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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): November
13, 2023
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 Blvd. 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
November 13, 2023, the Company issued a press release with respect to an update on positioning the Company’s lead compound, LB-100,
to enhance chemotherapy and immunology.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
We
are 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:
November 13, 2023 |
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
LIXTE
Biotechnology Provides Update on Clinical Progress and Expanding Collaborations
PASADENA,
Calif., November 13, 2023 – 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
benefit, today provided an update on its progress.
Clinical
Trial and Other Advancements
Year-to-date,
LIXTE has made advances in the development of LB-100 through important collaborations, including the following:
● | Collaboration
with GSK and The University of Texas - MD Anderson Cancer Center in an investigator-initiated
Phase 1b/2 clinical trial assessing whether adding LB-100 to GSK’s programmed death
receptor-1 (PD-1)-blocking monoclonal antibody may enhance the effectiveness of immunotherapy
in the treatment of ovarian clear cell carcinoma. GSK will provide dostarlimab and financial
support for the clinical trial. In addition to MD Anderson, the trial also will be open at
Northwestern University’s Robert H. Lurie Comprehensive Cancer Center. |
| |
● | The
first patient was enrolled in the Spanish Sarcoma Group (Grupo Español de Investigación
en Sarcomas – GEIS) trial to determine whether LB-100 given with a standard dose
of doxorubicin for the treatment of advanced soft tissue sarcomas (ASTS) will improve progression-free
survival and overall survival. This trial will enroll up to 170 patients and will begin in
partnership with GEIS clinical sites. |
| |
● | Sarah
Cannon Research Institute (SCRI) joined the City of Hope’s ongoing Phase 1b clinical
trial evaluating the addition of LB-100 to chemotherapy and immunotherapy for previously
untreated, extensive-stage small cell lung cancer. Adding SCRI is expected to reduce the
time required to demonstrate the feasibility, tolerability and efficacy of adding LB-100
to the current standard of care. |
| |
● | Expanded
collaboration with the Netherlands Cancer Institute (NKI) and Oncode Institute
to study pre-clinical drug synergies of LB-100 with chemotherapy and immunotherapy in various
cancers. The expansion follows a successful two-year collaboration in colon cancer and seeks
to discover additional treatment combinations with LB-100 for other cancer types. A recently
posted article in BioRxiv detailed that the collaboration demonstrated that
inhibition of PP2A in colon cancer cells by LB-100 may lead to an improvement in immunotherapy
response. |
Bas
van der Baan, LIXTE’s recently-appointed President and Chief Executive Officer, said, “Since the beginning of this year,
LIXTE has been expanding its collaborations with several prestigious, world-renowned cancer research institutions and pharmaceutical
companies that are testing our LB-100 compound to improve chemotherapy and immunotherapy treatment outcomes. We believe that LB-100 may
offer broad applicability to many types and stages of cancer, with the potential to benefit a wide range of patients.”
Other
Corporate News
● | Bas
van der Baan, 51, was named President and Chief Executive Officer of LIXTE in September
2023. He was subsequently named Chairman of the Board of Directors as a result of the passing
of LIXTE’s founder, Dr. John S. Kovach, on October 5, 2023. He had previously joined
LIXTE’s Board of Directors in June 2022. With more than two decades of experience in
the biotechnology industry, focused on oncology and diagnostics, Mr. van der Baan will lead
the Company as it works toward its mission of improving medical outcomes for patients undergoing
various chemotherapies and immunotherapies for cancer, while establishing and commercializing
LB-100. |
● | The
Company closed a registered direct offering with an institutional investor for 583,334
shares of common stock (including pre-funded warrants) and a concurrent private placement
of common warrants to purchase up to 583,334 shares of common stock at a purchase price of
$6.00 per common share in July 2023. The gross proceeds from the offering were approximately
$3,500,000, with net proceeds of approximately $3,137,000. |
Filing
of September 30, 2023 Quarterly Report on Form 10-Q
Additional
information with respect to LIXTE’s business, clinical trials and financial condition is contained in the Company’s Quarterly
Report on Form 10-Q for the quarterly period ended September 30, 2023, which has been filed with the U.S. Securities and Exchange Commission
at www.sec.gov.
About
LIXTE Biotechnology Holdings, Inc.
LIXTE
Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company developing a new class of cancer therapy, PP2A inhibitors. The
Company’s novel approach enhances the efficacy of both chemotherapy and immunotherapy, potentially providing new treatment
options for patients. At the core of the Company’s therapy is LB-100, LIXTE’s proprietary molecule that acts as
an inhibitor of the PP2A phosphatase with a favorable toxicity profile. LB-100 promotes the production of neoantigens
and cytokines, boosts T-cell proliferation, and disrupts the DNA repair mechanisms of cancer cells, potentially improving treatment outcomes.
The Company is conducting multiple clinical trials for solid tumors with unmet medical needs. LIXTE’s unique approach has
no known competitors and is covered by a comprehensive patent portfolio.
Additional
information about LIXTE can be found at www.lixte.com, on LinkedIn at https://www.linkedin.com/company/lixte-biotechnology-holdings-inc-/,
on Twitter at https://twitter.com/LixteBiotech, and by reviewing the Company’s filings with the United States Securities
and Exchange Commission at https://www.sec.gov.
Forward-Looking
Statements
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 clinical trials and collaborators
in such clinical trials, 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, and the patent and legal costs to protect and maintain the Company’s intellectual property worldwide, 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, research
results, competition from other similar businesses, and market and general economic factors. This discussion should be read in conjunction
with the Company’s filings with the United States Securities and Exchange Commission at www.sec.gov.
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 or Laurie Berman: (310) 279-5980
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