|By Marketwired .||
|May 7, 2014 05:30 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.
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
Feb. 12, 2016 06:00 PM EST Reads: 401
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
Feb. 12, 2016 06:00 PM EST
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee...
Feb. 12, 2016 04:45 PM EST
DevOps is not just last year’s buzzword. Companies with DevOps practices are 2.5x more likely to exceed profitability, market share, and productivity goals. But how do you enable high performance? What can you do right now to start? Find out from DevOps experts including Gene Kim, co-author of "The Phoenix Project," and the Dynatrace Center of Excellence.
Feb. 12, 2016 04:30 PM EST
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
Feb. 12, 2016 04:30 PM EST Reads: 191
SYS-CON Events announced today that Column Technologies will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a global technology solutions provider with over 400 employees, headquartered in the United States with offices in Canada, India, and the United Kingdom. Column Technologies provides “Best of Breed” technology solutions that automate the key DevOps principal...
Feb. 12, 2016 04:15 PM EST
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 12, 2016 04:15 PM EST Reads: 425
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
Feb. 12, 2016 03:00 PM EST
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 12, 2016 02:15 PM EST Reads: 449
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
Feb. 12, 2016 02:15 PM EST
As someone who has been dedicated to automation and Application Release Automation (ARA) technology for almost six years now, one of the most common questions I get asked regards Platform-as-a-Service (PaaS). Specifically, people want to know whether release automation is still needed when a PaaS is in place, and why. Isn't that what a PaaS provides? A solution to the deployment and runtime challenges of an application? Why would anyone using a PaaS then need an automation engine with workflow ...
Feb. 12, 2016 01:45 PM EST Reads: 230
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 12, 2016 01:00 PM EST Reads: 229
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
Feb. 12, 2016 12:30 PM EST Reads: 108
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 12, 2016 12:30 PM EST Reads: 263
CIOs and those charged with running IT Operations are challenged to deliver secure, audited, and reliable compute environments for the applications and data for the business. Behind the scenes these tasks are often accomplished by following onerous time-consuming processes and often the management of these environments and processes will be outsourced to multiple IT service providers. In addition, the division of work is often siloed into traditional "towers" that are not well integrated for cro...
Feb. 12, 2016 12:00 PM EST Reads: 499