Gh Research Plc · NASDAQ:GHRS
Gh Research — Investor Presentation (January 2024)
30 slides from Gh Research's investor presentation, Jan 5, 2024
Slide 1: GH Research PLC January 2024 Corporate Presentation
GH Research PLC (NASDAQ: GHRS) January 2024 Corporate Presentation 1
Slide 2: Disclaimer and forward-looking statements
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, promise or representation by the presenter or GH Research or any director, emp
Slide 3: Seeking Ultra-Rapid, Durable Remissions in Depression
SeekingUltra-Rapid, Durable Remissionsin Depression 3
Slide 4: Stage of Development: Pipeline
Stage of Development PROGRAMS INDICATION PRECLINICAL PHASE 1 PHASE 2a PHASE 2b PHASE 3 CURRENT STATUS GH001Mebufotenin (5-MeO-DMT)for inhalation administration Treatment-Resistant Depression (TRD) Phase 2b RDBPC trial initiated(GH001-TRD-201) Bipolar II Disorder* (BDII) Phase 2a POC trial initiated(
Slide 5: The Problem for Patients with Depression
The Problem for Patients with Depression Established Therapies are Slow-Acting ... Remission Rates in TRD < 15% 5 (STAR*D study, Remission Rate Over Time, Treatment Step 1 = Citalopram) (STAR*D study, Remission Rates Treatment Steps 1 to 4) Average time to remission is ~6 weeks ~33% no remission des
Slide 6: Large and Open Depression Market in the EU and US
First Line MDD Second Line MDD Treatment-Resistant Depression (TRD) Patients cycle through ineffective therapies for TRD Diagnosed: ~48M Treated (pharmacotherapy ± psychotherapy): ~24M Non-response to first line: ~13M Non-response to two prior lines: ~9M Large and Open Depression Market in the EU an
Slide 7: Mebufotenin (5-MeO-DMT) and GH001
Mebufotenin (5-MeO-DMT) and GH001 7 Mebufotenin (5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT) Naturally-occurring psychoactive substance from tryptamine class Highly potent agonist on 5-HT1A and 5-HT2A receptors GH001 (Mebufotenin administration via a proprietary pulmonary inhalation approach) Psych
Slide 8: GH001 Individualized Dosing Regimen (IDR)
GH001 – Individualized Dosing Regimen (IDR) for Maximization of Ultra-Rapid and Durable Remissions 8 GH001 Single Dose: Inter-Person Variability GH001 Individualized Dosing Regimen (IDR):Maximization of Ultra-Rapid and Durable Remissions MADRS score MADRS score MADRS score MADRS score Dose 1 Dose 1
Slide 9: Phase 1 Trial in Healthy Volunteers GH001-HV-101
Phase 1 Trial in Healthy Volunteers GH001-HV-101 9 (Completed) Clinicaltrials.gov ID: NCT04640831
Slide 10: Design of Phase 1 Trial in Healthy Volunteers (GH001-HV-101)
Design of Phase 1 Trial in Healthy Volunteers (GH001-HV-101) 10 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) Primary Endpoint: Safety until day 7 Peak Experience Scale (PE Scale)1 Part B (IDR) HV (n=4) Primary Endpoint: Safety until day 7 Peak
Slide 11: Part A and Part B – Safety Study
Part A (Single Dose) and Part B (IDR) – Safety 11 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 blo
Slide 12: Part A – Peak Experience Dose-Effects and Inter-Person Variability
Part A – Peak Experience (PE) Dose-Effectsand Inter-Person Variability 12 Average fordose group PE Scale PE Threshold PE, Peak Experience
Slide 13: Part B – Peak Experience Effect of IDR
Part B – Peak Experience (PE)Effect of Intraday Individualized Dosing Regimen (IDR) 13 PE Threshold PE, Peak Experience
Slide 14: Phase 1/2 Trial in Treatment-Resistant Depression GH001-TRD-102
(Completed) Phase 1/2 Trial inTreatment-Resistant DepressionGH001-TRD-102 14 Clinicaltrials.gov ID: NCT04698603
Slide 15: Design of Phase 1/2 Trial in TRD (GH001-TRD-102)
15 Design of Phase 1/2 Trial in TRD (GH001-TRD-102) Phase 1 (Single Dose) Phase 2 (IDR) GH001 12 mg (n=4) GH001 18 mg (n=4) TRD1 (n=8) Primary Endpoint: Safety until day 7 TRD1 (n=8) Primary Endpoint: MADRS remission day 7 (MADRS≤10) GH001 IDR6, 12, 18 mg to achieve PE (up to 3 doses, 3h interval) T
Slide 16: Phase 1 and Phase 2 – Safety
Phase 1 (Single Dose) and Phase 2 (IDR) – Safety 16 ADRs Phase 1 (Single Dose) Phase 2 (IDR) ADRs 12 mg (n=4) 18 mg (n=4) IDR1 (n=8) MedDRA Preferred Term Number of Events n n Abdominal discomfort 1 Anxiety 2 Depressive symptom 1* Dizziness 1 Feeling abnormal 1 1 Flashback 1 1 2 Headache 2 1 3 Muscl
Slide 17: Phase 1 (Single Dose) – Efficacy (MADRS)
Phase 1 (Single Dose) – Efficacy (MADRS) 17 2 of 4 (50%) in the 12 mg group and1 of 4 (25%) in the 18 mg group had a MADRS remission at day 7 2 of 8 patients had a PE and both had a MADRS remission at day 7 MADRS Remission / Response / Improvement Rate Day 7 PE, Peak Experience; MADRS, Montgomery–Ås
Slide 18: Phase 2 (IDR) – Efficacy (MADRS)
Phase 2 (IDR) – Efficacy (MADRS) 18 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 MADRS Remission / Response / Improvement Rate Day 7 PE, Peak Experience; MADRS, Montgomery–Åsberg Depressi
Slide 19: Phase 2 (IDR) – Efficacy (MADRS Change from Baseline)
Phase 2 (IDR) – Efficacy (MADRS Change from Baseline) 19 Hour 2 Day 1 Day 7 GH001 p=0.0018 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 remissions from day 1 and4 of 7 remissions from 2 hours Baseline1 1Baseline mean MADRS=32
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) 20 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%) -12.5 (-40%) Rate of PE 87
Slide 21: Phase 1 Clinical Pharmacology Trial in Healthy Volunteers GH001-HV-103
(Completed) Phase 1 Clinical Pharmacology Trial in Healthy Volunteers GH001-HV-103 21 Clinicaltrials.gov ID: NCT05163691
Slide 22: Design of Clinical Pharmacology Trial (GH001-HV-103)
Design of Phase 1 Clinical Pharmacology Trial in Healthy Volunteers (GH001-HV-103) 22 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 int
Slide 23: Single Dose and IDR – Safety and Further Results
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 administrati
Slide 24: Phase 2b Trial in Treatment-Resistant Depression GH001-TRD-201
(Initiated) Phase 2b Trial inTreatment-Resistant DepressionGH001-TRD-201 24 EudraCT Number: 2022-000574-26
Slide 25: Design of Phase 2b Trial in TRD (GH001-TRD-201)
Design of Phase 2b Trial in TRD (GH001-TRD-201) 25 GH001 IDR Placebo IDR n=80 Randomization 1:1 Up to 5 GH001 IDRs may be administered during the OLE pro re nata (PRN), based on specific re-treatment criteria D0 MADRS Primary Endpoint ΔMADRS (per FDA guidance for rapid-acting antidepressants*) D1 D7
Slide 26: Three-Layer Protection Strategy
Three-Layer Protection Strategy 26 LAYER 1: REGULATORY EXCLUSIVITY FDA: 5 years (+2.5 years paragraph IV stay) EMA: 10 years (+1 year for new indication) LAYER 2: PATENTS Patent families filed relating to mebufotenin (5-MeO-DMT), including: Novel uses in various disorders (including inhaled, nasal,
Slide 27: Board of Directors & Executive Management
Board of Directors & Executive Management 27 Florian Schönharting Michael Forer MSc Chairman of the Board, Co-founder BA, LLB Vice-Chairman of the Board Dermot Hanley Duncan Moore BSc, MBA Board Member MPhil, PhD Board Member Theis Terwey PD Dr. med. CEO, Co-founder Julie Ryan ACA, MAcc, BComm VP, F
Slide 28: Scientific Advisors
Scientific Advisors 28 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 29: Anticipated Milestones and Financial Overview
Anticipated Milestones and Financial Overview GH001 Complete double-blind phase of European multi-center, randomized, double-blind, placebo-controlled Phase 2b trial in TRD in Q3 2024, and provide top-line data in Q3 or Q4 2024 Provide update on U.S. IND clinical hold and planned Phase 1 clinical ph
Slide 30: Seeking Ultra-Rapid, Durable Remissions in Depression
SeekingUltra-Rapid, Durable Remissionsin Depression 30