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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.

The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

Jason Napodano, Seeking Alpha (4/16/14) "Cynapsus Therapeutics Inc.'s APL-130277, with far more convenient and simple dosing, less adverse events and far longer duration of action has enormous market-share grabbing—and expanding—opportunity. . .the company has huge upside, a clear exit strategy, a drug that works, a quick path to market, low risk to develop, a raise that is finally out of the way and data from CTH-104 is coming in a few days. That's why I like it here, right now. . .we'll see a filing of the new drug application, and then hopefully a potential takeout by big pharma."

Jerry Isaacson, LifeSci Advisors (4/15/14) "On April 15, Cynapsus Therapeutics Inc. completed a $25M financing led by health care-focused U.S. investors. The deal should provide sufficient resources to complete clinical trials supporting a new drug application submission for AP-130277. . .the strong balance sheet also gives the company substantial leverage in planned partnering or licensing negotiations with large pharmaceutical companies."

Jerry Isaacson, LifeSci Advisors (3/31/14) "On March 28, Cynapsus Therapeutics Inc. announced preliminary results from an ongoing pharmacokinetic study of APL-130277. . .results from the trial indicate that the 25 mg of apomorphine on the sublingual strip leads to an increase in blood concentration of the drug relative to the 15 mg dose. Final results from the trial are expected in April 2014."

Jason Napodano, Zacks Small-Cap Research (3/28/14) "Little-known Toronto, Canada-based Cynapsus Therapeutics Inc. is one of our best ideas for investment in the small-cap biotechnology sector. The company currently trades with a market capitalization of only $50M yet sits on a potential $750M drug for the treatment of Parkinson's disease. . .based on the data and market research that we have seen, Cynapsus shares offer a potential sixfold increase in returns." -Zacks Small-Cap Research

Daniel Pearlstein, M Partners (3/28/14) "Cynapsus Therapeutics Inc. released interim trial results from CTH-104, which has dosed nine of a total of 16 healthy human volunteers using the 25 mg APL-130277 strip. . .early signs are positive. The 25 mg strip achieved a higher concentration of apomorphine in the blood compared to the 10 mg and 15 mg strips; the side effects, nausea and vomiting, were mild to moderate and were not determined to be dose limiting."

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The Life Sciences Report Interview with Stephen Ireland (3/19/14) "Cynapsus Therapeutics Inc. will finish dosing the 25mg strength of APL-130277, then will embark on APL-130277 efficacy studies, the first of which will be in an Apokyn-naďve patient population. . .the company has development options from a regulatory perspective. It can go down a pure bioequivalence pathway and show the sublingual strip formulation has equivalent pharmacokinetics (PK: absorption, distribution, metabolism and excretion) as subcutaneous Apokyn injection, or it can go after superior safety, along with efficacy. Obviously, if Cynapsus can demonstrate superior safety and efficacy, it will put the product in an even stronger position in a market that is already forecast to be in excess of $700M per year. . .positive clinical data will make APL-130277 a very attractive asset for specialty pharma or large pharma, and I expect Cynapsus will be targeted for M&A activity before it gets a chance to commercialize the product. . . More >

Daniel Pearlstein, M Partners (3/12/14) "Activity in the neurology space is encouraging for our outlook on Cynapsus Therapeutics Inc. . .we assume a base-case scenario where 30% of Parkinson's disease patients could use APL- 130277. . .investor sentiment is building not only toward drugs that treat the underlying cause of disease but also those that treat the symptoms. We believe Cynapsus is well positioned in light of growing investor interest in the Parkinson's space."

Jason Napodano, Seeking Alpha (2/11/14) "Cynapsus Therapeutics Inc. is one of our best ideas for investment in the small-cap biotechnology sector. . .based on the data and market research that we have seen, the company's shares offer a potential 10x increase in returns. . .our work leads us to believe the global market opportunity for APL-130277 at around $724M."

Daniel Pearlstein, M Partners (2/7/14) "As Cynapsus Therapeutics Inc. prepares to enter discussions with the FDA, Dr. Judi Weissinger will play a key role in the progression of Cynapsus. Dr. Weissinger formerly spent ten years at the FDA at the director level and would know how to prepare for and interpret guidance from the FDA. She is a consultant. . .who has a wealth of regulatory experience to provide to the company, especially at this stage. . .we are maintaining our Buy recommendation and our 12-month target price of $1.90/share."

Daniel Pearlstein, M Partners (1/14/14) "We are initiating coverage of Cynapsus Therapeutics Inc. with a Buy recommendation and a $1.90 twelve-month price target. . .the company's current enterprise value is almost half as much as our estimate of its lead drug candidate's first full year of U.S. sales in 2017. We estimate that the company needs $20–25M to develop its drug up to a new drug application with the FDA and tap into a $2.5B market if approved. The company expects a lucrative exit strategy with an upfront licensing fee, milestone payments, plus sales royalties or outright acquisition within two to three years."

The Life Sciences Report Interview with Tracey Mumford (1/8/14) "Cynapsus Therapeutics Inc. is new to MJFF. We started funding the company in 2012. Cynapsus is working on a dissolvable apomorphine sublingual film as a rescue therapy for patients, again, having "off" episodes. Apomorphine is available in the European Union via injection, but is not available here in the U.S. Cynapsus' under-the-tongue administration is certainly preferable to an injection, which would be difficult for patients suffering an off episode since the episode may include muscle stiffness and/or the patient having trouble just starting movement. The Cynapsus product is in a phase 1b clinical trial in healthy volunteers to see if blood levels of apomorphine can be achieved via the film delivery system. We've funded the company for about $1M, and it has been able to raise some additional funding on the back of our investment." More >

Jason Napodano, Seeking Alpha (12/26/13) "We think Cynapsus Therapeutics Inc. shares will triple in value in 2014. . .the company is a little-known, small-cap Canadian pharmaceutical company that has, in our view, a far better solution to a major problem affecting Parkinson's patients. The concept is simple and the path to commercialization has been validated. The stock is cheap, and the risks are relatively low."

Jason Napodano, Seeking Alpha (11/26/13) "Cynapsus Therapeutics Inc. is developing APL-130277, a fast-dissolving, fast-acting thin film formulation of apomorphine that can be administered in the mouth. . .[this] little known small-cap Canadian pharmaceutical company has, in our view, a far better solution to a major problem affecting Parkinson's patients. The concept is simple and the path to commercialization has been validated. . .we like the story."

See ThruEquity (11/26/13) "We initiate coverage on Cynapsus Therapeutics Inc. with a price target of $1.54/share. . .we view the company as a highly speculative opportunity in the biotechnology field. The Parkinson's disease market presents a compelling opportunity for its lead compound, APL-130277."

Jason Napodano, Zacks Investment Research (8/23/13) "We initiated coverage of Cynapsus Therapeutics Inc. with a Buy rating. We believe the company's focus on developing a sublingual form of the injectable Parkinson's drug apomorphine offers significant upside potential with a limited financial commitment, and that its commercial strategy to partner with a larger pharmaceutical organization presents meaningful upside to investors today."

The Life Sciences Report Interview with Jason Napodano (8/1/13) "Cynapsus Therapeutics Inc. is a small Canadian company developing a sublingual formulation of a drug called apomorphine, which is a rescue medication for Parkinson's disease patients who experience something called 'off time,' a rigid or frozen state that occurs when their levodopa + carbidopa medication has worn off. Apomorphine is a rapid rescue medication for that 'off time' state. An injectable formulation of this product, called Apokyn, is on the market. It is absolutely the right drug because it works. But Apokyn is completely wrong for a patient who has dyskinesia (uncontrollable movements), because the patient can't administer his or her own drug subcutaneously with shaking hands. Neither is it feasible for patients in 'off' episodes—who are frozen—to give themselves a shot. Oral tablet formulations of apomorphine have failed because they get deactivated by the liver on first-pass metabolism. Cynapsus' sublingual film formulation of apomorphine is put under the tongue and dissolves in a very short period of time. Patients with dyskinesia can take it themselves. It just makes sense.

"The regulatory route for this reformulated drug is through the FDA's 505(b)2 pathway because the drug is already on the market, so Cynapsus doesn't have to generate a lot of efficacy data. It has go to the FDA with similar blood plasma bioequivalence and biomarker data as for the injectable apomorphine, to show the new formulation gets the drug into the blood at the right concentration. The company also has to demonstrate long-term safety, but we see this as a relatively low hurdle given the history of Apokyn. . .I think it could be a $500M or more opportunity. Parkinson's is an enormous indication, and almost all Parkinson's patients experience this on/off phenomenon. Apokyn was an orphan drug, protected for seven years, so no one has been able to develop an additional formulation. As soon as Apokyn came off orphan protection, Cynapsus got the patent for the sublingual formulation. This is a very clean, low-risk story, and I love the way Cynapsus has pulled this off, being the first to patent this delivery. If this were a U.S. stock, it would be four or five times the price it is now, but because it's in Canada, no one knows about it. Cynapsus reminds me a lot of Cipher when it was trading at $0.64 and no one was looking at it. All of a sudden, people started to take notice. That's where Cynapsus is right now." More >

Nathan Cali, Noble Financial (7/8/13) "We are initiating coverage on Cynapsus Therapeutics Inc. with a Buy rating and a 12-month price target of $1.75. . .it is a specialty pharmaceutical company currently advancing APL-130277, a non-injectable delivery of an already approved drug, apomorphine, for the treatment of Parkinson's disease with an expected patent life extending to 2031. In the U.S. alone, the therapeutic market to treat the symptoms and side effects of Parkinson's disease was $3.6B. . .we believe that upon approval, Cynapsus' APL-130277 rescue therapy apomorphine product would provide patients with a significantly better use product with better administration, elimination of pain from injections, and would allow patients better compliance with administration due to ease of use."

The Life Sciences Report Interview with Hugh Cleland (6/27/13) "I'll tell you about a second company utilizing the 505(b)(2) pathway: Cynapsus Therapeutics Inc. It is another holding in my two funds. The company is developing a sublingual form of the injectable Parkinson's disease drug apomorphine, which counters the debilitating "freeze-up" episodes common in Parkinson's patients. It has made huge strides since you and I spoke last November, including closing a financing of $7.3M, which greatly reduces the financing risk I have referenced. The company has also received funding from the Michael J. Fox Foundation. . .bioequivalence studies are a key part of the 505(b)2 pathway, and as such this phase 1 bioequivalence study will move the needle. It's not going to be the biggest value creation milestone, but it's an important milestone that—if successful—derisks the story and should create value in the shares. . .the Zacks report came out, and that has grabbed a lot of attention. The stock almost hit $0.50/share. I think that as more people become aware of the Zacks report, and as the company begins to hit its milestones, we'll see the stock move into a sustainable uptrend." More >

Jason Napodano, Zacks Small-Cap Research (6/5/13) "Cynapsus Therapeutics Inc. was the first company to secure a U.S. patent for a new sublingual film formulation of apomorphine, APL-130277, in April 2013. . .the product is an astutely designed reformulation of an existing approved and known to be effective drug. . .management at the company held a preinvestigational new drug meeting with the U.S. Food and Drug Administration, confirming the path to approval is bioequivalence to the reference product, subcutaneous apomorphine, via the 505(b)(2) pathway. . .we see low clinical development risk here." -Zacks Small-Cap Research

Jason Napodano, Zacks Small-Cap Research (6/3/13) "We are initiating coverage of Cynapsus Therapeutics Inc. with a Buy rating. . .we are initiating coverage of the company because we believe its focus on developing a sublingual form of the injectable Parkinson's disease drug apomorphine offers significant upside potential with a limited financial commitment, and that Cynapsus' commercial strategy to partner with a larger pharmaceutical organization presents meaningful upside to investors today. . .the company might just be an undiscovered gem for small-cap biotech investors." - Zacks Small-Cap Research

The Life Science Report with Ori Hershkovitz (5/30/13) "With Cynapsus Therapeutics Inc., we have a very small company that is very early in the game with a very good and relatively derisked idea. There is a good, already-approved drug for Parkinson's called apomorphine, which rescues PD patients from their "off" episodes—motor-nerve disturbances with muscle stiffness and sluggish movement. These episodes affect quality of life of 25–50% of PD patients. . .If apomorphine could be reformulated as a noninjectable product, it could be a billion-dollar therapy. The value proposition for Cynapsus is that it has reformulated apomorphine as a thin-film sublingual product, APL-130277 (sublingual apomorphine), that does not have to be injected. . .

"I think Cynapsus is flying under the radar. It's very rare to see an ugly duckling, so to speak, that turns out to be a beautiful swan. But every now and then you encounter one of these duckling companies, and you know that it's possible. Sales of sublingual apomorphine strips could easily fall in the billion-dollar range—or even more—if market share is taken from other dopamine agonists used to treat PD. . .all Cynapsus must show is that it can get apomorphine into the bloodstream at a certain level. If that can be accomplished without injection-site reactions, then we would have a winner. . .I would say that by year-end the data will be out. If positive, we are looking at a winner." More >

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."

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