DA-1726 Phase 1 IND Filing Expected by Year
End 2023
Board Strengthened with Recent Appointment of
Industry Veteran, James P. Tursi,
M.D.
Cash and Cash Equivalents of $25.8 Million, Expected to Fund the Company Into
the Fourth Quarter of 2024, Through Multiple Potential Value
Creating Milestones
BOSTON, Nov. 13,
2023 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on
a quest to transform cardiometabolic diseases, today announced
financial results for the third quarter ended September 30, 2023 and provided a corporate
strategic update.
"During the third quarter, we continued to advance the clinical
development of our two, next generation cardiometabolic assets,
which address the significant nonalcoholic steatohepatitis
(NASH) and obesity markets,"
stated Hyung Heon Kim, President and
Chief Executive Officer of NeuroBo. "Of note, we received first
site Institutional Review Board (IRB) approval and subsequently
dosed the first patient in our Phase 2a clinical trial of DA-1241,
a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, for the
treatment of NASH, marking the
achievement of a significant milestone for our most advanced asset
and reflecting our strong commitment to the timely development of
our pipeline programs. The two-part design of this study provides
us with the option for an interim analysis, expected in the first
half of next year and we anticipate the full data readout in the
second half of 2024. Based on strength of the data from our Phase
1a/1b studies in healthy volunteers
and patients with Type 2 diabetes (T2D), in which DA-1241
demonstrated a beneficial effect on liver inflammation and
fibrosis, lipid metabolism and glucose metabolism, and was shown to
be safe and well tolerated, we believe that the mechanism of action
of this promising cardiometabolic asset will translate into a safe
and effective treatment for NASH,
a disease with no current treatment options.
"As it relates to our second asset, DA-1726, a novel
oxyntomodulin (OXM) analogue which acts as a glucagon-like
peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual
agonist, DA-1726 has shown highly encouraging results in
preclinical testing including reduced food intake via activation of
the GLP-1 receptor as well as increased energy expenditure via
glucagon activation. Specifically, in obese mouse models, DA-1241
elicits similar weight loss efficacy compared to Tirzepatide, even
while consuming more food, and has exhibited superior weight loss
compared to Semaglutide, while also showing further improvements in
hepatic steatosis, inflammation, and fibrosis. As a result, we
believe DA-1726 will be an effective therapy to address the growing
obesity market. We intend to continue to advance DA-1726 through
the Investigational New Drug (IND) process during the fourth
quarter of this year. If the IND is accepted by the U.S. Food and
Drug Administration (FDA), we plan to initiate a Phase 1a safety
study in the first half of 2024, with a data readout expected in
the second half of 2024."
Mr. Kim continued, "Operationally, we are in a strong position,
with $25.8 million in cash and cash
equivalents at September 30, 2023,
which is expected to fund operations at least into the fourth
quarter of next year, through multiple potential value creating
milestones. As previously reported, in August, we signed a term
sheet with MThera Pharma Co., Ltd. (MTHERA) to out-license the
worldwide rights, outside of Korea, for NB-01, for the treatment of
painful diabetic neuropathy and we continue to consider strategies
to monetize our remaining legacy assets, ANA001, NB-02 and
Gemcabene, including potential out-licensing and acquisition
opportunities."
Third Quarter 2023 and Subsequent Highlights
- November 2023: Appointed James P.
Tursi, M.D., a pharmaceutical industry veteran, to its Board of
Directors and as a member of the Board's Nominating Committee.
- September 2023: Dosed the first
patient in the Phase 2a clinical trial of DA-1241, a novel
G-Protein-Coupled Receptor 119 (GPR119) agonist, for the treatment
of NASH, at The Pinnacle
Edinberg/South Texas Research Institute in Edinburg, Texas, under the supervision of
Principal Investigator, Dr. David
Ramirez.
- August 2023: Appointed current
Board member, Hyung Heon Kim, as the
Company's President and Chief Executive Officer.
- August 2023: Received the first
site IRB approval for Zeid Kayali,
M.D., Medical Director at Inland Empire Liver Foundation, in
Rialto, CA, to proceed with the
Phase 2a clinical trial of DA-1241, for the treatment of
NASH.
- August 2023: Signed a term sheet
with MTHERA to out-license the worldwide rights, excluding Korea,
for NB-01, for the treatment of painful diabetic neuropathy, and
allowing MTHERA to conduct research in order to seek new patents
for NB-01 and conduct clinical trials, including, but not limited
to, a potential Phase 3 clinical trial in the United States for the future
commercialization of NB-01.
Anticipated Clinical Milestones
- DA-1241 in NASH: Data
from an interim analysis of the Phase 2a clinical trial of DA-1241
in NASH expected to be available
in the first half of 2024. The full data readout is expected in the
second half of 2024.
- DA-1726 in Obesity: IND submission for a Phase 1 single
ascending dose (SAD) study and multiple ascending dose (MAD) study,
expected by year end 2023. Initiation of the Phase 1a safety study
targeted for the first half of 2024, pending IND acceptance by the
FDA, with a data readout expected in the second half of 2024.
Third Quarter 2023 Financial and Operating Results
- Research and Development (R&D) Expenses were
approximately $2.3 million for the
three months ended September 30, 2023
as compared to approximately $0.6
million for the three months ended September 30, 2022. The increase of approximately
$1.7 million was primarily due to
costs related to the Company's clinical trial of DA-1241 which was
initiated in the third quarter of 2023, including increases in
clinical trial costs and toxicology studies of $1.3 million and $0.4
million, respectively.
For the nine months ended September 30,
2023, R&D expenses were approximately $5.3 million, as compared to approximately
$2.5 million for the nine months
ended September 30, 2022. The
increase of approximately $2.8
million was primarily due to costs related to the Company's
clinical trial of DA-1241 which was initiated in the third quarter
of 2023, including increases in clinical trial costs, toxicology
studies and related drug manufacturing of $0.9 million, $1.6
million, and $0.5 million,
respectively. The increase was partially offset by a decrease of
$0.2 million in general research and
development overhead, as the Company was finishing the ANA001
study.
- General and Administrative Expenses were approximately
$1.6 million for the three months
ended September 30, 2023, compared to
approximately $2.5 million for the
three months ended September 30,
2022. The decrease of approximately $0.9 million was primarily due to a decrease in
professional fees of $0.7 million
related to the exploration of business opportunities during the
three months ended September 30,
2022, as well as a decrease in insurance costs of
approximately $0.2 million.
For the nine months ended September 30,
2023, G&A expenses were approximately $4.9 million, as compared to approximately
$6.7 million for the nine months
ended September 30, 2022. The
decrease of approximately $1.8
million was primarily due to a decrease in professional fees
of $1.0 million chiefly related to
the exploration of business opportunities during the nine months
ended September 30, 2022, as well as
a decrease in insurance costs of approximately $0.7 million and a decrease in stock-based
compensation of $0.5 million, offset
partially by increases in payroll and executive consultant fees in
the aggregate of $0.4 million.
- Net Loss for the three months ended September 30, 2023 was $3.8 million, or $0.09 per basic and diluted share, based on
40,606,537 weighted average shares of common stock outstanding,
compared with a net loss of $3.1
million, or $3.50 per basic
and diluted share, based on 888,693 weighted average shares of
common stock outstanding for the three months ended September 30, 2022.
Net Loss for the nine months ended September
30, 2023 was $7.2 million, or
$0.18 per basic and diluted share,
based on 40,517,356 weighted average shares of common stock
outstanding, compared with a net loss of $9.3 million, or $10.45 per basic and diluted share, based on
888,693 weighted average shares of common stock outstanding for the
nine months ended September 30,
2022.
- Cash and Cash Equivalents were $25.8 million as of September 30, 2023, compared with $33.4 million as of December 31, 2022. The company expects its cash
position will be adequate to fund operations at least into the
fourth quarter of 2024.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals,
Inc. is a clinical-stage biotechnology company on a quest to
transform cardiometabolic diseases. The company is currently
developing DA-1241 for the treatment of Non-Alcoholic
Steatohepatitis (NASH) and Type 2
Diabetes Mellitus (T2DM), and is developing DA-1726 for the
treatment of obesity. 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. In preclinical studies, DA-1241
demonstrated positive effect on liver inflammation, lipid
metabolism, weight loss, and glucose metabolism, reducing hepatic
steatosis, hepatic inflammation, and liver fibrosis, while also
improving glucose control. DA-1726 is a novel oxyntomodulin (OXM)
analogue that acts as a glucagon-like peptide-1 receptor (GLP1R)
and glucagon receptor (GCGR) dual agonist. OXM is a
naturally-occurring gut hormone that activates GLP1R and GCGR,
thereby decreasing food intake while increasing energy expenditure,
thus potentially resulting in superior body weight loss compared to
selective GLP1R 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, regulatory steps
and potential regulatory approval of our current and future product
candidates, the ability to realize the benefits of the license
agreement with Dong-A ST Co. Ltd., including the impact on future
financial and operating results of NeuroBo; the cooperation of our
contract manufacturers, clinical study partners and others involved
in the development of our current and future product candidates;
our ability to initiate and complete clinical trials on a timely
basis; our ability to recruit sites and subjects for our clinical
trials; costs related to the license agreement, known and unknown,
including costs of any litigation or regulatory actions relating to
the license agreement; our ability to out-license or sell assets
related to our legacy programs; 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
NeuroBo Pharmaceuticals, Inc.
Marshall Woodworth, Acting Chief
Financial Officer
ir@neurobopharma.com
- Tables to Follow -
NeuroBo
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheets
(in thousands,
except share amounts and par value)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
|
|
|
2023
|
|
December 31,
|
|
|
|
(unaudited)
|
|
2022
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
25,837
|
|
$
|
33,364
|
|
Prepaid
expenses
|
|
|
308
|
|
|
168
|
|
Total current
assets
|
|
|
26,145
|
|
|
33,532
|
|
Property and
equipment, net
|
|
|
41
|
|
|
2
|
|
Right-of-use
asset
|
|
|
218
|
|
|
—
|
|
Other
assets
|
|
|
21
|
|
|
—
|
|
Total assets
|
|
$
|
26,425
|
|
$
|
33,534
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,981
|
|
$
|
708
|
|
Accrued
liabilities
|
|
|
1,614
|
|
|
280
|
|
Warrant
liabilities
|
|
|
1,062
|
|
|
10,796
|
|
Lease liability,
short-term
|
|
|
65
|
|
|
—
|
|
Total current
liabilities
|
|
|
4,722
|
|
|
11,784
|
|
Lease liability,
long-term
|
|
|
153
|
|
|
—
|
|
Total
liabilities
|
|
|
4,875
|
|
|
11,784
|
|
Commitments and
contingencies (Note 4)
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
Preferred stock,
$0.001 par value per share; 10,000,000 shares authorized
as of September 30,
2023 and December 31, 2022; no shares issued or
outstanding as of
September 30, 2023 and December 31, 2022.
|
|
|
—
|
|
|
—
|
|
Common stock, $0.001
par value per share, 100,000,000 shares
authorized as of
September 30, 2023 and December 31, 2022; 38,429,185
and 25,436,019 shares
issued and outstanding as of September 30, 2023
and December 31, 2022,
respectively.
|
|
|
38
|
|
|
25
|
|
Additional paid–in
capital
|
|
|
124,463
|
|
|
117,520
|
|
Accumulated
deficit
|
|
|
(102,951)
|
|
|
(95,795)
|
|
Total stockholders'
equity
|
|
|
21,550
|
|
|
21,750
|
|
Total liabilities and
stockholders' equity
|
|
$
|
26,425
|
|
$
|
33,534
|
|
NeuroBo
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands,
except share and per share amounts)
(unaudited)
|
|
|
|
For the Three Months
Ended
|
|
For the Nine Months
Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
2,292
|
|
$
|
571
|
|
$
|
5,293
|
|
$
|
2,473
|
General and
administrative
|
|
|
1,601
|
|
|
2,533
|
|
|
4,926
|
|
|
6,725
|
Total operating
expenses
|
|
|
3,893
|
|
|
3,104
|
|
|
10,219
|
|
|
9,198
|
Loss from
operations
|
|
|
(3,893)
|
|
|
(3,104)
|
|
|
(10,219)
|
|
|
(9,198)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of
warrant liabilities
|
|
|
(87)
|
|
|
—
|
|
|
2,901
|
|
|
—
|
Interest income
|
|
|
162
|
|
|
—
|
|
|
162
|
|
|
—
|
Other expense
|
|
|
—
|
|
|
(9)
|
|
|
—
|
|
|
(93)
|
Loss before income
taxes
|
|
|
(3,818)
|
|
|
(3,113)
|
|
|
(7,156)
|
|
|
(9,291)
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
Net loss
|
|
|
(3,818)
|
|
|
(3,113)
|
|
|
(7,156)
|
|
|
(9,291)
|
Other comprehensive
loss, net of tax
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4)
|
Comprehensive
loss
|
|
$
|
(3,818)
|
|
$
|
(3,113)
|
|
$
|
(7,156)
|
|
$
|
(9,295)
|
Loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.09)
|
|
$
|
(3.50)
|
|
$
|
(0.18)
|
|
$
|
(10.45)
|
Weighted average shares
of common stock outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
40,606,537
|
|
|
888,693
|
|
|
40,517,356
|
|
|
888,693
|
|
|
|
|
|
|
|
|
|
|
|
|
|
View original
content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-third-quarter-2023-financial-results-and-provides-corporate-update-301986457.html
SOURCE NeuroBo Pharmaceuticals, Inc.