NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co. Ltd. Announce Strategic Collaboration to License and Develop Portfolio of Dong-A's Cardio-Metabolic Therapies
- 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 Millionin Equity to Strategic Collaboration
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
"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
"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
Under the terms of the license agreement, Dong-A will receive an upfront payment of
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
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.
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
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