Topher Kinsella, Watershed Therapeutics - Bladder Drug Delivery Platform | LSI USA '24

Topher Kinsella  0:02  
Music. Hi everybody. I'm Topher. I'm the CEO of watershed therapeutics. I like this company, not just because I'm involved in it, the same reason I like coming here because you get to see all the secrets that different companies know that you don't. And I'm, like, addicted to that. So this company got started on a bunch of secrets that I didn't know. The first was that women, after they had menopause, not their fault, but all of a sudden they can start getting lots of urinary tract infections like 3456, a year. There are some women that can't escape it. They have it constantly. I didn't know that. It's not surprising. People don't like talking about things that happen below the waist. The second surprise was that I had no idea how common it was. Again, no one wants to talk about it, but if you're in a room of 20 people, odds are one of them has this problem. That's how prevalent it is. There's millions of people in the United States that have this issue. That was really surprising to me, but I figured that's fine. UTI is a solved problem. You go down to Walgreens, you spend five bucks. UTI is gone. Well, that was the next thing that I was wrong about. These women have tried everything, the solutions that work no one can really tolerate. So you can either drink heroic amounts of water every day, but no one can keep that up. You can try to take over the counter medications, drink cranberry juice. If you mention that to someone, they will, they'll hit you. They know about cranberry juice. It doesn't work. They can use creams that they find uncomfortable, or they can take antibiotics every day for the rest of their life. And they really hate that. So it's not a solved problem. I was very surprised, and when we went to them and tried to figure out, what is it that you actually want. They said they wanted the impossible. They wanted something that had no side effects, that you didn't have to remember to take and just disappeared into the background of your life. And that requires a really outside the box thinking. So we came up with bladder drug depot. So if you put drug into the bladder, you skip the entire body, and so you don't have any of the side effects, and drug doesn't get absorbed from the bladder. If it did, it'd be a bad bladder, but you pee it all out immediately. So the next trick is, how do you design a bladder drug depot that can go in the bladder, but will stay there and stay there long enough that people would actually sign up for this. So if you can't last a month or three months, you're kind of dead in the water. And then the next thing would be, well, if you put something in my bladder, I'm going to feel it, and I'm not going to like that at all. And we found out that all the nerves that are in your bladder pretty much sit at the bottom. So if you can float, you hide, and you can't really feel it. So all that sounds crazy, but you string together all those little secrets and you can end up with an insight. So we went to ah, the clicker worked. So we did an first in human like feasibility study, and showed that we can insert this, that it would stay, that it would float, and that it was comfortable. We did this with a placebo product, so there's no drug involved, but the side effect profile was great, it wasn't uncomfortable, and we had 99.7% retention of the product. So this could very easily last a six or nine month platform for drug delivery if we wanted it to. So our heart is at stopping these women from having to suffer from all these UTIs. So we started with a generic antibiotic, which is Amy Cason, and figured out how to get it to release very slowly and consistently over time. So this is one month data showing that you would get no infections while this product is in there, but the release curve this could go out to three months without breaking a sweat. And we already know where all the patients are, because if you have this problem, you go to your primary care doctor, and they can't help you, and so they refer you to someone in hopes that they can, and that is always your urologist, and the urologist also doesn't have a new solution for you. So these patients get sort of cul de saced in the urology practice, where they're terrifically unhappy. The urologists are unhappy because they can't solve your problem and you're just stuck there. So if you can go into that environment and offer them a solution, something that's a procedure which urologists love and actually solves their problem, you're going to make a ton of people really, really happy. So obviously, once we figured out how to deliver drug into the bladder, have it stay there, have it be comfortable, your head immediately goes to, well, there's lots of bladder diseases. Does the drug have to go through the whole body to get there? I mean, that's like, like covering your car and oil to get some of it in your engine. So it turns out bladder cancer and overactive bladder are also really interesting fields for this technology, and we've already made additional products that have similar release profile to that antibiotic slide I showed you, so we can go into all these fields. It's really exciting. As far as where we are as a company, we are so young. We've been doing this for four and a half years. We've raised $6 million we're finishing our first in human right now. We're meeting with the FDA in May to confirm. Our development path, and we're raising a $20 million series A to take us through the IND and do our phase two study. And it's right around that data point that companies similar to ours have been acquired, even with just the UTI product going just to urologists. This could be a half a billion dollar peak year sale product. And the bladder drug delivery world is actually pretty small, and makes it really nice, because it means you can target the people that you really want. So we've collected people from urogen, which does sort of bladder drug delivery terrorist, that is the only other player in this space. And CG oncology, people that really know the bladder cancer market. And then finally, every time I tell urologists about this, they're incredibly excited, because they know how painful this problem is. They're overactive bladder patients. They're UTI patients. I mean, these people are so unhappy you can't imagine. It's like living with chronic migraine. But no one's invented Excedrin yet, so they really want something to exist. And the woman who wrote the national guidelines for how are you supposed to treat your current UTI, she's a huge believer. She actually flew down with us to do our first in human study and participated in that. So we have a lot of pull from the industry. So the $20 million series A we're going to retire a whole bunch of milestones for the company, get our first signal of efficacy, go straight to phase two, so we get to treat patients who actually have the disease, and then, if needed, go on to phase three and market launch. So that's our company. The only other salient things, I guess, are that all the IP was invented by us on napkins. So we own all of that. It's all fresh, so we have 20 years of exclusivity there. It's a very important problem. No one's paying attention to it, and the technology it forced us to make is really exciting, so I'm thrilled to be doing it. And thank you folks for sharing your time this morning and for LSI for hosting us. Thank you. Applause.