Cynapsus Therapeutics Inc.

Cynapsus Therapeutics Inc.

August 22, 2011 16:30 ET

Cynapsus Therapeutics Announces Second Quarter 2011 Financial Results and Recent Developments

TORONTO, ONTARIO--(Marketwire - Aug. 22, 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 six months ended June 30, 2011. The second quarter of 2011 represents the Company's second reporting period under International Financial Reporting Standards (IFRS). Unless specified otherwise, all amounts are in Canadian dollars.

"We had several major events in the quarter," said Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. "During the second quarter, we had a successful Pre-IND meeting with the US FDA to discuss preliminary clinical plans for APL-130277. In addition, we advanced our proposed acquisition of Adagio Pharmaceuticals, which is a critical piece of the ongoing development of the business, which is now expected to close on or around November 15, 2011. Finally, we completed further testing on our Parkinson's drug candidate formulation, resulting in a substantially complete clinical formulation that will be used in our first human clinical trials expected to start later this year. 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

  • Cynapsus completed a debenture financing in May for net proceeds of $460,000.
  • Cash and cash equivalents at June 30, 2011 of $185,992 (December 31, 2010: $193,484).
  • Net loss of $811,044 for the three months ended June 30, 2011 (June 30, 2010: Net loss of $429,703).
  • Report 102,103,219 common shares outstanding at June 30, 2011 (December 31, 2010: 93,359,219).

Recent Developments

Successful Meeting with US Food and Drug Administration (FDA)

On April 20, 2011, Cynapsus held a successful Pre-IND Meeting with the US FDA in Washington, DC, to discuss preliminary clinical plans for APL-130277, an apomorphine thin film strip formulation for the rescue of patients experiencing "OFF" periods in Parkinson's disease. The outcome of the meeting was positive, and the Company expects to enter its first human clinical trials of APL-130277 in the second half of 2011.

Proposed Acquisition of Adagio Pharmaceuticals

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. On August 17, 2011, subsequent to the quarter end, Cynapsus confirmed that it intends to proceed with the acquisition of Adagio as previously announced on April 26, 2011 (the "Proposed Transaction"). It is currently anticipated that the proposed transaction will be completed on or around November 15, 2011.

Improved APL 130277 Prototypes

In the second quarter, Cynapsus continued refinement of the APL-130277 prototypes in collaboration with an experienced cGMP thin-film manufacturer. Key improvements include advances in processing methodology, further increasing the speed of dissolution and the rate of absorption of the main active pharmaceutical ingredient, apomorphine hydrochloride. As a result, Cynapsus has a new lead-product candidate with a pharmacokinetic (PK) profile that is nearly identical to that of the FDA-approved injectable delivery of apomorphine hydrochloride. These results are important as they support our premise that APL-130277 thin-film strips provide efficacious serum levels that match closely the US FDA criteria for a 505(b)(2) submission.

Stock Option Grant

Effective August 19, 2011, the Corporation granted stock options to acquire 400,000 common shares. The stock options will be granted to Andrew Williams (COO/CFO) at an exercise price equal to $0.10 per share and with an expiry of 5 years. These stock options were issued to replace previously granted stock options that expired after 5 years.

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 and at the System for Electronic Document Analysis and Retrieval (SEDAR) at

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 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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