|By Marketwired .||
|May 7, 2014 05:31 PM EDT||
TORONTO, ONTARIO -- (Marketwired) -- 05/07/14 -- Cynapsus Therapeutics Inc. (TSX VENTURE: CTH)(OTCQX: CYNAF), a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of "off" motor symptoms of Parkinson's disease, today announced its results for the three months ended March 31, 2014. Unless specified otherwise, all amounts are in Canadian dollars.
Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, stated: "The first quarter of 2014 has been pivotal in establishing the foundation for Cynapsus to complete the next de-risking steps for the remainder of the year. The completion of the CTH-103 and CTH-104 clinical studies in the quarter, as well as the closing of a $25,000,000 financing in April, were significant accomplishments. Management is now primarily focused on the execution of the following three clinical studies: (1) the CTH-105 pilot study in patients with Parkinson's disease in Q3 2014; (2) the CTH-200 bioavailability study in Q3-Q4 2014; and (3) the CTH-300a efficacy study in apomorphine naive patients by the end of Q4 2014. We look forward to reporting our progress."
-- Cash and cash equivalents on hand at March 31, 2014 of $1,259,058 (December 31, 2013: $2,289,046). -- Subsequent to the end of the quarter, on April 15, 2014, the Company announced the closing of a short form prospectus offering for aggregate gross proceeds of $25,000,000. -- Net loss of $1,210,272 for the three months ended March 31, 2014 (March 31, 2013: Net loss of $351,593). -- Report 78,618,149 common shares outstanding at March 31, 2014 (December 31, 2013: 38,884,009 common shares).
The following achievements were made during the first three months of 2014:
-- Cynapsus announced results for the CTH-103 clinical trial. On January 13, 2014, Cynapsus announced positive top line data of the Comparative Biostudy (CTH-103) of APL-130277. The CTH-103 study was designed as a three-dose (10mg, 15mg and 25mg) active comparator, placebo-controlled, randomized cross-over trial to examine the pharmacokinetic profile of sublingual administered APL-130277 compared to (2mg, 3mg and 4mg) subcutaneous injections of apomorphine in healthy volunteers. The 10mg and 15mg APL-130277 sublingual thin film strips were crossed over to 2mg and 3mg subcutaneous injections, with N=15 and N=14 for the two cohorts, respectively. The intent in the CTH-103 study for the third cohort was to compare the 25mg sublingual thin film strip (APL-130277) to the 4mg subcutaneous injection, but this third cohort could not be dosed due to the dose-limiting adverse events experienced with the 3mg subcutaneous injection. The 15mg APL-130277 side effects were mild-to-moderate and not dose limiting. As a result, the Company completed the CTH-104 study, a single arm, healthy volunteer pharmacokinetic study to look at the 25mg APL-130277 sublingual strip (without a crossover to the injection). -- Cynapsus announced the appointment of Nan Hutchinson to the Board of Directors. On February 13, 2014, Cynapsus announced the appointment of a new director, Nan Hutchinson, who has more than twenty-five years of pharmaceutical experience spanning all aspects of commercialization, including strategic planning, marketing, business development, sales leadership, talent identification and development. -- Cynapsus announced results for the CTH-104 clinical trial. On March 28, 2014, Cynapsus announced interim summary results of the CTH-104 study of APL-130277. Final study results were announced on April 24, 2014. CTH- 104 study was a single dose, single arm, placebo-controlled, healthy volunteer pharmacokinetic study, which was designed to examine the pharmacokinetic profile of the 25mg dose of APL-130277. In total, 13 subjects completed the study (11 active and 2 placebo). The results from the CTH-104 study in human healthy volunteers demonstrated dose proportionality of the doses tested in CTH-103 (10mg and 15mg) and CTH- 104 (25mg). In addition, the results of CTH-104 showed that the 25mg dose was sustained over an extended period of time (162 minutes) above the minimal efficacious plasma concentration of apomorphine (approximately 3ng/ml), which is believed to be a level demonstrating symptomatic relief of "off" symptoms. -- Cynapsus announced the completion of a $25 million short form prospectus financing. Subsequent to the end of the first quarter, on April 15, 2014, the Corporation announced that it completed a short form prospectus offering of units for maximum aggregate gross proceeds of $25 million. Cynapsus intends to use the net proceeds from the offering to complete the U.S. clinical development of its Parkinson's drug candidate, APL-130277.
Annual and Special Meeting of Shareholders
Earlier in the day, on May 7, 2014, the Company held its Annual and Special Meeting of Shareholders. The following eight (8) individuals were re-elected as Directors of the Company for the ensuing year: Mr. Anthony Giovinazzo, Mr. Ronald Hosking, Mr. Tomer Gold, Ms. Nan Hutchinson, Dr. Perry Molinoff, Mr. Ilan Oren, Dr. Alan Ryley and Ms. Rochelle Stenzler. McGovern, Hurley, Cunningham, LLP was also re-appointed as the auditors of the Company for the ensuing year to serve at such remuneration as may be fixed by the Board of Directors. In addition, the stock option plan of the Company was approved, including the reservation for issuance of a "rolling" maximum number of 10% of the shares issuable under the stock option plan. The shareholders of the Company also voted in favour of amending the Company's stock option plan to allow for automatic extensions of the expiry date of stock options if the expiry date occurs during a blackout period, which amendment remains subject to the approval of the TSX Venture Exchange.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of "off" motor symptoms of Parkinson's disease. Cynapsus' drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is the only approved drug (in the United States, Europe, Japan and other countries) to rescue patients from "off" episodes. Cynapsus is focused on maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application ("NDA") expected to be submitted in 2016.
Over one million people in the U.S. and an estimated 4 to 6 million people globally suffer from 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. Based on a recent study and the results of the Corporation's Global 500 Neurologists Survey, 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.
Forward Looking Statements
This announcement contains "forward-looking statements" within the meaning of applicable securities laws. 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 its March 26, 2014, 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.
Neither the TSX Venture Exchange nor the OTCQX International has approved or disapproved of the contents of this press release.