BOSTON, May 17, 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 first quarter ended March 31,
2021.
First Quarter Achievements
- Broadened the potential for product candidate, Gemcabene, by
amending its Contingent Value Rights (CVR) agreement with the
holders of the outstanding CVRs, to incentivize the evaluation of
Gemcabene as a treatment for COVID-19. The CVRs were distributed to
the holders of Gemphire Therapeutics, Inc. common stock on
December 30, 2019, immediately prior
to its merger with NeuroBo. The CVR amendment will allow NeuroBo to
pursue Gemcabene as a therapy for COVID-19, with its own resources.
In exchange, CVR holders will receive 10% of certain gross proceeds
received by the company for any indication outside of treating
cardiometabolic diseases. CVR holders will retain the original CVR
for 80% of any proceeds of Gemcabene for cardiovascular
conditions.
- Strengthened the balance sheet with the successful completion
of a private placement of 2.5 million shares of common stock and
warrants to purchase up to an aggregate 2.5 million shares of
common stock, with aggregate gross proceeds to the company of
$10.0 million and net proceeds to the
company of approximately $9.2
million.
Management Commentary
"Throughout the first quarter of 2021, we continued to make
progress advancing the 60-patient Phase 2/3 clinical trial of our
lead drug candidate, ANA001, a proprietary oral niclosamide
formulation, as a treatment for moderate to severe COVID-19,"
stated Richard J. Kang, Ph.D.,
President and Chief Executive Officer of NeuroBo. "We remain
on track to report the data monitoring committee safety results of
this study and pharmacokinetic (PK) data from the Phase 1 in the
second quarter. In order to enhance enrollment in the Phase 2/3
study, we are in the process of expanding to sites in the U.S.
where the number of COVID-19 cases are increasing and including
clinical sites in countries overseas where COVID-19 is growing and
vaccinations are well behind the U.S. In addition, we expect
to report preclinical in vitro data demonstrating
Gemcabene's ability to treat COVID-19 variants alone and in
combination with ANA001."
Dr. Kang continued, "Our plans moving forward with NB-01 and
NB-02 remain under evaluation as we focus our resources on
advancing our COVID-19 franchise with ANA001 and Gemcabene.
With our recent fund raise, we believe NeuroBo has the financial
foundation to fund operations at the current level into the fourth
quarter of 2021 and we expect to achieve a number of value-creating
milestones with our COVID-19 programs in the coming months."
First Quarter 2021 Financial and Operating Results
- Research and Development (R&D) Expenses were
approximately $1.1 million for the
quarter ended March 31, 2021,
compared with approximately $2.2
million for the quarter ended March
31, 2020. The $1.0
million decrease was primarily attributed to overall
Contract Research Organization termination costs associated with
the Phase 3 clinical trials of NB-01 in the amount of $0.7 million and the further development of
Gemcabene under the CVR Agreement in the amount of $0.4 million that occurred during the first
quarter of 2020 with a small offset for increased research
activities in the first quarter of 2021 when compared with the
comparable quarter in the prior year.
- General and Administrative Expenses were $2.2 million for the three months ended
March 31, 2021, compared with
$2.6 million for the three months
ended March 31, 2020. The decrease of
$0.4 million was primarily due to a
reduction in transactional related costs in the amount of
$0.3 million with regard to the
company's acquisitions when compared with the comparable quarter in
the prior year. In addition, there was a reduction in legal costs
in the amount of $0.2 million in the
current quarter associated with the streamlining of the company's
intellectual property portfolio, offset in part by increases in
insurance premium costs during the current quarter of $0.1 million.
- Net Loss for the quarter ended March 31, 2021 was $3.3
million, or $0.15 per basic
and diluted share, based on 21,615,626 weighted average common
shares outstanding, compared with a net loss of $4.8 million, or $0.30 per basic and diluted share, based on
15,670,800 weighted average common shares outstanding for the
quarter ended March 31, 2020.
- Cash and Cash Equivalents were $13.0 million as of March
31, 2021, compared with $10.1
million as of December 31,
2020. Operating at its level of scientific activity during
the quarter ended March 31, 2021,
NeuroBo expects that its cash position will be adequate to fund
operations into the fourth quarter of 2021.
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)
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
|
|
|
2021
|
|
2020
|
|
|
|
(unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
13,035
|
|
$
|
10,089
|
|
Prepaid
expenses
|
|
|
831
|
|
|
546
|
|
Other
assets
|
|
|
28
|
|
|
48
|
|
Total current
assets
|
|
|
13,894
|
|
|
10,683
|
|
Right-of-use assets
and other
|
|
|
123
|
|
|
130
|
|
Property and
equipment, net
|
|
|
143
|
|
|
155
|
|
Total
assets
|
|
$
|
14,160
|
|
$
|
10,968
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
468
|
|
$
|
2,575
|
|
Accrued
liabilities
|
|
|
452
|
|
|
1,096
|
|
Lease liability,
short-term
|
|
|
24
|
|
|
24
|
|
Total current
liabilities
|
|
|
944
|
|
|
3,695
|
|
Lease liability,
long-term
|
|
|
65
|
|
|
70
|
|
Total
liabilities
|
|
|
1,009
|
|
|
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
March 31, 2021 and December 31, 2020; no shares issued or
outstanding
as of March 31, 2021 and December 31, 2020.
|
|
|
—
|
|
|
—
|
|
Common stock, $0.001
par value per share, 100,000,000 shares authorized
as of March 31, 2021 and December 31, 2020; 22,171,182 and
19,671,182
shares issued and outstanding as of March 31, 2021 and December 31,
2020,
respectively.
|
|
|
22
|
|
|
20
|
|
Additional paid–in
capital
|
|
|
82,990
|
|
|
73,713
|
|
Accumulated other
comprehensive income
|
|
|
7
|
|
|
14
|
|
Accumulated
deficit
|
|
|
(69,868)
|
|
|
(66,544)
|
|
Total stockholders'
equity
|
|
|
13,151
|
|
|
7,203
|
|
Total liabilities and
stockholders' equity
|
|
$
|
14,160
|
|
$
|
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
|
|
|
|
March 31,
|
|
|
|
2021
|
|
2020
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
1,143
|
|
$
|
2,152
|
|
General and
administrative
|
|
|
2,187
|
|
|
2,597
|
|
Total operating
expenses
|
|
|
3,330
|
|
|
4,749
|
|
Loss from
operations
|
|
|
(3,330)
|
|
|
(4,749)
|
|
Interest
income
|
|
|
6
|
|
|
20
|
|
Other income
(expense), net
|
|
|
—
|
|
|
(1)
|
|
Loss before income
taxes
|
|
|
(3,324)
|
|
|
(4,730)
|
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
|
Net loss
|
|
|
(3,324)
|
|
|
(4,730)
|
|
Other comprehensive
loss, net of tax
|
|
|
(7)
|
|
|
(34)
|
|
Comprehensive
loss
|
|
$
|
(3,331)
|
|
$
|
(4,764)
|
|
Loss per
share:
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.15)
|
|
$
|
(0.30)
|
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
21,615,626
|
|
|
15,670,800
|
|
View original
content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-first-quarter-2021-financial-results-301292944.html
SOURCE NeuroBo Pharmaceuticals, Inc.