Markets and our co-host, Zacks Small Cap Research. We're very pleased you joined us. The next presentation is from Nasus Pharma. Please note you may submit questions for the presenters, and you can also view a company's availability for one-on-one meetings by clicking Book a Meeting. At this point, I'm very pleased to welcome Dan Teleman, the Chief Executive Officer, and Eyal Rubin. He's the Executive Vice President and Chief Financial Officer of Nasus Pharma, which trades on the New York Stock Exchange under the symbol NSRX. Welcome, Dan and Eyal. Thanks, John. Appreciate the invite, and good afternoon, everyone. Looking forward to sharing more information and news about Nasus with all of you. Nasus is a pharmaceutical company based on a proprietary powder technology that is designed to enhance the intranasal absorption of various molecules. We're applying this technology across different therapeutic areas, different molecules, but our key focus is on our epinephrine intranasal powder product that is being developed for anaphylaxis as an alternative to the EpiPen, where we demonstrated very significant performance advantages over the EpiPen. We have a strong financial position that allows us to move this program forward into NDA submission as well as moving other products in development. As you can see, we're applying our powder technology across different therapeutic areas. I mentioned epinephrine being our lead product. This product is moving into its pivotal study later this year. We're looking at additional molecules that we are developing. We've disclosed the first one. This is ondansetron. This is a product that is being used for chemotherapy-induced nausea and vomiting. We have two additional molecules that we have not yet disclosed, both targeting very large market opportunities, one in the metabolic space, the other one is in the cardiovascular space. All those molecules are moving into clinical development during 2026. I want to share a bit of information about what our technology is all about and what's the uniqueness of our powder technology. Our powder technology is able to produce drug particles that have a very small size distribution. As you can see in the picture, we create particles that are 5-35 microns, and this is the optimal size range for particles to be absorbed through the nasal cavity. The other key element to our technology is the ability to create spherical particles. Again, you can see those in the picture. The spherical particles also enhance the intranasal absorption. What we get by combining small particles with spherical particles is a powder formulation that penetrates deeply into the nose, reaches the inner parts of the nose, where there's a much larger surface area of absorption, more vascular beds, compared to the more traditional liquid intranasal formulation that, as you can see on the slide, are heavier. They tend to concentrate in the lower part of the nose, where there's a smaller surface area of absorption, leading to faster and higher absorption of the powder formulation that we are developing. I mentioned that our key focus is epinephrine in anaphylaxis. For those of you who are not familiar with anaphylaxis, those are severe allergic reactions. They could be fatal in about 1% of cases. The anaphylactic reaction progresses very, very quickly. Within 3-5 minutes, about 30% of anaphylactic reactions could lead to respiratory arrest or shock. The main treatment for anaphylaxis is epinephrine, given as an injection, an intramuscular injection. The key is to get epinephrine to a patient in an anaphylactic shock as quickly as possible. The standard of care is the EpiPen or the epinephrine intramuscular injection. I'm sure many of you have seen someone who carries an EpiPen, maybe has a family member that has an EpiPen with them. Despite EpiPen being the standard of care, despite every patient that is at risk of anaphylactic reaction having to carry an EpiPen with it, with them, the EpiPen still has some very significant limitations. The first one is the fact that it's needle-based. Many patients, many families, family members are needle-phobic, are afraid of needles, and they delay the administration of the epinephrine because of this needle phobia. The other limitation is the fact that the EpiPen is very large. It's very bulky. It's not easy to carry around, and a lot of patients, particularly teenager and kids, avoid carrying the EpiPen with them. Last but not least, EpiPen includes epinephrine in a liquid formulation, meaning it has a very limited shelf life. The EpiPen has to be replaced every 12 months or so. Here comes our product, our solution. We're developing obviously a needle-free product, as you can see. It's very small. It's very compact. It's very easy to carry around. Because we're using a powder, it has a very long shelf life, long-term stability that doesn't require us to replace the product every 12 months or so. Anaphylaxis unfortunately is a very large market opportunity about $2.5 billion annually right now, expected to grow to about $4-$5 billion over the next few years, primarily because of the rising incidence of allergies. In the U.S. specifically, there's about 20 million patients that are at risk for an anaphylactic reaction. Only about 7 million of them, so about a third, actually have a prescription for an epinephrine auto-injector. Leaving a significant room for growth for products that are needle-free that could address both patients that want to switch from an EpiPen or patients who have no product right now and would prefer to start with a product that is needle-free. With our product, NS002, we completed several clinical studies to date. We reported interim analysis from a very comprehensive study back in January, and we will be reporting the top-line data next week. With that study now completed, we are paving the way to our pivotal study that will start in Q4 of this year. We'll read out in Q1 of 2027, enabling us to potentially file our NDA by mid 2027. You can see that we have some very significant milestones coming up ahead of us, some very significant data readouts over the next 12 months. In the anaphylaxis space, as I mentioned earlier, it's a very large market. It's a growing market, it's an expanding market, and with the introduction of needle-free epinephrine options, we expect this market to expand even more so and transition over time primarily to needle-free. The first needle-free product was approved about a year ago. It's a liquid intranasal formulation of epinephrine, a product called Neffy. There is a sublingual formulation in development. This is from a company called Aquestive. You have Nasus with its powder intranasal epinephrine. You can see the market capitalization of our well, of our peers, over $1 billion for ARS Pharmaceuticals, over $400 million for Aquestive, and then Nasus with about a $60 million market cap. With a product that we consider having the potential to be the best in class. If you look across the pharmacokinetic properties of the different products, you can easily see that our product is superior to all the other products either in development or on the market. This, and the importance of those pharmacokinetic properties has actually been recently validated in our market research. We conducted market research with allergists, and overwhelmingly, they all acknowledge that the speed of onset is the most important parameter, when selecting a new epinephrine program or product, coupled with the time to reach the maximal concentration and time to reach the critical threshold. Allergists really look at the speed of onset and the performance of the product as the most important attribute, and I think this is where our product and the advantages of our pharmacokinetic properties come into play. I mentioned the very comprehensive clinical study that we just completed. We announced interim results from that study back in January. This was a 50-subject study. All patients or subjects had allergic rhinitis, essentially meaning they had seasonal allergy. Subjects received either a single dose or a repeat dose of our nasal powder either under normal conditions or under nasal allergen challenge, which creates significant nasal congestion mimicking the early steps or stages of an anaphylactic reaction. Obviously, we compare that to either a single dose or a repeat dose of EpiPen, the standard of care for anaphylaxis. If I summarize the results of this study really quickly, this phase study demonstrated yet again and validated findings from our previous studies about the advantages of the powder technology, the superiority of the powder technology to have a more faster and higher absorption of epinephrine. Specifically, we demonstrated a shorter Tmax, so this is the time to reach the maximal concentration, and T100, which is the time to reach 100 picogram, the minimal threshold of epinephrine. Very importantly, we demonstrated that 91% of the subjects in the study already achieved the therapeutic threshold after 5 minutes, and close to 100% of subjects achieved that therapeutic threshold at around 10 minutes. Our Cmax, so this is the maximum concentration, was very comparable to EpiPen in the study. The pharmacodynamics, so this is the effect of the product on blood pressure and heart rate, tracked really well with that of EpiPen and always within normal physiological limits. Very importantly, the product was well-tolerated, no serious adverse events reported, no cardiovascular events, and most adverse events were local in nature, self-resolving, and mild. If we look at the pharmacokinetic properties and parameters, you see here the single dose, either under normal conditions or nasal challenge. You can see in both cases that we have faster, higher, and sustained absorption of epinephrine in the critical therapeutic time window, even under nasal allergic challenge. Even under a nasal congestion, you can see that we create sufficient amounts of epinephrine always above the therapeutic threshold of epinephrine for its efficacy. Very favorable PK profile compared to EpiPen. If we look at the actual pharmacokinetic properties, the Cmax, this is the maximum concentration. You can see it's very comparable to EpiPen. Where our biggest advantage is really in the speed of onset, as I mentioned earlier. We have a much shorter Tmax compared to EpiPen, and Tmax being the time to maximal concentration, and T100 time to reach the 100 picogram minimal threshold of epinephrine. You can see the very significant difference between EpiPen and our product. As we said earlier, I'll repeat that again, onset of action is the most important attribute of any epinephrine product because every minute counts when we deal with a life and death situation, particularly remembering that about a third of cases, a third of anaphylactic cases progress within 3 or 5 minutes. Excuse me. You can see here what I mentioned earlier. This is the proportion of subjects who reached the therapeutic threshold at different time points. You can see that after 5 minutes, already over 90% of subject already reached that therapeutic threshold, and getting close to 100% after 7.5 minutes. Getting the most amount of patients or subjects to the critical threshold at very, very early time points. Looking at the pharmacodynamic response. Epinephrine as a molecule is responsible for increasing heart rate and blood pressure, and this is what we're seeing here in the effect on the systolic blood pressure. We see a transient increase in the blood pressure, which resolves over time, very similar to EpiPen, and always within the normal range for systolic blood pressure and diastolic blood pressure. Same goes with the heart rate, a transient increase in heart rate that resolves over time and always within the normal range. Turning to the repeat dose portion of the study right now, you can see here again that our product demonstrated faster absorption, higher absorption, and sustained absorption, whether under normal conditions or nasal allergen challenge. In all cases, we are superior to EpiPen. The need for a second dose is coming from the fact that sometimes with EpiPen, patients do require a second dose. We needed to test the effect of a second dose. Like before, look at showing the pharmacokinetic response. You can see that we have a comparable Cmax, a comparable Tmax, and yet we continue to demonstrate at a very short T100, much shorter compared to EpiPen. Like before, looking at the pharmacodynamic response of a repeat dose, we see a transient increase always within the normal range, both under normal conditions and nasal allergen challenge. No effect on diastolic blood pressure as we expect. Again, a mild transient increase in the heart rate that resolves over time. In terms of safety, as I mentioned earlier, no severe adverse events reported, no cardiovascular adverse events, which is important. Most adverse events were local in nature, self-resolving, and mild. In terms of local side effects, we saw some runny nose, some administration site discomfort, and some nasal itching. Runny nose is very common in subjects with allergic rhinitis. In terms of the systemic side effects, very typical to epinephrine, so headache, nausea, some shakiness. We had no vomiting with a single dose and only a single vomiting after a repeat dose with the nasal allergen challenge. We have a very broad IP protection that covers both the basic technology, so the powder technology, as well as composition of matter that covers the different products, including the epinephrine product. Just as a quick summary before we move on to Q&A, Nasus has a proprietary powder technology that is designed to enhance the intranasal absorption of various molecules. Our lead product is designed as a needle-free, convenient, easily administered epinephrine for anaphylaxis, is a better alternative to the epinephrine autoinjector. Multiple phase 2 studies consistently demonstrated the superiority of our product compared to EpiPen, achieving faster absorption, higher absorption, consistent absorption. We think that the needle-free epinephrine market is a great market opportunity. It is large, it's growing, and it's shifting over the next few years to needle-free. We have the potential for a much longer shelf life for our product, given the dry powder. Very importantly, we are leveraging our powder technology to create a very robust pipeline that includes other molecules all representing significant market opportunities. With that, I'm gonna turn it over to questions. Happy to go over them. The first question is, how does your solution work during anaphylaxis, and why fast absorption in the first 5-10 minutes matters for patients? Yes. Thank you for the question. It's a very important. As I mentioned earlier, anaphylaxis is a very rapidly progressing condition. About 15 minutes, patients could be in respiratory arrest or shock and even death. Every minute counts when dealing with anaphylaxis because epinephrine is the only treatment for anaphylaxis. Getting epinephrine to patients quickly, but more importantly, generating sufficient amount of epinephrine in the plasma is critical. This is why a product like ours that has the fastest onset of action compared to all other products, either on the market or in development, is such a differentiating factor and because about 30% of the cases of anaphylaxis progress within 3 or 5 minutes. It's a very rapidly progressing disease. Getting epinephrine to patients quickly is critical, and generating the levels of epinephrine in the blood as quickly as possible is key. Thank you, Dan. How does NS002 differ from Orexo's OX640? A very good question. Thank you. Our powder technology has priority date in terms of its IP over all other powder technologies. Because of that, and again, it's important to know that our powder technology is really pure API particles. Majority of the formulation is pure API particles, and we use a small amount of lactose, it's an inert carrier, to help with the dispersion of the powder in the nasal cavity. Because of the priority of our IP, other companies that may want to develop powder formulations need to find workarounds. What Orexo did is, they essentially needed to take the epinephrine particles and coat them with sugars and other additives in order to be able to work around our IP. What that essentially creates is a formulation that by weight has a smaller amount of epinephrine compared to ours. Per milligram or per any quantity, because of the need to coat the epinephrine particles with the Orexo product, they deliver less epinephrine. Delivering less epinephrine clearly correlates with less pharmacokinetic advantages. You can look at the data. Orexo has a longer Tmax compared to our product, has a longer T100, creates a smaller Cmax. Our pharmacokinetic properties are superior to those of Orexo, meaning our product is expected to perform better, have a faster onset of action because of the uniqueness of our powder technology and the less amount of epinephrine that Orexo is able to deliver. Thank you, Dan. I'm gonna take the next one. Does the top-line data being released Monday reflect the same results as previous studies for NS002? Obviously, as a publicly traded company, we cannot relate to data or news that were not released yet. Nevertheless, I welcome and invite the investor to participate in the call that we have announced a couple of days ago. Next question is, are there any updates to the partnership deals with NS001? Again, if there will be a partnership for NS001, we will update accordingly. Thank you. What is the TAM for needle-free epinephrine powder? Sorry, TAM stands for? Total addressable market, I guess. Okay. Our powder technology has priority date in terms of its IP over all other powder technologies. Because of that, and again, it's important to know that our powder technology is really pure API particles. Majority of the formulation is pure API particles, and we use a small amount of lactose, it's an inert carrier, to help with the dispersion of the powder in the nasal cavity. technologies. Because of that, and again, it's important to know that our powder technology is really pure API particles. Majority of the formulation is pure API particles, and we use a small amount of lactose, it's an inert carrier, to help with the dispersion of the powder in the nasal cavity. technologies. Because of that, and again, it's important to know that our powder technology is really pure API particles. Majority of the formulation is pure API particles, and we use a small amount of lactose, it's an inert carrier, to help with the dispersion of the powder in the nasal cavity. Because of the priority of our IP, other companies that may want to develop powder formulations need to find workarounds. What Orexo did is they essentially needed to take the epinephrine particles and coat them with sugars and other additives in order to be able to work around our IP. What that essentially Because of the priority of our IP, other companies that may want to develop powder formulations need to find workarounds. What Orexo did is they essentially needed to take the epinephrine particles and coat them with sugars and other additives in order to be able to work around our IP. What that essentially Because of the priority of our IP, other companies that may want to develop powder formulations need to find workarounds. What Orexo did is they essentially needed to take the epinephrine particles and coat them with sugars and other additives in order to be able to work around our IP. What that essentially creates is a formulation that by weight has a smaller amount of epinephrine compared to ours. Per milligram or per any quantity, because of the need to coat the epinephrine particles with the Orexo product, they deliver less epinephrine. Delivering less epinephrine clearly correlates with less pharmacokinetic advantages. You can look at the data. creates is a formulation that by weight has a smaller amount of epinephrine compared to ours. Per milligram or per any quantity, because of the need to coat the epinephrine particles with the Orexo product, they deliver less epinephrine. Delivering less epinephrine clearly correlates with less pharmacokinetic advantages. You can look at the data. creates is a formulation that by weight has a smaller amount of epinephrine compared to ours. Per milligram or per any quantity, because of the need to coat the epinephrine particles with the Orexo product, they deliver less epinephrine. Delivering less epinephrine clearly correlates with less pharmacokinetic advantages. You can look at the data. creates is a formulation that by weight has a smaller amount of epinephrine compared to ours. Per milligram or per any quantity, because of the need to coat the epinephrine particles with the Orexo product, they deliver less epinephrine. Delivering less epinephrine clearly correlates with less pharmacokinetic advantages. You can look at the data. Orexo has a longer Tmax compared to our product, has a longer T100, creates a smaller Cmax. Our pharmacokinetic properties are superior to those of Orexo, meaning our product is expected to perform better, have a faster onset of action because of the uniqueness of our powder technology and the less amount of epinephrine that Orexo is Orexo has a longer Tmax compared to our product, has a longer T100, creates a smaller Cmax. Our pharmacokinetic properties are superior to those of Orexo, meaning our product is expected to perform better, have a faster onset of action because of the uniqueness of our powder technology and the less amount of epinephrine that Orexo is able to deliver. to deliver. We said that, if we look globally, the current market for epinephrine is about $2.5 billion, and it's growing double digits annually because of the rising incidence of allergies. Reports indicate it could be a $4-$5 billion in the next few years. This doesn't even take into account the introduction of needle-free epinephrine products that are expected to expand the market even further. If we look specifically in the U.S., as I think I mentioned earlier, about 20 million patients are at risk of anaphylaxis. Only about a third of them actually have a prescription right now for EpiPen. Those obviously are the first candidates, but that leaves about 13-14 million patients annually in the U.S. that do not have a prescription for EpiPen because of various reasons. Again, the need, the needle phobia and other issues and those would be great candidates for a needle-free epinephrine product. We see tremendous opportunity in this market, very large market, expanding market, growing market. Thank you, Dan. Yeah, I'll take the next one. Do you have any strategic partnerships for research and commercialization? As Dan mentioned, and I also, as a publicly traded company, once we have something to announce, obviously, we release it, and it's gonna be part of our official filings. I welcome the investor obviously to subscribe to our mailing list, and he's gonna be up to speed whenever we have something to announce. The next question, can you provide any color around the other pipeline opportunities in your IP portfolio? Happy to. As I said, in my presentation, one of the things that make Nasus unique is really the fact that we leverage this proprietary powder technology to develop a very robust pipeline of products. While I focused in my presentation primarily on epinephrine, our most advanced product, we are developing a revised pipeline. The next product that is expected to go into clinical development is ondansetron. The brand name for this product is Zofran. It's the most commonly used product for chemotherapy-induced nausea and vomiting. It comes in an oral tablet, and as you can imagine, patients that are nauseous, that are vomiting from their chemotherapy have a hard time taking oral medication. Switching the oral ondansetron to an intranasal product, we expect would enable patients to be able to tolerate the product better, take it more easier and also because of the faster absorption of powder, we expect the product to work faster than the oral tablet. Significant advantages to cancer patients by developing ondansetron as intranasal. In addition, there are two other molecules that we have not publicly disclosed yet. Both of them are targeting very, very large market opportunities. One is in the metabolic space. Again, we're looking to switch a product that is currently administered as an injectable to an intranasal, and in the cardiovascular space, again, take a product that's given orally and switch it into intranasal. We expect all those programs to be in the clinic or in clinical studies in the second half of 2026. Thank you, Dan, and we'll address the next question. What are your milestones for 2026, and are these initiatives fully funded? Yeah. Great question. Actually, I'm actually gonna go back to that slide 'cause it's important slide, and I want everyone to take away from this presentation is what is on that slide. If you bear with me for a second, I'm actually gonna get there. It's this one. For 2026, we actually have some very important and significant milestones ahead of us. Our IND is gonna be submitted in Q3. We will initiate our pivotal phase 3 study in Q4 of this year. This is a very quick, cost-effective study, and we expect to report the top-line data from the pivotal study by Q1 and then submit our NDA by mid-2027. As you can see, some very significant near-term milestones for our epinephrine program. As I mentioned earlier, we have three additional products that are moving into the clinical development, and all of those would occur in 2026 as well. Yeah, that was the last question. I guess back to our operator.