Gh Research Plc · NASDAQ:GHRS
Gh Research — Investor Presentation (August 2022)
28 slides from Gh Research's investor presentation, Aug 23, 2022
Slide 1: Corporate Presentation
1 Corporate Presentation GH Research PLC (NASDAQ: GHRS) GH Research August 2022 2022© GH Research PLC
Slide 2: Disclaimer Regarding Forward-Looking Statements
Disclaimer Regarding 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 t
Slide 3: Seeking Ultra-Rapid, Durable Remissions in Depression
Seeking Ultra-Rapid, Durable Remissions in Depression 3 2022© GH Research PLC
Slide 4: Stage of Development
Stage of Development PROGRAMS INDICATION PRECLINICAL PHASE 1 PHASE 2a PHASE 2b PHASE 3 Next Stage GH0015-MeO-DMT for inhalation administration Treatment-Resistant Depression (TRD) Initiate Phase 2b trial(GH001-TRD-201) Bipolar II Disorder* (BDII) Initiate POC Phase 2a trial(GH001-BD-202) Postpartum
Slide 5: The Problem for Patients with Depression
... Remission Rates in TRD < 15% Established Therapies are Slow-Acting ~33% no remission despite 4 treatment steps Adapted from Trivedi et al., Am J Psychiatry 2006 and Rush et al., Am J Psychiatry 2006 Average time to remission is ~6 weeks (STAR*D study, Remission Rate Over Time, Treatment Step 1 =
Slide 6: Large and Open Depression Market in the EU and US
Large and Open Depression Market in the EU and US 6 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 line
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 (IDR): 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 2 Dose 3 Dose 2 Dose 1 No remission Remission Remission Remission Remission Hypothetical Patient 1 Hypothetical Patient 2 Hypothetical Patient 3
Slide 9: Phase 1 Trial in Healthy Volunteers GH001-HV-101 (Completed)
Phase 1 Trial in Healthy Volunteers GH001-HV-101 (Completed) 9 Clinicaltrials.gov ID NCT04640831 2022© GH Research PLC
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 (Single Dose) and Part B (IDR) – 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
Average fordose group PE Scale PEThreshold Part A – Peak Experience (PE) Dose-Effectsand Inter-Person Variability 12 PE, Peak Experience 2022© GH Research PLC
Slide 13: Part B – Peak Experience Effect of Intraday Individualized Dosing Regimen
PEThreshold Part B – Peak Experience (PE)Effect of Intraday Individualized Dosing Regimen 13 PE, Peak Experience 2022© GH Research PLC
Slide 14: Phase 1/2 Trial in Treatment-Resistant Depression GH001-TRD-102 (Completed)
Phase 1/2 Trial in Treatment-Resistant Depression GH001-TRD-102 (Completed) 14 Clinicaltrials.gov ID NCT04698603 2022© GH Research PLC
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 16 Adverse Drug Reaction, or ADR, an adverse event with a relationship code to the investigational product of definite, probable, or possible, or where code is missingIDR, Individualized Dosing Regimen; C-SSRS, Columbia-Suicide Severity Rating Scale 2
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. 2022© GH Research PLC 2 of 4 (50%) in the 12
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)
Phase 2 (IDR) – Efficacy (MADRS Change from Baseline) 2022© GH Research PLC Baseline1 2 hours Day 1 Day 7 GH001 19 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 1Baselin
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) 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%) -12.8 (-41%) Rate of PE 87.5%
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 (Completed) 21 2022© GH Research PLC
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 Board Member 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, BComm VP, Fin
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 GH001 Submit clinical trial applications for multi-center, randomized, controlled Phase 2b trial in TRD in 3Q 2022 Submit U.S. IND for GH001 in TRD not later than 1Q 2023 Initiate proof-of-concept Phase 2a trials in BDII and in PPD in 3Q 2022 GH002 Submi
Slide 28: Seeking Ultra-Rapid, Durable Remissions in Depression
Seeking Ultra-Rapid, Durable Remissions in Depression 28 2022© GH Research PLC