Full Press Release Details
NeuroBo Pharmaceuticals, Inc.
and Dong-A ST Co. Ltd. Announce Strategic Collaboration to License and Develop Portfolio of Dong-A's Cardio-Metabolic Therapies
BOSTON, MA, and SEOUL, SOUTH KOREA, September 15,
2022 - 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.
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
Licensing Transaction
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.
(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
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.
NeuroBo Pharmaceuticals, Inc.
Rx Communications Group
E-mail: hhkim@donga.co.kr