HOUSTON, July 1, 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 in the brain
and central nervous system, today provided a business update.
Recent Highlights
- Secured an additional $4.7
million in gross proceeds from ATM at average price of
$2.32; extending the Company's cash
runway to Q2 2022;
- Granted Fast Track Designation from the U.S. Food and Drug
Administration (FDA) for lead investigational drug candidate,
Berubicin, for the treatment of patients with recurrent GBM;
and
- Commenced enrollment in potentially pivotal study evaluating
the efficacy and safety of Berubicin in the treatment of recurrent
GBM.
"In the last 60 days alone we have achieved fundamental
clinical, regulatory and corporate milestones that together
demonstrate CNS' operational, strategic and financial
strengths. We are continuously de-risking our Berubicin
clinical program by driving development of this truly novel
treatment forward as expeditiously as possible. In a mere 18 months
from our IPO our laser focus on this program created a potentially
pivotal study now open for enrollment with patient dosing expected
to commence at any time. With the addition of our recent Fast Track
Designation for GBM, we believe we are poised to execute on our
milestones ahead and bring a meaningful treatment to patients who
suffer from this devasting and heretofore incurable disease,"
commented John Climaco, CEO of CNS
Pharmaceuticals. "Additionally, the $4.7
million of ATM transactions significantly bolsters our cash
runway and provides funding to advance our important clinical
programs for several quarters to come. We are passionate about
driving Berubicin's development forward, creating value in the
near- and long-term, and most importantly making a positive impact
on patients lives."
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. The Company
recently announced the commencement of its potentially pivotal
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.
For more information about the potentially pivotal Berubicin
trial, visit clinicaltrials.gov and reference identifier
NCT04762069.
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.