Slide 1: Company Overview
Healingmental health disorders so that everyone everywhere can live a more fulfilled life. Company Overview Company Overview Exhibit 99.1
Slide 2: Forward-looking statements
This presentation may include forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, industry dynamics, business strategy and plans and our objectives
Slide 3: Founder-led team developing differentiated mental health treatments
We are a founder-led team aiming to develop differentiated treatments for patients suffering from mental health disorders Florian Brand Co-Founder & CEO Srinivas Rao, MD, PhD Co-Founder & CSO Christian Angermayer Founder & Chairman Lars Wilde Co-Founder Greg Weaver CFO Rolando Gutierrez, MD CMO 13 5
Slide 4: Mental health burden and atai's approach
1 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. 2 As a response to lack of innovation, atai focuses on compounds w
Slide 5: Meaningful R&D catalysts over the next months
Meaningful R&D catalysts over the next 18 months lead to a unique density of news flow, excluding potential for additional business development opportunities Empath partnered with Bionomics on PTSD drug development atai launched EmpathBio to develop EMP-01 for PTSD DemeRx received approval to start
Slide 6: Response to unmet need and lack of innovation
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. Founded in 2018 06
Slide 7: Significant burden and urgent need for innovation
SIGNIFICANT BURDEN Although mental health has become one of the largest global healthcare challenges, there has been little innovation for patients7 Affected people Global population with mental health disorders1 Of US population impacted Expected that more than half of US population will have a men
Slide 8: Resurgence in psychedelic therapies with regulatory momentum
A resurgence in psychedelic therapies is emerging as promising disease-modifying drug candidates progress with regulatory momentum Early research suggested efficacy in mental health Novel results and regulatory support underscore therapeutic value LSD synthesized by Dr. Albert Hofmann at Sandoz resear
Slide 9: Patient accounts from psychedelic studies
Griffiths et al., “Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance” (2006) Schenberg et al., “Treating drug dependence with the aid of ibogaine: A qualitative study” (2017) Watts et al., “Patients’ Accounts of Increased ‘
Slide 10: The atai platform: decentralized drug development
The atai platform: Decentralized drug development process that leverages our team and enabling technologies to aim for improved probability of clinical success Enabling Technologies Formulation and biomarkers Digital Therapeutics AI-enabled drug discovery Process Disciplined selection criteria (incl
Slide 11: Rapid growth via incubations and acquisitions
Rapid Growth via incubations and acquisitions: 6 psychedelic programs, 5 non-psychedelic programs and 6 enabling technologies Launched OCT 2020 Acquired stake in1 NOV 2018 Acquired stake in AUG 2019 Acquired stake in DEC 2019 Acquired larger stake in APR 2020 Launched JUN 2020 Launched JUN 2020 Acqu
Slide 12: Development program overview
Development program overview: Our company ownership, lead compounds, lead indications and stage of development Ownership %1 50.1%2 51.9% 59.5% 56.5%4 100% 100% 54.1%5 100% Preclinical Phase 1 Phase 2 Phase 3 PCN-101 / R-ketamine RL-007 / Compound3 DMX-1002 / Ibogaine NN-101 / N-acetylcysteine VLS-01
Slide 13: Early clinical signals for psilocybin therapy
Early clinical signals have shown psilocybin therapy leads to rapid and sustained reduction in depressive symptoms Low Dose 1st – High Dose 2nd High Dose 1st – Low Dose 2nd Low Dose: 1 or 3mg High Dose: 22 or 30mg 46 cancer patients with depression symptoms GRID-HAMD (Depression) Assessment 1 & 2nd
Slide 14: PCN-101 R-ketamine prior evidence and Phase 2 design
Note: MADRS = Montgomery-Asberg Depression Rate Scale, CADSS = Clinician-administered dissociative states scale, IV = Intravenous, PBO = Placebo. Leal et al., “Intravenous arketamine for treatment-resistant depression: open-label pilot study” (2020) PRIOR EVIDENCE IN HUMANS (THIRD PARTY STUDY1) DAY
Slide 15: R-ketamine vs. S-ketamine deep-dive
Deep-dive R-ketamine vs. S-ketamine: Higher-potency, longer lasting antidepressant effect and lower potential for abuse in preclinical models R-ketamine outperformed and outlasted S-ketamine in mice; confirmed in multiple other animal models in different labs Lower potential for abuse Conditioned plac
Slide 16: Ayahuasca trial and VLS-01 DMT summary
Placebo Ayahuasca Double-blind, randomized placebo-controlled trial with Ayahuasca in 29 patients with TRD Note: MADRS: Montgomery-Asberg Depression Rate Scale. Palhano-Fontes et al. “Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression”, Psychol Med (2019) SUMM
Slide 17: Salvinorin A RLS-01 summary
Study showed ability of S. divinorum leaf to reach hallucinogenic states of consciousness beyond serotonergic mechanisms. All six Hallucinogen Rating Scale (HRS) clusters were significantly elevated for participants given the active S. divinorum leaf. No significant adverse events were observed or r
Slide 18: Notes and sources
Note: 5HT2A-R = Serotonin 2A receptor, KOR = kappa-opioid receptor, NMDA-R = N-methyl-D-aspartate receptor, NET = Norepinephrine transporter, SERT = Serotonin Transporter, mGluR2 = Metabotropic glutamate receptor 2, GABA = Gamma-aminobutyric acid, DMT = Dimethyltryptamine, 5-MeO-DMT = 5-methoxy-N,N-
Slide 19: DMX-1002 ibogaine for opioid use disorder
Stage 1: Maximum Tolerated Dose Subject cohort: Recreational opioid users (up to 30 subjects) Objective: Dose finding HCQN Subscale Pre-dose (N=75) 5 4 3 2 1 0 Stage 2: Proof of Concept TREATMENT (MULTIPLE DOSES) Patient cohort: Opioid dependent patients (approximately 80 subjects) Discharge (N=74)
Slide 20: RL-007 for cognitive impairment in schizophrenia
(5-7 COHORTS) DAY Up to 56 Schizophrenia patients Primary endpoint: Safety and tolerability Secondary endpoint: EEG-based biomarkers of cognition RL-007 TID FOLLOW-UP -1 1 2 4 8 3 Note: CIAS = Cognitive impairment associated with schizophrenia; RL-007 is (2R, 3S)-2-amino-3-hydroxy-3-pyridin-4-yl-1-p
Slide 21: GRX-917 deuterated etifoxine
Part 2: Multiple Ascending Dose Etifoxine has a strong safety record: a review of over 14m prescriptions in France found no cases of abuse, misuse or dependence2 Part 1: Single Ascending Dose Up to 40 healthy subjects: Up to 5 cohorts PD Endpoint: qEEG Up to 36 healthy subjects: Up to 3 cohorts PD E
Slide 22: NN-101 intranasal N-acetylcysteine for mTBI
A: Placebo Count of patients None 1 2 3 4 30 20 10 0 5 B: Early oral NAC Count of patients None 1 2 3 4 30 20 10 0 5 Subject cohort: Healthy volunteers Objective: Identify optimized drug and device Primary endpoints: Brain bioavailability, safety, tolerability ESCALATING DOSE Treatment of 81 mTBI pa
Slide 23: EMP-01 MDMA derivative for PTSD
SUMMARY EMP-01 is an oral formulation of an MDMA derivative being developed for the treatment of PTSD A monoamine releaser and reuptake inhibitor with prominent effects on serotonin (5-HT) An entactogen; a compound class that increases feelings of empathy and closeness--with a potentially improved c
Slide 24: Digital therapeutics opportunity: Introspect
Pear Tx created a precedent Positive regulatory sentiment atai’s opportunity reSET-O © from Pear Therapeutics is the first prescription digital therapeutic that obtained FDA approval for treatment of patients with OUD (2018) FDA is supporting and stimulating Digital Health initiatives1: Aimed at impr
Slide 25: Financial Position
Financial Position Issuer (ticker) ATAI Life Sciences N.V. (NASDAQ: ATAI) Market capitalization ~$2.7B(1) Outstanding shares 154.8M Cash & cash equivalents ~$104M cash & cash equivalents as of March 31, 2021 ~$345M subsequently received in connection with the closing of Series D and IPO atai is well
Slide 26: Investor Contact
Investor Contact: Greg Weaver Chief Financial Officer Email: greg.weaver@atai.life 26
Slide 27: Appendix: Indication deep dives
Appendix ATAI PLATFORM INDICATION DEEP DIVES: Overview Depression CIAS SUD Anxiety mTBI MoA 27
Slide 28: The atai approach: platform approach
The atai approach: We are leveraging a platform approach to to aim for improved probability of clinical success Process People Enabling Technologies 28
Slide 29: Disciplined selection, capital allocation and optionality
Disciplined New Program Selection Prior evidence in humans to increase probability of success Capital Allocation and Decentralized Operations Optionality and Strategic Value Capture Our process is designed to aim for effective program selection, drug development and value capturing Differentiated tre
Slide 30: COMPASS Pathways creates a precedent
Case study: COMPASS Pathways creates a precedent for atai’s companies: From foundation in 2017 to public company today 2017 2018 2020 2019 NOW Aug 2017: Seed round GBP 3m Post money valuation: GBP 15m atai as co-investor 1 Sept 2018: Series A GBP 27m Oct 2018: Breakthrough designation Post money val
Slide 31: Our People
Our People: Over 50 atai professionals with strong track record and a group of experienced advisors support the CEOs of our companies with the execution of our trials 31 Ryan Barrett GC & Lead of Corporate Development Greg Bates VP, Regulatory Affairs Roman Dahl VP, Operations & Innovation Kasia Fran
Slide 32: Enabling technologies
Utilizes digital combination tools to empower atai’s programs, such as remote monitoring and remote counseling AI-enabled computational biophysics platform designed to optimize and accelerate drug discovery Potential to be a product engine for atai supporting the next generation of novel programs Di
Slide 33: Patient populations by indication
~300m Patients with Depression (global)1 ~33% of patients are resistant to front line treatments ~18m Patients with Cognitive Impairment Associated with Schizophrenia (global)3 No pharmacological treatments approved for CIAS ~20m Patients with Substance Use Disorder (US)4 ~75% of patients relapse wi
Slide 34: Robust ability to block strategy
Robust Ability to Block Strategy: IP, regulatory and restrictive covenants create framework for excluding would-be competitors New Chemical Entity Engine Drug & Digital Combo Therapeutics Exclusivity Strategy Differential De-scheduling Strategic Restrictive Covenants Leading IP and Regulatory Advisor
Slide 35: DEA scheduling process and precedents
Additional DEA process for schedule 1 process, takes approx. 4 months Successful precedents include GHB and THC FDA evaluates NDAs and shares a recommendation with the DEA on down-scheduling of the particular compound Source: FDA website * GHB = y-hydroxybutyric acid Phase 3 Phase 1 Phase 2 NDA revi
Slide 36: Depression
Depression 36
Slide 37: Depression opportunity overview
Includes mood stabilizers, atypical antipsychotics, and esketamine. Includes rTMS (repetitive transcranial magnetic stimulation), tDCS (transcranial direct current stimulation), ECT (electroconvulsive therapy), and DBS (deep-brain stimulation). World Health Organization (2020) Hasler et al., Acute p
Slide 38: atai targeting depression via complementary approaches
atai is targeting depression via multiple complementary approaches Depression TRD 5-HT2A-R agonist 6-8 hours COMP360 Company Compound Indication MoA Target / Drug Class Potential for at home use In-clinic duration Distribution channels S-ketamine/ psilocybin clinics Population / Drug class Convenien
Slide 39: Cognitive Impairment Associated with Schizophrenia
Cognitive Impairment Associated with Schizophrenia 39
Slide 40: Cognitive Impairment Associated with Schizophrenia (CIAS)
Cognitive Impairment Associated with Schizophrenia (CIAS) Schizophrenia is a chronic, psychiatric disorder characterized by a heterogeneous combination of symptoms, including psychosis, social withdrawal, flat emotional affect and cognitive impairment. Nearly all schizophrenia patients are affected by
Slide 41: RL-007 well positioned among CIAS therapies
RL-007 is well positioned, combining a history of safety with a signal of pro-cognitive effects in humans PIPELINE SUMMARY 9 Clinical Stage Therapies in Development for CIAS 12 Pre-Clinical Stage Therapies in Development 17 Different Mechanisms of Action Primary Indication MoA Current Phase Notes The
Slide 42: Substance Use Disorder
Substance Use Disorder 42
Slide 43: Substance Use Disorder opportunity overview
Substance Substance use disorders are highly prevalent disorders characterized by an inability to control the use of a legal or illegal drug, medication or other psychoactive compound ~20m US sufferers of SUD in 20171 ~2m US sufferers of OUD in 20171 ~48k US deaths from opioid drug overdose in 20172 S
Slide 44: DMX-1002 potential first disease-modifying treatment for OUD
DMX-1002 has the potential to become the first disease-modifying treatment for OUD, minimizing risk of relapse SUMMARY DMX-1002 could potentially become a paradigm-shifting therapy for Opioid Use Disorder Current standard of care for OUD is medication therapy, requiring opioid substitutes that carry
Slide 45: Anxiety
Anxiety 45
Slide 46: Anxiety opportunity overview
Anxiety Generalized Anxiety Disorder (GAD) Social Anxiety Disorder (SAD) ~40m Anxiety disorder sufferers in the US1 #1 Most common mental health disorder in the US1 ~7m GAD sufferers in the US2 Antidepressants (SSRIs) Benzodiazepines Psychotherapy Treatment options for anxiety disorders Obsessive- Com
Slide 47: GRX-917 can fill unmet need in GAD
GRX-917 can fill unmet need in Generalized Anxiety Disorder (GAD) with rapid onset and favorable safety profile SUMMARY There is an unmet need in GAD for therapies with rapid onset, high efficacy, and minimal side effects SSRI’s are current standard of care for GAD but require 4-6 weeks for onset o
Slide 48: Traumatic Brain Injury
Traumatic Brain Injury 48
Slide 49: Traumatic Brain Injury (TBI) opportunity overview
Traumatic Brain Injury (TBI) Traumatic brain injury typically occurs when a sudden force impacts the head or body, resulting in damage and functional impairment of the brain. atai initially focuses on mild traumatic brain injuries. ~1.7m People sustain TBI each year in US1 ~57k Annual TBI-related de
Slide 50: Adjacent indications may allow significant expansion
While mental health is the initial focus, adjacent indications may allow for significant expansion Anti-inflammatory properties make psychedelics potentially interesting for a variety of therapeutic indications1 Selected CNS indications of interest for psychedelic therapeutics * Company estimate bas
Slide 51: Novel disease-modifying strategies focusing on neuroplasticity
atai aims to develop novel disease-modifying strategies to restore mental health by focusing on neuroplasticity SSRIs localized to serotoninergic pathways with slow onset, mainly ↓AN: reduced stress, emotional blunting. Standard of Care 1 Buprenorphine ↓RN Opioid receptor agonists for maintenance; d
Slide 52: “Watching my best friend and business partner suffer, being let down by existing treatments
“Watching my best friend and business partner suffer, being let down by existing treatments and finally finding comfort in psychedelic therapies, was all the inspiration I needed to commit my life to this cause.” Florian Brand | CEO | atai life sciences 52