Lixte Biotechnology : Investor Fact Sheet – January 2023

NASDAQ: LIXT

January 2023

DEDICATED TO CREATING BETTER TREATMENTS FOR CANCER

LIXTE BIOTECHNOLOGY HOLDINGS, INC. is a clinical-stage drug discovery company using biomarker technology to identify enzyme targets associated with cancer to design novel compounds to attack those targets.

A BREAKTHROUGH IN CANCER VULNERABILITY

A major driver of cancer is defects in the "switches" that turn the biochemical pathways in cells on and off. Most cancer research has focused on "on" switches, because "off" switches, especially the master "off" switch (protein phosphatase or PP2A), were believed to cause intolerable toxicity in patients.

LIXTE has achieved a breakthrough in addressing cancer vulnerability with its novel, first-in-classlead compound, a PP2A inhibitor denoted as "LB-100", by demonstrating that it is readily tolerated in cancer patients at doses associated with anti-canceractivity. Most remarkably, it potentiates the effectiveness of immunotherapy, chemotherapy, and radiotherapy. The LB-100 compound, for which there are no known competitors, is currently being tested in three clinical studies, with other clinical studies being planned. Fifty+ pre- clinical studies with leading medical centers over the past 15 years have indicated that LB-100 may enhance standard therapies for many cancers.

KEY INVESTMENT CONSIDERATIONS

• Unique, effective, less toxic compound, LB-100 is a first-in-classanti-cancer agent with no known competitors.
• Total market for LB-100 is large, with the potential to treat many types of cancers.
• Extensive domestic and international patent portfolio.
• Partnerships and collaborations with top medical institutions and leading academic research centers to advance clinical development, including National Cancer Institute (NCI); Netherlands Cancer Institute (NKI); H. Lee Moffitt Cancer Center & Research Institute; Spanish Sarcoma Group (GEIS); City of Hope National Medical Center.
• Distinguished management team includes veterans of the National Institutes of Health, the Mayo Clinic, City of Hope, Fred Hutchinson Cancer Research Center, Taipei Medical University (TMU) and others.

UNIQUE LB-100 COMPOUND

• A novel, minimally toxic anti-cancer drug that enhances other anti-cancer therapies.
• LB-100inhibits the enzyme PP2A (Protein Phosphatase 2A), a master "off switch" in metabolic pathways that regulates many aspects of cell growth, cell cycle progression, repair of DNA damage, and regulation of T-cell immune function.
• LB-100lowers PP2A activity, potentially in all cancers, rendering those cancers more susceptible to immunotherapy, chemotherapy, and radiotherapy.
• Landmark Phase 1 clinical trial in adults at the Mayo Clinic, City of Hope, and US Oncology Network, showed that LB-100 is well-tolerated by cancer patients at doses associated with anti-cancer activity.

				LB-100
PRICE	52-WK. RANGE	AVG. VOL	COMMON SHARES O/S	MARKET CAP
$0.67 (01/23/23)	$0.43 - $4.95	37K	16.6M	$11.2M

Lixte Biotechnology Holdings, Inc. - 888-289-5533 - [e-mail] - www.lixte.com

PondelWilkinson Inc. - 310-279-5980 - [e-mail]

NASDAQ: LIXT

January 2023

DEDICATED TO CREATING BETTER TREATMENTS FOR CANCER

STRATEGY AND OPPORTUNITIES

LIXTE is focused on demonstrating that LB-100 markedly improves cytotoxic chemotherapy and immunotherapy therapy in early-stage clinical trials. Because extensive pre-clinical data suggest that LB-100 may be effective against many, if not most, human cancers, LIXTE is focusing on aggressive tumors for which clinical benefit can be detected early after initiating treatment.

The Company is exploring additional uses for LB-100. Studies in animals show that low doses of LB-100 enhance the effectiveness of immunotherapy for diverse cancer types through several mechanisms. For example, patients with genetic changes in ovarian clear cell cancers that are expected to reduce PP2A activity, have exceptionally long survival rates when treated with immune checkpoint therapy.

If LB-100 can be shown to significantly enhance standard treatment for small cell lung cancer and/or advanced soft tissue sarcoma, it will be a long-awaited achievement in improving cytotoxic chemotherapy of a very aggressive cancer. If LB-100 can be shown to significantly enhance the effectiveness of immune checkpoint therapy, it will be a landmark advance in cancer treatment in general.

THREE CLINICAL STUDIES…MORE PLANNED

LB-100 markedly improves standard anti-cancer

therapy in animal models of two aggressive diseases

Soft Tissue Sarcoma	Small Cell Lung Cancer
Opening soon.	Open, accruing patients.

Myelodysplastic Syndrome

Open, accruing patients.

MANAGEMENT

RECENT DEVELOPMENTS

• Spanish Agency for Medicines and Health Products authorized Phase 1b/randomized Phase 2 study for LB-100 plus doxorubicin (global standard for initial treatment of advanced soft tissue sarcomas vs. doxorubicin alone).
• Pre-clinicalresults of collaboration with Netherlands Cancer Institute revealed striking anti-cancer activity of LB-100 in novel drug combinations.

John S. Kovach, MD, Founder and CEO: Medical oncologist and clinical pharmacologist; former Director NCI Comprehensive Cancer Centers at Mayo Clinic and City of Hope.

James Miser, MD, Chief Medical Officer: Pediatric Oncologist, Seattle Children's Hospital; Fred Hutchinson Cancer Research Center; former CEO City of Hope National Medical Center.

Robert N Weingarten, Chief Financial Officer: Guardion Health Sciences; RespireRx Pharmaceuticals.

Eric J. Forman, Esq, Chief Operating Officer: Eric Forman Law, representing leading biotechnology companies.

ADVISORS

Robert Volkmann, PhD, Pre-Clinical Drug Development: BioPharma Works; Pfizer.

Daniel Von Hoff, MD, Cancer Clinical Trials: TGen (Translational Genomics Research

Institute); US Oncology, Scottsdale Healthcare's Clinical Research Institute.

FORWARD LOOKING STATEMENTS: This fact sheet contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements regarding the Company's financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future product demand, supply, manufacturing, costs, marketing, and pricing factors are all forward-looking statements. These statements are generally accompanied by words such as "intend," anticipate," "believe," "estimate," "potential(ly)," "continue," "forecast," "predict," "plan," "may," "will," "could," "would," "should," "expect," or the negative of such terms or other comparable terminology. The Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action that it may presently be planning. However, these forward-looking statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected or anticipated in the forward- looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies, available cash, research results, competition from other similar businesses, and market and general economic factors. This discussion should be read in conjunction with the Company's filings with the U.S. Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.