Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — H.C. Wainwright 28th Annual Global Investment Conference 2026
28 slides from Aquestive Therapeutics's conference presentation, Sep 17, 2026
Slide 1: H.C. Wainwright 28th Annual Global Investment Conference
H.C. Wainwright 28th Annual Global Investment Conference September 14, 2026
Slide 2: Disclaimer
© 2026 Aquestive Therapeutics, Inc. Disclaimer 2 This presentation and the accompanying oral commentary have been prepared by Aquestive Therapeutics, Inc. (“Aquestive,” the “Company,” “we,” “our” or “us”) and contain “forward-looking statements” within the meaning of the Private Securities Litigatio
Slide 3: Advancing Medicines to Bring Meaningful Improvement to Patients' Lives
Advancing Medicines to Bring Meaningful Improvement to Patients’ Lives 31. Aquestive Therapeutics data on file. 6 FDA approvals with products available on six continents 2.5+ billion PharmFilm® doses shipped worldwide 100+ patents filed in the U.S. and worldwide 20+ years Since the company was found
Slide 4: Dedicated and Experienced Leadership Team
Dedicated and Experienced Leadership Team 4 Daniel Barber President, CEO & Director Matthew Greenhawt Chief Medical Officer Peter Boyd Chief People Officer Melina Cioffi SVP, Regulatory Affairs Sherry Korczynski Chief Commercial Officer Matthew Davis Chief Development Officer Ernie Toth Chief Financ
Slide 5: Diversified Pipeline Fuels Our Growth Plan
Diversified Pipeline Fuels Our Growth Plan 51. Aquestive Therapeutics data on file. 2. Potential annual revenue after anticipated launch in 2027. Anaphylm (dibutepinephrine) sublingual film (SEVERE ALLERGIES, ANAPHYLAXIS) Received CRL on January 30, 2026 – expect to resubmit in Q3 2026 >$1B1 Annual
Slide 6: Our Technologies
Our Technologies 6 PharmFilm® PharmFilm® is a unique and versatile technology for high-performance drug delivery. Aquestive scientists combine the customizable features of PharmFilm® with patented formulation and engineering processes to optimize the delivery of active pharmaceutical ingredients (AP
Slide 7: Lead Asset Anaphylm (dibutepinephrine) sublingual film
Lead Asset Anaphylm (dibutepinephrine) sublingual film1 7 1. ANAPHYLM (dibutepinephrine) sublingual film is an investigational product candidate that has not been approved by the U.S. Food and Drug Administration. Safety and efficacy have not been established. Statements regarding potential benefits
Slide 8: Clinically Differentiated Epinephrine Delivery
Clinically Differentiated Epinephrine Delivery 8 Anaphylm (dibutepinephrine) sublingual film Needle-Free Easy to Use Designed to Work Quickly1 Device-Free Easy to Carry First and only non-device based, orally delivered epinephrine product candidate 1. Aquestive Therapeutics data on file.
Slide 9: Anaphylm Regulatory Milestones
Anaphylm Regulatory Milestones 9 Q1 2027Q4 2026Q3 2026Q2 2026Q1 2026 NDA Resubmission Ex-US filing in Canada Ex-U.S. filing in European Union • Aquestive intends to request expedited review of the NDA submission, but expedited review cannot be guaranteed • Ex-US expansion is on track – filing in Can
Slide 10: Packaging and Labeling Modifications
Packaging and Labeling Modifications¹ Proposed pouch labeling tested in Original NDA Human Factors Study Proposed pouch labeling tested in Resubmission Human Factors Study and PK Study Self-Administration arm² 1. Illustrative of proposed labeling and instructions for use shown. Final approved labeli
Slide 11: Human factors validation study showed significant improvement in key areas highlighted by the FDA
Human factors validation study showed significant improvement in key areas highlighted by the FDA in the CRL Description1 Original NDA Human Factors Study (N=166) Resubmission Human Factors Study (N=105) Unable to open pouch (# of participants) 1 0 Had difficulty opening pouch (# of participants) 26
Slide 12: Self-administration pharmacodynamics were generally in line with clinician-administered results
Self-administration pharmacodynamics were generally in line with clinician- administered results¹ Systolic Blood Pressure² Diastolic Blood Pressure² Heart Rate² 1. Aquestive Therapeutics data on file. 2. Mean changes with 95% confidence intervals. 12
Slide 13: Top-of-tongue administration resulted in clinically meaningful pharmacodynamic response
Top-of-tongue administration resulted in clinically meaningful pharmacodynamic response despite lower PK exposure (single dose)¹ Systolic Blood Pressure² Diastolic Blood Pressure² Heart Rate² 1. Aquestive Therapeutics data on file. 2. Mean changes with 95% confidence intervals. 13
Slide 14: It's not just "the carry"…. Pharmacologic Performance
It’s not just “the carry”…. 14 Pharmacologic Performance1 ● Higher Cmax and faster Tmax ● Pharmacodynamic response observed within the first minute after administration ● High Emax* and fast TEmax†, peaking between 5-11 minutes ● Robust pharmacodynamic activity observed within minutes following admi
Slide 15: Launch Preparations for Anaphylm (dibutepinephrine) sublingual film
Launch Preparations for Anaphylm (dibutepinephrine) sublingual film 15
Slide 16: Anaphylaxis: A Large, Growing Market with Significant Unmet Need
16 Anaphylaxis: A Large, Growing Market with Significant Unmet Need 32-40 million people at chronic risk for severe systemic Type 1 reaction in the US1 1 in 10 adults; 1 in 13 children Direct cost of anaphylaxis is $1.2 billion2 52% of surveyed patients with prior anaphylaxis never received an epine
Slide 17: The epinephrine market continues to grow; could reach ~7.5M TRxs/~$2.03B by 2029
1. U.S. Epinephrine for Anaphylaxis Treatment Market Size, Share & Industry Analysis; Fortune Business Insights, Mar 23, 2026; https://www.fortunebusinessinsights.com/u-s-epinephrine-for-anaphylaxis- treatment-market-110494 2. Symphony Health Data through 12/31/2025, Metys National Projected Data, A
Slide 18: Leveraging What We Have Learned from Recent Branded Launches
18 Allergists are the gatekeepers – they must KNOW your product Clinical differentiation is BETTER than convenience (prescribers need to trust the product will work) Patients are the decision makers – they must WANT your product Reducing complexity for patients is a MUST Payers want to kno
Slide 19: Broad Scientific and Prescriber Engagement Builds Anaphylm Awareness
19 50 Conferences Attended & Planned 275+ Booth Engagements 610+ Prescriber interactions 14 Manuscripts drafted 10 Conference abstracts submitted Broad Scientific and Prescriber Engagement Builds Anaphylm Awareness¹ 1. Year-to-date information.
Slide 20: Rapid Relief When it Matters Most
Rapid Relief When it Matters Most1 1. Aquestive Therapeutics data on file, excluding T-max data results for Neffy®, which can be found in the prescribing information located in the FDA-approved product label. No head-to-head studies have been conducted comparing Anaphylm and Neffy®. 20 12 MINUTES 20
Slide 21: Sales Force Designed to Target Priority Epi Prescribers
21 Sales footprint captures the majority of prescribing opportunity while maximizing commercial efficiency Focused Deployment ~75 SALES REPRESENTATIVES AT LAUNCH Designed to maximize reach and return with a disciplined commercial footprint Engagement with priority allergists and pediatricians Concen
Slide 22: Patient Support Services to Simplify Anaphylm Access
22 A coordinated model to improve affordability and drive treatment initiation for patients Patient Support Services to Simplify Anaphylm Access COVERAGE NAVIGATION Benefit verification Prior authorization assistance Coverage navigation AFFORDABILITY SUPPORT Copay assistance program Financ
Slide 23: Challenges with Current Epinephrine Auto-Injectors (EAIs)
Challenges with Current Epinephrine Auto-Injectors (EAIs) 23 1. Golden DBK, et al. (2024). Ann Allergy Asthma Immunol, 132(2), 124–176. 2. Pouessel G, et al. (2025). Clin Exp Allergy, 55(1), 36–51. 3. Lieberman JA, et al. (2023). Ann Allergy Asthma Immunol, 131(2), 185–193.e10. 4. Wang J. (2024). J
Slide 24: 96% of survey respondents preferred Anaphylm in a hands-on epinephrine preference survey
96% of survey respondents preferred Anaphylm in a hands-on epinephrine preference survey¹,² 1. Aquestive Therapeutics data on file. 2. Survey results reflect stated respondent preferences under controlled survey conditions and should not be interpreted as evidence of actual prescribing, utilization,
Slide 25: Market access capabilities are in place, with payer insights informing the next phase
25 Market access capabilities are in place, with payer insights informing the next phase of engagement Proactive Payer Engagement Supports Post-Approval Access Readiness TEAM READY Account team fully onboarded EARLY DIALOGUE 10+ presentations completed with stakeholders to date INSIGHT GENERATION Pa
Slide 26: A Promising Pipeline: AQST-108 (epinephrine) Topical Gel
A Promising Pipeline: AQST-108 (epinephrine) Topical Gel 26
Slide 27: AQST-108 has the potential to harness the benefits of a topical gel with prodrug technology
27 AQST-108 has the potential to harness the benefits of a topical gel with prodrug technology1 Administration process • Topical gel applied to affected skin (epidermis) • AQST-108 penetrates to dermis layer and converts slowly over time • AQST-108 converts to via interstitial esterases • Localized
Slide 28: Thank You
28 Thank You
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