TORONTO, ONTARIO--(Marketwire - Nov. 15, 2012) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH), a specialty pharmaceutical company developing the only non-injectable (i.e. sublingual) delivery of the only approved drug (apomorphine) for the rescue of "off" episodes in Parkinson's disease, today announced its results for the three and nine months ended September 30, 2012. Unless specified otherwise, all amounts are in Canadian dollars.
"In the third quarter our team achieved one of our most important accomplishments to date - a grant of USD $947,925 from The Michael J. Fox Foundation (MJFF)," said Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. "The ability of our team to meet the MJFF's stringent internal and external review of our project is a great achievement. With support from the MJFF, we will now study APL-130277 in a more robust Comparative Biostudy (CTH-103). The CTH-103 study is designed to mirror the design and conditions of our registration Bioequivalence Study, but on a smaller scale. In order to fund the Bioequivalence Study, the Company is currently working to raise $7 million by way of a short form prospectus offering for institutional investors. The closing is currently expected to be completed on or about December 15, 2012. We look forward to reporting further progress over the next 30 days."
- Cash at September 30, 2012 of $287,188 (December 31, 2011: $294,812).
- On July 18, 2012, the Company announced the closing of a non-brokered private placement raising gross proceeds of $100,000.
- On August 8, 2012, the Company announced that it has been awarded a grant of USD $947,925 from the Michael J. Fox Foundation. Funds awarded by MJFF are to be used solely for the Comparative Biostudy and are conditioned by meeting certain milestones and deliverables.
- Subsequent to the end of the third quarter, on October 24, 2012, the Company announced the closing of a brokered private placement raising gross proceeds of $170,000.
- Net loss of $641,123 for the three months ended September 30, 2012 (September 30, 2011: Net loss of $476,690)
- Report 140,887,219 common shares outstanding at September 30, 2012 (December 31, 2011: 131,743,219).
The following achievements were made during the quarter:
Cynapsus was awarded a grant from The Michael J. Fox Foundation to support clinical studies to develop APL-130277. On August 8, 2012 the Company announced that it has been awarded a grant of USD $947,925 from the MJFF. The grant was awarded under the Foundation's Edmond J. Safra Core Programs for Parkinson's Research, Clinical Intervention Awards aimed at supporting human clinical trials testing promising Parkinson's therapies that may significantly and fundamentally improve treatment for people with Parkinson's.
Cynapsus completed a second human volunteer pilot proof-of-concept clinical trial (CTH-102) of APL-130277. The results of the first study (CTH-101) were reported on January 10, 2012. The CTH-102 study was closed out in August 2012 after it was determined that the goal of finding a therapeutic dose had been reached. The first dose evaluated in the study was deemed to be dose proportional to the dose evaluated in the CTH-101 clinical pilot study and achieved a pharmacokinetic profile (Cmax, AUC and Tmax) that was sufficiently similar to subcutaneous injectable apomorphine. Management decided that it was unnecessary to proceed with a second dose, and then began preparations for a Comparative Biostudy (CTH-103) to be funded by the MJFF.
Cynapsus commenced activities for a Comparative Biostudy (CTH-103) of APL-130277. In the third quarter, the Company began work on CTH-103, a placebo-controlled, randomized cross-over Phase 1 trial in healthy volunteers to examine the pharmacokinetic profile of multiple dose strengths of APL-130277 as compared to equivalent doses of apomorphine subcutaneous injection. The study is expected to be completed in Q1 2013. The objective of this study is to directly compare the pharmacokinetic profile of APL-130277 to subcutaneous apomorphine in healthy subjects to more precisely design the subsequent Bioequivalence Study. The Bioequivalence Study is expected to be completed by the fall of 2013.
Cynapsus signed a term sheet for a $7 million short form prospectus offering. Based on efforts in the third quarter, on October 3, 2012, the Company announced that it signed a term sheet with a Health Care / Life Sciences focused Institutional Investment Group to be the lead investor in a short form prospectus offering of $7 million of its common shares and warrants. The closing is expected to be completed on or about December 15, 2012.
Stock Option Grant
Effective November 14, 2012, the Company granted stock options to acquire 462,500 common shares. The stock options were granted to a consultant of the Company at an exercise price equal to $0.10 per share and with an expiry of 5 years.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing the only non-injectable (i.e. sublingual) delivery of the only approved drug (apomorphine) to be used as a rescue therapy for "off" motor symptoms of Parkinson's disease. Over one million people in the U.S. and an estimated 5 million people globally suffer from Parkinson's disease. Parkinson's disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. Based on a recent study and the results of the Company's Global 500 Neurologists Survey, it is estimated that between 25 percent and 50 percent of patients experience "off" episodes in which they have impaired movement or speaking capabilities. Current medications only control the disease's symptoms, and most drugs become less effective over time as the disease progresses.
Cynapsus' drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is approved in an injection formulation to rescue patients from "off" episodes. Cynapsus is focused on maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2015. Cynapsus anticipates a trade sale or out-licensing to an appropriate global pharmaceutical partner before such an application is submitted.
More information about Cynapsus (TSX VENTURE:CTH) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
Forward Looking Statements
This announcement contains "forward-looking statements" within the meaning of applicable Canadian securities legislation. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes" or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will be taken", "occur" or "be achieved". Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Cynapsus to be materially different from those expressed or implied by such forward-looking statements, including but not limited to those risks and uncertainties relating to Cynapsus' business disclosed under the heading "Risk Factors" in its Annual Information Form filed on November 1, 2012 and its other filings with the various Canadian securities regulators which are available online at www.sedar.com. Although Cynapsus has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Cynapsus does not undertake to update any forward-looking statements, except in accordance with applicable securities laws.
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