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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):
December 18, 2023
___________________________
CNS Pharmaceuticals, Inc.
(Exact name of registrant as specified in its
charter)
___________________________
Nevada |
001-39126 |
82-2318545 |
(State or other jurisdiction of
incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
2100 West Loop South, Suite 900
Houston,
Texas 77027
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including
area code: (800) 946-9185
Not Applicable
(Former Name or Former Address, if Changed
Since Last Report)
___________________________
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 (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(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by
check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
Securities registered pursuant to Section
12(b) of the Act:
Title of each class |
Trading Symbols(s) |
Name of each exchange on which registered |
Common stock, par value $0.001 per share |
CNSP |
The NASDAQ Stock Market LLC |
| Item 7.01. | Regulation
FD Disclosure. |
On December
18, 2023, CNS Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the recommendation of the independent
Data Safety Monitoring Board that the Company’s ongoing global, potentially pivotal trial of the investigational agent, Berubicin
for the treatment of glioblastoma multiforme continue without any modification. A copy of the press release is attached to this report
as Exhibit 99.1 and is incorporated by reference herein.
The
information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be
deemed to be “filed” for the purpose of the Securities Exchange Act of 1934, as amended (“Exchange
Act”), nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act
of 1933, as amended, unless specifically identified therein as being incorporated by reference.
On December 18, 2023, the Company
announced the recommendation of the independent Data Safety Monitoring Board that the Company’s ongoing global, potentially pivotal
trial of the investigational agent, Berubicin for the treatment of glioblastoma multiforme continue without any modification.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
Signature
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.
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CNS Pharmaceuticals, Inc. |
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By: |
/s/ Chris
Downs |
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Chris Downs |
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Chief Financial Officer |
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Dated: December 18, 2023 |
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Exhibit 99.1
CNS Pharmaceuticals
Announces Successful Interim Analysis of Efficacy
and Safety Data
in Potentially Pivotal Study of Berubicin
Independent DSMB
recommends continuing clinical trial of Berubicin without modification
Enrollment expected
to be complete in early Q1 2024
HOUSTON, TX (December 18, 2023) – CNS
Pharmaceuticals, Inc. (NASDAQ: CNSP) (CNS or the Company), a biopharmaceutical company specializing in the development of
novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced the recommendation of the
independent Data Safety Monitoring Board (DSMB) that the Company’s ongoing global, potentially pivotal trial of the investigational
agent, Berubicin for the treatment of glioblastoma multiforme (GBM) continue without any modification. The recommendation follows the
DSMB’s pre-specified futility analysis of unblinded (to the DSMB only) efficacy and safety data in the Company’s trial of
Berubicin versus Lomustine, a standard of care in patients with recurrent GBM. More specifically, the DSMB reviewed the primary endpoint
of overall survival (OS) and secondary efficacy measures progression-free survival (PFF) and overall response rate (ORR), as well as
safety data in evaluable patients. In order to support continuing the trial, Berubicin’s efficacy had to be at least comparable
to Lomustine’s on the primary endpoint (OS).
“Having successfully reached this milestone,
we believe that this recommendation reflects Berubicin’s acceptable efficacy and safety profile, as defined in the trial protocol,
as of the interim analysis. Building on the foundation of strong enrollment laid by our team, our investigators and their patients, the
independent findings of the DSMB add to the Phase 1 trial data, where 44% of treated patients received a clinical benefit of stable disease
or better,” said John Climaco, CEO of CNS Pharma. “Finding an effective treatment for GBM remains one of the great challenges
in oncology, and more meaningful options for the many patients who fail first-line therapy are still desperately needed after decades
of research. With this recommendation to continue the study, our long-held belief that Berubicin will ultimately address the unmet clinical
need of GBM patients now moves closer to becoming reality.”
The potentially pivotal study of Berubicin is
a multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line
therapy and compared to Lomustine. Overall Survival is a rigorous endpoint that the FDA has recognized as the basis for approval of oncology
drugs when a statistically significant improvement can be shown relative to a randomized control arm.
For more information about this trial, visit
clinicaltrials.gov and reference identifier NCT04762069.
The FDA has granted CNS Pharmaceuticals Fast Track
Designation for Berubicin, which enables more frequent interactions with the agency for guidance on expediting the development and review
process. Additionally, the Company has received Orphan Drug Designation from the FDA for using Berubicin to treat malignant glioma, which
may provide seven years of marketing exclusivity upon approval of a New Drug Application (NDA).
About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against
more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce
deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling
cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete
response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin was developed by Dr. Waldemar Priebe, Professor
of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a clinical-stage pharmaceutical
company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central
nervous system. The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross
the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications
including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.
For more information, please visit www.CNSPharma.com,
and connect with the Company on Twitter, Facebook, and LinkedIn.
Forward-Looking Statements
Some of the statements in this press release are
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act
of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in
this press release include, without limitation, the Company’s timing of the final analysis, the ability to complete enrollment and
the timing thereof, and the ability to commercialize the product even if the trial is successful. These statements relate to future events,
future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable
as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking
statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,''
''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately''
or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are
only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk
Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from
time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press
release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release
to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACTS:
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
CNSP@jtcir.com
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