Slide 1: EPIPHAST II Trial Results Supplemental Materials
Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. September 2022 EPIPHAST II Trial Results Supplemental Materials 1
Slide 2: Forward Looking Statement
Advancing medicines. Solving problems. Improving lives. ® Forward Looking Statement This presentation includes 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: EPIPHAST II: Trial Results Key Takeaways
Advancing medicines. Solving problems. Improving lives. EPIPHAST II: Trial Results Key Takeaways 3 AQST-109 to EpiPen® 0.3mg (single dose) Confirmation of 12-minute median time to maximum concentration (Tmax) Faster observed median Tmax than either EpiPen® (22 minutes) or 0.3mg IM injection (45 minu
Slide 4: Symptoms of Anaphylactic Shock-System Involvement in Anaphylaxis
Advancing medicines. Solving problems. Improving lives. Symptoms of Anaphylactic Shock-System Involvement in Anaphylaxis *Potentially life-threatening symptoms. Simons FE. J Allergy Clin Immunol. 2009;124(4):625-636. Central nervous system • 10%-15% of episodes • Uneasiness, throbbing headache, dizz
Slide 5: Importance of Speed in Treating a Systemic Allergic Reaction
Advancing medicines. Solving problems. Improving lives. Importance of Speed in Treating a Systemic Allergic Reaction 5 10 15 20 25 30 Li ke lih oo d of U nf av or ab le O ut co m e R es ul tin g Fr om A na ph yl ax is Time (Minutes) Early treatment mitigates risk Delayed treatment increases the risk
Slide 6: Trial Design and Objectives
Advancing medicines. Solving problems. Improving lives. EPIPHAST II: Trial Design and Objectives • Healthy volunteers, randomized, open-label, 5-period trial • Designed to compare pharmacokinetics and pharmacodynamics of: – Single doses of AQST-109 to single doses of EpiPen® 0.3mg and epi 0.3mg IM i
Slide 7: EPIPHAST II: Topline Results
Advancing medicines. Solving problems. Improving lives. Treatment B as el in e A dj us te d E pi C m ax 15 (p g/ m L) 0 250 500 750 1000 1250 1500 1750 2000 IM 0.3 mg single (R1) EpiPen 0.3 mg single (R3) AQST-109 12 mg single (T1) EPIPHAST II: Topline Results Represents data from top-line results.
Slide 8: EPIPHAST II: Time to Maximum Concentration (Tmax)
Advancing medicines. Solving problems. Improving lives. Baseline Adjusted Epinephrine Tmax EPIPHAST II Treatment Ba se lin e Ad ju st ed E pi T m ax (m in ut es ) 0 15 30 45 60 75 90 IM 0.3 mg single (R1) EpiPen 0.3 mg single (R3) AQST-109 12 mg single (T1) EPIPHAST II: Time to Maximum Concentration
Slide 9: Pharmacodynamic (PD) Results
Advancing medicines. Solving problems. Improving lives. EPIPHAST II: Pharmacodynamic (PD) Results • AQST‐109 demonstrates a pharmacodynamic response for Systolic Blood Pressure (SBP) and Pulse consistent with that of EpiPen® • Pronounced early peak in PD implies rapid and robust onset of therapeutic
Slide 10: Repeat Dose Topline Results
Advancing medicines. Solving problems. Improving lives. EPIPHAST II: Repeat Dose Topline Results Represents data from top-line results. Figure derived from arithmetic means. Description AQST-109 Repeat Dose 0.3mg IM Repeat Dose # Subjects/#Dosings 23/24 23/24 Cmax (pg/ml) (ISCV%) 2134 755 AUC 0-t (h
Slide 11: EPIPHAST II: Repeat Dosing Post-Hoc Analysis
Property of Aquestive Therapeutics, Inc. Do not distribute.11 EPIPHAST II: Repeat Dosing Post-Hoc Analysis • Subjects with high Cmax levels were significantly above therapeutic thresholds and mean Cmax levels of the Reference Listed Drug (RLD) at time of second dosing • These subjects represent pati
Slide 12: Safety and Tolerability
Advancing medicines. Solving problems. Improving lives. EPIPHAST II: Safety and Tolerability • AQST-109’s single dose safety profile had a lower incidence of palpitations than that of the 0.3 mg EpiPen® • AQST-109’s repeat dose safety profile had a similar incidence of palpitations to that of the si
Slide 13: Trial Summary
Advancing medicines. Solving problems. Improving lives. EPIPHAST II: Trial Summary AQST-109 compared to EpiPen® 0.3mg (single dose) Confirmation of 12-minute median time to maximum concentration (Tmax) Faster observed median Tmax than either EpiPen (22 minutes) or 0.3mg IM injection (45 minutes)
Slide 14: Q & A Session
Advancing medicines. Solving problems. Improving lives. Q & A Session