GERMANTOWN, Md., March 27, 2020 /PRNewswire/ -- Seneca
Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused
on developing novel treatments for diseases of high unmet medical
need, today reported its financial results for the year ended
December 31, 2019.
Business Highlights for the Year Ended December 31, 2019
In early 2019, the Company shifted its operating strategy and
focus away from the development of our neural stem cell treatments
and initiated an out-licensing effort to partner these programs,
while seeking to in-license or acquire novel therapeutics that are
complementary to our current technologies and could benefit from
our development experience.
On July 17, 2019, we effected a
1-for-20 reverse stock split of our common stock;
In July of 2019, we completed an underwritten public offering of
our securities resulting in gross proceeds of approximately
$7.5 million;
On October 28, 2019, we changed
our name from Neuralstem, Inc. to Seneca Biopharma, Inc.
Financial Results for the Year Ended December 31, 2019
Cash Position and Liquidity: At December 31, 2019, cash was approximately
$5.1 million as compared to
approximately $5.8 million at
December 31, 2018. The
$0.7 million decrease is due to cash
used in operations of approximately $7.3
million partially offset by the proceeds from our
July 2019 underwritten offering.
Operating Loss: Operating loss for the year ended December 31, 2019 was $8.6
million compared to a loss of $8.3
million for 2018. The increase in operating loss for
the year was primarily due to the absence of revenue and a small
increase in research and development expenses. General and
administrative expenses totaled approximately $4.6 million during the two periods.
Net Loss: Net loss for the year ended December 31, 2019 was $8.4
million, or $3.80 per share,
compared to a loss of $4.9 million,
or $7.80 per share on a post-reverse
stock-split basis, for 2018. The change in net loss was
primarily attributed to non-cash related changes in the fair value
of our liability classified stock purchase
warrants.
R&D Expense: Research and development expense for the year
ended December 31, 2019 was
$4.1 million as compared to
$4.0 million for the year ended
December 31, 2018. The increase
was primarily attributable to an increase in external consulting
services engaged in the technical evaluation of our internal
programs as well as the evaluation of certain potential assets we
considered for acquisition. These costs were partially offset
by lower clinical trial expenditures as we wound down clinical
activates.
G&A Expense: General and administrative expense were
approximately $4.6 million for both
2019 and 2018. As noted above, in early 2019, the Company shifted
its operating strategy and initiated an out-licensing effort to
partner our neural stem cell treatments while seeking to acquire
novel therapeutics with the potential to be complementary to our
current technologies and that could benefit from our development
experience. Associated with this shift in strategic focus,
our G&A expenses in 2019 reflect an enhanced internal
management structure including individual consultants in key
roles.
Liquidity: In January 2020, the
Company entered into an agreement with certain accredited investors
from our July 2019 underwritten
offering. Under this agreement the exercise price of certain
warrants issued in the July offering were reduced from $2.70 to $1.36 to
induce the immediate cash exercise of such warrants. The Company
received approximately $6.8 million
in net proceeds. We believe that the proceeds from the warrant
exercise, along with our cash as of December
31, 2019, will be sufficient to fund our planned operations
for more than 12 months.
"With the proceeds from the January
2020 transaction, we have the capital to build out our
management team and continue our initiative of evaluating new
therapeutic products for development as well as seeking partners
for our promising neural stem-cell therapeutic NSI-566" commented
Dr. Kenneth Carter, Seneca's Executive Chairman. "On this
front, our China-based subsidiary
is readying a new facility which will be utilized to complete
activities for our China-based
stroke trial from which we are expecting top line data by the end
of this year. In addition, we recently held a discussion with the
US FDA regarding a path forward for our ALS program. We will
provide additional information on these programs when certain
activities are concluded."
Seneca Biopharma,
Inc.
|
|
|
|
|
Consolidated
Balance Sheets
|
|
|
|
|
|
December
31,
|
|
2019
|
|
2018
|
|
|
|
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$
|
5,114,917
|
|
$
|
5,787,110
|
Trade and other
receivables
|
21,064
|
|
294,057
|
Current portion of
related party receivable, net of discount
|
-
|
|
63,938
|
Prepaid
expenses
|
510,900
|
|
363,288
|
Total current
assets
|
5,646,881
|
|
6,508,393
|
|
|
|
|
Property and
equipment, net
|
41,036
|
|
90,311
|
Patents,
net
|
668,936
|
|
763,543
|
Related party
receivable, net of discount and current portion
|
-
|
|
298,238
|
ROU and other
assets
|
227,036
|
|
23,965
|
Total
assets
|
$
|
6,583,889
|
|
$
|
7,684,450
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
824,406
|
|
$
|
832,564
|
Accrued
bonuses
|
135,686
|
|
-
|
Short term notes and
other current liabilities
|
264,665
|
|
218,602
|
Total current
liabilities
|
1,224,757
|
|
1,051,166
|
|
|
|
|
Warrant liabilities,
at fair value
|
84,596
|
|
583,734
|
Lease liability, net
of current portion
|
148,543
|
|
-
|
Total
liabilities
|
1,457,896
|
|
1,634,900
|
|
|
|
|
Commitments and
contingencies (Note 8)
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
Preferred stock,
7,000,000 shares authorized, $0.01 par value; 200,000 and 1,000,000
shares issued and outstanding in 2019 and 2018,
respectively
|
2,000
|
|
10,000
|
Common stock, $0.01
par value; 300 million shares authorized, 3,866,457 and 910,253
shares issued and outstanding in 2019 and 2018,
respectively
|
38,665
|
|
9,103
|
Additional paid-in
capital
|
227,067,058
|
|
219,654,753
|
Accumulated other
comprehensive loss
|
(6,186)
|
|
(413)
|
Accumulated
deficit
|
(221,975,544)
|
|
(213,623,893)
|
Total
stockholders' equity
|
5,125,993
|
|
6,049,550
|
Total liabilities
and stockholders' equity
|
$
|
6,583,889
|
|
$
|
7,684,450
|
|
|
|
|
|
|
|
|
Seneca Biopharma,
Inc.
|
|
Consolidated
Statements of Operations and Comprehensive Loss
|
|
|
Year Ended
December 31,
|
|
2019
|
|
|
2018
|
|
|
|
|
|
Revenues
|
$
|
15,394
|
|
|
$
|
260,000
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development costs
|
4,061,450
|
|
|
3,960,191
|
General and
administrative expenses
|
4,585,638
|
|
|
4,559,265
|
Total operating
expenses
|
8,647,088
|
|
|
8,519,456
|
Operating
loss
|
(8,631,694)
|
|
|
(8,259,456)
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest
income
|
67,731
|
|
|
78,780
|
Interest
expense
|
(8,920)
|
|
|
(7,698)
|
Gain from change in
fair value of liability classified warrants
|
499,138
|
|
|
3,269,148
|
Write-off of related
party receivable and other income (expense)
|
(277,906)
|
|
|
(5,391)
|
Total other income
(expense)
|
280,043
|
|
|
3,334,839
|
|
|
|
|
|
Net loss
|
$
|
(8,351,651)
|
|
|
$
|
(4,924,617)
|
|
|
|
|
|
Net loss per common
share - basic and diluted
|
$
|
(3.80)
|
|
|
$
|
(7.54)
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
2,197,434
|
|
|
653,221
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
Net loss
|
$
|
(8,351,651)
|
|
|
$
|
(4,924,617)
|
Foreign currency
translation adjustment
|
(5,773)
|
|
|
(3,044)
|
Comprehensive
loss
|
$
|
(8,357,424)
|
|
|
$
|
(4,927,661)
|
|
|
|
|
|
|
|
|
|
|
About Seneca Biopharma, Inc.
Seneca Biopharma, Inc., is a clinical-stage biopharmaceutical
company developing novel treatments for diseases of high unmet
medical need. The Company is in the process of transforming the
organization through the acquisition or in-licensing of new science
and technologies, to develop with the goal of providing meaningful
therapies for patients.
Cautionary Statement Regarding Forward Looking
Information:
This news release contains "forward-looking statements" made
pursuant to the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements
relate to future, not past, events and may often be identified by
words such as "expect," "anticipate," "intend," "plan," "believe,"
"seek" or "will." Forward-looking statements by their nature
address matters that are, to different degrees, uncertain. Specific
risks and uncertainties that could cause our actual results to
differ materially from those expressed in our forward-looking
statements include risks inherent in the development and
commercialization of potential products, uncertainty of clinical
trial results or regulatory approvals or clearances, need for
future capital, dependence upon collaborators and maintenance of
our intellectual property rights. Actual results may differ
materially from the results anticipated in these forward-looking
statements. Additional information on potential factors that could
affect our results and other risks and uncertainties are detailed
from time to time in Seneca's
periodic reports, including its Annual Report on Form 10-K for the
year ended December 31, 2019, filed
with the Securities and Exchange Commission (SEC), and in other
reports filed with the SEC. We do not assume any obligation to
update any forward-looking statements.
Contact:
Hibiscus Bioventures
josh@hibiscusbio.com
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content:http://www.prnewswire.com/news-releases/seneca-biopharma-inc-reports-year-end-2019-fiscal-results-301030779.html
SOURCE Seneca Biopharma, Inc.