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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): February 27, 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 |
On
February 27, 2024, Lixte Biotechnology Holdings, Inc. (the “Company”) issued a press release announcing that René
Bernards, PhD, will present new pre-clinical data on the Company’s lead compound, LB-100, at the Joint Conference of European and
American Associations for Cancer Research being held in Dublin, Ireland on February 27 – 29, 2024. Dr. Bernards is professor of
molecular carcinogenesis at Utrecht University in Amsterdam and head of molecular carcinogenesis at the Netherlands Cancer Institute,
and is also a member of the Company’s Board of Directors.
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:
February 27, 2024 |
LIXTE BIOTECHNOLOGY HOLDINGS, INC. |
|
|
|
|
By: |
/s/
BASTIAAN VAN DER BAAN |
|
|
Bastiaan
van der Baan
|
|
|
President
and Chief Executive Officer |
INDEX
TO EXHIBITS
EXHIBIT
99.1
Professor
René Bernards to Present New Pre-Clinical Data
on
LIXTE’s LB-100 at Joint Conference of European and American Associations for Cancer Research
Conference
In Dublin, Ireland on February 27 - 29, 2024
Focuses
on How to Bring Basic Science Discoveries to the Clinic
PASADENA,
CA, February 27, 2024 — LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) (“LIXTE” or the “Company”),
a clinical stage biotechnology company developing a novel class of cancer therapy called PP2A inhibitors, today announced that René
Bernards, PhD, professor of molecular carcinogenesis at Utrecht University in Amsterdam and head of molecular carcinogenesis at the
Netherlands Cancer Institute, will present new pre-clinical data on LIXTE’s lead compound, LB-100, at the Joint Conference of
European and American Associations for Cancer Research this week in Dublin, Ireland. Dr. Bernards is also a member of LIXTE’s
Board of Directors.
In
his presentation, “Unexpected, but Highly Synergistic Combinations for Cancer Therapy,” Dr. Bernards will present data on
how stress imposed onto colon cancer cells by LB-100 drives cancer cells to evolve to less cancerous behavior.
“The
findings underscore the unique and what we believe to be exciting features and mechanism of action of LIXTE’s PP2A inhibitor, LB-100,”
said Dr. James Miser, LIXTE’s Chief Medical Officer. “While conventional cancer drugs aim to inhibit oncogenic signaling,
which tends to drive cancer cells into more aggressive behavior, LB-100 does exactly the opposite, overloading oncogenic signaling, and
thereby forcing cells to downregulate the signals that are characteristic for cancer cells. As a consequence, cancer cells are forced
to evolve to a less aggressive behavior.”
“This
new data greatly helps to position LB-100 clinically to the benefit of patients and is in addition to the well-established effects of
LB-100 on enhancing the efficacy of checkpoint immunotherapy,” added Bas van der Baan, LIXTE’s President and CEO.
LIXTE
yesterday announced it has entered into an exclusive Patent License Agreement with the National Institute of Neurological Disorders and
Stroke and the National Cancer Institute, both units of the National Institute of Health. The Company also recently announced dosing
of the first patient in a Phase 1b/2 clinical trial at MD Anderson Cancer Center to assess whether adding LIXTE’s LB-100 to GSK’s
programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab-gxly, may enhance the effectiveness of immunotherapy in
the treatment of ovarian clear cell carcinoma (OCCC).
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
or
PondelWilkinson
Inc. Investor Relations
pwinvestor@pondel.com
Roger
Pondel: (310) 279-5965; Laurie Berman: (310) 279-5962
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