SOURCE: Cynapsus Therapeutics Inc.

March 07, 2011 08:05 ET

Cynapsus Therapeutics Announces Fourth Quarter and Full-Year 2010 Financial Results and Recent Developments

TORONTO--(Marketwire - March 7, 2011) - Cynapsus Therapeutics Inc. (CTH: TSX-V), 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 year ended December 31, 2010. Unless specified otherwise, all amounts are in Canadian dollars.

In announcing the results, Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus said: "Since my appointment as President and CEO in November 2009, my strategy has been to build significant value over a three year period, and in the 3rd or 4th year, have this value realized for the benefit of all shareholders. This vision has not changed. I am pleased to report that in 2010 we have accomplished a number of important objectives, highlighted by the in- licensing of a Parkinson's drug candidate and the commencement of research activities. 2011 will most likely be a critical turning point for Cynapsus. We have a number of important newsflow events expected in 2011 and look forward to updating shareholders with news of our progress."

Financial Highlights

* Cash and cash equivalents at December 31, 2010 of $193,484 (December 31, 2009: $483,197).

* Subsequent to year end, on January 28, 2011, the Company announced the completion of a debenture financing for net proceeds of $276,000.

* Subsequent to year end, on February 3, 2011, the Company announced the completion of a non-brokered private placement financing for gross proceeds of $290,000.

* Net loss of $1,439,782 for the year ended December 31, 2010 (December 31, 2009: Net loss of $1,751,107)

* Report 93,359,219 common shares outstanding at December 31, 2010 (December 31, 2009: 89,665,219).

Operational Highlights

The following achievements were made during the year:

* Cynapsus entered into a License Option Agreement with Adagio Pharmaceuticals. On July 26, 2010, Cynapsus announced that it finalized and entered into a License Option Agreement with Adagio Pharmaceuticals Ltd. granting Cynapsus the option to execute a proposed exclusive, worldwide agreement to license all intellectual property relating to APL-130277, a reformulation of an approved Parkinson's drug. The two parties also finalized an exclusive worldwide license that would result in Cynapsus assuming product development and commercialization rights to APL-130277 from Adagio in return for development milestones and royalties to Adagio, including common shares of Cynapsus. On September 14, 2010 Cynapsus issued 750,000 common shares to Adagio based on a price of $0.10 per share.

* Cynapsus announced the results of a Parkinson's Disease Survey. On July 27, 2010, Cynapsus announced the results of a survey of neurologists and movement disorder specialists related to Parkinson's Disease ("PD") practices and treatments, specifically targeted at analyzing the use of apomorphine products. An independent, experienced, medical survey company in the United States questioned 50 neurologists in the US and Europe, who collectively treat approximately 12,000 Parkinson's patients for motor fluctuations. The data indicate that the majority of neurologists surveyed believe that Cynapsus' less-invasive, sublingual formulation of apomorphine (APL 130277), compared to the injectable form available in many markets, could be useful in the treatment of PD.

* Cynapsus announced the addition of Dr. Albert Agro to the Parkinson's Program Team. On July 29, 2010, Cynapsus announced that it has entered into an agreement with Dr. Albert Agro, an international clinical development expert in CNS diseases, for a portion of his time. Dr. Agro will focus on the development of Cynapsus' Parkinson's program and, subject to further financings in 2010, will join the company as Chief Medical Officer, with a more significant time commitment.

* Cynapsus announced the formation of a Clinical Advisory Board for its Parkinson's Program. On August 5, 2010, Cynapsus announced the formation of an international Clinical Advisory Board ("CAB"). The CAB, which is made up of world class knowledge expert physicians, including Dr. Warren Olanow and Dr. Fabrizio Stocchi, will provide counsel and guidance on a range of clinical design and management issues.

* Cynapsus announced survey results forecasting favourable acceptance of APL 130277 for Parkinson's, by US HMOs and Insurers. On November 8, 2010, Cynapsus announced that it had received favourable results from a survey conducted by a leading independent healthcare market research group. The survey results forecast favourable acceptance of APL 130277 by United States Health Maintenance Organizations (HMO) and insurers as well as an attractive range of pricing for the product from a reimbursement perspective.

* Cynapsus Announced Positive Proof of Concept Results in Animals for APL 130277. On December 2, 2010 Cynapsus announced that it successfully completed these studies ahead of schedule, with positive results. Cynapsus reported that its thin-strip prototypes dissolve rapidly under the tongue in a reasonable period of time achieving the targeted Tmax. In addition, Cynapsus has shown that its thin-strip prototypes deliver appropriate quantities of drugs to the blood stream achieving targeted AUC and Cmax. Cynapsus has achieved blood levels and a pharmacokinetic (PK) profile that are very similar to the FDA-approved injectable delivery of apomorphine hydrochloride.

* Cynapsus Signed Engagement Letter With Summer Street Research Partners to Provide Financial and Advisory Services. On December 15, 2010, Cynapsus announced that it has retained Summer Street Research Partners ("Summer Street") to provide financial and advisory services. Summer Street will serve as Cynapsus' exclusive advisor on any potential financing, partnering, merger, or acquisition transactions.

* Cynapsus Announced the Signing of a Definitive License Agreement. On December 31, 2010, Cynapsus executed a Definitive License Agreement with IntelGenx Corp. ("IntelGenx"), its former development partner, whereby IntelGenx agrees to pay a royalty on future sales of the INT0010 (formerly Relivar), a buccal/sublingual formulation of THC (dronabinol) for the symptomatic management of Multiple Sclerosis induced neuropathic pain and other conditions.

In addition, effective March 4, 2011, the Corporation granted stock options to acquire 750,000 common shares. The stock options will be granted to directors of the Corporation at an exercise price equal to $0.10 per share and with an expiry of 5 years. Of the total, 200,000 stock options will be granted to each of Anthony Giovinazzo (President & CEO) and Andrew Williams (COO/CFO), 150,000 to Nathan Bryson (CSO), and 100,000 to Alan Ryley (Director).

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 an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson's disease. The prevalence of Parkinson's disease, a chronic and progressive neurodegenerative disease that impacts motor activity, is increasing with the aging of the population. Current medications only control the disease's symptoms; however, these treatments become less effective over time as the disease progresses. Between 25 percent and 50 percent of patients experience episodes in which they cannot move or talk. 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 these episodes. The company is focused on rapidly maximizing the value of APL-130277 by advancing it to pivotal studies in advance of a New Drug Application expected to be completed by the end of 2013, followed by out-licensing to an appropriate pharmaceutical partner. More information about Cynapsus (CTH: TSX-V) is available at www.cynapsus.ca.

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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Source: Cynapsus Therapeutics Inc. via Thomson Reuters ONE

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Contact Information

  • Contact Information

    Cynapsus Therapeutics
    Andrew Williams
    COO & CFO
    (416) 703-2449 x253
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    Derek Moates
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    Robert E. Flamm, Ph.D.
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