BOSTON, Aug. 16, 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 second quarter ended June 30,
2021.
Management Commentary
"During the second quarter, we continued to advance the Phase
2/3 clinical trial of our 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., President
and Chief Executive Officer of NeuroBo. "While enrollment of
the Phase 2 portion of the trial in the U.S. had initially
progressed at a slow rate due to high vaccination rates and a
deceleration of COVID-19 hospitalizations, the spread of the Delta
variant has reversed that trend and enrollment has now accelerated.
As a result, we expect to complete the Phase 2 portion of the trial
in the fourth quarter. We look forward to a number of
value-creating milestones with our COVID-19 programs in the coming
months."
Dr. Kang continued, "In July, we were delighted to enhance our
Board of Directors with the elections of Hyung Heon Kim and Andrew Koven. Their collective industry
leadership experience and legal expertise is greatly valued as we
seek to advance our pipeline of multi-modal disease-modifying
therapies for viral, neuropathic, and neurodegenerative
diseases."
Second Quarter 2021 Financial and Operating Results
- Research and Development (R&D) Expenses were
$2.0 million for the three months
ended June 30, 2021 as compared to
$0.7 million for the three months
ended June 30, 2020. The $1.3 million increase in the second quarter of
2021 was primarily attributed to an overall increase in research
development activity in 2021 on a net basis when compared to the
comparable quarter in the prior year.
- General and Administrative Expenses were $1.9 million for the three months ended
June 30, 2021, compared to
$1.7 million for the three months
ended June 30, 2020. The increase of
$0.2 million in the current period
was primarily due to additional insurance premium costs of
$0.1 million, payroll costs of
$0.1 million and consulting costs of
$0.1 million, offset in part by a
reduction of facility related costs of $0.1
million when compared to the comparable period in the prior
year.
- Net Loss for the quarter ended June 30, 2021 was $3.9
million, or $0.18 per basic
and diluted share, based on 22,200,074 weighted average common
shares outstanding, compared with a net loss of $2.4 million, or $0.15 per basic and diluted share, based on
16,303,681 weighted average common shares outstanding for the
quarter ended June 30, 2020.
- Cash and Cash Equivalents were $9.5 million as of June
30, 2021, compared with $10.1
million as of December 31,
2020. Operating at its current level of clinical activity,
NeuroBo expects its cash position will be adequate to fund
operations into the first 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 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 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)
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
2021
|
|
2020
|
|
|
|
(unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
9,513
|
|
$
|
10,089
|
|
Prepaid
expenses
|
|
|
789
|
|
|
546
|
|
Other
assets
|
|
|
166
|
|
|
48
|
|
Total current
assets
|
|
|
10,468
|
|
|
10,683
|
|
Right-of-use assets
and other
|
|
|
117
|
|
|
130
|
|
Property and
equipment, net
|
|
|
134
|
|
|
155
|
|
Total
assets
|
|
$
|
10,719
|
|
$
|
10,968
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
347
|
|
$
|
2,575
|
|
Accrued
liabilities
|
|
|
811
|
|
|
1,096
|
|
Lease liability,
short-term
|
|
|
25
|
|
|
24
|
|
Total current
liabilities
|
|
|
1,183
|
|
|
3,695
|
|
Lease liability,
long-term
|
|
|
58
|
|
|
70
|
|
Total
liabilities
|
|
|
1,241
|
|
|
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 June 30, 2021
and December 31, 2020; no shares issued or outstanding as of June
30, 2021 and December 31, 2020.
|
|
|
—
|
|
|
—
|
|
Common stock, $0.001
par value per share, 100,000,000 shares authorized as of June 30,
2021 and December 31, 2020; 22,285,492 and 19,671,182 shares issued
and outstanding as of June 30, 2021 and December 31, 2020,
respectively.
|
|
|
22
|
|
|
20
|
|
Additional paid–in
capital
|
|
|
83,242
|
|
|
73,713
|
|
Accumulated other
comprehensive income
|
|
|
3
|
|
|
14
|
|
Accumulated
deficit
|
|
|
(73,789)
|
|
|
(66,544)
|
|
Total stockholders'
equity
|
|
|
9,478
|
|
|
7,203
|
|
Total liabilities and
stockholders' equity
|
|
$
|
10,719
|
|
$
|
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 Six Months
Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
2,012
|
|
$
|
674
|
|
$
|
3,155
|
|
$
|
2,826
|
|
General and
administrative
|
|
|
1,914
|
|
|
1,718
|
|
|
4,101
|
|
|
4,315
|
|
Total operating
expenses
|
|
|
3,926
|
|
|
2,392
|
|
|
7,256
|
|
|
7,141
|
|
Loss from
operations
|
|
|
(3,926)
|
|
|
(2,392)
|
|
|
(7,256)
|
|
|
(7,141)
|
|
Interest
income
|
|
|
5
|
|
|
8
|
|
|
11
|
|
|
28
|
|
Other expense,
net
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1)
|
|
Loss before income
taxes
|
|
|
(3,921)
|
|
|
(2,384)
|
|
|
(7,245)
|
|
|
(7,114)
|
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Net loss
|
|
|
(3,921)
|
|
|
(2,384)
|
|
|
(7,245)
|
|
|
(7,114)
|
|
Other comprehensive
(loss) income, net of tax
|
|
|
(4)
|
|
|
6
|
|
|
(11)
|
|
|
(28)
|
|
Comprehensive
loss
|
|
$
|
(3,925)
|
|
$
|
(2,378)
|
|
$
|
(7,256)
|
|
$
|
(7,142)
|
|
Loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.18)
|
|
$
|
(0.15)
|
|
$
|
(0.33)
|
|
$
|
(0.44)
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
22,200,074
|
|
|
16,303,681
|
|
|
21,909,464
|
|
|
15,987,240
|
|
View original
content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-second-quarter-2021-financial-results-301355545.html
SOURCE NeuroBo Pharmaceuticals, Inc.