Cynapsus Therapeutics Inc.
TSX VENTURE : CTH
OTCQX : CYNAF

Cynapsus Therapeutics Inc.

November 11, 2014 16:30 ET

Cynapsus Therapeutics Reports Third Quarter 2014 Financial Results and Recent Developments

TORONTO, ONTARIO--(Marketwired - Nov. 11, 2014) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH)(OTCQX:CYNAF), a specialty pharmaceutical company developing a convenient and easy to use sublingual thin film strip for the on-demand rescue of OFF motor symptoms of Parkinson's disease, today announced financial results for the three and nine months ended September 30, 2014. Unless specified otherwise, all amounts are in Canadian dollars.

"Throughout the first nine months of 2014 we have made significant progress advancing our strategic plan in key areas, including the clinical development of APL-130277 and strengthening our corporate leadership. Importantly, we also raised gross proceeds of $25 million through an equity financing, which we expect will fund APL-130277 development through to NDA submission with the U.S. FDA," stated Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. "We look forward to reporting further progress by year end, including results from the CTH-105 Phase 2 study with APL-130277 later this month, and remain focused on the preparatory work required for the commencement of Phase 3 studies in early 2015."

Financial highlights of the third quarter and first nine months of 2014 include:

  • Cash and cash equivalents at September 30, 2014 of $19,496,961 (December 31, 2013: $2,289,046).
  • Cash used in operating activities of $1,762,223 for the three months ended September 30, 2014 (three months ended September 30, 2013: $943,287).
  • Net loss of $1,691,808 for the three months ended September 30, 2014 (three months ended September 30, 2013: $1,257,624).
  • Net loss of $5,718,138 for the nine months ended September 30, 2014 (nine months ended September 30, 2013: $2,582,233).
  • Report 78,968,867 common shares outstanding at September 30, 2014 (December 31, 2013: 38,884,009 common shares).

Clinical and operational highlights of the third quarter and first nine months of 2014 include:

  • Appointed a new Chief Scientific Officer and EVP, CMC. On October 7, 2014, Cynapsus appointed Thierry Bilbault, Ph.D., Chief Scientific Officer and Executive Vice President of Chemistry, Manufacturing and Controls. Dr. Bilbault is a global pharmaceutical development and manufacturing operations leader with more than 20 years of experience in the evaluation, development, partnering, transfer and manufacturing of API and Drugs (Rx, Generics, OTC and OTC Switches) and Medical Device products. He has been involved with bringing more than 50 products to market, including over 10 U.S. New Drug Applications. Dr. Bilbault joins Cynapsus from Galderma Pharma S.A., where he was a Technical and Industrial Development Director. Prior to Galderma, he served as Vice President New Technology and Product Innovation at Novartis, and held several product development leadership roles at Pfizer and Alcon Laboratories.

  • Engaged Ernst & Young LLP as its new auditor. On September 19, 2014, the Company's Board of Directors appointed Ernst & Young LLP as the new auditor for the Company.

  • Initiated a Phase 2 clinical trial in the U.S. On July 17, 2014, Cynapsus announced the initiation of a Phase 2 clinical study for APL-130277. Specifically, clinical study CTH-105 was initiated per the proposal submitted to the U.S. FDA under the Company´s Investigational New Drug application. Top-line results of the CTH-105 study are expected to be released in November 2014.

  • Received a second grant from The Michael J. Fox Foundation for Parkinson's Research ("MJFF"). On July 8, 2014, Cynapsus announced that it has been awarded a new grant of US$500,000 from the MJFF to support clinical studies to develop APL-130277.

  • Reported no buccal mucosal irritation from U.S. FDA Registration Study of APL-130277 for Parkinson's disease. On May 14, 2014, Cynapsus announced no irritation was observed when testing the APL-130277 sublingual apomorphine formulation in a 28-day buccal mucosal irritation model in hamsters, either macroscopically (clinician observation of oral cavity) or microscopically.

  • Completed a $25 million short form prospectus financing. On April 15, 2014, Cynapsus announced that it completed a short form prospectus offering of units for maximum aggregate gross proceeds of $25 million. Cynapsus intends to use the proceeds from the offering to fund the U.S. clinical development of APL-130277 through to NDA submission.

  • Reported the results of 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. The 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.

  • Reported results of the CTH-103 clinical trial. On January 13, 2014, Cynapsus announced positive top line data of the CTH-103 Comparative Biostudy of APL-130277. The CTH-103 study was an active comparator, placebo-controlled, randomized cross-over trial to examine the pharmacokinetic profile of sublingual administered APL-130277 compared to 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.

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.

More than 1 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.

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