Company Pipeline to Focus on Cardiometabolic
Disease
Cash and Cash Equivalents to Fund the Company
into 2024
BOSTON, March 30,
2023 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company
primarily focused on cardiometabolic diseases, today announced
financial results for the year ended December 31, 2022.
"During 2022, we completed our planned shift in strategic
direction with the acquisition of two very promising
cardiometabolic assets that address the enormous nonalcoholic
steatohepatitis (NASH), obesity and type 2 diabetes markets,"
stated Joe Hooker, Interim President
and Chief Executive Officer of NeuroBo. "As previously announced,
in November 2022, we acquired an
exclusive global license (other than in Korea) to these assets from
Dong-A ST Co., Ltd. ("Dong-A"). In connection with the
license, Dong-A became our largest shareholder and demonstrated
their commitment as our long-term strategic partner with a
$15 million private investment in
NeuroBo. The promise of the new assets was further evidenced by the
concurrent $17.3 million public
offering, which we completed in an extremely challenging capital
markets environment. We are now uniquely positioned, with a cash
runway that should take the company into 2024 including the
initiation of a phase 2a study of DA-1241 in NASH in the third
quarter of 2023 and continuing enrollment into 2024 with data
expected in the second half of 2024. We also intend to advance
DA-1726 through the Investigational New Drug (IND) process, with
the goal of initiating a phase 1a safety study in the first half of
2024, for which data would be expected in the second half of 2024.
We are excited about the new direction of the company as well as
the potential of these assets and look forward to executing on
these new pipeline programs."
Management also noted that the Company's Board of Directors had
determined to focus the Company's financial resources and attention
on the development of DA-1241 for NASH and type 2 diabetes and
DA-1726 for NASH and obesity. The Company intends to continue to
consider licensing and acquisition opportunities with respect to
its legacy programs (ANA001, NB-01, NB-02 and Gemcabene).
2022 Financial and Operating Results
- Research and Development (R&D) Expenses were
$2.8 million for the year ended
December 31, 2022 as compared to
$6.5 million for the year ended
December 31, 2021. The $3.8 million decrease was primarily related to
reduced clinical trial activity and drug manufacturing costs of
approximately $2.7 as the Company
completed the ANA001 clinical trial and reduced payroll, consulting
and overhead costs of approximately $1.1
million.
- General and Administrative Expenses were $8.6 million for the year ended December 31, 2022, compared to $8.7 million for the year ended December 31, 2021. The decrease of $0.1 million was primarily due to decreases in
payroll, insurance and overhead of $0.5
million, $0.4 million and
$0.1 million, respectively, offset by
increases in legal and professional fees of $0.7 million, attributed mostly to the pursuit of
business opportunities, and by an increase in stock-based
compensation of $0.2 million.
- Net Loss for the year ended December 31, 2022 was $14.0 million, or $
5.43 per basic and diluted share, based on 2,573,624
weighted average shares of common stock outstanding, compared with
a net loss of $15.3 million, or
$19.81 per basic and diluted share,
based on 771,442 weighted average shares of common stock
outstanding for the year ended December 31,
2021.
- Cash and Cash Equivalents were $33.4 million as of December 31, 2022, compared with $16.4 million as of December 31, 2021. The company expects its cash
position will be adequate to fund operations into 2024
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals,
Inc. is a clinical-stage biotechnology company focused on therapies
for cardiometabolic diseases. Its primary therapeutics programs
include DA-1241 and DA-1726. DA-1241 is a novel G-Protein-Coupled
Receptor 119 (GPR119) agonist, which promotes the release of key
gut peptides GLP-1, GIP and PYY, which, in turn, play an important
role in glucose metabolism, lipid metabolism and weight loss.
DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a
glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor
(GCGR) dual agonist. OXM is a naturally-occurring, 37-amino acid
peptide hormone that is released from the gut after ingestion of a
meal, activating both the GLP-1 and glucagon receptors, prompting
reduced food intake as well as an increase in energy expenditure,
potentially resulting in superior body weight loss compared to
selective GLP-1 receptor agonists. For more information, please
visit www.neurobopharma.com.
Forward Looking Statements
Certain statements in this
release may be considered forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including without limitation, statements about the closing of the
offering of securities. Forward-looking statements are predictions,
projections and other statements about future events that are based
on current expectations and assumptions and, as a result, are
subject to risks and uncertainties. Many factors could cause actual
future events to differ materially from the forward-looking
statements in this release, including, without limitation, those
risks associated with our ability to execute on our commercial
strategy, the timeline for regulatory submissions and potential
regulatory approval of our current and future product candidates,
the ability to realize the benefits of the license from Dong-A,
including the impact on future financial and operating results of
NeuroBo; the ability to integrate the new product candidates into
NeuroBo's business in a timely and cost-efficient manner; the
cooperation of our contract manufacturers, clinical study partners
and others involved in the development of our current and future
product candidates; costs related to the license agreement, known
and unknown, including costs of any litigation or regulatory
actions relating to the license agreement; changes in applicable
laws or regulations; effects of changes to NeuroBo's stock price on
the terms of the license agreement and any future fundraising; and
other risks and uncertainties described in our filings with the
SEC. Forward-looking statements speak only as of the date when
made. NeuroBo does not assume any obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact:
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,
|
|
|
2022
|
|
2021
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
|
|
$
|
33,364
|
|
$
|
16,387
|
Prepaid
expenses
|
|
|
168
|
|
|
197
|
Total current
assets
|
|
|
33,532
|
|
|
16,584
|
Right-of-use assets
and other
|
|
|
—
|
|
|
105
|
Property and
equipment, net
|
|
|
2
|
|
|
110
|
Total assets
|
|
$
|
33,534
|
|
$
|
16,799
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
708
|
|
$
|
830
|
Accrued
liabilities
|
|
|
280
|
|
|
1,301
|
Warrant
liabilities
|
|
|
10,796
|
|
|
—
|
Lease liability,
short-term
|
|
|
—
|
|
|
26
|
Total current
liabilities
|
|
|
11,784
|
|
|
2,157
|
Lease liability,
long-term
|
|
|
—
|
|
|
45
|
Total
liabilities
|
|
|
11,784
|
|
|
2,202
|
Commitments and
contingencies
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
Preferred stock,
$0.001 par value per share; 10,000,000 shares authorized as of
December 31, 2022 and December 31, 2021; no shares issued or
outstanding as of December 31, 2022 and December 31,
2021.
|
|
|
—
|
|
|
—
|
Common stock, $0.001
par value per share, 100,000,000 shares authorized as of December
31, 2022 and December 31, 2021; 25,436,019 and 888,693 shares
issued and outstanding as of December 31, 2022 and December 31,
2021, respectively.
|
|
|
25
|
|
|
1
|
Additional paid–in
capital
|
|
|
117,520
|
|
|
96,420
|
Accumulated other
comprehensive income
|
|
|
—
|
|
|
4
|
Accumulated
deficit
|
|
|
(95,795)
|
|
|
(81,828)
|
Total stockholders'
equity
|
|
|
21,750
|
|
|
14,597
|
Total liabilities and
stockholders' equity
|
|
$
|
33,534
|
|
$
|
16,799
|
NeuroBo
Pharmaceuticals, Inc.
Consolidated
Statements of Operations and Comprehensive Loss
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
For the Year
Ended
|
|
|
|
December 31,
|
|
|
|
2022
|
|
2021
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
2,778
|
|
$
|
6,546
|
|
Acquired in-process
research and development
|
|
|
8,210
|
|
|
—
|
|
General and
administrative
|
|
|
8,640
|
|
|
8,752
|
|
Total operating
expenses
|
|
|
19,628
|
|
|
15,298
|
|
Loss from
operations
|
|
|
(19,628)
|
|
|
(15,298)
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
Interest income
|
|
|
—
|
|
|
14
|
|
Financing expense
|
|
|
(2,191)
|
|
|
—
|
|
Change in fair value of
warrant liabilities
|
|
|
7,935
|
|
|
—
|
|
Other expense
|
|
|
(83)
|
|
|
—
|
|
Total other
income
|
|
|
5,661
|
|
|
14
|
|
Loss before income
taxes
|
|
|
(13,967)
|
|
|
(15,284)
|
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
|
Net loss
|
|
|
(13,967)
|
|
|
(15,284)
|
|
Other comprehensive
loss, net of tax
|
|
|
(4)
|
|
|
(10)
|
|
Comprehensive
loss
|
|
$
|
(13,971)
|
|
$
|
(15,294)
|
|
Loss per
share:
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(5.43)
|
|
$
|
(19.81)
|
|
Weighted average shares
of common stock outstanding:
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
2,573,624
|
|
|
771,422
|
|
|
|
|
|
|
|
|
|
View original
content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-full-year-2022-financial-results-301786483.html
SOURCE NeuroBo Pharmaceuticals, Inc.