Hello, welcome to the Life Sciences Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small Cap Research, we are very pleased you have joined us. The next presentation is from Nasus Pharma. Their session will be moderated by John Vandermosten, Senior Equity Analyst with Zacks Small Cap Research. Please note you may submit questions for the presenter at any time. You can also view a company's availability for one-on-one meetings by clicking "Book a Meeting." At this point, I am very pleased to welcome Dan Teleman, Chief Executive Officer, and Eyal Rubin, Senior Vice President and Chief Financial Officer of Nasus Pharma, which trades on the NYSE American under the symbol NSRX. Welcome back, Dan and Eyal. Thank you, Lily. Well, great. Dan, Eyal, thank you for having me on here with you today and getting the chance to ask you some questions. As a brief introduction, Nasus Pharma is developing a powder formulation that converts active pharmaceutical ingredients into nasally administered products. With that very brief introduction, Dan, why don't you give us a summary of what your drug formulation technology is called and how it works? Thank you, John. First off, thanks for having us. Always a pleasure speaking with you and the audience, looking forward to the opportunity to share the Nasus story. To your question, our technology's called Nasax. It's very unique. It's a proprietary technology to Nasus, which is based essentially on particle engineering, and the technology has two key features. One is the ability of the technology to control the particle size. We create very tiny particles, five to 35 microns, and this is the optimal size range for intranasal absorption. The other key feature of this technology is the ability to create spherical particles. This combination of the tiny particles, their spherical shape, really creates a powder formulation that penetrates deeply into the nasal cavity, reaching the inner parts of the nasal passage, where there's a lot of vasculature, which enhances the absorption of the product. Dan, the company right now has a lead indication in anaphylaxis, which is an important area that patients with severe allergies can undergo. Give us some background on where you are right now in your development program for anaphylaxis and your candidate, NS002. With pleasure. As you rightfully said, our lead product is in the anaphylaxis space. Anaphylaxis, for those of the audience that are not familiar, are severe allergic reactions. They're very common. We're all familiar or know someone who is allergic to nuts, peanuts, milk, poison, medicines, and so on and so forth. A very common disease. We are developing our proprietary powder intranasal epinephrine for the treatment of anaphylaxis. This product is heading into its pivotal study, its phase III study, in Q4 of this year. We've already completed several clinical studies with the product, with the intranasal powder epinephrine. In all of them, we consistently demonstrated superior absorption of our product, having faster absorption and higher absorption compared to EpiPen, which is the current standard of care for anaphylaxis, EpiPen being the epinephrine auto-injector that I'm sure a lot of people are familiar with. The next question I think probably people would have is what is anaphylaxis? I think we probably all know a little bit what it is, but there are also a mechanism of action in the body that responds to allergens, that I thought you might give us a basic explanation of so people can understand what the condition is. Yeah, for sure. We'll try and do a very simple biology. Allergens trigger an immune response in our body, right? People that have allergies, that triggers an immune response, and that immune response, in return, triggers various systemic manifestations in different parts of the body. It could be in the skin, it could be the lungs, it could be the heart, it could be in the GI tract, or a combination of all of those. For instance, if we look at the cardiovascular system at the heart, we see blood pressure drops, so what we call shock. You could have respiratory arrest. You could have skin manifestations like angioedema. This is that swelling of the mouth, of the lips. Patients could have diarrhea, could have vomiting, could have nausea. A whole lot of symptoms could occur during an anaphylactic reaction. The key to treating an anaphylactic reaction is really to administer epinephrine as quickly as possible. I think epinephrine is the standard of care to treating anaphylaxis, has been so for many years, probably 100 years at this point. Giving epinephrine really then reverses all those effects of the anaphylactic reaction. You guys had a KOL event just a few days ago, where you had some experts in the space talk about some of the key elements of treating anaphylaxis, that, as you said, epinephrine is the standard of care for addressing that. What is the most important factor in addressing anaphylactic shock? Obviously you need to administer epinephrine, how should it be administered? Correct. You're absolutely right. The most important thing in treating anaphylaxis is administering epinephrine. The key is to administer epinephrine as quickly as possible. Data and studies have shown repeatedly that delayed administration of epinephrine leads to worse outcomes. It is key, it is paramount to administer epinephrine as quickly as possible. As we said a couple of times already, the standard of care today is EpiPen or epinephrine auto-injectors. There's several of them out there in the market. They have some very significant limitations, primarily around compliance. EpiPen and the like are auto-injectors. That means that the patient needs to administer the product themselves. They need to inject themselves with the auto-injector, or a family member needs to administer the patient with the auto-injector. There's a lot of issues associated with that. There's a lot of compliance issues. Patients are hesitant to administer EpiPen or epinephrine auto-injector many times. They do not carry the EpiPen with them at all times. They hesitate using it even though they recognize the symptoms of an anaphylactic reaction. Despite the availability of an epinephrine auto-injector the data shows that about half or 60%, half to 60% of the patients do not regularly carry EpiPen, do not use it properly, or do not use it at all, delay the usage of EpiPen. This concept of needle-free epinephrine, which our product is, it is a needle-free epinephrine product, is very enticing in this space because it really addresses all of the limitations of the epinephrine auto-injector. Being needle-free really reduces the hesitancy of many patients to administer. It is small. It is very convenient to carry, again, reduces the issue or the barrier of carrying the product. Now in specifically to our product, because we're using a dry powder, we have a very long shelf life compared to the auto-injectors, which have a limited shelf life because of the liquid nature of the epinephrine in those auto-injectors. In my mind, the most important factor in doing my background research is getting the epinephrine into the blood plasma so it can take effect. Allergic reactions can happen very quickly, and you showed how the NS002 works compared to EpiPen in your phase II study. Give us a summary of some of the key metrics there that you generated in that study. For sure. Just before we touch on this, just this is a great way to continue the discussion around the event. The KOLs after discussing the issues around anaphylaxis, the usage of epinephrine product for that matter is really its onset of action. The faster the product, meaning the faster the epinephrine gets [asthma] that are effective, the better the product is, the better the outcome of the patient is. The fact that onset of action is probably the most important parameter when physicians are choosing an epinephrine product. What we have demonstrated consistently, including in our most recent phase II study, which we announced back in March, is that we have a very fast onset of action. When we say onset of action, we look at several parameters, again, all around pharmacokinetic properties and parameters. The first one is what we call Tmax. This is the time for epinephrine to reach the maximal concentration in the plasma. In that regard, we were shorter than EpiPen by about five minutes, this is very, very important because, as you rightfully said, anaphylaxis is a very fast-progressing condition, could become fatal within a few minutes. About 30%, by the way, of patients in an anaphylactic reaction had that reaction occur within about three to five minutes. Getting to a short Tmax is critical. The other important parameter that we demonstrated in our phase II study is called T100. This is the time to reach a certain level of epinephrine in the blood, in this case, 100 pg. This is considered by the literature to be the threshold for efficacy for epinephrine. Epinephrine needs to get to a level of at least 100 pg in order for it to exert its hemodynamic effect, increasing blood pressure and heart rate. What we demonstrated in the phase II study is that we have an onset of action or time to reach 100 pg that is twice as fast as EpiPen, and this was statistically significant in the phase II. If you think about it, twice as fast in reaching the therapeutic threshold could be the difference many times between life or death or between the patient recovering or ending up in the ICU. The third, I think, very important parameter that we demonstrated in the clinical study was the proportion of patients who reached that threshold at different time points. Not just the median time to get to 100 pg, but essentially how many patients reached that threshold at different time points, focusing on the early time points, knowing those are the most critical for patients. What we showed in our phase II is that at two and a half minutes, we had almost three times more patients, compared to EpiPen, reaching the threshold. This was highly statistically significant. At five minutes, we still had about 50% more patients reaching the threshold. On every parameter that you can assess speed of onset, we were superior to EpiPen in our phase II study, and again, have demonstrated that in prior studies as well. Great. I'll mention to the viewers and investors that Nasus has some really great exhibits in their presentation that show the different arms of the study that could be helpful in showing the benefit there. One of the other features of your phase II was that you looked at patients under normal and nasally congested conditions. Why did you do that, and what differences did you find between those two groups? Yes. This is very critical because we know that in an anaphylactic reaction, congestion is something that often occurs to patients, and we wanted to demonstrate, and the FDA wants to see, that despite nasal congestion, there is still sufficient absorption of epinephrine through the nose. In our phase II study, as you mentioned, John, we really tested the product both under normal conditions as well as under induced nasal congestion, severe nasal congestion. What we demonstrated, again, was this consistent phenomena of superior absorption during the first few minutes, and we demonstrated that despite nasal congestion, we can still generate sufficient amount of epinephrine in the blood, certainly above the therapeutic threshold that I mentioned before. Okay. Your comparator in the phase II was EpiPen, which is a competitor, and there are other injectable competitors out there, Adrenaclick, I think, and a few others besides that. You also have some other forms of administration, including there's a nasal liquid form, as you mentioned, and I think there's also an under the tongue version. How does the competitive environment look with all those out there, and how can you differentiate yourself in the space? We need to remember that the anaphylaxis market is a very large market, and it's a growing market, and it's an expanding market. The reason for that, obviously, is that we're seeing a rising incidence of allergies. I think the incidence of allergy is growing double digits annually. Currently, epinephrine is about two and a half billion dollar market, covering, again, all forms of epinephrine, particularly the epinephrine autoinjectors. We see and we expect to see a transition towards needle-free products. If we look at other therapeutic categories, other therapeutic areas, whenever an intranasal product was introduced, where that intranasal product made clinical sense, we ultimately saw almost a complete shift to the intranasal product, in terms of market share. We expect the epinephrine market to grow and grow significantly, both because of the rising incidence of allergies, but also very much because of the introduction of the needle-free products that will entice more and more patients that are not currently carrying an EpiPen or an epinephrine autoinjector, do not get a prescription for an epinephrine autoinjector, do not refill the prescription regularly to ultimately select the needle-free product. We see the market shifting. We see the market growing. Because this is a very large market, we certainly think that it can accommodate several needle-free products. As you mentioned, the first needle-free product introduced or approved was about 15 months ago. It's a product called neffy. It's a liquid intranasal formulation of epinephrine. We are a powder formulation, as we talked earlier, and the advantages of powder formulations are very clear. Faster absorption, higher absorption because of the ability of the powder formulation to penetrate deeply into the nose, and get into the vascular rich areas. There's another formulation, a sublingual formulation, that is currently under development. Given the market being so large, we expect all the products to have a significant revenue. We expect to differentiate, and our KOLs were very clear about this, given our potential to be superior to EpiPen in terms of the onset of action, which, as we discussed, is probably the most important parameter in choosing an epinephrine product. We think we're going to have a product that is differentiated not just against EpiPen, but also against some of the other needle-free products. We think the superior clinical profile of the Nasus epinephrine is going to lead the way at the end of the day. Okay. Nasus is essentially phase III-ready, and you've planned a phase III study. Can you walk us through how that will progress? One of the points that I think is important is that this phase III study is actually relatively short compared to other phase III studies out there. Maybe you could talk about that too, Dan. Correct. This goes back to our strategy as a company, I'm hoping we're going to have some time to discuss this. Nasus, as I mentioned, is a platform technology. We are focusing on leveraging this powder technology across multiple therapeutic areas, particularly focusing on acute indications. The advantages of acute indications is that their pathway of development is relatively short and therefore more cost-effective. Without having to raise significant amount of money, Nasus can really build a very broad pipeline or portfolio of intranasal products, all addressing acute indications in very large markets. We'll touch on this, I'm sure, later, but specifically to our phase III with epinephrine, you're absolutely right. This is not a very large study. It's a very short study. We're following the patients or the subjects for only a few hours because this is the time that epinephrine stays in the plasma. The patient would come in, the subject would come in, and they will get either the Nasus intranasal product, EpiPen, or an injection of adrenaline, which is the intramuscular manual injection. We're going to be looking at the levels of epinephrine in the plasma for four hours, also going to be looking at the pharmacodynamic response. This is the effect on blood pressure and heart rate. This is what we need to do in the study from a regulatory perspective. We need to show that the product is comparable to EpiPen. We expect to be able to complete the study in about one quarter, have the data already in Q1 of 2027. A very fast timeline. Again, we plan to or we are repeating the same concept with additional molecules, all in the acute space, all allowing us to move through development very quickly and very cost-effectively. Great. I think we have time now for some audience questions, and there's one here that kind of follows on where you left off with the phase III milestones and asks about the key commercial catalysts over the next 12-18 months. What do you see as the key commercial catalysts after the phase III is complete? Yeah. We have several catalysts related both to epinephrine but also to our pipeline products. With epinephrine, once we complete the phase III study, we will be getting ready to submit our new drug application to the FDA later in 2027. There's some additional non-significant clinical studies to be completed around the phase III, but we expect to be submitting the NDA to the FDA in the second half of 2027. In addition, because we're developing our portfolio of products over this next 6-12 months, we will have multiple additional products in clinical development. We indicated that in Q3 of this year, we will be initiating a clinical study with ondansetron. This is our second product, intranasal ondansetron for chemotherapy and postoperative nausea and vomiting, a very significant market opportunity. Ondansetron right now is selling about, there's about $12 million annual prescription for ondansetron, Zofran, for the treatment of nausea and vomiting, and we think that the transition to an intranasal product really addresses a significant unmet need in this space. We look forward to initiating the first in-human study with ondansetron. In early 2027, we plan to initiate another clinical study with a third product. We have not yet disclosed the molecule, but it's a molecule in the cardiovascular space, targeting, again, a large set of indications in the cardiovascular space, where the switch of this molecule to intranasal would really, again, reduce significantly the time to onset of action of the product. In all those indications, whether this is chemotherapy-induced nausea and vomiting, whether this is the cardiovascular indications, onset of action is critical because it allows patients to administer the product themselves, have a very fast relief of symptoms, which could prevent them from going to the hospital because nowadays, many times if their symptoms are not alleviated, they end up in the ER and then usually for IV administration, which then adds up to the cost significantly. By switching ondansetron and the cardiovascular molecule to intranasal, we expect to increase adherence, reduce the time to onset, and therefore allow patients to manage themselves more effectively at the home environment. Okay. Very good. Eyal is there, and I thought I'd give him a chance to respond to something, too. I had a question about finances. There's also a viewer question about that as well, asking about how much runway that you have now following the $15 million private placement, and do you have enough to execute on the NS002 pivotal program and initiate the NS003 work. Eyal, what do you say? Thank you, John. Thanks for the question. We have a runway, as we probably mentioned in the past, until the mid-2027, let's put it this way. Definitely we have the means and the funds to run the pivotal study of the NS002, obviously initiate the NS003, also have top-line results for both, also submit the NDA of NS002, as Dan mentioned. We're fully funded until mid-2027. We have sufficient funds. Obviously, the company is any other company. I saw another question about the strategic partnerships. I'll defer it to Dan, obviously, on NS002. Every such partnership obviously will usually include also a down payment, which is an undiluted funding, that we might consider. Not that we are in need for funds at present. Obviously that might be a very interesting way, a non-dilutive one. Dan, why don't you take the strategic partnerships for NS002? Yeah. Again, I don't want to comment on things that have not been disclosed. Certainly, having a strategic collaboration partnership around the commercialization of NS002 is a key objective to Nasus. When we will have something to announce in that regard, we will do so. This is certainly a strategic objective for the company towards approval and commercialization. Another. Oh, I'm sorry. Were you going to say something, Dan? Yeah. No, go ahead, John. There's another investor question, which I think could be helpful to hear about. Roger Purcell brings up that NS002 has a higher therapeutic threshold within five minutes compared to EpiPen, and that's pretty impressive. How are payers, have you had a chance to talk with payers? You've had a chance to talk with KOLs. How are they responding to that benefit there? For sure. KOLs, including the KOLs that we had at our event a couple of weeks ago, but also many physicians that we speak with and during our market research, are extremely enthusiastic about this result. Again, they all emphasize how important the fast onset of epinephrine or an epinephrine product is. When they see our data from the phase II study, they are all extremely excited, realizing that this could be a significant game changer because it is so much faster than EpiPen. KOLs, physicians are very excited, very enthusiastic about this data. Many have indicated during our conversation, including the KOL event, that once the product is approved, this could be for them the first-line therapy given the fast onset of action. Okay. I think we have time for one more. Yeah, let's talk more about, I see a question here about, again, what we're taking from the NS002 development into NS003 and some of our other products. This is a great question because it really leverages all that we do, all that we have done in the past, all that we do right now into our future programs. It really focuses on the key strength of Nasus. The key strength lies in a great technology, the ability to create very unique, differentiated formulations very quickly given the know-how and experience of our formulation people, be able to produce the product very quickly for initial clinical studies. Because we're dealing with acute indications, those initial clinical studies and the entire clinical development is very quick and cost-effective. Many of the elements that we have developed for NS002 now and NS001 before, things like human factor studies, reliability, manufacturing, are all very similar and very comparable. With every product that we develop, we really have this institutional knowledge that allows us to do things faster, better, and cheaper because we're really following a very clear template in the acute space. Okay, great. Well, Dan, Eyal, well, perhaps we have time for just one short other question. Yes, please. I had something I wanted to ask you just about when you look at a new indication, what features do you look for when seeking to apply the Nasax technology? Yeah, this is a great question. This is something that we spend obviously a lot of time thinking about. There are several factors or parameters that we assess. One is obviously a technical parameter, which is whether the molecule can work with the technology. The technology actually is very broadly applicable, going anywhere from small molecules to large peptides. We have to make sure that the technology or the molecule fits with the technology. Strategically, we want to make sure, and what we examine very closely is whether this switch, this transition to intranasal really adds significant value. We know nowadays payers are not going to pay for convenience just because a drug can be administered intranasally. It has to prove and it has to demonstrate it has value. The value could be by enhanced clinical efficacy, such as onset of action, could be by having a better tolerability profile, or by increasing adherence of the patient. We want to make sure that we focus on at least one of those elements and see whether the transition to an intranasal can really affect one of those. Thirdly, as I repeatedly said, we focus on acute medical conditions, where the intranasal administration could have a significant impact on the patient outcome. Fourth is the overall market opportunity. We focus on indications on therapeutic areas where the commercial opportunity is significant. All of the markets we're looking at are above $1 billion. All very significant market opportunities for the molecule. Great. Well, thank you, Dan. Thank you, Eyal. It was great to chat with you. I think we should just reiterate the ticker symbol, NSRX for Nasus Pharma. Any closing comments? Well, thank you, John, for having us. It was a great time speaking with you and having the conversation. Hopefully, we're able to convey the value in the Nasus story, in the fact that we're a late-stage company getting ready for a pivotal study with epinephrine, having a very robust pipeline of significant opportunities, again, with leveraging our nasal platform. We think there's significant value to be created within at Nasus given the very significant milestones and catalysts coming up over the next 6- 12 months. Excellent. Thank you, John. Thank you