Successfully Completed a Financing of up to
$70 Million, With $20 Million Upfront and an Additional
$50 Million of Aggregate Gross
Proceeds Upon the Exercise in Full of Clinical Milestone-Based
Warrants
$27.9 Million in
Cash at End of Second Quarter
is Expected to Fund the Company Though Multiple
Value-Creating Milestones, Into the Second
Quarter of 2025. Assuming Positive Results From the DA-1726
Phase 1 MAD Study, the Company Anticipates That the Series A
Warrants From the June Financing Could be Exercised in the First
Half of 2025, Resulting in Gross Proceeds of $20 Million
In Pre-Clinical Models, DA-1726 Demonstrated
Superiority in Weight Loss, Retention of Lean Body Mass and Lipid-Lowering Effects, Plus
Superior Glucose Lowering Effects Compared to Survodutide;
Lipid-Lowering Effect Also Shown to be Superior Compared to
Tirzepatide
Fully Enrolled the SAD Part 1 of the Phase 1
Trial of DA-1726, With Top-Line Data Readout Expected in the Third
Quarter of 2024, and From the MAD Part 2 in the First Quarter of
2025
Planned Phase 1 Part 3 Trial of DA-1726 in
Obesity Will Assess Total Weight Loss at 24 Weeks, Exploring
Maximum Titratable Dose and Dietary Changes; Interim Data Readout
Expected Mid-2026 with Top-Line Data in the Second Half of
2026
Entered into a Joint Research Agreement,
Together With Dong-A ST and ImmunoForge to Develop a Long-Acting
Once-Monthly Formulation of DA-1726
Part 2 of the Phase 2a Trial of DA-1241 for
the Treatment of MASH Underway With Top-Line Data Expected in the
Fourth Quarter of 2024
CAMBRIDGE, Mass., Aug. 14,
2024 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company
focused on transforming cardiometabolic diseases, today announced
financial results for the second quarter ended June 30, 2024 and provided a corporate
update.
"During the second quarter and subsequently, we made remarkable
progress advancing the clinical development of our two, next
generation cardiometabolic assets and are now well capitalized to
execute on our upcoming DA-1726 milestones following our recent,
successful financing of up to $70
million in aggregate gross proceeds, with $20 million upfront and $50 million of clinical milestone-based
warrants," stated Hyung Heon Kim,
President and Chief Executive Officer of NeuroBo. "We expect this
financing will enable us to fully fund an early proof-of-concept
multicenter, randomized, double-blind, placebo-controlled Part 3 of
the Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin
(OXM) analog agonist that functions as a glucagon-like peptide-1
receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of
obesity. Part 3, which will begin upon completion of Part 2, will
explore changes in baseline, at 24 weeks, for total weight loss,
weight loss through fat or lean muscle mass reduction, dietary
changes, maximum-tolerated individualized dose and other
exploratory endpoints. Additionally, dosing of the first patient in
Part 2 of this trial, late in the second quarter, ahead of
schedule, is a further reflection of our strong commitment to
swiftly advancing the clinical development of DA-1726, which holds
promise as a highly differentiated therapy for the treatment of
obesity. It is also worth noting that, just last week, we signed a
joint research agreement, together with our collaboration partner,
Dong-A ST and ImmunoForge, as a first step toward potentially
developing a long-acting formulation of DA-1726 which would both
enhance patient compliance and ease of administration.
"During the American Diabetes Association (ADA) 84th Scientific
Sessions in June, we shared pre-clinical data that highlighted the
unique characteristics of DA-1726 compared to other obesity drugs
in the same class. The data suggests that DA-1726's unique GLP-1
and glucagon receptor activity ratio may be responsible for its
differentiated profile. In obese mouse models, DA-1726 demonstrated
significant reductions in cholesterol levels and superior weight
loss, compared to survodutide, a drug with the same mechanism of
action, while also exhibiting superior glucose lowering and
retention of relative lean body mass preservation. Previous
pre-clinical research also indicated that DA-1726 led to weight
reduction while consuming more food than tirzepatide. Additional
data presented at the ADA, from a hypercholesterolemia rat model,
confirmed that DA-1726 is also more effective than tirzepatide in
lowering cholesterol levels potentially due to its glucagon action
and GLP-1 effect, while also preventing weight gain. These
pre-clinical findings suggest that DA-1726 could emerge as a
best-in-class obesity drug with improved tolerability compared to
current GLP-1 agonists and those in late-stage clinical trials,
given its balanced activation of GLP1R and glucagon receptors,
while increasing energy expenditure. Yesterday, we announced the
full enrollment of the single ascending dose (SAD) Part 1, for
which we anticipate reporting top-line data in the third quarter of
this year and top-line data from the MAD Part 2 in the first
quarter of 2025. Upon clearance of an updated Investigational New
Drug (IND) application with the U.S. Food and Drug Administration
(FDA), we expect to dose the first patient in Part 3 during the
third quarter of 2025, providing an interim data readout in or
around mid-2026 and issuing top-line results in the second half of
2026."
Mr. Kim concluded, "Additionally, early in the quarter, we fully
enrolled Part 1 of the Phase 2a clinical trial for DA-1241, a novel
G-Protein-Coupled Receptor 119 (GPR119) agonist for treating MASH,
exploring the efficacy of DA-1241 in combination with sitagliptin,
a DPP-4 inhibitor, which we believe will show synergistic effects
compared to DA-1241, alone. New pre-clinical evidence on DA-1241 in
combination with semaglutide (Wegovy®), was presented at the EASL
Congress 2024, in June. Based on both pre-clinical and clinical
evidence generated to date, we continue to believe that DA-1241 has
the potential to be a safe and effective treatment for MASH and
anticipate reporting top-line results in the fourth quarter of this
year."
First Quarter 2024 and Subsequent Highlights
- August 2024: Completed enrollment
in the SAD Part 1 of the Phase 1 clinical trial evaluating DA-1726
for the treatment of obesity. A total of 45 participants were
enrolled and randomized into one of 5 cohorts, with each cohort
having been randomized in a 6:3 ratio of DA-1726 to placebo.
- August 2024: Signed a joint
research agreement, along with Dong-A ST and ImmunoForge, to
develop a long-acting, once-monthly, formulation of DA-1726
utilizing ImmunoForge's long-lasting half-life extension
Elastin-Like Polypeptide (ELP) platform technology.
- July 2024: Signed an exclusive
out-license agreement, providing MThera Pharma Co., Ltd. (MTHERA)
with the rights to develop and commercialize NB-01, one of four
legacy assets, for the treatment of painful diabetic neuropathy,
allowing MTHERA to conduct research and clinical trials, including,
but not limited to, a potential Phase 3 clinical trial in
the United States and South Korea, for the future commercialization
of NB-01.
- July 2024: Engaged veteran
biotech and pharmaceutical professional, Chris Fang, MD, as Advisor/Consulting Chief
Medical Officer, effective July, 2, 2024.
- June 2024: Completed enrollment
of Part 2 of the Phase 2a trial evaluating the efficacy and safety
of DA-1241 in MASH. Approximately 37 patients with presumed MASH
were randomized with a 2:1 ratio into 2 treatment groups: DA-1241
100 mg/sitagliptin 100 mg or placebo.
- June 2024: Dosed the first
patient in the MAD Part 2 of its two-part Phase 1 clinical trial of
DA-1726 a novel, dual oxyntomodulin (OXM) analog agonist that
functions as a glucagon-like peptide-1 receptor (GLP1R) and
glucagon receptor (GCGR), for the treatment of obesity.
- June 2024: Closed a concurrent
placement and registered direct offering priced at-the-market under
Nasdaq rules, with $20 million up
front with up to an additional $50
million of aggregate gross proceeds upon the exercise in
full of clinical milestone-based warrants.
- June 2024: Presented pre-clinical
data at the American Diabetes Association (ADA) 84th Scientific
Sessions, suggesting that DA-1726 demonstrated superiority in
weight loss, retention of lean body mass, and lipid-lowering
effects compared to survodutide.
- June 2024: Presented new
pre-clinical data, at the EASL Congress, that suggests DA-1241, in
combination with semaglutide (Wegovy®), a GLP1R agonist, improves
liver fibrosis and demonstrates additive hepatoprotective effects
in pre-clinical metabolic dysfunction-associated steatohepatitis
(MASH) models compared to either treatment alone.
- April 2024: Dosed the first
patient in the SAD Part 1 of its Phase 1 clinical trial of DA-1726
for the treatment of obesity.
- April 2024: Completed enrollment
of Part 1 of its two-part Phase 2a trial evaluating the efficacy
and safety of DA-1241 in MASH. Approximately 49 patients with
presumed MASH were randomized with a 1:2:1 ratio into 3 treatment
groups: DA-1241 50 mg, DA-1241 100 mg, or placebo.
Anticipated Clinical Milestones
- DA-1726 in Obesity: Top-line data from the single
ascending dose (SAD) Part 1 is expected in the third quarter of
2024. The last patient visit in the multiple ascending dose (MAD)
study Part 2 is expected in the fourth quarter of 2024 and the
top-line data is expected in the first quarter of 2025. Upon
clearance of an updated IND application with the FDA, the first
patient in Part 3 is expected to be enrolled during the third
quarter of 2025, with an interim data readout in or around mid-2026
and top-line results are expected in the second half of 2026.
- DA-1241 in MASH: Top-line results from the two-part
Phase 2a clinical trial of DA-1241 in MASH are expected to be
available in the fourth quarter of 2024.
Second Quarter Financial and Operating Results
- Research and Development (R&D) Expenses were
approximately $8.1 million for the
three months ended June 30, 2024, as
compared to approximately $2.4
million for the three months ended June 30, 2023. The increase of approximately
$5.7 million was primarily related to
increased R&D activities for DA-1241 and DA-1726 for the three
months ended June 30, 2024 following
commencement of the Phase 2a clinical trial for DA-1241 and Phase 1
trial for DA-1726, compared to the three months ended June 30, 2023 when R&D activities were
starting to ramp up following the acquisition of DA-1241 and
DA-1726 in the fourth quarter of 2022. Specifically, the
$5.7 million increase in R&D
expenses was primarily attributable to (i) $5.4 million in higher expenditures for
investigational drug manufacturing costs, non-clinical and
preclinical services, clinical trials and consulting and (ii)
$0.3 million in higher employee
compensation and benefits.
R&D expenses were approximately $13.0
million for the six months ended June
30, 2024, as compared to approximately $3.0 million for the six months ended
June 30, 2023. The approximately
$10.0 million increase was primarily
related to increased R&D activities for DA-1241 and DA-1726.
Specifically, the $10.0 million
increase in R&D expenses was primarily attributable to (i)
$9.3 million in higher expenditures
for investigational drug manufacturing costs, non-clinical and
preclinical services, clinical trials and consulting and (ii)
$0.7 million in higher employee
compensation and benefits.
- General and Administrative (G&A) Expenses were
approximately $2.0 million for the
three months ended June 30, 2024,
compared to approximately $1.4
million for the three months ended June 30, 2023. The increase of approximately
$0.6 million was primarily
attributable to $0.4 million in
higher employee compensation and benefits and $0.1 million in higher non-cash stock-based
compensation.
G&A expenses were approximately $4.0
million for the six months ended June
30, 2024, as compared to approximately $3.3 million for the six months ended
June 30, 2023. The approximately
$0.7 million increase was primarily
attributable to $0.4 million in
higher employee compensation and benefits and $0.2 million in higher non-cash stock-based
compensation.
- Other Income was approximately $31 thousand for the three months ended
June 30, 2024, as compared to
approximately $3.1 million for the
three months ended June 30, 2023. The
approximately $3.0 million decrease
was primarily attributable to a loss of $0.1
million related to the change in fair value of warrant
liabilities for the three months ended June
30, 2024, compared to a gain of $3.1
million for the three months ended June 30, 2023, partially offset by $0.2 million of interest income earned on the
cash balance for the three months ended June
30, 2024, of which there was none for the three months ended
June 30, 2023.
Other income was approximately $0.2
million for the six months ended June
30, 2024, as compared to approximately $3.0 million for the six months ended
June 30, 2023. The approximately
$2.8 million decrease was primarily
attributable to the recording of a loss of $0.2 million related to the change in fair value
of warrant liabilities for the six months ended June 30, 2024 compared to a gain of $3.0 million for three months ended June 30, 2023, partially offset by $0.4 million of interest income earned on the
cash balance for the six months ended June
30, 2024, of which there was none for the six months ended
June 30, 2023.
- Net Loss for the three months ended June 30, 2024, was approximately $10.1 million, or $1.85 per basic and diluted share, based on
5,428,906 weighted average shares of common stock, basic and
diluted, compared with a net loss of approximately $0.7 million, or $0.15 per basic and diluted share, based on
5,059,003 weighted average shares of common stock, basic and
diluted, for the three months ended June 30,
2023.
Net loss for the six months ended June 30,
2024, was approximately $16.8
million, or $3.19 per basic
and diluted share, based on 5,259,939 weighted average shares of
common stock, basic and diluted, compared with a net loss of
approximately $3.3 million, or
$0.66 per basic and diluted share,
based on 5,059,003 weighted average shares of common stock, basic
and diluted, for the six months ended June
30, 2023.
- Cash was approximately $27.9
million as of June 30, 2024,
compared to approximately $22.4
million as of December 31,
2023. The company expects its cash position will be adequate
to fund operations into the second quarter of 2025. The Company
anticipates that the Series A Warrants from the June financing
could be exercised in the first half of 2025, resulting in gross
proceeds of $20 million.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals,
Inc. is a clinical-stage biotechnology company focused on
transforming cardiometabolic diseases. The company is currently
developing DA-1726 for the treatment of obesity, and is developing
DA-1241 for the treatment of Metabolic Dysfunction-Associated
Steatohepatitis (MASH). 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. 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 pre-clinical 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.
For more information, please visit www.neurobopharma.com.
Forward Looking Statements
Certain statements in this
press 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", "potential", "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 press
release, including, without limitation, those risks associated with
NeuroBo's ability to execute on its commercial strategy; the
timeline for regulatory submissions; the 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 NeuroBo's contract manufacturers,
clinical study partners and others involved in the development of
NeuroBo's current and future product candidates; potential negative
interactions between NeuroBo's 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;
NeuroBo's 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; the effects of changes
in applicable laws or regulations; the 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
NeuroBo's filings with the Securities and Exchange Commission,
including NeuroBo's most recent Annual Report on Form 10-K..
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, Inc.
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
marshall.woodworth@neurobopharma.com
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
per share amounts)
|
|
|
|
As of
|
|
|
June 30,
2024
|
|
December 31,
2023
|
|
|
(Unaudited)
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
|
|
$
|
27,934
|
|
$
|
22,435
|
Prepaid expenses
and other current assets
|
|
|
583
|
|
|
77
|
Total current
assets
|
|
|
28,517
|
|
|
22,512
|
Property and
equipment, net
|
|
|
44
|
|
|
46
|
Right-of-use
asset
|
|
|
169
|
|
|
202
|
Other
assets
|
|
|
21
|
|
|
21
|
Total assets
|
|
$
|
28,751
|
|
$
|
22,781
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,632
|
|
$
|
821
|
Clinical trial accrued
liabilities
|
|
|
2,066
|
|
|
3,033
|
Accrued expenses and
other current liabilities
|
|
|
463
|
|
|
592
|
Warrant
liabilities
|
|
|
861
|
|
|
658
|
Related party
payable
|
|
|
3,617
|
|
|
789
|
Lease liability,
short-term
|
|
|
72
|
|
|
67
|
Total current
liabilities
|
|
|
9,711
|
|
|
5,960
|
Lease liability,
long-term
|
|
|
98
|
|
|
136
|
Total
liabilities
|
|
|
9,809
|
|
|
6,096
|
Commitments and
contingencies
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
Preferred stock,
$0.001 par value per share; 10,000 shares authorized as of
June 30, 2024 and December 31, 2023; no shares issued or
outstanding as
of June 30, 2024 and December 31, 2023
|
|
|
—
|
|
|
—
|
Common stock, $0.001
par value per share, 100,000 shares authorized as
of June 30, 2024 and December 31, 2023; 8,221 and 4,906 shares
issued
and outstanding as of June 30, 2024 and December 31, 2023,
respectively
|
|
|
8
|
|
|
5
|
Additional paid–in
capital
|
|
|
143,966
|
|
|
124,945
|
Accumulated
deficit
|
|
|
(125,032)
|
|
|
(108,265)
|
Total stockholders'
equity
|
|
|
18,942
|
|
|
16,685
|
Total liabilities and
stockholders' equity
|
|
$
|
28,751
|
|
$
|
22,781
|
NeuroBo
Pharmaceuticals, Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited - In
thousands, except share and per share amounts)
|
|
|
|
Three Months Ended June
30,
|
|
Six Months Ended June
30,
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
8,074
|
|
$
|
2,364
|
|
$
|
12,978
|
|
$
|
3,001
|
General and
administrative
|
|
|
2,010
|
|
|
1,442
|
|
|
3,987
|
|
|
3,325
|
Total operating
expenses
|
|
|
10,084
|
|
|
3,806
|
|
|
16,965
|
|
|
6,326
|
Loss from
operations
|
|
|
(10,084)
|
|
|
(3,806)
|
|
|
(16,965)
|
|
|
(6,326)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of
warrant liabilities
|
|
|
(133)
|
|
|
3,072
|
|
|
(203)
|
|
|
2,988
|
Interest income
|
|
|
164
|
|
|
—
|
|
|
401
|
|
|
—
|
Total other
income
|
|
|
31
|
|
|
3,072
|
|
|
198
|
|
|
2,988
|
Loss before income
taxes
|
|
|
(10,053)
|
|
|
(734)
|
|
|
(16,767)
|
|
|
(3,338)
|
Provision for income
taxes
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
Net loss and
comprehensive net loss
|
|
|
(10,053)
|
|
|
(734)
|
|
|
(16,767)
|
|
|
(3,338)
|
Loss per share of
common stock, basic and diluted
|
|
$
|
(1.85)
|
|
$
|
(0.15)
|
|
$
|
(3.19)
|
|
$
|
(0.66)
|
Weighted average shares
of common stock, basic and
diluted
|
|
|
5,428,906
|
|
|
5,059,003
|
|
|
5,259,939
|
|
|
5,059,003
|
View original
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SOURCE NeuroBo Pharmaceuticals, Inc.