Gh Research Plc · NASDAQ:GHRS
Gh Research — Investor Presentation (November 2022)
28 slides from Gh Research's investor presentation, Nov 10, 2022
Slide 1: Corporate Presentation
Corporate Presentation GH Research PLC (NASDAQ: GHRS) GH Research 2022© GH Research PLC 10 November 2022
Slide 2: Disclaimer Regarding Forward-Looking Statements
Disclaimer Regarding Forward-Looking Statements 2022© GH Research PLC 10 This presentation has been prepared by GH Research PLC (“GH Research”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promi
Slide 3: Seeking Ultra-Rapid, Durable Remissions in Depression
Seeking Ultra-Rapid, Durable Remissions in Depression 2022© GH Research PLC 10
Slide 4: Stage of Development
Stage of Development PROGRAMS INDICATION PRECLINICAL PHASE 1 PHASE 2a PHASE 2b PHASE 3 CURRENT STATUS GH0015-MeO-DMT for inhalation administration Treatment-Resistant Depression (TRD) Phase 2b CTAs submitted(GH001-TRD-201) Bipolar II Disorder* (BDII) Phase 2a POC trial initiated(GH001-BD-202) Postpa
Slide 5: The Problem for Patients with Depression
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 0 2 4 6 8 10 12 14 Cumulative Remission Rate (% Patients) Week 37% 31% 14% 13% 56% 62% 67% 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 1 Cumulative Remission Rate (%) (line) Remission Rates (%) (bar) ~33% no remi
Slide 6: Large and Open Depression Market in the EU and US
Large and Open Depression Market in the EU and US First Line MDD Diagnosed: ~48M Treated (pharmacotherapy ± psychotherapy): ~24M Second Line MDD Non-response to first line: ~13M Treatment-Resistant Depression (TRD) Non-response to two prior lines: ~9M Patients cycle through ineffective therapies for
Slide 7: 5-MeO-DMT and GH001
5-MeO-DMT (5-Methoxy-N,N-Dimethyltryptamine) Naturally-occurring psychoactive substance from tryptamine class Highly potent agonist on 5-HT1A and 5-HT2A receptors Psychoactive effects with ultra-rapid onset (within seconds) and short duration (5 to 30 min) High propensity to induce peak experiences
Slide 8: GH001 Individualized Dosing Regimen: More Chances for Remission
GH001 Single Dose: GH001 Individualized Dosing Regimen (IDR): More Chances for Remission MADRS score MADRS score MADRS score MADRS score Dose 1 Dose 1 Dose 1 No remission Remission Remission Remission Remission Hypothetical Patient 1 Hypothetical Patient 2 Hypothetical Patient 3 Hypothetical Patient
Slide 9: Phase 1 Trial in Healthy Volunteers GH001-HV-101 (Completed)
Phase 1 Trial in Healthy Volunteers GH001-HV-101 2022© GH Research PLC 10 (Completed) Clinicaltrials.gov ID NCT04640831
Slide 10: Design of Phase 1 Trial in Healthy Volunteers (GH001-HV-101)
GH001 Administration Day 1 Day 7 GH001 2 mg (n=4) GH001 6 mg (n=6) GH001 12 mg (n=4) GH001 18 mg (n=4) HV (n=18) Part A (Single Dose) Part B (IDR) Primary Endpoint: Safety until day 7 Peak Experience Scale (PE Scale)1 HV (n=4) Primary Endpoint: Safety until day 7 Peak Experience Scale (PE Scale)1 GH
Slide 11: Part A and Part B – Safety
Study Safety Group review No SAEs All ADRs mild, except two moderate (*) All ADRs resolved spontaneously Inhalation well-tolerated No noteworthy changes in vital parameters, except for temporary, non-clinically relevant increase in heart rate and blood pressure shortly after administration of GH001
Slide 12: Part A – Peak Experience Dose-Effects and Inter-Person Variability
70 60 50 40 30 20 10 0 100 90 80 2 mg 6 mg P4 P1 P2 P3 P9 P8 P10 P7 P5 P6 P13 P11 P14 P12 P15 P18 P17 P16 12 mg 18 mg Average for dose group 2022© GH Research PLC 11 PE Scale PE Threshold Part A – Peak Experience (PE) Dose-Effects and Inter-Person Variability PE, Peak Experience
Slide 13: Part B – Peak Experience Effect of Intraday Individualized Dosing Regimen
70 60 50 40 30 20 10 0 100 90 80 6 mg 6 mg 12 mg 6 mg 12 mg 6 mg 12 mg 18 mg P21 P19 P22 P20 PE Scale PE Threshold 2022© GH Research PLC 11 Part B – Peak Experience (PE) Effect of Intraday Individualized Dosing Regimen PE, Peak Experience
Slide 14: Phase 1/2 Trial in Treatment-Resistant Depression GH001-TRD-102
Phase 1/2 Trial in Treatment-Resistant Depression GH001-TRD-102 2022© GH Research PLC 11 (Completed) Clinicaltrials.gov ID NCT04698603
Slide 15: Design of Phase 1/2 Trial in TRD (GH001-TRD-102)
Key Assessments MADRS 2-hrs PE Scale Safety MADRS 1-day Cognitive function Safety MADRS 7-day Cognitive function Safety GH001 Administration Day 1 Day 7 Design of Phase 1/2 Trial in TRD (GH001-TRD-102) 15 PE, Peak Experience; MADRS, Montgomery-Åsberg Depression Rating ScaleIDR, Individualized Dosing
Slide 16: Phase 1 (Single Dose) and Phase 2 (IDR) – Safety
Phase 1 (Single Dose) and Phase 2 (IDR) – Safety IDR, Individualized Dosing Regimen; C-SSRS, Columbia-Suicide Severity Rating Scale 2022© GH Research PLC 16 Adverse Drug Reaction, or ADR, an adverse event with a relationship code to the investigational product of definite, probable, or possible, or
Slide 17: Phase 1 (Single Dose) – Efficacy (MADRS)
MADRS Remission / Response / Improvement Rate Day 7 Phase 1 (Single Dose) – Efficacy (MADRS) 17 PE, Peak Experience; MADRS, Montgomery–Åsberg Depression Rating ScaleMADRS remission = MADRS of ≤10; MADRS response = Reduction of ≥50% from baseline in MADRS; MADRS any improvement = any reduction from b
Slide 18: Phase 2 (IDR) – Efficacy (MADRS)
Phase 2 (IDR) – Efficacy (MADRS) 18 2022© GH Research PLC MADRS Remission / Response / Improvement Rate Day 7 Primary endpoint met: 7 of 8 patients (87.5%) had a MADRS remission at day 7, p<0.0001 7 of 8 patients had a PE and 6 of those had a MADRS remission at day 7 PE, Peak Experience; MADRS, Mont
Slide 19: Phase 2 (IDR) – Efficacy (MADRS Change from Baseline)
-19.3 -27.1 -24.4 -30 -25 -15 -10 -5 0 MADRS Mean Change From Baseline Mean (n=8) Phase 2 (IDR) – Efficacy (MADRS Change from Baseline) GH001 2022© GH Research PLC 19 p=0.0018 -20 p<0.0001 p<0.0001 Primary endpoint met: 7 of 8 patients (87.5%) had a MADRS remission at day 7, p<0.0001 7 of 7 remissio
Slide 20: MADRS and PE – Improved Outcome in Phase 2 (IDR) vs Phase 1
MADRS and PE – Observed Improved Outcome in Phase 2 (IDR) vs Phase 1 (Single Dose) 2022© GH Research PLC 19 Phase 2 (IDR) Phase 1 (Single Dose) 12 mg Phase 1 (Single Dose) 18 mg MADRS Remission Rate Day 7 87.5% (7 of 8) 50% (2 of 4) 25% (1 of 4) Mean MADRS Change Day 7 -24.4 (-76%) -21.0 (-65%) -12.
Slide 21: Phase 1 Clinical Pharmacology Trial in Healthy Volunteers GH001-HV-103
Phase 1 Clinical Pharmacology Trial in Healthy Volunteers GH001-HV-103 2022© GH Research PLC 19 (Completed)
Slide 22: Design of Phase 1 Clinical Pharmacology Trial (GH001-HV-103)
GH001 Administration Day 7 GH001 6 mg (n=8+2 placebo) GH001 12 mg (n=8+2 placebo) GH001 18 mg (n=8+2 placebo) HV (n=30) Single-Dose Part IDR Part HV (n=16) GH001 IDR6, 12, 18 mg to achieve PE (up to 3 doses, 1h interval, n=8) Key Assessments Safety Pharmacokinetics PE Scale Cognitive function Safety
Slide 23: Single Dose and IDR – Safety and Further Results
Safety Review No SAEs All ADRs mild All ADRs resolved spontaneously Inhalation well-tolerated No noteworthy changes in vital parameters, except for temporary, non-clinically relevant increase in heart rate and blood pressure shortly after administration of GH001 No clinically relevant changes in ECG
Slide 24: Three-Layer Protection Strategy
LAYER 1: REGULATORY EXCLUSIVITY FDA: 5 years (+2.5 years paragraph IV stay) EMA: 10 years (+1 year for new indication) LAYER 3: TECHNICALComplex bioequivalence for systemically-acting inhalation/intranasal products with high intra- and inter-subject variability LAYER 2: PATENTS Several patent applic
Slide 25: Board of Directors & Management
Board of Directors & Management 25 Florian Schönharting Michael Forer MSc Chairman of the Board, Co-founder BA, LLB Vice-Chairman of the Board 2022© GH Research PLC Dermot Hanley Duncan Moore BSC, MBA Board Member MPhil, PhD Board Member Theis Terwey PD Dr. med. CEO, Co-founder Julie Ryan ACA, MAcc,
Slide 26: Scientific Advisors
Scientific Advisors 26 Michael Thase M.D. Professor of Psychiatry, Perelman School of Medicine University of Pennsylvania Madhukar Trivedi M.D. Professor of Psychiatry, UT Southwestern Medical Center Mark Zimmerman M.D. Professor of Psychiatry and Human Behavior, Brown University Eduard Vieta Prof.
Slide 27: Anticipated Milestones and Financial Overview
Anticipated Milestones and Financial Overview 2022© GH Research PLC 23 GH001 Initiate multi-center, randomized, controlled Phase 2b trial in TRD in 1Q 2023 Submit U.S. IND for GH001 in TRD in 1Q 2023 Complete proof-of-concept Phase 2a trials in BDII and in PPD by the end of 2023 GH002 Initiate Phase
Slide 28: Seeking Ultra-Rapid, Durable Remissions in Depression
Seeking Ultra-Rapid, Durable Remissions in Depression 2022© GH Research PLC 23