What changed in this filing

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Item 9A. Controls and Procedures

2022-03-21 compared with 2021-03-26 · 1961 added, 2064 removed, 386 unchanged (91% of the section changed)

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of Disclosure Controls and Procedures

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 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,”

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

Act of 1934, as amended (the “Exchange Act), means controls and other procedures of a company that are designed to ensure

that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded,

processed, summarized and reported, within the time periods specified in the SEC’s rules and forms.

Disclosure controls

and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed

by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s

management, including its principal executive 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

As a result, even effective internal controls can provide only reasonable assurance with respect to financial statement

As conditions change over time so too may the effectiveness of internal controls.

Any controls and procedures, no

matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily

applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Management’s

Annual Report on Internal Controls Over Financial Reporting

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.

Moreover, in the future the Company may engage in business activities or transactions that could

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

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

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.

Company’s management is responsible for establishing and maintaining a system of disclosure controls and procedures (as defined

in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) that is designed

to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is

recorded, processed, summarized, and reported, within the time periods specified in the rules and forms.

Disclosure controls and procedures

include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the

reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its

principal executive officer(s) and principal financial officer(s), or persons performing similar functions, as appropriate to allow timely

decisions regarding required disclosure.

accordance with Exchange Act Rules 13a-15 and 15d-15, an evaluation was completed under the supervision and with the participation of

the Company’s management, including its Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design

and operation of the Company’s disclosure controls and procedures as of the fiscal year ended December 31, 2021, the end of the

most recent fiscal year covered by this report.

Based on that evaluation, the Company’s management concluded that the Company’s

disclosure controls and procedures were effective in providing reasonable assurance that information required to be disclosed in the

Company’s reports filed or submitted under the Exchange Act was recorded, processed, summarized, and reported within the time periods

specified in the rules and forms of the Securities and Exchange Commission (“SEC”).

Annual Report on Internal Control Over Financial Reporting

Company’s management, including its Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining

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

Internal control

over financial reporting is a process, including policies and procedures, designed to provide reasonable assurance regarding the reliability

of financial reporting and the preparation of financial statements for external reporting purposes in accordance with U.S.

accepted accounting principles.

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.

Company’s management assessed the Company’s internal control over financial reporting based on the Internal Control—Integrated

Framework (2013 Framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).

The Company’s

system of internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial

reporting and the preparation of financial statements for external purposes in accordance with U.S.

generally accepted accounting principles.

of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Therefore, even those

systems determined to be effective can provide only reasonable assurance of achieving their control objectives.

Furthermore, smaller

reporting companies face additional limitations.

Smaller reporting companies employ fewer individuals and find it more difficult to properly

segregate duties.

Smaller reporting companies tend to utilize general accounting software packages that lack a rigorous set of software

material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is

a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented

or deterred on a timely basis.

on the Company’s evaluation under the framework in COSO, the Company’s management, with the participation of the Chief Executive

Officer and Chief Financial Officer, concluded that the Company’s internal control over financial reporting was effective as of

December 31, 2021.

believes that the consolidated financial statements included in this report 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 31, 2021.

Report on Internal Control Over Financing Reporting

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.

in Internal Control Over Financial Reporting

Company’s management, including its Chief Executive Officer and 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, 2021 that has materially affected, or is reasonably likely to

materially affect, the Company’s internal control over financial reporting.

OTHER INFORMATION

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

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following table and text set forth the names of all of our directors and executive officers as of March 11, 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.

The 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.

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:

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Administrative Officer

Winson Sze Chun Ho

N Schwartzberg

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.

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

of our Board of Directors.

He received a B.A.

(cum laude) from Princeton University and an M.D.

(AOA) from the College

of Physicians & Surgeons, Columbia University.

Kovach trained in Internal Medicine and Hematology at Presbyterian Hospital,

Columbia University and spent six years in the laboratory of Chemical Biology at the National Institute of Arthritis and Metabolic

diseases studying control of gene expression in bacterial systems.

Kovach was recruited to the State University of New York at Stony Brook (“SUNY –

Stony Brook”) in Stony Brook,

New York in 2000 to found the Long Island Cancer Center (now named the Stony Brook University Cancer Center).

From 1994 to 2000,

Kovach was Executive Vice President for Medical and Scientific Affairs at the City of Hope National Medical Center in Los

Angeles, California.

(AOA) from the College of Physicians

& Surgeons, Columbia University.

Kovach trained in Internal Medicine and Hematology at Presbyterian Hospital, Columbia University,

and spent six years in the laboratory of Chemical Biology at the National Institute of Arthritis and Metabolic Diseases studying control

of gene expression in bacterial systems.

Kovach was recruited to the State University of New York at Stony Brook (“SUNY – Stony Brook”) in Stony Brook, New

York in 2000 to found the Long Island Cancer Center (now named the Stony Brook University Cancer Center).

From 1994 to 2000, Dr.

was Executive Vice President for Medical and Scientific Affairs at the City of Hope National Medical Center in Los Angeles, California.

His responsibilities included oversight of all basic and clinical research initiatives at the City of Hope.

During that time, Dr.

Kovach was also Director of the Beckman Research Center at City of Hope and a member of the Arnold and Mabel

Beckman Scientific Advisory Board in Newport Beach, California.

was also Director of the Beckman Research Center at City of Hope and a member of the Arnold and Mabel Beckman Scientific Advisory Board

in Newport Beach, California.

1976 to 1994, Dr.

Kovach was a consultant in oncology and director of the Cancer Pharmacology Division at the Mayo Clinic in Rochester,

During this time, he directed the early clinical trials program for evaluation of new anti-cancer drugs as principal

investigator of contracts from the National Cancer Institute.

From 1986 to 1994, he was also Chair of the Department of Oncology

and Director of the NCI-designated Mayo Comprehensive Cancer Center.

During this time, he directed the early clinical trials program for evaluation of new anti-cancer drugs as principal investigator

of contracts from the National Cancer Institute.

From 1986 to 1994, he was also Chair of the Department of Oncology and Director of the

NCI-designated Mayo Comprehensive Cancer Center.

During that time, Dr.

Kovach, working with a molecular geneticist,

Steve Sommer, M.D., Ph.D., published extensively on patterns of acquired mutations in human cancer cells as markers of environmental

mutagens and as potential indicators of breast cancer patient prognosis.

Kovach has published over 100 articles on the pharmacology,

toxicity and effectiveness of anti-cancer treatments and on the molecular epidemiology of breast cancer.

Kovach, working with a molecular geneticist, Steve Sommer, M.D.,

Ph.D., published extensively on patterns of acquired mutations in human cancer cells as markers of environmental mutagens and as potential

indicators of breast cancer patient prognosis.

Kovach has published over 100 articles on the pharmacology, toxicity and effectiveness

of anti-cancer treatments and on the molecular epidemiology of breast cancer.

February 23, 2017, Dr.

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

Stony Brook, as a result of which

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.

Kovach retired from his part-time (50%) academic position at SUNY – Stony Brook, as a result of which he

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

Miser, M.D., was appointed as Chief Medical Officer effective August 1, 2020.

Miser 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,

Since 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.

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.

Weingarten was appointed as 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.

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

(Nasdaq Capital Market:

GHSI) since June 2015 and Chairman of its Board

of Directors since July 2020.

Previously, Mr.

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

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

2017 to March 2020.

From July 2017 to June 2018, Mr.

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

and also served as its Vice President

and Chief Financial Officer.

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 Finance from the

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

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

Effective 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.

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

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 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.

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Cardozo School of Law.

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

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 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 –

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

currently a member of the Board of Directors of Gyrodyne LLC.

He also served on the Board of Trustees of Williams College and

of the Stony Brook (University) Foundation, where he chaired the Foundation’s Investment Committee.

Forman, M.D., is an internationally recognized expert in hematologic malignancies and bone marrow transplantation and is a

leader in preclinical and clinical cancer research.

He is co-editor of Thomas’

Hematopoietic Cell Transplantation, a definitive

textbook for clinicians, scientists and health care professionals.

Forman is the Francis and Kathleen McNamara Distinguished

Chair in Hematology and Hematopoietic Cell Transplantation at the City of Hope Comprehensive Cancer Center, a position he has

held since 1987.

Palmedo was appointed to our Board of Directors on June 30,

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

and economic development.

IRG was acquired 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 – 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 served on the boards of Asset Management Advisors, the Teton Trust Company, EHR Investments and C-Quest Capital, and is currently

a member of the Board of Directors of Gyrodyne LLC.

He also served on the Board of Trustees of Williams College and of the Stony Brook

(University) Foundation, where he chaired the Foundation’s Investment Committee.

Forman, M.D., is an internationally recognized expert in hematologic malignancies and bone marrow transplantation, and is a leader

in pre-clinical and clinical cancer research.

Forman was appointed to our Board of Directors on May 13, 2016.

He is co-editor of

Thomas’ Hematopoietic Cell Transplantation, a definitive textbook for clinicians, scientists and health care professionals.

Forman is the Francis and Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation at the City of Hope

Comprehensive Cancer Center, a position he has held since 1987.

nearly 40 years at City of Hope, Dr.

Forman has been instrumental in advancing the survival rates for patients suffering from

cancers of the blood and immune system such as leukemia, lymphoma and myeloma.

Director of the T Cell Immunotherapy Research Laboratory, his current research is focused on cancer immunotherapy, using the body’s

Forman has been instrumental in advancing the survival rates for patients suffering from cancers

of the blood and immune system such as leukemia, lymphoma and myeloma.

Director of the T Cell Immunotherapy Research Laboratory, his current research is focused on cancer immunotherapy, using the body’s

own immune system to attack cancer.

Pharmacological enhancement of patients’

immune responses to their cancers is of special

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.

Winson Sze Chun Ho

Sze Chun Ho, M.D., is presently a pediatric neurosurgery fellow at the University of Utah School of Medicine.

After receiving

from Yale University School of Medicine in 2011, Dr.

Ho had four years of training in Neurosurgery at the University

of Virginia, Charlottesville, Virginia.

Prior to his final year as chief resident at the University of Virginia, Dr.

three years doing molecular pharmacologic research on methods to enhance the efficacy of cancer therapy as a Clinical and Research

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

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.

is a physician, scientist, innovator, and philanthropist.

He is widely regarded as an expert in ribonucleotide

reductase, a critical target in cancer therapy and diagnostics.

He is President Emeritus of Taipei Medical University (TMU) and

Chair Professor of the Ph.D.

Pharmacological enhancement of patients’ 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.

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

Yen, M.D., Ph.D., F.A.C.P., is a physician, scientist, innovator, and philanthropist.

Yen was appointed to our Board of Directors

on August 4, 2018.

He is widely regarded as an expert in ribonucleotide reductase, a critical target in cancer therapy and diagnostics.

He is President Emeritus of Taipei Medical University (TMU) and Chair Professor of the Ph.D.

Program for Cancer Biology and Drug Discovery.

Prior to TMU, Dr.

Yen was the Allen and Lee Chao Endowed

Chair in Developmental Cancer Therapeutics, Chair of Molecular Pharmacology Department, Associate Director for Translational Research,

and Co-Director of the Developmental Cancer Therapeutics Program at the City of Hope NCI-designated Comprehensive Cancer Center,

Duarte California.

He has published more than 300 peer-reviewed articles, holds over 60 patents, and has commercialized multiple

methodologies involving nanoparticles, small and large molecule drugs, biomarkers, stem cells, and medical devices.

founded philanthropic organizations aimed at serving the global cancer community and holds membership in numerous professional

Yen was the Allen and Lee Chao Endowed Chair in Developmental Cancer Therapeutics, Chair of Molecular Pharmacology

Department, Associate Director for Translational Research, and Co-Director of the Developmental Cancer Therapeutics Program at the City

of Hope NCI-designated Comprehensive Cancer Center, Duarte California.

He has published more than 300 peer-reviewed articles, holds over

60 patents, and has commercialized multiple methodologies involving nanoparticles, small and large molecule drugs, biomarkers, stem cells,

and medical devices.

Yen also founded philanthropic organizations aimed at serving the global cancer community and holds membership

in numerous professional societies.

He serves on the boards of Fulgent Genetics and Tanvex BioPharma Inc.

N Schwartzberg, JD

N Schwartzberg, JD, ScD (hon), was appointed to our Board of Directors on April 9, 2021, and has been a consultant to the Company since

its inception.

Schwartzberg was the Chairman of the Board, President and Chief Executive Officer 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

Schwartzberg 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 ScD.

degree awarded by the Beckman Graduate School., which received its full

academic accreditation during Mr.

Schwartzberg’s tenure as the school’s president.

Schwartzberg was the only person in

the hundred-plus-year history of City of Hope to have served as both Chairman of the Board of Directors and as Chief Executive Officer.

Schwartzberg 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 Skechers USA, Inc.

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 Association.

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 .

Brown was appointed to our Board of Directors effective May 11, 2021.

Brown has been a practicing accountant for over thirty years.

Currently, her practice has a wide range of clients, varying in size, industry and geographic locations.

They include large national

corporations listed on the New York Stock Exchange, as well as Southern California businesses.

Other clients consist of professionals,

wholesalers and high net worth individuals.

Many of her clients have international and cross-border operations.

a consequence of her depth of experience, she regularly assists other professionals with their client’s issues and performs tax

research and analysis in connection with litigation and other matters including marital dissolution, tax and accounting with respect

to mergers and acquisitions, implementation of internal controls, and extensive work in the area of trusts and estates.

international tax matters and compliance are also a significant part of her practice.

Brown is a member in good standing of the California

Society of CPAs and the American Institute of Certified Public Accountants and has appeared as a speaker before both organizations.

ADVISORY COMMITTEE

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human molecular pathology;

management of human brain tumors;

the clinical management

of human brain tumors;

and medicinal chemistry.

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.

Von Hoff is currently Physician in Chief, Distinguished Professor and Director of the Clinical Translational Research Division

at the Translational Genomics Research Institute in Phoenix, Arizona.

Our objective is to meet with the committee as a group annually.

The committee has been

apprised of our general objectives and several of the specific challenges and leads for developing improved therapies for human brain

Members of the committee do not serve in any management capacity with us.

The committee currently consists of the following member:

Von Hoff, M.D., is currently Physician in Chief, Distinguished Professor and Director of the Clinical Translational Research

Division at the Translational Genomics Research Institute in Phoenix, Arizona.

He is also Chief Scientific Officer for US Oncology and

for Scottsdale Healthcare’s Clinical Research Institute.

He holds an appointment as Professor of Medicine, Mayo Clinic,

Scottsdale, Arizona.

for Scottsdale Healthcare’s Clinical Research Institute.

He holds an appointment as Professor of Medicine, Mayo Clinic, Scottsdale,

Von Hoff is a Fellow of the American College of Physicians.

Von Hoff’s major interest is in the development of new anticancer agents, both in the clinic and in the laboratory.

his colleagues were involved in the beginning of the development of many of the agents that are now used routinely, including

mitoxantrone, fludarabine, paclitaxel, docetaxel, gemcitabine, irinotecan, nelarabine, capecitabine and lapatinib.

he and his colleagues are concentrating on the development of molecularly targeted therapies, particularly for patients with advanced

pancreatic cancer.

Von Hoff’s major interest is in the development of new anticancer agents, both in the clinic and in the laboratory.

colleagues were involved in the beginning of the development of many of the agents that are now used routinely, including mitoxantrone,

fludarabine, paclitaxel, docetaxel, gemcitabine, irinotecan, nelarabine, capecitabine and lapatinib.

At present, he and his colleagues

are concentrating on the development of molecularly targeted therapies, particularly for patients with advanced pancreatic cancer.

Von Hoff has published more than 620 papers, 137 book chapters and over 1,050 abstracts.

Von Hoff received the 2010 David

Karnofsky Memorial Award from the American Society of Clinical Oncology for his outstanding contributions to cancer research

leading to significant improvement in patient care.

Von Hoff was appointed to President Bush’s National Cancer Advisory Board from 2004 to 2010.

Von Hoff received the 2010 David A.

Memorial Award from the American Society of Clinical Oncology for his outstanding contributions to cancer research leading to significant

improvement in patient care.

Von Hoff was appointed to President Bush’s National Cancer Advisory Board from 2004 to 2010.

Von Hoff is the past President

of the American Association for Cancer Research (the world’s largest cancer research organization), a Fellow of the American

College of Physicians, and a member and past board member of the American Society of Clinical Oncology.

He is a founder of ILEX™

Oncology, Inc.

(acquired by Genzyme in 2004 after Ilex had two agents, alemtuzumab and clofarabine, approved by the FDA for patients

with leukemia).

Von Hoff is founder and the Editor Emeritus of Investigational New Drugs –

The Journal of New Anticancer

and, Editor-in-Chief of Molecular Cancer Therapeutics.

He is a co-founder of the AACR/ASCO Methods in Clinical Cancer

Research Workshop.

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 .

of the American Association for Cancer Research (the world’s largest cancer research organization), a Fellow of the American College

of Physicians, and a member and past board member of the American Society of Clinical Oncology.

He is a founder of ILEX™ Oncology,

(acquired by Genzyme in 2004 after Ilex had two agents, alemtuzumab and clofarabine, approved by the FDA for patients with leukemia).

Von Hoff is founder and the Editor Emeritus of Investigational New Drugs – The Journal of New Anticancer Agents;

and, Editor-in-Chief

of Molecular Cancer Therapeutics.

He is a co-founder of the AACR/ASCO Methods in Clinical Cancer Research Workshop.

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.

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

Stephen Forman and son-in-law of board member 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, Yun Yen, Gil Schwartzberg and Regina Brown are

each an “independent director,” as defined under 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.

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.

of Directors serves 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:

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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.

audit committee consists of Regina Brown, 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 .

Philip Palmedo, with Ms.

Brown serving as chair.

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 Ms.

Brown qualifies as an “audit committee

financial expert,” as such term is defined in Item 407(d)(5) of Regulation S-K.

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;

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

4 unchanged sentences

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 .

Yen serving as chair.

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:

our 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;

1 unchanged sentence

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 may 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.

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.

Secretary, Lixte Biotechnology Holdings,

Inc., 680 East Colorado Boulevard, Suite 180, Pasadena, California 91101.

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;

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;

1 unchanged sentence

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.

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.

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 have entered 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.

Furthermore, 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

16(a) of the Securities Exchange Act of 1934, as amended, requires the Company’s directors and executive officers and persons

who own more than 10% of a registered class of the Company’s equity securities to file various reports with the Securities

and Exchange Commission concerning their holdings of, and transactions in, securities of the Company.

Copies of these filings

must be furnished to the Company.

the Company’s knowledge, based solely on its review of the copies of the Section 16(a) reports furnished to the Company

and any written representations to the Company, that no other reports were required, the Company believes that all individual

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 :

16(a) of the Securities Exchange Act of 1934, as amended, requires the Company’s directors and executive officers and persons who

own more than 10% of a registered class of the Company’s equity securities to file various reports with the Securities and Exchange

Commission concerning their holdings of, and transactions in, securities of the Company.

Copies of these filings must be furnished to

the Company’s knowledge, based solely on its review of the copies of the Section 16(a) reports furnished to the Company and any

written representations to the Company, that no other reports were required, the Company believes that all individual filing requirements

applicable to a director, officer, or beneficial owner of more than 10% of the Company’s common stock were complied with under

Section 16(a) of the Exchange Act during the year ended December 31, 2021, except as follows:

Eric Forman was late in filing one Form

4 and Glenn Krinsky was late in filing one Form 3, each document relating to the change of the trustee from Mr.

Forman to Mr.

with respect to the John and Barbara Kovach 2015 Trust.

EXECUTIVE COMPENSATION

1 unchanged sentence

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.

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

31, 2021, 2020 and 2019.

COMPENSATION TABLE

Stock Awards ($)

Option Awards ($)(1)

Non-Equity Incentive Plan Compensation ($)

Non-Qualified Deferred Compensation Earnings ($)

All Other Compensation ($)

Awards ($)(1)

Incentive Plan Compensation ($)

Non-Qualified

Deferred Compensation Earnings ($)

Other Compensation ($)

Weingarten (4)

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.

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

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 Financial 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,

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

were no option exercises during the years ended December 31, 2019, 2020 or 2021.

3 unchanged sentences

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.

intrinsic value of exercisable but unexercised in-the-money stock options held by our named executive officers at December 31, 2021 was

approximately $9,667, based on a fair market value of $1.19 per share on December 31, 2021.

July and August 2020, the Company entered into one-year employment agreements with its executive officers, consisting of Dr.

Kovach, Eric J.

Miser, and Robert N.

Weingarten, payable monthly, as described below.

The employment agreements

are 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, or by death, or by termination for cause.

These employment agreements were automatically renewed

for an additional one-year period in July and August 2021.

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.

John Kovach to continue to act as the Company’s

President, Chief Executive Officer and Chief Scientific Officer, with an annual salary of $250,000, payable monthly.

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.

include the oversight of the Company’s entire operations and strategic planning, and he will act as 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.

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.

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

as the Company’s Chief Administrative Officer reporting directly to the Company’s Chief Executive Officer, with an annual

salary of $120,000, payable monthly.

Effective May 1, 2021, Mr.

Forman’s annual salary was increased to $175,000.

primary function is to oversee the Company’s internal operations, including IT, licensing, legal, personnel, marketing, and corporate

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.

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.

James Miser, M.D., pursuant to which Dr.

Miser was appointed as the Company’s Chief Medical Officer, with an annual salary of $150,000.

Effective May 1, 2021, Dr.

annual salary was increased to $175,000.

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.

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.

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

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

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 for cause.

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

Weingarten pursuant to which Mr.

Weingarten was appointed as the Company’s Vice-President and Chief Financial Officer, with an annual salary of $120,000.

May 1, 2021, Mr.

Weingarten’s annual salary was increased to $175,000.

Weingarten was also granted stock options to acquire

350,000 shares of the Company’s common stock.

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”.

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

September 12, 2007, the Company entered into a consulting agreement with Gil N 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 stockholders.

Schwartzberg is currently a significant stockholder and director

of the Company.

Consideration under this consulting agreement, including amendments thereto, has been paid exclusively in the form of

stock options.

On August 2, 2018, the Company entered into a third amendment to the consulting agreement to extend it to January 28,

2024, as well as to extend the exercise date of previously issued, fully-vested stock options for 666,667 shares of common stock, exercisable

at $3.00 per share, from January 28, 2019 to January 28, 2024.

of Director Compensation

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.

May 22, 2019, in recognition of 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 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.

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) and was charged to general and administrative costs in the consolidated statement

of operations on the grant date.

January 6, 2021, in recognition of their service as directors of the Company over the past year, the Company granted fully-vested stock

options to purchase 50,000 shares of common stock to each of Dr.

Winson Sze Chun Ho, Dr.

Stephen Forman, and Dr.

Palmedo (an aggregate of 200,000 shares), 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 date.

The fair value of these stock options, as calculated

pursuant to the Black-Scholes option-pricing model, was determined to be $571,312 ($2.8566 per share) and was charged to general and

administrative costs in the consolidated statement of operations on the grant date.

April 9, 2021, Winson Sze Chun Ho resigned from the Company’s Board of Directors to focus on clinical and pre-clinical cancer research

in academic medicine.

Concurrent with his resignation, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created

Ho’s resignation.

In connection with his appointment to the Board of Directors, and in accordance with the Company’s

cash and equity compensation package for the members of the Board of Directors, Mr.

Schwartzberg was granted options exercisable for

a period of five years to purchase 250,000 shares of the Company’s common stock at an exercise price of $3.20 per share (the closing

market price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar

quarter-end until fully vested.

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

was determined to be $753,611 ($3.0144 per share), of which $376,800 was attributable to the stock options fully-vested on April 9, 2021

and was therefore charged to operations on that date.

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

charged to operations ratably from April 9, 2021 through June 30, 2023.

During the year ended December 31, 2021, the Company recorded

charges to general and administrative costs in the consolidated statement of operations of $500,235 with respect to these stock options.

May 11, 2021, the Board of Directors appointed Regina Brown to the Board of Directors.

In connection with her appointment to the Board

of Directors, and in accordance with the Company’s cash and equity compensation package for the members of the Board of Directors,

Brown was granted options exercisable for a period of five years to purchase 250,000 shares of the Company’s common stock at

an exercise price of $2.80 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting

12.5% on the last day of each subsequent calendar quarter-end until fully vested.

The fair value of these stock options, as calculated

pursuant to the Black-Scholes option-pricing model, was determined to be $658,363 ($2.6335 per share), of which $329,188 was attributable

to the stock options fully-vested on May 11, 2021 and was therefore charged to operations on that date.

The remaining unvested portion

of the fair value of the stock options is being charged to operations ratably from May 11, 2021 through June 30, 2023.

During the year

ended December 31, 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations

of $427,944 with respect to these stock options.

June 30, 2021, the Board of Directors, in accordance with the Company’s cash and equity compensation package for the independent

members of the Board of Directors, granted to each of the five non-officer directors of the Company stock options exercisable for a period

of five years to purchase 100,000 shares (a total of 500,000 shares) of the Company’s common stock at an exercise price of $3.03

per share (the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully

The total fair value of the 500,000 stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined

to be $1,421,095 ($2.84225 per share), which is being charged to operations ratably from July 1, 2021 through June 30, 2023.

year ended December 31, 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations

of $358,200 with respect to these stock options.

Compensation Table

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.

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

table set forth below presents the compensation awarded to, earned by or paid to our named directors for the years ended December 31,

2021, 2020 and 2019.

COMPENSATION TABLE

and Principal

Awards ($)(1)

Incentive Plan Compensation ($)

Non-Qualified

Deferred Compensation Earnings ($)

Other Compensation ($)

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

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

Resigned as a director of the Company effective April 9, 2021.

Appointed as a director of the Company effective April 9, 2021.

Appointed as a director of the Company effective May 11, 2021.

Advisory Committee Compensation

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

2019 or 2020.

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

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 our Scientific Advisory Committee.

The term of the agreement was for one year and provided for a quarterly cash fee of $4,000.

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, 2021 and 2020, respectively,

which were included in research and development costs in the consolidated statements of operations.

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:

July 14, 2020, our Board of Directors 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 for up to 2,333,333 shares of common stock, under terms and conditions as determined

by our Board of Directors.

Stockholders holding a majority of the voting power of our common stock approved the 2020 Plan pursuant to

an action by written consent dated July 31, 2020.

Stockholders were notified of such action by written consent pursuant to an Information

Statement dated August 31, 2020 and mailed to stockholders on or about September 3, 2020.

As of December 31, 2021, unexpired stock options

for 1,400,000 shares were issued and outstanding under the 2020 Plan.

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

participants’ interests with stockholders’ interests through incentives that are based upon the performance of our common

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

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.

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.

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”).

Features of the 2020 Plan

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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

The maximum number of shares that may

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

2020 Plan is administered by the Compensation Committee, which is comprised solely of independent members of our Board of Directors.

The Board of Directors 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 Compensation 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 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.

2 unchanged sentences

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.

Employees, consultants and members of our Board of Directors are eligible to receive awards under the 2020

The Compensation 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.

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

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.

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 2020 Plan is administered by the Compensation Committee of the Board of Directors, which consists of independent

board members.

With respect to certain awards issued under the 2020 Plan, the members of the Compensation Committee also must be “Non-Employee

Directors” under Rule 16b-3 of the Exchange Act.

Subject to the terms of the 2020 Plan, the Compensation Committee has the sole

discretion, among other things, to:

the individuals who will receive awards;

1 unchanged sentence

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;

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

Compensation 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

Awards may be subject to any policy that

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

of the Board of Directors, the Compensation 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

The Compensation

Committee determines, 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” exercise and sale program, or net exercise,

or through another method approved by the Compensation 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 Compensation

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.

Settlement of a SAR

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

SARs may not 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 Compensation Committee.

The Compensation 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.

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

The Compensation 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 Compensation 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.

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 may 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.

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

of descent and distribution.

However, the Compensation 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 Compensation 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.

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

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

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.

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 11, 2022 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

As of March 11, 2022, there were 13,746,593 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

Officers and Directors

248 Route 25A, No.

East Setauket, New York 11733

1,561,284 (1)

248 Route 25A, No.

East Setauket, New York 11733

248 Route 25A, No.

East Setauket, New York 11733

248 Route 25A, No.

East Setauket, New York 11733

Winson Sze Chun Ho

248 Route 25A, No.

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

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 March

11, 2022 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.

This table is based upon information supplied

by our directors, officers and principal stockholders and reports filed with the Securities and Exchange Commission.

and Address of Beneficial Owner

and Directors

East Colorado Boulevard, Suite 180

California 91101

1,561,284 (1)

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

New York, New York 10016

East Colorado Boulevard, Suite 180

California 91101

East Colorado Boulevard, Suite 180

California 91101

East Colorado Boulevard, Suite 180

California 91101

East Colorado Boulevard, Suite 180

California 91101

2,324,360 (6)

Gil Schwartzberg

5500 Military Trail, Suite 22, Box 356

Jupiter, Florida 33458

East Colorado Boulevard, Suite 180

California 91101

East Colorado Boulevard, Suite 180

California 91101

East Colorado Boulevard, Suite 180

California 91101

East Colorado Boulevard, Suite 180

California 91101

officers and directors as a group (nine persons)

Stockholders Owning More Than 5%

and Barbara Kovach 2015 Trust

Krinsky, Trustee

East Colorado Boulevard, Suite 180

California 91101

1,333,333 (4)

1 unchanged sentence

Military Trail, Suite 22, Box 356

Jupiter, Florida 33458

Florida 33458

1,645,807 (7)

1 unchanged sentence

Saint Andres Avenue

La Verne, California 91750

Verne, California 91750

1,957,500 (8)

Robert and Susan Greenberg

and Susan Greenberg

Manhattan Beach Boulevard

Manhattan Beach, California 90266

Beach, California 90266

1,380,264 (9)

Bahl and Kavit K.

3 Pheasant Run

Setauket, New York 11733

New York 11733

1,000,000 (16)

Palmer Avenue

Larchmont, New York 10538

Mayfair by the Sea II

Tower T8, 1/F, Unit A

New York 10538

by the Sea II

T8, 1/F, Unit A

Fo Chun Road Pak ShekKok

Taipo NT, Hong Kong SAR

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

East Colorado Boulevard, Suite 180

California 91101

1,474,988 (17)

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

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 John

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.

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 107,056 shares of common stock, stock warrants to purchase 21,053 shares of common stock and stock options to purchase 104,166 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.

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 58,137 shares of common stock, stock warrants to purchase 21,053 shares of common stock and stock options to purchase 104,166

1 unchanged sentence

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.

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

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

Kovach, as grantors, to the John

and Barbara Kovach 2015 Trust, an irrevocable trust dated July 6, 2015.

The primary beneficiaries of the trust are the two adult

daughters of John and Barbara Kovach.

Kovach, as grantors, to the John and

Barbara Kovach 2015 Trust, an irrevocable trust dated July 6, 2015.

The primary beneficiaries of the trust are the two adult daughters

of John and Barbara Kovach.

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

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shares of common stock owned by Eric J.

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

of Gil and Debbie Schwartzberg, and the trustee of the John and Barbara Kovach 2015 Trust.

Also includes 1,333,333 shares of common

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

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 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.

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

and Debbie Schwartzberg.

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

the following:

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.

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.

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.

Includes 343,926 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 292,709 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:

shares of common stock owned by the Gil Schwartzberg IRA;

shares of common stock owned by Continuum Capital Partners, LP, as to which Gil Schwartzberg has sole voting, dispositive

and investment control;

shares of common stock, stock options to purchase 291,666 shares of common stock and common stock warrants to purchase 83,333

shares of common stock owned by the Julie Schwartzberg Trust, as to which Gil Schwartzberg is the co-trustee;

shares of common stock, stock options to purchase 291,666 shares of common stock and common stock warrants to purchase 83,333

shares of common stock owned by the David N.

shares of common stock owned by Continuum Capital Partners, LP, as to which Gil Schwartzberg has sole voting, dispositive and investment

shares of common stock, stock options to purchase 291,666 shares of common stock and common stock warrants to purchase 83,333 shares

of common stock owned by the Julie Schwartzberg Trust, as to which Gil Schwartzberg is the co-trustee;

shares of common stock, stock options to purchase 291,666 shares of common stock and common stock warrants to purchase 83,333 shares

of common stock owned by the David N.

Sterling Trust, as to which Gil Schwartzberg is the co-trustee;

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;

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;

shares of common stock owned by the Julie Forman 2015 Trust, David Sterling trustee.

the following:

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

Separate Property, the wife of Gil Schwartzberg, as to which Gil Schwartzberg disclaims beneficial ownership or control.

Includes 417,474 shares of common stock owned by the Gil & Debbie Schwartzberg Family Trust dated November 19, 2003, Debbie

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

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

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

Property, the wife of Gil Schwartzberg, as to which Gil Schwartzberg disclaims beneficial ownership or control.

Includes 417,474 shares of common stock owned by the Gil & Debbie Schwartzberg Family Trust dated November 19, 2003, Debbie Schwartzberg

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

All stock options and

common stock warrants are immediately exercisable or within 60 days.

includes the following:

shares of common stock, stock options to purchase 291,666 shares of common stock and common stock warrants to purchase 83,333

shares of common stock owned by the Julie Schwartzberg Trust, as to which Debbie Schwartzberg is the co-trustee;

shares of common stock, stock options to purchase 291,666 shares of common stock and common stock warrants to purchase 83,333

shares of common stock owned by the David N.

shares of common stock, stock options to purchase 291,666 shares of common stock and common stock warrants to purchase 83,333 shares

of common stock owned by the Julie Schwartzberg Trust, as to which Debbie Schwartzberg is the co-trustee;

shares of common stock, stock options to purchase 291,666 shares of common stock and common stock warrants to purchase 83,333 shares

of common stock owned by the David N.

Sterling Trust, as to which Debbie Schwartzberg is the co-trustee;

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;

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;

shares of common stock owned by the Julie Forman 2015 Trust, David Sterling trustee.

the following:

shares of common stock and stock options to purchase 83,333 shares of common stock owned by the Gil & Debbie Schwartzberg

Family Trust dated November 19, 2003, Gil Schwartzberg Separate Property, as to which Debbie Schwartzberg, the wife of Gil

Schwartzberg, disclaims beneficial ownership or control;

shares of common stock and stock options to purchase 292,709 shares of common stock owned by the Gil & Debbie Schwartzberg Family

Trust dated November 19, 2003, Gil Schwartzberg Separate Property, as to which Debbie Schwartzberg, the wife of Gil Schwartzberg,

disclaims beneficial ownership or control;

shares of common stock owned by the Gil Schwartzberg IRA;

shares of common stock owned by Continuum Capital Partners, LP, as to which Gil Schwartzberg has sole voting, dispositive

and investment control.

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 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

power over the shares of preferred stock.

The shares of Series A Convertible Preferred Stock were acquired on March 17, 2015 and

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

shares of common stock owned by Continuum Capital Partners, LP, as to which Gil Schwartzberg has sole voting, dispositive and investment

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 210,000 shares of common stock owned by the Arthur and Jane Riggs 1990 Revocable

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

preferred stock.

The shares of Series A Convertible Preferred Stock were acquired on March 17, 2015 and January 15, 2016, are non-voting,

and are immediately convertible into common stock.

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.

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.

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.

Excludes stock options to purchase

shares of common stock owned by Dr.

Winson Sze Chun Ho, a former director of 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 209,375 shares of common stock.

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 129,163

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Consists of stock options to purchase 41,667 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.

Includes 141,655 shares of common stock owned by Glenn L.

Also includes 1,333,333 shares of common stock owned by the John and

Barbara Kovach 2015 Trust, as to which Glenn L.

Krinsky, as trustee, has voting, dispositive and investment control.

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE

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.

Related Party Transactions

the years ended December 31, 2019, 2020 and 2021, there have been no transactions, whether directly or indirectly, between the Company

and any of its officers, directors or affiliates, including their family members, except as described herein or elsewhere in this document.

Director Independence

Company considers Dr.

Philip Palmedo, Dr.

Stephen Forman, Dr.

Yun Yen, Gil Schwartzberg and Regina Brown to each be an “independent

director,” as defined under Nasdaq rules and by Rule 10-A-3 of the Exchange Act.

PRINCIPAL ACCOUNTING FEES AND SERVICES

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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,

Audit Fees (1)

Audit-Related Fees (2)

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.

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, 2020 and 2021.

Ended December 31,

Audit-Related

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

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

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

Audit-related

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

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.

fees represent fees incurred with respect to our Registration Statements on Forms S-1, S-3 and S-8 declared effective by the SEC

during the years ended December 31, 2020 and 2021.

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.

during the fiscal years ended

December 31, 2020 and 2021 were pre-approved by either our Audit Committee or 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

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

2 unchanged sentences

Statement Schedules

financial statement schedules have been omitted because the required information is not applicable, or not present in amounts

sufficient to require submission of the schedules, or because the information is included in the financial statements or notes

list of exhibits required to be filed as part of this Annual Report on Form 10-K is set forth in the Index to Exhibits, which

is presented elsewhere in this document, and is incorporated herein by reference.

financial statement schedules have been omitted because the required information is not applicable, or not present in amounts sufficient

to require submission of the schedules, or because the information is included in the financial statements or notes thereto.

list of exhibits required to be filed as part of this Annual Report on Form 10-K is set forth in the Index to Exhibits, which is presented

elsewhere in this document, and is incorporated herein by reference.

FORM 10-K SUMMARY

Form of Underwriter Agreement 22

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

of Underwriter Agreement 22

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

Kovach and Lixte Biotechnology, Inc.

Certificate of Incorporation, as filed with the Delaware Secretary of State on May 24, 2005 2

Certificate of Amendment of Certificate of Incorporation 3

Certificate of Designations for the Company’s Series A Convertible Preferred Stock 6

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

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.

of Incorporation, as filed with the Delaware Secretary of State on May 24, 2005 2

of Amendment of Certificate of Incorporation 3

of Designations for the Company’s Series A Convertible Preferred Stock 6

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

and Restated Bylaws 15

of Amendment of Certificate of Incorporation 23

of Warrant included in Unit 22

of Warrant Agent Agreement 22

Description of Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934, as amended 21

Agreement between Lixte Biotechnology Holdings, Inc.

and Theradex Systems, Inc.

dated January 12, 2010 4

Materials Cooperative Research and Development Agreement between Lixte Biotechnology Holdings, Inc.

and the National Institute of Neurological Disorders and Stroke dated October 18, 2013 5

Scientific Advisory Board Agreement between Lixte Biotechnology Holdings, Inc.

Cooperative Research and Development Agreement between Lixte Biotechnology Holdings, Inc.

and the National Institute of Neurological

Disorders and Stroke dated October 18, 2013 5

Advisory Board Agreement between Lixte Biotechnology Holdings, Inc.

and NDA Consulting Corp.

dated December 24, 2013 5

Collaboration Agreement between Lixte Biotechnology Holdings, Inc.

Collaboration

Agreement between Lixte Biotechnology Holdings, Inc.

and BioPharmaWorks LLC effective September 14, 2015 7

Form of First Warrant to purchase common stock issued to BioPharmaWorks LLC dated September 14, 2015 7

Form of Second Warrant to purchase common stock issued to BioPharmaWorks LLC dated September 14, 2015 7

Form of Securities Purchase Agreement dated as of February 24, 2017 between the Company and Lalit Bahl 9

Form of Securities Purchase Agreement dated as of April 3, 2017 between the Company and Hung Tak Ho 10

Consulting Agreement between Liberi Life Sciences Consultancy BV and Lixte Biotechnology Holdings, Inc.

dated and effective as of April 2, 2018 11

Clinical Trial Research Agreement between H.

of First Warrant to purchase common stock issued to BioPharmaWorks LLC dated September 14, 2015 7

of Second Warrant to purchase common stock issued to BioPharmaWorks LLC dated September 14, 2015 7

Trial Research Agreement between H.

Lee Moffitt Cancer Center and Research Institute Hospital, Inc.

and Lixte Biotechnology Holdings, Inc.

and Lixte Biotechnology Holdings,

dated and effective as of August 20, 2018 9

Exclusive License Agreement between H.

License Agreement between H.

Lee Moffitt Cancer Center and Research Institute Hospital, Inc.

and Lixte Biotechnology Holdings, Inc.

dated and effective as of August 20, 2018 (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 17, 2018) 12

Form of Warrant to Purchase Common Stock of Llxte Biotechnology Holdings, Inc.

(issued in connection with common stock unit rights offering that closed on November 30, 2018) 13

Collaboration Agreement for an Investigator-Initiated Clinical Trial between Lixte Biotechnology Holdings, Inc.

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.

dated and effective as of August 20, 2018 (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 17, 2018) 9

of Warrant to Purchase Common Stock of Llxte Biotechnology Holdings, Inc.

(issued in connection with common stock unit rights offering

that closed on November 30, 2018) 10

Collaboration

Agreement for an Investigator-Initiated Clinical Trial between Lixte Biotechnology Holdings, Inc.

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) 11

Agreement Between the Company and Dr.

James Miser 13+

Employment Agreement Between the Company and Robert N.

Agreement Between the Company and Robert N.

Weingarten 17+

Employment Agreement Between the Company and Dr.

Agreement Between the Company and Dr.

John Kovach 14+

Employment Agreement Between the Company and Eric Forman 18+

Agreement Between the Company and Eric Forman 15+

Stock Incentive Plan 16+

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

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

dated as of August 12, 2020 17

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* +

Trial Research Agreement between the Company and the City of Hope National Medical Center 18

to Employment Agreement between the Company and Eric Forman 22+

Collaboration Agreement by and between Lixte Biotechnology Holdings, Inc.

and the Netherlands Cancer Institute, Amsterdam, and Oncode

Institute, Utrecht, entered into on October 8, 2021 (certain portions of this Exhibit have been omitted based on a pending request

for confidential treatment being filed with the Securities and Exchange Commission).

Subsidiaries of the Registrant*

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 Scheme Document**

Taxonomy Extension Calculation Linkbase Document**

Taxonomy Extension Label Linkbase Document**

Taxonomy Extension Presentation Linkbase Document**

Taxonomy Extension Definition Linkbase Document**

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

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*

XBRL Instance Document (does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)

XBRL Taxonomy Extension Scheme Document

XBRL Taxonomy Extension Calculation Linkbase Document

XBRL Taxonomy Extension Label Linkbase Document

XBRL Taxonomy Extension Presentation Linkbase Document

XBRL Taxonomy Extension Definition Linkbase Document

Page Interactive Data File (formatted as Inline XBRL document and included in Exhibit 101.INS)

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 7,

2006 and incorporated herein by reference.

as an Exhibit to the Company’s Registration Statement on Form 10-SB, as filed with the Securities and Exchange Commission

on August 3, 2005 and incorporated herein by reference.

as Appendix A to the Company’s Information Statement, as filed with the Securities and Exchange Commission on September

as an Exhibit to the Company’s Registration Statement on Form 10-SB, as filed with the Securities and Exchange Commission on

August 3, 2005 and incorporated herein by reference.

as Appendix A to the Company’s Information Statement, as filed with the Securities and Exchange Commission on September 20,

2006 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

as an Exhibit to the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 15,

2013 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

as an Exhibit to the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 21,

2014 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 March

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on March 18,

2015 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 September

18, 2015 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

as an Exhibit to the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 28,

2016 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 February

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on August 23,

2018 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 April

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

5, 2018 and incorporated herein by reference.

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

August 2, 2018 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

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on August 6,

2019 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 December

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

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

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

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

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

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 July

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 Current Report on Form 8-K, as filed with the Securities and Exchange Commission on August

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 Current Report on Form 8-K, as filed with the Securities and Exchange Commission on January

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.

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

as an Exhibit to the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 26,

2021 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

as an Exhibit to the Company’s Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission on November

10, 2021 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.

101 to the Annual Report on Form 10-K shall be

deemed “furnished”

but not “filed”.

accordance with Section 13 and 15(d) of the Securities Exchange Act of 1934, the Registrant caused this report to be signed on

its behalf by the undersigned thereunto duly authorized.

accordance with Section 13 and 15(d) of the Securities Exchange Act of 1934, the Registrant caused this report to be signed on its behalf

by the undersigned thereunto duly authorized.

March 21, 2022

1 unchanged sentence

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.

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.

and Chief Executive Officer

President and Chief Financial Officer

WINSON SZE CHUN HO

GIL N SCHWARTZBERG

N Schwartzberg

BIOTECHNOLOGY HOLDINGS, INC.

2 unchanged sentences

Ended December 31, 2021 and 2020

Report of Independent Registered Public Accounting Firm

Consolidated Balance Sheets –

December 31, 2020 and 2019

Consolidated Statements of Operations –

Years Ended December 31, 2020 and 2019

Consolidated Statements of Stockholders’

Equity –

Years Ended December 31, 2020 and 2019

Consolidated Statements of Cash Flows –

Years Ended December 31, 2020 and 2019

Notes to Consolidated Financial Statements –

Years Ended December 31, 2020 and 2019

Report of Independent Registered Public Accounting Firm (PCAOB ID NO.

Consolidated Balance Sheets – December 31, 2021 and 2020

Consolidated Statements of Operations – Years Ended December 31, 2021 and 2020

Consolidated Statements of Stockholders’ Equity – Years Ended December 31, 2021 and 2020

Consolidated Statements of Cash Flows – Years Ended December 31, 2021 and 2020

Notes to Consolidated Financial Statements – Years Ended December 31, 2021 and 2020

OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

1 unchanged sentence

Biotechnology Holdings, Inc.

Setauket, New York

on the Consolidated Financial Statements

have audited the accompanying consolidated balance sheets of Lixte Biotechnology Holdings, Inc.

and subsidiary (the “Company”)

as of December 31, 2020 and 2019, and the related consolidated statements of operations, stockholders’

equity and cash flows

for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”).

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

of the Company as of December 31, 2020 and 2019, and the results of its consolidated operations and its consolidated cash flows

for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

and subsidiary (the “Company”)

as of December 31, 2021 and 2020, and the related consolidated statements of operations, stockholders’ equity and cash flows for

the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”).

opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company

as of December 31, 2021 and 2020, and the results of its consolidated operations and its consolidated cash flows for the years then ended,

in conformity with accounting principles generally accepted in the United States of America.

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

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 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.

in Note 1 to the consolidated financial statements, 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

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

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.

Our responsibility is to express an

opinion on the Company’s consolidated financial statements based on our audits.

We are a public accounting firm registered

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.

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

Our responsibility is to express an opinion

on the Company’s consolidated financial statements based on our audits.

We are a public accounting firm registered 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.

Those standards require that we plan and perform the audits

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

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

As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but

not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.

Those standards require that we plan and perform the audits to obtain

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

is not required to have, nor were we engaged to perform, an audit of its 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.

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

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

Such procedures included examining, on a test basis, evidence

regarding the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles

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

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

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

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

Such procedures included examining, on a test basis, evidence regarding

the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles used and significant

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

We believe that our audits

provide a reasonable basis for our opinion.

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.

critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated

or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial

statements and (2) involved especially challenging, subjective, or complex judgments.

The communication of critical audit matters does

not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical

audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

discussed in Note 5 to the consolidated financial statements, the Company issues equity awards to certain officers, employees and consultants

as compensation (the “Equity Awards”).

The fair values of these Equity Awards were determined as of the grant date using

a Black-Scholes option-pricing model (the “Black-Scholes Model”).

The selection of the valuation methodology and assumptions

utilized in the Black-Scholes Model are based, in part, upon assumptions for which management is required to use judgment, particularly

the risk-free interest rate, volatility, and dividend yield.

identified the valuation of the Equity Awards as a critical audit matter because of the significant judgments made by management to determine

the grant date fair values.

This required a high degree of auditor judgment and an increased expenditure of effort when performing audit

procedures to evaluate the reasonableness of management’s valuation methodology and related assumptions, including the risk-free

interest rate, volatility, and dividend yield.

audit procedures related to the determination of the fair values of the Equity Awards, including the valuation methodology and related

assumptions such as the risk-free interest rate, volatility, and dividend yield, consisted of the following, among others:

obtained an understanding of management’s process over the valuation of the Equity Awards, including those over the determination

of the valuation methodology and related assumptions, including the risk-free interest rate, volatility, and dividend yield.

obtained and read the Equity Award agreements and management’s valuation analyses, including supporting schedules and related narrative

evaluated management’s valuation methodology, including the selection of the model to determine the fair values of the Equity Awards.

evaluated the reasonableness of management’s valuation assumptions and the underlying source information of significant valuation

assumptions, including the risk-free interest rate, volatility, and dividend yield.

assessed whether management’s calculations of the fair values were applied in accordance with the selected methodology, including

testing the mathematical accuracy of the valuation analyses.

developed independent estimates for the fair values of the Equity Awards based on assumptions utilized by the Company in its calculations.

have served as the Company’s auditor since 2008.

Weinberg & Company, P.A .

2 unchanged sentences

BALANCE SHEETS

on research and development contract services

prepaid expenses and current assets

current assets

Advances on research and development contract services

Accrued interest receivable

Prepaid insurance

Other prepaid expenses and current assets

Total current assets

LIABILITIES AND STOCKHOLDERS’

AND STOCKHOLDERS’ EQUITY

payable and accrued expenses, including $ 32,500 and $ 0 to related parties at December 31, 2021 and 2020, respectively

offering costs

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 par value;

authorized –

10,000,000 shares;

issued and outstanding –

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 par value;

authorized –

100,000,000 shares;

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

and contingencies

Stockholders’

Stock, $ 0.0001 par value;

authorized – 10,000,000 shares;

issued and outstanding – 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

stock, $ 0.0001 par value;

authorized – 100,000,000 shares;

issued and outstanding – 13,746,593 shares and 12,402,157

shares at December 31, 2021 and 2020, respectively

paid-in capital

( 37,082,164 )

( 30,353,768 )

Total stockholders’

Total liabilities and stockholders’

stockholders’ equity

liabilities and stockholders’ equity

accompanying notes to consolidated financial statements.

1 unchanged sentence

STATEMENTS OF OPERATIONS

Years Ended December 31,

Ended December 31,

and expenses:

and administrative costs:

to related parties, including stock-based compensation of $ 2,201,280 and $ 480,634 for the years ended December 31, 2021 and 2020,

and licensing legal and filing fees and costs

and development costs, including $ 397,642 and $ 670,715 of stock-based compensation costs to a consultant for the years ended December

31, 2021 and 2020, respectively

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

from operations

( 6,720,445 )

( 3,266,440 )

Net loss per common share –

basic and diluted

Weighted average common shares outstanding –

basic and diluted

currency gain (loss)

$ ( 6,728,396 )

$ ( 3,264,882 )

loss per common share – basic and diluted

average common shares outstanding – basic and diluted

accompanying notes to consolidated financial statements.

BIOTECHNOLOGY HOLDINGS, INC.

STATEMENTS OF STOCKHOLDERS’

STATEMENTS OF STOCKHOLDERS’ EQUITY

Ended December 31, 2021 and 2020

Series A Convertible

A Convertible

Preferred Stock

Additional Paid-in

Total Stockholders’

Balance, December 31, 2018

Stockholders’

December 31, 2019

$ ( 27,088,886 )

Stock-based compensation expense

Balance, December 31, 2019

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

from sale of common stock in direct equity offering, net of offering costs

Proceeds from sale of common stock in direct equity offering, net of offering costs, shares

Exercise of warrants, shares

Exercise of options

Exercise of options, shares

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

stock issued for services

( 3,264,882 )

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

( 3,264,882 )

December 31, 2020

( 30,353,768 )

from sale of common stock in direct equity offering, net of offering costs

compensation expense

( 6,728,396 )

December 31, 2021

$ ( 37,082,164 )

accompanying notes to consolidated financial statements.

1 unchanged sentence

STATEMENTS OF CASH FLOWS

Cash flows from operating activities:

Ended December 31,

flows from operating activities:

$ ( 6,728,396 )

$ ( 3,264,882 )

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)

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)

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

compensation expense included in -

and administrative costs

and development costs

in operating assets and liabilities:

decrease in -

on research and development contract services

interest receivable

prepaid expenses and current assets

(decrease) in -

payable and accrued expenses

and development contract liabilities

cash used in operating activities

( 4,142,915 )

( 2,131,414 )

flows from financing activities:

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

from sale of common stock in direct equity offering, net of offering costs

of common stock warrants

of common stock options

of costs incurred in connection with sale of common stock units

cash provided by financing activities

increase (decrease)

at beginning of period

at end of period

disclosures of cash flow information:

investing and financing activities:

offering costs (paid subsequent to December 31, 2020)

accompanying notes to consolidated financial statements.

3 unchanged sentences

Organization and Basis of Presentation

Biotechnology Holdings, Inc., a Delaware corporation (“Holdings”), including its wholly-owned Delaware subsidiary,

Lixte Biotechnology, Inc.

(“Lixte”) (collectively, the “Company”), is a drug discovery company that uses

biomarker technology to identify enzyme targets associated with serious common diseases and then designs novel compounds to attack

those targets.

The Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and

in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers, and encompasses two major categories of compounds

at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic potential not only

for cancer but also for other debilitating and life-threatening diseases.

Company’s activities are subject to significant risks and uncertainties, including the need for additional capital, as described

The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations,

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

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.

Biotechnology Holdings, Inc., a Delaware corporation (“Holdings”), including its wholly-owned Delaware subsidiary, Lixte

Biotechnology, Inc.

(“Lixte”) (collectively, the “Company”), is a drug discovery company that uses biomarker

technology to identify enzyme targets associated with serious common diseases and then designs novel compounds to attack those targets.

The Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic

agents and/or x-ray and immune checkpoint blockers, and encompasses two major categories of compounds at various stages of pre-clinical

and clinical development that the Company believes have broad therapeutic potential not only for cancer but also for other debilitating

and life-threatening diseases.

The Company has developed two classes of drugs for the treatment of cancer, consisting of protein phosphatase

inhibitors (PTase-i), designated by us as the LB-100 series of compounds, and histone deacetylase inhibitors (HDACi), designated by us

as the LB-200 series of compounds.

Company’s activities are subject to significant risks and uncertainties, including the need for additional capital.

has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation

for a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund its

operating requirements.

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

the symbols “LIXT” and.

“LIXTW”, respectively.

December 31, 2021, the Company had cash of $ 4,823,745 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 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 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, 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.

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

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.

The Company’s independent registered public accounting firm, in its report on the Company’s consolidated financial statements

for the year ended December 31, 2021, 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 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.

The amount 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.

on current operating plans, the Company estimates that it will need to raise additional capital to fund its operations, including its

various clinical trial commitments, during the quarter ending September 30, 2022.

In addition, the Company’s operating plans 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 operations.

is also significant uncertainty as to the effect that the coronavirus pandemic 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, 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.

No fractional shares were

issued in connection with the reverse split, with any fractional shares resulting from the reverse split being rounded up to the nearest

share and per share amounts and information presented herein has been retroactively adjusted to reflect the reverse stock split for all

periods presented.

Summary of Significant Accounting Policies

1 unchanged sentence

accompanying consolidated financial statements of the Company have been prepared in accordance with United States generally accepted

accounting principles (“GAAP”) and include the financial statements of Holdings and its wholly owned subsidiary, Lixte.

Intercompany balances and transactions have been eliminated in consolidation.

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

the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during

the reporting period.

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.

accounting principles (“GAAP”) and include the financial statements of Holdings and its wholly owned subsidiary, Lixte.

balances and transactions have been eliminated in consolidation.

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

amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.

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.

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.

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.

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.

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.

is primarily held in a cash bank deposit program maintained by a major financial institution.

The 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 the 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 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 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.

costs also include the costs to produce the compounds used in research and clinical trials, which are charged to operations as incurred.

and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of

milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing

schedule is more appropriate.

However, payments for research and development costs that are contractually defined as non-refundable are

charged to operations as incurred.

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 accounted for when due, 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

in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s

consolidated statement of operations as those contract services are performed.

Expenses incurred under research and development

contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated

balance sheet, with a corresponding charge to research and development costs in the Company’s consolidated statement of

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.

in the Company’s consolidated balance sheet and are then charged to research and development costs in the Company’s consolidated

statement of operations as those contract services are performed.

Expenses incurred under research and development contracts in excess

of amounts advanced are recorded as research and development contract 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.

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 at each balance sheet 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

to the significant uncertainty associated with the successful development of one or more commercially viable products based on

the Company’s research efforts and related patent applications, all patent-related legal and filing fees and licensing-related

legal fees are charged to operations as incurred.

Patent and licensing-related legal and filing costs were $553,173 and $742,918

for the years ended December 31, 2020 and 2019, respectively.

Patent and licensing related legal and filing costs are included

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

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.

and Licensing Legal and Filing Fees and Costs

to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s

research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development

and protection of its intellectual property are charged to operations as incurred.

Patent and licensing legal and filing fees and costs

were $ 729,171 and $ 553,173 for the years ended December 31, 2021 and 2020, respectively.

Patent and licensing legal and filing fees and

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

Concentration

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.

Company periodically contracts with vendors and consultants to provide services related to the Company’s operations.

Charges incurred

for these services can be for a specific time period (typically one year) or for a specific project or task.

Costs and expenses incurred

that represented 10 % or more of general and administrative costs or research and development costs for the years ended December 31, 2021

and 2020 are described as follows.

and administrative costs for the years ended December 31, 2021 and 2020 include combined charges from two legal firms for general licensing

and patent prosecution costs relating to the Company’s intellectual properties representing 14.6 % and 27.1 %, respectively, of total

general and administrative costs.

General and administrative costs for the years ended December 31, 2021 and 2020 also included charges

for the fair value of stock options granted to directors and corporate officers representing 44.2 % and 23.5 %, respectively, of total

general and administrative costs for those periods.

and development costs for the year ended December 31, 2021 include charges from three vendors and consultants representing 30.3 %, 21.8 %,

and 14.4 %, respectively, of total research and development costs for that period.

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.

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

Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes.

Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial

statements and the tax basis of assets and liabilities.

the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and

the tax basis of assets and liabilities.

Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized.

In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of

its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination

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.

the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded

amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made.

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.

federal income taxes and income taxes of various state tax jurisdictions.

As the Company’s net

operating losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions

in which the Company currently operates or has operated in the past.

The Company had no unrecognized tax benefits as of December

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.

As the Company’s net operating

losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which

the Company currently operates or has operated in the past.

The Company had no unrecognized tax benefits as of December 31, 2021 or 2020

and does not anticipate any material amount of unrecognized tax benefits within the 12 months subsequent to December 31, 2021.

Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement,

presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP.

The tax effects of a position are recognized only if it is “more-likely-than-not”

to be sustained by the taxing authority

as of the reporting date.

If the tax position is not considered “more-likely-than-not”

to be sustained, then no benefits

of the position are recognized.

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.

tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as

of the reporting date.

If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of

the position are recognized.

The Company had not recorded any liability for uncertain tax positions as of December 31, 2021 or 2020.

Subsequent to December 31, 2021, 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, 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 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.

Options vest and expire according to terms established at the issuance date of each

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 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”).

The 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.

The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero.

Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development

costs, as appropriate, in the Company’s consolidated statements of operations.

The Company issues new shares of common stock

to satisfy stock option exercises.

costs, as appropriate, in the Company’s consolidated statements of operations.

The Company issues new shares of common stock to

satisfy stock option exercises.

(Loss) Per Share

Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS.

Basic EPS is measured

as the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period.

Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred

shares, warrants and stock options) as if they had been converted at the beginning of the periods presented, or issuance date,

Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss

per share) are excluded from the calculation of diluted EPS.

per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during

the respective periods.

Basic and diluted loss per common share was the same for all periods presented because all preferred shares,

warrants and stock options outstanding were anti-dilutive.

December 30, 2020 and 2019, the Company excluded the outstanding securities summarized below, which entitle the holders thereof

to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.

Series A Convertible Preferred Stock

Common stock warrants

Common stock options, including options issued in the form of warrants

Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS.

Basic EPS is measured as

the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period.

EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares,

warrants and stock options) as if they had been converted at the beginning of the periods presented, or issuance date, if later.

common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded

from the calculation of diluted EPS.

per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective

Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock

options outstanding were anti-dilutive.

December 31, 2021 and 2020, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire

shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.

Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share

A Convertible Preferred Stock

stock warrants

stock options, including options issued in the form of warrants

Value of Financial Instruments

authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation

techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified

and disclosed in one of three categories, as presented below.

Disclosure as to transfers in and out of Levels 1 and 2, and activity

in Level 3 fair value measurements, is also required.

Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability

to access as of the measurement date.

Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded

securities and exchange-based derivatives.

Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly

observable through corroboration with observable market data.

Financial assets and liabilities utilizing Level 2 inputs include

fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges.

Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity

to develop its own assumptions.

Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based

derivatives and commingled investment funds and are measured using present value pricing models.

Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based

on the lowest level input that is significant to the fair value measurement in its entirety.

In determining the appropriate levels,

the Company performs an analysis of the assets and liabilities at each reporting period end.

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.

authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques

used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed

in one of three categories, as presented below.

Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair

value measurements, is also required.

Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to

access as of the measurement date.

Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities

and exchange-based derivatives.

Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable

through corroboration with observable market data.

Financial assets and liabilities utilizing Level 2 inputs include fixed income securities,

non-exchange-based derivatives, mutual funds, and fair-value hedges.

Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop

its own assumptions.

Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives

and commingled investment funds and are measured using present value pricing models.

Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the

lowest level input that is significant to the fair value measurement in its entirety.

In determining the appropriate levels, the Company

performs an analysis of the assets and liabilities at each reporting period end.

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

December 2019, the Financial Accounting Standards board (the “FASB”) issued Accounting Standards Update (“ASU”)

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.

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

The Company adopted ASU 2019-12 effective January 1, 2021.

The adoption of ASU 2019-12 did not have any impact on the Company’s

consolidated financial statement presentation or disclosures.

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.

For contracts in an entity’s own equity, the type of contracts primarily affected by ASU 2020-06

are freestanding and embedded features that are accounted for as derivatives under the current guidance due to a failure to meet the

settlement assessment by removing the requirements to (i) consider whether the contract would be settled in registered shares, (ii) consider

whether collateral is required to be posted, and (iii) assess shareholder rights.

ASU 2020-06 is effective for fiscal years beginning

after December 15, 2023.

Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, and only if

adopted as of the beginning of such fiscal year.

The Company adopted ASU 2020-06 effective January 1, 2021.

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

a material impact on the Company’s financial statement presentation or disclosures.

Stockholders’

did not have any impact on the Company’s consolidated financial statement presentation or disclosures.

May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50),

Compensation — Stock Compensation (Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic

Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU

ASU 2021-04 provides guidance as to how an issuer should account for a modification of the terms or conditions or an

exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains classified after modification or exchange

as an exchange of the original instrument for a new instrument.

An issuer should measure the effect of a modification or exchange as

the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification

or exchange and then apply a recognition model that comprises four categories of transactions and the corresponding accounting treatment

for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and debt origination

or modification).

ASU 2021-04 is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods

within those fiscal years.

An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring

on or after the effective date.

Early adoption is permitted for all entities, including adoption in an interim period.

If an entity elects

to early adopt ASU 2021-04 in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes

that interim period.

The adoption of ASU 2021-04 is not expected to have any impact on the Company’s consolidated financial statement

presentation or disclosures.

does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material

impact on the Company’s financial statement presentation or disclosures.

Stockholders’ Equity

Company is authorized to issue a total of 10,000,000 shares of preferred stock, par value $ 0.0001 per share.

On March 17, 2015,

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

(subject to customary anti-dilution provisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion

at the conversion rate in the event of a merger or sale transaction resulting in gross proceeds to the Company of at least $21,875,000.

The Series A Convertible Preferred Stock has a liquidation preference based on its assumed conversion into shares of common stock.

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 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.

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’

On March 17, 2015, 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.

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, 2021 and 2020, 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 (subject

to customary anti-dilution provisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion at the conversion

rate in the event of a merger or sale transaction resulting in gross proceeds to the Company of at least $ 21,875,000 .

The Series A Convertible

Preferred Stock has a liquidation preference based on its assumed conversion into shares of common stock.

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 729,167 shares of common stock

at December 31, 2021 and 2020.

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 .

Accordingly, 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

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’ equity.

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).

As of December 31, 2021 and

2020, the Company had 13,746,593 shares and 12,402,157 shares, respectively, of common stock issued, issuable and outstanding.

November 30, 2020, the Company raised gross proceeds of $ 5,700,000 through a public offering of 1,200,000 units at a sale price of $ 4.75

Each unit consisted 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 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.

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 warrants to the underwriters 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 share.

December 21, 2020, the Company entered into a one-year services agreement with IRTH Communications, LLC for investor/public relations,

financial communications, and strategic consulting services.

The services agreement provided for the issuance of restricted shares of

common stock, fully vested upon issuance, with a grant date fair value of $ 100,000 , which resulted in the issuance of 27,420 shares of

common stock with a per share value of $ 3.65 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 .

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 $ 4,192,478 .

The total cash costs of this offering were $ 502,717 , resulting in net cash

proceeds of $ 3,689,761 .

Pursuant to the placement agents’ agreement, the Company granted warrants to the placement agents 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.

April 22, 2021, stock options held by an officer and two of the Company’s directors for 125,001 shares of common stock were exercised.

Such stock options consisted of 75,000 options at $ 0.72 per share, 16,667 options at $ 0.90 per share, and 33,334 options at $ 0.96 per

The exercise of these stock options generated total cash proceeds of $ 101,000 and resulted in the issuance of 125,001 shares of

common stock.

July 14, 2021, a stock option held by a consultant of the Company for 83,333 shares of common stock were exercised at $ 1.20 per share.

The exercise of this stock option generated total cash proceeds of $ 100,000 and resulted in the issuance of 83,333 shares of common stock.

Stock Warrants

summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the

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, 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

stock warrants on that date.

Accordingly, there was no intrinsic value attributed to exercisable but unexercised common stock

warrants at December 31, 2020.

summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s

public offering, during the years ended December 31, 2021 and 2020 is presented below.

Schedule of Warrants Outstanding

outstanding at December 31, 2019

outstanding at December 31, 2020

outstanding at December 31, 2021

exercisable at December 31, 2020

exercisable at December 31, 2021

December 31, 2021, the outstanding warrants are exercisable at the following prices per common share:

Schedule of Warrants Outstanding and Exercisable

on a fair market value of $ 1.19 per share on December 31, 2021, there was no intrinsic value attributed to exercisable but unexercised

common stock warrants at December 31, 2021.

with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 5.

Related Party Transactions

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.

party transactions include transactions with the Company’s officers, directors and affiliates.

N Schwartzberg

September 12, 2007, the Company entered into a consulting agreement with Gil N 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 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.

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.

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 stockholders.

Schwartzberg is currently a significant stockholder and director

of the Company.

Consideration under this consulting agreement, including amendments thereto, has been paid exclusively in the form of

stock options.

On August 2, 2018, the Company entered into a third amendment to the consulting agreement to extend it to January 28,

2024, as well as to extend the exercise date of previously issued, fully-vested stock options for 666,667 shares of common stock, exercisable

at $ 3.00 per share, from January 28, 2019 to January 28, 2024.

Agreements with Officers

July and August 2020, the Company entered into one-year employment agreements with its executive officers, consisting of Dr.

Kovach, Eric J.

Miser, and Robert N.

Weingarten, payable monthly, as described below.

The employment agreements

are 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, or by death, or by termination for cause.

These employment agreements were automatically renewed

for an additional one-year period in July and August 2021.

Company entered into an employment agreement with Dr.

Kovach dated July 15, 2020, effective October 1, 2020, for Dr.

Kovach to continue

to act as the Company’s President, Chief Executive Officer and Chief Scientific Officer with an annual salary of $ 250,000 .

the years ended December 31, 2021 and 2020, the Company paid $ 250,000 and $ 62,500 , respectively, to Dr.

Kovach under this employment

During the year ended December 31, 2020, the Company paid Dr.

Kovach a salary of $ 45,000 for services rendered as President,

Chief Executive Officer and Chief Scientific Officer prior to the effectiveness of the employment agreement.

These amounts were included

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

Company entered into an employment agreement with Dr.

Miser, M.D., effective August 1, 2020 to act as the Company’s Chief

Medical Officer with an annual salary of $ 150,000 .

Effective May 1, 2021, Dr.

Miser’s annual salary was increased to $ 175,000 .

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

During the years ended December

31, 2021 and 2020, the Company paid $ 166,667 and $ 62,500 , respectively, to Dr.

Miser under this employment agreement, which were included

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

Company entered into an employment agreement with Eric J.

Forman effective July 15, 2020, as amended on August 12, 2020, to act as the

Company’s Chief Administrative Officer with an annual salary of $ 120,000 .

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

member of the Company’s Board of Directors, and 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, at which firm the Company’s cash is on deposit and the Company maintains

a continuing banking relationship.

Effective May 1, 2021, Mr.

Forman’s annual salary was increased to $ 175,000 .

During the years

ended December 31, 2021 and 2020, the Company paid $ 156,667 and $ 30,000 , respectively, to Mr.

Forman under this employment agreement.

During the year ended December 31, 2020, the Company paid legal and consulting fees to the Eric Forman Law Office of $ 38,000 for services

rendered prior to Mr.

Forman’s appointment as Chief Administrative Officer.

These amounts were included in general and administrative

costs in the Company’s consolidated statements of operations for such periods.

Company entered into an employment agreement with Robert N.

Weingarten effective August 12, 2020 to act as the Company’s Vice President

and Chief Financial Officer with an annual salary of $ 120,000 .

Effective May 1, 2021, Mr.

Weingarten’s annual salary was increased

to $ 175,000 .

During the years ended December 31, 2021 and 2020, the Company paid $ 156,667 and $ 46,451 , respectively, to Mr.

under this employment agreement.

During the year ended December 31, 2020, the Company paid $ 79,995 to Mr.

Weingarten for accounting and

financial consulting services rendered prior to Mr.

Weingarten’s appointment as Vice President and Chief Financial Officer.

amounts were included in general and administrative costs in the Company’s consolidated statements of operations for such periods.

Arrangements for Board of Directors

April 9, 2021, the Board of Directors approved a comprehensive cash and equity compensation package for the members of the Board of Directors

and committee members.

Board of Directors approved the following cash compensation for non-officer independent directors, payable quarterly:

director compensation - $ 20,000 per year

of audit committee - additional $ 10,000 per year

of any other committees - additional $ 5,000 per year

of audit committee - additional $ 5,000 per year

of any other committees - additional $ 2,500 per year

cash compensation paid to independent directors was $ 92,833 for the year ended December 31, 2021.

compensation arrangements involving members of the Company’s Board of Directors.

officers and affiliates are described at Note

summary of related party costs, including compensation under employment and consulting agreements and fees paid to non-officer directors

for their services on the Board of Directors, for the years ended December 31, 2021 and 2020 is presented below.

This summary includes

the above-described payments to Mr.

Forman in 2020 prior to his appointment as Chief Administrative Officer and excludes the payments

Weingarten in 2020 prior to his appointment as Vice President and Chief Financial Officer.

Summary of Related Party Costs

Stock-Based Compensation

1 unchanged sentence

contractors, and consultants of the Company.

June 20, 2007, the Board of Directors of the Company approved the 2007 Stock Compensation Plan (the “2007 Plan”),

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 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, 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.

The risk-free

interest rate is based on the U.S.

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.

holding a majority of the voting power of the common stock of the Company approved the 2020 Plan pursuant to an action by written consent

dated July 31, 2020.

Stockholders of the Company were notified of such action by written consent pursuant to an Information Statement

dated August 31, 2020 and mailed to stockholders on or about September 3, 2020.

As of December 31, 2021, unexpired stock options for

1,400,000 shares were issued and outstanding under the 2020 Plan and 933,333 shares were available for issuance under the 2020 Plan.

April 9, 2021, the Board of Directors approved a comprehensive cash and equity compensation package for the members of the Board of Directors

and committee members.

Cash-based features of the compensation package are described at Notes 4 and 7.

features of the compensation package consisted of the annual granting of stock options to each non-officer director to purchase 100,000

shares of common stock at the closing market price on the earlier of the date of the annual meeting of shareholders or the last business

day of the month ending June 30, vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested , and the granting

of stock options to a new director to purchase 250,000 shares of common stock, exercisable at the closing market price on the grant date

for a period of five years, vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar

quarter-end until fully vested.

fair value of a stock option award is calculated on the grant date using the Black-Scholes option-pricing model.

The risk-free interest

rate is based on the U.S.

Treasury yield curve in effect as of the grant date.

The expected dividend yield assumption

is based on the Company’s expectation of dividend payouts and is assumed to be zero.

The expected 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.

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

was estimated using the Black-Scholes option-pricing model with the following assumptions:

Risk-free interest rate

0.23% to 0.31 %

Expected dividend yield

Expected volatility

Expected life

stock options requiring an assessment of value during the year ended December 31, 2019, the fair value of each stock option award

was estimated using the Black-Scholes option-pricing model with the following assumptions:

The expected dividend yield assumption is based on the

Company’s expectation of dividend payouts and is assumed to be zero.

The 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.

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, 2021, the fair value of each stock option award was

estimated using the Black-Scholes option-pricing model with the following assumptions:

Schedule of Fair Value of Each Option Award Estimated Assumption

interest rate

dividend yield

August 4, 2018, in conjunction with their appointments as directors of the Company, the Company granted stock options to each

Winson Sze Chun Ho and Dr.

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 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 ($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 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

Winson Sze Chun Ho, Dr.

Stephen Forman, and Dr.

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

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

$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

shares of the Company’s common stock in recognition of Mr.

Johnson’s continuing contributions to the development of

the Company’s proprietary compounds.

The stock options are exercisable for a period of five years from the date of grant

at $6.00 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 determined to be $434,024 ($5.2083 per share)

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.

stock options requiring an assessment of value during the year ended December 31, 2020, the fair value of each stock option award was

estimated using the Black-Scholes option-pricing model with the following assumptions:

interest rate

dividend yield

September 14, 2015, in connection with the Collaboration Agreement with BioPharmaWorks LLC (“BioPharmaWorks”) as described

at Note 7, the Company issued to BioPharmaWorks two stock options, in the form of warrants, to purchase 166,667 shares ( 83,333.5 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 grant date at $ 6.00 per share.

The second warrant vested on September 14, 2017 and was exercisable for a period of

five years from the grant date 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 166,667 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.

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 reflected as a charge to general and administrative 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 J.

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

have a term of five years and an exercise price of $ 7.14 per share, which was equal to the closing market 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 options vested as to 25% on August 12, 2020 and August 12, 2021, and will vest 25% on each of the

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.

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 is being charged to operations ratably from August 12, 2020 through August 12, 2023.

During the years ended December 31, 2021

and 2020, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $ 100,213 and

$ 138,926 , respectively, 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, 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.

The options have a term of five

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

effective date of the employment agreement.

The options vested as to 25% on August 1, 2020 and August 1, 2021, and will vest 25% on each

of the 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 is being charged to operations ratably from August 1, 2020 through August 1, 2023.

During the years ended December 31, 2021 and

2020, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $ 143,163 and $ 202,782 ,

respectively, 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.

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).

The options have a term of five

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

The options vested as to 25% on August 12, 2020 and August 12, 2021, and will vest 25% on each of the 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 is being charged to operations

ratably from August 12, 2020 through August 12, 2023.

During the years ended December 31, 2021 and 2020, the Company recorded charges

to general and administrative costs in the consolidated statement of operations of $ 100,213 and $ 138,926 , respectively, with respect

to these stock options.

January 6, 2021, in recognition of their service as directors of the Company over the past year, the Company granted fully-vested stock

options to purchase 50,000 shares of common stock to each of Dr.

Winson Sze Chun Ho, Dr.

Stephen Forman, and Dr.

Palmedo (an aggregate of 200,000 shares), 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 date.

The fair value of these stock options, as calculated

pursuant to the Black-Scholes option-pricing model, was determined to be $ 571,312 ($ 2.8566 per share) and was charged to general and

administrative costs in the consolidated statement of operations on the grant date.

April 9, 2021, Winson Sze Chun Ho resigned from the Company’s Board of Directors to focus on clinical and pre-clinical cancer research

in academic medicine.

Concurrent with his resignation, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created

Ho’s resignation.

In connection with his appointment to the Board of Directors, and in accordance with the Company’s

cash and equity compensation package for members of the Board of Directors, Mr.

Schwartzberg was granted options exercisable for a period

of five years to purchase 250,000 shares of the Company’s common stock at an exercise price of $ 3.20 per share (the closing market

price on the grant date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end

until fully vested.

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

to be $ 753,611 ($ 3.0144 per share), of which $ 376,800 was attributable to the stock options fully-vested on April 9, 2021 and was therefore

charged to operations on that date.

The remaining unvested portion of the fair value of the stock options is being charged to operations

ratably from April 9, 2021 through June 30, 2023.

During the year ended December 31, 2021, the Company recorded charges to general and

administrative costs in the consolidated statement of operations of $ 500,235 with respect to these stock options.

May 11, 2021, the Board of Directors appointed Regina Brown to the Board of Directors.

In connection with her appointment to the Board

of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors,

Brown was granted options exercisable for a period of five years to purchase 250,000 shares of the Company’s common stock at

an exercise price of $ 2.80 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder vesting

12.5% on the last day of each subsequent calendar quarter-end until fully vested.

The fair value of these stock options, as calculated

pursuant to the Black-Scholes option-pricing model, was determined to be $ 658,363 ($ 2.6335 per share), of which $ 329,188 was attributable

to the stock options fully-vested on May 11, 2021 and was therefore charged to operations on that date.

The remaining unvested portion

of the fair value of the stock options is being charged to operations ratably from May 11, 2021 through June 30, 2023.

During the year

ended December 31, 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations

of $ 427,944 with respect to these stock options.

June 30, 2021, the Board of Directors, in accordance with the recently adopted cash and equity compensation package for the members of

the Board of Directors, granted to each of the five non-officer directors of the Company stock options exercisable for a period of five

years to purchase 100,000 shares (a total of 500,000 shares) of the Company’s common stock at an exercise price of $ 3.03 per share

(the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested.

The total fair value of the 500,000 stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to

be $ 1,421,095 ($ 2.84225 per share), which is being charged to operations ratably from July 1, 2021 through June 30, 2023.

year ended December 31, 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations

of $ 358,200 with respect to these stock options.

November 8, 2021, the Company issued to BioPharmaWorks a stock option, in the form of a warrant, to purchase 200,000 shares of the Company’s

common stock.

The warrant is exercisable for a period of five years from the issue date at $ 2.06 per share (the closing market price

on the issue date).

The fair value of the fully-vested stock warrant, as calculated pursuant to the Black-Scholes option-pricing model,

was determined to be $ 397,642 ($ 1.9882 per share) and was charged to general and administrative costs in the consolidated statement of

operations on that date.

summary of stock-based compensation costs for the years ended December 31, 2021 and 2020 is as follows:

Related parties

Non-related parties

Total stock-based compensation costs

Summary of Stock-based Compensation Costs

stock-based compensation costs

summary of stock option activity, including options issued in the form of warrants, during the years ended December 31, 2021 and 2020

is presented below.

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

Summary of Stock Option Activity Including Options Form of Warrants

Average Remaining Contractual Life (in Years)

options outstanding at December 31, 2019

adjustment attributable to reverse stock split

Weighted average exercise price, reverse stock split

options outstanding at December 31, 2020

adjustment attributable to reverse stock split

options outstanding at December 31, 2021

options exercisable at December 31, 2020

options exercisable at December 31, 2021

deferred compensation expense for the outstanding value of unvested stock options was approximately $ 2,097,000 at December 31, 2021,

which will be recognized subsequent to December 31, 2020 over a weighted-average period of approximately thirty-one months.

which will be recognized subsequent to December 31, 2021 over a weighted-average period of approximately 18 months.

exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at December 31,

2021 are as follows:

Outstanding (Shares)

Exercisable (Shares)

intrinsic value of exercisable but unexercised in-the-money stock options at December 31, 2020 was approximately $747,750, based

on a fair market value of $3.17 per share on December 31, 2020.

stock options to acquire 150,000 shares of the Company’s common stock had not vested at December 31, 2020.

Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants

intrinsic value of exercisable but unexercised in-the-money stock options at December 31, 2021 was approximately $ 10,000 , based on a

fair market value of $ 1.19 per share on December 31, 2021.

stock options to acquire 662,500 shares of the Company’s common stock had not vested at December 31, 2021.

Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock.

1 unchanged sentence

reporting purposes and the amounts used for income tax purposes.

Significant components of the Company’s deferred tax assets

as of December 31, 2020 and 2019 are summarized below.

Start-up and organization costs

Research credits

Stock-based compensation

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

portion or all of the deferred tax assets will be realized.

The ultimate realization of deferred tax assets is dependent upon

the Company attaining future taxable income during the periods in which those temporary differences become deductible.

As of December

31, 2020 and 2019, management was unable to determine if it is more likely than not that the Company’s deferred tax assets

will be realized and has therefore recorded an appropriate valuation allowance against deferred tax assets at such dates.

federal tax provision has been provided for the years ended December 31, 2020 and 2019 due to the losses incurred during such

Significant components of the Company’s deferred tax assets as

of December 31, 2021 and 2020 are summarized below.

Schedule of Components of Deferred Tax Assets

and organization costs

operating loss carryforwards

deferred tax assets

( 8,995,000 )

( 6,979,000 )

deferred tax assets

assessing the potential realization of deferred tax assets, management considers whether it is more likely than not that some portion

or all of the deferred tax assets will be realized.

The ultimate realization of deferred tax assets is dependent upon the Company attaining

future taxable income during the periods in which those temporary differences become deductible.

As of December 31, 2021 and 2020, management

was unable to determine if it is more likely than not that the Company’s deferred tax assets will be realized and has therefore

recorded an appropriate valuation allowance against deferred tax assets at such dates.

federal tax provision has been provided for the years ended December 31, 2021 and 2020 due to the losses incurred during such periods.

The reconciliation below presents the difference between the income tax rate computed by applying the U.S.

federal statutory

rate and the effective tax rate for the years ended December 31, 2020 and 2019.

federal statutory rate and

the effective tax rate for the years ended December 31, 2021 and 2020.

Schedule of Effective Income Tax Rate

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

income taxes, net of federal tax benefit

related to stock-based compensation

to deferred tax asset

in valuation allowance

December 31, 2021, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately

1 unchanged sentence

Federal net operating losses, if not utilized earlier, expire through 2041 .

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 state net

operating loss carryovers include approximately $ 19,141,000 that was incurred 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.

In addition, the full New York net operating losses incurred in post-2015

tax years may be utilized in future tax years.

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 tax years may be utilized in future tax years.

Post-2015 New York net operating losses expire through 2040 .

As the Company’s

net operating losses have yet to be utilized, all previous tax years since 2006 remain open to examination by Federal authorities

and other jurisdictions in which the Company currently operates or has operated in the past.

The state net operating

loss carryovers also include approximately $ 4,146,000 that was incurred in the State of California.

As the Company’s net operating

losses have yet to be utilized, all previous tax years since 2006 remain subject to adjustment by Federal authorities and other jurisdictions

in which the Company currently operates or has operated in the past.

Commitments and Contingencies

Company may be subject to legal claims and actions from time to time as part of its business activities.

As of December 31, 2020,

the Company was not subject to any pending or threatened legal claims or actions.

As of December 31, 2021, the

Company was not subject to any pending or threatened legal claims or actions.

Trial Agreements

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).

December 31, 2021, the Company’s contractual commitments pursuant to clinical trial agreements, clinical trial monitoring agreements,

and agreements for the production of LB-100 for clinical use, as described below, aggregated $ 8,646,000 , which are currently scheduled

to be incurred through December 31, 2025.

The Company’s ability to conduct and fund these contractual commitments is subject to

the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of

such funds to the Company’s current or future clinical trial programs.

The Company expects that the full amount of these expenditures

will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration

are not modified or reduced.

Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can

frequently involve a series of changes and modifications over time as clinical data is obtained and analyzed, and are frequently modified,

suspended or terminated before the clinical trial endpoint.

Accordingly, such contractual commitments as discussed herein should be considered

as estimates only based on current clinical assumptions and conditions, and are typically subject to significant revisions over time.

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.

(“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

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 planned.

An interim analysis will be done after the first 21 patients

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

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 clinical trial is expected to be completed by June 30, 2025.

However, with additional funds, the Company would consider

adding two additional MDS centers to the Phase 2 portion of the study to accelerate patient accrual.

the years ended December 31, 2021 and 2020, the Company incurred costs of $ 18,443 and $ 41,142 , respectively, pursuant to this agreement,

which have been included in research and development costs in the Company’s consolidated statements of operations.

As of December

31, 2021, total costs of $ 104,677 have been incurred pursuant to this agreement.

The Company’s aggregate commitment pursuant to

this agreement, less amounts previously paid to date, totaled approximately $ 601,000 as of December 31, 2021, which is expected to be

incurred through December 31, 2025 .

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

The purpose of this clinical trial is to obtain information with respect to 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.

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 approximately 150 patients in this clinical trial over a period

of two years.

As advanced sarcoma is a very aggressive disease, the design 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 approximately 50% 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.

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 standards.

standards were adopted subsequent to the production of the Company’s existing LB-100 inventory.

new batch of LB 100 has been prepared and is now undergoing the multitude of analytical studies of the formulated product necessary to

gain approval for use in the European Union.

Regulatory reviews by the European Union have been delayed, as a result of which the final

review of the clinical product by Spanish regulatory authorities will also be delayed.

Accordingly, the clinical trial is now estimated

to begin during the quarter ending June 30, 2022 and be completed by June 30, 2025.

interim analysis of this clinical trial could indicate either inferiority or superiority of LB-100 plus doxorubicin as compared to doxorubicin

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 agreement.

Through December 31, 2021, the Company has paid GEIS an aggregate of $ 67,582 towards the second milestone payment for current work being

done under this agreement.

the years ended December 31, 2021 and 2020, the Company incurred costs of $ 24,171 and $ 43,411 , respectively, pursuant to this agreement,

which have been included in research and development costs in the Company’s consolidated statements of operations.

As of December

31, 2021, total costs of $ 155,053 have been incurred pursuant to this agreement.

The Company’s aggregate commitment pursuant to

this agreement, less amounts previously paid to date, totaled approximately $ 4,250,000 as of December 31, 2021, which is expected to

be incurred through December 31, 2025 .

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, also under

GMP conditions documented by an independent auditor.

The clinical drug product 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.

application documenting all steps taken to prepare the clinical drug product for clinical use must be submitted to the appropriate regulatory

authorities for review and approval before being used in a clinical trial.

November 2, 2021, the Company entered into a Development Agreement with Famar Health Care Services Madrid SA (“Famar”) to

prepare a new batch of clinical LB-100 for use in clinical trials to be conducted in the European Union.

During the year ended December

31, 2021, the Company incurred costs of $ 119,860 , pursuant to this agreement, which has been included in research and development costs

in the Company’s consolidated statements of operations.

The Company’s aggregate commitment pursuant to this agreement, less

amounts previously paid to date, totaled approximately $ 180,000 as of December 31, 2021, which is expected to be incurred through June

of December 31, 2021, the Company estimates that this program to provide new inventory of the clinical drug product for the Spanish sarcoma

study, and potentially for subsequent multiple trials within the European Union, including the costs incurred and to be incurred with

Famar as described above, will cost approximately $ 1,076,000 .

The Company’s aggregate commitments under this program, less amounts

previously paid to date, totaled approximately $ 318,000 as of December 31, 2021, which are expected to be incurred through December 31,

As the production of the new inventory of the clinical drug product is being conducted in Europe and is paid for in Euros, final

costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.

Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with the 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 treatment of 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.

clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete.

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.

The Company is currently seeking to add two additional centers

to increase the rate of accrual.

The Company expects this clinical trial to be completed by June 30, 2024.

the year ended December 31, 2021, the Company incurred costs, and total costs, of $ 378,511 , pursuant to this agreement.

The Company’s

aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 2,433,000 as of December

31, 2021, which is expected to be incurred through December 31, 2024, based upon a target of 42 enrollees.

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 approximately $ 800,000 .

The Company currently expects that enrollment in this clinical trial will range from approximately 18

to 30 enrollees, with 24 enrollees as the most likely number.

Should fewer than 42 enrollees be required, the Company has agreed to compensate

City of Hope on a per enrollee basis.

Cancer Institute Pharmacologic Clinical Trial.

In May 2019, the National Cancer Institute (NCI) initiated a glioblastoma (GBM) pharmacologic

clinical trial.

During the fourth quarter of 2019, the NCI enrolled the first two patients of a planned eight patient pharmacologic study

of the ability of LB-100 to enter the brain and penetrate recurrent brain tumors in patients where surgical removal of the cancers is

indicated (clinical trials registry NCT03027388).

This study is being conducted and funded by the NCI under a Cooperative Research and

Development Agreement, with the Company being required to provide the LB-100 clinical compound.

malignant brain tumors (gliomas) are very challenging to treat.

Radiation combined with the chemotherapeutic drug temozolomide has been

the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with some further benefit gained

by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients.

models of GBM, the Company’s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation,

temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment

in the clinic.

Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human

cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain is not known.

Unfortunately,

many drugs potentially useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.

NCI study is designed to determine the extent to which LB-100 enters recurrent malignant gliomas.

Patients having surgery to remove one

or more tumors will receive one dose of LB-100 prior to surgery and have blood and tumor tissue analyzed to determine the amount of LB-100

present and to determine whether the cells in the tumors show the biochemical changes expected to be present if LB-100 reaches its molecular

The goal is to obtain data in up to eight patients.

As a result of the innovative design of the NCI study, data from so few patients

should be sufficient to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100

to the standard treatment regimen for GBMs.

neurosurgical unit at the NCI, which had been closed due to the Covid-19 epidemic, has reopened, and patient accrual has resumed.

entry remains at two, with the goal to enter eight patients before analyzing results.

There is an urgent need to improve therapy for

this type of aggressive brain tumor.

If the NCI study shows that LB-100 does penetrate the brain, a clinical study of LB-100 in combination

with standard therapy for GBM, the drug temozolomide and radiation, both of which have been well documented in pre-clinical studies to

be significantly enhanced by LB-100, would be of significant interest to neuro-oncologists frustrated by decades of limited advances

in therapy for this common brain tumor in adults.

Trial Monitoring Agreements

September 12, 2018, the Company finalized a work order agreement with Theradex Systems, Inc.

(“Theradex”), an international

contract research organization (“CRO”), to monitor the Phase 1b/2 clinical trial being managed and conducted by Moffitt.

On September 12, 2018, the Company finalized a work order agreement with Theradex Systems, Inc.

(“Theradex”), an international

contract research organization (“CRO”), to monitor the Phase 1b/2 clinical trial being 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.

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.

At the current rate of

accrual, the clinical trial is expected to be completed by June 30, 2025.

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.

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.

years ended December 31, 2021 and 2020, the Company incurred costs of $ 9,750 and $ 18,663 , respectively, pursuant to this work order.

As of December 31, 2021, total costs of $ 91,885 have been incurred pursuant to this work order agreement.

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.

The Company’s aggregate

commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $ 868,000

as of December 31, 2021, which is expected to be incurred through June 30, 2025.

On 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.

During the year ended

December 31, 2021, the Company incurred costs of $ 24,626 , pursuant to this work order.

As of December 31, 2021, total costs of $ 24,626

have been incurred pursuant to this work order agreement.

The Company’s aggregate commitment pursuant to this clinical trial monitoring

agreement, less amounts previously paid to date, totaled approximately $ 314,000 as of December 31, 2021, which is expected to be incurred

through June 30, 2025.

and License Agreements

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.

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.

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 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

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 initial plan was 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, 2021 and 2020, 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 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.

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

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.

The clinical trial began at a single site in April 2019 and the first

patient was entered into the clinical trial in July 2019.

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

During the years ended December 31, 2021 and 2020, the Company recorded charges to operations of $ 24,999 and $ 25,001 , respectively,

in connection with its obligations under the License Agreement.

As of December 31, 2021, 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,

subject to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $50,000 in the

first four years after sales commence, and $100,000 in year five and each year thereafter, subject to reduction by 40% under certain

circumstances relating to the status of Valid Claims, as such term is defined in the License Agreement.

The Company’s obligation

to pay earned royalties under the License Agreement commences on the date of the first sale of a royalty-bearing product, and

shall automatically expire on a country-by-country basis on the date on which the last valid claim of the Licensed Patents expires,

lapses or is declared invalid, and the obligation to pay any earned royalties under the License Agreement shall terminate on the

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).

Company will be obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, subject

to reduction to 2% under certain circumstances, on a quarterly basis, with a minimum royalty payment of $ 50,000 in the first four years

after sales commence, and $ 100,000 in year five and each year thereafter, subject to reduction by 40% under certain circumstances relating

to the status of Valid Claims, as such term is defined in the License Agreement.

The Company’s obligation to pay earned royalties

under the License Agreement commences on the date of the first sale of a royalty-bearing product, and shall automatically expire on a

country-by-country basis on the date on which the last valid claim of the Licensed Patents expires, lapses or is declared invalid, and

the obligation to pay any earned royalties under the License Agreement shall terminate on the date on which the last valid claim of the

Licensed Patents expires, lapses, or is declared to be invalid in all countries.

Agreements with Officers

July and August 2020, the Company entered into one-year employment agreements with its executive officers, consisting of Dr.

Kovach, Eric J.

Miser, and Robert N.

Weingarten, which provided for aggregate annual compensation of $ 640,000 , payable

monthly (see Note 4).

The employment agreements are 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 , or by death, or by termination for cause.

employment agreements were automatically renewed for an additional one-year period in July and August 2021.

April 9, 2021, the Board of Directors increased the annual compensation of Eric J.

Forman, the Company’s Chief Administrative Officer,

Miser, the Company’s Chief Medical Officer, and Robert N.

Weingarten, the Company’s Chief Financial Officer,

under the employment agreements such that the total aggregate annual compensation of all officers increased to $ 775,000 , effective May

Significant Agreements and Contracts

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

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.

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

BioPharmaWorks to perform certain services for the Company.

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.

and advisory fees charged to operations pursuant to this agreement were $ 16,000 and $ 16,000 for the years ended December 31, 2021 and

2020, 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 BioPharmaWorks

to perform certain services for the Company.

Those services included, among other things:

(a) assisting the Company

to (i) commercialize its products and strengthen its patent portfolio, (ii) identify large pharmaceutical companies with potential

interest in the Company’s product pipeline, and (iii) prepare and deliver presentations concerning the Company’s products;

(b) at the request of the Board of Directors, serving as backup management for up to three months should the Company’s Chief

Executive Officer and scientific leader be temporarily unable to carry out his duties;

drug discovery and development;

and (d) identifying providers and overseeing tasks relating to clinical use and commercialization

of new compounds.

(a) assisting the Company to (i) commercialize

its products and strengthen its patent portfolio, (ii) identify large pharmaceutical companies with potential interest in the Company’s

product pipeline, and (iii) prepare and deliver presentations concerning the Company’s products;

(b) at the request of the Board

of Directors, serving as backup management for up to three months should the Company’s Chief Executive Officer and scientific leader

be temporarily unable to carry out his duties;

and (d) identifying

providers and overseeing tasks relating to clinical use and commercialization of new compounds.

BioPharmaWorks

was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development

The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods

unless terminated by a party not less than 60 days prior to the expiration of the applicable period.

In connection with the Collaboration

Agreement, the Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated

hourly rate in lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation.

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.

was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience.

The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated

by a party not less than 60 days prior to the expiration of the applicable period.

In connection with the Collaboration Agreement, the

Company agreed to pay BioPharmaWorks a monthly fee of $ 10,000 , subject to the right of the Company to pay a negotiated hourly rate in

lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation.

The Company recorded charges to

operations pursuant to this Collaboration Agreement of $ 120,000 and $ 120,000 for the years ended December 31, 2021 and 2020, 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 pre-clinical 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 pre-clinical studies will be conducted at The University of California

- Davis under the direction of Dr.

David Segal, an internationally recognized leader in AS research.

If the pre-clinical 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.

The 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.

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.

Conditioned 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.

research team at the University of California, Davis recently completed their pre-clinical study of the potential benefit of LB-100 in

a mouse model of AS, and the results are currently under review by FAST.

The preliminary analysis indicates that the positive results

previously reported by Chinese investigators were not confirmed in the US model.

The Company is awaiting input from FAST as to whether

it intends to continue to pursue pre-clinical studies of LB 100.

October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam (NKI),

one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center,

to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers,

as well as to identify the specific molecular mechanisms underlying the identified combinations.

The Company has agreed to fund the study

and provide a sufficient supply of LB-100 to conduct the study.

The study is expected to take approximately two years to conduct.

the year ended December 31, 2021, the Company incurred charges in the amount of $ 55,248 , with respect to this agreement, which amount

is included in research and development0 costs in the Company’s consolidated statements of operations.

of the Novel Coronavirus (Covid-19) on the Company’s Business Activities

global outbreak of the novel coronavirus (Covid-19) has led to 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

The extent to which the coronavirus may impact the Company’s business activities 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.

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 or more as a result

of the coronavirus pandemic.

the near term, there is also significant and continuing uncertainty as to the effect that the coronavirus may have on the capital markets

in general and on the amount and type of financing available to the Company in particular.

Company is continuing to monitor the situation and will adjust its current business and financing plans as more information and guidance

become available.

Subsequent Events

Company performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with

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.

Company performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with the SEC.

There were no material subsequent events which affected, or could affect, the amounts or disclosures in the consolidated financial statements.

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