Negative Points

• Aquestive Therapeutics Inc ( NASDAQ:AQST ) faces uncertainty regarding the FDA review timeline for the Anaphylm resubmission, with the base case being a six-month review, which could delay potential launch.

• The company recorded a one-time loss on extinguishment of debt of $11.7 million in Q2 2026, contributing to a net loss of $22.9 million for the quarter.

• SG&A expenses increased in Q2 2026 due to higher legal fees, severance costs, and personnel costs, partially offset by lower commercial spending.

• The company's cash position of $98.5 million may be insufficient to support a launch without additional funding, relying on $75 million from RTW and $20 million from Oaktree post-approval, which are subject to conditions.

• Aquestive Therapeutics Inc ( NASDAQ:AQST ) continues to face competition in the epinephrine market, and the need to convert patients from auto-injectors to Anaphylm may be challenging, as patients tend to refill rather than switch prescriptions.

Q & A Highlights

Q: Could you help frame how the recent PK and human factors study data potentially increases your conviction in the resubmission being very comprehensive? Can you give us updated thoughts on whether you think the FDA may use a shorter or accelerated timeframe to review the resubmission? A: Daniel Barber (President and CEO): We believe we have very convincingly and thoroughly answered the open questions the FDA put out. On the human factors side, the results are very clean. On the PK side, when self-administered, we saw no difference from clinician-administered. Even in the off-label arm the FDA requested, we saw encouraging pharmacodynamic data. Regarding the timeframe, our guidance remains a six-month review, but we are pressing the FDA in a supportive way to move faster given the thin package compared to the 10-month review they have already done. Dr. Matt Greenhawt (CMO) added that the data is reassuring, showing that even with off-target administration (top of tongue), there is still a clinically meaningful increase in heart rate and blood pressure, which is a great counseling point for families.

Q: We have often talked about the product profile differences that will be important for payer discussions, but in your prepared remarks, you mentioned some of the clinical differentiation factors. Curious if there are certain endpoints over others that you think are going to carry the most weight and how that portrays with the data that you have seen from Anaphylm so far. Then I wanted to ask for the Cmax data for the top of the tongue, the inaccurate usage, whether the FDA in advance of this had set a bar for what they were looking for. A: Daniel Barber (President and CEO): On the Cmax question, the FDA has pointed to two threshold marks in written communication and meetings: getting over 50 pg/mL and clearing 100 pg/mL, which we clearly do on the top of tongue. Positioning a product as simply "no needle" is not the path to success; the path is highlighting important clinical differentiation. Dr. Matt Greenhawt (CMO) explained that the differentiation is evident in the magnitude of effect and speed of onset. In his clinical experience, time is precious when giving epinephrine, and Anaphylm's rapid response within the critical 5-10 minute window is absolutely differentiating.

Q: Regarding 108, any learnings from the recently completed study in androgenic alopecia that gives you confidence that the effects of 108 are relevant to atopic derm and a broader slate of dermatological conditions? Also, can you speak to the rationale behind pursuing atopic derm first, and how this decision plays into your broader strategy with respect to the AdrenaVerse platform? A: Daniel Barber (President and CEO): Atopic derm is a well-worn path in dermatology and a good entry point for expanding into broader indications. While alopecia areata is still important, we want to get that first proof point through the gates. Dr. Matthew Davis (Chief Development Officer) added that in human trials of 108, they saw TSLP suppression and CCL3/CCL4 suppression. For atopic derm, itch is an IL-31, TSLP, and mast cell phenomenon. The preclinical program showed NF-?B modulation, which directly correlates with IL-31. They believe topical 108 will hit the areas that cause itch and could have a meaningful benefit.

Q: Going back to the human factor study. Maybe on the root cause of the failure. It seems like there was one open failure and two misplacements. Maybe any color you can add on what the root cause analysis concluded for each, and what residual risk justification goes into the submission. Then a second one, following up on 108. It felt also to us that this does actually seem to be quite an opportunity in atopic derm. One of the things that we were thinking through, though, was maybe more about dosing and long-term use, and maybe any color you could add about rebound erythema or tachyphylaxis with chronic dosing with epinephrine products in this disease. A: Daniel Barber (President and CEO): On the human factors data, everyone opened the pouch in the study; there were no failures to open. The one difficulty still successfully opened the pouch. The two misplacements weren't necessarily on top of the tongue or roof of the mouth; they just weren't completely in the sublingual cavity. Paired with the PK data, we're in a really good place. On 108 dosing, this is a local delivery system, not systemic. Dr. Matthew Davis (Chief Development Officer) explained that when topically applied, tipervefine has a super pharmacologic concentration on the skin, and carboxylesterase in interstitial fluid slowly breaks it down to epinephrine. This depot-like effect suggests the product may not even need to be dosed once a day, potentially allowing for extended-release dosing.

Q: Just one clarification, as you are on track for Q3 resubmission, can you comment, is this going to be a Class 1 or Class 2 resubmission? How does this affect the planned launch timeline, if at all? Secondly, I want to ask about something that your competitor, ARS Pharmaceuticals, has flagged previously that epinephrine patients tend to refill rather than return to the prescriber. Given this issue, how do you think about realistically the switchable pool by year one, say, and what's the mechanism that gets a patient to switch from existing auto-injector script? A: Melina Cioffi (SVP, Regulatory Affairs): There are two classifications: Class 1 (two-month review) and Class 2 (six-month review). It's at the agency's discretion, but given the succinct package with a focused scope on CRL items, it should be a streamlined review. Sherry Korczynski (Chief Commercial Officer) added that the market continues to grow at 6% year-over-year, and the allergist market continues to grow. A patient does need to see their allergist every year to get a prescription. The team will have a balanced and integrated approach across multiple channels to drive conversations with patients and allergists, leveraging the compelling switch story and clinical differentiation.

Q: I wanted to ask, first of all, about your ex-US plans for Anaphylm. If you could maybe give us a sense of how you are prioritizing the different territories and where you think from a regulatory standpoint, this product candidate might be most favorably received and what the underlying market dynamics are that would inform your prioritization of those territories. That would be very helpful. I also wanted to ask about, on a different front, how you are thinking about the potential long-term impact to Aquestive of the recent Cosette Pharmaceuticals transaction, and perhaps more importantly, the recently announced merger combination between Supernus and Indivior,

For the complete transcript of the earnings call, please refer to the full earnings call transcript .