- Shares of the Combined Company, NeuroBo Pharmaceuticals, Began
Trading on the Nasdaq Exchange Under the Symbol NRBO on December
31, 2019
- NeuroBo Pharmaceuticals to Focus on Advancing Clinical Stage
Pipeline for Neurodegenerative Diseases
NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology
company focused on multimodal, disease-modifying therapies for
neurodegenerative diseases, today reported that the previously
announced merger between NeuroBo Pharmaceuticals, Inc., (“NeuroBo”)
and Gemphire Therapeutics (Nasdaq: GEMP) closed on December 31,
2019. The new combined company, known as NeuroBo Pharmaceuticals
began trading on the Nasdaq exchange under the ticker “NRBO” on
December 31, 2019. NeuroBo will focus on advancing the company’s
clinical-stage pipeline for neurodegenerative diseases.
“We believe that the closing of the merger signifies a
transformative event that will provide NeuroBo with the opportunity
to achieve its next level of corporate growth as we continue to
advance our promising pipeline for neurodegenerative diseases,”
said Richard J. Kang, Ph.D., president and chief executive officer
of the combined company. “As we look ahead, we have some important
milestones on the horizon. The first study in our Phase 3 program
for our lead drug candidate, NB-01, for painful diabetic neuropathy
(PDN), will begin screening patients soon in the U.S. and we are
designing a first-in-human trial for NB-02, targeted at Alzheimer’s
disease and diseases associated with the pathological dysfunction
of tau proteins in the brain.”
The company’s novel lead program, NB-01, is an oral drug
candidate for painful diabetic neuropathy (PDN). In a randomized,
placebo-controlled Phase 2 clinical trial, NB-01 significantly
improved pain scores from baseline as measured by the NRS, an
11-point numeric rating scale commonly used in pain studies, and
showed an excellent safety profile when compared to retrospective
safety data on existing therapies. In pre-clinical studies in
animal models of diabetes, NB-01 reduced general inflammation and
neuro-inflammation as measured by IL-6 and TNF-α, reduced advanced
glycation end products (AGEs), which are implicated in diabetic
neuropathy, and elevated levels of nerve growth factor (NGF) to
normal physiological levels, which has been shown to promote nerve
growth, survival and repair. This multi-component drug approach has
the potential to address the underlying mechanisms of PDN, reduce
neuropathic pain symptoms and slow disease progression. Initiation
of enrollment in the first Phase 3 study with NB-01 is anticipated
in the first half of 2020 and will enroll approximately 460
subjects with PDN across the U.S.
NeuroBo’s IND-ready second drug candidate, NB-02, is targeted
for the treatment of Alzheimer’s disease and neurodegenerative
diseases associated with the pathological dysfunction of tau
proteins in the brain. Preclinical animal disease model studies of
NB-02 have provided evidence of efficacy and safety in
neurodegeneration.
In addition, NeuroBo plans to continue the advancement of
gemcabene, which has been in development by Gemphire for the
treatment of dyslipidemia. Gemcabene has been studied in more than
1,100 human subjects in a total of 25 Phase 1 and Phase 2 trials
with demonstrated efficacy and safety. The combined company expects
to submit an application with results of a preclinical mouse safety
study to the Food and Drug Administration (FDA) in early 2020 to
address a partial clinical hold related to gemcabene’s activation
of peroxisome proliferation-activated receptor (PPAR) and, if
approved, would be poised to progress into Phase 3 human studies.
The combined company will also continue to support the partnership
with Beijing SL Pharmaceutical, Co., Ltd. (“Beijing SL”), for
gemcabene rights in China.
Immediately after the closing of the merger, NeuroBo
shareholders owned 96.24%, and current Gemphire stockholders owned
3.76% of NeuroBo’s common stock. As part of the merger, Gemphire
stockholders received non-transferable contingent value rights
(CVRs) entitling the holders to receive in aggregate, after the
retention of $500,000 by the combined company and certain other
permitted deductions, 80% of the net proceeds, if any, in the event
the gemcabene assets are sold or licensed during the 10-year period
following the closing of the merger or pursuant to the license
agreement with Beijing SL.
The combined organization will operate under the leadership of
NeuroBo’s new President and Chief Executive Officer, Richard J.
Kang, Ph.D., and Chief Medical Officer, Mark Versavel, M.D., Ph.D.,
MBA. The board of directors of the combined organization is
comprised of seven directors: two directors from the former NeuroBo
board, one director from the former Gemphire board and four newly
appointed members designated by NeuroBo prior to the merger. Ms. Na
Yeon (Irene) Kim, M.S., MBA, was appointed as chairman of the
board. The corporate headquarters of the combined organization is
located in Boston, Massachusetts.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc., is focused on novel treatments
for neurodegenerative diseases affecting millions of patients
worldwide. The company’s multimodal approach has the potential to
address the multiple underlying mechanisms of neurodegenerative
diseases, alleviate symptoms and slow disease progression. The
company’s lead drug candidate, NB-01, for the treatment of painful
diabetic neuropathy (PDN) has been shown in a Phase 2 study to
significantly reduce pain symptoms associated with PDN with a
superior safety profile when compared to currently available
treatments. Enrollment in the first study in the Phase 3 program
for NB-01 in the U.S. is expected to begin in the first half of
2020, with a target enrollment of approximately 460 subjects with
PDN. NeuroBo’s IND-ready second drug candidate, NB-02, is focused
on the treatment of Alzheimer’s disease and neurodegenerative
diseases associated with the pathological dysfunction of tau
proteins in the brain.
NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman,
professor of neurology at Harvard Medical School and renowned
expert in neuropathic pain, and JK BioPharma Solutions, a
biotechnology consulting company, to commercialize natural
product-based research into ethical medicines. For more
information, visit: https://www.neurobopharma.com/.
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 therapeutic potential, timing and nature
of human trials and potential regulatory approval of NeuroBo’s
clinical programs and pipeline. 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: NeuroBo’s plans
to develop and commercialize its product candidates; the timing of
completion of NeuroBo’s planned clinical trials; the timing of the
availability of data from NeuroBo’s clinical trials; NeuroBo’s
plans to research, develop and commercialize its current and future
product candidates; NeuroBo’s ability to successfully collaborate
with existing collaborators or enter into new collaborations and to
fulfill its obligations under any such collaboration agreements;
the clinical utility, potential benefits and market acceptance of
NeuroBo’s product candidates; NeuroBo’s commercialization,
marketing and manufacturing capabilities and strategy; the impact
of government laws and regulations; NeuroBo’s ability to protect
its intellectual property position; and NeuroBo’s need for
additional financing to fulfill its stated goals; and other factors
discussed in the "Risk Factors" section of SEC filings the combined
company makes with the SEC from time to time. 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.
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Nicole Franklin Racepoint Global 617.624.3264
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