BOSTON, April 15, 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 year ended December 31, 2020 and
provided a corporate strategic update.
"In December 2020, we
significantly expanded our clinical pipeline with the acquisition
of ANA Therapeutics and the addition of lead drug candidate,
ANA001, a proprietary oral niclosamide formulation, currently in a
60-patient Phase 2/3 trial as a treatment for moderate to severe
COVID-19," stated Richard J. Kang,
Ph.D., President and Chief Executive Officer of NeuroBo. "The
recent approval of the Contingent Value Rights (CVR) Agreement
amendment from a majority of the company's CVR holders incentivizes
our evaluation of Gemcabene as a treatment for COVID-19 and expands
our pipeline in this indication of continued urgent need. We have a
series of potentially value creating milestones over the next
twelve months related to our development programs to treat
COVID-19. Regarding our Phase 2 trial for ANA001, we expect to
report the data monitoring committee safety results,
pharmacokinetic (PK) data and the top-line data readout. We also
look forward to releasing preclinical in vitro data for
Gemcabene against COVID-19 variants alone and in combination with
ANA001."
Dr. Kang continued, "Due to the COVID-19 pandemic, we paused our
plans to conduct Phase 3 trials for NB-01 in the first quarter of
2020. We continue to evaluate potential options for bringing
the NB-01 asset to the market through a different regulatory
pathway, including as an orphan drug for a rare disease indication.
In April 2020, 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. Although NB-02
was nearing an Investigational New Drug submission with the U.S.
Food and Drug Administration, we intend to postpone the first human
clinical trials until global macroeconomic conditions improve, with
a view toward commencing clinical trial activity in the second half
of 2021, subject to improvement of the constraints imposed by the
COVID 19-pandemic."
"Importantly, we significantly bolstered our balance sheet with
the $10.0 million private placement
of our common shares completed in January
2021, which we believe provides the resources to fund our
operations into the fourth quarter of this year," concluded Dr.
Kang.
Full Year 2020 Financial and Operating Results
Highlights
Upon the merger between Gemphire Therapeutics, Inc. and NeuroBo
Pharmaceuticals, Inc. ("NeuroBo") 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 before
January 1, 2020, 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 year ended December 31, 2020 and the operations of NeuroBo
as a private company for the comparable year ended December 31, 2019.
In December 2020, NeuroBo
successfully completed the acquisition of ANA Therapeutics, Inc.
("ANA") and its lead product candidate, ANA001, a proprietary oral
niclosamide formulation in Phase 2/3 clinical development as a
treatment for patients with moderate COVID-19.
- Research and Development (R&D) Expenses were
approximately $4.5 million for the
year ended December 31, 2020, as
compared to approximately $5.3
million for the year ended December
31, 2019. The $0.8 million
decrease was primarily related to the overall reduction of clinical
trial activity, as Contract Research Organization (CRO) fees,
supply and personnel related costs decreased by approximately
$2.5 million, offset in part by
approximately $1.3 million in CRO
termination costs associated with the March
2020 determination to postpone Phase 3 clinical trials of
NB-01 in the amount of approximately $1.3
million, and $0.4 million for
the development of Gemcabene, which was acquired in NeuroBo's 2019
business combination with Gemphire Therapeutics, Inc.
- Acquired In-process Research and Development Expenses
(IPR&D) for the year ended December 31,
2020 amounted to $17.3 million
and was attributable to research and development projects of
niclosamide which were in-process at the date NeuroBo acquired ANA.
Acquired in-process research and development expenses for the year
ended December 31, 2019 amounted to
$12.2 million and was attributable to
research and development projects of Gemphire, which were
in-process upon Gemphire's merger with NeuroBo. Current accounting
standards require that the fair value of IPR&D with no
alternative future use be charged to expense on the acquisition
date.
- General and Administrative Expenses were $7.8 million for the year ended December 31, 2020, compared to $2.7 million for the year ended December 31, 2019. The increase of $5.1 million was primarily due to the costs
associated with operating as a public company when compared to the
comparable prior year. The cost increases in 2020 included legal
costs of $1.6 million, $1.5 million in director and officer and other
insurance premiums, $0.8 million in
accounting and auditing fess, $0.6
million in board of director and other public company costs
and $0.6 million in stock-based
compensation.
- Net Loss for the year ended December 31, 2020 was $29.7 million, or $1.83 per basic and diluted share, based on
16,217,339 weighted average common shares outstanding, compared
with a net loss of $21.3 million, or
$4.08 per basic and diluted share,
based on 5,224,178 weighted average common shares outstanding for
the year ended December 31,
2019.
- Cash and Cash Equivalents were $10.1 million as of December 31, 2020, compared with $13.9 million as of December 31, 2019. Operating at its level of
scientific activity during the year ended December 31, 2020, 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)
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
10,089
|
|
$
|
13,908
|
|
Restricted
cash
|
|
|
—
|
|
|
15
|
|
Prepaid
expenses
|
|
|
546
|
|
|
153
|
|
Other
assets
|
|
|
48
|
|
|
42
|
|
Total current
assets
|
|
|
10,683
|
|
|
14,118
|
|
Right-of-use assets
and other
|
|
|
130
|
|
|
150
|
|
Property and
equipment, net
|
|
|
155
|
|
|
200
|
|
Total
assets
|
|
$
|
10,968
|
|
$
|
14,468
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,575
|
|
$
|
638
|
|
Accrued
liabilities
|
|
|
1,096
|
|
|
1,422
|
|
Lease liability,
short-term
|
|
|
24
|
|
|
22
|
|
Total current
liabilities
|
|
|
3,695
|
|
|
2,082
|
|
Lease liability,
long-term
|
|
|
70
|
|
|
94
|
|
Total
liabilities
|
|
|
3,765
|
|
|
2,176
|
|
Commitments and
contingencies (Notes 4, 5, 6 and 14)
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
Preferred stock,
$0.001 par value; 10,000,000 shares authorized as of December 31,
2020 and 2019, respectively; no shares issued or outstanding as of
December 31, 2020 and 2019.
|
|
|
—
|
|
|
—
|
|
Common stock, $0.001
par value per share, 100,000,000 shares authorized as of December
31, 2020 and 2019; 19,671,182 and 15,592,718 shares issued and
outstanding as of December 31, 2020 and 2019,
respectively.
|
|
|
20
|
|
|
16
|
|
Additional paid–in
capital
|
|
|
73,713
|
|
|
49,130
|
|
Accumulated other
comprehensive income
|
|
|
14
|
|
|
12
|
|
Accumulated
deficit
|
|
|
(66,544)
|
|
|
(36,866)
|
|
Total stockholders'
equity
|
|
|
7,203
|
|
|
12,292
|
|
Total liabilities and
stockholders' equity
|
|
$
|
10,968
|
|
$
|
14,468
|
|
NeuroBo
Pharmaceuticals, Inc.
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share and per share
amounts)
|
|
|
|
For the Year
Ended
|
|
|
December 31,
|
|
|
2020
|
|
2019
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
4,531
|
|
$
|
5,324
|
Acquired in–process
research and development
|
|
|
17,339
|
|
|
12,151
|
General and
administrative
|
|
|
7,846
|
|
|
2,701
|
Total operating
expenses
|
|
|
29,716
|
|
|
20,176
|
Loss from
operations
|
|
|
(29,716)
|
|
|
(20,176)
|
Loss on note
extinguishment
|
|
|
—
|
|
|
(1,114)
|
Interest income
(expense), net
|
|
|
39
|
|
|
(22)
|
Other expense,
net
|
|
|
(1)
|
|
|
—
|
Loss before income
taxes
|
|
|
(29,678)
|
|
|
(21,312)
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
Net loss
|
|
|
(29,678)
|
|
|
(21,312)
|
Other comprehensive
income, net of tax
|
|
|
2
|
|
|
10
|
Comprehensive
loss
|
|
$
|
(29,676)
|
|
$
|
(21,302)
|
Loss per
share:
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(1.83)
|
|
$
|
(4.08)
|
Weighted average
common shares outstanding:
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
16,217,339
|
|
|
5,224,178
|
|
|
|
|
|
|
|
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content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-full-year-2020-financial-results-and-provides-corporate-strategic-update-301270246.html
SOURCE NeuroBo Pharmaceuticals, Inc.