Click here to close now.

SYS-CON MEDIA Authors: Pat Romanski, Rex Morrow, Datical, Liz McMillan, John Wetherill, Ruxit Blog

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
“The year of the cloud – we have no idea when it's really happening but we think it's happening now. For those technology providers like Zentera that are helping enterprises move to the cloud - it's been fun to watch," noted Mike Loftus, VP Product Management and Marketing at Zentera Systems, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"Blue Box has been around for 10-11 years, and last year we launched Blue Box Cloud. We like the term 'Private Cloud as a Service' because we think that embodies what we are launching as a product - it's a managed hosted private cloud," explained Giles Frith, Vice President of Customer Operations at Blue Box, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
It’s no news that microservices are one of the top trends, if not the top trend, in application architectures today. Take large monolithic applications which are brittle and difficult to change and break them into smaller manageable pieces to provide flexibility in deployment models, facilitating agile release and development to meet today’s rapidly shifting digital businesses. Unfortunately, with this change, application and infrastructure management is more complex due to size and technology c...
IBM has acquired Blue Box Group, Inc., a managed private cloud provider built on OpenStack. Customers benefit from the ability to more easily deploy workloads across hybrid cloud environments. Financial details were not disclosed. Enterprises are seeking ways to embrace all types of cloud to address a wide range of workloads. Today's announcement reinforces IBM's commitment to deliver flexible cloud computing models that make it easier for customers to move to data and applications across cloud...
The WebRTC Meetup, where WebRTC enthusiasts exchange ideas, is being held on Wednesday, June 10, from 7 pm – 9 pm at the 4th WebRTC Summit, June 9-11, 2015, at the Javits Center in New York City, NY. The WebRTC Meetup is being hosted by the New York WebRTC Developer Group. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 4th WebRTC Summit continues our tradition of delivering the late...
We’re entering a new era of computing technology that many are calling the Internet of Things (IoT). Machine to machine, machine to infrastructure, machine to environment, the Internet of Everything, the Internet of Intelligent Things, intelligent systems – call it what you want, but it’s happening, and its potential is huge. IoT is comprised of smart machines interacting and communicating with other machines, objects, environments and infrastructures. As a result, huge volumes of data are bein...
In his General Session at 16th Cloud Expo, David Shacochis, host of The Hybrid IT Files podcast and Vice President at CenturyLink, will investigate three key trends of the “gigabit economy" though the story of a Fortune 500 communications company in transformation. Narrating how multi-modal hybrid IT, service automation, and agile delivery all intersect, he will cover the role of storytelling and empathy in achieving strategic alignment between the enterprise and its information technology.
SYS-CON Events announced today that the "First Containers & Microservices Conference" will take place June 9-11, 2015, at the Javits Center in New York City. The “Second Containers & Microservices Conference” will take place November 3-5, 2015, at Santa Clara Convention Center, Santa Clara, CA. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
"NuoDB is a transactionally consistent SQL database that does scale out, that does all the things you want in a cloud. If you want more transactional throughput, if you want higher availability if you want to run in multiple data centers this is a technology that can scale and still provide a single logical consistent database," explained Seth Proctor, CTO of NuoDB, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Thanks to widespread Internet adoption and more than 10 billion connected devices around the world, companies became more excited than ever about the Internet of Things in 2014. Add in the hype around Google Glass and the Nest Thermostat, and nearly every business, including those from traditionally low-tech industries, wanted in. But despite the buzz, some very real business questions emerged – mainly, not if a device can be connected, or even when, but why? Why does connecting to the cloud cre...
There will be 150 billion connected devices by 2020. New digital businesses have already disrupted value chains across every industry. APIs are at the center of the digital business. You need to understand what assets you have that can be exposed digitally, what their digital value chain is, and how to create an effective business model around that value chain to compete in this economy. No enterprise can be complacent and not engage in the digital economy. Learn how to be the disruptor and not ...
SYS-CON Events announced today that MediaTek Labs will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. MediaTek Labs is a global ecosystem initiative supporting Wearables and Internet of Things device creation, application development, and services based around MediaTek chipset offerings. Developers can use the MediaTek LinkIt™ ONE development platform and the LinkIt ONE HDK to easily access the features and functions of the...
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. 8th International Big Data Expo, co-located with 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. As advanced data storage, access and analytics technologies aimed at handling high-volume and/or fast moving data all move center stage, aided by the cloud computing bo...
IndependenceIT has been selected by nGenx to power Windows-based DaaS and application delivery on Google Compute Engine to support the delivery of GoldMine Cloud software. For independent software vendors (ISVs) like GoldMine, this expands the theater of operations to increase revenue opportunities while reducing software management and maintenance liabilities. IndependenceIT was selected by application and desktop pioneer, nGenx, to deliver its “Bring Your Own Cloud” strategy to GoldMine and o...
ProfitBricks has an early preview of its new Docker hosting platform. The ProfitBricks Docker platform enables its customers to build fully-portable applications within the ProfitBricks cloud. Unlike other Docker platforms, ProfitBricks’ Docker provides developers and system administrators with a platform with dedicated resources that autoscales the Docker hosts. Early access customers will be able to utilize up to 2,500 CPU core hours as part of ProfitBricks’ early access Docker preview.