Gh Research Plc · NASDAQ:GHRS
Gh Research — Investor Presentation (May 2025)
16 slides from Gh Research's investor presentation, May 8, 2025
Slide 1: GH Research PLC May 2025 Corporate Presentation
GH Research PLC (NASDAQ: GHRS) May 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 completed Phase 1 PK trial with proprietary device ongoing Lift FDA clinical hold in the US Ph
Slide 4: SPRAVATO has been established as a $1-5Bn drug in interventional psychiatry
SPRAVATO® has been established as a $1-5Bn drug in interventional psychiatry 4 2024 Worldwide Sales: $1.077B Estimated annual WAC of $32,400 -4.0 Approved for TRD Monotherapy and in Conjunction with an Oral AD -4.0 MADRS Points Mean Δ to Control Group aBaseline mean MADRS = 37 Abbreviations: MADRS =
Slide 5: Phase 2b Trial of GH001 in Patients with TRD: Design
Phase 2b Trial of GH001 in Patients with TRD: Design (GH001-TRD-201) 5 1Re-treatment criteria include the severity of depression and the effectiveness, tolerability, and number of previous IDRs. The patient meets one of the following criteria: i. has MADRS >18; or ii. has MADRS >10 and ≤18 and MADRS
Slide 6: Primary endpoint: -15.5 mean MADRS reduction vs placebo on Day 8
Abbreviations: LS = Least Squares; MADRS = Montgomery-Åsberg Depression Rating Scale; SE = Standard error Primary endpoint: GH001 led to -15.5 mean MADRS reduction from baseline on Day 8 compared with placebo (p<0.00001) Baseline 2 hours Day 2 Day 8 LS mean difference -15.5 P<0.00001 LS Mean (±SE) o
Slide 7: Secondary endpoints: 57.5% remission rate at Day 8 vs 0% placebo
1 Remission defined as a patient with a MADRS total score ≤10 2 Response defined as a patient with ≥50% reduction from baseline in total MADRS score Abbreviations: D = Day; MADRS = Montgomery-Åsberg Depression Rating Scale; PBO = Placebo Secondary endpoints: GH001 Led to 57.5% Remission Rate1 at Day
Slide 8: 77.8% Remission Rate at 6 Months in OLE Completers
77.8% Remission Rate at 6 Months in OLE Completers1 (n=54) OLE status (Jan 22nd 2025): 9 patients ongoing, 54 completed, 18 early terminations (comparable to other antidepressant trials4; n=1 due to AE) From the patients who completed the OLE: 77.8% (n=42) of patients were in remission5 at 6 months
Slide 9: Remission on Day 8 and at 6 Months
Remission on Day 8 / Remission at 6 Months 1 Remission defined as a patient with a MADRS total score ≤10 2 6 Months’ or ‘Month 6’ (end of trial) was at approximately 6 months post-study start (mean 168 days from Day 1 of double-blind period) 3 Patients who completed the 6-month OLE follow-up per pro
Slide 10: MADRS change across treatments in DB and OLE
1 Treatments 2-5 were administered in the OLE, and all patients were administered GH001 2 Includes patients who received GH001 in the DB period Abbreviations: BL = Baseline; DB = Double-blind; MADRS = Montgomery-Åsberg Depression Rating Scale; OLE = Open-label extension OLE data as of 22nd Jan 2025
Slide 11: Overall Summary of Safety
GH001 was well tolerated, and no serious adverse events (SAEs) were reported. All TEAEs were mild or moderate with no severe adverse events. The most common TEAEs in patients treated with GH001 were nausea, salivary hypersecretion, paresthesia, headache, and dysgeusia. No TEAEs of flashbacks were re
Slide 12: MADRS Change: GH001 and Spravato comparison
Spravato Mono MADRS Total Score Change from Baseline: GH001 and Spravato at D2 and Primary Endpoint (difference from comparator arm) Spravato +AD Spravato Mono GH001 vs Placebo Spravato + AD vs Placebo + AD from TRANSFORM-21 Spravato monotherapy (84mg) vs Placebo from TRD40052 Spravato +AD Not repor
Slide 13: Secondary Endpoints: Remission GH001 and Spravato Monotherapy
Secondary Endpoints: Remission1 GH001 Day 2 and Day 8 and Spravato Monotherapy (84mg) Day 2, Day 8 and Day 28 Note: To-date, no head-to-head comparisons of any other products to any of our product candidates in any clinical trial have been completed; results have been obtained from different trials
Slide 14: 83% fewer treatment visits with GH001 than with Spravato
83% fewer treatment visits with GH001 than with Spravato GH001 Based on ICER estimate Based on Phase 2b OLE data as of January 22, 2025 Treatment visits in 6 months 4 visits1 23 visits3 Note: To-date, no head-to-head comparisons of any other products to any of our product candidates in any clinical
Slide 15: Three-Layer Protection Strategy
Three-Layer Protection Strategy 15 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 16: Board of Directors & Executive Management
Board of Directors & Executive Management 16 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