HOUSTON, May 14, 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 March 31, 2021. Additionally, the Company
provided a clinical update as well as a business outlook.
"2021 is poised to be an exciting year for the Company.
Throughout the first quarter, we have made continued development
and regulatory progress on all fronts and are committed to driving
our novel treatments forward as expeditiously as possible with the
primary focus on our Berubicin program to improve patient outcomes
for GBM," commented John Climaco,
CEO of CNS Pharmaceuticals. "We are looking forward to the
near-term initiation of patient enrollment in our potentially
pivotal trial, which we believe will be a catalytic event in the
evolution of CNS Pharmaceuticals as it transitions us into a
late-stage clinical company. We look forward to gaining
additional insight into Berubicin's potential to unlock powerful
benefits in the fight against GBM which remains as one of the most
aggressive types of brain cancer. We believe there is significant
potential to unlock shareholder value over the course of the next
18 months and we look forward to providing continued updates and
driving momentum."
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
expects to commence patient enrollment in its potentially pivotal
study evaluating the efficacy of Berubicin in the treatment of
adult GBM in the second quarter. For more information about the
potentially pivotal Berubicin trial, visit clinicaltrials.gov and
reference identifier NCT04762069.
In addition to the Company's global trial, sublicensee partner
in Poland, WPD Pharmaceuticals,
will initiate a Phase 2 multicenter clinical trial of Berubicin in
GBM in the second half of 2021 and report an interim analysis of
the first 18 patients by Q1-Q2 2022.
Anticipated Upcoming Milestones:
- Commence patient enrollment in potentially pivotal study to
evaluate efficacy of Berubicin in the treatment of adult GBM in Q2
2021;
- WPD Pharmaceuticals to initiate a Phase 2 multicenter clinical
trial of Berubicin in GBM in the second half of 2021;
- The WPD trial interim analysis of the first 18 patients by
Q1-Q2 2022 for efficacy as well as an extensive pharmacokinetic
profile in these patients;
- CNS Pharmaceuticals to report interim analysis of U.S. adult
GMB trial when 50% of planned subjects reach 6 months in
study;
- WPD will commence a multicenter Phase 1 pediatric trial for
malignant CNS tumors in 2021;
- CNS will conduct pre-clinical evaluation of Berubicin for
additional CNS cancers and cancers metastatic to the brain,
including development of potential combination therapies for these
indications; and
- CNS Pharmaceuticals to expand pipeline in the evaluation of
other drugs for brain cancers.
The FDA has granted CNS Pharmaceuticals Orphan Drug Designation
for Berubicin, which provides seven years of marketing exclusivity
upon approval of an NDA. CNS Pharmaceuticals intends to file for
additional patents relating to Berubicin to further secure
intellectual property protections.
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.
Anticipated Upcoming Milestones
Summary of Financial Results for First Quarter 2021
The net loss for the three months ended March 31, 2021 was approximately $3.6 million compared to approximately
$2.0 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 2020. The Company reported Research and
development expenses of $2.2 million
for the three months ended March 31,
2021 compared to approximately $0.6
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 our Phase 2 study. General and
administrative expense was approximately $1.4 million for the three months ended
March 31, 2021 compared to
approximately $1.3 million for the
comparable period in 2020. The Company ended the quarter with
$11.0 cash and cash equivalents,
expected to fund operations into 2022.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary
and metastatic cancers of the brain and central nervous system. Its
lead drug candidate, Berubicin, is proposed for the treatment of
glioblastoma multiforme (GBM), an aggressive and incurable form of
brain cancer. CNS holds a worldwide exclusive license to the
Berubicin chemical compound and has acquired all data and know-how
from Reata Pharmaceuticals, Inc. related to a completed Phase 1
clinical trial with Berubicin in malignant brain tumors, which
Reata conducted in 2006. In this trial the overall response rate of
stable disease or better was 44%. This 44% disease control rate was
based on 11 patients (out of 25 evaluable patients) with stable
disease, plus responders. One patient experienced a durable
complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a
limited patient sample size and, while promising, are not a
guarantee that similar results will be achieved in subsequent
trials. During 2021, CNS expects to commence a Phase 2 clinical
trial of Berubicin for the treatment of GBM in the U.S., while a
sub-licensee partner undertakes a Phase 2 trial (with extensive PK)
in adults and a first-ever Phase 1 trial in pediatric GBM patients
in Poland. Its second drug
candidate, WP1244, is a novel DNA binding agent that has shown in
preclinical studies that it is 500 times more potent than the
chemotherapeutic agent daunorubicin in inhibiting tumor cell
proliferation.
For more information, please visit www.CNSPharma.com.
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SOURCE CNS Pharmaceuticals, Inc.