Recent approvals of potentially pivotal
Berubicin Study into Switzerland,
France, and Spain expected to significantly drive patient
enrollment
Opportunities for Berubicin to be used in
additional oncology indications with significant unmet
needs
HOUSTON, May 16, 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 quarter ended March 31, 2022 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.
"Since the start of 2022, we have significantly expanded our
international presence with clinical approvals in Spain, France
and Switzerland received for our
potentially pivotal study of Berubicin for the treatment of GBM.
Once again our team demonstrated its operational, clinical and
regulatory expertise this quarter. These efforts enable us to
continue building momentum with patient enrollment – the
cornerstone of any successful drug development program. The
unmet need in GBM is enormous and knows no geographic borders and
this critically important and state of the art trial will, most
importantly, advance a much needed potential treatment option to
patients. We have been and remain laser focused on executing on all
of our operational efforts and look forward to an exciting year
ahead," commented John Climaco, CEO
of 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 being evaluated in a
potentially pivotal global study evaluating its efficacy and safety
in the treatment of GBM. The potentially pivotal global trial is an
adaptive, multicenter, open-label, randomized and controlled study
in adult patients with recurrent glioblastoma multiforme (WHO Grade
IV) after failure of standard first-line therapy. Approximately 243
patients with GBM after failure of standard first line therapy will
be randomized in a 2:1 ratio to receive Berubicin or lomustine for
the evaluation of Overall Survival, the primary endpoint of the
study. Overall Survival is a rigorous endpoint that the U.S. Food
and Drug Administration (FDA) has recognized as a basis for
approval of oncology drugs when a statistically significant
improvement can be shown relative to a randomized control arm.
A pre-planned, non-binding futility analysis will be performed
after approximately 30 to 50% of all planned patients have
completed the primary endpoint at 6 months. This review will
include additional evaluation of safety as well as secondary
efficacy endpoints. Enrollment will not be paused during this
interim analysis.
The FDA recently 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
- Continue to 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 portfolio, 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 First Quarter
2022
The net loss for the three months ended March 31, 2022 was approximately $2.8 million compared to approximately
$3.6 million for the comparable
period in 2021. The change in net loss is primarily attributable to
increased drug manufacturing activities in 2021 in preparation for
the commencement of the Company's clinical trials as well as the
timing of annual employee incentive compensation, partially offset
by an increase in contract research organization expenses as we are
now actively conducting the trial of Berubicin.
The Company reported Research and development expenses of
$1.5 million for the three months
ended March 31, 2022 compared to
approximately $2.2 million for the
comparable period in 2021. The change in net loss is primarily
attributable to increased drug manufacturing activities in 2021 in
preparation for the commencement of the Company's clinical trials,
as well as by the payment of annual employee incentive compensation
during the three months ended March 31,
2021 and not having been paid by March 31, 2022, offset by an increase in expenses
during the three months ended March 31,
2022 related to contract research organization (CRO)
activites in conducting our trial of Berubicin.
General and administrative expense was approximately
$1.3 million for the three months
ended March 31, 2022 compared to
approximately $1.4 million for the
comparable period in 2021. This change is primarily due to the
payment of annual employee incentive compensation during the three
months ended March 31, 2021 and not
having been paid by March 31,
2022.
As of March 31, 2022, the Company
had cash of approximately $12.4
million and working capital of approximately $13.7 million. In early January 2022, the Company completed an offering
of common stock and warrants for gross proceeds of $11.5 million. The Company's current expectation
is that the 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 drug technology portfolio, 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 evaluating the use of the WP1244 portfolio in
the treatment of brain cancers, 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. 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.