BOSTON, May 20, 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
first quarter ended March 31,
2020.
"The first quarter and subsequent months have been another
productive period for the company, marked by the successful
completion, in a very challenging capital market, of a registered
direct common stock offering in April that bolstered our cash
position by $7.5 million,
significantly strengthening the balance sheet and providing a cash
runway through the first quarter of 2021. Additionally, we were
issued a key U.S. composition patent covering NB-02 which, given
its demonstrated multimodal therapeutic advantages, may represent
an important new alternative for the prevention and treatment of
Alzheimer's and other neurodegenerative disorders," stated
Richard J. Kang, Ph.D., President
and Chief Executive Officer of NeuroBo. "Subject to improvement of
global health and macroeconomic conditions, we plan to submit an
Investigational New Drug application to the U.S. Food and Drug
Administration (FDA) for NB-02 and to initiate a Phase 1 trial
in the first quarter of next year."
Dr. Kang continued, "We have continued to devote scientific
resources to evaluating the potential to bring the NB-01 asset to
the market through a different regulatory pathway. The avenues of
exploration include development of NB-01 as an orphan drug and/or a
nutraceutical (non-pharmaceutical) product. Additionally, we
submitted the complete response letter to the FDA and continue to
expect a reply in the second quarter regarding removal of the
partial clinical hold for Gemcabene, our novel, once-daily, oral
therapy designed to target known lipid metabolic pathways to lower
levels of LDL-C, hsCRP and triglycerides. If we receive a favorable
decision, we will be able to evaluate further options for this key
clinical asset."
First 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 March 31, 2020 and the operations of NeuroBo as a
private company for the comparable quarter ended March 31, 2019.
- Research and Development (R&D) Expenses were
$2.2 million for the three
months ended March 31, 2020 compared
with $1.8 million for the three
months ended March 31, 2019. The
$0.4 million increase in 2020 was
primarily attributed to the CRO termination costs associated with
the Phase 3 clinical trials of NB-01 in the amount of $0.7 million, and to the further development of
Gemcabene under the Contingent Value Rights Agreement in the amount
of $0.4 million, offset in part by
the overall reduction of clinical trial activity in the current
quarter when compared to the comparable period in the prior year.
R&D expenses during the three months ended March 31, 2020 and 2019 included stock-based
compensation of $14,000 and
$39,000, respectively.
- General and Administrative Expenses were $2.6 million for the first quarter ended
March 31, 2020, compared with
$0.7 million for the three
months ended March 31, 2019. The
increase of $1.9 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 first quarter of 2020.
- Net Loss for the first quarter ended March 31, 2020 was approximately $4.8 million, or $0.30 per basic and diluted share, based on
15,670,800 weighted average common shares outstanding, compared
with a net loss of approximately $2.5
million, or $0.48 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 $9.8 million as of March
31, 2020, compared with $13.9
million at December 31, 2019.
The company expects that its cash position, including the net
proceeds from the April 2020
registered direct common stock offering, will be adequate to fund
operations through the first 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
is currently postponed. In the interim, NeuroBo is exploring a
potential orphan drug indication and/or a nutraceutical pathway
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 is also
exploring an orphan drug pathway for NB-02. 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 Gemcabene 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)
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
|
|
2020
|
|
2019
|
|
|
|
(unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
9,799
|
|
$
|
13,908
|
|
Restricted
cash
|
|
|
15
|
|
|
15
|
|
Prepaid
expenses
|
|
|
1,332
|
|
|
153
|
|
Other
assets
|
|
|
65
|
|
|
42
|
|
Total current
assets
|
|
|
11,211
|
|
|
14,118
|
|
Right-of-use assets
and other
|
|
|
143
|
|
|
150
|
|
Property and
equipment, net
|
|
|
181
|
|
|
200
|
|
Total
assets
|
|
$
|
11,535
|
|
$
|
14,468
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,273
|
|
$
|
638
|
|
Accrued
liabilities
|
|
|
2,411
|
|
|
1,422
|
|
Lease liability,
short-term
|
|
|
22
|
|
|
22
|
|
Total current
liabilities
|
|
|
3,706
|
|
|
2,082
|
|
Lease and other
long-term liabilities
|
|
|
89
|
|
|
94
|
|
Total
liabilities
|
|
|
3,795
|
|
|
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 March 31, 2020 and December 31, 2019.
|
|
|
—
|
|
|
—
|
|
Common stock, $0.001
par value per share, 100,000,000 shares authorized; 15,677,307 and
15,592,718 shares issued and outstanding as of March 31, 2020 and
December 31, 2019, respectively.
|
|
|
16
|
|
|
16
|
|
Additional paid–in
capital
|
|
|
49,342
|
|
|
49,130
|
|
Accumulated other
comprehensive income
|
|
|
(22)
|
|
|
12
|
|
Accumulated
deficit
|
|
|
(41,596)
|
|
|
(36,866)
|
|
Total stockholders'
equity
|
|
|
7,740
|
|
|
12,292
|
|
Total liabilities and
stockholders' equity
|
|
$
|
11,535
|
|
$
|
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
|
|
|
|
March 31,
|
|
|
|
2020
|
|
2019
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
2,152
|
|
$
|
1,800
|
|
General and
administrative
|
|
|
2,597
|
|
|
651
|
|
Total operating
expenses
|
|
|
4,749
|
|
|
2,451
|
|
Loss from
operations
|
|
|
(4,749)
|
|
|
(2,451)
|
|
Interest (expense)
income, net
|
|
|
20
|
|
|
(13)
|
|
Other income
(expense), net
|
|
|
(1)
|
|
|
—
|
|
Loss before income
taxes
|
|
|
(4,730)
|
|
|
(2,464)
|
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
|
Net loss
|
|
|
(4,730)
|
|
|
(2,464)
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
Foreign currency
translation loss, net of tax
|
|
|
(34)
|
|
|
(2)
|
|
Total other
comprehensive loss
|
|
|
(34)
|
|
|
(2)
|
|
Comprehensive
loss
|
|
$
|
(4,764)
|
|
$
|
(2,466)
|
|
Loss per
share:
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.30)
|
|
$
|
(0.48)
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
15,670,800
|
|
|
5,166,812
|
|
View original
content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-first-quarter-2020-financial-results-301063091.html
SOURCE NeuroBo Pharmaceuticals, Inc.