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:

"On June 23, Cynapsus Therapeutics Inc. announced it had completed a public offering and raised $72.5M. The company also just recently uplisted to NASDAQ. This was a tiny Canadian company that was listed on the TSX Venture Exchange just two years ago; I began following Cynapsus when it had a market cap of $15M. Today its market valuation is just above $200M, at about $17/share. In my initiation report I called it an 'undiscovered gem'. . .APL-130277 is currently in Phase 3. It is a thin film strip formulation of apomorphine, which is a rescue medication used by Parkinson's patients to return them from akinetic, or 'off,' to 'on'. . .apomorphine has long been approved and is on the market in the U.S, but unfortunately it is a subcutaneous injection. . .it is a highly effective drug with a rather poor delivery system. Cynapsus has taken this drug and put it into a very simple and very easy-to-use delivery system, where the patient can self-rescue by letting the strip dissolve under the tongue. The compound is now in Phase 3, and because the apomorphine molecule is already approved in another form—by injection—the company is able to utilize the FDA's 505(b)(2) accelerated pathway to approval. Cynapsus has had two successful Phase 1 programs and a successful Phase 2 program. It recently met with the FDA and confirmed the 505(b)(2) pathway, which basically says the FDA will bless all the preclinical pharmacologic and toxicology data from previous work with apomorphine. Cynapsus doesn't have to go back and do that. It can move right into a Phase 3 trial, then do an extension safety trial, and then it can file a new drug application (NDA). It is in the efficacy Phase 3 trial now. We assume we'll have data in a little less than a year. . ." read more >

Daniel Pearlstein, M Partners (7/7/15)
"Cynapsus Therapeutics Inc. closed its U.S. offering on June 23, raising $72.5M (at $14/share) including the overallotment option. . .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."

Jason Napodano, Zacks Small-Cap Research (6/22/15)
"Cynapsus Therapeutics Inc. long-awaited U.S. initial public offering is set to close early next week. The company recently announced that it plans to offer 4.5M shares of common stock at a price of $14/share. Gross proceeds from the offering total $63M. . .signs point to fundamental strength."

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

More Expert Comments

Experts Commenting on This Company

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

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Investing Highlights
Completed End-of-Phase 2 Meeting With U.S. FDA
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