Cynapsus President and CEO Provides Update with Op
Cynapsus President and CEOProvides Update with Open Letter
Marketwire, January 7, 2011
TORONTO, CANADA – Anthony Giovinazzo, President and CEO ofCynapsus Therapeutics (CTH: TSX-V), has provided shareholders with a strategyupdate in an open letter that is available on the company web site(www.cynapsus.ca) and below.
Dear friends and shareholders,
A year has passed since my first update to you, following my appointmentin November 2009. This appointment was based on effecting a repositioning ofthe company in several different respects.
I want to take this opportunity to give you an update on our progress atCynapsus (formerly Cannasat Therapeutics Inc.) over the past year and provideyou some insights to our goals for 2011.
2011 will most likely be a critical turning point for Cynapsus, as theaccomplishment of our goals should allow past and future shareholders to seeCynapsus in a different light.
My strategy from the beginning has been to build significant value overa three year period, and in the 3rd or 4th year, have this value realized forthe benefit of all shareholders. This vision has not changed. I am also pleasedto report that during the past year we have accomplished a number of importantobjectives.
In my update last February, I described three major goals as ourpriority in 2010:
1. Secure pharmaceutical partnerships on Cynapsus’ THC formulationtechnology, for both Relivar (the buccal tablet) and a patented genericprototype. This was a lower risk reformulation approach which benefits frompatent protection for a significant period of time.
2. Rebrand the Company as a Central Nervous System (CNS) company, versusa cannabinoid company. Since our cannabinoid drug candidates fit into the CNSprofile, by positioning ourselves as a CNS company, we aimed to distanceourselves from some of the stigma associated with cannabinoids.
3. In-license or acquire a technology and/or a company that is in theCNS sector, which could drive significant potential value. In our first projectfor in-licensing, we were looking to lower the risk by reformulating anapproved drug.
In relation to these goals, I am pleased to report that in 2010 weaccomplished the following:
1. We signed a Definitive License Agreement with IntelGenx Corp. for theRelivar program. IntelGenx will, with one or more development andcommercialization pharmaceutical partners, take on the task of completing thisproject. Cynapsus will not spend any more capital or time, and will benefitfrom royalties on future sales.
We also significantly advanced our discussions with potential partnersfor a generic THC project. Our conclusion is that to maximize the potentialvalue from a partner, we may need to invest an additional 6 to 12 months ofwork. We are still in discussions with potential partners who continue toevaluate this opportunity.
2. We have successfully rebranded the company to its new focus as aclinical development company for diseases of the brain (Central Nervous System)and renamed it “Cynapsus Therapeutics Inc.” This name that has been widelyaccepted and applauded by investors and participants in the neuroscience field.
3. We successfully signed an option and license agreement for our newlead program in Parkinson’s disease. The project known as “APL-130277” and is afirst time oral/buccal thin film-strip reformulation of the drug apomorphine.Currently, apomorphine use in Parkinson’s is limited because it is onlyavailable as an injection, a dosage form that is considered both inconvenientand painful to use for patients. The convenience of a sublingual thin filmstrip delivery for patients experiencing ongoing daily movement disorders thatare caused by the disease and/or the use of Levodopa based therapies, couldtranslate into a substantial market opportunity. Since apomorphine is anapproved drug, the regulatory pathway for approval and eventual marketing ofsublingual apomorphine is significantly shortened, and could allow us to gainapproval as early as 2014.
In 2010, we have successfully completed a number of additional tasksthat have added value in a short period of time:
1. We established a Clinical Advisory Board for our Parkinson’s project,including world leading experts Dr. Fabrizio Stocchi and Dr. C. Warren Olanow.
2. We hired an internationally experienced Chief Medical Officer, Dr.Albert Agro, with specific experience in the development and approval of CNSdrugs, including Parkinson’s drugs.
3. We completed an in-depth survey of US and EU neurologists to gaugetheir acceptance and need for our apomorphine film-strip product. These surveyresults validated our product concept and showed that neurologists would valuean approved drug using our sublingual delivery system and would use the productto treat several categories of Parkinson’s patients.
4. We completed a US Health Management Organization (HMO) Survey whichvalidated that payers would accept our Parkinson’s product on their formularyand would be willing to reimburse patients who need the drug on a chronicbasis.
5. We successfully completed the first significant de-risking step ofthe Parkinson’s project by completing and reporting (in December 2010) theresults of animal model studies. The results demonstrated that our sublingualthin film strip system could deliver apomorphine into the bloodstream in asimilar manner as injection, in the right quantity and over the right period oftime.
6. We have engaged Summer Street Research Partners (SSRP) to advise usin 2011 on financial matters including capital raising. Based in Boston, SSRPis an institutional focused investment bank primarily targeting the lifesciences sector, with a highly reputable research team and research product.
As you can see, we have been focused and are working intensely toaccomplish more in less time while making prudent use of our availableresources.
Our ambitions for 2011 are equally significant. Specifically, we intendto:
1. Complete a larger financing to provide 12 to 24 months of capital,ideally from professionally managed investment funds. This will allow us tofurther develop our Parkinson’s project and de-risk it to the point where wecan gain maximum value from a potential acquirer or marketing partner.
2. Complete our submissions and interactions with the US FDA for theParkinson’s project, such that we commence our first Phase 1 human equivalencestudies.
3. Successfully complete the Phase 1 human clinical studies to furtherde-risk the project and allow it to move to its last stage of development,which should be completed in 2012.
4. Attract equity research coverage of the company, which should impactliquidity and stock performance accordingly.
I hope you find this summary useful. As always, thank you for yoursupport.
Please feel free to contact me if you have any questions.
Sincerely,
Anthony Giovinazzo
President and CEO