Good morning, welcome to the Nasus Pharma Virtual KOL Webinar. At this time, all attendees are in a listen-only mode, and a question- and- answer session will follow the formal presentations. As a reminder, this call is being recorded, and a replay will be made available on the Nasus website following the conclusion of the event. I'd now like to turn the call over to your host, Dan Teleman, Chief Executive Officer at Nasus Pharma. Please go ahead, Dan.
Thank you, Tara. Good morning, everyone. Appreciate you joining us this morning for our first KOL webinar to discuss our intranasal epinephrine for the treatment of anaphylaxis. With me, I have Dr. Dalia Megiddo, our Chief Development Officer, Eyal Rubin, our CFO, and I would like to introduce our guest speakers today. First, Dr. Michael Blaiss. Dr. Blaiss is a Clinical Professor of Pediatrics, Division of Allergy, Immunology at the Medical College of Georgia in Augusta, Georgia, an allergist at Good Samaritan Health Center in Georgia. Dr. Blaiss is a past president of the American College of Allergy, Asthma and Immunology. In addition, we have Dr. Joel Brooks. Dr. Brooks is an Assistant Professor of Pediatrics at the Columbia University College of Physicians and attending pediatrician in the Division of Allergy, Immunology, and Rheumatology at the NewYork-Presbyterian.
Dr. Brooks is deeply committed to medical education and serves on several committees within the Board of American Academy of Allergy and American College of Allergy, Asthma and Immunology. Thank you, Dr. Blaiss and Dr. Brooks, for joining us this morning. Quickly going over the agenda for today's webinar. I will start off with a quick overview of Nasus. I will then turn it over to Dr. Blaiss to discuss the emergency epinephrine delivery market, and then we'll turn it over to Dr. Brooks to discuss the unmet need for needle-free epinephrine, and we'll conclude with a Q&A session. Before we go into our speakers today, I want to introduce Nasus Pharma to those of you who are not familiar with the company. Nasus has and leverages a proprietary powder technology that enhances the intranasal absorption of different molecules to create a pipeline of clinically meaningful and differentiated products.
Our lead product, which we will be discussing today, is our powder intranasal epinephrine for the treatment of anaphylaxis, where in previous clinical studies, we demonstrated superior performance and absorption compared to EpiPen, the standard of care. The company is well-capitalized and has a strong financial position to move the epinephrine program to completion as well as move some of our earlier-stage pipeline into clinical development. I mentioned the fact that we are leveraging our proprietary platform technology, powder technology, to develop a pipeline of innovative products. We will obviously be focusing on our epinephrine product that moves into phase III this year. In addition, we are developing several additional intranasal products. The first one is our intranasal ondansetron. This is the first intranasal ondansetron being developed.
We released yesterday data from our clinical studies that demonstrated IV-like properties of our proprietary intranasal ondansetron, and this product is moving into its first-in-human clinical study in Q3. Beyond ondansetron, we have additional molecules that are currently in development. We have a cardiovascular asset that is being developed and will go into clinical studies in 2027, as well as a metabolic molecule that also will go into clinical studies in 2027. As you can see, we have a very broad pipeline of what we define as clinically meaningful and differentiated intranasal products, all leveraging the powder technology. Our powder technology, which is in the core of what we do, has two key features. The first is the ability to control the particle size of the powder. We create small, tiny particles that are in the size range of five to 35 micron.
This particle size range is the optimal for intranasal absorption. The second part of the technology is the ability to create spherical particles. This combination of the small, tiny particles and the spherical shape creates a unique powder formulation that penetrates deeply into the nose, reaching the inner parts of the nose, where there is high vasculature that enables higher and faster absorption compared to the more traditional liquid intranasal formulations, which are in nature heavy, concentrate in the lower part of the nose where there is less vasculature and therefore slower and lower absorption. Our proprietary powder intranasal addresses the major limitations of EpiPen, the standard of care for anaphylaxis, being needle-free, which we will talk, I'm sure, significantly on today's discussion.
It is very small, very easy to carry around, fits into a pocket. Very importantly, because of the dry powder, we have a very long shelf life of the product, significantly longer than the shelf life of the EpiPen, which needs to be replaced every 12 months or so. In terms of the development of our intranasal epinephrine, we completed several clinical studies to date. The most recent one, a very comprehensive phase II study, which we'll be reviewing today. We announced the top-line data back in March. This paves the way for us to move into our pivotal phase III study in Q4 of this year with top-line data of the pivotal study reported in Q1, followed by hopefully an NDA submission in 2027.
The last point I would like to make in my introduction is results from a recent market research that we have conducted, talking with allergists about the important attributes of new epinephrine products. What we heard consistently from our physicians is the onset of action or the speed of onset of action of an epinephrine product is the most important parameter when they select a new product. When we'll go over the data today, I think you'll be convinced that the Nasus product has the potential to have the fastest onset of action. With that, I want to turn it over to Dr. Blaiss for his presentation.
Thank you, Dan, good morning, everyone. I'm going to start us off this morning talking about redefining emergency epinephrine delivery. With that, we need to define exactly the condition we're talking about, and that in fact is anaphylaxis. In fact, the word anaphylaxis comes to us from the Greek, basically meaning without protection. In fact, this term was coined in the early 20th century by two French physicians who described the condition. When we talk about anaphylaxis, this is severe systemic, in fact, it has to involve at least two organ systems by definition to be anaphylaxis, and it can occur roughly within seconds to several minutes, depending upon the patient and the particular allergen. What is happening here is let's take a patient with a peanut allergy.
They would have, in fact, developed IgE antibodies, because this is a type 1 hypersensitivity reaction, that would be binding onto the mast cell. On re-exposure to that peanut, it would bind to these IgE molecules. This causes a change in this mast cell, and this mast cell contains hundreds of different chemical mediators such as histamine, leukotrienes, and others, that in fact lead to the symptoms that we see in a patient having an anaphylactic reaction. Very importantly, this is, of course, a medical emergency. The treatment of choice, as we all now understand, is the use of epinephrine as rapidly as possible to counteract the reaction. When we look at the prevalence of anaphylaxis, unfortunately, the numbers, in fact, have continued to increase, especially over the last 10- 20 years, and reasons for that are still not completely clear.
What we do know from the Anaphylaxis in America study done several years ago, that the lifetime prevalence of anaphylaxis in the U.S. is up to now 5.1% of the population. We're talking about over 15 million Americans, in fact, affected. This is not just a problem in the U.S. We're seeing definite increases, in fact, throughout the world as far as anaphylaxis in the population. One of the major causes of anaphylaxis that we see, in fact, has to do with food allergy. In fact, there has been a dramatic increase as far as the number of children in the U.S. that, in fact, have been diagnosed with food allergy. Numbers suggest somewhere about 1 in 13. This is not just a pediatric problem. We're seeing more and more adults being diagnosed with food allergy.
Again, it is a global problem also, estimated at over 220 million people, in fact, suffering with food allergy. Food is the most common cause of anaphylaxis in the pediatric population. In the adult population, it's medications. We also see anaphylaxis for many other things, including insect stings, latex, exercise. You may have heard of alpha-gal, which we can relate also as a type of food reaction. Then we have patients where it's, in fact, idiopathic and no etiology has been found. The symptoms, in fact, very importantly, can progress in minutes. Most commonly, it starts with skin manifestations, though not 100%. Usually urticaria or hives, though we can get angioedema and swelling. We can develop problems as far as in the lungs, with significant bronchospasm, cardiovascular problems such as hypotension, and unfortunately, in some patients, it can lead to death.
The gold standard, again, in the treatment of this condition, whether we look at guidelines from the U.S. or throughout the world, in fact, it's epinephrine. The use of antihistamines, corticosteroids really have minimal role. They can be as an adjuvant, but in most cases do not have any significant effect, especially with that acute problem that the patient is having with anaphylaxis. The problem is that for most patients, we can prevent mortality if, in fact, that they'll promptly use their epinephrine. Delay, in fact, of administering epinephrine is, in fact, a leading cause of death in the patient population. What we're looking at here is just a diagram of anaphylaxis. I mentioned about the mast cell, the allergen binding to IgE on the mast cell, and the release of these chemical mediators like histamine.
We have involvement, as we mentioned, in the lower airway, the skin, cardiovascular. Also need to mention the upper airway. In fact, we do get significant nasal congestion and rhinorrhea associated with anaphylaxis. Especially in patients that are having food allergy anaphylaxis, it's not uncommon to have nausea, vomiting, and diarrhea. Why is epinephrine the gold standard? Because in fact, it binds to receptors in all these organ systems that counteract the symptoms of anaphylaxis. We decrease that airway obstruction in the lungs and reduce the skin manifestations, increase blood pressure, decrease that congestion that's occurring in the nose, and decrease intestinal motility, which is leading to, again, the severe GI problems that these patients could be having. One of our biggest issues associated with epinephrine is, in fact, compliance. In fact, patients get the prescription. In most cases, they get it filled.
Unfortunately, when they're having symptoms, they don't use it. There have been many studies to look at this, and it's estimated that up to 83% of patients, in fact, just delay or just fail to use epinephrine auto-injector when needed. I can't tell you how many times I'll get a call from a parent or a patient going, "I think I'm having anaphylaxis. What should I do?" And I go, "Don't you have your epinephrine?" And they go, "Well, I wasn't sure if I should use it or not." We get into these types of situations all the time. What are some of the barriers of using an auto-injector? One, the patients are scared of that needle. They know they're going to get stuck when they use it. We see a big problem with them being too large to carry.
I could tell you that the majority of patients that come to see me, that I've given an auto-injector to, I ask them, do they have it with them when they come back to see me? I'll tell you, the majority, in fact, are not carrying it with them. They're concerned about the cause of pain occurring with injecting it either in themselves or their child. Patients can really panic when they're having an anaphylactic reaction. They may not remember how to use the device correctly, so this causes problems. We end up with a lot of consequences here. We have patients waiting to see if an antihistamine will work, and unfortunately, most of the time that's not going to happen. Schools' first responders may hesitate as far as wanting to inject children. Let's just watch and see what happens. Which again, should not be occurring.
One of the things that we'll see is accidental injection to the fingers. We'll see people wanting to see if their EpiPen will work, and they inject their finger. This can lead to, in fact, because of the vasoconstriction associated with epinephrine, that can lead to necrosis of that fingertip. That is a medical emergency that has to be treated correctly. The whole point here is that we have to get patients and get them epinephrine in a way that they'll use it. We can prevent so many deaths if in fact, we get prompt use of epinephrine. This leads to the very important point of speed of onset. In fact, we want to use epinephrine as quickly and get it into the bloodstream as fast as possible, to prevent the symptomatology and obviously to prevent a fatal outcome.
One of the key parameters that we look at as far as pharmacokinetics, and that has to do with how long it takes for the epinephrine in the blood to get to 100 pg/ml . This is a level from studies that suggest, in fact, can reverse anaphylactic type of reactions. A level below that 100 pg/ml , in fact, may not give enough effect to completely turn around an anaphylactic episode. From the phase II study, and I am going to show you more results from the phase II study in just a second. If we look at the Nasus product, NS002, we can see here that in fact, levels of 100 picograms per mil were reached in 1.69 minutes. You can compare that with what was seen with the gold standard, that being the EpiPen at 3.42 minutes.
You can see much more rapid onset of getting to that T100 with the use of the Nasus product. What we're seeing is, in fact, a change in the marketplace related to rescue epinephrine use. I think what we're going to continue to see in this market is going to a needle-free market in the patient population. Here we're looking at data from several sources that, in fact, have looked at the global epinephrine market. You can see here in 2024 that it was not quite $3 billion. It is estimated from SNS Insider and others that this market by 2032 will in fact double to almost $6 billion. When we look at the U.S. market in 2024, it is about $1 billion, and again, it is projected to double by 2032.
If we look at some of the latest data, the highest level when we look at rescue medication is in fact still with the use of the auto-injector, about 78%. The fastest growth now that we've had a neffy for over a year in the United States has in fact been that needle-free option. In fact, you can see here that in their first-year revenue, it was $72.2 million. In fact, this number is really on the low side of what it could have been because there was a great deal of problem, especially at the beginning as far as insurance coverage related to the product. I want to move on now and talk about the Nasus product, NS002, and look at its phase II data. To let you know, this was an open-label, randomized, parallel study.
There were 50 subjects who had a history of allergic rhinitis. As we mentioned, the comparator in this study was the EpiPen at the 0.3 mg auto-injector. Dosing was done single and repeat. The repeat dose, in fact, was done 10 minutes after the single dose. Why was that? Because about 10%-15% of patients that we see with anaphylaxis will require a second dose of epinephrine. We need to fact and see how well this product works on a repeat dose. The other thing is that these patients went through a nasal allergen challenge. That's why they had patients with allergic rhinitis. The reason was try to duplicate what would happen in the nose during an anaphylactic episode, and that is that severe nasal congestion.
In fact, then look at the absorption and to see if the absorption, in fact, is comparable to what one would see with EpiPen, other products, so that you would get levels that would, in fact, reverse an anaphylactic reaction. The key endpoints that are looked at in this study include pharmacokinetic and pharmacodynamic measures. I've mentioned about the T100. We have the Cmax, which is the concentration that is maximal after given the medication. Tmax is the time to reach that highest concentration. We also want to look at the area under the curve. Also, as far as pharmacokinetics, pharmacodynamics, I mean, we need to look at both systolic and diastolic blood pressure and also heart rate. Here again, we're looking at that T100, the time to reach, again T100 in the blood. As already mentioned, the Nasus product here are much more rapid.
You can see the statistics here, p-value 0.003, then EpiPen. Looked at here, it was the percent of the patients at first two and a half minutes and at five minutes, as far as reaching the 100 pg/ml . You can see here at two and a half minutes, it was over 2/3 of the patients that were on the Nasus product, versus 27% with EpiPen, and at five minutes, 88.4% with the Nasus product versus 64.6% with the EpiPen. Again, showing that rapid onset of action, which is needed to reverse anaphylaxis. Here we're looking at the peak plasma concentration or the Cmax, compared to EpiPen. You can see on the red bar here, the Nasus product under normal conditions, and basically it's equivalent to what one sees with the EpiPen. Again, non-inferiority as far as peak exposure achieved.
Then if we look here with the nasal congestion, we can see it's 379. It's about 70% of what's seen with EpiPen. Again, we see these levels at 379, much higher than that 100 pg/ml level. Again, under the nasal congestion, this would be a therapeutic dose to help reverse anaphylaxis. Here we're looking at the area under the curve. We're looking at plasma epinephrine exposure. What's important here is especially looking at the first several minutes, because again, the more rapid we can get it into the system, the more likely we can prevent or control the anaphylactic reaction.
If we look at the area in the curve in that first two and a half minutes, 0 to 2.5 minutes, we can see with the Nasus products, in fact, here in normal condition and with nasal challenge, you can see here it's about 3.5 times a higher level. If we look at the area under the curve, 0 to 10 minutes, in fact, with Nasus product, we see here it's about 50% higher than what one sees with the EpiPen. If we go through the whole process then the Nasus product normal conditions was equivalent to what was seen with EpiPen.
I think very importantly, when you look at the yellow line here, which is the nasal congestion line associated with the use of the Nasus product, you can see here again the excellent area under the curve results that we're seeing. Very importantly, to make sure that one is getting those levels into the blood system. Now, here we're looking at repeat dosing. If you look over on the left, this is under normal conditions, and you can see EpiPen, again, two doses were given, left leg, right leg. The Nasus product is done two different ways, either the same nostril for the second dose or the opposite nostril. What you can see here is that, in fact, you see much faster onset as far as absorption levels with the Nasus product compared to EpiPen. You see higher levels and that sustained absorption.
Levels, as we'll talk about side effects, that did not show any significant side effects in the patient population. If we look at under the nasal allergen challenge, I think you can see the same type of results. Again, that's very important because we're trying to repeat what could happen during anaphylaxis, again, getting those high levels into the blood with the repeat dose, which is extremely important because if a patient's requiring a repeat dose, they're probably having a very severe anaphylactic episode. Here we're looking at pharmacodynamic data. What's measured here is systolic and diastolic blood pressure and heart rate. I think what you can see here, looking at the systolic blood pressure, we're looking at EpiPen, with nasal congestion with the Nasus product, in normal conditions, look at the median change here.
Again, we see is what should be expected with an epinephrine, is you're going to see some increase in systolic blood pressure. Again, no evidence of levels that would lead to any type of cardiovascular problem in the patient. You see minimal change, which is what's expected with diastolic blood pressure. You see usually a very quick onset of an increased heart rate and then decreasing over time. Again, a heart rate that is not associated with that increase of any significant cardiac effects. Again, we're seeing the same type of pharmacodynamic effects that one sees with giving IM epinephrine. When we take a look in total as far as the safety tolerability in the phase II study, there were no serious adverse events that were reported. Most common adverse events, which were mild and transient, included some nasal discomfort and irritation.
As I mentioned, we saw comparable pharmacodynamic effects that we're seeing with the EpiPen, with the Nasus product. Again, did not see any type of side effects associated there in the patient population. The safety profile demonstrated in the phase II study was the same type of excellent safety profile that was seen, in fact, in the earlier dose-finding studies. We did the nasal allergen challenge because, again, this gives us a real-world way of trying to look at what would happen in the nose during anaphylaxis. As the data I showed you, especially a PK data, is that in fact we did see significant levels in the congested state, which really supports, again, this intranasal absorption with congestion, and showing that, in fact, we can get levels. That's very important in the use of this treatment intranasally for anaphylaxis.
Very important, the repeat dosing, because we mentioned there are a group of patients that may need more than one dose of epinephrine. The data from the PK studies, as I showed you, showed, again, a favorable profile as far as absorption in the blood, and there was no increase as far as any type of unseen safety problems associated with the second dose. Again, very important for labeling of this particular product when approved. If we look at some comparative data here between the Nasus product and neffy and Anaphylm. Anaphylm right now, as you may know, is under FDA review. This is a prodrug of epinephrine that is given sublingually. If we look at the T100, those products, they have not been reported at this time.
If we look at the Tmax of these products, you can see here we mentioned as far as the neffy product being at 30 here and Anaphylm at 12. Again, comparable to what we've seen of the Nasus product at 15. If we look at the Cmax, I think we can say they're all fairly comparable, little bit higher with the Nasus product and EpiPen compared to neffy and Anaphylm. If we look at that area under the curve, 0 to 10 minutes, again, the amount of absorption during that 10-minute period of time we had mentioned with the Nasus product that it was 50% higher than EpiPen. With both neffy and Anaphylm, it's lower than EpiPen. The Nasus product, as mentioned, is a dry powder, neffy being a liquid, and Anaphylm, as I mentioned, is a sublingual film.
There are differences as far as the shelf life. As mentioned again, this product, NS002, has a long shelf life, can be greater than five years. For neffy, the approval for the 1 mg dose is 24 months, 2 mg dose 30 months. EpiPen is somewhere in the 18 to 24-month range. It's projected that Anaphylm is about 24 months. Looking at attributes, and I think this is important when we look at tolerability of products for the patient. As far as nasal distribution, we had mentioned, again, the dry powder deposits throughout the nasal mucosa, so it's not really subject to pooling or runoff that one can see with a liquid formulation. As far as drug loss, since it's a dry powder, there's no significant drip down the nose or the throat, out of the nose or down the throat.
That can be an issue with a liquid product as far as drainage down the back of the throat. As far as formulation pH, the neffy product does require acidic formulation. The Nasus product does not. The acidic formulation of the liquid is for stability of the epinephrine. If we look at excipients for stability, there's no antioxidant preservative required for the powdered product, the Nasus product, compared to what we see with neffy, where we have sodium bisulfite, which is an antioxidant, and benzalkonium chloride, which is a preservative. If we look at some of the different attributes between the Nasus product and Anaphylm, one is administration during distress. Again, since it's intranasal, one can, even in distress, usually get that into the nose. The placement of the film, in some cases, it could be difficult, so that needs to be looked at.
As far as angioedema, there's no evidence as far as the nasal tissue of significant angioedema. One can see angioedema develop with anaphylaxis in the throat, the sublingual area, and that may limit as far as some of the absorption. We have limited data in true anaphylaxis, though I will mention that Anaphylm had to do a study with the oral allergy syndrome to replicate that, which in fact can lead to some mild swelling in the throat, and they were able to show normal absorption there. The FDA had required that test. As far as taste, there's no bitter sublingual taste, and virtually no taste with the powder. A bitter taste is possible in some patients with Anaphylm. The required holding time, obviously nasal spray is rapidly administered. The film, though, needs to stay under the tongue until it's dissolved.
From the literature that's been reported by Aquestive to this time, they talk about seconds as far as the absorption to occur. Again, if the patient doesn't leave it there, they're not going to get the full absorption. You also have that early removal risk if the patient accidentally spit it out or removed it prior to, again, it dissolving completely in the sublingual area. Why, in fact, should we be looking at this product, and what's the investment thesis here? I think this is a validated market. I can tell you as an allergist, I've been waiting for products that did not require a needle with the hope that patients would be able to have a smaller device that they could carry with them and use when it needs.
I think we can already see the strong market that neffy has, and I think that's just going to continue to grow. I showed you the strong PK data with the Nasus product compared to EpiPen, especially that quick onset of action getting to the T100 pg/ml . We have direct delivery here of epinephrine into the nose. Unlike a sublingual product that is a prodrug that has to be broken down first, down to epinephrine, and then one gets absorption. Then we have the powder advantage here. It has a very long shelf life. There's no refrigeration, and we showed the data, in fact, that it does work in congestion. The bottom line here is that we see this and it shouldn't be happening, and that is anaphylaxis killing patients who in fact have EpiPen and they just won't inject it.
As I mentioned, I think the needle-free market is going to continue to grow. I showed you the results in the phase II study of the quick onset of action with the Nasus product compared to EpiPen. We've gone on over the attributes that I think are very important related to the dry powder, and I think it really does differentiate from the other product that is on the market and the possible approval of a sublingual film in the near future. The pivotal study for the Nasus product will start in the fourth quarter of this year. I don't think there's any doubt now that the needle-free epinephrine market is a real market. I think that neffy has demonstrated that, and I believe it'll continue to grow.
I think that there are attributes here that are associated with the Nasus product that really should in fact help them to grow and build, hopefully with approval, and can be a market leader in this particular epinephrine rescue area. With that, I'm going to turn over to Dr. Joel Brooks for the next presentation.
Thank you very much, Dr. Blaiss. My name is Joel Brooks, and it is a pleasure to be with you all this morning. I'm here to talk about the unmet need for the needle-free epinephrine, the practicing allergist perspective. What are we seeing in patients, what are patients telling us that they need, and how are they functioning? What discussion do we have with them? First thing we have to talk about is what is the burden of food allergy? As Dr. Blaiss mentioned, this is a growing problem. Approximately 8% of U.S. children, millions of kids, have IgE immediate food allergies. 40% of children have multiple food allergies. About 10%, a little over 10% of the U.S. adults report food allergies, and that number is going to continue to grow as these pediatric patients become adults.
Pediatric anaphylaxis ED visits have increased approximately 3.2-fold from 2008-2016, and that number just continues to go upwards. We are looking at an upwards trajectory of children and adolescents being disproportionately affected by anaphylaxis, by food allergies. On the left here, we can see some of the examples of some of the more common food allergies. Peanut and milk are the ones we always think about, but shellfish and tree nuts are growing. This is over the course of a child's lifetime. Otherwise, egg is another common allergy. The truth is we have nine different food allergies, major food allergies, that are required on FDA labels of foods because food allergies are becoming so prevalent and so common. What does that look like? That looks like 42% ED visit rate.
Food allergic children with at least one food allergic related ED visit in their lifetime, with approximately 19% in the past year. There is a 2% lifetime prevalence for U.S. anaphylaxis, with ranging between 0.5%-2%. Children and adolescents are at the highest risk. Peanut is the leading cause of fatal or near fatal food-related anaphylaxis in the U.S. As noted, adults do have anaphylaxis from other issues related to medications, there is stinging insects, but when it comes to food related, peanut is still the most common that we see. These are not rare events. This is a life and death situation. Not often do we have such powerful, such well-functioning medications for such severe medical issues. What does that look like for patients and their families? What is the actual day-to-day, the daily burden for them? Studies do show food allergy significantly impairs quality of life.
Adolescents more affected than younger children. Why is that? It is because when kids are younger, they are infants, they are toddlers, their parents have a lot more control over their diet, over what they do. As kids get older, they start wanting to go out with friends. They start going to school. Suddenly their food allergies are significantly impairing their quality of life. Parents experience substantial psychosocial burdens, worse with multiple food allergies, severe reactions, trace exposures. What that means is the higher, then the greater likelihood of having a reaction to whether it is more foods, whether they have seen their child have more severe reactions, or whether it is the child is so sensitive to a food that even trace exposures, like the remaining trace that is on an ice cream scooper at the store is enough to trigger a reaction. This significantly increases the caregiver burden.
That is driven by the unpredictable threat of exposures, daily allergen management. This increases the anxiety, the dietary restrictions, and the social isolation, which is not just applied to the patient. It extends to the entire family. Suddenly families no longer go out to eat because they are afraid of having a reaction. Suddenly their child who was invited to a birthday party can no longer attend because they are afraid that if they go, their child is going to eat something. There is no more play dates for the family. That affects both the child and his ability to socialize, but also the family and their chance to leave their home, experience new things.
As studies have also shown, unfortunately, kids with food allergies are more likely to be bullied at school. Again, this increases that anxiety, the depression, all related to just the fact that they are allergic to foods.
That leads us to epinephrine. As we have mentioned today, it is the only true life-saving treatment that we have. It is the only approved first-line treatment for anaphylaxis. Delayed administration is associated with increased risk for biphasic reactions, hospitalization, and unfortunately, death. Most patients who died from anaphylaxis did not receive their timely epinephrine. This leads to the, whenever I am talking with a patient, I always use the analogy of a train leaving the station. The train leaves the station and you pull the brake, train stops. You let the train leave the station and it is going 60 mi/h and you pull the brake, the train is going to eventually stop, but it is not going to stop for miles and miles. Epinephrine works much the same way.
The faster we use it, the more beneficial it's going to be and the more we can head off the morbidity and mortality that's associated with allergic reactions and anaphylaxis. It works through vasoconstriction, bronchodilation, and helps stabilize the mast cells themselves. Pre-hospital epinephrine administration decreases the likelihood of hospital admission, yet there's still a massive gap between what should be happening and what actually does. Guidelines for anaphylaxis treatment have even been updated to suggest that if we use epinephrine in a timely enough manner after an allergic reaction and the symptoms resolve with just one dose, patients don't even have to always go to the emergency department. They can actually stay home. Under supervision with an adult, or if they are an adult, best to be around other fellow adults.
The idea is that if symptoms do resolve with just one epinephrine dose, they don't need to go to the emergency department. It doesn't have to be that reflex. That's significantly important for your family of four that's at a soccer game when one child has an allergic reaction. Suddenly it's no longer a question of, well, if I give the epinephrine, I have to bring them to the emergency department. Now it's we can watch them if they improve with just one dose. What's the unmet need here? As we've discussed today, the carrying rate, and this ranges between if it's pediatrics versus adult. Figure on the low end, we're looking at 44% of patients are carrying their epinephrine at all times, which means quite a few people are not. Millions are not carrying their epinephrine device. Non-use. Why by adults?
Well, 52% of them report not using their epinephrine auto-injector during their most severe reactions. There's our reliance on over-the-counter medications. 88% will use diphenhydramine alone. 89% used their over-the-counter medications before epinephrine, then there's the delay in treatment. There's an average of about 8.8 minutes before epinephrine administration among those who hesitate. Again, time is critical here. The faster we use it, train leaves the station, you pull the brake immediately, we can stop this. Patients are being prescribed their epinephrine, they're not carrying it. If when they do have their medications, they hesitate to reach for it, they're using the antihistamines, this does not treat anaphylaxis. What are some of the reasons that patients will report? This is particularly true in the pediatric population, but it does apply to adults as well.
The big and most important impact factor is needle fear. Nobody, especially kids, appreciate needles. They'll fight you on it. They will put up as much resistance as possible. Even in the office when we're treating anaphylaxis due to a food challenge, kids are very resistant to receiving any form of needle or any form of injection. Device size and bulk. It's bulky, it's hard to carry, doesn't fit well in a purse, doesn't always fit well in a backpack. We have to think about where we're going to store it. We don't want it to be in too hot or too cold location. There's the stigma of carrying a perceived weapon-like device. There's also a major lack of training and confidence.
Typically, in the office when I am having somebody practice using their EpiPen or their whatever form of auto-injector they have, the most common thing I see is, apart from leaving the safety on, once they remove the safety and they go to inject, they immediately remove the device instead of holding it against the skin as they are supposed to for at least five seconds, ideally. With that in mind, during an emergency situation where there is a lot going on, people are panicking, child's screaming and kicking, they go to administer it. If they forget, and it is very common to forget to hold it against the skin, the child might not even be getting the medication that they need. Then there is a prescription gap. Not every patient has an active prescription, and there is a couple of reasons for that.
Some of that relates to they have not seen their allergist in over a year, and they are meant to get new prescriptions on a more yearly basis. Some of them have not seen them for many years, and some just prefer and decline the prescriptions. First things first, we have to address this needle phobia problem because it is highly prevalent in children and adolescents, but it is not fair to say that that does not exist in adults either. Parents may hesitate to inject their child during emergencies. Again, that pause is critical. That pause is life-threatening. Auto-injector technique can feel intimidating during high-stress situations, very much so. I have even witnessed parents trying to administer it, and again, they immediately might go for the injection, but they are pulling their hand away immediately as well. How much of that medication is actually that patient receiving?
Children at the highest risk are often the least likely to receive that timely treatment that they need. That leads us to the case for the needle-free intranasal epinephrine. From a practicing allergist perspective, we need a device. We need a device that patients will use and carry. Intranasal delivery removes the single biggest barrier, the needle, as well as other issues, too. It does eliminate the needle fear. That is the primary driver of non-adherence. It is a more compact size, which will increase the daily carriage rates. It is a simple administration. There is no injection requirement. It does have comparable pharmacokinetic and pharmacodynamic data to the intramuscular injection. We have already seen it being used because FDA did approve an intranasal epinephrine in 2024. We are already seeing its use in the general population. With that in mind then, how do patients feel about this?
Data that was presented at the American Academy of Allergy, Asthma & Immunology shows that 75% of adults reported willingness to immediately use intranasal epinephrine versus 50% with auto-injectors. 78% of adolescents reported immediate willingness versus 69% with an auto-injector. The largest difference was observed amongst the needle-phobic participants. Whereas the first two points we are looking at the population study as a whole, they further broke it down by patients with needle phobia. The greatest difference, again, was noted between needle-phobic adults and adolescents. This data does suggest that reduced treatment hesitation with needle-free devices. HAPA preferences. 75.5% of adults reported likely or very likely to carry intranasal epinephrine versus only 67% were willing to carry the auto-injector. Amongst needle-phobic patients, that difference was even greater, so 81% versus 55% in favor of intranasal epinephrine versus an auto-injector. What else do patients mention?
They prioritize faster symptom relief and low device failure risk. They wanted a device that was going to not fail them when they needed it and was going to provide the fastest relief possible. Caregivers place great importance on route of administration, i.e., being able to dose intranasally versus having an auto-injector and having to administer a needle. Needle-free administration improved preference scores clearly, and the portability and simplicity influenced treatment decisions, meaning patients are no longer being asked to carry these bulky devices. They seem to be much more willing to carry some form of epinephrine. What are the critical attributes of the needle-free products? Try to remember SPEARS. SPEARS. First, S, speed of onset. Comparable or faster PK and PD to IM injection. Intranasal products do show rapid absorption, as we've seen from the prior stage studies. Portability. Compact size increases carriage rates.
First E, ease of use. No injection technique required. Simple nasal administration reduces user error. It's that simple. Efficacy in the real-world conditions. Nasal congestion, upper respiratory infections may actually enhance absorption, so it doesn't seem to be a limiting factor at all. R for reliability. Low device failure rate. This was a big concern for adult patients. Last S for stability. Room temperature storage, longer shelf life reduces waste, it reduces cost. Just remember SPEARS. Ultimately, how do I discuss epinephrine options with families? I emphasize the immediate epinephrine use for severe reactions. I emphasize and address barriers. What are they? The needle fears, the carrying habits, the prior experiences patients have had. They've lived this, especially adults, they've lived with this usually for so long. What are their concerns? We sit down, we have this discussion. We discuss the available delivery options.
It's important to empower adolescents with self-management strategies because ultimately we want them to be willing to carry the devices. It's no longer just having the discussion with their parents. We want the pediatric patients, we want the kids to be able to weigh in and have their own opinions and address their concerns. Shared decision-making improves adherence, as we've seen. The best epinephrine device is the one that patients will carry and use. As we've seen from past couple studies here, patients want, they're interested in this intranasal device. They want needle-free options for the treatment of anaphylaxis and their allergic reactions. Key takeaways. How are we going to close this gap? One, we know this is a growing epidemic, unfortunately. Food allergies disproportionately affects children with significant morbidity, mortality, and psychosocial burden. This is just an increasing problem. It's not decreasing, unfortunately.
There's dramatic underuse. Epinephrine is the only life-saving treatment, yet needle-related barriers drive dramatic underuse. Needle-free solution. Intranasal epinephrine addresses the core barriers of needle fear, device size, ease of use. Patients want this. There's a proven preference where the data is showing that patients significantly more willing to carry and immediately use a needle-free device. The takeaway from this is that patients are ready for alternative options to the auto-injector. They want alternative options to the auto-injector, most importantly, they're more willing to carry and to use alternatives to the auto-injector. With that in mind, the intranasal epinephrine is a phenomenal move forward for our patients. With that, I conclude my presentation.
Great. Thank you, Dr. Brooks. At this time, we'll be conducting a question- and- answer session with our speakers. To our analysts joining us live, please use the raise hand feature to indicate you have a question. Please hold for a brief moment. Our first question comes from Yale Jen at Laidlaw. Please go ahead, Yale.
First of all, thanks for taking the questions. It's a very insightful presentation. It's very helpful. Basically, I have two questions here. The first one is that giving the benefits of NS002 and with the assumption that maybe there's two more product may be approved by the time NS002 to be approved. The question is for the two doctors, how would you prioritize your patient that initially to take NS002 versus others? Because I assume that obviously can be used for all patients. Initially, how would you prioritize what type of a patient to use this first?
Dr. Blaiss, you wanna take that?
Sure. I think with all the patients, there's several things that I look at. When we have different products that have different attributes, I use what we call shared decision-making. In other words, going over the different products with them. What are their pros? What are their cons? A big part of it is also coverage out there as far as whatever type of health plan, and in fact, they're on. I think to me, one of the keys here, and I think you saw that from the survey that Dan showed that they did at last year's academy meeting, is that onset of action of the product. I think that one of the leads here for the Nasus product is, again, that very fast onset of action.
I think that's one of the key things that I think differentiates here, compared to the other products out there. I think that would be one of the things that I would definitely discuss with the patient.
Okay. Great. That's very helpful. Maybe just a follow-up here, which is that would you initially prescribe this to a patient that already have a history of anaphylactic, have the episodes, versus the patient, they may or may not have a prior history? I have a follow-up question for the company. Thanks.
Definitely if the patient has had an anaphylactic reaction, then obviously they would be a candidate for this product. If I'm understanding, if a patient has not had an anaphylactic reaction, and there are cases where we give epinephrine in those cases, if a patient, in fact, is on a sublingual immunotherapy tablet for their nasal allergies, it's recommended in the product insert that they have epinephrine. I think it's very important in these cases that they have an epinephrine that they'll use, that they can carry with them. Again, that is a fast action if, because they'll be using this treatment at home, therefore, something that'll work rapidly at home to counteract the anaphylactic reaction. I think this product would fit into that category also.
Okay, great. That's very helpful. Maybe just one question for the company, maybe even for the doctor as well. That given the better outcome, the phase II outcome, when you compare to EpiPen, specifically in T100 and maybe also in Tmax, would the company could consider-- I understand that the non-inferiority is the gold standard for approval. Given the attributes of NS002, would you also may be adding superiority consideration in the future clinical development, maybe potentially demonstrate a better outcome, and maybe have some commercial benefits as well? Thanks for hosting the conference.
Thanks, Yale. Appreciate you joining the call and for your thoughtful questions. In regards to your last question, we do not plan at this point to have any superiority or any other type of clinical studies compared to EpiPen. We are following the FDA guidelines and recommendation as it relates to the development of a needle-free epinephrine. What happens post-approval will be determined at that point, based on various considerations and needs.
Okay, great. Thanks a lot. I appreciate the hosting the conference, the KOL course.
Thanks for the questions, Yale. Our next question comes from Jason Butler at Citizens. Please go ahead, Jason.
Hi, thanks for taking the questions. Again, thanks for hosting this. Couple for the physicians to start with, and then I have a follow-up for the company. Can you speak to any direct experience with neffy in the commercial setting? Whether or not in your experience the product has had any positive impact on willingness to administer drug relative to the auto-injectors or avoiding delaying administration? Second question, based on the phase II results you've seen for NS002, how clinically meaningful are those differences, those improvements in time to the therapeutic threshold? How clinically meaningful are those changes versus what you see with auto-injectors? Thank you.
Thanks, Jason. Dr. Blaiss, can you start by answering the second question around the clinical meaningfulness? I'll open it up to both Dr. Blaiss and Dr. Brooks to comment about their experience with neffy.
Well, again, we don't have any head-to-head studies. We can't do studies of patients having anaphylaxis, giving them the different products to see, in fact, what would happen. I have to look at the different products, PK and PD levels and make a decision there. Again, I think it gets back to what would have the quickest onset of action, that would get to a level that as the FDA looks at that 100 pg/ml , I think that's very important here. I think as far as the way I look at it, I think that's an important measure as far as determining what product I would want for my patient, to have a very rapid effect as far as controlling their anaphylaxis. It doesn't mean the other products don't work, because they absolutely do.
It's one of the measures that I look at as far as deciding what I think may be best for a particular patient.
While you're on it, Dr. Blaiss, you want to comment potentially on your experience with neffy?
Yeah. I think neffy has been an excellent product. There's no doubt that patients have used it that would not normally use their EpiPen. In most cases because they're carrying the neffy product and they're not carrying the EpiPen. I know of patients where they were at a restaurant, they were having the start of a reaction. They used the product, it worked extremely well. As Joel had mentioned before, with some new guidelines, a patient did not have to go to the emergency department and was able to continue at the restaurant with their family. I have heard of a few patients, hadn't been mine, that have had some nasal irritation with the product. In general, basically everything I've heard it has been very good with the product.
Dr. Brooks?
Yeah. I actually can speak to it firsthand, secondhand in terms of use of neffy and how effective it can be and how it's changing the way, especially in pediatrics, patients are carrying it. My own niece and nephew, both have food allergies, and historically, they were not always the best about carrying their auto-injector devices. Since they got neffy they actually have it clipped to their backpacks, and it goes with them wherever they go. In fact, my nephew had, unfortunately, recently in the past year, had a very significant allergic reaction while eating at a restaurant. It was unknown, and he started having a full-on anaphylactic episode, and whereas in the past, it's been a fight to get him to use his EpiPen he immediately jumped to using neffy and immediately felt better.
Truth is, he said he was absolutely thrilled with using the intranasal device. That's a story that I've had mirrored by many other patients. Several patients have come to me the moment it became `FDA approved and said, "Hey, when can we start? When can we get this device?" That goes for adults and kids. Firsthand experience I have, I've actually used it in my office during food challenges, for the treatment of allergic reactions, and it does appear just as effective, when used quickly and appropriately, as an auto-injector or if, especially as what we use in the office, the needle and syringe model of we actually draw up the epinephrine. It's a far more effective, far more efficient option.
Yes, I can speak to it's definitely changing patient practices where patients are now far more willing to carry and use it. Practically speaking, those who are using it are happier with that device versus doing the injections. I have also, just like Dr. Blaiss said, one or two patients report some irritation from it. Based on their reports, they don't mind the irritation compared to the feeling of injecting a needle.
Great. Thank you. Dan, can you just speak to what the steps are between now and starting the pivotal study? What needs to be done? Is anything time gating? Thanks.
Yes, for sure. Thanks, Jason, for joining and for your questions. Between now and the initiation of the pivotal study, as we indicated in Q4, we're primarily focused on the production of the large-scale batches that are needed for the phase III and then registration. As soon as we are done with producing the larger scale batches, we will be ready to initiate the phase III.
Great. Thanks for taking the questions, and thanks again for hosting this.
Thank you.
Thanks for the questions, Jason. Our next question comes from John Vandermosten at Zacks. Please go ahead, John. John, you might be on mute. All right. It looks like John is having some technical issues right now, so we'll just go to the questions on the webcast. The first one reads, "Would you prescribe NS002 as a first-line replacement for EpiPen if phase III data confirms the absorption advantage?"
Thanks, Tara. I'll refer the question to both Dr. Blaiss and Dr. Brooks.
I can start. Absolutely. With the comparative data, that's what the FDA is looking at, both the PK and PD data. There's no doubt that I would definitely prescribe it, especially with the attributes we mentioned, instead of EpiPen, if approved by the FDA.
I'll echo that and say that with the data showing how quickly and how effective the PK and PD data is, I would absolutely prescribe it as first line, instead of a auto-injector of any kind.
Great. Thank you. The next question, "How do you view pricing and reimbursement for the new entrants versus EpiPen in the U.S.?"
Yeah, I'll take this. Obviously, pricing and reimbursement seem to have been a challenge for neffy. We hope that ARS does or continues to do a great job in securing reimbursement, and getting over hurdles around prior authorization and such. We have a bit of time to get there. I think from our perspective is that once ARS has worked through all those issues, new entrants to the market would have or should have an easier time to get past reimbursement and coverage.
Great. Thanks, Dan. Next question. Do you feel the market can absorb three new entrants? If so, how do you see EpiPen market share in five years?
I'll take this, then I can turn it over also to Dr. Michael Blaiss and Dr. Joel Brooks. Certainly, the market can accommodate more than one needle-free product. As we talked throughout the discussion today, throughout the presentation, this is a very large market. There are, unfortunately, many patients, millions of patients in the U.S. that are at risk of anaphylaxis and should be using an epinephrine product. Only a fraction, as we heard today, are actually getting a prescription or carrying the product with them as they should. Which means that the biggest market opportunity as we see it is not those just switching from EpiPen to a needle-free, but it's actually all those majority of patients who are electing right now not to have an epinephrine product or an epinephrine auto-injector with them.
With the introduction of needle-free products, we certainly see a switch from EpiPen, but we see a lot of new patients or new starters moving to those products. With millions of patients who could benefit from those products, we can certainly see multiple products being effective or multiple products being used. I think at the end of the day, as Dr. Michael Blaiss and Dr. Joel Brooks have discussed, there will be a discussion between the physicians and the patients around preferences and around other elements. We are confident that given the data we have for NS002, with its faster onset of action, with the large proportion of patients who reach the therapeutic threshold at very early time points, both of them are critically important and clinically meaningful.
The potential for a longer shelf life, we think our product really has the potential to be effectively competing in this needle-free market. Dr. Blaiss, anything you want to add, or Dr. Brooks?
Yeah. I always look at it, at allergy, the more different products I have and I can discuss with patients and get their opinion on, I think it's better for us and for the patient. Some may prefer a strip under the tongue versus a nasal spray. I think all of that is extremely important. I think there's a big underuse here. I think one is it will definitely grow the market to have more needle-free options out there because patients a lot of times won't even fill the EpiPen once you tell them it's got a needle and stuff. They won't even go get it. Having that. If you think about basically every restaurant should keep a needle-free epinephrine device.
Think about the airlines. I know that's been an issue that the allergy organizations have been working on for years, as far as getting devices onto airlines. It's something that really should be everywhere because we don't know when in fact an accidental anaphylactic reaction's going to occur. One is, as Joel mentioned, the increased number of patients that in fact are having anaphylaxis. Even though we're seeing treatments for food allergy, and we have omalizumab, all those patients still have to carry epinephrine. It doesn't get rid of the need for epinephrine, any of these treatments that are out there that are being done for food allergy. This market's going to continue to grow.
Great. Thank you. Sorry, Joel, did you have anything?
I was just going to second that, in that I think number one, there's plenty of space for all the products that are out there. In fact, I had this conversation with some of my own mentors who are very excited about the upcoming needle-free products in epinephrine at our last couple allergy meetings. There's a lot of interest. There's definitely a lot of space. Unfortunately, there's a lot of patients that are in need of this. To the last point of the question, which was where do we see the EpiPen share in five years from now is, in truth, the hope is that there will be more needle-free options, and the epinephrine share will go down because ultimately what we're seeing is patients want and are more willing to have a needle-free epinephrine device versus a needle-containing epinephrine device.
I do see that share decreasing with time.
Great. Thanks, Joel. We have John Vandermosten at Zacks who was able to fix his audio. Please go ahead, John.
Great. Thank you. I hope you guys can hear me now. Thank you for the presentation, Dr. Blaiss and Dr. Brooks. A question on your neffy patients that you prescribe to. Are these new patients that come in with new allergies, or are they experienced patients who had already had the EpiPen and just see so many shortcomings that they want to switch to something else? I'm also wondering the main reason, you mentioned needles, but there's a whole bunch of other reasons, too. Like you said, shelf life, size issues, and probably a bunch of other things. I'm wondering what the priority list of that would be why they would shift to neffy or nasal administration.
I concur. One, they've heard about it, they're interested to know if it's right for them or their child. Two, if it's a new patient, I go, again, shared decision-making. Everyone has heard of EpiPen. It's like Kleenex. Okay? Everyone knows about EpiPen, but a lot of the patients have not heard yet that there is another option out there. Discuss that with them and let them make a particular decision. Again, part of it is coverage and cost. We also have to look at that. Then there are patients, again, that have been on an EpiPen, they've heard about it or they've had a friend that's been on neffy and they would like to switch, and they want to know if that's okay. I mean, it's all of these scenarios that have been seen.
Okay. Dr. Brooks, did you have anything to add to that discussion?
Similarly, I'd say when it first came out, I had, interestingly, it was in the few months before it came out that I started having patients who were currently on an epinephrine auto-injector reaching out saying, "Hey, is this option out there? I've been hearing about this new product that's just a nasal spray." I'd say the first couple patients I transitioned were along the lines of people who were actually actively requesting to transition from an auto-injector. From there, new patients, it's very much a shared decision-making. There are those who will still ultimately prefer the old methods, or it's what somebody else in their family had, and they understand it, so they'll stick to that.
A lot, I'd say, of new patients, especially those with young kids who are just beginning their food allergy experiences, meaning they're the first in their families to have some form of allergy that requires an epinephrine device, that they're now far more open and much more interested in discussing the needle-free options. That's, I'd say, is the kind of population both. It's a mixture of both those who are transitioning from one device to another versus the new patients that are coming in that are requesting it.
To the point that we mentioned about patients, for example, with food allergies who are going on XOLAIR and that, as a case in point, it's actually typically most clinics will have a requirement that if you go on XOLAIR, regardless of whether it's for food allergy, anaphylaxis prevention, or any other indication, it's actually most clinics will have a requirement that they need some form of epinephrine device also. The need is still definitely going to be there, even with these kind of "treatments" that are available.
Okay. My next question is on the spectrum, I guess, of allergy, severe allergy, and propensity for anaphylaxis and how you look at those patients and where the cutoff is. I guess I don't really quite understand where anaphylaxis starts and perhaps epinephrine is needed prior to that. It would still be helpful, but I was hoping you could help me understand that spectrum and where you look at the point where it's appropriate to have one of these devices?
You bring up a point that has been debated in allergy for years now. How do you define anaphylaxis? In fact, we have different guidelines from different organizations that, in fact, define anaphylaxis differently related to what organ system's involved and certain symptoms. I think it is very hard to say black and white. In certain cases, it's hard to say black and white that that patient has had an anaphylactic reaction. I think I always err that if there's a question, it sounds like it may have been an anaphylactic reaction, I have no problems giving a patient epinephrine. One is, even in patients that are elderly that have severe cardiac disease, if someone is having anaphylaxis, you still give epinephrine. That is still the indication.
I think any time that I think from the history, if I can't completely document it, I'm going to give the patient a device with epinephrine. I'm not gonna take any chances. I will tell you at times that it's hard to tell for 100% whether that patient's previous episode that they're sent to me for was an anaphylactic reaction or not.
Okay. Yeah, go ahead, Dr. Brooks.
Yeah. I'll say to that also, to that point of if there is a doubt, my old teacher used to say, "If there is a doubt, there is no doubt." Meaning if you're thinking that there could be anaphylaxis, I will always err on the side of caution of treating it like it was anaphylaxis because ultimately there's very, very little side effect from overuse of epinephrine, meaning using it, jumping the gun to use it quicker than versus the opposite of hesitation. The train leaving the station analogy. Again, you stop, pull the brake as the train leaves the station. You stop whatever is going on, whether or not it was a mild reaction or more severe one. If you let that reaction build up, suddenly that train leaves the station and it's going 60 mi/h .
You pull the brake, it's not gonna stop for miles. Same thing with allergic reaction. If the reaction is allowed to go far enough, suddenly one device might not be enough. Suddenly they might need two. Suddenly they need to go to the ER and then potentially need an epinephrine drip. They might even need the ICU. The faster we use it, the better. To the point of there is the diagnostic criteria for anaphylaxis does change depending on the guidelines. I usually personally for my patients counsel them that, yes, the standard is two organ systems involved.
If we're seeing what I call systemic symptoms, meaning they start breaking out in hives, but the hives aren't just localized to the face, but they're now spreading across the body, or they start to cough and no other symptoms, it's a new onset cough or that, I'm typically going to tell them, "You got those symptoms. You had a possible exposure. Don't take a chance. Just use it and then let the symptoms go away." If they don't go away, then we know we definitely are in trouble. I always err on the side of caution. If I make the diagnosis of any form of food allergy, for example, they're going to walk out the office with a prescription for an epinephrine device.
Let me just say one other thing real quick. I tell every patient that if you think about using epinephrine, use it, because you're never wrong using epinephrine. You can only be wrong not using epinephrine. Every patient I tell that to before they leave the office.
Thank you. Last question, just a quick one for management. How will the pivotal study be different from the phase II study?
Thanks, John. We're still working on the final details of the pivotal study, but it will differ from the phase II study in two main aspects. First off, it's going to be in healthy volunteers as opposed to the subjects with allergic rhinitis or history of allergic rhinitis that we had in our phase II. Secondly, it's going to be a simpler study because it's not going to involve all the different arms that Dr. Blaiss mentioned. It's not going to be single dose, repeat dose, and the like. It's going to be a single administration of the Nasus product compared to EpiPen and compared to an intramuscular manual injection. Healthy volunteers, three arms, as opposed to the allergic rhinitis and the multiple arms we had in the phase II.
Great. Thank you for the questions, John. This concludes our Q&A session for today. Dan, I'll turn it back to you for quick closing remarks.
First off, thank you everyone for joining us today. I hope this was a very insightful and productive discussion. I want to thank very much our guest speakers today, Dr. Blaiss, Dr. Brooks. You have done an excellent job in your presentations. If I would like you to take away something from today's discussion, one is the product profile for NS002, our powder intranasal epinephrine, with the potential to be the best in class in the needle-free category, given the very fast onset of action, the longer-term shelf life, the percentage of patients who reach the therapeutic threshold at very early time points. We think the product could be extremely competitive in what we discussed is a large and very much growing market. In addition, Nasus, ticker symbol by the way, NSRX, for those of you who are not familiar, is really developing a pipeline of products.
I mentioned the intranasal ondansetron, which we released data yesterday moving into clinical studies, our continued focus on expanding that pipeline and generating additional value for the company and our shareholders as we develop additional products going into 2026 and 2027. With that, we can finish for today. Again, thank you everyone for joining, happy to continue the discussion if there's any other questions