BOSTON, Nov. 15, 2021 /PRNewswire/ -- NeuroBo
Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage
biotechnology company focused on developing and commercializing
multimodal disease-modifying therapies for viral, neuropathic and
neurodegenerative diseases, today announced financial results for
the third quarter ended September 30,
2021.
Third Quarter Highlights
"In October, following a positive recommendation from the
independent data safety monitoring board, we continued to advance
our phase 2/3 clinical trial of lead drug candidate, ANA001, a
proprietary oral niclosamide formulation, in development as a
treatment for patients with moderate to severe COVID-19," stated
Richard J. Kang, Ph.D., outgoing
President and Chief Executive Officer of NeuroBo. "We are
currently in the process of expanding the trial to clinical sites
in the Ukraine and Poland and expect to complete the 60-subject
phase 2 portion of the trial in the first quarter of 2022."
Dr. Kang continued, "Additionally, in October, we successfully
closed a registered direct offering, raising approximately
$14.0 million, significantly
bolstering our balance sheet enabling us to extend our cash runway
into the fourth quarter of 2022."
Management Transition
As previously announced, the Company has appointed Gil Price, M.D. as President and Chief Executive
Officer. Dr. Price will replace Dr. Kang, who is stepping down
following the filing of the Company's Form 10-Q for the quarter
ended September 30, 2021, to pursue
other opportunities. Dr. Kang will remain on the NeuroBo Board of
Directors, and will consult for NeuroBo for a period of up to one
year in order to help ensure an orderly transition.
"It has been a privilege to serve as Chief Executive Officer of
NeuroBo and guide it to the current stage of clinical development.
I am confident that the company will be in good hands under Gil's
stewardship and am pleased to work alongside the team during the
transition period and beyond as a continuing member of NeuroBo's
Board," added Dr. Kang.
Third Quarter 2021 Financial and Operating Results
- Research and Development (R&D) Expenses were
$1.4 million for the three months
ended September 30, 2021 as compared
to $1.3 million for the three months
ended September 30, 2020. The
$0.1 million increase in the third
quarter of 2021 was primarily attributable to an increase in
clinical trial costs in 2021 on a net basis when compared to the
comparable quarter in the prior year.
- General and Administrative Expenses were $2.1 million for the three months ended
September 30, 2021, compared to
$1.8 million for the three months
ended September 30, 2020. The
increase of $0.3 million in the
current period was primarily due to an increase in legal and
consulting costs of $0.2 million,
payroll costs of $0.1 million, public
company costs of $0.1 million and
insurance costs of $0.1 million,
offset in part by a reduction in facility related costs of
$0.1 million and stock-based
compensation of $0.1 million when
compared to the comparable prior year period.
- Interest Income for the quarters ended September 30, 2021 and 2020 was $3,000 and $6,000,
respectively, related to cash deposits.
- Net Loss for the quarter ended September 30, 2021 was $3.5 million, or $0.16 per basic and diluted share, based on
22,285,492 weighted average common shares outstanding, compared
with a net loss of $3.1 million, or
$0.19 per basic and diluted share,
based on 16,427,307 weighted average common shares outstanding for
the quarter ended September 30,
2020.
- Cash and Cash Equivalents were $7.0 million as of September 30, 2021, compared with $10.1 million as of December 31, 2020. Operating at its current level
of clinical activity and including the proceeds from the
October 2021 registered direct
offering, NeuroBo expects its cash position will be adequate to
fund operations into the fourth quarter of 2022.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology
company focused on developing and commercializing multi-modal
disease-modifying therapies for viral, neuropathic, and
neurodegenerative diseases, has a current portfolio of four
drug candidates. The company's recently acquired ANA001 candidate
is a proprietary oral niclosamide formulation in development as a
treatment for patients with moderate to severe COVID-19 (patients
not requiring ventilators). Niclosamide is a potential oral
antiviral and anti-inflammatory agent with a long history of use
and a well-understood safety profile in humans. ANA001 is currently
being studied in a 60-subject Phase 2/3 clinical trial conducted at
up to 20 clinical sites in the U.S. Niclosamide has demonstrated
both antiviral and immunomodulatory activity with possible
downstream effects on coagulation abnormalities observed in
COVID-19. The company's NB-01 candidate has been shown in a Phase 2
study to significantly reduce pain symptoms associated with painful
diabetic neuropathy (PDN), with a superior safety profile when
compared to currently available treatments. Due to the global
COVID-19 crisis, a planned Phase 3 study of NB-01 was postponed. In
the interim, NeuroBo is exploring a potential orphan drug
indication targeting chronic pain for NB-01. NeuroBo's NB-02 drug
candidate is focused on the treatment of Alzheimer's disease and
neurodegenerative diseases associated with the pathological
dysfunction of tau proteins in the brain. The company's fourth
program, Gemcabene, was previously being developed for the
treatment of dyslipidemia, a serious medical condition that
increases the risk of life-threatening cardiovascular disease.
Gemcabene is currently being assessed as an acute treatment for
COVID-19.
For more information
visit: https://www.neurobopharma.com.
Forward Looking Statements
Any statements in this press release that are not statements of
historical fact constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements include, but are not limited to,
statements regarding NeuroBo's development expenses, the
development of NeuroBo's product candidates and the therapeutic
potential, timing and nature of clinical trials and potential
regulatory approval of NeuroBo's clinical programs and pipeline.
Forward-looking statements are usually identified by the use of
words, such as "believes," "anticipates," "expects," "intends,"
"plans," "may," "potential," "will," "could" and similar
expressions. Actual results may differ materially from those
indicated by forward-looking statements as a result of various
important factors and risks. These factors, risks and uncertainties
include, but are not limited to: recent changes in NeuroBo's
management; the failure to obtain all of the benefits or recognize
all of the synergies anticipated from the ANA acquisition; the
integration of ANA potentially diverting management resources from
operational matters and other strategic opportunities; the effect
of future milestone payments and royalties specified in the ANA
acquisition agreement on the results of operations and financial
position of NeuroBo; the occurrence of health epidemics or
contagious diseases, such as COVID-19, and potential effects on
NeuroBo's business, clinical trial sites, supply chain and
manufacturing facilities; NeuroBo's ability to continue as a going
concern; the timing of completion of NeuroBo's planned clinical
trials, including with respect to ANA001 and Gemcabene; the timing
of the availability of data from NeuroBo's clinical trials,
including with respect to ANA001 and Gemcabene; NeuroBo's
plans to research, develop and commercialize its current and future
product candidates, including the potential alternative pathways
for NB-01; NeuroBo's ability to successfully collaborate with
existing collaborators or enter into new collaborations and to
fulfill its obligations under any such collaboration agreements;
the clinical utility, potential benefits and market acceptance of
NeuroBo's product candidates, including ANA001 and Gemcabene; the
impact of government laws and regulations; NeuroBo's ability to
protect its intellectual property position; and NeuroBo's need for
additional financing to fulfill its stated goals; and other factors
discussed in the "Risk Factors" section of NeuroBo's Annual Report
on Form 10-K filed with the Securities and Exchange Commission on
or about the date hereof. In addition, the forward-looking
statements included in this press release represent NeuroBo's views
as of the date hereof. NeuroBo anticipates that subsequent events
and developments will cause its views to change. However, while
NeuroBo may elect to update these forward-looking statements at
some point in the future, NeuroBo specifically disclaims any
obligation to do so. These forward-looking statements should not be
relied upon as representing NeuroBo's views as of any date
subsequent to the date hereof.
Contacts:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
- Tables to Follow -
NeuroBo
Pharmaceuticals, Inc.
|
Consolidated
Balance Sheets
|
(in thousands,
except share amounts and par value)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
2021
|
|
2020
|
|
|
|
(unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
6,984
|
|
$
|
10,089
|
|
Prepaid
expenses
|
|
|
812
|
|
|
546
|
|
Other
assets
|
|
|
48
|
|
|
48
|
|
Total current
assets
|
|
|
7,844
|
|
|
10,683
|
|
Right-of-use assets
and other
|
|
|
111
|
|
|
130
|
|
Property and
equipment, net
|
|
|
122
|
|
|
155
|
|
Total
assets
|
|
$
|
8,077
|
|
$
|
10,968
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
953
|
|
$
|
2,575
|
|
Accrued
liabilities
|
|
|
922
|
|
|
1,096
|
|
Lease liability,
short-term
|
|
|
26
|
|
|
24
|
|
Total current
liabilities
|
|
|
1,901
|
|
|
3,695
|
|
Lease liability,
long-term
|
|
|
51
|
|
|
70
|
|
Total
liabilities
|
|
|
1,952
|
|
|
3,765
|
|
Commitments and
contingencies (Notes 4, 5, 6 and 11)
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
Preferred stock,
$0.001 par value; 10,000,000 shares authorized as of September 30,
2021 and December 31, 2020; no shares issued or outstanding as of
September 30, 2021 and December 31, 2020.
|
|
|
—
|
|
|
—
|
|
Common stock, $0.001
par value per share, 100,000,000 shares authorized as of September
30, 2021 and December 31, 2020; 22,285,492 and 19,671,182 shares
issued and outstanding as of September 30, 2021 and December 31,
2020, respectively.
|
|
|
22
|
|
|
20
|
|
Additional paid–in
capital
|
|
|
83,349
|
|
|
73,713
|
|
Accumulated other
comprehensive income
|
|
|
4
|
|
|
14
|
|
Accumulated
deficit
|
|
|
(77,250)
|
|
|
(66,544)
|
|
Total stockholders'
equity
|
|
|
6,125
|
|
|
7,203
|
|
Total liabilities and
stockholders' equity
|
|
$
|
8,077
|
|
$
|
10,968
|
|
NeuroBo
Pharmaceuticals, Inc.
|
Consolidated
Statements of Operations and Comprehensive Loss
|
(in thousands,
except share and per share amounts)
|
(unaudited)
|
|
|
|
For the Three
Months Ended
|
|
For the Nine
Months Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
1,394
|
|
$
|
1,265
|
|
$
|
4,549
|
|
$
|
4,091
|
General and
administrative
|
|
|
2,070
|
|
|
1,795
|
|
|
6,171
|
|
|
6,110
|
Total operating
expenses
|
|
|
3,464
|
|
|
3,060
|
|
|
10,720
|
|
|
10,201
|
Loss from
operations
|
|
|
(3,464)
|
|
|
(3,060)
|
|
|
(10,720)
|
|
|
(10,201)
|
Interest
income
|
|
|
3
|
|
|
6
|
|
|
14
|
|
|
34
|
Other expense,
net
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1)
|
Loss before income
taxes
|
|
|
(3,461)
|
|
|
(3,054)
|
|
|
(10,706)
|
|
|
(10,168)
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
Net loss
|
|
|
(3,461)
|
|
|
(3,054)
|
|
|
(10,706)
|
|
|
(10,168)
|
Other comprehensive
(loss) income, net of tax
|
|
|
1
|
|
|
13
|
|
|
(10)
|
|
|
(15)
|
Comprehensive
loss
|
|
$
|
(3,460)
|
|
$
|
(3,041)
|
|
$
|
(10,716)
|
|
$
|
(10,183)
|
Loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.16)
|
|
$
|
(0.19)
|
|
$
|
(0.49)
|
|
$
|
(0.63)
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
22,285,492
|
|
|
16,427,307
|
|
|
22,036,184
|
|
|
16,135,000
|
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content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-third-quarter-2021-financial-results-301423860.html
SOURCE NeuroBo Pharmaceuticals, Inc.