Cynapsus Therapeutics Inc.
TSX VENTURE : CTH

Cynapsus Therapeutics Inc.

November 10, 2011 16:00 ET

Cynapsus Therapeutics Announces Third Quarter 2011 Financial Results and Recent Developments

TORONTO, ONTARIO--(Marketwire - Nov. 10, 2011) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH), a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson's disease, today announced its results for the nine months ended September 30, 2011. The third quarter of 2011 represents the Company's third reporting period under International Financial Reporting Standards (IFRS). Unless specified otherwise, all amounts are in Canadian dollars.

"During the third quarter, we continued our preparations for the APL 130277 single dose human proof of concept ("SDHPOC") study," said Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. "In addition, we also reaffirmed out commitment to close the proposed acquisition of Adagio Pharmaceuticals, which is a critical piece of the ongoing development of the business. The shareholder meeting to vote on the acquisition has been set for November 30, 2011, and the transaction is expected to close before year end. We look forward to reporting further progress on the Parkinson's program by year end, and remain focused on raising additional capital to fund further advances over the next 18 months."

Financial Highlights

  • Cash and cash equivalents at September 30, 2011 of $453,769 (December 31, 2010: $193,484).
  • Subsequent to the quarter end, on November 8, 2011, the Company announced the completion of a debenture financing for net proceeds of $150,000.
  • Net loss of $476,690 for the three months ended September 30, 2011 (September 30, 2010: Net loss of $401,793).
  • Report 103,803,219 common shares outstanding at September 30, 2011 (December 31, 2010: 93,359,219).

Recent Developments

Human Proof of Concept ("SDHPOC") Study

In the third quarter, Cynapsus continued preparations for the planned single dose human proof of concept ("SDHPOC") study. The goal is to obtain top line data in man that demonstrates fast-absorption and a Tmax comparable to the injectable form of the drug (Apokyn). Data acquired in the pilot study will define the parameters of a subsequent Phase 1 bioequivalence trial that compares the pharmacokinetics of sublingual APL-130277 to Apokyn as defined by section 505(b)(2) of the Federal Food, Drug and Cosmetic Act enforced by the United States Food and Drug Administration. This is a significant milestone and de-risking event for the project. It is currently expected that the SDHPOC study will be completed in next 60-90 days.

Proposed Acquisition of Adagio Pharmaceuticals

On August 17, 2011, Cynapsus confirmed that it intends to proceed with the acquisition of Adagio as previously announced on April 26, 2011 (the "Proposed Transaction"). On April 26, 2011, Cynapsus announced that it entered into a preliminary agreement with Adagio Pharmaceuticals Ltd. providing for the acquisition by Cynapsus of all of the issued and outstanding shares of Adagio in a share exchange. The acquisition would supersede and replace the License Option Agreement dated July 22, 2010 entered into by Cynapsus and Adagio with respect to the intellectual property owned by Adagio concerning the world-wide APL-130277 patent rights and know-how. The APL-130277 patent rights and know how are critical to the Corporation's long term objectives. The acquisition will ensure ownership of those rights by the Corporation and also align the interests of Adagio's senior management with those of the Corporation. It is expected that the proposed transaction will be completed on or around December 31, 2011.

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. 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. 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' 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 2013 or 2014. The Company anticipates out-licensing to an appropriate 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 press release 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 Cynapsus' current 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.

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