Slide 1: Phase 2 Topline Results Preventive Treatment of Episodic Migraine
Phase 2 Topline Results Preventive Treatment of Episodic Migraine October 2023 ABP - 450 ( prabotulinumtoxinA)
Slide 2: Forward Looking Statements
2 Forward Looking Statements Certain statements in this presentations may be considered forward - looking statements . Forward - looking statements generally relate to future events or AEON’s future financial or operating performance . For example, statements regarding continued listing on the New Y
Slide 3: Phase 2 Data in Episodic Migraine Provides Confidence to Move to Phase 3
3 Primary Endpoint Mean reduction in monthly migraine days (MMD) of 4.8 days ( 150U) and 5.0 days (195U) was numerically superior to placebo (4.2 days) at weeks 21 - 24, but did not meet statistical significance Phase 2 Data in Episodic Migraine Provides Confidence to Move to Phase 3 Key Secondary E
Slide 4: Addressable Patient Population ~3x Higher with Episodic Indication
4 Addressable Patient Population ~3x Higher with Episodic Indication 1. Prevention of chronic migraine is currently approved indication for Botox 2. No botulinum toxin is approved for prevention of episodic migraine 1.6M Total Addressable Patients 260M People 2020 US 18+ Population 40M Patients (15%
Slide 5: Overview of Phase 2 Study in Episodic and Chronic Migraine
5 Overview of Phase 2 Study in Episodic and Chronic Migraine 1 Dodick , et. al.; OnabotulinumtoxinA for Treatment of Chronic Migraine; Headache (2010); volume 50(6):919 - 1102 • N = 765 • ~60 sites in US, Canada & Australia • Includes both EM & CM patients • # headache days and migraine days/month e
Slide 6: Phase 2 Program Stratified for Episodic and Chronic Migraine
6 Phase 2 Program Stratified for Episodic and Chronic Migraine Headache Day is defined as: Migraine Day or Non - Migraine Headache Day Migraine Day is defined as: • At least 4 continuous hours of headache over the course of 1 Calendar Day per ICHD - 3 Criteria: o Migraine without aura o Migraine wit
Slide 7: Phase 2 Episodic Migraine: Subject Disposition
7 Phase 2 Episodic Migraine: Subject Disposition Disposition Analysis Placebo n (%) ABP - 450 150 units n (%) ABP - 450 195 units n (%) Total n (%) Randomized 98 99 108 305 Safety Analysis Set 97 (99.0) 99 (100) 109 (101) 305 (100) Full Analysis Set ( Fas *) 98 (100) 99 (100) 108 (100) 305 (100) Stu
Slide 8: Demographics and Baseline Characteristics
8 Demographics and Baseline Characteristics Headache Day is defined as: Migraine Day or Non - Migraine Headache Day Migraine Day is defined as: • At least 4 continuous hours of headache over the course of 1 Calendar Day per ICHD - 3 Criteria: o Migraine without aura o Migraine with aura o Probable m
Slide 9: Primary Endpoint: Change in Monthly Migraine Days (MMD) (Weeks 21-24)
9 Primary Endpoint: Change in Monthly Migraine Days (MMD) (Weeks 21 - 24) 1 See slide 16 - 4.2 (44.7%) - 4.8 (48.5%) - 5.0 (56.2%) - 0.6 - 0.8 -6 -5 -4 -3 -2 -1 0 Placebo (n=90) 150 U (n=92) 195 U (n=96) Mean Change From Baseline MMD LS Mean Diff (vs. Pl) p = 0. 2844 ( 150 U vs. Placebo) p=0. 1711 (
Slide 10: Secondary Endpoint: MMD Responder Rates Statistically Significant
10 Secondary Endpoint: MMD Responder Rates Statistically Significant * Statistically significant 52.1 58.9 69.0 0 10 20 30 40 50 60 70 80 Placebo (n=90) 150 U (n=92) 195 U (n=96) Rate (%) p=0. 2459 (150 U vs. p lacebo) p=0. 0132 (195 U vs. p lacebo) 22.5 37.0 33.8 0 10 20 30 40 50 60 70 80 Placebo (
Slide 11: Secondary Endpoint: Change in Monthly Headache Days (MHD) (Weeks 21-24)
11 Secondary Endpoint: Change in Monthly Headache Days (MHD) (Weeks 21 - 24) - 4.7 (43.9%) - 5.1 (47.2%) - 5.7 (55.8%) - 0.4 - 1 .0 -6 -5 -4 -3 -2 -1 0 Placebo (n=90) 150 U (n=92) 195 U (n=96) Mean Change From Baseline MHD LS Mean Diff (vs. Pl) p = 0. 5118 ( 150 U vs. Placebo) p=0. 1182 ( 195 U vs.
Slide 12: Change in Migraine Days (MMD) Over Time Shows Evidence of Dose Response
12 Change in Migraine Days (MMD) Over Time Shows Evidence of Dose Response 2 nd dose cycle administered at week 12 -6.0 -5.0 -4.0 -3.0 -2.0 -1.0 0.0 0 4 8 12 16 20 24 Placebo 195 U P=0.1315 P=0.1496 -6.0 -5.0 -4.0 -3.0 -2.0 -1.0 0.0 0 4 8 12 16 20 24 Placebo 150 U p=0.0602 p=0.3037 • Lower 150U dose
Slide 13: Change in Headache Days (MHD) Over Time Shows Evidence of Dose Response
13 Change in Headache Days (MHD) Over Time Shows Evidence of Dose Response -7.0 -6.0 -5.0 -4.0 -3.0 -2.0 -1.0 0.0 0 4 8 12 16 20 24 Placebo 195 U P=0.1182 P=0.0513 -7.0 -6.0 -5.0 -4.0 -3.0 -2.0 -1.0 0.0 0 4 8 12 16 20 24 Placebo 150 U p=0.0740 p=0.5118 2 nd dose cycle administered at week 12
Slide 14: MMD Responder Rates Over Time Show Evidence of Dose Response
14 MMD Responder Rates Over Time Show Evidence of Dose Response Responder Rate (≥50%) Responder Rate (≥75%) • From 5 - weeks onward, >30% patients on 195U demonstrated > 75% reduction in monthly migraine days
Slide 15: Exploratory Endpoint: Patient Global Impression of Severity (PGI-S) was Statistically Significant
15 Exploratory Endpoint: Patient Global Impression of Severity (PGI - S) was Statistically Significant * Statistically significant - 0.6 - 0.9 - 1 - 0.3 - 0.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 Placebo (n=90) 150 U (n=92) 195 U (n=96) Mean PGI - S LS Mean Diff (vs. Pl) p = 0. 0436 ( 150 U vs. p lacebo) p
Slide 16: Phase 3 Results of Approved CGRP Therapies for Episodic Migraine
16 Brand Generic Trial Duration Dose Primary endpoint N Change (days) Diff. from PBO p - value Aimovig erenumab STRIVE 24 wks 70 mg SC QM MMD (change from baseline to months 4 - 6) 312 - 3.2 - 1.4 <0.001 140 mg SC QM 318 - 3.7 - 1.9 <0.001 Placebo 316 - 1.8 — — ARISE 12 wks 70 mg SC QM MMD (change f
Slide 17: ABP-450 Has a Favorable Safety Profile
17 ABP - 450 Has a Favorable Safety Profile AE Summary Placebo (N=97) Number of patients (% of patients) ABP - 450 150 Units (N=99) Number of patients (% of patients) ABP - 450 195 Units (N=109) Number of patients (% of patients) Patients with Treatment - emergent Adverse Event ( TEAE ) 57 (58.8) 54
Slide 18: Efficacy Results from Phase 2 with ABP-450 in Episodic Migraine
18 Efficacy Results from Phase 2 with ABP - 450 in Episodic Migraine Primary Endpoint - mean change from baseline in monthly migraine days (MMD) at weeks 21 - 24 Key Secondary and Exploratory Endpoint – Statistically significant • Treatment effect (vs. placebo): – 4.2 days placebo – 4.8 days for 150
Slide 19: Actual Results vs. Simulated Sample Size
19 Actual Results vs. Simulated Sample Size Endpoints Actual Phase 2 Data Simulated Sample Size* 150U vs. Pbo (n: 92 vs. 90) 195U vs. Pbo (n: 96 vs. 90) 195U vs. Pbo (n: 200 vs. 200) 195U vs. Pbo (n: 400 vs. 400) Primary MMD at weeks 21 - 24 - 0.6 (p=0.2844) - 0.8 (p=0.1711) p=0.0409 p=0.0039 Post -
Slide 20: Next Steps and Upcoming Events
20 Next Steps and Upcoming Events Phase 2 in Chronic Migraine Considerations for Phase 3 in Episodic Migraine Enrollment now ~430 patients and expect to complete enrollment of 465 patients in Q4 Top - line results expected in 2H 2024 Differences from Phase 2 in episodic migraine: – Higher number of
Slide 21: Thank You
Thank You