Aquestive Therapeutics at Leerink’s Conference: Strategic Innovations Unveiled

On Monday, 10 March 2025, Aquestive Therapeutics (NASDAQ: AQST) presented at Leerink’s Global Healthcare Conference 2025, outlining its strategic priorities for the year. Led by CEO Dan Barber and CFO Ernie Toth, the company highlighted its focus on ANIFILM, a sublingual epinephrine film, and AQST-108, a topical gel for alopecia areata. Aquestive aims to address unmet needs in severe allergies and anaphylaxis, although challenges remain in safety and market competition.

Key Takeaways

• Aquestive is prioritizing the NDA filing for ANIFILM, targeting FDA approval in early 2026.
• The company holds $93 million in cash to support operations and the early stages of ANIFILM’s launch.
• AQST-108 is set to enter Phase 2a trials, targeting alopecia areata with promising early data expected by year-end.
• Libervant, while valuable, may be overshadowed by the potential of ANIFILM and AQST-108.
• Aquestive is considering partnerships to maximize the reach of its products.

Financial Results

Aquestive reported having $93 million in cash, ensuring funding through crucial phases such as the NDA filing for ANIFILM and its potential launch in 2026. This financial position supports the company’s strategic initiatives and operational activities, providing a runway into the early stages of commercialization.

Operational Updates

The primary focus for 2025 is the completion of the NDA submission for ANIFILM, with expected FDA acceptance in the second quarter. ANIFILM is designed as a convenient, non-device alternative for severe allergies, potentially reducing mortality rates that have stagnated over the past four decades. The product’s shelf life of 24 months offers a practical advantage over existing solutions.

Future Outlook

Aquestive is preparing for a potential Advisory Committee (AdCom) meeting, addressing safety concerns and efficacy demonstrated in the OASIS study. ANIFILM’s approval is anticipated by late January or early February 2026. Concurrently, Aquestive is advancing AQST-108 into Phase 2a trials, targeting alopecia areata with a novel topical gel formulation. The company believes this product could outperform current treatments like JAK inhibitors, which have notable side effects.

Q&A Highlights

During the Q&A, Aquestive discussed the expansion of ANIFILM’s label to include pediatric use for children weighing at least 30 kilos. The company is gearing up for potential AdCom discussions focusing on the delivery method and safety profile of ANIFILM. Additionally, the commercial team, led by experienced executives, is poised to leverage the product’s attributes to enhance market penetration.

In conclusion, Aquestive Therapeutics is making significant strides in addressing unmet medical needs with innovative solutions. For a more detailed account of the conference call, please refer to the full transcript below.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Nick Gasek, VP in Equity Research, Leerink Partners: I think they’re ready whenever. Awesome. This is working. Afternoon, everyone. Thanks for joining us at the Leerink Partners Global Healthcare Conference.

My name is Nick Gasek. I’m one of the VPs in Equity Research here at Leerink. Pleasure to have LeQuest of Therapeutics here with us today, joined by CEO Dan Barber, CFO Ernie Toth. Great to see you both.

Dan Barber, CEO, Aquestive Therapeutics: Thanks for having us. Nice to be here today.

Nick Gasek, VP in Equity Research, Leerink Partners: Great to have you. So I guess to kick it off, I think we can start with some bigger picture questions and then maybe dig a little deeper into the story from there. So I guess for investors who are new to Questive, you know, how would you summarize the company’s core focus areas in 2025, I guess, particularly with respect to Anifolm and Libervant?

Dan Barber, CEO, Aquestive Therapeutics: Sure. I mean, you said it perfectly, Nick. And first of all, thank you to you and the team here at Leerink for having us. Always a always a pleasure to to be here. In terms of our core, areas of focus in 2025, ANIFILM, which is our epinephrine sublingual film, is absolutely, the priority.

So we have to get through, the finishing of our filing, which will happen in the next few weeks. We started that, last week. We need to get our acceptance, which would happen in the second quarter. We may or may not have an AdCom in the second half of the year, so making sure that goes well and then getting to approval. And that’s just on the development side.

We also need to be ready for launch. So we’re doing a lot of work around that as well. And then the other piece that maybe people are less familiar with is, we do want to expand our product into international markets. So we will start the filing process in Europe, UK, Canada once we have our ANIFILM US FDA application into the FDA. So ANIFILM is clearly the center of our focus.

The other area that is emerging and you’ll hear us talk more about as the year goes on is our AQST 108 epinephrine topical gel product. So the, the prodrug epinephrine platform that we’re using for Anaphylm, we believe can be used for a lot of products. And so with AQST one zero eight, we’re taking that same great technology that our our science team has developed and putting it to work in, a topical gel for alopecia areata. So we’re excited about that product. We’ll have it into our Phase 2a this year and hopefully have some data by the end of the year.

But those two things are clearly the focus for this year.

Nick Gasek, VP in Equity Research, Leerink Partners: Sounds great. Maybe focusing a little bit on Anaphylm, could you talk a little bit about the value proposition here in severe allergy and anaphylaxis? And I guess, where do you think this product could ultimately fit in the

Dan Barber, CEO, Aquestive Therapeutics: treatment landscape? Sure. And I appreciate that question because, as far as we’re aware, we’re the only non device that’s in development. So, we do believe that when you look at the patient group that requires or needs a rescue product, which, by the way, is really underserved right now, we think we service all of the patients in that in that world. And why?

Because, our product not only is an oral product, but it can be carried on the back of your phone. If you can see, I don’t know if the camera can pick this up or not. If you can see the the yellow on the back of my phone, that’s actually our product. So when you look at what’s going on in the patient world, patients aren’t carrying their product. When someone has a severe allergic reaction, they’re very diligent about carrying their rescue product for about a year.

And then the second year, they’re somewhat diligent about carrying their product. And by the third year, they’re not carrying it. So providing a product that is an extension of you, is an extension of the way you live, which we all carry our phones, we think is a really important way to reach to all of those patients.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. No, that makes a lot of sense. I guess, thinking about the current Ebon effort landscape, what do you think some of the drivers are commercially or, I guess, from areas of unmet need? Should you really grow the pie from what we currently see with the auto injectors?

Dan Barber, CEO, Aquestive Therapeutics: Yeah. And it’s interesting. And I think we’re if I step away from just wearing my Aquestive hat for a second, and I look at the space and all of the different product or companies that are in this space, I think we’re having the wrong conversation, right? The, the mortality rate in this space has not moved in the last forty years. So think about that.

The auto injectors came on the market, now most recently the nasal sprays. Yet the same number of people are dying every year from anaphylaxis. That tells you that something’s wrong. When you dig deeper into, well, what’s wrong, there’s two things you find out. One is the population of people who have a prescription or have been given a prescription and didn’t fill it because they didn’t think it was important.

And then there’s a population of people who weren’t even aware they had, an alert, an allergen and so they had nothing with them. So I think the awareness part is huge here And not just us, but the other companies in this space need to work hard to make sure that the population that should be carrying a rescue product is carrying a rescue product. And I think not only will that, hopefully, ultimately impact the mortality rate, but by nature it will expand the market.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. No, I think that makes plenty of sense. So I guess, you know, if Benafillin was approved, it would probably be the second no needle epinephrine product on the market. So I’m curious in your view, you know, what types of patients would be drawn to this type of profile over what’s, you know, out there now and, you know, who do

Dan Barber, CEO, Aquestive Therapeutics: you think the early adopters would be? Sure. No. So, traditionally, and, Nick, this is something that you and I have talked about before, right? Traditionally, when a product is first to market, the ones behind it, don’t get as much of a market share because you’re talking about molecules, right?

And if I pick on the migraine space, if you think of triptans, sumatriptan, Imitrex was the first one to market, got the biggest market share. But then there were six more triptans that came, and they all came in pill form. So there were seven pills you could choose from. It’s hard for patients to or health care providers as well to differentiate in that environment. What we’re talking about here though is drug delivery.

It’s a delivery device. Right? So I think every year for patients when they come to the physician and they have that opportunity to choose between an auto injector, a nasal spray, and a film, we’ll have that opportunity every time to win over new patients. So, being a first mover is, of course, an advantage, But we don’t think in a delivery environment that we’re at a major disadvantage over time, over three to five years, being the second to market.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. And I guess maybe switching back to the filing, I guess, could you give us like a status update where that’s at? I know you mentioned that you’ve started the filing. Now when do you expect to complete that? And I wanted to ask you about the pediatric data?

Dan Barber, CEO, Aquestive Therapeutics: Sure. Absolutely. So we started our filing last week. Some people call it a rolling submission. We put in there’s modules in the, the NDAs, as you know.

We put in the module three, which is the CMC module. By the end of this month, we’ll have all of our modules in, which starts the clock for the FDA. So when the clock starts at the end of this month, there’ll be a ten month review cycle, which would put our potential approval date somewhere in late January or early February. Now, the FDA has, a sixty day period to decide whether they are accepting the FDA or the NDA for review or not, and then they have fourteen more days before they send you a letter. So you’ll hear people talk about a seventy four day letter after the end of this month.

Seventy four days later, we’ll get our letter accepting the FDA, and then that will take us to the approval period in late January, early February.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. Sounds like things are moving along nicely. Yeah. Yeah. No.

We’re very happy. That’s great. Maybe coming back to the pediatric study, you mentioned like the top line data was in line with your expectations. So I guess like what does that mean? What role is this data going to play in the filing overall?

Like, where you where do you think things land?

Dan Barber, CEO, Aquestive Therapeutics: Sure. Yeah. So this data is important to make sure we get our label all the way down to seven year well, it’s it’s based on, weight, so it’ll be thirty kilos, which is roughly a seven year old. Without this data, we would be from 17 years of age and up. So it’s important for making sure the label is complete, that this data goes into our NDA.

In terms of what the data looked like or what we were looking for, it was a very simple study. It’s a single dose study where, the pediatric subject comes in, they’re dosed with our product, we pull blood samples for a couple of hours and they go home. So when you look at the data, it’s just a line, right, which is it’s kind of a boring thing to look at. But what you want to be able to do is bridge that to your adult data. So when we say it’s in line with expectations, what we’re really saying is it looked exactly like we expected it to look and it ties to the adult data and there’s no outliers or issues we have to deal with.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. I guess, like, do you have plans to disclose that data down the line in terms of, like, patient numbers and things like that? Like, how should, you know, investors think about that?

Dan Barber, CEO, Aquestive Therapeutics: Yes. We absolutely will disclose the data. What we have to decide is what conference or poster or presentation format to do that in, but we absolutely will give that data to the public.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. I think that would be very helpful. And then, you know, you’ve been messaging, you know, you’re preparing for potential AdCom in the fall. I’m curious, like, you know, how that’s going and what topics do you think the FDA would want to dig into a possible meeting?

Dan Barber, CEO, Aquestive Therapeutics: Yeah. No. It’s, the AdCom is not only for us, but also on the FDA side, it’s a lot of work. Right? But for us, it’s an opportunity to tell our story.

So we have already hired a what’s called a regulatory communications firm. They’re already putting together the team in our company as well as KOLs who would present our data. And we’ll start that process of making sure we’re ready to tell our story the right way, if there were to be an advisory committee. In terms of what the FDA would ask, and just I’ll digress for one second just so people understand. The way it works is the FDA would come up with a series of questions, three or four, that they ask to their their standing advisory committee for that area.

So we would expect those questions to, one, be the utility of film in this space. Do does the committee see utility in the film? We think we we think we win that. The second, and third are usually around your application. So in our case, we do know that, with our product, when you take a second dose, there are what we call outliers where they get higher amounts of epinephrine than the known EpiPen, label.

And so what that means is you need, you meaning Aquestive, we need to prove safety on those outliers, which we think we have a compelling case for. The second place we would expect them to talk is on the tail of our curve, somewhere around forty five or sixty minutes, we know that we dip below the comparison to the manual I’m So that’s another spot where the FDA will likely have questions.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. That makes a ton of sense. And, you know, just thinking about other aspects of the profile, you know, from a PKPD standpoint, is there anything in the data that really stands out to you so far relative to the competitors or maybe even the

Dan Barber, CEO, Aquestive Therapeutics: auto injectors so far? Yeah. Well, we really believe that our profile is the best profile for a patient going through a severe allergic reaction. And Nick, if you remember last week with earnings, I used the phrase, it’s just common sense, right? Think about what’s happening in a subject or a patient, excuse me, when they’re having an allergic reaction.

First, your blood pressure is dropping. Second, histamine is well, first, I should say histamine is, is circulating through your body at a high level. Second, your blood pressure is dropping. Third, you may have some constriction in your airwaves. So bad things are happening, and you’re having a lot of anxiety about how do I get out of this moment.

And what do you want in that moment? You want a lot of epinephrine. Right? You want it to go away. So when you look at those first fifteen or thirty minutes, which as I mentioned before is when most fatalities occur, our curve looks very much like the auto injector curve.

So we are very comparable in those first fifteen or thirty minutes. And that’s where we think the life saving attributes of the product really come through. So when we think about the competitive advantage of our product, that curve to me is a really important part of the story.

Nick Gasek, VP in Equity Research, Leerink Partners: For sure. I’ve gotten this question from investors previously. It’s, you know, anaphylm, it’s an oral film. You know, you’re supposed to put it under your tongue. Mhmm.

What happens if I swallow it? Does it still work?

Dan Barber, CEO, Aquestive Therapeutics: Yeah. We actually did a study where and that was as the FDA asked us to build out our complete package for our filing. We had to do studies where it was with different liquids, So hot liquid, cold liquid, different pH levels. We we had people eat a peanut sandwich and then, take our product. And one of the things they asked us to do is have people swallow the film instead of having it go under the tongue and dissolve.

And what we find is the Cmax level, so the peak level, the peak concentration level, actually is still relatively high. I want to say it, I could be a little off in these numbers, but it still got to about two fifty picograms per milliliter. What we do see is that the Tmax goes out to about twenty five minutes. So we go from 12 to 25. But if you look at the other products in the market, their Tmaxes are already twenty, twenty five minutes.

So we know that when people swallow the film, they’re still getting a significant dose of epinephrine.

Nick Gasek, VP in Equity Research, Leerink Partners: For sure. I guess, like, maybe looking back at the conference Quad AI last weekend, you know, you had some new data there. Anything you were particularly excited about on those new datasets? There’s quite a bit there.

Dan Barber, CEO, Aquestive Therapeutics: No, thank you for that question. We had a full team in San Diego last weekend, and I know you had a chance to look at what the team was presenting. We presented four posters. And those posters were across two really critical areas for our company. First was, we did a study in the fall, we call it our OASIS study, where we exposed people to an aller a known allergen.

So if you’re allergic to pineapple, let’s say, we exposed you to pineapple, we allowed symptoms to occur, so edema, scratchy throat, whatever, there were systemic symptoms as well, and then we dosed our product. And what we saw is in a median time of five minutes, all symptoms are gone. So we know that our OASIS study shows our product works on localized edema very fast. And we know the study the OAS patients we were using, also ten percent of the time, it develops into anaphylaxis. So that OASIS data, we think, is very powerful.

And when we have the opportunity to talk with physicians, that will be a differentiator for us that no one else has. The other thing we showed in a couple

Nick Gasek, VP in Equity Research, Leerink Partners: of our

Dan Barber, CEO, Aquestive Therapeutics: posters was our excursion data. Right? So when you think about and I have to take it out again.

Nick Gasek, VP in Equity Research, Leerink Partners: You got to do it.

Dan Barber, CEO, Aquestive Therapeutics: It’s like a proud parent. Right? When you think about our product, it not only fits on the back of your phone, but you’re going to be at the soccer field. You’re going to be on a ski mountain. You’re going to be wherever you are over the course of a year with your product.

And so we’ve created the excursion data to show what happens. And if you let’s start with the easy side, the cold side. Right? If you are below the standard storing conditions, which for almost every drug on the planet is, well, except for ones that need to be refrigerated, is, I think 68 to 77 degrees Fahrenheit. You can go to minus 10 degrees Fahrenheit if you want with our product and still use it.

You cannot freeze our our product does not freeze. There’s not enough water in it for it to freeze. So that alone, we think, is a distinct advantage. But then if you go to the high side, so where you are in high temperatures, we tested our product at a 58 degrees Fahrenheit and held stability for, I think it was a month, or it was either a week or a month of time, which by the way, you and I couldn’t survive at 158 degrees Fahrenheit. So we know that our product can be put into extreme temperatures and still be durable.

So and I should mention, you can actually submerge in water for a week if you feel like it as well. So we think it’s very durable for people in the real world, and we think that’s also part of the story.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. And I guess just like assuming this product is stored at room temperature, you know, what’s typical shelf life? How does it compare to the, you know, auto injectors and

Dan Barber, CEO, Aquestive Therapeutics: and other competitors? Sure. Yeah. We filed with 24 of shelf life. So we will come to market with twenty four months.

The auto injectors, it’s hard to tell, but the the consensus I’ve seen is they’re somewhere around 18. The, nasal spray product, I believe the adult is at 30 and the pediatric’s at twenty four months. So look, from our perspective, people renew their prescriptions on an annual basis. Right? If you if you if I think about my wife and our children, every July or August, you’re into the doctor’s office and you’re saying, what do I need for the school year?

So we think the important thing is to make sure that the product is, has a shelf life that is well beyond that yearly renewal time period.

Nick Gasek, VP in Equity Research, Leerink Partners: Absolutely. And, maybe, you know, looking ahead, you know, assuming Adafilm’s approved to potential launch in early twenty twenty six, you know, what are you doing to prepare? How many reps you think you can have at launch? And, you know, how are you going to drive awareness maybe ahead of that launch? Sure.

Sure. Well, we’ve done a lot of work, building out the

Dan Barber, CEO, Aquestive Therapeutics: internal team already. So I’m excited, excited to to say we have not only an SVP of commercial who, by the way, used to run the EpiPen franchise at Mylan. So very excited that she’s part of the team. But we have a VP of sales. We have a VP of market access.

We have a marketing team that’s in place. So that kind of base infrastructure, we have. And they’ve done a phenomenal job of already building the advertising campaigns and the things that we would do from a marketing perspective. On the medical affairs side, we also have a medical affairs leader, as well as, some people around that person who are driving poster presence, conference presence, making sure we have publications. I believe, the number of conferences that we’re attending this year for Anifilm is something like 22.

So being out in the world on awareness right now is absolutely job number one.

Nick Gasek, VP in Equity Research, Leerink Partners: For sure. And I guess, like, you know, thinking about prescribers, you know, any specialties, you know, you’re planning on targeting initially? You know, do you think some specialties would be more receptive to an oral film versus the auto injectors or a nasal? How are you thinking about targeting the prescriber base?

Dan Barber, CEO, Aquestive Therapeutics: Sure. Yeah. So when you break apart the prescriber base, clearly, allergists and pediatricians are the place to start, right? You’re not going to go to kind of the general GP world until you’ve really built your brand and saturated those call points. So we’ll start with the allergists with big practices who, see a lot of people, and we’ll work our way down from there.

When you look at this space, while there are a large number of physicians who prescribe an EpiPen, the allergists really are at the center of that universe. So if you just think of you and I, if you were diagnosed with a need to carry an EpiPen, you would likely have that done by an allergist. And then you’d go back to your GP after that, right? And so that allergy call point is the central place to start.

Nick Gasek, VP in Equity Research, Leerink Partners: For sure. I guess, like, you know, with a competitor that recently launched, you know, any learnings you could take away from, I guess, the early days of that launch? And how are you personally thinking about maybe advertising promotion around your product if and when it’s approved? Sure.

Dan Barber, CEO, Aquestive Therapeutics: Well, I think of it in three ways. One, I continue to believe awareness is paramount in this space. And awareness is one of those places that the different competitors should be able to work together, because people are still dying from anaphylaxis. There clearly is a need for more people to be carrying whatever product. And we should all be working together to make sure that awareness is as big as possible so that we actually create the outcome that is good for patients, right?

The other two things that are important, one, we have seen with, the the product that’s out there now that some physicians want to see clinical efficacy. Right? Because even the EpiPen didn’t have any efficacy studies performed in order to be approved. So that leaves physicians in a spot where they they they usually have proof and they don’t have proof, right? So with our product, we will definitely come forward with our OASIS data and use that as a surrogate for efficacy where we show them, hey, while we couldn’t run a clinical efficacy study because it wouldn’t be safe to the patient, we have this great OASIS data that shows you how quickly the product is working the way it’s supposed to work.

The third thing that we, of course, have been watching is the payer. Right. The always famous payer universe. And that was one of the reasons we just brought in an in house market access person is we need to be out in the payer world telling our story now. Some of the payer problems are just inevitable.

So there will be NDC blocks. There will be plans that are just not friendly to new products. But the more effort and work and time you spend with payers, you will eventually get them to the right place. So, as we’ve watched Anifilm or, as we’ve watched our competitor and their experience, we want to be a little bit, more on the ball and learn from their experiences, Antifilm comes to market.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. That makes a ton of sense. I guess it might be a good time to pause, see if any questions from the audience. I can keep rolling. I want to make sure we have enough time to cover everything, but Libervant, you know, I’m curious, like, what’s your longer term outlook for this product?

I know it’s a commercial product right now. It’s revenue generating. You know, how do you envision this fitting into the acute, you know, repetitive seizure landscape longer term?

Dan Barber, CEO, Aquestive Therapeutics: Yeah. Well, my first thing is I just feel bad for Libervant, right? I feel bad for, the patients who use Libervant. I mean, these are two to five year olds who and think about it. If you’re a parent who has a two to five year old that’s just been diagnosed with epilepsy and put on a maintenance medication, and then you’re told, and by the way, if the maintenance medication doesn’t work, use this rectal gel.

I mean, that’s a terrible situation to be in as a parent. And we have a product that is currently on the market that they can use instead of the rectal gel. So, and for those who may not know, we, there is a court case involved in Libervant where potentially, we may not be able to always have the product available to two to five year olds. So I I I just I feel for these children who are on this product and, and need to need to keep having it with them. So there’s that in the short term.

In the long term, as of 2027, the orphan drug block that we’re under, expires and we’ll be able to, provide the product to, all age groups. And at that time, we will happily do that. We do believe Libervant continues to be a high value and a high value proposition product, and we will in 2027, whether it’s through our own efforts or working with someone else, make sure they have access to the product.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. I guess, like, maybe thinking ahead to 2027, how are you thinking about, like, label expansion into that older than 12 population? And how large do you think this opportunity could really be?

Dan Barber, CEO, Aquestive Therapeutics: Sure. Yeah. Libervant, I think it’s funny. If you had asked me that a couple of years ago, I would have said it’s a big opportunity for the company. When I look at Anifilm and I look at AQST one hundred and eight in our topical gel for alopecia areata, and I look at vitiligo perhaps right behind that, and then perhaps other places we use that prodrug epinephrine platform, those are big opportunities.

So with Libervant, the important thing is to make sure we get it to patients. Whether it is something that creates tremendous value for the company or not, I think it may be overshadowed by these other bigger opportunities over time.

Nick Gasek, VP in Equity Research, Leerink Partners: Definitely. I wanted to ask you about AQST 108 and allocation area. So I guess, you’re going to be starting a Phase 2A in the second quarter. I guess, like, what should investors be watching from an efficacy standpoint in that study? Is there like a bar you’re looking to beat or meet?

Like how should we think about that? Yes.

Dan Barber, CEO, Aquestive Therapeutics: Well, and we so we have a phase two a with 36 subjects. We do not have a placebo arm in it, which typically with a phase two a, you would. And the reason we have decided not to do that is because in this space, you track something called your SALT score. Right? So alopecia areata is a lot you get these blotchy losses of hair.

And, physicians will give you a score on the loss on hair loss based on different quadrants on your head. And then, in in a study, you check the change in SALT score. Right? So we feel, that the science lines up very nicely here that we can restore immune privilege for people who have lost it, in the, immune response, which is attacking their body by tampering that immune response down with epinephrine. And so when we think about a SALT score over a twelve week period, we think we’ll see a substantial change in that SALT score.

So we feel strongly enough about the science and the change that we can create that we think any placebo drift that could be in there by not having a placebo arm will be more than carried by that change. So that’s why we went with a simpler design, that we think will give a very nice, reading at twelve weeks.

Nick Gasek, VP in Equity Research, Leerink Partners: Sure. Sure. So I guess thinking about 108, you know, the topical gel profile, what features do you think would be attractive to patients in this space? Like, what do you think is really going to drive adoption relative to what, you know, what’s currently available on the market? JAKs and topical steroids, etcetera.

Dan Barber, CEO, Aquestive Therapeutics: Yeah. When I think people and and I actually happen to to know somebody, a a pediatric person who has alopecia areata. And it’s a very hard thing to deal with, right? And so, if you think about parents who are dealing with a child who has to go to school and deal with all of the stigma around alopecia areata, solving that quickly is important. And going to a JAK inhibitor where it is a systemic product, it has, known, significant side effects, it has a black box warning, That’s using a sledgehammer to solve that problem.

So if we can create a localized epinephrine that stops the, immune, issue that’s going on, allow hair growth to happen for, especially in that pediatric space, we think that’s a winner. So, we’re excited for that and we can’t wait for the data to come up.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. We look forward to that. Maybe a question for Ernie. I guess, how should we think about cash runway, use of cash over the next couple of quarters? How are you allocating resources across the different programs?

Ernie Toth, CFO, Aquestive Therapeutics: Well, Nick, as we just announced last week, you have $93,000,000 of pro form a cash after accounting for a year end balance and some recent raises we did through our ATM facility to bring in two high quality institutional healthcare investors. And we see that as providing runway into through everything this year that we’re dealing with. It’s the filing of the NDA, it’s preparing for an adcom, It’s the 108 study that you just asked Dan about. It’s all the pre commercial work of preparing for a launch next year. You know, sharing her team, being out there at the advocacy groups, doing all the payer work.

So we’re ready to launch next year upon approval. So it gets us into 2026 Hopefully an approval early first quarter and the initial stages of a launch.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. That’s very helpful. I know we’re coming up on time here, but I want to ask a bigger picture question to close out maybe. How are you thinking about potential partnerships either for Anifilm or Libervant or maybe even one hundred and eight? Is there any aspects you would be looking for in potential partners?

Are these programs something you want to be advancing alone all the way? Or how should investors think about that angle?

Dan Barber, CEO, Aquestive Therapeutics: Sure. So, from an Anifilm perspective, our focus is on maximizing the value for our stakeholders, right? We know this product has tremendous value, not only from an investor in a company standpoint, but from a patient standpoint. So we will we will only do something if it maximizes our reach. Right?

And in the meantime, we are preparing and are ready and will launch on our own if we can make sure that we reach the people who need this product. In terms of longer term and the other programs, I think what you’ll see us do over the years to come is make sure we focus in an area where we can leverage our knowledge and our ability and where we’re the best people for that spot, right? So, you won’t see us spread across a bunch of different areas that don’t add up to something that works together. And that’s the work that we’ll have to do as Antifone comes to market.

Nick Gasek, VP in Equity Research, Leerink Partners: Got it. Look forward to that. I think that’s all the time we have today. But thanks for joining us and enjoy the rest of the conference.

Dan Barber, CEO, Aquestive Therapeutics: Thanks, Nick. Appreciate it.

Nick Gasek, VP in Equity Research, Leerink Partners: Thank you.

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