Ataibeckley Inc. · NASDAQ:ATAI
Ataibeckley — ATAI Life Sciences — Investor Presentation (July 2021)
54 slides from Ataibeckley's investor presentation, Jul 13, 2021
Slide 1: Company Overview
Exhibit 99.1 Company Overview Company Overview Exhibit 99.1 Company Overview Company Overview
Slide 2: Disclaimer
02 Disclaimer This presentation may include forward-looking statements. All statements other statements. We caution you therefore against relying on these forward-looking necessarily subject to uncertainty and risk due to a variety of factors, including than statements of historical facts contained
Slide 3: atai leadership team
04 Christian Angermayer Florian Brand Srinivas Rao, MD, PhD Founder Co-Founder & CEO Co-Founder & CSO Lars Wilde Greg Weaver Rolando Gutierrez, MD Co-Founder CFO CMO NDAs through IND The atai team has collectively led regulatory approval applications04 Christian Angermayer Florian Brand Srinivas Rao
Slide 4: Mental health burden and atai platform approach
05 Mental health disorders have become one of largest global health burdens, exacerbated by the COVID-19 pandemic. Despite the unmet patient need, innovations remain limited, with only 7 new neuropsychiatric drugs approved since 2015. As a response to lack of innovation, atai focuses on compounds wi
Slide 5: Response to unmet need and lack of innovation in mental health
06 As a response to the significant unmet need and lack of innovation in the mental health treatment landscape, as well as the emergence of therapies that previously may have been overlooked or underused, including psychedelic compounds and digital therapeutics.06 As a response to the significant unme
Slide 6: Significant burden and urgent need for innovation
07 SIGNIFICANT BURDEN URGENT NEED FOR INNOVATION Affected people Respond inadequately Global population with mental health A third of patients with depression respond 1 disorders inadequately or relapse with current 5 treatments within certain indications Of US population impacted Slow onset of trea
Slide 7: History and regulatory momentum of psychedelic therapy
08 LSD synthesized by Dr. Stan Grof uses Psilocybin shows sustained FDA Breakthrough therapy Dr. Albert Hofmann at LSD to treat heroin decreases in depression and designations for psilocybin 1 3 5 7 Sandoz research labs addiction in Prague anxiety in cancer patients for treatment of TRD. Psychedelic
Slide 8: Patient testimonials on psychedelic experiences
09 “When I had a craving, “It sort of relieved a lot of “I felt like, just like a whole something in my head quickly stress, a lot of negative new reborn person… I had thought about the good part, thoughts within my body… not felt that happy in a long, the taste, the feeling, the high, opened my eye
Slide 9: atai platform: process, people, enabling technologies
10 Small teams with entrepreneurial Disciplined selection criteria Digital Therapeutics (including prior evidence in humans) autonomy develop our compounds Impactful capital allocation to Operational involvement of Formulation and biomarkers acquired and incubated companies interdisciplinary atai te
Slide 10: Company acquisitions and launches timeline
11 Acquired stake in Launched Acquired larger stake in Acquired stake in Acquired stake in PsyProtix COMPASS Pathways MAR 2021 IPO: $146m MAR 2021 Launched APR 2020 AUG 2019 NOV 2020 Launched Acquired SEPT 2020 Lead investor JUN 2020 InnarisBio Psyber MAR 2021 FEB 2021 Acquired stake in Acquired sta
Slide 11: Our programs
12 OUR PROGRAMS 1 Company Lead Compound Lead Indication Type Ownership % Preclinical Phase 1 Phase 2 Phase 3 PCN-101 / 2 TRD VIE 50.1% R-ketamine RL-007 / CIAS VIE 51.9% 3 Compound DMX-1002 / OUD VIE 59.5% Ibogaine NN-101 / 4 mTBI VIE 56.5% N-acetylcysteine KUR-101 / 5 OUD VIE 54.1% Deuterated mitra
Slide 12: Oral psilocybin (COMP360)
13 19.4% OWNERSHIP 1 PRIOR EVIDENCE IN HUMANS (THIRD PARTY STUDY ) Oral Psilocybin (COMP360) PRODUCT 46 cancer patients with depression symptoms 25 PHARMA- 5-HT2A-R agonist COLOGY 20 Rapid onset, potential for sustained efficacy PRODUCT 15 after single dose FEATURES p<0.05 p<0.05 Primary: Treatment
Slide 13: Subcutaneous R-ketamine (PCN-101)
14 OWNERSHIP 50.1% 1 PRIOR EVIDENCE IN HUMANS (THIRD PARTY STUDY ) Subcutaneous R-ketamine (PCN-101) PRODUCT 1 Mean MADRS over 7 days and median CADSS scores of TRD patients after single IV dose (0.5mg/kg) of R-ketamine (n=7) 40 35 PHARMA- Glutamatergic modulator 30 COLOGY 25 20 Rapid-acting, nonpsy
Slide 14: Profile of R- vs. S-ketamine
15 Lower potential for abuse Superior and more durable Profile of R- vs. S-ketamine S-ketamine 1 2 Forced swim test (third party study) Conditioned place preference score test (third party study) 1 hour 24 hours *** 500 500 *** * * * ** 400 400 240 * * 300 300 180 200 200 120 Ketamine (racemate) 100
Slide 15: DMT buccal film (VLS-01)
16 100% OWNERSHIP 1 Dimethyltryptamine (DMT) in a buccal PRIOR EVIDENCE IN HUMANS (THIRD PARTY STUDY ) transmucosal film (VLS-01), DMT is the active PRODUCT psychedelic moiety in Ayahuasca Double-blind, randomized placebo-controlled trial with Ayahuasca in 29 patients with TRD 45 PHARMA- 5-HT2A-R ag
Slide 16: Salvinorin A buccal formulation (RLS-01)
17 100% OWNERSHIP RLS-01 is a buccal formulation of Salvinorin A 1 PRIOR EVIDENCE IN HUMANS (THIRD PARTY STUDY ) (SalA), a naturally occurring psychedelic PRODUCT compound derived from the Salvia divinorum plant Participant ratings on Hallucinogen Rating Scale (HRS) completed 1h after drug administr
Slide 17: TRD treatments developed by atai companies vs competitors
18 TRD treatments being developed by atai companies Marketed therapies Phase II and III competitors Perception Compass Viridia Revixia J&J Various GH Research Sage / Praxis e.g. Lilly, Pfizer Company SAGE-217, MIJ-821, NRX- Compound COMP360 R-ketamine S-ketamine 5-MeO-DMT DMT Salvinorin A SSRI/SNRI P
Slide 18: Ibogaine HCl capsules (DMX-1002)
19 IB & NB 2 OWNERSHIP 59.5% 1 PRIOR EVIDENCE IN HUMANS (THIRD PARTY STUDY ) Ibogaine HCl capsules (DMX-1002), ibogaine is a naturally occurring psychedelic compound PRODUCT isolated from a West African shrub, iboga 5 Opioid mediated, cholinergic, glutamatergic PHARMA- 4 and monoaminergic receptor m
Slide 19: RL-007 oral capsules
20 OWNERSHIP 51.9% PRIOR EVIDENCE IN HUMANS (2R, 3S)-2-amino-3-hydroxy-3-pyridin-4-yl-1- pyrrolidin-1-yl-propan-1-one(L)-(+) tartrate salt PRODUCT oral capsules (RL-007) 1 2 Verbal learning Verbal delayed recall 0.35 0.4 p<0.05 ** p<0.05 ** ** 0.30 0.3 Cholinergic, glutamatergic and PHARMA- GABA-B r
Slide 20: Deuterated etifoxine (GRX-917)
21 OWNERSHIP 53.8% 1 PRIOR EVIDENCE IN HUMANS (THIRD PARTY STUDY ) Deuterated etifoxine HCl oral dosage form PRODUCT (GRX-917) Etifoxine works as rapidly as lorazepam, Non Inferiority Test Etifoxine facilitates endogenous production of with etifoxine continuing its effects beyond 30 neurosteroids li
Slide 21: Intranasal N-acetylcysteine (NN-101)
22 56.5% OWNERSHIP 1 PRIOR EVIDENCE IN HUMANS (THIRD PARTY STUDY AND NEURONASAL PILOT) Intranasal N-acetylcysteine (NN-101) PRODUCT NN-101 pilot Treatment of 81 mTBI patients with NAC (24h post blast) increased probability of symptom resolution by ~2x (OR = 3.60, p = 0.0062 overall) NN-101 was obser
Slide 22: EMP-01 MDMA derivative
23 100% OWNERSHIP 1 EMP-01 is an oral formulation of an MDMA PRIOR EVIDENCE IN HUMANS (THIRD PARTY STUDY ) derivative being developed for the PRODUCT treatment of PTSD MDMA-assisted therapy significantly reduced CAPS-V scores in PTSD patients (primary endpoint), (n=90) 50 A monoamine releaser and re
Slide 23: Digital therapeutics opportunity and FDA sentiment
24 Pear Tx created a precedent Positive regulatory sentiment atai’s opportunity reSET-O © from Pear Therapeutics is FDA is supporting and stimulating Aimed at improved therapeutic 1 the first prescription digital therapeutic Digital Health initiatives : outcomes that obtained FDA approval for treatme
Slide 24: Anticipated and recent milestones
25 Anticipated Milestones next 18 months Recent Milestones KUR-101 Phase 1 results Recognify started Phase 2a study in CIAS with RL-007 PCN-101 Phase 2a FSI DMX-1002 Phase 1/2 FSI EMP-01 Phase 1 results Perception closed licensing deal with Otsuka for Japan VLS-01 Phase 1 results atai entered strate
Slide 25: ATAI Life Sciences N.V. capitalization and cash
ATAI Life Sciences N.V. (NASDAQ: ATAI) Issuer (ticker) Market (1) ~$2.8B capitalization Outstanding 154.8M shares (2) Cash & cash • ~$449M cash & cash equivalents as of March 31, 2021 equivalents • In the second quarter of 2021, atai successfully completed an IPO and raised total gross proceeds of ~
Slide 26: Investor Contact
Investor Contact: Greg Weaver Chief Financial Officer Email: greg.weaver@atai.lifeInvestor Contact: Greg Weaver Chief Financial Officer Email: greg.weaver@atai.life
Slide 27: atai platform indication deep dives
27 ATAI PLATFORM INDICATION DEEP DIVES: • Overview • Depression • CIAS • SUD • Anxiety • mTBI • MoA27 ATAI PLATFORM INDICATION DEEP DIVES: • Overview • Depression • CIAS • SUD • Anxiety • mTBI • MoA
Slide 28: Process, People, Enabling Technologies
28 Process People Enabling Technologies28 Process People Enabling Technologies
Slide 29: Enabling technologies, people, process
29 Enabling Technologies People Process Small teams with entrepreneurial Disciplined selection criteria Digital Therapeutics autonomy develop our compounds (including prior evidence in humans) Operational involvement of Impactful capital allocation to Formulation and biomarkers interdisciplinary ata
Slide 30: Disciplined program selection and strategic value capture
30 Disciplined New Optionality and Capital Allocation and Program Selection Strategic Value Capture Decentralized Operations Prior evidence in humans to Small teams with entrepreneurial Internal Development increase probability of success autonomy develop our drugs Access to milestone-based funding,
Slide 31: COMPASS Pathways value creation and IPO
31 Successful IPO 2 Sept 2020: Market Cap : IPO USD USD 1.5bn atai as lead investor 146.6m Apr 2020: Post money Series B valuation: USD 80m GBP 325m atai as lead investor NOW Sept 2018: Post money Series A valuation: 1 atai as co-investor GBP 27m GBP 77m 2020 Aug 2017: Post money Seed round valuatio
Slide 32: Extended team and scientific advisors
32 Greg Bates Carrie Bowen, PhD Glenn Short, PhD Anne Johnson Ryan Barrett Anna Richardson VP, Regulatory Affairs Director, Neuroscience VP, Early Development VP, Global Controller GC & Lead of Chief of Staff, Director Corporate Development Stakeholder Engagement Georgina Kilfoil, PMP Majed Fawaz, Ph
Slide 33: Formulation, digital therapeutics, biomarker, AI drug discovery
33 Formulation & Digital AI Enabled Therapeutics BiomarkerStratification Drug Discovery PsyProtix Metabolomics based biomarker approach Wholly owned digital therapeutics platform Joint venture with Cyclica, with to develop precision psychiatry dedicated to providing more comprehensive, atai currently
Slide 34: Traditional vs decentralized development
34 Therapeutic area focus Traditional Decentralized development development (pipeline) (platform) Therapeutic area agnostic34 Therapeutic area focus Traditional Decentralized development development (pipeline) (platform) Therapeutic area agnostic
Slide 35: Patient populations and treatment gaps
36 Patients with Patients with Anxiety Patients with Patients with Patients with TBI 1 2 5 Depression (global) Cognitive Impairment Substance Use (US) Disorders (US) 4 Associated with Disorder (US) 3 Schizophrenia (global) ~33% of patients are resistant No pharmacological ~75% of patients relapse No
Slide 36: IP and exclusivity strategy
37 Drug & Digital Combo Robust Specialty New Chemical Therapeutics Pharma IP Strategy Entity Engine Exclusivity Strategy Strategic Pursuit of Differential Restrictive Extensions of De-scheduling Covenants Patent Scope Leading IP and Regulatory Advisors37 Drug & Digital Combo Robust Specialty New Chem
Slide 37: DEA scheduling and new drug application process
38 Additional DEA process for Typical new drug application process schedule 1 Phase 1 Phase 2 Phase 3 NDA review process, takes • FDA Review Scheduling approx. 4 months Parallel review of NDA recommendation from • 6-10 months documentation package FDA Successful Review down-scheduling NDA review Cha
Slide 38: Depression
Depression
Slide 39: Depression opportunity overview
40 Opportunity Overview Treatment resistant depression (TRD) is diagnosed after two failed courses of antidepressants. Treatment First onset Persistent resistant depression depression depression (MDD) (MDD) (TRD) 5 Global sufferers of Likelihood of relapse Global TRD patients 3 4 depression from curr
Slide 40: Depression program comparison
41 Depression Company Compound COMP360 DMT R-ketamine Salvinorin A Indication TRD TRD TRD TRD 5-HT2A-R 5-HT2A-R Glutamatergic Kappa opioid MoA Target / Drug Class agonist agonist modulator agonist Potential for at home use Concomitant SSRI therapy In-clinic duration 6-8 hours ~2 hours N/A ~2 hours S
Slide 41: Cognitive Impairment Associated with Schizophrenia
Cognitive Impairment | Associated with Schizophrenia Mi
Slide 42: CIAS opportunity overview
43 Opportunity Overview Global sufferers of of schizophrenia patients Lost life expectancy Schizophrenia is a chronic, psychiatric disorder 1 schizophrenia suffer from significant compared to general characterized by a heterogeneous combination 2 cognitive impairment population of symptoms, including p
Slide 43: Pipeline summary: CIAS therapies in development
44 PIPELINE SUMMARY 9 Clinical Stage Overview of Leading Clinical Stage Competitors for Cognitive Impairment Associated with Schizophrenia (CIAS) Therapies in Development for CIAS Therapy RL-007 SEP-363856 BI-425809 NBI-1065844 PF-03463275 BIIB-104 12 Pre-Clinical Stage Primary Indication CIAS Schiz
Slide 44: Substance Use Disorder
Substance Use Disorder
Slide 45: Substance use disorder opportunity overview
46 Opportunity Overview Substance use disorders are highly prevalent disorders characterized by an inability to control the use of a legal or illegal drug, medication or US sufferers of US sufferers of US deaths from opioid other psychoactive compound 1 1 2 SUD in 2017 OUD in 2017 drug overdose in 201
Slide 46: OUD summary: DMX-1002 vs standard of care
47 SUMMARY Single No Opioid Side Minimal Abuse High Adherence Therapy Mechanismof Action Therapeutic Effects Potential / Low Risk of Relapse Episode DMX-1002 could Disease Modification potentially become Single dose administered Ibogaine (DMX-1002) a paradigm-shifting in monitored setting, Mixed MoA p
Slide 47: Anxiety
Anxiety
Slide 48: Anxiety opportunity overview
49 Opportunity Overview Anxiety disorders develop when feelings of apprehension and unease persist over an extended period and potentially worsen over time Social Obsessive- Generalized Anxiety Compulsive Anxiety Disorder Disorder Disorder (SAD) (OCD) (GAD) Anxiety disorder Most common mental GAD su
Slide 49: Therapeutic options for generalized anxiety disorder
50 SUMMARY Overview of Current Therapeutic Options for Generalized Anxiety Disorder Non- Favorable Minimal Side Mechanism There is an unmet need Class Examples High Efficacy Rapid Onset safety profile Effects addictive of action in GAD for therapies with rapid onset, high GABA Channel A deu-etifoxine Be
Slide 50: Traumatic Brain Injury
Traumatic Brain Injury
Slide 51: TBI opportunity overview
52 Opportunity Overview Traumatic brain injury typically occurs when a sudden force impacts the head or body, resulting in damage and functional People sustain TBI Annual TBI-related Mild TBI accounts for impairment of the brain. atai initially focuses 1 2 each year in US deaths in US 70 - 80% of al
Slide 52: Adjacent indications and market sizes
53 Estimated 2026 Academic Publications While mental Indication Market Size ($BN) health is the initial Positive effects of psychedelics on depression and wellbeing scores in individuals reporting an Eating disorders 7.4* 2 eating disorder focus, adjacent Safety, tolerability, and efficacy of psiloc
Slide 53: Mechanism of action vs standard of care
54 SSRIs localized to serotoninergic Buprenorphine Benzodiazepines pathways with slow onset, mainly ↓RN Opioid receptor agonists for ↓AN: sedation, amnesia, impaired maintenance; drawbacks: respiratory motor performance; withdrawal ↓AN: reduced stress, emotional blunting. depression and maintained d
Slide 54: Florian Brand, CEO, atai life sciences
55 Florian Brand | CEO | atai life sciences55 Florian Brand | CEO | atai life sciences
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