John MacMahon, CytoKind - UVB Light to Treat Immune Disorders | LSI USA '24

John MacMahon  0:04  
My name is John    MacMahon. I'm co founder of Cytokind. I'm really pleased to be here and congratulations to the LSI. Team Scott is this has been a great conference we're really pleased and proud to be here. We are a combination of device with a ozempic size pharma upside and we'll walk you through, what we're doing is we're taking an existing device in dermatology, and we're translating it over to neurology. And it's a device today, but pharma upside tomorrow. The application of what we're looking at is really lying on 40 years of dermatology. And in dermatology, they use narrowband UVB lights shining on your skin where you have huge reservoirs of white blood cells, and they're motivated into your lymphatic system, and they stabilize your immunity. Where this is done most often is in the field of psoriasis, which is underappreciated as an autoimmune disease. It has a lot of similarities to broader autoimmunity. And that's why we're doing this translational work. I've been really pleased to have another strong team come around. This is our fifth startup that we've done. We have drug and device expertise as well as colleagues with multiple IPOs and over $2 billion dollars in in exits. The phototherapy which is the translational project, a product of using ultraviolet light clinically for a patient. And its field is called Photo immunology, maybe new terms to folks in the room. We have the global leaders on it. So we've done the largest aggregation of experts in the field. In particular, we have the former head of inflammatory risk at NIH, and Professor approval hearts who ran the largest trial of phototherapy, and Ms. She's based in Australia, and we'll talk about her data and how we've leveraged it. Now, the reason we're going into Ms. But we're thinking broadly about auto immunity is MS is the most sensitive disease to light around the equator, there is not multiple sclerosis. If you live in the northern half of the US you have, you have almost a double possibility of getting Ms. You'll have facet you'll get it earlier, your brain volumes will get smaller faster. And you'll have more disease severity than if you lived in the South. So the first thing you want to do if you get MS is move south, if you can. The the domain expertise in that field, really getting translated is sort of an outcomes razor idea. Like if that's the issue, why don't you just provide patients with phototherapy? And that's what we're doing. So this has been done academically, but it's not really got a commercial champion from dermatology into neurology before. And what we're doing in parallel, is we're applying state of the art multi omics. And the reason is, we don't know exactly what the body is producing that stabilizing the immune system. Think of it as sort of ambrosia for your immune system. This works in graft versus host, psoriasis vitiligo COVID. But they don't know exactly what's getting made. So we're going to do that in parallel with serial omics. Now, I mentioned Professor Prue heart. So she did the largest randomized trial for MS patients. And they found clinical immunological and quality of life improvements, and we're going to the quality of life and the immunology are all correlated, and we're going to walk through why that's, that's true. And then we've applied the state of the art omics to this. So there's a previous study, so she sent us biobank samples to try and let someone move the academic research forward. Now, Oktay Biosciences is our collaborator. They're based in Menlo Park, they have a validated proteomic profile specific to Ms. So what's going on in MS is you have an overactive immune system. Same thing in COVID, right, you have a lot of inflammation. And it is both biologically happening and clinically presenting now to present as lesions in the brain and Ms. But also presents in fatigue because your body is exhausted, and you end up being exhausted yourself. So this is the first validated test that not only does an overall score of one to 10 on disease activity, but it has four biological pathways that shows the underlying biology that's making that patient that clinical presentation, so we collaborated with them to look specifically at what we can find out about how this previous trial on phototherapy performed symbol hypothesis, the control group is going to continue to get worse. And how good is phototherapy? Are we just going to flatten it? Because there is no cure for Ms. Right? This is a this is a let presently a lifetime chronic condition, or can we actually invert it? That was really a fundamental opportunity for us to discover from someone else's trial data, how powerful this is. And and we hit a clear homerun randomized, even distributions of inflammation in both groups, at 90 days, 90 days, total divergence, the control patients getting worse, the treated patients getting better on their overall disease activity. And then when you dive down deeper into the biology, the individual biological pathways, neuro inflammation, neuronal integrity, so all these things about your nervous system, each one of those subcategories also diverged. And in a 20 patient cohort, we had statistical significance on a number of these fronts is super exciting stuff. So in our collaboration with them and their new test, we've showed it 90 days divergence, we also showed it 66 months, where they did fatigue test, that these patients fatigue was significantly reduced as well. In 12 months, half of the patients in the treatment group, were able to avoid going on to dmts, which are disease modifying therapies. They're 100,000 bucks apiece in the US. And they are not without their own issues. And then that's a lifetime subscription to those diseases. So super exciting stuff. And that allowed us to power a phase two trial. So as a startup, we have phase one data donated to us, we're now with the phase two, we have our omics partners to do metabolic proteomic profiles. So we're also using general metabolics. Now metabolics are in the news these days, because ozempic is a metabolic. This is an indigenously produced metabolite in your system that you're given. That's changing healthcare, it's really it's, it's, it's a great business, what he's doing for healthcare is really fantastic, but it's an upstream solution. So when we look at that, while we're doing these multi omics approaches, we're looking to be upstream as well. Now, from efficiency to go to market, we have partnered with the largest light producer in the world, they're based in Bryan, Ohio, and they will white label their existing line of products into any new indication we have. So the fundraising that we're looking for isn't on the manufacturing side, it's to go get data and get approval and get to revenue. The market for the MS on the device side, there's a million US patients 80% of them have fatigue, fatigue is really what we're gonna go after as a biomarker because it's unaddressed by any of the drugs that's out there. And there are a lot of drugs out there trying to help these patients, but they can't slow down the fatigue. And with a blended ASP of around 4000, it's over a $3 billion Tam. Additionally, so that's a device side, that's a device revenue pathway from a company that that just it's a perfect COVID model, right? We didn't have to go build a factory, we found all the partners. Now when we look at the Dacian upside, which we talked about is is finding this endogenous metabolite that's out there. So now we're going to switch to that and how we do that. So the way we look for something that's systemic and across all autoimmunity and non MS is we have datasets of our own from COVID donated in MS and donated from hypertension from a study in the UK. And in that van is the systemic response of phototherapy to inflammatory conditions. And then we're running the proteomics, metabolics and serology and once again in the middle of that Venn is a commonality of what has stabilized the inflammation across these diseases. And BARDA funded us to actually go do that because our original data was was just exceptional in COVID.

Thank you The, the opportunity there when we look at this target spot, who do we have on the team that can go find it is Professor Hector DeLuca, the godfather of vitamin D. So if you want to look for what sunlight does to your skin, you look at the vitamin D researchers. He's done eight metabolites over his career. they've done $20 billion in revenue. So if you have a failed kidney and you're on hemo, dialysis, you're taking at least one of the analogues that this gentleman has discovered in his career. So we have a license or an option agreement with worth his university for his IP that he finds in the space. And he's 94 and in the lab every day, so she's doing something, right. So we're looking for that with him with the, you know, we don't want to invent finding this. We have machine learning to do that. But he's a proven resource, the market for solutions for Ms. 65 billion worldwide, and none of them address fatigue. So we are complementary to the MS drug markets. And so we expect this round also to be getting us pharma introductions and partnerships. So what are we doing with the capital that we're looking to raise? Well, we've got our endogenous targets, some of which we've already identified from our phase one, Venn diagrams, we're going to validate them in a phase two trial, that phase two trial is pan Ms. So it has the largest inclusion criteria. So it's a real world sample. And within 18 months, we're going to have a new indication and revenue off that. Additionally, the pediatric MS patient population and their advocacy groups met with us. And they want to see this brought to pediatric patients as soon as possible. So we have a pending pediatric orphan device, we will no orphan drug, but an orphan device decision, which we'll know within six months that would give us revenue by the end of this year. In Ms. We're raising $15 million to get this done. It's a 24 month runway, we'll get to indications to revenue models, and we're going to internalize our omics research, it's presently in academic centers around the world. And we're gonna bring that expertise in house because the upside is so big. So in conclusion, when we think about what was exciting about this is it meets three of the fundamental things you can do for a healthy long life. And that is, get some good sleep. If you reduce the fatigue. get stressed out of your life. We can help you with that one. And third, go get some sun. So two out of three is not bad. So thank you all and congratulations, LSI for another great conference.