Gh Research Plc · NASDAQ:GHRS
Gh Research — Investor Presentation (October 2021)
24 slides from Gh Research's investor presentation, Oct 26, 2021
Slide 1: Corporate Presentation
1 Corporate Presentation GH Research PLC (NASDAQ: GHRS) GH Research October 2021 2021© GH Research PLC
Slide 2: Disclaimer Regarding Roadshow Communications and Forward-Looking Statements
Disclaimer Regarding Roadshow Communications 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,
Slide 3: Seeking Ultra-Rapid, Durable Remissions in Depression
Seeking Ultra - Rapid, Durable Remissions in Depression 3 2021© GH Research PLC
Slide 4: Company Status and Financing History
• GH Research was founded in 2018 • Seed Finance, 2018: Founders, BVF Partners LP • Series A, 2020: BVF Partners LP, Founders • Series B, 2021: RA Capital (co - lead), RTW Investments LP (co - lead), alo ngside other new investors, BVF Partners LP and Founders / Board of Directors • IPO, 2021 NASDAQ
Slide 5: The Problem for Patients with Depression
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 2 4 6 8 10 12 14 Cumulative Remission Rate (% Patients) Week ... Remission Rates in TRD < 15% Established Therapies are Slow - Acting 37% 31% 14% 13% 56% 62% 67% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 1 2
Slide 6: Large and Open Depression Market
Large and Open Depression Market 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
Slide 7: 5-MeO-DMT and GH001
• 5 - MeO - DMT (5 - methoxy - N,N - dimethyltryptamine) • Naturally - occurring psychoactive substance from tryptamine class • Structural analogue to serotonin • Highly potent agonist on 5 - HT1A and 5 - HT2A receptors • Psychoactive effects with ultra - rapid onset (within seconds) and short - liv
Slide 8: GH001 Individualized Dosing Regimen
Hypothetical Patient 2 MADRS score GH001 Dose 2 GH001 Dose 3 GH001 Dose 1 Hypothetical Patient 1 MADRS score GH001 Dose 1 Remission Remission Foundational IP The ultra - rapid action and short half - life of GH001 allows • Repeated administration within the same day • Maximization of remissions • Si
Slide 9: Phase 1 Trial in Healthy Volunteers
Phase 1 Trial in Healthy Volunteers GH001 - HV - 101 (completed) 9 GH001 - HV - 101; Clinicaltrials.gov ID NCT04640831 2021© GH Research PLC
Slide 10: Design of Phase 1 Trial in Healthy Volunteers
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 Part B 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 GH001 Intrad
Slide 11: Study Safety Group Review and Adverse Drug Reactions
Study Safety Group review • All ADRs mild, except two moderate (*) • All ADRs resolved spontaneously • No SAEs reported • Inhalation well - tolerated • No noteworthy changes in vital parameters, except for temporary, non - clinically relevant increase in heart rate and blood pressure shortly after a
Slide 12: Part A Peak Experience Dose-Effects and Inter-Person Variability
0 10 20 30 40 50 60 70 80 90 100 P4 P1 P2 P3 P9 P8 P10 P7 P5 P6 P13 P11 P14 P12 P15 P18 P17 P16 2 mg 6 mg 12 mg 18 mg Average for dose group PE Scale PE Threshold Part A – Peak Experience (PE) Dose - Effects and Inter - Person Variability 12 PE, peak experience 2021© GH Research PLC
Slide 13: Part B Peak Experience Effect of Intraday Uptitration
0 10 20 30 40 50 60 70 80 90 100 6 mg 6 mg 12 mg 6 mg 12 mg 6 mg 12 mg 18 mg P21 P19 P22 P20 PE Scale PE Threshold Part B – Peak Experience (PE) Effect of Intraday Uptitration 13 PE, peak experience 2021© GH Research PLC
Slide 14: Phase 1/2 Trial in Treatment-Resistant Depression
Phase 1/2 Trial in Treatment - Resistant Depression GH001 - MDD - 102 (ongoing) 14 GH001 - MDD - 102; Clinicaltrials.gov ID NCT04698603 2021© GH Research PLC
Slide 15: Design of Ongoing Phase 1/2 Trial in TRD
Phase 1, Part A (Completed) Phase 2, Part B (Ongoing) GH001 12 mg (n=4) GH001 18 mg (n=4) TRD 1 (n=8) Primary Endpoint: • Safety until day 7 TRD 1 (n=8) Primary Endpoint: • MADRS remission day 7 (MADRS≤10) Key Assessments MADRS 2 - hrs PE Scale Safety MADRS 1 - day Cognitive function Safety MADRS 7
Slide 16: Phase 1 Part A Primary Endpoint Safety
12 mg (n=4) Day 0 Day 1 Day 7 Dizziness 1 Headache 2 Flashback 1 Feeling abnormal 1 18 mg (n=4) Day 0 Day 1 Day 7 Feeling abnormal 1 Muscle spasms 1 Headache 1 Flashback 1 Adverse Drug Reactions Study Safety Group review • All ADRs mild • All ADRs resolved spontaneously • No SAEs reported • Inhalati
Slide 17: Ultra-Rapid and Durable Remissions After a Single Dose
31 10 8 3 0 4 8 12 16 20 24 28 32 36 0 24 48 72 96 120 144 168 MADRS Patient 1 (12 mg) PE Scale = 75.3 50% 25% 50% 50% 100% 100% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 12 mg 18 mg MADRS remission MADRS response MADRS any improvement MADRS Remission / Response / Improvement Rate Day 7 MADRS over
Slide 18: Intraday Uptitration to Potentially Further Increase Remission Rate
Phase 2, Part B (Ongoing) Phase 1, Part A (Completed) Single dose: 25 - 50% Remissions Observed 1 Intraday Uptitration: More Chances for Remission MADRS score MADRS score MADRS score MADRS score MADRS score 6 mg 6 mg 12 mg 18 mg 12 mg 12 or 18 mg 12 or 18 mg No remission Remission Remission Remissio
Slide 19: GH001 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: TECHNICAL Complex bioequivalence for systemically - acting inhalation products with high intra - and inter - subject variability LAYER 2: PATENTS Several patent application
Slide 20: Board of Directors & Management
Board of Directors & Management 20 Florian Schönharting Spike Loy Michael Forer MSc Chairman of the Board, Co - founder JD Board Member BA, LLB Board Member 2021© GH Research PLC Dermot Hanley Duncan Moore BSC, MBA Board Member MPhil, PhD Board Member Theis Terwey PD Dr. med. CEO, Co - founder Julie
Slide 21: Core Development Team
Core Development Team Markus Breuer Dipl. Chem. Dr. rer. nat. Patent Attorney, Co - founder Padraig O’Grady BSc, PhD Clinical Project Manager Kathy Dillon BSc, MSc CMC Project Manager Fiona Ryan BPharm, MSc, PhD Clinical Project Manager 21 Sarah Keady BSc, PhD Clinical Trial Manager 2021© GH Researc
Slide 22: Scientific Advisors
Scientific Advisors 22 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. D
Slide 23: Anticipated Milestones
Anticipated Milestones • GH001 • Expected completion of Part B of Phase 1/2 trial in TRD in 4Q 2021 • Expected completion of Phase 1 clinical pharmacology trial in Healthy Volunteers in 4Q 2021 • Finalize design of randomized, controlled Phase 2b trial in TRD • Initiation of proof - of - concept Pha
Slide 24: Seeking Ultra-Rapid, Durable Remissions in Depression
Seeking Ultra - Rapid, Durable Remissions in Depression 24 2021© GH Research PLC