TORONTO, ONTARIO--(Marketwired - Aug. 22, 2013) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH)(OTCQX:CYNAF), a specialty pharmaceutical company developing the only oral (sublingual) delivery of the only approved drug (apomorphine) to be used as a rescue therapy for "off" motor symptoms of Parkinson's disease, today announced its results for the six months ended June 30, 2013. Unless specified otherwise, all amounts are in Canadian dollars.
Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, stated: "The second quarter of 2013 was very busy period for us. As previously announced, in March 2013 the Company successfully raised $7.3 million, converted $4 million of debt to equity, and completed a 10:1 share consolidation. These three achievements placed the Company on a much more stable foundation and allowed us to focus on the Michael J. Fox Foundation sponsored CTH103 pilot PK healthy volunteer study of APL-130277, as well as preparations for an Investigational New Drug Application to the US FDA for a clinical bioequivalence study (CTH201). The CTH103 and CTH201 studies are the next critical de-risking milestones that we believe will drive significant shareholder value. The CTH103 study is expected to be completed in Q4 2013, and the CTH201 study is expected to be completed in mid-2014. We look forward to reporting our progress."
- Cash on hand at June 30, 2013 of $4,353,053 (December 31, 2012: $50,401).
- Net loss of $1,324,609 for the six months ended June 30, 2013 (June 30, 2012: Net loss of $1,595,526).
- Report 38,884,009 common shares outstanding at June 30, 2013 (December 31, 2012: 14,214,922 common shares).
The following achievements were made during the first six months of 2013:
- Cynapsus raised $6 million in first closing of short form prospectus offering, exchanges $4 million of debt for equity, and completes 10:1 share consolidation. On March 1, 2013, the Company announced that it completed a first closing of a short form prospectus offering of units for gross proceeds of $6,008,000. Concurrent with the closing of the Offering, the Company 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 Company completed a share consolidation of the Company'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 second closing of short form prospectus offering. On March 21, 2013, the Company 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 accelerated activities for a comparative biostudy of APL-130277. In the second quarter of 2013, the Company continued work on CTH103, 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 Q4 2013. The objective of this study is to directly compare the pharmacokinetic profile of APL-130277 to subcutaneous apomorphine in healthy subjects in order to more precisely design the subsequent Bioequivalence Study (CTH201). The Bioequivalence Study is expected to be completed in mid-2014.
- Cynapsus announced the appointment of two new Directors to the Board. On May 9, 2013, the Company 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. Following the first closing of the short form prospectus offering on March 1st, 2013, the Board of the Company agreed to allow Dexcel to nominate two new directors, subject to TSX Venture Exchange approval. Dexcel nominated Mr. Gold and Mr. Oren, and the Exchange has since reviewed and cleared their Personal Information Forms. Dexcel is a strategic investor in the Company and subscribed for $3,500,000 for 7,608,696 units of the Offering resulting in current ownership of 19.6% and 24.1% of all the issued and outstanding common shares of the Company on a basic and fully diluted basis, respectively. Dexcel is considered a "Control Person" under the policies of the Exchange.
- 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 Company announced that it had completed a white paper providing background clinical information on apomorphine. The paper identifies the potential benefits of APL-130277, the company'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 Marketplace in the United States. On July 18, 2013, subsequent to the end of the second quarter, the Company announced that its common shares were approved for trading in the United States on the OTCQX marketplace ("OTCQX"). Trading commenced immediately on OTCQX International under the symbol CYNAF. The Corporation will continue to trade on the TSX Venture Exchange under its existing symbol CTH.
The TSX Venture Exchange Inc. has not reviewed and does not accept responsibility for the adequacy or accuracy of this press release.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing the only oral (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)(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 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.