LIXTE Biotechnology Reports First Spanish Site Activated to Begin Accrual of Patients for a Phase 1b/2 Clinical Trial of LIXTE's Lead Anti-Cancer Compound, LB-100, Added to Doxorubicin as First-Line Treatment of Advanced

Biotechnology Reports First Spanish Site Activated to Begin Accrual of Patients for a Phase 1b/2 Clinical Trial of LIXTE's Lead

Anti-Cancer Compound, LB-100, Added to Doxorubicin as First-Line Treatment of Advanced Soft Tissue Sarcoma

clinical trial seeking to determine if the potentiation of cytotoxic chemotherapy by LB-100 occurs in cancer patients as has been shown

in multiple animal studies across a spectrum of cancers

CA, April 24, 2023 - LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) ("LIXTE") a clinical-stage drug discovery

company developing pharmacologically active drugs for use in cancer treatment, announced that the Spanish Sarcoma Research Group (Grupo

Espa ol de Investigaci n en Sarcomas, or GEIS) completed its first site initiation visit in preparation for the advanced

soft tissue sarcoma (ASTS) clinical trial at Fundaci n Jim nez D az University Hospital (Madrid).

Jim nez D az University Hospital is the home base of Dr. Javier Mart n-Broto, Coordinating Investigator of the clinical

trial, GEIS Co-Founder, and an internationally recognized expert in sarcoma research and therapy. Three additional GEIS-associated cancer

research centers, located in Valencia, Barcelona, and Madrid, Spain, are expected to be activated in the near-term, with Phase 1b patient

accrual planned to begin by mid-May 2023.

Phase 1b portion of the clinical trial to determine the recommended phase 2 dose (RP2D) is expected to be completed within approximately

nine months from commencement. Subsequently, up to ten more clinical sites are expected to join the international Phase 2 portion of

the study to enter up to 150 patients, randomized to standard cytotoxic chemotherapy with doxorubicin alone, versus doxorubicin plus

LB-100. Given the lack of effective first-line treatments for ASTS, this trial has been designed to provide data expected to be sufficient

to justify proceeding to a Phase 3 comparative study.

S. Kovach, MD, Founder and CEO of LIXTE, said, "We are very pleased to finally have an opportunity to test whether LB-100 improves

the treatment of ASTS. GEIS has been very patient, having had to wait several months for various regulatory approvals to introduce LB-100

into a European clinical trial program. The fact that this trial design is still relevant attests to the slow pace of finding better

treatments for this disease."

a more complete description of the science underlying the study developed by Dr. Mart n-Broto and his colleagues, please see:

Biotechnology Announces Approval of a Phase 1b/2 Randomized Trial of Doxorubicin +/-Lb-100 in Advanced Soft Tissue Sarcomas to be Conducted

by the Spanish Sarcoma Group

Spanish Sarcoma Group Will Lead a European Consortium to Evaluate the Ability of Lixte Biotechnology Holdings' LB-100 to Improve

First Line Therapy for Advanced Soft Tissue Sarcomas

LIXTE Biotechnology Holdings, Inc.

Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on new targets for cancer drug development and developing

and commercializing cancer therapies. LIXTE has achieved a breakthrough demonstrating that its first-in-class lead clinical PP2A inhibitor,

LB-100, is well-tolerated in cancer patients at doses associated with anti-cancer activity. Based on extensive published preclinical

data (see www.lixte.com), LB-100 has the potential to significantly improve outcomes for patients undergoing various chemotherapies

or immunotherapies. LIXTE's new approach has no known competitors and is covered by a comprehensive patent portfolio. Initial proof-of-concept

clinical trials are in progress.

GEIS (Grupo Espa ol de Investigaci n en Sarcomas)

is a non-profit organization in Spain engaged in the research, development and management of studies and clinical trials for sarcomas.

GEIS has a mission to ensure the best healthcare to sarcoma patients by helping bring new treatments to them through clinical research.

GEIS has successfully partnered with various institutions and companies to help bring new treatments to patients with sarcomas. Through

the group's many research projects it has created or participated in over the years, it has made a significant impact in the global

research effort to better treat patients with sarcomas. For more information: http://www.grupogeis.org.

announcement 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 resources, research results, competition from other similar businesses, and market and general economic factors.

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.

more information about LIXTE, Contact:

Inc. Investor Relations

Pondel: (310) 279-5965

Berman: (310) 279-5962

General Phone: (631) 830-7092

Investor Phone: (888) 289-5533