TORONTO, ONTARIO--(Marketwired - March 27, 2014) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH)(OTCQX:CYNAF), a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of "off" motor symptoms of Parkinson's disease, today announced its results for the year ended December 31, 2013. Unless specified otherwise, all amounts are in Canadian dollars.
Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, stated: "2013 was a pivotal year for Cynapsus. The year was highlighted by completion of our CTH-103 study, which was funded by The Michael J. Fox Foundation for Parkinson's Research, as well as the closing of a $7.3 million financing and the conversion of $4 million of debt to equity. We are now focused on the completion of the CTH-104 study, preparations for an Investigational New Drug Application to the U.S. FDA, and planning for additional clinical studies later this year. Interim results for the CTH-104 study will be announced shortly, with final results expected within the next 15 to 30 days. We look forward to reporting our progress."
- Cash and cash equivalents on hand at December 31, 2013 of $2,289,046 (December 31, 2012: $50,401).
- Subsequent to year end, in January, February and March 2014, 1,252,602 warrants were exercised to acquire 1,252,602 common shares for gross proceeds of $725,496.
- Net loss of $4,433,287 for the year ended December 31, 2013 (December 31, 2012: Net loss of $3,063,806).
- Report 38,884,009 common shares outstanding at December 31, 2013 (December 31, 2012: 14,214,922 common shares).
The following achievements were made during 2013:
- Cynapsus raised $6 million in a first closing of a short form prospectus offering, exchanged $4 million of debt for equity, and completed a 10:1 share consolidation. On March 1, 2013, the Corporation announced that it completed a first closing of a short form prospectus offering of units for gross proceeds of $6,008,376. Concurrent with the closing of the Offering, the Corporation and the holders of Series A to E debentures agreed to convert $4,030,244 in debt for common shares and warrants. In addition, the Corporation completed a share consolidation of the Corporation's issued and outstanding common shares on the basis of one (1) new common share for every ten (10) common shares issued and outstanding.
- Cynapsus raised $1.3 million in a second closing of a short form prospectus offering. On March 21, 2013, the Corporation announced that it completed a second closing of its short form prospectus offering of units for gross proceeds of $1,309,160. Total gross proceeds from the First Closing and the Second Closing of the Offering are equal to $7,317,160.
- Cynapsus announced the appointment of two new Directors to the Board. On May 9, 2013, the Corporation announced that Tomer Gold, the current Vice President, Research & Development of Dexcel Pharma ("Dexcel"), and Ilan Oren, currently Vice President, Business Development at Dexcel, joined its Board of Directors.
- Cynapsus published a white paper on apomorphine for "Off" periods in Parkinson's Disease and its alternative delivery development candidate APL-130277. On May 15, 2013, the Corporation announced that it had completed a white paper providing background clinical information on apomorphine. The paper identifies the potential benefits of APL-130277, the Corporation's proprietary, patented, sublingual thin-film strip system, specifically its ability to deliver apomorphine to patients in a more convenient and more well-tolerated manner.
- Cynapsus began trading on the OTCQX International in the United States. On July 18, 2013, the Corporation announced that its common shares were approved for trading in the United States on the OTCQX ("OTCQX"). Trading commenced immediately on OTCQX under the symbol CYNAF. The Corporation continues to trade on the TSX Venture Exchange under the symbol CTH.
- Cynapsus announced top-line data for the CTH103 clinical trial. Subsequent to year end, on January 13, 2014, Cynapsus announced positive top line data of the Comparative Biostudy (CTH-103) of APL-130277. The CTH-103 study was planned as a three-dose active comparator, placebo-controlled, randomized cross-over trial to examine the pharmacokinetic profile of sublingual administered APL-130277 compared to the subcutaneous injection of apomorphine in healthy volunteers. The 10mg and 15mg APL-130277 sublingual thin-film strips were crossed over to 2mg and 3mg subcutaneous injections. The intent in the CTH-103 study for the third cohort was to compare the 25mg sublingual thin film strip to the 4mg subcutaneous injection, but this third cohort could not be dosed due to the dose-limiting adverse events experienced with the 3mg subcutaneous injection. The Corporation is currently conducting the single arm, healthy volunteer pharmacokinetic study (CTH-104) to look at the 25mg APL-130277 sublingual strip without a crossover to the injection. Interim results will be announced shortly, with final results expected within the next 15 to 30 days.
- Cynapsus announced the appointment of Nan Hutchinson to the Board of Directors. Subsequent to year end, on February 13, 2014, Cynapsus announced the appointment of a new director, Nan Hutchinson, who has more than twenty-five years of pharmaceutical experience spanning all aspects of commercialization, including strategic planning, marketing, business development, sales leadership, talent identification and development.
Critical Next Steps
For development of APL-130277 in the United States, the Corporation will follow the 505(b)(2) regulatory pathway. Specifically, the Corporation is pursuing the reformulation of apomorphine from a subcutaneous injection to a convenient and more tolerable and safe sublingual thin film strip. The drug being delivered (apomorphine) is identical to the drug used in the injection, and its use will be intended as an acute rescue therapy for Parkinson's patients experiencing acute, intermittent hypomobility (i.e. "off" episodes) associated with advanced Parkinson's disease, which is the description of the use of apomorphine in the current US approved label.
The 505(b)(2) pathway will require that the Corporation provide statistically sufficient clinical evidence that Parkinson's patients experience management of their "off" episodes, as a result of delivery of apomorphine via the sublingual thin film strip route. The primary end point will be based on changes in the Unified Parkinson's Disease Rating Scale Part III (UPDRS III) movement score. In addition, the Corporation will be required to provide in a separate study, statistically sufficient clinical evidence that administering apomorphine via a sublingual thin film route results in Parkinson's patients experiencing low to no oral irritation as a result of multiple daily exposures to the drug for an extended period.
To achieve this, the Corporation currently expects to complete the following clinical studies:
- CTH-105 Pilot Study. A pilot study in patients with Parkinson's disease who are naïve to the use of apomorphine and who experience at least one daily "off" episode with a total duration of "off" in any 24-hour period of at least 2 hours. This study is planned to examine the effect of APL-130277 on relieving "off" episodes over a single day with a dose-titration used to determine dose strengths necessary for future clinical development. The CTH-105 study is expected to begin in mid-2014 subsequent to the acceptance of an Investigational New Drug (IND) application by the FDA. CTH-105 is expected to be completed by the end of Q3 2014.
- CTH-200 Bridging Study. A single dose, crossover comparative bioavailability and PK study in healthy volunteers. This study is designed to provide the clinical "bridge" to the FDA's finding of safety and efficacy for the Reference Listed Drug (s.c. Apomorphine). The CTH-200 Bridging Study is expected to begin in mid-2014 subsequent to completion of CTH-105. It is expected to be complete by end of Q3 2014 and is required under the FDA's 505(b)(2) regulations to demonstrate comparability to the reference listed drug.
- CTH-300a Efficacy Study in apomorphine naïve patients. A double-blind, placebo-controlled, parallel-design study with Parkinson's patients who have at least one "off" episode every 24 hours, with total "off" time of at least 2 hours. The primary end point will be the change in the UPDRS III score.
- CTH-300b Efficacy Study in apomorphine experienced patients. A double blind, placebo controlled, crossover-designed study with Parkinson's patients who are presently controlled with the use of apomorphine. The primary end point will be the change in the UPDRS III score. Upon successful completion of CTH-300a and CTH-300b, the Corporation will provide the results to the FDA and request a meeting to seek final guidance for the design of Safety Study (CTH-301).
- CTH-301 Safety Study. A long-term safety study in apomorphine naïve Parkinson's patients who have at least one "off" episode every 24 hours, with total "off" time of at least 2 hours. The Safety Study is expected to start in early 2015 and be completed by the end of 2015. The study will specifically look at the safety and tolerability of the new delivery route over a minimum period of 16 weeks.
The above clinical development plan has been vetted with both clinical experts and regulatory consultants who have expertise in overseeing FDA 505(b)(2) submissions to the Agency.
In parallel to the studies described above, the Corporation will be performing the necessary scale-up, process validation and stability as part of the Chemistry, Manufacturing and Controls ("CMC") requirements for the filing of the NDA. Accordingly, all development will be performed according to current Good Manufacturing Practices ("cGMP") methodology.
Upon completion of the efficacy and safety studies, as well as the CMC section, the Corporation expects to begin the preparation of a FDA 505(b)(2) NDA in 2016.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of "off" motor symptoms of Parkinson's disease. Cynapsus' drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is the only approved drug (in the United States, Europe, Japan and other countries) 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 ("NDA") expected to be submitted in 2016.
Over one million people in the U.S. and an estimated 4 to 6 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.
More information about Cynapsus (TSX VENTURE:CTH)(OTCQX:CYNAF) 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 securities laws. 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 latest Annual Information Form 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.
Neither of the TSX Venture Exchange or OTCQX has approved or disapproved the contents of this press release.