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Form 6-K GH Research PLC For: Mar 04

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March 4, 2022 4:27 PM EST
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of March, 2022.


Commission File Number: 001-40530

GH Research PLC
(Exact name of registrant as specified in its charter)

28 Baggot Street Lower
Dublin 2
D02 NX43
Ireland
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F
 ☒  
Form 40-F
 ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

GH Research PLC (the “Company”) will be participating in the Cowen 42nd Annual Health Care Conference starting on March 7, 2022. On March 4, 2022, the Company made available an updated investor presentation on its website to be used for presentation at the conference. A copy of the investor presentation is attached hereto as Exhibit 99.1.

The fact that this presentation is being made available and furnished herewith should not be deemed an admission as to the materiality of any information contained in the materials. The information contained in the presentation is being provided as of March 4, 2022 and the Company does not undertake any obligation to update the presentation in the future or to update forward-looking statements to reflect subsequent actual results.

SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
GH Research PLC
Date: March 4, 2022
  
   
 
By:
/s/ Julie Ryan
 
Name:
Julie Ryan
 
Title:
Vice President, Finance

EXHIBIT INDEX

Exhibit No.
Description
Corporate Presentation for March 2022


Exhibit 99.1

 1  Corporate PresentationGH Research PLC (NASDAQ: GHRS)    GH Research  March 2022  2022© GH Research PLC 
 
 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 the presenter or GH Research or any director, employee, agent, or adviser of GH Research. This presentation does not purport to be all-inclusive or to contain all of the information you may desire.This presentation does not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.  2    This presentation contains forward-looking statements, all of which are qualified in their entirety by this cautionary statement. Many of the forward-looking statements contained herein can be identified by the use of forward-looking words such as “may”, “anticipate”, “believe”, “could’, “expect”, “should”, “plan”, “intend”, “estimate”, “will”, “potential” and “ongoing”, among others, although not all forward-looking statements contain these identifying words.Any statements contained herein that do not describe historical facts are forward-looking statements that are based on management’s expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcomes, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, but are not limited to: the costs and uncertainties associated with GH Research’s research and development efforts; the inherent uncertainties associated with the conduct, timing and results of nonclinical and clinical studies of GH Research’s product candidates; GH Research’s ability to obtain, maintain, enforce and defend issued patents; the adequacy of GH Research’s capital resources and availability of additional funding; and other factors, risks and uncertainties described in GH Research’s filings with the U.S. Securities and Exchange Commission. Except as otherwise noted, these forward-looking statements speak only as of the date of this presentation, and GH Research undertakes no obligation to update or revise any of such statements to reflect events or circumstances occurring after this presentation. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond GH Research’s control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in any such forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. GH Research cautions you not to place undue reliance on the forward-looking statements contained in this presentation  2022© GH Research PLC 
 
 SeekingUltra-Rapid, Durable Remissionsin Depression  3  2022© GH Research PLC 
 
 Pipeline  4  2022© GH Research PLC        Stage of Development          PROGRAMS  INDICATION    PRECLINICAL  PHASE 1  PHASE 2a PHASE 2b  PHASE 3  Milestone  GH0015-MeO-DMT for inhalation administration  Treatment-Resistant Depression (TRD)            Initiate Phase 2b trial in TRD    Psychiatric Disorder*            Initiate Phase 2a trial in undisclosed psychiatric disorder    Psychiatric Disorder*            Initiate Phase 2a trial in undisclosed psychiatric disorder  GH002 / GH0035-MeO-DMT for injection / intranasal administration  Psychiatric or Neurological Disorder            Complete preclinical development        Complete    *In light of our completed Phase 1 clinical trial of GH001 in healthy volunteers and our completed Phase 1/2 trial in TRD, we plan to request clearance from European regulatory authorities to begin Phase 2a clinical trials in patients with two additional undisclosed psychiatric disorders 
 
 ... 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 = Citalopram)  The Problem for Patients with Depression  (STAR*D study, Remission Rates Treatment Steps 1 to 4)  5  2 or more prior therapies = Treatment-Resistant Depression (TRD)    2022© GH Research PLC 
 
 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: ~48MTreated (pharmacotherapy ± psychotherapy): ~24M  Non-response to first line: ~13M  Non-response to two prior lines: ~9M  Company estimates based on: https://www.nimh.nih.gov/health/statistics/major-depression.shtml; Wittchen et al., The size and burden of mental disorders and other disorders of the brain in Europe 2010, European Neuropsychopharmacology (2011); Rush et al., Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report, Am J Psychiatry 2006MDD, Major Depressive Disorder  2022© GH Research PLC 
 
 5-MeO-DMT (5-Methoxy-N,N-Dimethyltryptamine)Naturally-occurring psychoactive substance from tryptamine classHighly potent agonist on 5-HT1A and 5-HT2A receptorsPsychoactive effects with ultra-rapid onset (within seconds) and short duration (5 to 30 min)High propensity to induce peak experiences (PE), which may be a surrogate marker for therapeutic effectsGH001 (5-MeO-DMT administration via a proprietary inhalation approach)Intraday individualized dosing regimen for maximization of ultra-rapid remissions Single visit initial treatment, with no structured psychotherapy Potential for convenient and infrequent retreatment  5-MeO-DMT and GH001  7  2022© GH Research PLC  5-MeO-DMT    Foundational IP 
 
       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  Hypothetical Patient 1  Hypothetical Patient 2  No remission  No remission  No remission  Dose 1  GH001 – Individualized Dosing Regimen (IDR) Designed to Achieve Ultra-Rapid and Durable Remissions  8  2022© GH Research PLC        MADRS score  Dose 1 
 
 Phase 1 Trial in Healthy Volunteers GH001-HV-101(Completed)  9  Clinicaltrials.gov ID NCT04640831  2022© GH Research PLC 
 
 GH001Administration  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 7Peak Experience Scale (PE Scale)1  HV(n=4)  Primary Endpoint:Safety until day 7Peak Experience Scale (PE Scale)1  GH001 IDR6, 12, 18 mg to achieve PE(up to 3 doses, 3h interval)      Key Assessments  SafetyPE ScaleCognitive function  Safety  SafetyCognitive function  1The PE Scale averages answers scored by the subject by marking a visual analogue scale between 0 and 100 for the following three questions: 1. How intense was the experience; 2. To what extent did you lose control; 3. How profound (i.e., deep and significant) was the experience?  Design of Phase 1 Trial in Healthy Volunteers (GH001-HV-101)  10  2022© GH Research PLC  PE, Peak ExperienceIDR, Individualized Dosing Regimen 
 
 Study Safety Group reviewNo SAEsAll ADRs mild, except two moderate (*)All ADRs resolved spontaneouslyInhalation well-toleratedNo noteworthy changes in vital parameters, except for temporary, non-clinically relevant increase in heart rate and blood pressure shortly after administration of GH001No clinically significant changes in safety laboratory analyses, psychiatric safety assessments or measures of cognitive function  ADRs  Part A (Single Dose)        Part B (IDR)  ADRs  2 mg (N=4)  6 mg (N=6)  12 mg (N=4)  18 mg (N=4)  IDR1 (N=4)  MedDRA Preferred Term  n  n  n  n  n  Abnormal dreams           1     Anxiety     1  1        Clumsiness     1           Confusional state     1           Euphoric mood     1           Fatigue           1  1*  Feeling hot     1           Flashback           1     Hallucination           1     Head discomfort              1  Headache     2     1  1  Heart rate increased        1*        Hyperacusis           1     Insomnia           1     Mental fatigue           1     Nausea  2  1     1  2  Vision blurred  1              Part A (Single Dose) and Part B (IDR) – Safety  11  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  2022© GH Research PLC  16 mg (N=1); 6-12 mg (N=2); 6-12-18 mg (N=1) 
 
         Average fordose group  PE Scale  PEThreshold  Part A – Peak Experience (PE) Dose-Effectsand Inter-Person Variability  12  PE, Peak Experience  2022© GH Research PLC 
 
         PEThreshold  Part B – Peak Experience (PE)Effect of Intraday Individualized Dosing Regimen  13  PE, Peak Experience  2022© GH Research PLC 
 
 Phase 1/2 Trial inTreatment-Resistant DepressionGH001-TRD-102(Completed)  14  Clinicaltrials.gov ID NCT04698603  2022© GH Research PLC 
 
 Key Assessments  MADRS 2-hrsPE ScaleSafety  MADRS 1-dayCognitive functionSafety  MADRS 7-dayCognitive functionSafety  GH001Administration  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 Regimen  1Defined as inadequate response to at least two adequate courses of pharmacological therapy or one adequate course of pharmacological therapy and at least one adequate course of evidence-based psychotherapy   2022© GH Research PLC  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)     
 
 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   2022© GH Research PLC  Study Safety Group reviewNo SAEsAll ADRs mild, except three moderate*All ADRs resolved spontaneouslyInhalation well-toleratedNo noteworthy changes in vital parameters, except for temporary, non-clinically relevant increase in heart rate and blood pressure shortly after administration of GH001No clinically significant changes in safety laboratory analyses, vital signs, psychiatric safety assessments or measures of cognitive functionNo safety signal relating to suicidal ideation or suicidal behavior, based on C-SSRS and MADRS subscore item “suicidal thoughts”  ADRs  Phase 1 (Single Dose)    Phase 2 (IDR)  ADRs  12 mg (N=4)  18 mg (N=4)  IDR1 (N=8)  MedDRA Preferred Term  n  n  n  Abdominal discomfort        1  Anxiety        2  Depressive symptom        1*  Dizziness  1        Feeling abnormal  1  1     Flashback  1  1  2  Headache  2  1  3  Muscle discomfort      1  Muscle spasms     1     Nausea        2*  Paresthesia        1  Sensory disturbance      3  16-12 mg (N=6); 6-12-18 mg (N=2) 
 
 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 mg group and1 of 4 (25%) in the 18 mg group had a MADRS remission at day 72 of 8 patients had a PE and both had a MADRS remission at day 7 
 
 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<0.00017 of 8 patients had a PE and 6 of those had a MADRS remission at day 7  PE, Peak Experience; MADRS, Montgomery–Åsberg Depression Rating ScaleMADRS remission = MADRS of ≤10; MADRS response = Reduction of ≥50% from baseline in MADRS. 
 
 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<0.00017 of 7 remissions from day 1 and5 of 7 remissions from 2 hours  1Baseline mean MADRS=32 
 
 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% (7 of 8)  50% (2 of 4)  0% (0 of 4)  Mean PE Score  90.4 (at final dose)  58.2  59.1  2022© GH Research PLC  20  PE, Peak Experience; MADRS, Montgomery-Åsberg Depression Rating ScaleIDR, Individualized Dosing Regimen 
 
 Phase 1 Clinical Pharmacology Trial in Healthy Volunteers GH001-HV-103(Completed)  21  2022© GH Research PLC 
 
 GH001Administration  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  SafetyPharmacokineticsPE ScaleCognitive function    SafetyCognitive function  Safety  22  Day 30    GH001 IDR6, 12, 18 mg to achieve PE(up to 3 doses, 2h interval, n=8)  Primary Endpoint:Pharmacokinetic profile of 5-MeO-DMT and bufotenine    2022© GH Research PLC  Design of Phase 1 Clinical Pharmacology Trial in Healthy Volunteers (GH001-HV-103)  PE, Peak ExperienceIDR, Individualized Dosing Regimen 
 
 Safety ReviewNo SAEs All ADRs mildAll ADRs resolved spontaneouslyInhalation well-toleratedNo noteworthy changes in vital parameters, except for temporary, non-clinically relevant increase in heart rate and blood pressure shortly after administration of GH001No clinically relevant changes in ECG, safety laboratory analyses, peak flow assessment, and psychiatric safety assessments, including the C-SSRS  Single Dose and IDR – Safety   23  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; Pharmacokinetic analyses and analyses of various secondary endpoints are still ongoing.  2022© GH Research PLC  ADRs  Single-dose         IDR      6 mg (N=8)  12 mg (N=8)  18 mg (N=8)  Placebo (N=6)  1h interval (N=8)2  2h interval (N=8)3  MedDRA Preferred Term  n  n  n  n  n  n  Abnormal dreams            1  Chest discomfort     1            Crying        2     2     Dizziness       1         Dry mouth  1               Dyskinesia        1           Fatigue    1      2  1  Headache  3    1     1  1  Hypoesthesia oral    1            Paresthesia oral             1  Retching      1          Somnolence    1            Tachycardia      2         Tension             1  Tremor      1          26 mg (N=1), 6-12 mg (N=3); 6-12-18 mg (N=4)36-12 mg (N=3); 6-12-18 mg (N=5) 
 
       LAYER 1: REGULATORY EXCLUSIVITYFDA: 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: PATENTSSeveral patent applications filed: Novel aerosol compositions of matter of 5-MeO-DMTNovel manufacturing methods of 5-MeO-DMTNovel uses of 5-MeO-DMT in various disorders (including inhaled, intranasal, i.v., i.m., s.c., and other routes) ​  Three-Layer Protection Strategy  24  2022© GH Research PLC 
 
 Board of Directors & Management  25  Florian Schönharting  Spike Loy  Michael Forer  MScChairman of the Board, Co-founder  JDBoard Member  BA, LLBBoard Member  2022© GH Research PLC  Dermot Hanley  Duncan Moore  BSC, MBABoard Member  MPhil, PhDBoard Member  Theis Terwey  PD Dr. med. CEO, Co-founder  Julie Ryan  ACA, MAcc, BCommVP, Finance  Magnus Halle  BScManaging Director, Ireland, Co-founder 
 
 Scientific Advisors  26  Michael Thase  M.D.Professor of Psychiatry,Perelman School of MedicineUniversity 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. Dr. Head, Psychiatry Unit,Hospital Clínic de Barcelona  Michael Bauer  Prof. Dr. rer. nat. Dr. med.Chair, Department of Psychiatry and Psychotherapy,Technische Universität Dresden  Malek Bajbouj  Prof. Dr. med.Head, Center for Affective Neuroscience,Charité, Berlin  Johannes Ramaekers  Prof. Dr.Professor, Faculty of Psychologyand Neuroscience of Maastricht University  2022© GH Research PLC 
 
 Anticipated Milestones  GH001Request a pre-IND meeting with the FDA in Q1 20221 Initiate randomized, controlled Phase 2b trial in TRDRequest regulatory clearance for two Phase 2a trials in two additional psychiatric disorders in Q1 2022GH002 and GH003Complete preclinical work and initiate Phase 1 trial in Healthy Volunteers  27  2022© GH Research PLC  1EMA Scientific Advice not considered necessary at this time.  
 
 SeekingUltra-Rapid, Durable Remissionsin Depression  28  2022© GH Research PLC 
 


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