BOSTON, March 30, 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
year ended December 31, 2019 and
provided a corporate strategic update.
"The closing of the merger between Gemphire Therapeutics, Inc.
and NeuroBo Pharmaceuticals, Inc. at year end 2019 was a pivotal
moment for NeuroBo, as it provided increased visibility with a
Nasdaq listing and afforded the company a platform to pursue its
long-term goals," stated Richard J.
Kang, Ph.D., President and Chief Executive Officer of the
combined company. "With the current macroeconomic environment,
however, including the global health emergency caused by the
COVID-19 pandemic, we have recently taken a number of prudent
strategic steps to ensure that the company is positioned to weather
this unprecedented situation. Specifically, to conserve financial
resources, we have decided to postpone the initiation of Phase 3
clinical trials for NB-01, which would be very challenging in the
short- or medium-term. Consequently, in the first quarter of 2020,
we ceased work on Phase 3 trials for NB-01 and gave notice of
termination of all related contract arrangements with our contract
research organizations. We are currently re-evaluating alternatives
to bring the NB-01 asset to the market through a different
regulatory pathway. Development of NB-01 as an orphan drug is among
the alternatives we are considering, and we may conduct feasibility
studies to identify a rare disease relevant to NB-01. Additionally,
we are considering marketing the NB-01 product line as
nutraceutical products.
"We remain optimistic about the considerable promise of our
second program, NB-02, which, in preclinical studies, has shown
potential as a neuroprotective agent, and we believe that the
multimodal therapeutic advantages of NB-02 could potentially
represent a paradigm shift in the treatment of Alzheimer's disease
and other neurodegenerative diseases," continued Dr. Kang.
"Although NB-02 is almost ready for the submission of an
Investigational New Drug (IND) application to the U.S. Food and
Drug Administration (FDA), we intend to postpone our first-in-human
clinical trials until market conditions improve. In the interim, we
remain very excited about this particular program and, based on the
strength of the data generated to date, we are assessing whether to
pursue further development of NB-02 as an orphan drug."
Dr. Kang also noted that the company expects a response from the
FDA in the second quarter of this year regarding removal of the
partial clinical hold for Gemcabene.
With the above-described pause in clinical activity, management
noted that the $13.9 million in cash
on hand as of December 31, 2019,
should be sufficient to fund operations at current levels through
December 2020. "We look forward to
reinstating the clinical activities of our robust platform of
disease-modifying therapies for neurodegenerative and
cardiometabolic diseases and we are actively pursuing various
financing opportunities in the interim," concluded Dr. Kang.
Overview of Current Clinical Pipeline
- NB-01 – addresses a range of mechanisms that contribute
to neuropathic pain and nerve degeneration in diabetic and other
peripheral neuropathies. These include a decrease in key
inflammatory markers, restoration of nerve growth factor (NGF) to
normal levels, and reduction of advanced glycation end products
(AGEs). NB-01 also reduces levels of TNF-α and IL-6, both of which are markers of
inflammation, which are implicated in diabetes-related
complications. NB-01 also restores the neurotrophin NGF, which is
involved in nerve growth, maintenance and repair.
NB-01 was developed primarily as a treatment for painful diabetic
neuropathy (PDN), but NB-01 can also treat other neuropathic pain
conditions, including chemotherapy-induced peripheral neuropathy
and post-traumatic peripheral neuropathy. The global neuropathic
pain market is currently estimated to be greater than $5 billion and is projected to grow to more than
$10 billion by 2026. In the United States, there are currently only
three FDA-approved treatments for PDN.
The company believes that NB-01 has the potential to offer pain
alleviation with minimal side effects and to be potentially the
first disease-modifying therapy impacting the underlying disease
mechanisms. NB-01 has successfully completed two Phase 2
proof-of-concept clinical trials for PDN.
In addition to the pharmaceutical market to treat pain, there is a
very large and growing market for nutraceuticals in this arena.
Since NB-01 is derived from natural products, the company is
considering marketing NB-01 as a nutraceutical (non-pharmaceutical)
product.
- NB-02 - has the potential to treat the symptoms of
cognitive impairment and modify the progression of
neurodegenerative diseases associated with the malfunction of a
protein called tau, and with amyloid beta plaque deposition. NB-02
has shown considerable promise as a neuroprotective agent in
preclinical studies, demonstrating a multimodal mechanism of action
including inhibition of tau phosphorylation, acetylcholinesterase
(AChE) inhibition, inhibition of Aβ
toxicity and amyloid plaque formation, and anti-inflammatory
effects. The company intends to further leverage the benefits of
tau modulation by NB-02 in conjunction with the other pathway
effects to explore treatment of certain dementias such as the
tauopathies.
The company believes that leveraging the therapeutic advantages of
NB-02 will drive a paradigm shift in the treatment of Alzheimer's
disease and other neurodegenerative diseases. The company also is
assessing whether to pursue further development of NB-02 as an
orphan drug.
- Gemcabene – is a novel, once-daily, oral therapy
designed to target known lipid metabolic pathways to lower levels
of LDL-C, hsCRP and triglycerides, that originally was licensed
from Pfizer. It is in development for the treatment of
dyslipidemia, a serious medical condition that increases the risk
of life-threatening cardiovascular disease, focused on orphan
indications such as homozygous familial hypercholesterolemia
(HoFH), as well as severe hypertriglyceridemia (SHTG). Gemcabene
has been tested as a monotherapy and in combination with statins
and other drugs in more than 1,100 subjects across 25 Phase 1 and
Phase 2 clinical trials and has demonstrated promising evidence of
efficacy, safety and tolerability.
In August 2018, Gemphire announced
that the FDA, following submission of its two-year rodent
carcinogenicity study, had requested additional preclinical
studies, including a 13-week PPARα
knockout mouse study. The in vitro PPAR transactivation
studies and subchronic study of Gemcabene in PPARα knock-out mice are completed, and the
company is expecting to receive a response from the FDA in the
second quarter of 2020 regarding removal of the partial clinical
hold.
NeuroBo Financial and Operating Results Highlights
Although public company Gemphire was considered the legal
acquirer in the merger and issued shares of its common stock to
effect the merger, 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 operations of NeuroBo
as a private company except for the effects of the merger on
December 30, 2019 and the combined
operations of both companies for the post-merger balance of
December 2019.
- Research and Development (R&D) Expenses were
approximately $5.3 million for the
year ended December 31, 2019, as
compared to approximately $5.1
million for the year ended December
31, 2018. The increase of approximately $0.3 million was largely due to payroll costs in
connection with newly hired personnel and costs attributed to the
newly constituted Scientific Advisory Board, offset in part by a
reduction in clinical trial activity due to timing of underlying
studies.
- Acquired In-process Research and Development Expenses
were approximately $12.2 million for
the year ended December 31, 2019, as
compared to approximately $8.8
million for the year ended December
31, 2018. The increase of approximately $3.3 million was attributable to research and
development projects of Gemphire which were in-process at the
merger date and expensed on the merger date.
- General and Administrative Expenses were approximately
$2.7 million for the year ended
December 31, 2019, as compared to
approximately $1.6 million for the
year ended December 31, 2018. The
approximate increase of $1.1 million
was primarily due to an increase in personnel-related costs, legal
expenses, and operational consulting fees, among others.
- Net Loss for year ended December
31, 2019 was approximately $21.3
million, or $4.08 per basic
and diluted share, based on 5,224,178 weighted average common
shares outstanding, compared to a net loss of approximately
$15.5 million, or $3.65 per basic and diluted share, based on
4,251,330 weighted average common shares outstanding for the year
ended December 31, 2018.
- Cash and Cash Equivalents as of December 31, 2019 of $13.9
million should be sufficient to fund the company's
operations at the planned level of scientific activity through
December 2020.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for
neurodegenerative 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 lead 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. NeuroBo's IND-ready second 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.
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. 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 filed with the SEC 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
Melody
Carey
+1-917-322-2571
mcarey@rxir.com
Financials
NeuroBo
Pharmaceuticals, Inc.
|
Consolidated
Balance Sheets
|
(in
thousands)
|
|
|
|
|
At December
31,
|
|
|
|
2019
|
|
2018
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash
|
$
|
13,908
|
$
|
2,845
|
|
Restricted
Cash
|
|
15
|
|
-
|
|
Prepaid
expenses
|
|
153
|
|
929
|
|
Other
assets
|
|
42
|
|
34
|
Total current
assets
|
|
14,118
|
|
3,808
|
|
Right-of-use assets
and other
|
|
150
|
|
9
|
|
Property and
equipment, net
|
|
200
|
|
3
|
Total
assets
|
$
|
14,468
|
$
|
3,820
|
|
|
|
|
|
|
Liabilities,
redeemable convertible preferred
stock and stockholders' equity (deficit)
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts
payable
|
$
|
638
|
$
|
170
|
|
Accrued
liabilities
|
|
1,422
|
|
49
|
|
Lease liability,
short-term
|
|
22
|
|
-
|
Total current
liabilities
|
|
2,082
|
|
219
|
|
Convertible
notes-related party
|
|
-
|
|
118
|
|
Lease and other
long-term liabilities
|
|
94
|
|
23
|
Total
liabilities
|
|
2,176
|
|
360
|
Commitments and
contingencies
|
|
|
|
|
Redeemable
convertible preferred stock
|
|
-
|
|
16,746
|
Stockholders' equity
(deficit)
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
-
|
|
Common
stock
|
|
16
|
|
-
|
|
Additional paid-in
capital
|
|
49,130
|
|
2,266
|
|
Accumulated other
comprehensive income
|
|
12
|
|
2
|
|
Accumulated
deficit
|
|
(36,866)
|
|
(15,554)
|
Total stockholders'
equity (deficit)
|
$
|
12,292
|
|
(13,286)
|
Total liabilities,
redeemable convertible
preferred stock stockholders' equity (deficit)
|
$
|
14,468
|
$
|
3,820
|
NeuroBo
Pharmaceuticals, Inc.
|
Consolidated
Statements of Operations and Comprehensive Loss
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
For the Year
Ended
December
31,
|
|
|
|
|
2019
|
|
2018
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
$
|
5,324
|
$
|
5,066
|
|
Acquired in-process
research and development
|
|
12,151
|
|
8,815
|
|
General and
administrative
|
|
2,701
|
|
1,605
|
|
|
Total operating
expenses
|
|
20,176
|
|
15,486
|
Loss from
operations
|
|
(20,176)
|
|
(15,486)
|
|
Loss on
extinguishment
|
|
(1,114)
|
|
-
|
|
Interest (expense)
income, net
|
|
(22)
|
|
(40)
|
|
Other income
(expense), net
|
|
-
|
|
(3)
|
Loss before income
taxes
|
|
(21,312)
|
|
(15,529)
|
Provision for income
taxes
|
|
-
|
|
-
|
Net loss
|
|
|
(21,312)
|
|
(15,529)
|
Other comprehensive
loss, net of tax
|
|
10
|
|
2
|
Comprehensive
loss
|
$
|
(21,302)
|
$
|
(15,527)
|
Loss per
share
|
|
|
|
|
|
Net loss per
share, basic and diluted
|
$
|
(4.08)
|
$
|
(3.65)
|
Weighted average
common shares outstanding
|
|
|
|
|
|
Basic and
diluted
|
|
5,224,178
|
|
4,251,330
|
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SOURCE NeuroBo Pharmaceuticals, Inc.