straight-line basis, was approximately

$117,000 and $118,000 for the years ended December 31, 2019 and 2018, respectively, and is recorded in general and

administrative expenses in the accompanying statements of operations and comprehensive loss.

Other information

related to our leases is provided below.

December 31, 2019

Cash Flows Information

Cash paid for amounts

included in the measurement of lease liability:

cash flows from operating lease

Operating lease asset

obtained in exchange for lease obligation:

Remaining lease

Discount rate

payments under non-cancelable extended operating leases having initial or remaining terms of one year or more are as follows for

the remaining fiscal year and thereafter:

minimum lease payments year ending December 31,

future minimum lease payments, undiscounted

imputed interest

value of lease liabilities

Operating lease liabilities reported

as of December 31, 2019:

lease liabilities-current

lease liabilities-non-current

following table summarizes our lease obligations at December 31, 2019:

ended December 31,

minimum lease payments

time to time, we are party to legal claims and proceedings that arise in the ordinary course of business, which may relate to

our operations or assets.

These may include disputes and lawsuits related to intellectual property, licensing, contract law and

employee relations matters.

Periodically, the Company reviews the status of significant matters, if any exist, and assesses its

potential financial exposure.

If the potential loss from any claim or legal claim is considered probable and the amount can be

estimated, the Company accrues a liability for the estimated loss.

Legal proceedings are subject to uncertainties, and the outcomes

are difficult to predict.

Because of such uncertainties, accruals are based on the best information available at the time.

additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation.

We do not believe that any individual legal claim or proceeding that is currently pending is material to the Company or that these

claims and proceedings in the aggregate are material to the Company.

STOCKHOLDERS’

2017, the Company amended its Amended and Restated Certificate of Incorporation to authorize the issuance of up to 225,000,000

shares of common stock, $0.001 par value per share, and 15,000,000 of which are designated as preferred stock, consisting of

(i) 9,500 shares that have been designated Series A convertible preferred stock, (ii) 6,000 shares that have been designated as

Series B convertible preferred stock, and (iii) 1,880 shares that have been designated as Series C convertible preferred stock.

Pursuant to the terms of the Certificate of Incorporation, the board of directors has the authority to issue preferred stock in

one or more classes or series and to fix the designations, powers, preferences and rights, and the qualifications, limitations

or restrictions thereof, including dividend rights, conversion right, voting rights, terms of redemption, liquidation preferences

and the number of shares constituting any class or series, without further vote or action by the stockholders.

common share amounts and per share amounts were retroactively restated to reflect a 1-for-10 reverse stock split that was effective

Christopher L.

President of Finance, Chief Financial Officer

Financial and Accounting Officer)

March 31, 2022

of December 31, 2019, the Company had 19,108,331 shares of common stock, 0 shares of Series A convertible preferred stock, 1,850

shares of Series B convertible preferred stock and 240 shares of Series C convertible preferred stock issued and outstanding.

Each share of the Company’s common stock is entitled to one vote, and all shares rank equally as to voting and other matters.

Each share of Series A preferred stock is convertible by the holder at $4.00 per share;

subject to adjustment for stock splits,

stock dividends, subsequent rights offerings, pro rata distributions, and fundamental transactions.

Each share of Series B preferred

stock is convertible by the holder at $1.30 per share;

subject to customary adjustment in the event of future stock dividends

and stock splits.

Each share of Series C preferred stock is convertible by the holder at $1.64 per share;

subject to customary

adjustment in the event of future stock dividends and stock splits.

Holders are entitled to receive, and the Company shall pay,

dividends on outstanding shares of Series A preferred stock, on an as-if-converted-to-common-stock basis, equal to and in the

same form as dividends actually paid on outstanding common shares when, as and if such dividends are paid on outstanding common

Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, the holders of Series

A, Series B and Series C preferred stock shall be entitled to receive out of the assets, whether capital or surplus, of the Company

the same amount that a holder of common stock would receive if the Series A, Series B and Series C preferred stock were fully

converted to common stock, which amounts shall be paid pari passu with all common stockholders.

Holders of Series A, Series B

and Series C preferred stock have no voting rights.

However, as long as any shares of Series A, Series B and Series C preferred

stock are outstanding, the Company shall not, without the affirmative vote of the holders of a majority of the then outstanding

shares of Series A, Series B and Series C preferred stock, (a) alter or change adversely the powers, preferences or rights given

to the Series A, Series B and Series C preferred stock or alter or amend the applicable Certificate of Designation, (b) amend

the Company’s certificate of incorporation or other charter documents in any manner that adversely affects any rights of

the holders of Series A, Series B and Series C preferred stock, (c) increase the number of authorized shares of Series A, Series

B and Series C preferred stock, or (d) enter into any agreement with respect to any of the foregoing.

Capital Common Stock Purchase Agreement

May 4, 2017, the Company entered into a common stock purchase agreement with Aspire Capital Fund, LLC (“Aspire Capital”),

which the Company and Aspire amended and restated on March 29, 2019 and on July 23, 2019 (as amended and restated, the

“Aspire Purchase Agreement”).

The Aspire Purchase Agreement was amended and restated to adjust certain provisions

to improve the Company’s access to funding under the agreement.

The Company was not required to pay a commitment fee to

Aspire Capital to affect the amendment to the Aspire Purchase Agreement.

The Aspire Purchase Agreement provides access to the

Company of up to an aggregate of $6.5 million in proceeds through the sale of shares of its common stock through March 31, 2021.

Under the Aspire Purchase Agreement, as

amended, on any trading day the Company selected, it had the right, in its sole discretion, to present Aspire Capital with a purchase

notice (each, a “Purchase Notice”), directing Aspire Capital (as principal) to purchase up to 100,000 shares of its

common stock per trading day (which could be increased by as much as an additional 2,000,000 shares per trading day by mutual

agreement), up to an aggregate of $6,500,000 of its common stock, at a per share price (the “Purchase Price”) equal

to the lesser of:

(i) the lowest sale price of the Company’s common stock on the sale date, or (ii) the arithmetic average

of the three lowest closing sale prices for the Company’s common stock during the ten (10) consecutive trading days ending

on the trading day immediately preceding the sale date.

The aggregate purchase price payable by Aspire Capital on any one purchase

date could not exceed $500,000, unless otherwise mutually agreed.

In addition, on any date on which the Company submitted a Purchase

Notice to Aspire Capital in an amount of at least 100,000 shares and its stock price was not less than $0.25 per share, the Company

could also, in its sole discretion, present Aspire Capital with a volume-weighted average price purchase notice (each, a “VWAP

Purchase Notice”) directing Aspire Capital to purchase an amount of its common stock equal to up to 30% of the aggregate

shares of the Company’s common stock traded on its principal market on the next trading day (the “VWAP Purchase Date”),

as determined by the Company.

Under the terms of the Aspire Purchase Agreement, the number of shares that could be sold pursuant

to Aspire Capital was limited to 1,807,562 (the “Exchange Cap”), which represented 19.99% of the Company’s outstanding

shares of common stock as of March 29, 2019, the date the agreement was first amended and restated, unless stockholder approval

or an exception pursuant to the rules of the Nasdaq Capital Market was obtained to issue more than 19.99%.

This limitation would

not apply if, at any time the Exchange Cap was reached and at all times thereafter, the average price paid for all shares issued

under the Aspire Purchase Agreement was equal to or greater than $0.86 (the “Minimum Price”), which was the closing

price of the Company’s common stock immediately preceding the signing of the agreement.

As of December 31, 2019, the Company

has not sold any shares of common stock under this agreement.

Subsequent to December 31, 2019 the Company sold approximately 1.8

million shares of common stock under this agreement resulting in proceeds of approximately $0.5 million.

2018 Private Placement Financing

November 5, 2018, the Company closed a PIPE financing with certain institutional investors, a key vendor and a member of its board

of directors.

Net proceeds from the PIPE financing were approximately $5.5 million, after deducting placement agent fees and other

offering expenses.

The securities sold by the Company consisted of 6,000 shares of a newly designated class of Series B convertible

preferred stock of the Company, with a stated value of $1,000 per share and an initial conversion price per share of $1.30 ( subject

to customary adjustment for stock dividends and stock splits) and warrants to purchase an aggregate of 2,307,685 shares of the

Company’s common stock.

Each investor received a warrant to purchase a number of shares of common stock equal to one half

the number of shares of common stock into which their Series B convertible preferred stock is initially convertible.

are exercisable immediately for a five-year period and have an exercise price of $1.30 per share (subject to customary adjustment

for stock dividends and stock splits but without the down-round protective provisions of previously issued warrants).

received in the PIPE financing were allocated to each instrument on a relative fair value basis.

Total proceeds of $6.0 million

were allocated as follows:

$1.4 million to warrants issued and $4.6 million to Series B convertible preferred stock.

The allocation

resulted in an effective conversion price for the Series B preferred stock that was below the quoted market price of the Company’s

common stock on the closing date.

As such, the issuance was considered a beneficial conversion feature equal to the intrinsic

value of the conversion feature on the closing date, resulting in a deemed dividend for the Series B convertible preferred stock

of approximately $0.7 million, recognized on the closing date and recorded as a reduction of income available to common stockholders

in computing basic and diluted loss per share.

investors in the PIPE financing who at the time of closing of the PIPE financing owned shares of the Company’s Series A

convertible preferred stock, exchanged, on a 1 for 1 share basis, their shares of Series A convertible preferred stock for shares

of a newly designated class of Series C convertible preferred stock of the Company, with a stated value of $1,000 per share and

convertible into shares of the Company’s common stock at an initial conversion price per share of $1.64 (subject to customary

adjustment for stock dividends and stock splits), (“the Exchange”).

As the Series A convertible preferred stock contained

a beneficial conversion feature, the Exchange was considered an extinguishment equal to the excess of (a) the fair value of the

consideration transferred to the holders of the Series A convertible preferred stock over (b) the carrying amount of the Series

A convertible preferred stock on the Company’s balance sheet plus (c) the amount previously recognized for the beneficial

conversion feature, or approximately $0.2 million, which was recognized on the closing date and recorded as a reduction of income

available to common stockholders in computing basic and diluted loss per share.

At-the-Market

Offering Agreement

November 6, 2019, the Company entered into an at the market sales agreement (“ATM Agreement”) with AGP, pursuant to

which it may offer and sell, from time to time through AGP, shares of its common stock (the “Placement Shares”) having

an aggregate offering price of up to $3,673,159 (which was subsequently increased to $8,030,917), subject to the terms and conditions

of the ATM Agreement.

Unless earlier terminated pursuant to the terms of the ATM Agreement, the ATM Agreement will automatically

terminate upon the earlier to occur of (i) issuance and sale of all of the Placement Shares to or through AGP and (ii) August

As of December 31, 2019, the Company sold approximately 8.1 million shares of common stock under the ATM Agreement resulting

net proceeds to of approximately $1.4 million after commissions and expenses of approximately $50,000.

Subsequent to December

31, 2019 the Company sold approximately 16.8 million shares of common stock under this agreement resulting in net proceeds of

approximately $4.4 million after commissions and expenses of approximately $0.2 million.

to purchase an aggregate of 8,413,017 shares of the Company’s common stock were outstanding at December 31, 2019.

These warrants are all vested and exercisable, have exercise prices ranging from $0.15 to $93.00 per share, with a weighted

average exercise price of $0.95, and expire at various dates through November 2023.

STOCK-BASED COMPENSATION

Incentive Plans

Company has issued equity awards pursuant to its 2015 Equity Incentive Plan (the “2015 Plan”), 2009 Stock Plan and

2008 Stock Plan (collectively the “Plans”).

The Plans permit the Company to grant non-statutory stock options, incentive

stock options and other equity awards to the Company’s employees, outside directors and consultants;

however, incentive

stock options may only be granted to the Company’s employees.

Beginning June 29, 2015, no further awards may be granted

under the 2009 Stock Plan or 2008 Stock Plan.

However, to the extent awards under the 2008 Plan or 2009 Plan are forfeited or

lapse unexercised or are settled in cash, the common stock subject to such awards will be available for future issuance under

the 2015 Plan.

June 2017, the stockholders of the Company approved an amendment to the 2015 Plan at the 2017 annual meeting of stockholders,

which among other things, increased the number of shares that may be issued pursuant to awards under the 2015 Plan by 83,800 shares

of common stock.

September 2017, the stockholders of the Company approved an amendment to the 2015 Plan at a special meeting of stockholders, which

among other things, increased the number of shares that may be issued pursuant to awards under the 2015 Plan by 2,585,871 shares

of common stock.

As of December 31, 2019, the aggregate number of shares of common stock authorized for issuance under the 2015

Plan, as amended, was 2,750,000, and 1,737,615 shares were available for issuance as of December 31, 2019.

following represents a summary of the options granted to employees and non-employees that are outstanding at December 31, 2019

and changes during the period then ended:

Average Exercise Price

Intrinsic Value

Average Remaining Contractual Life (in years)

at December 31, 2018

at December 31, 2019

exercise price for an option issued under the Plans is determined by the Board of Directors, but will be (i) in the case of an

incentive stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than

110% of the fair market value per share on the date of grant;

or (B) granted to any other employee, no less than 100% of the fair

market value per share on the date of grant;

and (ii) in the case of a non-statutory stock option, no less than 100% of the fair

market value per share on the date of grant.

The options awarded under the Plans will vest as determined by the Board of Directors

but will not exceed a ten-year period.

The weighted average grant date fair value per share of options granted during the year

ended December 31, 2019 was $0.62.

Value of Equity Awards

Company utilizes the Black-Scholes option pricing model to value awards under its Plans.

Key valuation assumptions include:

dividend yield.

The expected dividend is assumed to be zero as the Company has never paid dividends and has no current

plans to pay any dividends on the Company’s common stock.

stock-price volatility.

As the Company’s common stock only recently became publicly traded, the expected volatility

is derived from the average historical volatilities of publicly traded companies within the Company’s industry that

the Company considers to be comparable to the Company’s business over a period approximately equal to the expected term.

interest rate.

The risk-free interest rate is based on the U.S.

Treasury yield in effect at the time of grant for zero

Treasury notes with maturities approximately equal to the expected term.

The expected term represents the period that the stock-based awards are expected to be outstanding.

The Company’s

historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because

of a lack of sufficient data.

Therefore, the Company estimates the expected term by using the simplified method provided by

The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life

of the options.

material factors incorporated in the Black-Scholes model in estimating the fair value of the options granted for the periods presented

were as follows (adjusted for 1-for-10 reverse stock split):

the year ended December 31,

dividend yield

stock-price volatility

interest rate

Company recognized stock-based compensation expense for services within general and administrative expense in the accompanying

statements of operations of approximately $438,000 and $646,000 for the years ended December 31, 2019 and 2018, respectively.

As of December 31, 2019, there was approximately $254,000 of total unrecognized compensation cost related to unvested stock-based

compensation arrangements.

This cost is expected to be recognized over a weighted average period of 1.4 years.

stock options were exercised during the year ended December 31, 2019 and 2018.

RELATED PARTY TRANSACTIONS

director of the Company is a managing director of Javelin Venture Partners GP, LLC, the general partner of Javelin Venture Partners

GP, L.P., which holds a significant investment in the Company’s common stock and warrants.

Two directors of the Company

have acted as a managing director of Stonehenge Partners, LLC, which holds an investment in the Company’s common

than disclosed, the Company has not entered into or been a participant in any transaction in which a related party had or will

have a direct or indirect material interest.

10  — INCOME TAXES

of December 31, 2019, the Company has net operating loss carryforwards of approximately $63.5 million available to reduce

future taxable income, if any, for Federal and state income tax purposes.

federal and state net operating loss carryforwards

will begin to expire in 2028.

of December 31, 2019, the Company has Federal and state research and development credit carryforwards of approximately $3.2 million

and $3.1 million, respectively, available to reduce future taxable income, if any, for Federal and state income tax purposes.

The Federal credit carryforwards begin to expire in 2029.

California credits have no expiration date.

the Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of the Company’s net operating loss and research

tax credit carryforwards to offset taxable income may be limited based on cumulative changes in ownership.

The Company has not

completed an analysis to determine whether any such limitations have been triggered as of December 31, 2019.

The Company has no

income tax affect due to the recognition of a full valuation allowance on the expected tax benefits of future loss carry forwards

based on uncertainty surrounding realization of such assets.

reconciliation of the statutory income tax rates and the Company’s effective tax rate is as follows:

income tax, net of federal benefit

& entertainment

for income taxes

tax effects of the temporary differences and carry forwards that give rise to deferred tax assets consist of the following:

of December 31,

operating loss carry forwards

and development credit

deferred tax assets

(21,728,813 )

deferred tax assets

Company did not record any accruals for income tax accounting uncertainties for the years ended December 31, 2019 and 2018 .

Authoritative

guidance requires companies to accrue interest and related penalties, if applicable, on all tax positions for which reserves have

been established consistent with jurisdictional tax laws.

The Company’s policy is to recognize interest and penalties that

would be assessed in relation to the settlement value of unrecognized tax benefits as a component of income tax expense.

did not accrue either interest or penalties from inception through December 31, 2019.

Company does not have any unrecognized tax benefits that will significantly decrease or increase within 12 months of December

Company’s major tax jurisdictions are the United States and California.

All of the Company’s tax years will remain

open three and four years for examination by the Federal and state tax authorities, respectively, from the date of utilization

of the net operating loss.

The Company does not have any tax audits pending.

11 — SUBSEQUENT EVENTS

On January 15, 2020,

Ritter entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Qualigen Inc.

(“Qualigen”),

pursuant to which the Merger Sub will merge with and into Qualigen, with Qualigen surviving as a wholly owned subsidiary of Ritter.

Upon closing, on a pro forma basis and based upon the number of shares of Ritter common stock expected to be issued in the merger,

the pre-merger Ritter securityholders are expected to own approximately 7.5% of the combined company, on a fully diluted basis,

and the pre-merger Qualigen securityholders are expected to own approximately 92.5% of the combined company, on a fully diluted

To consummate the merger, Ritter and Qualigen stockholders must adopt and approve the Merger Agreement and a series of

Merger-related proposals.

In addition to obtaining such stockholder approvals and appropriate regulatory approvals, each of the

other closing conditions set forth in the Merger Agreement must be satisfied or waived.

Risks Related to COVID-19 Pandemic

The recent outbreak of COVID-19 originated

in Wuhan, China, in December 2019 and has since spread to multiple countries, including the United States and several European

On March 11, 2020, the World Health Organization declared the outbreak a pandemic.

The COVID-19 pandemic is affecting

the United States and global economies and may affect the Company’s operations and those of third parties on which the Company

While the potential economic impact brought by, and the duration of, the COVID-19 pandemic is difficult to assess or predict,

the impact of the COVID-19 pandemic on the global financial markets may reduce the Company’s ability to access capital,

which could negatively impact the Company’s short-term and long-term liquidity and the Company’s and Qualigen’s

ability to complete the Plan of Merger on a timely basis or at all.

The ultimate impact of the COVID-19 pandemic is highly uncertain

and subject to change.

The Company does not yet know the full extent of potential delays or impacts on its business, financing

or other activities or on healthcare systems or the global economy as a whole.

However, these effects could have a material impact

on the Company’s liquidity, capital resources, operations and business and those of the third parties on which we rely.

March 31, 2022

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