TORONTO, ONTARIO -- (Marketwired) -- 04/26/13 -- Cynapsus Therapeutics Inc. (TSX VENTURE: CTH), a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson's disease, today announced its results for the fourth quarter and fiscal year ended December 31, 2012. Unless specified otherwise, all amounts are in Canadian dollars.
"2012 was a transformative year for Cynapsus with the achievement of multiple significant milestones. In particular, the year was highlighted by the completion of two human clinical trials for APL-130277, the announcement of a US$947,925 research grant from The Michael J. Fox Foundation (MJFF), a notice of allowance from the US Patent Office, and the announcement of the $6 to 8 million short form prospectus financing that was completed early this year," said Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. "As previously announced, in March 2013 the Company successfully raised $7.3 million, converted $4 million of debt to equity, and completed a 10:1 share consolidation. We are now focused on the completion of the MJFF sponsored CTH103 study, as well as preparations for an Investigational New Drug Application to the US FDA for a clinical Bioequivalence study. The BEQ study is the next critical de-risking milestone that we believe will drive significant shareholder value."
-- Cash and cash equivalents at December 31, 2012 of $50,401 (December 31, 2011: $294,812).-- Subsequent to year end, on March 1, 2013, the Company announced the first closing of the short form prospectus financing in aggregate principal amount of $6,008,000.-- Subsequent to year end, on March 1, 2013, the Company exchanged $4,031,406 in debt for shares and warrants.-- Subsequent to year end, on March 21, 2013, the Company announced the second closing of the short form prospectus financing in aggregate principal amount of $1,309,160.-- Net loss of $3,063,806 for the year ended December 31, 2012 (December 31, 2011: Net loss of $2,847,247)-- Concurrent with the March 1, 2013 financing, completed a 10:1 share consolidation.-- Report 14,214,922 common shares outstanding at December 31, 2012 on a post-consolidated basis (December 31, 2011: 13,174,322).
The following achievements were made during the year:
-- Cynapsus completed the first human volunteer pilot proof-of-concept clinical trial For APL-130277. In January 2012, the Company announced positive headline data from its human volunteer pilot proof-of-concept trial for APL-130277, a sublingual thin film strip formulation of apomorphine. The study showed a pharmacokinetic (PK) profile that compared favorably to injected apomorphine with a mean T-max of 25 minutes and good tolerability, and therefore confirms that APL-130277 has the potential to treat motor fluctuations or "off episodes" in Parkinson's disease. This was a significant milestone and de-risking event for the project.-- Cynapsus obtained independent research coverage. In February 2012, the Company announced that Loewen, Ondaatje, McCutcheon Limited ("LOM") initiated analyst coverage of the Company. LOM's biotech analyst initiation of research coverage provides further independent opinion and view of the strengths, risks and commercial potential of APL-130277.-- Cynapsus added an additional expert to the Clinical Advisory Board ("CAB"). In April 2012, the Company announced that it has appointed Dr. Abraham Lieberman to the CAB. Dr. Lieberman is the current Director of the Muhammad Ali Parkinson Center and Movement Disorder Clinic of the Barrow Neurological Institute at St. Joseph's Hospital and Medical Center in Phoenix, Arizona.-- Cynapsus completed a second human volunteer pilot proof-of-concept clinical trial of APL-130277. In August 2012, the Company announced the results of a second pilot study (CTH102) that identifies a dose which achieves therapeutic blood levels. The PK results were consistent with those of the first clinical pilot study showing a pharmacokinetic profile (Cmax, AUC and Tmax) that was similar to subcutaneous injectable apomorphine.-- Cynapsus received a research grant from The Michael J. Fox Foundation (MJFF) to support clinical studies to develop APL-130277. In August 2012, the Company announced that it had been awarded a grant of USD $947,925 from MJFF. The grant was awarded under the Foundation's Edmond J. Safra Core Programs for Parkinson's Research, Clinical Intervention Awards aimed at supporting human clinical trials testing promising Parkinson's therapies that may significantly and fundamentally improve treatment for people with Parkinson's.-- Cynapsus commenced activities for a comparative biostudy of APL-130277. In the third quarter of 2012, the Company began work on CTH103, a placebo-controlled, randomized cross-over Phase 1 trial in healthy volunteers to examine the pharmacokinetic profile of multiple dose strengths of APL-130277 as compared to equivalent doses of apomorphine subcutaneous injection. The study is expected to be completed in Q3 2013. The objective of this study is to directly compare the pharmacokinetic profile of APL-130277 to subcutaneous apomorphine in healthy subjects in order to more precisely design the subsequent Bioequivalence Study. The Bioequivalence Study is expected to be completed in early 2014.-- Cynapsus received a favourable ruling from the United States Patent and Trademark Office (USPTO). In December 2012, the Company announced that the USPTO issued a Notice of Allowance for the patent application 13/445,656 with critical claims directed to thin film compositions containing apomorphine formulated for sublingual administration. The allowed application will be the first to emerge as a U.S. patent from the company's patent application filings directed to sublingual apomorphine therapies.-- Cynapsus raised $6 million in first closing of short form prospectus offering, exchanges $4 million of debt for equity, and completes 10:1 share consolidation. Subsequent to the year end, on March 1, 2013, the Company announced that it completed a first closing of a short form prospectus offering of units for gross proceeds of $6,008,000. Concurrent with the closing of the Offering, the Company and the holders of Series A to E debentures agreed to convert $4,031,406 in debt for common shares and warrants. In addition, the Company completed a share consolidation of the Company's issued and outstanding common shares concurrent on the basis of one (1) new common share for every ten (10) common shares issued and outstanding.-- Cynapsus raised $1.3 million in second closing of short form prospectus offering. Subsequent to year end, on March 21, 2013, the Company announced that it completed a second closing of its short form prospectus offering of units for gross proceeds of $1,309,160. Total gross proceeds from the First Closing and the Second Closing of the Offering are equal to $7,317,160.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing the only non-injectable (i.e. sublingual) delivery of the only approved drug (apomorphine) to be used as a rescue therapy for "off" motor symptoms of Parkinson's disease. Over one million people in the U.S. and an estimated 5 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 Company'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.
Cynapsus' drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is approved in an injection formulation 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 expected to be submitted in 2015. Cynapsus anticipates a trade sale or out-licensing to an appropriate global pharmaceutical partner before such an application is submitted.
More information about Cynapsus (TSX VENTURE: CTH) 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 Canadian securities legislation. 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 Annual Information Form filed on November 1, 2012 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.
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