The Life Sciences Report
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Experts Commenting on This Company
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Cynapsus Therapeutics Inc.TICKER: CTH:TSX.V; CYNAF:OTCPKCynapsus 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. |
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Expert Comments:
The Life Sciences Report Interview with Hugh Cleland (11/15/12) "An investor can enter after a financing, when he or she knows the company is in a position to meet its milestones and won't be subject to further dilution. Cynapsus Therapeutics Inc. is doing that now, and is expected to close a CA$7M financing by the end of November. Because it uses the U.S. Food and Drug Administration's (FDA) 505(b)(2) regulatory approval pathway, instead of the standard phase 1-2-3 NDA process, its capital needs are much smaller. . .Cynapsus is timely to revisit because it has had two very significant developments since we last spoke. In August the company announced that it had been awarded a US$950K grant from the Michael J. Fox Foundation for Parkinson's Research. That's great independent validation for a tiny company like Cynapsus. But perhaps even greater validation came on Oct. 29, when Cynapsus announced its drug candidate, APL-130277 for Parkinson's disease, was recognized as one of the Top 10 Neurology Projects to Watch in 2012 by a joint selection committee that included Dr. Harry Tracy (an authority on pharmacological interventions for brain diseases and the editor of the biotechnology publication NeuroPerspective).
As a result, Cynapsus will be presenting APL-130277 at Elsevier's Therapeutic Area Partnerships meeting, to be held Nov. 28–30 in Boston. Together these developments give me a significantly higher degree of confidence that Cynapsus will be able to raise the money it needs. If the drug is as big as the CEO believes, the company could very well be worth more than CA$200M in three to five years. And remember, the company’s capital requirements are much lower because it can use the 505(b)(2) pathway, not the typical NDA pathway." More >
The Life Sciences Report Interview with Hugh Cleland (8/9/12) "Cynapsus Therapeutics Inc. is a 505(b)(2) pathway company taking an existing injectable drug, apomorphine, and moving it onto a thin film strip for sublingual delivery. Apomorphine is used to treat the freeze-up episodes that as many as 70% of Parkinson's disease patients experience at some time. A significant number of patients experience very serious freeze-up episodes quite frequently. Given that the drug is already approved and that toxicity and efficacy are not in question, a lot of risk has been taken off the table. That's one of the reasons I like Cynapsus specifically, and the 505(b)(2) pathway generally.
Although Amarin did not use the 505(b)(2) pathway to get FDA approval for its drug, I think the financial market strategy Amarin employed is a great model for many existing biotechs. . .Cynapsus is raising $500K to $1M to bridge it to this larger round, while a number of biotech funds do due diligence. I put a small amount into this bridge, and am doing what I can to help in other ways. . .if Cynapsus can raise the money it needs, I expect it will create shareholder value in the $100–300M range within two to three years. As far as drug development is concerned, Cynapsus is low risk. The biggest risk is financing at this point. If a large fund comes along to remove the financing risk, I expect the company will be well rewarded."
