SCYNEXIS, Inc. 12th Annual Cantor Fitzgerald Global Healthcare Conference
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Welcome to the Cantor Global Healthcare Conference. I'm Pete Stavropoulos, biotech analyst with Cantor. With us, we have SCYNEXIS, and I'm pleased to introduce David Angulo, President and Chief Executive Officer. Let's start off with an intro of yourself, followed by a snapshot of the company, and touch on the milestones that will shape the company over the next 12 to 18 months.
Thank you, Pete. Thank you for inviting us to really participate in the conference. Briefly about myself, I'm a physician by training. I'm a pediatrician and infectious disease physician by training. Been in the pharma industry for the past 30 years, and I joined SCYNEXIS initially as the Chief Medical Officer about 11 years ago, and I became the CEO about four years ago. A little bit about the company. SCYNEXIS is a biotech organization. We're based in Jersey City, New Jersey, and for the past years, we have been dedicated to developing our own proprietary platform of antifungal agents. This year, we decided to expand our portfolio of assets into a new product that we just acquired in autosomal dominant polycystic kidney disease, and we're focusing in the rare disease severity spaces.
Really critical milestones that we are anticipating to come in the next 18 months is really we are wrapping up two phase I studies, one with the product SCY-770 in ADPKD. We're doing a phase I study that is wrapping up this quarter, actually. We're also wrapping up a phase I study with an intravenous formulation of one of our antifungal agents. We're planning to initiate the phase II study in ADPKD by the end of this year, and we're anticipating to have an interim readout of efficacy of SCY-770 in the phase II study in ADPKD by the second half of next year. Those are probably the most significant milestones or catalysts that we're anticipating to come in the next months.
All right. The story of the company has sort of evolved considerably within the last year with the acquisition of 770. How are you characterizing the company and its sort of strategy today? You have two very different assets in hand. Are you a rare kidney disease-focused company, an antimicrobial company, or a combo?
Well, I would say that there is, at this point, very common elements in the two assets that we have. Both of them are addressing orphan conditions. What I will characterize the company as, we're focusing on developing products in areas of very high unmet medical need, orphan conditions, so rare diseases, and those diseases that are severe and have very significant impact in the life of the patient. So one of them is in the antimicrobial space, but also the indications that we're seeking for that product, invasive candidiasis, is an orphan condition, typically less than 100,000 a year in the U.S. In ADPKD, about 140,000 patients reported living with that particular condition.
That's really our focus has been in rare disease space and really the capabilities that we have developed over the years in developing products in those particular areas in which you really need to go into particular hospitals or the healthcare centers that are specialized in those particular conditions, really are very much applicable to both of these conditions.
All right. When you were evaluating the different opportunities, what stood out to you and convinced you SCY-770 would be a meaningful addition to the company's pipeline?
Yeah. We certainly did an intended look into other assets to be able to expand our pipeline. When we identified SCY-770, we were really impressed by several elements. Number one, the space. ADPKD is an area that still has a very significant unmet medical need. It really impacts the lives of many people in a very severe way. As you may know, many patients really end up having end-stage renal failure, and there is only one treatment available for that indication. It's not extraordinarily well-tolerated and has some safety limitations. So the space itself was really, really compelling to us if we can provide an advantage in that disease. The other is the asset.
The mechanism of action of the asset, of SCY-770, is a mechanism of action as an AMPK activator that has been, I would say, gravely advocated by the scientific community as being able to have a significant impact in ADPKD patients. That mechanism of action was extraordinarily attractive. The fact that the asset was already sufficiently developed. They already had, at the time that we acquired, seven phase I studies completed, one phase II study in another indication completed. The product was sufficiently advanced for us to be able to initiate a phase II study very rapidly and to really be able to create meaningful milestones and catalysts in the near term. Obviously, then we had the opportunity to really get into a very comfortable agreement with the selling company in the way that we were able to acquire the asset.
There were several elements there that really fit together very nicely.
Can you disclose the deal's terms?
Sure. We paid $8 million upfront, and then we have another $8 million in development milestones, of which we need to pay $2 million upon initiation of the phase II study, an additional $6 million upon initiation of the phase III. Then we have up to $180 million in the commercial milestones. The majority of those $180 million, about $125 if I'm not mistaken, are really with sales that are at $1 billion or above.
Right. And IP around this molecule?
Say that again. IP. The IP.
Well, the product is covered by several patents. The basic composition of matter patent runs until 2033. However, we also have another composition of matter patent that is related to the salt that we are specifically using in the oral formulation, and that runs up to 2042. Then we have other patents associated with the molecule, which is the method of use in ADPKD specifically. That goes up to 2041. So in general, all these are not considering any potential patent term extensions. And we need to remember as well, this is an orphan product. It's an orphan disease, so even beyond patent, the market exclusivity as well is suspected to be extended because this is an orphan condition.
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