Nick Talamantes 0:14
Bob, thank you so much for joining me in the studio to see you. Tell me a little bit about what you're doing at Neuraptive Therapeutics?
Bob Radie 0:21
Sure. So Neuraptive, were developing a very novel drug device combination product. At least our LEAD program, which we call NTX 001, is being developed for peripheral nerve injury and peripheral nerve repair. That's our primary focus right now, which is an area of pretty significant unmet medical need, there's been really little to no true advancements in, in treating people who suffer from traumatic peripheral nerve injuries over the last 30 to 40 years.
Nick Talamantes 0:51
So Bob, tell me what's the standard of care today look alike for peripheral nerve injuries.
Bob Radie 0:56
So typically, someone's going to show up having been part of some traumatic injury to the ER, level one level two Trauma Center, the primary goal of the care team, first thing they're going to do is obviously stabilize the other aspects of the injury, if there's bleeding, if there's broken bones, all of that is prioritized, the nerve repair aspect of of that treatment is typically de prioritized, the person will often be referred to a specialist and orthopedic surgeon or plastic surgeon who specializes in micro suturing. But there's no rush to do the nerve repair aspect of it, because there hasn't been a reason to rush in the past. Because primarily, what the surgeon is going to do is essentially so the two ends of the nerve back together, either directly if they're able to, or they oftentimes will have to use some sort of bridging material a conduit, an autographed and, or holographic product to actually bridge if there's a if there's a gap when the nerve is actually injured. And, and so that's the standard of care today is so the two ends of a nerve back together, either with or without some bridging material, and then wait for the proximal end of the nerve, which is still connected to the central nervous system to regrow. Good news is our peripheral nerves will regrow. Bad news is they grow very, very slowly, typically a millimeter or so a day. And because it's a regenerative process, it's fraught with risk, right. So oftentimes, by the time if the if the injury is you know, higher up in the upper extremity in the arm, think about how long it's going to take for a nerve to regrow at a millimeter a day, and you're not using this part of your body. So there's muscle atrophy. And if you don't get recovery soon enough, you may never fully recover either sensation or motor function in the affected limb. So that that's part of what attracted me to even join Neuraptive was, you know, the lack of really any disease modifying advancements in nerve repair really over the last 30 or 40 years.
Nick Talamantes 3:01
Yeah, it clearly sounds like there's an unmet need for a better solutions, other than stitching things together. How does your product differentiate itself, then from the standard of care,
Bob Radie 3:12
if you could prevent the degeneration of the axons distal to the injury from happening in the first place, in other words, not be dependent on regeneration to recover, that would be game changing. And so what we've developed is this product that we call NTX 001. It's a kit, it contains three sterile solutions, and a device and the surgeon if they use these three solutions during the normal standard of care repair surgery, in a very prescribed way. And I can go into as much detail as you want as to how that how that happens. What we've been able to show is that we can fuse the two ends of the injured nerve back together in the OR we can reestablish an electrical signal across the severed nerve. And by doing that we prevent that degeneration of the insides of the nerve the axons from from happening at all. And we've been able to quantify in preclinical studies and animal models that we can preserve 60 to 70% of the axons distal to the injury. So think about it. Now your recovery is no longer dependent on a regenerative process, you've essentially preserved the axons distal to injury. And so what we're doing right now is to clinical studies, prospectively designed randomized blinded studies, where we're actually comparing the standard of care surgery to standard of care plus NTX 001. And then measuring at 12 weeks, which is the primary data point, how much more function that person has so fits an injury in the arm as an example. You can do some testing of their ability to move their hands to feel points of pressure to feel heat to button a shirt to hold a fork, I mean, all these sorts of things that one would call activities of daily living. That's one of the studies that we're doing right now, we're doing a second study in facial nerve injury. This is a really fascinating area, facial nerves are part of our peripheral nervous system. Here, the injuries are less commonly due to trauma, and more commonly due to actually estrogenic causes so think about a dental procedure gone wrong. A plastic surgery procedure gone wrong, where a nerve gets inadvertently severed as part of that procedure, or in about 50 to 60,000 instance cases in the US, there's a tumor that will grow in your parotid gland. So we have a glands here on both sides of our face. And people about 50 or 60,000, in the US alone will actually develop a malignancy. And most of the time, in order for the surgeon to be able to remove that tumor, they have to intentionally sacrifice what's called the facial nerve that literally comes down and provide you power, and on both sides of your face. So there's one here and one here. And when they severed that nerve to be able to fully remove the tumor, you essentially lose the ability to move that half of your face. So you can't blink your eye. You can't smile, you drool, you have no control over that side of your mouth. And so if you just think about the debilitating nature of that both physically, but also almost psychologically, right? I mean, people don't want to leave their homes, they don't want to go out because they look very disfigured. So our second study, were actually, once the surgeon injures the facial nerve intentionally, then they would sew it back together and apply our technology. At the same time, with the hope that we were able to provide power back to that half of the face much faster than what is done today with the standard of care.
Nick Talamantes 6:51
Tell me a little bit about how this drug device technology works and how it's different from the standard of care.
Bob Radie 6:58
Absolutely. So I mentioned earlier, the product is made up of three sterile solutions and this device and I'm going to describe sort of what each of those do. So what the standard of care I mentioned earlier is the first thing a surgeon is going to do when he opens the patient up to repair the nervous he's going to trim the two ends of the nerve, the distal end and the proximal end to the injury. And that's done because what ends up happening, the body sort of walls off, calcium floods into both ends of the nerve when the injury occurs. It's sort of a degenerative on the distal side, and it's somewhat protective on the proximal side. So the first thing they want to do is they want to sort of trim the two ends of the nerve kind of create a clean area to you know, to co op the nerve back together. Once they trim the two ends of the severed nerve, that's where they would apply our first solution in our kit. And what that is it's a calcium free hypotonic solution. And essentially, by not having any calcium in there, it helps to remove any residual calcium that's been plugged into the two ends of the severed nerve. So it kind of forces the calcium out. It also serves to kind of remove any blood from the field as you want less blood in the area to be able to perform the micro suturing. So that's step one. And that's what the first solution is, then the surgeon would would micro suture the nerves back together again, that's part of standard of care not unique to our technology using and these are highly specialized, either orthopedic or plastic surgeons who are trained with this this type of micro suturing technique. At that point, they would take the device out of our kit and this is a medical grade silicone fluid containment device. And it's been specifically designed to be able to be inserted around the recently co opted nerve, it kind of collapses down and if you will, it creates a bath right in and around the area that's been recently co opted back together. And that's when the surgeon would place the second solution which goes into that into that little bath that's now surrounding the recently sutured nerve. And that second solution is polyethylene glycol you said PEG or peg, pretty well known product is known to be a fusing agent. And the way it fuses is it actually dehydrates the membranes of the axons on both sides, so much so that it creates instability. The best analogy I can give you it's not a perfect one is think about a welder who's going to weld two pipes together what are they use to destabilize the use heat, right? So they melt and then they they weld and then once it cools, it's connected back? Well, polyethylene glycol uses dehydration to create the same destabilization on both ends. And so when you dehydrate the two ends of the axons are able to actually fuse back together when you withdraw that polyethylene glycol it's like taking the heat away. If you're if you're welding, the thing now you've fused the nerves back together so that polyethylene glycol is applied. It's stays in the container for 90 to 120 seconds. Very specific timeframe, what we've learned through a lot of experimentation is less time doesn't allow for full fusion and more time doesn't really add any benefit. So 90 to 120 seconds later, the surgeon will go in with a blunt tip syringe withdraw that solution out of the containment device, take the device out, so the device does not stay in the body, it's just in there for a couple of minutes. And then they would apply the third solution, which is essentially lactated ringers, which really just provides us some osmotic balance back again, you know, kind of recreate osmotic balance, get calcium back into into the body in that field, and then they would just show the patient backup. And so very specific, each, each solution has a job, each solution has a purpose of what it's doing. But the most important is that second solution, because that's where the fusing occurs. Without the first solution, you wouldn't get that solution that fusing, either because of the calcium. So each each piece of this kit, is really, really important. But what we've been able to show essentially, is that by doing that, we've now fused the axon and right in the operating room, right in the OR, we can actually show that we can get an electrical signal across that severed nerve. And it wouldn't with the standard of care, you would not be able to get that electrical signal. And it's the ability to reestablish that signaling that keeps those axons distal to the injury alive. And they don't degenerate.
Nick Talamantes 11:32
So you're inhuman? How far away now are you then from taking this product and getting approval from the FDA?
Bob Radie 11:41
So the trauma study that I mentioned earlier, we've enrolled 42 subjects on our way to 60. We expect the top line data read out from that study in q4 of this year, perhaps q1 of next year, just depending on our enrollment rate. The facial nerve study is about six months behind that so mid 2024, we believe that that we could file an NDA on the strength of those two studies, meaning that we could have approval in the latter half of 2025. And be potentially on the market. And generating revenue as early as late 25, early 2026
Nick Talamantes 12:20
How many, I guess incident cases of trauma to the peripheral nerves are occurring each year in the United States.
Bob Radie 12:28
So there are about 700,000, emergency room Trauma Center visits in the US on an annual basis that involve nerve injury and require nerve repair. Now, not all of those are transected nerve. So some of those could be crushed. nerves that haven't been severed, but have been crushed our technology, at least as it's designed today won't help in those instances. But we believe about half a million of those cases are, are relevant to either a direct repair, meaning direct end to end repair, or an autograph repair, where they're going to harvest a segment of nerve from another part of the body to bridge any gaps, and then they would just fuse on both ends of that. So it's a pretty substantial market, where again, the standard of care really leaves people with lengthy recovery times and most often incomplete, where they just don't fully regain sensation regain motor function depending on the affected limb that that nerve is feeding.
Nick Talamantes 13:31
Do a little math for me, what does that translate to in terms of market size with your product?
Bob Radie 13:37
Yeah, so the the basic math and again, we've we're in the process of building our own internal forecasts as we speak, we've just in embarked on a pricing and reimbursement study with a third party to really evaluate you know, what, what kind of pricing could we could be supported in the marketplace based on standard of care and things that are done today. So you know, we're that's in progress for us. But I would just point to a An independent report that was done by a group called Delve insight. They put this out in 2020, where they estimated the market to be a $4 billion dollar market for all nerve repair by 2030. And then I layered in new products that were coming to the market, and one of those was was NTX 001, which they thought, you know, 20% market share would be feasible. So you can do that math, that's $800 million a year revenue product, you know, obviously, a lot of things would have to go right for us to, you know, to achieve that level of revenue. But I don't think it's out of the question, either, again, primarily because there's nothing else on the market today and nothing else that we're aware of in development that has the ability to prevent that degenerative process from occurring in the first place. And that's what's really game changing about what we're doing at Neuraptive.
Nick Talamantes 14:53
To get these clinical trials done to bring a product to market we all know it requires capital so are you guys currently raising today?
Bob Radie 15:00
we are we are we raising a $30 million Series B financing, we closed on about 12 million of that in the fourth quarter of 2022. And that round is still open as we speak. So we're actively seeking to top that round all the way up to the up to $30 million as we speak right now. And, you know, that would get us through the data readout of both of these ongoing studies that would also allow us to do some work with some other products and projects that we have, that we that aren't far as as far along as NTX 001. But things that we're really interested in, near adjacencies that would be complementary to the work that we're doing with NTX 001.
Nick Talamantes 15:44
You've just teased new applications for this technology platform, the nomenclature of NTX 001 implies to me that there is a 002 003. Could you talk a little bit more about what you're also potentially looking at diving into?
Bob Radie 16:00
Sure. And you know, before I dive into the other products, I'll just say that we believe there's other applications for NTX 001. So it's a bit of a platform within a product in and of itself. And I'll give you a few examples. So we talked about upper extremity trauma, we talked about facial nerve repair, there are other applications here as well. And one that we're very interested in is in the area of breast resensitization. So think of for women who go through a mastectomy reconstructive surgery, they often lose sensation in their breasts, which is both a safety issue as well as a quality of life issue for them as well. And so if there was a way that we could repower using NTX 001 and provide sensation, obviously, there would be real benefits there. And that's just a one other potential area. So we have a lot we want to do and continue to think about doing with NXT 001. The other things that we're looking at, there are some surgical devices that potentially would make the actual nerve repair process easier. Things like trimming the two ends of the nerve that I described earlier today, they use a scalpel, if we could come up with a way to more cleanly trim the two ends of the nerve without crushing them so that they can improve the coaptation. We have a device that we're we've done some preliminary work on. And then there's also some projects that are not home grown by us, but that we're in conversations with other third parties right now we signed a exclusive license agreement recently, our lamps our exclusive option agreement with a university that's developing a completely bio resorbable stimulator. So one thing we know is that electrical stimulation to a nerve helps it regrow and regenerate more quickly. And it's just not practical. So think about a person laying there having the nerve repaired and then the surgeon has to stimulate the nerve for 45 minutes in the or it's just tough to do right adds a lot of time, you know, the patient's opens. So there's a lot all kinds of sort of infection cautions there. But what if you could actually provide stimulation to the nerve once the injury is closed. And so we've got this ri on this bio, fully bio resorbable stimulator that would potentially be implanted. After the repair surgery during the repair surgery, I should say, on the proximal end of the nerve, and then one could stimulate it subcutaneously with a device that you can envision programming your phone, okay, stimulate my nerve for 45 minutes every day from this time to this time as a way to further speed recovery up as well. And then what's exciting about this is that it's fully bio resorbable. So it would just been two to three months just completely absorbed into the body. And it's made up of minerals and things that are no more exposure to, you're getting no more exposure than you would by taking a daily multivitamin. So really exciting. I would say adjacencies to what we're doing that we would like to continue to develop, again, assuming we're adequately funded to do so
Nick Talamantes 19:05
Maybe shifting gears a little bit, what brings you to LSI this year.
Bob Radie 19:09
So you know, I went to the conference that they had in and outside of London in September, it was my first time being at one of these LSI conferences, and I really enjoyed. It's a good mix of fellow entrepreneurs, founders, CEOs, you know, seeking to make people more aware of their technology. So you get to sort of rub elbows with people who are in the same boat that you are and it just is helpful to network in that regard. There are a lot of venture capital groups present at the meeting as well. And so we've had a pretty full docket of one on ones that we've been able to take that time to introduce interactive, talk about our fundraising efforts and hopefully plant the seeds to help us round out our series B. And then I guess the third reason is There's a lot of larger strategic kind of companies that are here that are all interested in what we're doing or if they they're not, we're trying to get them interested in what we're doing. So we've had a number of meetings, you know, with some of the larger Medtech device companies out there that are hunting for things to add to their portfolio that might be again, complementary to what they're doing. So for all of those reasons, this is a good conference for us to be at.
Nick Talamantes 20:26
Bob. I look forward to seeing what those seeds planted at our London meeting and this meeting will bloom into thank you so much for joining me. It's been a pleasure.
Bob Radie 20:33
Thank you so much.