Welcome!

News Feed Item

Cynapsus Therapeutics Reports First Quarter 2014 Financial Results and Recent Developments

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."

Financial Highlights


--  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).

Operational Highlights

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.

More information about Cynapsus (TSX VENTURE:CTH)(OTCQX:CYNAF) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.

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.

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
“We're a global managed hosting provider. Our core customer set is a U.S.-based customer that is looking to go global,” explained Adam Rogers, Managing Director at ANEXIA, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smart...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his general session at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore...
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Day 2 Keynote at 17th Cloud Expo, Sandy Ca...
Tricky charts and visually deceptive graphs often make a case for the impact IT performance has on business. The debate isn't around the obvious; of course, IT performance metrics like website load time influence business metrics such as conversions and revenue. Rather, this presentation will explore various data analysis concepts to understand how, and how not to, assert such correlations. In his session at 20th Cloud Expo, Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Sys...
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
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 ...
SYS-CON Events announced today that LeaseWeb USA, a cloud Infrastructure-as-a-Service (IaaS) provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LeaseWeb is one of the world's largest hosting brands. The company helps customers define, develop and deploy IT infrastructure tailored to their exact business needs, by combining various kinds cloud solutions.
Unsecured IoT devices were used to launch crippling DDOS attacks in October 2016, targeting services such as Twitter, Spotify, and GitHub. Subsequent testimony to Congress about potential attacks on office buildings, schools, and hospitals raised the possibility for the IoT to harm and even kill people. What should be done? Does the government need to intervene? This panel at @ThingExpo New York brings together leading IoT and security experts to discuss this very serious topic.
LogMeIn has completed its previously disclosed merger with Citrix Systems, Inc.’s GetGo, Inc. subsidiary, a wholly owned subsidiary consisting of Citrix’s GoTo family of service offerings. The merger officially closed after market hours on January 31, 2017. Effected through a Reverse Morris Trust transaction, the merger brings together two of the preeminent players in cloud connectivity to instantly create one of the world’s top 10 public SaaS companies, and a market leader with the scale, resou...
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.