NeuroOne Medical Technologies Corporation Common Stock Moody Capital Disruptive Growth & Life Science Conference

All right. Take it away, my friend. That was a great introduction. Thank you. Today we will be making some forward-looking statements. Here is the standard disclaimer, as I am sure you are all very familiar with. As you mentioned, my name is David Wambeke. I am the Chief Business Officer at NeuroOne. I joined the company about six months ago. Prior to that, I was at Pharmaceutical Research and Manufacturers of America, and prior to that, I was an investment banker. When I did join the company, I did invest personally. I put about $700,000 of my own money into it in a direct PIPE. I had previously been an investment banker with the company, so helped raise NeuroOne money in follow-on offerings and just got to know the company for a very long time.

I think that this slide, just at a big picture, really represents some of what the technology enables for patients. This is Clara. She is 18 years old. She had drug-resistant epilepsy. She had, on average, 10 seizures a night. All drugs had been failing her, and she is really in a pretty tough spot. She was treated with our OneRF Ablation System, so this is actually where we burn brain tissue, and we were able to deliver seizure freedom for one year for Clara. Our technology definitely has some profound implications for these patients who are suffering and need better treatments. Really quickly, about us and part of why I joined the company is, so we have a proven technology. We have four 510K FDA cleared devices. We also have a strategic partnership with Zimmer Biomet.

This is a $16 billion market capitalization company, and I will get a little bit more into them, but they have a ROSA ONE Brain robot that really kind of synergizes with what we have. They are a natural partner for us to partner with, and they are currently our main source of revenue. This year we are going to do about $9 million-$10 million of revenue. That was our guidance. We have these core markets, and the biggest one is epilepsy, which is served by Zimmer Biomet. It is about a $200 million market opportunity. When we look at our platform, I think what we see is the most exciting parts ahead. I will go into each of these. There is a significant expansion opportunity that we are going to be moving into in basivertebral nerve ablation. This is a market that is going from $200 million to $1 billion.

It went from $70 million to $200 million over the last three years, and it is in chronic lower back pain, and it is transformative for young surgeons in kind of defining their career. Drug delivery, I will get into that some more. That is the business that I lead and that I came on to do. We are also going to be looking at spinal cord stimulation. Very importantly, all three of these market opportunities are served by the same underlying thin film technology that we have developed, and we have kind of followed a playbook with the regulators where we are able to just adapt our platform. We are not starting from scratch every time. We are making modifications to the RF probe or to the RF generator, et cetera, and we have been successful in getting 510K clearances.

We do believe that, especially for BVNA, drug delivery, and spinal cord stim, that these are largely de-risked in our development approach. As I said, this is kind of our secret sauce, and it is the competitive moat behind every technology that we build. It is our thin film technology. What this enables us to do is produce circuits that are very, very flexible, very, very thin, and they allow us to keep the lumen of our devices wide open so that we can either, A, put drug through them, B, put an RF probe in it with a temperature monitor and ablate tissue. It is very challenging to make these and have them hold up in the brain parenchyma for up to 30 days. It is very challenging to get the right yields on these and to have the circuits not break.

We have this competitive moat that we think is very differentiated, both from a patent perspective, so we have 13 issued and pending patents. We also have OUS patents, but also just on the proprietary trade secrets. People who try to do this are going to very much struggle. It is not something that is easy to do. One of our lead engineers came from, gosh, I am forgetting the Elon Musk brain company, but Neuralink. Came from Neuralink, so has a strong background in this thin film technology, and that is really kind of what enables all of our products. We address some very large market opportunities. The first one there is in epilepsy and trigeminal neuralgia. Today, that is about a $200 million market opportunity. That is largely served by our distribution partner, Zimmer Biomet, who we think is the right partner to help us go to market with.

As I said, they will generate about $10 million of revenue for us this year. Drug delivery is an emerging and novel approach to delivering drug right into the brain. Cell and gene therapies, they are very large. You cannot give them intravenously, subcutaneously, or orally. They do not traverse the blood-brain barrier. They do not make it into the brain parenchyma, and they cannot do what they are intended to do. Next year, uniQure, which is a publicly traded company, should have the very first, I would say, large-scale drug approved for intraparenchymal delivery. This is a gene therapy for Huntington's disease. That drug is expected to do up to $2 billion of revenue.

It is really just the starting gun here for cell and gene therapies that are going to be delivered into brain parenchyma, and we have a very elegant solution that we think can dramatically reduce the procedure time. The procedure I just mentioned for uniQure, it takes 12 hours. It needs to be done under MRI the entire time, so it takes up a costly and consuming resource. We think that with our technology that we can get this procedure down to four times. It can be done in a CT scan outside of the MRI, and it can be potentially, from a commercial standpoint, very, very viable. BVNA, which I mentioned. Relievant Medsystems was acquired by Boston Scientific about three years ago. It was doing $70 million of revenue, and it has since grown to $200 million of revenue and represents the majority of the market.

We've now seen competitors like Medtronic get in. They've licensed Merit Medical Systems' technology. We've seen Stryker get in. BVNA is a transformative growth opportunity for lower back pain. You go into the spine and the basivertebral nerve, and you ablate that nerve, and it has tremendous outcomes for patients who are suffering from lower back pain. What we think our technology can do is we can dramatically reduce the procedure time. Currently, it takes about 10 minutes to create these lesions using existing systems. We believe that we can cut that down to 5, so the doctor doesn't have to sit there twiddling his thumbs. He can get on and do more procedures, get more billable codes. We also don't think you have to be as precise in the placement of the device.

We have much more degree of freedom because we can ablate at any different contact. We can ablate at contact 1, 2, 3, 4, 5, 6, whereas other devices are fixed in terms of the contacts. The positional placement for our BVNA device is much more forgiving if the surgeon isn't completely accurate in how they crack open the spine and get the probe in there. Then spinal cord stimulation, this is more of a longer-term opportunity for us. We're focused on it. It's a very big, mature market. What we have is with our thin film technology I described, we can roll up the paddle leads, and we can be able to do a spinal cord stimulation implant leads using a percutaneous placement. That means putting it into a needle and putting it into the back versus having to run a surgical procedure right now.

We think that's a chronic implant, so we do have more development work that we need to do it. Right now, our main focus is on BVNA and drug delivery. Our drug delivery devices will be ready for commercialization at the end of this month, and that's the business that I'm spearheading, and I think it represents a very large growth opportunity. By reference, there's a company called ClearPoint, CLPT is the ticker. They're about a $500 million market capitalization company. They're the ones that I mentioned. It takes about 12 hours to do their procedure under MRI, and that's our biggest competitor. We started the company. I'm based in Minneapolis. There's a bustling med tech community up in Minneapolis. We have a lot of great engineers and just talent up there. We also have the Mayo Clinic, and they've been a great partner to us.

There's two neurologists there that we showed that they were early investors in the company, and we work with them a lot. We're working right now on drug delivery with them and diffuse midline glioma, other people. It's just a great partnership that we've been able to foster. Then this one is our most important partnership, Zimmer Biomet. It's a $16 billion market capitalization company. Very, very large. They're known for hips and knees. Their bread and butter business is in that category. They also have this ROSA robot here. All the epilepsy procedures, not all, but the majority of epilepsy procedures now that are done, we're actually implanting depth electrodes into the brain, go through this ROSA robot. They have the largest market share. There are other people who are developing their own robots as well.

We can work on any one of them, but we've chosen to partner up with Zimmer to date. They're the commercial partner for us for our epilepsy products. They've paid us $8.5 million to date in licensing revenue. It's been a great partnership. They've given us non-dilutive capital, and we think they're the right partners to help us grow in the epilepsy market. This is our complete portfolio of products. I've kind of went through them. I'm not going to double-click into them much. Right now we focus on brain and pain. What you see are the FDA-cleared devices there on the right, which is our sEEG electrodes and our OneRF Ablation System. I'll just spend a little bit of time on the brain ablation system in a bit.

We have our drug delivery system, which is the business I lead. That's going to be kicking off here in the next month. We're going to have our devices ready. On the pain side, I've kind of talked about this basivertebral nerve ablation. We hopefully will be able to have a system developed and ready for commercialization in about a year's time. Right now, one of the next milestones that we're hoping to and we're working towards is trying to find a strategic partner who can work with us to commercialize that. There are a lot of very large companies that need this type of solution to have in their bag and be relevant with these pain docs. More to report on that in the future. In the interest of time, this is what a depth electrode looks like on the right-hand side.