Lixte Biotechnology and City of Hope Enroll First Patient in Phase 1b Trial of Lead Compound LB-100 for Treatment of Small Cell Lung Cancer Extensive preclinical data shows LB-100 increases the effectiveness of chemother

Lixte Biotechnology and City of Hope Enroll First

Patient in Phase 1b Trial of Lead Compound LB-100 for Treatment of Small Cell Lung Cancer

EAST SETAUKET, NY, June 2, 2021- Lixte Biotechnology

Holdings, Inc. (Nasdaq: LIXT), a clinical-stage drug discovery company developing pharmacologically active drugs for use in

cancer treatment, today announced the enrollment of the first patient in a Phase 1b clinical trial with City of Hope, a world-renowned

independent cancer research and treatment center. The trial will assess the combination of Lixte's first-in-class protein phosphatase

2A (PP2A) inhibitor LB-100 with a standard regimen for previously untreated, extensive stage-disease small cell lung cancer (ED-SCLC)

John S. Kovach, M.D., Lixte founder and chief executive

officer, said, "In collaboration with City of Hope, we are eager to pursue our well-grounded rationale for adding LB-100 to a standard

ED-SCLC regimen of carboplatin and etoposide chemotherapy plus atezolizumab to enhance effectiveness. In preclinical studies, the malignant

cells of this uniformly fatal cancer are genetically sensitive to PP2A inhibition by a process termed synthetic lethality and the effectiveness

of the standard regimen is enhanced by LB-100.

"Small cell lung cancer comprises approximately

15% of all lung cancers worldwide with about 30,000 new cases annually in the U.S.," Dr. Kovach continued. "The median survival

of patients with this especially aggressive type of lung cancer, even with current best' therapy, is approximately nine months.

Because of such rapid disease progression, the therapeutic benefit of adding LB-100 to the standard treatment may be seen early on in

this Phase 1b clinical trial."

Ravi Salgia, M.D., Ph.D., City of Hope's

Arthur & Rosalie Kaplan Chair in Medical Oncology, said, "We are hopeful that this trial testing a potentially more effective

therapeutic combination could provide another treatment option for small cell lung cancer patients. It is a disease that is currently

difficult to treat, particularly after a patient has relapsed, so more therapeutic options are needed."

In the Phase 1b trial of LB-100 for the treatment

of ED-SCLC, Lixte's lead compound will be given in combination with carboplatin, etoposide and atezolizumab, an FDA approved but

marginally effective regimen, in previously untreated ED-SCLC. The dose of LB-100 will be escalated with fixed doses of the 3-drug regimen

to reach a recommended Phase 2 dose (RP2D). Patient entry will then be expanded so that a total of 12 patients will be evaluable at the

RP2D to confirm its safety and to look for objective evidence of potential therapeutic activity as assessed by objective response rate,

duration of overall response, progression-free-survival and overall survival. The study is open at City of Hope in Duarte, California.

City of Hope is an independent

biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a

leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope's translational research

and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous

breakthrough cancer drugs are based on technology developed at the institution. AccessHopeTM, a wholly owned subsidiary,

was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope's

exceptional cancer expertise. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National

Comprehensive Cancer Network, City of Hope is ranked among the nation's "Best Hospitals" in cancer by U.S. News &

World Report. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.

About Lixte Biotechnology Holdings, Inc.

Lixte Biotechnology Holdings, Inc. (Nasdaq:

LIXT), is a clinical-stage pharmaceutical company dedicated to discovering drugs for more effective treatments for many forms of cancer

and other serious common diseases. A major driver of cancer is defects in the switches that turn the biochemical pathways in cells on

and off. Most cancer research over the past 30 years has focused on the "on" switches because the "off" switches,

especially the master "off" switch protein phosphatase (PP2A), were believed to cause intolerable toxicity in patients. Lixte

has achieved a breakthrough with its novel, first-in-class lead compound, PP2A inhibitor LB-100, by demonstrating that it is readily tolerated

in cancer patients at doses associated with anti-cancer activity. This innovative approach encourages cancer cells, damaged by chemo or

other cancer therapies, to continue to replicate before repairing the damage, leading to the more efficient death and elimination of those

cells from the body. Lixte has partnered with top medical institutions and leading academic research centers to advance the clinical development

of its compounds. The LB-100 compound, of which there are no competitors known to Lixte, is being tested in three clinical cancer treatment

studies with others in planning. www.lixte.com

Forward-Looking Statements

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example, 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

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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 http://www.sec.gov/edgar.shtml.

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