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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): August 15, 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
August 15, 2024, Lixte Biotechnology Holdings, Inc. (the “Company”) issued a press release announcing that it will be presenting
at two investor conferences.
On
August 19, 2024, the Company issued a press release providing an update on the Company’s recent activities.
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:
August 19, 2024 |
LIXTE
BIOTECHNOLOGY HOLDINGS, INC. |
|
(Registrant) |
|
|
|
|
|
|
|
By: |
/s/
BASTIAAN VAN DER BAAN |
|
|
Bastiaan
van der Baan |
|
|
Chief
Executive Officer |
INDEX
TO EXHIBITS
Exhibit
99.1
![](https://www.sec.gov/Archives/edgar/data/1335105/000149315224033144/ex99-1_001.jpg)
LIXTE
Biotechnology Holdings to Present at Two Investor Conferences
-Company
to Present August 20 at Investor Summit Summer 2024 Virtual Conference;
and September 9-11 at H.C. Wainwright 26th Annual Global Investment Conference-
PASADENA,
CALIF., August 15, 2024 - LIXTE Biotechnology
Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical
company, today announced it will be presenting at two investor conferences:
| ■ | The
Investor Summit Summer 2024 Virtual Conference Tuesday, August 20, 2024, at 2 p.m.
EDT/11 a.m. PDT. To access the presentation, visit LIXTE’s investor relations website
at https://ir.lixte.com/news-events/ir-calendar. |
| ■ | The
H.C. Wainwright 26th Annual Global Investor Conference, on demand starting at
7 a.m. EDT/4 a.m. PDT, September 9-11, 2024. To access the virtual presentation, register
for the conference at www.hcwevents.com/annualconference. |
Bas
van der Baan, CEO of LIXTE, will present an overview of the Company’s clinical trials with LB-100, its proprietary compound focused
on enhancing chemotherapy and immunotherapy treatments as cancer therapies. Proof-of-concept clinical
trials are currently in progress for colorectal, ovarian and sarcoma cancers, including trials funded by GSK and Roche.
About
LIXTE Biotechnology Holdings
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 enhance chemotherapies and immunotherapies and improve outcomes for patients with cancer.
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. LIXTE’s new approach is covered by a comprehensive patent portfolio. Proof-of-concept
clinical trials are currently in progress for colorectal, ovarian and sarcoma cancers. Additional information about LIXTE can be found
at www.lixte.com.
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
#
# #
Exhibit
99.2
![](https://www.sec.gov/Archives/edgar/data/1335105/000149315224033144/ex99-2_001.jpg)
LIXTE
Biotechnology Provides Update On Recent Activities and Developments
-Collaboration
with NKI and Funding Support for New Colorectal Cancer Clinical Trial
by
Major Pharma Company-
-Distinguished
Oncologist Jan Schellens Joins LIXTE as Chief Medical Officer-
-Preclinical
Data Published in Journal EMBO Reports Shows LB-100
as
Potentially Enhancing the Benefit of Immunotherapy-
-LIXTE
to Present at Two Upcoming Investor Conferences-
PASADENA,
CA, August 19, 2024 — LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq:
LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy,
today provided an update on the Company’s recent activities.
“We
are encouraged by the growing interest shown by major pharmaceutical companies in our proprietary compound, LB-100, as demonstrated by
their support in clinical trial collaborations,” said Bas van der Baan, LIXTE’s President and Chief Executive Officer.
“Highlighting
the Company’s recent progress is our new agreement with The Netherlands Cancer Institute, supported by F. Hoffmann- La Roche Ltd.
(“Roche”), which is funding the clinical trial in metastatic colorectal cancer and providing atezolizumab (Tecentriq®,
a PD-L1 inhibitor) through the imCORE network, an academic industry collaboration that aims at accelerating cancer immunotherapy research
through institution sponsored studies. Already underway is a proof-of-concept trial, funded by GSK, of LB-100 plus GSK’s dostarlimab-gxly
in ovarian clear cell cancer.
“We
are seeing encouraging results in the first phase of our clinical trial to determine appropriate dosing and toxicity for treating advanced
soft tissue sarcomas with a combination of LB-100 and standard-of-care chemotherapy and expect to see the data from this first phase
early in 2025. We are exploring alternative sites, including international locations, for our small cell lung cancer trial, following
termination of that clinical trial at City of Hope due to limited patient accrual,” Mr. van der Baan added.
Recent
Company Highlights:
| ■ | Collaboration
with the Netherlands Cancer Institute, supported by Roche, to conduct a new clinical trial
(NCT06012734 in clinicaltrials.gov) in immune therapy for unresponsive (MSI Low) metastatic
colorectal cancer. LIXTE is providing its lead compound, LB-100, and Roche will provide atezolizumab
(Tecentriq®,a PD-L1 inhibitor). The clinical trial will test recent findings
that indicate that LB-100 increases recognition of colorectal cancer cells by the immune
system. |
| ■ | Jan
Schellens, M.D., Ph.D., joined LIXTE as Chief Medical Officer effective August 1, 2024.
Dr. Schellens brings to the Company more than 25 years of clinical experience as a medical
oncologist, pharmacologist and clinical pharmacologist, including more than two decades developing
and bringing new drugs to market. Co-author of more 900 publications in peer-reviewed scientific
journals, Dr. Schellens has held leadership positions at the Netherlands Cancer Institute
in Amsterdam and the Dr. Daniel den Hoed Clinic-Erasmus University in Rotterdam. He was professor
of clinical pharmacology at Utrecht University in the Netherlands, where he earned his M.D.
degree, and he served as a board member and Chief Medical Officer of Byondis B.V. in Nijmegen,
Netherlands. Dr. Schellens also earned a Ph.D. degree in Pharmaceutical Sciences from Leiden
University in Leiden, Netherlands. |
| ■ | New
pre-clinical data in the journal EMBO Reports shows that LIXTE’s lead compound,
LB-100, can turn immunologically “cold” tumors “hot,” potentially
enhancing the benefit of immunotherapy. In a paper titled, “The Phosphatase Inhibitor
LB-100 Creates Neoantigens in Colon Cancer Cells through Perturbation of mRNA Splicing,”
the article reported that LIXTE’s collaborators from the Netherlands Cancer Institute
have demonstrated that treatment of cancer cells with LB-100 disrupts the normal processing
of the mRNA that encodes proteins, thereby generating neo-antigens that are presented to
the host immune system. This new mechanism adds to several previous discoveries showing that
LB-100 sensitizes cancer cells to immune checkpoint blockade. |
| ■ | LIXTE
will present at two upcoming investor conferences: the 2004 Summit Summer 2024 Virtual Conference,
August 20, 2024, and the H.C. Wainwright 26th Annual Global Investor Conference,
September 9-11, 2024. Both conferences will be virtual presentations. |
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 enhance chemotherapies and immunotherapies and improve outcomes for patients with cancer.
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. LIXTE’s new approach is covered by a comprehensive patent portfolio. Proof-of-concept
clinical trials are currently in progress for colorectal, ovarian and sarcoma cancers. Additional information about LIXTE can be found
at www.lixte.com.
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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Lixte Biotechnology (NASDAQ:LIXT)
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から 8 2023 まで 8 2024