GH Research Reports Second Quarter 2025 Financial Results and Provides Business Updates
GH Research (NASDAQ:GHRS) reported Q2 2025 financial results and provided significant updates on its clinical programs. The company's lead candidate GH001 achieved remarkable results in its Phase 2b trial for Treatment-Resistant Depression (TRD), demonstrating a 73% remission rate at 6 months with infrequent treatments and no required psychotherapy.
The company maintains a strong financial position with $308.7 million in cash and equivalents, bolstered by a $150 million public offering in Q1 2025. Q2 net loss improved to $0.15 per share from $0.20 year-over-year. GH Research continues engagement with FDA regarding the IND clinical hold response for GH001, with only one hold topic remaining. The company plans to initiate its global pivotal program in 2026.
GH Research (NASDAQ:GHRS) ha comunicato i risultati finanziari del secondo trimestre 2025 e ha fornito aggiornamenti importanti sui suoi programmi clinici. Il candidato principale dell'azienda, GH001, ha ottenuto risultati eccezionali nella fase 2b dello studio per la Depressione Resistente al Trattamento (TRD), mostrando un tasso di remissione del 73% a 6 mesi con trattamenti poco frequenti e senza necessità di psicoterapia.
L'azienda mantiene una solida posizione finanziaria con 308,7 milioni di dollari in liquidità e equivalenti, rafforzata da un offerta pubblica da 150 milioni di dollari nel primo trimestre 2025. La perdita netta del secondo trimestre è migliorata a 0,15 dollari per azione rispetto a 0,20 dollari nell'anno precedente. GH Research continua il dialogo con la FDA riguardo alla risposta al blocco clinico IND per GH001, con un solo punto di blocco ancora aperto. L'azienda prevede di avviare il suo programma globale pivotale nel 2026.
GH Research (NASDAQ:GHRS) informó los resultados financieros del segundo trimestre de 2025 y proporcionó actualizaciones significativas sobre sus programas clínicos. El candidato principal de la compañía, GH001, logró resultados notables en su ensayo de fase 2b para la Depresión Resistente al Tratamiento (TRD), demostrando una tasa de remisión del 73% a los 6 meses con tratamientos poco frecuentes y sin necesidad de psicoterapia.
La compañía mantiene una posición financiera sólida con 308,7 millones de dólares en efectivo y equivalentes, reforzada por una oferta pública de 150 millones de dólares en el primer trimestre de 2025. La pérdida neta del segundo trimestre mejoró a 0,15 dólares por acción desde 0,20 dólares interanual. GH Research continúa su interacción con la FDA respecto a la respuesta al bloqueo clínico IND para GH001, quedando solo un tema pendiente. La compañía planea iniciar su programa global pivotal en 2026.
GH Research (NASDAQ:GHRS)는 2025년 2분기 재무 결과를 발표하고 임상 프로그램에 대한 중요한 업데이트를 제공했습니다. 회사의 주요 후보물질인 GH001은 치료 저항성 우울증(TRD) 대상 2b상 시험에서 놀라운 결과를 달성했으며, 6개월 후 73%의 관해율을 드물게 시행하는 치료와 심리치료 없이 입증했습니다.
회사는 3억 870만 달러의 현금 및 현금성 자산을 보유하며 견고한 재무 상태를 유지하고 있으며, 2025년 1분기 1억 5천만 달러의 공개 발행0.15달러로 전년 동기 0.20달러에서 개선되었습니다. GH Research는 GH001에 대한 IND 임상 중단 대응과 관련하여 FDA와 계속 협의 중이며, 단 한 가지 중단 사안만 남아 있습니다. 회사는 2026년에 글로벌 중추 프로그램을 시작할 계획입니다.
GH Research (NASDAQ:GHRS) a publié ses résultats financiers du deuxième trimestre 2025 et a fourni des mises à jour importantes sur ses programmes cliniques. Le principal candidat de la société, GH001, a obtenu des résultats remarquables lors de son essai de phase 2b pour la dépression résistante au traitement (TRD), démontrant un taux de rémission de 73 % à 6 mois avec des traitements peu fréquents et sans nécessité de psychothérapie.
L'entreprise conserve une solide position financière avec 308,7 millions de dollars en liquidités et équivalents, renforcée par une offre publique de 150 millions de dollars au premier trimestre 2025. La perte nette du deuxième trimestre s'est améliorée à 0,15 dollar par action contre 0,20 dollar un an auparavant. GH Research poursuit ses échanges avec la FDA concernant la réponse au blocage clinique IND pour GH001, avec un seul point de blocage restant. La société prévoit de lancer son programme pivot mondial en 2026.
GH Research (NASDAQ:GHRS) berichtete über die Finanzergebnisse des zweiten Quartals 2025 und gab bedeutende Updates zu seinen klinischen Programmen bekannt. Der führende Kandidat des Unternehmens, GH001, erzielte bemerkenswerte Ergebnisse in der Phase-2b-Studie zur Behandlung von therapieresistenter Depression (TRD) und zeigte eine Remissionsrate von 73 % nach 6 Monaten bei seltenen Behandlungen und ohne erforderliche Psychotherapie.
Das Unternehmen verfügt über eine starke finanzielle Position mit 308,7 Millionen US-Dollar an liquiden Mitteln und Äquivalenten, gestützt durch ein öffentliches Angebot in Höhe von 150 Millionen US-Dollar im ersten Quartal 2025. Der Nettoverlust im zweiten Quartal verbesserte sich auf 0,15 US-Dollar je Aktie gegenüber 0,20 US-Dollar im Vorjahreszeitraum. GH Research setzt die Gespräche mit der FDA bezüglich der IND-Kliniksperre für GH001 fort, wobei nur noch ein Sperrthema offen ist. Das Unternehmen plant, sein globales wegweisendes Programm im Jahr 2026 zu starten.
- None.
- FDA clinical hold on GH001 IND still not fully resolved
- Increased G&A expenses to $5.7 million from $3.5 million year-over-year
Insights
GH Research shows promising TRD treatment efficacy with 73% remission rate while maintaining $308.7M cash runway for upcoming pivotal trials.
GH Research's latest quarterly update reveals encouraging progress for their lead candidate GH001, a mebufotenin-based treatment for depression. The fully completed Phase 2b trial in treatment-resistant depression (TRD) delivered exceptionally strong efficacy, with a placebo-adjusted MADRS reduction of
What makes these results particularly compelling is the treatment paradigm: remission was achieved with infrequent dosing and notably, without mandated psychotherapy - a significant departure from other psychedelic-based approaches that typically require resource-intensive therapeutic support. The safety profile appears robust with no treatment-related serious adverse events and, crucially, no treatment-emergent suicidal ideation or behavior over the 6-month period.
On the regulatory front, GH Research is making incremental progress with the FDA, with only one remaining hold topic on their IND response. While this suggests forward movement, the timeline for full resolution remains uncertain. Meanwhile, the company is prudently advancing a proprietary aerosol delivery device to support their global program.
Their secondary candidate GH002 (intravenous formulation) demonstrated pharmacokinetic equivalence to GH001 with an IND submission planned for Q4 2025. From a financial perspective, the
- Global pivotal program initiation on track for 2026
- Engagement with FDA on GH001 IND complete response ongoing
- The fully completed Open-Label Extension analysis confirms a
73% remission rate at 6 months with infrequent treatment visits and no psychotherapy - Treatment was well tolerated and no treatment related serious adverse events were reported. There was no evidence of treatment-emergent suicidal ideation or behavior
- Cash, cash equivalents and marketable securities of
$308.7 million as of June 30, 2025
DUBLIN, Aug. 07, 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 June 30, 2025, and provided updates on its business.
Business Updates
GH001 Update
We recently 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.
Engagement with the FDA on our IND complete response is ongoing. We are actively working on a plan with our respiratory, toxicology and regulatory experts to address the remaining topic.
GH001 Administered with Proprietary Aerosol Delivery Device
Our Phase 1 clinical pharmacology trial to evaluate our proprietary aerosol delivery device for administration of GH001 in healthy volunteers (GH001-HV-106) is ongoing in the United Kingdom. This trial is designed to support our global program for GH001, by bridging to the clinical data generated with the commercially available device that we have used in our clinical trials to date.
Final Data from Fully Completed Phase 2b TRD
We recently 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
Safety analysis confirmed that
In May 2025, we attended the American Society of Clinical Psychopharmacology Annual Meeting (ASCP) in Arizona, United States from May 27 – 30. We were accepted for a Pharmaceutical Pipeline Presentation where Professor Michael E. Thase, MD, Professor of Psychiatry, Perelman School of Medicine, University of Pennsylvania presented clinical data from a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with TRD (GH001-TRD-201). Additionally, two late-breaking posters presenting safety and tolerability data from the double-blind part of the Phase 2b trial in TRD as well as data from a proof-of-concept trial with GH001 in postpartum depression were exhibited.
GH002 Update
We have previously announced the completion of a Phase 1, dose-ranging clinical pharmacology trial of GH002, our proprietary intravenous mebufotenin HBr product candidate, in healthy volunteers.
Top-line results demonstrate that GH002 was well-tolerated with no severe or serious adverse events and produced ultra-rapid psychoactive effects. The pharmacokinetic profile of GH002 was equivalent to that of GH001. We expect to submit an IND with the FDA for GH002 in Q4 2025.
Global Pivotal Program Plans
Pivotal program planning has been ongoing since Q1 2025:
- We have established a steering committee with KOLs to review Phase 2b results and assist with design of pivotal program;
- CRO and site selection process is ongoing and we are scaling our team for efficient execution; and
- We are in the process of getting regulatory input on phase 3 requirements and preparation for end-of-phase 2 meeting is underway.
On that basis, we expect to initiate our global pivotal program in 2026.
Second Quarter 2025 Financial Highlights
Cash position
Cash, cash equivalents and marketable securities were
Research and development expenses
R&D expenses were
General and administrative expenses
G&A expenses were
Net loss
Net loss was
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 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 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 plans and expectations with respect to progressing development of GH002 including with respect to the timing, scope and likelihood of IND submission and approval with the FDA; our targets regarding the initiation of our first global pivotal program; our future results of operations and financial position, business strategy, product candidates, medical devices required to deliver these product candidates, research pipeline, ongoing and currently planned nonclinical studies and clinical trials, regulatory submissions and approvals and their effects on our business strategy, our expectations related to commencing trials in the US, research and development costs, cash runway, timing and likelihood of success, 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; those described in our filings with the U.S. Securities and Exchange Commission. 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 June 30, | Six months ended June 30, | ||||
| 2025 | 2024 | 2025 | 2024 | ||
| $’000 | $’000 | $’000 | $’000 | ||
| Operating expenses | |||||
| Research and development | (8,958) | (9,755) | (16,810) | (18,413) | |
| General and administration | (5,746) | (3,464) | (10,626) | (6,334) | |
| Loss from operations | (14,704) | (13,219) | (27,436) | (24,747) | |
| Finance income | 3,074 | 2,555 | 5,833 | 5,225 | |
| Finance expense | (174) | (178) | (352) | (357) | |
| Movement of expected credit loss | 13 | (3) | (6) | 47 | |
| Foreign exchange gain | 2,502 | 466 | 1,860 | 1,787 | |
| Total other income | 5,415 | 2,840 | 7,335 | 6,702 | |
| Loss before tax | (9,289) | (10,379) | (20,101) | (18,045) | |
| Tax charge/(credit) | - | - | - | - | |
| Loss for the period | (9,289) | (10,379) | (20,101) | (18,045) | |
| Other comprehensive (expense)/income | |||||
| Items that may be reclassified to profit or loss | |||||
| Fair value movement on marketable securities | (82) | (107) | (22) | (650) | |
| Currency translation adjustment | 457 | (446) | 989 | (1,735) | |
| Total comprehensive loss for the period | (8,914) | (10,932) | (19,134) | (20,430) | |
| Attributable to owners: | |||||
| Loss for the period | (9,289) | (10,379) | (20,101) | (18,045) | |
| Total comprehensive loss for the period | (8,914) | (10,932) | (19,134) | (20,430) | |
| Loss per share | |||||
| Basic and diluted loss per share (in USD) | (0.15) | (0.20) | (0.33) | (0.35) | |
GH RESEARCH PLC
Condensed Consolidated Interim Balance Sheet (Unaudited)
(in thousands)
| At June 30, | At December 31, | |
| 2025 | 2024 | |
| $’000 | $’000 | |
| ASSETS | ||
| Current assets | ||
| Cash and cash equivalents | 253,873 | 100,791 |
| Other financial assets | - | 19,387 |
| Marketable securities | 37,662 | 29,146 |
| Other current assets | 2,345 | 4,901 |
| Total current assets | 293,880 | 154,225 |
| Non-current assets | ||
| Marketable securities | 17,151 | 33,300 |
| Property, plant and equipment | 739 | 748 |
| Other non-current assets | 1,658 | - |
| Total non-current assets | 19,548 | 34,048 |
| Total assets | 313,428 | 188,273 |
| LIABILITIES AND EQUITY | ||
| Current liabilities | ||
| Trade payables | 3,447 | 3,741 |
| Lease liability | 364 | 255 |
| Other current liabilities | 6,155 | 4,957 |
| Total current liabilities | 9,966 | 8,953 |
| Non-current liabilities | ||
| Lease liability | 283 | 369 |
| Total non-current liabilities | 283 | 369 |
| Total liabilities | 10,249 | 9,322 |
| Equity attributable to owners | ||
| Share capital | 1,551 | 1,301 |
| Additional paid-in capital | 431,061 | 291,463 |
| Other reserves | 8,407 | 5,194 |
| Foreign currency translation reserve | (11,572) | (12,561) |
| Accumulated deficit | (126,268) | (106,446) |
| Total equity | 303,179 | 178,951 |
| Total liabilities and equity | 313,428 | 188,273 |
FAQ
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