Gh Research Plc · NASDAQ:GHRS
Gh Research — Investor Presentation (January 2025)
15 slides from Gh Research's investor presentation, Jan 10, 2025
Slide 1: GH Research PLC January 2025 Corporate Presentation
GH Research PLC (NASDAQ: GHRS) January 2025 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: Stage of Development
Stage of Development PROGRAMS INDICATION PRECLINICAL PHASE 1 PHASE 2a PHASE 2b PHASE 3 CURRENT STATUS MILESTONES GH001Mebufotenin for inhalation administration Treatment-Resistant Depression (TRD) Phase 2b RDBPC DB phase completed Phase 1 PK trial with proprietary device ongoing Phase 2b OLE complet
Slide 4: The Problem for Patients with Depression
The Problem for Patients with Depression Established Therapies are Slow-Acting ... Remission Rates in TRD < 15% 4 (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 2 or more prior thera
Slide 5: 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 6: SPRAVATO has been established as a $1-5Bn drug in interventional psychiatry
SPRAVATO® has been established as a $1-5Bn drug in interventional psychiatry Quarterly sales, $M; Estimated annual WAC of $32,400 Estimated 40 administration visits per year: In-clinic Mandatory 2-hour post-dose monitoring No driving or operating heavy machinery until next day No psychotherapeutic i
Slide 7: The GH001 Aspirational Profile
The GH001 Aspirational Profile Maximize Day 2 Response Rate ✔✔✔✔ ✔ Optimize Day 8 Primary Endpoint ✔✔✔✔ ✔ Optimize Fewer Administration Visits / Greater Durability ✔✔✔✔ ✔ Minimize Post-Discharge Restrictions None No driving or operating machinery until the next day after a restful sleep SPRAVATO® GH
Slide 8: >75% reduction in administration visits with GH001
>75% reduction in administration visits with GH001 8 GH001 Based on ICER estimate Based on Phase 2b trial design Administration visits in 6 months 1-6 visits Assumptions: SPRAVATO®: Assumes 23 administration visits, as per standard initiation protocol of 8 & 4 sessions in months 1 & 2, respectively,
Slide 9: GH001 Phase 1 Clinical Trials: Trial Design
GH001-HV-1032 (Healthy Volunteers) GH001 6 mg (n=8+2 placebo) GH001 12 mg (n=8+2 placebo) GH001 18 mg (n=8+2 placebo) GH001 IDR (6, 12, 18 mg)up to 3 doses, 1h interval (n=8) GH001 IDR (6, 12, 18 mg) up to 3 doses, 2h interval (n=8) 9 Completed GH001 Phase 1 Clinical Trials: Trial Design GH001-HV-10
Slide 10: GH001-TRD-102 Efficacy of the GH001 IDR
GH001-TRD-102 | Efficacy of the GH001 IDRPhase1/2 trial of GH001 in TRD (completed) 10 Abbreviations: MADRS = Montgomery–Åsberg Depression Rating Scale; IDR = Individualized dosing regimen aBaseline mean MADRS = 32. Sources: 1) Reckweg JT, et al. Front. Psychiatry. 2023. Hour 2 Day 2 Day 8 GH001 p=0
Slide 11: Safety and Tolerability of GH001 in Completed Phase Trials
Safety and Tolerability of GH001 in Completed Phase 1 TrialsGH001-HV-1011, GH001-HV-1032, and GH001-TRD-1023 11 Safety Parameters, n (% of population) Overall Population (n=78) Any TEAE 50 (64%) Headache 19 (24%) Anxiety 12 (15%) Nausea 8 (10%) Fatigue 7 (9%) Any Serious AE 0 (0%) Any AE leading to
Slide 12: Phase 2b Trial in Treatment-Resistant Depression GH001-TRD-201
(Initiated) Phase 2b Trial inTreatment-Resistant DepressionGH001-TRD-201 12 EudraCT Number: 2022-000574-26
Slide 13: GH001-TRD-201 Trial Design
GH001-TRD-201 Trial DesignPhase 2b trial in patients with TRD, n=801 13 Abbreviations: D = Day; h = Hour; BL = Baseline; IDR = Individualized dosing regimen; M = Month; MADRS = Montgomery–Åsberg Depression Rating Scale; OLE = Open-label extension; TRD = Treatment-resistant depression. a The double-b
Slide 14: Three-Layer Protection Strategy
Three-Layer Protection Strategy 14 LAYER 1: REGULATORY EXCLUSIVITY FDA: 5 years (+2.5 years paragraph IV stay) EMA: 10 years (+1 year for new indication) LAYER 2: PATENTS Granted patents and patent applications relating to mebufotenin, including: Novel uses in various disorders (including inhaled, n
Slide 15: Board of Directors & Executive Management
Board of Directors & Executive Management 15 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 Julie Ryan FCA, MAcc, BComm VP, Finance Magnus Halle BSc Managing Director