What changed in this filing

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Item 9A. Controls and Procedures

2021-03-26 compared with 2020-03-25 · 1775 added, 891 removed, 675 unchanged (80% of the section changed)

2 unchanged sentences

required by Rule 15d-15(b) of the Securities and Exchange Commission (the “SEC”), the Company carried out an evaluation,

under the supervision and with the participation of its management, consisting of the Company’s principal executive and

financial officer (who is the same person), of the effectiveness of the design and operation of the Company’s disclosure

controls and procedures as of December 31, 2019, the end of the most recent fiscal year covered by this report.

under the supervision and with the participation of its management, consisting of the Company’s principal executive officer

and principal financial officer, of the effectiveness of the design and operation of the Company’s disclosure controls and

procedures as of December 31, 2020, the end of the most recent fiscal year covered by this report.

term “disclosure controls and procedures,”

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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.

Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting

as defined in Rules 13a-15(f) under the Exchange Act.

The Company’s internal control over financial reporting is designed

to ensure that material information regarding the Company’s operations is made available to management and the board of

directors to provide them reasonable assurance that the published financial statements are fairly presented.

management, including its principal executive officer and principal financial officer, as appropriate, to allow timely decisions

regarding required disclosure.

are limitations inherent in any internal control, such as the possibility of human error and the circumvention or overriding of

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Annual Report on Internal Controls Over Financial Reporting

connection with the audit of the Company’s financial statements for the year ended December 31, 2019, the Company’s

management concluded that the Company had a material weakness in its internal controls resulting from the Chief Executive Officer

having almost complete responsibility for the processing of invoices and the preparation of checks, and the Company’s finance

department not having adequate internal staff to process the accounting information and prepare periodic financial statements

and footnotes.

While the Company has designed and implemented measures and systems that it believes address and mitigate these

control weaknesses, through expanded bookkeeping and review procedures and the services of qualified outside consultants with

expertise to perform specific accounting and finance functions, as well as review of major transactions and agreements by the

Board of Directors, the Company may not be successful in such efforts, which may undermine its ability to provide accurate, timely

and reliable reports on its financial and operating results.

In addition, if the Company identifies additional material weaknesses

in its internal control over financial reporting, the Company may not detect errors on a timely basis and its financial statements

Company’s management, consisting of its Chief Executive Officer and Chief Financial Officer, is responsible for establishing

and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) under the Exchange Act.

The Company’s

internal control over financial reporting is designed to ensure that material information regarding the Company’s operations

is made available to management and the Board of Directors to provide them reasonable assurance that the published financial statements

are fairly presented.

on the Company’s assessment, management has concluded that its internal control over financial reporting was not effective

as of December 31, 2020 to provide reasonable assurance regarding the reliability of financial reporting and the preparation of

financial statements in accordance with U.S.

Generally Accepted Accounting Principles, as described below.

connection with the audit of the Company’s consolidated financial statements for the year ended December 31, 2020, the Company’s

management has concluded that the Company had a material weakness in its internal controls at such date.

Until recently, the Company’s

Chief Executive Officer had almost complete responsibility for the processing of invoices and the preparation of checks, and the

Company’s finance department did not have adequate internal staff and resources to process the accounting information and

prepare periodic financial statements and footnotes.

In order to mitigate these internal control weaknesses, the Company had designed

and implemented measures and systems, including expanded bookkeeping and review procedures and the utilization of the services

of qualified outside consultants with the expertise to perform specific accounting and finance functions, as well as the review

of major transactions and agreements by the Board of Directors.

order to address these internal controls weaknesses, effective August 12, 2020, the Company entered into an Employment Agreement

with Robert N.

Weingarten to serve as the Company’s Vice President and Chief Financial Officer.

Weingarten is an experienced

business consultant and advisor focusing on accounting and SEC compliance issues.

Since 1979, Mr.

Weingarten has provided such

financial consulting and advisory services, has acted as chief financial officer, and has served on the boards of directors of

numerous public companies in various stages of development, operation or reorganization.

Weingarten has experience in a variety

of industries, including the pharmaceutical industry.

Weingarten is familiar with the financial and business operations of

the Company, as he has provided accounting and financial consulting services to the Company for a number of years with respect

to the preparation of the Company’s consolidated financial statements and certain other financial and compliance matters.

During the next several months, it is expected that Mr.

Weingarten will work with management to implement various policies and

procedures that are expected to address and mitigate these internal control weaknesses.

these efforts may not be fully successful, which could undermine the Company’s ability to provide accurate, timely and reliable

reports on its financial and operating results.

In addition, if the Company identifies additional material weaknesses in its internal

control over financial reporting, the Company may not detect errors on a timely basis and its consolidated financial statements

may be materially misstated.

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negatively affect its internal control over financial reporting and result in additional material weaknesses.

annual report does not include an attestation report of the Company’s independent registered public accounting firm regarding

internal control over financial reporting.

Management’s report was not subject to attestation by the Company’s independent

registered public accounting firm pursuant to rules of the SEC that permit the Company to provide only management’s report

in this report.

believes that the consolidated financial statements included in this Annual Report on Form 10-K fairly present, in all material

respects, the Company’s financial condition, results of operations and cash flows as of and for the period ended December

Annual Report on Form 10-K does not include an attestation report of the Company’s independent registered public accounting

firm regarding internal control over financial reporting.

Management’s report was not subject to attestation by the Company’s

independent registered public accounting firm pursuant to rules of the SEC that permit the Company to provide only management’s

report in this report.

in Internal Controls Over Financial Reporting

were no changes in our internal controls over financial reporting during or subsequent to the fourth quarter of the year ended

December 31, 2019 that materially affected or are reasonably likely to materially affect the Company’s internal controls

over financial reporting.

Company’s management, consisting of its Chief Executive Officer and its Chief Financial Officer, has determined that no

change in the Company’s internal control over financial reporting (as that term is defined in Rules 13(a)-15(f) and 15(d)-15(f)

of the Securities Exchange Act of 1934) occurred during or subsequent to the period ended December 31, 2020 that has materially

affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting, other than

the material weaknesses as noted above.

OTHER INFORMATION

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

following table and text set forth the names of all directors and executive officer of the Company as of December 31, 2019.

Board of Directors is comprised of only one class.

All of the directors will serve until the next annual meeting of stockholders

and until their successors are elected and qualified, or until their earlier death, retirement, resignation or removal.

are no family relationships between or among the directors, executive officer or persons nominated or charged by the Company to

become directors or executive officers.

The executive officer serves at the discretion of the Board of Directors and is appointed

to serve until the first Board of Directors meeting following the annual meeting of stockholders.

The brief descriptions of the

business experience of each director and executive officer and an indication of directorships held by each director in other companies

subject to the reporting requirements under the Federal securities laws are provided herein below.

Also provided are the biographies

of the members of the Scientific Advisory Committee.

Company’s directors and executive officer are as follows:

Held with the Registrant

Chief Executive Officer, Chief Financial Officer and Director

and Executive Officers

following table and text set forth the names of all of our directors and executive officers as of March 12, 2021.

Directors is comprised of only one class.

All of the directors will serve until the next annual meeting of stockholders and until

their successors are elected and qualified, or until their earlier death, retirement, resignation or removal.

The brief descriptions

of the business experience of each director and executive officers and an indication of directorships held by each director in

other companies subject to the reporting requirements under the Federal securities laws are provided herein below.

Also provided

are the biographies of the members of the Scientific Advisory Committee and our consultants.

directors and executive officers are as follows:

Held with the Company

Chief Executive Officer, Chief Scientific Officer, and Chairman of the Board of Directors

Medical Officer

President and Chief Financial Officer

Administrative Officer

Winson Sze Chun Ho

of Directors and Executive Officer

Kovach founded the Company in August 2005 and is its President, Chief Executive Officer, Chief Financial Officer and a

member of its Board of Directors.

of Directors and Executive Officers

Kovach founded the Company in August 2005 and is our President, Chief Executive Officer, Chief Scientific Officer and

a member of our Board of Directors.

He received a B.A.

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Stony Brook, as a result of which

he has been devoting 100% of his time to the Company’s business activities since that date.

he has been devoting 100% of his time to our business activities since that date.

Miser, M.D., is a pediatric hematologist/oncologist, internationally recognized as an expert in the study and treatment of

childhood cancers.

His outstanding career includes leadership positions as Clinical Director, Department of Pediatrics, Division

of Pediatric Hematology/Oncology, Children’s Hospital and Medical Center and Associate Member, Fred Hutchinson Cancer Research

Center, Seattle, Washington;

Chairman, Division of Pediatrics, Director, Department of Pediatric Hematology/Oncology, President

and Chief Executive Officer, and Chief Medical Officer, all at City of Hope National Medical Center, Duarte, California.

2009, he has been a member of the Active Staff, Department of Pediatrics at City of Hope, most recently part-time, and Chair Professor,

College of Medical Sciences and Technology, Taipei Medical University, Taipei, Taiwan.

Miser has extensive experience in the clinical development of new anti-cancer drugs for pediatric malignancies, leading many clinical

trials at institutional and national cancer study groups.

He is expert in the design and monitoring of clinical cancer trials

and was a member of the Soft Tissue Sarcoma Strategy Group, and Member of the New Agents Executive and Steering Committee, Phase

II Coordinator Children’s Cancer Group and Chairman, Data Monitoring Committee, National Wilms Tumor Society.

He has authored

more than a 100 peer reviewed articles dealing primarily with pediatric clinical cancer studies.

have entered into an Employment Agreement with Mr.

Weingarten to serve as our Vice President and Chief Financial Officer effective

August 12, 2020.

Weingarten is an experienced business consultant and advisor with a consulting practice focusing on accounting

and SEC compliance issues.

Since 1979, Mr.

Weingarten has provided such financial consulting and advisory services, has acted

as chief financial officer, and has served on the boards of directors of numerous public companies in various stages of development,

operation or reorganization.

Weingarten has experience in a variety of industries, including the pharmaceutical industry.

Weingarten has been a Director of Guardion Health Sciences, Inc.

since June 2015 and Chairman of its Board of Directors since

Previously, Mr.

Weingarten served as Lead Director on Guardion’s Board of Directors from January 2017 to March

From July 2017 to June 2018, Mr.

Weingarten was the Chief Financial Officer of Alltemp, Inc.

From April 2013 to February

Weingarten served on the Board of Directors of RespireRx Pharmaceuticals Inc.

and also served as its Vice President

and Chief Financial Officer.

Weingarten received a B.A.

in Accounting from the University of Washington in 1974, a M.B.A.

in Finance from the University of Southern California in 1975, and is a Certified Public Accountant (inactive) in the State of

Forman has led our business development as a consultant since 2013.

Effective as of October 1, 2020, Mr.

Forman was appointed

as our Chief Administrative Officer.

In his capacity as a consultant, and in his role as Chief Administrative Officer, his responsibilities

include overseeing all internal operations, the development of science/business collaborations, and the management of our growing

intellectual property portfolio.

Prior to his involvement with our company, he served as Counsel and Senior Project Manager at

Shore Group Associates managing in-house legal, tax, and regulatory affairs and supervising client relations for financial software

and mobile application development teams.

an attorney, Mr.

Forman has represented and advised both technology and biotechnology companies, entrepreneurs, non-profits, and

start-ups with a focus on intellectual property, licensing, corporate structure and transactions.

Forman earned a B.A.

degree Cum Laude from Loyola Marymount University and a J.D.

from the Benjamin N.

Cardozo School of Law.

He has an active law license and is a member of the New York State Bar Association.

Palmedo, Ph.D., is a physicist, entrepreneur and corporate manager.

Palmedo joined the Company’s Board of Directors

on June 30, 2006.

He founded and served as Chairman of the International Resources Group (IRG), an international consultancy in

energy, natural resources and economic development.

Palmedo joined our Board of Directors on June 30, 2006.

He founded and served as Chairman of the International Resources Group (IRG), an international consultancy in energy, natural

resources and economic development.

IRG was bought by L3 Communications in 2008.

Palmedo designed and was

the first President of the Long Island Research Institute formed by Brookhaven National Laboratory, Cold Spring Harbor Laboratory,

and SUNY –

Palmedo designed and was the first President

of the Long Island Research Institute formed by Brookhaven National Laboratory, Cold Spring Harbor Laboratory, and SUNY –

Stony Brook to facilitate the commercialization of technologies.

Palmedo joined in the formation

of Kepler Financial Management, Ltd., a quantitative financial research and trading company.

He was President and Managing Director

until 1991, when Renaissance Technologies Corporation acquired the company.

Palmedo joined in the formation of Kepler Financial

Management, Ltd., a quantitative financial research and trading company.

He was President and Managing Director until 1991, when

Renaissance Technologies Corporation acquired the company.

Palmedo served on the boards of Asset Management Advisors, the Teton Trust Company, EHR Investments and C-Quest Capital, and is

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immune responses to their cancers is of special

interest to the Company as the enzyme target of its lead clinical compound, LB-100, has been reported recently to be critical

to immune function.

interest to us as the enzyme target of its lead clinical compound, LB-100, has been reported recently to be critical to immune

Forman’s current work centers on T cells and their cancer-fighting potential.

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Fellow in the Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health.

His research included several studies of the Company’s lead clinical compound, the protein phosphatase 2A inhibitor LB-100,

including the demonstration that LB-100 potentiates the effectiveness of the immune checkpoint blocker PD-1 in several preclinical

These results were recently published in the scientific journal Nature Communications .

His research included several studies of our lead clinical compound, the protein phosphatase 2A inhibitor LB-100, including the

demonstration that LB-100 potentiates the effectiveness of the immune checkpoint blocker PD-1 in several preclinical models.

results were recently published in the scientific journal Nature Communications .

Yen, M.D., Ph.D., F.A.C.P.

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ADVISORY COMMITTEE

Scientific Advisory Committee (the “Committee”) was established to advise management of the Company in three areas:

Scientific Advisory Committee was established to advise our management in three areas:

human molecular pathology;

the clinical management of human brain tumors;

management of human brain tumors;

and medicinal chemistry.

The Company’s objective

is to meet with the Committee as a group annually, with some members participating via telephone conference.

The Committee members

have been apprised of the Company’s general objectives and several of the specific challenges and leads for developing improved

therapies for human brain tumors.

The Committee members do not serve in any management capacity with the Company.

of the Company’s Committee currently are:

Ojima, B.S., M.S., Ph.D.

Ojima is Distinguished Professor of Chemistry and Director, Institute of Chemical Biology and Drug Discovery, SUNY –

He is an internationally recognized expert in medicinal chemistry, including anticancer agents and enzyme inhibitors, development

of efficient synthetic methods for organic synthesis by means of organometallic reagents, homogeneous catalysis and organometallic

chemistry, peptide and peptide mimetics, beta-lactam chemistry, and organoflourine chemistry at the biomedical interface.

Ojima is a recipient of the Arthur C.

Cope Scholar Award (1994) and the E.

Hershberg Award (for important discovery of medicinally

active substances) (2001) from the American Chemical Society;

The Chemical Society of Japan Award (for distinguished achievements)

Outstanding Inventor Award from the Research Foundation of the State University of New York (2002).

He is a Fellow of

Guggenheim Memorial Foundation (1995 –), the American Association for the Advancement of Science (1997 –),

and The New York Academy of Sciences (2000 –).

Ojima is a member of the American Chemical Society, American Association for the Advancement of Science, American Association

for Cancer Research, American Peptide Society, the Chemical Society of Japan, the Society of Synthetic Organic Chemistry, Japan,

New York Academy of Sciences, and Signa Xi.

He has served as a consultant for E.

du Pont, Eli Lilly, Air Products & Chemicals,

Mitsubishi Chem.

Inc., Nippon Steel Corp., Life Science Division, Rhone-Poulenc Rorer, ImmunoGen, Inc., Taiho Pharmaceutical Co.,

Milliken & Co., Aventis Pharma, OSI Pharmaceuticals, Inc.

and Mitsubishi Chem.

Our objective is to meet with the Committee as a group annually, with

some members participating via telephone conference.

The Committee members have been apprised of our general objectives and several

of the specific challenges and leads for developing improved therapies for human brain tumors.

The Committee members do not serve

in any management capacity with us.

Our Committee currently is comprised as follows:

Von Hoff, M.D.

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Research Workshop.

Company does not presently have an audit committee.

The Board of Directors acts in that capacity and has determined that it does

not currently have a person qualifying as an audit committee financial expert serving on the Company’s Board of Directors.

Company’s Board of Directors adopted a code of ethics covering all of the Company’s executive officers and key employees.

A copy of the Company’s code of ethics will be furnished without charge to any person upon written request.

Requests should

Secretary, Lixte Biotechnology Holdings, Inc., 248 Route 25A, No.

Schwartzberg, JD, ScD (hon) has been a consultant to the Company since its inception.

Previously he was the Chairman of the Board,

President and CEO of the City of Hope National Medical Center, one of the nation’s leading biomedical research and treatment

facilities and a National Cancer Institute (NCI) Comprehensive Cancer Center.

Following his departure, the Graduate School of

Biological Science of The Beckman Research Institute at the City of Hope awarded him the degree of Doctor of Science, honoring

his work in the advancement of science through programmatic development and the growth of the Graduate School.

This was the first

degree awarded by the Beckman Graduate School., which received its full academic accreditation during Mr.

Schwartzberg’s

tenure as the school’s president.

He is now City of Hope Chairman Emeritus for life.

to his joining the City of Hope Mr.

Schwartzberg was Vice Chairman of the Board of Sterling Bank of Los Angeles, of which he was

a founder and where he served for many years as the Chairman of the Loan Committee until the bank’s sale.

Additionally,

he was a founding shareholder of Skechers USA, Inc.

He is currently a consultant to Skechers and both trustee and

co-trustee of trusts that hold the controlling interest in the company.

Schwartzberg earned a Juris Doctorate awarded magna cum laude.

He practiced law, specializing in business structure and transactions

and remains a member in good standing of the California Bar, He is the author of two books.

Warning Toxic Business Mistakes

and How to Avoid Making Them and Jane Austen’s Persuasion Annotated, a Royal Navy Reading Companion .

Relationships

Forman, our appointed Chief Administrative Officer, is the son of board member Dr.

Stephen Forman and son-in-law of our consultant

Gil Schwartzberg.

Julie Forman, the wife of Eric Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley

Wealth Management, where the Company’s cash is deposited and the Company maintains a continuing banking relationship.

Board of Directors undertook a review of the independence of our directors and considered whether any director has a relationship

with us that could compromise that director’s ability to exercise independent judgment in carrying out that director’s

responsibilities.

Our Board of Directors has affirmatively determined that Philip Palmedo, Stephen Forman, Winson Sze Chun Ho,

and Yun Yen are each an “independent director,”

as defined under the Nasdaq rules.

of Our Board of Directors

Board of Directors directs the management of our business and affairs, as provided by Delaware law, and conducts its business

through meetings of the Board of Directors and its standing committees.

We have a standing audit committee and compensation committee.

Our entire Board of Directors will serve in place of a nominating and corporate governance committee.

In addition, from time to

time, special committees may be established under the direction of the Board of Directors when necessary to address specific issues.

audit committee is responsible for, among other things:

and retaining the independent auditors to conduct the annual audit of our financial statements;

the proposed scope and results of the audit;

and pre-approving audit and non-audit fees and services;

accounting and financial controls with the independent auditors and our financial and accounting staff;

and approving transactions between us and our directors, officers and affiliates;

procedures for complaints received by us regarding accounting matters;

internal audit functions, if any;

the report of the audit committee that the rules of the SEC require to be included in our annual meeting proxy statement.

audit committee consists of Dr.

Philip Palmedo, Dr.

Yun Yen, and Dr.

Winson Sze Chun Ho, with Dr.

Palmedo serving

Our Board of Directors has affirmatively determined that each of the committee members meet the definition of “independent

director”

under the Nasdaq rules, and that they meet the independence standards under Rule 10A-3.

Each member of our audit

committee meets the financial literacy requirements of the Nasdaq rules.

In addition, our Board of Directors has determined that

Palmedo qualifies as an “audit committee financial expert,”

as such term is defined in Item 407(d)(5) of Regulation

Our Board of Directors has adopted a written charter for the audit committee, which is available on our principal corporate

website at www.lixte.com .

compensation committee is responsible for, among other things:

and recommending the compensation arrangements for executive management;

and reviewing general compensation policies with the objective to attract and retain superior talent, to reward individual

performance and to achieve our financial goals;

administering

our stock incentive plans;

the report of the compensation committee that the rules of the SEC require to be included in our annual meeting proxy statement.

compensation committee consists of Dr.

Stephen Forman and Dr.

Philip Palmedo, with Dr.

Our Board of Directors has determined that all three committee members are independent directors under Nasdaq rules.

Our Board of Directors has adopted a written charter for the compensation committee, which is available on our principal corporate

website at www.lixte.com .

and Corporate Governance

our entire Board of Directors serves in place of a nominating and corporate governance committee, our independent directors on

the board are responsible for, among other things:

members of the Board of Directors;

a set of corporate governance principles applicable to our company;

the evaluation of our Board of Directors.

Board of Directors will adopt resolutions addressing, among other things, the nomination process, as may be necessary in the future.

Board of Directors has adopted a code of ethics covering all of our executive officers and key employees.

A copy of our code of

ethics will be furnished without charge to any person upon written request.

Requests should be sent to:

Secretary, Lixte Biotechnology

Holdings, Inc., 248 Route 25A, No.

2, East Setauket, New York 11733.

on Liability and Indemnification Matters

Certificate of Incorporation contains provisions that limit the liability of our current and former directors for monetary damages

to the fullest extent permitted by Delaware law.

Delaware law provides that directors of a corporation will not be personally

liable for monetary damages for any breach of fiduciary duties as directors, except liability for:

breach of the director’s duty of loyalty to the corporation or its stockholders;

act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the Delaware General Corporation

transaction from which the director derived an improper personal benefit.

limitation of liability does not apply to liabilities arising under federal securities laws and does not affect the availability

of equitable remedies such as injunctive relief or rescission.

Certificate of Incorporation provides that we are authorized to indemnify our directors and officers to the fullest extent permitted

by Delaware law.

Our Amended and Restated Bylaws provide that we are required to indemnify our directors and executive officers

to the fullest extent permitted by Delaware law.

Our Amended and Restated Bylaws also provide that, upon satisfaction of certain

conditions, we are required to advance expenses incurred by a director or executive officer in advance of the final disposition

of any action or proceeding, and permit us to secure insurance on behalf of any officer, director, employee or other agent for

any liability arising out of his or her actions in that capacity regardless of whether we would otherwise be permitted to indemnify

him or her under the provisions of Delaware law.

Our Amended and Restated Bylaws also provide our Board of Directors with discretion

to indemnify our other officers and employees when determined appropriate by our Board of Directors.

We expect to enter into agreements

to indemnify our directors, executive officers and other employees as determined by the Board of Directors.

With certain exceptions,

these agreements provide for indemnification for related expenses, including, among other things, attorneys’

fees, judgments,

fines and settlement amounts incurred by any of these individuals in any action or proceeding.

We believe that these provisions

and agreements are necessary to attract and retain qualified persons as directors and officers.

We have obtained customary directors’

and officers’

liability insurance.

limitation of liability and indemnification provisions in our Certificate of Incorporation and Amended and Restated Bylaws may

discourage stockholders from bringing a lawsuit against our directors for breach of their fiduciary duty.

They may also reduce

the likelihood of derivative litigation against our directors and officers, even though an action, if successful, might benefit

us and other stockholders.

Further, a stockholder’s investment may be adversely affected to the extent that we pay the costs

of settlement and damage awards against directors and officers as required by these indemnification provisions.

At present, there

is no pending litigation or proceeding involving any of our directors, officers or employees for which indemnification is sought,

and we are not aware of any threatened litigation that may result in claims for indemnification.

with Section 16(a) of the Securities Exchange Act of 1934, as Amended

7 unchanged sentences

filing requirements applicable to the Company’s directors and executive officers were complied with under Section 16(a)

during the year ended December 31, 2020, except as follows:

Miser did not file a Form 3 or Form 4 with respect to

his appointment as Chief Medical Officer of the Company effective August 1, 2020 and the concurrent grant of options to him in

conjunction with such appointment :

EXECUTIVE COMPENSATION

Grants in 2018 and 2019 - Named Executive Officer

Option Exercises in 2018 and 2019 –

Named Executive Officer

Values at December 31, 2018 and at 2019 - Named Executive Officer

Company has not entered into any employment agreements with management.

Any future compensation arrangements are subject to the

approval of the Board of Directors.

the years ended December 31, 2018 and 2019, the Company paid Dr.

Kovach, the Company’s Chief Executive Officer and

Chief Financial Officer, an annual salary of $60,000.

Prior to February 23, 2017, Dr.

Kovach devoted approximately 50% of his

time to his academic commitments at SUNY –

Stony Brook and approximately 50% of his time to the Company’s business

Effective February 23, 2017, Dr.

Kovach retired from his part-time (50%) academic position at SUNY –

as a result of which he has been devoting 100% of his time to the Company’s business activities since that date.

Kovach is not compensated separately for his service on the Company’s Board of Directors.

Kovach is reimbursed for out-of-pocket

“ITEM 16.

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE –

Related Party Transactions”

for disclosures with respect to consulting agreements involving directors and related parties.

AND DIRECTOR COMPENSATION

Compensation Table

table set forth below presents the compensation awarded to, earned by or paid to our named executive officers for the years ended

December 31, 2020, 2019 and 2018.

COMPENSATION TABLE

Stock Awards ($)

Option Awards ($)(1)

Non-Equity Incentive Plan Compensation ($)

Non-Qualified Deferred Compensation Earnings ($)

All Other Compensation ($)

Weingarten (4)

(1) Consists of grant date fair value of option award calculated pursuant to the Black-Scholes option-pricing model.

Kovach has been the Company’s President and Chief Executive Officer since inception and entered into an employment

agreement with the Company effective July 15, 2020.

Miser has been the Company’s Chief Medical Officer since August 1, 2020.

In connection with his employment agreement,

Miser was awarded an option grant for 83,333 shares of the Company’s common stock valued at $6.8718 per share.

Weingarten has been the Company’s Vice President and Chief Executive Officer since August 12, 2020.

In connection

with his employment agreement, Mr.

Weingarten was awarded an option grant for 58,333 shares of the Company’s common stock

valued at $6.8718 per share.

Forman has been the Company’s Chief Administrative Officer since July 15, 2020.

In connection with his employment

agreement, Mr.

Forman was awarded an option grant for 58,333 shares of the Company’s common stock valued at $6.8718 per

were no option exercises during the years ended December 31, 2018, 2019 or 2020.

Equity Awards at December 31, 2020

table set forth below presents information regarding outstanding stock options held by our named executive officers as of December

There were no stock options issued and outstanding to our executive officers at December 31, 2019.

UNEXERCISABLE

August 1, 2020

August 1, 2025

August 12, 2020

August 12, 2025

October 16, 2017

October 16, 2022

August 12, 2020

August 12, 2025

intrinsic value of exercisable but unexercised in-the-money stock options held by our named executive officers at December 31,

2020 was approximately $75,669, based on a fair market value of $3.17 per share on December 31, 2020.

John Kovach .

On July 15, 2020, the Company entered into an employment agreement with Dr.

John Kovach pursuant to which Dr.

Kovach is to continue to act as the Company’s President, Chief Executive Officer and Chief Scientific Officer.

His responsibilities

shall be for the oversight of the Company’s entire operations and strategic planning, and shall be the primary contact between

the Company’s executive team and the Board of Directors, to whom he shall report.

Kovach shall supervise all scientific

endeavors, providing guidance to the Chief Medical Officer.

He shall be the principal spokesperson for the Company.

will receive an annual salary of $250,000, payable monthly.

The effective date of the agreement was October 1, 2020 and shall

remain in effect until the earlier of (i) one year from the effective date, automatically renewable for additional one-year periods

unless terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, (ii) his death,

or (iii) termination for cause.

During the year ended December 31, 2020, the Company incurred charges for salary in the amount

of $62,500 with respect to this agreement, which amount is included in general and administrative costs in the Company’s

consolidated statements of operations.

to the employment agreement described above, Dr.

Kovach was paid a salary of $45,000, $60,000 and $60,000 for the years ended

December 31, 2020, 2019 and 2018, respectively, which amounts are included in general and administrative costs in the Company’s

consolidated statements of operations.

On July 15, 2020, as amended on August 12, 2020, the Company entered into an employment agreement with Eric Forman,

pursuant to which Mr.

Forman will act as the Company’s Chief Administrative Officer reporting directly to the Company’s

Chief Executive Officer.

Forman’s primary function shall be to oversee the Company’s internal operations, including

IT, licensing, legal, personnel, marketing, and corporate governance.

Forman will receive an annual salary of $120,000, payable

Forman was also granted stock options to acquire 350,000 shares of the Company’s common stock.

The effective

date of the agreement was October 1, 2020 and shall remain in effect until the earlier of (i) one year from the effective date,

automatically renewable for additional one-year periods unless terminated by either party upon 60 days written notice prior to

the end of the applicable one-year period, (ii) his death, or (iii) termination for cause.

During the year ended December 31,

2020, the Company incurred charges for salary in the amount of $30,000 with respect to this agreement, which amounts is included

in general and administrative costs in the Company’s consolidated statements of operations.

to the employment agreement described above, Mr.

Forman was paid consulting fees of $38,000, $48,000 and $48,000 for the years

ended December 31, 2020, 2019 and 2018, respectively, which amounts are included in general and administrative costs in the Company’s

consolidated statements of operations.

James Miser .

On August 1, 2020, the Company entered into an employment agreement with Dr.

James Miser, M.D., pursuant to which

Miser was appointed as the Company’s Chief Medical Officer.

Under the employment agreement, Dr.

Miser will play a leadership

role in planning, implementation and oversight of clinical trials.

Miser will be responsible for assisting and developing

strategic clinical goals and the implementation and safety monitoring of investigational studies.

Miser will be the primary

medical monitor for all clinical investigational studies and for the oversight of third party CRO monitors.

Miser will work

closely with the Company’s Chief Executive Officer on the development of specific goals needed to ensure the timely implementation

of appropriate clinical studies needed for successful registration of therapeutic products and new drug development.

will be required to devote at least 50% of his business time to the Company’s activities.

Miser will receive an annual

salary of $150,000.

Miser was also granted stock options to acquire 500,000 shares of the Company’s common stock.

effective date of the agreement was August 1, 2020.

The agreement shall remain in effect until the earlier of (i) one year from

the effective date, automatically renewable for additional one-year periods unless terminated by either party upon 60 days written

notice prior to the end of the applicable one-year period, (ii) his death, or (iii) termination for cause.

During the year ended

December 31, 2020, the Company incurred charges for salary in the amount of $62,500 with respect to this agreement, which amount

is included in general and administrative costs in the Company’s consolidated statements of operations.

On August 12, 2020, the Company entered into an employment agreement with Robert N.

Weingarten pursuant to

Weingarten was appointed as the Company’s Vice-President and Chief Financial Officer.

Weingarten will receive

an annual salary of $120,000.

Weingarten was also granted stock options to acquire 350,000 shares of the Company’s common

The effective date of the agreement was August 12, 2020.

The agreement shall remain in effect until the earlier of (i)

one year from the effective date, automatically renewable for additional one-year periods unless terminated by either party upon

60 days written notice prior to the end of the applicable one-year period, (ii) his death, or (iii) termination for cause.

the year ended December 31, 2020, the Company incurred charges for salary in the amount of $46,451 with respect to this agreement,

which amount is included in general and administrative costs in the Company’s consolidated statements of operations.

to the employment agreement described above, Mr..

Weingarten was paid consulting fees of $79,995, $80,380 and $68,250 for the

years ended December 31, 2020, 2019 and 2018, respectively, which amounts are included in general and administrative costs in

the Company’s consolidated statements of operations.

have entered into various consulting agreements with Gil Schwartzberg, a key consultant to the Company, as described at “ITEM

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE”.

of Director Compensation

May 13, 2016, in conjunction with his appointment as a director of the Company, the Company granted to Dr.

options to purchase an aggregate of 200,000 shares of common stock under the 2007 Plan, exercisable for a period of five years

from vesting date at $0.16 per share, which was the fair market value of the Company’s common stock on such date.

of such stock option (100,000 shares) vested on May 13, 2016 and the remaining one-half of such stock option (100,000 shares)

vested on May 13, 2017.

The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,

was determined to be $31,180 ($0.1559 per share), of which $15,590 was attributable to the stock options fully-vested on May 13,

2016 and was therefore was charged to operations on that date.

The remaining unvested portion of the fair value of the stock options

was charged to operations ratably from May 13, 2016 through May 13, 2017.

During the year ended December 31, 2017, the Company

recorded a charge to operations of $5,681 with respect to these stock options.

October 16, 2017, in connection with his continuing role as a member of the Company’s Board of Directors, Dr.

Palmedo was granted fully-vested stock options to purchase 50,000 shares of the Company’s common stock.

The stock options

are exercisable for a period of five years from the date of grant at $0.15 per share, which was the fair market value of the Company’s

common stock on such date.

The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,

was determined to be $7,499 ($0.1500 per share), which was charged to operations on the date of grant.

October 16, 2017, in connection with his continuing role as a member of the Company’s Board of Directors, Dr.

Forman was granted fully-vested stock options to purchase 50,000 shares of the Company’s common stock.

The stock options

are exercisable for a period of five years from the date of grant at $0.15 per share, which was the fair market value of the Company’s

common stock on such date.

The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,

was determined to be $7,499 ($0.1500 per share), which was charged to operations on the date of grant.

August 4, 2018, in conjunction with their appointments as directors of the Company, the Company granted to Dr.

Winson Sze Chun

Yun Yen stock options for each person to purchase an aggregate of 200,000 shares of the Company’s common stock,

exercisable for a period of five years from the vesting date at $0.28 per share, which was the approximate fair market value of

the Company’s common stock on such date, with one-half of such stock options (100,000 shares each) vesting on August 4,

2018 and the remaining one-half of such stock options (100,000 shares each) vesting on August 4, 2019.

The fair value of these

stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $104,920 ($0.2623 per share),

of which $52,460 was attributable to the stock options fully-vested on August 4, 2018 and was therefore charged to operations

on that date.

The remaining unvested portion of the fair value of the stock options were charged to operations ratably from August

4, 2018 through August 4, 2019.

During the years ended December 31, 2019 and 2018, the Company recorded charges to operations

of $31,046 and $73,874, respectively, with respect to these stock options.

May 22, 2019, in recognition with their service as directors of the Company over the past year, the Company granted to Dr.

Sze Chun Ho, Dr.

August 4, 2018, in conjunction with their appointments as our directors, we granted to Dr.

Winson Sze Chun Ho and Dr.

stock options for each person to purchase an aggregate of 33,333 shares of our common stock, exercisable for a period of five

years from the vesting date at $1.68 per share, which was the approximate fair market value of the our common stock on such date,

with one-half of such stock options (16,667 shares each) vesting on August 4, 2018 and the remaining one-half of such stock options

(16,666 shares each) vesting on August 4, 2019.

The fair value of these stock options, as calculated pursuant to the Black-Scholes

option-pricing model, was determined to be $104,920 ($1.5738 per share), of which $52,460 was attributable to the stock options

fully-vested on August 4, 2018 and was therefore charged to operations on that date.

The remaining unvested portion of the fair

value of the stock options were charged to operations ratably from August 4, 2018 through August 4, 2019.

During the years ended

December 31, 2019 and 2018, we recorded charges to operations of $31,046 and $73,874, respectively, with respect to these stock

May 22, 2019, in recognition with their service as directors over the past year, we granted to Dr.

Winson Sze Chun Ho, Dr.

Stephen Forman, and Dr.

Philip Palmedo, fully-vested stock options to purchase an aggregate of 200,000

shares (50,000 shares each) of the Company’s common stock, exercisable for a period of five years from the vesting date

at $1.10 per share, which was the approximate fair market value of the Company’s common stock on such date.

The fair value

of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $189,060 ($0.9453

per share), which was attributable to the stock options fully vested on May 22, 2019 and was therefore charged to operations on

Philip Palmedo, fully-vested stock options to purchase an aggregate of 33,333 shares (8,333 shares

each) of our common stock, exercisable for a period of five years from the vesting date at $6.60 per share, which was the approximate

fair market value of our common stock on such date.

The fair value of these stock options, as calculated pursuant to the Black-Scholes

option-pricing model, was determined to be $189,060 ($5.6718 per share), which was attributable to the stock options fully vested

on May 22, 2019 and was therefore charged to operations on that date.

COMPENSATION TABLE

and Principal

Incentive Plan

Compensation ($)

Non-Qualified

Name and Principal

Stock Awards ($)

Option Awards ($)(1)

Non-Equity Incentive Plan Compensation ($)

Non-Qualified Deferred Compensation Earnings ($)

All Other Compensation ($)

Winson Sze Chun Ho

of grant date fair value of option award calculated pursuant to the Black-Scholes option-pricing model.

other compensation was paid in the form of cash.

Kovach is also the Company’s President, Chief Executive officer and Chief Financial Officer.

Kovach is also the Company’s President and Chief Executive Officer.

Advisory Committee Compensation

December 24, 2013, the Company entered into an agreement with NDA Consulting Corp.

(“NDA”) for consultation and advice

in the field of oncology research and drug development.

As part of the agreement, NDA also agreed to cause its president, Dr.

Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee.

In connection with this agreement,

NDA was granted stock options to purchase 100,000 shares of the Company’s common stock, which vested 25,000 shares on June

24, 2014, 2015, 2016 and 2017, exercisable for a period of five years from the date of grant at $0.13 per share, which was the

fair market value of the Company’s common stock on the grant date.

The fair value of these stock options, as calculated

pursuant to the Black-Scholes option-pricing model, was initially determined to be $12,960 ($0.13 per share).

The Company re-measures

the non-vested options to fair value at the end of each reporting period.

During the year ended December 31, 2017, the Company

recorded a charge to operations of $2,492 with respect to these stock options.

did not incur any compensation expense with respect to our Scientific Advisory Committee during the years ended December 31, 2018,

2019 or 2020.

Stock Incentive Plan

2020 Stock Incentive Plan (the “2020 Plan”) was adopted by our Board of Directors on July 14, 2020 and will be submitted

to our stockholders as soon as practicable.

Having an adequate number of shares available for future equity compensation grants

is necessary to promote our long-term success and the creation of stockholder value by:

us to continue to attract and retain the services of key service providers who would be eligible to receive grants;

participants’

interests with stockholders’

interests through incentives that are based upon the performance of

our common stock;

participants, through equity incentive awards, to achieve long-term growth in our business, in addition to short-term financial

a long-term equity incentive program that is competitive as compared to other companies with whom we compete for talent.

2020 Plan permits the discretionary award of incentive stock options (“ISOs”), non-statutory stock options (“NQSOs”),

restricted stock, restricted stock units (“RSUs”), stock appreciation rights (“SARs”), other equity awards

and/or cash awards to selected participants.

The 2020 Plan will remain in effect until July 14, 2030.

2020 Plan provides for the reservation of 2,333,333 shares of common stock for issuance thereunder (the “Share Limit”),

and provides that the maximum number of shares that may be issued pursuant to the exercise of ISOs is 2,333,333 (the “ISO

Limit”).

The number of shares available for issuance under the 2020 Plan constituted approximately 20.9% of our issued and

outstanding shares of common stock as of the date of board approval.

Features of the 2020 Plan

key features of the 2020 Plan are summarized as follows:

not terminated earlier by our Board of Directors, the 2020 Plan will terminate on July 14, 2030.

to a maximum aggregate of 2,333,333 shares of common stock may be issued under the 2020 Plan.

The maximum number of shares

that may be issued pursuant to the exercise of ISOs is also 2,333,333.

2020 Plan will generally be administered by a committee comprised solely of independent members of our Board of Directors.

This committee will be the Compensation Committee unless otherwise designated by our Board of Directors.

The board may designate

a separate committee to make awards to employees who are not officers subject to the reporting requirements of Section 16

of the Exchange Act.

consultants and board members are eligible to receive awards, provided that the Committee has the discretion to determine

(i) who shall receive any awards, and (ii) the terms and conditions of such awards.

may consist of ISOs, NQSOs, restricted stock, RSUs, SARs, other equity awards and/or cash awards.

options and SARs may not be granted at a per share exercise price below the fair market value of a share of our common stock

on the date of grant.

options and SARs may not be repriced or exchanged without stockholder approval.

maximum exercisable term of stock options and SARs may not exceed ten years.

are subject to recoupment of compensation policies adopted by us.

to Receive Awards .

Employees, consultants and our members of our Board of Directors and certain of our affiliated companies

are eligible to receive awards under the 2020 Plan.

The Committee determines, in its discretion, the selected participants who

will be granted awards under the 2020 Plan.

Subject to the 2020 Plan .

The maximum number of shares of common stock that can be issued under the 2020 Plan is 2,333,333

shares underlying forfeited or terminated awards (without payment of consideration), or unexercised awards become available again

for issuance under the 2020 Plan.

No fractional shares may be issued under the 2020 Plan.

No shares will be issued with respect

to a participant’s award unless applicable tax withholding obligations have been satisfied by the participant.

Administration

of the 2020 Plan .

The 2020 Plan will be administered by the Compensation Committee of the Board of Directors, which shall

consist of independent board members.

With respect to certain awards issued under the 2020 Plan, the members of the Committee

also must be “Non-Employee Directors”

under Rule 16b-3 of the Exchange Act.

Subject to the terms of the 2020 Plan,

the Committee has the sole discretion, among other things, to:

the individuals who will receive awards;

the terms and conditions of awards (for example, performance conditions, if any, and vesting schedule);

any defect, supply any omission, or reconcile any inconsistency in the 2020 Plan or any award agreement;

the vesting, extend the post-termination exercise term or waive restrictions of any awards at any time and under such terms

and conditions as it deems appropriate, subject to the limitations set forth in the 2020 Plan;

a participant to defer compensation to be provided by an award;

the provisions of the 2020 Plan and outstanding awards.

Committee may suspend vesting, settlement, or exercise of awards pending a determination of whether a selected participant’s

service should be terminated for cause (in which case outstanding awards would be forfeited).

Awards may be subject to any policy

that the Board of Directors may implement on the recoupment of compensation (referred to as a “clawback”

The members of the Board of Directors, the Committee and their delegates shall be indemnified by us to the maximum extent permitted

by applicable law for actions taken or not taken regarding the 2020 Plan.

In addition, the Committee may use the 2020 Plan to

issue shares under other plans or sub-plans as may be deemed necessary or appropriate, such as to provide for participation by

employees and those of any of our subsidiaries and affiliates.

A stock option is the right to acquire shares at a fixed exercise price over a fixed period of time.

The Committee

will determine, among other terms and conditions, the number of shares covered by each stock option and the exercise price of

the shares subject to each stock option, but such per share exercise price cannot be less than the fair market value of a share

of our common stock on the date of grant of the stock option.

The exercise price of each stock option granted under the 2020 Plan

must be paid in full at the time of exercise, either with cash, or through a broker-assisted “cashless”

sale program, or net exercise, or through another method approved by the Committee.

Stock options granted under the 2020 Plan

may be either ISOs or NQSOs.

In order to comply with Treasury Regulation Section 1.422-2(b), the 2020 Plan provides that no more

than 2,333,333 shares may be issued pursuant to the exercise of ISOs.

A SAR is the right to receive, upon exercise, an amount equal to the difference between the fair market value of the shares on

the date of the SAR’s exercise and the aggregate exercise price of the shares covered by the exercised portion of the SAR.

The Committee determines the terms of SARs, including the exercise price (provided that such per share exercise price cannot be

less than the fair market value of a share of our common stock on the date of grant), the vesting and the term of the SAR.

of a SAR may be in shares of common stock or in cash, or any combination thereof, as the Committee may determine.

be repriced or exchanged without stockholder approval.

A restricted stock award is the grant of shares of our common stock to a selected participant and such shares may

be subject to a substantial risk of forfeiture until specific conditions or goals are met.

The restricted shares may be issued

with or without cash consideration being paid by the selected participant as determined by the Committee.

The Committee also will

determine any other terms and conditions of an award of restricted stock.

RSUs are the right to receive an amount equal to the fair market value of the shares covered by the RSU at some future date after

The Committee will determine all of the terms and conditions of an award of RSUs.

Payment for vested RSUs may be in

shares of common stock or in cash, or any combination thereof, as the Committee may determine.

RSUs represent an unfunded and

unsecured obligation for us, and a holder of a stock unit has no rights other than those of a general creditor.

The 2020 Plan also provides that other equity awards, which derive their value from the value of our shares or

from increases in the value of our shares, may be granted.

In addition, cash awards may also be issued.

Substitute awards may

be issued under the 2020 Plan in assumption of or substitution for or exchange for awards previously granted by an entity which

we (or an affiliate) acquire.

Transferability of Awards .

Awards granted under the 2020 Plan generally are not transferrable other than by will or by

the laws of descent and distribution.

However, the Committee may in its discretion permit the transfer of awards other than ISOs.

In the event that we are a party to a merger or other reorganization or similar transaction, outstanding 2020

Plan awards will be subject to the agreement pertaining to such merger or reorganization.

Such agreement may provide for (i) the

continuation of the outstanding awards by us if we are a surviving corporation, (ii) the assumption or substitution of the outstanding

awards by the surviving entity or its parent, (iii) full exercisability and/or full vesting of outstanding awards, or (iv) cancellation

of outstanding awards either with or without consideration, in all cases with or without consent of the selected participant.

The Committee will decide the effect of a change in control of us on outstanding awards.

and Termination of the 2020 Plan .

The Board of Directors generally may amend or terminate the 2020 Plan at any time and

for any reason, except that it must obtain stockholder approval of material amendments to the extent required by applicable laws,

regulations or rules.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

following table sets forth, as of February 28, 2020, certain information regarding beneficial ownership of the Company’s

common stock (the only class of the Company’s voting equity securities issued and outstanding) by (i) each person or entity

who is known by the Company to own beneficially more than 5% of the Company’s outstanding shares of common stock, (ii) each

of the Company’s directors, and (iii) all directors and executive officers of the Company as a group.

As of February 28,

2020, there were 67,045,814 shares of the Company’s common stock issued and outstanding.

In computing the number and percentage

of shares beneficially owned by a person, shares of common stock that a person has a right to acquire within sixty (60) days of

February 28, 2020 pursuant to stock options, warrants, convertible preferred stock or other rights are counted as outstanding,

while these shares are not counted as outstanding for computing the percentage ownership of any other person.

Unless otherwise

indicated, the address for each stockholder listed in the following table is c/o Lixte Biotechnology Holdings, Inc., 248 Route

2, East Setauket, New York 11733.

This table is based upon information supplied by the Company’s directors, officers

and principal stockholders and reports filed with the Securities and Exchange Commission.

and Address of Beneficial Owner

table set forth below presents certain information regarding beneficial ownership of our common stock (the only class of our voting

equity securities issued and outstanding) as of March 12, 2021 by (i) each person or entity who is known by us to own beneficially

more than 5% of our outstanding shares of common stock, (ii) each of our directors, and (iii) all of our directors and executive

officers as a group.

As of March 12, 2021, there were 13,538,259 shares of our common stock issued and outstanding.

the number and percentage of shares beneficially owned by a person, shares of common stock that a person has a right to acquire

within sixty (60) days of March 12, 2021 pursuant to stock options, warrants, convertible preferred stock or other rights are

counted as outstanding, while these shares are not counted as outstanding for computing the percentage ownership of any other

This table is based upon information supplied by our directors, officers and principal stockholders and reports filed

with the Securities and Exchange Commission.

Name and Address of Beneficial Owner

of Beneficial

Directors and 5% stockholders

Officers and Directors

248 Route 25A, No.

Setauket, New York 11733

East Setauket, New York 11733

1,561,284 (1)

248 Route 25A, No.

Setauket, New York 11733

East Setauket, New York 11733

248 Route 25A, No.

Setauket, New York 11733

East Setauket, New York 11733

248 Route 25A, No.

Setauket, New York 11733

East Setauket, New York 11733

Winson Sze Chun Ho

248 Route 25A, No.

Setauket, New York 11733

officers and directors as a group (three persons)

and Barbara Kovach 2015 Trust

East Setauket, New York 11733

Robert Weingarten

248 Route 25A, No.

East Setauket, New York 11733

248 Route 25A, No.

East Setauket, New York 11733

1,423,182 (5)

248 Route 25A, No.

East Setauket, New York 11733

All officers and directors as a group (eight persons)

Other Stockholders Owning More Than 5%

John and Barbara Kovach 2015 Trust

Forman, Trustee

401 Park Avenue South, 10 th Floor

York, New York 10016

Park Avenue South, 10 th Floor

York, New York 10016

New York, New York 10016

1,333,333 (4)

Gil Schwartzberg

5500 Military Trail, Suite 22, Box 356

Florida 33458

Jupiter, Florida 33458

2,146,985 (6)

Debbie Schwartzberg

5500 Military Trail, Suite 22, Box 356

Florida 33458

Jupiter, Florida 33458

1,645,807 (7)

Arthur and Jane Riggs

4852 Saint Andres Avenue

Verne, California 91750

and Susan Greenberg

La Verne, California 91750

1,957,500 (8)

Robert and Susan Greenberg

228 Manhattan Beach Boulevard

Beach, California 90266

Manhattan Beach, California 90266

1,380,264 (9)

Bahl and Kavit K.

New York 11733

3 Pheasant Run

Setauket, New York 11733

1,000,000 (17)

1865 Palmer Avenue

by the Sea II

T8, 1/F, Unit A

NT, Hong Kong SAR

Includes of 1,100,000 shares of common stock and stock warrants to purchase 100,000 shares of common stock owned by the Philip

Palmedo Partnership, and 66,020 shares of common stock and stock options to purchase 550,000 shares of common stock owned by Dr.

Larchmont, New York 10538

Mayfair by the Sea II

Tower T8, 1/F, Unit A

21 Fo Chun Road Pak ShekKok

Taipo NT, Hong Kong SAR

1,084,210 (11)

Sabby Volatility Warrant Master Fund, Ltd.

c/o Ogier Fiduciary Services (Cayman) Limited

89 Nexus Way, Camana Bay

Grand Cayman KY1-9007

Cayman Islands

1,081,081 (16)

Includes 1,540,184 shares of common stock and stock warrants to purchase 21,100 shares of common stock owned as of record by the

Kovach Trust.

Kovach is a co-trustee of the Trust and has the exclusive right to control the investment of the assets

of the Trust.

Includes 183,333 shares of common stock and stock warrants to purchase 16,667 shares of common stock owned by the Philip Palmedo

Partnership, and 32,056 shares of common stock, stock warrants to purchase 21,053 shares of common stock and stock options to

purchase 141,666 shares of common stock owned by Dr.

Philip Palmedo.

Palmedo, as the general partner of the Philip Palmedo Partnership, has voting, dispositive and investment

control with respect to the common stock and common stock warrants owned by the partnership.

All stock options and common stock

warrants are immediately exercisable or within 60 days.

Includes of 22.500 shares of common stock owned by Dr.

Stephen Forman and stock options to purchase 300,000 shares of common stock

which are immediately exercisable or within 60 days.

Also includes 100,000 shares of common stock and stock warrants to purchase

100,000 shares of common stock owned by the Stephen Forman Living Trust dated 12/16/98.

Stephen Forman is trustee of the trust

and holds voting and dispositive power over the common stock and common stock warrants owned by the trust.

Palmedo, as the general partner of the Philip Palmedo

Partnership, has voting, dispositive and investment control with respect to the common stock and common stock warrants owned by

the partnership.

All stock options and common stock warrants are immediately exercisable or within 60 days.

Includes 24,803 shares of common stock, stock warrants to purchase 21,053 shares of common stock and stock options to purchase

99,999 shares of common stock which are immediately exercisable or within 60 days, owned by Dr.

Stephen Forman.

Also includes

16,667 shares of common stock and stock warrants to purchase 16,667 shares of common stock owned by the Stephen Forman Living

Trust dated 12/16/98.

Stephen Forman is trustee of the trust and holds voting and dispositive power over the common stock and

common stock warrants owned by the trust.

Includes 1,333,333 shares of common stock transferred by John Kovach and his wife, Barbara C.H.

4 unchanged sentences

Forman is the trustee of the John and Barbara Kovach 2015 Trust.

Includes 100,000 shares of common stock owned by Eric J.

Forman, stock options to purchase 300,000 shares of common stock and

stock warrants to purchase 20,000 shares of common stock.

Includes 21,931 shares of common stock, stock warrants to purchase 3,333 shares of common stock and stock options to purchase

64,585 shares of common stock owned by Eric J.

Eric Forman is the husband of Julie (Schwartzberg) Forman, the son-in-law

2 unchanged sentences

stock owned by the John and Barbara Kovach 2015 Trust, as to which Eric Forman, as trustee, has voting, dispositive and investment

Excludes 1,120,000 shares of common stock, stock options to purchase 1,750,000 shares of common stock and common stock

warrants to purchase 500,000 of common stock owned by the Julie Schwartzberg Trust, as to which Julie (Schwartzberg) Forman is

the beneficiary, and as to which Eric Forman disclaims beneficial ownership or control.

Also excludes 30,000 shares of common

stock owned by the Julie Forman 2015 Trust, the beneficiary of which is Cole Forman, the son of Eric and Julie Forman, as to which

David Sterling, as trustee, has voting, dispositive and investment control.

Also excludes 100,000 shares of common stock owned

by each of the Savannah Sterling Trust, Amanda Sterling Trust, Daniel Sterling Trust and Charles Sterling Trust, as to which Julie

Forman is the trustee.

Excludes 186,667 shares of common stock, stock options to purchase 291,666 shares of common stock and common stock warrants

to purchase 83,333 of common stock owned by the Julie Schwartzberg Trust, as to which Julie (Schwartzberg) Forman is the beneficiary,

and as to which Eric Forman disclaims beneficial ownership or control.

Also excludes 33,333 shares of common stock owned by the

Julie Forman 2015 Trust, the beneficiary of which is Cole Forman, the son of Eric and Julie Forman, as to which David Sterling,

as trustee, has voting, dispositive and investment control.

Also excludes 16,668 shares of common stock owned by each of the Savannah

Sterling Trust, Amanda Sterling Trust, Daniel Sterling Trust and Charles Sterling Trust, as to which Julie Forman is the trustee.

All stock options and stock warrants are immediately exercisable or within 60 days.

Includes 2,255,556 shares of common stock owned by the Gil & Debbie Schwartzberg Family Trust dated November 19, 2003, Gil

Schwartzberg Separate Property, as to which Gil Schwartzberg, as trustee, has voting, dispositive and investment control, and

stock options to purchase 500,000 shares of common stock owned by Gil Schwartzberg.

All stock options and common stock warrants

are immediately exercisable or within 60 days.

Includes 375,926 shares of common stock owned by the Gil & Debbie Schwartzberg Family Trust dated November 19, 2003, Gil Schwartzberg

Separate Property, as to which Gil Schwartzberg, as trustee, has voting, dispositive and investment control, stock warrants to

purchase 105,264 shares of common stock and stock options to purchase 83,334 shares of common stock owned by Gil Schwartzberg.

All stock options and common stock warrants are immediately exercisable or within 60 days.

includes the following:

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Includes 1,018,333 shares of common stock, 729,167 shares of common stock issuable upon conversion of 350,000 shares of Series

A Convertible Preferred Stock, and common stock warrants to purchase 1,260,000 shares of common stock owned by the Arthur and

Jane Riggs 1990 Revocable Trust.

A Convertible Preferred Stock, and common stock warrants to purchase 210,000 shares of common stock owned by the Arthur and Jane

Riggs 1990 Revocable Trust.

Arthur Riggs and his wife, Jane Riggs, are co-trustees of the trust and share voting and dispositive

2 unchanged sentences

January 15, 2016, are non-voting, and are immediately convertible into common stock.

Consists of 5,650,000 shares of common stock and common stock warrants to purchase 2,000,000 shares of common stock owned by the

Greenberg Family Trust dated May 3, 1988.

The trust is a revocable trust, and Arthur Greenberg and his wife, Susan Greenberg,

are co-trustees of the trust and share voting and dispositive power over the shares of common stock.

Includes 1,000,000 shares of common stock owned by Lawrence J.

Goldstein and common stock warrants to purchase 1,000,000 shares

of common stock owned by Lawrence J.

Also includes 1,000,000 shares of common stock and common stock warrants to purchase

1,000,000 shares of common stock owned by the Santa Monica Partners, L.P.

Goldstein is the sole managing member of

the general partner, SMP Asset Management LLC.

Excludes stock options to purchase 250,000 shares of common stock owned by Dr.

Winson Sze Chun Ho, a director of the Company and

the son of Hung Tak Ho, as to which Hung Tak Ho disclaims beneficial ownership or control.

Includes stock options to purchase 250,000 shares of common stock.

Excludes 6,000,000 shares of common stock owned by Hung Tak

Ho, the father of Dr.

Winson Sze Chun Ho, a director of the Company, as to which Dr.

Winson Sze Chun Ho disclaims beneficial ownership

Consists of 994,299 shares of common stock and common stock warrants to purchase 385,965 shares of common stock owned by the Greenberg

Family Trust dated May 3, 1988.

The trust is a revocable trust, and Arthur Greenberg and his wife, Susan Greenberg, are co-trustees

of the trust and share voting and dispositive power over the shares of common stock.

Includes 166,667 shares of common stock and stock warrants to purchase 166,667 shares of common stock owned by Lawrence J.

Also includes 166,667 shares of common stock and stock warrants to purchase 166,667 shares of common stock owned by the Santa

Monica Partners, L.P.

Goldstein is the sole managing member of the general partner, SMP Asset Management LLC.

Includes 1,042,105 shares of common stock and stock warrants to purchase 42,105 shares of common stock.

Excludes stock options

to purchase 91,667 shares of common stock owned by Dr.

Winson Sze Chun Ho, a director of ours, and the son of Hung Tak Ho, as

to which Hung Tak Ho disclaims beneficial ownership or control.

Includes stock options to purchase 91,667 shares of common stock.

with respect to securities authorized for issuance under equity compensation plans is provided at “ITEM 5.

MARKET FOR COMMON

EQUITY AND RELATED STOCKHOLDER MATTERS”.

Excludes 1,042,105 shares of common stock and common stock warrants

to purchase 42,105 shares of common stock owned by Hung Tak Ho, the father of Dr.

Winson Sze Chun Ho, a director of ours, as to

Winson Sze Chun Ho disclaims beneficial ownership or control.

Includes 52,632 shares of common stock, stock warrants to purchase 52,632 shares of common stock and stock options to purchase

91,666 shares of common stock which are immediately exercisable or within 60 days.

Consists of stock options to purchase 14,584 shares of common stock which are immediately exercisable or within 60 days.

Consists of stock options to purchase 20,834 shares of common stock which are immediately exercisable or within 60 days.

Consists of 1,081,081 shares of common stock pursuant to a Schedule 13G filed with the Securities and Exchange Commission on March

Includes 833,333 shares of common stock and stock warrants to purchase 166,667 shares of common stock.

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Related Party Transactions

Company’s principal office facilities are being provided without charge by Dr.

Kovach, the Company’s President,

Chief Executive Officer and Chief Financial Officer.

Such costs were not material to the Company’s consolidated financial

statements and accordingly, have not been reflected therein.

September 12, 2007, the Company entered into a consulting agreement with Gil Schwartzberg for Mr.

Schwartzberg to provide financial

advisory and consulting services to the Company with respect to financing matters, capital structure and strategic development,

and to assist management in communications with investors and shareholders.

Schwartzberg is currently a significant stockholder

of the Company and continues to be a consultant to the Company.

Consideration under this consulting agreement, including subsequent

extensions, has been paid exclusively in the form of stock options.

On January 28, 2014, the Company entered into a second amendment

to its consulting agreement with Mr.

Schwartzberg to extend it to January 28, 2019.

January 28, 2014, the Company entered into a second amendment to its consulting agreement with Mr.

Schwartzberg to extend such

agreement to January 28, 2019.

In conjunction with such amendment, the Company granted Mr.

Schwartzberg stock options to purchase

an additional 4,000,000 shares of common stock, exercisable at $0.50 per share for a period of the earlier of five years from

the grant date or the termination of the consulting agreement, with one-half of the stock options (2,000,000 shares) vesting immediately

and one-half of the stock options (2,000,000 shares) vesting on January 28, 2015.

Stock-based compensation expense with respect

to the grant of the stock options to purchase the 4,000,000 shares of common stock was previously charged to general and administrative

costs in the consolidated statement of operations over the vesting period.

August 2, 2018, the Company entered into a third amendment to its consulting agreement with Mr.

Schwartzberg to extend it to January

28, 2024, which was approved by the Company’s Board of Directors.

In conjunction with such amendment, the Company extended

the expiration date of the fully vested stock options for 4,000,000 shares of common stock previously granted to Mr.

Schwartzberg,

from January 28, 2019 to January 28, 2024.

The fair value of the extension of these vested stock options, as calculated pursuant

to the Black-Scholes option-pricing model, was measured for accounting purposes as the difference in the fair value of the stock

options immediately before and immediately after the extension date, and was determined to be $711,738 ($0.1779 per share), which

was reflected as a charge to general and administrative costs in the consolidated statement of operations for the year ended December

and consulting fees charged to operations for services rendered by the Eric Forman Law Office were $48,000 for the years ended

December 31, 2019 and 2018, respectively.

Eric Forman is the son-in-law of Gil Schwartzberg, a significant stockholder of and

consultant to the Company, and is the son of Dr.

Stephen Forman, who was elected to the Company’s Board of Directors on

May 13, 2016.

Julie Forman, the wife of Eric Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley

Wealth Management, where the Company maintains a continuing banking relationship.

In addition, in connection with his continuing

service as a consultant to the Company, Eric Forman was granted the following stock options:

October 16, 2017 - fully-vested stock options to purchase 100,000 shares of the Company’s common stock.

The stock options

are exercisable for a period of five years from the date of grant at $0.15 per share, which was the fair market value of the Company’s

common stock on such date.

The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,

was determined to be $14,997 ($0.1500 per share), which was charged to operations on the date of grant.

May 22, 2019 - fully-vested stock options to purchase 100,000 shares of the Company’s common stock, exercisable for a period

of five years from the vesting date at $1.10 per share, which was the approximate fair market value of the Company’s common

stock on such date.

The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was

determined to be $94,525 ($0.9453 per share), which was charged to operations on the grant date.

“ITEM 11.

EXECUTIVE COMPENSATION - Directors Compensation”

for disclosures with respect to compensation (both cash

and equity-based) to certain of the Company’s directors for services.

Director Independence

Company considers Dr.

Ho to be “independent directors”, as such term is defined

by the NASDAQ Rules or Rule 10A-3 of the Exchange Act.

following includes a summary of transactions since January 1, 2018 to which we have been a party, including transactions in which

the amount involved in the transaction exceeds the lesser of $120,000 or 1% of the average of our total assets at year-end for

the last two completed fiscal years, and in which any of our directors, executive officers or, to our knowledge, beneficial owners

of more than 5% of our capital stock or any member of the immediate family of any of the foregoing persons had or will have a

direct or indirect material interest, other than equity and other compensation, termination, change in control and other arrangements,

which are described elsewhere in this Annual Report on Form 10-K We are not otherwise a party to a current related party transaction,

and no transaction is currently proposed, in which the amount of the transaction exceeds the lesser of $120,000 or 1% of the average

of our total assets at year-end for the last two completed fiscal years and in which a related person had or will have a direct

or indirect material interest.

principal office facilities are being provided without charge by Dr.

Kovach, our President and Chief Executive Officer.

Such costs were not material to the consolidated financial statements and accordingly, have not been reflected therein.

September 12, 2007, we entered into a consulting agreement with Gil Schwartzberg for Mr.

Schwartzberg to provide financial advisory

and consulting services to us with respect to financing matters, capital structure and strategic development, and to assist management

in communications with investors and shareholders.

Schwartzberg is currently a significant stockholder of ours, and continues

to be a consultant to us.

Consideration under this consulting agreement, including subsequent extensions, has been paid exclusively

in the form of stock options.

On January 28, 2014, we entered into a second amendment to our consulting agreement with Mr.

to extend such agreement to January 28, 2019.

In conjunction with such amendment, we granted Mr.

Schwartzberg stock options to

purchase an additional 666,667 shares of common stock, exercisable at $3.00 per share for a period of the earlier of five years

from the grant date or the termination of the consulting agreement, with one-half of the stock options (333,334 shares) vesting

immediately and one-half of the stock options (333,333 shares) vesting on January 28, 2015.

On August 2, 2018, we entered into

a third amendment to our consulting agreement with Mr.

Schwartzberg to extend it to January 28, 2024, which was approved by our

Board of Directors.

In conjunction with such amendment, we extended the expiration date of the fully vested stock options for

666,667 shares of common stock previously granted to Mr.

Schwartzberg, from January 28, 2019 to January 28, 2024.

The fair value

of the extension of these vested stock options, as calculated pursuant to the Black-Scholes option-pricing model, was measured

for accounting purposes as the difference in the fair value of the stock options immediately before and immediately after the

extension date, and was determined to be $711,738 ($1.0674 per share), which was reflected as a charge to general and administrative

costs in the consolidated statement of operations for the year ended December 31, 2018.

and consulting fees charged to operations for services rendered by the Eric Forman Law Office were $38,000, $48,000 and $48,000

for the years ended December 31, 2020, 2019 and 2018, respectively, excluding amounts paid to Mr.

Forman pursuant to an employment

agreement during 2020.

Eric Forman is the son-in-law of Gil Schwartzberg, a significant stockholder of and consultant to the Company,

and is the son of Dr.

Stephen Forman, a member of the Company’s Board of Directors.

Julie Forman, the wife of Eric Forman

and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley Wealth Management, where the Company’s cash is

deposited and the Company maintains a continuing banking relationship.

addition, in connection with his continuing service as a consultant, Mr.

Forman was granted fully-vested stock options to purchase

16,667 shares of the Company’s common stock, exercisable for a period of five years from the grant date at $6.60 per share,

which was the approximate fair market value of the Company’s common stock on such date.

The fair value of these stock options,

as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $94,525 ($5.6718 per share) and was recorded

as a charge to general and administrative costs in the consolidated statement of operations on the grant date.

July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric Forman, Mr.

was granted options for 58,333 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

options have a term of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company’s

common stock on the grant date.

The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second

and third anniversaries of the grant date.

The fair value of these stock options, as calculated pursuant to the Black-Scholes

option-pricing model, was determined to be $400,855 ($6.8718 per share), of which $100,214 was attributable to the stock options

fully-vested on August 12, 2020 and was therefore charged to operations on that date.

The remaining unvested portion of the fair

value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023.

During the year

ended December 31, 2020, the Company recorded a charge to general and administrative costs in the consolidated statement of operations

of $138,926 with respect to these stock options.

Weingarten was appointed as our Vice President and Chief Financial Officer on August 12, 2020.

During the years ended December

31, 2020, 2019 and 2018, prior to Mr.

Weingarten’s appointment as an officer of the Company, we paid Mr.

Weingarten a total

of $79,995, $80,380 and $68,250, respectively, for accounting and financial consulting services rendered with respect to the preparation

of our consolidated financial statements and certain other financial and compliance matters.

August 12, 2020, in connection with the employment agreement entered into with Robert N.

Weingarten, Mr.

Weingarten was granted

options for 58,333 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

The options have

a term of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company’s common

stock on the grant date.

The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third

anniversaries of the grant date.

The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing

model, was determined to be $400,855 ($6.8718 per share), of which $100,214 was attributable to the stock options fully-vested

on August 12, 2020 and was therefore charged to operations on that date.

The remaining unvested portion of the fair value of the

stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023.

During the year ended December

31, 2020, the Company recorded a charge to general and administrative costs in the consolidated statement of operations of $138,926

with respect to these stock options.

August 1, 2020, in connection with an employment agreement entered into with Dr.

James Miser, M.D., Dr.

Miser was granted options

for 83,334 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

The options have a term

of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company’s common stock

on the effective date of the employment agreement.

The options vested as to 25% on the effective date, and will vest 25% on each

of the first, second and third anniversaries of the effective date.

The fair value of these stock options, as calculated pursuant

to the Black-Scholes option-pricing model, was determined to be $572,650 ($6.8718 per share), of which $143,163 was attributable

to the stock options fully-vested on August 1, 2020 and was therefore charged to operations on that date.

The remaining unvested

portion of the fair value of the stock options will be charged to operations ratably from August 1, 2020 through August 1, 2023.

During the year ended December 31, 2020, the Company recorded a charge to general and administrative costs in the consolidated

statement of operations of $202,782 with respect to these stock options.

Indemnification

have entered into indemnification agreements with each of our directors and executive officers.

These indemnification agreements

provide the directors and executive officers with contractual rights to indemnification and expense advancement that are, in some

cases, broader than the specific indemnification provisions contained under Delaware law.

Person Transaction Policy

have adopted a related person transaction policy that sets forth our procedures for the identification, review, consideration

and approval or ratification of related person transactions.

For purposes of our policy only, a related person transaction is

a transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which we

and any related person are, were or will be participants in which the amount involved exceeds the lesser of $120,000 or 1% of

the average of our total assets at year-end.

Transactions involving compensation for services provided to us as an employee or

director are not covered by this policy.

A related person is any executive officer, director or beneficial owner of more than

5% of any class of our voting securities, including any of their immediate family members and any entity owned or controlled by

such persons.

the policy, if a transaction has been identified as a related person transaction, including any transaction that was not a related

person transaction when originally consummated or any transaction that was not initially identified as a related person transaction

prior to consummation, our management must present information regarding the related person transaction to our audit committee,

or, if audit committee approval would be inappropriate, to another independent body of our Board of Directors, for review, consideration

and approval or ratification.

The presentation must include a description of, among other things, the material facts, the interests,

direct and indirect, of the related persons, the benefits to us of the transaction and whether the transaction is on terms that

are comparable to the terms available to or from, as the case may be, an unrelated third party or to or from employees generally.

Under the policy, we will collect information that we deem reasonably necessary from each director, executive officer and, to

the extent feasible, significant stockholder to enable us to identify any existing or potential related-person transactions and

to effectuate the terms of the policy.

In addition, under our code of business conduct and ethics, our employees and directors

will have an affirmative responsibility to disclose any transaction or relationship that reasonably could be expected to give

rise to a conflict of interest.

In considering related person transactions, our audit committee, or other independent body of

our Board of Directors, will take into account the relevant available facts and circumstances including, but not limited to:

risks, costs and benefits to us;

impact on a director’s independence in the event that the related person is a director, immediate family member of a

director or an entity with which a director is affiliated;

availability of other sources for comparable services or products;

terms available to or from, as the case may be, unrelated third parties or to or from employees generally.

policy requires that, in determining whether to approve, ratify or reject a related person transaction, our audit committee, or

other independent body of our Board of Directors, must consider, in light of known circumstances, whether the transaction is in,

or is not inconsistent with, our best interests and those of our stockholders, as our audit committee, or other independent body

of our Board of Directors, determines in the good faith exercise of its discretion.

PRINCIPAL ACCOUNTING FEES AND SERVICES

& Company, P.C.

acted as the Company’s independent registered public accounting firm for the years ended December 31,

2018 and 2019 and for the interim periods in such fiscal years.

The following table shows the fees that were incurred by the Company

for audit and other services provided by Weinberg & Company, P.C.

for the years ended December 31, 2018 and 2019.

acted as our independent registered public accounting firm for the fiscal years ended December 31, 2019 and

2020 and for the interim periods in such fiscal years.

The following table shows the fees that were incurred by us for audit and

other services provided by Weinberg & Company, P.C for the years ended December 31, 2019 and 2020.

Years Ended December 31,

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Audit-Related Fees (2)

All Other Fees

fees represent fees for professional services provided in connection with the audit of the Company’s annual financial

statements and the review of its financial statements included in the Company’s Quarterly Reports on Form 10-Q and services

that are normally provided in connection with statutory or regulatory filings.

Other Fees (4)

fees represent fees for professional services provided in connection with the audit of our annual financial statements included

in our Annual Reports on Form 10-K and the review of our interim financial statements included in our Quarterly Reports on

Form 10-Q and services that are normally provided in connection with statutory or regulatory filings, excluding those fees

included in Other Fees.

Audit-related

fees represent fees for assurance and related services that are reasonably related to the performance of the audit or review

of the Company’s financial statements and not reported above under “Audit Fees”.

of our financial statements and not reported above under “Audit Fees.”

fees represent fees for professional services related to tax compliance, tax advice and tax planning.

audit related services, tax services and other services rendered by Weinberg & Company, P.C.

were pre-approved by the Company’s

Board of Directors.

The Board of Directors has adopted a pre-approval policy that provides for the pre-approval of all services

performed for the Company by its independent registered public accounting firm.

fees represent fees incurred with respect to our Registration Statement on Form S-1, which was declared effective by the U.S.

Securities and Exchange Commission on November 24, 2020.

audit and audit-related services, tax services and other services rendered by Weinberg & Company, P.C.

during the fiscal years

ended December 31, 2019 and 2020 were pre-approved by our Board of Directors.

The Board of Directors has adopted a pre-approval

policy that provides for the pre-approval of all services performed for us by our independent registered public accounting firm.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

of documents filed as part of this report:

is made to the Index to Financial Statements on page F-1, where these documents are listed.

is made to the Index to Consolidated Financial Statements on page F-1, where these documents are listed.

Statement Schedules

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FORM 10-K SUMMARY

Form of Underwriter Agreement 22

Share Exchange Agreement dated as of June 8, 2006 among the Company, John S.

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Certificate of Amendment of Certificate of Designations of the Series A Convertible Preferred Stock .8

Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934*

Amended and Restated Bylaws 15

Certificate of Amendment of Certificate of Incorporation 23

Form of Warrant included in Unit 22

Form of Warrant Agent Agreement 22

Description of Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934, as amended 24

Master Agreement between Lixte Biotechnology Holdings, Inc.

26 unchanged sentences

and the Spanish Sarcoma Group as of July 31, 2019 (certain portions of this exhibit have been omitted based on a request for confidential treatment filed by the Company with the Securities and Exchange Commission that was granted on September 19, 2019) 14

Employment Agreement Between the Company and Dr.

James Miser 16+

Employment Agreement Between the Company and Robert N.

Weingarten 20+

Employment Agreement Between the Company and Dr.

John Kovach 17+

Employment Agreement Between the Company and Eric Forman 18+

2020 Stock Incentive Plan 19+

Master Services Agreement between Foundation for Angelman Syndrome Therapeutics (“FAST”) and Lixte Biotechnology Holdings, Inc.

dated as of August 12, 2020 20

Clinical Trial Research Agreement between the Company and the City of Hope National Medical Center 21

Amendment to Employment Agreement between the Company and Eric Forman* +

Consent of Weinberg & Company, P.A., Independent Registered Public Accounting Firm*

Officer’s Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*

Officer’s Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

Instance Document**

Taxonomy Extension Schema Document

Taxonomy Extension Scheme Document**

Taxonomy Extension Calculation Linkbase Document**

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6, 2019 and incorporated herein by reference.

of these Exhibits constitutes a management contract, compensatory plan or other arrangement.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July

17, 2020 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July

17, 2020 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July

17, 2020 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July

17, 2020 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July

17, 2020 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on August

18, 2020 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on January

22, 2021 and incorporated herein by reference.

as an Exhibit to the Company’s Registration Statement on Form S-1/A, as filed with the Securities and Exchange Commission

on November 16, 2020.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on November

27, 2020 and incorporated herein by reference.

as an Exhibit to the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March

25, 2020 and incorporated herein by reference.

a management contract or any compensatory plan, contract or arrangement.

accordance with Regulation S-T, the XBRL related information on Exhibit No.

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BIOTECHNOLOGY HOLDINGS, INC.

Chief Executive Officer and Chief

and Chief Executive Officer

accordance with the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the

Registrant in the capacity and on the dates indicated.

Chief Executive Officer and Chief Financial Officer

Financial and Accounting Officer and Director

and Chief Executive Officer

President and Chief Financial Officer

WINSON SZE CHUN HO

8 unchanged sentences

Years Ended December 31, 2020 and 2019

Consolidated Statement of Stockholders’

Consolidated Statements of Stockholders’

Equity –

19 unchanged sentences

As discussed in Note 1, the Company has no recurring source of revenue and has experienced negative operating cash flows since

The Company has financed its working capital requirements during this period primarily through the recurring sale of

its equity securities and the exercise of outstanding common stock options and purchase warrants.

These matters raise substantial

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

Management’s plans in regard to these matters are

also described in Note 1 to the consolidated financial statements.

These consolidated financial statements do not include any

adjustments that might result from the outcome of this uncertainty.

The Company has financed its working capital requirements primarily through the recurring sale of its equity securities.

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

Management’s plans

in regard to these matters are also described in Note 1 to the consolidated financial statements.

These consolidated financial

statements do not include any adjustments that might result from the outcome of this uncertainty.

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

2 unchanged sentences

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 (the “SEC”) and the PCAOB.

with the Public Company Accounting Oversight Board (United States) (the “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 (the “SEC”) and the PCAOB.

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

2 unchanged sentences

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.

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.

6 unchanged sentences

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

Audit Matter Description

described further in Note 1 to the consolidated financial statements, the Company has incurred losses in each year from inception

through December 31, 2020, and expects to incur additional losses in the future, and has no recurring source of revenue.

believes, based on the Company’s operating plan, that current working capital is not sufficient to fund operations and satisfy

the Company’s obligations as they come due for at least one year from the financial statement issuance date.

determined the Company’s ability to continue as a going concern is a critical audit matter due to the estimation and execution

uncertainty regarding the Company’s future cash flows and the risk of bias in management’s judgments and assumptions

in estimating these cash flows.

audit procedures related to the Company’s assertion as to its ability to continue as a going concern included the following,

among others:

gained an understanding of the Company’s process relating to the preparation of projected information and considerations

of the Company’s obligations.

tested the reasonableness of the projected operating expenses, and uses and sources of cash used in management’s assessment

of whether the Company has sufficient liquidity to fund operations for at least one year from the financial statement issuance

This testing included inquiries with management, comparison of prior period projections to actual results, and consideration

of positive and negative evidence impacting management’s projections.

evaluated the reasonableness of management’s assumptions related to the likelihood that the Company would be able to

reduce operating commitments and expenditures if required.

assessed management’s plans for dealing with any potential adverse effects of any potential conditions and events noted

that indicated there could be substantial doubt about the Company’s ability to continue as a going concern for a reasonable

period of time in the context of other audit evidence obtained during the audit to determine whether it supported or contradicted

the conclusion reached by management.

have served as the Company’s auditor since 2008.

4 unchanged sentences

Current assets:

Advances on research and development contract services

Accrued interest receivable

expenses and other current assets

Prepaid insurance

Other prepaid expenses and current assets

Total current assets

expense, less current portion

LIABILITIES AND STOCKHOLDERS’

Current liabilities:

Accounts payable and

accrued expenses

and development contract liabilities

current liabilities

Accounts payable and accrued expenses

Accrued offering costs

Research and development contract liabilities

Total current liabilities

Commitments and contingencies

Stockholders’

Preferred Stock, $0.0001

Preferred Stock, $0.0001 par value;

authorized –

1 unchanged sentence

issued and outstanding –

350,000 shares of Series A Convertible Preferred

Stock, $10.00 per share stated value, $50.00 per share cash redemption value;

aggregate cash redemption value –

liquidation preference based on assumed conversion into common shares –

350,000 shares of Series A Convertible Preferred Stock, $10.00 per share stated value, liquidation preference based on assumed conversion into common shares –

729,167 shares

Common stock, $0.0001

Common stock, $0.0001 par value;

authorized –

100,000,000 shares;

issued and outstanding –

67,045,814 shares

Additional paid-in

issued, issuable and outstanding –

12,402,157 shares and 11,174,737 shares at December 31, 2020 and 2019, respectively

Additional paid-in capital

Accumulated deficit

(30,353,768 )

(27,088,886 )

stockholders’

liabilities and stockholders’

Total stockholders’

Total liabilities and stockholders’

accompanying notes to consolidated financial statements.

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STATEMENTS OF OPERATIONS

Ended December 31,

Costs and expenses:

and administrative costs, including $362,631 and $833,612 to related parties for the years ended December 31, 2019 and 2018,

and development costs

Years Ended December 31,

Costs and expenses:

General and administrative costs, including $765,085 and $422,631 to related parties for the years ended December 31, 2020 and 2019, respectively

Research and development costs

Total costs and expenses

Loss from operations

Interest income

Interest expense

$ (3,264,882 )

$ (2,440,343 )

loss per common share –

Net loss per common share –

basic and diluted

average common shares outstanding –

Weighted average common shares outstanding –

basic and diluted

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BIOTECHNOLOGY HOLDINGS, INC.

STATEMENT OF STOCKHOLDERS’

STATEMENTS OF STOCKHOLDERS’

Ended December 31, 2020 and 2019

Stockholders’

Series A Convertible

Preferred Stock

Additional Paid-in

Total Stockholders’

Balance, December 31, 2018

$ (24,648,543 )

Sale of common stock

Costs incurred in connection

with the sale of common stock units

Exercise of common stock options

Stock-based compensation

expense, including $711,738 for extension of stock options to related party

Stock-based compensation expense

Balance, December 31, 2019

(27,088,886 )

Stock-based compensation

Proceeds from sale of common stock units in public offering, net of offering costs

Stock-based compensation expense, including $670,715 for extension of stock options

Common stock issued for services

Balance, December 31, 2020

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STATEMENTS OF CASH FLOWS

Cash flows from

operating activities:

Cash flows from operating activities:

$ (3,264,882 )

$ (2,440,343 )

Adjustments to reconcile

net loss to net cash used in operating activities:

Stock-based compensation

expense included in -

and administrative costs

and development costs

Changes in operating

assets and liabilities:

(Increase) decrease

interest receivable

expenses and other current assets

Increase (decrease)

payable and accrued expenses

and development contract liabilities

cash used in operating activities

Cash flows from

financing activities:

Exercise of common

stock options

Proceeds from sale

of common stock and common stock units

incurred in connection with the sale of common stock units

cash provided by financing activities

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

Stock-based compensation expense included in -

General and administrative costs

Research and development costs

Changes in operating assets and liabilities:

(Increase) decrease in -

Advances on research and development contract services

Accrued interest receivable

Prepaid insurance

Other prepaid expenses and current assets

Increase (decrease) in -

Accounts payable and accrued expenses

Research and development contract liabilities

Net cash used in operating activities

Cash flows from financing activities:

Proceeds from sale of common stock units in public offering, net of offering costs

Net cash provided by financing activities

Net increase (decrease)

at beginning of period

at end of period

Supplemental disclosures

of cash flow information:

Balance at beginning of period

Balance at end of period

Supplemental disclosures of cash flow information:

Cash paid for -

Non-cash investing and financing activities:

Accrued offering costs (paid subsequent to December 31, 2020)

accompanying notes to consolidated financial statements.

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and is dependent on periodic infusions of equity capital to fund its operating requirements.

Company’s common stock is traded on the OTCQB operated by the OTC Markets under the symbol “LIXT”.

Company’s consolidated financial statements have been presented on the basis that it is a going concern, which contemplates

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

The Company has not generated any

revenues from operations to date and does not expect to do so in the foreseeable future.

Furthermore, the Company has experienced

recurring operating losses and negative operating cash flows since inception and has financed its working capital requirements

during this period primarily through the recurring sale of its equity securities and the exercise of outstanding common stock

options and purchase warrants.

Company’s common stock and warrants issued in the public offering (see Note 3) are traded on The Nasdaq Capital Market under

the symbols “LIXT”

“LIXTW”, respectively.

December 31, 2020, the Company had cash of $5,069,266 available to fund its operations.

Because the Company is currently engaged

in Phase 2 clinical trials, it is expected that it will take a significant amount of time and resources to develop any product

or intellectual property capable of generating sustainable revenues.

Accordingly, the Company’s business is unlikely to

generate any sustainable operating revenues in the next several years and may never do so.

Even if the Company is able

to generate revenues through licensing its technologies or through product sales, there can be no assurance that the Company will

be able to achieve positive earnings and operating cash flows.

Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which

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

The Company has no recurring

source of revenue and has experienced negative operating cash flows since inception.

The Company has financed its working capital

requirements primarily through the recurring sale of its equity securities.

a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern

within one year of the date that the consolidated financial statements are being issued.

In addition, the Company’s independent

registered public accounting firm, in their report on the Company’s consolidated financial statements for the year ended

December 31, 2019, has also expressed substantial doubt about the Company’s ability to continue as a going concern.

Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund

its research and development activities and to ultimately achieve sustainable operating revenues and profits.

within one year of the date that the accompanying consolidated financial statements have been issued.

The Company’s independent

registered public accounting firm, in its report on the Company’s consolidated financial statements for the year ended December

31, 2020, has also expressed substantial doubt about the Company’s ability to continue as a going concern.

The Company’s

consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

December 31, 2019, the Company had cash and cash equivalents of $2,598,864 available to fund its operations.

Because the Company

is currently engaged in Phase 2 clinical trials, it is expected that it will take a significant amount of time to develop any

product or intellectual property capable of generating sustainable revenues.

Accordingly, the Company’s business is unlikely

to generate any sustainable operating revenues in the next several years and may never do so.

In addition, to the extent that

the Company is able to generate revenues through licensing its technologies or through product sales, there can be no assurance

that the Company will be able to achieve positive earnings and operating cash flows.

Company’s longer-term objective is to secure one or more strategic partnerships or licensing agreements with pharmaceutical

companies with major programs in cancer.

The Company expects that it will need to begin to raise additional capital no later than

the fourth quarter of 2020.

amount and timing of future cash requirements will depend on the pace and design of the Company’s clinical trial program.

As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurances

that the Company will be able to secure additional financing on acceptable terms, or at all, as and when necessary to continue

to conduct operations.

There is also significant uncertainty as to the affect that the coronavirus may have on the availability,

amount and type of financing in the future.

consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund

its research and development activities and to ultimately achieve sustainable operating revenues and profitability.

and timing of future cash requirements depends on the pace and design of the Company’s clinical trial program, which, in

turn, depends on the availability of operating capital to fund such activities.

November 30, 2020, the Company listed on The Nasdaq Capital Market in conjunction with the completion of its public offering of

units of common stock and warrants that generated net cash proceeds of $4,591,349.

Subsequently, on January 18, 2021, the Company

entered into a clinical trial agreement to carry out a Phase 1b clinical trial of LB-100, combined with a standard regimen for

untreated, extensive stage-disease small cell lung cancer.

This new clinical trial is being conducted through City of Hope, and

is estimated to cost from $2,500,000 to $2,900,000 and take approximately 18 to 24 months to conduct from its expected commencement

during the quarter ending June 30, 2021.

Combined with the Company’s existing clinical trial commitments, this new clinical

trial commitment represents an additional demand on the Company’s working capital resources.

Although the Company completed

a sale of common stock under a registered direct equity offering on March 2, 2021 that generated net proceeds of approximately

$3,690,000, the Company estimates that it will need to raise additional capital to fund its operations, including its various

clinical trial commitments, by mid-2022.

In addition, the Company’s operating plan may change as a result of many factors

which are currently unknown to the Company, including possible additional clinical trials, and the Company may need additional

funds sooner than currently planned.

market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurances

that the Company will be able to secure additional financing on acceptable terms, as and when necessary to continue to conduct

There is also significant uncertainty as to the effect that the coronavirus may have on the Company’s clinical

trial schedule and the amount and type of financing available to the Company in the future.

cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale

back or discontinue its clinical trial program and its technology and product development efforts, or obtain funds, if available

(although there can be no certainty), through strategic alliances that may require the Company to relinquish rights to certain

of its compounds, or to discontinue its operations entirely.

back or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and

product development efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the

Company to relinquish rights to and/or control of LB-100, or to discontinue operations entirely.

November 18, 2020, the Company effected a 1-for-6 reverse split of its outstanding shares of common stock.

No fractional shares

were issued in connection with the reverse split, with any fractional shares resulting from the reverse split were rounded up

to the nearest whole share.

share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock split

for all periods presented.

Summary of Significant Accounting Policies

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the reporting period.

Management bases its estimates on historical experience and on various assumptions that are believed to

be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the

basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information,

changes in facts and circumstances, historical experience and reasonable assumptions.

After such evaluations, if deemed appropriate,

those estimates are adjusted accordingly.

Some of those judgments can be subjective and complex, and therefore, actual results could differ materially

from those estimates under different assumptions or conditions.

Management bases its estimates on historical experience and on

various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances,

the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily

apparent from other sources.

Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing

currently available information, changes in facts and circumstances, historical experience and reasonable assumptions.

evaluations, if deemed appropriate, those estimates are adjusted accordingly.

Actual results could differ from those estimates.

Significant estimates include those

related to assumptions used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization

of deferred tax assets.

and Cash Equivalents

and cash equivalents include cash and short-term certificates of deposit.

The Company maintains its cash balances with financial

institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation (the “FDIC”).

The Company may periodically have cash balances in banks in excess of FDIC insurance limits.

The Company has not experienced any

losses to date resulting from this practice.

Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments

issued for services, and the realization of deferred tax assets.

including accrued interest, is primarily held in a cash bank deposit program maintained by a major financial institution.

Company’s policy is to maintain its cash balances with financial institutions with high credit ratings and in accounts insured

by the Federal Deposit Insurance Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation

(the “SIPC”).

The Company may periodically have cash balances in financial institutions in excess of FDIC and SIPC

insurance limits of $250,000 and $500,000, respectively.

The financial institution that currently holds the Company’s cash

balances also maintains supplemental insurance coverage for its customers’

cash balances.

The Company has not experienced

any losses to date resulting from this practice.

and Development

and development costs consist primarily of fees paid to consultants and outside service providers, and other expenses relating

to the acquisition, design, development and testing of the Company’s compounds and product candidates.

and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the acquisition,

design, development and clinical trials with respect to the Company’s compounds and product candidates.

Research and development

costs also include the costs to produce the compounds used in research and clinical trials.

and development costs are charged to operations ratably over the life of the underlying contracts, unless the achievement of milestones,

the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate.

incurred with respect to mandatory scheduled payments under research agreements without milestone provisions are recognized ratably

over the appropriate period, as specified in the agreement, and are recorded as liabilities in the Company’s consolidated

balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of

incurred with respect to mandatory scheduled payments under research agreements with milestone provisions are recognized as charges

to research and development costs in the Company’s consolidated statement of operations based on the achievement of such

milestones, as specified in the agreement.

Obligations incurred with respect to mandatory scheduled payments under research agreements

without milestone provisions are recognized ratably over the appropriate period, as specified in the agreement, and are recorded

as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs

in the Company’s consolidated statement of operations.

made pursuant to research and development contracts are initially recorded as advances on research and development contract services

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The Company reviews the status of its research and development contracts on a quarterly basis.

insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage

in excess of the amortization of the total policy premium charged to operations to date.

Such amortization is determined by amortizing

the total policy premium charged on a straight-line basis over the respective policy periods.

As the policy premiums incurred

are amortizable in the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance

sheet at each reporting date and amortized to the Company’s consolidated statement of operations for each reporting period.

of December 31, 2020, total insurance policy premiums, in excess of premiums paid to date, amounted to $175,658, and are payable

in six monthly installments of $29,767 through June 2021, with interest at 5.27% per annum.

As of December 31, 2019, there was

no unpaid insurance premium obligation.

and Licensing Related Legal and Filing Costs

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Concentration

Company periodically contracts with vendors and consultants to provide services related to the Company’s research and development

Agreements for these services can be for a specific time period (typically one year) or for a specific project or

The only such contract that represented 10% or more of general and administrative costs or research and development costs

for the years ended December 31, 2019 and 2018 is described below.

discussed at Note 7, effective as of July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated

Clinical Trial with GEIS to carry out a clinical trial entitled “Randomized phase I/II trial of LB-100 plus doxorubicin

doxorubicin alone in first line of advanced soft tissue sarcoma”.

The Company estimates that this clinical trial will

be completed and results will be published by June 2023.

Costs incurred pursuant to the agreement with GEIS are included in research

and development costs in the Company’s consolidated statements of operations.

During the year ended December 31, 2019, the

Company incurred costs of $87,471 pursuant to this agreement, reflecting 10.7% of total research and development costs for such

Company periodically contracts with vendors and consultants to provide services related to the Company’s operations.

incurred for these services can be for a specific time period (typically one year) or for a specific project or task.

expenses incurred that represented 10% or more of general and administrative costs or research and development costs for the years

ended December 31, 2020 and 2019 are described as follows.

and administrative costs for the years ended December 31, 2020 and 2019 include charges from a legal firm for general licensing

and patent prosecution costs relating to the Company’s intellectual properties representing 27.3% and 44.5%, respectively,

of total general and administrative costs.

General and administrative costs for the years ended December 31, 2020 and 2019 also

include charges for the amortized value of stock options granted to directors and officers representing 23.7% and 18.8%, respectively,

of total general and administrative costs.

and development costs for the year ended December 31, 2020 include charges from a consultant, and the value associated with extending

stock options previously granted to that consultant, representing 65.6% of total research and development costs, and charges from

a vendor representing 13.7% of total research and development costs.

Research and development costs for the year ended December

31, 2019 include charges for the value associated with fully-vested stock options granted to a consultant representing 52.9% of

total research and development costs, and charges from a consultant and from a vendor representing 12.2% and 10.7%, respectively,

of total research and development costs.

Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes.

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statements and the tax basis of assets and liabilities.

Company has elected to deduct research and development costs on a current basis for federal income tax purposes.

For federal tax

purposes, start-up and organization costs were deferred until January 1, 2008, at which time the Company began to amortize such

costs over a 180-month period.

Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized.

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its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination

Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in

the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made.

Should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future,

an adjustment to the deferred tax assets would be charged to operations in the period such determination was made.

Company is subject to U.S.

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The Company had no unrecognized tax benefits as of December

31, 2019 and 2018 and does not anticipate any material amount of unrecognized tax benefits within the next 12 months.

31, 2020 or December 31, 2019 and does not anticipate any material amount of unrecognized tax benefits within the 12 months subsequent

to December 31, 2020.

Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement,

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of the position are recognized.

As of December 31, 2019, the Company had not recorded any liability for uncertain tax positions.

In subsequent periods, any interest and penalties related to uncertain tax positions will be recognized as a component of income

Company periodically issues common stock and stock options to officers, directors, Scientific Advisory Committee members and consultants

for services rendered.

Options vest and expire according to terms established at the issuance date of each grant.

Stock grants,

which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting

December 31, 2018, the Company accounted for stock-based payments to officers and directors by measuring the cost of services

received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation

expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards.

accounted for stock-based payments to Scientific Advisory Committee members and consultants by determining the value of the stock

compensation based upon the measurement date at either (a) the date at which a performance commitment was reached or (b) at the

date at which the necessary performance to earn the equity instruments was complete.

accordance with the Company’s adoption of Accounting Standards Update 2018-07, Compensation –

Stock Compensation (Topic

Improvements to Nonemployee Share-Based Payment Accounting (see “Recent Accounting Pronouncements”

below), effective

January 1, 2019, stock options granted to members of the Company’s Scientific Advisory Committee and to outside consultants

are now accounted for consistent with the accounting for stock-based payments to officers and directors, as described above, by

measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with

the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting

period of the awards.

The Company had not recorded any liability for uncertain tax positions as of December 31, 2020

or December 31, 2019.

Subsequent to December 31, 2020, any interest and penalties related to uncertain tax positions will be recognized

as a component of income tax expense.

Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members,

contractors and consultants for services rendered.

Options vest and expire according to terms established at the issuance date

of each grant.

Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations

ratably over the vesting period.

Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members contractors

and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of

the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements

over the vesting period of the awards.

fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model,

and is affected by several variables, the most significant of which are the life of the equity award, the exercise price of the

stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common

Estimated volatility is based on the historical volatility of the Company’s common stock, calculated utilizing a

one-year look-back period, as the Company believes that such measurement period provides a more accurate and meaningful volatility

factor given the changes in the Company’s research and development program and capital requirements over the past several

and is affected by several variables, the most significant of which are the expected life of the stock option, the exercise price

of the stock option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of

the common stock.

Unless sufficient historical exercise data is available, the expected life of the stock option is calculated

as the mid-point between the vesting period and the contractual term (the “simplified method”).

Estimated volatility

is based on the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately

equal to the contractual life of the stock option being granted.

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

Treasury yield curve in effect at the time of grant.

The fair market value

of the common stock is determined by reference to the quoted market price of the Company’s common stock on the grant date.

Treasury yield

curve in effect at the time of grant.

The fair market value of the common stock is determined by reference to the quoted market

price of the Company’s common stock on the grant date.

Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development

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to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.

A Convertible Preferred Stock

Series A Convertible Preferred Stock

Common stock warrants

stock options, including options issued in the form of warrants

Common stock options, including options issued in the form of warrants

Value of Financial Instruments

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the Company performs an analysis of the assets and liabilities at each reporting period end.

carrying value of financial instruments (consisting of cash and cash equivalents, and accounts payable and accrued expenses) is

considered to be representative of their respective fair values due to the short-term nature of those instruments.

carrying value of financial instruments (consisting of accounts payable and accrued expenses) is considered to be representative

of their respective fair values due to the short-term nature of those instruments.

Accounting Pronouncements

Adopted Accounting Standards

June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)

2018-07, Compensation –

Stock Compensation (Topic 718):

Improvements to Nonemployee Share-Based Payment Accounting (“ASU

2018-07”).

ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and

services from nonemployees.

ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively

provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of

a contract accounted for under Revenue from Contracts with Customers (Topic 606).

ASU 2018-07 was effective for fiscal years beginning

after December 15, 2018, including interim periods within those fiscal years.

The Company adopted the provisions of ASU 2018-07

effective January 1, 2019 (see “Stock-Based Compensation”

The adoption of ASU 2018-07 did not have any impact

on the Company’s financial statement presentation or disclosures subsequent to its adoption.

Issued Accounting Standards

December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740):

Simplifying the Accounting for Income Taxes (“ASU

2019-12”).

ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions and enhances and simplifies

various aspects of the income tax accounting guidance in ASC 740.

ASU 2019-12 is effective for fiscal years, and interim periods

within those fiscal years, beginning after December 15, 2020.

The adoption of ASU 2018-07 is not expected to have any impact on

the Company’s financial statement presentation or disclosures subsequent to its adoption.

December 2019, the Financial Accounting Standards board (the “FASB”) issued Accounting Standards Update (“ASU”)

2019-12, Income Taxes (Topic 740):

Simplifying the Accounting for Income Taxes (“ASU 2019-12”).

ASU 2019-12 simplifies

the accounting for income taxes by removing certain exceptions and enhances and simplifies various aspects of the income tax accounting

guidance in ASC 740.

ASU 2019-12 will be effective January 1, 2021.

The adoption of ASU 2019-12 is not expected to have any impact

on the Company’s consolidated financial statement presentation or disclosures subsequent to its adoption.

August 2020, the FASB issued ASU 2020-06, Debt —

Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives

and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):

Accounting for Convertible Instruments and Contracts

in an Entity’s Own Equity (“ASU 2020-06).

ASU 2020-06 simplifies the accounting for convertible debt by eliminating

the beneficial conversion and cash conversion accounting models.

Upon adoption of ASU 2020-06, convertible debt proceeds, unless

issued with a substantial premium or an embedded conversion feature that is not clearly and closely related to the host contract,

will no longer be allocated between debt and equity components.

This modification will reduce the issue discount and result in

less non-cash interest expense in financial statements.

ASU 2020-06 also updates the earnings per share calculation and requires

entities to assume share settlement when the convertible debt can be settled in cash or shares.

ASU 2020-06 will be effective

January 1, 2024, and a cumulative-effect adjustment to the opening balance of retained earnings is required upon adoption.

adoption is permitted, but no earlier than January 1, 2021, including interim periods within that year.

The adoption of ASU 2020-06

is not expected to have any impact on the Company’s consolidated financial statement presentation or disclosures subsequent

to its adoption, with any effect being largely dependent on the composition and terms of outstanding financial instruments at

the time of adoption.

does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have

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On March 17, 2015,

the Company filed a Certificate of Designations, Preferences, Rights and Limitations (the “Certificate of Designations”)

of its Series A Convertible Preferred Stock with the Delaware Secretary of State to amend the Company’s certificate of incorporation.

The Company has designated a total of 350,000 shares as Series A Convertible Preferred Stock, which are non-voting and are not

subject to increase without the written consent of a majority of the holders of the Series A Convertible Preferred Stock or as

otherwise set forth in the Certificate of Designations.

The holders of each tranche of 175,000 shares of the Series A Convertible

Preferred Stock are entitled to receive a per share dividend equal to 1% of the annual net revenue of the Company divided by 175,000,

until converted or redeemed.

As of December 31, 2019, 9,650,000 shares of preferred stock were undesignated and may be issued

with such rights and powers as the Board of Directors may designate.

the Company filed a Certificate of Designations, Preferences, Rights and Limitations of its Series A Convertible Preferred Stock

with the Delaware Secretary of State to amend the Company’s certificate of incorporation.

The Company has designated a total

of 350,000 shares as Series A Convertible Preferred Stock, which are non-voting and are not subject to increase without the written

consent of a majority of the holders of the Series A Convertible Preferred Stock or as otherwise set forth in the, Preferences,

Rights and Limitations.

The holders of each tranche of 175,000 shares of the Series A Convertible Preferred Stock are entitled

to receive a per share dividend equal to 1% of the annual net revenue of the Company divided by 175,000, until converted or redeemed.

As of December 31, 2020 and 2019, 9,650,000 shares of preferred stock were undesignated and may be issued with such rights and

powers as the Board of Directors may designate.

share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 2.0833 shares of common stock

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The Series A Convertible Preferred Stock does not have a cash liquidation preference.

fully converted, the 350,000 outstanding shares of Series A Convertible Preferred Stock would convert into 4,375,000 shares of

common stock at December 31, 2019.

The Company has the right to redeem the Series A Convertible Preferred Stock up to the fifth

fully converted, the 350,000 outstanding shares of Series A Convertible Preferred Stock would convert into 729,167 shares of common

stock at December 31, 2020 and 2019.

The Company had the right to redeem the Series A Convertible Preferred Stock up to the fifth

anniversary of their respective closing dates (March 17, 2015 and January 21, 2016) at a price per share equal to $50.00.

Series A Convertible Preferred Stock has no right to cash, except with respect to the payment of the aforementioned dividend based

on the generation of revenues by the Company, and does not have any registration rights.

on the attributes of the Series A Convertible Preferred Stock described above, the Company has determined to account for the Series

as of December 31, 2020, the Company had the right to redeem the 175,000 shares of Series A Convertible Preferred Stock that were

issued on January 21, 2016, however, that right expired on January 21, 2021.

The Series A Convertible Preferred Stock has no right

to cash, except with respect to the payment of the aforementioned dividend based on the generation of revenues by the Company.

The shares of Series A Convertible Preferred Stock do not have any registration rights.

on the attributes of the Series A Convertible Preferred Stock as previously described, the Company has accounted for the Series

A Convertible Preferred Stock as a permanent component of stockholders’

Company is authorized to issue a total of 100,000,000 shares of common stock (par value $0.0001).

As of December 31, 2019 and

2018, the Company had 67,045,814 shares of common stock issued and outstanding.

November 30, 2018, the Company raised $4,500,000 through the sale to sixteen accredited investors of 9,000,000 units at a purchase

price of $0.50 per unit.

Each unit consisted of one share of common stock and one four-year warrant to purchase one share of common

stock at an exercise price of $1.00 per share.

Accordingly, a total of 9,000,000 shares of common stock and warrants to purchase

9,000,000 shares of common stock were issued by the Company.

The warrants do not have any reset provisions.

Company is authorized to issue a total of 100,000,000 shares of common stock, par value $0.0001 per share.

As of December 31,

2020 and 2019, the Company had 12,402,157 shares and 11,174,737 shares, respectively, of common stock issued, issuable and outstanding.

November 30, 2020, the Company raised gross proceeds $5,700,000 through a public offering of 1,200,000 units at a sale price of

$4.75 per unit.

Each unit consists of one share of common stock and one warrant to purchase one share of common stock exercisable

for five years at an exercise price of $5.70 per share.

Additionally, on December 7, 2020, the Company received an additional

$1,800 from the sale of 180,000 warrants as part of the overallotment option granted to the underwriters in the public offering.

The warrants sold on December 7, 2020 are exercisable for five years and represent the right to purchase one share of common stock

at an exercise price of $5.70 per share.

The total cash costs of the public offering were $1,110,451, resulting in net cash proceeds

of $4,591,349.

Pursuant to the underwriting agreement, the Company also granted to the underwriters warrants to purchase up to

120,000 shares of common stock commencing on May 24, 2021 and expiring on November 24, 2025, at an exercise price of $5.70 per

December 21, 2020, the Company entered into a services agreement with IRTH Communications, LLC and agreed to issue 27,420 shares

of common stock, fully vested upon issuance, with a grant date fair value of $100,000 ($3.65 per share), which was charged to

general and administrative costs in the consolidated statement of operations at December 31, 2020 (see Notes 5 and 7).

Stock Warrants

summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the

Company’s private placements, during the years ended December 31, 2019 and 2018 is presented below.

Company’s public offering, during the years ended December 31, 2020 and 2019 is presented below.

Number of Shares

Weighted Average

Exercise Price

Weighted Average

Life (in Years)

Warrants outstanding at December 31, 2018

Warrants outstanding at December 31, 2019

Warrants outstanding

at December 31, 2019

December 31, 2019, all outstanding warrants are exercisable at $1.000 per common share.

Warrants outstanding at December 31, 2020

Warrants exercisable at December 31, 2019

Warrants exercisable at December 31, 2020

on a fair market value of $3.17 per share on December 31, 2020, there were no exercisable but unexercised in-the-money common

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Related Party Transactions

Company’s Chairman and major stockholder, Dr.

John Kovach, was paid a salary of $60,000 for the years ended December 31,

2019 and 2018, respectively, which amounts are included in general and administrative costs in the Company’s consolidated

statements of operations.

Company’s principal office facilities are being provided without charge by Dr.

Kovach, the President and Chief Executive

Such costs were not material to the consolidated financial statements and accordingly, have not been reflected therein.

September 2007, the Company entered into a consulting agreement with Gil Schwartzberg for Mr.

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advisory and consulting services to the Company with respect to financing matters, capital structure and strategic development,

and to assist management in communications with investors and shareholders.

Schwartzberg is currently a significant stockholder

of the Company and continues to be a consultant to the Company.

Consideration under this consulting agreement, including subsequent

extensions, has been paid exclusively in the form of stock options.

January 28, 2014, the Company entered into a second amendment to its consulting agreement with Mr.

Schwartzberg to extend such

agreement to January 28, 2019.

In conjunction with such amendment, the Company granted Mr.

Schwartzberg stock options to purchase

an additional 4,000,000 shares of common stock, exercisable at $0.50 per share for a period of the earlier of five years from

the grant date or the termination of the consulting agreement, with one-half of the stock options (2,000,000 shares) vesting immediately

and one-half of the stock options (2,000,000 shares) vesting on January 28, 2015.

Stock-based compensation expense with respect

to the grant of the stock options to purchase the 4,000,000 shares of common stock was previously charged to general and administrative

costs in the consolidated statement of operations over the vesting period.

August 2, 2018, the Company entered into a third amendment to its consulting agreement with Mr.

Schwartzberg to extend it to January

28, 2024, which was approved by the Company’s Board of Directors.

In conjunction with such amendment, the Company extended

the expiration date of the fully vested stock options for 4,000,000 shares of common stock previously granted to Mr.

Schwartzberg,

from January 28, 2019 to January 28, 2024.

The fair value of the extension of these vested stock options, as calculated pursuant

to the Black-Scholes option-pricing model, was measured for accounting purposes as the difference in the fair value of the stock

options immediately before and immediately after the extension date, and was determined to be $711,738 ($0.1779 per share), which

was reflected as a charge to general and administrative costs in the consolidated statement of operations for the year ended December

and consulting fees charged to operations for services rendered by the Eric Forman Law Office were $48,000 for the years ended

December 31, 2019 and 2018, respectively.

Eric Forman is the son-in-law of Gil Schwartzberg, a significant stockholder of and

consultant to the Company, and is the son of Dr.

Stephen Forman, who was elected to the Company’s Board of Directors on

May 13, 2016.

Julie Forman, the wife of Eric Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley

Wealth Management, where the Company maintains a continuing banking relationship.

and to assist management in communications with investors and stockholders.

In January 2014 and August 2018, the Company entered

into respective amendments to this consulting agreement, which have extended the consulting agreement through January 28, 2024.

Consideration under this consulting agreement, including amendments, has been paid exclusively in the form of stock options.

Schwartzberg is currently a significant stockholder of the Company and continues to be a consultant to the Company.

and consulting fees charged to operations for services rendered by the Eric Forman Law Office were $38,000 and $48,000 for the

years ended December 31, 2020 and 2019, respectively, excluding amounts paid to Mr.

Forman pursuant to an employment agreement

during 2020 (see Note 7).

Eric Forman is the son-in-law of Gil Schwartzberg, a significant stockholder of and consultant to the

Company, and is the son of Dr.

Stephen Forman, a member of the Company’s Board of Directors.

Julie Forman, the wife of Eric

Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley Wealth Management, where the Company’s

cash is deposited and the Company maintains a continuing banking relationship.

Weingarten was appointed as the Company’s Vice President and Chief Financial Officer on August 12, 2020.

During the year

ended December 31, 2020 (prior to his appointment as Vice President and Chief Financial Officer), the Company paid Mr.

a total of $79,995 for accounting and financial consulting services rendered with respect to the preparation of the Company’s

consolidated financial statements and certain other financial and compliance matters.

During the year ended December 31, 2019,

the Company paid Mr.

Weingarten a total of $80,380 for similar accounting and financial consulting services rendered.

These amounts

are excluded from the summary of related party costs presented below.

summary of related party costs for the years ended December 31, 2020 and 2019 is as follows:

Related party costs:

compensation arrangements involving members of the Company’s Board of Directors and affiliates are described at Note 5.

compensation arrangements involving members of the Company’s Board of Directors.

officers and affiliates are described at

information with respect to cash compensation paid to the Company’s officers during the year ended December 31, 2020 pursuant

to employment agreements are provided at Note 7.

Stock-Based Compensation

Company issues common stock and stock options as incentive compensation to directors and as compensation for the services of independent

Company issues common stock and stock options as incentive compensation to directors and as compensation for the services of employees,

contractors and consultants of the Company.

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which provided for the granting of awards, consisting of stock options, stock appreciation rights, performance shares, and restricted

shares of common stock, to employees and independent contractors, for up to 2,500,000 shares of the Company’s common stock,

under terms and conditions as determined by the Company’s Board of Directors.

shares of common stock, to employees and consultants, for up to 416,667 shares of the Company’s common stock, under terms

and conditions as determined by the Company’s Board of Directors.

The 2007 Plan terminated on June 19, 2017.

As of December 31, 2019, unexpired stock options for 1,250,000 shares were issued and outstanding under the 2007 Plan.

As of December

31, 2020, unexpired stock options for 208,333 shares were issued and outstanding under the 2007 Plan.

July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which

provides for the granting of equity-based awards, consisting of stock options, restricted stock, restricted stock units, stock

appreciation rights, and other stock-based awards to employees, officers, directors and consultants of the Company and its affiliates

for up to 2,333,333 shares of the Company’s common stock, under terms and conditions as determined by the Company’s

Board of Directors.

fair value of each stock option awarded is calculated on the grant date using the Black-Scholes option-pricing model.

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The expected volatility is based on

the historical volatility of the Company’s common stock.

The expected life of the stock option is considered its full contractual

The fair market value of the common stock is determined by reference to the quoted market price of the common stock on the

the historical volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to

the contractual life of the stock option being granted.

Unless sufficient historical exercise data is available, the expected

life of the stock option is calculated as the mid-point between the vesting period and the contractual term (the “simplified

method”).

The fair market value of the common stock is determined by reference to the quoted market price of the common

stock on the grant date.

stock options requiring an assessment of value during the year ended December 31, 2020, the fair value of each stock option award

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Risk-free interest rate

dividend yield

0.23% to 0.31 %

Expected dividend yield

Expected volatility

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was estimated using the Black-Scholes option-pricing model with the following assumptions:

Risk-free interest rate

interest rate

dividend yield

Expected volatility

Expected life

August 4, 2018, in conjunction with their appointments as directors of the Company, the Company granted stock options to each

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Yun Yen to purchase an aggregate of 33,333 shares of the Company’s common stock, exercisable

for a period of five years from the vesting date at $0.28 per share, which was the approximate fair market value of the Company’s

for a period of five years from the grant date at $1.68 per share, which was the approximate fair market value of the Company’s

common stock on such date, with one-half of such stock options (16,667 shares for each director) vesting on August 4, 2018 and

the remaining one-half of such stock options (16,667 shares for each director) vesting on August 4, 2019.

The aggregate fair

value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $104,920

($0.2623 per share), of which $52,460 was attributable to the stock options fully-vested on August 4, 2018 and was therefore charged

to operations on that date.

The aggregate fair value

of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $104,920 ($1.5738

per share), of which $101,475 was attributable to the stock options fully-vested on August 4, 2018 and was therefore charged to

operations on that date.

The remaining unvested portion of the fair value of the stock options was charged to operations ratably

from August 4, 2018 through August 4, 2019.

During the years ended December 31, 2019 and 2018, the Company recorded charges to

operations of $31,046 and $73,874, respectively, with respect to these stock options.

During the year ended December 31, 2019, the Company recorded a charge to general

and administrative costs in the consolidated statement of operations of $31,046 with respect to these stock options.

May 22, 2019, in recognition with their service as directors of the Company over the past year, the Company granted to each of

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Philip Palmedo, fully-vested stock options to purchase an aggregate

of 200,000 shares (50,000 shares for each director) of the Company’s common stock, exercisable for a period of five years

from the vesting date at $1.10 per share, which was the approximate fair market value of the Company’s common stock on such

The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined

to be $189,060 ($0.9453 per share), which was charged to operations on the grant date.

May 22, 2019, in recognition of his continuing service as consultant to the Company, the Company granted to Eric Forman fully-vested

stock options to purchase 100,000 shares of the Company’s common stock, exercisable for a period of five years from the

vesting date at $1.10 per share, which was the approximate fair market value of the Company’s common stock on such date.

of 33,333 shares (8,333 shares to each director) of the Company’s common stock, exercisable for a period of five years from

the grant date at $6.60 per share, which was the approximate fair market value of the Company’s common stock on such date.

The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be

$94,525 ($0.9453 per share), which was charged to operations on the grant date.

$189,060 ($5.6718 per share) and was recorded as a charge to general and administrative costs in the consolidated statement of

operations on the grant date.

May 22, 2019, in recognition of his continuing service as consultant to the Company, the Company granted to Eric Forman fully-vested

stock options to purchase 16,667 shares of the Company’s common stock, exercisable for a period of five years from the grant

date at $6.60 per share, which was the approximate fair market value of the Company’s common stock on such date.

value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $94,525 ($5.6718

per share) and was recorded as a charge to general and administrative costs in the consolidated statement of operations on the

July 23, 2019, the Company granted Francis Johnson, a consultant to the Company, fully-vested stock options to purchase 83,333

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stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $434,024 ($5.2083 per share)

which was attributable to the stock options fully vested on July 23, 2019 and was therefore charged to operations on that date.

and was recorded as a charge to research and development costs in the consolidated statement of operations on the grant date.

September 14, 2015, in connection with the Collaboration Agreement with BioPharmaWorks as described at Note 7, the Company issued

to BioPharmaWorks two stock options, in the form of warrants, to purchase 166,666 shares (83,333 shares per warrant) of the Company’s

common stock.

The first warrant vested on September 14, 2016 and was exercisable for a period of five years from the date of grant

at $6.00 per share.

The second warrant vested on September 14, 2017 and was exercisable for a period of five years from the date

of grant at $12.00 per share.

On July 3, 2020, the Company’s Board of Directors approved an extension of the term of the

outstanding warrants to acquire an aggregate of 166,666 shares of the Company’s common stock from September 14, 2020 to

September 14, 2025.

The Company’s closing stock price on July 2, 2020 was $5.40 per share.

The fair value of the extension

of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was measured for accounting purposes

as the difference in the fair value of the stock options immediately before and immediately after the extension date and was determined

to be $670,715 ($4.0242 per share), which was recorded as a charge to research and development costs in the consolidated statement

of operations on that date.

July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric Forman, Mr.

was granted options for 58,333 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

options have a term of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company’s

common stock on the grant date.

The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second

and third anniversaries of the grant date.

The fair value of these stock options, as calculated pursuant to the Black-Scholes

option-pricing model, was determined to be $400,855 ($6.8718 per share), of which $100,214 was attributable to the stock options

fully-vested on August 12, 2020 and was therefore charged to operations on that date.

The remaining unvested portion of the fair

value of the stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023.

During the year

ended December 31, 2020, the Company recorded a charge to general and administrative costs in the consolidated statement of operations

of $138,926 with respect to these stock options.

August 1, 2020, in connection with an employment agreement entered into with Dr.

James Miser, M.D., Dr.

Miser was granted options

for 83,334 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

The options have a term

of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company’s common stock

on the effective date of the employment agreement.

The options vested as to 25% on the effective date, and will vest 25% on each

of the first, second and third anniversaries of the effective date.

The fair value of these stock options, as calculated pursuant

to the Black-Scholes option-pricing model, was determined to be $572,650 ($6.8718 per share), of which $143,163 was attributable

to the stock options fully-vested on August 1, 2020 and was therefore charged to operations on that date.

The remaining unvested

portion of the fair value of the stock options will be charged to operations ratably from August 1, 2020 through August 1, 2023.

During the year ended December 31, 2020, the Company recorded a charge to general and administrative costs in the consolidated

statement of operations of $202,782 with respect to these stock options.

August 12, 2020, in connection with the employment agreement entered into with Robert N.

Weingarten, Mr.

Weingarten was granted

options for 58,333 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

The options have

a term of five years and an exercise price of $7.14 per share, which was equal to the closing price of the Company’s common

stock on the grant date.

The options vested as to 25% on August 12, 2020, and will vest 25% on each of the first, second and third

anniversaries of the grant date.

The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing

model, was determined to be $400,855 ($6.8718 per share), of which $100,214 was attributable to the stock options fully-vested

on August 12, 2020 and was therefore charged to operations on that date.

The remaining unvested portion of the fair value of the

stock options will be charged to operations ratably from August 12, 2020 through August 12, 2023.

During the year ended December

31, 2020, the Company recorded a charge to general and administrative costs in the consolidated statement of operations of $138,926

with respect to these stock options.

December 21, 2020, the Company entered into a services agreement with IRTH Communications, LLC and agreed to issue 27,420 shares

of common stock, fully vested upon issuance, with a grant date fair value of $100,000 ($3.65 per share), which was charged to

general and administrative costs in the consolidated statement of operations at December 31, 2020 (see Note 7).

summary of stock-based compensation costs for the years ended December 31, 2020 and 2019 is as follows:

stock-based compensation costs

Related parties

Non-related parties

Total stock-based compensation costs

summary of stock option activity, including options issued in the form of warrants, during the years ended December 31, 2020 and

2019 is presented below.

Stock options

outstanding at December 31, 2017

Stock options outstanding

at December 31, 2018

options outstanding at December 31, 2019

options exercisable at December 31, 2018

options exercisable at December 31, 2019

was no deferred compensation expense for the outstanding value of unvested stock options at December 31, 2019.

Number of Shares

Weighted Average

Weighted Average Remaining Contractual Life (in Years)

Stock options outstanding at December 31, 2018

Stock options outstanding at December 31, 2019

Stock options outstanding at December 31, 2020

Stock options exercisable at December 31, 2019

Stock options exercisable at December 31, 2020

deferred compensation expense for the outstanding value of unvested stock options was approximately $894,000 at December 31, 2020,

which will be recognized subsequent to December 31, 2020 over a weighted-average period of approximately thirty-one months.

exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at December

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on a fair market value of $3.17 per share on December 31, 2020.

outstanding options to acquire shares of the Company’s common stock were vested at December 31, 2019.

stock options to acquire 150,000 shares of the Company’s common stock had not vested at December 31, 2020.

Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock.

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as of December 31, 2020 and 2019 are summarized below.

and organization costs

Start-up and organization costs

Research credits

Stock-based compensation

operating loss carryforwards

Total deferred tax

deferred tax assets

Net operating loss carryforwards

Total deferred tax assets

Valuation allowance

Net deferred tax assets

assessing the potential realization of deferred tax assets, management considers whether it is more likely than not that some

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rate and the effective tax rate for the years ended December 31, 2020 and 2019.

Ended December 31,

statutory tax rate

State income taxes,

net of federal tax benefit

Expirations related

to stock-based compensation

Adjustment to deferred

in valuation allowance

federal statutory tax rate

State income taxes, net of federal tax benefit

Expirations related to stock-based compensation

Adjustment to deferred tax asset

Change in valuation allowance

Effective tax rate

December 31, 2020, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately

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Federal net operating losses, if not utilized earlier, expire through 2040.

net operating loss carryovers were incurred solely in New York.

New York tax law requires New York net operating loss carryovers

from years prior to 2015 to be converted, by applying a formula, into a Prior Net Operating Loss Conversion (PNOLC) subtraction

net operating loss carryovers were incurred solely in the state of New York.

New York tax law requires New York net operating

loss carryovers from years prior to 2015 to be converted, by applying a formula, into a Prior Net Operating Loss Conversion (PNOLC)

subtraction pool.

The Company may utilize up to 1/10 of the PNOLC subtraction pool, or $928,313, each year.

Unutilized PNOLC amounts carry

forward to succeeding years until they expire in 2035.

Unutilized PNOLC amounts

carry forward to succeeding years until they expire in 2035.

In addition, the full New York net operating losses incurred in post-2015

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Trial Agreements

August 20, 2018, the Company and the Moffitt Cancer Center and Research Institute Hospital Inc., Tampa, Florida (“Moffitt”)

entered into a Clinical Trial Research Agreement (the “Clinical Trial Research Agreement”) effective for a term of

five years, unless terminated earlier by the Company pursuant to 30 days written notice.

Pursuant to the Clinical Trial Research

Agreement, Moffitt agreed to conduct and manage a Phase 1b/2 clinical trial to evaluate the therapeutic benefit of the Company’s

lead anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic

syndrome (MDS).

November 2018, the Company received approval from the FDA for its Investigational New Drug (IND) Application to conduct a Phase

1b/2 clinical trial to evaluate the therapeutic benefit of LB-100 in patients with low and intermediate-1 risk MDS who have failed

or are intolerant of standard treatment.

This clinical trial began in April 2019 and the first patient was entered into the clinical

trial in July 2019.

The clinical trial is expected to be completed over a period of two years, with final analysis and reporting

expected within three years.

This Phase 1b/2 clinical trial utilizes LB-100 as a single agent in the treatment of patients with

del(5q) myelodysplastic syndrome (del5qMDS) failing first line therapy.

The bone marrow cells of these patients are deficient

in PP2A and are especially vulnerable to further inhibition of PP2A by LB-100.

During the years ended December 31, 2019 and 2018,

the Company paid Moffitt $45,093 and $0, respectively, pursuant to this agreement.

As of December 31, 2019, total costs of $45,093

have been incurred pursuant to this agreement.

as of July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the

Spanish Sarcoma Group (Grupo Espanol de Investigacion en Sarcomas or “GEIS”), Madrid, Spain, to carry out a clinical

trial entitled “Randomized phase I/II trial of LB-100 plus doxorubicin vs.

doxorubicin alone in first line of advanced soft

tissue sarcoma”.

The purpose of this clinical trial is to obtain information about the efficacy and safety of the Company’s

lead anti-cancer clinical compound LB-100 combined with doxorubicin in soft tissue sarcomas.

Doxorubicin is the global standard

for initial treatment of advanced soft tissue sarcomas (ASTA).

Doxorubicin alone has been the mainstay of first line treatment

of ASTS for over 40 years, with little therapeutic gain from adding cytotoxic compounds to or substituting other cytotoxic compounds

for doxorubicin.

In animal models, LB-100 consistently enhances the antitumor activity of doxorubicin without apparent increases

GEIS has a network of referral centers in Span and across Europe that have an impressive track record of efficiently

conducting innovative studies in ASTS.

The Company has agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct

of this clinical trial, as well as to provide funding for the clinical trial.

The goal is to enter the first patient into this

clinical trial during the quarter ending June 30, 2020, with approximately 170 patients to be subsequently enrolled over a period

of two years.

The Company estimates that this clinical trial will be completed and results will be published by June 30, 2023.

The original start date for patient entry was delayed due to longer than expected processing

of formal approval of importation of LB-100 into the European Union.

This approval was originally expected to be received in the

quarter ended September 30, 2019, but was delayed and is now expected to be received during the quarter ending June 30, 2020.

During the year ended December 31, 2019, the Company incurred costs of $87,471 pursuant to this agreement.

As of December

31, 2019, total costs of $87,471 have been incurred pursuant to this agreement.

Company’s aggregate commitments pursuant to these clinical trial agreements, less amounts previously incurred to date under

these agreements, totaled approximately $5,000,000 as of December 31, 2019, which are expected to be incurred over the next five

years through 2024.

Effective August 20, 2018, the Company entered into a Clinical Trial Research Agreement with the Moffitt Cancer Center and

Research Institute Hospital Inc., Tampa, Florida, effective for a term of five years, unless terminated earlier by the Company

pursuant to 30 days written notice.

Pursuant to the Clinical Trial Research Agreement, Moffitt agreed to conduct and manage a

Phase 1b/2 clinical trial to evaluate the therapeutic benefit of the Company’s lead anti-cancer clinical compound LB-100

to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome (MDS).

November 2018, the Company received approval from the U.S.

Food and Drug Administration for its Investigational New Drug Application

(“IND”) to conduct a Phase 1b/2 clinical trial to evaluate the therapeutic benefit of LB-100 in patients with low

and intermediate-1 risk MDS who have failed or are intolerant of standard treatment.

Patients with MDS, although usually older,

are generally well except for severe anemia requiring frequent blood transfusions.

This Phase 1b/2 clinical trial utilizes LB-100

as a single agent in the treatment of patients with low and intermediate-1 risk MDS, including patients with del(5q) myelodysplastic

syndrome (del5qMDS) failing first line therapy.

The bone marrow cells of patients with del5qMDS are deficient in PP2A by virtue

of an acquired mutation and are especially vulnerable to further inhibition of PP2A by LB-100.

The clinical trial began at a single

site in April 2019 and the first patient was entered into the clinical trial in July 2019.

A total enrollment of 41 patients is

An interim analysis will be done after the first 21 patients are entered.

If there are 3 or more responders but fewer

than 7, an additional 20 patients will be entered.

If at any point there are 7 or more responders, this will be sufficient evidence

to support continued development of LB-100 for the treatment of low and intermediate-1 risk MDS.

Recruitment has been slow and

the Covid-19 pandemic has further reduced recruitment of patients into the protocol.

At the current rate of accrual, the trial

would be completed over a period of four years from its initiation, with the final analysis and reporting expected by July 2023.

However, with additional funds, the Company’s objective would be to add two additional MDS centers to the Phase 2 portion

of the study to accelerate patient accrual, with the goal of an earlier reporting date.

the years ended December 31, 2020 and 2019, the Company paid Moffitt $41,142 and $45,093, respectively, pursuant to this agreement.

As of December 31, 2020, total costs of $102,944 have been incurred pursuant to this agreement.

Effective July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with

the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas or “GEIS”), Madrid, Spain, to

carry out a study entitled “Randomized phase I/II trial of LB-100 plus doxorubicin vs.

doxorubicin alone in first line of

advanced soft tissue sarcoma”.

The purpose of this clinical trial is to obtain information about the efficacy and safety

of LB-100 combined with doxorubicin in soft tissue sarcomas.

Doxorubicin is the global standard for initial treatment of advanced

soft tissue sarcomas (“ASTS”).

Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40

years, with little therapeutic gain from adding cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin.

In animal models, LB-100 consistently enhances the anti-tumor activity of doxorubicin without apparent increases in toxicity.

has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative

studies in ASTS.

The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial,

as well as to provide funding for the clinical trial.

The goal was to enter the first patient during the quarter ending December

31, 2020, with approximately 150 patients to be enrolled over two years.

Advanced sarcoma is a very aggressive disease.

of the study assumes a median progression free survival (PFS, no evidence of disease progression or death from any cause) of 4.5

months in the doxorubicin arm and an alternative median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate a

statistically significant decrease in relative risk of progression or death by adding LB-100.

There is a planned interim analysis

of the primary endpoint when about half of the 102 events required for final analysis is reached.

Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020.

However, during

July 2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis

of the protocol, it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing

These regulations were adopted subsequent to the production of the Company’s existing LB-100 inventory.

is in the process of obtaining approval from the European Union regulatory authorities for new inventory of LB-100.

the clinical trial is now estimated to begin during the quarter ending September 30, 2021 and to be completed by the quarter ending

September 30, 2024.

The interim analysis is expected in June 2023 and could indicate either inferiority or superiority of LB-100

plus doxorubicin as compared to doxorubicin alone.

A positive study would have the potential to change the standard therapy for

this disease after four decades of failure to improve the marginal benefit of doxorubicin alone.

Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the

On February 18, 2020, the Company advanced $43,411 to GEIS towards a second milestone payment obligation of $87,471,

which was expected to become due and payable during the quarter ended June 30, 2020 based on the anticipated achievement of the

second milestone, and which was therefore recorded as an advance on the Company’s balance sheet at March 31, 2020.

as a result of the substantial delay in commencing the clinical trial as described above, the achievement of the second milestone

had been delayed until mid-2021 and the Company therefore determined to charge such advance to research and development costs

in the Company’s statement of operations at June 30, 2020.

Subsequently, on March 9, 2021, the Company paid an additional

$23,802 to GEIS for current work being done under this agreement.

during the years ended December 31, 2020 and 2019, the Company incurred costs of $43,411 and $87,471, respectively, pursuant to

this agreement.

As of December 31, 2020, total costs of $130,882 have been incurred pursuant to this agreement.

Company’s aggregate commitments pursuant to the aforementioned clinical trial agreements, less amounts previously paid to

date under these agreements, totaled approximately $5,230,000 as of December 31, 2020, consisting of approximately $4,614,000

relating to the GEIS clinical trial and approximately $616,000 relating to the Moffit clinical trial, which are expected to be

incurred over the next five years through December 31, 2025.

In order to manufacture

a new inventory supply of LB-100 for the GEIS clinical trial, the Company has engaged a number of vendors to carry out the multiple

tasks needed to make and gain approval of a new clinical product for investigational study in Spain.

These tasks include the synthesis

under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the steps

involved by an independent auditor.

The API is then transferred to a vendor that prepares the clinical drug product (DP), also

under GMP conditions documented by an independent auditor.

The DP is then sent to a vendor to test for purity and sterility, provide

appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials.

A formal application

documenting all steps taken to prepare the DP for clinical use must be submitted to the appropriate regulatory authorities for

review and approval before being used in a clinical trial.

The Company estimates

that this program to provide new inventory of the DP for the Spanish sarcoma study, and potentially for subsequent multiple trials

within the European Union, will cost from $600,000 and $700,000.

The Company’s remaining aggregate commitments under this

program, less amounts previously paid to date, totaled approximately $300,000 as of December 31, 2020, which are expected to be

incurred through June 30, 2021.

Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with City of Hope National

Medical Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City

of Hope”), to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase inhibitor,

combined with a standard regimen for untreated, extensive stage-disease small cell lung cancer (ED-SCLC).

LB-100 will be given

in combination with carboplatin, etoposide and atezolizumab, an FDA-approved but marginally effective regimen, to previously untreated

ED-SCLC patients.

The dose of LB-100 will be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended

Phase 2 dose (RP2D).

Patient entry will be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm the

safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration

of overall response, progression-free-survival and overall survival.

Company estimates that from 24 to 30 patients will be needed to complete this clinical trial, at an estimated cost of $2,500,000

to $2,900,000, respectively.

If a significant number of patients fail during the dose-escalation process, an increase of up to

12 patients would likely be necessary, at an estimated additional cost of $800,000.

clinical trial is planned to commence during the quarter ending June 30, 2021, with patient accrual expected to take approximately

18 to 24 months to conduct.

If LB-100 does potentiate the benefit of the standard regimen, some evidence could be noted at 12

months into the clinical trial, but an assessment of potential increased activity is likely to require at least 24 months.

Trial Monitoring Agreements

September 12, 2018, the Company finalized a work order agreement with Theradex Systems, Inc.

(Theradex”), an international

(“Theradex”), an international

contract research organization (“CRO”), to monitor the Phase 1b/2 clinical trial being managed and conducted by Moffitt.

The clinical trial is expected to be completed over a period of two years, with final analysis and reporting expected within three

Costs under this work order agreement are estimated to be approximately $954,000, with such payments expected to be divided

approximately 94% to Theradex for services and approximately 6% for payments for pass-through costs.

The costs of the Phase 1b/2

clinical trial being paid to or through Theradex are being recorded and charged to operations based on the periodic documentation

provided by the CRO.

During the years ended December 31, 2019 and 2018, the Company incurred costs of $51,586 and $11,906, respectively,

pursuant to this work order.

The clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019.

At the current

rate of accrual, the trial would be completed over a period of four years from its initiation, with the final analysis and reporting

expected by July 2023.

under this work order agreement are estimated to be approximately $954,000, with such payments expected to be divided approximately

94% to Theradex for services and approximately 6% for payments for pass-through costs.

The costs of the Phase 1b/2 clinical trial

being paid to or through Theradex are being recorded and charged to operations based on the periodic documentation provided by

During the years ended December 31, 2020 and 2019, the Company incurred costs of $18,663 and $51,586, respectively, pursuant

to this work order.

As of December 31, 2020, total costs of $75,788 have been incurred pursuant to this work order agreement.

Company expects to enter into a separate work order agreement with Theradex to monitor the GEIS clinical trial as described above.

Company’s aggregate commitments pursuant to this clinical trial monitoring agreement, less amounts previously paid to date

under this agreement, totaled approximately $874,000 as of December 31, 2020, which are expected to be incurred over the next

five years through June 30, 2025.

and License Agreements

March 22, 2018, the Company entered into a Patent Assignment and Exploitation Agreement (the “Agreement”) with INSERM

TRANSFERT SA, acting as delegatee of the French National Institute of Health and Medical Research (“INSERM”), for

the assignment to the Company of INSERM’S interest in United States Patent No.

9,833,450 entitled “Oxabicyloheptanes

and Oxabicycloheptenes for the Treatment of Depressive and Stress Disorders”, which was filed with the United States Patent

and Trademark Office in the name of INSERM and the Company as co-owners on February 19, 2015 and granted on May 12, 2017, and

related patent applications and filings.

INSERM is a French public institution dedicated to research in the field of health and

medicine that had previously entered into a Material Transfer Agreement (“MTA”) with the Company to allow INSERM to

conduct research on the Company’s proprietary compound LB-100 and/or its analogs for the treatment of depressive or stress

disorders in humans.

Pursuant to the Agreement, the Company has agreed to make certain milestone payments to INSERM aggregating

up to $1,750,000 upon achievement of development milestones and up to $6,500,000 upon achievement of commercial milestones.

Company also agreed to pay INSERM certain commercial royalties on net sales of products attributed to the Agreement.

The Company’s

current plan is to complete the validation process to evaluate LB-100 for the treatment of depressive or stress disorders in humans

within three years;

however, the exploitation of this patent for the treatment of depressive and stress disorders in humans will

require substantial additional capital and/or a joint venture or other type of business arrangement with a pharmaceutical company

with substantially greater capital and business resources than those available to the Company.

As there can be no assurances that

the Company will be able to obtain the capital or business resources necessary to focus on the exploitation of this patent, it

is uncertain as to when the Company may reach any of the development or commercialization milestones under the Agreement, if at

As of December 31, 2019 and 2018, no amounts were due under this agreement.

March 22, 2018, the Company entered into a Patent Assignment and Exploitation Agreement with INSERM TRANSFERT SA, acting as delegatee

of the French National Institute of Health and Medical Research, for the assignment to the Company of INSERM’S interest

in United States Patent No.

9,833,450 entitled “Oxabicyloheptanes and Oxabicycloheptenes for the Treatment of Depressive

and Stress Disorders”, which was filed with the United States Patent and Trademark Office in the name of INSERM and the

Company as co-owners on February 19, 2015 and granted on May 12, 2017, and related patent applications and filings.

a French public institution dedicated to research in the field of health and medicine that had previously entered into a Material

Transfer Agreement with the Company to allow INSERM to conduct research on the Company’s proprietary compound LB-100 and/or

its analogs for the treatment of depressive or stress disorders in humans.

Pursuant to the Agreement, the Company has agreed to

make certain milestone payments to INSERM aggregating up to $1,750,000 upon achievement of development milestones and up to $6,500,000

upon achievement of commercial milestones.

The Company also agreed to pay INSERM certain commercial royalties on net sales of

products attributed to the Agreement.

The Company’s current plan is to complete the validation process to evaluate LB-100

for the treatment of depressive or stress disorders in humans within three years;

however, the exploitation of this patent for

the treatment of depressive and stress disorders in humans will require substantial additional capital and/or a joint venture

or other type of business arrangement with a pharmaceutical company with substantially greater capital and business resources

than those available to the Company.

As there can be no assurances that the Company will be able to obtain the capital or business

resources necessary to focus on the exploitation of this patent, it is uncertain as to when, if at all, the Company may reach

any of the development or commercialization milestones under the Agreement.

As of December 31, 2020 and 2019, no amounts were

due under this agreement.

April 2, 2018, the Company entered into a consulting agreement for a term of two years with Liberi Life Sciences Consultancy BV,

located in The Netherlands, for consulting and advisory services with respect to sales and licensing, as well as the procurement

of investors in China, Japan and South Korea (the “Consulting Agreement”).

The Consulting Agreement provided for the

payment of a fixed, one-time retainer of EURO 15,000 (US $18,348), which was paid on April 5, 2018, and 2.5% of the net payments

received by the Company from sales of products or licensing activities arising directly and exclusively from leads generated by

the advisor during the term of the Consulting Agreement, and any investors introduced to the Company by the advisor that results

in an investment in the Company during the term of the Consulting Agreement.

The Company recorded the payment of the retainer

as a prepaid expense in the Company’s consolidated balance sheet, and is amortizing the retainer payment over the two-year

life of the Consulting Agreement, as a result of which the Company recorded charges to operations of $9,174 and $6,881 during

the years ended December 31, 2019 and 2018, respectively.

At December 31, 2019, the unamortized balance of the retainer payment

was $2,294, all of which was classified as a current asset in the Company’s consolidated balance sheet at such date.

December 31, 2018, the unamortized balance of the retainer payment was $11,468, of which $9,175 was classified as a current asset

and $2,293 was classified as a non-current asset in the Company’s consolidated balance sheet at such date.

August 20, 2018 (the “Effective Date”), the Company and Moffitt entered into an Exclusive License Agreement (the “License

Agreement”).

Pursuant to the License Agreement, Moffitt granted the Company an exclusive license under certain patents owned

by Moffitt (the “Licensed Patents”) relating to the treatment of MDS and a non-exclusive license under inventions,

concepts, processes, information, data, know-how, research results, clinical data, and the like (other than the Licensed Patents)

necessary or useful for the practice of any claim under the Licensed Patents or the use, development, manufacture or sale of any

product for the treatment of MDS which would otherwise infringe a valid claim under the Licensed Patents.

The Company is obligated

to pay Moffitt a non-refundable license issue fee of $25,000 after the first patient is entered into a Phase 1b/2 clinical trial

to be managed and conducted by Moffitt.

The clinical trial began in April 2019 and the first patient was entered into the clinical

trial in July 2019.

The clinical trial is expected to be completed over a period of two years, with final analysis and reporting

expected within three years.

The Company is also obligated to pay Moffitt an annual license maintenance fee of $25,000 commencing

on the first anniversary of the Effective Date and every anniversary thereafter until the Company commences payment of minimum

royalty payments.

The Company has also agreed to pay non-refundable milestone payments to Moffitt, which cannot be credited against

earned royalties payable by the Company, based on reaching various clinical and commercial milestones aggregating $1,897,000,

subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the

License Agreement.

During the years ended December 31, 2019 and 2018, the Company recorded charges to operations of $80,669 and

$0, respectively, in connection with its obligations under the License Agreement.

As of December 31, 2019, no milestones had yet

been attained.

of investors in China, Japan and South Korea.

The Consulting Agreement provided for the payment of a fixed, one-time retainer

of EURO 15,000 (US $18,348), which was paid on April 5, 2018, and 2.5% of the net payments received by the Company from sales

of products or licensing activities arising directly and exclusively from leads generated by the advisor during the term of the

Consulting Agreement, and any investors introduced to the Company by the advisor that results in an investment in the Company

during the term of the Consulting Agreement.

The Company recorded the payment of the retainer as a prepaid expense in the Company’s

consolidated balance sheet and amortized the retainer payment over the two-year life of the Consulting Agreement, as a result

of which the Company recorded charges to operations of $2,294 and $9,174 during the years ended December 31, 2020 and 2019, respectively.

As of December 31, 2020, the prepaid consulting fee had been fully amortized.

At December 31, 2019, the unamortized balance of

the retainer payment was $9,174, all of which was classified as a current asset in the Company’s consolidated balance sheet

at such date.

On March 1, 2020, the Consulting Agreement was extended to April 2, 2021 without any additional consideration.

August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt.

Pursuant to the License Agreement, Moffitt

granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating

to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research

results, clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under

the Licensed Patents or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise

infringe a valid claim under the Licensed Patents.

The Company was obligated to pay Moffitt a non-refundable license issue fee

of $25,000 after the first patient is entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt.

trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019.

is also obligated to pay Moffitt an annual license maintenance fee of $25,000 commencing on the first anniversary of the Effective

Date and every anniversary thereafter until the Company commences payment of minimum royalty payments.

The Company has also agreed

to pay non-refundable milestone payments to Moffitt, which cannot be credited against earned royalties payable by the Company,

based on reaching various clinical and commercial milestones aggregating $1,897,000, subject to reduction by 40% under certain

circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement.

During the years ended

December 31, 2020 and 2019, the Company recorded charges to operations of $25,001 and $80,669, respectively, in connection with

its obligations under the License Agreement.

As of December 31, 2020, no milestones had yet been attained.

Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products,

7 unchanged sentences

date on which the last valid claim of the Licensed Patents expires, lapses, or is declared to be invalid in all countries.

John Kovach .

On July 15, 2020, the Company entered into an employment agreement with Dr.

John Kovach pursuant to which Dr.

Kovach is to continue to act as the Company’s President, Chief Executive Officer and Chief Scientific Officer.

His responsibilities

shall be for the oversight of the Company’s entire operations and strategic planning, and shall be the primary contact between

the Company’s executive team and the Board of Directors, to whom he shall report.

Kovach shall supervise all scientific

endeavors, providing guidance to the Chief Medical Officer.

He shall be the principal spokesperson for the Company.

will receive an annual salary of $250,000, payable monthly.

The effective date of the agreement was October 1, 2020 and shall

remain in effect until the earlier of (i) one year from the effective date, automatically renewable for additional one-year periods

unless terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, (ii) his death,

or (iii) termination for cause.

During the year ended December 31, 2020, the Company incurred charges for salary in the amount

of $62,500 with respect to this agreement, which amount is included in general and administrative costs in the Company’s

consolidated statements of operations.

to the employment agreement described above, Dr.

Kovach was paid a salary of $45,000 and $60,000 for the years ended December

31, 2020 and 2019, respectively, which amounts are included in general and administrative costs in the Company’s consolidated

statements of operations.

On July 15, 2020, as amended on August 12, 2020, the Company entered into an employment agreement with Eric Forman,

pursuant to which Mr.

Forman will act as the Company’s Chief Administrative Officer reporting directly to the Company’s

Chief Executive Officer.

Forman’s primary function shall be to oversee the Company’s internal operations, including

IT, licensing, legal, personnel, marketing, and corporate governance.

Forman will receive an annual salary of $120,000, payable

Forman was also granted stock options to acquire 350,000 shares of the Company’s common stock, which are further

described in Note 6.

The effective date of the agreement was October 1, 2020 and shall remain in effect until the earlier of (i)

one year from the effective date, automatically renewable for additional one-year periods unless terminated by either party upon

60 days written notice prior to the end of the applicable one-year period, (ii) his death, or (iii) termination for cause.

the year ended December 31, 2020, the Company incurred charges for salary in the amount of $30,000 with respect to this agreement,

which amounts is included in general and administrative costs in the Company’s consolidated statements of operations.

to the employment agreement described above, Mr.

Forman was paid consulting fees of $38,000 and $48,000 for the years ended December

31, 2020 and 2019, respectively, which amounts are included in general and administrative costs in the Company’s consolidated

statements of operations (see Note 4).

James Miser .

On August 1, 2020, the Company entered into an employment agreement with Dr.

James Miser, M.D., pursuant to which

Miser was appointed as the Company’s Chief Medical Officer.

Under the employment agreement, Dr.

Miser will play a leadership

role in planning, implementation and oversight of clinical trials.

Miser will be responsible for assisting and developing

strategic clinical goals and the implementation and safety monitoring of investigational studies.

Miser will be the primary

medical monitor for all clinical investigational studies and for the oversight of third party CRO monitors.

Miser will work

closely with the Company’s Chief Executive Officer on the development of specific goals needed to ensure the timely implementation

of appropriate clinical studies needed for successful registration of therapeutic products and new drug development.

will be required to devote at least 50% of his business time to the Company’s activities.

Miser will receive an annual

salary of $150,000.

Miser was also granted stock options to acquire 500,000 shares of the Company’s common stock, which

are further described in Note 6.

The effective date of the agreement was August 1, 2020.

The agreement shall remain in effect

until the earlier of (i) one year from the effective date, automatically renewable for additional one-year periods unless terminated

by either party upon 60 days written notice prior to the end of the applicable one-year period, (ii) his death, or (iii) termination

During the year ended December 31, 2020, the Company incurred charges for salary in the amount of $62,500 with respect

to this agreement, which amount is included in general and administrative costs in the Company’s consolidated statements

of operations.

On August 12, 2020, the Company entered into an employment agreement with Robert N.

Weingarten pursuant to

Weingarten was appointed as the Company’s Vice-President and Chief Financial Officer.

Weingarten will receive

an annual salary of $120,000.

Weingarten was also granted stock options to acquire 350,000 shares of the Company’s common

stock, which are further described in Note 6.

The effective date of the agreement was August 12, 2020.

The agreement shall remain

in effect until the earlier of (i) one year from the effective date, automatically renewable for additional one-year periods unless

terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, (ii) his death, or

(iii) termination for cause.

During the year ended December 31, 2020, the Company incurred charges for salary in the amount of

$46,451 with respect to this agreement, which amount is included in general and administrative costs in the Company’s consolidated

statements of operations.

to the employment agreement described above, Mr.

Weingarten was paid consulting fees of $79,995 and $80,380 for the years ended

December 31, 2020 and 2019, respectively, which amounts are included in general and administrative costs in the Company’s

consolidated statements of operations (see Note 4).

Significant Agreements and Contracts

October 18, 2013, the Company entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with the National

Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) for a term of four years.

Surgical Neurology Branch of NINDS is conducting research characterizing a variety of compounds proprietary to the Company and

is examining the potential of the compounds for anti-cancer activity, reducing neurological deficit due to ischemia and brain

injury, and stabilizing catalytic function of misfolded proteins for inborn brain diseases.

Under an M-CRADA, a party provides

research material, in this case proprietary compounds from the Company’s pipeline, for study by scientists at NIH.

of material was for research only and did not imply any endorsement of the material on the part of either party.

Under the M-CRADA,

the NIH grants a collaborator an exclusive option to elect an exclusive or non-exclusive commercialization license.

June 14, 2017, the Company executed Amendment No.

1 to the M-CRADA, pursuant to which the Company agreed to provide funding in

the amount of $100,000 to the National Cancer Institute for use in acquiring technical, statistical and administrative support

for research activities.

The $100,000 amount was scheduled to be paid in two equal installments of $50,000, the first installment

of which was paid, as scheduled, on July 9, 2017, and which was charged to research and development costs in the consolidated

statement of operations on such date.

The second installment of $50,000 was scheduled to be paid on the June 14, 2018 anniversary

date of the amendment and was accreted ratably through such date and included in research and development contract liabilities

in the Company’s consolidated balance sheet.

Pursuant to revised and updated collaboration plans, on November 3, 2018, the

NINDS and the Company agreed to a cancellation of the second installment payment of $50,000.

Accordingly, the previously accreted

charge of $50,000, of which $25,000 was recorded during the year ended December 31, 2018, was reversed during the year ended December

December 24, 2013, the Company entered into an agreement with NDA Consulting Corp.

(“NDA”) for consultation and advice

in the field of oncology research and drug development.

for consultation and advice in the field of

oncology research and drug development.

As part of the agreement, NDA also agreed to cause its president, Dr.

Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee.

The term of the agreement was

for one year and provided for a quarterly cash fee of $4,000.

The agreement has been automatically renewed for additional one-year

terms on its anniversary date since 2014.

Consulting and advisory fees charged to operations pursuant to this agreement for the

years ended December 31, 2019 and 2018 were $16,000 and $16,000, respectively, which were included in research and development

costs in the consolidated statements of operations.

M.D., to become a member of the Company’s Scientific Advisory Committee.

The term of the agreement was for one year and

provided for a quarterly cash fee of $4,000.

The agreement has been automatically renewed for additional one-year terms on its

anniversary date since 2014.

Consulting and advisory fees charged to operations pursuant to this agreement were $16,000 and $16,000

for the years ended December 31, 2020 and 2019, respectively, which were included in research and development costs in the consolidated

statements of operations.

September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged

17 unchanged sentences

hourly rate in lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation.

2016, it was mutually agreed to suspend services and payments under the Collaboration Agreement, without extending its term, for

the period from November 1, 2016 through March 31, 2017.

The Collaboration Agreement resumed as scheduled on April 1, 2017.

April 2018, it was again mutually agreed to suspend services and payments under the Collaboration Agreement, without extending

its term, for the period from February 1, 2018 through the September 13, 2019 anniversary date.

In February 2019, the Company

and BioPharmaWorks subsequently agreed to resume the Collaboration Agreement effective March 1, 2019, and the Collaboration Agreement

is currently in effect.

The Company recorded charges to operations pursuant to this Collaboration Agreement for the years ended

December 31, 2019 and 2018 of $100,000 and $10,000, respectively, which were included in research and development costs in the

consolidated statements of operations.

In April 2018,

it was mutually agreed to suspend services and payments under the Collaboration Agreement, without extending its term, for the

period from February 1, 2018 through the September 13, 2019 anniversary date.

In February 2019, the Company and BioPharmaWorks

subsequently agreed to resume the Collaboration Agreement effective March 1, 2019, and the Collaboration Agreement is currently

The Company recorded charges to operations pursuant to this Collaboration Agreement of $131,650, including reimbursed

expenses of $11,650, and $100,000 for the years ended December 31, 2020 and 2019, respectively, which were included in research

and development costs in the consolidated statements of operations.

August 12, 2020, the Company entered into a Master Service Agreement with the Foundation for Angelman Syndrome Therapy (FAST)

to collaborate in supporting preclinical studies of the potential benefit of LB-100 in a mouse model of Angelman Syndrome (AS)

as reported in The Proceedings of The National Academy of Science (Wang et al, June 3, 2019).

The preclinical studies will take

place at The University of California - Davis under the direction of Dr.

David Segal, an internationally recognized leader in

If the preclinical studies confirm that LB-100 reduces AS signs in rodent models, the Company has agreed to enter

into discussions with FAST with respect to possible collaborations to most efficiently assess the benefit of LB-100 in patients

with AS, which is a rare disease affecting an estimated one out of 12,000 to one out of 20,000 persons in the United States.

genetic cause of AS, reduced function of a specific maternal gene called Ube3, has been understood for some time, but the molecular

abnormality resulting from the genetic lesion has now been shown to be increased concentrations of protein phosphatase 2A (PP2A),

a molecular target of the Company’s investigational compound, LB-100.

The Company has agreed to provide FAST with a supply

of LB-100 to be utilized in the conduct of this study, which is initially expected to be completed within three years.

on FAST’s completion of this study, the Company has agreed to pay FAST five percent (5%) of all proceeds, as defined in

the Master Service Agreement, received by the Company, up to a maximum of $250,000 from the exploitation of the study results.

December 21, 2020, the Company entered into a services agreement with IRTH Communications, LLC for investor/public relations,

financial communications and strategic consulting services, effective for an initial term of twelve months and renewable annually

The Company agreed to pay a monthly fee of $7,500, including any renewal term, and also agreed to issue restricted

shares of common stock, fully vested upon issuance, with a grant date fair value of $100,000 (see Note 5).

Upon the commencement

of any renewal term, the Company will be obligated to issue additional restricted shares of common stock, fully vested upon issuance,

with a grant date fair value of $100,000.

of the Novel Coronavirus (COVID-19) on the Company’s Business Operations

global outbreak of the novel coronavirus (COVID-19) has led to severe disruptions in general economic activities worldwide, as

businesses and governments have taken broad actions to mitigate this public health crisis.

light of the uncertain and continually evolving situation relating to the spread of COVID-19, this pandemic could pose a risk

to the Company.

The extent to which the coronavirus may impact the Company’s business operations will depend on future developments,

which are highly uncertain and cannot be predicted at this time.

The Company intends to continue to monitor the situation and

may adjust its current business plans as more information and guidance become available.

coronavirus pandemic presents a challenge to medical facilities worldwide.

As the Company’s clinical trials are conducted

on an outpatient basis, it is not currently possible to predict the full impact of this developing health crisis on such clinical

trials, which could include delays in and increased costs of such clinical trials.

Current indications from the clinical research

organizations conducting the clinical trials for the Company are that such clinical trials are being delayed or extended for several

months as a result of the coronavirus pandemic.

is also significant uncertainty as to the effect that the coronavirus may have on the amount and type of financing available to

the Company in the future.

Subsequent Events

Company performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with

There were no material subsequent events which affected, or could affect, the amounts or disclosures in the consolidated

financial statements.

Other than those matters described below, there were no material subsequent events which affected, or could affect, the

amounts or disclosures in the consolidated financial statements.

of Stock Options

January 6, 2021, in recognition of their service as directors of the Company over the past year, the Company granted to each of

Winson Sze Chun Ho, Dr.

Stephen Forman, and Dr.

Philip Palmedo, fully-vested stock options to purchase an aggregate

of 200,000 shares (50,000 shares to each director) of the Company’s common stock, exercisable for a period of five years

from the grant date at $3.21 per share, which was the approximate fair market value of the Company’s common stock on such

Trial Agreement

January 18, 2021, the Company executed a Clinical Research Support Agreement with City of Hope National Medical Center, an NCI-designated

comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City of Hope”), to carry out a Phase

1b clinical trial of LB-100.

Information with respect to this clinical trial agreement is provided at Note 7.

Trial Monitoring Agreement

February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated

clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party (see Note 7).

The Company estimates that it will incur approximately $335,000 of costs under this work order agreement through September 30,

of Common Stock

March 2, 2021, the Company completed the sale of 1,133,102 shares of common stock at a price of $3.70 per share in a registered

direct equity offering, generating gross proceeds of $4,192,477.

The total cash costs of this offering were approximately $502,447,

resulting in net proceeds of approximately $3,690,030.

Pursuant to the placement agents’

agreement, the Company granted

to the placement agents warrants to purchase up to 113,310 shares of common stock commencing on March 2, 2021 and expiring on

March 2, 2026, at an exercise price of $3.70 per share.

February and March 2021, the Company issued 3,000 shares of common stock upon the exercise of 3,000 warrants at $5.70 per share

and received cash proceeds of $17,100.

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