Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): May 8, 2024

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

delaware

001-39717

20-2903526

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

680 East Colorado Boulevard, Suite 180

Pasadena, California 91101

(Address of principal executive offices)

(631) 830-7092

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (See General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act of 1933 (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(e) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	LIXT	The Nasdaq Stock Market LLC
Warrant to Purchase Common Stock	LIXTW	The Nasdaq Stock Market LLC

Item 8.01 Other Events.

On May 8, 2024, Lixte Biotechnology Holdings, Inc. (the “Company”) issued a press release announcing that the Company is co-sponsoring an international scientific conference on “Therapeutic Over-Activation in Cancer” at Harvard’s Dana Farber Cancer Institute.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

The Company is filing as part of this Report the exhibits listed on the accompanying Index to Exhibits, which information is incorporated herein by reference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: May 9, 2024	LIXTE BIOTECHNOLOGY HOLDINGS, INC.
	(Registrant)

	By:	/s/ BASTIAAN VAN DER BAAN
		Bastiaan van der Baan President and Chief Executive Officer

INDEX TO EXHIBITS

Exhibit No.		Description

99.1		Press release announcing that Lixte Biotechnology Holdings, Inc. is co-sponsoring an international scientific conference on “Therapeutic Over-Activation in Cancer” at Harvard’s Dana Farber Cancer Institute.

104		Cover Page Interactive Data File (embedded within the Inline XBRL Document)

Exhibit 99.1

LIXTE Biotechnology Co-Sponsoring International Scientific Conference on “Therapeutic Over-Activation in Cancer”

Recent Findings Relate to LIXTE’s Lead Clinical Compound, LB-100, to be Presented at Workshop on May 9 and 10 at Harvard’s Dana Farber Cancer Institute in Boston

PASADENA, CA, May 8, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced it is co-sponsoring an international scientific workshop on “Therapeutic Over-Activation in Cancer” at Harvard University’s Dana Farber Cancer Institute on May 9 and 10, 2024 in Boston, Massachusetts.

This workshop will bring together leading experts from the pharmaceutical industry and academia to discuss a radically different approach to cancer therapy that is being spearheaded by LIXTE’s research team at the Netherlands Cancer Institute. This unconventional approach is based on the deliberate over-activation of oncogenic signaling in cancer cells as a therapeutic strategy using LIXTE’s lead compound, LB-100.

LIXTE is the only company that has a drug in clinical trials with demonstrated capacity to over-activate oncogenic signaling. The results obtained with LB-100 were recently posted online in a paper titled “Paradoxical Activation of Oncogenic Signaling as a Cancer Treatment Strategy” in the scientific journal Cancer Discovery, which will be published in the journal’s July 2024 issue. This study showed that LB-100 triggers hyper-activation of the signals that are responsible for the deregulated proliferation of cancer cells, thus leading to cell death. This approach is the opposite of most of the current generation of cancer therapies and opens potentially new treatment strategies. LIXTE currently has three ongoing clinical trials utilizing LB-100 to enhance various cancer therapies.

Professor René Bernards, Ph.D., of the Netherlands Cancer Institute (NKI), a leader in the field of molecular carcinogenesis and a member of LIXTE’s Board of Directors, is co-leading the workshop. The NKI presentation will focus on findings of a recent pre-clinical study showing that LIXTE’s lead compound, LB-100, can force cancer cells to give up their cancer-causing properties.

LIXTE’s lead compound, LB-100, is part of a pioneering effort in an entirely new field of cancer biology – activation lethality – that is advancing a new treatment paradigm.

About LIXTE Biotechnology Holdings, Inc.

LIXTE 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 demonstrated 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. Proof-of-concept clinical trials are in progress.

Forward-Looking Statement Disclaimer

This 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.

For more information about LIXTE, Contact: info@lixte.com

General Phone: (631) 830-7092; Investor Phone: (888) 289-5533

PondelWilkinson Inc. Investor Relations pwinvestor@pondel.com

Roger Pondel: (310) 279-5965; Laurie Berman: (310) 279-5962

Cover	May 08, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 08, 2024
Entity File Number	001-39717
Entity Registrant Name	LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Entity Central Index Key	0001335105
Entity Tax Identification Number	20-2903526
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	680 East Colorado Boulevard
Entity Address, Address Line Two	Suite 180
Entity Address, City or Town	Pasadena
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	91101
City Area Code	(631)
Local Phone Number	830-7092
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Common Stock [Member]
Title of 12(b) Security	Common Stock
Trading Symbol	LIXT
Security Exchange Name	NASDAQ
Warrant to Purchase Common Stock
Title of 12(b) Security	Warrant to Purchase Common Stock
Trading Symbol	LIXTW
Security Exchange Name	NASDAQ