GH Research Reports Third Quarter 2024 Financial Results and Provides Business Updates
GH Research has completed enrollment for its Phase 2b trial of GH001 (inhaled mebufotenin) in treatment-resistant depression, with top-line data expected by Q1 2025. The company reported $193.8 million in cash and equivalents as of September 30, 2024, down from $222.7 million at end-2023. Q3 2024 saw increased R&D expenses of $8.4 million (vs $7.1M in Q3 2023) and G&A expenses of $4.2 million (vs $2.6M in Q3 2023), resulting in a net loss of $12.1 million ($0.23 per share). The FDA clinical hold on GH001's IND continues, with ongoing nonclinical studies addressing inhalation toxicology concerns.
GH Research ha completato l'arruolamento per il suo studio di Fase 2b di GH001 (mebufotenina inalata) nel trattamento della depressione resistente ai trattamenti, con i dati preliminari attesi per il primo trimestre del 2025. L'azienda ha riportato 193,8 milioni di dollari in contante e equivalenti al 30 settembre 2024, in calo rispetto ai 222,7 milioni di dollari alla fine del 2023. Nel terzo trimestre del 2024 si sono registrati aumenti nelle spese di R&S di 8,4 milioni di dollari (rispetto a 7,1 milioni di dollari nel terzo trimestre del 2023) e spese generali e amministrative di 4,2 milioni di dollari (rispetto a 2,6 milioni di dollari nel terzo trimestre del 2023), portando a una perdita netta di 12,1 milioni di dollari (0,23 dollari per azione). Il blocco clinico della FDA sul IND di GH001 continua, con studi non clinici in corso per affrontare le preoccupazioni sulla tossicologia dell'inalazione.
GH Research ha completado la inscripción para su ensayo de Fase 2b de GH001 (mebufotenina inhalada) en la depresión resistente al tratamiento, con los datos preliminares esperados para el primer trimestre de 2025. La compañía reportó 193,8 millones de dólares en efectivo y equivalentes al 30 de septiembre de 2024, una disminución frente a los 222,7 millones de dólares a finales de 2023. En el tercer trimestre de 2024, se observaron aumentos en los gastos de I+D de 8,4 millones de dólares (frente a 7,1 millones en el tercer trimestre de 2023) y gastos administrativos de 4,2 millones de dólares (frente a 2,6 millones en el tercer trimestre de 2023), lo que resultó en una pérdida neta de 12,1 millones de dólares (0,23 dólares por acción). La suspensión clínica de la FDA sobre el IND de GH001 continúa, con estudios no clínicos en curso abordando preocupaciones sobre la toxicología por inhalación.
GH Research는 치료 저항성 우울증에 대한 GH001(흡입 메부포테닌) 2b상 시험의 모집을 완료했으며, 최종 데이터는 2025년 1분기에 기대하고 있습니다. 이 회사는 2024년 9월 30일 기준으로 현금 및 현금성 자산이 1억 9,380만 달러라고 보고했으며, 2023년 말 2억 2,270만 달러에서 감소했습니다. 2024년 3분기에는 연구 개발비용이 840만 달러(2023년 3분기 710만 달러 대비) 및 일반 관리비용이 420만 달러(2023년 3분기 260만 달러 대비) 증가하여, 순손실이 1,210만 달러(주당 0.23달러)로 나타났습니다. GH001의 IND에 대한 FDA의 임상 보류가 계속되며, 흡입 독성 문제를 다룬 비임상 연구가 진행되고 있습니다.
GH Research a achevé le recrutement pour son essai de Phase 2b de GH001 (mebufoténine inhalée) dans le traitement de la dépression résistante, avec des données préliminaires attendues pour le premier trimestre 2025. L'entreprise a rapporté 193,8 millions de dollars en espèces et équivalents au 30 septembre 2024, en baisse par rapport à 222,7 millions de dollars fin 2023. Au troisième trimestre 2024, les dépenses de R&D ont augmenté pour atteindre 8,4 millions de dollars (contre 7,1 millions de dollars au troisième trimestre 2023) et les dépenses générales et administratives ont atteint 4,2 millions de dollars (contre 2,6 millions de dollars au troisième trimestre 2023), ce qui a entraîné une perte nette de 12,1 millions de dollars (0,23 dollar par action). La suspension clinique de la FDA sur l'IND de GH001 se poursuit, avec des études non cliniques en cours pour traiter les préoccupations liées à la toxicologie de l'inhalation.
GH Research hat die Rekrutierung für seine Phase-2b-Studie zu GH001 (inhalatives Mebufotenin) bei behandlungsresistenter Depression abgeschlossen, wobei erste Ergebnisse bis zum ersten Quartal 2025 erwartet werden. Das Unternehmen berichtete am 30. September 2024 über 193,8 Millionen Dollar in liquiden Mitteln und Äquivalenten, ein Rückgang gegenüber 222,7 Millionen Dollar Ende 2023. Im dritten Quartal 2024 stiegen die F&E-Ausgaben auf 8,4 Millionen Dollar (verglichen mit 7,1 Millionen Dollar im dritten Quartal 2023) und die allgemeinen Verwaltungskosten auf 4,2 Millionen Dollar (verglichen mit 2,6 Millionen Dollar im dritten Quartal 2023), was zu einem Nettoverlust von 12,1 Millionen Dollar (0,23 Dollar pro Aktie) führte. Die klinische Aussetzung der FDA für den IND von GH001 bleibt bestehen, während nichtklinische Studien zur toxikologischen Sicherheit der Inhalation durchgeführt werden.
- Completed enrollment in Phase 2b trial for treatment-resistant depression
- Strong cash position of $193.8 million as of Q3 2024
- Progress on FDA clinical hold resolution pathway for device element
- Net loss increased to $12.1M in Q3 2024 from $5.6M in Q3 2023
- Cash position decreased by $28.9M from December 2023
- FDA clinical hold remains active on GH001
- Difficult recruitment leading to early termination of bipolar II disorder trial
- Increased operating expenses with R&D up 18.3% and G&A up 61.5% YoY
Insights
The Q3 results reveal concerning financial trends. Net loss more than doubled to
The clinical development program shows mixed signals. While completing enrollment for the Phase 2b TRD trial is positive, with results expected by Q1 2025, other areas face headwinds. The early termination of the bipolar II disorder trial due to recruitment difficulties is concerning. The FDA clinical hold on GH001 remains unresolved, with ongoing toxicology studies needed. The proprietary aerosol delivery device trial represents a critical pivot point - success could strengthen IP protection and commercial potential, while failure could significantly impact the development timeline. The PPD trial continuation suggests strategic prioritization of more promising indications.
- Phase 2b clinical trial of GH001 in patients with treatment-resistant depression completed enrolment of the double-blind phase in Q3 2024
- Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy volunteers is ongoing in the UK
- Cash, cash equivalents, other financial assets and marketable securities of
$193.8 million
DUBLIN, Nov. 14, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the third quarter ended September 30, 2024, and provided updates on its business.
Business Updates
GH001 in Patients with TRD
GH001, our proprietary inhaled mebufotenin (5-MeO-DMT) product candidate, is currently being investigated in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial in approximately 80 patients with treatment-resistant depression (TRD) (GH001-TRD-201). GH001 is administered on a single dosing day, without mandated in-trial psychotherapeutic intervention, consistent with our previously completed trials.
We completed enrolment of the double-blind phase in the third quarter of 2024, with top-line data expected to be available in the fourth quarter of 2024 or the first quarter of 2025. This trial includes a 6-month open-label extension which is on track for completion in the first quarter of 2025.
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.
Update on IND for GH001
As previously announced, our investigational new drug application (IND) for GH001 administered using our proprietary aerosol delivery device was placed on clinical hold by the U.S. Food and Drug Administration (FDA). Based on interactions with the FDA, we believe we have a path to respond on the device element of the hold. The nonclinical studies to address the inhalation toxicology aspect are ongoing.
Proof-of-Concept Trials with GH001
GH001 is being investigated in a proof-of-concept clinical trial in bipolar II disorder in patients with a current depressive episode (BDII) (GH001-BD-202). While increasing the number of sites has improved enrolment, recruitment has continued to be difficult and, for these reasons, the trial will end in the fourth quarter of 2024.
GH001 is also being investigated in a proof-of-concept clinical trial in patients with postpartum depression (PPD) (GH001-PPD-203). We continue to expect GH001-PPD-203 completion in the fourth quarter of 2024.
Third Quarter 2024 Financial Highlights
Cash position
Cash, cash equivalents, other financial assets 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 treatment of psychiatric and neurological disorders. GH Research PLC's initial focus is on developing its novel and proprietary mebufotenin (5-MeO-DMT) therapies for the treatment of patients with treatment-resistant depression (TRD).
GH Research PLC's annual report on Form 20-F filed with the U.S. Securities and Exchange Commission for the year ended December 31, 2023 is available at www.ghres.com and shareholders may receive a hard copy free of charge upon request.
About GH001
Our lead product candidate, GH001, is formulated for mebufotenin (5-MeO-DMT) administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with TRD. Based on the observed clinical activity, where
About GH002 and GH003
GH002 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach. We have completed a Phase 1 trial of GH002 in healthy volunteers. GH003 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intranasal administration approach. GH003 is currently in preclinical development. We anticipate developing GH002 and GH003 within our focus areas of psychiatric and neurological disorders.
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 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 preclinical studies and clinical trials, regulatory submissions and approvals and their effects on our business strategy, including our plans and expectations related to addressing the clinical hold on the GH001 IND, 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, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results 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 Income (Unaudited) (in thousands, except share and per share amounts) | |||||
| Three months ended September 30, | Nine months ended September 30, | ||||
| 2024 | 2023 | 2024 | 2023 | ||
| $’000 | $’000 | $’000 | $’000 | ||
| Operating expenses | |||||
| Research and development | (8,397) | (7,088) | (26,810) | (21,570) | |
| General and administration | (4,224) | (2,631) | (10,558) | (8,493) | |
| Loss from operations | (12,621) | (9,719) | (37,368) | (30,063) | |
| Finance income | 2,535 | 2,438 | 7,760 | 6,049 | |
| Finance expense | (181) | (184) | (538) | (534) | |
| Movement of expected credit loss | (2) | (17) | 45 | 1 | |
| Foreign exchange (loss)/gain | (1,845) | 1,833 | (58) | 232 | |
| Total other income | 507 | 4,070 | 7,209 | 5,748 | |
| Loss before tax | (12,114) | (5,649) | (30,159) | (24,315) | |
| Tax charge/(credit) | - | - | - | - | |
| Loss for the period | (12,114) | (5,649) | (30,159) | (24,315) | |
| Other comprehensive income/(expense) | |||||
| Items that may be reclassified to profit or loss | |||||
| Fair value movement on marketable securities | 908 | (428) | 258 | (1,216) | |
| Currency translation adjustment | 1,622 | (1,780) | (113) | (161) | |
| Total comprehensive loss for the period | (9,584) | (7,857) | (30,014) | (25,692) | |
| Attributable to owners: | |||||
| Loss for the period | (12,114) | (5,649) | (30,159) | (24,315) | |
| Total comprehensive loss for the period | (9,584) | (7,857) | (30,014) | (25,692) | |
| Loss per share | |||||
| Basic and diluted loss per share (in USD) | (0.23) | (0.11) | (0.58) | (0.47) | |
| GH RESEARCH PLC Condensed Consolidated Interim Balance Sheet (Unaudited) (in thousands) | ||
| At September 30, | At December 31, | |
| 2024 | 2023 | |
| $’000 | $’000 | |
| ASSETS | ||
| Current assets | ||
| Cash and cash equivalents | 90,059 | 78,420 |
| Other financial assets | 32,517 | 55,615 |
| Marketable securities | 27,461 | 27,525 |
| Other current assets | 4,909 | 2,529 |
| Total current assets | 154,946 | 164,089 |
| Non-current assets | ||
| Marketable securities | 43,806 | 61,142 |
| Property, plant and equipment | 859 | 1,069 |
| Total non-current assets | 44,665 | 62,211 |
| Total assets | 199,611 | 226,300 |
| LIABILITIES AND EQUITY | ||
| Current liabilities | ||
| Trade payables | 2,946 | 3,490 |
| Lease liability | 275 | 343 |
| Other current liabilities | 6,566 | 2,868 |
| Total current liabilities | 9,787 | 6,701 |
| Non-current liabilities | ||
| Lease liability | 458 | 631 |
| Total non-current liabilities | 458 | 631 |
| Total liabilities | 10,245 | 7,332 |
| Equity attributable to owners | ||
| Share capital | 1,301 | 1,301 |
| Additional paid-in capital | 291,463 | 291,463 |
| Other reserves | 4,866 | 4,651 |
| Foreign currency translation reserve | (10,620) | (10,507) |
| Accumulated deficit | (97,644) | (67,940) |
| Total equity | 189,366 | 218,968 |
| Total liabilities and equity | 199,611 | 226,300 |
FAQ
What is the current cash position of GH Research (GHRS) as of Q3 2024?
When will GH Research (GHRS) release top-line data for its Phase 2b TRD trial?
What was GH Research's (GHRS) net loss per share in Q3 2024?
Why is GH Research (GHRS) ending its bipolar II disorder trial?
