Cynapsus Therapeutics Inc. (CYNA) News http://ir.cynapsus.ca/rss The latest news released by Cynapsus Therapeutics Inc. (CYNA) en-us Equisolve Investor Relations Suite http://c.eqcdn.com/cynapsus/files/email/blue-logo-300px.png Cynapsus Therapeutics Inc. (CYNA) News http://ir.cynapsus.ca/rss 88 31 Sunovion Pharmaceuticals to Acquire Cynapsus Therapeutics http://ir.cynapsus.ca/news/detail/163/sunovion-pharmaceuticals-to-acquire-cynapsus-therapeutics Wed, 31 Aug 2021 17:07:00 -0400 http://ir.cynapsus.ca/news/detail/163/sunovion-pharmaceuticals-to-acquire-cynapsus-therapeutics - Includes Phase 3 product candidate APL-130277 in development for OFF episodes associated with Parkinson’s disease -

- Complements Sunovion’s robust portfolio and expands the Company’s leadership in treatments for central nervous system disorders -

MARLBOROUGH, Mass. & TORONTO--(BUSINESS WIRE)-- Sunovion Pharmaceuticals Inc. (Sunovion) and Cynapsus Therapeutics Inc. (Cynapsus) (NASDAQ: CYNA) (TSX: CTH) today announced that the companies have signed a definitive agreement under which Sunovion will acquire Cynapsus for US$40.50 per share in cash. The transaction has received unanimous approval by the Board of Directors of both companies and values Cynapsus at approximately US$624 million (or approximately CAN$820 million). The acquisition will be funded with cash on hand. The transaction is expected to close in the fourth quarter of 2016 (third quarter of Sunovion’s fiscal year). This agreement reflects Sunovion’s global strategy to expand and diversify its portfolio in key therapeutic areas, including neurology.

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Through this transaction, Sunovion would acquire Cynapsus’ product candidate, APL-130277, which is designed to be a fast-acting, easy-to-use, on-demand treatment option for managing OFF episodes associated with Parkinson’s disease (PD).

“Parkinson’s disease is a chronic, progressive neurodegenerative disease that affects more than four million people around the world, and there is a significant need for new options to treat the OFF episodes associated with it,” said Nobuhiko Tamura, Chairman and Chief Executive Officer, Sunovion. “We believe that APL-130277 is a novel late-stage candidate with the potential to make a real difference for patients and their families.”

“The acquisition of Cynapsus is well-aligned with Sunovion’s focus on the innovative application of science and medicine to help people with serious medical conditions and complements our robust product pipeline,” added Mr. Tamura. “We have high regard for the Cynapsus team and their work with the APL-130277 program.”

“With its leadership in therapies for central nervous system disorders and commercial experience specific to neurology, we believe Sunovion is best suited to advance APL-130277 in the United States and other key markets,” said Anthony J. Giovinazzo, President and CEO, Cynapsus. “This transaction culminates years of dedicated work by the Cynapsus team and represents significant value creation for our securityholders.”

The board of directors of Cynapsus, after consultation with its financial and legal advisors and based, in part, upon the unanimous recommendation of an independent special committee of the board of directors, has determined that the arrangement is in the best interest of Cynapsus and the consideration to be received by shareholders of Cynapsus is fair to such shareholders. The board of directors unanimously recommends that Cynapsus shareholders and warrantholders vote in favour of the transaction at a special meeting expected to be held on or about October 13, 2016.

The proposed sale of Cynapsus follows a full consideration of alternatives aimed at optimizing shareholder value for the company. “We believe that the proposed transaction with Sunovion results in the best outcome for our shareholders,” said Rochelle Stenzler, chair of the board of Cynapsus. “The transaction with Sunovion represents a significant premium to the current share price and we are recommending that our shareholders and warrantholders vote in favour of the transaction.”

Pursuant to the terms of the definitive agreement, upon closing of the proposed transaction, shareholders of Cynapsus will receive US$40.50 per common share in cash, and holders of warrants and stock options will receive a cash payment equal to the difference between US$40.50 and the exercise price of such warrant or stock option. The offer of US$40.50 per common share in cash represents a premium of 123 percent based on the volume weighted average closing price of Cynapsus’ common shares on the NASDAQ Global Market for the last twenty trading days. The companies expect to close the transaction following required securityholder, court and regulatory approvals and satisfaction of certain other customary closing conditions.

The transaction will be completed by way of a plan of arrangement under the Canada Business Corporations Act. The arrangement will require approval of at least two-thirds of the votes cast by Cynapsus shareholders and warrantholders voting together as a single class at a special meeting of such securityholders of Cynapsus. Voting and Support Agreements in support of the transaction have been signed by all directors and officers of Cynapsus and the company’s largest shareholder representing in the aggregate, approximately 18.33 percent of the Cynapsus securities entitled to vote to approve the transaction.

Full details of the transaction will be included in the management information circular to be filed with the applicable securities regulatory authorities and mailed to Cynapsus shareholders and warrant holders within approximately two weeks. Assuming receipt of all required regulatory approvals, the parties expect to close the arrangement in the fourth quarter of 2016.

BofA Merrill Lynch serves as financial advisor, and Borden Ladner Gervais LLP and Troutman Sanders LLP serve as legal advisors to Cynapsus. Stifel, Nicolaus & Company, Incorporated serves as financial advisor and Fasken Martineau DuMoulin LLP serves as a legal advisor to the Special Committee of Cynapsus. Nomura Securities International, Inc. serves as exclusive financial advisor, and Goodmans LLP, Reed Smith LLP, and Gibbons PC serve as legal advisors to Sunovion.

Adagio Amending Agreement
Cynapsus and the former shareholders of Adagio Pharmaceuticals Ltd. (“Adagio”) entered into a share purchase agreement dated as of December 22, 2011, as subsequently amended as of January 28, 2022 (the “Share Purchase Agreement”), pursuant to which Cynapsus acquired Adagio.

Cynapsus and the former shareholders of Adagio have amended the Share Purchase Agreement to provide, among other things, that if a change of control of Cynapsus, which would include the transaction with Sunovion, occurs before the successful completion and the first public announcement of the top-line data of the Final Safety Study (as defined in the Share Purchase Agreement), the CDN$2,500,000 of the purchase price still potentially payable to the former shareholders of Adagio shall be paid in cash (not common shares, as was originally contemplated in the Share Purchase Agreement) by Cynapsus, on the date on which the change of control transaction is completed.

As Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, is also a director, officer and majority shareholder of Adagio, the amendment of the Share Purchase Agreement constitutes a related party transaction pursuant to Multilateral Instrument 61-101 and the policies of the TSX. The amendment was necessary, and appropriate, as it ensures that if Sunovion acquires all of the common shares of Cynapsus, it would not have an obligation to potentially issue shares to the former Adagio shareholders post-closing of such acquisition. The amendment was entered into at the same time as the arrangement agreement with Sunovion and therefore was not announced more than 21 days before its execution.

About APL-130277
APL-130277, a novel formulation of apomorphine, a dopamine agonist, is being developed as a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It has been studied in all types of OFF episodes, including morning OFF episodes. APL-130277 is in Phase 3 clinical trials and has not been approved by the U.S. Food and Drug Administration (FDA).

In the ongoing Phase 3 trial, CTH-300, the blinded safety data was corroborated by the DSMB findings, which were announced in the press release dated August 15, 2016. If the ongoing pivotal Phase 3 clinical trials are successful, it is expected that a New Drug Application (NDA) for APL-130277 will be submitted to the U.S. Food and Drug Administration (FDA) during the first half of 2017 under the abbreviated Section 505(b)(2) regulatory pathway. A pivotal European clinical program evaluating the safety and efficacy of APL-130277 in PD patients is expected to be initiated in the fourth quarter of 2016.

About Parkinson’s Disease and OFF Episodes
More than 1 million people in the U.S. and an estimated 4 to 6 million people worldwide suffer from PD. The European Parkinson's disease Association estimates that 1.2 million people have PD in the European Union. PD is a chronic, progressive neurodegenerative disease characterized by motor symptoms, including tremor at rest, rigidity and impaired movement, as well as significant non-motor symptoms, including cognitive impairment and mood disorders. It is the second most common neurodegenerative disease behind Alzheimer’s disease, and PD’s prevalence is increasing with the aging of the population. OFF episodes are a complication of the disease. Up to 40 percent of all people with PD whose symptoms are otherwise managed with ongoing drug therapy experience OFF episodes at least once daily and up to six times daily, with each episode typically lasting between 30 and 120 minutes.1,2

About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. The Company has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological, and respiratory conditions. Sunovion’s track record of discovery, development and commercialization of important therapies has included Brovana® (arformoterol tartrate), Latuda® (lurasidone HCI), and most recently Aptiom® (eslicarbazepine acetate).

Headquartered in Marlborough, Mass. Sunovion is an indirect, wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the Company’s web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter @Sunovion and LinkedIn.

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan operating globally in major pharmaceutical markets, including Japan, the United States, China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com.

BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc.
LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
APTIOM is used under license from BIAL.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.
© 2016 Sunovion Pharmaceuticals Inc.

Sunovion Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies' and members of their senior management team. Forward-looking statements include, without limitation statement associated with the following: the timing of the closing of Sunovion’s acquisition of Cynapsus; Sunovion’s ability to expand and diversify its portfolio in key therapeutic areas, including neurology; APL-130277’s ability to be a fast-acting, easy-to-use, on-demand treatment option for managing OFF episodes associated with Parkinson’s disease (PD) or make a real difference for patients and their families; Sunovion’s ability to advance APL-130277 in the United States and other key markets; whether the transaction will result in the best outcome for Cynapsus’ shareholders; the parties’ ability to receive the required securityholder, court and regulatory approvals, satisfy other customary closing conditions and close the transaction; whether APL-130277 will be the first treatment for OFF episodes associated with PD that is administered sublingually (under the tongue); whether APL-130277 will avoid many of the issues associated with the currently available injectable formulation; whether APL-130277 will be easier for patients and caregivers to use; the timing of the data from the ongoing Cynapsus pivotal Phase 3 clinical trials; the potential success of the trials and the timing of a New Drug Application (NDA) for APL-130277, if any, to the U.S. Food and Drug Administration (FDA) during the first half of 2017 under the abbreviated Section 505(b)(2) regulatory pathway; the timing of a pivotal European clinical program evaluating the safety and efficacy of APL-130277 in PD patients; the timing and content of the details of the transaction included in the management information circular to be filed with the securities regulatory authorities and mailed to Cynapsus shareholders and warrant holders in advance of the special meeting; the ability to receive all required regulatory approvals, and the ability of the parties to close the arrangement in the fourth quarter of 2016. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: the effects of the transaction on relationships with employees, customers, other business partners or governmental entities; other business effects, including the effects of industry, economic or political conditions outside of the companies' control; actual or contingent liabilities; and other risks and uncertainties detailed by Sunovion’s parent company Sumitomo Dainippon Pharma in the Summary of Consolidated Financial Results [Japanese GAAP] (Unaudited) for quarterly earnings. All forward-looking statements are based on information currently available to Sunovion, and Sunovion assumes no obligation to update any such forward-looking statements.

About Cynapsus
Cynapsus is a specialty central nervous system pharmaceutical company that has been developing a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. For additional company information, please visit http://www.cynapsus.ca.

For more information about the Phase 3 studies, including enrollment criteria, please visit the following website: http://cth300and301trials.cynapsus.ca/

Cynapsus Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of applicable securities laws, including, without limitation, Cynapsus’s expectation for filing an NDA in the first half of 2017; expectations regarding Cynapsus’s clinical and regulatory activities, including the anticipated timing, completion and results of Phase 3 and other clinical studies; beliefs related to potential benefits, effectiveness and demand for, Cynapsus’s product candidate; statements relating to the proposed acquisition of Cynapsus, including (i) receipt of securityholder, court and regulatory approvals of, and the satisfaction of other conditions for, such transaction and (ii) the anticipated benefits, timing and closing of such transaction; and beliefs regarding Sunovion’s ability to advance APL-130277 in the United States and other markets. These forward-looking statements include information about possible or assumed future events or results of Cynapsus’s business, products, plans and objectives. These forward-looking statements are based on current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, shareholder and warrantholder approval of the proposed transaction; Cynapsus’ ability to obtain court, regulatory and other approvals in connection with the proposed transaction; uncertainties as to the timing of the completion of the transaction, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction and those factors identified under the caption “Risk Factors” in Cynapsus’s Form 10-Q for the quarter ended June 30, 2022 filed with the United States Securities and Exchange Commission (the “SEC”) on August 10, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and Cynapsus has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.

Additional Information and Where to Find It
Further information regarding the transaction will be contained in an information circular that Cynapsus will prepare and mail to its shareholders and warrantholders in connection with the Cynapsus shareholders’ and warrantholders’ meeting, with closing expected to occur in the fourth quarter of 2016. Cynapsus securityholders are urged to read the information circular once it becomes available, as it will contain important information concerning the proposed transaction. Cynapsus securityholders may obtain a copy of the arrangement agreement, information circular and other meeting materials when they become available at http://www.sec.gov and www.sedar.com.

This press release is for informational purposes only. It does not constitute an offer to purchase securities of Cynapsus or a solicitation or recommendation statement under the rules and regulations of the SEC or other applicable United States laws.

1 Denny 1999 J Neurolog Sci, v165, p18-23, table 3.
2 Schrag 2000 Brain v123, p2297-2305

Sunovion Pharmaceuticals Inc.
Patrick Gaffey, 508-787-4565
Executive Director, Corporate Communications
patrick.gaffey@sunovion.com
or
Cynapsus Therapeutics Inc.
Andrew Williams, 416-703-2449 x253
COO & CFO
awilliams@cynapsus.ca

Source: Sunovion Pharmaceuticals Inc.

]]>
Cynapsus Receives FDA Fast Track Designation for APL-130277 for the Treatment of OFF Episodes in Patients with Parkinson’s Disease http://ir.cynapsus.ca/news/detail/162/cynapsus-receives-fda-fast-track-designation-for-apl-130277-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease Mon, 29 Aug 2021 06:00:00 -0400 http://ir.cynapsus.ca/news/detail/162/cynapsus-receives-fda-fast-track-designation-for-apl-130277-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease

Company provides timing updates

TORONTO, Aug. 29, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for APL-130277, a product candidate for the treatment of OFF episodes in patients with Parkinson’s disease (PD).

“The FDA’s recognition of the significant need to address OFF episodes in Parkinson’s disease with the Fast Track Designation is further validation of the value in our fast-acting, thin strip approach,” said Anthony Giovinazzo, President and CEO of Cynapsus. “We look forward to continuing to work with the FDA to advance APL-130277 through the regulatory process to bring relief to patients suffering with OFF episodes as expeditiously as possible.  Our Phase 3 clinical program is nearing completion and we plan to submit a new drug application (NDA) to the FDA in the first half of 2017.”

FDA's Fast Track Designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and with the potential to address an unmet medical need. Companies that receive Fast Track Designation are provided the opportunity for more frequent interactions with FDA during clinical development and are potentially eligible for accelerated approval and/or priority review, if relevant criteria are met.  Additionally, companies that receive Fast Track Designation may be allowed to submit completed sections of their NDA for the drug on a rolling basis, resulting in the potential for an expedited FDA review process.

In addition, Cynapsus provided timing updates for two clinical trials.  Based on patient visit schedules, post the dose titration phase, top line data for the Phase 3 Efficacy trial CTH-300 is expected in mid-to-late fourth quarter of 2016.  Furthermore, the CTH-201 Phase 2 Thorough QT study, is expected to commence in the fourth quarter of 2016, and is planned to be completed in the first half of 2017.

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company expects to submit an NDA in the first half of 2017. For additional company information, please visit our website at www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the following website:  http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA in the first half of 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing, completion and results of Phase 3 and other clinical studies; beliefs related to potential benefits and effectiveness of, and demand for, the Company’s product candidate; and the anticipated effects of receiving Fast Track Designation and the anticipated timeframe for the making of regulatory submissions and completing regulatory review. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on August 10, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Announces Positive Opinion from Data and Safety Monitoring Board on Phase 3 Parkinson’s Disease Clinical Study Allowing for At-Home Titration http://ir.cynapsus.ca/news/detail/161/cynapsus-announces-positive-opinion-from-data-and-safety-monitoring-board-on-phase-3-parkinsons-disease-clinical-study-allowing-for-at-home-titration Mon, 15 Aug 2021 06:00:00 -0400 http://ir.cynapsus.ca/news/detail/161/cynapsus-announces-positive-opinion-from-data-and-safety-monitoring-board-on-phase-3-parkinsons-disease-clinical-study-allowing-for-at-home-titration

TORONTO, Aug. 15, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (CNS) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (PD), announced today that its Data Safety and Monitoring Board (DSMB) has completed a review of the safety data from the Company’s Phase 3 program including both the CTH-300 and CTH-301 clinical trials. Based on the DSMB’s recommendations, the CTH-300 trial will continue as planned. In addition, as a result of the DSMB’s review of the early safety data from both CTH-300 and CTH-301, the six-month open label CTH-301 study will be amended to allow for at-home titration, after the patient’s initial visit to the clinic.

The DSMB is an independent body of experts drawn from the fields of clinical medicine biostatistics and trial methodology, which functions under a charter approved by the U.S. Food and Drug Administration (FDA) to review the accumulated data of Cynapsus’ clinical trial and to provide recommendations to the Company.    

“We are very pleased with the DSMB’s positive recommendations to assess an amendment to allow at-home dose titration in the CTH-301, six-month open label safety study,” said Anthony Giovinazzo, President and CEO of Cynapsus.

“This decision is based upon the positive safety signal seen during titration in the CTH-300 double-blind 12-week efficacy study. Allowing the trial to proceed with the modification for at-home titration is expected to make it more convenient for PD patients to treat their OFF episodes. We believe this change may assist with patient compliance and allow Cynapsus to assess results in a more real-world setting,” said Dr. Albert Agro, Chief Medical Officer of Cynapsus.

Phase 3 Program Study Design

The CTH-300 study is a double-blind, placebo-controlled, parallel-design, two-part study.  The study has enrolled eligible PD patients and 102 PD patients have entered the Open Label dose titration phase (DTP). In the DTP, patients arrived at the clinic in the practically defined OFF state (withholding their morning dose of PD medications) and received the lowest dose of APL-130277 (10mg). Patients were assessed to determine if successful conversion from OFF to full ON occurred. If a full ON was not achieved, patients returned to the clinic on subsequent visits and received a higher dose of APL-130277 (at 5mg increments, up to 35mg) until the effective conversion dose was identified. Those patients that turned fully ON with a dose of APL-130277 during the DTP proceeded to the dose randomization part of the study where they were randomized to receive either the effective dose or placebo. The objective of the second part of CTH-300 is to evaluate the efficacy, safety and tolerability of APL-130277 versus placebo in patients with PD over a 12-week period. CTH-300 is well powered to demonstrate statistical significant reduction in MDS-UPDRS Part III with 80 patients randomized. A sample size of 80 randomized patients allows for greater than 90% power to achieve statistical significance at the primary and key secondary endpoint. The primary endpoint is a mean change in the MDS-UPDRS Part III score at 30 minutes after 12 weeks of at-home dosing.

The CTH-301 Phase 3 Safety Study (CTH-301) is a long-term open-label, single arm safety study involving PD patients who have at least one OFF episode per day, with total OFF time of at least two hours per day. The objective of CTH-301 is to evaluate the safety and tolerability of APL-130277 in up to 200 patients with PD over a six-month period.  Patients completing CTH-300 are eligible to enter CTH-301. In addition, de novo patients from approximately 65 sites in North America and Europe will be enrolled in CTH-301.

Data from CTH-300 and CTH-301 are expected to form the basis for the registration package necessary for a 505(b)(2) New Drug Application (NDA) with the FDA expected to be submitted in the first half of 2017.

About Cynapsus

Cynapsus is a specialty CNS pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company expects to submit an NDA in the first half of 2017. For additional company information, please visit our website at www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the following website:  http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA in the first half of 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing, completion and results of Phase 3 and other clinical studies; beliefs related to potential benefits and effectiveness of, and demand for, the Company’s product candidate; and expectations relating to at-home titration and the impact on the Company’s clinical trials. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on August 10, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Announces Publication in the Journal Movement Disorders of Data for the Treatment of OFF Episodes in Patients with Parkinson's Disease http://ir.cynapsus.ca/news/detail/160/cynapsus-announces-publication-in-the-journal-movement-disorders-of-data-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease Fri, 12 Aug 2021 06:00:00 -0400 http://ir.cynapsus.ca/news/detail/160/cynapsus-announces-publication-in-the-journal-movement-disorders-of-data-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease

- Results suggests APL-130277 rapidly and effectively converts patients from the OFF to full ON state -
- Manuscript published online ahead of print -

TORONTO, Aug. 12, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), today announced that data from its CTH-105 Phase 2 trial of APL-130277 for the treatment of OFF episodes in patients with Parkinson’s disease was published in the peer-reviewed journal Movement Disorders. The paper, titled “Sublingual Apomorphine (APL-130277) for the Acute Conversion of OFF to ON in Parkinson’s Disease” by Robert A. Hauser, M.D., et al., was published electronically ahead of print. The company had previously announced top-line data from the CTH-105 trial in November of 2014.

Key findings from the manuscript include:

  • A full ON response was achieved by 15 of 19 patients dosed (78.9%) with a mean dose of 18.4 mg

  • All 15 responders (100.0%) achieved a full ON response within 30 minutes from the time of administration, and 6 of 15 (40.0%) achieved a full ON response within 15 minutes of administration

  • The mean duration of ON time was 50 (SD 19.4) minutes with 9 of 15 (60.0%) patients remaining fully ON for 90 minutes

  • A significant improvement in Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS) from baseline was observed at all time points with a mean maximum change of 18.9 points

  • APL-130277 was safe and generally well-tolerated with no discontinuations because of adverse events

CTH-105 was a Phase 2 multicenter, open-label, clinical trial assessing APL-130277 in patients with Parkinson’s disease who experience OFF episodes, with a total duration of OFF of at least two hours daily. OFF episodes were achieved by having patients take their last dose of levodopa the night before coming into the clinic. Patients were not allowed to take their first dose of levodopa or other PD medications in the morning, resulting in a morning OFF state. Patients were then given escalating doses of APL-130277 (at a minimum of three hours between doses) until ON was achieved, as documented by study staff, the patient and a clinician assessment of MDS-UPDRS. The MDS-UPDRS score was measured at 15, 30, 45, 60 and 90 minutes.

Albert Agro, Ph.D., author and chief medical officer of Cynapsus, said “The Phase 2 results published in this manuscript confirm the preliminary findings announced in 2014 that APL-130277 was highly effective at rapidly and safely converting patients from OFF to full ON. We look forward to continued validation of our approach to treating patients suffering with OFF episodes with top-line data from our Phase 3 efficacy study expected late in the third quarter or early fourth quarter of this year. We also intend to share longer-term safety data and file our new drug application in the first half of 2017.”

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA in the first half of 2017. For additional company information, please visit our website at www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the following website:  http://cth300and301trials.cynapsus.ca/ 

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA in the first half of 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing, completion and results of Phase 3 and other clinical studies; and beliefs related to potential benefits and effectiveness of and demand for the Company’s product candidate. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on August 10, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Therapeutics Reports Second Quarter 2016 Financial Results and Recent Developments http://ir.cynapsus.ca/news/detail/159/cynapsus-therapeutics-reports-second-quarter-2016-financial-results-and-recent-developments Wed, 10 Aug 2021 16:10:00 -0400 http://ir.cynapsus.ca/news/detail/159/cynapsus-therapeutics-reports-second-quarter-2016-financial-results-and-recent-developments - Recent Positive Dose Titration Data from Pivotal Phase 3 Clinical Program -
- On Track for New Drug Application Submission in the First Half of 2017 -

TORONTO, Aug. 10, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (PD), today reported financial results for the quarter ended June 30, 2022 and provided an update on its product candidate and corporate activities. Unless specified otherwise, all amounts are in United States (U.S.) dollars.

“Recent positive results from the dose titration phase of our pivotal Phase 3 study signify our progress toward concluding our Phase 3 clinical program for APL-130277,” stated Anthony Giovinazzo, President and CEO of Cynapsus. “These positive interim data have given us confidence that our approach to treating OFF episodes will be successful.  We expect to conclude the efficacy portion of the Phase 3 trial soon and announce top-line data late in the third quarter or early in the fourth quarter of this year. In addition, we look forward to sharing longer-term safety data in the first half of 2017 and we intend to file our NDA with the U.S. FDA in the first half of 2017.”

Recent Business Highlights

  • Appointment of Frederick Driscoll to Board of Directors: On May 20, 2016, Cynapsus announced the appointment of Frederick W. Driscoll to its board of directors.  Mr. Driscoll has more than 30 years of financial management experience with biotechnology and medical device companies.  Mr. Driscoll is currently the chairman of the board of OXiGENE, Inc., and is also currently the chief financial officer at Flexion Therapeutics.  He is serving on Cynapsus’ audit committee.  

  • European Academy of Neurology Annual Meeting (EAN): In May 2016, Cynapsus attended the EAN in Copenhagen and presented three poster presentations.   Clinical data from a toxicology study in Hamsters showed that APL-130277 produced no buccal mucosal irritation.  An Evaluation of Physician Practices showed that physicians feel there is a high level of unmet need regarding treatment options for OFF episodes. In addition, an Evaluation of Patient and Caregiver Insights shared that OFF episodes negatively impact quality of life for PD patients.  The posters can be found in the product pipeline section under publications on the Cynapsus website www.cynapsus.ca.  

  • International Congress of Parkinson’s Disease and Movement Disorders (ICPDMD): In June 2016, Cynapsus attended the ICPDMD in Berlin and presented seven posters.  Four new presentations included (1) Physician primary research showing that the effective dose of APL-130277 converting patients to full ON from OFF is not correlated with commonly used measures, that disease severity is not predictive of the effective APL-130277 dose, and data suggests titrating patients from the lowest possible APL-130277 dose, (2) Patient/Caregiver primary research reported that OFF episodes have a negative impact on quality of life and that patients are open to new treatments, (3) An evaluation of physician practices noted that physicians believe there is a high unmet need for new treatment options for OFF episodes, (4) A Hamster mucosal toxicology study of APL-130277 showed the product candidate produced no irritation of the cheek pouch when administered at a relatively high dose over 28 days.  
    Three encore presentations displayed (1) APL-130277 converted patients from OFF to ON regardless of demographics or disease characteristics (2) Pharmacokinetic/Pharmacodynamic of APL-130277 confirmed, on average, that a minimum apomorphine plasma concentration of 2.64 ng/ml was needed to turn a patient to full ON from the OFF state, and (3) The Movement Disorder Society’s Uniform Parkinson’s Disease Rating Scale Part III (MDS-UPDRS) improvement of over 10 points and a change of 20% at 15 minutes post-APL-130277 dose was needed to turn a PD patient from morning OFF to the full ON state. The posters can be found in the product pipeline section under publications on the Cynapsus website www.cynapsus.ca.  

  • Announcement of Enrollment of Last Patient in Pivotal Phase 3 Efficacy Trial of APL-130277: On June 30, 2016, Cynapsus announced that the last patient was enrolled in the Phase 3 Efficacy trial, CTH-300, a double-blind, placebo-controlled, parallel-design study with PD patients who have at least one OFF episode every 24 hours, with total OFF time of at least two hours per day.

  • Announcement of Positive Phase 3 Dose Titration Results from Efficacy Trial of APL-130277: At Cynapsus’ Analyst and Investor Day on July 19, 2016, the Company detailed positive preliminary open-label dose titration (DTP) results.  Data showed the mean change in MDS-UPDRS from baseline to 30 minutes was 22 points. In addition, 60% of patients’ improvement in motor function was reported between 5-12 minutes after dosing and was maintained beyond 90 minutes. Furthermore, 83% of patients entering DTP turned from OFF to fully ON, 78% turned fully ON within 30 minutes and approximately 38% were fully ON at 15 minutes. The median dose of APL-130277 turning patients to fully ON was 20mg, and the product candidate was well tolerated by patients.  Sixteen percent of patients reported mild to moderate nausea, 8% reported dizziness, 4% reported somnolence, 2% reported vomiting and 1% reported symptomatic hypotension. There were no reports of local irritation.  Sixteen patients were dosed but did not complete the DTP; five discontinued due to an adverse event, nine discontinued due to the highest dose not effectively turning them from OFF to ON within 45 minutes and two discontinued for administrative reasons.

  • Announcement of European Clinical Plan Update for APL-130277: On July 18, 2016, Cynapsus provided an update on its European clinical plan for APL-130277 following meetings with regulatory authorities.  Cynapsus plans to conduct an active comparator study with sub-cutaneous apomorphine with up to 80 patients randomized in a four-week open label crossover study. Functional endpoints will be assessed and include the duration of ON, preference and ease-of-use of APL-130277, the use of patient diaries and the tolerability of APL-130277.    

Upcoming Milestones and Events

United States

  • World Parkinson Congress: Cynapsus will conduct a corporate symposium on “A Practical Approach to the Management of OFF periods in PD,” on September 22nd in Portland, Oregon
  • CTH-300 Phase 3 Efficacy Study: Top-line data expected late in the third quarter or early in the fourth quarter of 2016
  • CTH-301 Phase 3 Safety Study: Top-line data expected in the first half of 2017
  • CTH-201 Phase 2 Thorough QT Study:  Subject to FDA review and agreement, if required, this study is planned to begin in the second half of 2016.  If commenced, the trial is expected to be completed in the fourth quarter of 2016 or the first quarter of 2017
  • New Drug Application(NDA)submission: An NDA is expected to be submitted to the FDA in the first half of 2017

European Union

  • CTH-302 European Registration Study: An active comparator study is expected to commence in the fourth quarter of 2016

Q2 2016 Financial Results

  • Cash. Cash as of June 30, 2016, totaled $55.1 million as compared to $68.6 million as of March 31, 2016. Cash used in operating activities for the six months ended June 30, 2022 was $15.9 million versus $10.8 million for the six months ended June 30, 2015.  Cynapsus expects its cash as of June 30, 2022 to be sufficient to fund the Company into 2017. 
  • R&D Expense. Research and development expenses were $7.2 million for the three months ended June 30, 2016, compared to $6.8 million for the three months ended June 30, 2015, an increase of $0.4 million.  For the six months ended June 30, 2016, R&D expense was $12.4 million, compared to $9.2 million for the six months ended June 30, 2015.
  • OG&A Expense. Operations, general and administrative expenses were $2.7 million for the three months ended June 30, 2016, compared to $2.5 million for the three months ended June 30, 2015, an increase of $0.2 million. For the six months ended June 30, 2016, OG&A expense was $5.8 million, compared to $4.1 million for the six months ended June 30, 2015.
  • Loss for the Period.  For the three months ended June 30, 2016, loss for the period was $10.2 million, or $0.83 per share, as compared to loss for the period of $8.9 million, or $1.22 per share, for the three months ended June 30, 2015. For the six months ended June 30, 2016, loss for the period was $18.5 million, or $1.51 per share, as compared to loss for the period of $13.0 million, or $2.07 per share, for the six months ended June 30, 2015.    
  • Reported common shares outstanding as of June 30, 2022 were 12,321,566 common shares as compared to 12,309,366 common shares as of March 31, 2016.
   
Cynapsus Therapeutics Inc.
Interim Statements of Loss and Comprehensive Loss
(unaudited)
(in millions and in US dollars, except per share data)
 
   
      For the Three Months Ended   For the Six Months Ended  
      June 30,   June 30,  
        2016     2015*   2016     2015*  
                       
EXPENSES                          
                           
Research and development     $ 7,152     $ 6,830       $ 12,371         $ 9,183    
Operating, general and administrative       2,701       2,546         5,842           4,051    
Acquisition milestone share-based payment       -       -         -           1,209    
Unrealized foreign exchange gain       (10 )     (458 )       (14 )         (1,411 )  
Interest income and related charges       331       (5 )       331           (12 )  
Loss for the period       10,174       8,913         18,530           13,020    
                           
Other comprehensive loss                          
Foreign currency translation adjustment       -       192         -           1,494    
                           
Loss and other comprehensive loss for the period     $ 10,174     $ 9,105       $ 18,530         $ 14,514    
                           
Loss per share – basic and diluted     $ 0.83     $ 1.22       $ 1.51         $ 2.07    
                           
Weighted average number of shares outstanding
 
– basic and diluted
      12,315,869       7,316,076         12,303,454           6,280,674    
                                           

Cynapsus Therapeutics Inc.
Interim Statements of Financial Position
(unaudited)
(in millions and in US dollars)
 
   
      June 30,
2016
  December 31,
2015
 
      $   $  
ASSETS                
Current assets                
Cash       55,068     75,803  
Prepaid expenses and other current assets       1,082     629  
Total current assets       56,150     76,432  
Non-current assets                
Property, plant and equipment       473     409  
Intangible assets       16,273     3811  
                 
Total assets       72,896     77,221  
LIABILITIES                
Current liabilities                
Accounts payable and accrued liabilities       4,395     3,799  
Current portion of license payable       8,243     -  
Total current liabilities       12,638     3,799  
                 
Long-term liabilities                
Long-term portion of license payable       2,997     -  
Total long-term liabilities       2,997     -  
                 
Total liabilities       15,635     3,799  
                 
SHAREHOLDERS’ EQUITY                
Share capital       120,024     119,565  
Warrants       10,485     10,623  
Share-based payments       8,380     6,333  
Deficit       (70,962 )   (52,433 )
Accumulated other comprehensive loss       (10,666 )   (10,666 )
Total shareholders’ equity       57,261     73,422  
                 
Total liabilities and shareholders’ equity       72,896     77,221  
                 

*Certain comparative figures have been reclassified to conform to the financial statement presentation adopted for the current period and all amounts prior to January 1, 2022 have been restated for the change in reporting currency from Canadian dollars to U.S. dollars. 

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA in the first half of 2017. For additional company information, please visit our website at www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the following website:  http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA in the first half of 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing, completion and results of Phase 3 and other clinical studies; beliefs related to potential benefits and effectiveness of, and demand for, the Company’s product candidate; and expectations regarding the sufficiency of the Company’s cash. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on August 10, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc.]]>
Cynapsus Therapeutics Provides European Clinical Update for APL-130277 for the Treatment of OFF Episodes in Patients with Parkinson's Disease http://ir.cynapsus.ca/news/detail/157/cynapsus-therapeutics-provides-european-clinical-update-for-apl-130277-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease Mon, 18 Jul 2022 16:10:00 -0400 http://ir.cynapsus.ca/news/detail/157/cynapsus-therapeutics-provides-european-clinical-update-for-apl-130277-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease

-- Company plans to initiate pivotal program in fourth quarter --
-- Webcast with accompanying slides to discuss program tomorrow at 7:30 a.m. Eastern time --

TORONTO, July 18, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (CNS) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (PD), today provided an update on its European clinical plan following meetings with regulatory authorities.  Agreement with the EMA has been reached on the design, duration and size for the clinical studies as well as the endpoints.  Based on this, Cynapsus plans to initiate a pivotal clinical program evaluating the safety and efficacy of APL-130277 in PD patients in the fourth quarter of 2016.

Current European Clinical Trial Plan:

  • Expect to conduct an active comparator study with sub-cutaneous apomorphine
  • Up to 80 patients will be randomized in a 4-week open label crossover study
  • Functional endpoints will be assessed and will include the duration of ON, preference and ease-of-use
    of APL-130277, the use of patient diaries, and tolerability of APL-130277
  • The use of an anti-emetic should be limited during the study
  • Based on current trial timing, the European clinical trial is expected to commence in the fourth quarter of 2016

“We are pleased with the outcome of our meeting with the European regulatory authorities and appreciate the collaborative process that led to the agreed upon design of the study,” said Anthony Giovinazzo, President and CEO of Cynapsus. “We better understand the EMA’s guidance on the safety and efficacy requirements for the clinical study for the use of APL-130277 in patients with PD.  Furthermore, we are pleased that the design takes into account that the effect of apomorphine is well-established and the benefit of a sublingual application is apparent. We look forward to continuing to work closely with the European regulatory authorities to complete this study.”

About Parkinson’s Disease and OFF Episodes

The European Parkinson's disease Association estimates that 1.2 million people have PD in the European Union.  More than 1 million people in the U.S. and an estimated 4 to 6 million people worldwide suffer from PD. It is a chronic, progressive neurodegenerative disease characterized by motor symptoms, including tremor at rest, rigidity and impaired movement, as well as significant non-motor symptoms, including cognitive impairment and mood disorders. PD’s prevalence is increasing with the aging of the population. OFF episodes are a complication of the disease. An estimated one quarter to one half of all people with PD whose symptoms are otherwise managed with ongoing drug therapy experience OFF episodes at least once daily and up to six times daily, with each episode lasting between 30 and 120 minutes.

About Apomorphine

Apomorphine is the only drug approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States, which can be painful and difficult to administer, particularly while suffering an OFF episode.

Cynapsus’ APL-130277 product candidate is a sublingual formulation of apomorphine for the treatment of OFF episodes. If approved, APL‐130277 will provide patients with a convenient and easy alternative to multiple daily injections.

Conference Call and Webcast

Cynapsus management will host an analyst meeting and live webcast with accompanying slides to discuss these findings tomorrow at 7:30 a.m. Eastern time. To view the live webcast, visit the Investor Relations section of the Company’s website at www.cynapsus.ca.

A replay of the webcast will be available 2 hours after completion of the meeting, and archived for 90 days on the Company's website at www.cynapsus.ca in the Investor Relations section.

About Cynapsus

Cynapsus is a specialty CNS pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA in the first half of 2017. For additional company information, please visit our website www.cynapsus.ca.  For more information about the Phase 3 studies, including enrollment criteria, please visit the website found here http://cth300and301trials.cynapsus.ca/  

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA in the first half of 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing, completion and results of Phase 3 and other clinical studies; and beliefs related to potential benefits, effectiveness and demand for, the Company’s product candidate. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on May 11, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Company Contact:
Kristen Galfetti
Vice President, Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Therapeutics Announces Positive Phase 3 Dose Titration Phase Results with APL-130277 for the Treatment of OFF Episodes in Patients with Parkinson's Disease http://ir.cynapsus.ca/news/detail/158/cynapsus-therapeutics-announces-positive-phase-3-dose-titration-phase-results-with-apl-130277-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease Mon, 18 Jul 2022 16:10:00 -0400 http://ir.cynapsus.ca/news/detail/158/cynapsus-therapeutics-announces-positive-phase-3-dose-titration-phase-results-with-apl-130277-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease -- Webcast with accompanying slides to discuss these findings tomorrow at 7:30 a.m. Eastern time
Top-line CTH-300 results expected in late Q3 or early Q4 --

TORONTO, July 18, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics, Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (CNS) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (PD), today announced positive open-label dose titration phase (DTP) results from the ongoing CTH-300 pivotal Phase 3 efficacy and safety trial (CTH-300).

CTH-300 enrollment was completed on June 30, 2022 with 102 PD patients entering open-label DTP.   The DTP part of CTH-300 is now complete, with data available from the first 92 patients.  Remaining patient data will be entered upon completion of their first post-randomization visit.

Preliminary CTH-300 open-label DTP highlights include:

  • The mean change in Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS Part III) from baseline to 30 minutes was 22 points
  • In 60% of patients, improvement in motor function was reported between 5 and 12 minutes after dosing.
  • Improvement in motor function was maintained beyond 90 minutes with a mean improvement of the MDS UPDRS Part III of 16 points at that time point
  •  83% of patients entering the open-label dose titration phase turned from OFF to fully ON
  • 78% of patients entering the open-label dose titration phase turned fully ON within 30 minutes; approximately 38% were fully ON at 15 minutes
  • The median dose of APL-130277 turning patients to fully ON was 20mg
  • APL-130277 was well tolerated. During the dose titration period: 16% of patients reported nausea that was mostly mild in intensity; 8% of patients reported dizziness; 4% of patients reported somnolence; 2% of patients reported vomiting; and 1% of patients reported symptomatic hypotension
  • There were no reports of local irritation during the open-label DTP of the CTH-300 study
  • A total of 16 patients were dosed and did not complete the DTP of the study; five (5) of such patients discontinued due to an adverse event, nine (9) of such patients discontinued because the highest dose in this study was not sufficient to turn them from OFF to ON within 45 minutes and two (2) of such patients discontinued for administrative reasons.

“Top-line results from the DTP of CTH-300 corroborate our Phase 2 findings supporting the potential benefit of APL-130277 as an on-demand therapy for the management of OFF episodes in patients with Parkinson’s disease who suffer motor fluctuations,” said Dr. Albert Agro, Chief Medical Officer of Cynapsus. “The robustness of this preliminary clinical data, particularly the 22-point improvement in MDS-UPDRS Part III, gives us confidence that our sample size of 80 patients randomized, is more than sufficient to show statistical and clinical meaningful changes at 90% power in our primary and key secondary clinical endpoints.”

Figure 1 (below) demonstrates the change from baseline of the MDS-UPDRS Part III score at 15, 30, 45, 60 and 90 minutes post-dosing^

Table1.jpg


^Data captured is based on patients existing in the database as of July 15, 2022

Table 1 Illustrates the most common dopaminergic Adverse Events (AE) seen in CTH-300 Dose Titration Phase (n=92)*

N=92 Number of Patients with an Adverse Event
Any AE Mild AE Moderate AE Severe AE
N (%) N (%) N (%) N (%)
Nausea 15 (16) 12 (13) 2 (2) 1 (1)
Dizziness 7 (8) 4 (4) 3 (3) 0 (0)
Somnolence 4 (4) 3 (3) 1 (1) 0 (0)
Yawning 3 (3) 3 (3) 0 (0) 0 (0)
Vomiting 2 (2) 1 (1) 1 (1) 0 (0)
Symptomatic Hypotension 1 (1) 1 (1) 0 (0) 0 (0)
Stomatitis/ Irritation 0 (0) 0 (0) 0 (0) 0 (0)

* Data not final and subject to change

“The results seen in the open label dose titration period of CTH-300 are an important step in confirming earlier data that demonstrated that APL-130277 can provide PD patients with a safe, tolerable and rapid improvement in motor function during OFF episodes,” said Anthony Giovinazzo, President and CEO of Cynapsus. “We look forward to the completion of CTH-300 and preparing the overall study results for our NDA submission.  APL-130277 is being developed to address a significant unmet need facing people with Parkinson’s disease. The preliminary results from CTH-300 DTP lead us to believe that APL-130277 may be able to fulfill the unmet needs of Parkinson’s patients seeking to better manage their motor fluctuations.”

These Phase 3 dose titration results are only a snap shot and the final data and results from the Phase 3 study, when released, could differ from such results.

Phase 3 Program Study Design

The CTH-300 study is a double-blind, placebo-controlled, parallel-design, two-part study.  The study enrolled eligible PD patients and 102 patients entered the Open Label DTP. In the DTP, patients arrived to the clinic in the practically defined OFF state (withholding their morning dose of PD medications) and received the lowest dose of APL-130277 (10mg). Patients were assessed to determine if successful conversion from OFF to full ON occurred. If a full ON was not achieved, patients returned to the clinic on subsequent visits and received a higher dose of APL-130277 (at 5mg increments, up to 35mg) until the effective conversion dose was identified. Those patients that turned fully ON with a dose of APL-130277 during the DTP proceeded to the dose randomization part of the study where they were randomized to receive either the effective dose or placebo. The objective of the second part of CTH-300 is to evaluate the efficacy, safety and tolerability of APL-130277 versus placebo in patients with PD over a 12-week period.  CTH-300 is well powered to demonstrate statistical significant reduction in MDS-UPDRS Part III with 80 patients randomized. A sample size of 80 randomized patients allows for greater than 90% power to achieve statistical significance at the primary and key secondary endpoint.  The primary endpoint is mean change in the MDS-UPDRS Part III score at 30 minutes after 12 weeks of at-home dosing.

The CTH-301 Phase 3 Safety Study (CTH-301) is a long-term open-label, single arm safety study in PD patients who have at least one OFF episode per day, with total OFF time of at least two hours per day. The objective is to evaluate the safety and tolerability of APL-130277 in up to 200 patients with PD over a six-month period.  Patients completing CTH-300 are eligible to enter CTH-301. In addition, de novo patients from approximately 65 sites in North America and Europe will be enrolled in CTH-301.

Data from CTH-300 and CTH-301 are expected to form the basis for the registration package necessary for a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration expected to be submitted in the first half of 2017.

About Parkinson’s Disease and OFF Episodes

More than 1 million people in the U.S. and an estimated 4 to 6 million people worldwide suffer from PD. It is a chronic, progressive neurodegenerative disease characterized by motor symptoms, including tremor at rest, rigidity and impaired movement, as well as significant non-motor symptoms, including cognitive impairment and mood disorders.  PD’s prevalence is increasing with the aging of the population. OFF episodes are a complication of the disease. An estimated one quarter to one half of all people with PD whose symptoms are otherwise managed with ongoing drug therapy experience OFF episodes at least once daily and up to six times daily, with each episode lasting between 30 and 120 minutes.

About Apomorphine

Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States, which can be painful and difficult to administer, particularly while suffering an OFF episode.

Cynapsus’ APL-130277 product candidate is a sublingual formulation of apomorphine for the treatment of OFF episodes. If approved, APL‐130277 will provide patients with a convenient and easy alternative to multiple daily injections.

Conference Call and Webcast

Cynapsus management will host an analyst meeting and live webcast with accompanying slides to discuss these findings tomorrow at 7:30 a.m. Eastern time. To view the live webcast, visit the Investor Relations section of the Company’s website at www.cynapsus.ca.

A replay of the webcast will be available 2 hours after completion of the meeting, and archived for 90 days on the Company's website at www.cynapsus.ca in the Investor Relations section.

About Cynapsus

Cynapsus is a specialty CNS pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only drug approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA in the first half of 2017. For additional company information, please visit our website www.cynapsus.ca.  For more information about the Phase 3 studies, including enrollment criteria, please visit the website found here http://cth300and301trials.cynapsus.ca/  

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA in the first half of 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing, completion and results of Phase 3 and other clinical studies; and beliefs related to potential benefits, effectiveness and demand for, the Company’s product candidate. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-Q for the quarter ended March 31, 2022 filed with the United States Securities and Exchange Commission (the “SEC”) on May 11, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Company Contact:
Kristen Galfetti
Vice President, Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc.]]>
Cynapsus Therapeutics Announces 2016 Analyst and Investor Day http://ir.cynapsus.ca/news/detail/156/cynapsus-therapeutics-announces-2016-analyst-and-investor-day Wed, 06 Jul 2022 06:00:00 -0400 http://ir.cynapsus.ca/news/detail/156/cynapsus-therapeutics-announces-2016-analyst-and-investor-day

TORONTO, July 06, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (CNS) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (PD), today announced that it will host an analyst and investor day on Tuesday, July 19, 2016. 

The meeting will include presentations from Cynapsus executives and world-renowned clinical experts in PD. The event will start at 7:00 a.m. and will conclude at approximately 9:30 a.m. EDT.

A webcast of the event will be available in the investor section of Cynapsus’ website at www.cynapsus.ca. A replay of the webcast will be available on the website for 30 days after the conclusion of the event.

Speakers to include:

  • C. Warren Olanow, M.D., Mt. Sinai School of Medicine, New York
  • Fabrizio Stocchi, M.D., PhD, IRCCS San Raffaele Rome, Italy
  • Anthony Giovinazzo, President & CEO of Cynapsus
  • Albert Agro, Ph.D., Chief Medical Officer of Cynapsus

About Cynapsus

Cynapsus is a specialty CNS pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. Cynapsus successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus’ Phase 3 clinical program for APL-130277 plans to rely on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the company intends to submit a new drug application (NDA) near the end of 2016 or in early 2017. For additional company information, please visit our website www.cynapsus.ca. For more information about the Phase 3 studies please visit the website http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA near the end of 2016 or in early 2017; and expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing and completion of clinical studies. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2022 filed with the United States Securities and Exchange Commission (the “SEC”) on May 11, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Company Contact:
Kristen Galfetti
Vice President, Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Event Contact:
The Trout Group
Jennifer Porcelli
Senior Vice President
(646) 378-2962
jporcelli@troutgroup.com

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Therapeutics Enrolls Last Patient in Pivotal Phase 3 Efficacy Trial of APL-130277 to Treat OFF Episodes in Patients with Parkinson’s Disease http://ir.cynapsus.ca/news/detail/155/cynapsus-therapeutics-enrolls-last-patient-in-pivotal-phase-3-efficacy-trial-of-apl-130277-to-treat-off-episodes-in-patients-with-parkinsons-disease Thu, 30 Jun 2022 06:00:00 -0400 http://ir.cynapsus.ca/news/detail/155/cynapsus-therapeutics-enrolls-last-patient-in-pivotal-phase-3-efficacy-trial-of-apl-130277-to-treat-off-episodes-in-patients-with-parkinsons-disease

Dose titration phase results expected in mid to late July with top-line results expected near the end of Q3 2016

TORONTO, June 30, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (CNS) pharmaceutical company developing and preparing to commercialize APL-130277, a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (PD), announced today that the last patient has been enrolled in its pivotal Phase 3 efficacy study, CTH-300.  Dose titration phase results from this study are expected in mid to late July and top-line data are expected to be released near the end of the third quarter of 2016. 

The CTH-300 trial is a double-blind, placebo-controlled, parallel-design study with PD patients who have at least one OFF episode every 24 hours, with total OFF time of at least two hours per day. The study objective is to evaluate the efficacy and safety of APL-130277 versus placebo in patients with PD. Patients will each be observed for 12 weeks, with dosing at home and in clinic. The primary endpoint is mean change in the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale Part III score at 30 minutes after dosing in the clinic at week 12. The key secondary endpoint will be the percentage of patients who convert from the OFF to the ON state at or before 30 minutes of dosing with APL-130277 at the week 12 visit.

About Parkinson’s Disease and OFF Episodes

More than 1 million people in the U.S. and an estimated 4 to 6 million people worldwide suffer from Parkinson's disease. Parkinson’s disease is a chronic, progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. OFF episodes are a complication of Parkinson’s disease characterized by motor symptoms, including tremor at rest, rigidity and impaired movement, as well as significant non-motor symptoms such as cognitive impairment and mood disorders. An estimated one quarter to one half of all people with Parkinson’s disease whose symptoms are otherwise managed with ongoing drug therapy experience OFF episodes at least once daily and up to six times daily, with each episode lasting between 30 and 120 minutes.

About Cynapsus

Cynapsus is a specialty CNS pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus’ Phase 3 clinical program for APL-130277 plans to rely on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the company intends to submit an NDA near the end of 2016 or in early 2017. For additional company information, please visit our website www.cynapsus.ca. For more information about the Phase 3 studies please visit the website http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the anticipated timing, completion and results of Phase 3 and other clinical studies; the Company’s expectation for filing an NDA near the end of 2016 or in early 2017; and beliefs related to potential benefits and effectiveness of Cynapsus’ product candidate. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 9, 2016, as amended by Amendment No. 1 to Form 10-K/A filed with the SEC on March 18, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Company Contact:
Kristen Galfetti
Vice President, Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Therapeutics Announces Data Presentations at the International Congress of Parkinson’s Disease and Movement Disorders http://ir.cynapsus.ca/news/detail/154/cynapsus-therapeutics-announces-data-presentations-at-the-international-congress-of-parkinsons-disease-and-movement-disorders Tue, 21 Jun 2022 06:30:00 -0400 http://ir.cynapsus.ca/news/detail/154/cynapsus-therapeutics-announces-data-presentations-at-the-international-congress-of-parkinsons-disease-and-movement-disorders -- Presentations include results from physician, patient and caregiver primary research, positive preclinical toxicology results and physician OFF episode treatment practices --

TORONTO, June 21, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (CNS) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson's disease (PD), announced that seven posters will be presented today at the 20th International Congress of Parkinson's Disease and Movement Disorders (ICPDMD) Annual Meeting in Berlin.

The following data will be presented today:

New Poster Presentations

  1. Physician Primary Research Insights - Holly Shill, M.D. (Poster #836)
    • APL-130277 dose needed to convert patients to Full ON from OFF state not correlated with commonly used measures
    • Disease severity not predictive of APL-130277 dose required to convert a PD patient from OFF to Full ON
    • Data supports titrating patients from lowest available APL-130277 dose
  2. Patient/Caregiver Primary Research Insights - Eric J. Pappert, M.D. (Poster #837)
    • Over 30% of patients and caregivers reported OFF episodes in first year post diagnosis
    • An additional 53% indicated OFF episodes commenced 2-3 years post diagnosis
    • Patients and caregivers believe that OFF episodes have a negative impact on Quality of Life
    • Patients are open to new treatments
  3. Treatment of OFF Episodes: An Evaluation of Physician Practices - Eric J. Pappert, M.D. (Poster #838)
    • Physicians are concerned about OFF episodes in the management of Parkinson's disease
    • Physicians report their patients are aware of OFF episodes
    • Physicians believe there is a high unmet need for new treatment options for OFF episodes
  4. Hamster Mucosal Toxicology Study of APL-130277 - Albert Argo, Ph.D. (Poster #846)
    • APL-130277 produced no irritation of the cheek pouch when administered at a relatively high dose

Encore Poster Presentations

  1. Efficacy of APL-130277 to Convert OFF to Full ON by Demographics and Baseline Disease Characteristics - Holly Shill, M.D. (Poster #848)
    • APL-130277 converts patients with PD from OFF to Full ON, regardless of demographics or disease characteristics
  2. PK/PD of APL-130277 - Eric J. Pappert, M.D. (Poster #850)
    • On average, a minimum apomorphine plasma concentration of 2.64 ng/ml was needed to turn a patient to Full ON from the OFF state
    • Plasma levels above this minimum efficacious concentration resulted in sustained improvements in motor function and ON time
    • Responders had large, clinically meaningful Movement Disorder Society's Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) changes at all time-points while the non-responders had some motor improvement, but not enough to convert from OFF to Full ON
  3. CTH-105: Change for ON - Holly Shill, M.D. (Poster #851)
    • A MDS-UPDRS III improvement of over 10 points and a change of 20% at 15 minutes post-APL-130277 dose was needed to turn a PD patient from the morning OFF state to Full ON

The posters will be accessible from Cynapsus' corporate website at www.cynapsus.ca.

"These data presented at ICPDMD complement Cynapsus' positive results shared at prior medical meetings and demonstrate an encouraging clinical profile and further support the potential opportunity that APL-130277 may have in effectively treating OFF episodes in patients with Parkinson's disease." said Albert Agro, PhD, chief medical officer of Cynapsus. "In addition, data support our belief that there exists a high unmet need, that physicians are concerned about the lack of adequate treatments for OFF episodes and that patients are open to new treatment options. We expect to share additional clinical data from our pivotal Phase 3 efficacy trial by the end of the third quarter of 2016 and anticipate using these data to file our new drug application near the end of 2016 or in early 2017."

Cynapsus Sponsored Symposium

Cynapsus also hosted a satellite symposium at ICPDMD. Additional information can be found below and at the website link: http://www.mdscongress2016.org/

Title: From OFF to ON - Treating Levodopa-Induced OFF Periods in Patients with Parkinson's Disease

The symposium was held on Sunday, June 19, 2022 and included discussions on the treatment of motor fluctuations and OFF episodes in Parkinson's Disease. Participants included C. Warren Olanow, Fabrizio Stocchi, Anthony Schapira and Karl Kieburtz.

About Cynapsus

Cynapsus is a specialty CNS pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a "turning ON" medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit a new drug application near the end of 2016 or in early 2017. For additional company information, please visit our website www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the website found here http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company's expectation for filing an NDA near the end of 2016 or in early 2017; expectations regarding the Company's clinical and regulatory activities, including without limitation, the anticipated timing, completion and results of Phase 3 and other clinical studies; and beliefs related to potential benefits and effectiveness of, and demand for, our product candidate. These forward-looking statements include information about possible or assumed future results of the Company's business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company's current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption "Risk Factors" in the Company's Form 10-K filed with the United States Securities and Exchange Commission (the "SEC") on March 9, 2016, as amended by Amendment No. 1 to Form 10-K/A filed with the SEC on March 18, 2016, and its other filings and reports in the United States with the SEC available on the SEC's web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information

Company Contact:
Kristen Galfetti
Vice President, Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca

Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc.

]]>
Cynapsus Therapeutics Announces Data Presentations at the European Academy of Neurology Annual Meeting http://ir.cynapsus.ca/news/detail/153/cynapsus-therapeutics-announces-data-presentations-at-the-european-academy-of-neurology-annual-meeting Mon, 30 May 2022 02:00:00 -0400 http://ir.cynapsus.ca/news/detail/153/cynapsus-therapeutics-announces-data-presentations-at-the-european-academy-of-neurology-annual-meeting -- Presentations include positive preclinical toxicology results, quality-of-life data and physician OFF episode treatment practices --

TORONTO, May 30, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics, Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (CNS) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson's disease (PD), today announced that three clinical posters will be presented today at the 2nd Congress of the European Academy of Neurology (EAN) Annual Meeting, in Copenhagen.

The following data will be presented by Eric J. Pappert, M.D., Vice President Global Medical Affairs, Cynapsus Therapeutics, today from 12:30-13:15 p.m. CET.

Poster Presentations

  1. Apomorphine Film (APL-130277) Produces No Buccal Mucosal Irritation: Results from a 28-Day Toxicology Study in Hamsters (Poster #31123)
    • 28-day toxicology study in 16 hamsters
    • APL-130277, Cynapsus' apomorphine film, produced no irritation of the cheek pouch buccal mucosal of male and female hamsters when administered at a dose of 2.08 mg (15 times higher than a 30 mg dose in a 60 kg human) three times daily for 28 consecutive days
  2. Treatments of OFF Episodes in Parkinson's Disease: An Evaluation of Physician Practices (Poster #31122)
    • Responses from 120 caregivers and patients on the impact of OFF episodes on quality of life (QoL) and satisfaction with current patient treatment
    • 32.6% of patients and caregivers indicated that they had OFF episodes in the first year post diagnosis
    • 53.3% of patients and caregivers indicating that OFF episodes started 2-3 years post diagnosis
    • Patients and caregivers reported that OFF episodes had a negative impact on QoL
  3. The Treatment of OFF Episodes in Parkinson's Disease: An Evaluation of Patient and Caregiver Insights (Poster #31121)
    • 102 physicians who treat patients with PD were queried on their practices and attitudes regarding the treatment of OFF episodes
    • Physicians are concerned about OFF episodes and feel that their patients are aware of OFF episodes
    • Physicians feel that there is a fairly high level of unmet need regarding treatment options for OFF episodes

The posters will be accessible from Cynapsus' corporate website at www.cynapsus.ca.

"We are pleased to share data demonstrating that the APL-130277 sublingual thin film produced no signs of mucosal irritation in hamsters at doses significantly higher than the highest dose planned for patients," said Albert Agro, Ph.D., chief medical officer of Cynapsus. "These data, in addition to prior positive results shared at medical meetings, provide evidence of the potential safety of APL-130277 in treating OFF episodes. In addition, information gathered through extensive surveys we conducted supports our beliefs that physicians are concerned about OFF episodes and that there exists a high unmet need. Most importantly, survey results showed patients are open to new treatments that would result in an improved quality-of-life. We look forward to sharing clinical data from our pivotal Phase 3 efficacy trial over the next several months and anticipate using these data to file our new drug application (NDA) near the end of 2016 or in early 2017."

Cynapsus also hosted a satellite symposium at EAN. Additional information can be found below and at the website link: https://www.eaneurology.org.

Cynapsus Sponsored Symposium

From OFF to ON - New approaches to the treatment of OFF episodes in Parkinson's Disease

The symposium was held on Saturday, May 28, 2016, and included discussions on Levodopa-induced OFF episodes, approaches to the treatment of OFF episodes and rescue therapies. Participants included C. Warren Olanow, Fabrizio Stocchi and Anthony H.V. Scharpira.

About Cynapsus

Cynapsus is a specialty CNS pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a "turning ON" medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA near the end of 2016 or in early 2017. For additional company information, please visit our website www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the website found here http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company's expectation for filing an NDA near the end of 2016 or in early 2017; expectations regarding the Company's clinical and regulatory activities, including without limitation, the anticipated timing and completion of clinical studies; and beliefs related to potential demand for our product candidate. These forward-looking statements include information about possible or assumed future results of the Company's business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company's current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption "Risk Factors" in the Company's Form 10-K filed with the United States Securities and Exchange Commission (the "SEC") on March 9, 2016, as amended by Amendment No. 1 to Form 10-K/A filed with the SEC on March 18, 2016, and its other filings and reports in the United States with the SEC available on the SEC's web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information

Company Contact:
Kristen Galfetti
Vice President, Investor Relations
(416) 703-2499 x246
kgalfetti@cynapsus.ca

Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc.

]]>
Cynapsus Therapeutics Appoints Frederick Driscoll to Its Board of Directors http://ir.cynapsus.ca/news/detail/152/cynapsus-therapeutics-appoints-frederick-driscoll-to-its-board-of-directors Fri, 20 May 2022 06:00:00 -0400 http://ir.cynapsus.ca/news/detail/152/cynapsus-therapeutics-appoints-frederick-driscoll-to-its-board-of-directors

TORONTO, May 20, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (“Cynapsus” or the “Company”) (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (“CNS”) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (“PD”), today announced the appointment of Frederick W. Driscoll to its board of directors, effective May 20, 2016. Mr. Driscoll has more than 30 years of financial management experience with biotechnology and medical device companies.  Mr. Driscoll will also serve on Cynapsus’ audit committee.

Mr. Driscoll is currently the chairman of the board of OXiGENE, Inc. (NASDAQ:OXGN).  Mr. Driscoll is also currently the chief financial officer at Flexion Therapeutics (NASDAQ:FLXN) where he led a successful $75 million initial public offering and a $100 million follow-on offering. Prior to Flexion, he was chief financial officer for Novavax where he led a team that secured more than $250 million through a combination of investment funding and commercial and government contracts. He was also instrumental in increasing Novavax's institutional shareholder base, expanding analyst coverage and implementing numerous financial reforms that strengthened that company's position. Prior to Novavax, Mr. Driscoll served as chief financial officer and subsequently chief executive officer of publicly-traded Genelabs Technologies, Inc., chief financial officer of private company Astraris, Inc. and chief executive officer of OXiGENE.

"We are excited to have Fred join our Board. His financial management experience in the pharmaceutical industry will be invaluable as Cynapsus advances its pivotal Phase 3 clinical program for APL-130277 and prepares for commercialization. Fred’s background will complement the other members of the Board as we work together to successfully shape Cynapsus' future and help change the lives of PD patients struggling with OFF episodes," commented Rochelle Stenzler, Chair of the Board of Cynapsus.

Mr. Driscoll holds a bachelor's degree in accounting and finance from Bentley University in Waltham, Massachusetts.

About Cynapsus

Cynapsus is a specialty CNS pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit a new drug application near the end of 2016 or in early 2017. For additional company information, please visit our website at www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the following website: http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA near the end of 2016 or in early 2017; and expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing and completion of clinical studies. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 9, 2016, as amended by Amendment No. 1 to Form 10-K/A filed with the SEC on March 18, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Therapeutics Reports First Quarter 2016 Financial Results and Recent Developments http://ir.cynapsus.ca/news/detail/151/cynapsus-therapeutics-reports-first-quarter-2016-financial-results-and-recent-developments Wed, 11 May 2022 16:30:00 -0400 http://ir.cynapsus.ca/news/detail/151/cynapsus-therapeutics-reports-first-quarter-2016-financial-results-and-recent-developments Focus on Advancement of Pivotal Phase 3 Clinical Program in 2016

TORONTO, May 11, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (“PD”), today reported financial results for the quarter ended March 31, 2022 and provided an update on its product candidate and corporate activities. Unless specified otherwise, all amounts are in United States (“U.S.”) dollars.

“2016 is a critical year for Cynapsus as we continue to focus on the management and conclusion of our pivotal Phase 3 clinical program for APL-130277,” stated Anthony Giovinazzo, President and CEO. “We expect to announce top-line data from the CTH-300 Phase 3 efficacy trial in the second or third quarter of this year and we intend to file our NDA with the U.S. FDA near the end of 2016 or in early 2017.  We are also refining our U.S. commercialization strategy and engaging with European regulatory authorities to finalize our clinical development strategy in Europe.”

Change in Functional and Reporting Currency

Effective January 1, 2016, the functional and reporting currency of Cynapsus and our subsidiary changed to the U.S. dollar in order to better reflect our underlying performance. We determined that our expenditures and cash flows are now principally denominated in U.S. dollars, and are expected to remain principally denominated in U.S. dollars in the future.  Accordingly, our unaudited condensed interim consolidated financial statements included in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 are expressed in U.S. dollars.  The Canadian dollar had previously been the functional and reporting currency of our business and our consolidated financial statements for periods through December 31, 2021 were previously expressed in Canadian dollars.

Upcoming Milestones and Events

United States

  • CTH-300 Phase 3 Efficacy Study: Top-line data expected in the second or third quarter of 2016.
  • CTH-301 Phase 3 Safety Study: Top-line data expected in the fourth quarter of 2016 or the first quarter of 2017.
  • CTH-201 Phase 2 Thorough QT Study:  Subject to FDA review and agreement, if required, this study is planned to begin in the second half of 2016.  If commenced, the trial is expected to be completed in the fourth quarter of 2016 or the first quarter of 2017.
  • New Drug Application(NDA)submission: An NDA is expected to be submitted near the end of 2016 or in early 2017.

European Union

  • 2nd Congress of the European Academy of Neurology Meeting: Three posters with clinical data will be presented on May 30, 2016, in Copenhagen, Denmark.
  • 20th International Congress of Parkinson’s Disease and Movement Disorders Meeting: Seven posters with clinical data will be presented on June 21, 2016, in Berlin, Germany.
  • European Medicines Agency (EMA) Meeting: A pre-submission meeting is expected to occur with the EMA in the second quarter of 2016.
  • CTH-302 European Registration Study: An active comparator study is expected to commence in the second half of 2016.

Recent Business Highlights

  • MJFF Collaboration on Wearable Device: On January 7, 2016, Cynapsus and The Michael J. Fox Foundation for Parkinson’s Research (“MJFF”) announced that they are working together to incorporate wearable device technology and “big data” approaches into Cynapsus’ pivotal Phase 3 clinical study of APL-130277.  This is a pilot effort to understand how clinical studies can harness data science approaches to objectively measure disease progression with the goal of speeding progress toward breakthroughs in drug development. The project builds on MJFF’s ongoing data science partnership with Intel Corporation, launched in August 2014, to develop platforms for the storage of large volumes of patient-generated data and algorithms to glean insights from this data. 
  • MonoSol Rx License Agreement. On April 1, 2016, subsequent to the end of the first quarter, Cynapsus and MonoSol Rx, LLC (“MonoSol Rx”) entered into a license agreement pursuant to which MonoSol Rx granted Cynapsus an exclusive, worldwide license (with the right to sub-license) to certain intellectual property, including existing and future patents and patent applications covering all oral films containing apomorphine for the treatment of OFF episodes in PD patients, as well as two other fields. Under the license agreement, MonoSol Rx has received and will receive, as applicable, up front and contingent milestone payments and mid-single-digit royalty payments on net sales of APL-130277.
  • American Academy of Neurology Annual Meeting (AAN): In April 2016, Cynapsus attended the AAN and presented in three poster presentations updated clinical data from the Phase 2 trial of APL-130277.   Results showed that APL-130277 significantly improved PD symptoms (as measured by MDS-UPDRS Part III), was generally safe and well tolerated, and rapidly turning patients from the OFF to ON state, regardless of varying disease severity. 

Q1 2016 Financial Results

  • Cash. Cash as of March 31, 2022 totaled $68.6 million as compared to $75.8 million as of December 31, 2015. Cash used in operating activities for the three months ended March 31, 2022 was $7.3 million versus $4.6 million for the three months ended March 31, 2015.  Cynapsus expects its cash as of March 31, 2022 to be sufficient to fund the Company into 2017. 
  • R&D Expense. Research and development expenses were $5.2 million for the three months ended March 31, 2016, compared to $2.4 million for the three months ended March 31, 2015, an increase of $2.8 million.  The increase in research and development expenses was primarily due to increased activity associated with the APL-130277 program. Expenditures increased as a result of increases in consulting, clinical research, packaging development, patent protection, analytics, scientific communications and educational initiatives, and scale-up chemistry, manufacturing and controls work for APL-130277. 
  • OG&A Expense. Operations, general and administrative expenses were $3.1 million for the three months ended March 31, 2016, compared to $1.5 million for the three months ended March 31, 2015, an increase of $1.6 million.  The increase in OG&A expenses was primarily related to increases in investor and public relations activities, professional and consulting fees, activities in preparing for commercialization, and travel costs. 
  • Net Loss.  For the three months ended March 31, 2016, net loss was $8.4 million, or $0.68 per share, as compared to a net loss of $4.1 million, or $0.78 per share, for the three months ended March 31, 2015.
  • Reported common shares outstanding as of March 31, 2022 were 12,309,366 common shares as compared to 12,278,133 common shares as of December 31, 2015.
 
Cynapsus Therapeutics Inc.
Consolidated Statements of Loss and Comprehensive Loss
(unaudited)
(in thousands, except per share and shares outstanding data)
(in U.S. dollars)
      Three months ended
March 31,
     
        2016       2015      
Expenses                  
Research and development       $ 5,219         $ 2,353        
Operating, general and administrative         3,141           1,504        
Acquisition milestone share-based payment         -           1,209        
Unrealized foreign exchange gain         (4 )         (953 )      
Other interest income and related charges         -           (7 )      
Loss for the period         8,356           4,106        
                       
Other comprehensive loss                      
Foreign currency translation adjustment         -           1,303        
Loss and comprehensive loss for the period       $ 8,356         $ 5,409        
Loss per share – basic and diluted       $ 0.68         $ 0.78        
Weighted Average number of shares outstanding - basic and diluted         12,291,040           5,233,766        
                               
                               

Cynapsus Therapeutics Inc.
Consolidated Statements of Financial Position
(unaudited)
(in thousands)
(in U.S. dollars)
   
               
        March 31,     December 31,
        2016     2015
Assets            
Current assets:            
Cash     $   68,622       $   75,803  
Prepaid expenses and other current assets         500           629  
Total current assets         69,122           76,432  


Property, plant and equipment
        470           409  
Intangible assets         372           380  
Total assets     $   69,964       $   77,221  
 

Liabilities and shareholders' equity
           
Current liabilities:            
Accounts payable and accrued liabilities         3,659           3,799  
Total liabilities         3,659           3,799  


Shareholders' equity:
           
Share capital         119,891           119,565  
Warrants         10,523           10,623  
Share-based payments         7,346           6,333  
Deficit         (60,789 )         (52,433 )
Accumulated other comprehensive loss         (10,666 )         (10,666 )
Total shareholders' equity         66,305           73,422  
Total liabilities and shareholders’ equity     $   69,964       $   77,221  
                         

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA near the end of 2016 or in early 2017. For additional company information, please visit our website at www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the following website:  http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA near the end of 2016 or in early 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing and completion of clinical studies; and expectations regarding the sufficiency of the Company’s cash. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 9, 2016, as amended by Amendment No. 1 to Form 10-K/A filed with the SEC on March 18, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc.]]>
Cynapsus Therapeutics Announces Results of AGM http://ir.cynapsus.ca/news/detail/150/cynapsus-therapeutics-announces-results-of-agm Wed, 11 May 2022 16:15:00 -0400 http://ir.cynapsus.ca/news/detail/150/cynapsus-therapeutics-announces-results-of-agm

TORONTO, May 11, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH) (“Cynapsus” or the “Company”), a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (“PD”), announced today the results of voting at its 2016 Annual and Special Meeting of shareholders (the “AGM”) held on May 10, 2022 in Toronto, Ontario.

A total of 7,603,279 common shares were voted at the AGM, representing 61.8% of the votes attached to all outstanding common shares.

Shareholders voted to re-elect the Company’s eight member board of directors (the “Board”). A summary of voting results relating to the re-election of the Board is below:

Name   Total Votes For (%)        Total Votes Withheld (%)
Anthony Giovinazzo     6,387,511 (99.93%) 4,588 (0.07%)
Tomer Gold 6,387,529 (99.93%) 4,570 (0.07%)
Ronald Hosking 6,387,406 (99.93%) 4,693 (0.07%)
Tamar Howson 6,386,511 (99.91%) 5,588 (0.09%)
Nan Hutchinson 5,246,056 (82.07%) 1,146,043 (17.93%)
Perry Molinoff 6,386,264 (99.91%) 5,835 (0.09%)
Ilan Oren 6,388,511 (99.94%) 3,588 (0.06%)
Rochelle Stenzler 4,497,327 (70.36%) 1,894,772 (29.64%)
     

In addition, Cynapsus shareholders voted to pass ordinary resolutions approving the following matters:

  • Ernst & Young LLP, Chartered Professional Accountants as the Company’s auditors with 7,595,395 (99.90%) total votes cast “For” and 7,884 (0.10%) total votes “Withheld”.

  • The Amended and Restated 10% “rolling” Stock Option Plan of the Company with 6,356,704 (99.45%) total votes cast “For” and 35,395 (0.55%) total votes “Against”.

  • New general by-law number 4 of the Company (the “New By-Law”) and the repeal of existing general by-law number 3 with 4,201,023 (65.72%) total votes cast “For” and 2,191,076 (34.28%) total votes “Against”.  The New By-Law contains, among other things, advance notice provisions (the “Advance Notice Provisions”) which fix a deadline by which shareholders must provide notice to the Company of nominations for election to the board of directors, and require nominating shareholders to provide specified information in respect of their nominee. The Advance Notice Provisions will be operative for the next shareholders’ meeting at which directors are to be elected.

Voting results for the AGM are also available on SEDAR at www.sedar.com.

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit a new drug application near the end of 2016 or in early 2017. For additional company information, please visit our website at www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the following website: http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA near the end of 2016 or in early 2017; and expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing and completion of clinical studies. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 9, 2016, as amended by Amendment No. 1 to Form 10-K/A filed with the SEC on March 18, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Therapeutics to Present at Several Upcoming Investor Conferences http://ir.cynapsus.ca/news/detail/149/cynapsus-therapeutics-to-present-at-several-upcoming-investor-conferences Thu, 28 Apr 2022 06:00:00 -0400 http://ir.cynapsus.ca/news/detail/149/cynapsus-therapeutics-to-present-at-several-upcoming-investor-conferences

TORONTO, April 28, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (“PD”), today announced that senior management will present a corporate overview at the following upcoming investor conferences:

  • Bloom Burton & Co. HealthCare Investor Conference on May 2, 2022 at 10:00 a.m. ET at the Sheraton Centre Hotel in Toronto
  • Deutsche Bank Securities 41st Annual Health Care Conference on May 4, 2022 at 11:20 a.m. ET at the InterContinental Hotel in Boston
  • Bank of America Merrill Lynch 19th Annual Health Care Conference on May 12, 2022 at 11:20 a.m. PT at the Encore at Wynn Hotel in Las Vegas

Additional details and live webcasts of Cynapsus’ presentations at the Deutsche Bank and Bank of America Merrill Lynch conferences may be accessed from the Company’s website at http://ir.cynapsus.ca/ir-calendar. Replays of the webcasts will be available on Cynapsus website following the live presentation until August 4, 2016.

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA near the end of 2016 or in early 2017. For additional company information, please visit our website www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the website found here http://cth300and301trials.cynapsus.ca/

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s intention of submitting an NDA near the end of 2016 or early in 2017. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 9, 2016, as amended by Amendment No. 1 to Form 10-K/A filed with the SEC on March 18, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Cynapsus Therapeutics, Inc.
Kristen Galfetti
Vice President Investor Relations
& Corporate Communications
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Therapeutics Announces Data Presentations at the American Academy of Neurology Annual Meeting http://ir.cynapsus.ca/news/detail/24/cynapsus-therapeutics-announces-data-presentations-at-the-american-academy-of-neurology-annual-meeting Fri, 15 Apr 2022 06:00:00 -0400 http://ir.cynapsus.ca/news/detail/24/cynapsus-therapeutics-announces-data-presentations-at-the-american-academy-of-neurology-annual-meeting Poster Presentations Include Clinical Data on Efficacy, Safety and Disease Severity

TORONTO, ONTARIO -- (Marketwired) -- 04/15/16 -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA)(TSX:CTH), a specialty central nervous system ("CNS") pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson's disease ("PD"), today announced that three clinical posters will be presented on Sunday, April 17, 2022 at the 68th American Academy of Neurology (AAN) Annual Meeting, in Vancouver, British Columbia, Canada.

The first of three presentations highlights efficacy data from Cynapsus' CTH-105 Phase 2 trial utilizing a sublingual thin film of apomorphine, APL-130277, to treat OFF episodes in adult patients with PD. Results demonstrated patients' mean time to full ON of 24 minutes and mean duration of ON of 50 minutes. In addition, there was a statistically significant and clinically meaningful improvement in motor function at all time-points as measured by Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III). The second poster presentation discusses safety data from the same trial. The safety conclusions of this study indicated that APL-130277 was generally well-tolerated. Most adverse events ("AE"s) were mild to moderate in severity, there were no discontinuations due to an AE, and there was no apparent dose-response relationship with AEs observed. The third poster looks at the effects of sublingual apomorphine by disease severity on the acute management of OFF episodes in PD. Results from this study showed that APL-130277 rapidly converts PD patients of various disease severity from OFF to the full ON state. The posters will be accessible from Cynapsus' corporate website at www.cynapsus.ca.

"The clinical data for APL-130277 in treating OFF episodes in Parkinson's disease continue to be encouraging. The efficacy and safety data across a range of patients provide important insights on how our product candidate could be used to improve patient care," said Albert Agro, Ph.D., Cynapsus' chief medical officer. "Solid results from our Phase 2 study provide us confidence and optimism as we look forward to reporting clinical data from our Pivotal Phase 3 efficacy trial over the next several months. We anticipate that these data will be used to file our new drug application ("NDA") near the end of 2016 or in early 2017."

The following data will be presented Sunday, April 17, 2022 at AAN from 4:00-5:30 p.m. PDT.

Poster Presentations

  1. Safety of Sublingual Apomorphine (APL-130277) for the Treatment of OFF Episodes in Patients with Parkinson's Disease (Poster #337)
    Presenter: Stuart Isaacson, M.D., Parkinson's and Movement Disorders Specialist, Boca Raton Regional Hospital, Director, Clinical Research Center, Parkinson's Disease and Movement Disorders Center, Boca Raton, Florida
  1. The Effects of Sublingual Apomorphine (APL-130277) by Disease Severity on the Acute Management of OFF Episodes in Parkinson's Disease (Poster #336)
    Presenter: Holly Shill, M.D., Neurologist, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, Director, Muhammad Ali Parkinson Center at Barrow Neurological Institute, Phoenix
  1. Efficacy of Sublingual Apomorphine (APL-130277) for the Treatment of OFF Episodes in Patients with Parkinson's Disease (Poster #335)
    Presenter: Robert Hauser, M.D., M.B.A., Professor, Director College of Medicine - Neurology, Director, Parkinson's Disease and Movement Disorders Center, University of Southern Florida, Tampa, Florida

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a "turning ON" medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA near the end of 2016 or in early 2017. For additional company information, please visit our website www.cynapsus.ca. For more information about the Phase 3 studies, including enrollment criteria, please visit the website found here http://cth300and301trials.cynapsus.ca/.

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company's expectation for filing an NDA near the end of 2016 or in early 2017; and expectations regarding the Company's clinical and regulatory activities, including without limitation, the anticipated timing and completion of clinical studies. These forward-looking statements include information about possible or assumed future results of the Company's business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company's current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption "Risk Factors" in the Company's Form 10-K filed with the United States Securities and Exchange Commission (the "SEC") on March 9, 2016, as amended by Amendment No. 1 to Form 10-K/A filed with the SEC on March 18, 2016, and its other filings and reports in the United States with the SEC available on the SEC's web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Company Contact:
Kristen Galfetti
Vice President, Investor Relations
(416) 703-2499 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc.

]]>
Cynapsus Therapeutics and MonoSol Rx Announce Global IP Licensing Agreement http://ir.cynapsus.ca/news/detail/23/cynapsus-therapeutics-and-monosol-rx-announce-global-ip-licensing-agreement Mon, 04 Apr 2022 06:00:00 -0400 http://ir.cynapsus.ca/news/detail/23/cynapsus-therapeutics-and-monosol-rx-announce-global-ip-licensing-agreement - Strengthening Intellectual Property for Sublingual Delivery of Apomorphine to Treat OFF Episodes in Parkinson’s Disease Patients -

TORONTO and WARREN, N.J., April 04, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (“Cynapsus” or the “Company”) (NASDAQ:CYNA) (TSX:CTH), and MonoSol Rx LLC (“MonoSol Rx”) today announced that they have signed a global licensing agreement for certain intellectual property (“IP”) including existing patents, patent applications, and future patents and patent applications covering all oral films containing apomorphine for the treatment of OFF episodes in Parkinson’s disease (“PD”) patients.

Cynapsus, the developer of APL-130277, a “turning ON” medication containing apomorphine in a fast-acting, easy-to-use, sublingual thin film for all types of OFF episodes associated with PD, holds global commercialization rights for APL-130277. Cynapsus also has a substantial patent portfolio, including issued and pending patent applications in the United States and certain other jurisdictions, covering APL-130277 and its use in the treatment of PD. MonoSol Rx has key issued industry-leading patents and pending patent applications as well as significant expertise and know-how in film technology which together with the Cynapsus’ IP, creates a significant patent portfolio further strengthening APL-130277 commercial protection.

Under the license agreement, MonoSol Rx will receive up front and contingent milestone payments and single-digit royalty payments on net sales of APL-130277.

“We are delighted to have signed the agreement with MonoSol Rx for their intellectual property portfolio covering pharmaceutical films which will broaden our IP protection for APL-130277 as we move closer to commercialization.  Cynapsus aims to provide patients suffering with PD a patient-friendly way to treat their often debilitating OFF episodes,” said Anthony Giovinazzo, President and CEO of Cynapsus. “We continue to focus on completing our Phase 3 clinical trials and filing our NDA with the FDA near the end of 2016 or in early 2017.”

Keith J. Kendall, CEO of MonoSol Rx, commented, “MonoSol Rx has the world’s leading portfolio of intellectual property and knowhow relating to film applications in the pharmaceutical industry.  We are very pleased to license our technology to Cynapsus.  For MonoSol Rx this is recognition for the value of the capabilities and differentiation that PharmFilm® represents for patients and partners. Entering into this licensing agreement with Cynapsus benefits both parties and we are happy to be aligned with Cynapsus in providing PD patients with more convenient and effective therapies.”

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA near the end of 2016 or in early 2017.  For additional company information, please visit our website www.cynapsus.ca.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® drug delivery technology to develop products that improve patient outcomes and address unmet needs. These pharmaceutical and over-the-counter products are developed independently and with partners. PharmFilm can provide a benefit to patients by improving the efficacy, safety, and convenience of currently marketed pharmaceutical products, new molecular entities, and combination products. MonoSol Rx's leadership in film drug delivery is supported by strong IP protection, a robust pipeline of prescription drug formulations, and two FDA-approved products - Suboxone® (buprenorphine and naloxone) sublingual film and Zuplenz® (ondansetron) oral soluble film. For press releases and other company information, visit www.monosolrx.com. More information about PharmFilm can be found at www.pharmfilm.com.

Cynapsus Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA near the end of 2016 or in early 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing and completion of clinical studies; and beliefs regarding the Company’s IP protection for APL-130277. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 9, 2016, as amended by Amendment No. 1 to Form 10-K/A filed with the SEC on March 18, 2016, and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information

Cynapsus

Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca

Media Contact:
Matt Middleman
Russo Partners LLC
(212) 845-4272
matt.middleman@russopartnersllc.com

MonoSol Rx
Investor Contact:
Lee Roth
The Ruth Group
Vice President
(646) 536-7000
lroth@theruthgroup.com

 

Source: Cynapsus Therapeutics Inc.; MonoSol Rx

]]>
Cynapsus Therapeutics Reports Financial Results for the Fourth Quarter and Year Ended 2015 http://ir.cynapsus.ca/news/detail/22/cynapsus-therapeutics-reports-financial-results-for-the-fourth-quarter-and-year-ended-2015 Wed, 09 Mar 2022 16:15:00 -0500 http://ir.cynapsus.ca/news/detail/22/cynapsus-therapeutics-reports-financial-results-for-the-fourth-quarter-and-year-ended-2015

Focus on Advancement of Pivotal Phase 3 Clinical Program in 2016

TORONTO, March 09, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (“PD”), today reported financial results for the fourth quarter and year ended December 31, 2021 and provided an update on its product candidate and corporate activities. Unless specified otherwise, all amounts are in Canadian dollars.

“Following the successful completion of an $89.3 million (USD$72.5 million) initial public offering in the United States and listing on NASDAQ in June, we have been focused on the commencement and management of our pivotal Phase 3 clinical program for APL-130277,” stated Anthony Giovinazzo, President and CEO. “2016 is a critical year for Cynapsus as we also intend to file our NDA with the U.S. FDA near the end of 2016 or in early 2017.  We will also be working with European regulatory authorities to map out our clinical strategy and commence clinical activities in Europe.”

Upcoming Milestones

United States

  • CTH-300 Phase 3 Efficacy Study: Top-line data expected in the second or third quarter of 2016.
  • CTH-301 Phase 3 Safety Study: Top-line data expected in the fourth quarter of 2016 or the first quarter of 2017.
  • CTH-201 Phase 2 Thorough QT Study: Subject to FDA review and agreement, if required, this study is planned to begin in the second half of 2016.  If commenced, the trial is expected to be completed in the fourth quarter of 2016 or the first quarter of 2017.
  • New Drug Application(NDA)submission: An NDA is expected to be submitted near the end of 2016 or in early 2017.

European Union

  • European Medicines Agency (EMA) Meeting: A pre-submission meeting is expected to occur with the EMA in the second quarter of 2016.
  • CTH-302 European Registration Study: An active comparator study is expected to commence in the second half of 2016.

Recent Business Highlights

  • CTH-200 Bioavailability and Pharmacokinetic Study: In December 2015, Cynapsus announced the successful completion of bridging study comparing product candidate APL-130277 to subcutaneous apomorphine.
  • XXI World Congress on Parkinson’s Disease (IAPRD): In December 2015, Cynapsus attended the IAPRD and presented in five poster presentations updated clinical data from the Phase 2 trial of APL-130277.   Results showed that APL-130277 significantly improved PD symptoms (as measured by MDS-UPDRS Part III), rapidly turning patients from the OFF to ON state, and was generally safe and well tolerated.  
  • MJFF Collaboration on Wearable Device: In January 2016, Cynapsus and The Michael J. Fox Foundation for Parkinson’s Research announced that they will work together to incorporate wearable device technology and “big data” approaches into Cynapsus’ pivotal Phase 3 clinical study of APL-130277.  This is a pilot effort to understand how clinical studies can harness data science approaches to objectively measure disease progression with the goal of speeding progress toward breakthroughs in drug development. The project builds on MJFF’s ongoing data science partnership with Intel Corporation, launched in August 2014, to develop platforms for the storage of large volumes of patient-generated data and algorithms to glean insights from this data.

Full Year 2015 Financial Results

  • Cash and Investments. Cash as of December 31, 2021 totaled $104.9 million as compared to $17.5 million as of December 31, 2014. Cash used in operating activities for the 12 months ended December 31, 2021 was $32.2 million versus $10.0 million for the 12 months ended December 31, 2014.  Cynapsus expects its cash as of December 31, 2021 to be sufficient to fund the Company into 2017. 
  • R&D Expense. Research and development expenses were $27.4 million for the year ended December 31, 2015, compared to $5.7 million for the year ended December 31, 2014, an increase of $21.7 million.  The increase in research and development expenses was primarily due to higher headcount and increases in consulting fees, clinical research, packaging development, patent protection, analytics, scientific communications and educational initiatives, and scale-up CMC work for APL-130277.    
  • OG&A Expense. Operations, general and administrative expenses were $11.4 million for the year ended December 31, 2015, compared to $5.8 million for the year ended December 31, 2014, an increase of $5.6 million.  The increase in general and administrative expenses was primarily related to increases in investor and public relations activities, professional and consulting fees, and pre-approval commercialization activities. 
  • Net Loss.  For the year ended December 31, 2015, net loss attributed to common shareholders was $27.5 million, or $2.97 per share, as compared to a net loss of $10.8 million, or $2.56 per share, for the year ended December 31, 2014.        
  • Reported common shares outstanding as of December 31, 2021 were 12,278,133 as compared to December 31, 2021 common shares of 5,020,869, as adjusted for the 16:1 share consolidation completed on May 15, 2015.

Cynapsus Therapeutics, Inc.
Consolidated Statements of Loss and Comprehensive Loss
(unaudited)
(in thousands, except per share data)
(in Canadian dollars)
      Three months ended
December 31,
    Year ended 
December 31,
         
      2015     2014     2015     2014
Expenses                        
Research and development       $   8,639         $   3,094         $   27,402         $   5,703  
Operating, general and administrative         3,675           2,365           11,376           5,761  
Acquisition milestone share-based payment         -           -           1,500           -  
Loss on Impairment of intangible assets         -           94           -           94  
Unrealized foreign exchange gain         (3,782 )         (437 )         (12,789 )         (691 )
Other interest income and related charges         (2 )         (16 )         (19 )         (48 )
Loss and comprehensive loss       $   8,530         $   5,100         $   27,470         $   10,819  
Loss per share – basic and diluted       $   0.70         $   1.03         $   2.97         $   2.56  
Weighted Average number of shares outstanding - basic and diluted          12,160           4,966           9,246           4,232  


 Cynapsus Therapeutics, Inc.
Consolidated Statements of Financial Position
(unaudited)
(in thousands)
(in Canadian dollars)
   
               
        December 31,     December 31,
        2015     2014
Assets            
Current assets:            
Cash     $   104,911       $   17,448  
Prepaid expenses and other current assets         870           270  
Total current assets         105,781           17,718  
                         
Property and equipment, net         567           258  
Intangible assets, net         527           575  
Total assets     $   106,875       $   18,551  
             
Liabilities and shareholders' equity            
Current liabilities:            
Accounts payable and accrued liabilities         5,240           3,081  
Total liabilities         5,240           3,081  
             
Shareholders' equity:            
Share capital         142,581           31,741  
Warrants         11,486           13,452  
Share-based payments         7,548           2,788  
Deficit         (59,981 )         (32,511 )
Total shareholders' equity         101,634           15,470  
Total liabilities and shareholders’ equity     $   106,875       $   18,551  
                         

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA near the end of 2016 or in early 2017.

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA near the end of 2016 or in early 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing and completion of clinical studies; and expectations regarding the sufficiency of the Company’s cash. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 9, 2022 and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Therapeutics Provides Company Update at Cowen & Co. 36th Annual Health Care Conference http://ir.cynapsus.ca/news/detail/21/cynapsus-therapeutics-provides-company-update-at-cowen-co-36th-annual-health-care-conference Mon, 07 Mar 2022 06:00:00 -0500 http://ir.cynapsus.ca/news/detail/21/cynapsus-therapeutics-provides-company-update-at-cowen-co-36th-annual-health-care-conference

TORONTO, March 07, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (“PD”), today announced that President and CEO, Anthony Giovinazzo, will present a company overview and update today at the Cowen & Co., 36th Annual Health Care Conference.  The presentation will take place at the Boston Marriott Copley Place Hotel at 1:20 p.m. EST in the Vineyard conference room on the 4th Floor.

Following the live presentation, a video webcast of the presentation will be available online at http://wsw.com/webcast/cowen30/cyna and the presentation materials will be available on the Cynapsus web site, www.cynapsus.ca, in the Investor’s section.  The webcast will be archived for 90 days following the event.

The presentation includes updates on the Company’s development program including:

Clinical and Regulatory Activities (see detailed descriptions below)

  • CTH-300 Phase 3 Efficacy Study: all sites are actively recruiting approximately 126 patients in total for the trial.  Top-line data expected in the second or third quarter of 2016
  • CTH-301 Phase 3 Safety Study: all sites are actively recruiting approximately 100 additional patients that will be added to patients brought in from the CTH-300 study. Top-line data expected in the fourth quarter of 2016 or the first quarter of 2017
  • European Medicines Agency (EMA): meeting expected to occur in the second quarter of 2016
  • CTH-302 European Registration Study: trial expected to commence in the second half of 2016
  • CTH-201 Phase 2 Thorough QT Study: if required, this study is planned to begin in the second half of 2016, subject to FDA review and agreement. If commenced, the trial is expected to be completed in the fourth quarter of 2016 or the first quarter of 2017
  • New Drug Application (“NDA”) submission expected near the end of 2016 or in early 2017

“We continue to make progress both in our clinical development of APL-130277 and in preparing for a commercial presence,” stated Anthony Giovinazzo, President and CEO. “We look forward to reporting further progress in 2016, and remain focused on completing our Phase 3 studies and filing our new drug application with the U.S. FDA near the end of 2016 or in early 2017.”

About the Cynapsus Phase 3 Efficacy Study (CTH-300)

On June 29, 2015, Cynapsus announced enrollment of the first patient in the CTH-300 clinical trial, a pivotal Phase 3 study to examine the efficacy, safety and tolerability of APL-130277 for the acute treatment of OFF episodes in patients with PD. The CTH-300 trial is a double-blind, placebo-controlled, parallel-design study with an estimated enrollment of 126 PD patients in 35 centers who have at least one OFF episode every 24 hours, with total OFF time of at least two hours per day. The study objective is to evaluate the efficacy and safety of APL-130277 versus placebo in patients with PD. The 126 patients will each be observed for 12 weeks, with dosing at home and in clinic. The primary endpoint will be measured at week 12 in clinic and will be the mean change in the MDS-UPDRS Part III score at 30 minutes after dosing. The key secondary endpoint will be the percentage of patients who convert from the OFF to the ON state at or before 30 minutes of dosing with APL-130277 in clinic at the week 12 visit.

About the Cynapsus Phase 3 Safety Study (CTH-301)

On September 2, 2015, Cynapsus announced enrollment of the first patient in the CTH-301 clinical trial, a pivotal Phase 3 study to examine the safety and tolerability of APL-130277 for the acute treatment of OFF episodes in patients with PD. The CTH-301 trial is a six-month, open-label, single arm safety study in PD patients who have at least one OFF episode every 24 hours, with total OFF time of at least two hours per day. The primary endpoint for the study is the safety and tolerability of APL-130277 in patients with PD. The secondary endpoints examine efficacy variables including the change in the MDS-UPDRS Part III scores over the six months of treatment. Sites will recruit patients over several months, with each patient being evaluated for six months. An estimated 226 patients will be enrolled, including up to 126 who had been enrolled in the CTH-300 efficacy study and rolled over to this study, plus an additional 100 new patients.

About the Cynapsus European Regulatory Study (CTH-302)

Based on advice from European regulators and European experts, the Company is planning to run an active comparator study in PD patients who suffer the debilitating effects of OFF episodes. This study is expected to start in the second half of 2016. The data from this study will be submitted to European regulatory authorities, in addition to the information submitted in the U.S. NDA.

About the Cynapsus Phase 2 Thorough QT Study (CTH-201)

If required by the U.S. regulatory authorities, the preliminary design for this Phase 2 study is  randomized, double-blind, placebo-controlled three-period crossover, positive control, QT-evaluation that will analyze APL-130277 in approximately 40 patients with PD experiencing OFF episodes.  This study, if required, is planned to begin in the second half of 2016, subject to FDA review and agreement.  If commenced, the trial is expected to be completed in the fourth quarter of 2016 or the first quarter of 2017.

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company has successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit an NDA near the end of 2016 or in early 2017.

Forward-Looking Statements
This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s expectation for filing an NDA near the end of 2016 or in early 2017; expectations regarding the Company’s clinical and regulatory activities, including without limitation, the anticipated timing and completion of clinical studies; and expectations for reporting further progress in 2016. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on November 12, 2021 and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information

Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti@cynapsus.ca

Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com


 

Source: Cynapsus Therapeutics Inc. ]]>
Cynapsus Therapeutics to Present at Cowen & Co. 36th Annual Health Care Conference http://ir.cynapsus.ca/news/detail/20/cynapsus-therapeutics-to-present-at-cowen-co-36th-annual-health-care-conference Tue, 01 Mar 2022 08:00:00 -0500 http://ir.cynapsus.ca/news/detail/20/cynapsus-therapeutics-to-present-at-cowen-co-36th-annual-health-care-conference

TORONTO, March 01, 2022 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (“PD”), today announced that its President and CEO, Anthony Giovinazzo, will present an overview of the Company's PD program and outlook at the Cowen & Co. 36th Annual Health Care Conference at the Boston Marriott Copley Place Hotel, on Monday, March 7, 2022 at 1:20 p.m. EST in the Vineyard conference room, 4th Floor.

Following the live presentation, a video webcast of Cynapsus’ presentation and a copy of the presentation materials will be available on the Company's web site, www.cynapsus.ca, in the Investors' section, and through the Cowen website: http://wsw.com/webcast/cowen30/cyna. The webcast and presentation will be archived on the Company's website and on the Cowen website for 90 days following the event.

About Cynapsus

Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with PD. The Company completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated a Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit a new drug application (“NDA”) near the end of 2016.

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the Company’s intention of submitting an NDA near the end of 2016. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on November 12, 2021 and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law. 

Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.

Contact Information
Cynapsus Therapeutics, Inc.
Kristen Galfetti
Vice President Investor Relations
& Corporate Communications
(416) 703-2449 x246
kgalfetti@cynapsus.ca
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com

Source: Cynapsus Therapeutics Inc. ]]>