What changed in this filing

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Item 9A. Controls and Procedures

2025-03-24 compared with 2024-03-19 · 1243 added, 935 removed, 1677 unchanged (56% of the section changed)

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

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

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

corporate website (www.lixte.com).

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directors and executive officers are as follows:

Held with the Company

Held with Company

Chief Executive Officer, and Chairman of the Board of Directors

Medical Officer

President and Chief Financial Officer

President and Chief Operating Officer

and Chief Medical Officer

President and Chief Financial Officer, Secretary

René Bernards

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

Effective September

26, 2023, Mr.

September 26, 2023, Mr.

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

Kovach, as President and Chief Executive Officer.

passed away on October 5, 2023.

Kovach passed away on October 5, 2023.

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

van der Baan was appointed as

Chairman of the Board of Directors.

van der Baan was

appointed as Chairman of the Board of Directors.

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

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

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

van der Baan joined Kreatech,

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

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

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

Miser is a pediatric hematologist/oncologist, internationally

recognized as an expert in the study and treatment of childhood cancers.

His outstanding career includes leadership positions as Clinical

Director, Department of Pediatrics, Division of Pediatric Hematology/Oncology, Children’s Hospital and Medical Center and Associate

Member, Fred Hutchinson Cancer Research Center, Seattle, Washington;

Chairman, Division of Pediatrics, Director, Department of Pediatric

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

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

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

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

trials at institutional and national cancer study groups.

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

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

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

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

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

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

Schellens, M.D., Ph.D.

Schellens was appointed as our Chief Medical Officer effective August 1, 2024.

Schellens has more than 25 years of clinical experience

as a medical oncologist, pharmacologist and clinical pharmacologist, including more than two decades developing and bringing new drugs

Co-author of more than 900 publications in peer-reviewed scientific journals, Dr.

Schellens has held leadership positions

at the Netherlands Cancer Institute in Amsterdam and the Dr.

Daniel den Hoed Clinic-Erasmus University in Rotterdam.

He was professor

of clinical pharmacology at Utrecht University in the Netherlands, where he earned his M.D.

degree, and he served as a board member and

Chief Medical Officer of Byondis B.V.

from January 2019 through September 2023.

He also earned a Ph.D.

degree in Pharmaceutical Sciences

from Leiden University in Leiden, Netherlands.

Schellens served for 17 years as a board member of the Dutch Medicines Evaluation

Board and for 12 years as a member and chairperson of the Scientific Advisory Board Oncology of the EMA.

From 2016 to the present, he

has served as a part-time Chief Medical Officer of Modra Pharmaceuticals B.V., an Amsterdam-based company that successfully completed

a Phase 2b clinical study of ModraDoc006/r, a boosted oral taxane therapeutic, in contrast to the standard-of-care IV chemotherapy docetaxel,

in patients with prostate cancer.

Schellens plays a leadership role in the planning, implementation and oversight of the Company’s clinical trials and is responsible

for assisting in the development of strategic clinical goals and the implementation and safety monitoring of investigational studies.

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

He is responsible for the regulatory strategy and implementation of the strategy and the primary contact for regulators.

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

of appropriate clinical studies needed for the successful registration of therapeutics products.

Schellens services are principally

rendered in the Netherlands.

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

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

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

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

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

Weingarten was a Director of Guardion Health Sciences, Inc.

since June 2015 and was Chairman of its Board of Directors from July 2020

through October 2024.

Weingarten also served on the audit, compensation, and nominating and corporate governance committees of Guardion

Health Sciences, Inc.

during such period.

Previously, Mr.

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

received a B.A.

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

January 2017 through March 2020.

Weingarten received a B.A.

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

in Finance from the University of Southern California

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

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.

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

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

Forman earned a B.A.

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

from the Benjamin N.

Cardozo School of Law.

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

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

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

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that have only modest activity on their own.

Advisory Committee

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

human molecular pathology;

the clinical management

of human brain tumors;

and medicinal chemistry.

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

The committee has been

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

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

The committee currently consists of one member, as

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

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

He is also Chief Scientific Officer for US Oncology and

for Scottsdale Healthcare’s Clinical Research Institute.

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

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

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

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

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

At present, he and his colleagues

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

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

Von Hoff received the 2010 David A.

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

improvement in patient care.

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

Von Hoff is the past President

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

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

He is a founder of ILEX™ Oncology,

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

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

and, Editor-in-Chief

of Molecular Cancer Therapeutics.

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

Relationships

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

Stephen Forman and son-in-law of former board

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

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

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

a continuing banking relationship.

Forman, the Company’s Vice President and Chief Operating Officer during the years ended December 31, 2024, 2023 and 2022 was the

son of board member Dr.

Stephen Forman and the son-in-law of former board member Gil Schwartzberg, who passed away on October 30, 2022.

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

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

Eric Forman resigned

as Vice President and Chief Operating Officer of the Company effective December 31, 2024.

of Our Board of Directors

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

Bas van der Baan was late in filing his

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

Rene Bernards was late in filing his Form

4 in connection with the grant of stock options on June 30, 2024, and Rene Bernards, Yun Yen, Regina Brown and Stephen Forman were late

in filing their Form 4’s in connection with the grant of stock options on September 30, 2024.

EXECUTIVE COMPENSATION

AND DIRECTOR COMPENSATION

Compensation Table

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

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COMPENSATION TABLE

Stock Awards ($)

Option Awards ($)(1)

Non-Equity Incentive Plan Compensation ($)

Non-Qualified Deferred Compensation Earnings ($)

All Other Compensation ($)

Bas van der Baan (6)

Incentive Plan Compensation

Non-Qualified

Deferred Compensation Earnings

Other Compensation

van der Baan (6)

Weingarten (4)

Schellens (7)

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

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Kovach terminated upon his death on October 5, 2023.

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

Miser was appointed as Chief Medical Officer on August 1, 2020.

In connection with his employment agreement, Dr.

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

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

On May 29, 2024, the Company elected not to renew its employment agreement

Miser, as a result of which such employment agreement expired on July 31, 2024.

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

In connection with his employment

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

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

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

In connection with his employment agreement,

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Effective November 6, 2022, Mr.

Forman was promoted to Vice President and Chief Operating Officer.

Forman was appointed as Vice President and Chief Operating Officer.

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

share and valued at $3.282 per share.

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

The employment agreement with Mr.

Forman terminated upon his resignation as an officer of the Company

effective December 31, 2024.

Bas van der Baan was appointed as President and Chief Executive Officer on September 26, 2023.

In connection with his employment agreement,

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and valued at $1.612 per share.

The compensation information provided herein excludes compensation as a Director received before his

appointment as President and Chief Executive Officer.

On May 31, 2024, the Company entered into a consulting agreement with Dr.

Schellens, M.D., Ph.D., Pursuant to the agreement,

effective July 1, 2024, the Company engaged Dr.

Schellens as a consultant, and, effective August 1, 2024, as the Company’s Chief

Medical Officer.

In connection with his employment agreement, Mr.

Schellens was awarded an option grant for 15,000 shares of common stock

exercisable for a period of five years at $2.39 per share and valued at $1.938 per share.

were no option exercises by officers during the years ended December 31, 2024, 2023 or 2022.

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Bas van der Baan

June 17, 2022 (1)

June 17, 2022

June 17, 2027

June 30, 2023 (1)

September 30, 2023

June 30, 2028

September 26, 2023

December 31, 2023

September 26, 2028

November 6, 2022

October 5, 2024

August 1, 2020

September 30, 2024

August 1, 2020

November 6, 2022

July 31, 2025

November 6, 2022

July 31, 2025

August 12, 2020

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November 6, 2022

November 6, 2027

December 31, 2025

(1) Granted in his capacity as a Director before date of officer appointment on September 26, 2023.

on a fair market value of $2.03 per share on December 31, 2024, the intrinsic value attributed to exercisable but unexercised common

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The employment agreements

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

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

end of the applicable one-year period, or by death, or by termination for cause.

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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

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

Forman was also granted stock options to acquire 5,833 shares of the Company’s common stock.

The effective date

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

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

renewable for additional one-year periods unless terminated by either party upon 60 days written notice prior to the end of the applicable

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

The employment agreement with Mr.

Forman terminated upon his resignation

as an officer of the Company effective December 31, 2024.

James Miser .

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annual salary was increased to $175,000.

Under the employment agreement, Dr.

Miser plays a leadership role in planning, implementation

and oversight of clinical trials.

Miser is responsible for assisting and developing strategic clinical goals and the implementation

and safety monitoring of investigational studies.

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

for the oversight of third party CRO monitors.

Miser works closely with the Company’s Chief Executive Officer on the development

of specific goals needed to ensure the timely implementation of appropriate clinical studies needed for successful FDA approval of therapeutic

products and the clinical development of new drugs.

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

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

Miser was also granted stock options to acquire 8,334 shares of the Company’s common stock.

The effective date

of the agreement was August 1, 2020 and remains in effect until the earlier of (i) one year from the effective date, automatically renewable

for additional one-year periods unless terminated by either party upon 60 days written notice prior to the end of the applicable one-year

period, (ii) his death, or (iii) termination for cause.

The effective date of the agreement

was August 1, 2020 and remained in effect until the earlier of (i) one year from the effective date, automatically renewable for additional

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

his death, or (iii) termination for cause.

On May 29, 2024, the Company elected not to renew its employment agreement with Dr.

as a result of which such employment agreement expired on July 31, 2024.

Schellens, M.D., Ph.D.

On May 31, 2024, the Company entered into a consulting agreement with Dr.

Schellens, M.D.,

Pursuant to the agreement, effective July 1, 2024, the Company engaged Dr.

Schellens as a consultant, and, effective August 1,

2024, as the Company’s Chief Medical Officer.

The term of the agreement is in effect from July 1, 2024 until the earliest of (i)

termination by either party upon sixty days’ notice, (ii) Dr.

Schellens’ death or disability, or (iii) termination by the

Company for breach as provided in the agreement.

Under the agreement, Dr.

Schellens provides his services for two days per week with

the specific days in each week based on arrangements agreed to from time to time between Dr.

Schellens and the Company’s Chief

Executive Officer.

The Company pays Dr.

Schellens an annual compensation of 104,000 Euros (approximately $108,000 as of December 31,

2024), payable on a monthly basis.

On July 1, 2024, in connection with the consulting agreement, Dr.

Schellens was granted stock options

to purchase 15,000 shares of the Company’s common stock.

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

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5,833 shares of the Company’s common stock.

The effective date of the agreement was August 12, 2020 and remains in effect until

The effective date of the agreement was August 12, 2020 and remained in effect until

the earlier of (i) one year from the effective date, automatically renewable for additional one-year periods unless terminated by either

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

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

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.

Consideration under this consulting agreement, including amendments

thereto, was paid exclusively in the form of stock options.

On August 2, 2018, the Company entered into a third amendment to the consulting

agreement to extend it to January 28, 2024, as well as to extend the exercise date of previously issued, fully-vested stock options for

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

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

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

Directors terminated.

of Directors Compensation

January 6, 2021, in recognition of their service as directors of the Company over the past year, the Company granted stock options to

purchase 5,000 shares of common stock to each of Dr.

Winson Sze Chun Ho, Dr.

Stephen Forman, and Dr.

Philip Palmedo (an

aggregate of 20,000 shares), which were fully vested upon issuance and exercisable for a period of five years at $32.10 per share, which

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

The fair value of these stock options, as calculated

pursuant to the Black-Scholes option-pricing model, was determined to be $571,312 ($28.566 per share) and was charged to general and

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

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

in academic medicine.

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

Ho’s resignation.

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

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

Schwartzberg was granted stock options to purchase 25,000

shares of the Company’s common stock, exercisable for a period of five years at an exercise price of $32.00 per share (the closing

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

quarter-end until fully 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 ($30.144 per share), of which $376,800 was attributable to the portion of the stock

options fully vested on April 9, 2021 and was therefore charged to operations on that date.

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 and his service on the Board of Directors terminated.

During the years ended

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

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

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

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

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

(a total of 80,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $20.00

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 80,000 stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be

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

For the years

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

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

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

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

Compensation Table

June 30, 2024, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the

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

of 40,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $2.37 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 $73,976 ($1.8494 per share), which is being charged to operations ratably from July 1, 2024 through June 30, 2026.

During the year ended December 31, 2024, the Company record a charge general and administrative costs in the consolidated statement of

operations of $18,648 with respect to these stock options.

June 30, 2024, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officer

directors of the Company a total of 16,598 stock options to purchase shares of the Company’s common stock, exercisable for a period

of five years at an exercise price of $2.37 per share (the closing market price on the grant date) The stock options were granted in

lieu of cash compensation, are exercisable for a period of five years and were immediately vested.

The number of stock options granted

to each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitled

to receive for the quarter ended June 30, 2024, divided by their quarterly value as determined pursuant to the Black-Scholes option-pricing

model, and was determined to be $27,500 ($1.6570 per share), which was charged to operations on June 30, 2024, the date on which the

stock options were fully vested.

September 30, 2024, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officer

directors of the Company a total of 21,217 stock options to purchase shares of the Company’s common stock, exercisable for a period

of five years at an exercise price of $1.87 per share (the closing market price on the grant date) The stock options were granted in

lieu of cash compensation, are exercisable for a period of five years and were immediately vested.

The number of stock options granted

to each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitled

to receive for the quarter ended September 30, 2024, divided by their quarterly value as determined pursuant to the Black-Scholes option-pricing

model, and was determined to be $27,500 ($1.2961 per share), which was charged to operations on September 30, 2024, the date on which

the stock options were fully vested.

January 20, 2025, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officer

directors of the Company a total of 16,665 stock options to purchase shares of the Company’s common stock, exercisable for a period

of five years at an exercise price of $2.33 per share (the closing market price on the grant date) The stock options were granted in

lieu of cash compensation, are exercisable for a period of five years and were immediately vested.

The number of stock options granted

to each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitled

to receive for the quarter ended December 31, 2024, divided by their grant date value as determined pursuant to the Black-Scholes option-pricing

model, and was determined to be $27,500 ($1.65002 per share).

The grant date value of the stock options of $27,500 was accrued at December

31, 2024 and charged to operations at that date.

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

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Name and Principal

Stock Awards ($)

Option Awards

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All Other Compensation

Winson Sze Chun Ho

Gil Schwartzberg

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

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

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

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

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

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

form of cash.

Bernards received all of his compensation from June 15, 2022 through

March 31, 2024 in the form of cash.

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

compensation received after appointment as President and Chief Executive Officer on September 26, 2023.

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

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

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

Advisory Committee Compensation

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, $16,000 and $16,000 for the years ended December 31,

Advisory Committee;

Scientific Advisory Committee was established to advise the Company’s management in three areas:

human molecular pathology;

clinical management of human brain tumors;

and medicinal chemistry.

Members of the Scientific Advisory Committee do not serve in any

management capacity with the Company.

During the years ended December 31, 2024, 2023 and 2022, the Scientific Advisory Committee consisted

of one member, Dr.

Von Hoff, M.D.

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

for consultation and advice in the field

of oncology research and drug development.

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

Von Hoff, M.D., serve on the Company’s Scientific Advisory Committee during the term of such consulting agreement.

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

The consulting agreement had been automatically

renewed for additional one-year terms on its anniversary date, most recently on December 24, 2023, but was subsequently terminated by

mutual agreement effective September 30, 2024.

As a result of the termination of the consulting agreement effective September 30, 2024,

Von Hoff also ceased to be a member of the Scientific Advisory Committee at that time.

and advisory fees charged to operations pursuant to this consulting agreement were $12,000, $16,000 and $16,000 for the years ended December

31, 2024, 2023 and 2022, respectively, which were included in research and development costs in the consolidated statements of operations.

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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

the interests of participants with the interests of stockholders 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;

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to a maximum aggregate of 750,000 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 maximum number of shares that

may be issued pursuant to the exercise of ISOs is also 750,000.

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

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Name and Address of Beneficial Owner

Amount and Nature

of Beneficial

Percent of Class

Officers and Directors

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Pasadena, California 91101

680 East Colorado Boulevard, Suite 180

Pasadena, California 91101

All officers and directors as a group (9 persons)

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Pasadena, California 91101

John and Barbara Kovach 2015 Trust

Krinsky, Trustee

680 East Colorado Boulevard, Suite 180

Pasadena, California 91101

Arthur and Jane Riggs 1990 Irrevocable Trust

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owned by the trust.

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

Kovach and his wife, Barbara C.H.

Kovach, as grantors, to the John and

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

The primary beneficiaries of the trust are the two adult daughters

of John and Barbara Kovach.

Krinsky is the trustee of the trust.

Includes stock options to purchase 17,500 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.

includes the following:

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

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

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

Julie (Schwartzberg) Forman is the trustee and beneficiary.

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

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

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

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

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

Trust, as to which Julie Forman is the trustee.

Consists of 25,000 shares of common stock.

Includes 5,263 shares of common stock, stock warrants to purchase 5,263 shares of common stock and stock options to purchase 46,563 shares

of common stock.

Includes 25,000 shares of common stock and stock options to purchase 13,203 shares of common stock.

Consists of stock options to purchase 20,833 shares of common stock.

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Includes 630 shares of common stock and stock options to purchase 67,423 shares of common stock.

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

of common stock.

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE

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& Company, P.A.

acted as our independent registered public accounting firm for the fiscal years ended December 31, 2023 and 2022

and for the interim periods in such fiscal years.

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

provided by Weinberg & Company, P.A.

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

2024 and 2023 and for the interim periods in such fiscal years.

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

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

for the years ended December 31, 2024 and 2023.

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Other Fees (4)

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

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

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

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

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

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

Company’s financial statements and not reported above under Audit Fees.

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

fees represent fees incurred with respect to our Registration Statements on Form S-3 and Form S-8.

fees represent fees incurred with respect to the Company’s Registration Statements on Form S-1 and Form S-3.

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

during the fiscal years ended

December 31, 2023 and 2022 were pre-approved by either our Audit Committee or by our Board of Directors.

The Board of Directors has adopted

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

December 31, 2024 and 2023 were pre-approved by either the Company’s Audit Committee or by the Company’s Board of Directors.

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

by its independent registered public accounting firm.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

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

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

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

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

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

FORM 10-K SUMMARY

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Kovach and Lixte Biotechnology, Inc., filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 7, 2006 and incorporated herein by reference.

Certificate of Incorporation, as filed with the Delaware Secretary of State on May 24, 2005, filed as Exhibit 3.1 to the Company’s Registration Statement on Form 10-SB, as filed with the Securities and Exchange Commission on August 3, 2005 and incorporated herein by reference.

Certificate of Incorporation, as filed with the Delaware Secretary of State on May 24, 2005, f iled as Exhibit 3.1 to the Company’s Registration Statement on Form 10-SB, as filed with the Securities and Exchange Commission on August 3, 2005 and incorporated herein by reference.

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

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

Form of Common Stock Purchase Warrant, filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on February 13, 2025 and incorporated herein by reference.

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

Form of Placement Agent Warrant, filed as Exhibit 4.2 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on February 13, 2025 and incorporated herein by reference.

Master Agreement between Lixte Biotechnology Holdings, Inc.

and Theradex Systems, Inc.

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

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

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

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

Scientific Advisory Board Agreement between Lixte Biotechnology Holdings, Inc.

and NDA Consulting Corp.

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

Clinical Trial Agreement dated as of June 10, 2024 between the Company and the Netherlands Cancer Institute, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on June 14, 2024 and incorporated herein by reference.

Collaboration Agreement between Lixte Biotechnology Holdings, Inc.

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and the Spanish Sarcoma Group as of July 31, 2019 (certain portions of this exhibit have been omitted based on a request for confidential treatment filed by the Company with the Securities and Exchange Commission that was granted on September 19, 2019), filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on August 6, 2019 and incorporated herein by reference.

Employment Agreement Between the Company and Dr.

James Miser, filed as Exhibit 10.03 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 17, 2020 and incorporated herein by reference.+

Amendment No.

1 to Collaboration Agreement dated March 11, 2025 for an Investigator-Initiated Clinical Trial between Lixte Biotechnology Holdings, Inc.

and the Spanish Sarcoma Group as of July 31, 2019, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on March 14, 2025 and incorporated herein by reference.

Consulting Agreement between the Company and Dr.

Jan Schellens, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on June 5, 2024 and incorporated herein by reference.+

Employment Agreement between the Company and Robert N.

Weingarten, filed as Exhibit 10.02 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on August 18, 2020 and incorporated herein by reference.+

Employment Agreement Between the Company and Eric Forman, filed as Exhibit 10.02 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 17, 2020 and incorporated herein by reference.+

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

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

Lixte Technology Holdings, Inc.

Lixte Biotechnology Holdings, Inc.

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

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Investigator-Initiated Clinical Research Support Agreement between City of Hope National Medical Center and City of Hope Medical Foundation and Lixte Biotechnology Holdings, Inc., filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on January 22, 2021 and incorporated herein by reference.

Collaboration Agreement by and between Lixte Biotechnology Holdings, Inc.

and the Netherlands Cancer Institute, Amsterdam, and

Oncode Institute, Utrecht, entered into on October 8, 2021 (certain portions of this Exhibit have been omitted), filed as Exhibit

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

2021 and incorporated herein by reference.

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

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

Compensation Clawback Policy+*

to Contract between Lixte Biotechnology Holdings, Inc.

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

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

incorporated herein by reference.

Compensation Clawback Policy, filed as Exhibit 10.16 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the Securities and Exchange Commission on March 19, 2024, and incorporated herein by reference.+

Amendment to Contract between Lixte Biotechnology Holdings, Inc.

and MRI Global effective April 17, 2022, filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, as filed with the Securities and Exchange Commission on May 10, 2023 and incorporated herein by reference.

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

Securities Purchase Agreement, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on February 13, 2025 and incorporated herein by reference.

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

Amendment No.

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

and the Netherlands Cancer Institute,

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

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

and the Netherlands Cancer Institute, Amsterdam, and the Oncode Institute, Utrecht, entered into on October 8, 2021, filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, as filed with the Securities and Exchange Commission on November 9, 2023 and incorporated herein by reference.

Amendment No.

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

letter between H.

Amendment No.

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

and the Netherlands Cancer Institute, Amsterdam, and the Oncode Institute, Utrecht, entered into on November 29, 2024, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on December 2, 2024 and incorporated herein by reference.

Termination letter between H.

Lee Moffitt Cancer Center and Research Institute, Inc.

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

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

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

and the Company dated October 4, 2023 and effective as of September 30, 2023, filed as Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, as filed with the Securities and Exchange Commission on November 9, 2023 and incorporated herein by reference.

Exclusive Patent License Agreement between Lixte Biotechnology, Inc.

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

of Stock-Based Compensation

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

and consultants related to stock-based awards.

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

employees and consultants based on estimated fair values.

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

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

discussed in Note 6 to the financial statements, the Company recognized $418,422 of compensation expense related to stock-based awards

to certain officers, employees and consultants.

Management accounts for stock-based compensation based on the estimated fair value of

each award granted, which is amortized as expense over the requisite service period of the award.

management’s estimate of the valuation of stock-based compensation was complex and highly judgmental due to the subjectivity of

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

audit procedures related to 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 management’s

valuation analyses.

obtained and read the stock-based award agreements, and obtained board minutes and board resolutions related to the stock-based awards.

evaluated the option price model management selected to determine the fair value, and evaluated the reasonableness of management’s

significant valuation assumptions, and tested the mathematical accuracy of management’s valuation analyses.

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

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Other prepaid expenses

Total current assets

LIABILITIES AND STOCKHOLDERS’ EQUITY

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Accounts payable and accrued expenses, including $ 27,500 and $ 36,250 to related parties at December 31, 2024 and 2023, respectively

Research and development contract liabilities

Research and development contract liabilities, including $ 0 and $ 120,768 to related parties at December 31, 2024 and 2023, respectively

Total current liabilities

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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 – 72,917 shares

Common stock, $ 0.0001 par value;

authorized – 100,000,000 shares;

issued and outstanding – 2,249,290 shares and 1,664,706 shares at December 31, 2023 and 2022, respectively

issued and outstanding – 2,249,290 shares at December 31, 2024 and 2023

Additional paid-in capital

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Costs and expenses:

Research and development costs

General and administrative costs

Compensation to related parties, including stock-based compensation of $ 773,203 and $ 1,502,776 for the years ended December 31, 2023 and 2022, respectively

Patent and licensing legal and filing fees and costs

Other costs and expenses

Research and development costs, including $ 0 and $ 43,264 of stock-based compensation costs to a consultant for the years ended December 31, 2023 and 2022, respectively

Total costs and expenses

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A Convertible

Stockholders’

Additional Paid-in

Total Stockholders’

Balance, December 31, 2022

$ ( 43,394,699 )

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

Proceeds from sale of securities in registered direct equity offering,

net of offering costs

Exercise of pre-funded common stock warrants

Exercise of common stock options

Stock-based compensation

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( 48,481,728 )

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

Exercise of pre-funded common stock warrants

Exercise of common stock options

Stock-based compensation

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Cash flows from financing activities:

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

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

offering costs

Exercise of pre-funded common stock warrants

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Net cash provided by financing activities

Net increase (decrease)

( 3,164,536 )

( 1,149,904 )

Balance at beginning of period

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(collectively,

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

a drug class called Protein Phosphatase 2A inhibitors.

the “Company”), is a clinical-stage biopharmaceutical company focused on identifying new targets for cancer drug development

and developing and commercializing cancer therapies.

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

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

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

The Company believes that inhibitors of protein phosphatases have

significant therapeutic potential for a broad range of cancers.

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

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

or no toxicity.

Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A, which is used to enhance cytotoxic agents,

radiation, immune checkpoint blockers and other cancer therapies.

The Company believes that inhibitors of protein phosphatases have significant

therapeutic potential for a broad range of cancers.

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

inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity.

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

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

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

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

operating requirements.

and Chief Executive Officer

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

Kovach, as President and Chief Executive Officer.

Kovach passed away on October 5, 2023.

Effective October 6, 2023, Mr.

was appointed as Chairman of the Board of Directors.

Kovach was also the Company’s Chief Scientific Officer.

Listing and Reverse Stock Split

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

and “LIXTW”, respectively.

Reverse Stock Split

On June 2, 2023, the Company effected a 1-for-10 reverse split of

its outstanding shares of common stock.

The authorized number of shares of common stock and the par value per share were not affected

by the reverse stock split.

No fractional shares were issued in connection with the reverse stock split, with all fractional shares being

rounded up to the next whole share.

All share and per share amounts and information presented herein have been retroactively adjusted

to reflect the reverse stock split for all periods presented.

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

respectively.

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

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

No fractional shares were issued in connection with the reverse split,

with any fractional shares resulting from the reverse split being rounded up to the next whole share.

All share and per share amounts

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

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

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

However, there can be no assurances that the Company will be able to

remain in compliance with the $ 1.00 minimum closing bid price requirement of Nasdaq over time.

In addition, Nasdaq has other continued

listing requirements, one of which is maintaining a minimum net stockholders’ equity of $ 2,500,000 .

August 23, 2024, the Company received a letter from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock

Market LLC (“Nasdaq”) on August 19, 2024 indicating that the Company was not in compliance with the minimum stockholders’

equity requirement of $ 2,500,000 for continued listing on the Nasdaq Capital Market under Listing Rule 5550(b) (the “Stockholders’

Equity Requirement”).

October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement, which

outlined the Company’s proposed initiatives to regain compliance by raising equity capital through various registered equity offerings.

October 21, 2024, the Staff provided notice (the “Notice”) to the Company that it had granted an extension through February

18, 2025 to regain compliance with the Stockholders’ Equity Requirement, which required that the Company complete its capital raising

initiatives and evidence compliance with the Stockholders’ Equity Requirement through filing a Current Report on Form 8-K with

the Securities and Exchange Commission (the “SEC”) providing certain required information.

of February 18, 2025, the Company had not gained compliance with the Stockholders’ Equity Requirement.

Accordingly, on February

19, 2025, the Company received a Staff determination letter from the Staff stating that the Company did not meet the terms of the extension

because it did not complete its proposed financing initiatives to regain compliance.

Company timely filed an appeal and requested a Hearing before a Nasdaq Hearings Panel (the “Panel”), which has been granted.

The Hearing request automatically stayed Nasdaq’s delisting of the Company’s common shares and warrants pending the Panel’s

Pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an additional extension through no

later than August 18, 2025.

At the upcoming hearing, the Company will present its plan for regaining and sustaining compliance with the

Stockholders’ Equity Requirement for continued listing.

However, there can be no assurances that the Hearings Panel will grant

the Company an extension of time to regain compliance, or that the Company will be able to regain compliance during any extension period.

During the appeal process the Company’s common shares and warrants will continue to trade on The Nasdaq Capital Market.

Company intends to take reasonable measures available to regain compliance under Nasdaq’s listing rules and to remain listed on

However, there can be no assurances that the Company will ultimately regain compliance with the Stockholders’ Equity Rule,

or be able to maintain compliance with all other applicable requirements for continued listing on Nasdaq.

If the Company does not regain

compliance with Nasdaq’s continued listing requirements within the time period permitted by Nasdaq, then the Company’s securities

will be delisted from Nasdaq.

the year ended December 31, 2024, the Company recorded a net loss of $ 3,585,965 and used cash in operations of $ 3,164,536 .

31, 2024, the Company had cash of $ 1,038,952 available to fund its operations.

Because the Company is currently engaged in various early-stage

clinical trials, it is expected that it will take a significant amount of time and resources to develop any product or intellectual property

capable of generating sustainable revenues.

Accordingly, the Company’s business is unlikely to generate any sustainable operating

revenues in the next several years and may never do so.

Even if the Company is able to generate revenues through licensing its technology,

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

earnings and operating cash flows.

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

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

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

Subsequently, the Company completed a securities offering

that generated gross proceeds of $ 1,050,003 during February 2025 before deducting the placement agent’s fees and related offering

the Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time

and resources to develop any product or intellectual property capable of generating sustainable revenues.

Accordingly, the Company’s

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

Even if the Company

is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance

that the Company will be able to achieve and maintain positive earnings and operating cash flows.

At March 14, 2025, the Company’s

remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred

aggregated approximately $ 526,000 (see Note 8), which are currently scheduled to be incurred through approximately December 31, 2027.

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

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

The Company has no recurring source of revenue

and has experienced negative operating cash flows since inception.

The Company has financed its working capital requirements through

the recurring sale of its equity securities.

The consolidated financial statements also

do not reflect any adjustments relating to the recoverability of assets and liabilities that might be necessary if the Company is unable

to continue as a going concern.

The Company has no recurring source of revenues and has experienced negative operating cash flows since

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

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

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availability of operating capital to fund such activities.

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

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

LB-100 through approximately September 30, 2024.

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

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

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

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

In addition, the Company’s operating plans may change

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

sooner than planned.

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

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

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

on current operating plans, the Company estimates that its existing cash resources at December 31, 2024, and the funds raised subsequent

to December 31, 2024, will provide sufficient working capital to fund the current clinical trial program with respect to the development

of the Company’s lead anti-cancer clinical compound LB-100 through approximately September 30, 2025.

However, existing cash

resources will not be sufficient to complete the development of and obtain regulatory approval for the Company’s product candidate,

which will require that the Company raise significant additional capital.

The Company estimates that it will need to raise additional

capital to fund its operations by mid-2025 to be able to proactively manage its current business plan during the remainder of 2025 and

In addition, the Company’s operating plans may change as a result of many factors that are currently unknown and/or

outside of the control of the Company, and additional funds may be needed sooner than planned.

The Company is considering various strategies

and alternatives to obtain the required additional capital.

However, as 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.

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

or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development

efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights

to and/or control of LB-100, or to discontinue operations entirely.

Reclassifications

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

Such reclassifications, individually

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

efforts, or obtain funds, if available, through strategic alliances, joint ventures or other transaction structures that could require

the Company to relinquish rights to and/or control of LB-100, or to curtail or discontinue operations entirely.

Summary of Significant Accounting Policies

of Consolidation

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

(“GAAP”) and include the financial statements of Lixte Biotechnology Holdings, Inc.

and its wholly-owned subsidiary, Lixte

Biotechnology, Inc.

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

accounting principles (“GAAP”) and include the financial statements of Lixte Biotechnology Holdings, Inc.

and its wholly-owned

subsidiary, Lixte Biotechnology, Inc.

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 Company’s Chief Operating Decision Maker, which is the Company’s

President and Chief Executive Officer.

Company’s President and Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”) and evaluates

performance and makes operating decisions about allocating resources based on internal financial data presented on a consolidated basis.

Because the CODM evaluates financial performance on a consolidated basis, the Company has determined that it operates in a single reportable

segment, which consists of the development of a drug class called Protein Phosphatase 2A inhibitors, and is comprised of the consolidated

financial results of the Company.

The CODM uses consolidated net income (loss) as the sole measure of segment profit or loss.

segment information, including significant segment expenses, is presented at Note 3.

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

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

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

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

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

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

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

Research and development costs also include the costs to manufacture 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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reporting period.

costs consist of costs incurred with respect to equity financing transactions, including legal fees.

Such costs are deferred and charged

to additional paid-in capital upon the successful completion of such financings, or are charged to operations if and when such financings

are abandoned or terminated.

and Licensing Legal and Filing Fees and Costs

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fees and costs were $ 243,186 and $ 978,244 for the years ended December 31, 2024 and 2023, 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.

Patent and licensing legal and

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

Concentration

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represented 10 % or more of general and administrative costs or research and development costs for the years ended December 31, 2024 and

2022 are described as follows.

2023 are described below.

and administrative costs for the years ended December 31, 2024 and 2023 include charges from legal firms and other vendors for general

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

general and administrative costs, respectively.

General and administrative costs for the years ended December 31, 2023 and 2022 also

included charges for the fair value of stock options granted to directors and corporate officers representing 18.4 % and 30.3 %, respectively,

of total general and administrative costs.

licensing and patent prosecution costs relating to the Company’s intellectual properties representing 8.6 % and 23.3 % of total general

and administrative costs, respectively.

General and administrative costs for the year ended December 31, 2024 also include charges from

two vendors and consultants representing 15.0 % and 13.1 % , respectively, of total general and administrative costs.

General and administrative

costs for the year ended December 31, 2023 also include charges from a vendor and consultant representing 10.4 % of total general and

administrative costs.

General and administrative costs for the years ended December 31, 2024 and 2023 also included charges for the fair

value of stock options granted to directors and corporate officers representing 14.7 % and 18.4 % , respectively, of total general and administrative

and development costs for the year ended December 31, 2024 include charges from three vendors and consultants representing 39.2 % , 29.0 %

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Research and development costs for the year ended December 31, 2023

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

include charges from three vendors and consultants representing 29.9 % , 25.2 % and 13.7 % , respectively, of total research and development

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

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

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

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

Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred

tax assets would be charged to operations in the period such determination was made.

to the uncertainty of the Company’s ability to realize the benefit of the deferred tax assets, the net deferred tax assets are

fully offset by a valuation allowance at December 31, 2024 and 2023.

In the event the Company was to determine that it would be able

to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be

credited to operations in the period such determination was made.

Should the Company determine that it would not be able to realize all

or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period

such determination was made.

Company is subject to U.S.

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the Company currently operates or has operated in the past.

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

The Company had no unrecognized tax benefits as of December 31, 2024 or 2023

and does not anticipate any material amount of unrecognized tax benefits through December 31, 2025.

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Subsequent to December 31, 2024, any interest and penalties related to uncertain tax positions will be recognized as a component of income

Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members,

contractors and consultants for services rendered.

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

Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over

the vesting period.

Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members, contractors, and

consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards,

with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting

period of the awards.

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

cash for the services.

Company periodically issues common stock and stock options to officers, directors, employees, contractors and consultants for services

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

Stock grants, which are generally

time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period.

Company accounts for stock-based payments to officers, directors, employees, contractors, and consultants by measuring the cost of services

received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense

on the straight-line basis in the Company’s financial statements over the vesting period of the awards.

Recognition of compensation

expense for non-employees is in the same period and manner as if the Company had paid cash for the services.

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

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Changes in the estimated fair value

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

of the warrants that are liability-classified are recognized as a non-cash gain or loss in the statement of operations at each balance

At December 31, 2024 and 2023, the Company did not have any liability-classified warrants.

(Loss) Per Share

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

Anti-dilutive securities

Currency Translation

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

During the years ended December 31,

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

at the average rate of 1.0824 and 1.0538 , respectively.

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

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

the years ended December 31, 2024 and 2023, the Company incurred various costs and expenses denominated in Euros, which were converted

into United States dollars at the average rate of 1.0823 and 1.0820 Euros per United States dollar, respectively.

As of December 31,

2024 and 2023, the Company did not hold any currencies other than the United States dollar in its bank accounts, and was not a party

to any foreign currency forward or exchange contracts.

Value of Financial Instruments

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

carrying value of financial instruments (consisting of accounts payable and accrued expenses) is considered to be representative of their

respective fair values due to the short-term nature of those instruments.

carrying value of financial instruments, which consists of accounts payable and accrued expenses is considered to be representative of

their respective fair values due to the short-term nature of those instruments.

Accounting Pronouncements

May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-04,

Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation

(Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40):

Issuer’s Accounting

for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”).

provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified

written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument

for a new instrument.

An issuer should measure the effect of a modification or exchange as the difference between the fair value of the

modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition

model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt

origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification).

ASU 2021-04 was

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

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

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

The adoption of ASU 2021-04 did not have any impact on the Company’s

consolidated financial statements, including their presentation and related disclosures.

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

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

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

ASU 2023-03 amends the FASB Accounting Standards Codification

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

120, SEC Staff Announcement at the March 24, 2022

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

July 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-03,

Presentation of Financial Statements (Topic 205), Income Statement — Reporting Comprehensive Income (Topic 220), Distinguishing

Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation — Stock Compensation (Topic 718) (“ASU 2023-03”).

ASU 2023-03 amends the FASB Accounting Standards Codification to include Amendments to SEC Paragraphs pursuant to SEC Staff Accounting

120, SEC Staff Announcement at the March 24, 2022 EITF Meeting, and SEC Staff Accounting Bulletin Topic 6.B, Accounting

Series Release 280 — General Revision of Regulation S-X:

Income or Loss Applicable to Common Stock.

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

associated with its adoption.

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

The adoption of ASU 2023-03

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

As ASU 2023-03 did not provide

any new guidance, there was no transition or effective date associated with its adoption.

The Company adopted ASU 2023-03 immediately

upon its issuance in July 2023.

The adoption of ASU 2023-03 did not have any impact on the Company’s consolidated financial statement

presentation and related disclosures.

November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosure.

amends the FASB Accounting Standards Codification to require additional reportable segment disclosures of a public entity by requiring

disclosure of significant segment expenses that are regularly provided to the chief operating decision maker, requiring other new disclosures,

and requiring enhanced interim disclosures.

ASU 2023-07 requires public entities with a single reportable segment to provide all

the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280 on an interim and annual basis.

is effective for annual periods beginning after December 15, 2023, and interim periods beginning after December 15, 2024, and is applied

retrospectively.

The Company adopted ASU 2023-07 effective January 1, 2024 for the 2024 annual period on a retrospective basis.

adoption of ASU 2023-07 resulted in additional required segment-related disclosures (see Note 3).

November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures

(Subtopic 220-40).

ASU 2024-03 amends the FASB Accounting Standards Codification to require specified information about certain costs

and expenses in the notes to the financial statements at each interim and annual reporting period, including disclosure of the amounts

of purchases of inventory;

employee compensation;

depreciation;

intangible asset amortization;

and depreciation, depletion, and amortization

included in each relevant expense caption on the face of the income statement within continuing operations that contains any of the expense

categories previously listed.

Disclosure will also be required of the total amount of selling expenses and an entity’s definition

of selling expenses in annual reporting periods.

ASU 2024-03 does not change or remove current expense disclosure requirements, but does

affect where and how this information is presented in the notes to the financial statements.

ASU 2024-03 is effective for annual reporting

periods beginning January 1, 2027, and interim periods within annual reporting periods beginning January 1, 2028.

Early adoption is permitted.

The Company is in the process of evaluating ASU 2024-03 to determine its impact on the Company’s consolidated financial statement

presentation and related disclosures.

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

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

Research and Development Costs

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

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

such costs have been incurred.

of Research and Development Costs

Ended December 31,

Reclassifications

a result of the adoption of ASU 2023-07 effective January 1, 2024, certain reclassifications have been made to the prior year statement

of operations to conform it to the current year presentation.

In presenting general and administrative costs on the Company’s consolidated

statement of operations for the year ended December 31, 2023, $ 1,718,180 of compensation to related parties, $ 978,244 of patent and licensing

legal and filing fees and costs, and $ 1,495,712 of other costs and expenses were shown separately.

In presenting the Company’s

consolidated statement of operations for the year ended December 31, 2024, the Company has combined these categories into general and

administrative costs in the accompanying consolidated statement of operations for the year ended December 31, 2023.

These reclassifications

had no effect on the reported results of operations, including loss from operations and net loss.

Segment Information

Company’s chief operating decision maker (“CODM”) has been identified as the Company’s President and Chief Executive Officer

The Company’s CODM evaluates performance and makes operating decisions about allocating resources based on financial

data presented on a consolidated basis.

Because the CODM evaluates financial performance on a consolidated basis, the Company has determined

that it has a single operating segment composed of the consolidated financial results of the Company.

following table presents the significant segment expenses (10% or greater) and other segment items regularly reviewed by the Company’s

CODM and included in general and administrative costs.

of Information by segment

Years Ended December 31,

Compensation to related parties:

Patent and licensing legal and filing fees and costs

Other consulting and professional fees

Insurance expense

Other costs and expenses, net

Total general and administrative costs

following table presents the significant segment expenses (10% or greater) and other segment items regularly reviewed by the Company’s

CODM, and included in research and development costs.

Years Ended December 31,

Clinical and related oversight costs

Preclinical research focused on development of additional novel anti-cancer compounds

Regulatory service costs

Total research and development costs

following table presents a summary of research and development costs for the years ended December 31, 2024 and 2023 based on the respective

geographical regions where such costs were incurred.

Years Ended December 31,

United States

and development costs

following table presents the Company’s total assets by segment at December 31, 2024 and 2023.

Research and development assets

Corporate assets

Stockholders’ Equity

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

If fully converted, the 350,000 outstanding shares

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

The 350,000 outstanding shares of Series A Convertible

Preferred Stock were convertible into a total of 72,917 shares of common stock at December 31, 2024 and 2023.

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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As of December 31, 2024 and

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

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

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

No fractional shares

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

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

all periods presented.

2023, the Company had 2,249,290 shares of common stock issued and outstanding.

June 2, 2023, the Company effected a 1-for-10 reverse

split of its outstanding shares of common stock.

The authorized number of shares of common stock and the par value per share were

not affected by the reverse stock split.

No fractional shares were issued in connection with the reverse stock split, with all

fractional shares being rounded up to the next whole share.

All share and per share amounts and information presented herein have

been retroactively adjusted to reflect the reverse stock split for all periods presented.

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

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

12, 2022 Sale of Common Stock

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

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

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

$ 5,141,384 .

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

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

20, 2023 Sale of Common Stock and Warrants

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

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The shares of common stock issuable upon

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

on August 21, 2023.

exercise of the warrants were registered for resale on a registration statement on Form S-3 declared effective by the SEC on May 2, 2024.

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

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In addition, the warrants issued to the institutional investor contain

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

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

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

valuation, as defined in the warrant agreement.

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

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

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

The Company will account for any such cash payment

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

a “fundamental transaction” provision which provides that if any defined fundamental transactions are within the Company’s

control and are consummated, the holder of the unexercised common stock warrants would be entitled to receive, at its option, in exchange

for extinguishment of such warrants, cash consideration equal to a Black-Scholes valuation amount, as defined in the warrant agreement.

The fundamental transaction provision includes (i) a sale, lease, assignment, transfer, conveyance or other disposition of all or substantially

all of the assets of the Company in one or a series of related transactions, or (ii) a change in control of the Company by which it,

directly or indirectly, in one or more related transactions, consummates a stock or share purchase agreement or other business combination

with another person or group, whereby such other person or group acquires more than 50% of the voting power of the common equity of the

such fundamental transaction is not within the Company’s control, including not being approved by the Company’s Board of

Directors, the warrant holder would only be entitled to receive the same type or form of consideration (and in the same proportion) equal

to the Black-Scholes valuation amount of the remaining unexercised portion of the warrant on the date of consummation of such fundamental

transaction as the holders of the Company’s common stock receive.

Accordingly, these warrants are classified as a component of

permanent stockholders’ equity.

The Company will account for any cash payment for a warrant redemption as a distribution from stockholders’

equity, as and when a fundamental transaction is consummated and such cash payment is required to be made.

Stock Warrants

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public offering, during the years ended December 31, 2024 and 2023 is presented below.

Schedule of Warrants Outstanding

of Warrants Outstanding

Number of Shares

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Schedule of Warrants Outstanding and Exercisable

Exercise Prices

Outstanding (Shares)

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

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

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

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

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

to a purchase price of $ 57.00 .

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

common stock warrants at December 31, 2023.

warrants exercisable at $ 57.00 per share at December 31, 2024 consist of 1,497,000 publicly-traded warrants, described herein on a pre-split

1-for-10 basis, that were issued as part of the Company’s November 2020 public offering of units, and are exercisable for a period

of five years thereafter.

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

such publicly-traded warrant currently now represents the right to purchase 1/10th of a share of common stock at the original exercise

price of $ 5.70 per share.

Accordingly, the exercise of 10 warrants, each exercisable at $ 5.70 , are required to acquire one share of post-split

common stock, which is equivalent to a purchase price of $ 57.00 per share.

on the closing fair market value of $ 2.03 per share on December 31, 2024, there was no intrinsic value attributed to exercisable but

unexercised common stock warrants at December 31, 2024.

with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 6.

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prior to the end of the applicable one-year period, or by death, or by termination for cause.

These employment agreements were automatically

renewed for additional one-year periods in July and August 2021, 2022 and 2023.

Except as noted below, these employment

agreements were automatically renewed for additional one-year periods in July and August 2021, 2022, 2023 and 2024.

Company entered into an employment agreement with Dr.

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

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

Kovach under this employment

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

for such periods.

The employment agreement with Dr.

Kovach terminated upon his death on October 5, 2023.

During the year ended December 31, 2023, the Company

paid $ 190,860 to Dr.

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

consolidated statement of operations for such periods.

Company entered into an employment agreement with Dr.

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

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

During the years ended December

31, 2023 and 2022, the Company paid $ 175,000 and $ 175,000 , respectively, to Dr.

Miser under this employment agreement, which costs are

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

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

On May 29, 2024, the Company elected

not to renew its employment agreement with Dr.

Miser, as a result of which such employment agreement expired on July 31, 2024.

the years ended December 31, 2024 and 2023, the Company paid $ 102,083 and $ 175,000 , respectively, to Dr.

Miser under this employment

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

for such periods.

Company entered into an employment agreement with Eric J.

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Effective October 1, 2022, Mr.

Forman has been provided a monthly office rent allowance,

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

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

Forman was provided a monthly office rent allowance,

pursuant to which the Company paid $ 16,435 and $ 15,571 for the years ended December 31, 2024 and 2023, respectively, on Mr.

The employment agreement with Mr.

Forman terminated upon his resignation as an officer of the Company effective December 31,

During the years ended December 31, 2024 and 2023, the Company paid $ 200,000 and $ 200,000 , respectively, to Mr.

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

of operations for such periods.

Forman under this

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

operations for such periods.

Company entered into an employment agreement with Robert N.

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In addition, Mr.

van der Baan will

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

The term of the employment agreement

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

termination provisions as described in the employment agreement.

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

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

consolidated statements of operations for such period.

René Bernards to the Board of Directors

van der Baan is eligible

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

The term of the employment agreement is for

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

provisions as described in the employment agreement.

During the years ended December 31, 2024 and 2023, the Company paid $ 153,495 and

$ 40,639 , respectively, to Mr.

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

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

May 31, 2024, the Company entered into a consulting agreement with Dr.

Schellens, M.D., Ph.D.

Pursuant to the agreement, effective

July 1, 2024, the Company engaged Dr.

Schellens as a consultant, and, effective August 1, 2024, as the Company’s Chief Medical

The term of the agreement is in effect from July 1, 2024 until the earliest of (i) termination by either party upon sixty days’

notice, (ii) Dr.

Schellens’ death or disability, or (iii) termination by the Company for breach as provided in the agreement.

the agreement, Dr.

Schellens provides his services for two days per week with the specific days in each week based on arrangements agreed

to from time to time between Dr.

Schellens and the Company’s Chief Executive Officer.

The Company pays Dr.

Schellens an annual

compensation of 104,000 Euros (approximately $ 108,000 as of December 31, 2024), payable on a monthly basis.

During the year ended December

31, 2024, the Company paid $ 56,226 to Dr.

Schellens under this consulting agreement, which costs are included in general and administrative

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

as of June 15, 2022, Dr.

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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 , which was paid upon his

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

During the years ended December 31,

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

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

his appointment, it was agreed that Dr.

Bernards would receive annual compensation for his services on the Board only in the form of

cash, in lieu of the annual June 30 grant of stock options as provided to the Company’s other non-officer directors.

years ended December 31, 2024 and 2023, the Company recorded charges to general and administrative costs in the consolidated statement

of operations of $ 10,000 and $ 40,000 , respectively, with respect to his annual cash board compensation.

conjunction with the Company’s efforts to preserve cash, effective with the quarter ended June 30, 2024, Dr.

Bernards agreed to

receive equity-based compensation for his services on the Board, for the quarters ended June 30, 2024, September 30, 2024 and December

In order to reconcile his Board compensation with that of the other non-officer directors, Dr.

Bernards has agreed to receive

the same Board compensation, both in form and amount, as the other non-officer directors.

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

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

their services on the Board of Directors.

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

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

their services on the Board of Directors (the “Board Plan”), which was subsequently amended effective May 25, 2022 and July

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

compensation for directors, payable quarterly, is as follows:

director compensation - $ 20,000 per year

director compensation - $ 20,000 per year (except for Dr.

Bernards, who was paid an additional annual cash fee of $ 40,000 , in lieu of

the annual June 30 grant of stock option as described below, through March 31, 2024)

of audit committee – additional $ 10,000 per year

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

conjunction with the Company’s efforts to preserve cash, the Board approved an amendment to the Board Plan, such that for the quarters

ended June 30, 2024, September 30, 2024 and December 31, 2024, the non-officer directors (including Dr.

Bernards) received, in lieu of

cash compensation, stock options exercisable for a period of five years, vesting immediately, to purchase common stock at an exercise

price based on the closing market price upon issuance, with the amount of such stock options equal to the cash payment such director

would otherwise have been entitled to receive for such quarter, divided by their quarterly value as determined pursuant to the Black-Scholes

option-pricing model.

The Board may extend this amendment to the Board Plan for additional quarterly periods subsequent to December 31,

compensation for directors is as follows:

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for their services on the Board of Directors, for the years ended December 31, 2024 and 2023, is presented below.

Summary of Related Party Costs

Related party costs:

of Related Party Costs

Ended December 31,

Related party costs:

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

Schedule of Fair Value of Each Option Award Estimated Assumption

Risk-free interest rate

Expected dividend yield

Expected volatility

Expected life

of Fair Value of Each Option Award Estimated Assumption

interest rate

dividend yield

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

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

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

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

Risk-free interest rate

3.03 % to 3.63 %

Expected dividend yield

Expected volatility

128.03 % to 153.17 %

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 stock options to purchase 5,833 shares of the Company’s common stock.

interest rate

dividend yield

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

Forman was granted

stock options to purchase 5,833 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

The options are exercisable for a period of five years at an exercise price of $ 71.40 per share, which was equal to the closing market

price of the Company’s common stock on the grant date.

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

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

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

model, was determined to be $ 400,855 ($ 68.718 per share), of which $ 100,214 was attributable to the portion of the stock options fully

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

The remaining unvested portion of the fair value of the

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

The Company recorded charges to general

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

2022, respectively, with respect to these stock options.

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

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

Company’s common stock on the grant date.

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

25% vesting on August 12, 2023.

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

was determined to be $ 400,855 ($ 68.718 per share), of which $ 100,214 was attributable to the portion of the stock options fully vested

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

The remaining unvested portion of the fair value of the stock

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

The Company recorded a charge to general and

administrative costs in the consolidated statement of operations for the year ended December 31, 2023 of $ 61,501 with respect to these

stock options.

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

Miser, M.D., Dr.

Miser was granted stock options

to purchase 8,333 shares of the Company’s common stock.

Miser was granted stock options to purchase

8,333 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

The options are exercisable

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

common stock on the 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 .

The options are exercisable for a

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

stock on the 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.

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

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stock options was charged to operations ratably from August 1, 2020 through August 1, 2023.

The Company recorded charges to general and

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

respectively, with respect to these stock options.

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

The Company recorded a charge to general

and administrative costs in the consolidated statement of operations for the year ended December 31, 2023 of $ 83,544 with respect to

these stock options.

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

Weingarten, Mr.

Weingarten was granted stock

options to purchase 5,833 shares of the Company’s common stock.

Weingarten was granted stock options to purchase

5,833 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

The options are

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

common stock on the grant date.

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

August 12, 2023 .

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

to be $ 400,855 ($ 68.718 per share), of which $ 100,214 was attributable to the portion of the stock options fully vested on August 12,

The options are exercisable for a

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

stock on the grant date.

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

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

be $ 400,855 ($ 68.718 per share), of which $ 100,214 was attributable to the portion of the stock options fully vested on August 12, 2020

and was therefore charged to operations on that date.

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

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

The Company recorded charges to general and administrative

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

with respect to these stock options.

April 9, 2021, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by a former director’s resignation.

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

package for members of the Board of Directors, Mr.

Schwartzberg was granted stock options to purchase 25,000 shares of the Company’s

common stock, exercisable for a period of five years at an exercise price of $ 32.00 per share (the closing market price on the grant

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

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

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

was therefore charged to operations on that date.

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

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

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

Schwartzberg on that date.

The Company recorded charges to general and administrative costs

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

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

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

The Company recorded a charge to general and administrative costs

in the consolidated statement of operations for the year ended December 31, 2023 of $ 61,501 with respect to these stock options.

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

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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 25,000 shares of the Company’s common stock, exercisable for a period of five year s

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

at an exercise price of $ 28.00 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder

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

Company recorded charges to general and administrative costs in the consolidated statement of operations of $ 76,388 and $ 154,042 for

the years ended December 31, 2023 and 2022, respectively, with respect to these stock options.

Company recorded a charge to general and administrative costs in the consolidated statement of operations for the year ended December

31, 2023 of $ 76,388 with respect to these stock options.

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

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($ 28.423 per share), which was charged to operations ratably from July 1, 2021 through June 30, 2023.

The Company recorded charges to

general and administrative costs in the consolidated statement of operations of $ 211,413 and $ 638,915 for the years ended December 31,

2023 and 2022, respectively, with respect to these stock options.

The Company recorded a charge to

general and administrative costs in the consolidated statement of operations for the year ended December 31, 2023 of $ 211,413 with respect

to these stock options.

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

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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 25,000 shares of the Company’s common stock, exercisable for a period of five years

at an exercise price of $ 7.40 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 ($ 6.341 per share),

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

on that date.

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

17, 2022 through June 30, 2024.

The Company recorded charges to general and administrative costs in the consolidated statement of operations

of $ 38,885 and $ 100,249 for the years ended December 31, 2023 and 2022, respectively, with respect to these stock options.

van der Baan was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of

five years at an exercise price of $ 7.40 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.

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

per share), of which $ 79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 and was therefore charged

to operations on that date.

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

June 17, 2022 through June 30, 2024.

During the years ended December 31, 2024 and 2023, the Company recorded charges to general and administrative

costs in the consolidated statement of operations of $ 19,390 and $ 38,885 , respectively, with respect to these stock options.

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

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

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

The Company recorded charges to general and administrative costs in the consolidated statement of operations of $ 94,881 and $ 63,777 for

the years ended December 31, 2023 and 2022, respectively, with respect to these stock options.

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

the years ended December 31, 2024 and 2023, the Company recorded charges to general and administrative costs in the consolidated statement

of operations of $ 47,310 and $ 94,881 , respectively, with respect to these stock options.

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

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

recorded a total charge to general and administrative costs in the consolidated statement of operations of $ 61,448 and $ 75,520 for the

years ended December 31, 2023 and 2022, respectively, with respect to these stock options.

November 6, 2022, the Company issued a stock option, in the form of a warrant, to BioPharmaWorks to purchase 10,000 shares of the Company’s

common stock, which was fully vested upon issuance and is exercisable for a period of five years at $ 5.025 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 ($ 4.326 per share) and was charged to general and administrative costs in the consolidated statement of operations on that

years ended December 31, 2024 and 2023, the Company recorded charges to general and administrative costs in the consolidated statement

of operations of $ 42,565 and $ 61,448 , respectively, with respect to these stock options.

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

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

The Company recorded a total charge to general and administrative costs in the consolidated statement of operations of $ 48,464 for the

year ended December 31, 2023 with respect to these stock options.

During the years ended December 31, 2024 and 2023, the Company recorded charges to general and administrative costs in the consolidated

statement of operations of $ 96,532 and $ 48,464 , respectively, with respect to these stock options.

September 26, 2023, in connection with the employment agreement entered into with Bas van der Baan, Mr.

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to operations ratably from September 26, 2023 through September 30, 2026.

The Company recorded a charge to general and administrative

costs in the consolidated statement of operations of $ 35,178 for the year ended December 31, 2023 with respect to these stock options.

During the years ended December 31, 2024 and 2023, the Company

recorded charges to general and administrative costs in the consolidated statement of operations of $ 134,114 and $ 35,178 , respectively,

with respect to these stock options.

June 30, 2024, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the

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

of 40,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $ 2.37 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 $ 73,976 ($ 1.8494 per share), which is being charged to operations ratably from July 1, 2024 through June 30, 2026.

During the year ended December 31, 2024, the Company record a charge general and administrative costs in the consolidated statement of

operations of $ 18,648 with respect to these stock options.

June 30, 2024, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officer

directors of the Company a total of 16,598 stock options to purchase shares of the Company’s common stock, exercisable for a period

of five years at an exercise price of $ 2.37 per share (the closing market price on the grant date) The stock options were granted in

lieu of cash compensation, are exercisable for a period of five years and were immediately vested.

The number of stock options granted

to each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitled

to receive for the quarter ended June 30, 2024, divided by their quarterly value as determined pursuant to the Black-Scholes option-pricing

model, and was determined to be $ 27,500 ($ 1.6570 per share), which was charged to operations on June 30, 2024, the date on which the

stock options were fully vested.

July 1, 2024, in connection with the consulting agreement with Dr.

Schellens, M.D., Ph.D., Dr.

Schellens was granted stock options

to purchase 15,000 shares of the Company’s common stock.

The options can be exercised on a cashless basis.

The options are exercisable

for a period of five years at an exercise e price of $ 2.39 per share, which was equal to the closing market price of the Company’s

common stock on the grant date.

The options vest quarterly over a three-year period commencing on the last day of each calendar quarter

commencing September 30, 2024.

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

was determined to be $ 29,074 ($ 1.9382 per share), which is being charged to operations ratably from July 1, 2024 through June 30, 2027.

During the year ended December 31, 2024, the Company record a charge general and administrative costs in the consolidated statement of

operations of $ 4,863 with respect to these stock options.

September 30, 2024, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officer

directors of the Company a total of 21,217 stock options to purchase shares of the Company’s common stock, exercisable for a period

of five years at an exercise price of $ 1.87 per share (the closing market price on the grant date) The stock options were granted in

lieu of cash compensation, are exercisable for a period of five years and were immediately vested.

The number of stock options granted

to each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitled

to receive for the quarter ended September 30, 2024, divided by their quarterly value as determined pursuant to the Black-Scholes option-pricing

model, and was determined to be $ 27,500 ($ 1.2961 per share), which was charged to operations on September 30, 2024, the date on which

the stock options were fully vested.

January 20, 2025, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officer

directors of the Company a total of 16,665 stock options to purchase shares of the Company’s common stock, exercisable for a period

of five years at an exercise price of $ 2.33 per share (the closing market price on the grant date) The stock options were granted in

lieu of cash compensation, are exercisable for a period of five years and were immediately vested.

The number of stock options granted

to each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitled

to receive for the quarter ended December 31, 2024, divided by their grant date value as determined pursuant to the Black-Scholes option-pricing

model, and was determined to be $ 27,500 ($ 1.65002 per share).

The grant date value of the stock options of $ 27,500 was accrued at December

31, 2024 and charged to operations at that date.

Philip Palmedo, a director of the Company since 2006, did not stand for re-election to the Company’s Board of Directors at the

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Kovach, the Chairman of the Board of Directors and the Company’s President and Chief Executive Officer, and

Chief Scientific Officer, died on October 5, 2023.

Accordingly, the unvested stock options for each such person ceased vesting effective

as of the respective dates that their service to the Company terminated.

Furthermore, the expiration date of all vested stock options

owned by each such person contractually expired one year from the respective dates that each of their services to the Company terminated.

Chief Scientific Officer, died on October 5, 2023, the employment agreement of the Company’s Chief Medical Officer, Dr.

Miser expired on July 31, 2024, and the employment agreement of the Company’s Vice President and Chief Operating Officer, Eric

Forman, terminated upon his resignation from the Company on December 31, 2024.

Accordingly, the unvested stock options for each such

person ceased vesting effective as of the respective dates that their services to the Company terminated.

Furthermore, the expiration

date of all vested stock options owned by each such person contractually expire one year from the respective dates that their services

to the Company terminate.

summary of stock-based compensation costs for the years ended December 31, 2024 and 2023 is as follows:

Summary of Stock-based Compensation Costs

of Stock-based Compensation Costs

Related parties

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is as follows:

Summary of Stock Option Activity Including Options Form of Warrants

of Stock Option Activity Including Options Form of Warrants

Number of Shares

Weighted Average

Weighted Average Remaining Contractual Life (in Years)

Weighted Average

Contractual Life

Stock options outstanding at December 31, 2022

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

Exercise Prices

Outstanding (Shares)

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

stock options was approximately $ 8,000 at December 31, 2023.

Exercisable (Shares)

on the closing fair market value of $ 2.03 per share on December 31, 2024, the intrinsic value attributed to exercisable but unexercised

common stock options was approximately $ 12,000 at December 31, 2024.

stock options to acquire 203,334 shares of the Company’s common stock had not vested at December 31, 2024.

Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock.

the exercise of such stock options, the Company expects to satisfy the related stock obligations through the issuance of authorized but

unissued shares of common stock.

income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial

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Schedule of Effective Income Tax Rate

Ended December 31,

Years Ended December 31,

federal statutory tax rate

income taxes, net of federal tax benefit

related to stock-based compensation

to deferred tax asset

in valuation allowance

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, 2024, the Company has available net operating loss carryforwards for federal and state income tax purposes of approximately

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Trial Agreements

December 31, 2023, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical

trial monitoring agreements not yet incurred, as described below, aggregated $ 6,412,000 , including clinical trial agreements of $ 6,013,000

and clinical trial monitoring agreements of $ 399,000 , which, based on current estimates, are currently scheduled to be incurred through

approximately December 31, 2027.

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

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

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

The Company expects that the full amount of these expenditures will

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

not modified or reduced.

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

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

or terminated before the clinical trial endpoint is reached.

Accordingly, such contractual commitments as discussed herein should be

considered as estimates only based on current clinical assumptions and conditions and are typically subject to significant modifications

and revisions over time.

following is a summary of the contractual clinical trials discussed below as of December 31, 2023:

March 14, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial

monitoring agreements not yet incurred, as described below, aggregated $ 526,000 , including clinical trial agreements of $ 264,000 and

clinical trial monitoring agreements of $ 262,000 , which, based on current estimates, are currently scheduled to be incurred through approximately

December 31, 2027.

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

of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company’s

current or future clinical trial programs.

The Company expects that the full amount of these expenditures will be incurred only if such

clinical trial programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced.

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

of changes and modifications over time as clinical data is obtained and analyzed, and is frequently modified, suspended or terminated,

in part based on receipt or lack of receipt of an indication of clinical benefit or activity, before the clinical trial endpoint is reached.

Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current clinical assumptions

and conditions and are typically subject to significant modifications and revisions over time.

following is a summary of the Company’s ongoing contractual clinical trials described below as of March 14, 2025:

of Contractual Clinical Trials

combined with carboplatin, etoposide and atezolizumab in small cell lung cancer

of Hope and Sarah Cannon

patients entered

combined with doxorubicin in sarcoma

patient entered

in high grade gliomas

0 pharmacology study

of Clinical Trial

Projected End Date

Study Objective

Clinical Update

of Preliminary Efficacy

LB-100 combined with atezolizumab in microsatellite

stable metastatic colorectal cancer (Phase 1b)

Netherlands Cancer Institute (NKI)

December 2026

Determine RP2D with atezolizumab

First patient entered August 2024, in total two patients entered

LB-100 combined with doxorubicin in advanced soft

tissue sarcoma (Phase 1b)

Recruitment completed September 2024

Determine MTD and RP2D

Fourteen patients entered

December 2025

Doxorubicin with or without LB-100 in advanced soft

tissue sarcoma (Randomized Phase 2)

Determine efficacy:

Clinical trial not yet begun (subject to completion of Phase 1b GEIS clinical

LB-100 combined with dostarlimab

in ovarian clear cell carcinoma (Phase 1b/2)

December 2027

Determine the OS of patients with recurrent ovarian

clear cell carcinoma

Nine patients entered

December 2026

Company has no financial contractual commitment associated with this clinical trial at March 14, 2025.

Cancer Institute.

the penetration of LB-100 into high grade gliomas after IV injection

No or minimal penetration of LB-100 into high grade gliomas after IV injection

with or without LB-100 in sarcoma

trial not yet begun (subject to completion of Phase 1b GEIS clinical trial)

combined with dostarlimab in ovarian clear cell carcinoma

the survival of patients with ovarian clear cell carcinoma

patients entered at December 31, 2023

The financial contractual commitment of the GEIS Randomized

Phase 2 clinical trial is included in the financial contractual commitment of the GEIS Phase 1b trial.

There is no remaining financial contractual commitment associated

with this clinical trial.

Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with the City of Hope National Medical

Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City of Hope”),

to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase inhibitor, combined with an

FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer (“ED-SCLC”).

will be given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved standard of care regimen, to previously untreated

ED-SCLC patients.

The dose of LB-100 will be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended Phase

2 dose (“RP2D”).

Patient entry will be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm the

safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration of overall

response, progression-free survival and overall survival.

Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute

(“NKI”) (see Note 5) to conduct a Phase 1b clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined

with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F.

Hoffman-La Roche Ltd.

(“Roche”), for patients with microsatellite

stable metastatic colorectal cancer.

Under the agreement, the Company will provide its lead compound, LB-100, and under a separate agreement

between NKI and Roche, Roche will provide atezolizumab and financial support for the clinical trial.

The Company has no obligation to

and will not provide any reimbursement of clinical trial costs.

Pursuant to the agreement and the protocol set forth in the agreement,

the clinical trial will be conducted by NKI at NKI’s site in Amsterdam by principal investigator Neeltje Steeghs, MD, PhD, and

NKI will be responsible for the recruitment of patients.

The agreement provides for the protection of the respective intellectual property

rights of each of the Company, NKI and Roche.

Phase 1b clinical trial will evaluate safety, optimal dose and preliminary efficacy of LB-100 combined with atezolizumab for the treatment

of patients with metastatic microsatellite stable colorectal cancer.

Immunotherapy using monoclonal antibodies like atezolizumab can

enhance the body’s immune response against cancer and hinder tumor growth and spread.

LB-100 has been found to improve the effectiveness

of anticancer drugs in killing cancer cells by inhibiting a protein called PP2A on cell surfaces.

Blocking PP2A increases stress signals

in tumor cells expressing the PP2A protein.

Accordingly, combining atezolizumab with LB-100 may enhance treatment efficacy for metastatic

colorectal cancer, as cancer cells with heightened stress signals are more vulnerable to immunotherapy.

study comprises a dose escalation phase and a dose expansion phase.

The objective of the dose escalation phase is to determine the recommended

Phase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab.

The dose expansion phase will further investigate

the preliminary efficacy, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination.

trial opened in August 2024 with the enrollment of the first patient.

A total of two patients have been enrolled to date.

Patient accrual

is expected to take up to 24 months, with a maximum of 37 patients with advanced colorectal cancer to be enrolled in this study.

principal investigator of the colorectal study testing LB-100 in combination with atezolizumab is currently investigating two Serious

Adverse Events (“SAEs”) observed in the clinical trial.

The Investigational Review Board (IRB) of the Netherlands Cancer

Institute has requested additional information with respect to these SAEs and the study has been paused for enrollment until the IRB’s

questions have been satisfactorily addressed (see “Specific Risks Associated with the Company’s Business Activities - Serious

Adverse Events” below for additional information).

Company has no financial contractual commitment associated with this clinical trial.

Effective January 18, 2021, the Company executed a Clinical Research Support Agreement (the “Agreement”) with

the City of Hope National Medical Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively,

“City of Hope”), to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase

inhibitor, combined with an FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer (“ED-SCLC”).

LB-100 was given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved standard of care regimen, to previously

untreated ED-SCLC patients.

The LB-100 dose was to be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended

Phase 2 dose (“RP2D”).

Patient entry was to be expanded so that a total of 12 patients would be evaluable at the RP2D to

confirm the safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration

of overall response, progression-free survival, and overall survival.

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

patient accrual was slower than expected, the Company has been seeking to add additional sites to increase the rate of patient accrual.

Effective March 6, 2023, the Sarah Cannon Research Institute (“SCRI”), Nashville, Tennessee, joined the City of Hope’s

ongoing Phase 1b clinical trial.

The Company is continuing its efforts to add additional sites.

The addition of SCRI is expected to expedite

and expand the accrual of patients to this clinical trial, thus reducing the time required to demonstrate the feasibility, tolerability,

and efficacy of adding LB-100 to the current standard treatment regimen.

With the addition of SCRI, the Company currently expects that

this clinical trial will be completed by March 31, 2026.

the years ended December 31, 2023 and 2022, the Company incurred costs of $ 69,001 and $ 0 , respectively, pursuant to this agreement, which

are included in research and development costs in the Company’s consolidated statements of operations.

As of December 31, 2023,

total costs of $ 447,512 have been incurred pursuant to this agreement.

Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 2,433,000

as of December 31, 2023, which is expected to be incurred through March 31, 2026.

If a significant number of patients fail during the

dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional cost of approximately

Company currently expects that enrollment in this clinical trial will range from approximately 18 to 30 enrollees, with 24 enrollees

as the most likely number.

Should fewer than 42 enrollees be required, the Company has agreed to compensate City of Hope on a per enrollee

If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment

of a very aggressive disease.

Because patient

accrual was slower than expected, effective March 6, 2023, the Company and City of Hope added the Sarah Cannon Research Institute (“SCRI”),

Nashville, Tennessee, to the ongoing Phase 1b clinical trial.

The Company and City of Hope continued efforts to increase patient accrual

by adding additional sites and by modifying the protocol to increase the number of patients eligible for the clinical trial.

of these efforts to increase patient accrual and to decrease time to completion was evaluated in subsequent quarters.

evaluating patient accrual through June 30, 2024, the Company and City of Hope agreed to close the clinical trial.

Pursuant to the terms

of the Agreement, the Company provided notice to City of Hope of the Company’s intent to terminate the Agreement effective as of

July 8, 2024.

Upon closure, the Company incurred a prorated charge of $ 207,004 for the cost of patients enrolled to date, which is included

in accounts payable and accrued expenses at December 31, 2024 .

the year ended December 31, 2024 and 2023, the Company incurred costs of $ 285,019 and $ 69,001 , respectively, pursuant to this Agreement.

As of December 31, 2024, total costs of $ 732,532 had been incurred pursuant to this Agreement.

Effective July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the

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These tasks included

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

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

steps involved by an independent auditor.

7 unchanged sentences

for subsequent multiple trials within the European Union, had cost approximately $ 1,144,000 .

Although the production of new inventory

has been completed, nominal trailing costs subsequent to December 31, 2023 may be incurred.

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

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, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report

prepared by December 31, 2026.

In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at

Fundación Jiménez Díaz University Hospital (Madrid).

clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of ASTS.

Consequently, this

clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31,

In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación Jiménez

Díaz University Hospital (Madrid).

Up to 170 patents will be entered into the clinical trial.

The Phase 1b portion of the protocol is expected to be completed by June 30, 2024, at which time the Company expects to have data on

both response and toxicity from this portion of the clinical trial, and subject to clinical results, anticipates that it will be able

to proceed to a related Phase 2 study.

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

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.

During the years ended December 31, 2023 and 2022, the Company incurred costs of $ 268,829 and $ 260,770 , respectively, pursuant to this

Such costs, when incurred, are included in research and development costs in the Company’s consolidated statements of

Through December 31, 2023, the Company has paid GEIS an aggregate of $ 684,652 for work done under this agreement through

the fourth milestone.

The recruitment for the Phase 1b

portion of the protocol was extended with two patients and was completed during the quarter ended September 30, 2024.

The Company expects

to have data on toxicity and preliminary efficacy from this portion of the clinical trial during the quarter ending December 31, 2025.

the focus on the combination of LB-100 with immunotherapy in ovarian clear cell carcinoma and colorectal cancer and the availability

of capital resources, the Company entered into Amendment No.

1 to the Collaboration Agreement effective March 11, 2025 that relieved

the Company of the financial obligation to support the randomized Phase 2 portion of the clinical trial contemplated in the Collaboration

Agreement of approximately $ 3,095,000 .

As a result, it is uncertain as to whether the Phase 2 portion of this clinical trial will proceed.

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

During the years ended December 31, 2024 and 2023, the Company incurred costs of $ 0 and $ 268,829 , respectively, pursuant to this agreement.

Through December 31, 2024, the Company has incurred charges of $ 684,652 for work done under this agreement through the fourth milestone.

Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 264,000

as of December 31, 2023, which is expected to be incurred through December 31, 2027.

As the work is being conducted in Europe and is

paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.

Such fluctuations

are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate.

for the Phase 1b portion of this clinical trial as of March 14, 2025, which is scheduled to be incurred through December 31, 2025.

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, and have not been significant.

Anderson Cancer Center Clinical Trial .

On September 20, 2023, the Company announced an investigator-initiated Phase 1b/2 collaborative

clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 (“PD-1”) blocking antibody of GSK plc

(“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma

The study objective is to determine the overall survival (“OS”) of patients with OCCC.

trial is being sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and is being conducted at The

University of Texas - MD Anderson Cancer Center.

The Company is providing LB-100 and GSK is providing dostarlimab-gxly and financial

support for the clinical trial.

On January 29, 2024, the Company announced the entry of the first patient into this clinical trial.

Company currently expects that this clinical trial will be completed by December 31, 2027.

February 25, 2025, the Company announced that it has added the Robert H.

Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern

University as a second site in a clinical trial combining the Company’s proprietary compound LB-100 with GSK’s dostarlimab

to treat ovarian clear cell cancer.

Patient recruitment is underway, and the first patient has been dosed.

Effective August 20, 2018, the Company entered into a Clinical Trial Research Agreement with the Moffitt Cancer Center and Research

Institute Hospital Inc., Tampa, Florida (“Moffitt”), effective for a term of five years.

Pursuant to the Clinical Trial Research

Agreement, Moffitt agreed to conduct and manage a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of the Company’s

lead anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic

syndrome (“MDS”).

November 2018, the Company received approval from the U.S.

Food and Drug Administration for its Investigational New Drug (“IND”)

Application to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and

intermediate-1 risk MDS who had failed or were intolerant of standard treatment.

This Phase 1b/2 clinical trial utilized LB-100 as a

single agent in the treatment of patients with low and intermediate-1 risk MDS.

clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019.

year ended December 31, 2023, the clinical trial was closed.

Although the maximum tolerated dose (“MTD”) was not achieved,

there was no dose-limiting toxicity noted.

the years ended December 31, 2024 and 2023, the Company incurred costs of $ 0 and $ 16,165 , respectively, pursuant to this agreement.

of December 31, 2024, total costs of $ 147,239 had been incurred pursuant to this agreement.

September 2023, the Company decided not to pursue further studies in MDS, as other, more promising, opportunities had become available

(see “Patent and License Agreements - Moffitt” below).

Cancer Institute Pharmacologic Clinical Trial.

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and other aggressive brain tumors.

Trial Monitoring Agreements

Anderson Cancer Center Clinical Trial .

On September 20, 2023, the Company announced an investigator-initiated Phase 1b/2 collaborative

clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 (“PD-1”) blocking antibody of GSK plc

(“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma

The clinical trial is being sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”)

and is being conducted at The University of Texas - MD Anderson Cancer Center.

The Company is providing LB-100 and GSK is providing dostarlimab-gxly

and financial support for the clinical trial.

On January 29, 2024, the Company announced the entry of the first patient into this clinical

The Company currently expects that this clinical trial will be completed by July 31, 2025.

Effective August 20, 2018, the Company entered into a Clinical Trial Research Agreement with the Moffitt Cancer Center and Research

Institute Hospital Inc., Tampa, Florida (“Moffitt”), effective for a term of five years, unless terminated earlier by the

Company pursuant to 30 days written notice.

Pursuant to the Clinical Trial Research Agreement, Moffitt agreed to conduct and manage a

Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of the Company’s lead anti-cancer clinical compound

LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome (“MDS”).

November 2018, the Company received approval from the U.S.

Food and Drug Administration for its Investigational New Drug (“IND”)

Application to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and

intermediate-1 risk MDS who have failed or are intolerant of standard treatment.

Patients with MDS, although usually older, are generally

well except for severe anemia requiring frequent blood transfusions.

This Phase 1b/2 clinical trial utilized LB-100 as a single agent

in the treatment of patients with low and intermediate-1 risk MDS.

clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019.

year ended December 31, 2023, the clinical trial was closed.

In this clinical trial, single agent LB-100 was used on a new schedule of

days 1, 3, and 5 every 3 weeks.

Although MTD was not achieved, there was no dose-limiting toxicity on this schedule at doses that were

greater than the MTD in the Phase 1 clinical trial of LB-100 on the Monday, Tuesday, Wednesday schedule.

the years ended December 31, 2023 and 2022, the Company incurred costs of $ 16,165 and $ 26,397 , respectively, pursuant to this agreement,

which have been included in research and development costs in the Company’s consolidated statements of operations.

On May 15, 2024, the Company signed a letter of intent with Theradex to monitor the MD Andersen

investigator-initiated Phase 1b/2 collaborative clinical trial to assess whether adding LB-100 to a human programmed death receptor-1

(“PD-1”) blocking antibody of GSK plc (“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy

in the treatment of ovarian clear cell carcinoma (“OCCC”).

On August 19, 2024, the Company signed a work order agreement

with Theradex to monitor the MD Anderson clinical trial.

The study oversight is expected to be completed by January 31, 2027.

under this letter of intent and related work order agreement are estimated to be approximately $ 95,000 .

During the year ended December

31, 2024, the Company incurred costs of $ 26,763 pursuant to this letter of intent and subsequent work order.

As of December 31, 2024,

31, 2023, total costs of $ 147,239 have been incurred pursuant to this agreement.

Company has decided not to pursue further studies in MDS, as other opportunities have become available (see “Patent and License

Agreements - Moffitt” below).

Trial Monitoring Agreements

On September 12, 2018, the Company finalized a work order agreement with Theradex Systems, Inc.

(“Theradex”), an international

contract research organization (“CRO”), to monitor the Phase 1b/2 clinical trial being managed and conducted by Moffitt.

The clinical trial began in April 2019 and the first patient was entered into the clinical trial in July 2019.

costs of the Phase 1b/2 clinical trial being paid to or through Theradex have been recorded and charged to operations based on periodic

documentation provided by the CRO.

During the years ended December 31, 2023 and 2022, the Company incurred costs of $ 20,884 and $ 35,403 ,

respectively, pursuant to this work order.

As of December 31, 2023, total costs of $ 148,172 have been incurred pursuant to this work

order agreement.

a result of the closure of the Company’s Clinical Trial Research Agreement with Moffitt during the year ended December 31, 2023

(see “Clinical Trial Agreements – Moffitt” above), this work order agreement with Theradex to monitor the Clinical

Trial Research Agreement with Moffitt was similarly suspended, although nominal oversight trailing costs subsequent to December 31, 2023

are expected to be incurred relating to the closure of the Moffitt study.

total costs of $ 26,763 have been incurred pursuant to this letter of intent and subsequent work order.

Company’s aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $ 70,000

as of December 31, 2024, which is expected to be incurred through December 31, 2027.

On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated

1 unchanged sentence

Costs under this

work order agreement are estimated to be approximately $ 335,000 .

During the years ended December 31, 2023 and 2022, the Company incurred

costs of $ 20,240 and $ 33,815 , respectively, pursuant to this work order.

As of December 31, 2023, total costs of $ 78,681 have been incurred

work order agreement were estimated to be approximately $ 335,000 .

During the years December 31, 2024 and 2023, the Company incurred costs

of $ 10,642 and $ 20,240 , respectively, pursuant to this work order.

As of December 31, 2024, total costs of $ 89,323 had been incurred

pursuant to this work order agreement.

Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled

approximately $ 258,000 as of December 31, 2023, which is expected to be incurred through March 31, 2026.

a result of the closure of the Agreement with City of Hope effective July 8, 2024 (see “Clinical Trial Agreements – City

of Hope” above), the work order agreement with Theradex to monitor this clinical trial was concurrently terminated, although nominal

oversight trailing costs subsequent to July 8, 2024 are expected to be incurred relating to the closure of this study.

On June 22, 2023, the Company finalized a work order agreement with Theradex, to monitor the GEIS investigator-initiated clinical

Phase I/II randomized trial of LB-100 plus doxorubicin vs.

doxorubicin alone in first line of advanced soft tissue sarcomas.

is expected to be completed by June 30, 2026.

doxorubicin alone in first line of advanced soft tissue sarcoma.

oversight is expected to be completed by December 31, 2026.

under this work order agreement are estimated to be approximately $ 153,000 , with such payments expected to be allocated approximately

72 % to Theradex for services and approximately 28 % for payments for pass-through software costs.

During the years ended December 31,

2024 and 2023, the Company incurred costs of $ 34,593 and $ 14,862 , respectively, pursuant to this work order.

As of December 31, 2024,

total costs of $ 49,455 have been incurred pursuant to this work order agreement.

Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled

approximately $ 104,000 as of December 31, 2024, which is expected to be incurred through December 31, 2026.

Cancer Institute.

On August 27, 2024, the Company finalized a work order agreement with Theradex, to monitor the NKI Phase 1b clinical

trial of LB-100 combined with atezolizumab, a PD-L1 inhibitor, for patients with microsatellite stable metastatic colorectal cancer.

The study oversight is expected to be completed by May 31, 2027.

under this work order agreement are estimated to be approximately $ 106,380 , with such payments expected to be allocated approximately

47 % to Theradex for services and approximately 53 % for payments for pass-through software costs.

During the year ended December 31, 2024,

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Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled

approximately $ 141,000 as of December 31, 2023, which is expected to be incurred through June 30, 2026.

approximately $ 88,000 as of December 31, 2024, which is expected to be incurred through May 31, 2027.

and License Agreements

Institute of Health.

Effective February 23, 2024, the Company entered into a Patent License Agreement (the “License Agreement”)

with the National Institute of Neurological Disorders and Stroke (“NINDS”) and the National Cancer Institute (“NCI”),

each an institute or center of the National Institute of Health (“NIH”).

Pursuant to the License Agreement, the Company has

licensed on an exclusive basis the NIH’s intellectual property rights claimed for a Cooperative Research and Development Agreement

(“CRADA”) subject invention co-developed with the Company, and the licensed field of use, which focuses on promoting anti-cancer

activity alone, or in combination with standard anti-cancer drugs.

The scope of this clinical research extends to checkpoint inhibitors,

immunotherapy, and radiation for the treatment of cancer.

The License Agreement is effective, and shall extend, on a licensed product,

licensed process, and country basis, until the expiration of the last-to-expire valid claim of the jointly owned licensed patent rights

in each such country in the licensed territory, estimated at twenty years, unless sooner terminated.

License Agreement contemplates that the Company will seek to work with pharmaceutical companies and clinical trial sites (including comprehensive

cancer centers) to initiate clinical trials within timeframes that will meet certain benchmarks.

Data from the clinical trials will be

the subject of various regulatory filings for marketing approval in applicable countries in the licensed territories.

Subject to the

receipt of marketing approval, the Company would be expected to commercialize the licensed products in markets where regulatory approval

has been obtained.

Company is obligated to pay the NIH a non-creditable, non-refundable license issue royalty of $ 50,000 and a first minimum annual royalty

within sixty days from the effective date of the Agreement.

The first minimum annual royalty of $ 25,643 was prorated from the effective

date of the License Agreement to the next subsequent January 1.

Thereafter, the minimum annual royalty of $ 30,000 is due each January

1 and may be credited against any earned royalties due for sales made in that year.

The license issue royalty of $ 50,000 and the first

minimum annual royalty of $ 25,643 , were paid in April 2024.

The second minimum annual royalty for 2025 of $ 30,000 , was paid in December

2024 and is included in other prepaid expenses at December 31, 2024 in the accompanying consolidated balance sheet.

Company is obligated to pay the NIH, on a country-by-country basis, earned royalties of 2% on net sales of each royalty-bearing product

and process, subject to reduction by 50% under certain circumstances relating to royalties paid by the Company to third parties, but

not less than 1%.

The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first

commercial sale of a royalty-bearing product or process and expires on the date on which the last valid claim of the licensed product

or licensed process expires in such country.

Company is obligated to pay the NIH benchmark royalties, on a one-time basis, within sixty days from the first achievement of each such

The License Agreement defines four such benchmarks, which the Company is required to pursue based on “commercially reasonable

efforts” as defined in the License Agreement, with deadlines of October 1, 2024, 2027, 2029 and 2031, respectively, each with a

different specified benchmark payment amount payable within thirty days of achieving such benchmark.

The October 1, 2024 benchmark of

$ 100,000 was defined as the dosing of the first patient with a licensed product in a Phase 2 clinical study of such licensed product

in the licensed fields of use.

The Company had not commenced a Phase 2 clinical study as of December 31, 2024.

The total of all such

benchmark payments is $ 1,225,000 .

Company is obligated to provide annual reports to the NIH on its progress toward the development and commercialization of products under

the licensed patents.

These reports, due within sixty days following the end of each calendar year, must include updates on research

and development activities, regulatory submissions, manufacturing efforts, sublicensing, and sales initiatives.

If any deviations from

the established commercial development plan or agreed-upon benchmarks occur, the Company is obligated to provide explanation and may

amend the commercial development plan and the benchmarks, which, subject to certain conditions, the NIH shall not unreasonably withhold,

condition, or delay approval of any request of the Company to amend the commercial development plan and/or the benchmarks and to extend

the time periods of the benchmarks.

Company is obligated to pay the NIH sublicensing royalties of 5 % on sublicensing revenue received for granting each sublicense within

sixty days of receipt of such sublicensing revenue.

the year ended December 31, 2024, the Company incurred costs of $ 75,643 in connection with its obligations under the License Agreement.

Such costs when incurred have been included in general and administrative costs in the Company’s consolidated statement of operations.

As of December 31, 2024, total costs of $ 75,643 have been incurred pursuant to this agreement.

The Company’s aggregate commitment

pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 1,795,000 as of December 31, 2024, which is

expected to be incurred over approximately the next twenty years.

Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt.

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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 was also obligated to pay Moffitt an annual

license maintenance fee of $ 25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the

Company commences payment of minimum royalty payments.

The Company had also agreed to pay non-refundable milestone payments to Moffitt,

which could not be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones

aggregating $ 1,897,000 , subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term

is defined in the License Agreement.

October 4, 2023, the Company received a counter-signed termination letter dated September 29, 2023 with respect to the Exclusive License

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The Company and Moffitt agreed that no

termination fee shall be due or payable by the Company, and Moffitt acknowledged that no payments are owed by the Company under the Agreement.

termination fee was due or payable by the Company, and Moffitt acknowledged that no payments are owed by the Company under the Agreement.

the year ended December 31, 2023, the Company recorded a credit to operations of $ 9,109 representing the reversal of obligations previously

recorded with respect to the Exclusive License Agreement.

During the year ended December 31, 2022, the Company recorded charges to operations

of $ 25,000 , in connection with its obligations under the Exclusive License Agreement.

Agreements with Officers

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

Kovach, Eric J.

Miser, and Robert N.

Weingarten, which provided for aggregate annual cash compensation

of $ 640,000 , payable monthly (see Note 5).

These employment agreements were automatically renewable for additional one-year periods unless

terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination

These employment agreements were automatically renewed for additional one-year periods in July and August 2021, 2022 and 2023.

April 9, 2021, the Board of Directors increased the annual cash compensation of Eric J.

Miser, and Robert N.

under the employment agreements, such that the aggregate annual compensation for all officers increased to $ 775,000 , effective May 1,

November 6, 2022, Mr.

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

Forman is being provided an office allowance of approximately $ 1,500 per month through December 31, 2023.

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

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

The term of the employment

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

to early termination as described in the employment agreement.

Under the employment agreement, Mr.

van der Baan’s annual salary

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

In addition, Mr.

van der Baan will be eligible to

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

van der Baan was appointed as Chairman of

the Board of Directors upon the death of Dr.

Kovach, who died on October 5, 2023.

aggregate annual cash compensation for all officers was $ 700,000 as of December 31, 2023.

Significant Agreements and Contracts

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.

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

ended December 31, 2023 and 2022, respectively, which were included in research and development costs in the consolidated statements

of operations.

On December 24, 2013, the Company entered into a consulting agreement with NDA Consulting Corp.

for consultation

and advice in the field of oncology research and drug development.

As part of the consulting agreement, NDA also agreed to have its president,

Von Hoff, M.D., serve on the Company’s Scientific Advisory Committee during the term of such consulting agreement.

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

The consulting agreement had been

automatically renewed for additional one-year terms on its anniversary date, most recently on December 24, 2023, but was subsequently

terminated by mutual agreement effective September 30, 2024.

Consulting and advisory fees charged to operations pursuant to this consulting

agreement were $ 12,000 and $ 16,000 for the years ended December 31, 2024 and 2023, respectively.

BioPharmaWorks .

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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 (see Note 6).

The Company recorded

charges to operations pursuant to this Collaboration Agreement of $ 120,000 and $ 120,000 for the years ended December 31, 2023 and 2022,

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

lieu of the monthly fee.

Effective March 1, 2024, the compensation payable under the Collaboration Agreement was converted to an hourly

rate structure.

Company recorded charges to operations pursuant to this Collaboration Agreement of $ 39,200 and $ 120,000 during the years ended December

31, 2024 and 2023, respectively, which were included in research and development costs in the consolidated statements of operations.

Cancer Institute .

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modified by Amendment No.

The Development Collaboration Agreement is intended to identify the most promising drugs to be combined

with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular

mechanisms underlying the identified combinations.

The Company agreed to fund the study, at an approximate cost of 391,000 Euros and

provide a sufficient supply of LB-100 to conduct the study.

Development Collaboration Agreement is a preclinical study intended to identify the most promising drugs to be combined with LB-100,

and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying

the identified combinations.

The Company agreed to fund the preclinical study, at an approximate cost of 391,000 Euros and provide a

sufficient supply of LB-100 to conduct the preclinical study.

October 3, 2023, the Company entered into Amendment No.

2 to the Development Collaboration Agreement with NKI, which provides for additional

research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and adds

500,000 Euros (approximately $ 526,000 at October 3, 2023) to the operating budget being funded by the Company.

research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and added

500,000 Euros to the operating budget being funded by the Company.

October 4, 2024, the Company entered into Amendment No.

3 to the Development Collaboration Agreement with NKI, which suspended Amendment

2 and provided for a new study term of one year and starts upon the dosing of the first patient in the trial at a project cost of

100,000 Euros.

the years ended December 31, 2024 and 2023, the Company incurred charges in the amount of $ 210,362 and $ 226,150 , respectively, with respect

to this agreement, which amounts are included in research and development costs in the Company’s consolidated statements of operations.

As of December 31, 2023, total costs of $ 485,556 have been incurred pursuant to this agreement, as amended.

The Company’s aggregate

commitment pursuant to this agreement, as amended, less amounts previously paid to date, totaled approximately $ 595,000 as of December

31, 2023, which is expected to be incurred through October 8, 2026.

As the work is being conducted in Europe and is paid for in Euros,

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

The Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical trials

in the United States.

On June 10, 2022, the contract was amended to reflect a new total contract price of $ 273,980 for services to be

rendered through April 30, 2023.

Effective April 17, 2023, the contract was further amended to reflect a new total contract price of

$ 326,274 for services to be rendered through April 30, 2024.

During the years ended December 31, 2023 and 2022, the Company incurred

costs of $ 32,307 and $ 27,702 , respectively, pursuant to this work order.

As of December 31, 2023, total costs of $ 248,298 have been incurred

As of December 31, 2024, total costs of $ 695,918 have been incurred pursuant to this agreement.

The Company’s aggregate commitment

pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 104,000 as of December 31, 2024, which is expected

to be incurred through October 8, 2026.

As the work is being conducted in Europe and is paid for in Euros, final costs are subject to

foreign currency fluctuations between the United States Dollar and the Euro.

As amended, the Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical

trials in the United States.

During the years ended December 31, 2024 and 2023, the Company incurred costs of $ 23,308 and $ 32,307 , respectively,

pursuant to this contract.

Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $ 78,000 as

of December 31, 2023.

As of December 31, 2024, total costs of $ 340,522 have been incurred pursuant to this contract.

Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $ 118,000

as of December 31, 2024.

Risks Associated with the Company’s Business Activities

Adverse Events

Company’s lead drug candidate, LB-100, is currently undergoing various clinical trials, and there is a risk that one or more of

these trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to the Company’s drug

candidate or to another company’s drug used in combination in one of the Company’s clinical trials.

It is possible that the

SAEs could be attributable to the Company’s drug candidate and could include, but not be limited to, unexpected severe side effects,

treatment-related deaths, or long-term health complications.

A dose given could result in non-tolerable adverse events defined as dose-limiting

toxicity (DLT).

When two DLTs occur at the same dose-level, that dose-level is considered too high and unsafe.

Further treatment is only

allowed at lower dose-levels that have previously been found safe.

an SAE or a pattern of SAEs is observed during the course of a clinical trial involving the Company’s drug candidate, the U.S.

Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory authorities may issue a clinical hold, requiring

the Company to pause or discontinue further enrollment and dosing in its clinical trial.

It is also possible that the clinical trial

could be terminated.

Any of these actions could delay or halt the development of the Company’s drug candidate, increase development

costs, and negatively impact the Company’s ability to ultimately achieve regulatory approval.

Additionally, if an SAE is confirmed

to be drug-related, the Company may be required to conduct additional studies, modify the study design, or abandon further development

of the drug candidate altogether, which could materially impact the Company’s business, financial condition, and prospects.

occurrence of an SAE and any resulting clinical hold could also harm the Company’s reputation with patients, physicians, health

institutions, and investors, diminish its ability to attract clinical trial participants, and damage its ability to interest investors

and obtain financing in the future.

There can be no assurance that the Company will not experience such SAEs in the future or that any

related clinical hold will be lifted in a timely manner, or at all.

principal investigator of the colorectal study testing LB-100 in combination with atezolizumab (Roche PD-L1 inhibitor) is currently investigating

two SAEs observed in the clinical trial that was launched in August 2024.

The Netherlands Cancer Institute (“NKI”) Institutional

Review Board (the “IRB”) has put the colorectal cancer study on hold.

The adverse reactions that developed in the two patients

were dyspnea (shortness of breath) due to lung toxicity possibly or probably related to the combination of LB-100 and atezolizumab in

one patient and fever and aphasia possibly or probably related to the combination of LB-100 and atezolizumab in the second patient.

patient who developed lung toxicity deceased due to the combination of lung metastases of colorectal cancer and dyspnea.

with fever and aphasia fully recovered from the adverse events with supportive medication.

the identified adverse events in the two patients in the clinical trial, the IRB requested from the principal investigator of the study

at the NKI information as to whether the adverse events could have been caused by the combination of LB-100 and atezolizumab and information

about the mode of action of the combination of LB-100 and atezolizumab.

The principal investigator is preparing a response to the IRB

detailing the safety experience with LB-100 given alone and in combination with other cancer drugs, especially doxorubicin and dostarlimab.

Doxorubicin is a well-known chemotherapy, and dostarlimab is a well-known immunotherapy of which the mode of action is closely related

to that of atezolizumab.

reported adverse events in the colorectal cancer study have not been seen in any other patients thus far treated with LB-100 alone or

in combination with other cancer drugs.

Through February 2025, a total of 78 patient have received or are receiving experimental treatment

It is expected that it will take at least two months to prepare a detailed response to the IRB, during which time the Company

intends to update the safety overview of LB-100.

Business Risks

The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout

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Although the Covid-19 outbreak

has subsided, the extent to which the coronavirus pandemic may reappear and impact the Company’s clinical trial programs and capital

raising efforts in the future is uncertain and cannot be predicted.

has subsided, the extent to which the coronavirus or any other pandemics may reappear and impact the Company’s clinical trial programs

and capital raising efforts in the future is uncertain and cannot be predicted.

and Interest Rate Risk.

The Company does not believe that inflation or increasing interest rates has had a material effect on its

operations to date, other than its impact on the general economy.

However, there is a risk that the Company’s operating costs could

become subject to inflationary and interest rate pressures in the future, which would have the effect of increasing the Company’s

The Company does not believe that inflation or increasing interest rates have had a material effect on its

operations to date, other than their 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

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publicly-traded shares.

Investor confidence, market sentiment, and access to capital may all be negatively influenced.

Investor confidence, market sentiment, and access to capital could all be negatively influenced.

Such geopolitical

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of operations may differ from current estimates.

Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance

become available.

Cybersecurity

The Company has established policies and processes for assessing, identifying and managing material risk from cybersecurity

threats, and has integrated these processes into its overall risk management systems and processes.

The Company routinely assesses material

risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through its information and email systems

that may result in adverse effects on the confidentiality, integrity, or availability of the Company’s information and email systems

or any information residing therein.

The Company conducts periodic risk assessments to identify cybersecurity threats, as well as assessments

in the event of a material change in the Company’s business practices that may affect information systems that are vulnerable to

such cybersecurity threats.

These risk assessments include identification of reasonably foreseeable internal and external risks, the

likelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems and

safeguards in place to manage such risks.

The Company has not encountered any cybersecurity challenges to date that have materially impaired

its operations or financial condition.

Company is continuing to monitor these matters and will adjust its current business and financing plans as more information becomes available.

Subsequent Events

Company performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with the SEC.

Other than those matters described below, there were no material subsequent events which affected, or could affect, the amounts or disclosures

in the consolidated financial statements.

License Agreement

February 23, 2024, the Company entered into a Patent License Agreement (the “License Agreement”) with the National Institute

of Neurological Disorders and Stroke (“NINDS”) and the National Cancer Institute (“NCI”), each an institute or

center of the National Institute of Health (“NIH”).

Pursuant to the License Agreement, the Company has licensed exclusively

NIH’s intellectual property rights claimed for a Cooperative Research and Development Agreement (“CRADA”) subject invention

co-developed with the Company, and the licensed field of use, which focuses on promoting anti-cancer activity alone, or in combination

with standard anti-cancer drugs.

The scope of this clinical research extends to checkpoint inhibitors, immunotherapy, and radiation for

the treatment of cancer.

The License Agreement is effective, and shall extend, on a licensed product, licensed process, and country basis,

until the expiration of the last-to-expire valid claim of the jointly owned licensed patent rights in each such country in the licensed

territory, unless sooner terminated.

License Agreement contemplates that the Company will seek to work with pharmaceutical companies and clinical trial sites (including comprehensive

cancer centers) to initiate clinical trials within timeframes that will meet certain benchmarks.

Data from the clinical trials will be

the subject of various regulatory filings for marketing approval in applicable countries in the licensed territories.

Subject to the

receipt of marketing approval, the Company would be expected to commercialize the licensed products in markets where regulatory approval

has been obtained.

Company is obligated to pay the NIH a non-creditable, non-refundable license issue royalty of $ 50,000 and a first minimum annual royalty

of $ 30,000 , within sixty days from the effective date of the Agreement.

The first minimum annual royalty may be prorated from the effective

date of the License Agreement to the next subsequent January 1.

Thereafter, the minimum annual royalty of $ 30,000 is due each January

1 and may be credited against any earned royalties due for sales made in that year.

Company is obligated to pay the NIH, on a country-by-country basis, earned royalties of 2% on net sales of each royalty-bearing product

and process, subject to reduction by 50% under certain circumstances relating to royalties paid by the Company to third parties, but

not less than 1%.

The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first

commercial sale of a royalty-bearing product or process and expires on the date on which the last valid claim of the licensed product

or licensed process expires in such country.

Company is obligated to pay the NIH benchmark royalties, on a one-time basis, within sixty days from the first achievement of each such

The License Agreement defines four such benchmarks, with deadlines of October 1, 2024, 2027, 2029 and 2031, respectively,

each with a different specified benchmark payment amount payable within thirty days of achieving such benchmark.

The October 31, 2024

benchmark is defined as the dosing of the first patient with a licensed product in a Phase 2 clinical study of such licensed product

in the licensed fields of use.

The total of all such benchmark payments is $ 1,225,000 .

Company is obligated to pay the NIH sublicensing royalties of 5 % on sublicensing revenue received for granting each sublicense within

sixty days of receipt of such sublicensing revenue.

Other than as described below, there were no material subsequent events which affected, or could affect, the amounts or disclosures in

the consolidated financial statements.

August 23, 2024, the Company received a letter from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock

Market LLC (“Nasdaq”) on August 19, 2024 indicating that the Company was not in compliance with the minimum net stockholders’

equity requirement of $ 2,500,000 for continued listing on the Nasdaq Capital Market under Listing Rule 5550(b) (the “Stockholders’

Equity Requirement”).

October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement, which

outlined the Company’s proposed initiatives to regain compliance by raising equity capital through various registered equity offerings.

October 21, 2024, the Staff provided notice (the “Notice”) to the Company that it had granted an extension through February

18, 2025 to regain compliance with the Stockholders’ Equity Requirement, which required that the Company complete its capital raising

initiatives and evidence compliance with the Stockholders’ Equity Requirement through filing a Current Report on Form 8-K with

the Securities and Exchange Commission (the “SEC”) providing certain required information.

of February 18, 2025, the Company had not gained compliance with the Stockholders’ Equity Requirement.

Accordingly, on February

19, 2025, the Company received a Staff determination letter from the Staff stating that the Company did not meet the terms of the extension

because it did not complete its proposed financing initiatives to regain compliance.

Company timely filed an appeal and requested a Hearing before a Nasdaq Hearings Panel (the “Panel”), which has been granted.

The Hearing request automatically stayed Nasdaq’s delisting of the Company’s common shares and warrants pending the Panel’s

Pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an additional extension through no

later than August 18, 2025.

At the upcoming hearing, the Company will present its plan for regaining and sustaining compliance with the

Stockholders’ Equity Requirement for continued listing.

However, there can be no assurances that the Hearings Panel will grant

the Company an extension of time to regain compliance, or that the Company will be able to regain compliance during any extension period.

Company intends to take reasonable measures available to regain compliance under Nasdaq’s listing rules and to remain listed on

However, there can be no assurances that the Company will ultimately regain compliance with the Stockholders’ Equity Rule,

or be able to maintain compliance with all other applicable requirements for continued listing on Nasdaq.

If the Company does not regain

compliance with Nasdaq’s continued listing requirements within the time period permitted by Nasdaq, then the Company’s securities

will be delisted from Nasdaq.

of At-the-Market Sales Agreement

Capital, LLC.

Effective January 6, 2025, the Company entered into an At-the-Market Sales Agreement (the “Sales Agreement”)

with WallachBeth Capital, LLC (the “Agent”) pursuant to which the Company may offer and sell from time to time through the

Agent, acting as agent, shares of its common stock, $ 0.0001 par value per share, having an aggregate offering price of up to $ 1,700,000 ,

subject to the terms and conditions of the Agreement.

The issuance and sale, if any, of shares of common stock through the Agent under

the Sales Agreement was to be made pursuant to the Company’s effective shelf registration statement on Form S-3 (File No.

(the “Registration Statement”) filed with the Securities and Exchange Commission (the “SEC”) on April 23, 2024,

and declared effective on May 2, 2024.

offering of shares of the Company’s common stock pursuant to the Sales Agreement was scheduled to terminate upon the earliest of

(i) the sale of the maximum dollar amount of shares of common stock subject to the Sales Agreement, (ii) the termination of the Sales

Agreement by the Company or the Agent, and (iii) the expiration of the shelf registration statement on Form S-3 (File No.

on the third anniversary of the initial effective date of such registration statement.

On March 7, 2025, the Company provided a notice

of termination of the Sales Agreement to the Agent, which, pursuant to the terms of the Sales Agreement, will become effective 10 days

after issuance, or March 18, 2025.

No shares of common stock were sold under this Sales Agreement.

of Securities Pursuant to Securities Purchase Agreement

February 11, 2025, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain purchasers

named therein (the “Purchasers”), pursuant to which the Company agreed to issue and sell, (a) in a registered direct offering

(the “Registered Offering”), an aggregate of 434,784 shares (the “Shares”) of the Company’s common stock,

par value $ 0.0001 per share (the “Common Stock”), at an offering price of $ 2.415 per share, and (b) in a concurrent private

placement (the “Private Offering”), warrants (the “Common Stock Warrants”) to purchase an aggregate of 434,784

shares of Common Stock.

The Common Stock Warrants were immediately exercisable for a term of five years from issuance at an exercise

price of $ 2.29 per share.

Common Stock Warrants and the shares of Common Stock underlying the Common Stock Warrants have not been registered under the Securities

Act of 1933, as amended (the “Securities Act”), and have been issued in reliance on an exemption from the registration requirements

of the Securities Act afforded by Section 4(a)(2) thereof.

The Common Stock Warrants and the shares of the Company’s Common Stock

underlying the Common Stock Warrants may not be offered or sold in the United States in the absence of an effective registration statement

or exemption from applicable registration requirements.

The Company has agreed to file a registration statement to cover the resale of

any share of Common Stock issuable upon the exercise of the Common Stock Warrants by April 4, 2025.

The Registered Offering and Private

Offering are referred to herein as the “Offering”.

Offering resulted in gross proceeds of $ 1,050,003 before deducting the placement agent’s fees and related offering expenses.

Shares were offered by the Company pursuant to a prospectus supplement to the Company’s effective shelf registration statement

on Form S-3 (Registration No.

333-278874), which was initially filed with the Securities and Exchange Commission (the “Commission”)

on April 23, 2024, and was declared effective by the Commission on May 2, 2024.

The Offering closed on February 13, 2025 (the “Closing

Wainwright & Co., LLC acted as the exclusive placement agent for the offering.

a Fundamental Transaction (as defined in the Common Stock Warrants) occurs, then the successor entity will succeed to, and be substituted

for the Company, and may exercise every right and power that the Company may exercise and will assume all of the Company’s obligations

under the Common Stock Warrants with the same effect as if such successor entity had been named in the Common Warrant itself.

of shares of the Company’s Common Stock are given a choice as to the securities, cash or property to be received in such a Fundamental

Transaction, then the holder of the Common Stock Warrants shall be given the same choice as to the consideration it would receive upon

any exercise of the Common Stock Warrants following such a Fundamental Transaction.

Additionally, as more fully described in the Common

Stock Warrants, in the event of certain Fundamental Transactions, the holders of such Common Stock Warrants will be entitled to receive

cash consideration in an amount equal to the Black-Scholes value of the Common Stock Warrants on the date of consummation of such Fundamental

the Closing Date, the Company issued to the Placement Agent, or its designees, warrants (the “Placement Agent’s Warrants”)

to purchase up to 32,609 shares of Common Stock, which represents 7.5 % of the Shares sold in the Registered Offering.

The Placement Agent’s

Warrants have an exercise price of $ 3.0188 per share, and a term of five years form the commencement of the sales pursuant to the Offering

and otherwise have the same terms as the Common Stock Warrants.

Placement Agent’s Warrants and the shares of Common Stock underlying the Placement Agent’s Warrants have not been registered

under the Securities Act and have been issued in reliance on an exemption from the registration requirements of the Securities Act afforded

by Section 4(a)(2) thereof.

The Placement Agent’s Warrants and the shares of the Company’s Common Stock underlying the Placement

Agent’s Warrants may not be offered or sold in the United States in the absence of an effective registration statement or exemption

from applicable registration requirements.

As soon as practicable (and in any event by April 4, 2025), the Company has agreed to file

a registration statement on Form S-1 providing for the resale by the Purchasers of the Common Warrant Shares issued and issuable upon

exercise of the Common Warrants.

The Company is obligated to use commercially reasonable efforts to cause such registration statement

to become effective within 120 days following the Closing Date and to keep such registration statement effective at all times until no

Purchaser owns any Common Warrants or Common Warrant Shares issuable upon exercise thereof.

Significant Developments

March 11, 2025, the Company entered into Amendment No.

1 to the Collaboration Agreement between the Company and GEIS that relieved the

Company of the financial obligation to support the randomized Phase 2 portion of the clinical trial contemplated in the Collaboration

Agreement of approximately $ 3,095,000 (see Note 8).

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