GERMANTOWN, Md., Aug. 13, 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 quarter ended
June 30, 2020.
Business Highlights for 2020 to date.
During the First Half of 2020, the Company achieved the
following business milestones:
- Completed offerings resulting in net proceeds of over
$14.8 million.
- Continued progress on both the Company's out-licensing effort
to partner NSI-566 and NSI-189 programs and initiative to
in-license or acquire novel therapeutics.
- Appointed of Matthew W. Kalnik,
Ph.D. as President and Chief Operating Officer and Dane R. Saglio as Chief Financial Officer.
- Affirmed guidance that data readout from the Company's non-GCP
Phase II trial evaluating NSI-566, for the treatment of chronic
ischemic stroke, is expected during the second half of 2020.
- Announced that as a result of feedback received from the FDA,
Seneca believes that the existing
Phase 1 and 2 trial results support moving into a Phase 3 clinical
study for ALS.
- Completion of the Company's stem cell manufacturing facility in
Suzhou, China which will be used
to manufacture NSI-566 for clinical trials within China.
Financial Results for the Quarter Ended June 30, 2020
Cash Position and Liquidity: At June 30, 2020, cash was approximately
$15.8 million as compared to
approximately $10 million at
March 31, 2020. The increase in
cash is attributed to the May 2020
warrant exercises and registered direct offering.
Operating Loss: Operating loss for the quarter ended
June 30, 2020 was $1.9 million compared to a loss of $1.9 million for the comparable 2019
period. For the six-month period ended June 30, 2020, the operating loss was
$3.9 million versus $4.4 million for the six months ended
June 30, 2019. The decrease in
operating loss for 2020 was primarily due to a decrease in R&D
expenses as we continue to wind down the clinical programs. This
decrease was partially offset by an increase in G&A expenses
which reflects an enhanced management structure to support
corporate objectives as compared to the same period of 2019.
Net Loss: Net loss for the quarter ended June 30, 2020 was $2.0
million, or $0.15 per share,
compared to a loss of $1.4 million,
or $1.45 per share on a post-reverse
stock-split basis, for the same period in 2019. For the 2020
six-month period the net loss was $9.5
million, or $0.92 per share
versus a net loss of $4.6 million, or
$4.78 per share for the same period
in 2019. The 2020 increase in net loss was primarily
attributed to a non-cash expense of $5.6
million related to the January
2020 warrant inducement transaction.
Seneca Biopharma,
Inc.
|
Unaudited
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
2020
|
|
2019
|
|
|
|
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$
15,834,832
|
|
$
5,114,917
|
Trade and other
receivables
|
16,938
|
|
21,064
|
Prepaid
expenses
|
390,646
|
|
510,900
|
Total current
assets
|
16,242,416
|
|
5,646,881
|
|
|
|
|
Property and
equipment, net
|
21,698
|
|
41,036
|
Patents,
net
|
630,554
|
|
668,936
|
ROU and other
assets
|
206,994
|
|
227,036
|
Total
assets
|
$
17,101,662
|
|
$
6,583,889
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts payable and
accrued expenses
|
$
542,976
|
|
$
824,406
|
Accrued
bonuses
|
98,750
|
|
135,686
|
Short-term note and
other current liabilities
|
34,250
|
|
264,665
|
Total current
liabilities
|
675,976
|
|
1,224,757
|
|
|
|
|
Warrant liabilities,
at fair value
|
62,623
|
|
84,596
|
Lease liability, net
of current portion
|
128,770
|
|
148,543
|
Total
liabilities
|
867,369
|
|
1,457,896
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
Preferred stock,
7,000,000 shares authorized, $0.01 par value; 200,000 shares
issued and outstanding at June 30, 2020 and December 31,
2019
|
2,000
|
|
2,000
|
Common stock, $0.01
par value; 300,000,000 shares authorized, 17,295,703 and
3,866,457 shares issued and outstanding at June 30, 2020 and
December 31, 2019,
respectively
|
172,957
|
|
38,665
|
Additional paid-in
capital
|
247,568,205
|
|
227,067,058
|
Accumulated other
comprehensive loss
|
(7,166)
|
|
(6,186)
|
Accumulated
deficit
|
(231,501,703)
|
|
(221,975,544)
|
Total
stockholders' equity
|
16,234,293
|
|
5,125,993
|
Total liabilities
and stockholders' equity
|
$
17,101,662
|
|
$
6,583,889
|
Seneca Biopharma,
Inc.
|
Unaudited
Condensed Consolidated Statements of Operations and Comprehensive
Loss
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
Revenues
|
$
2,500
|
|
$
7,894
|
|
$
8,520
|
|
$
10,394
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development expenses
|
446,032
|
|
954,453
|
|
1,142,921
|
|
2,468,916
|
General and
administrative expenses
|
1,503,822
|
|
971,822
|
|
2,803,417
|
|
1,916,424
|
Total operating
expenses
|
1,949,854
|
|
1,926,275
|
|
3,946,338
|
|
4,385,340
|
Operating
loss
|
(1,947,354)
|
|
(1,918,381)
|
|
(3,937,818)
|
|
(4,374,946)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
6,915
|
|
10,852
|
|
20,204
|
|
39,852
|
Interest
expense
|
(7,850)
|
|
(507)
|
|
(10,429)
|
|
(2,524)
|
Warrant inducement
expense
|
-
|
|
-
|
|
(5,620,089)
|
|
-
|
Gain (loss) on fair
value of liability classified warrants
|
(2,652)
|
|
436,126
|
|
21,973
|
|
96,011
|
Other income
(expense)
|
-
|
|
34,989
|
|
-
|
|
(309,306)
|
Total other income
(expense)
|
(3,587)
|
|
481,460
|
|
(5,588,341)
|
|
(175,967)
|
|
|
|
|
|
|
|
|
Net loss
|
$
(1,950,941)
|
|
$
(1,436,921)
|
|
$
(9,526,159)
|
|
$
(4,550,913)
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.15)
|
|
$
(1.45)
|
|
$
(0.92)
|
|
$
(4.78)
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic
and diluted
|
12,642,972
|
|
993,854
|
|
10,391,065
|
|
952,567
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
Net loss
|
$
(1,950,941)
|
|
$
(1,436,921)
|
|
$
(9,526,159)
|
|
$
(4,550,913)
|
Foreign currency
translation adjustment
|
(18)
|
|
(1,013)
|
|
(980)
|
|
(2,756)
|
Comprehensive
loss
|
$
(1,950,959)
|
|
$
(1,437,934)
|
|
$
(9,527,139)
|
|
$
(4,553,669)
|
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 filed with the Securities and Exchange Commission
(SEC), including its Annual Report on Form 10-K for the year ended
December 31, 2019, its Quarterly
Reports on Form 10-Q as well as and in other reports filed with the
SEC. We do not assume any obligation to update any forward-looking
statements.
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content:http://www.prnewswire.com/news-releases/seneca-biopharma-reports-2020-second-quarter-results-301111504.html
SOURCE Seneca Biopharma, Inc.