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Cynapsus Therapeutics Inc.

Cynapsus Therapeutics Inc. is a specialty clinical development company. Its lead drug candidate, APL-130277, is the only oral (sublingual-strip) delivery of the only approved rescue therapy for Parkinson's patients who experience daily "off," or freezing episodes. The current method of delivery is an inconvenient and painful injection. The reformulation could address a large moderate-to-severe patient population, approximately 25% to 50% of all Parkinson's patients. The potential annual market could grow to well beyond $1B per year. Cynapsus plans to derisk the project over the next two years, after which a new drug application can be submitted, and execute a substantial transaction with a large pharmaceutical company.

Expert Comments:

Jason Napodano, Zacks Small-Cap Research (3/18/15)
"Cynapsus Therapeutics Inc. will conduct a short bridging study, CTH-200, to start in Q2/15; CTH-200 will be a single-dose, crossover comparative bioavailability and pharmacokinetic study in healthy volunteers. This study is designed to allow the company to use the safety and efficacy data for the reference listed drug (Apokyn) in its 505(b)(2) new drug application submission to the U.S. Food and Drug Administration." -Zacks Small-Cap Research

Daniel Pearlstein, M Partners (3/12/15)
"Cynapsus Therapeutics Inc. announced that after meeting with the FDA, agreement was reached on the design, duration, and size for the Phase 3 trials, as well as for primary and key secondary endpoints; the company plans to begin the first of these trials in Q2/15. . .trial pathway includes CTH-200, CTH-300, and CTH-301 as expected, with an update on timing and patient enrollment. . .upon completion of the efficacy and safety studies, as well as the Chemistry, Manufacturing and Controls, Cynapsus intends to prepare and submit a 505(b)(2) New Drug Application to the FDA in mid-late 2016."

"Third-party validation is always a good place to see a checked box. One company we cover that actually has had experience in that realm is Cynapsus Therapeutics Inc. The company has received two grants totaling $1.5M from The Michael J. Fox Foundation for Parkinson's Research. We believe that vote of confidence is very advantageous, and helps support our thesis on the company. Cynapsus is developing its lead candidate, APL-130277 (sublingual apomorphine strips), via the defined lower-risk U.S. Food and Drug Administration (FDA) 505(b)(2) regulatory pathway. Apomorphine is already approved, and is considered a safe drug for treating Parkinson's disease patients. Cynapsus is pursuing an efficacy pathway to generate its own label. The drug targets patients having "off" episodes, or hypomobility, with muscle stiffness and difficulty in moving. Off episodes affect up to half of Parkinson's patients. Cynapsus has reformulated apomorphine into a thin, easy-to-use film strip that goes under the tongue. Once commercialized, patients would take multiple doses to replace apomorphine currently used as an injection. It's hard to inject yourself in that off state; it's much easier to slip a thin strip under your tongue. We believe payers and insurers might reimburse this product, since early results have shown that APL-130277 may have a better adverse effect profile and longer duration of effect compared to the already approved drug, Apokyn or APO-Go (apomorphine hydrochloride injection). . ." read more >

Jason Napodano, Zacks Investment Research (1/5/15)
"We continue to believe that Cynapsus Therapeutics Inc.'s stock represents an attractive opportunity for investors. We believe APL-130277 is a superior drug in design, safety and mechanism of action to CVT-301, a drug recently acquired by Acorda Therapeutics Inc. for $525M in cash; we estimate that Cynapsus is approximately two to four months behind Acorda in Phase 3 development of their respective drugs but would not be surprised to see Cynapsus pass Acorda when it comes to final approval." -Zacks Equity Research

Daniel Pearlstein, M Partners (11/20/14)
"Yesterday Cynapsus Therapeutics Inc. released positive top-line results from clinical trial CTH-105, a study in 16 Parkinson's disease patients who are naive to the use of apomorphine and who experience at least one daily 'off' episode. This was the first time Cynapsus used the drug in the desired patient population. . .we maintain our Buy rating and increase our 12-month target to $2.15/share (previously $1.75/share) by lowering our discount rate to 17% from 20% to reflect reduced clinical risk now that Cynapsus has generated some early positive data in Parkinson's patients."

Daniel Pearlstein, M Partners (11/19/14)
"Cynapsus Therapeutics Inc. released results this morning from clinical study CTH-105, an open-label study that examined the effect of APL-130277 in 16 Parkinson's disease patients. . .14 of 16 patients treated with APL-130277 were converted from 'off' to 'on'. . .clinically meaningful improvement in motor control was measured and defined. . .meaningful improvement occurred in as early as 10 minutes after administration of APL-130277 and lasted longer than 90 minutes. . .Cynapsus is now planning to conduct much larger pivotal studies of longer duration and patient sample sizes to confirm these results."

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