NEW YORK, Aug. 9, 2017 /PRNewswire/ -- Neurotrope,
Inc. (NASDAQ: NTRP), a clinical-stage biopharmaceutical company
developing novel therapies for neurodegenerative diseases,
including Alzheimer's disease (AD), today provided a business
update outlining recent clinical development progress and financial
results for the quarter ended June 30,
2017.
Clinical Development Highlights
- Presented clinical results from its recently completed 12-week
Phase 2 trial demonstrating that moderate-to-severe AD patients
treated with 20 µg Bryostatin-1 showed sustained improvement in
cognition on the SIB scale at all time points tested, compared to
standard of care, at the Alzheimer's Association International
Conference 2017 in London in
July 2017.
- Announced top-line results identifying the 20 µg low dose as
potentially beneficial in its Phase 2 study of Bryostatin-1 in
patients with moderate-to-severe AD in May
2017.
"As we finalize the post hoc analyses of our recently completed
trial, we will gain input from our clinical advisors and the FDA on
our roadmap to advance the development of bryostatin for
Alzheimer's disease," said Susanne
Wilke, PhD, CEO of Neurotrope. "Based on our Phase 2 results
and expert opinion received to date, a follow-on dose optimization
study will be considered to confirm how the strength of the
therapeutic signal observed with the low dose bryostatin can be
maintained and enhanced. Biomarker and imaging studies will also be
evaluated to measure drug access and the effects of PKC epsilon
activation in the brain. Once our planning is complete,
we will provide an update."
Second Quarter 2017 Financial Results (Unaudited)
As of June 30, 2017, the Company
had approximately $21.5 million of
cash and cash equivalents. For the quarter ended June 30, 2017, the Company's cash burn rate
relating to recurring expenses was approximately $1.1 million. The Company's only significant
financial commitment is the remaining amounts due to Worldwide
Clinical Trials for the recent Phase 2 clinical trial of
approximately $2.4 million, of which
$1.5 million is reflected on the
Company's balance sheet as of June 30,
2017.
About Neurotrope
Neurotrope is at the forefront of developing a new approach to
combatting AD and other neurodegenerative diseases. The
Company's world-class science offers the potential to realize a
paradigm shift to overcome one of today's most challenging clinical
problems — finding a way to slow or even prevent the progression of
AD.
In addition to the Company's Phase 2 trial of Bryostatin-1 in
moderate to severe AD, Neurotrope has also conducted preclinical
studies of bryostatin as a potential treatment for Fragile X
Syndrome, Niemann-Pick Type C disease and Rett Syndrome—three rare
genetic diseases for which only symptomatic treatments are
currently available. The FDA has granted Orphan Drug Designation to
Neurotrope for Bryostatin-1 as a treatment for Fragile X
Syndrome. Bryostatin-1 has already undergone testing in more
than 1,500 people in cancer studies, thus creating a large safety
data base that will further inform clinical trial designs in
AD.
Forward-Looking Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking
statements. These forward-looking statements include statements
regarding the Phase 2 study and further studies, and continued
development of use of Bryostatin-1 for Alzheimer's dementia and
other cognitive diseases. Such forward-looking statements are
subject to risks and uncertainties and other influences, many of
which the Company has no control over. These statements are subject
to the risk that further analyses of the Phase 2 data may lead to
different interpretations of the data than the analyses conducted
to date and/or may identify important implications of the Phase 2
data that are not reflected in these statements. Clinical trial
data are subject to differing interpretations, and regulatory
agencies, medical and scientific experts and others may not share
the Company's views of the Phase 2 data. There can be no
assurance that the clinical program for Bryostatin-1 will be
successful in demonstrating safety and/or efficacy that we will not
encounter problems or delays in clinical development, or that
Bryostatin-1 will ever receive regulatory approval or be
successfully commercialized. Actual results and the timing of
certain events and circumstances may differ materially from those
described by the forward-looking statements as a result of these
risks and uncertainties. Additional factors that may influence or
cause actual results to differ materially from expected or desired
results may include, without limitation, the Company's inability to
obtain adequate financing, the significant length of time
associated with drug development and related insufficient cash
flows and resulting illiquidity, the Company's patent portfolio,
the Company's inability to expand the Company's business,
significant government regulation of pharmaceuticals and the
healthcare industry, lack of product diversification, availability
of the Company's raw materials, existing or increased
competition, stock volatility and illiquidity, and the
Company's failure to implement the Company's business plans or
strategies. These and other factors are identified and described in
more detail in the Company's filings with the SEC, including the
Company's Annual Report on Form 10-K for the year ended
December 31, 2016 and on Form 10-Q
for the quarter ending June 30, 2017.
The Company does not undertake to update these forward-looking
statements.
Please visit www.neurotropebioscience.com for further
information.
Contact information:
Investors
Jeffrey Benison, Director of Corporate Communications
Neurotrope Bioscience, Inc.
973.242.0005 Ext. 101
jbenison@neurotropebioscience.com
Media
James Heins
Senior Vice President
ICR Healthcare
203.856.2121
james.heins@icrinc.com
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SOURCE Neurotrope, Inc.