<SEC-DOCUMENT>0001140361-25-043042.txt : 20251124
<SEC-HEADER>0001140361-25-043042.hdr.sgml : 20251124
<ACCEPTANCE-DATETIME>20251124092101
ACCESSION NUMBER:		0001140361-25-043042
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20251124
FILED AS OF DATE:		20251124
DATE AS OF CHANGE:		20251124

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			GH Research PLC
		CENTRAL INDEX KEY:			0001855129
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				000000000
		STATE OF INCORPORATION:			L2
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-40530
		FILM NUMBER:		251509911

	BUSINESS ADDRESS:	
		STREET 1:		JOSHUA DAWSON HOUSE
		STREET 2:		DAWSON STREET
		CITY:			DUBLIN 2
		STATE:			L2
		ZIP:			D02 RY95
		BUSINESS PHONE:		353 1 437 8334

	MAIL ADDRESS:	
		STREET 1:		JOSHUA DAWSON HOUSE
		STREET 2:		DAWSON STREET
		CITY:			DUBLIN 2
		STATE:			L2
		ZIP:			D02 RY95
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>ef20059892_6k.htm
<DESCRIPTION>6-K
<TEXT>
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      <div style="text-align: center; font-size: 14pt; font-weight: bold;">UNITED STATES</div>
      <div style="text-align: center; font-size: 14pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
      <div style="text-align: center; font-size: 12pt; font-weight: bold;">Washington, D.C. 20549</div>
      <div>&#160;</div>
      <div style="text-align: center; font-size: 18pt; font-weight: bold;">FORM 6-K</div>
      <div><br>
      </div>
      <div style="text-align: center; text-indent: -6.85pt; margin-left: 6.85pt; font-weight: bold;">REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF
        1934</div>
      <div><br>
      </div>
      <div style="text-align: center;">For the month of November 2025.</div>
      <div>&#160;</div>
      <div style="text-align: center; font-weight: bold;">Commission File Number: 001-40530</div>
      <div><br>
      </div>
      <div style="text-align: center; font-size: 24pt; font-weight: bold;">GH Research PLC</div>
      <div style="text-align: center; font-weight: bold;">(Exact name of registrant as specified in its charter)</div>
      <div><br>
      </div>
      <div style="text-align: center; font-weight: bold;">Joshua Dawson House</div>
      <div style="text-align: center; font-weight: bold;">Dawson Street</div>
      <div style="text-align: center; font-weight: bold;">Dublin 2</div>
      <div style="text-align: center; font-weight: bold;">D02 RY95</div>
      <div style="text-align: center; font-weight: bold;">Ireland</div>
      <div style="text-align: center; font-weight: bold;">(Address of principal executive office)</div>
      <div><br>
      </div>
      <div style="text-align: center;">Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:</div>
      <div><br>
      </div>
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              <div style="text-align: center;">Form 20-F</div>
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            <td style="width: 6%; vertical-align: top; padding-bottom: 2px;">&#160;</td>
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              <div style="text-align: center;">Form 40-F</div>
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            <td style="width: 6%; vertical-align: top; border-bottom: 2px solid rgb(0, 0, 0);">&#160;</td>
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      <div style="text-align: justify; color: #000000;">GH Research PLC announces acceptance to the Promising Targets Oral Session at the 64<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">th</sup> American College of Neuropsychopharmacology (ACNP) annual meeting (the &#8220;<font style="font-weight: bold;">Congress</font>&#8221;) where it will present results related to its GH001-TRD-201 clinical trial. The Congress is scheduled to take place from January 12-15, 2026, in
            Nassau, Bahamas.</div>
      <div><br>
      </div>
      <div style="text-align: justify; color: #000000;">A copy of the abstract for the presentation to be presented by Prof Michael E. Thase during the Congress is attached hereto as Exhibit 99.1.</div>
      <div><br>
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      <div style="text-align: center; font-weight: bold;">EXHIBIT INDEX</div>
      <div><br>
      </div>
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              <td style="width: 5%; text-align: left; vertical-align: top; background-color: rgb(204, 238, 255);"><a href="ef20059892_ex99-1.htm">99.1</a></td>
              <td style="width: 95%; background-color: rgb(204, 238, 255);">
                <div><font style="color: #000000;">Abstract for presentation </font>to be presented by Prof Michael E.
                    Thase with Title: GH001 Improves Illness Severity, Anxiety Symptoms, and Quality of Life in Patients with Treatment-Resistant Depression</div>
              </td>
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      <div style="text-align: center; font-weight: bold;">SIGNATURE</div>
      <div><br>
      </div>
      <div>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.</div>
      <br>
      <table cellspacing="0" cellpadding="0" border="0" id="za7e0b23d869c4a0fa7ed38589edd027f" style="font-family: 'Times New Roman'; font-size: 10pt; width: 100%; border-collapse: collapse; text-align: left; color: #000000;">

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              <div style="font-weight: bold;">GH Research PLC</div>
            </td>
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            <td style="width: 50%; vertical-align: top;">
              <div>Date: November 24, 2025</div>
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              <div>By:</div>
            </td>
            <td style="width: 45%; vertical-align: top; border-bottom: 2px solid rgb(0, 0, 0);">
              <div>/s/ Julie Ryan</div>
            </td>
          </tr>
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            <td style="width: 50%; vertical-align: top;"><br>
            </td>
            <td style="width: 5%; vertical-align: top;">
              <div>Name:</div>
            </td>
            <td style="width: 45%; vertical-align: top;">
              <div>Julie Ryan</div>
            </td>
          </tr>
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            <td style="width: 50%; vertical-align: top;"><br>
            </td>
            <td style="width: 5%; vertical-align: top;">
              <div>Title:</div>
            </td>
            <td style="width: 45%; vertical-align: top;">
              <div>Vice President, Finance</div>
            </td>
          </tr>

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      <div style="text-align: center;"><font style="font-size: 8pt; color: rgb(0, 0, 0); font-weight: normal; font-style: normal;" class="BRPFPageNumber">3</font></div>
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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ef20059892_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    <div style="text-align: right;"> <font style="font-weight: bold;">Exhibit 99.1</font><br>
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    <div>
      <div style="text-align: justify; font-weight: bold;">GH001 Improves Illness Severity, Anxiety Symptoms, and Quality of Life in Patients with Treatment-Resistant Depression</div>
      <div><br>
      </div>
      <div style="text-align: justify;">Michael E. Thase<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1,2</sup>*, Bernhard T. Baune<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3,4,5</sup>, Narc&#237;s Cardoner<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">6</sup>, Kelly Doolin<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">7</sup>, Rosa Maria Due&#241;as Herrero<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">8</sup>, Lubo&#353; Jan&#367;<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">9</sup>, John R. Kelly<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">10,11</sup>,
        Rachael Maclsaac<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">7</sup>, Shane J. McInerney<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">12</sup>, Alexander Nawka<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">13</sup>, Tom&#225;&#353; P&#225;len&#237;&#269;ek<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">14</sup>, V&#237;ctor P&#233;rez Sola<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">15,16,17,18</sup>, Andreas Reif<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">19,20</sup>, Claire Sweeney<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">7</sup>, Madhukar H. Trivedi<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">21</sup>,
        Velichka Valcheva<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">7</sup>, Eduard Vieta<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">18,22</sup>, Wies&#322;aw J. Cuba&#322;a<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">23</sup></div>
      <div><br>
      </div>
      <div style="text-align: justify;">*Presenting author: Michael E. Thase; thase@pennmedicine.upenn.edu</div>
      <div><br>
      </div>
      <div style="text-align: justify;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup>Department of
        Psychiatry, University of M&#252;nster, M&#252;nster, Germany; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">4</sup>Department of Psychiatry, University of Melbourne, Melbourne, VIC, Australia; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">5</sup>The Florey Institute of Neuroscience and Mental Health, Parkville, VIC, Australia; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">6</sup>Hospital
        Santa Creu i Sant Pau, Mental Health Research Group, Institut de Recerca Sant Pau, Universitat Aut&#242;noma de Barcelona, CIBERSAM, Barcelona, Spain; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">7</sup>GH Research, Dublin, Ireland; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">8</sup>Parc Sanitari Sant Joan de Deu Hospital de Dia
        de Numancia, Barcelona, Spain; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">9</sup>A-Shine SRO, Pilsen, Czechia; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">10</sup>Psychedelic Research Group: Trinity College Dublin and Tallaght University Hospital, Dublin, Ireland; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">11</sup>Department of Psychiatry, Tallaght
        University Hospital, Dublin, Ireland; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">12</sup>Department of Psychiatry, University Hospital Galway, Galway, Ireland; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">13</sup>Institut Neuropsychiatrick&#233; P&#233;&#269;e, Praha, Czechia; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">14</sup>Psyon s.r.o., Prague, Czechia; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">15</sup>Mental
        Health Institute, Hospital del Mar, Barcelona, Spain; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">16</sup>Neurosciences Research Group, Hospital del Mar Research Institute (IMIM), Barcelona, Spain; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">17</sup>Department of Psychiatry and Department of Experimental and Health
        Sciences, Pompeu Fabra University, Barcelona, Spain; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">18</sup>Centro de Investigaci&#243;n Biom&#233;dica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">19</sup>Department of Psychiatry, Psychosomatic Medicine and
        Psychotherapy, University Hospital Frankfurt &#8211; Goethe University, Frankfurt am Main, Germany; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">20</sup>Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">21</sup>Center
        for Depression Research and Clinical Care, Peter O&#8217;Donnell Jr. Brain Institute and the Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">22</sup>Hospital Clinic de Barcelona, Institute of
        Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain; <sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">23</sup>Department of Psychiatry, Faculty of Medicine, Medical University of Gda&#324;sk, Gda&#324;sk, Poland</div>
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    <div style="text-align: justify;"><font style="font-weight: bold;">Study Design:</font> This Phase 2b multicenter trial (NCT05800860) assessed the efficacy and safety of GH001, a synthetic form of mebufotenin (5-methoxy-N,N-dimethyltryptamine [5
      MeO-DMT]) for pulmonary inhalation, in patients with treatment-resistant depression (TRD). The trial included a 7-day, randomized, double-blind, placebo-controlled part (Part 1) and a 6 month open-label extension (OLE; Part 2). The primary endpoint
      of this trial was the mean change in Montgomery&#8211;&#197;sberg Depression Rating Scale (MADRS) from baseline to Day 8. Secondary efficacy endpoints included the severity of illness assessed by the Clinical Global Impression-Severity (CGI-S), anxiety symptoms
      assessed by the Hamiliton Rating Scale for Anxiety (HAM-A), and quality of life assessed by the Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF). Efficacy assessments were performed at baseline (pre-dose on Day 1
      [Part 1]), on Day 1 (2 hours post-dose), Day 2, and Day 8 after each treatment, and at each monthly visit up to Month 6. Efficacy results were summarized descriptively. To reduce the risk of functional unblinding, all efficacy endpoints were
      administered by independent blinded raters.</div>
    <div><br>
    </div>
    <div style="text-align: justify;"><font style="font-weight: bold;">Participants:</font> This trial enrolled 81 patients who met the following criteria for TRD: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for major
      depressive disorder, confirmed by the Mini-International Neuropsychiatric Interview; current major depressive episode duration of &#8804;2 years; nonresponse to &#8805;2 and &#8804;5 oral antidepressant treatments after &#8805;6 weeks; and screening and baseline scores of
      &#8805;20 on the 17-item Hamilton Depression Rating Scale. The current major depressive episode was validated using the Massachusetts General Hospital &#8211; Structured Assessment for Evaluation of Risk criteria interview.</div>
    <div><br>
    </div>
    <div style="text-align: justify;"><font style="font-weight: bold;">Intervention:</font> In Part 1, patients were randomized 1:1 to receive an individualized dosing regimen (IDR) of up to three escalating doses of GH001 (6, 12, and 18 mg) or placebo IDR
      on a single day with a 1-hour interval between doses. The criteria for administration of the second and third doses in the IDR were based on patients&#8217; subjectively reported psychoactive effects and the safety and tolerability at the previous dose
      level according to the trial physician&#8217;s judgement. In Part 2, patients could receive up to five GH001 IDR treatments over 6 months as needed based on the patient&#8217;s MADRS score and the safety and tolerability of the previous dose(s). This trial was
      conducted under the supervision of qualified healthcare professionals, providing psychological support per standard of care, but without any planned psychotherapeutic intervention before, during, or after dosing.</div>
    <div><br>
    </div>
    <div style="text-align: justify;"><font style="font-weight: bold;">Data Collection and Analysis:</font> The current analysis examines the effect of GH001 on the secondary efficacy endpoints CGI-S, HAM-A, and Q-LES-Q-SF up to 6 months in patients with
      TRD. Statistical analysis of the data reported herein was completed on August 12, 2025. A total of 81 patients were randomized in Part 1 (GH001 IDR, n=40; placebo IDR, n=41). Change in MADRS total score from baseline to Day 8 of Part 1 was
      significantly greater with GH001 versus placebo (least squares [LS] mean difference [standard error (SE)], &#8722;15.5 [1.7]; <font style="font-style: italic;">P</font>&lt;0.0001). This significant improvement in depressive symptoms was mirrored by
      changes in CGI-S, HAM-A, and Q-LES-Q-SF scores in Part 1. LS mean (SE) difference in change from baseline to Day 8 for GH001 versus placebo was &#8722;2.5 (0.3), &#8722;10.0 (1.4), and 21.4 (2.4), for CGI-S, HAM-A, and Q-LES-Q-SF, respectively (<font style="font-style: italic;">P</font>&lt;0.0001 for each assessment). All 81 (100%) patients transitioned directly to the OLE and 63 patients (77.8%) completed the OLE. Remission (MADRS total score &#8804;10) was achieved by 73.0% of patients who
      completed the OLE. At Month 6, patients who completed the OLE showed significant improvements across secondary efficacy endpoints compared with baseline: mean (standard deviation [SD]) CGI-S decreased by &#8722;3.0 (1.4; <font style="font-style: italic;">P</font>&lt;0.0001),

      mean (SD) HAM-A decreased by &#8722;13.3 (7.2; <font style="font-style: italic;">P</font>&lt;0.0001), and mean (SD) Q-LES-Q-SF increased by 24.8 (14.1; <font style="font-style: italic;">P</font>&lt;0.0001). Patients received a mean of four GH001 IDR
      treatments throughout the trial with a median duration of psychoactive effects of 11 minutes. Results from this analysis indicate that treatment of TRD with GH001 results in durable reductions of illness severity and anxiety symptoms, as well as
      improvements in quality of life, that are maintained at Month 6 with infrequent retreatments.</div>
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