BOSTON, Aug. 11, 2020 /PRNewswire/ -- NeuroBo
Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage
biotechnology company focused on developing and commercializing
multimodal, disease-modifying therapies for neurodegenerative and
cardiometabolic diseases, today announced financial results for the
second quarter ended June 30,
2020.
"As planned, throughout the second quarter, our Board,
management and scientific team evaluated a number of potential
options for advancing the NB-01 clinical asset through different
regulatory pathways," stated Richard J.
Kang, Ph.D., President and Chief Executive Officer of
NeuroBo. "Development of NB-01 as an orphan drug is key among
the alternatives we are considering, and we may conduct feasibility
studies to identify a specific rare disease relevant to this
product candidate. While we had considered marketing NB-01 as a
nutraceutical product, we have now determined not to pursue this
pathway at this time."
Dr. Kang continued, "We are preparing an Investigational New
Drug ("IND") application to the U.S. Food and Drug Administration
("FDA") for NB-02. We intend to postpone the first human clinical
trials for NB-02 until global health and macroeconomic conditions
improve, with a view toward commencing clinical trial activity in
the first half of 2021, subject to improvement of the constraints
imposed by the COVID-19 pandemic. We are also considering engaging
with a strategic partner to assist with clinical trials for
NB-02."
The Company previously announced, in May
2020, that it received written communication from the FDA
stating that the clinical development program for Gemcabene remains
on a partial clinical hold. The Company is reviewing its options
regarding Gemcabene.
Second Quarter Financial and Operating Results
Highlights
Upon the merger between Gemphire Therapeutics, Inc. and NeuroBo
Pharmaceuticals, Inc. at year-end 2019, the formerly private
NeuroBo was considered the accounting acquirer. In accordance with
generally accepted accounting principles, the historical financial
statements of private company, NeuroBo, are considered the
financial statements of the combined company, with the merger
accounted for as an acquisition of the Gemcabene family of
related assets on December 30, 2019.
The following highlights, therefore, represent the combined
operations of both companies for the quarter ended June 30, 2020 and the operations of NeuroBo as a
private company for the comparable quarter ended June 30, 2019.
- Research and Development (R&D) Expenses were
approximately $0.7 million for the
three months ended June 30, 2020
compared with approximately $0.9
million for the three months ended June 30, 2019. The approximately $0.3 million decrease in the second quarter of
2020 was primarily due to the overall reduction of clinical trial
activity given the March 2020
decision to postpone Phase 3 clinical trials of NB-01. R&D
expenses during the three months ended June
30, 2020 and 2019 included stock-based compensation of
$4,000 and $16,000, respectively.
- General and Administrative Expenses were $1.7 million for the three months ended
June 30, 2020, compared with
$0.9 million for the three months
ended June 30, 2019. The increase of
$0.8 million was primarily due to the
ramp up costs associated with operating and reporting as a public
company and to post-Merger support costs in the second quarter of
2020. Stock-based compensation costs during the three-month periods
ended June 30, 2020 and 2019 were
$0.2 million and $63,000, respectively.
- Net Loss for the second quarter ended June 30, 2020 was approximately $2.4 million, or $0.15 per basic and diluted share, based on
16,303,681 weighted average common shares outstanding, compared
with a net loss of approximately $1.9
million, or $0.37 per basic
and diluted share, based on 5,166,812 weighted average common
shares outstanding for the same period in 2019.
- Cash and Cash Equivalents were $14.3 million as of June
30, 2020, compared with $13.9
million at December 31, 2019.
The Company expects that its cash position, which includes the net
proceeds from the April 2020
registered direct common stock offering, will be adequate to fund
operations into the second quarter of 2021.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals,
Inc. is focused on novel treatments for neurodegenerative and
cardiometabolic diseases affecting millions of patients worldwide.
The company's multimodal approach has the potential to address the
multiple underlying mechanisms of neurodegenerative diseases,
alleviate symptoms and slow disease progression. The company's drug
candidate, NB-01, for the treatment of painful diabetic neuropathy
(PDN), has been shown in a Phase 2 study to significantly reduce
pain symptoms associated with PDN with a superior safety profile
when compared to currently available treatments. Due to global
COVID-19 crisis, a planned Phase 3 study was postponed. In the
interim, NeuroBo is exploring a potential orphan drug indication
targeting chronic pain for NB-01. NeuroBo's drug candidate, NB-02,
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 third
program, Gemcabene, is focused on developing and commercializing
therapies for the treatment of dyslipidemia, a serious medical
condition that increases the risk of life-threatening
cardiovascular disease.
NeuroBo Pharmaceuticals was jointly founded by Dr. Roy
Freeman, professor of neurology at Harvard Medical
School and renowned expert in neuropathic pain, and JK
BioPharma Solutions, a biotechnology consulting company, to
commercialize natural product-based research into ethical
medicines. In December 2019, NeuroBo
merged with Gemphire Therapeutics and through such merger, became
listed on the Nasdaq Stock Market and added the Gemcabene family of
related assets to its portfolio. 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
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: 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; the timing of the availability of data from NeuroBo's
clinical trials; 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; 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 and in our other filings with the Securities and
Exchange Commission. 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
Melody
Carey
+1-917-322-2571
mcarey@rxir.com
- Tables to Follow -
NeuroBo
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheets
(in thousands,
except share amounts and par value)
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
2020
|
|
2019
|
|
|
|
(unaudited)
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
14,298
|
|
$
|
13,908
|
|
Restricted
cash
|
|
|
—
|
|
|
15
|
|
Prepaid
expenses
|
|
|
908
|
|
|
153
|
|
Other
assets
|
|
|
37
|
|
|
42
|
|
Total current
assets
|
|
|
15,243
|
|
|
14,118
|
|
Right-of-use
assets
|
|
|
105
|
|
|
116
|
|
Property and
equipment, net
|
|
|
172
|
|
|
200
|
|
Other
assets
|
|
|
32
|
|
|
34
|
|
Total
assets
|
|
$
|
15,552
|
|
$
|
14,468
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,683
|
|
$
|
638
|
|
Accrued
liabilities
|
|
|
1,426
|
|
|
1,422
|
|
Lease liability,
short-term
|
|
|
23
|
|
|
22
|
|
Total current
liabilities
|
|
|
3,132
|
|
|
2,082
|
|
Lease and other
long-term liabilities
|
|
|
82
|
|
|
94
|
|
Total
liabilities
|
|
|
3,214
|
|
|
2,176
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
Preferred stock,
$0.001 par value; 10,000,000 shares authorized; no shares
issued or outstanding as of June 30, 2020 and December 31,
2019.
|
|
|
—
|
|
|
—
|
|
Common stock, $0.001
par value per share, 100,000,000 shares authorized;
16,427,307 and 15,592,718 shares issued and outstanding as of June
30, 2
020 and December 31, 2019, respectively.
|
|
|
17
|
|
|
16
|
|
Additional paid–in
capital
|
|
|
56,317
|
|
|
49,130
|
|
Accumulated other
comprehensive (loss) income
|
|
|
(16)
|
|
|
12
|
|
Accumulated
deficit
|
|
|
(43,980)
|
|
|
(36,866)
|
|
Total stockholders'
equity
|
|
|
12,338
|
|
|
12,292
|
|
Total liabilities and
stockholders' equity
|
|
$
|
15,552
|
|
$
|
14,468
|
|
NeuroBo
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands,
except share and per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three
Months Ended
|
|
For the Six Months
Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
674
|
|
$
|
948
|
|
$
|
2,826
|
|
$
|
2,748
|
|
General and
administrative
|
|
|
1,718
|
|
|
939
|
|
|
4,315
|
|
|
1,590
|
|
Total operating
expenses
|
|
|
2,392
|
|
|
1,887
|
|
|
7,141
|
|
|
4,338
|
|
Loss from
operations
|
|
|
(2,392)
|
|
|
(1,887)
|
|
|
(7,141)
|
|
|
(4,338)
|
|
Interest income
(expense), net
|
|
|
8
|
|
|
(14)
|
|
|
28
|
|
|
(27)
|
|
Other expense,
net
|
|
|
—
|
|
|
—
|
|
|
(1)
|
|
|
—
|
|
Loss before income
taxes
|
|
|
(2,384)
|
|
|
(1,901)
|
|
|
(7,114)
|
|
|
(4,365)
|
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Net loss
|
|
|
(2,384)
|
|
|
(1,901)
|
|
|
(7,114)
|
|
|
(4,365)
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
currency translation loss, net of tax
|
|
|
6
|
|
|
11
|
|
|
(28)
|
|
|
9
|
|
Total other
comprehensive loss
|
|
|
6
|
|
|
11
|
|
|
(28)
|
|
|
9
|
|
Comprehensive
loss
|
|
$
|
(2,378)
|
|
$
|
(1,890)
|
|
$
|
(7,142)
|
|
$
|
(4,356)
|
|
Loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.15)
|
|
$
|
(0.37)
|
|
$
|
(0.44)
|
|
$
|
(0.84)
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
16,303,681
|
|
|
5,166,812
|
|
|
15,987,240
|
|
|
5,166,812
|
|
View original
content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-second-quarter-2020-financial-results-301110298.html
SOURCE NeuroBo Pharmaceuticals, Inc.