Brad Sorensen: Hello everyone, I’m Brad Sorensen. I’m a senior analyst with Zacks Small Cap Research, and I am thrilled to be joined by the CEO of NurExone, a very exciting company that I cover. And I’m going to introduce you to Dr. Lior, as I like to call him. And there’s been some really exciting announcements about the products and the development there. So, Lior, please take it away and just tell us a little bit about NurExone.
Dr. Lior Shaltiel: Sure. So NurExone is a company, a startup from Israel, that made it all the way to Canada in 2022. The technology came from two elite universities in Israel, the University of Tel Aviv and the Technion, which is the MIT of Israel. A lot of people know about it. It’s mainly in engineering. It’s a combination of two professors who want to find a solution for the regeneration of neurons after spinal cord injury.
So, think about it. We came from one indication, one product. And now, with the perspective of time, we have several products in our portfolio. We have a very strong platform technology. We have a product with several indications. The major one, which is called ExoPTEN. The major one is still, of course, acute spinal cord injury, but we found out that it’s also relevant for optic nerve damage, facial nerve, and you know, we can go further on and on. And, but my board always says, please stay focused. And this is what we do. We stay focused on these, those very, very interesting indications. With the spinal cord injury, we have also orphan drug designation in Europe and the United States. And we will get into the technology, why we are so unique in the exosome field.
And this week, I will keep it for your question later, but I think we’re celebrating now three and a half years of being a publicly traded company. We are working to the highest standards, regulatory-wise and also financially. And we are getting into the next step soon, too, getting out of Canada, or getting the company uplisted into the US, getting into the larger market. I think this is also a very interesting point to discuss today.
Brad Sorensen: Yeah, no, definitely. And you led me right where I wanted to go because you have all these indications, and you, I know, because I cover you, keep getting more and more, and you have to stay focused. But why is that? What’s the science behind exosomes and your process, and why it has the potential it looks like to be an almost miracle breakthrough to treat all of these conditions?
Dr. Lior Shaltiel: So, let’s start with exosomes. Exosomes are tiny vesicles that cells, mainly stem cells, secrete during a very routine physiological process. This is like a tiny envelope, a letter, a package from Amazon, I always like to call it. They’re sending, the cell is sending it from a good and healthy tissue to a damaged tissue. So those exosomes are, I would say, a very guided or clear package with the right address, and they’re going to inflammation. They’re going to damaged tissue. Okay. And when we have that, and we mix it with the knowledge that in acute traumatic injury of the spinal cord or CNS, for the central nervous system in general, you have the first step of inflammation. And the second step that you want to deal with is to promote regeneration. So this drug delivery system, I think it’s the ultimate drug delivery system, is first of all, reducing inflammation, because this is part of nature, this is natural beauty of the exosomes, to reduce the inflammation by the fact that they conjugate, they are inside this inflammation and promote, in the second step, the regeneration. So, using that, the exosomes with the siRNA, this is exactly the synergistic effect that you wanted to see.
We want to promote even more the regenerative activity of the exosomes. When we combine the exosomes and the siRNA that we load inside, we can see a synergistic effect. And this synergistic effect, this is the way you cross the threshold. If you cross the threshold, you start to see functional recovery because it doesn’t matter if you regenerate the neurons if you don’t see a function. And we see regeneration of neurons and also gain of function. Let’s say motoric way and also sensoric urine bladder activity. And we did it in even two different models, a full twin section of the spinal cord. Let’s ask the question: if we cut the spinal cord, can we reconnect the nerves? We could achieve it. And then, if going into the physiological model, the effect was even larger, 100% of the rats showed improvement of motor function.
Brad Sorensen: Yeah, I’ve seen those studies, and it’s pretty amazing, actually, what has been done. So, you have the exosomes, and you’ve explained that let’s get into specific NurExone, and you’ve developed that ExoPTEN product. Explain that, and what the process is, and how that affects potential patients.
Dr. Lior Shaltiel: So, the product is the combination between the exosomes as a drug delivery system and the siRNA. And then, to get it as you said, the product, we had to go into a tech transfer. We had to go from the university out to the industry and ask we make this product that we take as a license from the Technion and Tel Aviv, a product with the freedom to operate.
So, we ask ourselves, what is the source of the cells? Tick, we have a master cell bank, our property that we can produce tomorrow in a GMP facility with one of the best potent, raw materials, our cell source. And then we ask ourselves, the administration route. Intrathecal, intranasal, is it covered? Yes, we have a patent. This patent is granted in the US, and we have other territories, Russia, Japan, and Israel. And we’re writing for other territories. And then we ask ourselves, how do we load those exosomes with siRNA? We have our IP on that. And this is a general IP, not necessarily to ExoPTEN, it’s relevant for other siRNA, even small molecules that can be loaded into the exosomes. And then the third one, the other two patterns, what we load inside. Also, the sequence of the siRNA that we use, and the chemical modification, are in a PCT late-stage.
This makes NurExone not a product; we are using ExoPTEN as a product, a lead product to go into the clinical phase as a pharmaceutical company, but we have a platform because what is unique about NurExone is that we have not modified our cell source, and we produce, as a first step, the exosomes in the naive form. We don’t manipulate them. The manipulation of the exosomes is achieved by mixing with the siRNA. And this is the huge advantage compared to Codiak, which failed, that genetically modified the cell source. We are not touching what is good in nature; we try to improve it.
Brad Sorensen: You’re enhancing it instead of modifying it.
Dr. Lior Shaltiel: Enhancing it, exactly. Exactly.
Brad Sorensen: And I think that is the key here. I want people to pay attention, you said you severed a spinal cord in rats and then regenerated it. That’s pretty exciting. But also, just recently, you mentioned the other conditions. You released some good test results, really exciting, actually, regarding glaucoma. How does it affect glaucoma? What are the results you’ve seen in the initial testing you’ve done on that?
Dr. Lior Shaltiel: Sure. So, it’s actually another test that we have done. We have the first step saying one dose, and now we show a dose-dependent activity of ExoPTEN in optic nerve damage. And I want to just make it clearer. Glaucoma is one indication that can be relevant here. Okay. But we have other indications that affect the optic nerve and damage it, like NAION or ION, or other indications that actually can irreversibly damage the optic nerve. And what we wanted to show, this model is for glaucoma or similar to the glaucoma by compressing the optic here, if we have good results, as we see, we translated furthermore into a talk study, et cetera, we can have one product for several indications. We actually need to choose the best one to get it through the FDA regarding the ophthalmology approach.
Brad Sorensen: Right, and that’s a great point, and I hope investors understand how unique this is and the opportunity. So, what everybody’s going to be asking is, what are the next steps? When are human tests going to start on this? The end goal is getting it to patients, for their benefit mainly, but also for investors to see the payoff.
Dr. Lior Shaltiel: Sure. So even before getting to a full clinical study, which we intend to get in by the end of 2026, submitting the IND, plus or minus, I would say, I think we will be in a position to use it even before. And that will support the IND submission. With our evaluation, we will be able to do it even in the middle of 2026, maybe the beginning of the second half. And this is our goal now, to have human data even before the full IND submission. It actually will help us to submit the IND and then, you know, we will be able to run the official phase 1/2a in clinical trials.
Brad Sorensen: Additionally, you mentioned it briefly, if you want to expand on this, that’s great, but that you’ve been granted the orphan drug designation, and that’s a pretty big deal with the FDA.
Dr. Lior Shaltiel: It is, and it’s even a big deal in Europe, and we have it in Europe, not like in the US, you actually can get financial support in the late stage in order to bring it to the market. It’s huge also to get in the US, don’t misunderstand me wrong, because you actually have some kind of market exclusivity by protecting your patent regardless of others. And second, can go, you can get advice or get benefits from the FDA and support in order to get it through the regulatory pathway. We have good communication with the FDA. I believe that we will be in a position at the beginning of 2026 to also have a type C meeting to update the FDA on our process. We are quite advanced with the CMC and the analytical methods in order to supply the spec of our product. The manufacturing looks good.
We didn’t touch it so far in the interview, but we are going to produce the naive exosomes first. Okay. This is our drug substance. And this is the market by itself. I mean, I want to be a pharmaceutical company, but my value proposition here is that I can create a stream of revenue by producing those exosomes for myself. And after that, the extra will go as a B2B business to cosmetics or aesthetics, where I’m just a supplier for those exosomes because it’s not manipulated.
It’s a huge demand and also a huge change in the US regulatory-wise, in Florida, Utah, and other states that we say, okay, we’re allowed to use cell therapy, and its derivatives rives if it’s not modified and if it’s produced in a good manufacturing or a good, good manufacturing practice for treating patients in pain, dermatology, and orthopedics. And this is a huge market. If we thought that our market for the naive exosomes is the Far East or less advanced countries, now you can get it legally in the US.
Brad Sorensen: Right, yeah. That was actually a great lead into my next question, because that’s a potential revenue source. And that’s what the other question that people are going to have is: what’s the financial position? How is your capital position for the testing to come? And you mentioned you have potential for revenue from a couple of different sources, and that will certainly help out, because we’re at an inflection point, as you mentioned, that beginning of ’26 is going to be a big point. So how are you guys standing? How much more money do you think you have to raise? How much revenue do you think you might get in the near future? Those kinds of things.
Dr. Lior Shaltiel: We are part of an uplisting into the US market. It will be in the next four to six months, I believe, already in Q1, 2026. By then, money will be injected into the company. And even before, the market, everybody can see the market. We went up even more than 1.1 because of the pattern in the US. But good for us, it’s actually triggered acceleration of warrants, so people are liquidating their money, which is fine. I think it’s temporary. I don’t want to speak too much about the market itself, but here we are talking about a relatively large acceleration of warrants, and this will inject more funds into the company. We already have investors that accelerate, and we are still waiting for the deadline here. After sharing with the other investors how much money we could inject into the company, I think you will be able to see that we are in a good position.
Brad Sorensen: Yeah, I agree. I have looked at it, and I do want to mention that I commend Dr. Lior on the expense control. They run a pretty tight ship over there. That’s where you can kind of see some of these operations getting kind of loose with the money. That certainly isn’t the case.
Dr. Lior Shaltiel: We are very cautious about the situation. It’s not easy. The micro environment is tough. But we know how to execute so far, and we’re getting more and more attention. I just came in September from an on-site event at the Healthtech Hub, part of ARMI, the American Regenerative Manufacturing Institute. We were part of cohort eight there, and we have started to establish more and more contact in the US, and I think some of that will also bring a potential partnership.
Brad Sorensen: Yeah, that’s another potential as well. So, there’s a lot of potential there, and the company’s in good financial shape.
Dr. Lior Shaltiel: Very important to say that potential is good, but through the course of the three and a half years as a public and even before, you can say that we could execute and we will continue to do so.
Brad Sorensen: Yeah, that’s what I was going to say, that this isn’t a fly-by-night, just come-lately company. This is one that has history, and you can go back and look at it. And of course, I have, they have shown that they can operate and execute very well and have a good plan in place, which is not always the case.
Dr. Lior Shaltiel: I’ll give you an example. We talked about the acceleration of warrants exercised. We had two events before, and our history shows that the first one was 85% exercised, and the second one 100%. So, I don’t think that this statistic will be different here.
Brad Sorensen: I agree with you. I think we’re at an inflection point. That’s why I wanted to have you on because I wanted investors to really get a good look at what your company is doing and have the opportunity to get in kind of before the ramp up because we’re right at that point. And it’s a very good story. So, I encourage you if you’re listening to this. And you have questions, contact me, contact NurExone, and we can give you some more details. Read my research out there. You’ll find it pretty informative and very positive because I’m very positive about this company. Are there any last comments you want to make, Lior?
Dr. Lior Shaltiel: Thank you. I would say really stay tuned, read Zacks reports. I think they are very detailed. I think we’re giving you a lot of work because we are publishing, I would say, every two weeks, something. It’s our ability to produce first results and also impact. I mean, yesterday we published regarding the impact. Dr. Ina Sarel, our CMC quality and regulation head, has been invited to give a speech, invited. It’s nothing paid. It’s actually the opposite. We’re invited to give a speech in Cambridge the UK, on precision medicine, specialized in exosomes.
When I’m going to conferences, we are considered to be the pioneers in the fields, or the success, good case study, how to do it right, even if we are just in the preclinical stage, because we have a lot of know-how. We can produce a lot of know-how patterns, and we think out of the box. Taking a private company that’s just part of the tech transfer activity from what universities are doing to a publicly traded company in Canada. Only that raises a lot of questions. But if you ask me the opposite, with the last three years of the market, whether I will be a private company, I’m not sure that I will be able to raise more than $18 million. And this is the track record that we provide. The company till now could raise $18 million and I think that with the acceleration of warrants, we will even cross the 20.
Brad Sorensen: Yeah, that’s a great point. And yeah, I would like to say find out who’s contacting them, who’s asking for their expertise. And the FDA has seen this as a worthy enterprise to kind of be invested in as well. The authorities in Europe have as well. So, I encourage you, like Lior said, thank you for tossing some business my way. Read our research, read my research. I cover them very extensively, and I’m unbiased. Obviously, would like them to do well, but I tell you what they’re doing, and thankfully, they provide me a lot of good news to get out there. So, thank you very much for joining us. And like I said, if you have any questions, contact me. My information is always on my reports, and I can get in contact with Lior. He’s very accessible. So, thank you and have a good day.
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