HOUSTON, Aug. 13, 2021 /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 of the brain
and central nervous system (CNS), today reported its financial
results for the quarter ended June 30,
2021. Additionally, the Company provided a clinical update
of its anti-cancer drug candidates currently in development for the
treatment of primary and metastatic brain and CNS cancer.
Recent Highlights
- Commenced patient enrollment in potentially pivotal US-based
trial evaluating the efficacy and safety of Berubicin in the
treatment of recurrent GBM;
- Granted Fast Track Designation by the U.S. Food and Drug
Administration (FDA) for lead investigational drug candidate,
Berubicin, for the treatment of patients with recurrent GBM;
and
"Over the course of the second quarter, our team continued to
execute on corporate, clinical and regulatory strategies to drive
our Berubicin program toward regulatory approval as fast as
possible. We are guided by our passion to answer one of the
most devastating unmet clinical needs in medicine:
unbelievably, patients suffering today from recurrent GBM still
cannot turn to a single approved treatment anywhere in the world
for hope. Simply put, this must change and we are the company
to change it. With the FDA's recent award of Fast Track
Designation for our lead program, we believe we are poised to
finally bring a desperately-needed treatment to GBM patients
potentially through this accelerated pathway. Building on a
foundation of sixty years of successful anthracycline use against
numerous deadly cancers as well as powerful data from our Phase 1
study of Berubicin, the only anthracycline which appears to cross
the blood brain barrier in adults, we wholeheartedly believe in its
potential to transform the current treatment landscape and the
lives of patients," commented John
Climaco, CEO of CNS Pharmaceuticals. "After a quarter of
amazing progress we are well positioned for even more significant
advancements of our development programs which we expect will
continue to drive shareholder value in the near and long term."
Clinical Programs Update
Berubicin – Novel anthracycline
CNS' lead product candidate, Berubicin, is a novel anthracycline
and the first drug of its kind which appears to cross the
blood-brain barrier. Berubicin is currently in development for the
treatment of a number of serious brain and CNS oncology
indications. The Company recently announced the commencement of its
potentially pivotal US-based study evaluating the efficacy of
Berubicin in the treatment of adult GBM, one of the most aggressive
types of brain cancer. Patient dosing is expected to commence in
the third quarter of 2021.
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. Taken together we believe
these important designations can be seen as a recognition of the
significance of not only the unmet clinical need in GBM, but of our
Berubicin program.
For more information about the potentially pivotal Berubicin
trial, visit clinicaltrials.gov and reference identifier
NCT04762069.
Berubicin Upcoming Milestones
Berubicin Development in the U.S.
- Commence patient dosing in potentially pivotal study to
evaluate efficacy of Berubicin in the treatment of adult GBM in Q3
2021.
Berubicin Development in the EU with Sublicensee
Partner
- Initiate Phase 2 multicenter clinical trial of Berubicin in
adults with GBM in the second half of 2021;
- Initiate Phase 1 pediatric study in the second half of 2021;
and
- Interim analysis of the first 18 patients in adult Phase 2
study expected in 2022.
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. CNS Pharmaceuticals is
evaluating the use of WP1244 in the treatment of brain cancers,
pancreatic, ovarian, and lymphomas.
WP1244 Upcoming Milestones
Summary of Financial Results for Second Quarter 2021
The net loss for the six months ended June 30, 2021 was approximately $3.8 million compared to approximately
$2.4 million for the comparable
period in 2020. The change in net loss is attributable to increased
personnel and activity associated with preparing for the Company's
clinical trials in 2021. The Company reported research and
development expenses of $4.8 million
for the six months ended June 30,
2021 compared to approximately $2.1
million for the comparable period in 2020. The expenses
incurred during the period were related to drug manufacturing and
labor related to the preparation of the Company's Phase 2 study.
General and administrative expense was approximately $2.5 million for the six months ended
June 30, 2021 compared to
approximately $2.3 million for the
comparable period in 2020.
As of June 30, 2021, the Company
had cash and subscription receivable (fully collected on
July 1, 2021) of approximately
$10.5 million and working capital of
approximately $12.1 million. Our
current expectation is that our cash on hand (including the
subscription receivable collected in full on July 1, 2021) is sufficient to fund our
operations into the second quarter of 2022. 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, 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 WP1244 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. Forward-looking statements in this press
release include, without limitation, the ability of the Company's
cash runway to extend until Q2 2022 and the timing of patient
dosing to commence. 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.