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Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 8:00 a.m. ET Investor Relations - Faith Pomeroy-Ward President and Chief Executive Officer - Daniel Barber Chief Financial Officer - Ernie Toth Chief Medical Officer - Dr. Matt Greenhawt Senior Vice President, Regulatory Affairs - Melina Cioffi Chief Commercial Officer - Sherry Korczynski Chief Development Officer - Dr. Matthew Davis Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Second Quarter Aquestive Therapeutics Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would like now to turn the conference over to Faith Pomeroy-Ward, Investor Relations. Please go ahead. Faith Pomeroy: Thank you, operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan Barber, President and 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 second quarter ended June 30, 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 Greenhawt, Chief Medical Officer; Melina Cioffi, Senior Vice President, Regulatory Affairs; Sherry Korczynski, 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 Aquestive's website within the Investors section shortly following the conclusion of this call. To remind you, the Aquestive team will be discussing some non-GAAP financial measures this morning as part of its review of second 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 Investors section of Aquestive'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 filed with the U.S. Securities and Exchange Commission on March 4, 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 Aquestive 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. Daniel Barber: Thanks, Faith, and good morning, everyone. I am excited to share today that not only have we completed the necessary studies for Anaphylm resubmission, but that we remain on track to resubmit before the end of this quarter. This is less than 8 months from when we received a complete response letter from the FDA. Our resubmission will include the results from our most recent human factors validation study. As a reminder, this study provides information on how participants interacted with our improved packaging and instructions for use. In the complete response letter received earlier this year, the FDA indicated participants experienced difficulty opening our pouch and incorrectly administered the film too many times. I am pleased to say that after updating our packaging, labeling and instructions for use, our most recent human factors validation study showed statistically speaking, a major reduction in both categories. Under the previous packaging, we had 26 individuals indicate difficulty opening our packaging, and we had 6 individuals tear the film. This time, we had only 1 participant show difficulty and no one tore the film. In the previous study, 20 participants placed the film incorrectly on top of their tongue or on the roof of their mouth. This time, we had only 2 participants misplaced the dose during administration. This data is further supported by our latest pharmacokinetic or PK study. In this study, we saw no statistical difference between clinician-administered and self-administered drug product. Keep in mind, subjects who self-administered were given our revised packaging and instructions for use and had no coaching by clinical staff during the administration. We also had an encouraging result when the film was purposely misplaced by clinicians on top of the subject's tongue. This data was requested by the FDA to further understand what might happen if the film is misadministered. We saw rapid and meaningful changes in blood pressure and heart rate. The changes from baseline were higher than manual IM during the critical first 15 minutes and in line with what we have seen from EpiPen in our other studies. This means that in the evaluated misadministration scenario, pharmacodynamic responses compared favorably to manual IM administration. Even on PK, while we saw lower levels as expected compared to on-label sublingual administration, we still reached meaningful Cmax levels. This is a very encouraging outcome for the program. As we approach our planned resubmission for Anaphylm, it is a good time to review the compelling opportunity that exists for Anaphylm here in the U.S. While the epinephrine rescue market is largely generic, the need for improved clinical and carrying offerings in this category is significant. And we believe these needs could support conversion to a branded product over time, if approved. As a large PBM publicly wrote earlier in the year about Anaphylm, this advancement stands out because emergency treatment is a category where ease of use and readiness really matter. That need starts with patients, caregivers and healthcare providers. Our interactions with the allergy community indicate there is a widespread desire among patients and caregivers for an epinephrine that is oral, works quickly, is easy to use, easy to carry and durable. Many years of research and data tell us patients still do not carry or use their epinephrine. The data also shows that medical devices such as auto-injectors are often not where you need it, when you need it, when anaphylaxis occurs. We believe the conversion from auto-injectors starts with the allergists, and we can accomplish this efficiently. Our focus at launch will be on the allergy community, which will allow us to keep our cash burn down as we prepare for a potential launch, if approved. We believe that allergists convert their prescriptions to the first and only noninvasive orally delivered epinephrine product for the treatment of type 1 allergic reactions, including anaphylaxis, if approved by the FDA, the rest of the market could follow over time. Clearly, the desire for better products in this space is strong among patients, caregivers and healthcare providers. This brings us to payer coverage. The first point I want to be clear on today is that we believe clinical differentiation matters to payers. Let me repeat that. Clinical differentiation matters. This goes beyond just offering a no-needle solution. In our case, the benefits from an oral medication are significant. Not only do we believe we are easier to carry than auto-injectors, our product has shown in our studies meaningful clinical differentiation from the auto-injector on time to maximum concentration or Tmax and on change from baseline blood pressure following administration. Our data demonstrates this, and we believe payers may find this meaningful. This, along with the ease of carry and use aspects of Anaphylm are important. We have a great clinical story to share, and we have already heard from multiple counterparts at various payer groups about the difficulties their individual family members face with auto-injectors. Payer coverage is also a function of product pricing. This is the single most important decision any brand will make at launch. We are actively building our pricing strategy. And for now, we'll keep this confidential. What I will say is that based on the ongoing volume in this market, we continue to believe the market opportunity for epinephrine branded products exceeds $1 billion a year and could potentially reach $2 billion a year over time. This is driven not just by payer dynamics, but also by prescription volumes. The epinephrine rescue market has been growing for years even without significant promotional activities. Over the last few years, the market has grown annually by around 6%, and this holds true for 2026 year-to-date. Given the large gap between prescriptions and prevalence, the continued expansion of allergy diagnoses and new product offerings, we believe this growth rate could continue for the foreseeable future. So from my perspective, the compelling opportunity in this category remains intact. We have an expanding and growing market dominated by outdated technology. We believe our product provides meaningful clinical differentiation that could support payer adoption, all while being efficient in our allergist-focused launch strategy, if approved. Now let's talk about medical affairs and our commercial launch preparations. Our Chief Medical Officer, Dr. Matt Greenhawt and his team continue to interact with allergists on a daily basis and continue to attend all key allergy conferences. In fact, I believe awareness of Anaphylm within the allergy community is now quite high. Matt recently told me that during a major allergy conference, it was difficult to find physicians who are unfamiliar with Anaphylm. That is a testament to the team's consistent engagement with allergists over the last several years. Interaction after interaction, the team continues to share the excitement for Anaphylm to be potentially approved. Our commercial team has launch preparations fully underway. As previously shared, the team has made excellent progress preparing for launch. Sales leadership has put plans in motion to bring on our regional sales directors and training. Marketing is driving all promotional materials and programs to be launch-ready in a manner consistent with applicable pre-approval requirements, and we are building out our commercial analytics capabilities. Simply put, we have the right experienced leadership in place and remain on track to hit the ground running as soon as possible, if approved by the FDA. Now let's turn to AQST-108. I must admit, I was surprised after our May earnings call by how much interest we received in our atopic dermatitis program. One of the most common reactions was, "I've never thought about epinephrine for atopic dermatitis," along with questions on how we believe the science works. We have included extra slides in our supplemental materials to further elucidate the science. Simply put, a localized topical epinephrine application may have the potential to provide a meaningful treatment approach in atopic dermatitis and could potentially support a dosing profile that does not require daily administration. This could allow us to position AQST-108 with low-cost, less effective generics and significantly higher-priced biologics. We will have more to say on this program after we have completed the resubmission of Anaphylm. Now let's turn to our partnering and base business activities. We continue to engage in active partnering processes for Libervant in the U.S. and Anaphylm outside of the U.S., and we expect to have more to say as those processes progress. Our base business as well remains cash flowing on a consistent basis. After interacting with Indivior, we also believe that there is no near-term impact to our base business based on the proposed Indivior-Supernus merger. We continue to manage our cash carefully. As a reminder, we continue to expect $75 million in launch funds from RTW following FDA approval as well as $20 million from Oaktree. This, along with the potential cash that could be generated from our out-licensing activities if completed on acceptable terms, means we believe we are positioned to support an effective launch of Anaphylm, assuming FDA approval, satisfaction of applicable funding conditions and execution of our planned commercial strategy. In conclusion, the epinephrine market remains a healthy and growing market that is well positioned for potential conversion from auto-injectors. We are on track to resubmit our NDA in Q3. Our cash position is expected to support a potential launch, and we will have more to say on AQST-108 later in the year. With that, I will turn the call over to Ernie. Ernie Toth: Thank you, Dan, and good morning, everyone. By now, you will have seen our second quarter 2026 financial results in the earnings release issued last evening and detailed in our Form 10-Q filing. As we typically do, we will address most of the detailed discussion regarding the quarter during Q&A, and I will focus my remarks on the financial performance, operating spend and liquidity. During the second quarter, our primary financial focus remains supporting the Anaphylm resubmission process while maintaining a strong balance sheet and financial flexibility. During the quarter, we also completed our refinancing with Oaktree, establishing a new $150 million debt facility that lowers our cost of capital, extends our interest-only period and enhances our financial flexibility as we prepare for a potential Anaphylm launch, if approved by the FDA. As Dan discussed, we successfully completed the human factors validation study and PK study for Anaphylm and results support resubmission of the NDA in the third quarter of 2026. We are also continuing to manage the business with a disciplined approach to capital allocation. Our commercial team is advancing launch preparations in a manner consistent with applicable pre-approval requirements, while our medical affairs team continues to engage with the allergy community. At the same time, we remain focused on carefully managing cash as we move towards resubmission and prepare for a potential launch, if approved. Now let me walk through the second quarter results. Total revenues increased to $13.8 million in the second quarter 2026 from $10 million in the second quarter 2025. The 38% increase was primarily driven by increases in manufacture and supply revenue and increases in license and royalty revenue. Manufacture and supply revenue increased to $11.9 million in the second quarter 2026 from $9.6 million in the second quarter of 2025, primarily due to increases in Suboxone revenues, partially offset by lower Ondif revenues. License and royalty revenue increased to $1.3 million in the second quarter 2026 from $0.8 million in the second quarter 2025, primarily due to royalty revenue from Zevra. Total revenues increased to $28.3 million for the 6 months ended June 30, 2026, from $18.7 million for the 6 months ended June 30, 2025. The 51% increase was primarily driven by increases in license and royalty revenues and increases in manufacture and supply revenue. Manufacturing and supply revenue increased to $20.7 million for the 6 months ended June 30, 2026, from $16.8 million for the 6 months ended June 30, 2025, primarily due to increases in Suboxone revenues, partially offset by lower Ondif revenues. License and royalty revenue increased to $6.7 million for the 6 months ended June 30, 2026, from $1.6 million for the 6 months ended June 30, 2025, primarily due to royalty revenue from Zevra. Research and development expenses decreased to $4 million in the second quarter of 2026 from $4.1 million in the second quarter of 2025. The decrease in research and development expenses was primarily due to lower development and manufacturing costs associated with the Anaphylm program, partially offset by increases in preclinical costs. Research and development expenses decreased to $8.2 million for the 6 months ended June 30, 2026, from $9.5 million for the 6 months ended June 30, 2025. The decrease in research and development expenses was primarily due to a decrease in the clinical trial costs and product research expenses associated with the Anaphylm program and decreases in share-based compensation, partially offset by increase in personnel costs. Selling, general and administrative expenses increased to $14.1 million in the second quarter of 2026 from $12.7 million in the second quarter of 2025. The increase primarily represents higher legal fees of approximately $2.1 million, higher severance costs of approximately $1.4 million, which includes acceleration of share-based compensation, higher personnel costs of approximately $0.9 million and higher share-based compensation expenses of approximately $0.3 million as well as other expenses, partially offset by lower commercial spending of approximately $2.6 million and lower regulatory and licensing fees of approximately $1.2 million. Selling, general and administrative expenses decreased to $25 million for the 6 months ended June 30, 2026, from $31.8 million for the 6 months ended June 30, 2025. The decrease primarily represents lower commercial spending of approximately $4.5 million, the one-time Anaphylm PDUFA fee of $4.3 million in the prior year period, lower legal fees of approximately $1.3 million, lower regulatory and licensing fees of approximately $1.9 million, partially offset by higher severance costs of approximately $2 million, which includes acceleration of share-based compensation, higher personnel costs of approximately $1.4 million and higher share-based compensation expenses of approximately $1.8 million as well as other expenses. In the second quarter of 2026, the company recognized a one-time loss on extinguishment of debt of $11.7 million, which represents the difference between the carrying value of the 13.5% notes as of May 12, 2026, and the total payoff amount of the 13.5% notes. Aquestive's net loss for the second quarter of 2026 was $22.9 million or $0.18 for both basic and diluted loss per share compared to the net loss in the second quarter of 2025 of $13.5 million or $0.14 for both basic and diluted loss per share. Excluding the impact of the onetime recognition of the loss and extinguishment on the company's 13.5% notes, the net loss in the second quarter of 2026 was $11.2 million. Aquestive's net loss for the 6 months ended June 30, 2026, was $30.9 million or $0.25 for both basic and diluted loss per share compared to the net loss for the 6 months ended June 30, 2025, of $36.5 million or $0.37 for both basic and diluted loss per share. Excluding the impact of the one-time recognition of the loss on extinguishment on the company's 13.5% notes, the net loss for the 6 months ended June 30, 2026, was $19.2 million. Non-GAAP adjusted EBITDA loss was $5.2 million in the second quarter of 2026 compared to a non-GAAP adjusted EBITDA loss of $9.3 million in the second quarter of 2025. Non-GAAP adjusted EBITDA loss was $7 million for the 6 months ended June 30, 2026, compared to a non-GAAP adjusted EBITDA loss of $27 million for the 6 months ended June 30, 2025. Turning to the balance sheet. We ended the second quarter of 2026 with $98.5 million in cash and cash equivalents. Combined with the flexibility provided by our Oaktree facility and the expected availability of $75 million in launch funding from RTW and $20 million from Oaktree following FDA approval of Anaphylm, we believe we are well positioned to support our planned commercial strategy and launch preparation. As Dan noted, we also continue to engage in active partnering processes for Libervant in the U.S. and Anaphylm outside of the U.S., and we expect to have more to say as those processes progress.?Our base business also remains cash flowing on a consistent basis.? We are maintaining our full year 2026 financial guidance.?For 2026, the company expects to have total revenue of $46 million to $50 million and non-GAAP adjusted EBITDA loss of $35 million to $30 million. In summary, the second quarter reflects continued financial discipline and execution across the business.?We delivered year-over-year revenue growth, improved non-GAAP adjusted EBITDA performance, ended the quarter with a strong cash position, and remain focused on funding the key priorities that Dan outlined today.?Those priorities including completing the Anaphylm resubmission in Q3, preparing for a potential launch if approved by the FDA, advancing AQST-108, and continuing to evaluate partnering opportunities.? With that, I will now turn the line back to the operator to open the line for questions. Operator: [Operator Instructions] The first question will come from Roanna Ruiz with Leerink Partners.? Roanna Clarissa Ruiz: A couple questions from me.?One, could you help frame how the recent PK and human factors study data potentially increases your conviction in the resubmission being very comprehensive??Can you give us updated thoughts on whether you think the FDA may use a shorter or accelerated timeframe to review the resubmission? Daniel Barber: Sure.?Good morning, Roanna.?I will give you my thought on the PK human factors overview, and then I will ask Matt to give a little bit more color.?We know from the original review that the FDA's clinical team was bought into and signed off on the approval of our product.?So we know from a clinical perspective that there's conviction on the FDA side from at least the interactions we've had in the back and forth and what we've seen from documentation.?We know that the CRL was limited to the things that not only we shared with you, but also to that idea that the packaging was difficult to open and our instructions weren't clear for administration.?When we look at the data that we just generated, we believe we have very convincingly and thoroughly answered the open questions the FDA put out. As you heard in the prepared remarks, on the human factors side, we think the results are very clean, and on the PK side, when self-administered, we saw no difference from clinician-administered.?Even when we look at this off-label arm that the FDA asked us to produce, we see some really interesting pharmacodynamic data.?Before I answer the timeframe question you had, I will just ask Matt to give his thoughts on the pharmacodynamic data. Matthew Greenhawt: In looking at the results, the one theme that I keep coming back to is just how reassuring it was to look up the results that we got.?I think, as Dan said, when you look at the repeat of the self-administration and the healthcare provider, we got exactly what we were expecting, and it is in range with what we have seen before.?So it is nice to see the reinforcement and replication of that data.?Then you look at the off-target, the top of tongue.?Those were really great data to see that there is with that, in a way that we do not intend the product to be used, that you are still getting a very clinically meaningful increase in your heart rate and blood pressure. I think, in my opinion as a clinician, when I am prescribing a drug to a family, to a parent, they want reassurance that this is going to work.?I think we are able to look at these data and in a way that we see a response, which in a way that you would not want the drug to be taken, you are still going to get a response.?I think that is among the more reassuring things that you can counsel a family when they are making a decision on what product they would prefer to be prescribed.?So, very pleased with the results. Daniel Barber: Going to your second question on the timeframe, our guidance to everyone remains the same.?If the classification system at the FDA would tend to say this is a 6-month review, so our guidance is this will be a 6-month review.?However, we are already engaged with the FDA on the fact that our application is coming their way.?We do think this is a very thin package compared to the 10-month review they have already done and the conclusions that they have reached.?We will be pressing them in a supportive way, not in an aggressive way, that this is an opportunity to move faster.?So whether they take that opportunity or not is up to them, and the standard time would be 6 months. Roanna Clarissa Ruiz: Yes.?That's helpful.?And a quick follow-up.?Thinking ahead, how would physicians typically interpret the HF and PK data on top of the existing data you've already produced, and how are you thinking about leveraging this information with the field force, detailing docs, things like that, assuming Anaphylm is eventually approved? Daniel Barber: Yes.?I'll give it to Matt in a second again to give you his thoughts on how a physician might think about this data.?But let me be clear with the data that we've generated.?We have a great clinical story, and you heard me say that in prepared comments.?So not only in the payer world, where we think there's an ability to position the product in an important way from a clinical perspective, but also with Matt's team, the MSLs, and of course with Sherry and all her efforts and her marketing team and sales team.?We will absolutely be showing all of the great data we have, including the data we just generated.?But I'll let Matt give his thoughts. Matthew Greenhawt: Yes.?I think Dan said it well.?On the medical affairs side, we're very excited to get out to the next conference to be able to start sharing these details with the allergy community, and in our visits to physician offices.?How we would look at these data, this is just building more of just rounding out the story of an already sort of very nice tale.?We've got great data.?We have a product that in our studies shows a very strong magnitude of effect, and that magnitude of effect occurs very early, within a couple of minutes.?Comparatively in our studies, we've consistently seen that the magnitude of that effect exceeds that we're comparing it to.?You sort of synthesize what we just released. We were able to show that even with the top of tongue, again, probably we really would prefer you not take it this way, but if you do, even in the setting of low resulting PK, the resulting PD is overlapping with the same magnitude of change that we saw when we used EpiPen in our pivotal study.? That to me, just sort of at this point is, I don't want to say, icing on the cake, but it's a really nice feature to be able to have to counsel your patients.?And again, if you're looking at the totality of our data, we have a consistent picture of rapid onset of the drug reaching high levels, and these are very clinically meaningful levels.?So, combine this now with human factors data that shows that clearly we've improved on sort of previous performance.?Again, reassurance. That is the one word, and it is nice to have these data, to see it over and over again in a number of different studies with the PK and PD data consistency.?It is a nice thing to have to be able to counsel your patients. Operator: Thank you.?The next question is going to come from Kristen Kluska with Cantor.? Kristen Kluska: Congrats on these data you announced earlier in the week.?A few questions from me.?The first one, we have often talked about the product profile differences that will be important for payer discussions, but in your prepared remarks, you mentioned some of the clinical differentiation factors.?Curious if there are certain endpoints over others that you think are going to carry the most weight and how that portrays with the data that you have seen from Anaphylm so far.?And then I wanted to ask for the Cmax data for the top of the tongue, the inaccurate usage, whether the FDA in advance of this had set a bar for what they were looking for.?I know in literature they talk about this 100 picograms per milliliter being important, but is there a timeframe associated with when they would want to see that?? Daniel Barber: Sure.? Let me go in reverse order.?On the Cmax question.?As we all know, the FDA is reticent to ever give you bright lines of what you need or don't need.?But we know from our correspondence over several years that there's 2 threshold marks that they have pointed to, both in written communication with us and in meetings.?And the first one is this idea of getting over 50 picograms per milliliter, which we clearly do, on the top of tongue.?The second is this idea of clearing 100 picograms per milliliter, which we also do.?So we think from a PK perspective, and I'll hand it over to Matt in a second, and obviously as a practicing physician, I think you'll hear him say PK is not really where practicing physicians focus. But from an FDA perspective, where PK can be more important, I think we have, at least from the bars they have talked about in the past, we have what we need from, again, an off-label, or off-use, I should say, because the label's obviously in progress, an off-use administration.? Matt, I think this is your lucky day.?It's coming back your way.?I will let Matt talk about the clinical differentiation he sees, but I think it's worth pointing out again, I think one of the learnings we have in watching this market develop is positioning a product as simply no needle is not the path to success.?The path to success is highlighting the important clinical differentiation that you have.?Then, of course, all of the important features like use and carry come along with that. But I'll let Matt talk about the specific clinical differentiation [ item C ], things that are meaningful. Matthew Greenhawt: Yes, I think differentiation is the word, and if you look at our data, and I'll highlight, going back to our published pivotal trial, the 301 study, the differentiation is very evident when you look at the magnitude of effect that our drug reaches versus what the comparator drugs reach in that study.?The magnitude of change is, you can see it very clearly.?It is greater.?But more importantly, it's happening faster, much faster.?And that makes a huge difference.? In my clinical experience, and I'll disclose, I'm also a patient.?I have venom allergy.?I get stung.?Hopefully, I try not to get stung, but I get stung,?I don't want something that's going to take a long time to kick in.?I want that effect very rapidly, and I want a maximal effect. I don't sort of want a gradual increase in sort of marginal peaks of how much my blood pressure and heart rate are going to respond.?And that's what we see with our data, a rapid response in high levels.?And when you're giving epinephrine to a patient, you got a very small window in which you're watching to see, is this going to work??What do I have to do next??It's sometimes 5 to 10 minutes.? So, you look at where the time to these onsets hit, it's within that window.?We feel, not only is the change clinically meaningful, but it's happening in a timeframe that fits when we have to make a decision.?Are we going to say that the patient's going to be okay in that when we're watching them, or are we going to have to escalate care? So to us, we believe that our properties are absolutely differentiating in that respect.?And again, my [ career ] giving out doses of epinephrine, time is precious and you really don't want to mess around with that. Operator: The next question's going to come from David Amsellem with Piper Sandler.?Your line is open. Unknown Analyst: Hi, this is [indiscernible] for David.? First, regarding 108, any learnings from the recently completed study in androgenic alopecia that gives you confidence that the effects of 108 are relevant to atopic derm and a broader slate of dermatological conditions??That's number 1.?Number 2, also on 108, can you speak to the rationale behind pursuing atopic derm first, and how this decision plays into your broader strategy with respect to the AdrenaVerse platform??Thank you. Daniel Barber: Sure.?Thank you for giving a little bit of airtime to 108.?Obviously, we are incredibly excited about Anaphylm and where we are and what we are doing.?But we do believe AdrenaVerse has broader use, and 108 is the first place we are putting that to work.?Starting with the rationale on atopic derm, that is pretty straightforward.?It is a well-worn path in the dermatology space that atopic derm is a good entry point and a good first initial indication for expanding into broader indications.?While we think alopecia areata is still an important indication and one that is out there for us, we want to get that first proof point through the gates.? We have obviously been a little hampered by just the ability to focus on 108 while also bringing Anaphylm forward, and clearly, our resources are focused on Anaphylm. But to the extent that we have been able to move 108 forward, and we plan on doing that as we go forward, we do think that the science is there in a compelling way.? I will turn it over to Matthew Davis to just give you his thoughts quickly and remind everyone why we feel good from a scientific perspective. Matthew Davis: We are incredibly excited.?In our human trials of 108, we saw TSLP suppression.?We saw CCL3 and CCL4 suppression.?When you think of atopic derm, the number 1 symptom that you want to alleviate is itch.?Itch is not just a histaminic mast cell phenomenon.?When it comes to atopic derm, it is actually an IL-31 phenomenon, TSLP phenomenon, and mast cell.?When we looked at our preclinical program, we saw an NF-KB modulation, and that is a direct correlation with IL-31.?So if you throw together the 3 main causes of itch for atopic dermatitis, we believe that topical 108 is going to hit those areas that cause itch, and we believe that it could have a meaningful benefit.?So I am very excited. Daniel Barber: More to come as time goes on.?But appreciate the questions on 108. Operator: Thank you.?The next question will come from Mazi Alimohamed with Oppenheimer.? Mazahir Alimohamed: Just really 2 for us.?One, going back to the human factor study.?Maybe on the root cause of the failure.?It seems like there was 1 open failure and 2 misplacements.?Maybe any color you can add on what the root cause analysis concluded for each, and what residual risk justification goes into the submission.?Then a second one, following up on 108.?It felt also to us that this does actually seem to be quite an opportunity in atopic derm.?One of the things that we were thinking through, though, was maybe more about dosing and long-term use, and maybe any color you could add about rebound erythema or tachyphylaxis with chronic dosing with epinephrine products in this disease. Daniel Barber: Sure.?Yes.?Thank you for 2 really insightful questions.?First, I appreciate the opportunity to clarify on the human factors data.?I want to be really clear.?Everyone opened the pouch in our human factors study.?We had no failures to open the pouch.?The one difficulty that we had still successfully opened the pouch.?The way that human factor studies work, without diving in too deep, is it's a ranking of identified risks.?One is you opened it easily, one is you didn't open it, or another is you had some difficulty but opened it.?The one who opened it with some difficulty still opened the pouch.? In terms of the misplacements, the 2 misplacements weren't necessarily on top of the tongue or roof of the mouth.?They just weren't completely in the sublingual cavity. If you pair that with the PK data and the conversation that we had with Matt earlier, you would expect if there had been PK around those individuals, and I'm completely giving an opinion, we don't have that data.?You would expect they would be somewhere between the self-admin data that is under the tongue and the data that was worst case scenario generated by clinicians as the FDA requested.?I think we're in a really good place on that data, and I don't think there's any additional justification necessary for those 2 things.? On 108 dosing over time, and I will pass it back to Matthew, I'll just highlight and remind you that this is a local delivery system that we're talking about, not a systemic.?I hopefully didn't steal all Matthew's thunder.?I'm sure he can say it way better than I could. Matthew Davis: This is an incredible opportunity.?So what we found, our preclinical team has done amazing work.?When you topically apply 108, the [ tipervefine ] has a super pharmacologic concentration on the skin.?The carboxylesterase in your interstitial fluid slowly will break that down to epinephrine.?So your question about tachyphylaxis is a great one and a vital one.?Because we appear to have this depot-like effect, we do believe that this is foreshadowing that maybe we can dose this product not even once a day.?So more to come on that.?But we believe, first of all, when you talk about immunology, with cellular-based immunology, PK does not always correlate to PD.?We are going to study the effect, this depot effect, and we believe that we can have an extended-release dosing of this product.?More to come. Operator: Thank you.?The next question will come from Francois Brisebois with LifeSci. Unknown Analyst: Good morning.?Thank you for our question.?This is [ Eka ] on for Frank this morning.?Congratulations on the progress.?2 questions from us.?Just one clarification, as you are on track for Q3 resubmission. Can you comment, is this going to be a Class 1 or Class 2 resubmission??How does this affect the planned launch timeline, if at all??And secondly, I want to ask about something that your competitor, ARS, has flagged previously that epinephrine patients tend to refill rather than return to the prescriber.?So given this issue, what's the -- how do you think about realistically the switchable pool by year 1, say, and what's the mechanism that gets a patient to switch from existing auto-injector script? Daniel Barber: No, 2 good questions.?The first, we did talk a little bit about the timing for the filing, but I will ask Melina to talk a little bit more about the classifications and what that means. Melina Cioffi: Certainly.?So there are 2 classifications that the agency will use to categorize an NDA resubmission.?It's a very dated system from about 30 years ago, and there's really just those 2 classifications.?One being a Class 1, a 2-month review.?Second one being that of a 6-month review.?And there's a very limited scope in terms of what would qualify for a 2-month review.?It's not really well defined.?Certainly, it would be at the discretion of the agency as to whether or not they categorize this Class 1 or Class 2.?But as Dan had indicated, we certainly will be offering a very succinct package with a very focused scope on the CRL items.?And so I do think that, at least from my regulatory experience, given the data that we will be providing, it really should be a very streamlined review for the agency. Again, it's certainly at their discretion, but I do think that they should be able to review what we consider to be a very succinct package quite quickly if they choose. Daniel Barber: And I appreciate the commercial question because Sherry has been sitting here patiently with all the great stuff her team has been doing.?I will pass it over to her on your question. Sherry Korczynski: Yes.? As you know, this market continues to be so big and it continues to grow.?I mean, year-over-year, we are seeing 6% or so growth, and even more encouraging is the allergist market continues to grow.?So when we think about how efficient our launch will be with it being allergist-focused. We have been very focused, if you will, on understanding that process.?And so the one thing that is really important foundationally is a patient does need to see their allergist every year to get a prescription.?And so I cannot really comment on the competitor as to what or why they said that.?But look, we will have a very balanced and integrated approach across multiple channels to drive those conversations with the patient and their allergist.?We have got a really compelling switch story, as you have heard all morning long. And my team is preparing to drive that messaging and that clinical differentiation that we believe is absolutely the icing on the cake. Operator: Thank you.?And the next question will come from Raghuram Selvaraju with H.C.?Wainwright.? Raghuram Selvaraju: Thank you all and congrats also on the progress. I wanted to ask, first of all, about your ex-U.S. plans for Anaphylm.?If you could maybe give us a sense of how you are prioritizing the different territories and where you think from a regulatory standpoint, this product candidate might be most favorably received and what the underlying market dynamics are that would inform your prioritization of those territories.?That would be very helpful.?I also wanted to ask about, on a different front, how you are thinking about the potential long-term impact to Aquestive of the recent Cosette Pharmaceuticals transaction, and perhaps more importantly, the recently announced merger combination between Supernus and Indivior, given your longstanding historical relationship with Indivior.?What you see as potential opportunities going forward in the context of those two developments. Daniel Barber: Sure.? I will go in reverse order on this one as well and hit the long-term impact question and then give you some thoughts on the ex-U.S. market.?I will also ask Melina to weigh in again on the regulatory piece.?So first, probably most importantly on the long-term impact, with the Indivior-Supernus merger, we of course, have been in contact with Indivior with our, I do not know, I guess it is a 20-year relationship now.?And not only do we know that Suboxone sublingual film continues to have strong usage, as you have seen from their results, but also that it is an important part of the story and will continue to be an important part of the story.?While that is a legacy part of our business, it is a profitable part of our business, and we expect that to continue as is. In terms of Cosette, they clearly are doing a good job with Sympazan.?They are actually local to us here.?We know the team there.?We think they are a good home for Sympazan.?We look forward to seeing what they do with the product.?In terms of ex-U.S., I will start with how we prioritize or where the opportunity is in the markets.?And quite frankly, just like here in the U.S., epinephrine is a mature market from an understanding standpoint.?So we know the opportunity in Europe is mathematically larger than the opportunity in Canada, which is larger than the opportunity in the U.K.?So in terms of markets, that would be the order of importance.?But in terms of how we file, I will let Melina tell you what we are thinking. Melina Cioffi: Thank you, Dan.?So we are targeting Canada, Europe, and the U.K.?We will be beginning that process this year in the fourth quarter.?There was a question in terms of how the regulators view the product.?I will just remind folks that we did have the opportunity to engage with all 3 regional health authorities.?Not only were they confirmatory that the existing data package would suffice for filing, but I will just say that they also expressed interest.?And I think that there is this concept of an unmet need that, at least from a regulator perspective, the groups understand. Operator: Thank you.?[Operator Instructions] The next question comes from Thomas Flaten with Lake Street. Thomas Flaten: I guess to bring Sherry back on the phone.?With respect to launch readiness and the potential for an expedited review, how are you thinking through, I guess, being ready for either scenario??And then, I guess, with a focus on managing contingency offers for sales reps with maybe a bit of a variable timeline around review time and potential approval. Daniel Barber: Well, before Sherry gives you her thoughts, I do want to give her a lot of credit.?It's never easy to have a moving target.?So I have definitely asked her to be ready for 3 or 4 different dates, which she has done a great job at, but I'll let her give you her thoughts. Sherry Korczynski: Well, for lack of a better phrase, the beauty of having the CRL is it has provided us time.?I was very fortunate to be able to keep the majority of my team on board.?And so we have taken, as I have stated -- shared before, we have taken these months to really, really hone in and refine our plan.?From agencies and vendors we are using, and then also, Dan says there is a few scenario plans.?I will tell you, we have got quite a few scenario plans.?And so it will be a great problem to have if we get the 2-month approval.?So we will be ready for it.?Will it impact hiring??Sure.?I mean, we are not going to carry our salespeople for months on end, as we stated. Well, once we have the package filed, we should have fairly shortly thereafter further understanding of timing as Melina has shared with us.?And then that will allow us to determine when we are able to make those contingency offers for sales people. Daniel Barber: I do just want to continue to remind everyone that our base case, and Thomas, we are excited too, so I appreciate the question, but our base case is a 6-month review. Thomas Flaten: Then, more broadly, strategically with respect to the AdrenaVerse platform, Dan, are you thinking about that as a kind of a rich internal development pipeline, or do you view it more as an opportunity for partnerable assets that you could farm out??And I guess more specifically with respect to AQST-108 assuming success in AD, is this something we could see you build a commercial presence in the derm space, or would you ultimately look to partner that out? Daniel Barber: Yes, I think the great thing about this moment for Aquestive is we have the ability to grow in several different places.?With Matt Greenhawt and his experience and background, and Sherry's depth in the allergy space as well.?As we launch Anaphylm and find our ground and our market share, we will absolutely be active in that space and want to be a leader in that space.?With the technology we have, that [ bleeds ] nicely into dermatology, which is right next to allergy.?In fact, there's a variety of practices that we know in this country that are both allergy and dermatology.?One side is allergy, one side is dermatology.?So with Matthew Davis and some of the development experience we have, we do think we can play in that dermatology world as well. So if I answer your question more from a what would I like to see the company do over the next coming years, I would like to see us play in both areas and become a much larger company with multiple products. Operator: Thank you.?I show no further questions at this time.?I will now turn the call back over to Dan for closing remarks. Daniel Barber: Thank you, Michelle.?As you heard today from our prepared remarks in the Q&A, this is a really exciting time for Aquestive.?We do feel as though, and the expression goes that we're hitting on all cylinders.?We are on track to file Anaphylm in the coming weeks.?The epinephrine market, as Sherry said, remains healthy and growing, and we've positioned the company to launch Anaphylm quickly if approved by the FDA.?So with that, thank you for joining us, and have a great day. Operator: This concludes today's conference call.?Thank you for participating, and you may now disconnect. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the rapid turnaround for Anaphylm resubmission to successful human factors and PK studies that addressed specific FDA concerns regarding packaging and administration errors. The company is positioning Anaphylm as a clinically differentiated product, emphasizing faster time to maximum concentration and superior blood pressure response compared to traditional auto-injectors. Strategic focus for the potential launch is centered on the allergy community, aiming for high efficiency by targeting allergists who drive the majority of branded prescription conversions. Management believes clinical differentiation, rather than just being a 'no-needle' solution, is the primary driver for securing favorable payer coverage and market adoption. The epinephrine market is viewed as a $1 billion to $2 billion annual opportunity, characterized by consistent 6% annual growth and a significant gap between patient prevalence and prescription volume. Operational discipline is maintained through a lean commercial structure and secured funding commitments of $95 million contingent on FDA approval. Resubmission of the Anaphylm NDA is on track for Q3 2026, with management assuming a standard 6-month Class 2 review while exploring possibilities for an expedited timeline. The company plans to initiate regulatory filings for Anaphylm in Canada, Europe, and the U.K. starting in the fourth quarter of 2026. Strategic prioritization of AQST-108 for atopic dermatitis is based on the potential for a localized, non-daily dosing profile that bridges the gap between low-cost generics and high-priced biologics. Financial guidance for 2026 remains unchanged, projecting total revenue between $46 million and $50 million with a focus on preserving cash for launch activities. Commercial launch preparations include a phased hiring approach for regional sales directors and training, triggered by regulatory clarity following the resubmission. A one-time loss on extinguishment of debt totaling $11.7 million was recognized in Q2 2026 following the payoff of 13.5% notes. The company established a new $150 million debt facility with Oaktree to lower the cost of capital and extend interest-only periods ahead of the potential Anaphylm launch. Management noted that the proposed Indivior-Supernus merger is expected to have no near-term impact on the company's base manufacturing and supply business. The human factors study showed a major reduction in both opening difficulty and administration errors; for instance, only 1 participant showed difficulty opening the new packaging compared to 26 in the previous study, and only 2 participants misplaced the dose compared to 20 in the previous study. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expects a 6-month Class 2 review but will advocate for a faster process given the 'thin' nature of the resubmission package compared to the original 10-month review. The resubmission is highly focused on the specific CRL items, which may allow for a more streamlined agency review. Studies showed that even when purposely misplaced on the tongue, the product achieved pharmacodynamic responses (blood pressure and heart rate) comparable to manual IM administration. This data serves as a 'reassurance' factor for clinicians and parents, proving the drug remains effective even if administered incorrectly. The product utilizes a local delivery system that creates a 'depot-like' effect, potentially allowing for extended-release dosing rather than daily application. Preclinical data showed NF-KB modulation correlating with IL-31, while human trials of 108 demonstrated suppression of key itch-related markers like TSLP, positioning it as a novel treatment for dermatological conditions. The strategy relies on the fact that patients must see an allergist annually for refills, providing a natural intervention point for switching to a non-invasive option. Marketing will focus on the 'carry and use' benefits alongside clinical data to overcome the inertia of generic refills.

This article first appeared on GuruFocus. Total Revenue: $13.8 million in Q2 2026, up 38% from $10 million in Q2 2025. Manufacture and Supply Revenue: $11.9 million in Q2 2026, up from $9.6 million in Q2 2025, driven by higher Suboxone revenues partially offset by lower Ondif revenues. License and Royalty Revenue: $1.3 million in Q2 2026, up from $0.8 million in Q2 2025, primarily due to royalty revenue from Zevra. Total Revenue (Six Months): $28.3 million for H1 2026, up 51% from $18.7 million in H1 2025. R&D Expenses: $4 million in Q2 2026, down from $4.1 million in Q2 2025. SG&A Expenses: $14.1 million in Q2 2026, up from $12.7 million in Q2 2025, due to higher legal fees, severance, and personnel costs partially offset by lower commercial spending. Net Loss: $22.9 million, or $0.18 per share, in Q2 2026, compared to a net loss of $13.5 million, or $0.14 per share, in Q2 2025. Excluding a one-time $11.7 million loss on debt extinguishment, net loss was $11.2 million. Non-GAAP Adjusted EBITDA Loss: $5.2 million in Q2 2026, improved from a loss of $9.3 million in Q2 2025. Cash Position: $98.5 million in cash and cash equivalents at the end of Q2 2026. Full-Year 2026 Guidance: Total revenue expected between $46 million and $50 million; non-GAAP adjusted EBITDA loss expected between $35 million and $30 million. Warning! GuruFocus has detected 7 Warning Signs with AQST. Is AQST fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Aquestive Therapeutics Inc (NASDAQ:AQST) is on track to resubmit its Anaphylm NDA in Q3 2026, less than eight months after receiving a CRL, with improved human factors study results showing a major reduction in packaging difficulties and administration errors. The latest PK study showed no statistical difference between clinician-administered and self-administered Anaphylm, and even in a misadministration scenario, pharmacodynamic responses compared favorably to manual IM administration. The company believes the epinephrine rescue market opportunity exceeds $1 billion annually, with potential to reach $2 billion, driven by consistent market growth of around 6% per year. Aquestive Therapeutics Inc (NASDAQ:AQST) completed a refinancing with Oaktree, establishing a new $150 million debt facility that lowers cost of capital and extends the interest-only period, enhancing financial flexibility. Total revenues increased 38% year-over-year in Q2 2026, driven by higher manufacture and supply revenue and license and royalty revenue, with non-GAAP adjusted EBITDA loss improving to $5.2 million from $9.3 million in the prior year quarter. Aquestive Therapeutics Inc (NASDAQ:AQST) faces uncertainty regarding the FDA review timeline for the Anaphylm resubmission, with the base case being a six-month review, which could delay potential launch. The company recorded a one-time loss on extinguishment of debt of $11.7 million in Q2 2026, contributing to a net loss of $22.9 million for the quarter. SG&A expenses increased in Q2 2026 due to higher legal fees, severance costs, and personnel costs, partially offset by lower commercial spending. The company's cash position of $98.5 million may be insufficient to support a launch without additional funding, relying on $75 million from RTW and $20 million from Oaktree post-approval, which are subject to conditions. Aquestive Therapeutics Inc (NASDAQ:AQST) continues to face competition in the epinephrine market, and the need to convert patients from auto-injectors to Anaphylm may be challenging, as patients tend to refill rather than switch prescriptions. Q: Could you help frame how the recent PK and human factors study data potentially increases your conviction in the resubmission being very comprehensive? Can you give us updated thoughts on whether you think the FDA may use a shorter or accelerated timeframe to review the resubmission? A: Daniel Barber (President and CEO): We believe we have very convincingly and thoroughly answered the open questions the FDA put out. On the human factors side, the results are very clean. On the PK side, when self-administered, we saw no difference from clinician-administered. Even in the off-label arm the FDA requested, we saw encouraging pharmacodynamic data. Regarding the timeframe, our guidance remains a six-month review, but we are pressing the FDA in a supportive way to move faster given the thin package compared to the 10-month review they have already done. Dr. Matt Greenhawt (CMO) added that the data is reassuring, showing that even with off-target administration (top of tongue), there is still a clinically meaningful increase in heart rate and blood pressure, which is a great counseling point for families. Q: We have often talked about the product profile differences that will be important for payer discussions, but in your prepared remarks, you mentioned some of the clinical differentiation factors. Curious if there are certain endpoints over others that you think are going to carry the most weight and how that portrays with the data that you have seen from Anaphylm so far. Then I wanted to ask for the Cmax data for the top of the tongue, the inaccurate usage, whether the FDA in advance of this had set a bar for what they were looking for. A: Daniel Barber (President and CEO): On the Cmax question, the FDA has pointed to two threshold marks in written communication and meetings: getting over 50 pg/mL and clearing 100 pg/mL, which we clearly do on the top of tongue. Positioning a product as simply "no needle" is not the path to success; the path is highlighting important clinical differentiation. Dr. Matt Greenhawt (CMO) explained that the differentiation is evident in the magnitude of effect and speed of onset. In his clinical experience, time is precious when giving epinephrine, and Anaphylm's rapid response within the critical 5-10 minute window is absolutely differentiating. Q: Regarding 108, any learnings from the recently completed study in androgenic alopecia that gives you confidence that the effects of 108 are relevant to atopic derm and a broader slate of dermatological conditions? Also, can you speak to the rationale behind pursuing atopic derm first, and how this decision plays into your broader strategy with respect to the AdrenaVerse platform? A: Daniel Barber (President and CEO): Atopic derm is a well-worn path in dermatology and a good entry point for expanding into broader indications. While alopecia areata is still important, we want to get that first proof point through the gates. Dr. Matthew Davis (Chief Development Officer) added that in human trials of 108, they saw TSLP suppression and CCL3/CCL4 suppression. For atopic derm, itch is an IL-31, TSLP, and mast cell phenomenon. The preclinical program showed NF-?B modulation, which directly correlates with IL-31. They believe topical 108 will hit the areas that cause itch and could have a meaningful benefit. Q: Going back to the human factor study. Maybe on the root cause of the failure. It seems like there was one open failure and two misplacements. Maybe any color you can add on what the root cause analysis concluded for each, and what residual risk justification goes into the submission. Then a second one, following up on 108. It felt also to us that this does actually seem to be quite an opportunity in atopic derm. One of the things that we were thinking through, though, was maybe more about dosing and long-term use, and maybe any color you could add about rebound erythema or tachyphylaxis with chronic dosing with epinephrine products in this disease. A: Daniel Barber (President and CEO): On the human factors data, everyone opened the pouch in the study; there were no failures to open. The one difficulty still successfully opened the pouch. The two misplacements weren't necessarily on top of the tongue or roof of the mouth; they just weren't completely in the sublingual cavity. Paired with the PK data, we're in a really good place. On 108 dosing, this is a local delivery system, not systemic. Dr. Matthew Davis (Chief Development Officer) explained that when topically applied, tipervefine has a super pharmacologic concentration on the skin, and carboxylesterase in interstitial fluid slowly breaks it down to epinephrine. This depot-like effect suggests the product may not even need to be dosed once a day, potentially allowing for extended-release dosing. Q: Just one clarification, as you are on track for Q3 resubmission, can you comment, is this going to be a Class 1 or Class 2 resubmission? How does this affect the planned launch timeline, if at all? Secondly, I want to ask about something that your competitor, ARS Pharmaceuticals, has flagged previously that epinephrine patients tend to refill rather than return to the prescriber. Given this issue, how do you think about realistically the switchable pool by year one, say, and what's the mechanism that gets a patient to switch from existing auto-injector script? A: Melina Cioffi (SVP, Regulatory Affairs): There are two classifications: Class 1 (two-month review) and Class 2 (six-month review). It's at the agency's discretion, but given the succinct package with a focused scope on CRL items, it should be a streamlined review. Sherry Korczynski (Chief Commercial Officer) added that the market continues to grow at 6% year-over-year, and the allergist market continues to grow. A patient does need to see their allergist every year to get a prescription. The team will have a balanced and integrated approach across multiple channels to drive conversations with patients and allergists, leveraging the compelling switch story and clinical differentiation. Q: I wanted to ask, first of all, about your ex-US plans for Anaphylm. If you could maybe give us a sense of how you are prioritizing the different territories and where you think from a regulatory standpoint, this product candidate might be most favorably received and what the underlying market dynamics are that would inform your prioritization of those territories. That would be very helpful. I also wanted to ask about, on a different front, how you are thinking about the potential long-term impact to Aquestive of the recent Cosette Pharmaceuticals transaction, and perhaps more importantly, the recently announced merger combination between Supernus and Indivior, For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Aquestive Therapeutics, Inc.? Here are five stocks we like better. Aquestive plans to resubmit Anaphylm’s FDA application before the end of Q3 after revised packaging and instructions substantially reduced pouch-opening, film-tearing and administration errors in validation studies. Management is assuming a six-month review, though the FDA could potentially grant a two-month review. The company is preparing an allergist-focused U.S. launch and expects to pursue Anaphylm filings in Canada, Europe and the U.K. beginning in Q4, with potential post-approval funding of $75 million from RTW and $20 million from Oaktree. Q2 revenue rose 38% year over year to $13.8 million, while adjusted EBITDA loss improved to $5.2 million; reported net loss widened to $22.9 million largely because of an $11.7 million one-time debt-extinguishment charge. Aquestive maintained 2026 revenue guidance of $46 million to $50 million. Aquestive Therapeutics (NASDAQ:AQST) said it plans to resubmit its new drug application for Anaphylm, its epinephrine sublingual film candidate for type 1 allergic reactions including anaphylaxis, before the end of the third quarter after completing studies requested by the U.S. Food and Drug Administration. President and Chief Executive Officer Dan Barber said the resubmission will come less than eight months after the company received a complete response letter from the FDA. The agency had cited issues involving pouch opening and administration of the film under the prior packaging and instructions for use. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat Barber said Aquestive updated Anaphylm’s packaging, labeling and instructions and then completed a human factors validation study. In the prior study, 26 participants reported difficulty opening the packaging and six tore the film. In the latest study, one participant experienced difficulty opening the pouch, while no participants tore the film, according to the company. The company also reported fewer administration errors. Under the earlier packaging, 20 participants placed the film on top of the tongue or roof of the mouth instead of in the intended location. In the latest study, two participants misplaced the dose, Barber said. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be A separate pharmacokinetic study found no statistical difference between clinician-administered and self-administered Anaphylm, according to the company. Participants who self-administered the product used the revised packaging and instructions without coaching from clinical staff. Aquestive also evaluated a scenario in which clinicians intentionally placed the film on top of a subject’s tongue. Barber said the company observed rapid and meaningful changes in blood pressure and heart rate, with changes from baseline higher than manual intramuscular epinephrine during the first 15 minutes and in line with EpiPen findings from other company studies. He added that, while drug levels were lower than with intended sublingual administration, the study still reached what the company described as meaningful maximum concentration levels. → First Solar’s Profit Engine Faces a New Policy Test in Washington Chief Medical Officer Matt Greenhawt said the data were reassuring because they showed a pharmacodynamic response even when the product was administered in a manner not intended for use. He said the results could help clinicians counsel patients and families about the product if it is approved. Management continues to use a six-month FDA review as its base-case assumption. Barber said the company will discuss whether the agency could review the resubmission more quickly because it expects to submit a focused package addressing the complete response letter. Senior Vice President of Regulatory Affairs Melina Cioffi said the FDA has discretion to classify a resubmission as either a two-month Class 1 review or a six-month Class 2 review. Barber said Aquestive is preparing for a potential Anaphylm launch through an allergist-focused approach, which it believes could help limit cash burn. The company believes the epinephrine rescue market has grown about 6% annually in recent years, including in 2026 year to date, and estimated that the opportunity for branded epinephrine products exceeds $1 billion annually and could potentially reach $2 billion over time. The company said it is developing its pricing strategy and cited what it views as clinical differentiation, ease of carrying the product and ease of use as factors that could be relevant in payer discussions. Chief Commercial Officer Sherry Korczynski said the company is preparing sales leadership, training, promotional materials and commercial analytics while managing timing scenarios around a potential FDA decision. Questoive also said it is pursuing partnerships for Libervant in the U.S. and for Anaphylm outside the U.S. Cioffi said the company expects to begin regulatory processes for Anaphylm in Canada, Europe and the U.K. in the fourth quarter. She said the company has engaged with health authorities in those regions and that they indicated the existing data package could support filings. Chief Financial Officer Ernie Toth reported second-quarter revenue of $13.8 million, up 38% from $10 million a year earlier. Manufacture and supply revenue rose to $11.9 million from $9.6 million, primarily due to higher Suboxone revenue, partly offset by lower Ondif revenue. License and royalty revenue increased to $1.3 million from $0.8 million, primarily reflecting royalties from Zevra. Research and development expense declined slightly to $4 million from $4.1 million, while selling, general and administrative expense increased to $14.1 million from $12.7 million. The increase in SG&A included higher legal fees, severance costs, personnel expenses and share-based compensation, partly offset by lower commercial spending and lower regulatory and licensing fees. Net loss was $22.9 million, or $0.18 per share, compared with a net loss of $13.5 million, or $0.14 per share, in the prior-year quarter. The quarter included an $11.7 million one-time loss on extinguishment of debt related to the payoff of the company’s 13.5% notes. Excluding that debt-extinguishment loss, net loss was $11.2 million, according to the company. Non-GAAP adjusted EBITDA loss improved to $5.2 million from $9.3 million a year earlier. Cash and cash equivalents totaled $98.5 million at June 30. During the quarter, Aquestive completed a refinancing with Oaktree that established a new $150 million debt facility. Toth said the facility lowered the company’s cost of capital, extended its interest-only period and increased financial flexibility. The company maintained its full-year 2026 guidance for revenue of $46 million to $50 million and a non-GAAP adjusted EBITDA loss of $30 million to $35 million. Management also said it expects $75 million in launch funding from RTW and $20 million from Oaktree following FDA approval of Anaphylm, subject to applicable funding conditions. Aquestive said it expects to provide further updates later this year on AQST-108, a topical epinephrine program being evaluated initially for atopic dermatitis. Barber said the company views atopic dermatitis as an entry indication that could support broader dermatology development. Chief Development Officer Matthew Davis said early human studies showed suppression of TSLP, CCL3 and CCL4, while preclinical work showed NF-κB modulation. He said the company believes local delivery and a potential depot-like effect could support an extended dosing profile, though further study is planned. Aquestive Therapeutics, Inc is a specialty pharmaceutical company focused on the development and commercialization of novel drug delivery systems. Leveraging its proprietary PharmFilm® technology, Aquestive designs thin-film formulations that facilitate sublingual, buccal and oral delivery of small molecules, offering rapid onset of action and improved patient compliance compared with traditional dosage forms. The company's lead product, Libervant® (diazepam) Buccal Film, is approved by the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Aquestive Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Successfully completed human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film Remains on track to resubmit Anaphylm NDA to the FDA in Q3 2026 Continues pre-launch medical affairs activities and payer engagement On track to begin ex-U.S. filings of Anaphylm in Q4 2026 Company to host investor call on August 12, 2026, at 8:00 a.m. ET WARREN, N.J., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced financial results for the second quarter ended June 30, 2026, and provided a strategic business update. “The epinephrine rescue market continues to grow and remains available for conversion from older medical device technology including autoinjectors,” said Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics. “As we bring Anaphylm to market, if approved by the FDA, we believe we can be instrumental in driving conversion in the allergist office and, ultimately, the broader market. As we prepare to resubmit our application to the FDA in the coming weeks, our full attention will be to prepare for a focused, allergist-first launch of Anaphylm as quickly as possible, if approved by the FDA. In the meantime, our medical affairs team continues to interact with the allergy community on a daily basis.” “We also continue to expand our understanding of our AdrenaVerse epinephrine prodrug platform and the opportunity it presents,” continued Daniel Barber. “Controlling the absorption and release of epinephrine allows us to target a variety of indications, especially in dermatological indications such as atopic dermatitis. The well-documented ability of epinephrine to lower histamine release through stabilizing mast cells while also downregulating key inflammatory components of atopic dermatitis creates the potential for a compelling product profile. Although AQST-108 is still in early-stage development, we are encouraged by the emerging data and plan on continuing to advance the program as we look towards 2027.” Anaphylm™ (dibutepinephrine) sublingual filmAnaphylm is an oral epinephrine product candidate being developed for the treatment of type I allergic reactions, including anaphylaxis. The Company believes Anaphylm has the potential to be the first and only non-invasive, orally delivered epinephrine product for the treatment of type I allergic reactions, including anaphylaxis, if approved by the U.S. Food and Drug Administration (FDA). In the second quarter of 2026, Aquestive completed the human factors validation study and the pharmacokinetic (PK) study required to address the deficiencies identified in the Complete Response Letter (CRL) issued by the FDA dated January 30, 2026. The human factors validation study evaluated a revised packaging design, incorporating modifications to the pouch opening, instructions for use, pouch and carton labeling. The study results showed significant improvement across each deficiency identified in the CRL. Based on preliminary data, the PK study met its primary endpoints. No administration errors were observed in the self-administration arm of the PK study. In addition, there were no serious adverse events and no events that led to study drug discontinuation. The Company reaffirms its guidance to resubmit the Anaphylm New Drug Application (NDA) in the third quarter of 2026. As previously disclosed, the CRL did not identify any chemistry, manufacturing, or controls (CMC) deficiencies, and clinical results supporting comparability to autoinjectors were not questioned by the FDA. The Company will request an expedited review upon resubmission, though no shortened or expedited review timeline can be guaranteed. Aquestive continues to advance its global regulatory strategy for Anaphylm. The Company remains on track to submit regulatory applications in Canada by the end of 2026 and in the European Union in the first quarter of 2027. The Company expects its existing clinical data to support regulatory submissions in additional markets in 2027, including the United Kingdom. Aquestive continues to advance commercial readiness in anticipation of a potential Anaphylm launch. The Company's Medical Affairs team is driving healthcare professional awareness, and the Company recently strengthened its Scientific Advisory Board to further support scientific exchange and education. Aquestive also maintains active partnerships with leading allergy-focused patient advocacy organizations. In parallel, the commercial team continues to refine launch execution and market access strategies. These efforts are supported by the Company's experienced commercial team and its established infrastructure, enabling Aquestive to execute a focused and disciplined launch strategy, if Anaphylm is approved by the FDA. AQST-108 (epinephrine) topical gelAQST-108 is a topical epinephrine prodrug gel product candidate being evaluated for various potential dermatologic indications. The Company completed the AQST-108 Phase 1 study in androgenic alopecia with no safety concerns observed, supporting continued development. The program is expanding into additional dermatologic inflammatory indications, including atopic dermatitis. This disciplined, data-driven approach is consistent with the Company’s strategy of maximizing the value of the AdrenaVerse™ platform while maintaining focus on the Anaphylm NDA resubmission. Atopic dermatitis affects approximately 7%–10% of U.S. adults and 10%–20% of children, making it one of the most common chronic inflammatory skin diseases in the U.S. AQST-108 is believed to have potential immunomodulatory effects, including downregulation of certain chemoattractants and inflammatory mediators, while stabilizing mast cells. Based on this mechanism, Aquestive believes AQST-108’s potential may extend beyond atopic dermatitis and alopecia areata to additional dermatologic inflammatory and immunologic indications. Aquestive’s AdrenaVerse™ platform comprises approximately 20 epinephrine prodrugs designed to enable control of absorption and conversion rates of epinephrine across a range of dosage forms and delivery sites. The Company continues to analyze the AdrenaVerse platform’s long-term potential to address multiple indications. Commercial Collaborations and Other Aquestive continues to manufacture products for the licensing and supply collaborations that it has established. The Company manufactured approximately 48 million doses in the second quarter 2026, compared to approximately 37 million doses in the second quarter 2025. The Company continues to manufacture Indivior’s Suboxone® Sublingual Film product and the Company's other global collaborations, including Sympazan® (clobazam) oral film product for Cosette Pharmaceuticals, Inc. in the U.S., Ondif® (ondansetron) oral film product for Hypera Pharma in Brazil and Emylif® (riluzole) oral film product by Zambon S.p.A. in Europe. Aquestive’s manufacturing business remains steady. On April 8, 2026, Cosette Pharmaceuticals, Inc. ("Cosette"), a United States-based, branded specialty pharmaceutical company, acquired the rights to Sympazan for the treatment of seizures associated with Lennox-Gastaut Syndrome in patients two years of age and older, from Assertio Holdings, Inc. ("Assertio"), including Assertio's rights under the Company's License Agreement for Sympazan with Otter Pharmaceuticals, LLC, a subsidiary of Assertio (the "Assertio License Agreement"). Cosette will continue to purchase Sympazan® (clobazam) Oral Film Product and pay royalties and milestones to Aquestive under the Assertio License Agreement. Sales of royalty-based products, inclusive of Sympazan, contributed to the Company's revenue in the second quarter of 2026. The Company, being a U.S. based manufacturer with intellectual property domiciled in the U.S., confirms that its supply chain currently remains largely unaffected by both implemented and proposed government tariffs, providing continued reliability and stability in production and global distribution for the near term. Libervant® (diazepam) buccal film is currently tentatively approved in the United States for epilepsy patients ages 12 years and older and is expected to become eligible for full approval following the expiration in January 2027 of the orphan drug exclusivity protecting another company's FDA-approved product. Aquestive believes expanding patient access to non-invasive seizure rescue therapies is vital and remains committed to putting Libervant in the hands of epilepsy patients as soon as permitted by FDA approval and applicable regulatory requirements. Second Quarter 2026 FinancialsTotal revenues increased to $13.8 million in the second quarter 2026 from $10.0 million in the second quarter 2025. The 38% increase was primarily driven by increases in manufacture and supply revenue and increases in license and royalty revenue. Manufacture and supply revenue increased to $11.9 million in the second quarter 2026 from $9.6 million in the second quarter 2025, primarily due to increases in Suboxone revenues, partially offset by lower Ondif revenues. License and royalty revenue increased to $1.3 million in the second quarter 2026 from $0.8 million in the second quarter 2025, primarily due to royalty revenue from Zevra. Research and development expenses decreased to $4.0 million in the second quarter 2026 from $4.1 million in the second quarter 2025. The decrease in research and development expenses was primarily due to lower development and manufacturing costs associated with the Anaphylm program, partially offset by increases in preclinical costs. Selling, general and administrative expenses increased to $14.1 million in the second quarter 2026 from $12.7 million in the second quarter of 2025. The increase primarily represents higher legal fees of approximately $2.1 million, higher severance costs of approximately $1.4 million which includes acceleration of share-based compensation, higher personnel costs of approximately $0.9 million, and higher share-based compensation expenses of approximately $0.3 million as well as other expenses, partially offset by lower commercial spending of approximately $2.6 million, lower regulatory and licensing fees of approximately $1.0 million related to the regulatory fee for Libervant, and lower regulatory expenses related to Anaphylm of approximately $0.2 million. In the second quarter 2026, the Company recognized a one-time loss on extinguishment of debt of $11.7 million, which represents the difference between the carrying value of the 13.5% Notes as of May 12, 2026 and the total payoff amount of the 13.5% Notes. Aquestive’s net loss for the second quarter 2026 was $22.9 million, or $0.18 for both basic and diluted loss per share, compared to the net loss in the second quarter 2025 of $13.5 million, or $0.14 for both basic and diluted loss per share. Excluding the impact of the one-time recognition of the loss on extinguishment on the Company's 13.5% Notes, the net loss in the second quarter 2026 was $11.2 million. The increase in net loss was primarily driven by the loss on extinguishment of debt, decreases in interest income and other income, net and increases in selling, general, and administrative expenses, partially offset by increases in revenues, and decreases in manufacture and supply expenses and research and development expenses. Non-GAAP adjusted EBITDA loss was $5.2 million in the second quarter 2026, compared to non-GAAP adjusted EBITDA loss of $9.3 million in the second quarter 2025. Cash and cash equivalents were $98.5 million as of June 30, 2026. 2026 OutlookAquestive's full-year 2026 financial guidance remains unchanged. The Company expects: Tomorrow’s Conference Call and Webcast ReminderThe Company will host a conference call at 8:00 a.m. ET on Wednesday, August 12, 2026. In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal PIN. A live webcast of the call will be available on Aquestive’s website at: Second Quarter 2026 Earnings Call. About Anaphylm™Anaphylm™ (dibutepinephrine) sublingual film is a polymer matrix-based epinephrine prodrug product. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The primary packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate. About AQST-108AQST-108 (epinephrine) topical gel is a topically delivered adrenergic agonist prodrug product candidate. Aquestive completed a first-in-human study for AQST-108 without any serious or topical adverse events observed. AQST-108 is based on Aquestive’s AdrenaVerse™ platform which contains a library of over twenty epinephrine prodrugs intended to control absorption and conversion rates across a variety of possible dosage forms and delivery sites. About Libervant®Libervant® (diazepam) buccal film is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA approval for U.S. market access received in April 2024 for Libervant was for these epilepsy patients between two and five years of age. However, the FDA converted this approval to a "tentative approval" due to a subsequent court ruling finding that the FDA did not have authority to approve Libervant for U.S. market access for patients aged between two and five years due to the existing orphan drug market exclusivity granted by the FDA to an intranasal spray of another company. The FDA granted tentative approval in August 2022 for Libervant for treatment of these epilepsy patients twelve years of age and older.  We filed for FDA approval for use of Libervant for epilepsy patients aged between 6 and 11 years in Q2 2026. U.S. market access for Libervant for epilepsy patients twelve years of age and older is currently subject to the expiration of the existing orphan drug market exclusivity of the previously FDA approved drug scheduled to occur in January 2027. Important Safety InformationDo not give Libervant to your child between the ages of two and five if your child is allergic to diazepam or any of the ingredients in Libervant or has an eye problem called acute narrow angle glaucoma. What is the most important information I should know about Libervant? Libervant is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens: Do not allow your child to drive a motor vehicle, operate heavy machinery, or ride a bicycle until you know how taking Libervant with opioids affects your child. Risk of abuse, misuse, and addiction. Libervant is used in children 2 to 5 years of age. The unapproved use of Libervant has a risk for abuse, misuse, and addiction, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in Libervant). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. Physical dependence and withdrawal reactions. Libervant is intended for use if needed in order to treat higher than usual seizure activity. Benzodiazepines, including Libervant, can cause physical dependence and withdrawal reactions, especially if used daily. Libervant is not intended for daily use. Do not give your child more Libervant than prescribed or give Libervant more often than prescribed. Libervant can make your child sleepy or dizzy and can slow your child’s thinking and motor skills. Do not allow your child to drive a motor vehicle, operate machinery, or ride a bicycle until you know how Libervant affects your child. Do not give other drugs that may make your child sleepy or dizzy while taking Libervant without first talking to your child’s healthcare provider. When taken with drugs that cause sleepiness or dizziness, Libervant may make your child’s sleepiness or dizziness much worse. Like other antiepileptic medicines, Libervant may cause suicidal thoughts or actions in a small number of people, about 1 in 500. Call a healthcare provider right away if your child has any of these symptoms, especially if they are new, worse, or worry you: Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your child’s healthcare provider as scheduled. Call your child’s healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If your child has suicidal thoughts or actions, your child’s healthcare provider may check for other causes. What are the possible side effects of Libervant? The most common side effects of Libervant are sleepiness and headache. These are not all the possible side effects of Libervant. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information about Libervant, talk to your doctor, and see Product Information: Medication Guide and Instructions For Use. About Aquestive Therapeutics, Inc.Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. The worldwide leader in delivering trusted, quality medications on oral film, Aquestive operates as both a developer of its own proprietary products and a Contract Development and Manufacturing Organization (CDMO) for licensees, with its headquarters in New Jersey and U.S.-based manufacturing facilities in Indiana. The Company is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents using proprietary, best-in-class technologies like PharmFilm®. Aquestive's AdrenaVerse™ platform contains a library of more than 20 epinephrine prodrugs enabling the pursuit of various potential allergy and dermatological indications. The Company is advancing Anaphylm™ (dibutepinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis, and AQST-108 (epinephrine) topical gel for various potential dermatological conditions. For more information, visit Aquestive.com and follow us on LinkedIn. Non-GAAP Financial InformationThis press release and our webcast earnings call regarding our quarterly financial results contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP adjusted EBITDA loss, non-GAAP adjusted EBITDA (loss) income excluding adjusted R&D expenses, non-GAAP adjusted costs and expenses and other adjusted expense measures, because such measures exclude, as applicable, share-based compensation expense, loss on extinguishment of debt, interest expense, interest expense related to the sale of future revenue, interest income, depreciation, amortization, and income taxes. Specifically, the Company adjusts net loss for certain non-cash expenses, including share-based compensation expenses; loss on extinguishment of debt; depreciation and amortization; and interest expense related to the sale of future revenue, interest income and other income, net and income taxes, with a result of adjusted EBITDA loss. Similarly, manufacture and supply expense, R&D expense, and selling, general and administrative expense were adjusted for certain non-cash expenses of share-based compensation expense and depreciation and amortization. Adjusted EBITDA loss and these non-GAAP expense categories are used as a supplement to the corresponding GAAP measures to provide additional insight regarding the Company’s ongoing operating performance. These measures supplement the Company’s financial results prepared in accordance with GAAP. Aquestive management uses these measures to analyze its financial results, and its future manufacture and supply expenses, gross margins, R&D expense and selling, general and administrative expense and to help make managerial decisions. In management’s opinion, these non-GAAP measures provide added transparency into the operating performance of Aquestive and added insight into the effectiveness of our operating strategies and actions. The Company may provide one or more revenue measures adjusted for certain discrete items, such as fees collected on certain licensed products, in order to provide investors added insight into our revenue stream and breakdown, along with providing our GAAP revenue. Such measures are intended to supplement, not act as substitutes for, comparable GAAP measures and should not be read as a measure of liquidity for Aquestive. Adjusted EBITDA loss and the other non-GAAP measures are also likely calculated in a way that is not comparable to similarly titled measures reported by other companies. Non-GAAP OutlookIn providing the outlook for non-GAAP adjusted EBITDA and non-GAAP gross margin, we exclude certain items which are otherwise included in determining the comparable GAAP financial measures. In order to inform our outlook measures of non-GAAP adjusted EBITDA and non-GAAP gross margin, a description of the adjustments which have been applicable in determining non-GAAP Adjusted EBITDA and non-GAAP gross margin for these periods are reflected in the tables below. In providing outlook for non-GAAP gross margin, the Company adjusts for non-cash share-based compensation expense and depreciation and amortization. The Company is providing such outlook only on a non-GAAP basis because the Company is unable to predict with reasonable certainty the totality or ultimate outcome or occurrence of these adjustments for the forward-looking period such as share-based compensation expense, income tax, amortization, and certain other adjusted items, which can be dependent on future events that may not be reliably predicted. Based on past reported results, where one or more of these items have been applicable, such excluded items could be material, individually or in the aggregate, to reported results. Forward-Looking Statement Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (dibutepinephrine) sublingual film through clinical development and approval by the FDA, including our ability to address the concerns raised by the FDA in the CRL dated January 30, 2026 and the Type A meeting with the FDA, and the timing of our resubmission and FDA review of the NDA; the advancement and related timing of potential international regulatory filings and marketing authorizations for Anaphylm outside of the U.S.; that Anaphylm will be the first and only non-invasive, orally delivered epinephrine product, if Anaphylm is approved by the FDA; the commercial launch strategy if Anaphylm is approved by the FDA; the advancement, growth and related timing of our AdrenaVerse™ pipeline epinephrine prodrugs, including AQST-108 (epinephrine) topical gel, through clinical development and the FDA regulatory approval process, including with respect to the design and timing of clinical studies, including those necessary to support the indications of alopecia areata, atopic dermatitis and potential other treatment indications for AQST-108; market access for Libervant® (diazepam) buccal film for epilepsy patients experiencing acute repetitive seizures (ARS) upon expiration of orphan drug market exclusivity of an approved FDA product of another company; the future commercial opportunity of Anaphylm, Libervant and AQST-108 should these product candidates be approved by the FDA; the potential benefits our product candidates could bring to patients, including with respect to Anaphylm, Libervant and AQST-108, if these product candidates are approved by the FDA, and acceptance by patients, prescribers and payors of our product candidates as an alternative to existing standards of care for the targeted medical indication of these product candidates; that our supply chain is largely unaffected by implemented and proposed government tariffs and will be reliable and stable in production and global distribution for the near term; our cash requirements, cash funding and cash burn; short-term and longer term liquidity, including access to additional funds if Anaphylm is approved by the FDA, and the ability to fund our business operations and key objectives in 2026 and beyond, including the launch of Anaphylm, if approved by the FDA; our growth and future financial and operating results and financial position, including with respect to our 2026 financial outlook; and business strategies, market opportunities, and other statements that are not historical facts. Such forward‑looking statements also include statements regarding anticipated timelines, milestones, and guidance relating to regulatory submissions, clinical studies, regulatory interactions, and potential approvals, which are inherently uncertain and subject to change based on regulatory feedback, protocol alignment, data sufficiency, and other factors outside the Company’s control. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for Anaphylm and AQST-108; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates Anaphylm, Libervant and AQST-108, or failure to receive FDA approval at all of any or all of these product candidates; risk of the Company’s ability to generate sufficient clinical and other human factor data, including with respect to our submission of pharmacokinetic and pharmacodynamic (PK/PD) comparability data for FDA approval of Anaphylm; risks associated with our ability to address the FDA’s comments on and identified deficiencies in our NDA, including the concerns raised by the FDA in the CRL and Type A meeting for Anaphylm, and whether the FDA may request further information from us (including additional clinical studies), disagree with our protocols, study designs, and findings or otherwise undertake a lengthy review of the resubmission of our NDA; challenges regarding the following commercial launch of Anaphylm, if approved by the FDA; risk of delays in advancement of the regulatory approval process of our product candidates, including Anaphylm and Libervant, outside of the U.S., or failure to receive approval at all of any or all of these product candidates by such foreign regulatory authorities; including risks that regulatory authorities outside the United States may require different, additional, or more extensive clinical, non‑clinical, human factors, pharmacokinetic, or manufacturing data than anticipated, or may not accept data generated for U.S. regulatory purposes; risk of FDA inspections of manufacturing and clinical study sites for any of our product candidates, including Anaphylm, Libervant and AQST-108; risk of government shutdowns or actions to reduce government workforces on the ability of the FDA to act on a timely basis or at all on the approval of our product candidates, including Anaphylm, Libervant and AQST-108; risks associated with the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm, Libervant and AQST-108, if these product candidates are approved by the FDA; risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product candidates, including Anaphylm, Libervant and AQST-108; risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our debt and ATM facilities, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements to support our business operations, key initiatives and growth strategy, and other cash needs, at the times and in the amounts needed, and to fund future clinical development and commercial activities for our product candidates, including Anaphylm, Libervant and AQST-108, should these product candidates be approved by the FDA , including risks that assumptions underlying projected cash runway, liquidity, and capital sufficiency may prove incorrect due to changes in operating plans, regulatory requirements, timing or scope of clinical activities, market conditions, or the availability, timing, and terms of financing; risk of the impact of our obligations under the Company's Purchase Agreement and the Royalty Rights Agreement with third parties, each of which agreements requires the Company to make payments to each counterparty thereof, respectively, of a portion of our revenues, on our ability to contribute to the funding of our operations; risk that our manufacturing capabilities will be sufficient to support demand of our product candidates in the U.S. and abroad, including Anaphylm and Libervant, if such product candidates should be approved by the FDA and other regulatory authorities, and our licensed products in the U.S. and abroad; risk of eroding market share for Suboxone® as a sunsetting product, which accounts for a substantial part of our current operating revenue; risk of default of our debt instruments; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance in the U.S. and abroad of our product candidates, including Anaphylm, Libervant, and AQST-108 should these product candidates be approved by the FDA and other regulatory authorities, and for our licensed products in the U.S. and abroad; risk associated with the size and growth of our product markets and expected related revenues and sales; risk associated with our compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to our products; risk that our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the U.S. Patent and Trademark Office or, if issued, will be sufficient to provide long-term commercial success of these product candidates; risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business, including relating to our products and product candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against us including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions, including due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and changing interest rates; risks related to the impact of pandemic diseases on our business; risks and uncertainties related to general economic, political (including the Ukraine, Israel and Iran wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; risks related to uncertainty about presidential administration initiatives and their impact on our business, including imposition of government tariffs and other trade restrictions; and other uncertainties affecting the Company including those 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 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law. Libervant®, PharmFilm®, Sympazan® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners. Investor inquiries:Astr PartnersBrian [email protected]

Aquestive Therapeutics (NASDAQ:AQST) shares rose 9.5% on Monday after the pharmaceutical company reported positive human factors and pharmacokinetic study results for Anaphylm, strengthening its preparations to resubmit a New Drug Application to the U.S. Food and Drug Administration. The studies evaluated Anaphylm (dibutepinephrine) sublingual film and were designed to address issues raised by regulators during the product’s previous review. Aquestive plans to resubmit its NDA during the third quarter of 2026, seeking approval of Anaphylm for the treatment of Type 1 allergic reactions, including anaphylaxis. Results from the human factors validation study indicated substantial improvements following changes to Anaphylm’s packaging and instructions for use. The redesigned packaging reduced the median time required to open the pouch to 3 seconds, compared with 17 seconds in the previous human factors study. Revised instructions also reduced instances of incorrect film placement by more than 80% compared with the earlier validation study. The improvements directly address concerns identified by the FDA when it issued a Complete Response Letter to Aquestive in January 2026. During the earlier study, regulators identified problems including difficulty opening the pouch, accidental tearing of the film and incorrect placement during administration. In the latest study, the number of participants experiencing difficulty opening the pouch declined to just 1 out of 105, compared with 26 out of 166 previously. The pharmacokinetic study also provided supportive results for self-administration of Anaphylm. Participants who administered the treatment themselves recorded a geometric mean Cmax of 391.7 pg/mL and a median Tmax of 12 minutes. That compared with a Cmax of 357.6 pg/mL and a median Tmax of 12 minutes when the treatment was administered by a clinician. Manual intramuscular administration, meanwhile, produced a Cmax of 334.5 pg/mL and a median Tmax of 45 minutes. The results therefore showed that self-administered Anaphylm achieved pharmacokinetic performance comparable to clinician administration while reaching its median maximum concentration considerably faster than manual intramuscular administration. Aquestive additionally evaluated Anaphylm when the film was deliberately placed on top of the tongue rather than administered in the intended position. The company said this arm of the pharmacokinetic study produced clinically meaningful pharmacodynamic results that were comparable to, or greater in magnitude than, those observed with injectable epinephrine. This finding could be particularly relevant to the product’s potential real-world use, where correct administration may be more difficult during an emergency allergic reaction. No serious adverse events were reported during the pharmacokinetic study, while no participants across either study required premature removal of the film. The 9.5% rise in Aquestive shares reflects investor optimism that the latest results have addressed important deficiencies identified in the January Complete Response Letter, potentially strengthening the company’s planned third-quarter 2026 NDA resubmission for Anaphylm. Aquestive Therapeutics stock price

WARREN, N.J., July 29, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it will report results for the second quarter ended June 30, 2026, and provide an update on recent developments in its business after market close on Tuesday, August 11, 2026. Management will host a conference call for investors at 8:00 a.m. ET on Wednesday, August 12, 2026. To participate, please register in advance here to obtain a local or toll-free phone number and your personal pin. A live webcast of the call will be available on the Investors section of Aquestive’s website at: Second Quarter 2026 Earnings Call Following the call, a replay of the webcast will be available on the Investors section of the Company’s website at https://investors.aquestive.com/events-and-presentations. The webcast will be archived for 30 days.About Aquestive Therapeutics, Inc. Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. The worldwide leader in delivering trusted, quality medications on oral film, Aquestive operates as both a developer of its own proprietary products and a Contract Development and Manufacturing Organization (CDMO) for licensees, with its headquarters in New Jersey and U.S.-based manufacturing facilities in Indiana. The Company is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents using proprietary, best-in-class technologies like PharmFilm®. Aquestive's AdrenaVerse™ platform contains a library of more than 20 epinephrine prodrugs enabling the pursuit of various potential allergy and dermatological indications. The Company is advancing Anaphylm™ (dibutepinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis, and AQST-108 (epinephrine) topical gel for various potential dermatological conditions, including alopecia areata, atopic dermatitis and hypertrophic scars. For more information, visit Aquestive.com and follow us on LinkedIn. Forward Looking Statements This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidates, including Anaphylm™ (dibutepinephrine) sublingual film and AQST-108 (epinephrine prodrug) topical gel, through clinical development and approval by the U.S. Food and Drug Administration (FDA) for the respective targeted indications. These forward-looking statements are based on the Company’s current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of its product development activities and clinical trials, including relating to Anaphylm and AQST-108, and other risks and uncertainties affecting the Company described in the “Risk Factors” section and in other sections included in its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law. PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. Investor inquiries: Astr Partners Brian Korb [email protected]

This article first appeared on GuruFocus. Total Revenue: $14.4 million in Q1 2026, up from $8.7 million in Q1 2025, a 66% increase. License and Royalty Revenue: Increased to $5.4 million in Q1 2026 from $0.8 million in Q1 2025. Manufacturer and Supply Revenue: Increased to $8.8 million in Q1 2026 from $7.2 million in Q1 2025. Research and Development Expenses: Decreased to $4.2 million in Q1 2026 from $5.4 million in Q1 2025. Selling, General and Administrative Expenses: Decreased to $11 million in Q1 2026 from $19.1 million in Q1 2025. Net Loss: $8.1 million or $0.07 per share in Q1 2026, compared to $22.9 million or $0.24 per share in Q1 2025. Non-GAAP Adjusted EBITDA Loss: $1.7 million in Q1 2026, compared to $17.6 million in Q1 2025. Cash and Cash Equivalents: Approximately $110 million at the end of Q1 2026. 2026 Revenue Guidance: $46 million to $50 million. 2026 Non-GAAP Adjusted EBITDA Loss Guidance: $35 million to $30 million. Warning! GuruFocus has detected 7 Warning Signs with AQST. Is AQST fairly valued? Test your thesis with our free DCF calculator. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Aquestive Therapeutics Inc (NASDAQ:AQST) has completed significant regulatory milestones for Anaphylm, including a Type A meeting with the FDA and interactions with the UK and European regulatory bodies. The company secured a $150 million debt facility with Oak Tree, improving interest rate terms and extending the interest-only period, which enhances financial flexibility. Total revenues increased by 66% in the first quarter of 2026 compared to the same period in 2025, driven by higher license and royalty revenues. Aquestive Therapeutics Inc (NASDAQ:AQST) has a strong cash position of approximately $110 million, providing sufficient capital to complete FDA-required studies and support ongoing operations. The company is actively pursuing international expansion, with plans to file for regulatory approval in Canada, the UK, and the European Union without needing additional clinical studies. The approval and launch of Anaphylm are contingent on FDA feedback and review processes, which introduces uncertainty in the timeline. Despite progress, the company acknowledges that coverage and reimbursement for Anaphylm will be a challenge and will take time to establish. The company's net loss for the first quarter of 2026 was $8.1 million, although this is an improvement from the previous year. Aquestive Therapeutics Inc (NASDAQ:AQST) faces significant risks and uncertainties related to the development, regulatory approval, and commercialization of its products. The company is heavily reliant on the successful approval and launch of Anaphylm, which could impact financial performance if delayed or unsuccessful. Q: Can you provide more details on the progress and timeline for Anaphylm's US filing and ongoing study interactions? A: Daniel Barber, CEO: We are ready to proceed with the studies for Anaphylm. The study design is complete, and sites are prepared to start. We expect to have top-line data by our August earnings call. The only pending item is the FDA's review of our human factors protocol, which we expect to receive soon. This gives us confidence in our timeline. Q: Regarding AQST-108, how does the biomarker data compare to other programs targeting similar indications? A: Matthew Davis, Chief Development Officer: The TSLP biomarker signal is intriguing as it crosses Th1, Th2-driven inflammation pathways. This provides optionality for conditions like alopecia areata and atopic dermatitis. The data is directional, but it confirms we're looking at the right mechanisms. Q: How are you addressing coverage and reimbursement challenges for Anaphylm? A: Daniel Barber, CEO: Coverage and reimbursement are challenging for any life sciences company. We are working on foundational efforts to ensure coverage, but it will take time. Sherry Korczynski, SVP of Sales and Marketing, added that they are setting up best-in-class patient support services to reduce friction in physicians' offices. Q: What are the learnings from the launch of a similar product, and how are they influencing your commercialization strategy? A: Daniel Barber, CEO: The key learning is that despite having an innovative product, basic launch efforts like engaging with doctors and securing coverage are crucial. Sherry Korczynski emphasized the importance of reducing friction in physicians' offices and ensuring awareness and believability in the product. Q: Can you elaborate on the Oak Tree financing and its impact on your runway through the launch of Anaphylm? A: Ernest Toth, CFO: The Oak Tree financing, along with RTW Investments, provides us with a strong capital position, ensuring runway through the launch of Anaphylm, if approved. This puts the company in its best capital position ever. Q: How are you planning to address the friction in physicians' offices regarding Anaphylm prescriptions? A: Daniel Barber, CEO: While we are working on reducing friction, we are keeping some strategies confidential. Sherry Korczynski mentioned robust discussions with PBMs and payers and setting up support services to ease the process for physicians. Q: What is the status of Anaphylm's ex-US regulatory filings, and how are you approaching partnerships in those markets? A: Daniel Barber, CEO: We have met with regulatory bodies in Canada, the UK, and the EU, confirming that existing clinical data is sufficient for filings. We are actively pursuing partnerships in Europe, with economics expected to be within industry norms. Q: How do you plan to further explore the TSLP biomarker data in future studies for AQST-108? A: Matthew Davis, Chief Development Officer: We are excited about the TSLP findings, which guide us towards inflammatory states in dermatology. We plan to expand biomarker studies to explore the broad-based immunomodulatory potential of our platform. For the complete transcript of the earnings call, please refer to the full earnings call transcript.