Cynapsus Therapeutics Inc.
TSX VENTURE : CTH

Cynapsus Therapeutics Inc.

May 23, 2013 09:28 ET

Cynapsus Therapeutics Reports First Quarter 2013 Financial Results and Recent Developments

TORONTO, ONTARIO--(Marketwired - May 23, 2013) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH), 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, today announced its results for the three months ended March 31, 2013. Unless specified otherwise, all amounts are in Canadian dollars.

Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, stated: "The first quarter of 2013 was transformative. 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 have placed the Company on a much more stable foundation. We are now focused on the completion of 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 (BEQ) study. The CTH103 and BEQ studies are the next critical de-risking milestones that we believe will drive significant shareholder value. We look forward to reporting our progress."

Financial Highlights

  • On March 1, 2013 the Company announced the first closing of the short form prospectus offering for aggregate gross proceeds of $6,008,000.
  • Concurrent with the March 1, 2013 offering, the Company exchanged $4,030,244 in debt for shares and warrants.
  • Concurrent with the March 1, 2013 offering, the Company completed a 10:1 share consolidation.
  • On March 21, 2013, the Company announced the second closing of the short form prospectus offering for aggregate gross proceeds of $1,309,160.
  • Cash on hand at March 31, 2013 of $6,102,093 (December 31, 2012: $50,401).
  • Net loss of $1,504,593 for the three months ended March 31, 2013 (March 31, 2012: Net loss of $603,408).
  • Report 38,844,009 common shares outstanding at March 31, 2013 (December 31, 2012: 14,214,922 common shares).

Operational Highlights

In the first 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 Q3 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. The Bioequivalence Study is expected to commence in early 2014.

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.

The TSX Venture Exchange Inc. has not reviewed and does not accept responsibility for the adequacy or accuracy of this press release.

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