LIXT Lixte Biotechnology Holdings Inc

 

 

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): September 20, 2023

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

 

delaware		001-39717		20-2903526
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification Number)

 

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, par value $0.0001 per share		LIXT		The NASDAQ Stock Market, LLC
Warrants to Purchase Common Stock, par value $0.0001 per share		LIXTW		The NASDAQ Stock Market, LLC

 

 

 

Item 8.01.

Other Events.

 

On September 20, 2023, the Company issued a press release regarding a Phase 1b collaborative trial to be conducted at the University of Texas MD Anderson Cancer Center to assess whether adding LB-100, the Company’s lead compound, to GSK’s Dostarlimab enhances the effectiveness in the treatment of ovarian clear cell carcinoma.

 

Item 9.01.

Financial Statements and Exhibits.

 

(d) There is filed as part of this report the exhibit listed on the accompanying Index to Exhibits, which exhibit 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: September 20, 2023	LIXTE BIOTECHNOLOGY HOLDINGS, INC.
	By:	/s/ JOHN S. KOVACH
		John S. Kovach, Chief Executive Officer

 

 

INDEX TO EXHIBITS

 

Exhibit No.		Description
99.1		Press Release regarding a Phase 1b collaborative trial to be conducted at the University of Texas MD Anderson Cancer Center to assess whether adding LB-100, the Company’s lead compound, to GSK’s Dostarlimab enhances the effectiveness in the treatment of ovarian clear cell carcinoma.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

EXHIBIT 99.1

 

 

LIXTE Biotechnology Announces a Supported Collaborative Trial to Study LIXTE’s First-in-Class PP2A Inhibitor, LB-100, Plus GSK’s Immunotherapy, Dostarlimab, in Clear-Cell Ovarian Cancer

 

The Phase 1b Clinical Trial Focuses on Assessing the Safety and Efficacy of the Two-Drug Combination in a Cancer Associated with Longer Survival to Immunotherapy When Genetically Deficient in PP2A

 

PASADENA, CA, September 20, 2023 — LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”), today announced a Phase 1b collaborative clinical trial to assess whether adding Lixte’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC). The clinical trial is sponsored by The University of Texas MD Anderson Cancer Center and will be conducted at MD Anderson and will also be open at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center. LIXTE will provide LB-100; GSK will provide dostarlimab and financial support for the clinical trial.

 

The clinical trial is based on the observation of longer survival of patients with OCCC treated with immunotherapy whose cancer cells have an acquired gene mutation resulting in a reduction in PP2A. This finding was reported by the lead clinical investigators of this new trial¹: Amir Jazaeri MD, Professor of Gynecologic Oncology at MD Anderson, and Emily Hinchcliff, MD, MPH, Assistant Professor of Obstetrics and Gynecology at Northwestern University Feinberg School of Medicine. The observation by Drs. Jazaeri and Hinchcliff, that a genetically acquired reduction in PP2A enhances sensitivity to immunotherapy, raises the possibility that reducing PP2A pharmacologically with LB-100 will enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody dostarlimab in patients with OCCC lacking the genetic reduction in PP2A.

 

John S. Kovach, M.D., LIXTE’s founder and Chief Executive Officer, said, “Preclinical data supports the idea that LB-100 enhances the efficacy of PD-1 therapy.¹ Clinical data also supports this idea, in that patients with ovarian clear cell carcinoma with dysfunctional PP2A due to somatic mutations in PPP2R1A have shown dramatically longer survival after treatment with immune checkpoint blockers”.

 

Dr. Hinchcliff, said, “OCCC is a comparatively chemotherapy resistant disease and therefore has very limited options for treatment. This clinical trial is an exciting alternative approach that leverages the potential synergy between these two agents and is aiming to improve the impact immunotherapy may have for these patients.”

 

¹ Hinchcliff EM, Patel A, Fellman B, Westin SN, Sood A, Soliman P, Shafer A, Meyer L, Fleming N, Bathala Y, Ganeshan D, Hwu P, Lu K, Jazaeri A. Loss-of-function mutations in PPP2R1A Correlate with Exceptional Survival in Ovarian Clear Cell Carcinomas Treated with Immune Checkpoint Inhibitors. National oral presentation at SGO Annual Meeting, March 2022

 

 

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 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.

 

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

 

or

PondelWilkinson Inc. Investor Relations

pwinvestor@pondel.com

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

 

v3.23.3

Cover	Sep. 20, 2023
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 20, 2023
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, par value $0.0001 per share
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	LIXT
Security Exchange Name	NASDAQ
Warrants to Purchase Common Stock, par value $0.0001 per share
Title of 12(b) Security	Warrants to Purchase Common Stock, par value $0.0001 per share
Trading Symbol	LIXTW
Security Exchange Name	NASDAQ

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