HOUSTON, March 12, 2020 /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, today announced business highlights and
financial results for the three months ended December 31, 2019 and Fiscal Year 2019.
Business highlights for the fourth quarter of 2019 and recent
weeks include the following:
- Selected a leading Polish institution for the Phase 1
pediatric trial with Berubicin in glioblastoma multiforme
("GBM"). In February 2020, CNS
announced the selection of Children's Memorial Health Institute,
the largest pediatric hospital in Poland as the single site for this pediatric
trial which is expected to commence in the second half of
2020.
- Completed final Good Manufacturing Practice ("GMP")
reprocessing and purity validation of the existing batch of its
lead drug candidate Berubicin. In February 2020, the Company announced the final
GMP reprocessing of the existing batch of Berubicin, reporting the
GMP material met all specifications and analytical testing is now
underway. The Company is continuing large-scale production of
Berubicin and intends to utilize this supply to complete its
planned Phase 2 clinical trial for patients with GBM.
- Licensed a novel DNA-binding technology from The
University of Texas MD Anderson Cancer
Center to expand the clinical pipeline. In January 2020, CNS entered into a licensing
agreement with MD Anderson, granting the Company rights to develop
and commercialize WP1244, a new class of DNA-binding agent designed
to cross the blood-brain barrier for the potential treatment of
primary and metastatic brain cancers. WP1244 has been shown in
preclinical studies to be 500-times more potent than the
chemotherapeutic agent daunorubicin in inhibiting tumor cell
proliferation.
- Received positive feedback from the U.S. Food and Drug
Administration ("FDA") for Pre-IND (Investigational New Drug)
proposal. In its December 2019
positive response to the Company's Pre-IND request, the FDA
indicated that the proposal to use a previously manufactured and
currently available supply of a lyophilized drug product (i.e.,
Berubicin) in the Phase 2 clinical trial appears reasonable.
Furthermore, the FDA noted that the requested dosage regimen for
the planned Phase 2 trial with Berubicin in GBM, which will be
based on the Reata Phase 1 trial, was reasonable.
- Closed initial public offering ("IPO") of common stock.
The Company closed its IPO of 2,125,000 shares of common stock at
an offering price of $4.00 per share
on November 13, 2019 and an
additional 318,750 shares pursuant to the exercise in full of the
underwriters' over-allotment option sold at the IPO price of
$4.00 per share on November 20, 2019. Gross proceeds from the
offering, including the exercise of the underwriters'
over-allotment option, were $9.8
million and will be used to fund CNS' clinical trials and
for working capital.
"Since completing our IPO we are very pleased with the progress
we have made toward initiating our Phase 2 clinical study of
Berubicin to treat GBM, which represents a significant unmet
medical need," stated John M.
Climaco, Chief Executive Officer of CNS
Pharmaceuticals. "We believe Berubicin has the ability to
cross the blood-brain barrier with positive responses in these
types of tumors, as demonstrated in the Phase 1 study conducted by
Reata. In the second half of this year, we look forward to
initiating our Phase 2 clinical study in adults in the U.S., as
well as two studies conducted in Poland by our sub-license partner, WPD
Pharmaceuticals, including a Phase 2 study in adults which will
mirror our U.S.-based study, and a first-ever Phase 1 study in
children. In addition, we plan to perform further preclinical
studies for our recently licensed WP1244 drug candidate, a novel
and potent DNA binding agent with high potency to inhibit tumor
cell proliferation."
Fourth Quarter Financial Results
General and administrative expense was $1.0 million for the fourth quarter of 2019,
compared with $0.2 million for the
prior-year period. The increase is largely attributable to the
expanded corporate infrastructure implemented in order to advance
the Company's clinical development program following its IPO.
Research and development expense for the fourth quarter of 2019
was $1.5 million, compared with
$0 for the fourth quarter of 2018.
The expense in the quarter was largely related to the cost of
reprocessing and validating the existing batch of Berubicin needed
for the commencement of the Phase 2 clinical trial, as well as
starting the production of a new batch of the drug necessary for
the contemplated clinical trials, both in the U.S. and in
Poland.
The net change in cash in the fourth quarter of 2019 was
$6.3 million. As of December 31, 2019, CNS had cash and cash
equivalents of $7.2 million, which
includes $8.8 million in net proceeds
from our IPO.
Conference Call
CNS senior management will provide a business update in a
conference call and live audio webcast beginning at 4:30 p.m. Eastern time today, March 12, 2020. The conference call dial-in and
webcast information is as follows:
DOMESTIC
DIAL-IN:
|
(844)
535-4071
|
INTERNATIONAL
DIAL-IN:
|
(706)
679-2458
|
PASSCODE:
|
1254059
|
WEBCAST:
|
CNS Business Update
Conference Call.
|
For those unable to participate in the live conference call or
webcast, a replay will be available beginning approximately two
hours after the close of the conference call. To access the replay,
dial 855-859-2056 or 404-537-3406. The replay passcode
is 1254059. The replay can be accessed for a period of time on the
CNS website at CNS Business Update Conference Call.
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
trial with Berubicin in GBM which Reata conducted in 2006. In
this trial, 44% of patients experienced a statistically significant
improvement in progression-free survival. 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 February 2020. In the second half of 2020, 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 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.
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 to further
the clinical development of Berubicin in the United States and Poland. 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 in the Company's SEC
filings, including under the heading "Risk Factors" in the Form S-1
filed on October 7, 2019. 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.
CNS
Pharmaceuticals, Inc.
|
Statements of
Operations
|
|
|
|
Year Ended
Dec. 31, 2019
|
|
|
Year Ended
Dec. 31, 2018
|
|
|
3 Mon.
Ended Dec. 31, 2019
|
|
|
3 Mon.
Ended Dec. 31, 2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
$
|
1,978,643
|
|
|
$
|
860,520
|
|
|
$
|
1,039,337
|
|
|
$
|
208,583
|
|
Research and
development
|
|
|
1,854,334
|
|
|
|
21,267
|
|
|
|
1,484,394
|
|
|
|
–
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
3,832,977
|
|
|
|
881,787
|
|
|
|
2,523,731
|
|
|
|
208,583
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(3,832,977)
|
|
|
|
(881,787)
|
|
|
|
(2,523,731)
|
|
|
|
(208,583)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on settlement of
liabilities
|
|
|
–
|
|
|
|
(6,286,841)
|
|
|
|
–
|
|
|
|
(6,286,841)
|
|
Loss on change in
fair value of SAFE agreements
|
|
|
–
|
|
|
|
(122,120)
|
|
|
|
–
|
|
|
|
(122,120)
|
|
SAFE agreement
expenses
|
|
|
–
|
|
|
|
(54,454)
|
|
|
|
–
|
|
|
|
–
|
|
Interest
expense
|
|
|
(26,152)
|
|
|
|
(28,615)
|
|
|
|
(3,617)
|
|
|
|
(10,632)
|
|
Amortization of debt
discount
|
|
|
(18,082)
|
|
|
|
(18,082)
|
|
|
|
–
|
|
|
|
(3,337)
|
|
Total other
expense
|
|
|
(44,234)
|
|
|
|
(6,510,112)
|
|
|
|
(3,617)
|
|
|
|
(6,422,930)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,877,211)
|
|
|
$
|
(7,391,899)
|
|
|
$
|
(2,527,348)
|
|
|
$
|
(6,631,513)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share -
basic and diluted
|
|
$
|
(0.28)
|
|
|
$
|
(0.70)
|
|
|
$
|
(0.17)
|
|
|
$
|
(0.63)
|
|
Weighted average
shares outstanding - basic and diluted
|
|
|
13,647,908
|
|
|
|
10,510,551
|
|
|
|
15,072,760
|
|
|
|
10,536,004
|
|
CNS
Pharmaceuticals, Inc.
|
Balance
Sheets
|
|
|
|
December 31,
2019
|
|
|
December 31,
2018
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
7,241,288
|
|
|
$
|
282,736
|
|
Restricted
cash
|
|
|
–
|
|
|
|
272,397
|
|
Prepaid
expenses
|
|
|
652,622
|
|
|
|
33,000
|
|
Total current
assets
|
|
|
7,893,910
|
|
|
|
588,133
|
|
|
|
|
|
|
|
|
|
|
Fixed
Assets
|
|
|
|
|
|
|
|
|
Furniture and
equipment, net
|
|
|
18,165
|
|
|
|
–
|
|
|
|
|
|
|
|
|
|
|
Long-Term
Assets:
|
|
|
|
|
|
|
|
|
Deferred issuance
costs
|
|
|
–
|
|
|
|
95,200
|
|
|
|
|
|
|
|
|
|
|
Total
Assets
|
|
$
|
7,912,075
|
|
|
$
|
683,333
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
243,666
|
|
|
$
|
128,071
|
|
Accounts payable and
accrued expenses - related party
|
|
|
45,833
|
|
|
|
794
|
|
Accrued
expenses
|
|
|
21,500
|
|
|
|
23,599
|
|
Convertible notes
payable, net of discount
|
|
|
–
|
|
|
|
281,918
|
|
Notes
payable
|
|
|
–
|
|
|
|
35,000
|
|
SAFE
agreements
|
|
|
–
|
|
|
|
763,249
|
|
Total current
liabilities
|
|
|
310,999
|
|
|
|
1,232,631
|
|
|
|
|
|
|
|
|
|
|
Total
Liabilities
|
|
|
310,999
|
|
|
|
1,232,631
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' Equity
(Deficit):
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.001 par value, 5,000,000 shares authorized and 0 shares issued
and outstanding
|
|
|
–
|
|
|
|
–
|
|
Common stock, $0.001
par value, 75,000,000 shares authorized and 16,450,234 and
12,694,504 shares issued and outstanding, respectively
|
|
|
16,450
|
|
|
|
12,695
|
|
Additional paid-in
capital
|
|
|
19,073,098
|
|
|
|
7,049,268
|
|
Accumulated
deficit
|
|
|
(11,488,472)
|
|
|
|
(7,611,261)
|
|
Total Stockholders'
Equity (Deficit)
|
|
|
7,601,076
|
|
|
|
(549,298)
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities
and Stockholders' Equity (Deficit)
|
|
$
|
7,912,075
|
|
|
$
|
683,333
|
|
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SOURCE CNS Pharmaceuticals, Inc.