Cynapsus Therapeutics Reports Second Quarter 2015 Financial Results and Recent Developments
(firmenpresse) - TORONTO, ONTARIO -- (Marketwired) -- 08/14/15 -- Cynapsus Therapeutics Inc. (NASDAQ: CYNA)(TSX: CTH) ("Cynapsus" or the "Company"), a specialty Central Nervous System ("CNS") pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson''s disease ("PD"), today announced financial results for the three and six months ended June 30, 2015. Unless specified otherwise, all amounts are in Canadian dollars.
"In the first six months of 2015, we have made significant progress advancing our strategic plan, including work related to the commencement of Phase 3 clinical trials for APL-130277. Importantly, we also raised gross proceeds of approximately $110 million through the completion of a $21 million private placement in March and an $89 million U.S. Re-IPO in June, the latter of which included a listing on NASDAQ Global Market under the stock symbol ''CYNA''. Looking forward, we remain focused on the completion of Phase 3 bridging, efficacy and safety studies of APL-130277 over the next 12 to 16 months, as well as pre-approval commercialization efforts in the U.S. market, and initial regulatory and clinical activities for European market registration," stated Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus.
Financial Highlights
Operational Highlights
Results of Annual and Special Meeting of Shareholders
In respect of the Annual and Special Meeting of shareholders of the Company held on May 7, 2015 (the "Meeting"), the following sets forth a brief description of each matter which was voted upon at the Meeting and the outcome of the vote:
About Cynapsus
Cynapsus is a specialty CNS pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand turning ON of debilitating OFF episodes associated with PD. The Company recently completed a Phase 2 clinical trial for its lead product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a "turning ON" medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit a new drug application in 2016.
Forward-Looking Statements
This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, our focus on completing Phase 3 studies of APL-130277 over the next 12 to 16 months, pre-approval commercialization efforts in the U.S. and European market registration. These forward-looking statements include information about possible or assumed future results of the Company''s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company''s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption "Risk Factors" in the Company''s Form 10-Q filed with the United States Securities and Exchange Commission (the "SEC") on August 14, 2015 and its other filings and reports in the United States with the SEC available on the SEC''s web site, and in Canada with the various Canadian securities regulators, which are available online at . Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.
Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.
Contacts:
Cynapsus Therapeutics Inc.
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
Cynapsus Therapeutics Inc.
Andrew Williams
COO & CFO
(416) 703-2449 x253
Russo Partners LLC
Matt Middleman
(212) 845-4272
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Datum: 14.08.2015 - 14:00 Uhr
Sprache: Deutsch
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