Marc Giroux Presents Kurve Therapeutics at LSI USA '23

Transcription

Marc Giroux  0:05  

Thank you very much, I've got laryngitis. So we're gonna do the best we can. The show must go on. We are phase three ready right now we've done phase one, phase two and phase two B in three different indications. So we're ready to take one step to launch. So we're one clinical trials short of launch. So we're a little bit of a unicorn, but we're in a good position right now, because we're doing neuro degenerative diseases, and it is a completely unmet need. So most of the things we're doing have no therapies at all. We've got at nose to brain peer reviews on our nose to brain drug delivery period. So these are all successes in clinical trials, FDA guided and placebo controlled, and we've met our endpoints and separated from placebo. quite significantly, we've run five in Alzheimer's, clinical trials, we've run two completed ones in Parkinson's. And a third one is underway with Parkinson's as we speak. We're were pioneering some research with a neurologist here in Newport Beach. And we have 150 patients and compassionate use with him on a polyclonal antibody that was originally done through an infusion. And we're doing now through intranasal drug delivery. So if you take a look at it, the same drug that was put in the infusion that cost you 10,000 A month sitting in a chair, we can do for $350 a month. And you don't, you don't have to go anywhere, it takes a minute and a half per session, five sessions, or every two weeks. So you're talking about a minimally invasive treatment you can do at home. But we also got head to head with the infusion, the same drug, we got 3,000% more into the brain than the infusion did. So that gives us tremendous dose flexibility, we can take a toxic dose and drop it way down, get more in the brain get greater efficacy, but be much, much safer. Alright, so we've we've done that, you know, that run with Adji, helm and those kinds of things, we can actually make it worthwhile. Now, these are all the things we've delivered nose to brain, it's quite a list, the exception of live uninor vaccines, a lot of these things have been done as combinations. We've done combinations in parallel in a single dose, we've done as many as four in four separate reservoirs that actually get the drug into the nasal cavity. So we've done stem cells very recently where we shrunk a tumor by 50%. Very exciting. We've got other stem cell applications, we have some car T cell applications for glioma. So we shrunk a glioblastoma by 50% in a stem cell. And we're doing nanoparticles now as well, and we've done them in the past. This is the stuff that's already in process. Okay, so Alzheimer's, and Parkinson's are much closer to launch, MS and ALS are in the early stages. But all of these are available for separate investment, overall investment. The data slide we have here, which we're quite excited about it 18 peer reviews, we've got so much data that it's really overwhelming. Anybody needs any of that we're happy to share, it's in the public domain. Anyway, anybody wants this deck, they can also get that just see me afterwards. But here we are head to head with a competitive device. And that competitive device is no longer trying to do neuro. Because they failed they we have 18 peer reviews as successes, they have three peer reviews as failures. So we actually separated significantly from Placebo. And they actually just ran the random placebo line straight across at 18 months, we're continuing to separate. So this is something that continues to move along. And our principal investigator as you know, showed that you know, with with curved device, we actually got a disease modifying effect. And we can see changes in the biomarkers, and the NIH has called this call this out publicly to run a phase three. So that's where we're at right now. And that's why we're here. We also have some really exciting new intellectual property, and it was born out of this slide. Okay, so what everybody wants to know, is it can you get the drugs actually in the brain? And we say, well, yeah, we should, we'll show you that we can. Okay, so we've settled this back before 2010. Nobody really questions us anymore on that. But if we want to treat things in the nasal cavity, we want to get to where this one on the left is get all the way up to the roof of the nasal cavity go all the way back. But if we want to do nose to brain we don't want to do that. We want to get just to the olfactory region, which is the one on the left. You can see where it's concentrated there. There's a ball of it. So we're not going to waste the drug in places where it doesn't have access to the brain, in the one here on the right depresses looking straight at you, you can see a bulges on the right a little bit because that's where we wanted most of the droplets to go, because we're in control of that. But what happens if you want to shoot a brain tumor, the brain tumor is not in the front of the brain, right, you want to be able to move that dose. So when I was looking at this slide, I said, I gotta take that deposition, and move it to where the brain tumor is, in addition to the to the glioblastoma work that we're doing. Well, let me tell you how we're going to do that. First, we have in the past, we've delivered nanoparticles there nanospheres, that inside those sphere are the drug, that's where the active is. So we actually get it in the brain. And we're going to be able to move that nanosphere to where it's going to be needed. And the reason why we can do that is we're not in the blood, we're not trying to use the circulatory system, we're the extracellular space, that is the CSF inside your skull. And while it's sitting in that state, it has the opportunity to be relocated, so we can migrate it to another place. And those nanospheres are going to keep the drug from being delivered until it gets there. We can also do this more than once. So it can be controlled release, or we can move it to another part of the brain after the first wave has been released. So there can be a sphere inside his fear, where it gives you a dose immediately. And then six hours later, the next one will dissolve and you'll get your next dose. So there's a lot of opportunity here. So here we see the tumors at the back of the brain, we doing delivery to the front, we're then going to move it and it's going to then drop right there. So the brainstem targets when we were doing all of our nose to brain work kept calling us up say can you I know we know you're getting some to the brainstem because we can test for that. But we need more there to do these things, we can make a real difference if we could concentrate them more than we are. So where we're really interested in moving these things forwards most of these are already in process traumatic brain injury we're doing with the with the DOD with the army in in Maryland, and Lewy Body disease we're doing here in Newport Beach, and it has been spectacular. commercialization strategy is very, very conducive to get big pharma on board, the base unit gets sold once the cartridge is refillable as not refillable, it comes as a as a filled cartridge, you just toss it when it's empty, pop a new one on. We have active electronics inside these things. And we can Compliance Monitor, okay. Big Pharma will tell you after efficacy, we want to we want to know we want to know how to drive compliance, well, we can actually track that it can be done through Wi Fi through the cloud, through the USB port where the doctor at a visit just downloads the information, dose counting something the FDA really wants, but we can also alert the patient through their phone, hey, it's time to use your machine. And if you're cognitively impaired, that can be that can be quite effective. We have a pipeline of 16 different things we're working on right now, four of them are spoken for. So if you're a venture capitalist and you want to you want to do something in the CNS, you can invest in Kurve Therapeutics as a whole and help us run our phase three, or you can simply take out a field of use by the license. And now we're partners you put in your own team. And we will then will then be your partner will work with you a manufacturer and we'll deliver it for you. So we have a lot of opportunity here for to invest, you can license a field of use, you can form a new CO or we do a joint venture, you can do a straight up Reg D or you can buy RegA+ stock. Investing in curve therapeutics means that you invest in all of our disease states, but you can take a field of use and go run with it. Okay, so we have a versatile technology platform where the only ones who can successfully deliver these things in the brain. And you saw that list with a new IP, we're going to be at the forefront of CNS delivery for the foreseeable future, because we're going to be able to even the ones that don't need targeting, we can just make sure they don't leave that area. So anybody wants to talk to us. We're happy to do that. You want a copy of the deck. You want some business plans or some of our data. Happy to share with you 13 seconds over so thank you all