Aeon Biopharma, Inc. · AMEX:AEON
Aeon Biopharma — Investor Presentation (October 2023)
34 slides from Aeon Biopharma's investor presentation, Oct 19, 2023
Slide 1: Corporate Presentation October 2023
Corporate Presentation October 2023
Slide 2: Forward Looking Statements
2 Forward Looking Statements This presentation includes forward - looking statements . All statements other than statements of historical facts contained in this presentation, including statements concerning possible or assumed future actions, business strategies, events or results of operations, an
Slide 3: Investment Highlights
3 Investment Highlights Botulinum toxin has demonstrated utility across dozens of published uses expected to be accessible to ABP - 450; accelerated and simplified commercialization timeline due to existing aesthetic BLA (separately held by Evolus) and manufacturing site approved by FDA, EMA and Hea
Slide 4: Leadership Team with Highly Relevant Industry Experience and Track Record of Success
4 Leadership Team with Highly Relevant Industry Experience and Track Record of Success Experienced Management Team Marc Forth Chad Oh, MD Chief Executive Officer Chief Medical Officer • 25+ years of Biopharma experience • Former US Business Lead for BOTOX ® Therapeutic • 16 years at Allergan dedicat
Slide 5: Botulinum Toxin: The Ultimate Platform Product
5 Botulinum Toxin: The Ultimate Platform Product
Slide 6: Global Therapeutic Toxin Landscape
6 Global Therapeutic Toxin Landscape AbbVie Inc. Merz Pharma Ipsen Group Molecular Size 900 kDa 900 kDa 150 kDa ~400 kDa 150 kDa Approved Indications 1. Blepharospasm 2. Strabismus 3. Cervical Dystonia 4. Hyperhidrosis 5. Spasticity 6. Chronic Migraine 7. Overactive Bladder 8. Neurogenic Detrusor Ov
Slide 7: ABP-450 Indications: Pipeline in a Product
7 Indication Current Phase 2020 2021 2022 2023 2024 Recent/Upcoming Milestones 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H ABP - 450 Episodic Migraine 1 Phase 2 ongoing x IND accepted Oct 2020 x First patient treated Mar 2021 x Enrollment completed Dec 2022 • P2 data - Fall 2023 Chronic Migraine 2 x IND accepted
Slide 8: Global Therapeutic Toxin Market – 9.9% Projected Growth Through 2027
8 Global Therapeutic Toxin Market – 9.9% Projected Growth Through 2027 • Current indications: Organic growth in current indications driven primarily by continued investment in disease awareness and growing patient populations • New indications: Development in therapeutic specialties that do not curr
Slide 9: Model Allows Reimbursement Based Solely on Therapeutic Pricing
9 No competitive product has therapeutic indications under separate BLA Model Allows Reimbursement Based Solely on Therapeutic Pricing *Average selling price Value to Physician Consistent, predictable reimbursement Value to Payor Potential to offer financial incentives • Original BLA expected to all
Slide 10: Migraine (episodic and chronic prophylaxis)
(episodic and chronic prophylaxis) Migraine
Slide 11: Migraine Market Resurgence From New Players is Benefitting Toxins
11 Migraine Market Resurgence From New Players is Benefitting Toxins New CGRPs are rapidly expanding the market driven by new product launches and promotional investment Migraine affects ~40M people in the United States & ~1B people worldwide every year, making it the third most prevalent illness in
Slide 12: Botox Still Showing Impressive YoY Growth Despite New CGRPs
12 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Normalized Botox 560,178 591,747 596,955 603,957 571,818 562,773 617,901 638,988 656,238 709,350 728,967 733,767 755,091 777,729 797,475 769,050 CGRPs 252,687 365,078 46
Slide 13: Addressable Patient Population ~3x Higher with Episodic Indication
13 Addressable Patient Population ~3x Higher with Episodic Indication 1.6M Total Addressable Patients 260M People Estimated US 18+ Population 40M Patients (15%) Estimated Migraine and severe HA Patients 9.4M Patients (24%) Episodic Migraine (6 - 14 HA/month) 4.0M Patients (10%) Chronic Migraine (15+
Slide 14: ABP-450 Phase 2 Migraine Study Design
14 • 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 in
Slide 15: Independent Analysis of Phase 2 Episodic and Chronic Cohorts
15 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= 99 195 U N=108 Placebo N= 98 Chronic Migraine N=~465 ≥ 15 headache days
Slide 16: Smart Injection Paradigm Targeting Nerves - Differentiation from Botox
16 26 injection sites* (195 Units) in P2 migraine protocol focused on specific nerves vs. 39 with Botox (195 units) targeting muscles Smart Injection Paradigm Targeting Nerves - Differentiation from Botox *22 injection sites in low dose (150 Units)
Slide 17: Phase 3 Trials for CGRPs in Episodic Migraine
17 Phase 3 Trials for CGRPs in Episodic Migraine Not intended for cross - trial comparisons; Sources: package inserts; Neurol Ther (2021) 10:469 – 497 Brand Generic Company Trial Duration Dose Primary Endpoint N Change (days) Difference from placebo p - value Aimovig erenumab STRIVE 24 Weeks 70 mg S
Slide 18: Tolerability Comparison of ABP-450 and Botox Studies
18 Tolerability parameter (% of pts) Pooled PREEMPT studies 1 COMPEL 2 REPOSE 3 CM - PASS 4 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 – 41.2 Serious TEAEs 4
Slide 19: Gastroparesis
Do AEON BIOPHARMA Gastroparesis
Slide 20: Gastroparesis Opportunity for ABP-450
20 Gastroparesis Opportunity for ABP - 450 • 2019 FDA Guidance for Industry 1 • Since a well - defined and reliable patient reported outcome (PRO) is not yet available, FDA recommends that the core signs and symptoms be included as endpoints. • Anticipate initiating a Phase 2a study in 2024 • Our pr
Slide 21: Opportunity for a Targeted Treatment for Gastroparesis
21 Provides an Opportunity for a Targeted Treatment for Gastroparesis Injections in the Pylorus and Pyloric Sphincter Region Sclerotherapy needle Esophagogastroduodenoscopy Plan to administer injections of ABP - 450 using a standard sclerotherapy needle in the pylorus and pyloric sphincter region Es
Slide 22: Posttraumatic Stress Disorder (PTSD)
Posttraumatic Stress Disorder (PTSD)
Slide 23: Posttraumatic Stress Disorder (PTSD)
23 Posttraumatic Stress Disorder (PTSD) • PTSD is well defined with broad disease awareness • A psychiatric disorder that may occur in people who experience or witness a traumatic event or events • Categories of symptoms include intrusion (involuntary memories), avoidance, alterations in cognition a
Slide 24: Posttraumatic Stress Disorder Associated with the Stellate Ganglion
24 Posttraumatic Stress Disorder Associated with the Stellate Ganglion Source: Image Left: Rae Olmsted KL, Bartoszek M, Mulvaney S, et al. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stre ss Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020;77(2):130 – 138. doi:1
Slide 25: ABP-450 Pre-Clinical PTSD Study
25 Stellate ganglion (sympathetic) block using ultrasound guidance • Establish safety and preliminary efficacy signal • Rats placed in supine position under anesthesia • Administer approximately 10 - 20 µl of active, following standard protocols • Observe for 1 - 2 weeks after the injection • Monito
Slide 26: Cervical Dystonia
Do AEON BIOPHARMA Cervical Dystonia
Slide 27: Cervical Dystonia Opportunity for ABP-450
27 Cervical Dystonia Opportunity for ABP - 450 • Potential for efficient development • Potential to allow participation in segment of on - label movement disorders • Potential to leverage into a broader muscle spasticity indication and label with a focused clinical program Important Indication for M
Slide 28: Cervical Dystonia Phase 2 Study Design
28 Open Label Extension Proposed to Occur in Parallel with Phase 3 Trial Cervical Dystonia Phase 2 Study Design - Dose Ranging • First patient dosed April 2021 • Phase 2 top line data reported in September 2022 Randomized Double - Blinded Placebo - Controlled Study 20 weeks Randomized R 1 - week bas
Slide 29: Phase 2 Data Conclusions
29 Phase 2 Data Conclusions • Phase 2 trial met primary and other key endpoints, supporting the safety and efficacy of ABP - 450 in reducing signs and symptoms associated with CD. • ABP - 450 demonstrated adverse event rates similar to, or lower than, other botulinum toxin products for the treatment
Slide 30: Financial Overview
Do AEON BIOPHARMA Financial Overview
Slide 31: Financial Overview
31 Financial Overview Sufficient capital to fund operations beyond topline data from ongoing Phase 2 study of ABP - 450 for episodic migraine in Fall 2023 $0 D ebt 27.4M Basic Shares Outstanding $25M Cash at Close 1 14.48M Warrants 2 19.45M Total Potential Earnout Shares 1. Proforma as of 7 - 24 - 2
Slide 32: ABP-450 Clinical and Regulatory Timeline and Earnout Structure
32 ABP - 450 – Clinical and Regulatory Timeline 2025 2H 1H 2026 2H 1H 2027 2H 1H 2028 2H 1H 2029 2H 1H Earnout Deadline Chronic Migraines Episodic Migraines Cervical Dystonia 14.45M 5 M 2M shares - upon first patient dosed in Phase 3 study in the first to occur between CM or EM prior to 06/30/25 202
Slide 33: Investment Highlights
33 Investment Highlights Botulinum toxin has demonstrated utility across dozens of published uses expected to be accessible to ABP - 450; accelerated and simplified commercialization timeline due to existing aesthetic BLA (separately held by Evolus) and manufacturing site approved by FDA, EMA and He
Slide 34: Thank you
Thank you DoAEON BIOPHARMA
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