Dosing of First Patient in Phase 2a Clinical
Trial of DA-1241 Expected September
2023
Cash and Cash Equivalents of $28.7 Million, Expected to Fund the Company into
2024, Through Multiple Clinical Milestones
BOSTON, Aug. 9, 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 second quarter ended June
30, 2023 and provided a corporate strategic update.
"During the second quarter and thereafter, we have made
significant progress advancing the development of our two promising
cardiometabolic assets, which address the underserved nonalcoholic
steatohepatitis (NASH) market and the significant obesity and type
2 diabetes (T2D) markets," stated Joe
Hooker, Interim President and Chief Executive Officer of
NeuroBo. "Notably, in May, we received U.S. Food and Drug
Administration (FDA) approval of our Investigational New Drug (IND)
application for DA-1241, a novel G-Protein-Coupled Receptor 119
(GPR119) agonist, for the treatment of NASH. This was followed,
just recently, with receipt of first site Institutional Review
Board (IRB) approval for the Phase 2a clinical trial of DA-1241. We
look forward to working closely with our contract research
organization (CRO) partner and our site investigators, with the
goal to dose the first patient next month. We believe that the
mechanism of action of DA-1241 will translate into a new and
effective treatment for NASH. In preclinical studies, 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 in Phase 1a/1b studies in healthy volunteers and patients
with T2D. As previously announced, the two-part design will provide
optionality for an interim analysis in the first half of 2024, and
we anticipate a full data readout in the second half of 2024.
"Additionally, in June, positive preclinical data was presented
at the American Diabetes Association's 83rd Scientific Sessions,
demonstrating that 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, elicits superior
weight loss efficacy compared to Semaglutide (SEMA) and Tirzepatide
(TIR) and effective glycemic control in mice models. We intend to
advance DA-1726 through the IND process during the second half of
this year. If accepted by the 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. Based on the preclinical
evidence demonstrating superior body weight loss compared with
other selective GLP1R agonists, we are optimistic about the
potential of DA-1726 to address the significant obesity
market."
Mr. Hooker added, "We have also made progress toward our goal of
evaluating potential out-licensing and acquisition opportunities
for our four legacy therapeutic programs and recently announced
signing of 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. With MTHERA's deep
knowledge of manufacturing, evaluating the quality of, and
researching natural medicines and botanical drugs, we consider it
the optimal partner to progress the clinical development of NB-01.
Meanwhile, we continue to evaluate potential opportunities for our
three remaining legacy therapeutic programs, ANA001, NB-02 and
Gemcabene. With a cash cushion of $28.7
million at quarter end to fund operations through multiple,
near-term value creating milestones, we are enthusiastic about the
potential of our cardiometabolic assets and look forward to
continued execution to drive shareholder value."
Second Quarter 2023 and Subsequent Highlights
- 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, a novel GPR119 agonist, for the
treatment of NASH. The dosing of the first patient in part one of
the two-part, Phase 2a clinical trial is expected to occur in
September of 2023.
- 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.
- June 2023: Presented preclinical
data on DA-1726, a novel OXM analogue functioning as a GLP1R and
GCGR dual agonist, showing an ability to elicit superior weight
loss efficacy compared to SEMA and TIR. Additionally, DA-1276 has
shown effective glycemic control. The data was presented in one
ePoster theater discussion and two general poster presentations at
the American Diabetes Association's 83rd Scientific Sessions.
- May 2023: Appointed Mark A.
Glickman, a highly accomplished pharmaceutical industry executive
with more than 30 years of industry experience, to the Board of
Directors.
- May 2023: Received FDA clearance
for the Company's IND application for a two-part, Phase 2a clinical
trial of DA-1241 for the treatment of NASH.
Second Quarter 2023 Financial and Operating Results
- Research and Development (R&D) Expenses were
approximately $2.4 million for the
three months ended June 30, 2023 as
compared to approximately $1.0
million for the three months ended June 30, 2022. The approximate $1.4 million increase was primarily related to
costs as the Company prepared for the clinical trial of DA-1241,
set to begin in the third quarter of 2023, including increases in
drug manufacturing and toxicology studies of $0.7 million and $0.6
million, respectively. The increase is also partially
attributable to related clinical study and overhead costs in the
aggregate of $0.1 million.
For the six months ended June 30,
2023, R&D expenses were approximately $3.0 million, as compared to approximately
$1.9 million for the six months ended
June 30, 2022. The approximate
$1.1 million increase was primarily
related to costs as the Company prepared for the clinical trial of
DA-1241 set to begin in the third quarter of 2023, including
increases in toxicology studies and related to drug manufacturing
of $0.9 million and $0.6 million, respectively. The increase is
partially offset by a decrease in clinical trial costs of
$0.4 million, as the Company was
finishing the ANA 001 study during the six months ended
June 30, 2022, and a decrease in drug
manufacturing for the Company's legacy assets of $0.1 million.
- General and Administrative Expenses were approximately
$1.4 million for the three months
ended June 30, 2023, as compared to
approximately $2.2 million for the
three months ended June 30, 2022. The
decrease of approximately $0.8
million in the current period was primarily due to a
decrease in professional fees of $0.5
million related to the exploration of business opportunities
during the three months ended June 30,
2022, as well as a decrease in insurance costs of
approximately $0.2 million, and a
decrease in stock-based compensation of $0.2
million, offset primarily by increases in employee payroll
and executive consultants in the aggregate of $0.1 million.
For the six months ended June 30,
2023, G&A expenses were approximately $3.3 million, as compared to approximately
$4.2 million for the six months ended
June 30, 2022. The decrease of
approximately $0.9 million in the
current period was primarily due to a decrease in professional fees
of $0.3 million related to the
exploration of business opportunities during the six months ended
June 30, 2022, as well as a decrease
in insurance costs of approximately $0.4
million, and a decrease in stock-based compensation of
$0.5 million, offset primarily by
increases in employee payroll and executive consultants in the
aggregate of $0.3 million.
- Net Loss for the three months ended June 30, 2023 was $0.7
million, or $0.02 per basic
and diluted share, based on 40,472,026 weighted average shares of
common stock outstanding, compared with a net loss of $3.3 million, or $3.72 per basic and diluted share, based on
888,693 weighted average shares of common stock outstanding for the
three months ended June 30, 2022.
Net Loss for the six months ended June 30,
2023 was $3.3 million, or
$0.08 per basic and diluted share,
based on 40,472,026 weighted average shares of common stock
outstanding, compared with a net loss of $6.2 million, or $6.95 per basic and diluted share, based on
888,693 weighted average shares of common stock outstanding for the
six months ended June 30, 2022.
- Cash and Cash Equivalents were $28.7 million as of June
30, 2023, compared with $33.4
million as of December 31,
2022. 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 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 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; 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
- Tables to Follow -
NeuroBo
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheets
(in thousands,
except share amounts and par value)
|
|
|
|
June 30,
|
|
|
|
|
|
2023
|
|
December 31,
|
|
|
|
(unaudited)
|
|
2022
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
28,688
|
|
$
|
33,364
|
|
Prepaid
expenses
|
|
|
486
|
|
|
168
|
|
Total current
assets
|
|
|
29,174
|
|
|
33,532
|
|
Property and
equipment, net
|
|
|
5
|
|
|
2
|
|
Total assets
|
|
$
|
29,179
|
|
$
|
33,534
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
967
|
|
$
|
708
|
|
Accrued
liabilities
|
|
|
2,041
|
|
|
280
|
|
Warrant
liabilities
|
|
|
975
|
|
|
10,796
|
|
Total current
liabilities
|
|
|
3,983
|
|
|
11,784
|
|
Total
liabilities
|
|
|
3,983
|
|
|
11,784
|
|
Commitments and
contingencies (Note 4)
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
Preferred stock,
$0.001 par value per share; 10,000,000 shares authorized
as of June 30, 2023 and December 31, 2022; no shares issued or
outstanding
as of June 30, 2023 and December 31, 2022.
|
|
|
—
|
|
|
—
|
|
Common stock, $0.001
par value per share, 100,000,000 shares authorized
as of June 30, 2023 and December 31, 2022; 38,241,685 and
25,436,019 shares
issued and outstanding as of June 30, 2023 and December 31, 2022,
respectively.
|
|
|
38
|
|
|
25
|
|
Additional paid–in
capital
|
|
|
124,291
|
|
|
117,520
|
|
Accumulated
deficit
|
|
|
(99,133)
|
|
|
(95,795)
|
|
Total stockholders'
equity
|
|
|
25,196
|
|
|
21,750
|
|
Total liabilities and
stockholders' equity
|
|
$
|
29,179
|
|
$
|
33,534
|
|
NeuroBo
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands,
except share and per share amounts)
|
|
|
|
For the Three Months
Ended
|
|
For the Six Months
Ended
|
|
|
June 30,
|
|
June 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
2,364
|
|
$
|
982
|
|
$
|
3,001
|
|
$
|
1,902
|
General and
administrative
|
|
|
1,442
|
|
|
2,237
|
|
|
3,325
|
|
|
4,192
|
Total operating
expenses
|
|
|
3,806
|
|
|
3,219
|
|
|
6,326
|
|
|
6,094
|
Loss from
operations
|
|
|
(3,806)
|
|
|
(3,219)
|
|
|
(6,326)
|
|
|
(6,094)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of
warrant liabilities
|
|
|
3,072
|
|
|
—
|
|
|
2,988
|
|
|
—
|
Other expense
|
|
|
—
|
|
|
(84)
|
|
|
—
|
|
|
(84)
|
Loss before income
taxes
|
|
|
(734)
|
|
|
(3,303)
|
|
|
(3,338)
|
|
|
(6,178)
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
Net loss
|
|
|
(734)
|
|
|
(3,303)
|
|
|
(3,338)
|
|
|
(6,178)
|
Other comprehensive
loss, net of tax
|
|
|
—
|
|
|
(3)
|
|
|
—
|
|
|
(4)
|
Comprehensive
loss
|
|
$
|
(734)
|
|
$
|
(3,306)
|
|
$
|
(3,338)
|
|
$
|
(6,182)
|
Loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.02)
|
|
$
|
(3.72)
|
|
$
|
(0.08)
|
|
$
|
(6.95)
|
Weighted average shares
of common stock outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
40,472,026
|
|
|
888,693
|
|
|
40,472,026
|
|
|
888,693
|
|
|
|
|
|
|
|
|
|
|
|
|
|
View original
content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-second-quarter-2023-financial-results-and-provides-corporate-update-301897216.html
SOURCE NeuroBo Pharmaceuticals, Inc.