NYSE: NSRX
Lily: Hello, and welcome to the Life Sciences Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small Cap Research, we are very pleased you have joined us. The next presentation is from Nasus Pharma. Their session will be moderated by John Vandermosten, Senior Equity Analyst with Zacks Small Cap Research. At this point, I am very pleased to welcome Dan Teleman, Chief Executive Officer, and Eyal Rubin, Senior Vice President and Chief Financial Officer of Nasus Pharma, which trades on the NYSE American under the symbol NSRX. Welcome back, Dan and Eyal.
Dan Teleman: Thank you, Lily.
John Vandermosten: Great. And Dan, Eyal, thank you for having me on here with you today and getting a chance to ask you some questions. As a brief introduction, Nasus Pharma is developing a powder formulation that converts active pharmaceutical ingredients into nasally administered products. With that very brief introduction, Dan, why don't you give us a summary of what your drug formulation technology is called and how it works?
DT: Thank you, John. First off, thanks for having us. Always a pleasure speaking with you and the audience. Looking forward to the opportunity to share the Nasus story. To your question, our technology is called Nasax. It's a very unique, it's a proprietary technology to Nasus, which is based essentially on particle engineering. And the technology has two key features. One is the ability of the technology to control the particle size. We create very tiny particles, 5 to 35 microns, and this is the optimal size range for intranasal absorption. The other key feature of this technology is the ability to create spherical particles. So this combination of the tiny particles and their spherical shape really creates a powder formulation that penetrates deeply into the nasal cavity, reaching the inner parts of the nasal passage, where there's a lot of vasculature, which enhances the absorption of the product.
JV: Dan, the company right now has a lead indication in anaphylaxis, which is an important area that patients with severe allergies can undergo. Give us some background on where you are right now in your development program for anaphylaxis and your candidate, NS-002.
DT: With pleasure. As you rightfully said, our lead product is in the anaphylaxis space. Anaphylaxis, for those in the audience who are not familiar, is a severe allergic reaction. They're very common. We're all familiar with or know someone who is allergic to nuts, peanuts, milk, poison, medicines, and so on and so forth. A very common disease. We are developing our proprietary powder intranasal epinephrine for the treatment of anaphylaxis. This product is heading into its pivotal study, its Phase III study, in Q4 of this year. We've already completed several clinical studies with the product, intranasal powder epinephrine. In all of them, we consistently demonstrated superior absorption of our product, having faster absorption and higher absorption compared to EpiPen, which is the current standard of care for anaphylaxis, EpiPen being the epinephrine autoinjector that I'm sure a lot of people are familiar with.
JV: And the next question people probably would have is: what is anaphylaxis? I think we all know a little bit about what it is, but there are also some mechanisms of action in the body that respond to allergens, which I thought you might give us a basic explanation of, so people can understand what the condition is.
DT: For sure. We'll try to do a very simple biology. Allergens trigger an immune response in our body, right? People who have allergies, that triggers an immune response. And that immune response, in return, triggers various systemic manifestations in different parts of the body. It could be in the skin. It could be the lungs. It could be the heart. It could be in the GI tract or a combination of all of those. For instance, if we look at the cardiovascular system at the heart, we see blood pressure drop, so what we call shock. You could have respiratory arrest. You could have skin manifestations like angioedema. This is that swelling of the mouth, of the lips. Patients could have diarrhea, could have vomiting, or could have nausea. A whole lot of symptoms could occur during an anaphylactic reaction. And the key to treating an anaphylactic reaction is really to administer epinephrine as quickly as possible. Epinephrine is the standard of care for treating anaphylaxis. It's been so for many years, probably 100 years at this point. And so giving epinephrine really then reverses all those effects of the anaphylactic reaction.
JV: You guys had a KOL event just a few days ago where you had some experts in the space talk about some of the key elements of treating anaphylaxis, and that, as you said, epinephrine is the standard of care for addressing that. But what is the most important factor in addressing anaphylactic shock? I mean, obviously you need to administer epinephrine, but how should it be administered?
DT: Correct. You're absolutely right. The most important thing in treating anaphylaxis is administering epinephrine. But the key is to administer epinephrine as quickly as possible. Data and studies have shown repeatedly that delayed administration of epinephrine leads to worse outcomes. It is key; it is paramount to administer epinephrine as quickly as possible. As we said a couple of times already, the standard of care today is EpiPen or epinephrine autoinjectors. There are several of them out there in the market, but they have some very significant limitations, primarily around compliance. EpiPen and the like are autoinjectors. That means that the patient needs to administer the product himself. They need to inject themselves with the autoinjector, or a family member needs to administer the patient with the autoinjector.
DT: And there are a lot of issues associated with that. There are a lot of compliance issues. Patients are hesitant to administer EpiPen or an epinephrine autoinjector many times. They do not carry the EpiPen with them at all times. They hesitate to use it even though they recognize the symptoms of an anaphylactic reaction. Despite the availability of an epinephrine autoinjector, the data shows that about half to 60% of the patients do not regularly carry EpiPen, do not use it properly, or do not use it at all, or delay the usage of EpiPen. And so this concept of needle-free epinephrine, which our product is, so it's a needle-free epinephrine product, is very enticing in this space because it really addresses all of the limitations of the epinephrine autoinjector.
DT: Being needle-free really reduces the hesitancy of many patients to administer. It is small, and it is very convenient to carry. Again, reduces the issue or the barrier of carrying the product. And specifically to our product, because we're using a dry powder, we have a very long shelf life compared to the autoinjectors, which have a limited shelf life because of the liquid nature of the epinephrine in those autoinjectors.
JV: In my mind, the most important factor in doing my background research is getting the epinephrine into the blood plasma so it can take effect. Allergic reactions can happen very quickly. And you showed how the NS-002 works compared to EpiPen in your Phase II study. Give us a summary of some of the key metrics that you generated in that study.
DT: For sure. Just before we touch on this, this is a great way to continue the discussion around the KOL event. …the KOLs, after discussing the issues around anaphylaxis, the usage of … epinephrine product for that matter, is really its onset of action. The faster the product, meaning the faster the epinephrine gets to the plasma and is effective, the better the product is, the better the outcome for the patient is. And the fact that onset of action is probably the most important parameter when physicians are choosing an epinephrine product. What we have demonstrated consistently, including in our most recent Phase II study, which we announced back in March, is that we have a very fast onset of action.
DT: And when we say onset of action, we really look at several parameters, again, all around pharmacokinetic properties and parameters. The first one is what we call Tmax. This is the time for epinephrine to reach the maximal concentration in the plasma. In that regard, we were shorter than EpiPen by about five minutes. And this is very, very important because, as you rightfully said, anaphylaxis is a very fast-progressing condition and could become fatal within a few minutes. About 30%, by the way, of patients in anaphylactic reaction had that reaction occur within about three to five minutes. Getting to a short Tmax is critical. The other important parameter that we demonstrated in our Phase II study is called T100. This is the time to reach a certain level of epinephrine in the blood, in this case, 100 picograms.
DT: This is considered by the literature to be the threshold for efficacy for epinephrine. Epinephrine needs to get to a level of at least 100 picograms in order for it to exert its hemodynamic effect, increasing blood pressure and heart rate. What we demonstrated in the Phase II study is that we have an onset of action or time to reach 100 picograms, which is twice as fast as EpiPen. And this was statistically significant in the Phase II. And if you think about it, twice as fast in reaching the therapeutic threshold could be the difference many times between life or death, or between the patient recovering or ending up in the ICU. The third, I think, very important parameter that we demonstrated in the clinical study was the proportion of patients who reached that threshold at different time points.
DT: Not just the median time to get to 100 picograms, but essentially how many patients reached that threshold at different time points, focusing on the early time points, knowing those are the most critical for patients. What we showed in our Phase II is that at two and a half minutes, we had almost three times more patients compared to EpiPen reaching the threshold. This was highly statistically significant. And at five minutes, we still had about 50% more patients reaching the threshold. On every parameter that you can assess the speed of onset, we were superior to EpiPen in our Phase II study. And again, have demonstrated that in prior studies as well.
JV: Great. And I'll mention to the viewers and investors that Nasus has some really great exhibits in their presentation that show the different arms of the study that could be helpful in showing the benefit there. All right. One of the other features of your Phase II was that you looked at patients under normal and nasally congested conditions. Why did you do that, and what differences did you find between those two groups?
DT: Yes, this is very critical because we know that in an anaphylactic reaction, congestion is something that often occurs in patients. And we wanted to demonstrate, and the FDA wants to see, that despite nasal congestion, there is still sufficient absorption of epinephrine through the nose. And so in our Phase II study, as you mentioned, John, we really tested the product both under normal conditions as well as under induced nasal congestion, severe nasal congestion. And what we demonstrated again was this consistent phenomenon of superior absorption during the first few minutes. And we demonstrated that despite nasal congestion, we can still generate a sufficient amount of epinephrine in the blood, certainly above the therapeutic threshold that I mentioned before.
JV: Okay. Your comparator in the Phase II was EpiPen, which is a competitor. And there are other injectable competitors out there, Adrenaclick, I think, and a few others besides that. And then you also have some other forms of administration, including a nasal liquid form, as you mentioned, and then I think there's also an under-the-tongue version. How does the competitive environment look with all those out there, and how can you differentiate yourself in that space?
DT: We need to remember that the anaphylaxis market is a very large market, and it's a growing market, and it's an expanding market. The reason for that, obviously, is that we're seeing a rising incidence of allergies. I think the incidence of allergy is growing in double digits annually. Currently, epinephrine is about a $2.5 billion market, covering, again, all forms of epinephrine, particularly the epinephrine autoinjectors. But we see, and we expect to see, a transition towards needle-free products. If we look at other therapeutic categories, other therapeutic areas, whenever an intranasal product was introduced, where that intranasal product made clinical sense, we ultimately saw almost a complete shift to the intranasal product in terms of market share.
DT: We expect the epinephrine market to grow and grow significantly, both because of the rising incidence of allergies, but also very much because of the introduction of the needle-free products that will entice more and more patients that are not currently carrying an EpiPen or an epinephrine autoinjector, do not get a prescription for an epinephrine autoinjector, do not refill the prescription regularly to ultimately select the needle-free product. We see the market shifting. We see the market growing. And because this is a very large market, we certainly think that it can accommodate several needle-free products. As you mentioned, the first needle-free product introduced or approved was about 15 months ago. It's a product called Neffy. It's a liquid intranasal formulation of epinephrine, and we are a powder formulation, as we talked earlier, and the advantages of powder formulations are very clear. Faster absorption, higher absorption because of the ability of the powder formulation to penetrate deeply into the nose and get into the vascular-rich areas.
DT: There's another formulation, a sublingual formulation, that is currently under development. But given the market being so large, we expect all the products to have a significant revenue. And we expect to differentiate, and our KOLs were very, very clear about this, given our potential to be superior to EpiPen in terms of the onset of action, which, as we discussed, is probably the most important parameter in choosing an epinephrine product. We think we're going to have a product that is differentiated not just against EpiPen, but also against some of the other needle-free products. And we think the superior clinical profile of the Nasus epinephrine is going to lead the way at the end of the day.
JV: Okay. Nasus is essentially Phase III ready, and you've planned a Phase III study. Can you walk us through how that will progress? And one of the points that I think is important is that this Phase III study is actually relatively short compared to other Phase III studies out there. Maybe you could talk about that too, Dan.
DT: Correct. And this goes back to our strategy as a company, and I'm hoping we're going to have some time to discuss this. Nasus, as I mentioned, is a platform technology. We are focusing on leveraging this powder technology across multiple therapeutic areas, particularly focusing on acute indications. The advantages of acute indications are that their pathway of development is relatively short and therefore more cost-effective. Without having to raise a significant amount of money, Nasus can really build a very broad pipeline or portfolio of intranasal products, all addressing acute indications in very large markets. We'll touch on this, I'm sure, later, but specifically to our Phase III with epinephrine, you're absolutely right. This is not a very large study. It's a very short study. We're following the patients or the subjects for only a few hours because this is the time that epinephrine stays in the plasma.
DT: The patient would come in, the subject would come in, and they would get either the Nasus intranasal product, EpiPen, or an injection of adrenaline, which is the intramuscular manual injection. And we're going to be looking at the levels of epinephrine in the plasma for four hours, and also going to be looking at the pharmacodynamic response. This is the effect on blood pressure and heart rate. This is what we need to do in the study from a regulatory perspective. We need to show that the product is comparable to EpiPen. We expect to be able to complete the study in about one quarter. Have the data already in Q1 of '27. A very fast timeline. And again, we plan to, or we are repeating the same concept with additional molecules, all in the acute space, all allowing us to move through development very quickly and very cost-effectively.
JV: Great. I think we have time now for some audience questions. And there's one here that kind of follows on where you left off with the Phase III milestones, and it asks about the key commercial catalysts over the next 12 to 18 months. What do you see as the key commercial catalysts after the Phase III is complete?
DT: We have several catalysts related to epinephrine, but also to our pipeline products. With epinephrine, once we complete the Phase III study, we will be getting ready to submit our New Drug Application to the FDA later in '27. There are some additional studies to be completed around the Phase III, but we expect to be submitting the NDA to the FDA in the second half of '27. In addition, because we're developing our portfolio of products over the next 6 to 12 months, we will have multiple additional products in clinical development. We indicated that in Q3 of this year, we will be initiating a clinical study with ondansetron. This is our second product, intranasal ondansetron, for chemotherapy and postoperative nausea and vomiting. A very significant market opportunity.
DT: Right now, there are about 12 million annual prescriptions for ondansetron, Zofran, for the treatment of nausea and vomiting. And we think that the transition to an intranasal product really addresses a significant unmet need in this space. We look forward to initiating the first-in-human study with ondansetron. In early '27, we plan to initiate another clinical study with a third product. We have not yet disclosed the molecule, but it's a molecule in the cardiovascular space targeting, again, a large set of indications in the cardiovascular space where the switch of this molecule to intranasal would really, again, reduce significantly the time to onset of action of the product.
DT: And in all those indications, whether this is chemotherapy-induced nausea and vomiting, whether this is the cardiovascular indications, onset of action is critical because it allows patients to administer the product themselves and have a very fast relief of symptoms, which could prevent them from going to the hospital. Nowadays, many times, if their symptoms are not alleviated, they end up in the ER, usually for IV administration, which then adds to the cost significantly. By switching ondansetron and the cardiovascular molecule to intranasal, we expect to increase adherence, reduce the time to onset, and therefore allow patients to manage themselves more effectively in the home environment.
JV: Okay. Very good. Eyal is there, and I thought I'd give him a chance to respond to something too. I had a question about finances, and there's also a viewer question about that as well, asking about how much runway that you have now following the $15 million private placement, and whether you have enough to execute on the NS-002 pivotal program and initiate the NS-003 work? Eyal, what do you say?
Eyal Rubin: Thank you, John. Thanks for the question. We have a runway, as we probably mentioned in the past, until mid-2027, let's put it this way. And definitely, we have the means and the funds to run the pivotal study of the NS-002. Obviously, initiate the NS-003, and also have top-line results for both, and also submit the NDA of NS-002, as Dan mentioned. We're fully funded until mid-year 2027 with sufficient funds. Obviously, the company, as any other company, and I saw another question about the strategic partnerships, and I'll defer it to Dan, obviously, on NS-002, but every such partnership obviously usually includes also a down payment, which is a non-dilutive funding that we might consider, not that we are in need for funds at present, but obviously that might be a very interesting way, a non-dilutive one. But Dan, why don't you take the strategic partnerships for NS-002?
DT: Again, I don't want to comment on things that have not been disclosed. Certainly, having a strategic collaboration partnership around the commercialization of NS-002 is a key objective for Nasus, and when we have something to announce in that regard, we will do so. But this is certainly a strategic objective for the company towards approval and commercialization.
JV: There's another investor question, which I think could be helpful to hear about. Roger Persall brings up that NS-002 has a higher therapeutic threshold within five minutes compared to EpiPen. And that's pretty impressive. Have you had a chance to talk with payers? You've had a chance to talk with KOLs. How are they responding to that benefit there?
DT: For sure. KOLs, including the KOLs that we had at our event a couple of weeks ago, but also many physicians that we speak with and during our market research, are extremely enthusiastic about this result. Again, they all emphasize how important the fast onset of epinephrine or an epinephrine product is. And when they see our data from the Phase II study, they're all extremely excited, realizing that this could be a significant game changer because it is so much faster than EpiPen. KOLs and physicians are very excited, very enthusiastic about this data. And many have indicated during our conversation, including at the KOL event, that once the product is approved, this could be for them the first-line therapy given the fast onset of action.
JV: Okay. I think we have time for one more.
DT: I see a question here about, again, what we're taking from the NS-002 development into NS-003 and some of our other products. This is a great question because it really leverages all that we do, all that we have done in the past, and all that we do right now into our future programs. It really focuses on the key strength of Nasus. And the key strength lies in a great technology, the ability to create very unique, differentiated formulations very quickly, given the know-how and experience of our formulation people, and be able to produce the product very quickly for initial clinical studies. Because we're dealing with acute indications, those initial clinical studies and the entire clinical development are very, very quick and cost-effective. And many of the elements that we have developed for NS-002 now and NS-001 before, things like human factors studies, reliability, and manufacturing, are all very similar and very comparable. And so with every product that we develop, we really have this institutional knowledge that allows us to do things faster, better, and cheaper because we're really following a very clear template in the acute space.
JV: Okay, great. Dan, Eyal, I think, perhaps we have time for just one other short question. I had something I wanted to ask you: when you look at a new indication, what features do you look for when seeking to apply the Nasax technology?
DT: This is a great question. This is something that we spend, obviously, a lot of time thinking about. And there are several factors or parameters that we assess. One is obviously a technical parameter, which is whether the molecule can work with the technology. The technology is actually very broadly applicable, going anywhere from small molecules to large peptides. We have to make sure that the molecule fits with the technology. But then, strategically, we want to make sure, and what we examine very closely is whether this switch, this transition to intranasal, really adds significant value. We know nowadays payers are not going to pay for convenience just because a drug can be administered intranasally. It has to prove, and it has to demonstrate that it has value.
DT: The value could be by enhanced clinical efficacy, such as onset of action, could be by having a better tolerability profile, or by increasing adherence of the patient. We want to make sure that we focus on at least one of those elements and see whether the transition to an intranasal can really affect one of those. Thirdly, as I repeatedly said, we focus on acute medical conditions where the intranasal administration could have a significant impact on the patient outcome. And fourth is the overall market opportunity. We focus on indications, on therapeutic areas where the commercial opportunity is significant. We're looking at markets that are... All of the markets we're looking at are above a billion dollars. Very significant market opportunities for the molecule.
JV: Great. Thank you, Dan. Thank you, Eyal. It was great to chat with you.
DT: Thank you, John, for having us. It was a great time speaking with you and having the conversation. Hopefully, we're able to convey the value in the Nasus story and the fact that we're a late-stage company getting ready for a pivotal study with epinephrine, having a very robust pipeline of significant opportunities, again, leveraging our nasal platform. And we think there's significant value to be created at Nasus, given the very significant milestones and catalysts coming up over the next six to 12 months.
JV: Excellent.
DT: Thank you, John.
ER: Thank you.
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