Received First Site Institutional Review Board
(IRB) Approval to Proceed With the Phase 1 Trial
of DA-1726 in Obesity
Phase 1 Trial of DA-1726 Expected to Dose
First Patient in Second Quarter of 2024
Received Safety Review Committee (SRC)
Approval Recommending That the Two-Part Phase 2a Trial of DA-1241
for the Treatment of MASH Continue Without Modification
Data from the Phase 2a Trial of DA-1241
Expected in the Second Half of 2024
Cash of $22.4
Million, Expected to Fund the Company Into the Fourth
Quarter of 2024
CAMBRIDGE, Mass., March 28,
2024 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company
focused on transforming cardiometabolic diseases, today announced
financial results for the year ended December 31, 2023 and provided a corporate
strategic update.
"Throughout 2023 and into the first quarter of 2024, we made
remarkable progress advancing the clinical development of our two,
next generation cardiometabolic assets, which address the
significant metabolic dysfunction-associated steatohepatitis (MASH)
and obesity markets," stated Hyung Heon
Kim, President and Chief Executive Officer of NeuroBo. "Most
recently, we received Safety Review Committee (SRC) approval,
recommending that the Phase 2a clinical trial for DA-1241, a novel
G-Protein-Coupled Receptor 119 (GPR119) agonist for treating MASH,
continue without modification. The SRC recommendation was based on
no significant safety trends found in the first six months of study
conduct, which is an early indication of the safety of DA-1241.
Pre-clinical safety data, reported in January, showed promising
results for DA-1241 in combination with sitagliptin, a DPP4
inhibitor. Enrollment for Part 2 has also begun, indicating a
strong commitment to the timely development of our pipeline
programs. As previously reported, based on the pre-clinical
evidence to date, DA-1241 has been shown to effectively improve
hepatic and systemic inflammation, with the sitagliptin combination
therapy showing synergistic anti-inflammatory effects. The drug has
also been shown to be well tolerated in both healthy volunteers and
patients with type 2 diabetes mellitus (T2DM). We continue to
believe that DA-1241 has the potential to be a safe and effective
treatment for MASH and look forward to reporting full trial data in
the second half of this year.
"Our second asset, DA-1726, a novel oxyntomodulin (OXM) analogue
acting as a GLP1R and GCGR dual agonist, is currently in
preparations for a Phase 1 study for the treatment of obesity. In
February of this year, shortly after the U.S. Food and Drug
Administration (FDA) cleared our Investigational New Drug (IND)
application for the clinical trial, we received our first site
Institutional Review Board (IRB) approval to proceed with the Phase
1 clinical trial. Importantly, in preclinical testing, DA-1726
showed superior weight loss compared to semaglutide (Wegovy®), and
its administration resulted in similar weight reduction even while
consuming more food compared to tirzepatide (Zepbound™).
Additionally, DA-1726 has shown improvements in hepatic steatosis,
inflammation, and fibrosis. Given this data, we believe DA-1726's
balanced combination of reduced food intake and increased energy
expenditure can potentially be a safe and effective therapy for
obesity. We have begun screening patients with the goal of
randomizing the first patient in the second quarter of this year
and anticipate reporting top-line data from the single ascending
dose (SAD) Part 1 in the first half of 2025, and from the multiple
ascending dose (MAD) Part 2 in the second half of 2025."
Mr. Kim concluded, "It is an exciting time at NeuroBo and to add
to this, I would like to welcome Marshall
Woodworth, who was recently appointed as our permanent Chief
Financial Officer. He has already made a significant impact on the
company and its financial operations and his continued
contributions to the team will be key as we continue to execute on
the clinical development of our two promising cardiometabolic
assets."
Fourth Quarter 2023 and Subsequent Highlights
- March 2024: Received SRC approval
recommending that the two-part Phase 2a trial of DA-1241 for the
treatment of MASH continue without modification following a blinded
safety review of the first six months of study conduct.
- March 2024: Announced the
appointment of Marshall Woodworth as
Chief Financial Officer, following his tenure as Acting Chief
Financial Officer.
- February 2024: Received first
site Institutional Review Board (IRB) approval for Alexander Prezioso, M.D., Investigator, Clinical
Pharmacology of Miami, in
Hialeah, FL, to proceed with the
Phase 1 clinical trial of DA-1726 for the treatment of
obesity.
- February 2024: Announced that the
FDA has cleared its Investigational New Drug (IND) application for
the Phase 1 trial DA-1726 in obesity, previously submitted in
December 2023.
- January 2024: Reported positive
pre-clinical safety data of DA-1241 in combination with
sitagliptin, a DPP4 inhibitor. The pre-clinical results
demonstrated that once daily oral administration in rats, of
sitagliptin alone (180 mg/kg/day), DA-1241 alone (100 mg/kg/day),
or sitagliptin in combination with DA-1241 (up to 180/100 mg/kg/day
sitagliptin+DA-1241) for 13 weeks, was well tolerated with no
adverse effects. Additionally, the company announced it had opened
enrollment for Part 2 of its Phase 2a clinical trial of DA-1241
when co-administered with sitagliptin for the treatment of
MASH.
- December 2023: Effected a 1-for-8
reverse stock split to regain compliance with the Nasdaq minimum
bid price requirement. On January 8,
2024, company received notification from Nasdaq that it had
regained compliance.
- 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 and Governance
Committee.
Anticipated Clinical Milestones
- DA-1241 in MASH: Full data from the Phase 2a clinical
trial of DA-1241 in MASH is expected to be available in the second
half of 2024.
- DA-1726 in Obesity: Initiation of a Phase 1 single
ascending dose (SAD) study and multiple ascending dose (MAD) study,
expected in the second quarter of 2024. Top-line data from the
single ascending dose (SAD) Part 1 is expected in the first half of
2025 and from the multiple ascending dose (MAD) Part 2 in the
second half of 2025.
Full Year 2023 Financial and Operating Results
- Research and Development (R&D) Expenses were
approximately $9.2 million for the
year ended December 31, 2023, as
compared to approximately $2.8
million for the year ended December
31, 2022. The increase of approximately $6.4 million was primarily attributable to (i)
$6.3 million in higher expenditures
for investigational drug manufacturing costs, non-clinical and
pre-clinical services, clinical trials and consulting, (ii)
$0.1 million in higher stock-based
compensation, and (iii) $0.1 million
in higher employee compensation and benefits.
- General and Administrative Expenses were approximately
$6.7 million for the year ended
December 31, 2023, compared to
approximately $8.6 million for the
year ended December 31, 2022. The
decrease of approximately $1.9
million was primarily due to (i) $0.9
million in lower insurance cost, (ii) $0.7 million in lower stock-based compensation,
(iii) $0.3 million in lower legal and
professional fees, and (iv) $0.3
million in lower employee compensation and benefits. The
decreases were partially offset by an increase of $0.2 million in state non-income taxes and fees
as well as public company costs.
- Total Operating Expenses were approximately $15.9 million for the year ended December 31, 2023, compared to approximately
$19.6 million for the year ended
December 31, 2022. The approximately
$3.7 million decrease was primarily
attributable to (i) $8.2 million in
lower acquired in-process R&D expenses and (ii) $1.9 million in lower general and administrative
expenses. The decreases were partially offset by $6.4 million in higher R&D expenses.
- Other Income was approximately $3.4 million for the year ended December 31, 2023, compared to approximately
$5.7 million for the year ended
December 31, 2022. The decrease was
primarily attributable to a decrease of $5.0
million in gain related to the change in fair value of
warrant liabilities. The decrease was partially offset by
$0.5 million of interest income
recorded in 2023 and $2.3 million of
financing and other expenses incurred in 2022.
- Net Loss for the year ended December 31, 2023, was $12.5 million, or $2.46 per basic and diluted share, based on
5,071,101 weighted average shares of common stock outstanding,
compared with a net loss of $14.0
million, or $43.42 per basic
and diluted share, based on 321,703 weighted average shares of
common stock outstanding for the year ended December 31, 2022.
- Cash was $22.4 million as
of December 31, 2023, compared with
$33.4 million as of December 31, 2022. The company expects its cash
position will be adequate to fund operations into the fourth
quarter of 2024.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals,
Inc. is a clinical-stage biotechnology company focused on
transforming cardiometabolic diseases. The company is currently
developing DA-1241 for the treatment of Metabolic
Dysfunction-Associated Steatohepatitis (MASH) 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 that promotes the release of key gut peptides GLP-1, GIP,
and PYY. In preclinical studies, DA-1241 demonstrated a 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
functions 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.
Words such as "believes", "expects", "anticipates", "may", "will",
"should", "seeks", "approximately", "intends", "projects," "plans",
"estimates" or the negative of these words or other comparable
terminology (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. 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 NeuroBo's ability to
execute on its commercial strategy; the timeline for regulatory
submissions; ability to obtain regulatory approval through the
development steps of NeuroBo's 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 NeuroBo's current and future product
candidates; potential negative interactions between our product
candidates and any other products with which they are combined for
treatment; NeuroBo's ability to initiate and complete clinical
trials on a timely basis; our ability to recruit subjects for its
clinical trials; whether NeuroBo receives results from NeuroBo's
clinical trials that are consistent with the results of
pre-clinical and previous clinical trials; impact of costs related
to the license agreement, known and unknown, including costs of any
litigation or regulatory actions relating to the license agreement;
effects of 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, except as required by
law.
Contacts:
|
|
|
|
|
|
NeuroBo
Pharmaceuticals
|
Rx
Communications Group
|
|
Marshall H.
Woodworth
|
Michael
Miller
|
|
Chief Financial
Officer
|
+1-917-633-6086
|
|
+1-857-299-1033
|
mmiller@rxir.com
|
|
marshall.woodworth@neurobopharma.com
|
|
|
- Tables to Follow -
NeuroBo
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheets
|
(in thousands,
except share amounts and par value)
|
|
|
|
As of December
31,
|
|
|
2023
|
|
|
2022
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
|
|
$
|
22,435
|
|
$
|
33,364
|
Prepaid and other
current assets
|
|
|
77
|
|
|
168
|
Total current
assets
|
|
|
22,512
|
|
|
33,532
|
Property and
equipment, net
|
|
|
46
|
|
|
2
|
Right-of-use
asset
|
|
|
202
|
|
|
—
|
Other
assets
|
|
|
21
|
|
|
—
|
Total assets
|
|
$
|
22,781
|
|
$
|
33,534
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
821
|
|
$
|
708
|
Accrued
liabilities
|
|
|
4,414
|
|
|
280
|
Warrant
liabilities
|
|
|
658
|
|
|
10,796
|
Lease liability,
short-term
|
|
|
67
|
|
|
—
|
Total current
liabilities
|
|
|
5,960
|
|
|
11,784
|
Lease liability,
long-term
|
|
|
136
|
|
|
—
|
Total
liabilities
|
|
|
6,096
|
|
|
11,784
|
Commitments and
contingencies (Note 4)
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
Preferred stock,
$0.001 par value per share; 10,000,000 shares authorized as of
December 31, 2023 and 2022; no shares issued or outstanding as of
December
31, 2023 and 2022.
|
|
|
—
|
|
|
—
|
Common stock, $0.001
par value per share, 100,000,000 shares authorized as of
December 31, 2023 and 2022; 4,906,032 and 3,179,502 shares issued
and
outstanding as of December 31, 2023 and 2022,
respectively.
|
|
|
5
|
|
|
25
|
Additional paid–in
capital
|
|
|
124,945
|
|
|
117,520
|
Accumulated
deficit
|
|
|
(108,265)
|
|
|
(95,795)
|
Total stockholders'
equity
|
|
|
16,685
|
|
|
21,750
|
Total liabilities and
stockholders' equity
|
|
$
|
22,781
|
|
$
|
33,534
|
NeuroBo
Pharmaceuticals, Inc.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(in thousands,
except share and per share amounts)
|
|
|
|
Year Ended December
31,
|
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
9,158
|
|
$
|
2,778
|
Acquired in-process
research and development
|
|
|
—
|
|
|
8,210
|
General and
administrative
|
|
|
6,728
|
|
|
8,640
|
Total operating
expenses
|
|
|
15,886
|
|
|
19,628
|
Loss from
operations
|
|
|
(15,886)
|
|
|
(19,628)
|
Other income
(expense):
|
|
|
|
|
|
|
Change in fair value of
warrant liabilities
|
|
|
2,955
|
|
|
7,935
|
Interest income
|
|
|
461
|
|
|
—
|
Financing expense
|
|
|
—
|
|
|
(2,191)
|
Other expense
|
|
|
—
|
|
|
(83)
|
Total other
income
|
|
|
3,416
|
|
|
5,661
|
Loss before income
taxes
|
|
|
(12,470)
|
|
|
(13,967)
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
Net loss
|
|
$
|
(12,470)
|
|
$
|
(13,967)
|
Loss per share of
common stock, basic and diluted
|
|
$
|
(2.46)
|
|
$
|
(43.42)
|
Weighted average shares
of common stock, basic and diluted
|
|
|
5,071,101
|
|
|
321,703
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(12,470)
|
|
$
|
(13,967)
|
Other comprehensive
loss, net of tax
|
|
|
—
|
|
|
(4)
|
Comprehensive
loss
|
|
$
|
(12,470)
|
|
$
|
(13,971)
|
View original
content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-year-end-2023-financial-results-and-provides-corporate-update-302101543.html
SOURCE NeuroBo Pharmaceuticals, Inc.