Aquestive Therapeutics, Inc. · NASDAQ:AQST

Aquestive Therapeutics — Investor Presentation (October 2021)

12 slides from Aquestive Therapeutics's investor presentation, Oct 25, 2021

  1. Slide 1: AQST-109: Topline Results from Phase 1 PK Study (Study 210010)

    Anaphylaxis and Epinephrine AQST-109: Topline Results from Phase 1 PK Study (Study 210010) October 25, 2021 Advancing medicines. Solving problems. © 2021 Aquestive Therapeutics, Inc. All rights reserved. Improving lives.

  2. Slide 2: Forward Looking Statement

    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 te

  3. Slide 3: Executive Summary

    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 Median

  4. Slide 4: Study 210010 (First in Human) Overview

    AQST-109: Study 210010* (First in Human) Overview Aquestive Therapeutics recently completed Study 210010, a first in human study that evaluated four film formulations at multiple dosage strengths. Study 210010 (“010 Study”) Single-ascending dose (SAD) N=up to 6 per cohort • Single-ascending dose stu

  5. Slide 5: Absorption and Conversion

    AQST-109: Absorption and Conversion The results from Study 210010 demonstrate that AQST-109 is rapidly absorbed and converted into epinephrine. Baseline-Corrected Mean Epinephrine Concentration over Time Following Administration of AQST-109 12 mg 1000 Form 1 Form 2 800 Form 3 Form 1 Form 2 Form 3 Fo

  6. Slide 6: Tmax Range Comparison

    AQST-109: Tmax Range Comparison AQST-109 and Autoinjector Tmax Values Median Epinephrine Tmax with bars for Minimum and Maximum • Tmax (or time to maximum concentration) is Auvi-Q* a critical parameter for rescue medications EpiPen^ • The highest observed Tmax values for EpiPen* AQST-109 at 12 mg we

  7. Slide 7: Pharmacodynamic (PD) Results Consistent with Observed EpiPen Responses

    AQST-109: Pharmacodynamic (PD) Results Consistent with Observed EpiPen Responses Mean Change from Baseline Systolic Blood Pressure over Time 20 12 mg AQST-109 Form 1 12 mg AQST-109 Form 2 • Literature indicates that subjects should see a 15 0.3 mg IM EpiPen change in systolic blood pressure over tim

  8. Slide 8: Epinephrine Autoinjector Safety History

    Epinephrine Autoinjector Safety History Epinephrine delivered by autoinjectors (EpiPen, Auvi-Q) have affirmed a well-established AE profile Auvi-Q EpiPen Doses = 67 Doses = 135 N (%) N (%) General and Admin. Site 34 (50.7) 79 (58.5) Conditions Nervous System 12 (17.9) 23 (17) Disorders CV 2 (3) 3 (2

  9. Slide 9: Adverse Events Following 12 mg Dose

    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 Formulation 2 Formulation 3 Formulation 4 n=6 n=8 n=6 n=7 Mild Moderate Mild Moderate Mild Moderate Mild Moder

  10. Slide 10: What Comes Next: Adaptive Design Study for AQST-109

    What Comes Next: Adaptive Design Study for AQST-109 Part Part Part 1 Read Out 2 Read Out 3 Optimal Test Prep for Formulation/Dose Pivotal trial • Preferred Formulation/ • Test • Repeat Dose Dose from 010 Study • Test (Replicate) • Dosing Conditions • 6 Formulation/Dose • 0.3 mg IM inj • Administrati

  11. Slide 11: PharmFilm Platform Projecting Robust Stability

    PharmFilm® Platform Projecting Robust Stability Chemical Stability • > 2 years room temperature • > 6 months accelerated conditions Environmental Stability • Light resistant • Water resistant • Withstands extreme cold conditions • Exploring high temperature excursions 11

  12. Slide 12: Patent Applications Extending into 2042

    Patent Applications Extending into 2042 Title Patent Status • 1 US patent application allowed • 8 Foreign applications ENHANCED DELIVERY EPINEPHRINE COMPOSITIONS • Priority date: May 5, 2016 • Possible patent term to 2037 • 2 US applications ENHANCED DELIVERY EPINEPHRINE AND PRODRUG • 8 Foreign appl

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