BOSTON, Nov. 13, 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
third quarter ended September 30,
2020.
"Throughout the third quarter and recent weeks, we continued to
evaluate a variety of potential options for bringing the NB-01
asset to the market through a different regulatory pathway,
including as an orphan drug or a rare disease indication," stated
Richard J. Kang, Ph.D., President
and Chief Executive Officer of NeuroBo.
"We had continued work on preparing an Investigational New Drug
(IND) application for submission to the U.S. Food and Drug
Administration (FDA) for NB-02, our multi-component drug compound
that, in pre-clinical models, has shown to impact multiple pathways
involved in neurodegenerative disease. Given the global
resurgence of COVID-19, we have postponed continued work on the IND
and 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 second half of 2021.
"We are also evaluating a number of potential opportunities that
complement our multi-modal drug platforms. Our development
activity is mindful of conserving financial resources. Toward
that end, we believe we have the resources to fund our operations
into the third quarter of 2021," concluded Dr. Kang.
Third 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 September 30, 2020 and the operations of NeuroBo
as a private company for the comparable quarter ended September 30, 2019.
- Research and Development (R&D) Expenses were
$1.3 million for the three months
ended September 30, 2020, compared to
$1.2 million for the three months
ended September 30, 2019. The
$0.1 million increase in the third
quarter of 2020 was primarily attributed to CRO termination costs
of $0.6 million, offset in part by
the reduction in clinical trial activity of $0.3 million, given the determination in
March 2020 to postpone Phase 3
clinical trials of NB-01. R&D expenses during the three months
ended September 30, 2020 and 2019
included stock-based compensation of zero and $60,000, respectively.
- General and Administrative Expenses were $1.8 million for the three months ended
September 30, 2020, compared with
$2.5 million for the three months
ended September 30, 2019. The
decrease of $0.7 million was
primarily due to the reduction in transaction related costs that
occurred during the third quarter of 2019 associated with legal,
accounting and other consulting support of $1.6 million, offset by cost increases in the
current quarter of $0.9 million
related largely to director and officer insurance premiums of
$0.4 million, public company related
costs of $0.2 million, stock based
compensation costs of $0.2 million,
and payroll related costs of $0.1
million. Stock-based compensation costs during the
three-month periods ended September 30,
2020 and 2019 were $0.2
million and a credit of $(6,000), respectively.
- Net Loss for the third quarter ended September 30, 2020 was approximately $3.1 million, or $0.19 per basic and diluted share, based on
16,427,307 weighted average common shares outstanding, compared
with a net loss of approximately $3.6
million, or $0.70 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 $12.4 million as of September 30, 2020, compared with $13.9 million at December
31, 2019. The Company expects that its cash position will be
adequate to fund operations into the third quarter of 2021.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals,
Inc. has a current portfolio of three drug candidates. 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 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 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 third program, Gemcabene, was developed 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; the economic
feasibility of developing NB-01 under an alternative pathway
including pursuant to the terms of NeuroBo's exclusive license
agreement with Dong-A ST; 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)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
2020
|
|
2019
|
|
|
|
(unaudited)
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
12,353
|
|
$
|
13,908
|
|
Restricted
cash
|
|
|
—
|
|
|
15
|
|
Prepaid
expenses
|
|
|
511
|
|
|
153
|
|
Other
assets
|
|
|
34
|
|
|
42
|
|
Total current
assets
|
|
|
12,898
|
|
|
14,118
|
|
Right-of-use
assets
|
|
|
100
|
|
|
116
|
|
Property and
equipment, net
|
|
|
167
|
|
|
200
|
|
Other
assets
|
|
|
33
|
|
|
34
|
|
Total
assets
|
|
$
|
13,198
|
|
$
|
14,468
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,101
|
|
$
|
638
|
|
Accrued
liabilities
|
|
|
2,491
|
|
|
1,422
|
|
Lease liability,
short-term
|
|
|
23
|
|
|
22
|
|
Total current
liabilities
|
|
|
3,615
|
|
|
2,082
|
|
Lease and other
long-term liabilities
|
|
|
77
|
|
|
94
|
|
Total
liabilities
|
|
|
3,692
|
|
|
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 September 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
September
30, 2020 and December 31, 2019, respectively.
|
|
|
17
|
|
|
16
|
|
Additional paid–in
capital
|
|
|
56,526
|
|
|
49,130
|
|
Accumulated other
comprehensive (loss) income
|
|
|
(3)
|
|
|
12
|
|
Accumulated
deficit
|
|
|
(47,034)
|
|
|
(36,866)
|
|
Total stockholders'
equity
|
|
|
9,506
|
|
|
12,292
|
|
Total liabilities and
stockholders' equity
|
|
$
|
13,198
|
|
$
|
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 Nine
Months Ended
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
1,265
|
|
$
|
1,150
|
|
$
|
4,091
|
|
$
|
3,898
|
|
General and
administrative
|
|
|
1,795
|
|
|
2,495
|
|
|
6,110
|
|
|
4,085
|
|
Total operating
expenses
|
|
|
3,060
|
|
|
3,645
|
|
|
10,201
|
|
|
7,983
|
|
Loss from
operations
|
|
|
(3,060)
|
|
|
(3,645)
|
|
|
(10,201)
|
|
|
(7,983)
|
|
Interest income
(expense), net
|
|
|
6
|
|
|
24
|
|
|
34
|
|
|
(3)
|
|
Other (expense)
income, net
|
|
|
—
|
|
|
—
|
|
|
(1)
|
|
|
—
|
|
Loss before income
taxes
|
|
|
(3,054)
|
|
|
(3,621)
|
|
|
(10,168)
|
|
|
(7,986)
|
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Net loss
|
|
|
(3,054)
|
|
|
(3,621)
|
|
|
(10,168)
|
|
|
(7,986)
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
currency translation gain (loss), net of
tax
|
|
|
13
|
|
|
(11)
|
|
|
(15)
|
|
|
(2)
|
|
Total other
comprehensive income (loss)
|
|
|
13
|
|
|
(11)
|
|
|
(15)
|
|
|
(2)
|
|
Comprehensive
loss
|
|
$
|
(3,041)
|
|
$
|
(3,632)
|
|
$
|
(10,183)
|
|
$
|
(7,988)
|
|
Loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.19)
|
|
$
|
(0.70)
|
|
$
|
(0.63)
|
|
$
|
(1.55)
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
16,427,307
|
|
|
5,166,812
|
|
|
16,135,000
|
|
|
5,166,812
|
|
View original
content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-third-quarter-2020-financial-results-301172950.html
SOURCE NeuroBo Pharmaceuticals, Inc.