GERMANTOWN, Md., Nov. 10, 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
September 30, 2020.
Business Highlights for 2020 to date.
During 2020, the Company achieved the following business
milestones:
- Completed offerings resulting in net proceeds of over
$14.7 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 Matthew W. Kalnik,
Ph.D. as President and Chief Operating Officer and Dane R. Saglio as Chief Financial Officer.
- Announced the completion of the last subject's follow-up
assessment in the Company's non-GCP Phase II trial evaluating
NSI-566, for the treatment of chronic ischemic stroke.
- 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 September 30, 2020
Cash Position and Liquidity: At September 30, 2020, cash was approximately
$12.7 million as compared to
approximately $15.8 million at
June 30, 2020.
Operating Loss: Operating loss for the quarter ended
September 30, 2020 was $2.3 million compared to a loss of $2.1 million for the comparable 2019
period. For the nine-month period ended September 30, 2020, the operating loss was
$6.3 million versus $6.5 million for the nine months ended
September 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 September 30, 2020 was $2.3 million, or $0.13 per share, compared to a loss of
$1.8 million, or $0.59 per share on a post-reverse stock-split
basis, for the same period in 2019. For the 2020 nine-month
period the net loss was $11.8
million, or $0.93 per share
versus a net loss of $6.3 million, or
$4.80 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.
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Seneca Biopharma,
Inc.
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|
Unaudited
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
2020
|
|
2019
|
|
|
|
|
|
ASSETS
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
Cash and cash
equivalents
|
$
12,651,728
|
|
$
5,114,917
|
|
Trade and other
receivables
|
8,779
|
|
21,064
|
|
Prepaid
expenses
|
1,431,398
|
|
510,900
|
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Assets held for
sale
|
899,538
|
|
-
|
|
Total current
assets
|
14,991,443
|
|
5,646,881
|
|
|
|
|
|
Property and
equipment, net
|
15,040
|
|
41,036
|
|
Patents,
net
|
152,625
|
|
668,936
|
|
ROU and other
assets
|
10,439
|
|
227,036
|
|
Total
assets
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$
15,169,547
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|
$
6,583,889
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|
|
|
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LIABILITIES AND
STOCKHOLDERS' EQUITY
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CURRENT
LIABILITIES
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|
|
|
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Accounts payable and
accrued expenses
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$
577,558
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$
824,406
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Accrued
bonuses
|
98,750
|
|
135,686
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Short-term note and
other current liabilities
|
-
|
|
264,665
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Liabilities
associated with assets held for sale
|
325,812
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|
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Total current
liabilities
|
1,002,120
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|
1,224,757
|
|
|
|
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Warrant liabilities,
at fair value
|
44,954
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|
84,596
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Lease liability, net
of current portion
|
-
|
|
148,543
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Total
liabilities
|
1,047,074
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|
1,457,896
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STOCKHOLDERS'
EQUITY
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|
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Preferred stock,
7,000,000 shares authorized, $0.01 par value; 200,000 shares issued
and outstanding at September 30, 2020 and December 31,
2019
|
2,000
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2,000
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|
Common stock, $0.01
par value; 300,000,000 shares authorized, 17,295,703 and 3,866,457
shares issued and outstanding at September 30, 2020 and December
31, 2019, respectively
|
172,957
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38,665
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Additional paid-in
capital
|
247,775,027
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227,067,058
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Accumulated other
comprehensive loss
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(3,986)
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(6,186)
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Accumulated
deficit
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(233,823,525)
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(221,975,544)
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Total
stockholders' equity
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14,122,473
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5,125,993
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Total liabilities
and stockholders' equity
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$
15,169,547
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$
6,583,889
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Seneca Biopharma,
Inc.
Unaudited Condensed Consolidated Statements of Operations and
Comprehensive Loss
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
|
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2020
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2019
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2020
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2019
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Revenues
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$
2,500
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$
2,500
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$
11,020
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$
12,894
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|
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Operating
expenses:
|
|
|
|
|
|
|
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Research and
development expenses
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466,014
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|
825,486
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|
1,608,935
|
|
3,294,402
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General and
administrative expenses
|
1,880,122
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|
1,301,189
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|
4,683,539
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|
3,217,613
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Total operating
expenses
|
2,346,136
|
|
2,126,675
|
|
6,292,474
|
|
6,512,015
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Operating
loss
|
(2,343,636)
|
|
(2,124,175)
|
|
(6,281,454)
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(6,499,121)
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|
|
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Other income
(expense):
|
|
|
|
|
|
|
|
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Interest
income
|
7,731
|
|
15,234
|
|
27,935
|
|
55,086
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|
Interest
expense
|
(3,586)
|
|
(1,913)
|
|
(14,015)
|
|
(4,437)
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Warrant inducement
expense
|
-
|
|
-
|
|
(5,620,089)
|
|
-
|
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Gain on fair value of
liability classified warrants
|
17,669
|
|
320,785
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|
39,642
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|
416,796
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Other income
(expense)
|
-
|
|
26,935
|
|
-
|
|
(282,371)
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Total other income
(expense)
|
21,814
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|
361,041
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|
(5,566,527)
|
|
185,074
|
|
|
|
|
|
|
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Net loss
|
$
(2,321,822)
|
|
$
(1,763,134)
|
|
$
(11,847,981)
|
|
$
(6,314,047)
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|
|
|
|
|
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Net loss per share -
basic and diluted
|
$
(0.13)
|
|
$
(0.59)
|
|
$
(0.93)
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|
$
(4.80)
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
17,306,672
|
|
2,975,779
|
|
12,713,094
|
|
1,316,597
|
|
|
|
|
|
|
|
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Comprehensive
loss:
|
|
|
|
|
|
|
|
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Net loss
|
$
(2,321,822)
|
|
$
(1,763,134)
|
|
$
(11,847,981)
|
|
$
(6,314,047)
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Foreign currency
translation adjustment
|
3,180
|
|
(4,501)
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|
2,200
|
|
(7,257)
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Comprehensive
loss
|
$
(2,318,642)
|
|
$
(1,767,635)
|
|
$
(11,845,781)
|
|
$
(6,321,304)
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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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SOURCE Seneca Biopharma, Inc.
