TORONTO, ONTARIO--(Marketwire - April 16, 2012) - Anthony Giovinazzo, President and CEO of Cynapsus Therapeutics (TSX VENTURE:CTH), 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 friends and shareholders,
I want to take this opportunity to give you an update on our progress at Cynapsus over the past year and provide you some insights to our goals for 2012.
At the outset I would like to thank the Board of Directors and all our shareholders for their continued support and patience as we continue the re-direction of Cynapsus into a high value company.
I would also like to thank our small team of employees, consultants and vendors for their loyalty to the company and their performance under tight timelines and significant workloads. We have accomplished much together in this last year.
Our strategy since my appointment in November 2009 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.
If you recall, last year I indicated that 2011 "will most likely be a critical turning point for Cynapsus, as the accomplishment of our goals should allow past and future shareholders to see Cynapsus in a different light". We think we accomplished this in a number of different ways.
|We had four stated goals for 2011:
- Complete a larger financing to provide 12 to 24 months of capital, ideally from professionally managed investment funds. This would 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.
- Complete our submissions and interactions with the US Food and Drug Administration (US FDA) for the Parkinson's project, such that we commence our first Phase 1 human equivalence studies.
- Successfully complete Phase 1 human clinical studies to further de-risk the project and allow it to move to its last stage of development.
- Attract equity research coverage of the Company, which should impact liquidity and stock performance accordingly.
|With these specific goals in mind, I can report that our efforts in 2011 have resulted in the following:
- Larger Equity Financing. Despite best efforts, we did not complete the large financing as had been planned. Our timing had us make this effort in Q2 of last year, a period when Greece and other macro events caused institutional investors to pull back. In our case, although we had a potential financing book of over $10 million, the lead investor involved was not able to complete the transaction due to market conditions. While challenging, we did recover from this setback and raised approximately $2 million to allow us to accomplish a number of important de-risking activities.
- Meeting with US FDA. In April 2011 we met in person with the US FDA to discuss and gain guidance on our plan to advance the APL-130277 project from a regulatory and clinical perspective. The agency confirmed that under certain conditions, we could pursue what is called a 505(b)(2) bioequivalence path, which would require one Phase 1 type bioequivalence pharmacokinetic study, as well as one pivotal safety study with Parkinson's patients (approximately 150 patients). From start to finish, we estimate that these studies should be completed before the end of 2013 (subject to capital availability).
- First Human Phase 1 Study. In December 2011 we successfully completed our first Phase 1 healthy human volunteer pilot study. The study showed a pharmacokinetic (PK) profile that compared favorably to injected apomorphine with a mean T-max of 25 minutes and good tolerability, and therefore confirms that APL-130277 has the potential to treat motor fluctuations or "off episodes" in Parkinson's disease (See January 10, 2012 press release).
- Equity Research Coverage. In December 2011, we attracted interest from the Noverra Research group, who completed a Watch List report on Cynapsus (See press release December 28, 2011). In February 2012, we also announced that Loewen, Ondaatje, McCutcheon Limited ("LOM") initiated analyst coverage of Cynapsus (See February 29, 2012 press release).
|In 2011, we successfully completed a number of additional tasks that have added value in a short period of time:
- Pharma Due Diligence. We completed confidentiality agreements with 6 international pharmaceutical companies, who entered into significant due diligence efforts, as a first step towards evaluating interest in our project.
- Global Neurologist Survey. We completed a critical global 500 neurologist survey, which confirmed the substantial unmet medical need for a more convenient form of Apomorphine, as represented by APL-130277 (See December 8, 2011 press release). The survey included neurologists and movement disorder specialists in the United States, Europe, Japan, China and select countries in the Rest of the World. Collectively, these 500 professionals treat approximately 62,000 Parkinson's patients per year.
- Acquisition of Adagio Pharmaceuticals. We completed the acquisition of 100 % of Adagio Pharmaceuticals Ltd., which included the ownership of the APL-130277 related intellectual property, for shares only, which are held in an escrow account, subject to specific capital raising requirements of up to $8 million (See press release December 22, 2011).
- Media Coverage. Cynapsus was included or the subject of several major United States based industry publications, which ran articles on the subject of drug development for Parkinson's disease, including InVivo, The Pink Sheet, GEN, BioWorld Insight and more.
|As you can see, we have been focused and are working intensely to accomplish more in less time while making prudent use of our available resources. Our plan and execution focus for 2012 will be to deliver several critical new building blocks of value and de-risking of the APL-130277 asset. Successful completion of these goals should result in 2012 becoming a major break out year for Cynapsus in several respects.
|Goals for 2012
- Closing one or more equity capital transactions, with a cumulative minimum of $3 million of new cash.
- File a US Initial New Drug (IND) application, to allow us to complete the APL-130277 Bioequivalence Study in the United States.
- Complete the APL-130277 Bioequivalence Study, which would be a substantial de-risking event for the company and the project.
- Obtain biotech analyst initiation of research coverage, which provides further independent opinion and view of the strengths, risks and commercial potential of APL-130277. (This was accomplished at the end of February. See February 29, 2012 press release.)
|The accomplishment of these goals should substantially affect the risk/reward perception of the company, in a positive fashion. In addition to these critical goals, we have other tasks and goals which we will also prioritize for 2012, namely:
- We are currently running a second Phase 1 healthy human volunteer pilot study, to provide some additional insights related to a two dose comparison, as well as some minor changes to the prototype composition;
- Seek to qualify for and submit an application to obtain a listing on the OTCQX stock exchange in the United States. This will allow United States investors to more easily follow and/or purchase shares of Cynapsus.
- Engage an additional US focused investor awareness and relations firm. This relationship will allow us to build a deeper and credible following in the United States.
- Strengthen our Board of Directors with 2 or 3 new US-based Directors. Our goal is to add new Directors who have significant international large pharmaceutical experience in drug development in the Central Nervous System, and business development, partnering and M&A experience.
- Add one additional expert to our Clinical Advisory Board, ideally an individual who has extensive experience in the clinical management of Parkinson's patients.
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.
Anthony Giovinazzo, President and CEO
About Cynapsus Therapeutics
Cynapsus is a specialty clinical development pharmaceutical company targeting diseases of the brain. Cynapsus' lead drug candidate, APL-130277, is a reformulation of an approved drug (apomorphine), for the treatment of motor fluctuation in Parkinson's disease. APL-130277 is designed to address a much larger moderate to severe patient population, which represents a significant portion of Parkinson's patients.
Cynapsus' strategy is to grow its portfolio of drug candidates through in-licensing and acquisitions, and to advance projects to Phase 2 proof-of-concept clinical studies. Once the drug candidates are sufficiently derisked, Cynapsus intends to out-license the programs to the appropriate pharmaceutical marketing partners for a combination of upfront, milestone, and royalty payments.
More information about Cynapsus (TSX VENTURE:CTH) is available at www.cynapsus.ca.
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.
The TSX Venture Exchange Inc. has not reviewed and does not accept responsibility for the adequacy or accuracy of this press release.