Neurotrope Provides Business Update and Reports Second Quarter 2017 Financial Results
NEW YORK – August 9, 2017 – 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.
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.
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.
Jeffrey Benison, Director of Corporate Communications
Neurotrope Bioscience, Inc.
973.242.0005 Ext. 101
Senior Vice President