Cynapsus Therapeutics Reports 2014 Annual Results
March 17, 2022
TORONTO – Cynapsus Therapeutics Inc. (TSX: CTH) (OTCQX: CYNAF), a specialty pharmaceutical company focused on the treatment of OFF episodes in Parkinson’s disease, today announced financial results for the year ended December 31, 2014. Unless specified otherwise, all amounts are in Canadian dollars.
“In 2014 we made significant progress advancing our strategic plan in key areas, including the clinical development of APL-130277 and strengthening our corporate leadership. Most notably, we also raised gross proceeds of $25 million through an equity financing, and received a second grant from the Michael J. Fox Foundation,” stated Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. “We look forward to reporting further progress in 2015, and remain focused on the preparatory work required for the commencement of Phase 3 studies in this year’s second quarter.”
Financial Highlights:
• Cash and cash equivalents as of December 31, 2021 of $17,448,497 (December 31, 2013: $2,289,046).
• Subsequent to the year ended December 31, 2014, 6,406,871 warrants were exercised for cash proceeds to the Company of $4,041,905.
• Cash used in operating activities of $9,990,841 for the year ended December 31, 2021 (year ended December 31, 2013: $4,182,839).
• Net loss of $10,818,587 for the year ended December 31, 2021 (year ended December 31, 2013: $4,433,287).
• Reported 80,334,449 common shares outstanding as of December 31, 2021 (December 31, 2013: 38,884,009 common shares).
Clinical and Preclinical Highlights:
• Reported details for the Company’s Phase 3 pivotal program. On March 11, 2015, following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company announced that an agreement was reached on the design, duration and size for the Phase 3 program clinical studies, as well as for primary and key secondary endpoints. As a result, Cynapsus plans to initiate a pivotal Phase 3 program evaluating the safety and efficacy of APL-130277 in Parkinson’s disease (PD) patients in the second quarter of 2015.
• Reported results of the CTH-105, a Phase 2 clinical trial in Parkinson’s patients. On November 19, 2014, Cynapsus announced positive top-line results of the CTH-105 Phase 2 clinical study of APL-130277. A further update was provided on March 11, 2015. In the CTH-105 Phase 2 open-label multicenter study, APL-130277 was assessed in 19 patients with PD who experienced the debilitating effects of OFF episodes, with a total duration of OFF of at least two hours daily. The primary efficacy endpoint was the percentage of patients who achieved ON following APL-130277 administration.
• Reported the results of the CTH-104 clinical trial. On April 24, 2014, Cynapsus announced final study results of the CTH-104 study of APL-130277, a single-dose, single-arm, placebo-controlled study in healthy volunteers that 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 results of the CTH-103 Comparative Biostudy of APL-130277. The CTH-103 study was an active comparator, placebo-controlled, randomized crossover trial to examine the pharmacokinetic profile of sublingual APL-130277 compared with 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.
• 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.
Organizational Highlights:
• 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 APIs, drugs (Rx, generics, OTC and OTC switches) and medical devices. 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.
• Appointed a new Vice President, Medical Affairs. On November 24, 2014, Cynapsus appointed Jordan Dubow, M.D. as Vice President, Medical Affairs. He is a board-certified neurologist with fellowship training in movement disorders and vascular neurology. Prior to this role, Dr. Dubow was Medical Director, Neuroscience Clinical Development at AbbVie/Abbott, where he served as the Clinical Lead for Duodopa/Duopa, and most notably helped achieve regulatory approval in the U.S. and Canada.
• Appointed a new Director to the Board of Directors. On February 13, 2014, Nan Hutchinson was appointed to the Board of Directors. Ms. Hutchinson has more than 25 years of pharmaceutical experience spanning all aspects of commercialization, including strategic planning, marketing, business development and sales leadership. Previously she was Senior Vice President of Marketing and Sales for URL Pharma, a privately held pharmaceutical company, helping transform the commercial organization and leading to its acquisition by Takeda Pharmaceutical. Prior to URL Pharma, Ms. Hutchinson was Senior Vice President of Marketing at Bristol-Myers Squibb where she ran a $2 billion multi-asset portfolio and had worldwide P&L responsibility in the Global Group.
• Appointed a second new Director to the Board of Directors. On March 12, 2015, Tamar Howson was appointed to the Board of Directors. Ms. Howson is a seasoned business development executive within the pharmaceutical industry, having formerly served as Senior Vice President at both Bristol-Myers Squibb and SmithKline Beecham. Ms. Howson currently serves as a business development and strategy consultant to biopharmaceutical companies and she also serves as a director at Actavis, Oxigene Pharmaceuticals, Cardax and Organovo. She has formerly served as a director at several biotechnology companies, including Ariad, Idenix Pharmaceuticals, NPS Pharmaceuticals, SkyePharma and Warner Chilcott.
• 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.
• Up-listed to the Toronto Stock Exchange. On November 28, 2014, Cynapsus’ common shares commenced trading on the Toronto Stock Exchange (TSX) with its common shares ceasing to trade on the TSX Venture Exchange concurrently. The Company’s common shares continue to trade under the symbol “CTH.”
Issuance of Common Shares to Former Shareholders of Adagio
Cynapsus also announced today that under the share purchase agreement dated December 22, 2011, and amended on January 28, 2015, between the Company and the former shareholders of Adagio Pharmaceuticals Ltd. (the “Adagio Shareholders”), the Company has issued 1,119,403 common shares of the Company to the Adagio Shareholders at a deemed value of $1.34 per share with an aggregate issue price of $1,500,000. The common shares issued to the Adagio Shareholders, who are substantially represented by key management and therefore are related parties, represent a milestone consideration payable under the amended share purchase agreement. Of the total, 602,442 shares were issued to Cynapsus’ President and Chief Executive Officer. All shares issued to the Adagio Shareholders are subject to a four month hold period.
Material Agreement
Cynapsus also announced today that it has entered into an agreement (the “ARx Agreement”) with ARx, LLC (“ARx”) whereby ARx agreed to provide Cynapsus with formulation, CMC and clinical unit production of APL-130277 and certain related services to support the Company’s clinical studies of APL-130277. Under the ARx Agreement, ARx also assigned all of its right, title and interest in and to the Cynapsus patent family entitled “Sublingual Films”, of which ARx was previously a co-owner with Cynapsus. In turn, Cynapsus granted ARx a non-exclusive license to this patent family in all fields other than generic APL-130277 applications.
In addition, under the terms of the ARx Agreement, all APL-130277-related intellectual property generated pursuant to the ARx Agreement is owned by Cynapsus. Cynapsus in turn granted ARx an exclusive license to all intellectual property generated under the ARx Agreement in all fields, in respect of other products and formulations. The parties further agreed that they anticipate entering into a commercial supply agreement prior to Cynapsus’ filing for FDA approval of APL-130277.
About Cynapsus
Cynapsus is a specialty pharmaceutical company developing a sublingual thin filmstrip for the acute rescue of OFF episodes associated with Parkinson’s disease. Cynapsus’ drug candidate, APL-130277, currently in late-stage clinical development, is an easy-to-use, fast-acting, formulation of apomorphine, which is the only approved drug (in the United States, Europe, Japan and other countries) to rescue patients from OFF episodes. Cynapsus anticipates completing pivotal studies to support a 505(b)(2) New Drug Application (NDA) expected to be submitted in 2016.
Parkinson’s disease is a chronic and progressive neurodegenerative disease. OFF episodes are periods of time during which PD symptoms re-emerge despite taking PD medicines. Symptoms include stiffness, slow movements and difficulty in starting movements, greatly impacting a patient’s quality of life and ability to work. More than 1 million people in the U.S. and an estimated 4 to 6 million people globally suffer from Parkinson's disease with prevalence increasing with the aging of the population. It is estimated that up to one half of all people with Parkinson’s disease experience OFF episodes at least once daily and up to six times daily, with each episode lasting between 30 and 120 minutes.
More information about Cynapsus (TSX: CTH) (OTCQX: CYNAF) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
Contact Information
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
[email protected]
Andrew Williams
COO & CFO
(416) 703-2449 x253
[email protected]
LHA
Anne Marie Fields
(212) 838-3777
[email protected]
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 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 nor the OTCQX International has approved or disapproved of the contents of this press release.
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