TORONTO, CANADA – Cynapsus Therapeutics Inc. (CTH: TSX-V), a specialty pharmaceutical company developing the only oral formulation of the only approved drug (apomorphine) for the rescue of “off” episodes in Parkinson’s disease, today announced its results for the three and six months ended June 30, 2012. Unless specified otherwise, all amounts are in Canadian dollars.
“In the second quarter our team continued to focus on de-risking and progressing our APL-130277 sublingual thin film strip,” said Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. “Of particular significance, activities in the second quarter resulted in one of our most important accomplishments to date – a grant of USD $947,925 from The Michael J. Fox Foundation (MJFF), which was announced on August 8, 2012. The ability of our team to meet the MJFF’s stringent internal and external review of our project is a great achievement. The second quarter also included the addition of Dr. Perry Molinoff and Dr. Abraham Lieberman to the Board of Directors and Clinical Advisory Board, respectively. Their deep scientific knowledge and experience will be a great asset to the Company going forward. Finally, the second quarter also saw the commencement of a second pilot clinical study, CTH-102, which helped us obtain critical information for the sublingual thin film strip configuration. With support from the MJFF, we will now study APL-130277 in a more robust Comparative Biostudy (CTH-103) planned for Q4 2012. This CTH-103 study is designed to mirror the design and conditions of our registration Bioequivalence Study, but on a smaller scale. We look forward to reporting further progress by year end, and remain focused on raising additional capital to fund the critical Bioequivalence Study scheduled for the first half of 2013.”
• Cash at June 30, 2012 of $75,135 (December 31, 2011: $294,812).
• Subsequent to quarter end, on July 18, 2012, the Company announced the closing of a non-brokered private placement raising gross proceeds of $100,000.
• Subsequent to quarter end, 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.
• Net loss of $992,118 for the three months ended June 30, 2012 (June 30, 2011: Net loss of $811,044).
• Report 135,487,219 common shares outstanding at June 30, 2012 (December 31, 2011: 131,743,219).
The following achievements were made during the quarter:
Cynapsus applied for a grant from The Michael J. Fox Foundation (MJFF) to support clinical studies to develop APL-130277. Based on activities in the second quarter, on August 8, 2012, subsequent to the quarter end, the Company announced that it has been awarded a grant of USD $947,925 from 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 added an additional expert to the Clinical Advisory Board (“CAB”). On April 23, 2012, the Company announced that it has appointed Dr. Abraham Lieberman to the CAB. Dr. Lieberman is the current Director of the Muhammad Ali Parkinson Center and Movement Disorder Clinic of the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, Arizona.
Cynapsus engaged a United States focused investor awareness and relations firm. On May 17, 2012, the Company announced that it has retained JSDC, Inc. ("JSDC") to provide investor relations services for the Company. JSDC will undertake to use its well-established relationships with the institutional and retail investment communities to assist the Company in fostering productive, continuing relationships with analysts, brokers, potential investors, and other financial professionals, as well as to manage information flow to the Company's current shareholders.
Cynapsus added two new Directors to its Board of Directors. On May 30, 2012, the Company announced that Dr. Perry Molinoff and Anthony Giovinazzo were named as candidates to join its Board of Directors at the May 30, 2012 Annual and Special Meeting of Shareholders. At the meeting, Mr. Giovinazzo and Dr. Molinoff were nominated and elected to the Board, along with Mr. Ronald Hosking, Dr. Julia Levy, Dr. Alan Ryley, Ms. Rochelle Stenzler and Mr. Alan Torrie.
Cynapsus commenced a second human volunteer pilot proof-of-concept clinical trial of APL-130277. During the quarter, the Company began work on a second Phase 1 healthy human volunteer pilot study. The results of the first study (CTH-101) were reported on January 10, 2012. This second pilot 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 our first 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 (see August 8, 2012 press release).
Cynapsus commenced activities for a Comparative Biostudy (CTH-103) of APL-130277. Subsequent to the end of the second quarter, the Company began work on 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 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 bio-equivalent registration trial to support an FDA 505(b)(2) US New Drug Application in 2015.
In addition, effective August 29, 2012, the Company granted stock options to acquire 812,500 common shares. The stock options were granted to directors, an officer and a consultant of the Company at an exercise price equal to $0.10 per share and with an expiry of 5 years.
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About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson’s disease. Over one million people in the United States 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 the IMPACT Registry Study and the results of Cynapsus’ Global 500 Neurologists Survey, 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’ lead drug candidate, APL-130277, is an easy-to-administer, fast-acting and oral reformulation of an approved drug, apomorphine, used to rescue patients from “off” episodes. Cynapsus is focused on rapidly 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 out-licensing to an appropriate pharmaceutical partner before such an application is submitted.
More information about Cynapsus (CTH: TSX-V) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
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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 and Uncertainties” in “Management's Discussion and Analysis of Operating Results and Financial Condition” for the year ended December 31, 2011, 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.