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.

Contacts:
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
[email protected]

Cynapsus Therapeutics
Andrew Williams
COO & CFO
(416) 703-2449 x253
[email protected]

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
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settle...
The use of containers by developers -- and now increasingly IT operators -- has grown from infatuation to deep and abiding love. But as with any long-term affair, the honeymoon soon leads to needing to live well together ... and maybe even getting some relationship help along the way. And so it goes with container orchestration and automation solutions, which are rapidly emerging as the means to maintain the bliss between rapid container adoption and broad container use among multiple cloud host...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...
Blockchain. A day doesn’t seem to go by without seeing articles and discussions about the technology. According to PwC executive Seamus Cushley, approximately $1.4B has been invested in blockchain just last year. In Gartner’s recent hype cycle for emerging technologies, blockchain is approaching the peak. It is considered by Gartner as one of the ‘Key platform-enabling technologies to track.’ While there is a lot of ‘hype vs reality’ discussions going on, there is no arguing that blockchain is b...
Imagine if you will, a retail floor so densely packed with sensors that they can pick up the movements of insects scurrying across a store aisle. Or a component of a piece of factory equipment so well-instrumented that its digital twin provides resolution down to the micrometer.
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning infra...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
"Since we launched LinuxONE we learned a lot from our customers. More than anything what they responded to were some very unique security capabilities that we have," explained Mark Figley, Director of LinuxONE Offerings at IBM, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
When shopping for a new data processing platform for IoT solutions, many development teams want to be able to test-drive options before making a choice. Yet when evaluating an IoT solution, it’s simply not feasible to do so at scale with physical devices. Building a sensor simulator is the next best choice; however, generating a realistic simulation at very high TPS with ease of configurability is a formidable challenge. When dealing with multiple application or transport protocols, you would be...
The cloud era has reached the stage where it is no longer a question of whether a company should migrate, but when. Enterprises have embraced the outsourcing of where their various applications are stored and who manages them, saving significant investment along the way. Plus, the cloud has become a defining competitive edge. Companies that fail to successfully adapt risk failure. The media, of course, continues to extol the virtues of the cloud, including how easy it is to get there. Migrating...
Nordstrom is transforming the way that they do business and the cloud is the key to enabling speed and hyper personalized customer experiences. In his session at 21st Cloud Expo, Ken Schow, VP of Engineering at Nordstrom, discussed some of the key learnings and common pitfalls of large enterprises moving to the cloud. This includes strategies around choosing a cloud provider(s), architecture, and lessons learned. In addition, he covered some of the best practices for structured team migration an...
In his session at 21st Cloud Expo, Raju Shreewastava, founder of Big Data Trunk, provided a fun and simple way to introduce Machine Leaning to anyone and everyone. He solved a machine learning problem and demonstrated an easy way to be able to do machine learning without even coding. Raju Shreewastava is the founder of Big Data Trunk (www.BigDataTrunk.com), a Big Data Training and consulting firm with offices in the United States. He previously led the data warehouse/business intelligence and B...
No hype cycles or predictions of a gazillion things here. IoT is here. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, an Associate Partner of Analytics, IoT & Cybersecurity at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He also discussed the evaluation of communication standards and IoT messaging protocols, data...