Slide 1: Anaphylm Human Factors and Clinical Study Supplemental Materials
1 September 2024 Advancing medicines. Solving problems Advancing medicines. Solving problems. Improving lives. Anaphylm Human Factors and Clinical Study Supplemental Materials August 10, 2026
Slide 2: Forward-Looking Statements and Data Limitations
© 2026 Aquestive Therapeutics, Inc. 2 Forward-Looking Statements and Data Limitations This presentation contains 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,
Slide 3: Background
3 Background • Aquestive modified its packaging, labeling, and instructions for use for Anaphylm (dibutepinephrine) sublingual film in response to a Complete Response Letter received from the United States Food and Drug Administration (FDA) in January 2026. • After completing a Type A meeting with t
Slide 4: Packaging and labeling modifications simplified opening and added an illustration
4 Packaging and labeling modifications included simplifying the opening process and adding an illustration to the pouch labeling¹ Proposed pouch labeling tested in Original NDA Human Factors Study Proposed pouch labeling tested in Resubmission Human Factors Study and PK Study Self-Administration arm
Slide 5: Human Factors Results
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Slide 6: Human factors studies
6 Human factors studies • Aquestive conducted a human factors validation study in 105 untrained participants. Study cohorts included experienced and naïve adults and pediatrics, as well as bystanders, EMTs, and school nurses. • Observations were tracked for a variety of factors including ability to
Slide 7: Human factors validation study showed significant improvement in key areas highlighted by the FDA
7 Human factors validation study showed significant improvement in key areas highlighted by the FDA in the CRL Description2 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)
Slide 8: Self-administration arm showed completion of observed human factors tasks as expected
8 Self-administration arm showed completion of observed human factors tasks as expected 1. Excerpts from the clinical pharmacology section from FDA Complete Response Letter received on January 30, 2026. 2. Aquestive Therapeutics, Inc. Data on File. Self Administration Task2 Expected Response Complet
Slide 9: Topline Clinical Study Results
Topline Clinical Study Results
Slide 10: Pharmacokinetic study evaluated self-administration and purposely incorrect top-of-tongue placement
10 Pharmacokinetic (PK) study evaluated self-administration and purposely incorrect top-of-tongue placement • Aquestive conducted a PK study in healthy subjects comparing self- administration to clinician-administered using the improved instructions for use. Both manual IM and film were administered
Slide 11: Self-administered PK is comparable to clinician-administered
11 Self-administered PK is comparable to clinician-administered ¹ HCP-Admin (N=48) Self-Admin (N=24) Manual IM (N=48) Geometric mean Cmax* (%CV) 357.6 (130.2) 391.7 (136.8) 334.5 (66.8) Median Tmax 12 12 45 *Baseline-unadjusted epinephrine concentrations reported in pg/mL 1. Aquestive Therapeutics,
Slide 12: Self-administration pharmacodynamics were generally in line with clinician-administered results
12 Self-administration pharmacodynamics were generally in line with clinician-administered results¹ Systolic Blood Pressure² Diastolic Blood Pressure² Heart Rate² 1. Aquestive Therapeutics, Inc. Data on File. 2. Mean changes with 95% confidence intervals.
Slide 13: Purposeful misplacement on top-of-tongue resulted in Geometric mean Cmax exceeding 100 pg/mL
13 Purposeful misplacement on top-of-tongue resulted in Geometric mean Cmax exceeding 100 pg/mL (single dose)¹ Top of Tongue (N=24) Manual IM (N=48) Geometric mean Cmax* (%CV) 112.7 (63.8) 334.5 (66.8) Median Tmax 35 45 *Baseline-unadjusted epinephrine concentrations reported in pg/mL 1. Aquestive T
Slide 14: Top-of-tongue administration resulted in clinically meaningful pharmacodynamic response despite lower PK exposure
14 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, Inc. Data on File. 2. Mean changes with 95% confidence intervals.