Cynapsus Therapeutics Inc.
TSX VENTURE : CTH

Cynapsus Therapeutics Inc.

November 11, 2010 16:49 ET

Cynapsus Therapeutics Reports Results for the Nine Months Ended September 30, 2010

TORONTO, ONTARIO--(Marketwire - Nov. 11, 2010) - Cynapsus Therapeutics Inc. ("Cynapsus") (formerly Cannasat Therapeutics Inc.) (TSX VENTURE:CTH), a specialty clinical development pharmaceutical company targeting CNS diseases, today announced its results for the nine months ended September 30, 2010. Unless specified otherwise, all amounts are in Canadian dollars.

In announcing the results, Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus said: "The third quarter was a very productive period for the Company, highlighted by the in-licensing of a Parkinson's drug candidate and the commencement of research activities. We also completed two debenture financings that brought some much needed cash into the Company. 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 in 2011."

Operational Highlights

The following achievements were made during the third quarter:

  • 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 relating 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 indicates that the majority of neurologists surveyed believe that Cynapsus' less-invasive, sublingual formulation of apomorphine (APL 130277) 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 provided a research update for its Parkinson's Program. On September 23, 2010, Cynapsus provided an update on the progress of its research activities on its lead drug candidate, APL 130277. Specifically, the Company discussed advances related to Active Pharmaceutical Ingredient (API) Supply, Formulation Development and Product Development and Manufacture. 
  • Cynapsus announced survey results forecasting favourable acceptance of APL 130277 for Parkinson's, by US HMOs and Insurers. On November 8, 2010, subsequent to the quarter end, 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.

Financial Highlights

  • Cynapsus announced the completion of two debenture financings, on July 19, 2010 and August 4, 2010, for net proceeds of $644,000.
  • Cash and cash equivalents at September 30, 2010 of $347,720 (December 31, 2009: $483,197).
  • Net loss of $399,928 for the period ended September 30, 2010 (September 30, 2009: Net loss of $338,931), in line with expectations.
  • Report 92,991,219 common shares outstanding at September 30, 2010 (December 31, 2009: 89,665,219).

In addition, effective November 10, 2010, the Corporation granted stock options to acquire 200,000 common shares. The stock options will be granted to directors at an exercise price equal to $0.10 per share and with an expiry of 5 years. Of the total, 50,000 stock options will be granted to each of Dr. Alan Ryley (Director), Rochelle Stenzler (Director), Alan Torrie (Director) and Donald Ziraldo (Director).

About Cynapsus Therapeutics

Cynapsus is a specialty clinical development pharmaceutical company targeting diseases of the brain. Cynapsus has a lower risk Parkinson's drug candidate ("APL-130277"), which is a reformulation of an approved drug. APL-130277 is designed to address a much larger moderate to severe patient population, which represents close to 50% of Parkinson's patients. Cynapsus also has a proprietary formulation technology for cannabinoid drug candidates, which may be used to treat neuropathic pain associated with multiple sclerosis and cancer, as well as for nausea/vomiting and appetite stimulation.

Cynapsus' strategy is to grow its portfolio of drug candidates through in-licensing and acquisitions, and to advance projects to Phase 2 proof-of-concept clinical studies. Once the drug candidates are sufficiently derisked, Cynapsus intends to out-license the programs to the appropriate pharmaceutical marketing partners for a combination of upfront, milestone, and royalty payments.

More information about Cynapsus (TSX VENTURE:CTH) is available at www.cynapsus.ca.

About APL 130277

Cynapsus is developing APL 130277 as a convenient and fast acting reformulation of FDA-approved apomorphine (a proven dopamine agonist that addresses motor fluctuation for Parkinson's patients). APL 130277 is a reformulation of the currently marketed injection into an oral formulation that will follow an expedited clinical development path of 18-24 months based on the FDA's 505b(2) submission process. In addition to addressing the needs of severe Parkinson's patients who currently have access to only the inconvenient and painful subcutaneous apomorphine injection, APL 130277 has the potential to become adjunctive therapy for moderate Parkinson's patients as well. APL 130277 could be used 2 to 3 times daily to allow for a fast rescue of patients experiencing motor fluctuations in addition to therapy with various forms of levodopa.

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.

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

Contact Information

  • Cynapsus Therapeutics Inc.
    Andrew Williams
    COO & CFO
    (416) 703-2449 (Ext. 253)
    (416) 703-8752 (FAX)
    awilliams@cynapsus.ca