Aquestive Therapeutics, Inc.

Thank you for standing by. Welcome to the Q3 2025 Equestive Therapeutics, Inc. Earning Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message, advise your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Brian Cobb, please go ahead, sir.

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. We're going to provide an overview of the company's recent business developments and performance for the third quarter of 2025, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Gary Slatko, Interim Chief Medical Officer, Sherry Korchinski, Chief Commercial Officer, Laurie Brander, Chief Legal Officer, and Peter Boyd, Chief People Officer. As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday. In addition, a recording of today's call will be made available on Equesta's website within the Investors section shortly following the conclusion of this call. To remind you, the Equesta team will be discussing some non-GAAP financial measures this morning as part of its review of third quarter 2025 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 section of Equestria'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 yesterday's earnings release, as well as the risks and uncertainties affecting the company as described in the risk factors section and in other sections included in the company's annual report on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8K filed with the U.S. Securities and Exchange Commission. 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 its 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 are attributable to a questive or any person acting on its behalf or 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.

Thanks, Brian. Good morning, everyone, and thank you for joining us today. This morning, we are holding our earnings call from the American College of Asthma, Allergy, and Immunology annual conference here in Orlando, Florida. This is one of the largest allergy-focused conferences in the US, and we are proud to be here supporting the college at their annual gathering. We have almost 20 colleagues on site this week and a host of events, including multiple poster presentations, a fully staffed medical affairs booth on the exhibition floor, and multiple engagements with investigators. This truly is an exciting week for the Equestria team. This is also emblematic of the increased awareness of our anafilm dibute epinephrine sublingual film program within the allergy community. In fact, our latest data suggests most allergists are now aware of our sublingual film program, and over 25% have even completed our continuous medical education, or CME, presentation offered through Medscape, the leading provider of CME materials for physicians. As we approach our FDA scheduled action date of January 31st for anafilm, we are well positioned from an allergist awareness perspective. In case anyone hasn't been paying attention, anafilm, if approved by the FDA, will be the first and only oral medication for the treatment of severe allergic reactions, including anaphylaxis. Today, healthcare providers, caregivers, and patients must choose between two types of medical devices, auto-injectors and nasal sprays. We believe our portability low barrier to use, and fast absorption profile creates a transformational offering for the allergy community. Following our equity raise and strategic financing agreement that we announced this past August, our pre-launch activities have accelerated and remain on track for a first quarter 2026 launch if Anifilm receives FDA approval. Our marketing materials are ready to go and are only awaiting a final label. We are in the process of hiring our district managers and will hire sales reps upon FDA approval. Our market access team is in full swing and interacting with payers under acceptable pre-approval guidelines. Our supply chain is prepared to rapidly produce material once final labeling has been provided by the FDA. And importantly, Our medical affairs team is fully deployed as you heard from my opening statements regarding this week's conference. Simply put, we are ready to go. Now let's turn to the FDA. Given the government shutdown, we requested the FDA provide us with a status update on the review timing of our filing. I am pleased to say that as of this last update, the FDA confirmed they are aiming for an on-time review of our application. As we reported to you in September, the FDA has informed us that we will not have an advisory committee meeting. However, we remain ready to provide further information, if necessary, to the FDA reviewers. We will keep everyone appropriately updated as we learn more and as we get closer to our action date. As we begin looking towards 2026, there are two very important priorities in our business. One, putting together the best possible launch of Anafilm, and two, exploiting the science behind our Adreniverse platform. If you recall, we made the strategic choice to slow down our Adreniverse pipeline initiatives in the first half of 2025 while we worked on fully funding our launch. Now, It is time to get going. To better accomplish these goals, I announced several leadership changes earlier this week. First, to better support Anifilm, I've asked Dr. Gary Slatko to become our interim chief medical officer. Gary has the perfect blend of medical affairs expertise and deep understanding of our Anifilm development program. Some of you may recall Gary was previously our Chief Medical Officer from 2018 to 2023. I have also promoted Peter Boyd to Chief People Officer. This is a critical role as we expand our organization to include a full commercial team. On the Adreniverse side, I am very excited to announce the addition of Dr. Matthew Davis as our Chief Development Officer. Matthew and his team will be very focused in 2026 on kick-starting our R&D efforts and driving clinical proof points that show the value our Adreniverse platform can create. While anaphyloma is transformational to the allergy community and to Equestis, it is just the beginning of our story. Through the efforts of Matthew and his team, I am confident there are multiple significant programs yet to come. The first of these programs is our AQST 108 development program for the treatment of alopecia areata. We have completed the pre-IND meeting process with the FDA and will be submitting our IND shortly. We expect to be in the clinic with our next study, a safety study in men, starting in January, and expect this study to complete rapidly. With the funding just received by the company, we will look to advance our progress on this front. Our international efforts for anafilm as well continue to gather steam. We had a positive interaction with Health Canada in the third quarter and are excited to share that no further studies are required for filing our application. We anticipate filing in Canada in the first half of 2026. We have also continued our interactions with the European Medicines Agency, or EMA, and expect to have full feedback regarding the application process by early in the first quarter of 2026. We will continue to advance our regulatory interactions as we work towards the appropriate partnerships in these territories. Our base business continues to be an important provider of cash flow and capabilities, and we expect this to continue in 2026. We continue to see stable demand from Indivior our largest base customer. We have also seen significant growth in our South American partnership focused on the Brazilian market. Our manufacturing team is prepared to take a leading role in supply of anafilm to our commercial team and eventually around the world. Finally, from a financing perspective, we are now well positioned to fully fund our business through the commercial launch of anafilm, if approved by the FDA. As Ernie will discuss with you in a moment, one of the last pieces to the puzzle in locking in our finances is refinancing our existing debt. We are well on our way with this effort, and as of today, I expect this to close before the end of the year. So, to summarize, as we look forward, you should expect the following. We will be ready to launch in the first quarter if AnnaFilm is approved on time by the FDA. We will begin to make rapid progress on our broader Adreniverse platform and advance our pipeline. We will continue to actively progress our regulatory applications for Annafilm outside the U.S. And our base business, along with our financing from August, have us financially well-positioned for 2026 and beyond. Now, I will turn the call over to Ernie.