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Cynapsus Therapeutics Inc.

Cynapsus Therapeutics Inc. is a specialty pharmaceutical company developing a fast-acting, easy-to-use, sublingual, thin film for the on-demand management of debilitating "off" episodes associated with Parkinson’s Disease. The current method of delivery is an inconvenient and painful injection. The reformulation could address a large moderate-to-severe patient population, approximately 25–50% of all Parkinson's patients. The potential annual market could grow to well beyond $1B/year. The company plans to derisk the project over the next two years, after which a new drug application can be submitted.

Expert Comments:

Daniel Pearlstein, M Partners (5/27/15)
"Cynapsus Therapeutics Inc. announced it filed a form F-10 registration statement with the U.S. Securities and Exchange Commission for an offering up to US$60M and the filing of an application to list on the NASDAQ. . .the proposed offering could provide capital for commercial launch in both the U.S. and Europe should APL-130277 receive FDA approval in the U.S. and European Medicines Agency approval in Europe. . .we continue to like Cynapsus as a play in the Parkinson's space as the company has progressed through Phases 1 and 2 within the last two years and now is in Phase 3 efficacy and safety trials."

Daniel Pearlstein, M Partners (4/1/15)
"Yesterday Cynapsus Therapeutics Inc. announced a $21M private placement at $0.95 (no warrants). . .upon closing, the company should have close to $40M in cash. . .use of proceeds should provide a runway beyond clinical trial research and development and new drug application submission including preparing for a potential commercial launch as well as drug registration in Europe."

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

More Expert Comments

Experts Commenting on This Company

Nathan Cali, Managing Director, Specialty Pharmaceuticals – Noble Financial
Jerry Isaacson, Managing Director and Senior Analyst – LifeSci Advisors, LifeSci Capital
Jason Napodano, Managing Director and Senior Biotech Analyst – Zacks Investment Research
Daniel Pearlstein, Equity Research Analyst – M Partners
Brandon Primack, Senior Equity Research Analyst – SeeThruEquity
Ajay Tandon, CEO – SeeThruEquity

The information provided above is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.
Investing Highlights
 
Completed End-of-Phase 2 Meeting With U.S. FDA
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Cynapsus Therapeutics Inc. Content