What changed in this filing

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Item 9A. Controls and Procedures

2023-03-29 compared with 2022-03-21 · 1408 added, 1155 removed, 1192 unchanged (68% of the section changed)

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Held with the Company

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

Medical Officer

President and Chief Financial Officer

Administrative Officer

N Schwartzberg

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

René Bernards

Bas van der Baan

of Directors and Executive Officers

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peer-reviewed articles dealing primarily with pediatric clinical cancer studies.

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

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

Weingarten is an experienced

business consultant and advisor with a consulting practice focusing on accounting and SEC compliance issues.

Since 1979, Mr.

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

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

Weingarten has experience in a variety

of industries, including the pharmaceutical industry.

Weingarten was familiar

with the financial and business operations of the Company, as he had provided accounting and financial consulting services to the Company

for a number of years prior to his appointment as Vice President and Chief Financial Officer with respect to the preparation of the Company’s

consolidated financial statements and certain other financial and compliance matters.

Weingarten has provided such financial consulting and advisory services, has acted as chief financial officer, and has served

on the boards of directors of numerous public companies in various stages of development, operation or reorganization.

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

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

(Nasdaq Capital Market:

GHSI) since June 2015 and Chairman of its Board

of Directors since July 2020.

since June 2015 and Chairman of its Board of Directors since July 2020.

Weingarten also serves on the audit, compensation, and nominating and corporate governance committees of Guardion Health Sciences,

Previously, Mr.

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

2017 to March 2020.

From July 2017 to June 2018, Mr.

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

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

and also served as its Vice President and Chief

Financial Officer.

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.

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

in Finance from the

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

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

Effective October 1, 2020, Mr.

Forman was appointed as

our Chief Administrative Officer.

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

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

property portfolio.

Prior to his involvement with our Company, he served as Counsel and Senior Project Manager at Shore Group Associates,

managing in-house legal, tax, and regulatory affairs and supervising client relations for financial software and mobile application development

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.

Forman has led our business development efforts since 2013.

Effective as of October 1, 2020, Mr.

Forman was appointed as our Chief Administrative

Officer, and effective as of November 6, 2022, Mr.

Forman was promoted to Vice President and Chief Operating Officer.

In his roles as

Chief Administrative Officer and Chief Operating Officer, his responsibilities include overseeing all internal operations, the development

of science/business collaborations, and the management of our growing intellectual property portfolio.

Prior to his involvement with

our company, he served as Counsel and Senior Project Manager at Shore Group Associates managing in-house legal, tax, and regulatory affairs

and supervising client relations for financial software and mobile application development teams.

an attorney, Mr.

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

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

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

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

and economic development.

IRG was acquired by L3 Communications in 2008.

Palmedo designed and was the first President of the Long

Island Research Institute formed by Brookhaven National Laboratory, Cold Spring Harbor Laboratory, and SUNY – Stony Brook to facilitate

the commercialization of technologies.

Palmedo joined in the formation of Kepler Financial Management, Ltd., a quantitative

financial research and trading company.

He was President and Managing Director until 1991, when Renaissance Technologies Corporation

acquired the company.

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

a member of the Board of Directors of Gyrodyne LLC.

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

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

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

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

N Schwartzberg, JD

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

its inception.

Schwartzberg was the Chairman of the Board, President and Chief Executive Officer of the City of Hope National Medical

Center, one of the nation’s leading biomedical research and treatment facilities and a National Cancer Institute (NCI) Comprehensive

Cancer Center.

Following his departure, the Graduate School of Biological Science of The Beckman Research Institute at the City of Hope

Schwartzberg the degree of Doctor of Science, honoring his work in the advancement of science through programmatic development

and the growth of the Graduate School.

This was the first ScD.

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

academic accreditation during Mr.

Schwartzberg’s tenure as the school’s president.

Schwartzberg was the only person in

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

Schwartzberg is now City of Hope Chairman Emeritus for life.

to his joining the City of Hope, Mr.

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

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

Additionally, he was a founding

shareholder of Skechers USA, Inc.

He is currently a consultant to Skechers and both trustee and co-trustee of trusts that

hold the controlling interest in the Skechers USA, Inc.

Schwartzberg earned a Juris Doctorate awarded magna cum laude.

He practiced law, specializing in business structure and transactions,

and remains a member in good standing of the California Bar Association.

He is the author of two books.

Warning Toxic Business Mistakes

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

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

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

René Bernards

René Bernards was appointed to our Board of Directors effective June 15, 2022.

Bernards is a leader in the field of molecular

carcinogenesis, working at the Netherlands Cancer Institute in Amsterdam.

His research focuses on identifying effective new drug combinations,

new drug targets, and mechanisms of resistance to anti-cancer drugs.

He has also co-founded four biotechnology companies to bring his

scientific discoveries to clinical oncology practice.

He is a member of the Royal Netherlands Academy of Sciences, an International Honorary

Member of the American Academy of Arts and Sciences and an International Member of the National Academy of Sciences (USA).

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.

ADVISORY COMMITTEE

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

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

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

the Company’s cash is deposited and the Company maintains a continuing banking relationship.

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 Philip Palmedo, Stephen Forman, Yun Yen, Gil Schwartzberg and Regina Brown are

each an “independent director,” as defined under Nasdaq rules.

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.

of Our Board of Directors

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audit committee is responsible for, among other things:

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

the proposed scope and results of the audit;

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

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

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

procedures for complaints received by us regarding accounting matters;

internal audit functions, if any;

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

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 Dr.

Philip Palmedo, with Ms.

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

Brown serving as chair.

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compensation committee is responsible for, among other things:

and recommending the compensation arrangements for executive management;

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

and to achieve our financial goals;

administering

our stock incentive plans;

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

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.

Philip Palmedo, with Dr.

René Bernards, with Dr.

Yen serving as chair.

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

Our Board of Directors has adopted

a written charter for the compensation committee, which is available on our principal corporate website at www.lixte.com .

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

Our Board of Directors has

adopted a written charter for the compensation committee, which is available on our principal corporate website at www.lixte.com .

and Corporate Governance

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responsible for, among other things:

members of the Board of Directors;

a set of corporate governance principles applicable to our company;

the evaluation of our Board of Directors.

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.

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

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

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

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

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

transaction from which the director derived an improper personal benefit.

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.

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

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

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

Eric Forman was late in filing one Form

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

Forman to Mr.

with respect to the John and Barbara Kovach 2015 Trust.

Section 16(a) of the Exchange Act during the year ended December 31, 202s, 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.

EXECUTIVE COMPENSATION

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COMPENSATION TABLE

Awards ($)(1)

Incentive Plan Compensation ($)

Non-Qualified

Deferred Compensation Earnings ($)

Other Compensation ($)

Stock Awards ($)

Option Awards ($)(1)

Non-Equity Incentive Plan Compensation ($)

Non-Qualified Deferred Compensation Earnings ($)

All Other Compensation ($)

Weingarten (4)

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with the Company effective July 15, 2020.

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.

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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.

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$6.8718 per share.

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

In connection with his employment agreement,

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

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

On November 6, 2022, Mr.

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

valued at $0.3282 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.

Equity Awards at December 31, 2022

table set forth below presents information regarding outstanding stock options held by our named executive officers as of December 31,

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

UNEXERCISABLE

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

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

November 6, 2022

November 6, 2027

August 1, 2020

August 1, 2025

November 6, 2022

November 6, 2027

August 12, 2020

August 12, 2025

November 6, 2022

November 6, 2027

October 16, 2017

October 16, 2022

August 12, 2020

August 12, 2025

November 6, 2022

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.

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

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These employment agreements were automatically renewed

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

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

John Kovach .

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

Effective November

Forman was promoted to Vice President and Chief Operating Officer with an annual salary of $200,000.

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

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of the Company.

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

stock options.

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,

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

of Director Compensation

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

Winson Sze Chun Ho, Dr.

Stephen Forman, and Dr.

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

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

value of our common stock on such date.

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

model, was determined to be $189,060 ($5.6718 per share) and was charged to general and administrative costs in the consolidated statement

of operations on the grant date.

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

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

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

Accordingly, Mr.

Schwartzberg’s

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

of Directors Compensation

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.

Palmedo (an aggregate of 200,000 shares), exercisable for a period of five years from the grant date at $3.21 per share, which was the

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

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

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

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

Schwartzberg was granted options exercisable for

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

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.

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

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

and was therefore charged to operations on that date.

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

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

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

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

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.

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

In connection with her appointment to the Board

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

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

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

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

The fair value of these stock options, as calculated

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

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

The remaining unvested portion

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

During the year

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

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

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

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

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

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

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

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

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

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

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

June 30, 2021, 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 five non-officer directors of the Company stock options to purchase 100,000 shares (a total

of 500,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $3.03 per share

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

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.

as of June 15, 2022, Dr.

René Bernards was appointed to the Company’s Board of Directors.

As a 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.

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.

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

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,

Baan 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 $0.74 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 $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.

June 30, 2022, 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 five non-officer directors of the Company stock options to purchase 100,000 shares (a total

of 500,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $0.74 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 $316,700 ($0.6334 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.

November 6, 2022, the Board of Directors granted to each of the four officers of the Company stock options to purchase 200,000 shares

(a total of 800,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $2.00

per share, vesting 25% on issuance and 25% on each anniversary date thereafter until fully vested, subject to continued service.

total fair value of the 800,000 stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be

$262,560 ($0.3282 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.

Compensation Table

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COMPENSATION TABLE

and Principal

Awards ($)(1)

Incentive Plan Compensation ($)

Non-Qualified

Deferred Compensation Earnings ($)

Other Compensation ($)

Name and Principal

Stock Awards ($)

Option Awards ($)(1)

Non-Equity Incentive Plan Compensation ($)

Non-Qualified Deferred Compensation Earnings ($)

All Other Compensation ($)

Winson Sze Chun Ho

Gil Schwartzberg

René Bernards

Bas van der Baan

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

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

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

Appointed as a director of the Company effective April 9, 2021 and died on October 30, 2022.

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

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.

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

Accordingly, his term as a director of the Company ended effective

October 7, 2022.

Advisory Committee Compensation

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

for consultation and advice in the field of oncology research

and drug development.

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

for consultation and advice in the field of oncology

research and drug development.

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

Von Hoff, M.D., to become a member

of our Scientific Advisory Committee.

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

agreement has been automatically renewed for additional one-year terms on its anniversary date since 2014.

Consulting and advisory fees

charged to operations pursuant to this agreement were $16,000 and $16,000 for the years ended December 31, 2021 and 2020, respectively,

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

Von Hoff, M.D., to become

a member of the Company’s Scientific Advisory Committee.

The term of the agreement was for one year and provided for a quarterly

cash fee of $4,000.

The agreement has been automatically renewed for additional one-year terms on its anniversary date since 2014.

and advisory fees charged to operations pursuant to this agreement were $16,000 and $16,000 for the years ended December 31, 2022 and

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

Stock Incentive Plan

July 14, 2020, our Board of Directors adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which provides for the granting

of equity-based awards, consisting of stock options, restricted stock, restricted stock units, stock appreciation rights, and other stock-based

awards to employees, officers, directors and consultants for up to 2,333,333 shares of common stock, under terms and conditions as determined

by our Board of Directors.

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

an action by written consent dated July 31, 2020.

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

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

As of December 31, 2021, unexpired stock options

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

July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which was subsequently

approved by the stockholders of the Company.

The 2020 Plan provides for the granting of equity-based awards, consisting of stock options,

restricted stock, restricted stock units, stock appreciation rights, and other stock-based awards to employees, officers, directors and

consultants of the Company and its affiliates, initially for a total of 2,333,333 shares of the Company’s common stock, under terms

and conditions as determined by the Company’s Board of Directors.

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 adequate number of shares available for future equity compensation grants is necessary to promote our long-term success and the creation

of stockholder value by:

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

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

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.

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.

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

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key features of the 2020 Plan are summarized as follows:

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

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

The maximum number of shares that may

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

2020 Plan 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.

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.

to Receive Awards .

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discretion, among other things, to:

the individuals who will receive awards;

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

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

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

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

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

the provisions of the 2020 Plan and outstanding awards.

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.

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

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

and Address of Beneficial Owner

and Directors

Except as noted,

the Company’s executive office is reflected as the address of all officers, directors and other stockholders owning more than 5%.

Name and Address of Beneficial Owner

of Beneficial

Officers and Directors

608 East Colorado Boulevard, Suite 180

California 91101

Pasadena, California 91101

1,611,284 (1)

East Colorado Boulevard, Suite 180

California 91101

East Colorado Boulevard, Suite 180

California 91101

Bas van der Baan

Amsterdam P7 1098CP

608 East Colorado Boulevard, Suite 180

California 91101

Pasadena, California 91101

608 East Colorado Boulevard, Suite 180

California 91101

2,324,360 (6)

Pasadena, California 91101

René Bernards

Koningsvaren 37

Abcoude P7 1391AD

608 East Colorado Boulevard, Suite 180

California 91101

Pasadena, California 91101

608 East Colorado Boulevard, Suite 180

California 91101

Pasadena, California 91101

608 East Colorado Boulevard, Suite 180

California 91101

Pasadena, California 91101

608 East Colorado Boulevard, Suite 180

California 91101

officers and directors as a group (nine persons)

Stockholders Owning More Than 5%

and Barbara Kovach 2015 Trust

Pasadena, California 91101

All officers and directors as a group (nine persons)

Other Stockholders Owning More Than 5%

John and Barbara Kovach 2015 Trust

Krinsky, Trustee

608 East Colorado Boulevard, Suite 180

California 91101

1,333,333 (4)

Debbie Schwartzberg

Military Trail, Suite 22, Box 356

Florida 33458

1,645,807 (7)

Arthur and Jane Riggs

Pasadena, California 91101

608 East Colorado Boulevard, Suite 180

Pasadena, California 91101

16204 Andalucia Lane

Delray Beach, Florida 33446

Arthur and Jane Riggs 1990 Irrevocable Trust

Jane Riggs, Trustee

4852 Saint Andres Avenue

Verne, California 91750

1,957,500 (8)

and Susan Greenberg

La Verne, California 91750

Robert and Susan Greenberg

228 Manhattan Beach Boulevard

Beach, California 90266

1,380,264 (9)

Manhattan Beach, California 90266

Bahl and Kavit K.

New York 11733

1,000,000 (16)

Palmer Avenue

New York 10538

by the Sea II

T8, 1/F, Unit A

3 Pheasant Run

Setauket, New York 11733

Mayfair by the Sea II

Tower T8, 1/F, Unit A

21 Fo Chun Road Pak ShekKok

NT, Hong Kong SAR

1,084,210 (11)

Taipo NT, Hong Kong SAR

608 East Colorado Boulevard, Suite 180

California 91101

1,474,988 (17)

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

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.

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

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

of common stock owned by Dr.

Philip Palmedo.

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

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

All stock options and common

stock warrants are immediately exercisable or within 60 days.

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

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

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 10,000 shares of common stock and stock options to purchase 171,875 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.

Stephen Forman.

Also includes 16,667 shares

of common stock and stock warrants to purchase 16,667 shares of common stock owned by the Stephen Forman Living Trust dated 12/16/98.

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

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.

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of John and Barbara Kovach.

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

Includes 38,598 shares of common stock, stock warrants to purchase 3,333 shares of common stock and stock options to purchase 62,500

shares of common stock owned by Eric J.

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

and Debbie Schwartzberg.

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

the following:

shares of common stock, stock options to purchase 291,666 shares of common stock and common

stock warrants to purchase 83,333 of common stock owned by the Julie Schwartzberg Trust,

as to which Julie (Schwartzberg) Forman is the beneficiary, and as to which Eric Forman disclaims

beneficial ownership or control.

shares of common stock owned by the Julie Forman 2015 Trust, the beneficiary of which is

Cole Forman, the son of Eric and Julie Forman, as to which David Sterling, as trustee, has

voting, dispositive and investment control.

shares of common stock owned by each of the Savannah Sterling Trust, Amanda Sterling Trust,

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

Includes 343,926 shares of common stock owned by the Gil & Debbie Schwartzberg Family Trust dated November 19, 2003, Gil Schwartzberg

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

105,264 shares of common stock and stock options to purchase 292,709 shares of common stock owned by Gil Schwartzberg.

All stock options

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

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

Includes 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.

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

Debbie Schwartzberg.

includes the following:

shares of common stock owned by the Gil Schwartzberg IRA;

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

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

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

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

of common stock owned by the David N.

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

shares of common stock owned by each of the Savannah Sterling Trust, Amanda Sterling Trust, Daniel Sterling Trust and Charles Sterling

Trust, as to which Julie Forman is the trustee;

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

the following:

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

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

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

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

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.

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.

Consists of 150,000 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:

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

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

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

of common stock owned by the David N.

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

shares of common stock owned by each of the Savannah Sterling Trust, Amanda Sterling Trust, Daniel Sterling Trust and Charles Sterling

Trust, as to which Julie Forman is the trustee;

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

the following:

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

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

disclaims beneficial ownership or control;

shares of common stock owned by the Gil Schwartzberg IRA;

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

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

Preferred Stock, and common stock warrants to purchase 210,000 shares of common stock owned by the Arthur and Jane Riggs 1990 Revocable

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

preferred stock.

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

and are immediately convertible into common stock.

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.

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

Preferred Stock owned by the Arthur and Jane Riggs 1990 Irrevocable Trust dated November 18, 1990.

Jane Riggs is the trustee of the Arthur

and Jane Riggs 1990 Irrevocable Trust.

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

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

Consists of 994,299 shares of common stock and common stock warrants to purchase 385,966 shares of common stock owned by the Greenberg

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

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

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

Partners, L.P.

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

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

Excludes stock options to purchase

shares of common stock owned by Dr.

Winson Sze Chun Ho, a former director of of the Company, and the son of Hung Tak Ho, as to which

Hung Tak Ho disclaims beneficial ownership or control.

Includes stock options to purchase 209,375 shares of common stock.

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

2 unchanged sentences

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

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

Consists of 833,333 shares of common stock.

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

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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.

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE

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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.

Director Independence

Company considers Dr.

Philip Palmedo, Dr.

Stephen Forman, Dr.

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

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, P.C.

& Company, P.A.

acted as our independent registered public accounting firm for the fiscal years ended December 31, 2022 and 2021

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

provided by Weinberg & Company, P.C for the years ended December 31, 2020 and 2021.

Ended December 31,

Audit-Related

fees represent fees for 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 Forms S-1, S-3 and S-8 declared effective by the SEC

during the years ended December 31, 2020 and 2021.

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

provided by Weinberg & Company, P.A.

for the years ended December 31, 2022 and 2021.

Years Ended December 31,

Audit Fees (1)

Audit-Related Fees (2)

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

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

during the fiscal years ended

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EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

of documents filed as part of this report:

List of documents filed

as part of this report:

Financial Statements

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

Statement Schedules

Financial Statement Schedules

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

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FORM 10-K SUMMARY

of Underwriter Agreement 22

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

Form of Underwriter Agreement 22

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

Kovach and Lixte Biotechnology, Inc.

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

of Amendment of Certificate of Incorporation 3

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

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

and Restated Bylaws 15

of Amendment of Certificate of Incorporation 23

of Warrant included in Unit 22

of Warrant Agent Agreement 22

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

Agreement between Lixte Biotechnology Holdings, Inc.

Master Agreement between Lixte Biotechnology Holdings, Inc.

and Theradex Systems, Inc.

dated January 12, 2010 4

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

and the National Institute of Neurological

Disorders and Stroke dated October 18, 2013 5

Advisory Board Agreement between Lixte Biotechnology Holdings, Inc.

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

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

Scientific Advisory Board Agreement between Lixte Biotechnology Holdings, Inc.

and NDA Consulting Corp.

dated December 24, 2013 5

Collaboration

Agreement between Lixte Biotechnology Holdings, Inc.

Collaboration Agreement between Lixte Biotechnology Holdings, Inc.

and BioPharmaWorks LLC effective September 14, 2015 7

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

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

Trial Research Agreement between H.

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,

and Lixte Biotechnology Holdings, Inc.

dated and effective as of August 20, 2018 9

License Agreement between H.

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

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

(issued in connection with common stock unit rights offering

that closed on November 30, 2018) 10

Collaboration

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

and the Spanish Sarcoma Group as

of July 31, 2019 (certain portions of this exhibit have been omitted based on a request for confidential treatment filed by the Company

with the Securities and Exchange Commission that was granted on September 19, 2019) 11

Agreement Between the Company and Dr.

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

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

and the Spanish Sarcoma Group as of July 31, 2019 (certain portions of this exhibit have been omitted based on a request for confidential treatment filed by the Company with the Securities and Exchange Commission that was granted on September 19, 2019) 11

Employment Agreement Between the Company and Dr.

James Miser 13+

Agreement Between the Company and Robert N.

Employment Agreement Between the Company and Robert N.

Weingarten 17+

Agreement Between the Company and Dr.

Employment Agreement Between the Company and Dr.

John Kovach 14+

Agreement Between the Company and Eric Forman 15+

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+

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

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

dated as of August 12, 2020 17

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

to Employment Agreement between the Company and Eric Forman 22+

Collaboration Agreement by and between Lixte Biotechnology Holdings, Inc.

and the Netherlands Cancer Institute, Amsterdam, and Oncode

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

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

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*

4 unchanged sentences

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

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

XBRL Taxonomy Extension Scheme Document

XBRL Taxonomy Extension Calculation Linkbase Document

XBRL Taxonomy Extension Label Linkbase Document

XBRL Taxonomy Extension Presentation Linkbase Document

XBRL Taxonomy Extension Definition Linkbase Document

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

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

2006 and incorporated herein by reference.

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

August 3, 2005 and incorporated herein by reference.

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

2006 and incorporated herein by reference.

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

2013 and incorporated herein by reference.

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

2014 and incorporated herein by reference.

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

2015 and incorporated herein by reference.

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

18, 2015 and incorporated herein by reference.

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

2016 and incorporated herein by reference.

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

2018 and incorporated herein by reference.

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

5, 2018 and incorporated herein by reference.

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

2019 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 17,

2020 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 17,

2020 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 17,

2020 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 17,

2020 and incorporated herein by reference.

as an Exhibit to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 17,

2020 and incorporated herein by reference.

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

2020 and incorporated herein by reference.

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

22, 2021 and incorporated herein by reference.

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

November 16, 2020.

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

27, 2020 and incorporated herein by reference.

as an Exhibit to the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 25,

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.

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

10, 2021 and incorporated herein by reference.

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

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.

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.

and Chief Executive Officer

President 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.

and Chief Executive Officer

President and Chief Financial Officer

GIL N SCHWARTZBERG

N Schwartzberg

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

BIOTECHNOLOGY HOLDINGS, INC.

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OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

the Board of Directors and Stockholders

the Stockholders and Board of Directors

Biotechnology Holdings, Inc.

on the Consolidated Financial Statements

on the Financial Statements

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

2 unchanged sentences

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

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

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

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

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.

1 unchanged sentence

cash flows since inception.

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

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.

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.

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.

14 unchanged sentences

Accordingly, we express no such opinion.

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

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

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

the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles used and significant

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

We believe that our audits

provide a reasonable basis for our opinion.

audits included performing procedures to assess the risks of material misstatement of the 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 financial statements that was communicated

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

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

The communication of critical audit matters does

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

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

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

as compensation (the “Equity Awards”).

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

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

The selection of the valuation methodology and assumptions

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

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

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

the grant date fair values.

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

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

interest rate, volatility, and dividend yield.

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

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

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

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

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

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

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

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

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

testing the mathematical accuracy of the valuation analyses.

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

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

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.

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

that management utilized in determining the fair value of the stock-based awards.

This required a high degree of effort and judgement

in selecting auditor procedures to evaluate management’s estimates and assumptions as it relates to the determination of the fair

values of stock-based compensation.

audit procedures related to the of the stock-based awards, including the valuation methodology and related assumptions such as the risk-free

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

obtained 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.

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

have served as the Company’s auditor since 2008.

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BALANCE SHEETS

on research and development contract services

prepaid expenses and current assets

Current assets:

AND STOCKHOLDERS’ EQUITY

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

offering costs

and development contract liabilities

Advances on research and development contract services

Prepaid insurance

Other prepaid expenses and current assets

Total current assets

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

and contingencies

Stockholders’

Stock, $ 0.0001 par value;

Accounts payable and accrued expenses, including $ 46,982 and $ 32,500 to related parties at December 31, 2022 and 2021, respectively

Research and development contract liabilities

Total current liabilities

Commitments and contingencies

Stockholders’ equity:

Preferred Stock, $ 0.0001 par value;

authorized – 10,000,000 shares;

issued and outstanding – 350,000 shares of Series A Convertible

Preferred Stock, $ 10.00 per share stated value, liquidation preference based on assumed conversion into common shares – 729,167

stock, $ 0.0001 par value;

issued and outstanding – 350,000 shares of Series A Convertible Preferred Stock, $ 10.00 per share stated value, liquidation preference based on assumed conversion into common shares – 729,167 shares

Common stock, $ 0.0001 par value;

authorized – 100,000,000 shares;

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

shares at December 31, 2021 and 2020, respectively

paid-in capital

issued and outstanding – 16,646,593 shares and 13,746,593 shares at December 31, 2022 and 2021, respectively

Additional paid-in capital

Accumulated deficit

( 43,394,699 )

( 37,082,164 )

stockholders’ equity

liabilities and stockholders’ equity

Total stockholders’ equity

Total liabilities and stockholders’ equity

accompanying notes to consolidated financial statements.

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STATEMENTS OF OPERATIONS

Ended December 31,

and expenses:

and administrative costs:

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

and licensing legal and filing fees and costs

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

31, 2021 and 2020, respectively

Years Ended December 31,

Costs and expenses:

from operations

General and administrative costs:

Compensation to related parties, including stock-based compensation of $ 1,502,776 and $ 2,201,280 for the years ended December 31, 2022 and 2021, respectively

Patent and licensing legal and filing fees and costs

Other costs and expenses

Research and development costs, including $ 43,264 and $ 397,642 of stock-based compensation costs to a consultant for the years ended December 31, 2022 and 2021, respectively

Total costs and expenses

Loss from operations

( 6,311,481 )

( 6,720,445 )

currency gain (loss)

Interest income

Interest expense

Foreign currency loss

$ ( 6,312,535 )

$ ( 6,728,396 )

loss per common share – basic and diluted

average common shares outstanding – basic and diluted

Net loss per common share – basic and diluted

Weighted average common shares outstanding – basic and diluted

accompanying notes to consolidated financial statements.

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Ended December 31, 2022 and 2021

A Convertible

Series A Convertible

Preferred Stock

Stockholders’

December 31, 2019

Additional Paid-in

Total Stockholders’

Balance, December 31, 2020

$ ( 30,353,768 )

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

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

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

Exercise of warrants, shares

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

Exercise of warrants

Exercise of options

Exercise of options, shares

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

stock issued for services

Stock-based compensation expense

( 6,728,396 )

December 31, 2020

Balance, December 31, 2021

( 37,082,164 )

Balance, value

( 37,082,164 )

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

compensation expense

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

Stock-based compensation expense

( 6,312,535 )

December 31, 2021

Balance, December 31, 2022

$ ( 43,394,699 )

Balance, value

$ ( 43,394,699 )

2 unchanged sentences

STATEMENTS OF CASH FLOWS

Ended December 31,

flows from operating activities:

Years Ended December 31,

Cash flows from operating activities:

$ ( 6,312,535 )

$ ( 6,728,396 )

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

compensation expense included in -

and administrative costs

and development costs

in operating assets and liabilities:

decrease in -

on research and development contract services

interest receivable

prepaid expenses and current assets

(decrease) in -

payable and accrued expenses

and development contract liabilities

cash used in operating activities

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

Stock-based compensation expense included in -

General and administrative costs

Research and development costs

Changes in operating assets and liabilities:

(Increase) decrease in -

Advances on research and development contract services

Prepaid insurance

Other prepaid expenses and current assets

Increase in -

Accounts payable and accrued expenses

Research and development contract liabilities

Net cash used in operating activities

( 4,611,737 )

( 4,142,915 )

flows from financing activities:

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

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

of common stock warrants

of common stock options

of costs incurred in connection with sale of common stock units

cash provided by financing activities

increase (decrease)

at beginning of period

at end of period

disclosures of cash flow information:

investing and financing activities:

offering costs (paid subsequent to December 31, 2020)

Cash flows from financing activities:

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

Exercise of 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)

Balance at beginning of period

Balance at end of period

Supplemental disclosures of cash flow information:

Cash paid for -

accompanying notes to consolidated financial statements.

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Organization and Basis of Presentation

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

Biotechnology, Inc.

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

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

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

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

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

and life-threatening diseases.

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

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

as the LB-200 series of compounds.

Biotechnology Holdings, Inc., a Delaware corporation, including its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc.

(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.

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

2 unchanged sentences

operating requirements.

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

the symbols “LIXT” and.

“LIXTW”, respectively.

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.

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Even if the Company is able to generate revenues through licensing

its technologies or through product sales, there can be no assurance that the Company will be able to achieve positive earnings and operating

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.

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

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and has experienced negative operating cash flows since inception.

The Company has financed its working capital requirements primarily

through the recurring sale of its equity securities.

The Company has financed its working capital requirements through

the recurring sale of its equity securities.

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

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

for the year ended December 31, 2021, has also expressed substantial doubt about the Company’s ability to continue as a going concern.

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

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The amount and timing of future

cash requirements depends on the pace and design of the Company’s clinical trial program, which, in turn, depends on the availability

of operating capital to fund such activities.

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

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

In addition, the Company’s operating plans may

change as a result of many factors which are currently unknown to the Company, including possible additional clinical trials, and the

Company may need additional funds sooner than currently planned.

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

cash requirements depends on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the

availability of operating capital to fund such activities.

on current operating plans, the Company estimates that 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.

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

Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.

is also significant uncertainty as to the effect that the coronavirus pandemic may have on the Company’s clinical trial schedule

and the amount and type of financing available to the Company in the future.

cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back

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

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

balances and transactions have been eliminated in consolidation.

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.

Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated

with serious common diseases and then designing novel compounds to attack those targets.

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.

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

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Significant estimates include those related to assumptions

used in accruals for potential liabilities, valuing equity instruments issued for services, and the realization of deferred tax assets.

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

The Company’s policy is to maintain

its cash balances with financial institutions with high credit ratings and in accounts insured by the Federal Deposit Insurance Corporation

(the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”).

The Company may periodically

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

The financial institution that currently holds the Company’s cash balances also maintains supplemental insurance coverage for its

customers’ cash balances.

The Company has not experienced any losses to date resulting from this practice.

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.

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

(“Morgan Stanley”).

Morgan Stanley is a FINRA-regulated broker-dealer.

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.

and Development

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

design, development and clinical trials with respect to the Company’s compounds and product candidates.

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

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

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charged to operations as incurred.

incurred with respect to mandatory scheduled payments under research agreements with milestone provisions are recognized as charges to

research and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones,

as specified in the agreement.

Obligations incurred with respect to mandatory scheduled payments under research agreements without milestone

provisions are accounted for when due, are recognized ratably over the appropriate period, as specified in the agreement, and are recorded

incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research

and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified

in the respective agreement.

Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions

are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded

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

Company’s consolidated statement of operations.

made pursuant to research and development contracts are initially recorded as advances on research and development contract services

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

statement of operations as those contract services are performed.

Expenses incurred under research and development contracts in excess

of amounts advanced are recorded as research and development contract liabilities in the Company’s consolidated balance sheet,

with a corresponding charge to research and development costs in the Company’s consolidated statement of operations.

reviews the status of its research and development contracts on a quarterly basis.

made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated

balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those

contract services are performed.

Expenses incurred under contracts in excess of amounts advanced are recorded as research and development

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

in the Company’s consolidated statement of operations.

The Company reviews the status of its various clinical trial and research

and development contracts on a quarterly basis.

insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in

excess of the amortization of the total policy premium charged to operations at each balance sheet date.

Such amortization is determined

by amortizing the total policy premium charged on a straight-line basis over the respective policy periods.

Such amount is determined by

amortizing the total policy premium charged on a straight-line basis over the respective policy period.

As the policy premiums incurred

are amortizable in the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated balance

sheet at each reporting date and amortized to the Company’s consolidated statement of operations for each reporting period.

are generally amortizable over the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated

balance sheet at each reporting date and appropriately amortized to the Company’s consolidated statement of operations for each

reporting period.

and Licensing Legal and Filing Fees and Costs

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

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

Patent and licensing legal and filing fees and costs

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

Patent and licensing legal and filing fees and

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

and protection of the Company’s intellectual property are charged to operations as incurred.

Patent and licensing legal and filing

fees and costs were $ 1,268,308 and $ 729,171 for the years ended December 31, 2022 and 2021, respectively.

Patent and licensing legal

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

Concentration

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and 2021 are described as follows.

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

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

general and administrative costs.

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

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

general and administrative costs for those periods.

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

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

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

licensing and patent prosecution costs relating to the Company’s intellectual properties representing 26.5 % and 14.6 % of total

general and administrative costs, respectively.

General and administrative costs for the years ended December 31, 2022 and 2021 also

included charges for the fair value of stock options granted to directors and corporate officers representing 30.3 % and 44.2 %, respectively,

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 %,

15.1 % and 12.1 %, respectively, of total research and development costs.

Research and development costs for the year ended December 31,

31, 2020 include charges from a consultant, and the value associated with extending stock options previously granted to that consultant,

representing 65.6 % of total research and development costs, and charges from a vendor representing 13.7 % of total research and development

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

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

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

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

and does not anticipate any material amount of unrecognized tax benefits through December 31, 2023.

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

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

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

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

from the calculation of diluted EPS.

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

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

options outstanding were anti-dilutive.

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

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

are excluded from the calculation of diluted EPS.

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

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

outstanding were anti-dilutive.

December 31, 2022 and 2021, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire

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

A Convertible Preferred Stock

stock warrants

stock options, including options issued in the form of warrants

Series A Convertible Preferred Stock

Common stock warrants

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

Value of Financial Instruments

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on or after the effective date.

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

If an entity elects

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

that interim period.

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

presentation or disclosures.

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.

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.

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.

of Research and Development Costs

United States

Stockholders’ Equity

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to 1 % of the annual net revenue of the Company divided by 175,000 , until converted or redeemed.

As of December 31, 2021 and 2020, 9,650,000

shares of preferred stock were undesignated and may be issued with such rights and powers as the Board of Directors may designate.

As of December 31, 2022 and 2021, the

Company had 9,650,000 shares of undesignated preferred stock which may be issued with such rights and powers as the Board of Directors

may designate.

share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 2.0833 shares of common stock (subject

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at December 31, 2022 and 2021.

The Company had the right to redeem the Series A Convertible Preferred Stock up to the fifth anniversary

of their respective closing dates (March 17, 2015 and January 21, 2016) at a price per share equal to $ 50.00 .

Accordingly, as of December

31, 2020, the Company had the right to redeem the 175,000 shares of Series A Convertible Preferred Stock that were issued on January

however, that right expired on January 21, 2021.

The Series A Convertible Preferred Stock has no right to cash, except with

respect to the payment of the aforementioned dividend based on the generation of revenues by the Company.

The shares of Series A Convertible

Preferred Stock do not have any registration rights.

The Series A Convertible Preferred Stock has no right to cash, except with respect to the payment of the

aforementioned dividend based on the generation of revenues by the Company.

The shares of Series A Convertible Preferred Stock do not

have any registration rights.

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

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

Each unit consisted of one share of common stock and one warrant to purchase one share of common stock exercisable for five

years at an exercise price of $ 5.70 per share.

Additionally, on December 7, 2020, the Company received an additional $ 1,800 from the

sale of 180,000 warrants as part of the overallotment option granted to the underwriters in the public offering.

The warrants sold are

exercisable for five years and represent the right to purchase one share of common stock at an exercise price of $ 5.70 per share.

total cash costs of the public offering were $ 1,110,451 , resulting in net cash proceeds of $ 4,591,349 .

Pursuant to the underwriting agreement,

the Company also granted warrants to the underwriters to purchase up to 120,000 shares of common stock commencing on May 24, 2021 and

expiring on November 24, 2025, at an exercise price of $ 5.70 per share.

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

financial communications, and strategic consulting services.

The services agreement provided for the issuance of restricted shares of

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

common stock with a per share value of $ 3.65 per share.

February and March 2021, the Company issued 3,000 shares of common stock upon the exercise of 3,000 warrants at $ 5.70 per share and received

cash proceeds of $ 17,100 .

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 cash

proceeds of $ 3,689,761 .

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

up to 113,310 shares of common stock commencing on March 2, 2021 and expiring on March 2, 2026, at an exercise price of $ 3.70 per share.

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

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

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

common stock.

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

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

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 .

April 12, 2022, the Company completed the sale of 2,900,000 shares of common stock at a price of $ 2.00 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 .

Pursuant to the placement agents’ agreement, the Company granted warrants to the placement agents to purchase 290,000

shares of common stock at an exercise price of $ 2.00 per share exercisable through April 14, 2027.

Stock Warrants

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

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

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

Schedule of Warrants Outstanding

outstanding at December 31, 2019

outstanding at December 31, 2020

outstanding at December 31, 2021

exercisable at December 31, 2020

exercisable at December 31, 2021

Number of Shares

Weighted Average

Exercise Price

Weighted Average

Life (in Years)

Warrants outstanding at December 31, 2020

Warrants outstanding at December 31, 2021

( 1,500,000 )

Warrants outstanding at December 31, 2022

Warrants exercisable at December 31, 2021

Warrants exercisable at December 31, 2022

December 31, 2022, the outstanding warrants are exercisable at the following prices per common share:

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

N Schwartzberg

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

Schwartzberg to provide financial

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

assist management in communications with investors and stockholders.

Schwartzberg is currently a significant stockholder and director

of the Company.

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

stock options.

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

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

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

Agreements with Officers

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These employment agreements were automatically renewed

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

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

Company entered into an employment agreement with Dr.

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Kovach under this employment

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

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

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

These amounts were included

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

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

Company entered into an employment agreement with Dr.

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31, 2022 and 2021, the Company paid $ 175,000 and $ 166,667 , respectively, to Dr.

Miser under this employment agreement, which were included

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

Miser under this employment agreement, which costs are

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

Company entered into an employment agreement with Eric J.

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

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

member of the Company’s Board of Directors, and a significant stockholder of and consultant to the Company, and is the son of Dr.

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

to the Company, and is the son of Dr.

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

Julie Forman, the wife of Eric Forman and the daughter of Gil Schwartzberg,

is Vice President of Morgan Stanley Wealth Management, at which firm the Company’s cash is on deposit and the Company maintains

a continuing banking relationship.

Julie Forman, the wife of Mr.

Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley Wealth Management, at which firm the Company’s

cash is on deposit and with which the Company maintains a continuing banking relationship.

Effective May 1, 2021, Mr.

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

During the years

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

Forman under this employment agreement.

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

rendered prior to Mr.

Forman’s appointment as Chief Administrative Officer.

These amounts were included in general and administrative

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

annual salary was increased to $ 175,000 .

Additionally, effective November 6, 2022, Mr.

Forman was promoted to Vice President and Chief

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.

Company entered into an employment agreement with Robert N.

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During the years ended December 31, 2022 and 2021, the Company paid $ 175,000 and $ 156,667 , respectively, to Mr.

under this employment agreement.

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

Weingarten for accounting and

financial consulting services rendered prior to Mr.

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

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

Arrangements for Board of Directors

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

and committee members.

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

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

of operations.

René Bernards to the Board of Directors

as of June 15, 2022, Dr.

René Bernards was appointed to the Company’s Board of Directors as an independent director.

Bernards is a leader in the field of molecular carcinogenesis and is employed by the Netherlands Cancer Institute in Amsterdam.

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.

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.

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:

director compensation - $ 20,000 per year

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

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

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

officers and affiliates are described at Note

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

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.

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, 2021 and 2020 is presented below.

This summary includes

the above-described payments to Mr.

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

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

for their services on the Board of Directors, for the years ended December 31, 2022 and 2021 is as follows:

Summary of Related Party Costs

Related party costs:

Stock-Based Compensation

Company issues common stock and stock options as incentive compensation to directors and as compensation for the services of employees,

contractors, and consultants of the Company.

July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which provides

for the granting of equity-based awards, consisting of stock options, restricted stock, restricted stock units, stock appreciation rights,

and other stock-based awards to employees, officers, directors and consultants of the Company and its affiliates for up to 2,333,333

shares of the Company’s common stock, under terms and conditions as determined by the Company’s Board of Directors.

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

dated July 31, 2020.

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

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

As of December 31, 2021, unexpired stock options for

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

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

and committee members.

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

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

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

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

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

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

quarter-end until fully vested.

Company periodically issues common stock and stock options as incentive compensation to directors and as compensation for the services

of employees, contractors, and consultants of the Company.

July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which was subsequently

approved by the stockholders of the Company.

The 2020 Plan provides for the granting of equity-based awards, consisting of stock options,

restricted stock, restricted stock units, stock appreciation rights, and other stock-based awards to employees, officers, directors and

consultants of the Company and its affiliates, initially for a total of 2,333,333 shares of the Company’s common stock, under terms

and conditions as determined by the Company’s Board of Directors.

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.

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

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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:

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

Schedule of Fair Value of Each Option Award Estimated Assumption

interest rate

dividend yield

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

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

interest rate

dividend yield

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

at Note 7, the Company issued to BioPharmaWorks two stock options, in the form of warrants, to purchase 166,667 shares ( 83,333.5 shares

per warrant) of the Company’s common stock.

The first warrant vested on September 14, 2016 and was exercisable for a period of

five years from the grant date at $ 6.00 per share.

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

five years from the grant date at $ 12.00 per share.

On July 3, 2020, the Company’s Board of Directors approved an extension of

the term of the outstanding warrants to acquire an aggregate of 166,667 shares of the Company’s common stock from September 14,

2020 to September 14, 2025 .

The Company’s closing stock price on July 2, 2020 was $ 5.40 per share.

The fair value of the extension

of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was measured for accounting purposes as the

difference in the fair value of the stock options immediately before and immediately after the extension date and was determined to be

$ 670,715 ($ 4.0242 per share), which was reflected as a charge to general and administrative costs in the consolidated statement of operations

on that date.

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

Risk-free interest rate

Expected dividend yield

Expected volatility

187.7 % to 198.79 %

Expected life

3.5 to 5 years

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

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

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

The options can be exercised on a cashless basis.

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

common stock on the grant date.

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

second and third anniversaries of the grant date.

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

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

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

The remaining unvested portion of the fair value of the stock

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

During the years ended December 31, 2021

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

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

The options 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.

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 .

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

Miser, M.D., Dr.

Miser was granted options

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

Miser was granted stock options

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

The options can be exercised on a cashless basis.

The options have a term of five

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

effective date of the employment agreement.

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

of the second and third anniversaries of the effective date.

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

option-pricing model, was determined to be $ 572,650 ($ 6.8718 per share), of which $ 143,163 was attributable to the stock options fully-vested

on August 1, 2020 and was therefore charged to operations on that date.

The remaining unvested portion of the fair value of the stock

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

During the years ended December 31, 2021 and

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

respectively, with respect to these stock options.

The options 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 effective date of the employment agreement.

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 .

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

Weingarten, Mr.

Weingarten was granted options

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

Weingarten was granted stock

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

The options can be exercised on a cashless basis.

The options have a term of five

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

The options vested as to 25% on August 12, 2020 and August 12, 2021, and will vest 25% on each of the second and third anniversaries

of the grant date.

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

to be $ 400,855 ($ 6.8718 per share), of which $ 100,214 was attributable to the stock options fully-vested on August 12, 2020 and was therefore

charged to operations on that date.

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

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

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

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

to these stock options.

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

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

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.

Palmedo (an aggregate of 200,000 shares), exercisable for a period of five years from the grant date at $ 3.21 per share, which was the

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

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

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

Schwartzberg was granted options exercisable for a period

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

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

until fully vested.

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

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

charged to operations on that date.

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

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

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

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

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 .

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

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

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

The fair value of these stock options, as calculated

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

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

The remaining unvested portion

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

During the year

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

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

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

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

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

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

June 30, 2021, 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 five non-officer directors of the Company stock options to purchase 100,000 shares (a total

of 500,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $ 3.03 per share

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

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

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

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

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

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

common stock.

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

on the issue date).

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

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

operations on that date.

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

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

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,

Baan 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 $ 0.74 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 $ 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 .

June 30, 2022, 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 five non-officer directors of the Company stock options to purchase 100,000 shares (a total

of 500,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $ 0.74 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 $ 316,700 ($ 0.6334 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 .

November 6, 2022, the Board of Directors granted to each of the four officers of the Company stock options to purchase 200,000 shares

(a total of 800,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $ 2.00

per share, vesting 25 % on issuance and 25 % on each anniversary date thereafter until fully vested, subject to continued service.

total fair value of the 800,000 stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be

$ 262,560 ($ 0.3282 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.

November 6, 2022, the Company issued a stock option, in the form of a warrant, to BioPharmaWorks to purchase 100,000 shares of the Company’s

common stock, which was fully vested upon issuance and is exercisable for a period of five years at $ 0.5025 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 $ 43,264 ($ 0.4326 per share) and was charged to general and administrative costs in the consolidated statement of operations on

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

summary of stock-based compensation costs for the years ended December 31, 2022 and 2021 is as follows:

Summary of Stock-based Compensation Costs

stock-based compensation costs

Related parties

Non-related parties

Total stock-based compensation costs

summary of stock option activity, including options issued in the form of warrants, during the years ended December 31, 2022 and 2021

is presented below.

is as follows:

Summary of Stock Option Activity Including Options Form of Warrants

Average Remaining Contractual Life (in Years)

options outstanding at December 31, 2019

adjustment attributable to reverse stock split

Weighted average exercise price, reverse stock split

options outstanding at December 31, 2020

adjustment attributable to reverse stock split

options outstanding at December 31, 2021

options exercisable at December 31, 2020

options exercisable at December 31, 2021

deferred compensation expense for the outstanding value of unvested stock options was approximately $ 2,097,000 at December 31, 2021,

which will be recognized subsequent to December 31, 2021 over a weighted-average period of approximately 18 months.

Number of Shares

Weighted Average

Weighted Average Remaining Contractual Life (in Years)

Stock options outstanding at December 31, 2020

Rounding adjustment attributable to reverse stock split

Stock options outstanding at December 31, 2021

Stock options outstanding at December 31, 2022

Stock options exercisable at December 31, 2021

Stock options exercisable at December 31, 2022

deferred compensation expense for the outstanding value of unvested stock options was approximately $ 882,000 at December 31, 2022, which

will be recognized subsequent to December 31, 2022 over a weighted-average period of approximately 15 months.

exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at December 31,

1 unchanged sentence

Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants

intrinsic value of exercisable but unexercised in-the-money stock options at December 31, 2021 was approximately $ 10,000 , based on a

fair market value of $ 1.19 per share on December 31, 2021.

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.

stock options to acquire 1,075,000 shares of the Company’s common stock had not vested at December 31, 2022.

3 unchanged sentences

Significant components of the Company’s deferred tax assets as

of December 31, 2021 and 2020 are summarized below.

of December 31, 2022 and 2021 are as follows:

Schedule of Components of Deferred Tax Assets

and organization costs

operating loss carryforwards

deferred tax assets

Research credits

Stock-based compensation

Net operating loss carryforwards

Total deferred tax assets

Valuation allowance

( 10,846,000 )

( 8,995,000 )

deferred tax assets

Net deferred tax assets

assessing the potential realization of deferred tax assets, management considers whether it is more likely than not that some portion

11 unchanged sentences

federal statutory tax rate

income taxes, net of federal tax benefit

related to stock-based compensation

to deferred tax asset

in valuation allowance

December 31, 2021, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately

$ 23,173,000 and $ 23,287,000 , respectively.

Federal net operating losses, if not utilized earlier, expire through 2041 .

The state net

operating loss carryovers include approximately $ 19,141,000 that was incurred in the State of New York.

New York tax law requires New

York net operating loss carryovers from years prior to 2015 to be converted, by applying a formula, into a Prior Net Operating Loss Conversion

(PNOLC) subtraction pool.

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.

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.

state net operating loss carryovers include approximately $ 19,141,000 that were incurred in the State of New York.

New York tax law requires

New York net operating loss carryovers from years prior to 2015 to be converted, by applying a formula, into a Prior Net Operating Loss

Conversion (PNOLC) subtraction pool.

The Company may utilize up to 1/10 of the PNOLC subtraction pool, or $ 928,313 , each year.

Unutilized PNOLC

amounts carry forward to succeeding years until they expire in 2035.

In addition, the full New York net operating losses incurred in

post-2015 tax years may be utilized in future tax years.

PNOLC amounts carry forward to succeeding years until they expire in 2035.

In addition, the full New York net operating losses incurred

in post-2015 tax years may be utilized in future tax years.

Post-2015 New York net operating losses expire through 2040 .

The state net operating

loss carryovers also include approximately $ 4,146,000 that was incurred in the State of California.

As the Company’s net operating

losses have yet to be utilized, all previous tax years since 2006 remain subject to adjustment by Federal authorities and other jurisdictions

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

The state net

operating loss carryovers also include approximately $ 8,899,000 that was incurred in the State of California.

addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions of state law, if a

corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in the ownership

of its equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change

tax attributes to offset its post-change income might be limited.

the Company’s net operating losses have yet to be utilized, all previous tax years since 2006 remain subject to adjustment by Federal

authorities and other jurisdictions in which the Company currently operates or has operated in the past.

Commitments and Contingencies

Company may be subject to legal claims and actions from time to time as part of its business activities.

As of December 31, 2021, the

Company was not subject to any pending or threatened legal claims or actions.

As of December 31, 2022 and

2021, the Company was not subject to any pending or threatened legal claims or actions.

Trial Agreements

December 31, 2021, the Company’s contractual commitments pursuant to clinical trial agreements, clinical trial monitoring agreements,

and agreements for the production of LB-100 for clinical use, as described below, aggregated $ 8,646,000 , which are currently scheduled

to be incurred through December 31, 2025.

The Company’s ability to conduct and fund these contractual commitments is subject to

the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of

such funds to the Company’s current or future clinical trial programs.

The Company expects that the full amount of these expenditures

will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration

are not modified or reduced.

Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can

frequently involve a series of changes and modifications over time as clinical data is obtained and analyzed, and are frequently modified,

suspended or terminated before the clinical trial endpoint.

Accordingly, such contractual commitments as discussed herein should be considered

as estimates only based on current clinical assumptions and conditions, and are typically subject to significant revisions over time.

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

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well as to provide funding for the clinical trial.

The goal was to enter approximately 150 patients in this clinical trial over a period

The goal is to enter approximately 150 patients in this clinical trial over a period

of two years.

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standards were adopted subsequent to the production of the Company’s existing LB-100 inventory.

new batch of LB 100 has been prepared and is now undergoing the multitude of analytical studies of the formulated product necessary to

gain approval for use in the European Union.

Regulatory reviews by the European Union have been delayed, as a result of which the final

review of the clinical product by Spanish regulatory authorities will also be delayed.

Accordingly, the clinical trial is now estimated

to begin during the quarter ending June 30, 2022 and be completed by June 30, 2025.

interim analysis of this clinical trial could indicate either inferiority or superiority of LB-100 plus doxorubicin as compared to doxorubicin

A positive study would have the potential to change the standard therapy for this disease after four decades of failure to improve

the marginal benefit of doxorubicin alone.

order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out

the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain.

These tasks included

the synthesis under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the

steps involved by an independent auditor.

The API was then transferred to a vendor that prepares the clinical drug product, also under

GMP conditions documented by an independent auditor.

The clinical drug product was then sent to a vendor to test for purity and sterility,

provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials.

application documenting all steps taken to prepare the clinical drug product for clinical use must be submitted to the appropriate regulatory

authorities for review and approval before being used in a clinical trial.

of December 31, 2022, 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.

October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos

y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead

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.

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.

interim analysis of this clinical trial will be done before full accrual of patients is completed to determine whether the study has

the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone.

A positive study

would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit

of doxorubicin alone.

Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement.

Through December 31, 2021, the Company has paid GEIS an aggregate of $ 67,582 towards the second milestone payment for current work being

done under this agreement.

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,

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be incurred through December 31, 2025.

order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company has engaged a number of vendors to carry

out the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain.

These tasks include

the synthesis under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the

steps involved by an independent auditor.

The API is then transferred to a vendor that prepares the clinical drug product, also under

GMP conditions documented by an independent auditor.

The clinical drug product is then sent to a vendor to test for purity and sterility,

provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials.

application documenting all steps taken to prepare the clinical drug product for clinical use must be submitted to the appropriate regulatory

authorities for review and approval before being used in a clinical trial.

November 2, 2021, the Company entered into a Development Agreement with Famar Health Care Services Madrid SA (“Famar”) to

prepare a new batch of clinical LB-100 for use in clinical trials to be conducted in the European Union.

During the year ended December

31, 2021, the Company incurred costs of $ 119,860 , pursuant to this agreement, which has been included in research and development costs

in the Company’s consolidated statements of operations.

The Company’s aggregate commitment pursuant to this agreement, less

amounts previously paid to date, totaled approximately $ 180,000 as of December 31, 2021, which is expected to be incurred through June

of December 31, 2021, the Company estimates that this program to provide new inventory of the clinical drug product for the Spanish sarcoma

study, and potentially for subsequent multiple trials within the European Union, including the costs incurred and to be incurred with

Famar as described above, will cost approximately $ 1,076,000 .

The Company’s aggregate commitments under this program, less amounts

previously paid to date, totaled approximately $ 318,000 as of December 31, 2021, which are expected to be incurred through December 31,

As the production of the new inventory of the clinical drug product is being conducted in Europe and is paid for in Euros, final

costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.

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

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clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete.

If LB-100 does

potentiate the benefit of the standard regimen, some evidence could be noted at 12 months into the clinical trial, but an assessment

of potential increased activity is likely to require at least 24 months.

The Company is currently seeking to add two additional centers

to increase the rate of accrual.

The Company expects this clinical trial to be completed by June 30, 2024.

the year ended December 31, 2021, the Company incurred costs, and total costs, of $ 378,511 , pursuant to this agreement.

The Company’s

aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 2,433,000 as of December

31, 2021, which is expected to be incurred through December 31, 2024, based upon a target of 42 enrollees.

If a significant number of

patients fail during the dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional

cost of approximately $ 800,000 .

The Company currently expects that enrollment in this clinical trial will range from approximately 18

to 30 enrollees, with 24 enrollees as the most likely number.

Should fewer than 42 enrollees be required, the Company has agreed to compensate

City of Hope on a per enrollee basis.

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.

Cancer Institute Pharmacologic Clinical Trial.

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clinical trial.

During the fourth quarter of 2019, the NCI enrolled the first two patients of a planned eight patient pharmacologic study

of the ability of LB-100 to enter the brain and penetrate recurrent brain tumors in patients where surgical removal of the cancers is

indicated (clinical trials registry NCT03027388).

This study is being conducted and funded by the NCI under a Cooperative Research and

Development Agreement, with the Company being required to provide the LB-100 clinical compound.

This study is being conducted and funded by the NCI under a Cooperative Research and Development Agreement, with the

Company being required to provide the LB-100 clinical compound.

malignant brain tumors (gliomas) are very challenging to treat.

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present and to determine whether the cells in the tumors show the biochemical changes expected to be present if LB-100 reaches its molecular

The goal is to obtain data in up to eight patients.

As a result of the innovative design of the NCI study, data from so few patients

should be sufficient to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100

to the standard treatment regimen for GBMs.

neurosurgical unit at the NCI, which had been closed due to the Covid-19 epidemic, has reopened, and patient accrual has resumed.

entry remains at two, with the goal to enter eight patients before analyzing results.

There is an urgent need to improve therapy for

this type of aggressive brain tumor.

If the NCI study shows that LB-100 does penetrate the brain, a clinical study of LB-100 in combination

with standard therapy for GBM, the drug temozolomide and radiation, both of which have been well documented in pre-clinical studies to

be significantly enhanced by LB-100, would be of significant interest to neuro-oncologists frustrated by decades of limited advances

in therapy for this common brain tumor in adults.

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.

Trial Monitoring Agreements

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accrual, the clinical trial is expected to be completed by June 30, 2025.

under this work order agreement are estimated to be approximately $ 954,000 , with such payments expected to be divided approximately 94%

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 the periodic documentation provided by the CRO.

years ended December 31, 2021 and 2020, the Company incurred costs of $ 9,750 and $ 18,663 , respectively, pursuant to this work order.

As of December 31, 2021, total costs of $ 91,885 have been incurred pursuant to this work order agreement.

The Company’s aggregate

commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $ 868,000

as of December 31, 2021, which is expected to be incurred through June 30, 2025.

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.

On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated

clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party.

During the year ended

December 31, 2021, the Company incurred costs of $ 24,626 , pursuant to this work order.

As of December 31, 2021, total costs of $ 24,626

have been incurred pursuant to this work order agreement.

The Company’s aggregate commitment pursuant to this clinical trial monitoring

agreement, less amounts previously paid to date, totaled approximately $ 314,000 as of December 31, 2021, which is expected to be incurred

through June 30, 2025.

Costs under this

work order agreement are estimated to be approximately $ 335,000 .

During the years ended December 31, 2022 and 2021, 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.

and License Agreements

March 22, 2018, the Company entered into a Patent Assignment and Exploitation Agreement with INSERM TRANSFERT SA, acting as delegatee

of the French National Institute of Health and Medical Research, for the assignment to the Company of INSERM’S interest in United

States Patent No.

9,833,450 entitled “Oxabicyloheptanes and Oxabicycloheptenes for the Treatment of Depressive and Stress Disorders”,

which was filed with the United States Patent and Trademark Office in the name of INSERM and the Company as co-owners on February 19,

2015 and granted on May 12, 2017, and related patent applications and filings.

INSERM is a French public institution dedicated to research

in the field of health and medicine that had previously entered into a Material Transfer Agreement with the Company to allow INSERM to

conduct research on the Company’s proprietary compound LB-100 and/or its analogs for the treatment of depressive or stress disorders

Pursuant to the Agreement, the Company has agreed to make certain milestone payments to INSERM aggregating up to $ 1,750,000

upon achievement of development milestones and up to $ 6,500,000 upon achievement of commercial milestones.

The Company also agreed to

pay INSERM certain commercial royalties on net sales of products attributed to the Agreement.

The Company’s initial plan was to

complete the validation process to evaluate LB-100 for the treatment of depressive or stress disorders in humans within three years;

however, the exploitation of this patent for the treatment of depressive and stress disorders in humans will require substantial additional

capital and/or a joint venture or other type of business arrangement with a pharmaceutical company with substantially greater capital

and business resources than those available to the Company.

As there can be no assurances that the Company will be able to obtain the

capital or business resources necessary to focus on the exploitation of this patent, it is uncertain as to when, if at all, the Company

may reach any of the development or commercialization milestones under the Agreement.

As of December 31, 2021 and 2020, no amounts were

due under this agreement.

August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt.

Pursuant to the License Agreement, Moffitt granted

the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating to the treatment

of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results, clinical data,

and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents or the use,

development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under the Licensed

The Company was obligated to pay Moffitt a non-refundable license issue fee of $ 25,000 after the first patient is entered into

a Phase 1b/2 clinical trial to be managed and conducted by Moffitt.

The clinical trial began at a single site in April 2019 and the first

patient was entered into the clinical trial in July 2019.

The Company is also obligated to pay Moffitt an annual license maintenance

fee of $ 25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the Company commences

payment of minimum royalty payments.

The Company has also agreed to pay non-refundable milestone payments to Moffitt, which cannot be

credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones aggregating $ 1,897,000 ,

subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in the License

During the years ended December 31, 2021 and 2020, the Company recorded charges to operations of $ 24,999 and $ 25,001 , respectively,

in connection with its obligations under the License Agreement.

Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt.

Pursuant to the License Agreement,

Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating

to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results,

clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents

or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under

the Licensed Patents.

The Company was obligated to pay Moffitt a non-refundable license issue fee of $ 25,000 after the first patient

was entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt.

The clinical trial began at a single site in April

2019 and the first patient was entered into the clinical trial in July 2019.

The Company is also obligated to pay Moffitt an annual license

maintenance fee of $ 25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the Company

commences payment of minimum royalty payments.

The Company has also agreed to pay non-refundable milestone payments to Moffitt, which

cannot be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones aggregating

$ 1,897,000 , subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term is defined in

the License 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.

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party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination for cause.

employment agreements were automatically renewed for an additional one-year period in July and August 2021.

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.

Forman, the Company’s Chief Administrative Officer,

Miser, the Company’s Chief Medical Officer, and Robert N.

Weingarten, the Company’s Chief Financial Officer,

Miser, and Robert N.

under the employment agreements, such that the total aggregate annual compensation of all officers increased to $ 775,000 , effective May

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.

Significant Agreements and Contracts

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

for consultation and advice in the field of oncology

research and drug development.

Consulting Corp.

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

for consultation and advice

in the field of oncology research and drug development.

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

Von Hoff, M.D., to become

a member of the Company’s Scientific Advisory Committee.

The term of the agreement was for one year and provided for a quarterly

cash fee of $ 4,000 .

The agreement has been automatically renewed for additional one-year terms on its anniversary date since 2014.

and advisory fees charged to operations pursuant to this agreement were $ 16,000 and $ 16,000 for the years ended December 31, 2021 and

2020, respectively, which were included in research and development costs in the consolidated statements of operations.

September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged BioPharmaWorks

to perform certain services for the Company.

Those services included, among other things:

(a) assisting the Company to (i) commercialize

its products and strengthen its patent portfolio, (ii) identify large pharmaceutical companies with potential interest in the Company’s

product pipeline, and (iii) prepare and deliver presentations concerning the Company’s products;

(b) at the request of the Board

of Directors, serving as backup management for up to three months should the Company’s Chief Executive Officer and scientific leader

be temporarily unable to carry out his duties;

and (d) identifying

providers and overseeing tasks relating to clinical use and commercialization of new compounds.

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

The term of the agreement was for one year

and provided for a quarterly cash fee of $ 4,000 .

The agreement has been automatically renewed for additional one-year terms on its anniversary

date since 2014.

Consulting and advisory fees charged to operations pursuant to this agreement 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.

BioPharmaWorks .

Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged

BioPharmaWorks to perform certain services for the Company.

Those services included, among other things, assisting the Company to commercialize

its products and strengthen its patent portfolio;

identifying large pharmaceutical companies with a potential interest in the Company’s

product pipeline;

assisting in preparing technical presentations concerning the Company’s products;

consultation in drug discovery

and development;

and identifying providers and overseeing tasks relating to clinical development of new compounds.

BioPharmaWorks

was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience.

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Company agreed to pay BioPharmaWorks a monthly fee of $ 10,000 , subject to the right of the Company to pay a negotiated hourly rate in

lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation.

The Company recorded charges to

operations pursuant to this Collaboration Agreement of $ 120,000 and $ 120,000 for the years ended December 31, 2021 and 2020, respectively,

lieu of the monthly payment, and agreed to issue to BioPharmaWorks certain equity-based compensation (see Note 6).

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.

August 12, 2020, the Company entered into a Master Service Agreement with the Foundation for Angelman Syndrome Therapy (FAST) to collaborate

in supporting pre-clinical studies of the potential benefit of LB-100 in a mouse model of Angelman Syndrome (AS) as reported in The Proceedings

of The National Academy of Science (Wang et al, June 3, 2019).

The pre-clinical studies will be conducted at The University of California

- Davis under the direction of Dr.

David Segal, an internationally recognized leader in AS research.

If the pre-clinical studies confirm

that LB-100 reduces AS signs in rodent models, the Company has agreed to enter into discussions with FAST with respect to possible collaborations

to most efficiently assess the benefit of LB-100 in patients with AS, which is a rare disease affecting an estimated one out of 12,000

to one out of 20,000 persons in the United States.

The genetic cause of AS, reduced function of a specific maternal gene called Ube3,

has been understood for some time, but the molecular abnormality resulting from the genetic lesion has now been shown to be increased

concentrations of protein phosphatase 2A (PP2A), a molecular target of the Company’s investigational compound, LB-100.

has agreed to provide FAST with a supply of LB-100 to be utilized in the conduct of this study, which is initially expected to be completed

within three years.

Conditioned on FAST’s completion of this study, the Company has agreed to pay FAST five percent ( 5 %) of all

proceeds, as defined in the Master Service Agreement, received by the Company, up to a maximum of $ 250,000 from the exploitation of the

study results.

research team at the University of California, Davis recently completed their pre-clinical study of the potential benefit of LB-100 in

a mouse model of AS, and the results are currently under review by FAST.

The preliminary analysis indicates that the positive results

previously reported by Chinese investigators were not confirmed in the US model.

The Company is awaiting input from FAST as to whether

it intends to continue to pursue pre-clinical studies of LB 100.

October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam (NKI),

one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center,

to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers,

as well as to identify the specific molecular mechanisms underlying the identified combinations.

The Company has agreed to fund the study

and provide a sufficient supply of LB-100 to conduct the study.

The study is expected to take approximately two years to conduct.

the year ended December 31, 2021, the Company incurred charges in the amount of $ 55,248 , with respect to this agreement, which amount

is included in research and development0 costs in the Company’s consolidated statements of operations.

of the Novel Coronavirus (Covid-19) on the Company’s Business Activities

global outbreak of the novel coronavirus (Covid-19) has led to disruptions in general economic activities worldwide, as businesses and

governments have taken broad actions to mitigate this public health crisis.

light of the uncertain and continually evolving situation relating to the spread of Covid-19, this pandemic could pose a risk to the

The extent to which the coronavirus may impact the Company’s business activities will depend on future developments, which

are highly uncertain and cannot be predicted at this time.

The Company intends to continue to monitor the situation and may adjust its

current business plans as more information and guidance become available.

coronavirus pandemic presents a challenge to medical facilities worldwide.

As the Company’s clinical trials are conducted on an

outpatient basis, it is not currently possible to predict the full impact of this developing health crisis on such clinical trials, which

could include delays in and increased costs of such clinical trials.

Current indications from the clinical research organizations conducting

the clinical trials for the Company are that such clinical trials are being delayed or extended for several months or more as a result

of the coronavirus pandemic.

the near term, there is also significant and continuing uncertainty as to the effect that the coronavirus may have on the capital markets

in general and on the amount and type of financing available to the Company in particular.

Company is continuing to monitor the situation and will adjust its current business and financing plans as more information and guidance

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.

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.

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,

Risks Associated with the Company’s Business Activities

The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout

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.

Chain Issues.

The Company does not currently expect that supply chain issues will have a significant impact on its business activities,

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,

affect the Company.

Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance

become available.

1 unchanged sentence

Company performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with the SEC.

There were no material subsequent events which affected, or could affect, the amounts or disclosures in the consolidated financial statements.

Other than the matter noted 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 .

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