Cynapsus Announces Parkinson’s Drug Candidate Progress and Upcoming Milestones
Marketwire, November 23, 2021
TORONTO, CANADA – (Marketwire) – Anthony Giovinazzo, President and CEO of Cynapsus Therapeutics (CTH: TSX-V), has provided shareholders with a strategy update in an open letter that is available on the company web site (www.cynapsus.ca) and below.
Dear Shareholders,
It has been almost six months since our Annual and Special Meeting of Shareholders (AGM) held on May 31, 2011, and so I want to take this opportunity to give you an update on our progress since then, and to provide you with some insights to our goals going forward.
Upcoming Milestones and Goals
Since I joined Cynapsus in November 2009, our strategy has been to build significant value over a three year period, and in the 3rd or 4th year, have this value realized for the benefit of all shareholders. This vision has not changed. I am pleased to report that during the past two years we have accomplished a number of important milestones, all of which have been communicated to you at the AGM and in numerous press releases.
Since the AGM, our focus has been to deliver meaningful data on the two most critical aspects of our program: (1) verification of the larger market potential, and (2) the ability of our proprietary thin film strip system to mimic the injectable delivery of apomorphine. With these two derisking data sets, we believe we will substantially increase the value of the project and interest in it by potential Pharma partners. With this in mind, in the coming months we are:
1. Completing a larger neurologist survey. In the next 15 days, the Company expects to complete and announce the results of a 500 neurologist survey covering the major markets (US, Europe, Asia). This deeper neurologist survey is necessary not just for ongoing Pharma discussions, but also to support larger financing efforts.
2. Completing the Adagio acquisition. In the next 30 days, pending shareholder approval on November 30, 2011, the Company expects to complete the Adagio acquisition. The APL-130277 patent rights and know how are critical to the Company’s long term objectives and the acquisition will ensure full ownership of those rights by the Company.
3. Completing the first APL 130277 human clinical study. In the next 60 days, the Company expects to complete and announce the results of our human volunteer proof of concept study with APL 130277. The goal is to obtain top line data in man that demonstrates fast absorption and a Tmax comparable to the injectable form of the drug (Apokyn). Data acquired in the pilot study will define the parameters of a subsequent Phase 1 bioequivalence trial that compares the pharmacokinetics of sublingual APL-130277 to Apokyn as defined by section 505(b)(2) of the Federal Food, Drug and Cosmetic Act enforced by the United States Food and Drug Administration. This is a significant milestone and de-risking event for the project.
4. Progressing Pharma discussions, having entered into confidentiality agreements with six (6) large US and Global pharmaceutical companies. Several of these companies have completed preliminary and advanced due diligence on the APL 130277 project. Subject to the results of the neurologist survey and human proof-of-concept study, as well as final due diligence, we anticipate receiving written expressions of interest from several of these parties to negotiate a relationship in the first half of 2012.
5. Expecting to complete a larger financing to provide 12 to 24 months of capital, ideally from professionally managed investment funds. This will allow us to further develop our Parkinson’s project and de-risk it to the point where we can gain maximum value from a potential acquirer or marketing partner. Of note, we have continued to work closely with Summer Street Research Partners (SSRP) on financial matters including capital raising. Based in New York and Boston, SSRP is an institutional focused investment bank primarily targeting the life sciences sector, with a highly reputable research team and research product.
Upcoming Shareholder Meeting on November 30, 2021
As you may know, Cynapsus recently called a Special Meeting of the Shareholders for Wednesday, November 30th, 2011 at 10am at the offices of Owens Wright LLP, 20 Holly Street, 3rd Floor, Toronto, Ontario.
You should have received the Shareholder and proxy material by mail. In the package, you will notice that there are two (2) resolutions which are to be voted on by the shareholders:
1. To consider, and if thought fit, to pass, with or without amendment, a special resolution to approve, subject to the acceptance by the TSX Venture Exchange Inc. (the "Exchange"), the Proposed Acquisition of Adagio on the terms set out in the Information Circular dated October 28, 2011;
2. To consider, and if thought fit, to pass, with or without amendment, a special resolution to approve, subject to the acceptance by the Exchange, the consolidation of the issued and outstanding Common shares on the basis of up to 25 existing Common shares for one new Common share as more particularly set forth in the Information Circular dated October 28, 2011.
Regarding the potential share consolidation, please note that we will NOT be consolidating the shares unless several things happen, including but not limited to: the successful completion of the proof of concept study, a larger financing and/or pharma partnership, and final Board review and approval. Since several institutional investors have specifically requested that our shares be consolidated prior to completing a larger financing, we felt it prudent to go to shareholders and seek approval, just in case we need to act quickly to close a financing early in 2012. Finally, please be aware that Management is very sensitive to the issues associated with share consolidations, and so we would only proceed if required.
If you have time, it would be helpful if you would complete the proxy and return it to Equity Financial Trust Company no later than Monday, November 28th, 2011. Alternatively, you can email or fax or the proxy to my attention at 416-703-8752, and I will make sure it gets delivered to Equity Financial.
I hope you find this summary useful. As always, thank you for your support.
Please feel free to contact me if you have any questions.
Sincerely,
Anthony Giovinazzo, C.Dir.
President & CEO
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson’s disease. Parkinson’s disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. It is estimated that between 25 percent and 50 percent of patients experience “off episodes” in which they have impaired movement or speaking capabilities. Current medications only control the disease’s symptoms, and most drugs become less effective over time as the disease progresses.
Cynapsus’ lead drug candidate, APL-130277, is an easy-to-administer, fast-acting and oral reformulation of an approved drug, apomorphine, used to rescue patients from off episodes. Cynapsus is focused on rapidly maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2013 or 2014. The Company anticipates out-licensing to an appropriate pharmaceutical partner before such an application is submitted.
More information about Cynapsus (CTH: TSX-V) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
Contact Information
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
[email protected]
Andrew Williams
COO & CFO
(416) 703-2449 x253
[email protected]
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of applicable Canadian securities legislation. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes" or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will be taken", "occur" or "be achieved". Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Cynapsus to be materially different from those expressed or implied by such forward-looking statements, including but not limited to those risks and uncertainties relating to Cynapsus’ business disclosed under the heading “Risk Factors” in Cynapsus' current Annual Information Form and its other filings with the various Canadian securities regulators which are available online at www.sedar.com. Although Cynapsus has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Cynapsus does not undertake to update any forward-looking statements, except in accordance with applicable securities laws.
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