Aquestive Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the first quarter 2026, a Quest of Therapeutics earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, we'll open up for questions. To ask a question during a session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's call is being recorded. I would like to hand it over to our first speaker, Faith Pomeroy Ward. Please go ahead.

Thank you, Operator. Good morning and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of the company's reported financial results for the first quarter ended March 31st, 2026, and a progress update on the company's key 2026 objectives, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Matt Greenhut, Chief Medical Officer, Melina Chaffee, Senior Vice President, Regulatory Affairs, Sherry Korchinski, Chief Commercial Officer, and Dr. Matthew Davis, Chief Development Officer. As a reminder, the company's remarks today correspond with the earnings release that was issued after market close yesterday. In addition, a recording of today's call and related supplemental materials will be made available on Equestive's website within the investors section shortly following the conclusion of this call. To remind you, the Equestive team will be discussing some non-GAAP financial measures this morning as part of its review of first quarter 2026 results. A description of these measures, along with a reconciliation to GAAP, can be found in the earnings release issued yesterday, which is posted on the investor's section of Equestiv's website. During the call, the company will be making forward-looking statements. We remind you of the company's safe harbor language as outlined in today's earnings release, as well as the risks and uncertainties affecting the company as described in the risk factor section and in other sections included in the company's annual report on Form 10-K, filed with the U.S. Securities and Exchange Commission on March 4th, 2026. As with any pharmaceutical company with product candidates under development and products being commercialized, there are significant risks and uncertainties with respect to the company's business and the development regulatory approval, and commercialization of its products and other matters related to operations. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. Actual results may differ materially from these statements. All forward-looking statements attributable to a questive or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement and the cautionary statements contained in the earnings release issued yesterday. The company assumes no obligation to update its forward-looking statements after the date of this conference call, whether as a result of new information, future events, or otherwise, except as required under applicable law. Now, I would like to turn the call over to Dan.

Good morning, and thank you for joining us today. In the last 62 days since our earnings call, we have progressed the company significantly. For anisome-dibute epinephrine sublingual film, we have completed our type A face-to-face meeting with the FDA, completed a teleconference with the UK regulatory body known as MHRA, submitted our pediatric investigational plan to the European Medicines Agency, and submitted our human factors protocol for review by the FDA. In addition, we have closed on a new debt facility with a leading life sciences debt provider and completed our phase one safety study in humans for our pipeline program, AQST 108. We are also on track to attend over 40 conferences and submit over 20 publications this year. It is a testament to the Equestive team that they were able to complete so much important work in such a brief period of time. The question of course is where does this work take us and how do we expect the coming months to unfold? Today I am providing guidance that we currently expect to have our human factors data and potentially our pharmacokinetic data for anafilm available in time for our August earnings call. Now the completion of this data is dependent on the FDA providing responses to our human factors protocol on time and the responses being within expectations, including with respect to the scope and content of that feedback. With these assumptions in mind, we continue to guide to a third quarter resubmission to the FDA, recognizing this timing remains subject to FDA feedback and ongoing review processes. As we've stated in the past, we currently expect our resubmission of the NDA for anafilm to be classified as a type two submission with a six month review although final classification is determined by the FDA. We will request an expedited review upon our submission, and we'll do everything we can to communicate with the FDA and support their review process, recognizing that any decision on review timing rests solely with the FDA. We believe the comments by FDA's leadership on the need for the agency to provide more timely feedback and review points to a broader agency focus, and in this case, may create the possibility of aligning with the FDA on a faster process. This, of course, cannot be guaranteed. Our commercial preparations continue to progress. Importantly, we were pleased to enter into a $150 million debt facility with Oaktree, a leading life sciences debt provider. While Ernie will talk about this in more detail, at a global level, this agreement unlocks several important things for Equestiff. One, we have improved the interest rate terms on our existing debt and principal payments will not begin for several years. Two, this completes the pre-approval requirements for the RTW funding. And three, we have the ability to access $20 million in additional capital if anafilm is approved by the FDA. Taken together with our existing cash and the RTW deal, we currently project that we will have greater than $150 million in cash at launch, and this is before considering ex-U.S. anafilm and U.S. Libervin outlicensing deals. We plan on using this cash to focus on building intense awareness and access within the allergy community for anafilm. We have already shared our plans for launch of anafilm with you, if approved by the FDA, including a strong medical affairs presence, a 75-person sales force, and a focused marketing effort. We have also been watching and learning from the launch of a nasal spray product in the market. Our research within the allergy community indicate that building clarity, trust, and support for allergists is key to unlocking prescriptions. This may seem obvious, but just think of the daily pressures allergists face in running their practices. Fitting into their world in a meaningful and credible way in furtherance of patient access to anafilm is task number one, two, and three for us. While the U.S. market is incredibly important to us, we can't forget that 96% of the world's population does not live in the U.S. I truly believe Anifilm is a product that will save lives, and we want as many people as possible on this planet to ultimately have access to it. Our LeadXUS strategy continues to be Canada and Europe, and we've made significant progress. As I mentioned before, we recently completed a comprehensive and positive interaction with MHRA, the UK's regulatory body. I'm pleased to say we received confirmation that we do not need to conduct additional studies before submitting our application to MHRA in the UK. We also recently submitted our pediatric investigational plan to the European Medicines Agency, or EMA, for the European Union. Aligning with EMA on this plan is essential to submitting our application. We now know that we can submit applications in the EU, UK, and Canada without conducting further clinical studies. Between the US, Canada, the UK, and the European Union, our product if approved in each of these regions, could eventually be available to almost one billion people in the next several years. Now let's talk about our product pipeline. Given the excitement around anafilm, people often forget that we are utilizing our epinephrine prodrug platform, Adreniverse, to advance treatment in other indications. Our lead asset is AQST-108, and we recently completed a phase one safety study in men with androgenic areata. I am pleased to say that there were no drug-related adverse events observed in the study, and we also saw no appreciable signs of systemic absorption of our epinephrine prodrug or of epinephrine itself. We did, however, see something intriguing. Now, keep in mind, this is very early phase one study data. Our chief development officer, Dr. Matthew Davis, added biomarker assays to the study to see if we could detect changes in key proteins associated with both alopecia areata and androgenic areata, along with other dermatological conditions such as atopic dermatitis. While this information is not statistically powered and should be viewed as directional only, we were pleased to see in subjects with alopecia that the cytokine TSLP appeared to be impacted by AQST108. This was not the case when subjects were given placebo. This is very exciting as the signaling pathway for TSLP involves the activation of JAK1 and of JAK2. We have included preliminary data on this work in our supplemental material available under the Presentations section of the Investor page on our website. We will talk more about the next studies for AQST 108 in the coming months once we have resubmitted our anti-film application in the U.S. Our business development efforts and base business continue to move forward. Our business development team is currently in active negotiations on multiple programs for Europe, the U.S., and South America. We have also had outreach from additional regions of the world, including China and Australia. We are prioritizing this work based on the territory and program involved. We expect to have more to say on this topic in the months to come. In summary, we expect to provide a significant data update in August, assuming the FDA keeps to its review timeline and provides constructive comments to our human factor study protocol. We continue to drive awareness in the epilepsy community ahead of a potential product launch of Anifilm if approved by the FDA. Our international filing efforts continue to be a priority, and our AQSC 108 program continues to show promise for expansion into potential multiple indications. With that, I will turn the call over to Ernie.