Q1 2026 Aquestive Therapeutics Inc Earnings Call

May 14, 2026

Operator: Good day. Thank you for standing by. Welcome to the First Quarter 2026 Aquestive Therapeutics Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, we'll open up for questions. To ask a question during the session, you will need to press star 11 on your telephone. You'll then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's call is being recorded. I would now like to hand it over to our first speaker, Faith Pomeroy-Ward. Please go ahead.

Operator: Good day. Thank you for standing by. Welcome to the First Quarter 2026 Aquestive Therapeutics Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, we'll open up for questions. To ask a question during the session, you will need to press star o on your telephone. You'll then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's call is being recorded. I would now like to hand it over to our first speaker, Faith Pomeroy-Ward. Please go ahead.

Speaker #2: Good day, and thank you for joining. Welcome to the first quarter 2026 Aquestive Therapeutics earnings conference call. At this time, all participants are in listen-only mode.

Speaker #2: After speakers' presentation, we'll open up for questions. Just a question during the session: you will need to press star 11 on your telephone, you then hear an automated message advising your hand is raised.

Speaker #2: To withdraw your question, please press star one-one again. Please be advised that today's call is being recorded, and I would like to hand it over to our first speaker, Faith Pomeroy Ward.

Speaker #2: Please go ahead.

Speaker #3: Thank you, operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of the company's reported financial results for the first quarter ended March 31, 2026, and a progress update on the company's key 2026 objectives, followed by a Q&A session.

Faith Pomeroy-Ward: Thank you, operator. Good morning and welcome to today's call. On today's call, I am joined by Dan Barber, Chief Executive Officer, and Ernie Toth, Chief Financial Officer, who are going to provide an overview of the company's reported financial results for the first quarter ended 31 March 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. Matthew 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.

Speaker #3: During the Q&A session, the team will be joined by Dr. Matt Greenhart, Chief Medical Officer, Melina Chaffee, Senior Vice President, Regulatory Affairs, Sherry Korczynski, Chief Commercial Officer, and Dr. Matthew Davis, Chief Development Officer.

Speaker #3: As a reminder, the company's remarks today correspond with the earnings release that was issued after market closed yesterday. In addition, a recording of today's call and related supplemental materials will be made available on Aquestive's website within the investors section shortly following the conclusion of this call.

Speaker #3: To remind you, the Aquestive team will be discussing some non-GAAP financial measures this morning as part of its review of first quarter 2026 results.

Faith Pomeroy-Ward: To remind you, the Aquestive team will be discussing some non-GAAP financial measures this morning as part of its review of Q1 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 today'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 4 March 2026.

Speaker #3: 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.

Speaker #3: During the call, the company will be making forward-looking statements. We remind you of the company's Safe Harbor language as outlined in today's earnings release, as well as the risks and uncertainties affecting the company as described in other sections included in the company's annual report on Form 10-K filed with the US Securities and Exchange Commission on March 4, 2026.

Speaker #3: As with any 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.

Faith Pomeroy-Ward: 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.

Speaker #3: 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.

Speaker #3: 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 pharmaceutical company product statements contained in the earnings release issued yesterday.

Speaker #3: 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.

Speaker #3: Now, I would like to turn the call over to Dan.

Speaker #4: Good morning, and thank you for joining us today. In the last 62 days, since our earnings call, we have progressed the company significantly. For Anisome Debut Epinephrine Sublingual Film, we have completed our Type A face-to-face meeting with the FDA, completed a teleconference with the UK regulatory body known as MHRA, submitted our pediatric investigational plan to the European Medicines Agency, and submitted our human factors protocol for review by the FDA.

Daniel Barber: Good morning, and thank you for joining us today. In the last 62 days since our earnings call, we have progressed the company significantly. For Anaphylm dibutepinephrine sublingual film, we have completed our Type A face-to-face meeting with the FDA, completed a teleconference with the UK regulatory body known as MHRA, submitted our pediatric investigational plan to the European Medicines Agency, and submitted our human factors protocol for review by the FDA. In addition, we have closed on a new debt facility with a leading life sciences debt provider and completed our phase I safety study in humans for our pipeline program, AQST-108. We are also on track to attend over 40 conferences and submit over 20 publications this year. It is a testament to the Aquestive team that they were able to complete so much important work in such a brief period of time.

Dan Barber: Good morning, and thank you for joining us today. In the last 62 days since our earnings call, we have progressed the company significantly. For Anaphylm dibutepinephrine sublingual film, we have completed our Type A face-to-face meeting with the FDA, completed a teleconference with the UK regulatory body known as MHRA, submitted our pediatric investigational plan to the European Medicines Agency, and submitted our human factors protocol for review by the FDA. In addition, we have closed on a new debt facility with a leading life sciences debt provider and completed our phase I safety study in humans for our pipeline program, AQST-108. We are also on track to attend over 40 conferences and submit over 20 publications this year. It is a testament to the Aquestive team that they were able to complete so much important work in such a brief period of time.

Speaker #4: In addition, we have closed on a new debt facility with a leading life sciences debt provider and completed our phase one safety study in humans for our pipeline program AQST 108.

Speaker #4: We are also on track to attend over 40 conferences and submit over 20 publications this year. It is a testament to the Aquestive team that they were able to complete so much important work in such a brief period of time.

Speaker #4: The question, of course, is where does this work take us, and how do we expect the coming months to unfold? Today, I am providing guidance that we currently expect to have our human factors data, and potentially our pharmacokinetic data, for Anisome available in time for our August earnings call.

Daniel Barber: The question, of course, is where does this work take us, and how do we expect the coming months to unfold? Today, I am providing guidance that we currently expect to have our human factors data and potentially our pharmacokinetic data for Anaphylm available in time for our August earnings call. The completion of this data is dependent on the FDA providing responses to our human factors protocol on time and the responses being within expectations, including with respect to the scope and content of that feedback. With these assumptions in mind, we continue to guide to a Q3 resubmission to the FDA, recognizing this timing remains subject to FDA feedback and ongoing review processes. As we've stated in the past, we currently expect our resubmission of the NDA for Anaphylm to be classified as a Type 2 submission with a 6-month review.

Dan Barber: The question, of course, is where does this work take us, and how do we expect the coming months to unfold? Today, I am providing guidance that we currently expect to have our human factors data and potentially our pharmacokinetic data for Anaphylm available in time for our August earnings call. The completion of this data is dependent on the FDA providing responses to our human factors protocol on time and the responses being within expectations, including with respect to the scope and content of that feedback. With these assumptions in mind, we continue to guide to a Q3 resubmission to the FDA, recognizing this timing remains subject to FDA feedback and ongoing review processes. As we've stated in the past, we currently expect our resubmission of the NDA for Anaphylm to be classified as a Type 2 submission with a 6-month review.

Speaker #4: Now, the completion of this data is dependent on the FDA providing responses to our human factors protocol on time and the responses being within expectations, including with respect to the scope and content of that feedback.

Speaker #4: With these assumptions in mind, we continue to guide to a third quarter resubmission to the FDA recognizing that this timing remains subject to FDA feedback and ongoing review processes.

Speaker #4: As we've stated in the past, we currently expect our resubmission of the NDA for Anisome to be classified as a type two submission with a six-month review, although final classification is determined by the FDA.

Daniel Barber: Although final classification is determined by the FDA. We will request an expedited review upon our submission, and we'll do everything we can to communicate with the FDA and support their review process, recognizing that any decision on review timing rests solely with the FDA. We believe the comments by FDA's leadership on the need for the agency to provide more timely feedback and review points to a broader agency focus, and in this case, may create the possibility of aligning with the FDA on a faster process. This, of course, cannot be guaranteed. Our commercial preparations continue to progress. Importantly, we were pleased to enter into a $150 million debt facility with Oaktree, a leading life sciences debt provider. While Ernie will talk about this in more detail, at a global level, this agreement unlocks several important things for Aquestive.

Dan Barber: Although final classification is determined by the FDA. We will request an expedited review upon our submission, and we'll do everything we can to communicate with the FDA and support their review process, recognizing that any decision on review timing rests solely with the FDA. We believe the comments by FDA's leadership on the need for the agency to provide more timely feedback and review points to a broader agency focus, and in this case, may create the possibility of aligning with the FDA on a faster process. This, of course, cannot be guaranteed. Our commercial preparations continue to progress. Importantly, we were pleased to enter into a $150 million debt facility with Oaktree, a leading life sciences debt provider. While Ernie will talk about this in more detail, at a global level, this agreement unlocks several important things for Aquestive.

Speaker #4: We will request an expedited review upon our submission and will do everything we can to communicate with the FDA and support their review process, recognizing that any decision on review timing rests solely with the FDA.

Speaker #4: We believe the comments by FDA's leadership on the need for the agency to provide more timely feedback and review point to a broader agency focus and, in this case, may create the possibility of aligning with the FDA on a faster process.

Speaker #4: This, of course, cannot be guaranteed. Our commercial preparations continue to progress. Importantly, we were pleased to enter into a 150 million dollar debt facility with Oaktree a leading life sciences debt provider.

Speaker #4: While earning, we'll talk about this in more detail at a global level. This agreement unlocks several important things for Aquestive. One, we have improved the interest rate terms on our existing debt, and principal payments will not begin for several years.

Daniel Barber: One, we have improved the interest rate terms on our existing debt, and principal payments will not begin for several years. Two, this completes the pre-approval requirements for the RTW funding. Three, we have the ability to access $20 million in additional capital if Anaphylm is approved by the FDA. Taken together with our existing cash and the RTW deal, we currently project that we will have greater than $150 million in cash at launch, and this is before considering ex-US Anaphylm and US Libervant out licensing deals. We plan on using this cash to focus on building intense awareness and access within the allergy community for Anaphylm. We have already shared our plans for launch of Anaphylm with you, if approved by the FDA, including a strong medical affairs presence, a 75-person sales force, and a focused marketing effort.

Dan Barber: One, we have improved the interest rate terms on our existing debt, and principal payments will not begin for several years. Two, this completes the pre-approval requirements for the RTW funding. Three, we have the ability to access $20 million in additional capital if Anaphylm is approved by the FDA. Taken together with our existing cash and the RTW deal, we currently project that we will have greater than $150 million in cash at launch, and this is before considering ex-US Anaphylm and US Libervant out licensing deals. We plan on using this cash to focus on building intense awareness and access within the allergy community for Anaphylm. We have already shared our plans for launch of Anaphylm with you, if approved by the FDA, including a strong medical affairs presence, a 75-person sales force, and a focused marketing effort.

Speaker #4: Two, this completes the pre-approval requirements for the RTW funding, and three, we have the ability to access $20 million in additional capital if Anisome is approved by the FDA.

Speaker #4: Taken together, with our existing cash and the RTW deal, we currently project that we will have greater than $150 million in cash at launch, and this is before considering ex-US Anisome and US Librivent out-licensing deals.

Speaker #4: We plan on using this cash to focus on building intense awareness and access within the allergy community for Anisome. We have already shared our plans for launch of Anisome with you if approved by the FDA including a strong medical affairs presence, a 75-person sales force, and a focused marketing effort.

Speaker #4: We have also been watching and learning from the launch of a nasal spray product in the market. Our research within the allergy community indicates that building clarity, trust, and support for allergists is key to unlocking prescriptions.

Daniel Barber: We have also been watching and learning from the launch of a nasal spray product in the market. Our research within the allergy community indicate that building clarity, trust, and support for allergists is key to unlocking prescriptions. This may seem obvious, but just think of the daily pressures allergists face in running their practices. Fitting into their world in a meaningful and credible way in furtherance of patient access to Anaphylm is task number 1, 2, and 3 for us. While the US market is incredibly important to us, we can't forget that 96% of the world's population does not live in the US. I truly believe Anaphylm is a product that will save lives, and we want as many people as possible on this planet to ultimately have access to it. Our lead ex-US strategy continues to be Canada and Europe, and we've made significant progress.

Dan Barber: We have also been watching and learning from the launch of a nasal spray product in the market. Our research within the allergy community indicate that building clarity, trust, and support for allergists is key to unlocking prescriptions. This may seem obvious, but just think of the daily pressures allergists face in running their practices. Fitting into their world in a meaningful and credible way in furtherance of patient access to Anaphylm is task number 1, 2, and 3 for us. While the US market is incredibly important to us, we can't forget that 96% of the world's population does not live in the US. I truly believe Anaphylm is a product that will save lives, and we want as many people as possible on this planet to ultimately have access to it. Our lead ex-US strategy continues to be Canada and Europe, and we've made significant progress.

Speaker #4: This may seem obvious, but just think of the daily pressures allergists face in running their practices. Fitting into their world in a meaningful and credible way, in furtherance of patient access to Anisome, is task number one to and three for us.

Speaker #4: While the US market is incredibly important to us, we can't forget that 96% of the world's population does not live in the US. I truly believe Anisome is a product that will save lives, and we want as many people as possible on this planet to ultimately have access to it.

Speaker #4: Our lead ex-US strategy continues to be Canada and Europe, and we've made significant progress. As I mentioned before, we recently completed a comprehensive and positive interaction with MHRA, the UK's regulatory body. I'm pleased to say we received confirmation that we do not need to conduct additional studies before submitting our application to MHRA in the UK.

Daniel Barber: As I mentioned before, we recently completed a comprehensive and positive interaction with MHRA, the UK's regulatory body. I'm pleased to say we received confirmation that we do not need to conduct additional studies before submitting our application to MHRA in the UK. We also recently submitted our pediatric investigational plan to the European Medicines Agency, or EMA, for the European Union. Aligning with EMA on this plan is essential to submitting our application. We now know that we can submit applications in the EU, UK, and Canada without conducting further clinical studies. Between the US, Canada, the UK, and the European Union, our product, if approved in each of these regions, could eventually be available to almost 1 billion people in the next several years. Now let's talk about our product pipeline.

Dan Barber: As I mentioned before, we recently completed a comprehensive and positive interaction with MHRA, the UK's regulatory body. I'm pleased to say we received confirmation that we do not need to conduct additional studies before submitting our application to MHRA in the UK. We also recently submitted our pediatric investigational plan to the European Medicines Agency, or EMA, for the European Union. Aligning with EMA on this plan is essential to submitting our application. We now know that we can submit applications in the EU, UK, and Canada without conducting further clinical studies. Between the US, Canada, the UK, and the European Union, our product, if approved in each of these regions, could eventually be available to almost 1 billion people in the next several years. Now let's talk about our product pipeline.

Speaker #4: We also recently submitted our pediatric investigational plan to the European Medicines Agency or EMA for the European Union. Aligning with EMA on this plan is essential to submitting our application.

Speaker #4: We now know that we can submit applications in the EU, UK, and Canada without conducting further clinical studies. Between the US, Canada, the UK, and the European Union, our product if approved in each of these regions could eventually be available to almost one billion people in the next several years.

Speaker #4: Now let's talk about our product pipeline. Given the excitement around Anisome, people often forget that we are utilizing our epinephrine prodrug platform Adrenoverse to advance treatment in other indications.

Daniel Barber: Given the excitement around Anaphylm, people often forget that we are utilizing our epinephrine prodrug platform, AdrenaVerse, to advance treatment in other indications. Our lead asset is AQST-108, and we recently completed a phase I safety study in men with androgenetic alopecia. I am pleased to say that there were no drug-related adverse events observed in the study, and we also saw no appreciable signs of systemic absorption of our epinephrine prodrug or of epinephrine itself. We did, however, see something intriguing. Now, keep in mind this is very early phase I study data. Our Chief Development Officer, Dr. Matthew Davis, added biomarker assays to the study to see if we could detect changes in key proteins associated with both alopecia areata and androgenetic alopecia, along with other dermatological conditions such as atopic dermatitis.

Dan Barber: Given the excitement around Anaphylm, people often forget that we are utilizing our epinephrine prodrug platform, AdrenaVerse, to advance treatment in other indications. Our lead asset is AQST-108, and we recently completed a phase I safety study in men with androgenetic alopecia. I am pleased to say that there were no drug-related adverse events observed in the study, and we also saw no appreciable signs of systemic absorption of our epinephrine prodrug or of epinephrine itself. We did, however, see something intriguing. Now, keep in mind this is very early phase I study data. Our Chief Development Officer, Dr. Matthew Davis, added biomarker assays to the study to see if we could detect changes in key proteins associated with both alopecia areata and androgenetic alopecia, along with other dermatological conditions such as atopic dermatitis.

Speaker #4: Our lead asset is AQST-108, and we recently completed a Phase 1 safety study in men with androgenic areata. I am pleased to say that there were no drug-related adverse events observed in the study, and we also saw no appreciable signs of systemic absorption of our epinephrine prodrug or of epinephrine itself.

Speaker #4: We did, however, see something intriguing. Now, keep in mind this is very early phase one study data. Our chief development officer, Dr. Matthew Davis, added biomarker assays to the study to see if we could detect changes in key proteins associated with both alopecia areata and androgenic areata along with other dermatological conditions such as atopic dermatitis.

Speaker #4: While this information is not statistically powered, it should be viewed as directional only, we were pleased to see in subjects with alopecia that the cytokine TSLP appeared to be impacted by AQST 108.

Daniel Barber: While this information is not statistically powered and should be viewed as directional only, we were pleased to see in subjects with alopecia that the cytokine TSLP appeared to be impacted by AQST-108. This was not the case when subjects were given placebo. This is very exciting as the signaling pathway for TSLP involves the activation of JAK1 and of JAK2. We have included preliminary data on this work in our supplemental material available under the presentations section of the investor page on our website. We will talk more about the next studies for AQST-108 in the coming months once we have resubmitted our Anaphylm application in the US. Our business development efforts and base business continue to move forward. Our business development team is currently in active negotiations on multiple programs for Europe, the US, and South America.

Dan Barber: While this information is not statistically powered and should be viewed as directional only, we were pleased to see in subjects with alopecia that the cytokine TSLP appeared to be impacted by AQST-108. This was not the case when subjects were given placebo. This is very exciting as the signaling pathway for TSLP involves the activation of JAK1 and of JAK2. We have included preliminary data on this work in our supplemental material available under the presentations section of the investor page on our website. We will talk more about the next studies for AQST-108 in the coming months once we have resubmitted our Anaphylm application in the US. Our business development efforts and base business continue to move forward. Our business development team is currently in active negotiations on multiple programs for Europe, the US, and South America.

Speaker #4: This was not the case when subjects were given placebo. This is very exciting, as the signaling pathway for TSLP involves the activation of JAK1 and JAK2.

Speaker #4: We have included preliminary data on this work in our supplemental material, available under the Presentations section of the Investor page on our website. We will talk more about the next studies for AQST-108 in the coming months, once we have resubmitted our Anaphylm application in the US.

Speaker #4: Our business development efforts and base business continue to move forward. Our business development team is currently in active negotiations on multiple programs for Europe, the US, and South America.

Speaker #4: We have also had outreach from additional regions of the world including China, and Australia. We are prioritizing this work based on the territory and program involved.

Daniel Barber: We have also had outreach from additional regions of the world, including China and Australia. We are prioritizing this work based on the territory and program involved. We expect to have more to say on this topic in the months to come. In summary, we expect to provide a significant data update in August, assuming the FDA keeps to its review timeline and provides constructive comments to our human factors study protocol. We continue to drive awareness in the epilepsy community ahead of a potential product launch of Anaphylm if approved by the FDA. Our international filing efforts continue to be a priority, and our AQST-108 program continues to show promise for expansion into potential multiple indications. With that, I will turn the call over to Ernie.

Dan Barber: We have also had outreach from additional regions of the world, including China and Australia. We are prioritizing this work based on the territory and program involved. We expect to have more to say on this topic in the months to come. In summary, we expect to provide a significant data update in August, assuming the FDA keeps to its review timeline and provides constructive comments to our human factors study protocol. We continue to drive awareness in the epilepsy community ahead of a potential product launch of Anaphylm if approved by the FDA. Our international filing efforts continue to be a priority, and our AQST-108 program continues to show promise for expansion into potential multiple indications. With that, I will turn the call over to Ernie.

Speaker #4: We expect to have more to say on this topic in the months to come. In summary, we expect to provide a significant data update in August assuming the FDA keeps to its review timeline and provides constructive comments to our human factor study protocol.

Speaker #4: We continue to drive awareness in the epilepsy community ahead of a potential product launch of Anisome if approved by the FDA. Our international filing efforts continue to be a priority and our AQST 108 program continues to show promise for expansion into potential multiple indications.

Speaker #4: With that, I will turn the call over to Ernie.

Speaker #1: Thank you, Dan, and good morning, everyone. By now, you have seen our first quarter 2026 financial results and the earnings release issued last evening and detailed in our Form 10-Q filing.

Ernie Toth: Thank you, Dan, good morning, everyone. By now, you will have seen our Q1 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 financial performance, operating spend, and liquidity. During the Q1, our primary financial focus remained supporting progress on Anaphylm following receipt of the FDA Complete Response Letter on 30 January 2026, while maintaining a strong balance sheet and financial flexibility. Subsequent to quarter end, we completed a Type A meeting with the FDA and aligned on the remaining requirements for approval, including a human factors validation study and a PK study, both of which are currently underway.

Speaker #1: 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 financial performance, operating spend, and liquidity.

Speaker #1: During the first quarter, our primary financial focus remained supporting progress on Anisome following receipt of the FDA Complete Response Letter on January 30, 2026, while maintaining a strong balance sheet and financial flexibility.

Speaker #1: Subsequent to quarter end, we completed a Type A meeting with the FDA and aligned on the remaining requirements for approval including a human factors validation study and a PK study both of which are currently underway.

Speaker #1: During the quarter, we extended our strategic funding agreement with RTW Investments through June 30, 2027, further strengthening our liquidity runway and financial flexibility as we work towards the Anisome resubmission.

Ernie Toth: During the quarter, we extended our strategic funding agreement with RTW Investments through 30 June 2027, further strengthening our liquidity runway and financial flexibility as we work towards Anaphylm resubmission. We announced the refinancing of our existing debt with a new $150 million debt facility with certain funds and accounts managed by Oaktree Capital Management. This transaction reduces our interest rate, extends the interest-only period, saving $45 million in principal payments over the next 3 years on the existing debt that were scheduled to commence on 30 June, and provides additional flexibility to fund the launch of Anaphylm, if approved by the FDA.

Speaker #1: Additionally, we announced the refinancing of our existing debt with a new $150 million debt facility with certain funds and accounts managed by Oaktree Capital Management.

Speaker #1: This transaction reduces our interest rate extends the interest-only period saving 45 million dollars in principal payments over the next three years on the existing debt that were scheduled to commence on June 30th and provides additional flexibility to fund the launch of Anisome if approved by the FDA.

Speaker #1: The new debt facility is available in four tranches, with Tranche A of $55 million refinancing the existing debt. Tranche B of $20 million is available upon FDA approval of Anisome.

Ernie Toth: The new debt facility is available in four tranches, with Tranche A of $55 million refinancing the existing debt, Tranche B of $20 million available upon FDA approval of Anaphylm, Tranche C of $25 million available upon achieving certain sales levels, and Tranche D of $50 million available upon mutual consent of Oaktree and the company. Now, let me walk you through our Q1 results. Total revenues increased to $14.4 million in Q1 2026 from $8.7 million in Q1 2025. The 66% increase was primarily driven by increases in license and royalty revenue and increases in manufacturer and supplier revenue.

Speaker #1: Tranche C of $25 million is available upon achieving certain sales levels. And tranche D of $50 million is available upon mutual consent of Oak Tree and the company.

Speaker #1: Now, let me walk you through our first quarter results. Total revenues increased to 14.4 million dollars in the first quarter 2026 from 8.7 million dollars in the first quarter 2025.

Speaker #1: The 66% increase was primarily driven by increases in license and royalty revenue, and increases in manufacturer and supplier revenue. License and royalty revenue increased to $5.4 million in the first quarter of 2026 from $0.8 million in the first quarter of 2025, primarily due to the recognition of royalty revenue from Zephyr.

Ernie Toth: License and royalty revenue increased to $5.4 million in Q1 2026 from $0.8 million in Q1 2025, primarily due to the recognition of royalty revenue from Zevra. Manufacturer and supplier revenue increased to $8.8 million in Q1 2026 from $7.2 million in Q1 2025, primarily due to increases in SUBOXONE revenues, partially offset by lower Ondif revenues. Research and development expenses decreased to $4.2 million in Q1 2026 from $5.4 million in Q1 2025. The decrease in research and development expenses was primarily due to lower clinical trial costs associated with the Anaphylm development program, partially offset by increases in R&D personnel costs.

Speaker #1: Manufacturer and supplier revenue increased to $8.8 million in the first quarter of 2026 from $7.2 million in the first quarter of 2025, primarily due to increases in Suboxone revenues, partially offset by lower Ondif revenues.

Speaker #1: Research and development expenses decreased to 4.2 million dollars in the first quarter 2026 from 5.4 million dollars in the first quarter 2025. The decrease in research and development expenses was primarily due to lower clinical trial costs associated with the Anisome development program partially offset by increases in R&D personnel cost.

Ernie Toth: Selling, general and administrative expenses decreased to $11 million in Q1 2026 from $19.1 million in Q1 2025. The decrease primarily represents the one-time Anaphylm PDUFA fee of $4.3 million in the prior year period, lower legal fees of approximately $3.4 million, lower commercial spending of approximately $2 million, and lower regulatory and licensing fees of approximately $0.5 million, partially offset by higher severance costs of approximately $0.6 million, higher personnel costs of approximately $0.5 million, and higher share-based compensation expenses of approximately $0.5 million.

Speaker #1: Selling general and administrative expenses decreased to 11 million dollars in the first quarter 2026 from 19.1 million dollars in the first quarter 2025. The decrease primarily represents the one-time Anisome PDUFA fee of 4.3 million dollars in the prior year period, lower legal fees of approximately 3.4 million dollars, lower commercial spending of approximately 2 million dollars, and lower regulatory and licensing fees of approximately 0.5 million dollars partially offset by higher severance costs of approximately 0.6 million dollars higher personnel costs of approximately 0.5 million dollars and higher share-based compensation expenses of approximately 0.5 million dollars.

Speaker #1: Aquestive's net loss for the first quarter 2026 was $8.1 million, or $0.07 for both basic and diluted loss per share, compared to the net loss in the first quarter 2025 of $22.9 million, or $0.24 for both basic and diluted loss per share.

Ernie Toth: Aquestive's net loss for Q1 2026 was $8.1 million, or $0.07 for both basic and diluted loss per share, compared to the net loss in Q1 2025 by $22.9 million or $0.24 for both basic and diluted loss per share. The decrease in net loss was primarily driven by increases in revenues, decreases in selling, general, and administrative expenses and research and development expenses, partially offset by decreases in interest income and other income net. Non-GAAP adjusted EBITDA loss was $1.7 million in Q1 2026, compared to non-GAAP adjusted EBITDA loss of $17.6 million in Q1 2025. Turning to the balance sheet, we ended Q1 2026 with approximately $110 million in cash and cash equivalents.

Speaker #1: The decrease in net loss was primarily driven by increases in revenues decreases in selling general and administrative expenses and research and development expenses partially offset by decreases in interest income and other income net.

Speaker #1: Non-GAAP adjusted EBITDA loss was $1.7 million in the first quarter 2026, compared to non-GAAP adjusted EBITDA loss of $17.6 million in the first quarter 2025.

Speaker #1: Turning to the balance sheet, we ended the first quarter 2026 with approximately 110 million dollars in cash and cash equivalents. This cash position provides us with sufficient capital to complete the remaining FDA-required studies for Anisome continue advancing AQSP 108 and our Adrenoverse platform and support ongoing operations and regulatory planning including potential XUS regulatory filings and preparing for the US commercial launch of Anisome if approved by the FDA.

Ernie Toth: This cash position provides us with sufficient capital to complete the remaining FDA-required studies for Anaphylm, continue advancing AQST-108 and our AdrenaVerse platform, and support ongoing operations and regulatory planning, including potential ex-US regulatory filings and preparing for the US commercial launch of Anaphylm, if approved by the FDA. At this time, we are not updating full-year financial guidance as our near-term focus remains on execution of the remaining Anaphylm study requirements and achieving regulatory milestones. We expect to provide additional financial and operational updates as those milestones are reached. For 2026, the company expects total revenue of $46 million to $50 million and non-GAAP adjusted EBITDA loss of -$35 million to -$30 million as of 13 May 2026.

Speaker #1: At this time, we are not updating full-year financial guidance as our near-term focus remains on execution of the remaining Anisome study requirements and achieving regulatory milestones.

Speaker #1: We expect to provide additional financial and operational updates as those milestones are reached. For 2026, the company expects total revenue of $46 million to $50 million and a non-GAAP adjusted EBITDA loss of $35 million to $30 million as of May 13th, 2026.

Speaker #1: In summary, the first quarter of 2026 reflects disciplined financial execution a strong cash position and continued focus on advancing Anisome towards resubmission while carefully managing expenses across the organization.

Ernie Toth: In summary, the first quarter of 2026 reflects disciplined financial execution, a strong cash position, and continued focus on advancing Anaphylm towards resubmission while carefully managing expenses across the organization. With that, I will now turn the line back to the operator to open the line for questions.

Speaker #1: With that, I will now turn the line back to the operator to open the line for questions.

Operator: Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the community roster. One moment for our first question.

Speaker #2: Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced to withdraw your question.

Speaker #2: Please press star 11 again. Please stand by while we compile the Q&A roster. One moment for the first question. Our first question will come from Lina Rana Reese from Lyric Partners.

Operator 2: First question from the line of Roanna Ruiz from Leerink Partners. Your line is open.

Operator: First question from the line of Roanna Ruiz from Leerink Partners. Your line is open.

Speaker #2: Your line is open.

Roanna Ruiz: Great. Good morning, everyone. A couple from me. First on Anaphylm, could you give us a little bit more detail on how things are going preparing for the US filing and ongoing study interactions or activities? It sounds like you reiterated your timeline. You know, what gives you added conviction to be able to hit that milestone?

Speaker #3: Great. Good morning, everyone. So a couple from me. First on Anisome, could you give us a little bit more detail on how things are going preparing for the US filing and ongoing study interactions or activities?

Speaker #3: It sounds like you reiterated your timeline. What gives you added conviction to be able to hit that milestone?

Daniel Barber: Sure. Good morning, Roanna. Nice to hear your voice. I think the way to think about this moment in time for Aquestive, especially with Anaphylm, is we're ready to go. We have a great team here who has the study designs completely ready. We have the sites with standing by, ready to start the studies. We've given guidance on timing of when we expect to have top-line data in our August earnings. The only trigger that we are waiting for is, as we told you in our last release, the FDA reviewing our human factors protocol, which we have commitment from the FDA on the turnaround of that, which we expect to be in the next few weeks.

Dan Barber: Sure. Good morning, Roanna. Nice to hear your voice. I think the way to think about this moment in time for Aquestive, especially with Anaphylm, is we're ready to go. We have a great team here who has the study designs completely ready. We have the sites with standing by, ready to start the studies. We've given guidance on timing of when we expect to have top-line data in our August earnings. The only trigger that we are waiting for is, as we told you in our last release, the FDA reviewing our human factors protocol, which we have commitment from the FDA on the turnaround of that, which we expect to be in the next few weeks.

Speaker #4: Sure. Good morning, Ruana. Nice to hear your voice. So I think that the way to think about this moment in time for Aquestive especially with Anisome is we're ready to go.

Speaker #4: We have a great team here who has the study designs completely ready. We have the sites standing by, ready to start the studies.

Speaker #4: We've given guidance on the timing of when we expect to have top-line data in our August earnings. The only trigger that we are waiting for is, as we told you in our last release, the FDA reviewing our human factors protocol, which we have commitment from the FDA on the turnaround of that, which we expect to be in the next few weeks.

Speaker #4: And as soon as we have that, we will start our studies and be on our way. So that's where the conviction on our timing comes from.

Daniel Barber: As soon as we have that, we will start our studies and be on our way. That's where the conviction on our timing comes from. I think, when you look across the broader business, you can see that we're ready to go, whether it be medical awareness or our balance sheet as well.

Dan Barber: As soon as we have that, we will start our studies and be on our way. That's where the conviction on our timing comes from. I think, when you look across the broader business, you can see that we're ready to go, whether it be medical awareness or our balance sheet as well.

Speaker #4: And I think when you look across the broader business, you can see that we're ready to go, whether it be medical awareness or a balance sheet as well.

Speaker #3: Sounds good. And I wanted to ask a question about AQSP 108 as well. The biomarker data sounds interesting. Could you help frame that? How does that compare to other programs you've seen going after a similar indications even if they're different mechanism agents?

Roanna Ruiz: Sounds good. I wanted to ask a question about AQST-108 as well. The biomarker data sounds interesting. Could you help frame that? How does that compare to other programs you've seen going after similar indications, even if they're different mechanism agents? Like, how should we think about this early signal?

Speaker #3: How should we think about this early signal?

Speaker #4: Sure. And I'll let Matthew Davis take that one.

Daniel Barber: Sure. I'll let Matthew Davis take that one.

Dan Barber: Sure. I'll let Matthew Davis take that one.

Matthew Davis: Hi, Roanna. Think about TSLP. What's intriguing about this signal is the fact that, one, it crosses across TH1/TH2-driven inflammation, JAK/STAT1, JAK/STAT2. When you think of dermatology, you would think of mechanisms that would be beneficial for alopecia areata, androgenetic alopecia, atopic derm. There's a lot of optionality that this gives us. The fact that we also saw the correct orientation with CCL3 and CCL4 would be confirmational, remember, this is directional-only data, that we're looking at the right things right now. This gives AQST-108 topical a lot of optionality in the dermatologic space.

Speaker #5: Hi, Ruana. I think about TSLP. What's intriguing about this signal is the fact that, one, it crosses across TH1, TH2-driven inflammation jacks out one, jacks out two.

Speaker #5: So when you think of dermatology, you would think of mechanisms that would be beneficial for alopecia areata, androgenic alopecia, atopic derm, and there's a lot of optionality that this gives us.

Speaker #5: The fact that we also saw the correct orientation with CCL3 and CCL4 would be confirmational. And remember, this is directional-only data. That we're looking at the right things right now.

Speaker #5: So this gives 108 topical a lot of optionality in the dermatologic space. So Ruana, just to add on to what Matthew said, what we like about this moment for this program is, one, we obviously are not going to lose focus on Anisome.

Daniel Barber: Roanna, just to add on to what Matthew said, what we like about this moment for this program is, one, we obviously are not going to lose focus on Anaphylm. Our attention remains there. We've been looking to create the data and the reasons to believe on why our AdrenaVerse platform is a meaningful way to build the company. As Matthew just walked you through, these early results show, we think we're starting to find that proof.

Dan Barber: Roanna, just to add on to what Matthew said, what we like about this moment for this program is, one, we obviously are not going to lose focus on Anaphylm. Our attention remains there. We've been looking to create the data and the reasons to believe on why our AdrenaVerse platform is a meaningful way to build the company. As Matthew just walked you through, these early results show, we think we're starting to find that proof.

Speaker #5: Our attention remains there. But we've been looking to create the data and the reasons to believe on why our Adrenoverse platform is a meaningful way to build the company.

Speaker #5: And as Matthew just walked you through, these early results show we think we're starting to find that proof.

Speaker #3: Sounds great. Thanks.

Roanna Ruiz: Sounds great. Thanks.

Operator 2: Thank you. Our next question will come from the line of Kristin Kuska from Cantor. Your line is open.

Operator: Thank you. Our next question will come from the line of Kristin Kuska from Cantor. Your line is open.

Speaker #2: Thank you. And our next question will come from line of Kristen Kluska from Cantor. Your line is open.

Speaker #6: Hi. Good morning, everybody, and congrats on all of the progress. So, I wanted to ask how your market research and conversations have been going about coverage and reimbursement.

Kristin Kuska: Hi, good morning, everybody, and congrats on all of the progress. I wanted to ask how your market research and conversations have been going about coverage and reimbursement. I think there's been a lot of great work to support the enthusiasm is there. Assuming you get an approval, what gives you confidence that you will get the coverage that the patients that want Anaphylm will be able to get their hands on it?

Kristen Kluska: Hi, good morning, everybody, and congrats on all of the progress. I wanted to ask how your market research and conversations have been going about coverage and reimbursement. I think there's been a lot of great work to support the enthusiasm is there. Assuming you get an approval, what gives you confidence that you will get the coverage that the patients that want Anaphylm will be able to get their hands on it?

Speaker #6: I think there's been a lot of great work to support the enthusiasm is there. But assuming you got an approval, what give you confidence that you will get the coverage that the patients that want Anisome will be able to get their hands on it?

Daniel Barber: Sure. Good morning, Kristin. Well, look, I hopefully have been consistent on this point all along. Coverage and reimbursement is a struggle for every company in life sciences. There is no doubt when we launch that Sherri and her team have a lot of work to do to get coverage for the product at the level we want the product to be available to people. Sherri, I'll pass it over to her in a second here, her and her team are doing a lot of the great foundational work to make that happen. I do wanna set the expectation right for everyone listening today. It will take time, and it will be something that we have to build as we go through our launch.

Dan Barber: Sure. Good morning, Kristin. Well, look, I hopefully have been consistent on this point all along. Coverage and reimbursement is a struggle for every company in life sciences. There is no doubt when we launch that Sherri and her team have a lot of work to do to get coverage for the product at the level we want the product to be available to people. Sherri, I'll pass it over to her in a second here, her and her team are doing a lot of the great foundational work to make that happen. I do wanna set the expectation right for everyone listening today. It will take time, and it will be something that we have to build as we go through our launch.

Speaker #4: Sure. And good morning, Kristen. Well, look, I think I hopefully have been consistent on this point all along. Coverage and reimbursement is a struggle for every company in life sciences.

Speaker #4: So there is no doubt when we launch that Sherry and her team have a lot of work to do to get coverage for the product at the level we want the product to be available to people.

Speaker #4: So, Sherry—and I'll pass it over to her in a second here—she and her team are doing a lot of the great foundational work to make that happen.

Speaker #4: But I do want to set the expectation right for everyone listening today. It will take time. And it will be something that we have to build as we go through our launch.

Daniel Barber: With that, I'll let Sherry provide her view.

Speaker #4: And with that, I'll let Sherry provide her view.

Dan Barber: With that, I'll let Sherry provide her view.

Speaker #3: Yeah, thanks, Dan. Hi, Kristen. Good morning. As we've been talking about, ensuring as many patients have access to Anisome is our number one priority.

Sherry Korczynski: Yeah. Thanks, Dan. Hi, Kristin. Good morning. You know, as we've been talking about, ensuring as many patients have access to Anaphylm is our number one priority. Rapid payer coverage and reducing the friction at our HCPs office is key. As Dan mentioned, we have watched and learned from the recent nasal launch. We see what has worked, what hasn't worked. We're adjusting our strategy accordingly. We continue to have very robust discussions with the PBMs and the payers. From the research and from our one-on-one meetings, there is significant interest in our product. As Dan has mentioned, you know, it's going to take some time. What I can assure you with, Kristin, is we are setting up a best-in-class hub and patient support services.

Speaker #3: And rapid payer coverage and reducing the friction at our HCPs' offices is key. Like Dan mentioned, we have watched and learned from the recent nasal launch.

Speaker #3: We see what has worked, what hasn't worked. We're adjusting our strategy. Accordingly, and we continue to have very robust discussions with the PBMs and the payers.

Speaker #3: From the research and from our one-on-one meetings, there is significant interest in our product. But as Dan has mentioned, it's going to take some time.

Speaker #3: But what I can assure you with, Kristen, is we are setting up a best-in-class hub and patient support services. We are investing heavily into ensuring that there is as little friction, even with those prior auths, that there's as little friction and pain for our physicians' offices.

Sherry Korczynski: We are investing heavily into ensuring that there is as little friction, even with those prior auths.

Sherry Korczynski: That there's as little friction and pain for our physicians' offices. That's the one thing we've learned, we've taken our learnings, and we're applying them to how and what we will do. At the end of the day, we are very, very invested in ensuring that both patients and HCPs are aware of Anaphylm, are prepared to prescribe Anaphylm, and ultimately, that our patient gets their Anaphylm prescription.

Speaker #3: That's the one thing we've learned and so we've taken our learnings and we're applying them to how and what we will do. And so at the end of the day, we are very, very invested in ensuring that both patients and HCPs are aware of Anisome.

Speaker #3: And then our prepared to prescribe Anisome and ultimately that our patient gets their Anisome prescription.

Speaker #6: Okay, thank you. And then, just on that awareness angle, what do you think is going to be the biggest push that you're going to have to do in terms of getting the word out there?

Kristin Kuska: Okay, thank you. Just on that awareness angle, what do you think is gonna be the biggest push that you're going to have to do in terms of getting the word out there? How would you say potentially having this extra time since the CRL in your original planning has benefited that?

Kristen Kluska: Okay, thank you. Just on that awareness angle, what do you think is gonna be the biggest push that you're going to have to do in terms of getting the word out there? How would you say potentially having this extra time since the CRL in your original planning has benefited that?

Speaker #6: And how would you say potentially having this extra time since the CRL in your original planning has benefited that?

Speaker #4: Yeah. Look, when it comes to awareness—

Daniel Barber: Yeah. Look, when it comes to awareness.

Dan Barber: Yeah. Look, when it comes to awareness.

Kristin Kuska: Dan, do you wanna-

Kristen Kluska: Dan, do you wanna-

Speaker #6: Dan, do you want to? Go ahead.

Daniel Barber: I'm-

Dan Barber: I'm-

Kristin Kuska: Go ahead.

Kristen Kluska: Go ahead.

Daniel Barber: When it comes to awareness, I'm incredibly pleased with where we are as a company. We're definitely, in my view, I'll use the phrase punching above our weight. I'm gonna pass it over to Matthew Greenhawt in a second. A lot of that is because of his efforts and the team around him and with him and their efforts out in the field. As I mentioned in the prepared comments, this year we'll be at 40 conferences and have 20 publications. That is an extensive awareness campaign. Matt, maybe you could provide some of your thoughts on what you see.

Speaker #4: When it comes to awareness, I'm incredibly pleased with where we are as a company. We're definitely in my view, I'll use the phrase punching above our weight.

Dan Barber: When it comes to awareness, I'm incredibly pleased with where we are as a company. We're definitely, in my view, I'll use the phrase punching above our weight. I'm gonna pass it over to Matthew Greenhawt in a second. A lot of that is because of his efforts and the team around him and with him and their efforts out in the field. As I mentioned in the prepared comments, this year we'll be at 40 conferences and have 20 publications. That is an extensive awareness campaign. Matt, maybe you could provide some of your thoughts on what you see.

Speaker #4: And I'm going to pass it over to Matt Greenhart in a second. But a lot of that is because of his efforts and the team around him and with him and their efforts out in the field, as I mentioned in the prepared comments.

Speaker #4: This year, we'll be at 40 conferences and have 20 publications. And that is an extensive awareness campaign. But Matt, maybe you could provide some of your thoughts on what you see.

Matthew Greenhawt: Good morning. Hope everybody's doing well. I mean, we've been busy. We've gone to, what, 13 conferences to date. We're gonna hit over 40 ideally. You know, just writing papers. There's a lot of data. There's a great story to tell here, you know, doing my best to get this out and hopefully, you know, this will go through publication, you know, some point this summer to early fall. You know, we go and we meet with people at these meetings. There's a lot of enthusiasm. There's a lot of excitement. It's great to have the opportunity to just sit and talk about what our story is, what we believe this product can do, and just be there to reassure and answer the questions about really anything that they wanna know.

Speaker #5: Yeah, good morning. Hope everybody's doing well. Yeah, I mean, we've been busy. We've gone to 13 conferences to date. We're going to head over 40, ideally.

Speaker #5: Just writing papers is a lot of data. There's a great story to tell here, and I'm doing my best to get this out. Hopefully, this will go through publication at some point this summer to early fall.

Speaker #5: We go and we meet with people at these meetings. There's a lot of enthusiasm, there's a lot of excitement, and it's great to have the opportunity to just sit and talk about what our story is, what we believe this product can do, and just be there to reassure and answer questions about really anything that they want to know.

Matthew Greenhawt: It's been a nice opportunity to really get out and meet everybody. Again, these are mostly my former colleagues, so it's, you know, it's nice to be able to interact with them and share, you know, my enthusiasm about this product and again, where we believe that this is gonna go.

Speaker #5: So, we have a nice opportunity to really get out and meet everybody. And again, these are mostly my former colleagues, so it's nice to be able to interact with them and share my enthusiasm about this product.

Speaker #5: And again, where we believe that this is going to go.

Daniel Barber: I think we see that coming through in the survey work we do when we ask, are you aware of our product. You see those numbers steadily going up over time.

Speaker #4: And I think we see that coming through in the survey work we do when we ask, 'Are you aware of our product?' And you see those numbers steadily going up over time.

Dan Barber: I think we see that coming through in the survey work we do when we ask, are you aware of our product. You see those numbers steadily going up over time.

Kristin Kuska: Thanks, everyone.

Kristen Kluska: Thanks, everyone.

Speaker #3: Thanks, everyone.

Operator 2: Thank you. Our next question will come from line of David Amsellem from Piper Sandler. Your line is open.

Operator: Thank you. Our next question will come from line of David Amsellem from Piper Sandler. Your line is open.

Speaker #2: Thank you. And our next question will come from line of David Amsalem from Piper Sandler. Your line is open.

[Analyst] (Piper Sandler): Hi, everyone. This is now John for David. Thanks for taking our questions. Just a couple quick ones from us. First with Nefi, now that that's been on the market for around 18 months, can you elaborate on the learnings from that launch that are influencing any changes to your commercialization strategy? That's number one. Number two, with the Oaktree financing in place and the pre-approval conditions for the additional RTW financing met, is that sufficient runway through the launch of Anaphylm? If you could provide some clarification there, that'd be great. Thank you.

Speaker #7: Hi, everyone. This is now going for David. Thanks for taking our questions. Just a couple of quick ones from us. So first, with Nessie, now that that's been on the market for around 18 months, can you elaborate on the learnings from that launch that are influencing any changes to your commercialization strategy?

Speaker #7: That's number one. And number two, with the Oaktree financing in place and the pre-approval conditions for the additional RTW financing met, is that sufficient runway through the launch of Anisome?

Speaker #7: So, if you could provide some clarification, that would be great. Thank you.

Speaker #4: Sure. Yeah. Well, let me go and reverse order. And let's start with Oaktree. And I'm going to pass it over to Ernie for a minute here.

Daniel Barber: Sure. Yeah. Well, let me go in reverse order, let's start with Oaktree. I'm gonna pass it over to Ernie for a minute here. From our perspective, I'll open with that piece by saying, look, we're incredibly excited about the relationship with Oaktree. Now with both RTW and Oaktree as key backers of the organization, we think we're well-positioned. Ernie can give you his thoughts on the runway through the launch.

Dan Barber: Sure. Yeah. Well, let me go in reverse order, let's start with Oaktree. I'm gonna pass it over to Ernie for a minute here. From our perspective, I'll open with that piece by saying, look, we're incredibly excited about the relationship with Oaktree. Now with both RTW and Oaktree as key backers of the organization, we think we're well-positioned. Ernie can give you his thoughts on the runway through the launch.

Speaker #4: From our perspective, I'll open with that piece by saying, look, we're incredibly excited about the relationship with Oaktree. And now with both RTW and Oaktree, as key backers of the organization, we think we're well positioned.

Speaker #4: But Ernie can give you his thoughts on runway through the launch.

Ernie Toth: Certainly. You mentioned with the refinancing of the existing debt with Oaktree, that satisfied the second condition for under or first condition under RTW, was that we refinance our existing debt, so we have access to that capital. Second, being that we get approval on Anaphylm. As we've said publicly, both in our oral and written statements, that this provides us a runway through the launch next year. If approved, it puts the company in probably the best capital position it has ever been, and we feel confident that we'll have the funds in place ready to launch on approval of Anaphylm.

Speaker #8: Certainly. You mentioned with the refinancing of the existing debt with Oaktree, that satisfied the second condition for under or first condition under RTW was that we refinance our existing debt.

Speaker #8: So we have access to that capital, second, being that we get approval on Anisome. As we've said publicly, both Ben Ora and Britain statements, that this provides us runway through the launch next year.

Speaker #8: If approved, it puts the company in probably the best capital position it has ever been. And we feel confident that we'll have the funds in place, ready to launch on approval of Anisome.

Daniel Barber: Let me go back to your first question, which was on the learnings from Nefi. I'll give you my thought, and then I'll ask Sherri to also give hers. For me, I think the key learning is no matter how innovative your product, and we clearly believe our product is innovative and potentially transformative in this space, you can't take anything for granted. All of the hard work, the basic blocking and tackling work of launching a drug, being out in front of the doctors, telling your story, getting coverage, all of that you have to do no matter how innovative your product is. We are definitely focused on making sure we're ready to do all of that hard work. Sherri, I'll let you add your thoughts to that as well.

Speaker #4: And let me go back to your first question, which was on the learnings from Nessie. I'll give you my thought, and then I'll ask Sherry to also give hers for me, I think the key learning is no matter how innovative your product and we clearly believe our product is innovative and potentially transformative in this space, you can't take anything for granted.

Dan Barber: Let me go back to your first question, which was on the learnings from Nefi. I'll give you my thought, and then I'll ask Sherri to also give hers. For me, I think the key learning is no matter how innovative your product, and we clearly believe our product is innovative and potentially transformative in this space, you can't take anything for granted. All of the hard work, the basic blocking and tackling work of launching a drug, being out in front of the doctors, telling your story, getting coverage, all of that you have to do no matter how innovative your product is. We are definitely focused on making sure we're ready to do all of that hard work. Sherry, I'll let you add your thoughts to that as well.

Speaker #4: All of the hard work, the basic blocking and tackling work of launching a drug, being out in front of the doctors, telling your story, getting coverage, all of that you have to do no matter how innovative your product is.

Speaker #4: So we are definitely focused on making sure we're ready to do all of that hard work. But Sherry, I'll let you add your thoughts to that as well.

Speaker #6: Sure. Thanks so much. And thanks so much for the question. Look, as you know, having a non-device oral easiest-to-carry epinephrine is a game changer in the marketplace.

Sherry Korczynski: Sure. Thanks so much. Thanks so much for the question. You know, look, as you know, having a non-device oral easiest to carry epinephrine, it is a game changer in the marketplace. Again, as Dan mentioned, no matter, you know, you build a better mousetrap, that doesn't necessarily mean it will come. We've seen this in this marketplace. As you know, I ran the EpiPen brand, and we saw the same thing happen with Auvi-Q. Just because you build a better mousetrap doesn't mean that everyone will come. What have we learned? I think one is how do we reduce that friction?

Speaker #6: But again, as Dan mentioned, no matter you build a better mousetrap, that doesn't necessarily mean they will it will come. And we've seen this in this marketplace.

Speaker #6: As you know, I ran the EpiPen brand. And we saw the same thing happen with Avicu. So just because you build a better mousetrap doesn't mean that everyone will come.

Speaker #6: So what have we learned? I think one is how do we reduce that friction? And so as I just mentioned to Kristen, we are really working hard in our very robust discussions with the PBMs and payers, but also working on setting up the best-in-class hub and support services to support the offices.

Sherry Korczynski: As I just mentioned to Kristin, we are really working hard in our very robust discussions with the PBMs and payers, but also working on setting up the best-in-class hub and support services to support the offices. I think we heard from ARS back in their May, their March earnings call, is that they were kind of doubling down in the allergist space. You know, increasing reach and frequency in the allergist. We know that this market is driven by the allergists and the high-prescribing pediatricians. Our plan, as you know, we've moved to 75 reps as well as then obviously the managers and the support around that, is critical to drive this product forward.

Speaker #6: I think we heard from ARS back in their March earnings call is that they were kind of doubling down in the allergist space, increasing reach and frequency in the allergist.

Speaker #6: We know that this market is driven by the allergist and the high prescribing pediatricians. Our plan, as you know, we've moved to 75 reps as well as then obviously the managers and the support around that is critical.

Speaker #6: To drive this the product forward. And so look, I think at the end of the day, reducing friction in the physician's office is critical.

Sherry Korczynski: Look, I think at the end of the day, reducing friction in the physician's office is critical, ensuring that physicians and patients have awareness and really driving believability in the product. Matt's team is out there doing a fantastic job. I mean, our market research shows the awareness with the HCPs has gone from a 33% to 66%. The increased effort in publications and all the medical work that is being done will only continue to do that. That only gets us so far, right? With the awareness, we have to have doctors believe in it. All of the scientific work Matt and his team are doing, the publications we will continue to put out are critically important. Physicians have to get experience with the product in their office.

Speaker #6: Ensuring that physicians and patients have awareness and really driving believability in the product. So Matt's team is out there doing a fantastic job. I mean, our market research shows the awareness with the HCPs has gone from a 33% to 66%.

Speaker #6: So the increased effort in publications and all the medical work that is being done will only continue to do that. But that only gets us so far, right?

Speaker #6: With the awareness, we have to have doctors believe in it. So all of the scientific work Matt and his team are doing, the publications we will continue to put out are critically important.

Speaker #6: And then physicians have to get experience with the product in their office. And so we will look to launch a program upon approval. So physicians can get that actual real-world experience.

Sherry Korczynski: You know, we will look to launch a program upon approval so physicians can get that actual real-world experience.

Matthew Greenhawt: Great. Thank you.

[Analyst] (Piper Sandler): Great. Thank you.

Matthew Greenhawt: Does that answer your question, David?

Sherry Korczynski: Does that answer your question, David?

Speaker #6: Does that answer your question, David?

Speaker #7: It does. Thanks.

[Analyst] (Piper Sandler): It does. Thanks.

Operator 2: Thank you. Our next question comes from the line of Francois Brisebois from LifeSci Capital. Your line is open.

Operator: Thank you. Our next question comes from the line of Francois Brisebois from LifeSci Capital. Your line is open.

Speaker #9: Thank you. And our next question comes line of Francois Brisbois from LifeSight Capital. Your line is open.

Speaker #10: Hey, guys. Thanks for the questions here. So I was just wondering on that friction, pain, and the physician's office, is this something where it's kind of it's always the same issue?

François Brisebois: Hey, guys. Thanks for the questions here. I was just wondering on that friction pain in the physician's office, is this something where it's kind of always the same issue? Is there one problem that seems to be recurrent everywhere that's easily fixable, or is this a situation where it depends on the practice, it depends on the state, it depends on the doctor? How, you know, how far can you guys go in terms of better understanding if you have to do, like, a custom approach to each office, or is there something where it's like, I think we've got something here that is the main problem most of the time?

Speaker #10: Is there one problem that seems to be recurrent everywhere that's easily fixable, or is this a situation where it depends on the practice, it depends on the state, it depends on the doctor?

Speaker #10: How far can you guys go in terms of better understanding if you have to do a custom approach to each office? Or is there something where it's like, 'I think we've got something here that is the main problem most of the time?'

Daniel Barber: Good morning, Frank. Good to hear your voice. I'll say, let me position it this way, while we're working on it and Sherry gave you the kind of the big overview, we definitely will be keeping a decent amount of our playbook to ourselves. Yes, we do see opportunity on how to manage the friction. We do, as Sherry talked about, see some of the basic steps that every company takes, like having a good hub, like being there with frequency. In terms of the tailor-made approach and how we tackle that, some of that we're gonna hold back on for right now. I guess the way I'll leave it with you is more to come.

Dan Barber: Good morning, Frank. Good to hear your voice. I'll say, let me position it this way, while we're working on it and Sherry gave you the kind of the big overview, we definitely will be keeping a decent amount of our playbook to ourselves. Yes, we do see opportunity on how to manage the friction. We do, as Sherry talked about, see some of the basic steps that every company takes, like having a good hub, like being there with frequency. In terms of the tailor-made approach and how we tackle that, some of that we're gonna hold back on for right now. I guess the way I'll leave it with you is more to come.

Speaker #8: Morning, Frank. Good to hear your voice. So I'll say let me position it this way. While we're working on it and Sherry gave you kind of the big overview, we definitely will be keeping a decent amount of our playbook to ourselves.

Speaker #8: So yes, we do see opportunity on how to manage the friction. We do, as Sherry talked about, see some of the basic steps that every company takes, like having a good hub, like being there with frequency.

Speaker #8: But in terms of the tailor-made approach and how we tackle that, some of that we're going to hold back on for right now. But I'll, I guess, the way I'll leave it with you is more to come.

Speaker #10: Okay. Great. And on the in terms of the FDA, there's just so much with you guys at the FDA right now. Has the personnel changed?

François Brisebois: Okay, great. On the, in terms of the FDA, there's just so much with you guys with the FDA right now. Has the personnel changed? Any updates on? There's obviously been quite a bit of change with the FDA. Anything in terms of your case that has changed or has been more worrisome about this timing? I think you guys are waiting on the review from the human factors protocol. If you just, in terms of timeline and expectations and comfort. You mentioned there could be a possibility where things even accelerate. Can you just dig a little bit more into your, what you can share about FDA interactions?

Speaker #10: Any updates on there's obviously been quite a bit of change with the FDA. Anything in terms of your case that has changed or has been more worrisome about this timing?

Speaker #10: I think you guys are waiting on the review from the Human Factors Protocol. If you just in terms of timeline and expectations and comfort, and then you mentioned there could be a possibility where things even accelerate.

Speaker #10: Can you just dig a little bit more into your what you can share about FDA interactions?

Speaker #8: Sure. Well, I'll talk about the acceleration piece, and then I'll pass it over to Melina to talk about her view on the stability of the people we're interacting with.

Daniel Barber: Sure. Well, I'll talk about the acceleration piece, and then I'll pass it over to Melina to talk about her view on the stability of the people we're interacting with. To be clear, it is as we believe we will be assigned a 6-month review clock, because that would seem what the statutes are saying. However, we firmly believe that the package we're going to be putting in, as all of us are aware, will be the human factors study and the PK study that we're doing, and that's it. We do believe there's an opportunity to say to the FDA, this is a limited package and it shouldn't require the full 6 months.

Dan Barber: Sure. Well, I'll talk about the acceleration piece, and then I'll pass it over to Melina to talk about her view on the stability of the people we're interacting with. To be clear, it is as we believe we will be assigned a 6-month review clock, because that would seem what the statutes are saying. However, we firmly believe that the package we're going to be putting in, as all of us are aware, will be the human factors study and the PK study that we're doing, and that's it. We do believe there's an opportunity to say to the FDA, this is a limited package and it shouldn't require the full 6 months.

Speaker #8: So to be clear, it is we believe we will be assigned a six-month review clock because that would seem like what the statutes are saying.

Speaker #8: However, we firmly believe that the package we're going to be putting in, as all of us are aware, will be the Human Factors study and the PK study that we're doing and that's it.

Speaker #8: So we do believe there's an opportunity to say to the FDA, "This is a limited package," and it shouldn't require the full six months.

Speaker #8: We also would note there's precedence for that in the other recent branded product in this space. So that will be our approach on pushing for hopefully action sooner than the full six months.

Daniel Barber: We also would note there's precedence for that in the other recent branded product in this space. That will be our approach on pushing for hopefully action sooner than the full six months. In terms of the stability of the individuals at the FDA, I'll pass it over to Melina.

Dan Barber: We also would note there's precedence for that in the other recent branded product in this space. That will be our approach on pushing for hopefully action sooner than the full six months. In terms of the stability of the individuals at the FDA, I'll pass it over to Melina.

Speaker #8: But in terms of the stability of the individuals at the FDA, I'll pass it over to Melina.

Speaker #11: Thank you. Good morning, Frank. The team the review team across the board, across the various divisions, remain intact, meaning that these are the same individuals that have worked with us early on during the development of the product as well as during the review.

Melina Cioffi: Thank you. Good morning, Frank. The team, the review team across the board, across the various divisions, remain intact, meaning that these are the same individuals that have worked with us early on during the development of the product as well as during the review. We foresee no abrupt changes at this point.

Speaker #11: So we foresee no abrupt changes at this point.

Speaker #10: All right. Thank you very much.

François Brisebois: All right. Thank you very much.

Operator 2: Thank you. Our next question comes from the line of Mazahir Alemo-Alemoomahad from Oppenheimer. Your line is open.

Operator: Thank you. Our next question comes from the line of Mazahir Alemo-Alemoomahad from Oppenheimer. Your line is open.

Speaker #9: Thank you. And our next question comes line of Mazahir Alimo Omahad from Oppenheimer. Your line is open.

Mazahir Alemo-Alemoomahad: Good morning, everyone. Thank you for taking our questions and thank you for the really comprehensive earnings call. Just a couple from us. I guess the first one is in terms of the Zevra royalty, how should we think about this $5.4 million? Is that a run rate figure, or were there any catch-up payments in Q1 that make this a high watermark for the year? Kinda one more that's a little bit more mechanistic on this TSLP biomarker. Kinda seems like JAK1/2 sits downstream of TSLP signaling and that JAK inhibitors that, which currently carry the black box warning largely due to their exposure, could limit the uptake.

Speaker #12: Good morning, everyone. Thank you for taking our questions. And thank you for the really comprehensive earnings call. So just a couple for months. I guess the first one is in terms of the Zebra royalty, how should we think about this 5.4 million?

Mazahir Alimohamed: Good morning, everyone. Thank you for taking our questions and thank you for the really comprehensive earnings call. Just a couple from us. I guess the first one is in terms of the Zevra royalty, how should we think about this $5.4 million? Is that a run rate figure, or were there any catch-up payments in Q1 that make this a high watermark for the year? Kinda one more that's a little bit more mechanistic on this TSLP biomarker. Kinda seems like JAK1/2 sits downstream of TSLP signaling and that JAK inhibitors that, which currently carry the black box warning largely due to their exposure, could limit the uptake.

Speaker #12: Is that a run rate figure, or were there any catch-up payments in Q1 that make this a high watermark for the year? And then kind of one more that's a little bit more mechanistic on this TSLP biomarker.

Speaker #12: So kind of seems like JAK12 sits downstream of TSLP signaling, and that JAK inhibitors which currently carry the black box warning largely due to their exposure.

Speaker #12: Could limit the uptake. So I guess how confident are you that AQST's topical delivery profile would avoid the systemic JAK inhibition risks that currently limit the oral agents?

Mazahir Alemo-Alemoomahad: How, I guess, how confident are you that AQST's topical delivery profile would avoid the systemic JAK inhibition risks that currently limit the oral agents? Thank you.

Mazahir Alimohamed: How, I guess, how confident are you that AQST's topical delivery profile would avoid the systemic JAK inhibition risks that currently limit the oral agents? Thank you.

Speaker #12: Thank you.

Daniel Barber: I'll let Ernie start with the Zevra royalty and then go to Matthew for the TSLP.

Speaker #8: So, I'll let Ernie start with the Zebra royalty, and then go to Matthew for the TSLP.

Dan Barber: I'll let Ernie start with the Zevra royalty and then go to Matthew for the TSLP.

Ernie Toth: Hi, Mazi. No, you should not think of this as run rate for the year. You know, you've got to remember that what we receive from Zevra is a part of an agreement we have with them where we have an economic interest in one of their products, Azstarys. Zevra recently sold that product, and as a result of that, received a $50 million payment, of which we were entitled to 10% of. That is what accounts for the $5 million, approximately $5 million in Q1.

Speaker #13: Hi, Mazi. So no, you should not think of this as run rate for the year. We've got to remember that what we receive from Zebra, as a part of an agreement we have with them, where we have an economic interest in one of their products as TARIS, Zebra recently sold that product and as a result of that received a $50 we were entitled to 10% of.

Speaker #13: So that is what accounts for the $5 million approximately $5 million in the first quarter.

Daniel Barber: Let's turn to your question on TSLP, which I'll give to Matthew.

Speaker #8: And let's turn to your question on TSLP, which is Matthew.

Dan Barber: Let's turn to your question on TSLP, which I'll give to Matthew.

Matthew Davis: That's an absolutely great question. When you think about the broad-based nature of immunomodulation when it comes to the AdrenaVerse, you should think that we're not a specific actor inhibiting one pathway. The healthy normal subjects that volunteered for this trial did not have an elevated TSLP. They did not have elevated CCL3, CCL4. The topical AQST-108 did not actually modulate those patients. The patients that had androgenetic alopecia, they're not, this is not a broad-based inflammatory condition, but they did have elevated TSLP, and the topical 108 did reduce that directionally. Our pre-clinical research and also the published literature says that topical beta-2 agonists have a broad-based immunomodulator. They're not specifically targeting one pathway. A JAK inhibitor specifically basically targets one pathway.

Speaker #11: That's absolutely a great question. So when you think about the broad-based nature of immunomodulation, when it comes to the Adrenoverse, you should think that we're not a specific actor inhibiting one pathway.

Speaker #11: So the Healthy Normal subjects that volunteer for this trial did not have an elevated TSLP. They did not have elevated CCL3, CCL4. And the topical AQST108 did not actually modulate those patients.

Speaker #11: So the patients that had androgenic alopecia is not a broad-based inflammatory condition, but they did have elevated TSLP. And the topical 108 did reduce that directionally.

Speaker #11: So, our preclinical research and also the published literature say that topical beta-2 agonists have a broad-based immunomodulatory effect, not specifically targeting one pathway. A JAK inhibitor, specifically, basically targets one pathway.

Matthew Davis: Now, as the program advances, we'll find out more about it, and we will inform you as we get more data. That's sort of the differentiation between a broad-based modulation versus a single pathway inhibitor.

Speaker #11: Now, as a program advances, we'll find out more about it and we will inform you as we get more data. But that's sort of the differentiation between a broad-based modulation versus a single pathway inhibitor.

Speaker #12: Very helpful. Thank you for the added color.

Mazahir Alemo-Alemoomahad: Very helpful. Thank you for the added color.

Mazahir Alimohamed: Very helpful. Thank you for the added color.

Speaker #9: Thank you. And our next question comes line of Raghuram Salvaraju from HC Wainwright. Your line is open.

Operator 2: Thank you. Our next question comes from the line of Raghuram Selvaraju from H.C. Wainwright. Your line is open.

Operator: Thank you. Our next question comes from the line of Raghuram Selvaraju from H.C. Wainwright. Your line is open.

Jan Zu: Hi, good morning. Thank you for taking my question. This is Jan Zu sitting in for Ram. I have a few questions. The first is for Anaphylm. For Anaphylm ex-US, you said that you have existing clinical data that's enough to support filings in Canada, EU, UK, and so on. I'm just wondering, how are you thinking about sequencing, partnering, you know, price access, all the works, and the retained economics across those markets?

Raghuram Selvaraju: Hi, good morning. Thank you for taking my question. This is Jan Zu sitting in for Ram. I have a few questions. The first is for Anaphylm. For Anaphylm ex-US, you said that you have existing clinical data that's enough to support filings in Canada, EU, UK, and so on. I'm just wondering, how are you thinking about sequencing, partnering, you know, price access, all the works, and the retained economics across those markets?

Speaker #10: Hi. Good morning. Thank you for taking my question. This is Jan Zew sitting in for Rome. So I have a few questions. The first is for Anafilm.

Speaker #10: So for Anafilm XUS, you said that you have existing clinical data that's enough to support filings in Canada/EU/UK and so on. And I'm just wondering, how are you thinking about sequencing partnering price access, all the works?

Speaker #10: And the retained economics across those markets?

Speaker #8: Sure. Yeah. So and we can go into further detail if you want on the existing clinical piece. But as Melina and her team have worked very hard.

Daniel Barber: Sure, yeah. We can go into further detail if you want on the existing clinical piece, but as Melina and her team have worked very hard, we've met with the regulatory bodies in Canada, UK, and EMA. That's where our comfort comes from, that the existing clinical package is sufficient. We are working rapidly towards regulatory filings in multiple jurisdictions. From that perspective, we're in good shape. From the partnering perspective, we're well on our way in Europe in particular. I would say the economics are similar to what you would expect for a program at this stage. We do understand the markets. We've done our work in those markets.

Dan Barber: Sure, yeah. We can go into further detail if you want on the existing clinical piece, but as Melina and her team have worked very hard, we've met with the regulatory bodies in Canada, UK, and EMA. That's where our comfort comes from, that the existing clinical package is sufficient. We are working rapidly towards regulatory filings in multiple jurisdictions. From that perspective, we're in good shape. From the partnering perspective, we're well on our way in Europe in particular. I would say the economics are similar to what you would expect for a program at this stage. We do understand the markets. We've done our work in those markets.

Speaker #8: We've met with the regulatory bodies in Canada, UK, and EMA so that's where our comfort comes from that the existing clinical package is sufficient.

Speaker #8: And we are working rapidly towards regulatory filings in multiple jurisdictions. So, from that perspective, we're in good shape. From the partnering perspective, we're well on our way.

Speaker #8: In Europe in particular, I would say the economics are similar to what you would expect for a program at this stage. So we do understand the markets.

Speaker #8: We've done our work in those markets. We understand what we should retain versus what a partner should be able to also be rewarded and feel good about.

Daniel Barber: We understand what we should retain versus what a partner should be able to also be rewarded and feel good about. I think those I would guide you to being within industry norms. In terms of timing, I've learned over the year with BD deals, timing is always a tricky thing. What I would tell you is we are on our way, and when we get to the right place, you guys will be the first to know.

Dan Barber: We understand what we should retain versus what a partner should be able to also be rewarded and feel good about. I think those I would guide you to being within industry norms. In terms of timing, I've learned over the year with BD deals, timing is always a tricky thing. What I would tell you is we are on our way, and when we get to the right place, you guys will be the first to know.

Speaker #8: So I think those I would guide you to being within industry norms. And in terms of timing, I've learned over the year with BD deals timing is always a tricky thing.

Speaker #8: So what I would tell you is we are on our way and when we get to the right place, you guys will be the first to know.

Speaker #10: Great. Thank you. And now with respect to the Oaktree facility, would you be able to disclose what the payment prepayment provisions are there? For example, what are the catch restrictions, for example?

Jan Zu: Great. Thank you. Now with respect to the Oaktree facility, would you be able to disclose what the payment, prepayment provisions are there? For example, like what are the cash restrictions, for example?

Raghuram Selvaraju: Great. Thank you. Now with respect to the Oaktree facility, would you be able to disclose what the payment, prepayment provisions are there? For example, like what are the cash restrictions, for example?

Daniel Barber: I think everything is disclosed in the Form 8-K. It's pretty extensive disclosure on the covenants and the restrictions and everything, I would refer you to it. I would just broadly say, we are happy with not only the quality of the provider we have with Oaktree, but the ability to run our business and grow our business without being restrained. We think that is a key part of this announcement. Great. Thank you so much.

Speaker #8: I think everything is disclosed in the 8-K. It's pretty extensive disclosure on the covenants and the restrictions and everything, so I would refer you to it.

Dan Barber: I think everything is disclosed in the Form 8-K. It's pretty extensive disclosure on the covenants and the restrictions and everything, I would refer you to it. I would just broadly say, we are happy with not only the quality of the provider we have with Oaktree, but the ability to run our business and grow our business without being restrained. We think that is a key part of this announcement. Great. Thank you so much.

Speaker #13: I would just broadly say we are happy with not only the quality of the debt provider we have with Oaktree, but the ability to run our business and grow our business without being restrained.

Speaker #13: So we think that is a key part of this announcement.

Speaker #10: Great. Thank you so much.

Speaker #9: Thank you. Once again, that's Star 101 for questions. Star 101. Our next question comes line of Jim Malloy from Alliance Global Partners. Your line is open.

Operator 2: Thank you. Our next question will come from the line of James Molloy from Alliance Global Partners. Your line is open.

Operator: Thank you. Our next question will come from the line of James Molloy from Alliance Global Partners. Your line is open.

[Analyst] (Alliance Global Partners): Hello, this is Laura in for James Molloy. Thank you for taking our questions. For AQST-108, you've touched on this already a bit, how do you think you're going to further look into the TSLP biomarker data in future studies for 108, and how meaningful do you think this finding is for the atopic dermatitis indication specifically that you're looking to study?

Laura Suriel: Hello, this is Laura in for James Molloy. Thank you for taking our questions. For AQST-108, you've touched on this already a bit, how do you think you're going to further look into the TSLP biomarker data in future studies for 108, and how meaningful do you think this finding is for the atopic dermatitis indication specifically that you're looking to study?

Speaker #14: Hello, this is Laura Inn for Jim Malloy. Thank you for taking our questions. So, for AQST-108—you've touched on this already a bit—but how do you think you're going to further look into the TSLP biomarker data in future studies for 108?

Speaker #14: And how meaningful do you think this finding is for the atopic dermatitis indication specifically that you're looking to study?

Speaker #8: Sure. I'll pass it over to Matthew in a second. But I would say we're definitely excited. It definitely is a positive thing and something that we're happy to see.

Daniel Barber: Sure. I'll pass it over to Matthew in a second, but I would say, you know, we're definitely excited. It definitely a positive thing and something that we're happy to see and confirmatory of what we thought we would see. But as Matthew guided, it is early stage. It is early stage information. And I also do wanna just reiterate that in the short term, so over these next few months, everyone's brainpower, resources, time, including Matthew's, will be heavily geared towards making sure we get our Anaphylm resubmission right. That is definitely priority number 1. But I'll let Matthew give you his thoughts on what might come next.

Dan Barber: Sure. I'll pass it over to Matthew in a second, but I would say, you know, we're definitely excited. It definitely a positive thing and something that we're happy to see and confirmatory of what we thought we would see. But as Matthew guided, it is early stage. It is early stage information. And I also do wanna just reiterate that in the short term, so over these next few months, everyone's brainpower, resources, time, including Matthew's, will be heavily geared towards making sure we get our Anaphylm resubmission right. That is definitely priority number 1. But I'll let Matthew give you his thoughts on what might come next.

Speaker #8: And confirmatory of what we thought we would see. But as Matthew guided, it is early stage. It is early stage information. And I also do want to just reiterate that in the short term, so over these next few months, everyone's brainpower resources time, including Matthew's, will be heavily geared towards making sure we get our Anafilm resubmission right.

Speaker #8: So that is definitely priority number one. But I'll let Matthew give you his thoughts on what might come next.

Matthew Davis: I'm very, very excited about the direction of discovery of the TSLP, but please remember this is one of many biomarkers. It guides you towards inflammatory states dermatologically, topically, but also in additional programs, we want to expand upon the biomarkers and the utilization of biomarkers because we believe based on literature and based on our own preclinical work, that there is a lot of opportunity, and we believe that the topical beta-2 agonists, adrenergics in general really can have the potential of being a broad-based immunomodulator. As we develop our programs, once we're done with Anaphylm, we will guide everyone of what direction we're going and what information we're gonna be looking at. This is a really exciting first step.

Speaker #3: I'm very, very excited about the direction of discovery of the TSLP. But please remember, this is one of many biomarkers. So it guides you towards inflammatory-stage dermatologically and topically.

Speaker #3: But also, in additional programs, we want to expand upon the biomarkers and the utilization of biomarkers because we believe based on literature and based on our own preclinical work that there is a lot of opportunities.

Speaker #3: And we believe that the topical beta-2 blockers and the adrenovirus in general really can have the potential of being a broad-based amino modulator. And as we develop our programs once we're done with Anafilm, we will guide everyone of what direction we're going and what information we're going to be looking at.

Speaker #3: But this is a really exciting first step.

[Analyst] (Alliance Global Partners): Got it. Thank you. Also for Anaphylm, with plans to expand globally, are you still on track to file for full submission to the EMA and Health Canada by the end of the year? How would you just compare the overall US versus ex-US timing? Thank you.

Laura Suriel: Got it. Thank you. Also for Anaphylm, with plans to expand globally, are you still on track to file for full submission to the EMA and Health Canada by the end of the year? How would you just compare the overall US versus ex-US timing? Thank you.

Speaker #14: Got it. Thank you. And also, for Anafilm, with plans to expand globally, are you still on track to file for full submission to the EMA and Health Canada by the end of the year?

Speaker #14: And how would you just compare the overall US versus XUS timing? Thank you.

Speaker #8: Yeah. Well, the US timing, obviously, we've been very open about. We continue to guide to a Q3 submission. We think it's a six-month review.

Daniel Barber: Well, the US timing, obviously, we've been very open about, we continue to guide to a Q3 submission. We think it's a 6-month review. We're going to try to get the review to be faster, obviously the math there is pretty basic. On Canada, we continue to see a 2026 filing. On Europe, we're definitely shooting for a 2026 filing. We're gonna be right up against the New Year's holiday where that falls. Whether that is late Q4 or early Q1, I'm not sure that the calendar turn is what matters on that so much as getting it right and getting it in as fast as we can.

Dan Barber: Well, the US timing, obviously, we've been very open about, we continue to guide to a Q3 submission. We think it's a 6-month review. We're going to try to get the review to be faster, obviously the math there is pretty basic. On Canada, we continue to see a 2026 filing. On Europe, we're definitely shooting for a 2026 filing. We're gonna be right up against the New Year's holiday where that falls. Whether that is late Q4 or early Q1, I'm not sure that the calendar turn is what matters on that so much as getting it right and getting it in as fast as we can.

Speaker #8: We're going to try to get the review to be faster. So obviously, the map there is pretty basic. On Canada, we continue to see a 2026 filing.

Speaker #8: On Europe, we're definitely shooting for a 2026 filing. We're going to be right up against the New Year's holiday where that falls. So whether that is late Q4 or early Q1, I'm not sure that the calendar turn is what matters on that so much as getting it right and getting it in as fast as we can.

Speaker #14: Great. Thank you for taking the questions.

[Analyst] (Alliance Global Partners): Great. Thank you for taking the questions.

Laura Suriel: Great. Thank you for taking the questions.

Speaker #9: Thank you. I'm not showing any further questions at this time. I would now like to turn back over to Dan Barber for closing remarks.

Operator 2: Thank you. I am not showing any further questions at this time. I would now like to turn it back over to Daniel Barber for closing remarks.

Operator: Thank you. I am not showing any further questions at this time. I would now like to turn it back over to Daniel Barber for closing remarks.

Speaker #8: Thank you, Victor. As I said earlier in the call, we are in our view ready to go. We're ready to conduct our studies. We're ready to build our awareness even further.

Daniel Barber: Thank you, Victor. As I said earlier in the call, we are in our view, ready to go. We're ready to conduct our studies. We're ready to build our awareness even further. If approved by the FDA, we're on track to launch Anaphylm. We look forward to updating you on our additional progress in the months to come. With that, thank you for joining us, and have a great day.

Dan Barber: Thank you, Victor. As I said earlier in the call, we are in our view, ready to go. We're ready to conduct our studies. We're ready to build our awareness even further. If approved by the FDA, we're on track to launch Anaphylm. We look forward to updating you on our additional progress in the months to come. With that, thank you for joining us, and have a great day.

Speaker #8: And if approved by the FDA, we're on track to launch Anafilm. And we look forward to updating you on our additional progress in the months to come.

Speaker #8: And with that, thank you for joining us. And have a great day.

Operator 2: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.