What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2024-03-19 compared with 2023-03-29 · 1316 added, 1304 removed, 1296 unchanged (67% of the section changed)

11 unchanged sentences

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

the Company’s management, including its Chief Executive Officer and its 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, 2023, the end of the

5 unchanged sentences

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, including its Chief Executive Officer and its 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).

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

generally 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

9 unchanged sentences

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

Smaller reporting companies employ fewer individuals and can find it more difficult

to properly segregate duties.

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

set of software controls.

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

1 unchanged sentence

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, 2022.

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

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

of December 31, 2023.

believes that the consolidated financial statements included in this report fairly present, in all material respects, the Company’s

6 unchanged sentences

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, 2022 that has materially affected, or is reasonably likely to

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

Company’s management, including 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, 2023 that has materially affected, or is reasonably

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

OTHER INFORMATION

the quarter ended December 31, 2023, no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of the Company adopted

or terminated a “Rule 10b5-1 trading arrangement” as such term is defined in Item 408(a) of Regulation S-K.

As of December

31, 2023, the Company did not have a “Rule 10b5-1 trading arrangement” in effect with respect to its securities.

Trading Policy

Company has adopted insider trading policies and procedures governing the purchase, sale, and other disposition of its securities, which

has been filed as an exhibit to this report and has been posted to the investor information/governance section of the Company’s

corporate website (www.lixte.com).

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

13 unchanged sentences

Held with the Company

President, Chief Executive Officer, Chief Scientific

Officer, and Chairman of the Board of Directors

Chief Medical Officer

Vice President and Chief Financial Officer

Vice President and Chief Operating Officer

Chief Executive Officer, and Chairman of the Board of Directors

Medical Officer

President and Chief Financial Officer

President and Chief Operating Officer

René Bernards

Bas van der Baan

of Directors and Executive Officers

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, 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.

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 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.

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.

(“Bas”) van der Baan was appointed to the Company’s Board of Directors effective June 17, 2022.

Effective September

26, 2023, Mr.

van der Baan replaced the Company’s founder, Dr.

Kovach, as President and Chief Executive Officer.

passed away on October 5, 2023.

Effective October 6, 2023, as a result of the passing of Dr.

van der Baan was appointed as

Chairman of the Board of Directors.

van der Baan has over 20 years of experience in the biotechnology industry, with a key focus on oncology and diagnostics.

He has extensive

knowhow in the process of managing a compound from clinical development to reimbursement and commercialization, as well as the establishment

of partnerships with the pharmaceutical industry, academic collaborators, distributors, insurance companies and governments to successfully

launch new oncology products.

van der Baan was most recently the Chief Clinical Officer of Agendia, an oncology molecular diagnostic

company based in Irvine, California and Amsterdam, Netherlands through July 15, 2023.

van der Baan is an independent director of

Tethis S.p.A., a Milan, Italy-based developer of a novel platform for liquid biopsy testing.

van der Baan was co-founder of ThromboDx,

a liquid biopsy company that was acquired in 2016, Qameleon Therapeutics, a company developing synthetic lethal drug combinations for

cancer treatment, and Oncosence, an oncology drug development company using senescence as target for drug development.

started his career in 1997 at a specialty chemicals division of Unilever that was acquired by ICI.

van der Baan joined Kreatech,

a biotechnology company acquired by Leica that specialized in life science reagents for gene expression, DNA and protein analysis.

van der Baan holds a Master’s Degree in Molecular Sciences from the Wageningen University in the Netherlands.

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

5 unchanged sentences

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.

Hematology/Oncology, President and Chief Executive Officer, and Chief Medical Officer, at the City of Hope National Medical Center, Duarte,

Miser was a member of the Active Staff, Department of Pediatrics at the City of Hope, until 2022, 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

1 unchanged sentence

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.

a member of the Soft Tissue Sarcoma Strategy Group, and Member of the New Agents Executive and Steering Committee, Vice Chairman for

Solid Tumors and Phase II Coordinator for the Children’s Cancer Group and Chairman, Data Monitoring Committee, National Wilms Tumor

He has authored more than a 100 peer-reviewed articles dealing primarily with pediatric clinical cancer studies.

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

13 unchanged sentences

Weingarten served as Lead Director on Guardion’s Board of Directors from January 2017 to March 2020.

July 2017 to June 2018, Mr.

Weingarten was the Chief Financial Officer of Alltemp, Inc.

From April 2013 to February 2017, Mr.

served on the Board of Directors of RespireRx Pharmaceuticals Inc.

and also served as its Vice President and Chief Financial Officer.

Weingarten received a B.A.

received a B.A.

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

in Finance from the University of Southern

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

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 efforts since 2013.

17 unchanged sentences

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

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, M.D., was appointed to our Board of Directors effective May 13, 2016.

Forman is an internationally recognized expert in

hematologic malignancies and bone marrow transplantation, and is a leader in preclinical and clinical cancer research.

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 the City of Hope, Dr.

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

3 unchanged sentences

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.

to the Company, as the enzyme target of its lead clinical compound, LB-100, has been reported 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.

Yen, M.D., Ph.D., F.A.C.P., was appointed to our Board of Directors effective August 4, 2018.

Yen 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.

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.

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 has 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.

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.

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

2 unchanged sentences

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.

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.

René Bernards

9 unchanged sentences

Additionally,

he is a fellow of the American Association for Cancer Research (AACR), and has received the Princess Takamatsu Memorial Lectureship at

this year’s AACR annual meeting where he presented new data on the unexpected effectiveness of the Company’s lead compound,

LB-100, when given with a variety of standard and investigational anti-cancer compounds that have only modest activity on their own.

van der Baan was appointed to our Board of Directors effective June 17, 2022.

van der Baan has over 20 years of experience in

the biotechnology industry, with a key focus on oncology and diagnostics.

He has extensive knowhow in the process of managing a

compound from clinical development to reimbursement and commercialization, as well as the establishment of partnerships with the

pharmaceutical industry, academic collaborators, distributors, insurance companies and governments to successfully launch new

oncology products.

van der Baan is currently under contract as the Chief Clinical Officer of Agendia, an oncology molecular

diagnostic company, through July 15, 2023.

Van der Baan is an independent director of Tethis S.p.A.

in Milan, Italy.

Baan was co-founder of ThromboDx, a liquid biopsy company that was acquired in 2016, Qameleon Therapeutics, a company developing

synthetic lethal drug combinations for cancer treatment, and Oncosence, an oncology drug development company using senescence as

target for drug development.

van der Baan started his career in 1997 at a specialty chemicals division of Unilever that got

acquired by ICI.

van der Baan joined Kreatech, a biotechnology company acquired by Leica that specialized in life

science reagents for gene expression, DNA and protein analysis.

van der Baan holds a Master’s Degree in Molecular Sciences

from the Wageningen University in The Netherlands.

he is a fellow of the American Association for Cancer Research (AACR).

Bernards has presented new data on the unexpected effectiveness

of the Company’s lead clinical compound, LB-100, when given with a variety of standard and investigational anti-cancer compounds

that have only modest activity on their own.

Advisory Committee

8 unchanged sentences

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

The committee currently consists of the following member:

The committee currently consists of one member, as

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

4 unchanged sentences

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.

Von Hoff’s major interest is in the development of new anti-cancer 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,

17 unchanged sentences

Relationships

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

Stephen Forman and son-in-law of former board member Gil Schwartzberg.

Julie Forman, the wife of Eric Forman and the daughter of the late 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 Dr.

Stephen Forman, Dr.

Yun Yen, Regina Brown, Dr.

René Bernards and

Bas van der Baan are each an “independent director,” as defined under Nasdaq rules.

Forman, our Vice President and Chief Operating Officer, is the son of board member Dr.

Stephen Forman and son-in-law of former board

member Gil Schwartzberg, who passed away on October 30, 2022.

Julie Forman, the wife of Eric Forman and the daughter of the late 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.

of Our Board of Directors

6 unchanged sentences

audit committee is responsible for, among other things:

approving and retaining

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

reviewing the proposed

scope and results of the audit;

reviewing and pre-approving

audit and non-audit fees and services;

reviewing accounting and

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

reviewing and approving

transactions between us and our directors, officers and affiliates;

establishing procedures

for complaints received by us regarding accounting matters;

overseeing internal audit

functions, if any;

preparing 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 Regina Brown, Dr.

Yun Yen, and Bas van der Baan, with Ms.

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

the proposed scope and results of the audit;

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

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

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

procedures for complaints received by us regarding accounting matters;

internal audit functions, if any;

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

audit committee currently consists of Regina Brown, Dr.

Yun Yen and Dr.

René Bernards, 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.

of Directors has determined that each of the committee members meet the definition of an “independent director,” as defined

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

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 .

Brown qualifies as an “audit committee financial expert,” as such term is defined in Item 407(d)(5) of Regulation S-K.

Board of Directors has adopted a written charter for the audit committee, which is available on our corporate website at www.lixte.com.

compensation committee is responsible for, among other things:

reviewing and recommending

the compensation arrangements for executive management;

establishing and reviewing

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

our financial goals;

administering our stock

incentive plans;

preparing the report of

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

compensation committee consists of Dr.

Stephen Forman and Dr.

and recommending the compensation arrangements for executive management;

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

and to achieve our financial goals;

administering

our stock incentive plans;

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

compensation committee currently consists of Dr.

Yun Yen, Regina Brown and Dr.

René Bernards, with Dr.

Yen serving as chair.

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 .

Board of Directors has determined that each of the three committee members meet the definition of an “independent director”,

as defined under Nasdaq rules.

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

on our corporate website at www.lixte.com.

and Corporate Governance

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:

nominating members of the

Board of Directors;

developing a set of corporate

governance principles applicable to our company;

overseeing the evaluation

of our Board of Directors.

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

Directors are responsible for, among other things:

members of the Board of Directors;

a set of corporate governance principles applicable to the Company;

the evaluation of our Board of Directors.

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

10 unchanged sentences

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

any breach of the director’s

duty of loyalty to the corporation or its stockholders;

any act or omission not

in good faith or that involves intentional misconduct or a knowing violation of law;

unlawful payments of dividends

or unlawful stock repurchases or redemptions as provided in Section 174 of the Delaware General Corporation Law;

any transaction from which

the director derived an improper personal benefit.

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

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

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

transaction from which the director derived an improper personal benefit.

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

7 unchanged sentences

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.

of their actions in that capacity, regardless of whether we would otherwise be permitted to indemnify them under the provisions of Delaware

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

2 unchanged sentences

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.

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

These provisions 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

2 unchanged sentences

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

Copies of these filings must be furnished to

Copies of these filings are required to 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

1 unchanged sentence

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, 202s, except as follows:

Section 16(a) of the Exchange Act during the year ended December 31, 2023, except as follows:

Bas van der Baan was late in filing his

Form 3 in connection with his appointment to the Board of Directors on June 17, 2022.

Form 4 in connection with his appointment as President and Chief Executive Officer on September 26, 2023.

EXECUTIVE COMPENSATION

9 unchanged sentences

All Other Compensation ($)

Bas van der Baan (6)

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.

Kovach was the President and Chief Executive Officer from inception through September 26, 2023.

Effective July 15, 2020, the

Company entered into an employment agreement with Dr.

On November 6, 2022, Dr.

Kovach was awarded an option grant for 200,000 shares of the Company’s

common stock valued at $0.3282 per share.

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.

Miser was awarded an option grant for 200,000 shares of the Company’s common stock valued at $0.3282 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.

Kovach was awarded an option grant for 20,000

shares of common stock, exercisable for a period of five years at $20.00 per share and valued at $3.282 per share.

The employment agreement

Kovach terminated upon his death on October 5, 2023.

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

In connection with his employment agreement, Dr.

Miser was awarded

an option grant for 8,334 shares of common stock, exercisable for a period of five years at $71.40 per share and valued at $68.718 per

On November 6, 2022, Dr.

Miser was awarded an option grant for 20,000 shares of common stock, exercisable for a period of five

years at $20.00 per share and valued at $3.282 per share.

Weingarten has been the Vice President and Chief Financial Officer since August 12, 2020.

In connection with his employment

agreement, Mr.

Weingarten was awarded an option grant for 5,833 shares of common stock, exercisable for a period of five years at $71.40

per share and valued at $68.718 per share.

On November 6, 2022, Mr.

Weingarten was awarded an option grant for 200,000 shares of the Company’s common stock

Weingarten was awarded an option grant for 20,000 shares of common

stock, exercisable for a period of five years at $20.00 per share and valued at $3.282 per share.

Forman was the Chief Administrative Officer from July 15, 2020 to November 6, 2020.

In connection with his employment agreement,

Forman was awarded an option grant for 5,833 shares of common stock, exercisable for a period of five years at $71.40 per share and

valued at $68.718 per share.

Forman had been the Company’s Chief Administrative Officer from July 15, 2020 to November 6, 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

Effective November 6, 2022, Mr.

Forman was promoted to the Company’s Vice President and Chief Operating Officer.

November 6, 2022, Mr.

Forman was awarded an option grant for 200,000 shares of the Company’s common stock valued at $0.3282 per

were no officer option exercises during the years ended December 31, 2022, 2021 or 2020.

Forman was promoted to Vice President and Chief Operating Officer.

Forman was awarded an option grant for 20,000 shares of common stock, exercisable for a period of five years at $20.00 per

share and valued at $3.282 per share.

Bas van der Baan has been President and Chief Executive Officer since September 26, 2023.

In connection with his employment agreement,

van der Baan was awarded an option grant for 250,000 shares of common stock exercisable for a period of five years at $1.95 per share

and valued at $1.612 per share.

were no option exercises by officers during the years ended December 31, 2023, 2022 or 2021.

Equity Awards at December 31, 2023

1 unchanged sentence

UNEXERCISABLE

November 6, 2022

Bas van der Baan

September 26, 2023

December 31, 2023

September 26, 2028

November 6, 2022

October 5, 2024

August 1, 2020

10 unchanged sentences

November 6, 2027

October 16, 2017

October 16, 2022

August 12, 2020

4 unchanged sentences

November 6, 2027

was no intrinsic value of exercisable but unexercised in-the-money stock options held by our named executive officers at December 31,

2022, based on a fair market value of $0.51 per share on December 31, 2022.

on a fair market value of $2.35 per share on December 31, 2023, the intrinsic value attributed to exercisable but unexercised common

stock options held by our named executive officers was approximately $8,000 at December 31, 2023.

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

12 unchanged sentences

His responsibilities

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.

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.

included the oversight of the Company’s entire operations and strategic planning, and to act as the primary contact between the

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

Kovach supervised all scientific endeavors, providing

guidance to the Chief Medical Officer.

He was the principal spokesperson for the Company.

The effective date of the agreement was October

1, 2020 and remained 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 employment agreement with Dr.

Kovach terminated upon his death on October 5, 2023.

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

8 unchanged sentences

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

of the employment agreement was October 1, 2020 and remains 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

7 unchanged sentences

Under the employment agreement, Dr.

Miser will play a leadership role in planning, implementation

Miser plays 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

Miser is 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 is the primary medical monitor for all clinical investigational studies and

for the oversight of third party CRO monitors.

Miser works 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 FDA approval of therapeutic

products and the clinical development of new drugs.

Miser is 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.

of the agreement was August 1, 2020 and remains 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.

5 unchanged sentences

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

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

van der Baan .

Effective September 26, 2023, the Company entered into an employment agreement with Bas van der Baan to act as the

Company’s President and Chief Executive Officer and as Vice Chairman of the Board of Directors, with an annual salary of $150,000.

Effective October 6, 2023, Mr.

van der Baan was appointed as Chairman of the Board of Directors upon the death of Dr.

Kovach on October

van der Baan’s annual salary may be increased from time to time at the sole discretion of the Board of Directors.

In addition, Mr.

van der Baan will be eligible to receive an annual bonus as determined at the sole discretion of the Board of Directors.

van der Baan was also granted stock options to acquire 250,000 shares of the Company’s common stock.

The term of the employment

agreement is for three years and is automatically renewable for additional one-year periods unless terminated by either party, subject

to early termination provisions as described in the employment agreement.

and Practices – Option Grants

The Company has a comprehensive compensation program for its non-officer directors for their service on the Board of Directors.

program, as amended, has been in place since April 9, 2021.

The Company, with the input and advice of its Compensation Committee, has

issued only stock options to its officers and directors.

compensation for directors under this compensation program is as follows:

of new directors – The Company grants options to purchase 25,000 shares of common stock, exercisable for a period of five years,

at the closing market price on the date of grant, vesting 50% on the grant date and the remaining 50% vesting 12.5% on the last day of

each calendar quarter beginning in the quarter immediately subsequent to the date of the grant until fully vested, subject to continued

At the discretion of the Board of Directors, for a nominee to the Board of Directors who is restricted by their respective institution

or employer from receiving equity-based compensation, in lieu of the grant of such stock options, the Company may elect to pay a one-time

cash fee of $100,000 to such director, payable upfront.

grant of options to directors – Effective on the last business day of the month of June, the Company grants options to purchase

10,000 shares of common stock, exercisable for a period of five years, at the closing market price on the date of grant, vesting 12.5%

on the last day of each calendar quarter beginning in the quarter immediately subsequent to the date of grant until fully vested, subject

to continued service.

If any director has served for less than 12 full calendar months on the grant date, the amount of such stock option

grant is prorated based on the length of service of such director.

At the discretion of the Board of Directors, for a nominee to the

Board of Directors who is restricted by their respective institution or employer from receiving equity-based compensation, in lieu of

the grant of such stock options, the Company may elect to pay an annual cash fee of $40,000 to such director, payable quarterly.

The Company has no specific policy or program with respect to the discretionary grant of options to its officers.

The Company granted

options to its officers concurrent with their respective appointments during the year ended December 31, 2020.

The Company also granted

discretionary stock options to its officers during the year ended December 31, 2022.

It is the Company’s policy that any such option

grants take into account the existence of material non-public information when determining the timing of such a grant and the specific

terms of such award.

Clawback Policy

Board of Directors believes that it is in the best interests of the Company and its stockholders to create and maintain a culture that

emphasizes integrity and accountability and that reinforces the Company’s pay-for-performance compensation philosophy.

of Directors has therefore adopted a compensation recoupment policy, which provides for the recovery of erroneously awarded incentive

compensation from the Company’s executive officers in the event of a triggering event, and which has been filed as an exhibit to

this report and has been posted to the investor information/governance section of the Company’s corporate website (www.lixte.com).

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

2 unchanged sentences

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, was paid exclusively in the form of stock

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.

Consideration under this consulting agreement, including amendments

thereto, was 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

66,667 shares of common stock, exercisable at $30.00 per share, from January 28, 2019 to January 28, 2024.

Schwartzberg, who was appointed as a director of the Company effective April 9, 2021, died on October 30, 2022.

2 unchanged sentences

unvested stock options ceased vesting effective as of the date of his death, and the expiration date of all vested stock options owned

Schwartzberg are contractually scheduled to expire one year from the date that his service on the Company’s Board of Directors

Schwartzberg contractually expired on October 30, 2023, one year from the date that his service on the Company’s Board of

Directors terminated.

of Directors Compensation

9 unchanged sentences

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

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

in academic medicine.

13 unchanged sentences

on October 30, 2022, the date that Mr.

Schwartzberg died.

During the years ended December 31, 2022 and 2021, the Company recorded charges

to general and administrative costs in the consolidated statement of operations of $126,684 and $500,235, respectively, with respect

to these stock options.

Schwartzberg died and his service on the Board of Directors terminated.

During the years ended

December 31, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations

of $126,684 and $500,235, respectively, with respect to these stock options.

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

1 unchanged sentence

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

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

years 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

Brown was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years

at an exercise price of $28.00 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, subject to continued service.

3 unchanged sentences

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 years ended December 31, 2022 and 2021, the Company recorded charges to general and

administrative costs in the consolidated statement of operations of $154,042 and $427,944, respectively, with respect to these stock

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

May 11, 2021 through June 30, 2023.

During the years ended December 31, 2023, 2022 and 2021, the Company recorded charges to general

and administrative costs in the consolidated statement of operations of $76,388, $154,042 and $427,944, respectively, 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 members of the

4 unchanged sentences

The fair value of these 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,

was determined to be $1,421,095 ($28.4225 per share), which was charged to operations ratably from July 1, 2021 through June 30, 2023.

During the years ended December 31, 2023, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated

6 unchanged sentences

fee of $40,000, payable quarterly.

During the year ended December 31, 2022, the Company recorded charges to general and administrative

costs in the consolidated statement of operations of $133,873 with respect to his cash board compensation.

During the years ended December 31, 2023 and 2022, the Company recorded charges to general and administrative

costs in the consolidated statement of operations of $62,500 and $133,873, respectively, with respect to his cash board compensation.

June 17, 2022, the Board of Directors appointed Bas van der Baan to the Board of Directors.

5 unchanged sentences

The fair value

of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $158,525 ($0.6341 per

share), of which $79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 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 June 17, 2022 through June 30, 2024.

During the year ended December 31, 2022, the Company recorded a total charge to general and

administrative costs in the consolidated statement of operations of $100,249 with respect to these stock options.

of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $158,525 ($6.341 per share),

of which $79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 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 June

17, 2022 through June 30, 2024.

During the years ended December 31, 2023 and 2022, the Company recorded charges to general and administrative

costs in the consolidated statement of operations of $38,885 and $100,249, respectively, with respect to these stock options.

June 30, 2022, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the

5 unchanged sentences

was determined to be $316,700 ($6.334 per share), which is being charged to operations ratably from July 1, 2022 through June 30, 2024.

During the year ended December 31, 2022, the Company recorded a total charge to general and administrative costs in the consolidated

statement of operations of $63,777 with respect to these stock options.

For the years ended December 31, 2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated

statement of operations of $94,881 and $63,777, respectively, with respect to these stock options.

November 6, 2022, the Board of Directors granted to each of the four officers of the Company stock options to purchase 20,000 shares

3 unchanged sentences

$262,560 ($3.282 per share), which is being charged to operations ratably from November 6, 2022 through November 6, 2025.

year ended December 31, 2022, the Company recorded a total charge to general and administrative costs in the consolidated statement of

operations of $75,520 with respect to these stock options.

For the years

ended December 31, 2023 and 2022, the Company recorded a total charge to general and administrative costs in the consolidated statement

of operations of $61,448 and $75,520, respectively, with respect to these stock options.

June 30, 2023, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the

Board of Directors, granted to each of the four non-officer directors of the Company stock options to purchase 10,000 shares (a total

of 40,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $5.88 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,

subject to continued service.

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

was determined to be $192,593 ($4.8131 per share), which is being charged to operations ratably from July 1, 2023 through June 30, 2025.

For the year ended December 31, 2023, the Company recorded a total charge to general and administrative costs in the consolidated statement

of operations of $48,464 with respect to these stock options.

Compensation Table

13 unchanged sentences

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.

Kovach, the founder of the Company, served as Chairman of the Board of Directors until his death on October 5, 2023.

to September 26, 2023, Dr.

Kovach was also the President, Chief Executive Officer and Chief Scientific Officer of the Company.

did not receive any separate compensation for his services as a member of the Board of Directors.

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

2 unchanged sentences

Appointed as a director of the Company effective June 15, 2022.

Bernards received all of his compensation in 2022 in the form of

Appointed as a director of the Company effective June 17, 2022.

Bernards received all of his compensation in 2022 and 2023 in the

form of cash.

Appointed as a director of the Company effective June 17, 2022, and as Chairman of the Board of Directors on October 6, 2023.

Did not stand for re-election at the annual meeting of stockholders.

1 unchanged sentence

October 7, 2022.

Appointed as a director of the Company effective May 13, 2016.

Appointed as a director of the Company effective August 4, 2018.

Advisory Committee Compensation

8 unchanged sentences

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, 2022 and

2021, respectively, which were included in research and development costs in the consolidated statements of operations.

and advisory fees charged to operations pursuant to this agreement were $16,000, $16,000 and $16,000 for the years ended December 31,

2023, 2022 and 2021, respectively, which were included in research and development costs in the consolidated statements of operations.

Stock Incentive Plan

6 unchanged sentences

On October 7, 2022, the stockholders of the Company approved

an amendment to the 2020 Plan to increase the number of common shares issuable thereunder by 1,800,000 shares, to a total of 4,133,333

of December 31, 2022, unexpired stock options for 2,603,125 shares were issued and outstanding under the 2020 Plan and 1,530,208 shares

were available for issuance under the 2020 Plan.

an amendment to the 2020 Plan to increase the number of common shares issuable thereunder by 180,000 shares, to a total of 413,333 shares.

On November 27, 2023, the stockholders of the Company approved an amendment to the 2020 Plan to increase the number of common shares

issuable thereunder by 336,667 shares, to a total of 750,000 shares.

of December 31, 2023, unexpired stock options for 495,000 shares were issued and outstanding under the 2020 Plan and 255,000 shares were

available for issuance 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:

Enabling us to continue

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

Aligning participants’

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

Motivating participants,

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

Providing a long-term equity

incentive program that is competitive as compared to other companies with whom we compete for talent.

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

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”),

3 unchanged sentences

2020 Plan provides for the reservation of 750,000 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 4,133,333 (the “ISO Limit”).

provides that the maximum number of shares that may be issued pursuant to the exercise of ISOs is 750,000 shares (the “ISO Limit”).

Features of the 2020 Plan

key features of the 2020 Plan are summarized as follows:

If not terminated earlier

by our Board of Directors, the 2020 Plan will terminate on July 14, 2030.

Up to a maximum aggregate

of 4,133,333 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 4,133,333.

The 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.

Employees, 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.

Awards may consist of ISOs,

NQSOs, restricted stock, RSUs, SARs, other equity awards and/or cash awards.

Stock 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.

Stock options and SARs

may not be repriced or exchanged without stockholder approval.

The maximum exercisable

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

Awards are subject to recoupment

of compensation policies adopted by us.

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

to a maximum aggregate of 4,133,333 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 4,133,333.

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 repriced or exchanged without stockholder approval.

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

are subject to recoupment of compensation policies adopted by us.

to Receive Awards .

16 unchanged sentences

discretion, among other things, to:

Select the individuals

who will receive awards;

Determine the terms and

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

Correct any defect, supply

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

Accelerate 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;

Permit a participant to

defer compensation to be provided by an award;

Interpret the provisions

of the 2020 Plan and outstanding awards.

the individuals who will receive awards;

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

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

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

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

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

the provisions of the 2020 Plan and outstanding awards.

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

1 unchanged sentence

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.

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

The members 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.

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

66 unchanged sentences

Officers and Directors

Bas van der Baan

680 East Colorado Boulevard, Suite 180

Pasadena, California 91101

1,611,284 (1)

Bas van der Baan

Amsterdam P7 1098CP

680 East Colorado Boulevard, Suite 180

3 unchanged sentences

René Bernards

Koningsvaren 37

Abcoude P7 1391AD

680 East Colorado Boulevard, Suite 180

6 unchanged sentences

Pasadena, California 91101

All officers and directors as a group (nine persons)

680 East Colorado Boulevard, Suite 180

Pasadena, California 91101

All officers and directors as a group (9 persons)

Other Stockholders Owning More Than 5%

John and Barbara Kovach 2015 Trust

Krinsky, Trustee

680 East Colorado Boulevard, Suite 180

2 unchanged sentences

Pasadena, California 91101

16204 Andalucia Lane

Delray Beach, Florida 33446

680 East Colorado Boulevard, Suite 180

Pasadena, California 91101

John and Barbara Kovach 2015 Trust

Krinsky, Trustee

680 East Colorado Boulevard, Suite 180

Pasadena, California 91101

Arthur and Jane Riggs 1990 Irrevocable Trust

2 unchanged sentences

La Verne, California 91750

Robert and Susan Greenberg

228 Manhattan Beach Boulevard

Manhattan Beach, California 90266

Bahl and Kavit K.

3 Pheasant Run

Setauket, New York 11733

Mayfair by the Sea II

Tower T8, 1/F, Unit A

21 Fo Chun Road Pak ShekKok

Taipo NT, Hong Kong SAR

680 East Colorado Boulevard, Suite 180

Pasadena, California 91101

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

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.

Also includes stock options to purchase 50,000 shares of common stock owned by Dr.

All stock options are immediately

exercisable or within 60 days.

Includes 154,018 shares of common stock and stock warrants to purchase 2,110 shares of common stock owned by the John S.

dated September 22, 2015.

The primary beneficiary of the trust is Barbara C.

Kovach and Alexandra E.

are co-trustees of the trust and have the exclusive right to control the investment of the assets of the trust.

Includes 11,000 shares of common stock and stock options to purchase 68,853 shares of common stock owned by Bas van der Baan.

options are immediately exercisable or within 60 days.

Includes 3,751 shares of common stock and stock options to purchase 183,333 shares of common stock which are immediately exercisable

or within 60 days, owned by Dr.

Includes 375 shares of common stock and stock options to purchase 28,334 shares of common stock owned by Dr.

Stephen Forman.

Also includes 71,054 shares of common stock and stock warrants to purchase 21,053 shares

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

Stephen Forman is trustee of the trust and holds voting and

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

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

Also includes

7,105 shares of common stock and stock warrants to purchase 2,105 shares of common stock owned by the Stephen Forman Living Trust dated

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

owned by the trust.

Includes 133,333 shares of common stock transferred by John S.

Kovach and his wife, Barbara C.H.

Kovach, as grantors, to the John and

2 unchanged sentences

of John and Barbara Kovach.

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

Krinsky is the trustee of the trust.

Includes stock options to purchase 17,500 shares of common stock owned by Eric J.

All stock options and common stock warrants

are immediately exercisable or within 60 days.

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

Debbie Schwartzberg.

Eric Forman is the husband of Julie (Schwartzberg)

Forman, and the son-in-law of Gil and Debbie Schwartzberg.

includes the following:

79,710 shares of common

stock and stock warrants to purchase 5,264 shares of common stock owned by the Eric Forman Revocable Trust.

All stock options and

common stock warrants are immediately exercisable or within 60 days.

shares of common stock and stock warrants to purchase 526 shares of common stock owned by the Eric Forman Revocable Trust.

the following, as to which Eric Forman disclaims beneficial ownership or control:

461,279 shares of common

stock and stock options to purchase 472,396 shares of common stock owned by the Julie Schwartzberg Trust, as to which Julie (Schwartzberg)

Forman is the trustee and beneficiary.

69,721 shares of common

stock and common stock warrants to purchase 52,632 shares of common stock owned by the Julie Forman Inherited IRA.

87,081 shares of common

stock owned by the Julie Forman 2015 Trust, an irrevocable trust, the beneficiaries of which are the minor children of Eric and Julie

Forman, as to which Scott Forman, brother of Eric Forman, as trustee, has voting, dispositive and investment control.

90,001 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 and stock options to purchase 47,240 shares of common stock owned by the Julie Schwartzberg Trust, as to which

Julie (Schwartzberg) Forman is the trustee and beneficiary.

shares of common stock owned by the Schwartzberg Trust fbo Julie Forman, dtd 3/3/23, as to which Julie Forman is the trustee.

shares of common stock and common stock warrants to purchase 5,263 shares of common stock owned by the Julie Forman Inherited IRA.

shares of common stock owned by the Julie Forman 2015 Trust, an irrevocable trust, the beneficiaries of which are the minor children

of Eric and Julie Forman, as to which Scott Forman, brother of Eric Forman, 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.

Consists of 25,000 shares of common stock.

Includes 318,415 shares of common stock and stock options to purchase 472,396 shares of common stock owned by the Julie Schwartzberg

Trust, as to which Julie (Schwartzberg) Forman is the trustee and beneficiary.

includes the following:

69,721 shares of common

stock and common stock warrants to purchase 52,632 shares of common stock owned by the Julie Forman Inherited IRA.

90,001 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.

142,864 shares of common

stock owned by the Schwartzberg Trust fbo Julie Forman, dtd 3/3/23, as to which Julie Forman is the trustee.

the following, as to which Julie Forman disclaims beneficial ownership or control:

Stock options to purchase

110,416 shares of common stock owned by Eric J.

All stock options and common stock warrants are immediately exercisable or

within 60 days.

87,081 shares of common

stock owned by the Julie Forman 2015 Trust, an irrevocable trust, the beneficiaries of which are the minor children of Eric and Julie

Forman, as to which Scott Forman, brother of Eric Forman, as trustee, has voting, dispositive and investment control.

79,710 shares of common

stock and stock warrants to purchase 5,264 shares of common stock owned by the Eric Forman Revocable Trust.

All stock options and

common stock warrants are immediately exercisable or within 60 days.

Consists of stock options to purchase 15,833 shares of common stock.

Includes 101,833 shares of common stock and 72,917 shares of common stock issuable upon conversion of 350,000 shares of Series A Convertible

4 unchanged sentences

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 385,966 shares of common stock owned by the Greenberg

Family Trust dated May 3, 1988.

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

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

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

Includes 6,300 shares of common stock and stock options to purchase 328,125 shares of common stock.

Includes 52,632 shares of common stock, stock warrants to purchase 52,632 shares of common stock and stock options to purchase 216,666

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

Consists of stock options to purchase 93,749 shares of common stock which are immediately exercisable or within 60 days.

Consists of stock options to purchase 112,500 shares of common stock which are immediately exercisable or within 60 days.

Consists of 833,333 shares of common stock.

Consists of stock options to purchase 18,333 shares of common stock.

Includes 14,166 shares of common stock owned by Glenn L.

2 unchanged sentences

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

Includes 142,864 shares of common stock owned by the Schwartzberg Trust fbo David Sterling, dtd 3/3/23, as to which David Sterling is

includes the following:

69,722 shares of common

stock and common stock warrants to purchase 52,632 shares of common stock owned by the David Sterling Inherited IRA.

263,336 shares of common

stock owned by the David N.

Sterling Trust, as to which Debbie Schwartzberg is the trustee.

Includes 630 shares of common stock and stock options to purchase 47,500 shares of common stock.

Includes 5,263 shares of common stock, stock warrants to purchase 5,263 shares of common stock and stock options to purchase 28,334 shares

of common stock.

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Related Party Transactions

the years ended December 31, 2022, 2021 and 2020, 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,

other than as disclosed below.

Kovach has been the Company’s President, Chief Executive Officer and Chief Scientific Officer since inception.

entered into an employment agreement with the Company effective October 1, 2020 that increased his annual salary from $60,000 to $250,000.

Kovach was paid $107,500 for the year ended December 31, 2020 for his services as the Company’s President, Chief Executive

Officer and Chief Scientific Officer.

Forman was appointed as the Company’s Chief Administrative Officer effective July 15, 2020.

Forman was paid $30,000 from

July 15, 2022 through December 31, 2022 for his services as the Company’s Chief Administrative Officer.

During the year ended December

31, 2020 (prior to Mr.

Forman’s appointment as Chief Administrative Officer), the Company paid the Eric Forman Law Office a total

of $38,000 for legal and consulting services rendered with respect to various corporate and administrative matters.

Miser was appointed as the Company’s Chief Medical Officer effective August 1, 2020.

Miser was paid $62,500 from August

1, 2020 through December 31, 2020 for his services as the Company’s Chief Medical Officer.

Weingarten was appointed as the Company’s Vice President and Chief Financial Officer effective August 12, 2020.

was paid $46,451 from August 12, 2020 through December 31, 2020 for his services as the Company’s Vice President and Chief Financial

During the year ended December 31, 2020 (prior to Mr.

Weingarten’s appointment as Vice President and Chief Financial Officer),

the Company paid Mr.

Weingarten 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.

the years ended December 31, 2023, 2022 and 2021, there were no transactions, either directly or indirectly, between the Company and

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

Director Independence

Company considers Dr.

Stephen Forman, Dr.

Yun Yen, Regina Brown, Dr.

René Bernards, and Bas van der Baan 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

Company considers that Dr.

Yun Yen, Regina Brown and Dr.

René Bernards are each an “independent director,” as defined

under Nasdaq rules and by Rule 10A-3 of the Exchange Act.

PRINCIPAL ACCOUNTANT FEES AND SERVICES

& Company, P.A.

8 unchanged sentences

Other Fees (4)

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

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

services that are normally provided in connection with statutory or regulatory filings, excluding those fees included in Other Fees.

Audit-related fees represent

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

and not reported above under Audit Fees.

Tax fees represent fees

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

Other fees represent fees

incurred with respect to our Registration Statements on Forms S-3 and S-8 declared effective by the SEC during the year ended December

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 Statements on Form S-3 and Form S-8.

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

4 unchanged sentences

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

List of documents filed

as part of this report:

Financial Statements

of documents filed as part of this report:

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

Financial Statement Schedules

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 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.

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

Underwriting Agreement, dated as of November 25, 2020, between the Company and WestPark Capital, Inc.

and WallachBeth, LLC, filed as Exhibit 1.1 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.

Share 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 21

Kovach and Lixte Biotechnology, Inc., filed as Exhibit 2.1 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.

Certificate of Incorporation, as filed with the Delaware Secretary of State on May 24, 2005, filed as Exhibit 3.1 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.

Certificate of Amendment of Certificate of Incorporation, filed as Appendix A to the Company’s Information Statement, as filed with the Securities and Exchange Commission on September 19, 2006 and incorporated herein by reference.

Certificate of Designations for the Company’s Series A Convertible Preferred Stock, filed as Exhibit 4.01 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.

Certificate of Amendment of Certificate of Designations of the Series A Convertible Preferred Stock, filed as Exhibit 3.4 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, as filed with the Securities and Exchange Commission on March 28, 2016 and incorporated herein by reference.

Amended and Restated Bylaws, filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on November 10, 2022 and incorporated herein by reference.

Certificate of Amendment of Certificate of Incorporation, filed as Exhibit 3.1 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.

Certificate of Amendment to the Certificate of Incorporation of Lixte Biotechnology Holdings, Inc., filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on June 6, 2023 and incorporated herein by reference.

Description of Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934, as amended, filed as Exhibit 4.1 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the Securities and Exchange Commission on March 25, 2020 and incorporated herein by reference.

Form of Public Warrant included in Unit, filed as Exhibit 4.2 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.

Form of Common Stock Purchase Warrant, filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 20, 2023 and incorporated herein by reference.

Form of Placement Agent Warrant, filed as Exhibit 4.3 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 20, 2023 and incorporated herein by reference.

Master Agreement between Lixte Biotechnology Holdings, Inc.

and Theradex Systems, Inc.

dated January 12, 2010 4

dated January 12, 2010, filed as Exhibit 10.15 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, as filed with the Securities and Exchange Commission on March 15, 2013 and incorporated herein by reference.

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

and the National Institute of Neurological Disorders and Stroke dated October 18, 2013, filed as Exhibit 10.16 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013, as filed with the Securities and Exchange Commission on March 21, 2014 and incorporated herein by reference.

Scientific Advisory Board Agreement between Lixte Biotechnology Holdings, Inc.

and NDA Consulting Corp.

dated December 24, 2013 5

dated December 24, 2013, filed as Exhibit 10.17 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013, as filed with the Securities and Exchange Commission on March 21, 2014 and incorporated herein by reference.

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

Clinical Trial Research 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 9

Exclusive 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) 9

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) 10

and BioPharmaWorks LLC effective September 14, 2015, filed as Exhibit 10.01 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.

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), filed as Exhibit 10.1 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.

Employment Agreement Between the Company and Dr.

James Miser 13+

James Miser, filed as Exhibit 10.03 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.+

Employment Agreement Between the Company and Robert N.

Weingarten 17+

Employment Agreement Between the Company and Dr.

John Kovach 14+

Employment Agreement Between the Company and Eric Forman 15+

Second Amendment to Employment Agreement Between the Company and Eric Forman*+

2020 Stock Incentive Plan 16+

Master 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 18

Amendment to Employment Agreement between the Company and Eric Forman 22+

Development 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).

Insider Trading Policy*

Subsidiaries of the Registrant*

Weingarten, filed as Exhibit 10.02 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.+

Employment Agreement Between the Company and Eric Forman, filed as Exhibit 10.02 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.+

Amendment to Employment Agreement between the Company and Eric Forman, filed as Exhibit 10.21 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the Securities and Exchange Commission on March 26, 2021.+

Second Amendment to Employment Agreement between the Company and Eric Forman, filed as Exhibit 10.15 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the Securities and Exchange Commission on March 29, 2023 and incorporated herein by reference.+

Lixte Technology Holdings, Inc.

2020 Stock Incentive Plan, filed as Exhibit 10.1 to the Company Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 17, 2020 and incorporated herein by reference.+

Lixte Biotechnology Holdings, Inc.

2020 Stock Incentive Plan (as amended), filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on November 28, 2023 and incorporated herein by reference.+

Investigator-Initiated Clinical Research Support Agreement between City of Hope National Medical Center and City of Hope Medical Foundation and Lixte Biotechnology Holdings, Inc., filed as Exhibit 10.1 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.

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), filed as Exhibit

10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, as filed with the Securities and Exchange Commission on November 10,

2021 and incorporated herein by reference.

Insider Trading Policy, filed as Exhibit 10.21 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the Securities and Exchange Commission on March 29, 2023 and incorporated herein by reference.

Compensation Clawback Policy+*

to Contract between Lixte Biotechnology Holdings, Inc.

and MRI Global effective April 17, 2022, filed as Exhibit 10.1 to the

Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, as filed with the Securities and Exchange Commission on May 10, 2023 and

incorporated herein by reference.

Securities Purchase Agreement, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 20, 2023 and incorporated herein by reference.

Employment Agreement between the Company and Bastiaan van der Baan effective September 26, 2023, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on September 27, 2023 and incorporated herein by reference.

1 to Development Collaboration Agreement by and between Lixte Biotechnology Holdings, Inc.

and the Netherlands Cancer Institute,

Amsterdam, and the Oncode Institute, Utrecht, entered into on October 8, 2021, filed as Exhibit 10.3 to the Company’s

Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, as filed with the Securities and Exchange Commission on November 9, 2023 and incorporated herein by

Amendment No.

2 to Development Collaboration Agreement by and between Lixte Biotechnology Holdings, Inc.

and the Netherlands Cancer Institute, Amsterdam, and the Oncode Institute, Utrecht, entered into on October 13, 2023 (certain portions of this Exhibit have been omitted), filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on October 17, 2023 and incorporated herein by reference.

letter between H.

Lee Moffitt Cancer Center and Research Institute, Inc.

and the Company dated October 4, 2023 and effective as of

September 30, 2023, filed as Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, as filed with the Securities and

Exchange Commission on November 9, 2023 and incorporated herein by reference.

Exclusive Patent License Agreement between Lixte Biotechnology, Inc.

and the National Institute of Neurological Disorders and Stroke and the National Cancer Institute, each a component of the National Institute of Health, effective as of February 23, 2024, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on February 26, 2024 and incorporated herein by reference.

Subsidiaries of the Registrant, filed as Exhibit 21.1 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the Securities and Exchange Commission on March 29, 2023 and incorporated herein by reference.

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

3 unchanged sentences

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

Inline XBRL Instance Document

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

Inline XBRL Taxonomy Extension

Scheme Document

Inline XBRL Taxonomy Extension

Calculation Linkbase Document

Inline XBRL Taxonomy Extension

Label Linkbase Document

Inline XBRL Taxonomy Extension

Presentation Linkbase Document

Inline XBRL Taxonomy Extension

Definition Linkbase Document

Cover Page Interactive

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

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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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.

Filed 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 Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 26,

2021 and incorporated herein by reference.

Filed 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.

Filed herewith.

Indicates a management

contract or any compensatory plan, contract or arrangement.

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)

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

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

2 unchanged sentences

BIOTECHNOLOGY HOLDINGS, INC.

President and Chief Executive Officer

BASTIAAN VAN DER BAAN

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.

President and Chief Executive Officer

March 29, 2023

Vice President and Chief Financial Officer

March 29, 2023

Bas van der Baan

March 29, 2023

René Bernards

March 29, 2023

BASTIAAN VAN DER BAAN

and Chief Executive Officer

President and Chief Financial Officer

RENE BERNARDS

BIOTECHNOLOGY HOLDINGS, INC.

15 unchanged sentences

as of December 31, 2023 and 2022, 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 financial position of the Company as of

December 31, 2022 and 2021, and the results of its operations and its 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.

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

In our opinion, the

financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022,

and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted

in the United States of America.

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

As discussed in Note

1 to the financial statements, the Company has no recurring source of revenue and has experienced negative operating cash flows since

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

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

Management’s plans in regard

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

These consolidated financial statements do not

include any adjustments that might result from the outcome of this uncertainty.

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

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.

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 financial statements.

These financial statements do not include any adjustments that might

result from the outcome of this uncertainty.

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

Our responsibility is to express an opinion on the Company’s

financial statements based on our audits.

We are a public accounting firm registered with the Public Company Accounting Oversight Board

(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.

securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

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

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

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

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

4 unchanged sentences

Accordingly, we express no such opinion.

audits included performing procedures to assess the risks of material misstatement of the consolidated 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 consolidated financial statements.

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

Audit Matter Description

critical audit matter communicated below is a matter arising from the current period audit of the consolidated 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 matter below, providing a separate opinion on the critical audit matters or on the accounts or disclosures to which

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.

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 our especially challenging, subjective, or complex judgments.

The communication of the critical audit matter

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

matter below, providing a separate opinion on the critical audit matters or on the accounts or disclosures to which it relates.

of Stock-Based Compensation

discussed in Note 6 to the consolidated financial statements, the Company recognized $1,546,040 of compensation expense to certain officers,

employees and consultants related to stock-based awards.

The Company accounts for stock-based compensation for all stock-based awards

made to officers, employees and consultants based on estimated fair values.

discussed in Note 6 to the financial statements, the Company recognized $773,203 of compensation expense to certain officers, employees

and consultants related to stock-based awards.

The Company accounts for stock-based compensation for all stock-based awards made to officers,

employees and consultants based on estimated fair values.

identified the valuation of stock-based compensation as a critical audit matter because of the subjectivity of the inputs and assumptions

5 unchanged sentences

interest rate, volatility, and dividend yield, consisted of the following, among others:

obtained and read the stock-based award agreements, evaluated the reasonableness of management’s significant valuation assumptions,

and tested the mathematical accuracy of managements valuation analyses.

obtained and read the stock-based award agreements

evaluated the reasonableness of management’s significant valuation assumptions, and tested the mathematical accuracy of management’s

valuation analyses.

developed independent estimates for the fair values of the stock-based awards.

7 unchanged sentences

Prepaid insurance

Other prepaid expenses and current assets

Other prepaid expenses

Total current assets

34 unchanged sentences

Interest expense

Foreign currency loss

Foreign currency gain (loss)

$ ( 5,087,029 )

6 unchanged sentences

Ended December 31, 2023 and 2022

Series A Convertible

Preferred Stock

Additional Paid-in

Total Stockholders’

A Convertible

Stockholders’

Balance, December 31, 2021

$ ( 37,082,164 )

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

Exercise of warrants

Exercise of options

Stock-based compensation expense

Proceeds from sale of securities in registered direct equity offering, net of offering costs

Stock-based compensation

( 6,312,535 )

2 unchanged sentences

( 43,394,699 )

Balance, value

( 43,394,699 )

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

Stock-based compensation expense

Proceeds from sale of securities in registered direct equity offering, net of offering costs

Exercise of pre-funded common stock warrants

Exercise of common stock options

Stock-based compensation

( 5,087,029 )

2 unchanged sentences

$ ( 48,481,728 )

Balance, value

$ ( 48,481,728 )

14 unchanged sentences

Prepaid insurance

Other prepaid expenses and current assets

Increase in -

Other prepaid expenses

Increase (decrease) in -

Accounts payable and accrued expenses

4 unchanged sentences

Cash flows from financing activities:

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

Exercise of common stock warrants

Proceeds from sale of securities in registered direct offering, net of offering costs

Exercise of pre-funded common stock warrants

Exercise of common stock options

Payment of costs incurred in connection with sale of common stock units in November 2020

Net cash provided by financing activities

Net increase (decrease)

( 1,149,904 )

Balance at beginning of period

9 unchanged sentences

(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 corporate office is located in Pasadena,

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.

The Company believes that inhibitors of protein phosphatases have broad therapeutic

potential not only for cancer but also for other debilitating and life-threatening diseases.

The Company is directing its efforts on

clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer

activity at doses that produce little or no toxicity.

the “Company”), is a clinical-stage biopharmaceutical company dedicated to improving patients’ lives by developing

a drug class called Protein Phosphatase 2A inhibitors.

The Company’s corporate office is located in Pasadena, California.

Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A, used in combination with cytotoxic agents

and/or x-ray, immune checkpoint blockers and other cancer therapies.

The Company believes that inhibitors of protein phosphatases have

significant therapeutic potential for a broad range of cancers.

The Company is focusing on the clinical development of a specific protein

phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity at doses that produce little

or no toxicity.

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

2 unchanged sentences

operating requirements.

Notification of Failure to Satisfy a Continued Listing Rule

Company’s common stock and the warrants are traded on The Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”,

respectively.

June 24, 2022, the Company received a written notice (the “Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”)

that the Company had not been in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for a

period of 30 consecutive business days.

Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum closing bid price

of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists

if the deficiency continues for a period of 30 consecutive business days.

The Notice had no immediate effect on the listing of the Company’s

common stock on The Nasdaq Capital Market.

accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided a compliance period of 180 calendar days from the date of

the Notice, or until December 21, 2022, to regain compliance with the minimum closing bid price requirement.

On December 22, 2022, the

Company received a written notice from Nasdaq that the Company was eligible for a second 180 calendar day compliance period, or until

June 19, 2023, in order to regain compliance with the $1.00 minimum bid price requirement.

Nasdaq’s determination to grant the

second compliance period was based on the Company meeting the continued listing requirement for market value of publicly held shares

and all other applicable requirements for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price requirement,

and the Company’s written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse

stock split, if necessary.

Company can generally achieve compliance with the minimum closing bid price requirement if the minimum closing bid price per share of

the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days during the 180-day compliance period.

However, under certain circumstances, Nasdaq can extend this 10-day trading period to a maximum of 20 days.

The Company anticipates that

its shares of common stock and warrants will continue to be listed and traded on The Nasdaq Capital Market during the compliance period

ending June 19, 2023.

order to achieve compliance with the minimum closing bid price per share requirement, the Company intends to file a proxy statement to

hold a special meeting of stockholders to seek approval to effect a reverse stock split of its issued and outstanding shares of common

However, there can be no assurance that the Company will be successful in this regard and will be able to regain compliance with

the minimum closing bid price requirement by June 19, 2023, in which case the Company anticipates Nasdaq would provide a notice to the

Company that its shares of common stock and warrants are subject to delisting, and the Company’s common shares and warrants would

then be delisted.

December 31, 2022, the Company had cash of $ 5,353,392 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 technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and

maintain positive earnings and operating cash flows.

and Chief Executive Officer

September 26, 2023, Bas van der Baan, a director of the Company since June 17, 2022, replaced the Company’s founder, Dr.

Kovach, as President and Chief Executive Officer.

Kovach passed away on October 5, 2023.

Effective October 6, 2023, Mr.

was appointed as Chairman of the Board of Directors.

Kovach was also the Company’s Chief Scientific Officer.

Listing and Reverse Stock Split

Company’s common stock and the warrants are traded on the Nasdaq Capital Market (“Nasdaq”) under the symbols “LIXT”

and “LIXTW”, respectively.

June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock in order to remain in compliance

with the $1.00 minimum closing bid price requirement of Nasdaq.

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 next whole share.

All share and per share amounts

and information presented herein have been retroactively adjusted to reflect the reverse stock split for all periods presented.

there can be no assurances that the Company will be able to remain in compliance with the $1.00 minimum closing bid price requirement

of Nasdaq over time, or that it will be successful in maintaining compliance with any of the other continued listing requirements of

the year ended December 31, 2023, the Company recorded a net loss of $ 5,087,029 and used cash in operations of $ 4,293,265 .

31, 2023, the Company had cash of $ 4,203,488 available to fund its operations.

Because the Company is currently engaged in various early-stage

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 technology,

product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and maintain positive

earnings and operating cash flows.

At December 31, 2023, the Company’s remaining financial contractual commitments pursuant to

clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $ 6,344,000 (see Note 8),

which are currently scheduled to be incurred through approximately December 31, 2027.

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

4 unchanged sentences

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

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

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

In addition, our independent registered public

accounting firm has included an explanatory paragraph in their report with respect to this uncertainty that accompanies our audited consolidated

financial statements as of and for the year ended December 31, 2023.

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

3 unchanged sentences

availability of operating capital to fund such activities.

on current operating plans, the Company estimates that existing cash resources will provide sufficient working capital to fund the current

clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately

December 31, 2023.

However, existing cash resources will not be sufficient to complete the development of and obtain regulatory approval

for the Company’s product candidate, as a result of which the Company will need to raise significant additional capital to do so.

The Company estimates that it will need to raise additional capital to fund its operations, including its various clinical trial commitments,

during the latter part of the fiscal year ending December 31, 2023.

In addition, the Company’s operating plans may change as a

result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner

than planned.

on current operating plans, the Company estimates that its existing cash resources at December 31, 2023 will provide sufficient working

capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound

LB-100 through approximately September 30, 2024.

However, existing cash resources will not be sufficient to complete the development

of and obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional

The Company estimates that it will need to raise additional capital to fund its operations by mid-2024 to be able to proactively

manage its current business plan during the remainder of 2024 and during 2025.

In addition, the Company’s operating plans may change

as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed

sooner than planned.

The Company is considering various strategies and alternatives to obtain the required additional capital.

market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the

4 unchanged sentences

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 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.

Reclassifications

comparative amounts in 2022 have been reclassified to conform to the current year’s presentation.

Such reclassifications, individually

and in the aggregate, were not material to the results of operations or financial condition of the Company.

Summary of Significant Accounting Policies

of Consolidation

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 Lixte Biotechnology Holdings, Inc.

and its wholly-owned

subsidiary, Lixte Biotechnology, Inc..

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 Lixte Biotechnology Holdings, Inc.

and its wholly-owned subsidiary, Lixte

Biotechnology, Inc.

Intercompany balances and transactions have been eliminated in consolidation.

2 unchanged sentences

The Company’s operating segment is reported

in a manner consistent with the internal reporting provided to the Chief Operating Decision Maker, which is the Company’s President,

Chief Executive Officer and Chief Scientific Officer.

in a manner consistent with the internal reporting provided to the Company’s Chief Operating Decision Maker, which is the Company’s

President and Chief Executive Officer.

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

11 unchanged sentences

Significant estimates include those related to assumptions

used in the calculation of accruals for clinical trial costs and other potential liabilities, valuing equity instruments issued for services,

and the realization of deferred tax assets.

used in the calculation of accruals for clinical trial costs and other potential liabilities, and valuing equity instruments issued for

is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC

2 unchanged sentences

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 periodically has cash

balances in financial institutions in excess of the FDIC and SIPC insurance limits of $ 250,000 and $ 500,000 , respectively.

Morgan Stanley

Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers.

The Company has not experienced

any losses to date resulting from this policy.

balances with financial institutions in the United States 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 periodically

has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $ 250,000 and $ 500,000 , respectively.

Stanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers.

The Company has not

experienced any losses to date resulting from this policy.

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 clinical compound and product candidate.

Research and development

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

The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States and in the European Union

in accordance with the laws and regulations of such jurisdictions.

and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation,

design, development, and management of clinical trials with respect to the Company’s clinical compound and product candidate.

and development costs also include the costs to manufacture compounds used in research and clinical trials, which are charged to operations

The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States and in the

European Union in accordance with the laws and regulations of such jurisdictions.

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

27 unchanged sentences

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

to the significant uncertainty associated with the successful development of 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

7 unchanged sentences

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, 2022

and 2021 are described as follows.

and administrative costs for the years ended December 31, 2022 and 2021 included charges from legal firms and other vendors for general

for these services can be for a specific 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, 2023 and

2022 are described as follows.

and administrative costs for the years ended December 31, 2023 and 2022 include charges from legal firms and other vendors for general

licensing and patent prosecution costs relating to the Company’s intellectual properties representing 23.3 % and 25.6 % of total

3 unchanged sentences

of total general and administrative costs.

and development costs for the year ended December 30, 2022 included charges from four vendors and consultants representing 21.0 %, 19.3 %,

and development costs for the year ended December 31, 2023 include charges from three vendors and consultants representing 29.9 %, 25.2 %

and 13.7 %, respectively, of total research and development costs.

Research and development costs for the year ended December 31, 2022

2021 included charges from three vendors and consultants representing 30.3 %, 21.8 % and 14.4 %, respectively.

include charges from four vendors and consultants representing 21.0 % , 19.3 % , 15.1 % and 12.1 % , respectively, of total research and development

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

11 unchanged sentences

the Company currently operates or has operated in the past.

The Company had no unrecognized tax benefits as of December 31, 2022 or 2021

The Company had no unrecognized tax benefits as of December 31, 2023 and

2022 and does not anticipate any material amount of unrecognized tax benefits through December 31, 2024.

12 unchanged sentences

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.

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.

Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid

cash for the services.

fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is

15 unchanged sentences

satisfy stock option exercises.

Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s

specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities

from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”).

The assessment considers whether the

warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether

the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the

Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance

outside of the Company’s control, among other conditions for equity classification.

The Company has determined that the warrants

issued in the July 20, 2023 equity financing (see Note 4) meet the requirements for equity classification.

This assessment, which requires

the use of professional judgment, is conducted when the warrants are issued and at the end each subsequent quarterly period while the

warrants are outstanding.

For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required

to be recorded as a component of additional paid-in capital at the time of issuance.

For issued or modified warrants that do not meet

all of the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair

value on the date of issuance and remeasured at fair value at each balance sheet date thereafter.

Changes in the estimated fair value

of the warrants are recognized as a non-cash gain or loss on the statements of operations.

(Loss) Per Share

11 unchanged sentences

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

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

Series A Convertible Preferred Stock

1 unchanged sentence

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

Anti-dilutive securities

Currency Translation

consolidated financial statements are presented in the United States dollar, which is the functional and reporting currency of the Company.

Company periodically incurs a cost or expense in a foreign jurisdiction denominated in a local currency.

The Company purchases the required

foreign currency to pay such cost or expense on an as-needed basis.

Such cost or expense is converted into United States dollars for

financial statement purposes based on the foreign currency conversion rate in effect on the transaction date.

The Company purchases the

requisite foreign currency to pay such cost or expense on an as-needed basis.

Any gain or loss resulting from the purchase of the foreign

currency is included as foreign currency gain (loss) in the consolidated statement of operations.

During the years ended December 31,

2023 and 2022, the Company incurred various costs and expenses denominated in Euros, which were converted into United States dollars

at the average rate of 1.0824 and 1.0538 , respectively.

As of December 31, 2023 and 2022, the Company did not hold any currencies other

than the United States dollar in its bank accounts, and was not a party to any foreign currency forward or exchange contracts.

Value of Financial Instruments

23 unchanged sentences

Accounting Pronouncements

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

May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 815-40):

Issuer’s Accounting

for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“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 was

effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.

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

The Company adopted ASU 2021-04 effective January 1, 2022.

The adoption of ASU 2021-04 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.

consolidated financial statements, including their presentation and related disclosures.

July 2023, the FASB issued ASU 2023-03, Presentation of Financial Statements (Topic 205), Income Statement — Reporting Comprehensive

Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation — Stock Compensation

(Topic 718) Presentation of Financial Statements (“ASU 2023-03”).

ASU 2023-03 amends the FASB Accounting Standards Codification

to include Amendments to SEC Paragraphs pursuant to SEC Staff Accounting Bulletin No.

120, SEC Staff Announcement at the March 24, 2022

EITF Meeting, and SEC Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280 — General Revision of Regulation S-X:

Income or Loss Applicable to Common Stock.

As ASU 2023-03 did not provide any new guidance, there was no transition or effective date

associated with its adoption.

Accordingly, the Company adopted ASU 2023-03 immediately upon its issuance.

The adoption of ASU 2023-03

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.

The Company adopted ASU 2021-04 effective January 1, 2022.

The adoption of ASU 2021-04 did not have any

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

did not have any impact on the Company’s consolidated financial statements, including their presentation and related 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.

impact on the Company’s financial statements, including their presentation and related disclosures.

Research and Development Costs

and development costs, including costs associated with clinical trials involving the Company’s lead clinical compound LB-100, are

summarized below based on the respective geographical regions where such costs are incurred.

summary of research and development costs for the years ended December 31, 2023 and 2022, including costs associated with clinical trials

involving the Company’s lead clinical compound LB-100, are summarized below based on the respective geographical regions where

such costs have been incurred.

of Research and Development Costs

Ended December 31,

United States

and development costs

Stockholders’ Equity

17 unchanged sentences

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, 2022 and 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.

Stock does not have any cash liquidation preference rights or any registration rights.

If fully converted, the 350,000 outstanding shares

of Series A Convertible Preferred Stock would convert into 72,917 shares of common stock at December 31, 2023 and 2022.

on the attributes of the Series A Convertible Preferred Stock as previously described, the Company has accounted for the Series A Convertible

2 unchanged sentences

As of December 31, 2023 and

2021, the Company had 16,646,593 shares and 13,746,593 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.

Additionally, on December

7, 2020, the Company sold an additional 180,000 warrants for $ 1,800 as part of the overallotment option granted to the underwriters of

the public offering.

The warrants sold represented the right to purchase one share of common stock and are exercisable for a period of

five years 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 issued warrants to the underwriters of the public offering

to purchase 120,000 shares of common stock exercisable at $ 5.70 per share through November 24, 2025.

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 proceeds

of $ 3,689,761 .

Pursuant to the placement agents’ agreement, the Company granted warrants to the placement agents to purchase 113,310

shares of common stock at an exercise price of $ 3.70 per share exercisable through March 2, 2026.

February and March 2021, the Company issued 3,000 shares of common stock upon the exercise of warrants for 3,000 shares exercisable at

$ 5.70 per share for total cash proceeds of $ 17,100 .

April 22, 2021, the Company issued 125,001 shares of common stock upon the exercise of various stock options for total cash proceeds

of $ 101,000 as follows:

options held by an officer and two directors of the Company for 75,000 shares exercisable at $ 0.72 per share,

options for 16,667 shares exercisable at $ 0.90 per share, and options for 33,334 shares exercisable at $ 0.96 per share.

July 14, 2021, the Company issued 83,333 shares of common stock upon the exercise of a stock option held by a consultant to the Company

for 83,333 shares at $ 1.20 per share for total cash proceeds of $ 100,000 .

2022, the Company had 2,249,290 shares and 1,664,706 shares, respectively, of common stock issued and outstanding.

June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock.

authorized number of shares of common stock and the par value per share were not affected by the reverse stock split.

No fractional shares

were issued in connection with the reverse stock split, as all fractional shares were rounded up to the next 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.

March 10, 2023, the Company issued 1,250 shares of common stock upon the exercise of a stock option in the form of a warrant held by

a consultant to the Company for 1,250 shares exercisable at $ 5.025 per share for total cash proceeds of $ 6,281 .

12, 2022 Sale of Common Stock

April 12, 2022, the Company completed the sale of 290,000 shares of common stock at a price of $ 20.00 per share in a registered direct

equity offering, generating gross proceeds of $ 5,800,000 .

The total cash costs of this offering were $ 658,616 , resulting in net proceeds

of $ 5,141,384 .

offering, generating gross proceeds of $ 5,800,000 .

The total cash costs of this offering were $ 658,616 , resulting in net proceeds of

$ 5,141,384 .

Pursuant to the placement agents’ agreement, the Company granted warrants to the placement agents to purchase 29,000

shares of common stock at an exercise price of $ 20.00 per share exercisable through April 14, 2027.

20, 2023 Sale of Common Stock and Warrants

July 20, 2023, the Company sold 180,000 shares of common stock at a price of $ 6.00 per share and pre-funded warrants to purchase 403,334

shares of common stock at a price of $ 5.9999 per pre-funded warrant to an institutional investor in a registered direct offering.

pre-funded warrants had an exercise price of $ 0.0001 per share, were immediately exercisable upon issuance, and were valid and exercisable

until all pre-funded warrants were exercised in full.

the period from July 24, 2023 through August 7, 2023, the 403,334 pre-funded warrants, exercisable at $ 0.0001 per common share, were

exercised for total cash proceeds of $ 41 , resulting in the issuance of 403,334 shares of common stock.

The pre-funded warrants were determined

to be common stock equivalents.

a concurrent private placement to the institutional investor, the Company also sold warrants to purchase 583,334 shares of common stock.

Each common warrant had an initial exercise price of $ 6.00 per share, was immediately exercisable upon issuance, and expires five years

thereafter on July 20, 2028 .

The common warrants and the shares of common stock issuable upon exercise of the common warrants were not

registered under the Securities Act of 1933, as amended (the “Securities Act”) and were offered pursuant to the exemption

provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

The shares of common stock issuable upon

exercise of the warrants were subsequently registered for resale on a registration statement on Form S-3 declared effective by the SEC

on August 21, 2023.

registered direct offering and the concurrent private placement generated gross proceeds of $ 3,499,964 .

The total cash costs of the registered

direct offering and the private placement were $ 362,925 , resulting in net proceeds of $ 3,137,039 .

Pursuant to the placement agent agreement,

the Company granted the placement agent warrants to purchase 35,000 shares of common stock at an exercise price of $ 6.60 per share and

expiring on July 20, 2028 .

exercise prices of the warrants issued to the institutional investor (exercisable at $ 6.00 per share) and to the placement agent (exercisable

at $ 6.60 per share) are subject to customary adjustments for stock splits, stock dividends, stock combinations, reclassifications, reorganizations,

or similar events affecting the Company’s common stock.

In addition, the warrants issued to the institutional investor contain

a “fundamental transaction” provision whereby in the event of a fundamental transaction (a sale or transfer of assets or

ownership of the Company as defined in the warrant agreement) within the Company’s control, the holder of the unexercised common

stock warrants would be entitled to receive, in exchange for extinguishment of such warrants, cash consideration equal to a Black-Scholes

valuation, as defined in the warrant agreement.

If such fundamental transaction is not within the Company’s control, the warrant

holder would only be entitled to receive the same form of consideration (and in the same proportion) as the holders of the Company’s

common stock, hence these warrants are classified as a component of permanent equity.

The Company will account for any such cash payment

for a warrant redemption as a distribution from stockholders’ equity, as and when such cash payment is made.

Stock Warrants

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

November 2020 public offering of its securities, during the years ended December 31, 2022 and 2021 is presented below.

public offering, during the years ended December 31, 2023 and 2022 is presented below.

Schedule of Warrants Outstanding

6 unchanged sentences

Warrants outstanding at December 31, 2022

( 1,500,000 )

Warrants outstanding at December 31, 2023

3 unchanged sentences

Schedule of Warrants Outstanding and Exercisable

Outstanding (Shares)

warrants exercisable at $ 57.00 per share at December 31, 2023 consist of 1,497,000 publicly-traded warrants pre-split 1-for-10 that were

issued as part of the Company’s November 2020 public offering of units and are exercisable for a period of five years thereafter.

As a result of the 1-for-10 reverse split of the Company’s common stock effective June 2, 2023, each such publicly-traded warrant

currently represents the right to purchase 1/10th of a share of common stock at the original exercise price of $ 5.70 per share.

upon exercise, 10 warrants, each exercisable at $ 5.70 , will be required to acquire one share of post-split common stock, which is equivalent

to a purchase price of $ 57.00 .

on a fair market value of $ 2.35 per share on December 31, 2023, there was no intrinsic value attributed to exercisable but unexercised

4 unchanged sentences

Agreements with Officers

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

July and August 2020, the Company entered into one-year employment agreements with each of its executive officers at that time, consisting

Kovach, Eric J.

1 unchanged sentence

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 additional one-year periods in July and August 2021 and 2022.

These employment

agreements were 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 additional one-year periods in July and August 2021, 2022 and 2023.

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, 2022 and 2021, the Company paid $ 250,000 and $ 250,000 , respectively, to Dr.

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

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

During the years ended December 31, 2023 and 2022, the Company paid $ 190,860 and $ 250,000 , respectively, to Dr.

Kovach under this employment

agreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operations

for such periods.

The employment agreement with Dr.

Kovach terminated upon his death on October 5, 2023.

Company entered into an employment agreement with Dr.

7 unchanged sentences

Miser under this employment agreement, which costs are

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

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.

1 unchanged sentence

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

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

former member of the Company’s Board of Directors who died on October 30, 2022 and a significant stockholder of and consultant

Forman is the son-in-law of Gil Schwartzberg (deceased),

a former member of the Company’s Board of Directors who died on October 30, 2022 and was a significant stockholder of and consultant

to the Company, and is the son of Dr.

8 unchanged sentences

Operating Officer with an annual salary of $ 200,000 .

During the years ended December 31, 2022 and 2021, the Company paid $ 178,819 and

$ 156,667 , respectively, to Mr.

Forman under this employment agreement, which costs are included in general and administrative costs in

the Company’s consolidated statements of operations.

Effective October 1, 2022, Mr.

Forman has been provided a monthly office rent allowance,

pursuant to which the Company paid $ 15,571 and $ 937 , respectively, on Mr.

Forman’s behalf for the years ended December 31, 2023

During the years ended December 31, 2023 and 2022, the Company paid $ 200,000 and $ 178,819 , respectively, to Mr.

this employment agreement, which costs are 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.

6 unchanged sentences

under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated statements

of operations.

of operations for such periods.

Company entered into an employment agreement with Bastiaan van der Baan effective September 26, 2023 to act as the Company’s President

and Chief Executive Officer and as Vice Chairman of the Board of Directors, with an annual salary of $ 150,000 .

Effective October 6, 2023,

van der Baan was appointed as Chairman of the Board of Directors upon the death of Dr.

Kovach on October 5, 2023.

van der Baan’s

annual salary may be increased from time to time at the sole discretion of the Board of Directors.

In addition, Mr.

van der Baan will

be eligible to receive an annual bonus as determined at the sole discretion of the Board of Directors.

The term of the employment agreement

is for three years and is automatically renewable for additional one-year periods unless terminated by either party, subject to early

termination provisions as described in the employment agreement.

During the year ended December 31, 2023, the Company paid $ 40,639 to

van der Baan under this employment agreement, which costs are included in general and administrative costs in the Company’s

consolidated statements of operations for such period.

René Bernards to the Board of Directors

3 unchanged sentences

new director, in lieu of a grant of stock options, Dr.

Bernards received a one-time cash board fee of $ 100,000 , payable immediately,

and an annual cash board fee of $ 40,000 , payable quarterly.

October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, 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, as described at Note 8.

Bernards received a one-time cash board fee of $ 100,000 , which was paid upon his

appointment to the Board of Directors, and an annual cash board fee of $ 40,000 , payable quarterly.

During the years ended December 31,

2023 and 2022, the Company recorded charges to general and administrative costs in the consolidated statement of operations of $ 62,500

and $ 133,873 , respectively, with respect to his cash board compensation.

on October 8, 2021, the Company had entered into a Development Collaboration Agreement (subsequently amended and extended) with the Netherlands

Cancer Institute, Amsterdam, 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 (see Note

Arrangements for Members of the Board of Directors

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

Board of Directors and committee members.

April 9, 2021, the Board of Directors approved a comprehensive cash and equity compensation program for the non-officer directors for

their services on the Board of Directors.

Effective May 25, 2022, the Board of Directors approved an amendment to the program.

who also serve on the Board of Directors are not compensated separately for their service on the Board of Directors.

compensation for independent directors, payable quarterly, is as follows:

compensation for directors, payable quarterly, is as follows:

director compensation - $ 20,000 per year

3 unchanged sentences

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

compensation for independent directors is as follows:

of new independent directors - The Company will grant options to purchase 250,000 shares of common stock, exercisable for a period of

five years, at the closing market price on the date of grant, vesting 50 % on the grant date and the remaining 50 % vesting 12.5 % on the

last day of each calendar quarter beginning in the quarter immediately subsequent to the date of the grant until fully vested, subject

compensation for directors is as follows:

of new directors – The Company grants options to purchase 25,000 shares of common stock, exercisable for a period of five years ,

at the closing market price on the date of grant, vesting 50% on the grant date and the remaining 50% vesting 12.5% on the last day of

each calendar quarter beginning in the quarter immediately subsequent to the date of the grant until fully vested, subject to continued

At the discretion of the Board of Directors, for a nominee to the Board of Directors who is restricted by their respective institution

or employer from receiving equity-based compensation, in lieu of the grant of such stock options, the Company may elect to pay a one-time

cash fee of $ 100,000 to such director, payable upfront.

grant of options to directors – Effective on the last business day of the month of June, the Company grants options to purchase

10,000 shares of common stock, exercisable for a period of five years , at the closing market price on the date of grant, vesting 12.5%

on the last day of each calendar quarter beginning in the quarter immediately subsequent to the date of grant until fully vested, subject

to continued service.

At the discretion of the Board of Directors, for a nominee to the Board of Directors who is restricted by their

respective institution or employer from receiving equity-based compensation, in lieu of the grant of such stock options, the Company

may elect to pay a one-time cash fee of $ 100,000 to such director, payable upfront.

grant of options to independent directors - Effective on the last business day of the month of June, the Company will grant options to

purchase 100,000 shares of common stock, exercisable for a period of five years, at the closing market price on the date of grant, vesting

12.5 % on the last day of each calendar quarter beginning in the quarter immediately subsequent to the date of grant until fully vested,

subject to continued service.

If any director has served for less than 12 full calendar months at the grant date, the amount of such

stock option grant shall be prorated based on the length of service of such director.

At the discretion of the Board of Directors, for

a nominee to the Board of Directors who is restricted by their respective institution or employer from receiving equity-based compensation,

in lieu of the grant of such stock options, the Company may elect to pay an annual cash fee of $ 40,000 to such director, payable quarterly.

cash compensation paid to independent directors was $ 266,020 and $ 92,833 , respectively, for the years ended December 31, 2022 and 2021.

If any director has served for less than 12 full calendar months on the grant date, the amount of such stock option

grant is prorated based on the length of service of such director .

At the discretion of the Board of Directors, for a nominee to the

Board of Directors who is restricted by their respective institution or employer from receiving equity-based compensation, in lieu of

the grant of such stock options, the Company may elect to pay an annual cash fee of $ 40,000 to such director, payable quarterly.

cash compensation paid to non-officer directors was $ 163,479 and $ 266,020 , respectively, for the years ended December 31, 2023 and 2022.

compensation granted to members of the Company’s Board of Directors, officers and affiliates is described at Note 6.

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, 2022 and 2021 is as follows:

for their services on the Board of Directors, for the years ended December 31, 2023 and 2022, is presented below.

Summary of Related Party Costs

Related party costs:

Related party costs

Stock-Based Compensation

8 unchanged sentences

On October 7, 2022, the stockholders of the Company approved

an amendment to the 2020 Plan to increase the number of common shares issuable thereunder by 1,800,000 shares, to a total of 4,133,333

of December 31, 2022, unexpired stock options for 2,603,125 shares were issued and outstanding under the 2020 Plan and 1,530,208 shares

were available for issuance under the 2020 Plan.

an amendment to the 2020 Plan to increase the number of common shares issuable thereunder by 180,000 shares, to a total of 413,333 shares.

On November 27, 2023, the stockholders of the Company approved an amendment to the 2020 Plan to increase the number of common shares

issuable thereunder by 336,667 shares, to a total of 750,000 shares.

of December 31, 2023, unexpired stock options for 495,000 shares were issued and outstanding under the 2020 Plan and 255,000 shares were

available for issuance under the 2020 Plan.

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

12 unchanged sentences

stock options requiring an assessment of value during the year ended December 31, 2023, the fair value of each stock option award was

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

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

Schedule of Fair Value of Each Option Award Estimated Assumption

Risk-free interest rate

3.03 % to 3.63 %

Expected dividend yield

Expected volatility

128.03 % to 153.17 %

Expected life

3.5 to 5 years

stock options requiring an assessment of value during the year ended December 31, 2022, the fair value of each stock option award was

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

stock options requiring an assessment of value during the year ended December 31, 2022, the fair value of each stock option award was

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

Risk-free interest rate

3.03 % to 3.63 %

Expected dividend yield

9 unchanged sentences

The options vested 25% on August 12, 2020, 2021 and 2022, respectively,

with the final 25% vesting on August 12, 2023, subject to continued service.

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

portion of 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.

the years ended December 31, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement

of operations of $ 100,213 and $ 100,213 , respectively, with respect to these stock options .

with the final 25% vesting on August 12, 2023 .

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

model, was determined to be $ 400,855 ($ 68.718 per share), of which $ 100,214 was attributable to the portion of 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 was charged to operations ratably from August 12, 2020 through August 12, 2023.

The Company recorded charges to general

and administrative costs in the consolidated statement of operations of $ 61,501 and $ 100,213 for the years ended December 31, 2023 and

2022, respectively, with respect to these stock options.

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

7 unchanged sentences

The options vested 25% on August 1, 2020, 2021 and 2022, respectively,

with the final 25% vesting on August 1, 2023, subject to continued service.

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

portion of 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.

the years ended December 31, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement

of operations of $ 143,163 and $ 143,163 , respectively, with respect to these stock options .

with the final 25% vesting on August 1, 2023 .

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

model, was determined to be $ 572,650 ($ 68.718 per share), of which $ 143,163 was attributable to the portion of 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 was charged to operations ratably from August 1, 2020 through August 1, 2023.

The Company recorded charges to general and

administrative costs in the consolidated statement of operations of $ 83,544 and $ 143,163 for the years ended December 31, 2023 and 2022,

respectively, with respect to these stock options.

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

3 unchanged sentences

The options can be exercised on a cashless basis.

are exercisable for a period of five years at 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 25% on August 12, 2020, 2021 and 2022, respectively, with the final

25% vesting on August 12, 2023, subject to continued service.

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 portion of 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, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated statement of operations

of $ 100,213 and $ 100,213 , 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 stock options to

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

Winson Sze Chun Ho, Dr.

Stephen Forman, and Dr.

Philip Palmedo (an

aggregate of 200,000 shares), which were fully vested upon issuance and exercisable for a period of five years 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 stock options to purchase 250,000

shares of the Company’s common stock, exercisable for a period of five years 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, subject to continued service.

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 portion of 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 was being charged to operations ratably from April 9, 2021 through June 30, 2023, although vesting terminated

on October 30, 2022, the date that Mr.

Schwartzberg died.

During the years ended December 31, 2022 and 2021, the Company recorded charges

to general and administrative costs in the consolidated statement of operations of $ 126,684 and $ 500,235 , respectively, with respect

to these stock options .

The options are

exercisable for a period of five years at an exercise price of $ 71.40 per share, which was equal to the closing market price of the Company’s

common stock on the grant date.

The options vested 25% on August 12, 2020, 2021 and 2022, respectively, with the final 25% vesting on

August 12, 2023 .

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

to be $ 400,855 ($ 68.718 per share), of which $ 100,214 was attributable to the portion of 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 was

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

The Company recorded charges to general and administrative

costs in the consolidated statement of operations of $ 61,501 and $ 100,213 for the years ended December 31, 2023 and 2022, respectively,

with respect to these stock options.

April 9, 2021, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by a former director’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 stock options to purchase 25,000 shares of the Company’s

common stock, exercisable for a period of five years at an exercise price of $ 32.00 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

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

$ 753,611 ($ 30.144 per share), of which $ 376,800 was attributable to the portion of the stock options fully vested on April 9, 2021 and

was therefore charged to operations on that date.

Although the remaining unvested portion of the fair value of the stock options was

being charged to operations ratably from April 9, 2021 through June 30, 2023, the vesting of these stock options terminated on October

30, 2022 as a result of the death of Mr.

Schwartzberg on that date.

The Company recorded charges to general and administrative costs

in the consolidated statement of operations of $ 126,684 for the year ended December 31, 2022 with respect to these stock options.

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

1 unchanged sentence

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

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

years 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, subject to continued service.

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 portion of 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 years ended December 31, 2022 and 2021, the Company recorded charges to general and

administrative costs in the consolidated statement of operations of $ 154,042 and $ 427,944 , respectively, with respect to these stock

Brown was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five year s

at an exercise price of $ 28.00 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 ($ 26.335 per share), of which $ 329,188 was attributable

to the portion of 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 was charged to operations ratably from May 11, 2021 through June 30, 2023.

Company recorded charges to general and administrative costs in the consolidated statement of operations of $ 76,388 and $ 154,042 for

the years ended December 31, 2023 and 2022, respectively, 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 members of the

2 unchanged sentences

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

subject to continued service.

The fair value of these 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,

During the years ended December 31, 2022 and 2021, the Company recorded charges to general and administrative costs in the consolidated

statement of operations of $ 638,915 and $ 358,200 , respectively, with respect to these stock options .

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

common stock, which was fully vested upon issuance and is exercisable for a period of five years at $ 2.06 per share (the closing market

price on the issue date).

The fair value of the 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

The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $ 1,421,095

($ 28.423 per share), which was charged to operations ratably from July 1, 2021 through June 30, 2023.

The Company recorded charges to

general and administrative costs in the consolidated statement of operations of $ 211,413 and $ 638,915 for the years ended December 31,

2023 and 2022, respectively, with respect to these stock options.

June 17, 2022, the Board of Directors appointed Bas van der Baan to the Board of Directors.

5 unchanged sentences

The fair value

of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $ 158,525 ($ 0.6341 per

share), of which $ 79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 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 June 17, 2022 through June 30, 2024.

During the year ended December 31, 2022, the Company recorded a total charge to general and

administrative costs in the consolidated statement of operations of $ 100,249 with respect to these stock options .

of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $ 158,525 ($ 6.341 per share),

of which $ 79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 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 June

17, 2022 through June 30, 2024.

The Company recorded charges to general and administrative costs in the consolidated statement of operations

of $ 38,885 and $ 100,249 for the years ended December 31, 2023 and 2022, respectively, with respect to these stock options.

June 30, 2022, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the

5 unchanged sentences

was determined to be $ 316,700 ($ 6.334 per share), which is being charged to operations ratably from July 1, 2022 through June 30, 2024.

During the year ended December 31, 2022, the Company recorded a total charge to general and administrative costs in the consolidated

statement of operations of $ 63,777 with respect to these stock options .

The Company recorded charges to general and administrative costs in the consolidated statement of operations of $ 94,881 and $ 63,777 for

the years ended December 31, 2023 and 2022, respectively, with respect to these stock options.

November 6, 2022, the Board of Directors granted to each of the four officers of the Company stock options to purchase 20,000 shares

3 unchanged sentences

$ 262,560 ($ 3.282 per share), which is being charged to operations ratably from November 6, 2022 through November 6, 2025.

year ended December 31, 2022, the Company recorded a total charge to general and administrative costs in the consolidated statement of

operations of $ 75,520 with respect to these stock options.

recorded a total charge to general and administrative costs in the consolidated statement of operations of $ 61,448 and $ 75,520 for the

years ended December 31, 2023 and 2022, respectively, with respect to these stock options.

November 6, 2022, the Company issued a stock option, in the form of a warrant, to BioPharmaWorks to purchase 10,000 shares of the Company’s

2 unchanged sentences

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

to be $ 43,264 ($ 0.4326 per share) and was charged to general and administrative costs in the consolidated statement of operations on

to be $ 43,264 ($ 4.326 per share) and was charged to general and administrative costs in the consolidated statement of operations on that

June 30, 2023, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the

Board of Directors, granted to each of the four non-officer directors of the Company stock options to purchase 10,000 shares (a total

of 40,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $ 5.88 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,

subject to continued service .

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

was determined to be $ 192,593 ($ 4.8131 per share), which is being charged to operations ratably from July 1, 2023 through June 30, 2025.

The Company recorded a total charge to general and administrative costs in the consolidated statement of operations of $ 48,464 for the

year ended December 31, 2023 with respect to these stock options.

September 26, 2023, in connection with the employment agreement entered into with Bas van der Baan, Mr.

van der Baan was granted stock

options to purchase 250,000 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

are exercisable for a period of five years at an exercise price of $ 1.95 per share, which was equal to the closing market price of the

Company’s common stock on the grant date.

The options vest in equal increments quarterly over a three-year period commencing on

the last day of each calendar quarter commencing October 1, 2023, subject to continued service .

The fair value of these stock options,

as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $ 403,066 ($ 1.612 per share), which is being charged

to operations ratably from September 26, 2023 through September 30, 2026.

The Company recorded a charge to general and administrative

costs in the consolidated statement of operations of $ 35,178 for the year ended December 31, 2023 with respect to these stock options.

Philip Palmedo, a director of the Company since 2006, did not stand for re-election to the Company’s Board of Directors at the

Company’s Annual Meeting of Stockholders held on October 7, 2022, and Gil Schwartzberg, a director of the Company, died on October

Accordingly, the unvested stock options for each such person ceased vesting effective as of the respective dates that their

service on the Company’s Board of Directors terminated.

Furthermore, the expiration date of all vested stock options owned by such

persons are contractually scheduled to expire one year from the respective dates that their service on the Company’s Board of Directors

Company’s annual meeting of stockholders held on October 7, 2022.

Gil Schwartzberg, a former director of the Company, died on October

Kovach, the Chairman of the Board of Directors and the Company’s President and Chief Executive Officer, and

Chief Scientific Officer, died on October 5, 2023.

Accordingly, the unvested stock options for each such person ceased vesting effective

as of the respective dates that their service to the Company terminated.

Furthermore, the expiration date of all vested stock options

owned by each such person contractually expired one year from the respective dates that each of their services to the Company terminated.

summary of stock-based compensation costs for the years ended December 31, 2023 and 2022 is as follows:

10 unchanged sentences

Stock options outstanding at December 31, 2021

Rounding adjustment attributable to reverse stock split

Stock options outstanding at December 31, 2022

4 unchanged sentences

will be recognized subsequent to December 31, 2023 over a weighted-average period of approximately 26 months.

exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at December 31,

2022 are as follows:

December 31, 2023, the outstanding common stock options,, including options issued in the form of warrants, are exercisable at the following

prices per common share:

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, 2022 was approximately $ 750 , based on a fair

market value of $ 0.51 per share on December 31, 2022.

Outstanding (Shares)

on a fair market value of $ 2.35 per share on December 31, 2023, the intrinsic value attributed to exercisable but unexercised common

stock options was approximately $ 8,000 at December 31, 2023.

stock options to acquire 299,791 shares of the Company’s common stock had not vested at December 31, 2023.

6 unchanged sentences

Research credits

Capitalized research and development

Stock-based compensation

17 unchanged sentences

Schedule of Effective Income Tax Rate

Ended December 31,

federal statutory tax rate

State income taxes, net of federal tax benefit

Expirations related to stock-based compensation

Adjustment to deferred tax asset

Change in valuation allowance

Effective tax rate

December 31, 2022, the Company has available net operating loss carryforwards for federal and state income tax purposes of

approximately $ 27,803,000

and $ 28,040,000 ,

respectively.

income taxes, net of federal tax benefit

related to stock-based compensation

to deferred tax asset

in valuation allowance

December 31, 2023, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately

$ 28,111,000 and $ 32,617,000 , respectively.

Federal net operating losses from tax years preceding 2018, if not utilized earlier, expire

through 2038.

Federal net operating losses generated in a tax year beginning after 2017 have an indefinite carryforward

The utilization of federal net operating loss carryforwards is subject to various limitations.

Federal net operating losses generated in a tax year beginning after 2017 have an indefinite carryforward period.

The utilization

of federal net operating loss carryforwards is subject to various limitations.

state net operating loss carryovers include approximately $ 19,141,000 that were incurred in the State of New York.

18 unchanged sentences

As of December 31, 2023 and

2021, the Company was not subject to any pending or threatened legal claims or actions.

2022, the Company was not subject to any threatened or pending lawsuits, legal claims or legal proceedings.

Trial Agreements

December 31, 2022, the Company’s unpaid remaining contractual commitments pursuant to clinical trial agreements, and clinical trial

monitoring agreements, as described below, aggregated $ 7,892,000 , 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

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, 2022 and 2021, the Company incurred costs of $ 26,397 and $ 18,443 , respectively, pursuant to this agreement,

which have been included in research and development costs in the Company’s consolidated statements of operations.

December 31, 2023, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical

trial monitoring agreements not yet incurred, as described below, aggregated $ 6,412,000 , including clinical trial agreements of $ 6,013,000

and clinical trial monitoring agreements of $ 399,000 , which, based on current estimates, are currently scheduled to be incurred through

approximately December 31, 2027.

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 are obtained and analyzed, and are frequently modified, suspended

or terminated before the clinical trial endpoint is reached.

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 modifications

and revisions over time.

following is a summary of the contractual clinical trials discussed below as of December 31, 2023:

of Contractual Clinical Trials

combined with carboplatin, etoposide and atezolizumab in small cell lung cancer

of Hope and Sarah Cannon

patients entered

combined with doxorubicin in sarcoma

patient entered

in high grade gliomas

0 pharmacology study

Cancer Institute

the penetration of LB-100 into high grade gliomas after IV injection

No or minimal penetration of LB-100 into high grade gliomas after IV injection

with or without LB-100 in sarcoma

trial not yet begun (subject to completion of Phase 1b GEIS clinical trial)

combined with dostarlimab in ovarian clear cell carcinoma

the survival of patients with ovarian clear cell carcinoma

patients entered at December 31, 2023

The financial contractual commitment of the GEIS Randomized

Phase 2 clinical trial is included in the financial contractual commitment of the GEIS Phase 1b trial.

There is no remaining financial contractual commitment associated

with this clinical trial.

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 an

FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer (“ED-SCLC”).

will be given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved standard of care 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.

patient accrual was slower than expected, the Company has been seeking to add additional sites to increase the rate of patient accrual.

Effective March 6, 2023, the Sarah Cannon Research Institute (“SCRI”), Nashville, Tennessee, joined the City of Hope’s

ongoing Phase 1b clinical trial.

The Company is continuing its efforts to add additional sites.

The addition of SCRI is expected to expedite

and expand the accrual of patients to this clinical trial, thus reducing the time required to demonstrate the feasibility, tolerability,

and efficacy of adding LB-100 to the current standard treatment regimen.

With the addition of SCRI, the Company currently expects that

this clinical trial will be completed by March 31, 2026.

the years ended December 31, 2023 and 2022, the Company incurred costs of $ 69,001 and $ 0 , respectively, pursuant to this agreement, which

are included in research and development costs in the Company’s consolidated statements of operations.

As of December 31, 2023,

total costs of $ 447,512 have been incurred pursuant to this agreement.

The Company’s aggregate commitment pursuant to

this agreement, less amounts previously paid to date, totaled approximately $ 590,000 as of December 31, 2022, which is expected to be

incurred through December 31, 2025 .

Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 2,433,000

as of December 31, 2023, which is expected to be incurred through March 31, 2026.

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

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

If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment

of a very aggressive disease.

Effective July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the

5 unchanged sentences

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.

Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years, with little improvement in survival 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

2 unchanged sentences

well as to provide funding for the clinical trial.

The goal is 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.

The goal is to enter approximately 150 to 170 patients in this clinical trial over

a period of two to four years.

The Phase 1 portion of the study began in the quarter ended June 30, 2023 to determine the recommended

Phase 2 dose of the combination of doxorubicin and LB-100.

As advanced sarcoma is a very aggressive disease, the design of the Phase

2 portion 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.

12 unchanged sentences

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

application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory

authorities for review and approval before being used in a clinical trial.

of December 31, 2023, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially

for subsequent multiple trials within the European Union, had cost $ 1,144,169 .

While the production of new inventory has been completed,

nominal amounts of trailing costs are expected to be incurred during the year ending December 31, 2023.

for subsequent multiple trials within the European Union, had cost approximately $ 1,144,000 .

Although the production of new inventory

has been completed, nominal trailing costs subsequent to December 31, 2023 may be incurred.

October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos

1 unchanged sentence

clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas

Consequently, the GEIS clinical trial is currently scheduled to commence during the quarter ending June 30, 2023 and to be completed

by December 31, 2025.

Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report

prepared by December 31, 2026.

In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at

Fundación Jiménez Díaz University Hospital (Madrid).

Up to 170 patents will be entered into the clinical trial.

The Phase 1b section of the protocol is expected to

be completed by June 30, 2024, at which time the Company expects to have data on both response and toxicity from this portion of the

clinical trial.

The Phase 1b portion of the protocol is expected to be completed by June 30, 2024, at which time the Company expects to have data on

both response and toxicity from this portion of the clinical trial, and subject to clinical results, anticipates that it will be able

to proceed to a related Phase 2 study.

interim analysis of this clinical trial will be done before full accrual of patients is completed to determine whether the study has

4 unchanged sentences

Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement.

Through December 31, 2022, the Company has paid GEIS an aggregate of $ 415,823 for work done under this agreement through the third milestone.

the years ended December 31, 2022 and 2021, the Company incurred costs of $ 260,770 and $ 24,171 , 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, 2022, total costs of $ 415,823 have been incurred pursuant to this agreement.

The Company’s aggregate commitment pursuant to

this agreement, less amounts previously paid to date, totaled approximately $ 3,743,000 as of December 31, 2022, which is expected to

be incurred through December 31, 2025.

As the work 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.

Such fluctuations are recorded in the consolidated statements

of operations as foreign currency gain or loss, as appropriate.

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.

patient accrual has been slower than expected, the Company is currently seeking to add two additional sites to increase the rate of patient

accrual, with at least one major site expected to be added by June 30, 2023.

With the additional sites, the Company expects that this

clinical trial will be completed by December 31, 2024.

Without the additional sites, the Company expects that this clinical trial will

be completed no sooner than December 31, 2025.

March 6, 2023, Sarah Cannon Research Institute (SCRI), Nashville, Tennessee, joined the City of Hope’s ongoing Phase 1b clinical

trial to assess the combination of the Company’s first-in-class protein phosphatase 2A (PP2A) inhibitor, LB-100, with a standard

regimen for previously untreated, extensive stage small cell lung cancer disease.

SCRI, one of the largest community-based cancer trial

centers in the United States, is expected to expedite and expand the accrual of patients to this clinical trial, thus reducing the time

required to demonstrate the feasibility, tolerability and efficacy of adding LB-100 to the current standard treatment regimen.

the years ended December 31, 2022 and 2021, the Company incurred costs of $ 0 and $ 378,511 , respectively, 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, 2022, 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 .

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

If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment

of a very aggressive disease.

During the years ended December 31, 2023 and 2022, the Company incurred costs of $ 268,829 and $ 260,770 , respectively, pursuant to this

Such costs, when incurred, are included in research and development costs in the Company’s consolidated statements of

Through December 31, 2023, the Company has paid GEIS an aggregate of $ 684,652 for work done under this agreement through

the fourth milestone.

Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 3,580,000

as of December 31, 2023, which is expected to be incurred through December 31, 2027.

As the work 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.

Such fluctuations

are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate.

Cancer Institute Pharmacologic Clinical Trial.

In May 2019, the National Cancer Institute (NCI) initiated a glioblastoma (GBM) pharmacologic

clinical trial.

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.

In May 2019, the National Cancer Institute (“NCI”) initiated a glioblastoma

(“GBM”) pharmacologic clinical trial.

This study was being conducted and funded by the NCI under a Cooperative Research and

Development Agreement, with the Company responsible for providing 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

the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with little 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.

3 unchanged sentences

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

As a result of the innovative design of the NCI study, data from a 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.

patients have been entered and analysis of the blood and tissue will now proceed.

If there is evidence in at least two of the patients

of penetration of LB 100 into tumor tissue, the study will be deemed as successful.

The results of this study are expected during 2023.

cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain was not known.

Many drugs potentially

useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.

NCI study was designed to determine the extent to which LB-100 enters recurrent malignant gliomas.

Patients having surgery to remove

one or more tumors received one dose of LB-100 prior to surgery and had blood and tumor tissue analyzed to determine the amount of LB-100

present and to determine whether the cells in the tumors showed the biochemical changes expected to be present if LB-100 reached its

molecular target.

As a result of the innovative design of the NCI study, it was believed that data from a few patients would 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.

Blood and brain tumor tissue were analyzed from seven patients after intravenous infusion of a single dose of LB-100.

Results of the investigation demonstrated that there was virtually no entry of LB-100 into the brain tumor tissue.

Accordingly, alternative

methods of drug delivery will be required to determine if LB-100 has meaningful clinical anti-cancer activity against glioblastoma multiforme

and other aggressive brain tumors.

Anderson Cancer Center Clinical Trial .

On September 20, 2023, the Company announced an investigator-initiated Phase 1b/2 collaborative

clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 (“PD-1”) blocking antibody of GSK plc

(“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma

The clinical trial is being sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”)

and is being conducted at The University of Texas - MD Anderson Cancer Center.

The Company is providing LB-100 and GSK is providing dostarlimab-gxly

and financial support for the clinical trial.

On January 29, 2024, the Company announced the entry of the first patient into this clinical

The Company currently expects that this clinical trial will be completed by July 31, 2025.

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 (“Moffitt”), 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 toxicity and 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 (“IND”)

Application to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and 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 utilized LB-100 as a single agent

in the treatment of patients with low and intermediate-1 risk MDS.

clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019.

year ended December 31, 2023, the clinical trial was closed.

In this clinical trial, single agent LB-100 was used on a new schedule of

days 1, 3, and 5 every 3 weeks.

Although MTD was not achieved, there was no dose-limiting toxicity on this schedule at doses that were

greater than the MTD in the Phase 1 clinical trial of LB-100 on the Monday, Tuesday, Wednesday schedule.

the years ended December 31, 2023 and 2022, the Company incurred costs of $ 16,165 and $ 26,397 , 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, 2023, total costs of $ 147,239 have been incurred pursuant to this agreement.

Company has decided not to pursue further studies in MDS, as other opportunities have become available (see “Patent and License

Agreements - Moffitt” below).

Trial Monitoring Agreements

3 unchanged sentences

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 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 allocated 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 periodic documentation provided by the CRO.

the years ended December 31, 2022 and 2021, the Company incurred costs of $ 35,403 and $ 9,730 , respectively, and as of December 31, 2022,

total costs of $ 127,288 have been incurred.

The Company’s aggregate commitment pursuant to this agreement, less amounts previously

paid to date, totaled approximately $ 842,000 as of December 31, 2022, which is expected to be incurred through June 30, 2025.

costs of the Phase 1b/2 clinical trial being paid to or through Theradex have been recorded and charged to operations based on periodic

documentation provided by the CRO.

During the years ended December 31, 2023 and 2022, the Company incurred costs of $ 20,884 and $ 35,403 ,

respectively, pursuant to this work order.

As of December 31, 2023, total costs of $ 148,172 have been incurred pursuant to this work

order agreement.

a result of the closure of the Company’s Clinical Trial Research Agreement with Moffitt during the year ended December 31, 2023

(see “Clinical Trial Agreements – Moffitt” above), this work order agreement with Theradex to monitor the Clinical

Trial Research Agreement with Moffitt was similarly suspended, although nominal oversight trailing costs subsequent to December 31, 2023

are expected to be incurred relating to the closure of the Moffitt study.

On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated

3 unchanged sentences

During the years ended December 31, 2023 and 2022, the Company incurred

costs of $ 33,815 and $ 24,626 , respectively, and as of December 31, 2022, total costs of $ 58,441 have been incurred.

The Company’s

aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 284,000 as of December

31, 2022, which is expected to be incurred through June 30, 2025.

costs of $ 20,240 and $ 33,815 , respectively, pursuant to this work order.

As of December 31, 2023, total costs of $ 78,681 have been incurred

pursuant to this work order agreement.

Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled

approximately $ 258,000 as of December 31, 2023, which is expected to be incurred through March 31, 2026.

On June 22, 2023, the Company finalized a work order agreement with Theradex, to monitor the GEIS investigator-initiated clinical

Phase I/II randomized trial of LB-100 plus doxorubicin vs.

doxorubicin alone in first line of advanced soft tissue sarcomas.

is expected to be completed by June 30, 2026.

under this work order agreement are estimated to be approximately $ 153,000 , with such payments expected to be allocated approximately

72 % to Theradex for services and approximately 28 % for payments for pass-through software costs.

During the year ended December 31, 2023,

the Company incurred costs of $ 14,862 , pursuant to this work order.

As of December 31, 2023, total costs of $ 14,862 have been incurred

pursuant to this work order agreement.

Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled

approximately $ 141,000 as of December 31, 2023, which is expected to be incurred through June 30, 2026.

and License Agreements

10 unchanged sentences

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 Agreement.

During the years ended December 31, 2022 and 2021, the Company recorded charges to operations of $ 25,000 and $ 25,000 ,

respectively, in connection with its obligations under the License Agreement.

As of December 31, 2022, 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.

The Company was 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 had also agreed to pay non-refundable milestone payments to Moffitt,

which could not 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.

October 4, 2023, the Company received a counter-signed termination letter dated September 29, 2023 with respect to the Exclusive License

Agreement dated August 20, 2018 between the Company and Moffitt, effective September 30, 2023.

The Company and Moffitt agreed that no

termination fee shall be due or payable by the Company, and Moffitt acknowledged that no payments are owed by the Company under the Agreement.

the year ended December 31, 2023, the Company recorded a credit to operations of $ 9,109 , representing the reversal of obligations previously

recorded with respect to the Exclusive License Agreement.

During the year ended December 31, 2022, the Company recorded charges to operations

of $ 25,000 , in connection with its obligations under the Exclusive License Agreement.

Agreements with Officers

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

July and August 2020, the Company entered into one-year employment agreements with each of its executive officers at that time, consisting

Kovach, Eric J.

Miser, and Robert N.

Weingarten, which provided for aggregate annual compensation of $ 640,000 , payable

monthly (see Note 5).

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 additional one-year periods in July and August 2021 and 2022.

April 9, 2021, the Board of Directors increased the annual compensation of Eric J.

Weingarten, which provided for aggregate annual cash compensation

of $ 640,000 , payable monthly (see Note 5).

These employment agreements were 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

These employment agreements were automatically renewed for additional one-year periods in July and August 2021, 2022 and 2023.

April 9, 2021, the Board of Directors increased the annual cash compensation of Eric J.

Miser, and Robert N.

under the employment agreements, such that the total aggregate annual compensation of all officers increased to $ 775,000 , effective May

under the employment agreements, such that the aggregate annual compensation for all officers increased to $ 775,000 , effective May 1,

November 6, 2022, Mr.

Forman was promoted to Vice President and Chief Operating Officer, with an annual salary of $ 200,000 .

the total aggregate annual compensation of all officers increased to $ 800,000 , effective November 6, 2022.

In addition, effective October

Forman is being paid an office rent allowance of $ 600 per month.

total aggregate annual compensation of all officers increased to $ 800,000 , effective November 6, 2022.

Forman is being provided an office allowance of approximately $ 1,500 per month through December 31, 2023.

September 26, 2023, the Company entered into an employment agreement with Bastiaan van der Baan to act as the Company’s President

and Chief Executive Officer and as Vice Chairman of the Board of Directors with an annual salary of $ 150,000 .

The term of the employment

agreement is for three years and is automatically renewable for additional one-year periods unless terminated by either party, subject

to early termination as described in the employment agreement.

Under the employment agreement, Mr.

van der Baan’s annual salary

may be increased from time to time at the sole discretion of the Board of Directors.

In addition, Mr.

van der Baan will be eligible to

receive an annual bonus as determined at the sole discretion of the Board of Directors.

van der Baan was appointed as Chairman of

the Board of Directors upon the death of Dr.

Kovach, who died on October 5, 2023.

aggregate annual cash compensation for all officers was $ 700,000 as of December 31, 2023.

Significant Agreements and Contracts

31 unchanged sentences

The Company recorded

charges to operations pursuant to this agreement of $ 120,000 and $ 120,000 for the years ended December 31, 2022 and 2021, respectively,

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

for Angelman Syndrome Therapy.

Effective 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 were to 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.

The Company has agreed to provide FAST with a supply of LB-100 to be utilized in the

conduct of this study, which was 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.

The preliminary analysis indicates that the positive results previously reported by Chinese investigators were

not confirmed in the US model.

The Company is currently awaiting input from FAST as to whether it intends to continue to pursue pre-clinical

studies of LB 100.

To date, FAST has not indicated whether it desires to pursue further studies of LB-100, but in light of the failure

to confirm the Chinese study results, the Company does not plan to pursue further studies of AS.

charges to operations pursuant to this Collaboration Agreement of $ 120,000 and $ 120,000 for the years ended December 31, 2023 and 2022,

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

Cancer Institute .

On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer

Institute, Amsterdam (see Note 5), 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.

During the years ended December 31, 2022 and 2021, the Company incurred charges in the amount of

$ 204,158 and $ 55,248 , respectively, with respect to this agreement, which amounts are included in research and development costs in the

Company’s consolidated statements of operations.

As of December 31, 2022, total costs of $ 259,406 have been incurred pursuant to

this agreement.

The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately

$ 262,000 as of December 31, 2022, which is expected to be incurred through June 30, 2025.

As the work 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.

Institute, Amsterdam (“NKI”) (see Note 5), one of the world’s leading comprehensive cancer centers, and Oncode Institute,

Utrecht, a major independent cancer research center, for a term of three years.

The Development Collaboration Agreement was subsequently

modified by Amendment No.

The Development Collaboration Agreement is intended 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 agreed to fund the study, at an approximate cost of 391,000 Euros and

provide a sufficient supply of LB-100 to conduct the study.

October 3, 2023, the Company entered into Amendment No.

2 to the Development Collaboration Agreement with NKI, which provides for additional

research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and adds

500,000 Euros (approximately $ 526,000 at October 3, 2023) to the operating budget being funded by the Company.

the years ended December 31, 2023 and 2022, the Company incurred charges in the amount of $ 226,150 and $ 204,158 , respectively, with respect

to this agreement, which amounts are included in research and development costs in the Company’s consolidated statements of operations.

As of December 31, 2023, total costs of $ 485,556 have been incurred pursuant to this agreement, as amended.

The Company’s aggregate

commitment pursuant to this agreement, as amended, less amounts previously paid to date, totaled approximately $ 595,000 as of December

31, 2023, which is expected to be incurred through October 8, 2026.

As the work 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.

The Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical trials

in the United States.

On June 10, 2022, the contract was amended to reflect a new total contract price of $ 273,980 and an estimated completion

date of April 30, 2023.

During the years ended December 31, 2022 and 2021, the Company incurred costs of $ 27,702 and $ 17,782 , respectively,

pursuant to this agreement.

As of December 31, 2022, total costs of $ 219,611 have been incurred pursuant to this agreement.

The Company’s

aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 55,000 as of December 31,

On June 10, 2022, the contract was amended to reflect a new total contract price of $ 273,980 for services to be

rendered through April 30, 2023.

Effective April 17, 2023, the contract was further amended to reflect a new total contract price of

$ 326,274 for services to be rendered through April 30, 2024.

During the years ended December 31, 2023 and 2022, the Company incurred

costs of $ 32,307 and $ 27,702 , respectively, pursuant to this work order.

As of December 31, 2023, total costs of $ 248,298 have been incurred

pursuant to this contract.

Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $ 78,000 as

of December 31, 2023.

Risks Associated with the Company’s Business Activities

1 unchanged sentence

the world as businesses and governments implemented broad actions to mitigate this public health crisis.

The extent to which the coronavirus

pandemic may impact the Company’s business activities and capital raising efforts will depend on future developments, which are

uncertain and cannot be predicted.

The Company is continuing to monitor this situation and will adjust its current business plans to

the extent additional information and guidance become available.

The coronavirus pandemic has also presented a challenge to medical facilities

Although the Company’s clinical trials are conducted on an outpatient basis, the coronavirus pandemic appears to have

caused some delays in the Company’s clinical trials, but the impact of the coronavirus pandemic appears to be subsiding.

The Company does not believe that inflation has had a material effect on its operations to date, other than its impact on the

general economy.

However, there is a risk that the Company’s operating costs could become subject to inflationary and interest

rate pressures in the future, which would have the effect of increasing the Company’s operating costs (including, specifically,

clinical trial costs), and which would put additional stress on the Company’s working capital resources.

Although the Covid-19 outbreak

has subsided, the extent to which the coronavirus pandemic may reappear and impact the Company’s clinical trial programs and capital

raising efforts in the future is uncertain and cannot be predicted.

and Interest Rate Risk.

The Company does not believe that inflation or increasing interest rates has had a material effect on its

operations to date, other than its impact on the general economy.

However, there is a risk that the Company’s operating costs could

become subject to inflationary and interest rate pressures in the future, which would have the effect of increasing the Company’s

operating costs (including, specifically, clinical trial costs), and which would put additional stress on the Company’s working

capital resources.

Chain Issues.

1 unchanged sentence

including its ongoing clinical trials.

There are various indications that the United States economy may be entering a recessionary period.

Although unclear at

this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn,

There are some indications that the United States economy may be at risk of entering a recessionary period.

Although unclear

at this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn,

affect the Company.

The geopolitical landscape poses inherent risks that could significantly impact the operations and financial performance of

In the event of a military conflict, supply chain disruptions, geopolitical uncertainties, and economic repercussions may

adversely affect the Company’s ability to conduct research, develop, test and manufacture products, and distribute them globally.

This could lead to delays in product development, interruptions in the supply of critical materials, and delays in clinical trials, thereby

impeding the Company’s clinical development and commercialization plans.

Furthermore, the impact of a conflict on global financial

markets may result in increased volatility and uncertainty in the capital markets, thereby affecting the valuation of the Company’s

publicly-traded shares.

Investor confidence, market sentiment, and access to capital may all be negatively influenced.

Such geopolitical

risks are outside the control of the Company, and the actual effects on the Company’s business, financial condition and results

of operations may differ from current estimates.

Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance

2 unchanged sentences

Company performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with the SEC.

Other than the matter noted below, there were no material subsequent events which affected, or could affect, the amounts or disclosures

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.

March 10, 2023, the Company issued 12,500

shares of common stock upon the exercise of a stock option in the form of a warrant held by a consultant to the Company for 12,500

shares exercisable at $ 0.5025

per share for total cash proceeds of $ 6,281 .

License Agreement

February 23, 2024, the Company entered into a Patent License Agreement (the “License Agreement”) with the National Institute

of Neurological Disorders and Stroke (“NINDS”) and the National Cancer Institute (“NCI”), each an institute or

center of the National Institute of Health (“NIH”).

Pursuant to the License Agreement, the Company has licensed exclusively

NIH’s intellectual property rights claimed for a Cooperative Research and Development Agreement (“CRADA”) subject invention

co-developed with the Company, and the licensed field of use, which focuses on promoting anti-cancer activity alone, or in combination

with standard anti-cancer drugs.

The scope of this clinical research extends to checkpoint inhibitors, immunotherapy, and radiation for

the treatment of cancer.

The License Agreement is effective, and shall extend, on a licensed product, licensed process, and country basis,

until the expiration of the last-to-expire valid claim of the jointly owned licensed patent rights in each such country in the licensed

territory, unless sooner terminated.

License Agreement contemplates that the Company will seek to work with pharmaceutical companies and clinical trial sites (including comprehensive

cancer centers) to initiate clinical trials within timeframes that will meet certain benchmarks.

Data from the clinical trials will be

the subject of various regulatory filings for marketing approval in applicable countries in the licensed territories.

Subject to the

receipt of marketing approval, the Company would be expected to commercialize the licensed products in markets where regulatory approval

has been obtained.

Company is obligated to pay the NIH a non-creditable, non-refundable license issue royalty of $ 50,000 and a first minimum annual royalty

of $ 30,000 , within sixty days from the effective date of the Agreement.

The first minimum annual royalty may be prorated from the effective

date of the License Agreement to the next subsequent January 1.

Thereafter, the minimum annual royalty of $ 30,000 is due each January

1 and may be credited against any earned royalties due for sales made in that year.

Company is obligated to pay the NIH, on a country-by-country basis, earned royalties of 2% on net sales of each royalty-bearing product

and process, subject to reduction by 50% under certain circumstances relating to royalties paid by the Company to third parties, but

not less than 1%.

The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first

commercial sale of a royalty-bearing product or process and expires on the date on which the last valid claim of the licensed product

or licensed process expires in such country.

Company is obligated to pay the NIH benchmark royalties, on a one-time basis, within sixty days from the first achievement of each such

The License Agreement defines four such benchmarks, with deadlines of October 1, 2024, 2027, 2029 and 2031, respectively,

each with a different specified benchmark payment amount payable within thirty days of achieving such benchmark.

The October 31, 2024

benchmark is defined as the dosing of the first patient with a licensed product in a Phase 2 clinical study of such licensed product

in the licensed fields of use.

The total of all such benchmark payments is $ 1,225,000 .

Company is obligated to pay the NIH sublicensing royalties of 5 % on sublicensing revenue received for granting each sublicense within

sixty days of receipt of such sublicensing revenue.

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