Colin Kealey Presents NeuroSigma at LSI USA '23

Transcription

Colin Kealey  0:05  

Oh, just want to thank all of you for staying till the bitter end. I'm sure it was to see the NeuroSigma presentation. So hopefully I can make it all worthwhile for you. She said my name is Colin Keeley, President, CEO, NeuroSigma. So, we have developed the world's first medical device for the treatment of pediatric ADHD. Our device, sort of similar to the previous speaker targets the V1 branch of the trigeminal nerve. So the previous speaker was targeting the occipital nerve for migraines. Our target is the V1 branch of the trigeminal, which is the fifth cranial nerve that provides primarily sensation to the face, but is also involved in things like autonomic nervous system, muscles of mastication, things like that. I think it does help to hear a little bit about our history. So the guy that invented this is an epileptologist at UCLA named Christa Giorgio and he was involved back in the early 2000s, late 90s With the development of vagus nerve stimulation for treating epilepsy, the implantable neurostimulation device. And the reason he invented this is because he concluded that he likes VNS as a treatment for epilepsy. But ultimately, it is limited because it is an implantable medical device. And if you look at the data, there's about a 1/3 Responder rate. So basically, you got to do three implants to get one good response. And for an invasive, expensive surgical procedure with all its attendant risks, that's just not good enough. And while VNS has been commercially successful, it remains a niche epilepsy treatment sort of at the end of the treatment paradigm. So he conceived of TNS etns as a non invasive, wearable to address some of those issues. Now you can say okay, but you said he was an epilepsy Doctor, how did you get to ADHD? Very quickly, that was based on some clinical observations of Chris's epilepsy patients coming in and talking about things like improvement in executive function, attention, and mood, which then led to clinical trials and then ultimately led to our FDA approval as the first ever medical device for treating pediatric ADHD. So where do I put this thing? Alright, so I would bet that most of you understand that ADHD is primarily treated with stimulant medications. There were 70 million ADHD prescriptions in the United States last year 40 million for just Adderall alone. And I think there can be some cynicism about ADHD as a market. I shared that cynicism to a certain extent before I got involved in this. But the reality is, is that no one has their seven year old child at the pediatric psychiatrist, because they want to put them on Adderall, right? You have your kid there, because you have a problem. And Adderall just happens to be the best solution that we have now, but there are serious side effects risk for abuse and addiction. And the number one reason that patients stopped their medication is in fact, the side effects. So we believe we have a better solution. It is the monarch e TMS system. Again, this is a wearable medical medical device that patients place on their forehead to stimulate the v1 branch. And you can see that as our FDA indication statement. Their neuro signals mission basically is to provide the efficacy of the drugs without the side effects. Now ADHD is a very large market, about $10 billion in the United States, and $30 billion globally. So we have a differentiated product compelling clinical dataset in a very large market. Mechanism of action. I won't get too deep into this, but we have some pet data to show that there is this dual mechanism of action the regions in blue are regions of decreased brain activity when using TMS the red is areas of increased metabolic activity. We believe that the blue is responsible for the anti seizure effect and that the red in these pre frontal cortical brain regions known to be associated with executive function, attention and mood are responsible for the anti ADHD effect. Now this is our data. This was conducted at UCLA by a Kol in the field guy named Jim McGough, he was the president of the American Academy of Child and Adolescent Psychiatry, he set up our trial exactly like a drug study, because he's been helping to run drug studies for the past 30 years or so, our primary endpoint ADHD RS four scale, very commonly used gold standard scale in this industry, what we found is a number one a very statistically significant effect p of point 005. And then a Cohen's d effect size, which you know, the separation between treatment and control of 0.5, which is consistent with a non stimulant ADHD medication, but it actually gets a little more interesting than that. So, if you look at our data, what's a little different about us as compared to a drug is if you give a kid a stimulant, it's pretty rare that they're not going to respond. People respond to stimulants. That's why you drink coffee every morning, right? So etns is a little bit different. Our patients very clearly seem to fall into responders and non responders, and it's about a 50% response rate. And if you look at our blinded data, and you say, Okay, let's take the kids only in the treatment group, separate them into responders. than non responders, something very interesting happens where that Cohen's d effect size goes from 0.4 all the way to a 1.6. And we achieve an average 44% reduction in ADHD symptoms that is in line with best in class medications like Vyvanse, and Adderall XR. So essentially, what I'm saying is in half the kids that use this thing, you can get a response that is just as good as the best medications in this field, with virtually no side effects, okay, you get a little bit of skin irritation, some people don't like the sensation, but it is a very benign therapy. Now, if you look at our data, you'll see that our pivotal trial, pivotal trial had 62 subjects, right. The reality is I'm going up against drug companies, right. And if you look at the kind of dataset that a drug company is going to go to market with, they're going to have many hundreds of patients large, double blind, multicenter, randomized controlled trials. And my primary thesis for NeuroSigma is that if we are going to compete, we are going to have to develop a pharmaceutical quality dataset. So that's what we're doing right now, we have almost $6 million in grant money with our academic partners in the US, the United Kingdom, we're doing a total of 375 subjects at four different centers, we're going to do all sorts of cool scientific stuff along with that, we think we can take a cognitive profile and EEG profile and predict who will be a responder a priori, we're going to do fMRI to really understand exactly what's happening. But bottom line, these trials are already enrolling, we think they're going to be done sometime towards the end of 2024. And that when we have this multicenter multi hundreds of patients dataset, we are going to be in a position to fundamentally change the way that ADHD is treated worldwide. And in my opinion, that's the name of the game. That's what we're all trying to do. Right. That's how you achieve commercial success in this industry as you change treatment paradigms. I do have a background as a physician, I am aware that just because you can prove something statistically, that does not mean you have a good product, but we do have a good product. And the way I know that is I get these nice emails from others, and you can read it for yourself. But this is why we come to work in the morning, and it makes us feel good about what we're doing. It's a unique business model for a medical device. It's more pharmaceutical, like our goal is to drive prescriptions through the physician's office, we're not selling the hospitals, we're not in the or with the physician. So I think that makes it again, a much more scalable opportunity than a traditional implantable medical device. This is our three phase launch plan, we raised about $5 million. Last year, we're in the midst of raising a $20 million round right now to keep keep essentially our early commercialization going as well as work on market access, and then do some pipeline development for the epilepsy indication. I'll briefly show you some data there. For whatever reason, this has gotten a lot of traction over in Asia, they have a cultural reticence to prescribe stimulants. So we have some very credible partners in China, Japan, and South Korea. And we expect more news about that later this year. We are launching the next generation device. Hopefully around mid 2023, maybe August, September. I know I'm running out of time, but it's going to be a lot higher margins for us as well as more advanced, easier, more patient friendly format. This is our pipeline. I told you about the two trials for epilepsy, we did get a breakthrough device designation and epilepsy last year. It's based on this data here we have a 40% response rate after 18 weeks or so six months three to six months using the device that's in line with best in class medications. Again, if you look up a drug, like vimpat from UCB pharma that was a blockbuster drug came out about five or six years ago, they had approximately a 40 to 50% response rate in the same population. So we think this is a very high priority target for the next phase of our development. This is the team again, my name is Colin Kealey. My chief medical officers guy named Ian Cook who's a professor of psychiatry at UCLA, a leader in sort of neuromodulation for psychiatry, and then we're also working with some executives from Shire, you know, now acquired by Takeda that helped launch drugs like Adderall, XR, and Vyvanse. So that is the presentation. Thank you for your time.