HOUSTON, March 3, 2022 /PRNewswire/ -- 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 reported its financial results
for the year ended December 31, 2021
and provided a clinical update of its anti-cancer drug candidates
currently in development for the treatment of primary and
metastatic brain and CNS cancer.
2021 Key Highlights
- May 2021: Commenced patient
enrollment in the potentially pivotal study (CNS-201) evaluating
efficacy of Berubicin in the treatment of adult recurrent
Glioblastoma Multiforme (rGBM), one of the most aggressive types of
brain cancer;
- June 2021: FDA granted Fast Track
Designation to CNS Pharmaceuticals for Berubicin for the treatment
of recurrent GBM;
- September 2021: Dosed first group
of patients with Berubicin in the potentially pivotal study for the
treatment of GBM;
- December 2021: Received approval
from "swissethics," the umbrella organization of the cantonal
Ethics Committees (EC) in Switzerland, for the Company's potentially
pivotal study of Berubicin for the treatment of recurrent GBM;
and
- January 6, 2022: Announced a
$11.5M private placement, priced
at-the-market under Nasdaq rules.
"Operationally 2021 was a
terrific year for the Company as we established the global
framework for building and expanding our potentially pivotal
clinical study of berubicin for the treatment of GBM. Our priority
remains focused on advancing berubicin to bring a meaningful
treatment to patients, families and clinicians, who currently have
extremely limited and often ineffective treatment options. I am
continually impressed by the speed and efficiency with which our
small team has executed our Berubicin trial. At the onset of 2022
we completed a $11.5 million private
placement which enables us to continue driving the development of
berubicin this year towards the milestones ahead of us," commented
John Climaco, CEO of CNS
Pharmaceuticals. "While staying steadfast in our primary goal of
bringing berubicin to GBM patients, we are also continually
evaluating platform opportunities for expansion into additional
oncology indications to bolster our pursuit of therapies for
patients through developing novel treatments for primary and
metastatic cancers. I am very pleased with the progress we've made
over the past year, but am even more so looking forward to what
lays ahead for CNS Pharmaceuticals."
Clinical Programs Update
Berubicin – Novel anthracycline
CNS' lead product 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. In mid-2021
the Company announced it has dosed the first group of patients in
its potentially pivotal study evaluating the efficacy of Berubicin
in the treatment of adult GBM, one of the most aggressive types of
brain cancer. Further patient enrollment, randomization and dosing
is currently underway as well as a robust lineup of clinical sites
located globally which are advancing toward activation and
enrollment.
The FDA granted CNS Pharmaceuticals Fast Track Designation for
Berubicin which enables more frequent interactions with the FDA to
expedite the development and review process. As previously
announced, the Company also received Orphan Drug Designation from
the FDA which may provide seven years of marketing exclusivity upon
approval of an NDA.
For more information about the potentially pivotal Berubicin
trial, visit clinicaltrials.gov and reference identifier
NCT04762069.
Upcoming Milestones
- Expand potentially pivotal study to evaluate efficacy of
Berubicin in the treatment of adult GBM into additional
countries;
- Interim analysis of the trial when 30-50% of the total expected
patients have been on study for 6 months (expected during first
half of 2023); and
- Complete enrollment in potentially pivotal clinical trial for
GBM.
WP1244 Portfolio - Novel class of DNA-binding agents
The Company continues to advance the development of its WP1244
drug technology, which utilizes anthracycline and distamycin-based
scaffolds to create small molecule agents and is believed to be
500x more potent than daunorubicin in inhibiting tumor cell
proliferation. Preclinical studies of WP1244 demonstrated high
uptake in the brain with antitumor activity. The Company's
development work has produced a new mesylate salt of WP1244, now
identified as WP1874. The enhanced solubility of this salt may
increase its ability to be formulated for use in an IV infusion,
while maintaining similar potency and toxicity characteristics.
Going forward, WP1874 will be the primary focus in our development
efforts of the WP1244 portfolio. CNS Pharmaceuticals is also
evaluating the use of WP1244/WP1874 in the treatment of other
primary brain and central nervous system cancers, as well as
cancers metastatic to the brain including pancreatic, ovarian, and
lymphomas.
Upcoming Milestones
Summary of Financial Results for the Full Year 2021
The net loss for the year ended December
31, 2021 was approximately $14.0
million compared to approximately $9.5 million for the comparable period in 2020.
The change in net loss is attributable to increased personnel and
activity associated with preparing for and commencing the Company's
potentially pivotal clinical trial of Berubicin for recurrent
glioblastoma multiforme in 2021. The Company reported research and
development expenses of $9.3 million
for the year ended December 31, 2021
compared to approximately $5.1
million for the comparable period in 2020. The expenses
incurred during the period were related to drug manufacturing and
labor related to the preparation for and commencement of the
Company's potentially pivotal Berubicin study. General and
administrative expense was approximately $4.7 million for the year ended December 31, 2021 compared to approximately
$4.4 million for the comparable
period in 2020.
As of December 31, 2021, the
Company had cash of approximately $5.0
million and working capital of approximately $5.3 million. In early January 2022, the Company completed an offering
of common stock and warrants for gross proceeds of $11.5 million. Our current expectation is that
our cash on hand and the proceeds from the offering during January
is sufficient to fund our operations into the first quarter of
2023. The timing and costs of clinical trials are difficult to
predict and trial plans may change in response to evolving
circumstances and as such the foregoing estimates may prove to be
inaccurate.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals 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.
Additionally, the Company is advancing the development of its
WP1244/WP1874 drug technology, which utilizes anthracycline and
distamycin-based scaffolds to create small molecule agents and is
believed to be 500x more potent than daunorubicin in inhibiting
tumor cell proliferation. Preclinical studies of WP1244
demonstrated high uptake in the brain with antitumor activity. CNS
Pharmaceuticals is also evaluating the use of WP1244/WP1874 in the
treatment of other primary brain and central nervous system
cancers, as well as cancers metastatic to the brain including
pancreatic, ovarian, and lymphomas.
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 ability of the Company's
cash runway to extend into the first quarter of 2023; the CNS's
ability to expand its potentially pivotal study to evaluate
efficacy of Berubicin in the treatment of adult GBM into additional
countries; the timing of the interim analysis of the trial; CNS's
ability to complete enrollment in potentially pivotal clinical
trial for GBM; and CNS's ability to file an IND for WP1244/WP1874
in 2023. 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.
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SOURCE CNS Pharmaceuticals, Inc.