Reunion Neuroscience — Investor Presentation (January 2023)
31 slides from Reunion Neuroscience's investor presentation, Jan 9, 2023
Slide 1: Corporate presentation January 9, 2023
Corporate presentation January 9, 2023
Slide 2: Disclaimer
This presentation of Reunion Neuroscience Inc (the “Company”) is for information only and shall not constitute an offer to buy , s ell, issue or subscribe for, or the solicitation of an offer to buy, sell or issue, or subscribe for any securities in any jurisdiction in which such offer, solici tat ion
Slide 3: Mainstream Mental Health Headlines Q4 2022
3 10/5 10/10 12/9 As student mental health needs soar, schools turn to telehealth 10/21 10/10 10/10 10/11 10/20 90% of US adults say the United States is experiencing a mental health crisis, CNN/KFF poll finds As Suicides Rise, US Military Seeks to Address Mental Health World Mental Health Day: “It’
Slide 4: Psychedelic-Focused Headlines Q4 2022
4 9/28 9/28 12/9 11/10 10/4 10/11 10/21 10/25 11/29 12/4 12/5 12/6 Psychedelic - Focused Headlines Q4 2022 How One Company is Making Psychedelic Therapy a Workplace Benefit 11/3 11/3 10/26 11/3 Psychedelic therapy is moving to the next frontier: workplace perk A CEO saw how psychedelics treated his
Slide 5: Introducing Reunion Neuroscience Inc.
• Reunion Neuroscience is a clinical - stage drug development company focused on innovating therapeutic solutions for mental health conditions . • The Company’s lead asset, RE 104 is a proprietary, novel psychedelic serotonergic drug being developed for post - partum depression as a potential fast -
Slide 6: The Urgent and Unmet Needs of Mental Health
The Urgent and Unmet Needs of Mental Health 900 M Affected by mental health disorders globally 1 person dies by suicide every 11 minutes in the US 322 M Suffering with depression globally 800,000 Deaths from suicide globally Sources: www.who.int/news/fact - sheets/detail/depression ; www.ncbi.nim.ni
Slide 7: COVID Pandemic Increased Demand for Mental Health Treatment
COVID - 19 Pandemic Increased Demand for Mental Health Treatment American Psychological Association 2021 Practitioner Survey* demonstrates ↑ demand across all treatment areas: Greatest increases: ▪ Depressive disorder ▪ Anxiety disorder ▪ Trauma - and stress - related disorders Capacity increases: ▪
Slide 8: Limitations of Traditional Antidepressants
Limitations of Traditional Antidepressants Traditional Antidepressants* ▪ Slow onset of action (several weeks) ▪ Poor response rates (~30% treatment resistant) ▪ Adverse events (AEs) lead to product switching or combinations, complicated treatment algorithms for prescribers ▪ Common bothersome AEs i
Slide 9: Reunion's Focus – Serotonergic Psychedelics Present Advantages
Reunion’s Focus – Serotonergic Psychedelics Present Advantages Mechanism – Serotonin agonism ▪ Fast onset after a single dose (<24h) ▪ High initial response rates (up to 70%) with psilocybin and DMT in early trials ▪ Complete remission rates up to 30% at 3 weeks and durable efficacy to 12 weeks, wit
Slide 10: Mechanistic Phases of Serotonergic Psychedelic Treatment
Mechanistic Phases of Serotonergic Psychedelic Treatment Acute Effects – “Circuit Reboot” In - clinic/Monitored Disruption of traditional patterns of thinking and acute stimulation of neural connectivity providing insights .* Durable Effects – “New Normal” Post - dose/Integration Continuous effects
Slide 11: Mission and Mechanistic Rationale
Mission: To Develop Innovative Therapeutic Solutions for Underserved Mental Health Conditions 11 Mechanistic Rationale Classical Psychedelic Shortcomings Novel Serotonergic Psychedelics • Serotonin - 2A agonism can catalyze psychotherapy through stimulation of neuroconnectivity and neuorplasticitiy
Slide 12: Activity profile of 4-OH-DiPT described by Alexander Shulgin
Activity profile of 4 - OH - DiPT was originally described by Alexander Shulgin, the “Godfather of MDMA”. PhD Chemistry (Harvard, UC Berkley) Studied Psychiatry, Neurology (UCSF) Employed: Dow Corning, DEA (expert) Introduced MDMA to psychotherapy and is credited as the Godfather of Psychedelics. Au
Slide 13: RE104 – Reunion's Lead Clinical-Stage Asset
RE104 – Reunion’s Lead Clinical - Stage Asset Design Factor Rationale RE104 Structure 4 - OH - DiPT RE - 104 is a prodrug of 4 - OH - DiPT ( isoprocin ). The active species has short duration of action, few metabolites, fast elimination. Pharmacology similar to 4 - OH - DMT (psilocybin active form)
Slide 14: RE104's Pharmacological Profile is Similar to Psilocybin
RE104’s Pharmacological Profile is Similar to Psilocybin 14 5HT2A Binding Psilocybin RE104 Active form 110 nM 4 - OH - DMT 120 nM 4 - OH - DiPT Anecdotal reports indicate 4 - OH - DiPT is a psychedelic hallucinogen with short duration ( 2 - 3 h) of the acute phase . Relative Binding Constants* 4 - O
Slide 15: RE104 Unique Pharmacokinetics
RE104 Unique Pharmacokinetics 15 Psilocybin RE104 ROA oral sc inj Active form 4 - OH - DMT 4 - OH - DiPT Tmax (min) 90 - 120 60 t 1/2 (min) 120 35 PK profiles of active substances* in rodent model 4 - OH - DMT ** 4 - OH - DiPT sc , subcutaneous; ROA, route of administration *Active drug levels after
Slide 16: RE104 Intellectual Property Extends to 2041
Patent granted April 5, 2022 via Track One process ▪ Priority June 30, 2020 ▪ Expiry June 30, 2041 ▪ Favorable PCT ISR/Written Opinion Patent claims: ▪ COM/NCE, family of hemi - esters of HO - tryptamines, including 4 - OH - DiPT and 4 - OH - DMT ▪ Formulations, including RE104 developmental project
Slide 17: RE104 Preclinical and CMC
RE104 Preclinical and CMC Phase 1 Chemistry, Manufacturing & Controls (CMC) complete ▪ 2 GMP compliant global API suppliers ▪ 2 GMP drug product manufacturers ▪ Further scale - up and process optimization ongoing Observations from IND - enabling safety pharmacology and toxicology to date ▪ Defined N
Slide 18: RE104 Phase 1 Design and Timelines
A Double - Blind, Randomized, Placebo - Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of RE104 HCl In Healthy Volunteers RE104 Phase 1 Design and Timelines 18 Endpoints • Primary: Safety and tolerability of a single dose • Sec
Slide 19: RE104 Phase 1 Q1 2023 Deliverables
RE104 Phase 1 Q1 2023 Deliverables 19 ▪ Safety: ▪ Are there any safety signals that suggest additional monitoring or eligibility criteria be addressed in phase 2? ▪ At what dose is the probability of challenging experiences “too high”? ▪ Pyschoactive experience duration and pharmacokinetics (PK): ▪
Slide 20: RE104 Phase 1 Top-line Interim Results
RE104 Phase 1 Top - line Interim Results 20 ▪ First - in - human Phase 1 study in n=32 healthy volunteers ▪ Four ascending dose cohorts of 8 subjects (n=6 active RE104, n=2 placebo) ▪ RE104 was shown to be safe and well tolerated, with no serious or severe adverse events at any of the four dose leve
Slide 21: RE104 Phase 2 Indication Selection
RE104 Phase 2 Indication Selection Depression $ 4B addressable market* with 1 approved product Premium pricing possible Short development/ potential for fast timeline $ 20B addressable market * highly competitive landscape 3 rd line medication with less pricing power Consider development as second i
Slide 22: RE104 Potential PPD Product Profile
RE104 Potential PPD Product Profile Parameter RE104 ( Isoprocin Glutarate ) PPD Psilocybin TRD Zulresso ® ( brenaxolone ) PPD SSRI TRD, PPD Pharmacology Serotonergic Psychedelic Serotonergic Psychedelic Benzodiazepine like Classical antidepressant Single dose x x 60 - hr infusion Short psychoactive
Slide 23: Proposed Randomized Phase 2 Study Schema
R 1:1 Population ▪ Female, age 18 - 45 ▪ ≤12 months post - partum ▪ PPD Diagnosis (DSM - 5 Axis I: onset during pregnancy or ≤ 4 weeks from delivery ) ▪ Moderate or severe based on HAMD - 17 and CGI ▪ Overtly healthy Proposed Randomized Phase 2 Study Schema RE104 HCl Single subcutaneous Dose TBD Pla
Slide 24: RE104 Regulatory and Clinical Development
▪ Phase 1 readout of safety and intensity will guide dose selection for Phase 2 ▪ Prior precedent in PPD will serve as a roadmap for Phase 2 development ▪ Open IND with Phase 2 PPD Protocol in 2023 ▪ Positive Phase 2 POC in PPD would be indicator for other depression indications RE104 Regulatory and
Slide 25: RE200s – Better Tolerated and More Selective Serotonergic Psychedelics
RE200’s – Developing Better Tolerated and More Selective Serotonergic Psychedelics Conceived to address a broader population with unmet need by designing molecules with improved selectivity ▪ Reduced serotonin - 2B agonism may allow dosing in high - risk patients ▪ Reduced psychoactivity allowing at
Slide 26: Reunion Team
26 Reunion Team 26 Nathan Bryson, PhD Chief Science Officer Greg Mayes President & Chief Executive Officer Edward Smith Chief Financial Officer Curtis Weber, CLO General Counsel, Corporate Secretary Aviva Asnis - Alibozek, DMSc , PA - C Vice President, Medical Affairs Beatrix Taylor, MSc Vice Presid
Slide 27: Scientific/Clinical Advisors
27 Scientific/Clinical Advisors Anita Clayton, MD Psychiatry Sidney Kennedy, MD Psychiatry Matt Johnson, PhD Psychology Michael Ehlers, MD, PhD Robert Alexander, MD Psychiatry, Neurology Sheryl Kingsberg, PhD Psychology
Slide 28: Board of Directors
28 Barry Fishman Ellen Lubman Greg Mayes Joseph del Moral Chairman and Founder Dieter Weinand Helen Boudreau Board of Directors 28 Hannan Fleiman
Slide 29: Investment Highlights
Investment Highlights 29 ▪ Lead asset - RE104 is a patented, clinical - stage serotonergic psychedelic with a differentiated composition profile designed to offer key therapeutic advantages ▪ Short duration psychedelic experience and fast - onset efficacy ▪ Durable efficacy from a single dose (month
Slide 30: Contact Us
CONTACT US [email protected]
Slide 31: RE104 Psychedelic Development Landscape
31 Serotonergic Nonspecific NMDA antagonists Parameter Reunion Compass Cybin GH Research Small MAPS Janssen atai (Perception) Drug Candidate RE - 104 Isoprocin Glutarate Comp360 Psilocybin* CYB003 D - psilocin GH001 5 - MeO - DMT SPL026 DMT MDMA Spravato ® (S - ketamine) PCN - 101 R - ketamine Route
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