-- Engagement with FDA on GH001 IND complete response ongoing
-- Full dataset from the Phase 2b clinical trial of GH001 in TRD reported in
July 2025
-- Long-term clinical data on safety and efficacy from Open-Label Extension
presented at ECNP in October 2025
-- Cash, cash equivalents and marketable securities of $293.9 million as of
September 30, 2025
DUBLIN, Nov. 06, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today reported financial results for the quarter ended September 30, 2025, and provided updates on its business.
Business Updates
GH001 Update
In July 2025, we announced that we received a communication from the U.S. Food and Drug Administration (FDA) relating to our complete response to the clinical hold of our Investigational New Drug Application (IND) for GH001, with only one hold topic remaining.
We are actively working with experts to address the remaining topic and engagement with the FDA on our IND complete response is ongoing.
Final Data from Fully Completed Phase 2b TRD
In July 2025, we reported on the full dataset from the Phase 2b clinical trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201).
The primary endpoint was met with a highly significant placebo adjusted reduction from baseline of -15.5 points in Montgomery-Åsberg Depression Rating Scale (MADRS) total score on Day 8 (p<0.0001).
The full analysis of the open-label extension (OLE) confirms a 73% remission rate at 6 months with infrequent treatment visits and no mandated psychotherapeutic intervention.
There were no treatment-related serious adverse events during the full 6-month duration of the trial. No treatment-emergent events of suicidal intent or suicidal behavior occurred during the 6-month duration of the trial.
In October 2025, we attended the 38th Annual European College of Neuropsychopharmacology Congress (ECNP) in Amsterdam, the Netherlands. At the conference, the long-term safety and efficacy data from the OLE of our randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with TRD (GH001-TRD-201) were presented at the Novel Therapies Symposium by Professor Wies aw J. Cuba a, MD, PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk. In addition, at the same conference, two posters were exhibited on the OLE safety and tolerability data as well as data on the psychoactive effects of GH001 in patients with TRD from GH001-TRD-201.
We continue to expect to initiate our global pivotal program in 2026.
Third Quarter 2025 Financial Highlights
Cash position
Cash, cash equivalents and marketable securities were $293.9 million as of September 30, 2025, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6 million as of December 31, 2024. Other financial assets are comprised of money market funds, and marketable securities are comprised of investment grade bonds.
Research and development expenses
R&D expenses were $10.6 million for the quarter ended September 30, 2025, compared to $8.4 million for the same quarter in 2024. The increase is primarily due to increased expenses relating to technical development activities and employee expenses, partly offset by a decrease in clinical development expenses.
General and administrative expenses
G&A expenses were $6.0 million for the quarter ended September 30, 2025, compared to $4.2 million for the same quarter in 2024. The increase is primarily due to an increase in professional fees and employee expenses.
Net loss
Net loss was $14.0 million, or $0.23 loss per share, for the quarter ended September 30, 2025, compared to $12.1 million, or $0.23 loss per share, for the same quarter in 2024.
About GH Research PLC
GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression. GH Research PLC's initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with treatment-resistant depression (TRD). Based on the observed clinical activity in our Phase 2b trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that our mebufotenin product candidates have the potential to change the way TRD is treated today.
About GH001
Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that GH001 has the potential to change the way TRD is treated today.
About GH002
GH002 is our mebufotenin product candidate formulated for administration via a proprietary intravenous approach. We have completed a Phase 1 trial of GH002 in healthy volunteers.
Forward-Looking Statements
This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding the clinical hold on GH001, including plans and expectations for progressing any nonclinical programs and any other work needed to lift the continuing clinical hold and the timing required for the FDA to lift such clinical hold; our targets regarding the initiation of our first global pivotal program; our business strategy, product candidates and cash runway, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, the risk that the FDA does not accept our responses to the clinical hold issues and that we will be unable to fully address the FDA's concerns and lift the clinical hold on GH001; the risk that we may not be able to submit an IND for GH002, or to commence clinical trials in the United States on the timelines we are targeting; and those other risks described in our filings with the U.S. Securities and Exchange Commission from time to time. No assurance can be given that such future results, plans, or expectations or targets will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Relations:
Julie Ryan
GH Research PLC
investors@ghres.com
GH RESEARCH PLC
Condensed Consolidated Interim Statement of Comprehensive
Loss (Unaudited)
(in thousands, except share and per share amounts)
Three months ended Nine months ended
September 30, September 30,
--------------------
2025 2024 2025 2024
$'000 $'000 $'000 $'000
--------- ---------
Operating expenses
Research and
development (10,567) (8,397) (27,377) (26,810)
General and
administration (5,998) (4,224) (16,624) (10,558)
--------- ---------
Loss from operations (16,565) (12,621) (44,001) (37,368)
--------- --------- --------- --------
Finance income 2,783 2,535 8,616 7,760
Finance expense (21) (181) (373) (538)
Movement of
expected credit
loss 30 (2) 24 45
Foreign exchange
(loss)/gain (247) (1,845) 1,613 (58)
--------- --------- --------- --------
Total other income 2,545 507 9,880 7,209
--------- --------- --------- --------
Loss before tax (14,020) (12,114) (34,121) (30,159)
Tax
charge/(credit) - - - -
--------- --------- --------- --------
Loss for the period (14,020) (12,114) (34,121) (30,159)
========= ========= ========= ========
Other comprehensive
(expense)/income
Items that may be
reclassified to profit
or loss
Fair value
movement on
marketable
securities (33) 908 (55) 258
Currency
translation
adjustment (63) 1,622 926 (113)
Total comprehensive
loss for the period (14,116) (9,584) (33,250) (30,014)
========= ========= ========= ========
Attributable to
owners:
Loss for the
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