Transforming cancer treatment with Protein Phosphatase 2A inhibitors

Unveiling the first of a novel class of therapeutic agents

LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company developing a new class of cancer therapy called PP2A inhibitors.

The Company's innovative approach enhances the efficacy of both chemotherapy and immunotherapy, potentially providing new treatment options for patients. At the core of the Company's therapy is LB-100, the Company's proprietary compound that acts as an inhibitor of PP2A with a favorable toxicity profile. LB-100 promotes the production of cytokines, boosts T-cell proliferation, and generates neoantigens. Moreover, it disrupts the DNA repair mechanisms of cancer cells, potentially improving treatment outcomes. The Company is conducting multiple clinical trials for solid tumors with unmet medical needs. The Company's unique approach has no known competitors and is covered by a comprehensive patent portfolio.

Pioneering a novel class of cancer therapy

Chemotherapy and immunotherapy face common challenges that have limited their success rates, including limited efficacy due to resistance and potential for side effects that can restrict the dosage or duration of treatment.

LIXTE has pioneered a novel class of cancer therapy that strongly enhances the efficacy of both chemotherapies and immunotherapies in pre-clinical models.

At the core of this approach lies our proprietary compound, LB-100, which acts as an inhibitor of PP2A, a critical enzyme involved in multiple cellular functions.

LIXTE has developed a first-in-class enhancer of chemotherapy and immunotherapy

In addition to pursuing novel therapies, we believe we should try to increase the efficacy of existing treatments so that they work for a broader range of patients.

CHEMOTHERAPY

LB-100

IMMUNOTHERAPY

+ LB-100

+ LB

-100

Enhanced

Enhanced

chemotherapy efficacy

immunotherapy efficacy

Stimulates cell proliferation

Promotes production of

Inhibits DNA repair

neoantigens

Increases release of cytokines

Enhances T cell proliferation

LB-100 is a first-in-classPP2A-inhibitor and has a promising safety profile

LB-100 is a small molecule inhibitor of PP2A, a critical enzyme involved in multiple

LB-100

cellular functions.

Demonstrated safety in phase 1 clinical trials

Demonstrated anti-cancer activity in 25+ publications

Convenient IV delivery and cost-effective manufacturing

Good Manufacturing Practice production in place

FDA: Investigational New Drug status

EMA: Investigational Medicinal Product Dossier approval in Europe in 2022

NASDAQ

PRICE

52-WK. RANGE

AVG. VOL

COMMON SHARES O/S

MARKET CAP

LIXT

$2.45 (09/29/23)

$1.58 - $27.00

28K

2.25M

$5.5M

LIXTE already has proof of concept that it works: Inhibition of PP2A by LB-100 is effective in numerous cancer models

LB-100 has been shown to inhibit a spectrum of human cancers.

In extensive pre-clinical studies, LB-100, when coupled with standard cytotoxic drug therapies, potentiates the effectiveness of such regimens against hematologic cancers and solid tumors without enhancing toxicity.

In addition, as recently shown, low doses of LB-100 significantly increase the effectiveness of PD-1immune-checkpoint blockade by activating cytotoxic T cells and CAR-T cells.

Overall survival - Immunotherapy

Tumors with a PP2A inactivating mutation (red line) have a much better response and thus survival when treated with immunotherapy.

Nature Genetics 2019 Feb;51(2):202-206

LIXTE is building a robust pipeline in multiple cancer indications

LB-100 + Chemotherapy

LB-100 + Chemotherapy

LB-100 + Immunotherapy

Advanced Soft Tissue

Advanced Small Cell Lung

Ovarian Clear Cell

Sarcoma

Cancer

Cancer

NCT05809830

NCT04560972

Phase 1b/2

Phase 1b

Phase 2

Status: recruiting

Status: recruiting

Status: IRB approval, opening

Led by an experienced and committed team

Our team brings decades of collective expertise in clinical and drug development, ensuring comprehensive knowledge and experience in advancing innovative therapies. Our Board of Directors is comprised of esteemed business leaders and renowned key opinion leaders in the fields of clinical medicine and oncology.

Management

Bas van der Baan, CEO & President. Biotechnology Executive with more than 20 years experience in bringing innovation to the patient. Most recently the Chief Clinical Officer of Agendia.

John Kovach, MD, CSO & Executive Chairman. Extensive experience in oncology research, established the Long Island Cancer Center, Exec. VP for Medical and Scientific Affairs at the City of Hope National Medical Center.

James Miser, MD, CMO. Globally recognized expert in childhood cancer research and treatment. Extensive experience in clinical development, significant contributions to pediatric clinical cancer studies.

Eric Forman, Esq, COO & VP. Extensive expertise in intellectual property, licensing, and corporate transactions.

Robert Weingarten, CFO & VP. Seasoned CFO and business consultant with 30+ years of finance and SEC compliance experience.

Board of Directors

Prof. René Bernards. Leader in the field of molecular carcinogenesis. Extensive experience in cancer drug development. Netherlands Cancer Institute in Amsterdam

Stephen Forman, MD. Internationally recognized expert in hematological cancers. Professor of Hematology & Hematopoietic Cell Transplantation, City of Hope National Medical Center

Regina Brown, CPA. Accountant with decades of expertise. Compliance, taxation and internal control implementation

Yun Yen MD, PhD, FACP. Distinguished cancer investigator. Former Chairman, Molecular Pharmacology, City of Hope. Former President of Taipei Medical University

Key Investment Considerations

Clinical-stage

Innovative approach

Proprietary

Conducting multiple clinical

pharmaceutical

enhancing chemo- and

compound

trials for solid tumors,

company developing a

immunotherapy

LB-100 acting as a

including Advanced

new class of cancer

efficacy, providing new

safe and potent

Soft Tissue Sarcoma,

therapy called PP2A

options for cancer

inhibitor of PP2A.

Ovarian Clear Cell Cancer

inhibitors.

patients.

and Small Cell Lung Cancer.

www.lixte.com

General Phone: +1 631 830-7092

LIXTE Biotechnology Holdings, Inc.

Investor Phone: +1 888 289-5533

680 E Colorado Blvd., Suite 180. Pasadena, CA 91101

Email: info@lixte.com

Forward looking statements This information packet 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. For example, statements regarding the Company's financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future activities, including the continuing development of proprietary compounds, the planning, funding, coordination and potential results of clinical trials, the patent and legal costs to protect and maintain the Company's intellectual property worldwide, and the Company's ability to obtain and maintain compliance with Nasdaq's continued listing requirements, 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 the Company 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 United States Securities and Exchange Commission at www.sec.gov.

Readers are urged to read the risk factors set forth in the Company's filings with the United States Securities and Exchange Commission at https://www.sec.gov. 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.

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Lixte Biotechnology Holdings Inc. published this content on 03 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 October 2023 17:48:14 UTC.