Bob Radie Presents Neuraptive Therapeutics at LSI USA '23

Transcription

Bob Radie  0:05  

Good morning everyone. My name is Bob Radie, Chairman and CEO of Neuraptive. Pleasure to have the opportunity to present Neuraptive to you. So unwrapped, we're a private venture backed company today exclusively focused on improving outcomes for people who suffer from traumatic peripheral nerve injuries. We have the LEAD program that we call NTX 001 that I'll spend the majority of my time with you this morning walking you through what this program is, it's a novel drug device combination that we believe has the opportunity to really be disease modifying as it relates to improving speed of recovery and extensive recovery from individuals who suffer from traumatic peripheral nerve injuries. The program itself, our LEAD program is currently in to mid stage clinical programs that I'll describe in great detail. We've received Fast Track designation from the FDA, we believe this program has orphan drug potential as well. And I'll describe why we're following on a somewhat abbreviated pathway to approval. peripheral nerve injury, peripheral nerve repair is an area of significant unmet medical need. In fact, it's pretty amazing that there have been very few advances significant advances of any sort, over the last 30 to 40 years to improve outcomes for people who suffer from peripheral nerve injuries. In addition to you know, civilians, this is a significant area of interest as well for the Department of Defense. For the government who's already provided some funding to advance our program, we believe there's opportunities for additional funding from the government, as well as the fact that the government will likely be a future customer of ours, as peripheral nerve injuries are common for our warfighters as well. In addition to myself, Evan Zanes, who's in the audience here is our Chief Operating Officer and head of r&d. Andy and Seth, join me as our executive team. We've been around for a while, we've done a lot of different things, Evans had the pleasure of having over 11 different products of pharmaceutical products and devices approved through his career. And needless to say, we've sort of been there done that a number of times, let me describe the problem. And then I'll describe the potential solution. And so think about peripheral nervous system. So everything except the brain in the spine, as a series of wires, obviously, much like an electrical wire, if you cut an electrical wire, you lose an immediate, immediate loss of signaling, it's the same with our peripheral nerve. So the minute you have an injury, think about a car accident, a DUI project at home, maybe you're cooking, maybe you're an industrial accident, maybe it's a crime related incident, you have an immediate loss of electrical signaling when a nerve gets severed. And what happens is distal to the injury. All have the axons inside of the nerve will degenerate, it is part of our body's immunological response. And typically within three or four days, all of the axons distal to the injury are no longer there. So your recovery is 100% dependent on the proximal end of the nerve, regenerating and regrowing good news, our nerves will regrow our peripheral nerves do in fact grow. Bad news is it's a very slow process about a millimeter a day. And because it's a regenerative process, it's fraught with risk. And so most people have a very lengthy time to recovery. And most people don't ever regain full sensation or full function to the limb that's been affected by by the this traumatic injury. What's done today, what's the standard of care today? Well, if the injury is such that the surgeon can just sew the two ends of the nerve back together, it's known as a primary repair, well, they will micro suture the two ends of the nerve together, the only reason they do that today is to provide the proximal end of the nerve, a pathway to regrow back down and increase the chances that the regrowth will occur and will and land in the right spot. There are occasions when there is a gap in the nerve that is injured. So there is a segment of the nerve that is ablated. And so they need to do something to bridge that gap and there are synthetic conduits on the market today. There is an Allah graph to cadaver source Allah graph products that's that's the cellular realize that can decellularized that can be used to bridge that gap. And very commonly, surgeons will actually harvest a segment of nerves from another nerve in the body, usually the sural nerve in the leg, where they'll actually take a piece of that nerve and use it to bridge any gaps. The most important thing to take away from the standard of care today is that nothing that's done today prevents the degenerative process from occurring distal to the injury. All of these techniques, everything that's done today as part of the standard of care is simply there to improve the regeneration process, but it doesn't prevent degeneration. And that's really where our technology comes in. What is NTX 001. It's a drug device combination made up of three sterile solutions, and a device component. And I'm going to show you a video in a moment of how this is used in the surgical field at the time the surgeon is doing the nerve repair surgery, but suffice to say in our preclinical models In our in our clinical experiences, we're actually able to show that we can fuse two ends of the nerve back together, reestablish an electrical signal in the operating room, and therefore prevent that degeneration distal to the injury from occurring in the first place. And what that should mean in our clinical studies is a much faster time to recovery and a more complete recovery for people who suffer from these types of traumatic injuries. So I have a brief video here that I'll show you, essentially showing you what the standard of care is today. So here I'm showing a nerve severed in the arm, the first thing the surgeon is going to do is he's going to prep the nerve. This is part of standard of care today, where they're going to essentially trim the two ends of the severed nerve, just increasing the opportunity in the likelihood for a nice clean suturing back together again. So this again, is what's done today as part of the standard of care. Once the surgeon trims both ends of the nerve, using typical using a scalpel and a tongue depressor. They'll then apply the first solution in our kit, which is a hypotonic calcium free solution that essentially works to blow any additional calcium out of the two ends of the nerve. And also clear any blood from the field, the surgeon will then perform the micro suturing that is done today as part of the standard of care, he would then place this device that's part of our kit around the recently collected nerve, and then put second solution and this is the fusing solution that essentially is put into this containment device for 90 to 120 seconds that that solution is then removed with a blunt tip syringe, the device is then removed. And then the surgeon would bathe the sutured area with the third solution, which is essentially lactated ringers, which just brings everything back to the osmotic balance that you want to have before the patient is closed up. So this whole process adds about five to seven minutes to the normal surgical procedure that occurs today. So we're not increasing OR time significantly, which is important. It's relatively simple process. We've trained over 60 surgeons to date as part of our clinical trial program. And all of those trainings have gone extremely well and the surgeons are very excited about the ease of use. I won't get too deep into the mechanism of action except to say that what's really occurring here is that we are with that second solution. Once we prep the nerve, we use the calcium free solution, we are essentially dehydrating the membranes of the axons on both sides using the second solution. And that dehydration causes destabilization and allows the two ends of the nerve to fuse and is a biophysical process. Even though these are drugs. This is not a biochemical reaction, it's a biophysical process, we're essentially fusing the nerves and we've been able to quantify that we're able to preserve 60 to 70% of the axons distal to the injury, which again, in a standard of care example, would they would degenerate completely. We've done a lot of work, preclinical work on both small nerves like the rat sciatic nerve, which approximates what a human digital nerve looks like, as well as a pig median nerve, which approximates a lot of what a human median nerve looks like. And it's pretty fascinating to see the results when you can actually watch right in the operating suite, the animal's ability to then receive a signal on the end of the nerve that's been severed once the suture and application of our technology occurs. Sorry for the pictures, but we're applying this in two clinical areas of very much importance. The first is upper extremity, nerve repair. So from the brachial plexus, down to the fingers. These are injuries that typically occur as part of some sort of accident. Again, I described what those could be. The second study that we're doing is in facial nerve repair here. While it could be due to trauma, it's often due to eye estrogenic causes so a plastic surgery, surgery gone bad, a dental procedure gone bad, perhaps somebody has a tumor in their parotid gland. And in order for the surgeon to fully remove that tumor, they have to sacrifice the facial nerve. Once that facial nerve is sacrificed, you lose the ability to move half of your face. You can't smile, you can't chew your drool, you can't blink that eye. It is a very, very lengthy recovery. And it is a recovery that is very, really challenges your ability to really live your life. And people often become reclusive during this period of recovery, which can take 12 to 18 months for you to get those ability to move that half of your face again, our two studies are ongoing as we speak. They're very similar in design, one to one randomization where the patients present. This is I'm showing you here the trauma study but the design for the facial nerve study is very similar. They will be randomized either to standard of care alone, which again would be just direct repair and waiting for regeneration or standard of care plus NTX 001. The primary endpoint is a 12 week data readout which at 12 weeks The standard of care nerve procedure really would have very little opportunity to show any effect in 12 weeks time because you're now waiting for that regeneration. So we have 42 subjects enrolled in this subject on our way to on this study on our way to 60. We should have top line data read out from this study, in the latter half of the latter part of this year, early part of 2024. The facial nerve study will read out about six months after that. And then there's a third clinical study going on with the funds from the Department of Defense shown at the bottom of this slide, with a consortium of academic centers anchored by Johns Hopkins where they're actually studying the use of our drug under our IND in gap nerve repairs, where they're actually harvesting a segment of nerve from the leg and using that to bridge a gap. And then fusing both ends using our technology. market size here, estimated to be 4 billion ish by 2030. There are over 700,000 injuries in the US on an annual basis that involve nerve repair, and present in level one and level two trauma centers across the across the US. So with that kind of brings us back to the beginning of where we are. Thank you for your time and attention. We are actively raising a series B, we have raising up to 30 million for which we've already closed on about 15 but the round is still open. So if anybody's interested please let me know. And thank you for your time.