Aeon Biopharma, Inc. · AMEX:AEON
Aeon Biopharma — Priveterra Acquisition — SPAC Merger (February 2023)
41 slides from Aeon Biopharma's SPAC merger presentation, Feb 24, 2023
Slide 1: KOL Event: Botulinum Toxin and Migraine Prevention
KOL EVENT: Botulinum Toxin and Migraine Prevention February 24, 2023
Slide 2: Disclaimer
Disclaimer 2 About This Presentation This investor presentation (“Presentation”) does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed Business Combination or (ii) an offer to sell, a solicitation of an offer to buy,
Slide 3: Disclaimer (Cont'd)
Disclaimer (Cont’d) 3 Targets This Presentation contains certain long - term financial targets of the Company. Neither Priveterra’s nor the Company’s independent auditors have audited, studied, reviewed, compiled or performed any procedures with respect to the targets for the purpose of their inclus
Slide 4: Agenda
Agenda Migraine Overview and Current Treatment Landscape – Stewart J. Tepper, MD ABP - 450 Clinical Program in Migraine – Chad Oh, MD (Chief Medical Officer) Fireside Chat and Q&A Session – Moderated by Corey Davis (LifeSci Advisors) I Opening and Introduction – Marc Forth (President & Chief Executi
Slide 5: Speakers: Stewart J. Tepper, MD
5 Speakers Stewart J. Tepper, MD Stewart J . Tepper, MD is a Professor of Neurology at the Geisel School of Medicine at Dartmouth College in Hanover, New Hampshire . He is Director of the Dartmouth Headache Center in the Department of Neurology of Dartmouth - Hitchcock Medical Center . Dr . Tepper w
Slide 6: Speakers: Andrew M. Blumenfeld, MD
6 Speakers Andrew M. Blumenfeld, MD Andrew M . Blumenfeld, MD is Director of : The Los Angeles Headache Centre with offices in San Diego and Los Angeles . He is Board - certified in Neurology by the American Board of Psychiatry and Neurology and is also certified in Headache Medicine . Dr Blumenfeld
Slide 7: Advancing Novel Therapies with a Well-Established Neurotoxin
Source: 1. Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2021 7 Advancing Novel Therapies with a Well - Established Neurotoxin Management team with significant neurotoxin and biopharma experience Differentiated business model designed to deliver enhanced value to payors
Slide 8: Migraine Market is Large with Continued Need for Additional Therapies
Sources: 1. Bonafede, Study Summary: Costs Associated with Migraine in the US (2018) 8 Migraine Market is Large with Continued Need for Additional Therapies Patient Burden • Migraine is a complex neurological condition that affects ~ 40 million Americans every year , with the majority of sufferers b
Slide 9: Approximately 13.4M Patients Living with 6+ Headaches/Month in U.S.
Sources: 1 . 2017 US Census Projections 2. Burch, The Prevalence and Impact of Migraine and Severe Headache in the United States: Figures and Trends From Government Hea lth Studies (2018); 3. Lipton, Migraine in America Symptoms and Treatment (MAST) Study: Baseline Study Methods, Treatment Patterns,
Slide 10: Development Timeline Includes Multiple Clinical Near-Term Milestones
Chronic (>15 headache days AND >8 migraine days / month) Episodic (<15 headache days AND 6 - 14 migraine days / month) Asterisk in dicates phase is complete 10 Development Timeline Includes Multiple Clinical Near - Term Milestones Chronic Migraine Episodic Migraine Indication Current Phase ABP - 450
Slide 11: Migraine Overview and Current Treatment Landscape
Migraine Overview and Current Treatment Landscape Stewart J. Tepper, MD
Slide 12: Areas of Need in Neurotoxin Therapy for Migraine
Stewart J. Tepper , MD Areas of Need in Neurotoxin Therapy for Migraine - The Opportunities for Aeon Stewart J. Tepper, MD, FAHS Professor of Neurology Geisel School of Medicine at Dartmouth Hanover, New Hampshire, USA
Slide 13: Introduction
Stewart J. Tepper , MD Introduction • There are numerous areas of need in migraine prevention • Neurotoxins address many of these needs • There is an opportunity for new neurotoxins with new indications
Slide 14: Case
Stewart J. Tepper , MD Case • 27 year old woman with disabling high frequency episodic migraine, (EM) with 10 - 12 significant headache days per month • She says there are months that are worse and months where she is better, higher and lower frequencies of monthly headache days • For prevention she
Slide 15: The Artificiality of Episodic and Chronic Migraine Definitions
Stewart J. Tepper , MD The Artificiality of Episodic and Chronic Migraine Definitions
Slide 16: Chronic Migraine ICHD3 Criteria and New Proposed CM Criteria
Stewart J. Tepper , MD Chronic Migraine (CM), ICHD3 Criteria and New Proposed CM Criteria • Headache ≥15 days/month for >3 months • ≥5 previous migraine attacks (link to EM) • ≥8 days/month for >3 months: • Meet criteria for migraine • Believed by the patient to be migraine at onset and relieved by
Slide 17: The Roller Coaster of EM and CM
Stewart J. Tepper , MD The Roller Coaster of EM and CM Patient has some months with Chronic Migraine [CM] (headache ≥15 days per month) Patient has some months with High Frequency Episodic Migraine [HFEM] (headache 10 - 14 days per month) ICHD - 3. Cephalalgia 2013; 33(9) 629 – 808 . Serrano et al.
Slide 18: Problem #1: She is ineligible for Botox
Stewart J. Tepper , MD Problem #1: She is ineligible for Botox • The provider told her she is ineligible for Botox because it is only approved for CM, and she has EM as her diagnosis • In reality, she is probably yo - yoing up and down between EM and CM, but that does not help • Botox is indicated o
Slide 19: Solution for Problem #1
Stewart J. Tepper , MD Solution for Problem #1 • Aeon is studying ABP - 450, prabotulinumtoxinA , for both EM and CM in their randomized controlle d trial • This will offer an indication for prevention of all of migraine, both EM and CM • This will allow its use for this patient and many more, espec
Slide 20: Inadequate, Partial Response to Anti-CGRP Therapy Monoclonal Antibodies
Stewart J. Tepper , MD Inadequate , Partial Response to Anti - CGRP Therapy Monoclonal Antibodies
Slide 21: Problem #2
Stewart J. Tepper , MD Problem #2 • The patient was put on an anti - CGRP therapy monoclonal antibody (MAB) • These are approved for all migraine, EM and CM • But she only had a reduction of - 3 days, going from 11 headache days per month to 8, leaving her with two significant headache days per week
Slide 22: Solution
Stewart J. Tepper , MD Solution • Combination of neurotoxin + anti - CGRP therapy MABs is at least additive and can be synergistic • Hundreds of patients have been reported in large case series showing additional benefit from the combination, in which combining the two medication categories improve
Slide 23: The EM Problem
Stewart J. Tepper , MD The EM Problem
Slide 24: The EM Problem
Stewart J. Tepper , MD The EM Problem • The problem of migraine prevention for a disabled EM patient is significant • The prevalence of EM in the population is 12%; the prevalence of CM is 1 - 2%, so the numbers suggest a significant unmet need
Slide 25: Protocol Improvement
Stewart J. Tepper , MD Protocol Improvement
Slide 26: Less injections, better protocol
Stewart J. Tepper , MD Less injections, better protocol • My colleagues will describe the improved protocol for ABP - 450 • Suffice it to say, this should address the patient’s concern about 31 injections and side effects reported with Botox in the pivotal trials
Slide 27: Summary: Unmet Needs May Be Met with ABP-450
Stewart J. Tepper , MD Summary : Unmet Needs May Be Met with ABP - 450
Slide 28: Summary of Unmet Needs in Migraine Prevention
Stewart J. Tepper , MD Summary of Unmet Needs in Migraine Prevention • Patients need a neurotoxin migraine prevention with an indication for all of migraine, both EM and CM • The up and down frequency of migraine results in unpredictability and limits migraine preventive therapy availability • Patie
Slide 29: Thank you!
Stewart J. Tepper , MD Thank you!
Slide 30: The Benefits of a New Injection Paradigm
The Benefits of a New Injection Paradigm Andrew M. Blumenfeld, MD
Slide 31: Anterior / Lateral Injection Sites
Anterior / Lateral Injection Sites 31
Slide 32: Posterior Injection Sites
Posterior Injection Sites 32
Slide 33: Tolerability Parameters Across Botulinum Toxin Studies
Tolerability parameter (% of pts) Pooled PREEMPT studies [ 15 ] COMPEL [ 16 ] REPOSE [ 38 ] CM - PASS [ 51 ] ABP - 450 (EM) ABP - 450 (CM) DB OLE OL OL OL DB DB BoNT/A ( n = 687) PL ( n = 692) BoNT/A ( n = 1205) BoNT/A ( n = 716) BoNT/A ( n = 633) BoNT /A ( n = 1160) TEAEs 62.4** 51.7 58.3 60.9 – 41
Slide 34: ABP-450 Clinical Program in Migraine
ABP - 450 Clinical Program in Migraine Chad Oh, MD Chief Medical Officer
Slide 35: Phase 2 Study Design
• N = 765 • ~60 sites in US, Canada & Australia • Includes both EM & CM patients • # headache days and migraine days/month established during 4 - week baseline prior to randomization • 3 arms: 150 Units, 195 Units, PBO • 2 injection cycles, 3 months apart • 6 - month treatment duration • Novel injec
Slide 36: Independent Analysis of Phase 2 Episodic and Chronic Cohorts
36 Independent Analysis of Phase 2 Episodic and Chronic Cohorts Randomization and Stratified for Episodic Migraine and Chronic Migraine Episodic Migraine N=300 <15 headache days / month And 6 - 14 migraine days / month 150 U N=100 195 U N=100 Placebo N=100 Chronic Migraine N=465 ≥ 15 headache days /
Slide 37: Phase 2 Timelines by Cohort
Episodic Migraine Cohort Chronic Migraine Cohort First Patient Treated March 2021 April 2021 Completion of Enrollment December 2022 3Q 2023 Top line report (TLR) 2H 2023 2024 Estimated TLR for P3 BOTOX Episodic Migraine ( Abbvie ; NCT05028569) January 31, 2024 Phase 2 Timelines by Cohort 37
Slide 38: Endpoint Expectations for Phase 2 Episodic Migraine
BOTOX PREEMPT2 1 Phase 3 in chronic migraine • Baseline migraine days were 19.8 days • Change from baseline (CFB) for Botox and placebo was 45% and 33%, respectively Phase 2 assumptions: • Projected CFB of ABP - 450 and placebo is 45% and 33%, respectively • Treatment effect between placebo and acti
Slide 39: Conclusions and ABP-450 Competitive Profile
Conclusions and ABP - 450 Competitive Profile Migraine Indication Patient Population Low Switching Barriers Injection Paradigm Pricing Dynamics AEON will be the second botulinum toxin product in migraine prevention, the single largest toxin therapeutic indication for the market leader (45% of therap
Slide 40: Fireside Chat and Q&A
Fireside Chat and Q&A Moderated by: Corey Davis Managing Director LifeSci Advisors 40
Slide 41: Thank you
Thank you