... Okay, good morning, everybody. Welcome to day two of the Cantor Conference. Very happy to have Daniel Barber, the CEO, and Ernie Toth, the CFO. Thank you so much for being here this morning. Thank you. Thanks for having us. We're very excited to be here. I think we're about one hour post a press release, with some interesting information you put out this morning. Sure. Yes. No, we're very excited to announce that we heard from the FDA, and on our lead product, which is Anaphylm epinephrine sublingual film, excuse me, we will not have an advisory committee meeting. So one of the big discussion points with our review has been, will we have to go before a panel or not? Given the interactions with the FDA, we're very excited that they came back and said that we do not need an AdCo m. Okay. Well, that was perfect timing, as they say. It was. It It was. So definitely wanna talk about that in more depth, but maybe to first take a couple steps back here. I know there's way more to the company beyond just Anaphylm. So do you mind just giving us a quick overview, and then most of our discussion today will be on Anaphylm. Sure. Yeah, no, and I appreciate that. So, from a company perspective, we actually have a robust base business that we've had for years that continues to grow and do well. Our Anaphylm is our lead asset, as you said. I'm sure we'll spend a lot of time on it today. But the interesting thing about Anaphylm is it's actually a prodrug of epinephrine, and what that allows us to do is create a really robust intellectual property estate around prodrugs and epinephrine, which no one has done before. So while Anaphylm is our lead product, and the most exciting, most current thing in the company, we believe behind that there are multiple programs that will come along, and we actually already have one in process. We call it our AQST-108 program for alopecia areata. So we're very excited about the platform. This is the strongest the company's ever been, and from our view, we're just getting started. All right. Awesome. So I definitely wanna talk about this space in general in more detail. I think people think they get it. Most of us, unfortunately, know somebody that has to carry an EpiPen around, but the reality is that I don't think people truly appreciate a lot of the aspects of food allergies and the need for carrying an EpiPen. So the golden rule is, it's not enough just carrying an EpiPen, right? You gotta know how to use it. You gotta know when to use it. You have to be around someone that knows how to use it. So can you essentially walk us through why the EpiPen is not always the most ideal tool to have in these situations? Are there hesitancies? Why can it be dangerous? The prevalence of people at risk of having a severe allergic reaction or anaphylaxis is fairly large. It's, if you go by the advocacy groups, it's over 30 million, some would put it at 40 million, yet there's only 5 million scripts a year, so 5 million scripts, 30-40 million people at risk. The biggest problem with this space is people simply don't carry a product. Mm. They don't carry a product because they believe behaviorally they can avoid the risk. So what we believe our product does is it changes that benefit-risk ratio, where someone says, "I don't wanna carry a medical device because I have to always remember it, carry it with me. It's something additional I have to bring with me." We change that to something that you can bring with you without even thinking about it. We actually. You know I have the sample with me, right? We actually have our product. I don't even know where the camera is, but our product goes on the back of your phone. If you see the yellow on the back of this phone, that's the actual product. So we believe that by creating a product that's with you whenever you need it, and that you don't have to think about, we've created something that people will have with them when a severe allergic reaction happens. The last thing I would say on that front is it's interesting when you start to think about carrying something on your phone, because then you learn how often people actually look at their phone, right, and if you look at the literature, the average person looks at their phone 96 times a day, and that works out to about every 10 minutes, so we always have our phones with us. I can tell you that coming to this session today, I did not bring my EpiPens with me, but I did bring my cell phone. There you go. There you go. Case already made. Right. So you're at the regulatory filing stage, and sometimes I think investors just traditionally say, "Oh, this is a tough space. We know about the Neffy experience." So I guess, first, what items would you say that you had in common with that product, and then where are there key differences? Sure. Well, I think there's a lot in common with the nasal spray. One, I would say, both companies are looking to help people, right? Yeah. While we are competitors, I think there's a real need in this space, and there is a need to have multiple products so people can choose what's best for them. And I think sometimes in our industry, we forget that we're all here to help people, right? Yeah, of course. So I think that is a very common trait. In terms of the review with the FDA, the bar is the same for both products, right? We're following what's called a comparability pathway, where you compare yourself to the auto-injectors that have already been approved, and you track what your exposure in blood looks like over time. So, our interactions with the FDA have been all around comparability, and have been focused on where we are the same and where we are different to auto-injectors. Okay, thank you. One of the advantages, though, to not being the first to really pioneer a needleless form of epinephrine, though, is that you can kinda learn from their experience, right? No doubt. No doubt. Was that something you took advantage of during your own filing package and submission? Sure. Yeah, look, one of the few advantages of being second, to your point, is at every step, you get to see- Mm-hmm What happened ahead of you. In terms of the review process, we definitely believe that listening to the FDA and doing everything they ask you to do is critical, not just in our space, but in any space. So we've been very careful with this particular application to make sure that every study the FDA wanted, we did, that every arm of the study they wanted, we did it the way they wanted to see it. So we made sure that it was the, we believe, the most thorough package that's been put together. In fact, our package has over 900 dosings and over 300 subjects, and as far as we're aware, that is the largest package ever put together for an epinephrine submission. In terms of what the FDA is after, I truly believe they have the same goal in mind that we do. I think they want good, quality products that work the way they're supposed to put into the public. So as long as you understand where they're coming from and why they're asking you the questions they're asking you, I think you can have a very positive set of interactions. I would actually say, in our case, the FDA has been incredibly consistent across multiple years with their approach and their questions to us. Okay. You are, however, the pioneers as it comes to oral administration, so you're really the first up to bat for this. We are. Yes. We are. Yes. You know, when we think about looking at epinephrine and understanding whether or not a product can be safely and efficacious, what are the unique things that Aquestive had to do for that route of administration? Yeah, sure. So, that has been a journey over time, and, anytime you change the route of administration for a drug, especially a rescue drug that potentially saves someone's life, there's naturally a lot of questions around: How does it work? How will it be used? What could go wrong? So we've had to do a multitude of studies, which we believe are fair questions by the FDA, but a multitude of studies that show what happens when you take our product and you misplace it in the oral cavity, or if you drink water with it, or if you drink hot liquid or cold liquid, actually, at one point, we even had to do a study where people ate a peanut sandwich, waited, I don't know, a minute or two minutes, and then took our product. So we think we've created a really robust view for the FDA of what happens when you take our product after a variety of things have gone into your oral cavity. What does happen in those scenarios? It all remains the same. The blood curve remains the same, and we show a great consistency with our product. Okay. Yeah. No, the peanut sandwich, I would imagine a lot of people- Mm ... probably have that allergy in the environment and- Yeah ... stickiness and stuff, so that's a good one to ask- Yeah and make sure. Yeah. So, one thing I've always appreciated about Aquestive is the level of transparency. You quite literally have a slide deck on your website that talks about everything you discussed with the pre-NDA meeting, what the questions were, what your potential responses or solutions would be. So I did wanna just kind of go through a few of those, because obviously, it's been some time since that has happened, and you- Yep ... submitted the package. One of them was on the PK sustainability after a single dose. Mm-hmm. Can you maybe talk about that point and the data you showcased? Sure, yeah. So, with our product, at around 40 minutes... So I should back up. When you're trying to show comparability to other products, the way you do that is you show your blood levels across time, and then you show the other products' blood levels across time, and it's literally you can just track it on a chart, right? Are you similar? Are you different? And in our case, around 40 minutes, our blood levels fall below the blood levels of the product we're comparing, the products we're comparing ourselves to. So that leads to a natural question from the FDA of, "Well, is that okay?" And from our standpoint, we believe that's a very acceptable outcome for this disease state, because if you look at the label for EpiPen, if your symptoms don't abate within five to 15 minutes, you take a second dose. So if you're out at 40 minutes and you're still having symptoms, long ago you should have taken a second dose. If you're at 40 minutes and your symptoms have abated, you should be fine. So we've given that argument to the FDA. It would appear they understand our position, and I think we feel very good about where we are in that particular issue. Just like an EpiPen, if you're gonna get a prescription, you would get two. You do get two. Right? Okay. Yes, you do get two. Okay, so in that situation, you can easily handle it. Yeah. So on that note, I would love to talk a little bit more about the onset of action of the product. Sure. It's very apparent. Data shows that the initial minutes after the reaction are kind of when you have the highest risk, right? Mm-hmm. So why is that so important? Yeah, well, this has been a really interesting journey for us as a company. So the first prodrug we created for this, for anaphylaxis and severe allergic reactions, had a longer period of time before it really showed up in the bloodstream. Mm-hmm. So the first 10 or 15 minutes, you didn't see much, and then it would really shoot up quickly. And this was years ago, and we put this in front of a group of KOLs in the space, and all of them said, "This is not good enough. Okay. And because from their point of view, if you have someone who's having a severe allergic reaction, which is causing mast cell degranulation in their body, you need fast relief, right? You need to stop that cascade as quickly as you can. So we actually went back to the drawing board, and we created the prodrug that we're now using, which is our AQST-109 Anaphylm product, and that prodrug, within a matter of a couple of minutes, starts to really go up fast. In fact, we have the fastest Tmax, so time to maximum concentration, in this space. We have a 12-minute Tmax, which if you look at the comparative products, everyone else is 20 minutes or over. So for someone who's having a severe reaction and starting to go down the path that leads to anaphylaxis, that quick uptake, we believe, is the perfect profile to rescue a patient in that setting. Okay. But beyond just how fast the drug works, how do you think about the time it takes to actually take the product? Sure ... compared to an EpiPen? Sure. Well, it, that one is definitely it depends, right? Yeah. For most people, they will delay use of an EpiPen, and there's a lot of literature out there around why someone would delay use. Some people, it's they don't want to use a needle. Some people, it's this is a medical device that makes me real... I must be really sick in order to wanna use this, so there's kind of this barrier to perception. Some people, it's the cost of replacement. "Gee, if I use it, I'm gonna have to go back to the doctor and go get another one." What we really like about our oral product is we believe the use will be very fast. We believe it falls right into the habits of patients, where typically they may start with a Benadryl or an antihistamine before they go to their auto-injector, and our product lends itself to that same type of idea, so we think people will use our product quicker. We think that will also lead to better results, and that's definitely one of the benefits of the product. Okay, thanks. Another item that you disclosed in your pre-NDA package, presentation, I should say, was the non-allergen exposure arm versus the allergen exposure arm in the OASIS allergen challenge, so- Sure ... What was the justification you made there? Yeah, so the FDA asked us to do a study showing if blood levels changed if there was an allergen present versus no allergen. And so we created. We actually had several back-and-forths with the FDA in how to create that model, 'cause no one had done that for an oral product before. And we came upon with the FDA a really clever solution, which is using people who have OAS, which is if you're exposed to. Often it's a fruit for an individual. It creates edema. It can create a lot of the signs of a reaction, and sometimes it does lead to anaphylaxis. And so we did expose people to an allergen, track their blood levels, and then had them come back and did the same without an allergen, and we were able to show that there's no statistical difference between, those two arms, which allows us to bridge to the rest of our package. But I think the really powerful thing around that study, which we call our OASIS study, is it shows that we stop edema in its tracks, which kind of makes sense. As one of the KOLs said to me, "Gee, if you're putting the film where the edema is, and the epinephrine's stopping the edema," kind of makes sense to everyone, right? And in our study, if you did not have an allergen, it took about 45 minutes for your edema, to come down. If you had an allergen and then took our film, you had your edema disappear in five minutes. So we believe that shows the strength of our product, and we think that's a great study to showcase. Okay, thanks. So let's fast-forward to today. Since you had that pre-NDA meeting, you took the time on the feedback. You submitted the data package, the full package, I should say. Mm-hmm. And then today, you announced that the FDA told you they would not need an ad com. Yes. So what do you think happened? Well, as you know, it's a process to get to today. Yes. Right? So we had multiple interactions with the FDA before we filed. We had a robust pre-NDA meeting, which is, Kristen, as you pointed out, we basically put all of the notes out in the public domain from that- Yeah ... that interaction. And since our filing, we've had a multitude of information requests from the FDA, which is their standard process, right? So they've asked us questions. We've responded to those questions. They've asked us questions on the CMC side, on the clinical side, on the human factors side, so right around the areas of the review you would expect. And from my perspective, none of the questions were unexpected. None of the questions, I believe, were red flags of, "Oh, my God, how do we answer this? Yeah. And so I believe the equation for the FDA is we're on track. We've answered their questions. They have the information they need. There's no reason to get a group of people together to discuss it further in a public domain. So we think it's a really positive sign, and we're really excited. Okay. So, we still have a few months. You have a PDUFA date at the end of January. What are kind of the expectations from here to now? There's gonna be late cycle review meeting. Mm-hmm. Would you expect, like, just more standard informational requests? Mm-hmm. Anything else, that you're kind of looking for? Sure. So, And as you know, we have six previous approvals, so we've been through this cycle a lot with the FDA in various divisions. And typically from this point on, there will be an intense period of time where there's a lot of information requests, and each of the groups inside the FDA has basically a checklist they have to go through to make sure we've done all the work we're supposed to do. So as they go through that checklist, and they read our NDA, if they have questions, that's where the questions come to us. So that process will take most likely a couple more months. As we get into the end of the year, the hope would be that there's discussions on the label. That's always a good sign, if you're getting feedback and information from the FDA on what your label looks like. And then as we get into January, we're right on top of our PDUFA date. ... Okay, great. We are rooting for you and wishing you all the best during that process. Yeah, these patients need several options, and ones that don't involve needles, that's for sure. So, let's fast-forward and assume an approval, and maybe shift to how you're thinking about market opportunity, right? So who do you think are gonna be the, the typical patient profiles that will want Anaphylm out of the gate? And then, you know, earlier we talked about this whole notion that a lot of people just don't wanna carry around an EpiPen, and- Yeah ... I can assure you, everyone is definitely carrying their cellphone. Right. Now that they may have an option, is this a market you could penetrate into as well? Sure, sure. Well, if you're okay, I'll start in a different place, and then I'll come back to your- Yep, go ahead. ... to your question. We're really excited to be where we are in terms of preparation for a commercial launch. With the help of your peers on the banking side, in just a literally a few weeks ago, we were able to line up $160 million of financing for our launch. That, along with the money we have on hand, means we'll have the better part of $200 million available to us for the launch of Anaphylm. So we think we're in a great spot in terms of preparation. We think we're in a great spot in terms of our financial position, and when we get to market, we'll be able to robustly go after the patients who could best benefit from the product, which leads to your question: Who are they, right? Mm-hmm. From our research, while we do believe that everyone could benefit from our product, we don't think there's a group that wouldn't- Right ... there is a sequence of who is going to be the early adopters and who will most resonate with our value proposition right away and over and over again, the groups that come center stage are the college-age individuals, teenagers, moms who are worried about their child carrying their rescue medication. In fact, as we go around and talk with the advocacy groups and patients, one of the stories you hear on repeat is the idea of a mom worrying about their child carrying their rescue medication. In fact, we had a mom who would talk about their son going out on the weekends, and they'd go into their bedroom, and they would see their rescue medication, their auto-injector- Mm ...sitting on their dresser, and the mom would just get anxious and worry about what was gonna happen. So with our product, you don't have to worry about that. That's one of the key benefits we believe that comes from our product, is in that age group where people aren't paying attention to ensuring they're safe, we provide them with something where they can always be safe. Okay, thank you. And then how do you think about specific physician types to reach out to PCPs, allergists? Yep. I think also, and at least in my experience, any kind of doctor I see, they, they have your full list of medicines, and sometimes they'll just say, "Hey," like, "is your EpiPen up to date? Is it expired? Right. Do you need a new one? Yep, yeah. Yeah, the detailing path, I'll call it, for HCPs, is very straightforward here. Allergists are at the core of this market, so there's 4,000-5,000 allergists in the country. They are the largest on their own percentage of scripts that go out. So our focus would at the very beginning be on allergists. We also would go to high-decile pediatricians, so as you would expect. That gets you to about half the market between the allergists and the pediatricians. The rest of the market, the GPs, is spread very widely, but what you find is individuals go to their allergist to first be diagnosed and have a rescue product, and then they use their GP for their refill. Okay. The GP piece, we believe, will spread as time goes on. Okay, so even if you're going to your allergist initially, and then if you go to your PCP, and maybe it's early, and they haven't heard about the product yet, they can say, "Hey, I've been on... Using this, and now it's just time for me to get a new one. Exactly. Okay. And then what's the plan ex-US, which is something you've recently mentioned has been a priority and a focus for the company? And do reimbursement and treatment dynamics tend to differ across these regions? Sure. Yeah, as you know, outside the US, the dynamics can be very different. So the important markets, at least from a sales perspective, for rescue products are Europe, the UK, Canada, Japan. So we've started the outreach in a couple of these markets. We just had a meeting with EMA last week. That was our initial meeting. We sent our initial package in. We'll send a full, robust briefing book to them now, and by the end of the year, we'll have their feedback on that briefing book. So I think we're in a good place to really accelerate our interactions in Europe. We'll be with Health Canada in a couple of weeks here in September. Health Canada is important to us because not only is it an important market, but we also did a lot of our studies in Canada, so we think that's a great market and may even be the first place that we put our ex-US filings in, so it is an important part of our story, and as we get into 2026 and 2027, you'll see us do a lot more on the international front. Okay, great. Maybe just to switch gears here now to alopecia areata- Sure ... I wanted to give a single question shout-out to that program. Just, why epinephrine for this indication? And we, you know, you're not the first to conceptually think that, "Okay, this might be a therapeutic way to look here," but others haven't succeeded, so what might be different now? That's right. Yeah, no, and thank you so much for asking a question outside of Anaphylm. Yeah. People, we would hope people will keep in mind that when I say this is just the beginning for us, I really mean that. The products that will come behind Anaphylm with our epinephrine prodrug platform, we think will be really meaningful. And what we've done, that no one else has done before, is if you think about epinephrine, it has a half-life of five minutes. So it's something people have not been able to control, right? Which is why you see it given in a hospital setting via IV, or it's used in injection form, or now in nasal form. Our prodrug technology allows us to create tails, right? So depending on the functional group that we add to the molecule, we can create a long tail, we can create a short tail, and that allows us to create different levels of exposure. And it also allows us to gain absorption because we block the vasoconstriction. So if you look at alopecia areata, if you just take epinephrine and put it on the surface of the scalp, it doesn't penetrate, and it's gone quickly. With our AQST-108, we get penetration, we get the 108 sticking around for a very long time, and that tamps down the immune response, which is taking away immune privilege and causing the alopecia areata to occur. So in our animal studies, in our preclinical studies, we've had some really nice success, which we've shared publicly, and we're looking forward to getting into our Phase 2a in 2026. Okay, great. So, yeah, again, a very exciting day. Mm-hmm. The question I have for you is, why should an investor own Aquestive now, versus just simply saying, "I'll wait to see how the approval decision plays out in January? Sure. So from my perspective, we have a lot of momentum right now. We have built this company to a place where it's ready for its first major commercial product to come to market. It's ready to have a pipeline behind that, that could really accelerate and drive the company. And now is a great time, especially, when you look at where we are in our life cycle or our growth cycle, to get in before we've really taken the company even further. Okay. And then could you please remind us of the cash position and runway, including the recent strategic funding agreement? Sure. So we were very fortunate in early August to raise the money that Dan had mentioned before. It came in two different ways, of an equity raise, which Cantor helped co-lead. And we were able to raise $85 million with a lead of RTW and some very high-quality healthcare investors who are new to the story. So we're very happy to have that. And then on the heels of that, we announced the $75 million revenue interest financing also from RTW. That is conditioned upon approval of Anaphylm with the January 31st PDUFA date. But combine those two recent influxes, or recent transactions, on our existing cash, it provides us the runway to get through the rest of this year with all the pre-commercial prep around advocacy and payer discussions, and things along that way. Build out some of the early commercial infrastructure through next year, and now we have the dry powder, so to speak, to launch, have a credible launch of Anaphylm next year. So it gets us through 2026, and into through most of 2027. We haven't given the exact cash guidance yet. Mm. ... but it is the best this company has ever been funded. Capital structure, high-quality investors, so we're very happy with the capital that we have today, to be able to have a credible launch of Anaphylm. Awesome. Well, we are rooting for you- Mm ... and, thank you so much for being here. Thank you for having us. Thank you. Very excited to be here today. Quick question. Oh. With the launch less than six months away, you know, target like allergist and GP. You're kind of doing any DTC strategy, or leverage other like social media, as a marketing strategy? Sure. So the question, if people didn't hear it, is what is our DTC strategy and our social media strategy? And it's really. This is a really interesting time in pharma, right? So I'll actually divide those two things a little bit. When I hear DTC, I think of Super Bowl ads and traditional media, right? And from our perspective, there's a place for DTC. In our strategy, that will be later on. So you won't see us put ads on NBC or do big, splashy campaigns with a celebrity. That's not how we'll start our world. We think that's an expensive approach that comes later on. What we will do is social media absolutely is a great and very cost-efficient way to get word out about your product. So you will see us be very active on the social media front right away. I think I had more- We're, we're- Like a telehealth approach. Oh, you were talking about... Okay, it wasn't DTC advertising. You were asking, will we have a te- So like, telehealth. Will we have a telehealth approach? Yeah, look, as the market evolves, in general, not just with our product or our space, you're seeing the idea of telehealth and cash pay become more important, right? You've seen Lilly start a program along with other multiple big companies, and also our competitor has had cash pay and telehealth as a part of theirs. So I think those are kind of, maybe the way to put it, is table stakes in today's world, so we will have that offering like everyone else, but there is no way around, I believe, the standard approach of having sales reps talking to healthcare professionals, and making sure that you have a good payer approach as well. Thank you. Thanks again. Thank you. Thank you very much.