- Exclusive License Agreement to Develop and Commercialize Phase
II Clinical Stage New Chemical Entity DA-1241 for the Treatment of
NASH / Type 2 Diabetes and
- Phase I Ready DA-1726 for the Treatment of NASH / Obesity
- Dong-A Commits $15 Million in
Equity to Strategic Collaboration
BOSTON and SEOUL,
South Korea, Sept. 15,
2022 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc.
("NeuroBo") (Nasdaq: NRBO), and Dong-A ST Co., Ltd. ("Dong-A")
(KOSE: A000640) today announced that they have entered into a
conditional exclusive license agreement for NeuroBo to develop and
commercialize DA-1241 and DA-1726, which are currently being
evaluated for the treatment of nonalcoholic steatohepatitis (NASH),
obesity and type 2 diabetes.
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-1241 is a
synthetic, selective small molecule, suitable for oral
administration and has been shown to be well tolerated in phase 1
studies. Further, its multimodal mechanism appears to induce strong
anti-NASH effects, supported by potential best-in-class efficacy,
as demonstrated in pre-clinical studies.
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. The beneficial effects of this
dual mechanism of DA-1726 on weight loss compared to selective
GLP-1 activity has been demonstrated in animal models.
Additionally, DA-1726 has shown the ability to improve hepatic
steatosis, inflammation and fibrosis when compared to the GLP-1
agonist, semaglutide in these same models.
Under the license agreement, NeuroBo will be responsible for
global development, regulatory and commercial activities other than
for certain Asian-Pacific geographies. Dong-A will manufacture
clinical supplies and initial commercial supplies of the product at
its manufacturing facility in Korea.
"The acquisition of these two cardiometabolic assets marks a
seismic shift for NeuroBo, providing us with a highly promising,
diversified pipeline with several upcoming value inflection points
in the NASH and obesity space -- areas with enormous market
opportunity," stated Gil Price,
M.D., President and Chief Executive Officer of NeuroBo. "Through
this agreement, Dong-A, one of our largest shareholders, has
reaffirmed its commitment to remain a long-term strategic partner
of NeuroBo. Dong-A is dedicated to our success and we are grateful
it has also committed to provide continued support to facilitate
the clinical development of the licensed assets. Once the
transaction has closed, which is contingent upon certain closing
conditions, we will be uniquely positioned to initiate a phase 2a
study of DA-1241 in NASH in the first half of 2023, with data
expected in the second half of 2024. We also intend to initiate a
phase 1a safety study of DA-1726 in the first half of 2023, for
which data is expected in the second half of 2023. We are truly
excited about the prospects of NeuroBo as we transition to a
cardiometabolic company across the large and growing markets of
obesity and NASH."
"We are highly enthusiastic about this opportunity to accelerate
development of our novel treatments in partnership with NeuroBo.
Dong-A plans to continue to strengthen its R&D capability and
to seek additional collaboration opportunities to establish
ourselves in the US market", said Min Young
Kim, Chief Executive Officer of Dong-A.
About the Proposed Licensing
Transaction
Under the terms of the license agreement, Dong-A will receive an
upfront payment of $22 million in
Series A convertible preferred stock, which will automatically
convert into common stock upon receipt of requisite stockholder
approval, and will be eligible to receive commercial- and
regulatory-based milestone payments, dependent upon the
achievement of specific regulatory and commercial developments.
Dong-A will also be entitled to single digit royalties on net sales
of the two assets. Dong-A has also agreed to commit $15,000,000 toward financing the assets, subject
to NeuroBo's ability to obtain additional financing under the terms
of the license agreement.
The license agreement has been approved by the board of
directors of NeuroBo. The transaction is expected to close in the
third quarter of 2022, subject to obtaining third party financing
for development of the assets and other customary closing
conditions.
Additional information about the transaction will be provided in
a Current Report on Form 8-K that will be filed by NeuroBo with the
Securities and Exchange Commission ("SEC") and will be available
at www.sec.gov.
Honigman LLP is serving as legal counsel to NeuroBo. Moelis
& Company is acting as financial advisor to Dong-A for the
transaction and Willkie Farr &
Gallagher LLP is serving as legal counsel to Dong-A.
About NeuroBo
Pharmaceuticals
NeuroBo Pharmaceuticals, Inc., is a clinical-stage biotechnology
company historically focused on therapies for neurodegenerative,
infectious, and, upon closing of the license agreement,
cardiometabolic diseases. Its therapeutics programs currently
include ANA001, an oral niclosamide formulation, which is in Phase
2/3 clinical trials to treat patients with moderate coronavirus
disease (COVID-19); NB-01 for the treatment of painful diabetic
neuropathy; NB-02 for the treatment of symptoms of cognitive
impairment and to modify the progression of neurodegenerative
diseases associated with the malfunction of tau protein; and
gemcabene currently being assessed as an acute treatment for
COVID-19 in combination with ANA001. NeuroBo Pharmaceuticals, Inc.
is headquartered in Boston,
Massachusetts. For more information, please
visit www.neurobopharma.com.
About Dong-A
Dong-A ST Co., Ltd. (KOSE: A000640) is a leading healthcare
company in South Korea with a
business focus on developing, manufacturing and distributing
pharmaceutical products and medical devices worldwide. Dong-A has
successfully developed and marketed several products globally and
continues to develop prospective clinical candidates. Dong-A also
provides licensed-in and licensed-out drugs, and medical devices,
including high-technology medical devices, custom-made products,
and sets of artificial cardiac circuits for use in open-heart
surgery. Dong-A has over 5,500 employees including 2,300 in the
pharmaceutical sector. Dong-A was founded in 1932 and is
headquartered in Seoul, South
Korea.
No Offer or Solicitation
This press release does not and shall not constitute an offer to
sell or the solicitation of an offer to buy any securities, nor
shall there be any sale of these securities in any state or other
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such state or other jurisdiction. Any offer,
if at all, will be made only by means of a prospectus, including a
prospectus supplement, forming a part of the effective registration
statement.
Forward Looking
Statements
Any statements in this press release that are not statements of
historical fact constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements include, but are not limited to,
statements regarding the licensing agreement, NeuroBo's integration
of the assets licensed therein, the effect of the proposed
licensing transaction on NeuroBo's business strategy, the market
size and potential growth opportunities of NeuroBo's current and
future product candidates, NeuroBo's capital requirements and use
of proceeds, clinical development activities, the timeline for, and
results of, clinical trials, regulatory submissions, and potential
regulatory approval and commercialization of its current and future
product candidates. Forward-looking statements are usually
identified by the use of words, such as "believes," "anticipates,"
"expects," "intends," "plans," "may," "potential," "will," "could"
and similar expressions. Actual results may differ materially from
those indicated by forward-looking statements as a result of
various important factors and risks. These factors, risks and
uncertainties include, but are not limited to: (1) the structure,
timing and ability to satisfy the conditions to closing the license
agreement; (2) NeuroBo's ability to be continued to be listed on
the NASDAQ Capital Market; (3) the ability to realize the benefits
of the license agreement, including the impact on future financial
and operating results of NeuroBo; (4) the ability to integrate the
new product candidates to be licensed as part of the transaction
into NeuroBo's business in a timely and cost‐efficient manner; (5)
the cooperation of our contract manufacturers, clinical study
partners and others involved in the development of our current and
future product candidates; (6) costs related to the license
agreement, known and unknown, including costs of any litigation or
regulatory actions relating to the license agreement; (7) changes
in applicable laws or regulations; (8) effects of changes to
NeuroBo's stock price on the terms of the license agreement and any
future fundraising; and (9) the ability of NeuroBo to successfully
raise funds to meet the conditions of the license agreement. Please
refer to NeuroBo's most recent annual report on Form 10-K, as well
as NeuroBo's subsequent filings on Form 10-Q and Form 8-K, which
are available on the SEC's website (www.sec.gov), for a full
discussion of the risks and other factors that may impact any
forward-looking statements in this press release. In addition, the
forward-looking statements included in this press release represent
NeuroBo's views as of the date hereof. NeuroBo anticipates that
subsequent events and developments will cause its views to change.
However, while NeuroBo may elect to update these forward-looking
statements at some point in the future, NeuroBo specifically
disclaims any obligation to do so. These forward-looking statements
should not be relied upon as representing NeuroBo's views as of any
date subsequent to the date hereof.
Contacts
Investors & Media:
NeuroBo Pharmaceuticals, Inc.
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
Or
Dong-A ST Co., Ltd.
Hyung Heon
Kim
E-mail: hhkim@donga.co.kr
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SOURCE NeuroBo Pharmaceuticals, Inc.