Greetings. Welcome to Nasus Pharma's review of phase II data. At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. At this time, I'll hand the conference over to Dan Teleman, CEO. Dan, you may now begin. Thank you, operator. Good morning, everyone, and thank you for joining us today. I'm Dan Teleman, CEO of Nasus Pharma, and with me on the call are Dr. Dalia Megiddo, Chief Development Officer, and Eyal Rubin, Chief Financial Officer and EVP. On this call, we will review the top-line analysis from the single and repeat dose clinical study of NS002, our intranasal powder epinephrine product candidate. We released the interim analysis back in January. For anyone new to Nasus Pharma, we'll provide a short introduction about the company and our technology, then move on to NS002 and then the recent trial results. We'll then make time for questions and answers before we close the call. For anyone new to Nasus Pharma, we're a clinical stage pharmaceutical company that leverage its proprietary powder technology, called Nasax, to develop innovative intranasal products. Our powder formulation is engineered to achieve comprehensive distribution across the nasal cavity, providing an increased absorption surface area. This enables significantly faster drug absorption compared to traditional liquid intranasal formulation. This technological advantage is particularly valuable for emergency medications, where speed of onset is critical. Our lead product candidate is NS002, an intranasal epinephrine powder designed to treat anaphylaxis, a severe and potentially life-threatening allergic reaction that requires immediate treatment. Our Nasax technology is particularly suitable for anaphylaxis because successful treatment is fundamentally dependent on the speed of epinephrine absorption. A plasma concentration threshold of 100 picograms is required to effectively initiate the reversal of anaphylactic symptoms, especially its cardiovascular symptoms. The time to reach this therapeutic threshold, known as T100, is therefore a critical pharmacokinetic parameter when evaluating any epinephrine product, as faster onset could mean the difference between life and death. The current standard of care for anaphylaxis treatment is the epinephrine intramuscular auto-injector, such as EpiPen. However, despite the critical importance of immediate treatment, studies show that many patients fail to carry or use auto-injectors due to needle phobia, the bulky size of the devices, and hesitations during emergencies. NS002 addresses these barriers as a needle-free, compact, and easy-to-use alternative. Additionally, NS002 dry powder formulation provides enhanced stability and shelf life advantages compared to liquid formulations, an important consideration for a medication that must be carried at all times. While patient convenience is important, healthcare providers prioritize clinical performance above all else. Our market research with board-certified allergists validates the critical importance of the pharmacokinetic advantages NS002 demonstrates. 90% of allergists surveyed ranked speed of onset as either critically or very important when prescribing an epinephrine product. Furthermore, 87% indicated that T100, time to therapeutic threshold, is either extremely or very clinically meaningful when comparing epinephrine products. This data confirms that NS002 pharmacokinetic profile directly addresses the attributes physicians value most. With that, I'll turn it over to Dr. Dalia Megiddo. Thank you, Dan. This phase II study was designed to address feedback from U.S. Food and Drug Administration and incorporates learning from other epinephrine development program. We enrolled 50 healthy adults with a history of allergic rhinitis to evaluate NS002 under conditions that simulates real-world scenarios such as nasal congestion or the need for a second dose. Each subject, therefore, received both single and repeat doses of NS002 and EpiPen under normal condition, and then after a nasal allergen challenge, a condition that induces significant nasal congestion, mimicking the early stages of an anaphylactic reaction. This rigorous design allows us to evaluate NS002 performance across the full spectrum of conditions patients may encounter during actual emergencies. In accordance with FDA feedback, we also tested whether a second dose should be administered in the same nostril or in the contralateral nostril. We assessed comprehensively the pharmacokinetic, pharmacodynamic, and safety parameters throughout the study. Thank you, Dalia. Summarizing the data from the top-line analysis, the study demonstrated NS002 differentiated and potentially superior profile compared to traditional epinephrine auto-injectors. We can see rapid and high epinephrine absorption demonstrated by a shorter T100 and Tmax compared to EpiPen, with more subjects reaching T100 within five and 10 minutes compared to EpiPen. The maximum concentration, or Cmax, was comparable to EpiPen. Pharmacodynamic response of NS002 tracks EpiPen and is within normal physiological limits. Consistently with previous study, NS002 was well-tolerated with no serious adverse events reported. Adverse events were local, mild, and self-resolving. Let's take a closer look at the data. In the critical first five minutes following administration, epinephrine absorption with NS002 is both faster and higher than EpiPen under both normal conditions and nasal congestion. We see consistently higher absorption over time compared to EpiPen. Importantly, even under challenging nasal allergic conditions, NS002 maintains epinephrine levels above the therapeutic threshold, demonstrating the robustness of our Nasax powder platform and differentiating NS002 from other intranasal approaches. Breaking down these pharmacokinetic parameters, we see that NS002 achieves a maximum epinephrine concentration comparable to EpiPen. However, the critical difference lies in the speed of absorption. NS002 demonstrates a substantially faster Tmax, and most importantly, a T100 that is twice as fast as EpiPen. To put this in perspective, NS002 reaches the therapeutic threshold in a median of 1.69 minutes compared to 3.42 minutes for EpiPen, representing a statistically significant improvement. As our market research confirmed, this rapid onset of action is the most important attribute physicians consider when selecting an epinephrine product. The data in this figure is particularly compelling. At 2.5 minutes, about 67% of subjects receiving NS002 had already reached the therapeutic threshold compared to 27% with EpiPen. At 5 minutes post-administration, 88% of subjects receiving NS002 had reached the therapeutic threshold compared to only 64% with EpiPen. This represents the highest proportion of subjects achieving therapeutic threshold at this early time point that we have observed across published data for epinephrine products, whether currently marketed or in clinical development. We carefully monitored the effects of NS002 on the pharmacodynamic parameters, systolic and diastolic blood pressure, and heart rate. Consistent with epinephrine mechanism of action, we see a transient increase in the systolic blood pressure and heart rate. The increase is tracking well with that of EpiPen and always within normal physiological conditions. Moving on to repeat dosing, we can see in both normal and under nasal allergen challenge, NS002 provides equivalent or better absorption of epinephrine compared to EpiPen. NS002 absorption consistently exceeds EpiPen performance and importantly is independent of which nostril is used for administration, a key finding for real-world use where patients experiencing anaphylaxis may require a second dose. This consistent performance across dosing scenarios is particularly significant as up to 20% of anaphylactic reactions may require repeat epinephrine administration. Looking at the individual pharmacokinetic attributes with repeat dosing, we have comparable Cmax, a comparable Tmax, and as before, a considerably faster T100. Consistent with previous studies, NS002 administration is safe and well-tolerated with no serious adverse events reported. Most adverse events were localized and self-resolving, with the overwhelming majority classified as mild. To summarize, the top-line results of this phase 2 study comparing NS002 intranasal epinephrine powder to EpiPen has demonstrated that NS002 possesses a differentiated and potentially superior profile compared to traditional autoinjectors, with performance attributes that directly address the clinical needs identified by physicians. First, across all conditions tested, including repeat dose and nasal allergen challenge, NS002 reached the therapeutic epinephrine threshold twice as fast as EpiPen, with median T100 of 1.69 minutes versus 3.42 minutes. This rapid onset of action is the most important attribute allergists consider when comparing epinephrine products. Second, we observed that 88% of subjects receiving NS002 achieved the therapeutic threshold within five minutes compared to 64% with EpiPen, representing the highest early achievement rate in published epinephrine product data. Third, in the critical 10-minute therapeutic window, NS002 achieved 60% higher total epinephrine absorption compared to EpiPen, potentially enabling faster symptom resolution when every second counts. Finally, NS002 demonstrated a favorable safety profile consistent with previous studies, with no serious adverse events reported. Based on these compelling results, we are advancing NS002 toward a pivotal study planned for initiation in the fourth quarter of 2026. We look forward to continuing to update you on our progress as we work to bring this potentially life-saving innovation to patients. We believe NS002 represents an important strategic asset for the company, and if successfully developed, has the potential to drive meaningful long-term value for our shareholders and other stakeholders. With that, we're happy to take your questions. Operator? Thank you. We'll now be conducting a question-and-answer session. If you'd like to ask a question at this time, you may press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please for our first question. Thank you. Our first question is from the line of Jason Butler with Citizens JMP. Please proceed with your questions. Hi. Thanks for taking the questions, and let me say congrats on the results. They look really compelling. A couple from us. First of all, Dan, can you talk about next steps with FDA and how we should think about the design of the pivotal trial? Yes, for sure. Thanks, Jason, and thanks for the question. We are planning to have an interaction with the FDA later this year as part of our IND, where we will be submitting our proposed protocol for the pivotal study. Based on the FDA's feedback on the pivotal study, we will proceed with the pivotal study as we indicated in the fourth quarter. Great. The repeat dose data look strong, but can you talk about the potential need for a repeat dose with NS002, and how that might compare to both EpiPen and other epinephrine candidates? Yes, thank you for the question. We're particularly excited about the percentage of subjects who require or get to the therapeutic threshold at different time points. As we demonstrated in this study and in prior studies, we get over 90% of subjects to the therapeutic threshold at very early time point, something that could potentially translate into a lesser need for a second dose. We know from the published data for EpiPen that roughly about 15% of subjects or patients in an anaphylactic reaction may require a second administration. Therefore, this is something that we wanted to check in this study. We know the FDA is looking for this information. Whether that would translate into real world benefit remains to be seen. We think the data certainly supports the potential for a lesser need with NS002 to have a second administration compared to EpiPen and potentially other products. Great. Last question from me. Market research outcome looks really clear that T100 is really impactful for prescribers. Can you talk about any data you generated in this study or other work that you've done that speaks to how physicians would think about the potential proportion of patients that would switch to a needle-free option over time? In this particular research, we have not yet looked at the question of switching from EpiPen to needle-free. This is certainly something that we plan to look at in future market research. What we have heard from allergists in this research is that they're certainly open to switching patients. In fact, all the allergists that we have surveyed have had at least one patient that has been switched to another needle-free epinephrine product. To us, this is encouraging that physicians are certainly open to switching patients to needle-free epinephrine products and will be able to differentiate between products based on those attributes, particularly the onset of action. Great. Thanks again and congrats again on great data. Thank you, Jason. Appreciate it. Our next question is from the line of Yale Jen with Laidlaw. Please proceed with your questions. Good morning and thanks for taking the questions and, congrats on all your great data. My first question is that, As we compare the data to the EpiPen at this moment, do you feel based on the data NS002 potentially could be, almost a best-in-class, treatment regardless whether it's needle-free or, injectable? Hello, Yale, and thank you for your question. Can you just repeat the question or 'cause I couldn't hear it clearly? Thank you. Sure. Do you feel that based on the data, at this point, by comparison, do you feel that NS002 could potentially be a best in class treatment, regardless whether it's needle-free or injectable? Thanks, Yale. We certainly think that NS002 has the potential to be the best in class, whether we compare it to auto-injectors or other epinephrine products. When we look across the different pharmacokinetic parameters, we're looking across different studies, of course, and so then that has to be very clear. When we look across different studies, different data, we think NS002 really demonstrates the best profile compared to other products, whether it's the faster onset of action, really the fastest onset of action that has been reported. Whether we look at Cmax or, more importantly, whether we look at 300, we demonstrated the highest proportion of subjects who reached that therapeutic threshold at different time points, particularly during the early time points, again, the highest number across all products. When we also look at the amount of epinephrine that is being absorbed in the timeframe, call it, up to 10 minutes, which is probably the most important time window for treating an anaphylactic reaction, we get the most amount of epinephrine during that time period. Judging based on those pharmacokinetic parameters, we think that NS002 could potentially be the best in class. Okay, great. This is very helpful. One, two more questions here. The first one is, in terms of the, on the PD side, your systolic pressure and the heart rate was higher than epinephrine. Do you feel that have any impact or how do you assess this? Yeah. I will address this, and then I will also have Dr. Dalia Megiddo address as well. When we look at the pharmacodynamic response of the effect on systolic and diastolic and heart rate, while it is slightly higher than EpiPen, it does track exactly with EpiPen, so it goes up at the same time point and goes down at the same time point. Probably most importantly, we see that we are always within the normal physiological range, right? We never go above 140 on the systolic, and we never go above 80 beats per minute on the heart rate. While it is slightly higher, the difference, first off, is not meaningful and the range, or the rates, and the values are always within the normal range. I'll let Dalia see if she has anything else to add. Hi. Absorption, rate of absorption of epinephrine, both increased systolic blood pressure and heart rate are part of the pharmacodynamic effects, normal pharmacodynamic effects of epinephrine. Because epinephrine compared to EpiPen, we see quicker reaction in terms of the systolic and diastolic blood pressure, and we see higher because the overall absorption is higher than the EpiPen. All in all, that is not a side effect. That is the effect of epinephrine. For us, this translates into the actual physiological effect that we are looking for when we are treating an anaphylactic patient. Okay, great. That's very, very helpful. Maybe the last question here is that, will this data, are you guys planning to publish this data in any peer review journals in the near future and then maybe presenting at any medical conferences, if you have any already in mind? Thanks. Yes, most certainly. We are planning to publish the data in a well-respected journal, and also in an upcoming conference either later this year or beginning of next year. We think this data is very meaningful, very impactful, and we certainly want to get it out, published. I mean, I'm sorry. Maybe the last one or just follow up on that. In terms of medical conferences, do you have anything in mind at this point, or are you still contemplating that? Yeah. There's two main conferences in the U.S. related to allergy and particularly anaphylaxis. One is the ACAAI, and the second one is the American College of Allergy, Asthma & Immunology. We're gonna be targeting one of those. Okay, great. That's very helpful. Again, congrats on the very outstanding data. Thank you, Yale. Appreciate it. Our next question is from the line of Raghuram Selvaraju with H.C. Wainwright & Co. Please proceed with your questions. Thanks so much for taking my questions, and congrats on the data. Firstly, I was wondering if you could comment on the relative profile of your product candidate versus Neffy, particularly with respect to the performance on the Tmax parameter as well as the tolerability profile as this pertains to any observed instances of nasal passage irritability. Thank you. Thanks, Ram, and I appreciate you joining the call. We don't wanna make any direct comparisons to products that we have not tested directly. All we can do is compare the data across different studies. When we did this comparison, as I indicated before, we think we have a superior product profile. We have a shorter Tmax. We have a shorter T100, and we get many more subjects to the therapeutic threshold at very early time points. Overall, we think we have the potential to have a superior product profile. In regards to the tolerability, we've observed a very favorable tolerability profile in this study, as well as our previous studies, very minimal nasal irritation, and other parameters. We think this is one of the significant advantages of our powder formulation, where the potential tolerability profile could be superior to other type of formulations. Okay. Very helpful. With respect to the potential future timeline for development, can you maybe comment on what this could look like from a timing perspective, particularly with respect to within what time frame it might be possible to envisage the filing of an NDA for this product candidate if it were to hypothetically follow a similar development process, a similar development workflow to that which was pursued by Neffy? Yes, most definitely. As Dalia indicated earlier, when we presented the data, we designed this particular study with prior FDA feedback, as well as observing what the FDA had requested from other products in development. We incorporated all that feedback into this study. Going forward, the main study that is necessary is the pivotal study, which we indicated should start in Q4 of this year with top line data reporting by Q1 of 2027. Assuming all goes well, we are targeting an NDA in the second half of 2027. Thank you so much. Thank you, Ram. The next question is from the line of John Vandermosten with Zacks. Please proceed with your question. Great. Thank you. There are a lot of different body weights for patients, but only a couple of dosage strengths of epinephrine. Were you able to look at the performance of plasma concentration by weight at all in this study? Thank you, John. No, we did not look at body weight for to look at the product based on body weight. None of the other epinephrine products, either on the market or in development, has looked at performance per body weight. Again, at least as it pertains to adults. When it comes to pediatrics, the dose does change based on weight, but in adult patients, it does not. It's a consistent dose. Got it. What explains the lower level of epinephrine plasma concentrations in subjects undergoing the challenge? Yes. Thank you. I'll turn this question over to Dalia. Hi. In the condition of nasal allergen challenge, we see two periods. The first period is characterized by quicker absorption because of the mechanism of nasal allergen challenge, whereby the epithelial junction are damaged, and we see a quicker absorption of drug. Later on, the congestion itself, the fluid in the nose probably prevents the absorption of additional epinephrine. I have to say that this is something that we have seen in all nasal products, whether in development or commercial. However, what is important is the sustainability of clinical dose. We have not seen that in other products, but in our product, even though the level of epinephrine is below EpiPen after about 10 or 15 minutes, it still maintains the clinical dose, the above 150. We know that even though the level is lower than EpiPen, it is still clinically meaningful. Great. Thank you, Dalia. Last one for me is just what marks do you anticipate you'll need to hit for FDA approval? Is it superior performance or matching performance that will get you the approval for this NDA? Yes. Thank you, John, for the question. For FDA purposes or for any regulatory approval purposes, the bar or the standard is comparative bioavailability, meaning we need to show and demonstrate that we are comparable to EpiPen. That's the bar. There's no superiority that is necessary for approval. However, obviously for commercial purposes, we think that our product profile being potentially superior to EpiPen is certainly going to be an advantage. For regulatory approval purposes, comparability to EpiPen is what is necessary. Great. Thank you, Dan. Thanks, John. The next question is from the line of William Wood with B. Riley Securities. Please proceed with your questions. Hi. Yes, thank you for taking our questions, and congrats on the data. Just thinking about in terms of market uptake here. A key part of uptake, apart from just efficacy, is having the device drug on you when an attack occurs. Could you just sort of speak to the compact nature of your device and how this could lead to an increased penetrance in the market, potentially on a person or in, I'll say, EMT setting. Just remind me, is NS 002 a single-use device or do you have the option for, say, two pumps, two drug deliveries, one in each nostril or something to that degree? Thanks, William, for the question. Let's start with the latter. NS 002 is a single-use device. Same for other intranasal epinephrine products or two injectors. It's a single-use device. However, it's gonna be supplied in a two-pack, in the case a second dose is needed. As I indicated earlier, given the data that we have observed in this study and in prior studies, we think there is the potential for lower need of a second dose with our product. For regulatory purposes, the product is gonna be supplied as two doses in one box. As it relates to the device itself, it's a very small device. It's easy to carry. It fits into any pocket or any purse or anything else. We think it's gonna be much more convenient for patients to carry compared to the current auto-injectors. It is also important to note that our product, because it uses a dry powder, again, compared to liquid formulations, has the potential to have an even longer shelf life, which we think, again, is gonna be very important to patients and families, given the fact that the current auto-injectors have to be replaced every 12 months or so because again, epinephrine is in a solution. The fact that we have a dry powder can increase significantly the shelf life, which is also gonna be a great benefit to patients. Appreciate that extra color there. Then just thinking in terms of your pivotal, I know you have your FDA meeting coming up and sort of announcements later this year. In terms of how we should sort of think about the design and the duration, do you think it's an appropriate sort of idea or thought to compare this to your current NP 007 study? You know, is it gonna be requiring both a single, and then sort of the repeat dosing or Maybe just how should we think about that in terms of what you're presenting today? Yes. The pivotal study as we envision it right now, and this is based on prior feedback from the FDA, but again, we will confirm this with the FDA later on. We expect the pivotal study to be conducted in healthy volunteers only. Again, it's different than NP007. It's not gonna be in subjects with allergic rhinitis. It's gonna be healthy volunteers only. It's gonna be a single-dose administration comparing NS002 to a single dose of EpiPen, and will also include an administration of 0.5 milligrams intramuscular adrenaline. And this is again an FDA requirement to also compare in the pivotal study to the intramuscular injection. Those would be the three arms in the pivotal study, NS002, EpiPen, and 0.5 mg intramuscular injection, single dose. We have not finalized the number of subjects, but we expect the number to be around 70-100. In terms of timelines, as I mentioned, we plan to initiate the study in Q4. Because it's a fairly simple, straightforward study, we expect the top-line data to be available in Q1 2027. Got it. Very helpful. I appreciate you taking our questions and congrats again on the data. Thank you. Thank you, William. Thank you. As a reminder to ask a question at this time, you may press star one. Thank you. At this time, there are no additional questions. I'll hand the floor back to management for closing remarks. Thank you. Thank you everyone for joining us today, as we review the top-line data from our phase II study of a single and repeat dose. As we indicated, we are very excited with these results. We demonstrated in this study a very favorable safety profile, a very superior, potentially superior, performance in terms of onset of action, which is the most important parameter for physicians and patients. We look forward to advancing the development as quickly as possible with the hope to have this product submitted for an NDA in 2027. With that, thank you everyone, and have a good day. This will conclude today's conference. You may disconnect your lines at this time. We thank you for your participation.