Slide 1: AQST-109: Topline Results from Phase 1 PK Study (Study 210010)
© 2021 Aquestive Therapeutics, Inc. All rights reserved. Advancing medicines. Solving problems. Improving lives. Anaphylaxis and Epinephrine AQST-109: Topline Results from Phase 1 PK Study (Study 210010) October 25, 2021
Slide 2: Forward Looking Statement
2 Forward Looking Statement Certain statements in this presentation include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those
Slide 3: Executive Summary
3 Executive Summary • Successful development of a sublingual epinephrine product relies on pharmacokinetic (PK) and pharmacodynamic (PD) comparability to existing epinephrine injection products • AQST-109 has delivered promising results from a First in Human PK/PD study in healthy volunteers o Media
Slide 4: AQST-109: Study 210010 (First in Human) Overview
4 AQST-109: Study 210010* (First in Human) Overview Cohort 1 0.6 mg/mL SL drops Single-ascending dose (SAD) N=up to 6 per cohort Cohort 2 1.2 mg/mL SL drops Cohort 3 3 mg SL film (formulation 1) Cohort 4-7 (1 per formulation) 4 formulations of SL film Dose escalation 6 mg, 12 mg, 18 mg, 24 mg (9 mg
Slide 5: AQST-109: Absorption and Conversion
5 AQST-109: Absorption and Conversion Represents data from top-line results. Figure derived from arithmetic means. Description Form 1 12 mg Form 2 12 mg Form 3 12 mg Form 4 12 mg Cmax (pg/ml) 552 762 164 307 AUC 0-t (hr*pg/ml) 634 603 329 303 Tmax (min) 15 15 20 10 Tmax Range (min) 15-25 10-35 20-50
Slide 6: AQST-109: Tmax Range Comparison
6 AQST-109: Tmax Range Comparison AQST-109 and Autoinjector Tmax Values • Tmax (or time to maximum concentration) is a critical parameter for rescue medications • The highest observed Tmax values for AQST-109 at 12 mg were below the highest Tmax values for autoinjectors • The median Tmax values for
Slide 7: AQST-109: Pharmacodynamic (PD) Results Consistent with Observed EpiPen Responses
7 AQST-109: Pharmacodynamic (PD) Results Consistent with Observed EpiPen Responses Represents data from top-line results. EpiPen data overlay is from Study 160445. SBP=Systolic Blood Pressure • Literature indicates that subjects should see a change in systolic blood pressure over time after the admi
Slide 8: Epinephrine Autoinjector Safety History
8 Epinephrine Autoinjector Safety History Epinephrine delivered by autoinjectors (EpiPen, Auvi-Q) have affirmed a well-established AE profile Auvi-Q Doses = 67 EpiPen Doses = 135 N (%) N (%) General and Admin. Site Conditions 34 (50.7) 79 (58.5) Nervous System Disorders 12 (17.9) 23 (17) CV 2 (3) 3
Slide 9: AQST-109: Adverse Events Following Dose
9 AQST-109: Adverse Events Following 12 mg Dose The treatments have been generally well-tolerated. Most AEs were of mild severity and there have been no serious* adverse events. Formulation 1 n=6 Formulation 2 n=8 Formulation 3 n=6 Formulation 4 n=7 Mild Moderate Mild Moderate Mild Moderate Mild Mod
Slide 10: What Comes Next: Adaptive Design Study for AQST-109
Part 3 10 What Comes Next: Adaptive Design Study for AQST-109 • Preferred Formulation/ Dose from 010 Study • 6 Formulation/Dose Optimizations • 0.5 mg IM injection • Test • Test (Replicate) • 0.3 mg IM inj • 0.3 mg IM inj (replicate) • Repeat Dose • Dosing Conditions • Administration Change* Part 2
Slide 11: PharmFilm Platform Projecting Robust Stability
11 PharmFilm® Platform Projecting Robust Stability Environmental Stability • Light resistant • Water resistant • Withstands extreme cold conditions • Exploring high temperature excursions Chemical Stability • > 2 years room temperature • > 6 months accelerated conditions
Slide 12: Patent Applications Extending into 2042
12 Patent Applications Extending into 2042 Title Patent Status ENHANCED DELIVERY EPINEPHRINE COMPOSITIONS • 1 US patent application allowed • 8 Foreign applications • Priority date: May 5, 2016 • Possible patent term to 2037 ENHANCED DELIVERY EPINEPHRINE AND PRODRUG COMPOSITIONS • 2 US applications