Take care. Next up in today's Biotech Resurgence: Platforms and Pipelines of Today's Innovators is Nasus Pharma, ticker NSRX on the New York Stock Exchange American. Presenting today will be Dan Teleman, the CEO and a board member, and Eyal Rubin, who is the CFO. Gentlemen, are you there? Yes, we are. Good afternoon everyone. Good afternoon to you too. I see you've already got your presentation up. That is perfect. Let me get the formalities out of the way and then you can launch. As is always the case, viewers, you can ask a question of the CEO and CFO here by clicking the Q&A button at the bottom of your Zoom window and typing your question into the text box. You can then submit it from there. Let me read the safe harbor statement. This segment may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements. Any statements that are not historical fact should also be considered forward-looking statements. Of course, forward-looking statements involve risks and uncertainties. Dan and Eyal, please go right ahead. Thanks again for having us, and we look forward to sharing the Nasus story with everyone. Who we are and what we do. Nasus has a proprietary and very unique delivery technology based on a powder that we have developed. We're leveraging this powder technology to develop multiple intranasally administered products that we think have significant clinical value. Our lead product is our powder intranasal epinephrine for the treatment of anaphylaxis, where we most recently announced data from our phase II study. The phase II study was extremely successful and demonstrated that we have superior absorption properties compared to EpiPen, which is the standard of care right now for anaphylaxis. We are well-funded through multiple significant milestones, as we'll talk through the presentation. You see here our pipeline. As I mentioned, we're leveraging this very unique powder technology to develop multiple clinically differentiated therapies. Epinephrine is our lead product. This is going into phase III very soon. We plan to initiate the pivotal phase III study in Q4 of this year with readout of the phase III already happening in Q1 of 2027, followed by a potential NDA submission by mid 2027. We are also developing other differentiated products using the same powder technology. The next product that is moving into the clinic is our intranasal powder formulation of ondansetron. This is the most commonly prescribed medication for chemotherapy-induced nausea and vomiting, where the current standard of care is oral tablets. As you can see, that program is also moving into the clinic this year. We have some additional programs that are also moving into the clinic this year where we have not yet disclosed the molecule. If you look at Nasus from a value perspective, we have multiple products. All of them are moving in clinical development, and we expect some very significant milestones over the next 6-12 months for all those programs. What makes our platform or technology unique? We are able to control the particle size of this powder, as well as the shape of the particles. We create very small particles. They're 5-35 microns, and they are spherical in nature, as you can see in the picture. This combination of both small-sized particles and spherical particles creates a powder formulation that penetrates deeply into the nose, getting into the parts of the nose, the inner parts of the nose, where there is a large surface area of absorption, significant vascular beds, which enhance the absorption. When you compare that to what we all know, the traditional liquid intranasal formulations, those are heavy, the particles are heavier, and therefore the liquid intranasal formulations concentrate in the lower part of the nose where there's less area of absorption, and therefore lower absorption compared to our powder formulation. This unique and very important difference between our powder formulation and the traditional liquid formulation really then drives the clinical performance of all the products that we develop. Our lead product, as I mentioned, is in anaphylaxis. Anaphylaxis are severe allergic reactions. They could be fatal in about 1% of cases. The most important thing to realize and recognize about anaphylaxis or severe allergic reactions is they progress very quickly. Patients can get into respiratory arrest or shock within 15 minutes, and about 30% or a third of the patients can actually have a severe anaphylactic reaction within five minutes. Speed of treatment, getting epinephrine to patients as quickly as possible is paramount, and this is the most important factor in treating an anaphylactic reaction. Getting epinephrine to patients as quickly as possible and building epinephrine levels in the blood as quickly as possible. The standard of care right now, as I mentioned, is EpiPen. EpiPen, as you can see here, is a fairly large, bulky device. It's not very easy to use. It's certainly not very easy to carry around, given its size. Probably the biggest limitation with EpiPen is that it's a needle-based product, so patients or caregivers or families need to inject the EpiPen, the epinephrine, in the muscle, and many patients are really scared about needles. This concept of needle phobia is very present, is very pronounced, is very well documented. Many patients, because of this needle phobia, this fear of needles, are delaying the administration of epinephrine, and that really could lead to worse outcomes. Last but not least, the EpiPen contains epinephrine, the active molecule, in a liquid solution. Therefore, it has a very limited shelf life. This product needs to be replaced every 12 months or so. Here comes our solution, our product called NS-002. Obviously, it's a needle-free product, so we already avoid the biggest limitation, which is the needle-free. As you can see, it's also very small, it's very compact, very easy to use, and very convenient to carry, so making it easier for many patients to keep that with them at all times. Very importantly, because we're using a powder formulation, which is very stable, it has no contact with moisture, it has a very long shelf life and a very long stability profile. We are really making the product much more comfortable and usable for patients. Anaphylaxis is a very large market opportunity, right now estimated at about $2.5 billion, growing at double digits because of the rising incidence of allergies. As we know, more people are allergic to a lot of things, and we can see that in the growth rate. If we look at the U.S. specifically, about 20 million patients annually are at risk of anaphylactic reaction. Yet surprisingly, only 7 million of them actually have a prescription for EpiPen, this life-saving product. The other two-thirds, the other 13-14 million patients, do not even carry or have a prescription for EpiPen, which could be life-saving. Out of the 7 million that have a prescription for EpiPen, many of them do not carry the EpiPen with them at all times, as we talked, or do not refill the product on a regular basis. Really creating a significant opportunity for what we call needle-free epinephrine products. If we look at our product and where we are right now and where we're going with this, we completed several clinical studies. As I mentioned, the most recent clinical study, we announced data several weeks ago, very strong, very compelling data, which I will share with everyone momentarily. This really paves the way for our phase III, our pivotal study to be initiated in Q4. Because we're dealing with an acute situation, a single administration condition, our clinical studies are very short, are very cost-effective, and therefore we start the phase III, the pivotal study in Q4, and we will already report data in Q1. As you can see, meaningful milestones related to this program, over the next 6-9 months, followed by an NDA submission later in 2027. If we look at the competitive environment, there are two public comparables that are competitors of ours. The first one is a company called ARS Pharma. They have developed an intranasal liquid formulation of epinephrine, and as you recall, I really talked about the differences between powder and liquid and why powder is superior to liquid, and you'll see that as we look through the data. Nonetheless, their product, called neffy, was approved about a year ago and was launched, is in the market. The ARS market cap is about $1 billion right now. Aquestive is another company. They have developed a sublingual formulation, a thin film of epinephrine, which recently received a CRL, and their market cap is about half a billion. You have Nasus Pharma with a market cap right now of about $30 million. A big discrepancy, a big gap between our market cap and our other competitors. Yet we think we have the potential to be the best in class in this category. If you look at the data from our clinical studies compared to EpiPen, the standard of care, or our competitors, I think that becomes very clear. I will call everyone's attention to probably two very important parameters. One is T-100. This is the time to reach 100 picograms of epinephrine in plasma. 100 picograms is considered the threshold of efficacy of epinephrine. There needs to be at least 100 picograms in the plasma for epinephrine to be efficacious, to increase blood pressure and heart rate, which is what epinephrine does. Look at the data. EpiPen, the standard of care, is about 3.5 minutes. We are at 1.7 minutes, so half the time of the standard of care to get to the therapeutic threshold. This difference is not just clinically meaningful. Again, we're dealing with a clinical situation with a disease that progresses very quickly and every minute counts. This two minute difference is very meaningful, and that difference is also statistically significant. If you look at our competitors, you can see the numbers, they're much higher than EpiPen. We have the product with the fastest onset of action compared to everyone in a condition, in a situation where onset of action is probably the most important parameter that physicians look at, and this was confirmed by our market research. Also, if you look at the percent of patients who reach that threshold, not just what the average or median time is, but how many patients actually get to that level at different time points. As you can see with our product, already 88% of subjects already reached that therapeutic threshold at five minutes, compared to EpiPen, the standard of care, with 64%. 20% more patients, and this is very meaningful and also statistically significant. Again, you can see the results for our competitors. We have a product that really has the potential to be the best in class, has the features of a product that physicians care about the most, yet there is a big discrepancy in the valuation, which we think makes the company very, very interesting and attractive. I mentioned the most recent clinical study that we just completed and announced results a few weeks ago. It was a very robust phase II study. It included 50 subjects with allergic rhinitis. This is seasonal allergy, and those subjects received a nasal allergy challenge, meaning they got a small amount of allergen in the nose, which creates significant nasal congestion. What we wanted to demonstrate in the study is the performance of the product administered either as a single dose, which is what happens most of the time, as a repeat dose, with and without the nasal challenge, and obviously always comparing to the standard of care, which is either a single or a repeat dose of EpiPen. Broadly speaking, the study really confirmed the findings from our prior clinical studies, really demonstrating that the powder platform has superior absorption compared to EpiPen. Specifically, we demonstrated a shorter Tmax, so this is the time to reach the maximum concentration, and a shorter time to reach the therapeutic threshold. We had many more subjects reaching the therapeutic threshold at very early time points. We were also able to demonstrate that we delivered total amount of epinephrine that is higher compared to EpiPen in that first 5-10 minutes, which are the most critical time window for patients in an anaphylactic reaction. The pharmacodynamic effect, again, this is the effect on blood pressure and heart rate, was very similar to that of EpiPen, and always within normal limits. The product was really well-tolerated. There were no SAEs, no cardiovascular events, only mild local adverse events that resolved spontaneously and quickly. If we look at the actual PK curve, so this is the level of epinephrine in the plasma at different time points. The red line is EpiPen. The blue line is our product. Very easy to see that we have faster absorption in the first 10 minutes, which is the important time period, and that level is being sustained over a long period of time. Even with nasal congestion, again, the significant amount of nasal congestion that is being caused, this is the results with the green line. We have absorption that is sustainable and is always above the therapeutic threshold. Our product works very well in normal conditions as well as under nasal congestion, and this is very unique to our product. These are the pharmacokinetic properties of the product. I call your attention to what I said before, the T-100, as you can see, it is half the time of EpiPen, and this was statistically significant and obviously very clinically relevant. The Cmax is very comparable to that of EpiPen. Very importantly, and I think this is something that people really need to get their handle on. This looks at the percent of patients who reach that therapeutic threshold at different time points. Again, the focus is on the early time points, which matter the most for patients in an anaphylactic reaction. Look at what happens at 2.5 minutes. With our product, close to 70% of patients already reached the therapeutic threshold versus only 27% with EpiPen. This is a huge difference, and that difference was also very statistically significant. You can see the P-value. That continues at 5 minutes. You can still see the significant difference and the statistical power. Obviously, with time, EpiPen catches up, but we are really focused on those first 5, 10 minutes, which are the most critical for patients in an anaphylactic reaction. When we look at the pharmacodynamic response, so this is the effect on the systolic blood pressure, we see a transient increase, and this is what we expect from any epinephrine product, and we see it's always within the normal limits. Same with heart rate. We see a transient increase in heart rate, which is within normal limits. As you can see, about 8-10 beats per minute for a few minutes, which is what we want from a product in an anaphylactic reaction to occur. We then looked at a repeat administration. In certain cases with EpiPen, about 10%-15% of patients may require a second dose because the first dose was not sufficient to resolve the anaphylactic symptoms. Therefore, we need to see what happens when a second dose is administered. Here you see the same results in normal conditions and under nasal challenge. In all situations, our product performed better than EpiPen. Two doses of our product were superior to two doses of EpiPen with and without nasal challenge. This is very important, and I think another key differentiator between Nasus's epinephrine product and other products in development, or other needle-free epinephrine products. Same with the other pharmacokinetic properties, demonstrating a much shorter Tmax, statistically significant, and a much shorter time to reach therapeutic threshold, significantly shorter than EpiPen in a statistically significant manner. The product, as I mentioned, was very well tolerated after single and repeat administration. No SAEs, and this is critical. No cardiovascular AEs. Most AEs, as I mentioned, were local in nature. Almost all local AEs were self-resolving and did not require any treatment. On the local side, we saw primarily runny nose, but again, keep in mind, those were subject with allergic rhinitis, seasonal allergy, so runny nose is an expected adverse event or outcome in the subject. Other than that, really, some nasal itching and some nasal congestion. On the systemic side, nothing out of the ordinary. It was all what one would expect from any epinephrine product. This is similar between EpiPen and our product. We have a very broad IP for our company. The IP covers both the technology itself, this unique powder technology that I keep referring to, and we also have IP on the individual products that we develop. The IP has been granted, goes to 2038, without any patent term extensions that we would expect to have. We have a very long patent life for our products. Just as a quick summary, and then happy to take questions. Nasus is really leveraging its proprietary powder technology to develop a pipeline of clinically differentiated and clinically meaningful products addressing acute and emergency medicine situations. Our lead product, our powder intranasal epinephrine for anaphylaxis, has demonstrated superior performance and absorption compared to EpiPen, the standard of care in multiple clinical studies. We are now getting ready for our pivotal study, which we'll start in Q4, and we'll read out. We are advancing our additional pipeline products, again, all addressing significant market opportunities, and those will be in clinical studies in Q3 or Q4 of this year. We have multiple milestones, multiple value-creating events over the next six to 12 months, and we think this makes Nasus a very unique company with multiple catalysts and attractive valuation. Thank you for your time and attention, and happy to take any questions at this point. Yes, we already have many for you. Walk us through the T-100 data in more detail. At 2.5 minutes, 67% of NS002 subjects were at therapeutic levels versus 27% for EpiPen. How should investors think about the clinical significance of that gap in a real anaphylaxis scenario? Thank you for that. It's a great question. I want to paint the picture here for everyone just to think about. Imagine you're with your kid at a birthday party and your kid is allergic to peanuts, and accidentally, they get exposed to peanuts. All of a sudden, you're in this party, and your kid starts having difficulties breathing and is falling. You're stressed, you're panicked, and you need to give them their EpiPen. The EpiPen, as I mentioned, is not an easy product to use. The parent, in this case, needs to pull it out. They need to take it out of the case. They need to stick the needle in the thigh. They need to wait a few seconds. All of that is happening while everyone is panicked. The kid is panicked. The kid may not be breathing. The parent is panicked. Time is of the essence in this life-threatening clinical emergency, and when you keep that in mind, that anaphylaxis is a very time-sensitive clinical situation, this data becomes very important because what we show is that already after two and a half minutes, our product had reached the therapeutic level in close to 70% of the patients, compared to 27% with EpiPen. Again, if you look at five minutes, that number goes even higher, and the T-100 is really the driving force behind this. We have the shortest time compared to EpiPen, half the time to reach the therapeutic threshold, which, as we said, in a clinical emergency where every minute counts, that difference is very meaningful. The NAC or nasal allergic challenge data showed NS002 maintained its PK profile under congested nasal conditions. How does this compare to what we know about neffy's performance under similar conditions, and why does powder versus liquid matter here? Definitely. Another important question. Let's look at our data, and I think this is the case. The nasal allergic challenge, again, is that small amount of allergen that is placed in the subject's nose and creates significant nasal congestion. That mimics what happens in the initial stages of an anaphylactic reaction in certain patients. As you can see here in the green line, we always maintain a therapeutic level of epinephrine despite the nasal congestion. We are always above that 100 picogram threshold that I keep referring to. This is unique to Nasus. Other products in development were not able to show or demonstrate the sustained absorption of epinephrine despite nasal congestion. This really, this difference is driven by the proprietary powder because the powder, as I said, gets distributed throughout the nose, gets into deeper parts of the nose where a liquid formulation cannot get to. That explains really the difference in the absorption properties, the faster onset of absorption, the higher total absorption, which allows us to maintain those levels even in nasal congestion. neffy is already on the market with $72 million in fiscal year 2025 revenue and global approvals and filings. Anaphylm got a CRL, but plans to resubmit in the third quarter of 2026. How do you position NS002 as best in class when you are the latest entrant and are years behind on your regulatory timeline? Yeah. It's a great question, and I think this comes down to where I think investors should really appreciate the opportunity in Nasus. First off, neffy's approval is a great step for this therapeutic area for patients, for families, for physicians. It really provided them the first needle-free option after many years, and this is something that patients have been longing for many years. neffy, or ARS, the company behind neffy, is really the trailblazer, so to speak, in this space. They make significant investment in medical education, in marketing, in patient education, in reimbursement, working with payers. This is really paving the way for us that when we enter the market, and again, the gap is not that big, it's not years, we're going to be probably three years behind neffy, give or take, by the time we get approval. The fact that neffy has made all those investments and really increased the awareness within the medical community, within patients, I think really paves the way for us. Then when we enter the market, I think the data would speak for itself. Because when we speak with physicians, they say clearly that what they're interested in is a product with a faster or the fastest onset of action possible. When you look at our data, this is precisely what we provide. We have the product with the fastest onset of action. When physicians will need to make the choice in the future, I think they will choose our product at that point. Excuse me, I was on mute. Sorry about that. No problem. What are allergists and emergency physicians telling you about when they prioritize when choosing between needle-free epinephrine options? Is onset of action actually the primary decision driver, or are formulary access, cost, and device familiarity more important? All the other factors that you mentioned are clearly important. We are certainly doing a lot of work in those other areas. By far, when we speak to physicians, when we do market research, the one thing that comes consistently is what physicians care most about is onset of action. A product that works fast and is reliable. Assuming in a few years that playing field, right, of reimbursement and everything else, is the same then, based on what we hear from clinicians, from physicians, from key opinion leaders, they would make their decision based on speed of onset, which is where we excel. We have time for one more question. 30 seconds. Gentlemen, can you answer this one? What are the one or two things that the market is most underappreciating about your company right now? 30 seconds. For sure. One is the fact that we have the best data out there for any epinephrine product, whether it's injectable or non-injectable. The phase II was superb, was excellent, and I think the market is not yet appreciating the strong performance of this product and the significant discrepancy between the valuations with our competitors. The other is the fact that we are a platform technology. We're developing multiple products, multiple unique, clinically meaningful, clinically differentiated products for different therapeutic areas, all having significant value, and all of them are also moving very quickly to the clinic. We're not a one-trick company. We're not a one-product company. We're really a company with a very robust pipeline, very valuable pipeline. Thank you very much. It's Nasus Pharma, ticker NSRX on the New York Stock Exchange American. For more information, use the ticker NSRX at RedChip.com. Call us, 1-800-REDCHIP. Thank you very much, gent-