GH Research Reports Third Quarter 2026 Financial Results and Provides Business Update
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Rhea-AI Summary
GH Research (Nasdaq: GHRS) reported third-quarter financial results and outlined plans to advance GH001 into pivotal depression trials using single-dose delivery. Cash, cash equivalents and marketable securities were $350.6 million at September 30, 2026, versus $280.7 million at year-end 2025. Quarterly net loss narrowed to $12.450 million from $14.020 million.
In healthy volunteers, a planned pivotal dose produced a peak experience in 7 of 8 participants. The company expects an FDA End-of-Phase 2 meeting in Q1 2027, followed shortly by pivotal trials in treatment-resistant depression, subject to final alignment. In an open-label postpartum depression trial, all ten patients reached remission at 2 hours, Day 2 and Day 8; pivotal initiation is targeted for H2 2027, subject to regulatory alignment. Vanina Popova was appointed Chief Development Officer.
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Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointPostpartum depression Phase 2a met its primary endpoint: Day 8 depression-rating reduction of 35.4 points, p<0.0001.
- Moderate pointCash, cash equivalents and marketable securities increased to $350.6 million from $280.7 million at year-end 2025.
- Moderate pointQuarterly net loss narrowed to $12.450 million, or $0.18 per share, from $14.020 million, or $0.23.
- Moderate pointFDA initial feedback on the treatment-resistant depression pivotal program design was positive, the company said.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Treatment-resistant depression pivotal initiation is expected shortly after the Q1 2027 FDA End-of-Phase 2 meeting.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Postpartum depression pivotal initiation is targeted for the second half of 2027 using single-dose delivery.
- Moderate pointPhase 2b patient-reported quality of life improved 20.6 points at Day 8, p<0.0001, maintained at Month 6.
- Moderate pointPhase 2b anhedonia factor score improved by 9.9 points at Day 8, p<0.0001, maintained at Month 6.
5 minor points
- Minor pointQuarterly R&D expenses declined to $10.071 million from $10.567 million a year earlier.
- Minor pointQuarterly administrative expenses declined to $5.285 million from $5.998 million a year earlier.
- Minor pointGH001-HV-106 showed peak experience in 88% of participants, 7 of 8, at the planned pivotal dose.
- Minor pointAll ten postpartum depression patients were in remission at 2 hours, Day 2 and Day 8.
- Minor pointBipolar II Phase 2a data showed rapid, clinically meaningful improvement in anhedonia, the company reported.
Negative
- Moderate pointNine-month net loss widened to $46.563 million, or $0.71 per share, from $34.121 million, or $0.56.
- Moderate pointTreatment-resistant depression pivotal design and initiation remain subject to final FDA alignment.
- Moderate pointPostpartum depression pivotal initiation remains subject to final regulatory alignment.
- Minor pointNine-month R&D expenses increased to $34.849 million from $27.377 million a year earlier.
- Minor pointNine-month administrative expenses increased to $18.711 million from $16.624 million a year earlier.
2 minor points
- Minor pointNine-month total other income declined to $6.997 million from $9.880 million a year earlier.
- Minor pointPostpartum depression Phase 2a evidence comes from an open-label trial involving ten patients.
Key Figures
- PPD remission
- 10 of 10 patients
- In remission at 2 hours, Day 2 and Day 8 after a single administration day
- MADRS reduction
- -35.4 points; p<0.0001
- Phase 2a PPD trial, change from baseline on Day 8
- Peak experience rate
- Up to 88% (7 of 8 participants)
- GH001-HV-106 at a single dose planned for the pivotal program
- Loaded dose delivered
- 82% to 89%, compared with 55% to 79%
- ADS bench testing compared with the third-party vaporizer
- Cash, cash equivalents and marketable securities
- $350.6 million
- As of September 30, 2026; compared with $280.7 million at December 31, 2025
- Net loss
- $12.5 million; $0.18 loss per share
- Quarter ended September 30, 2026; compared with $14.0 million and $0.23 per share in the prior-year quarter
Previous Earnings Reports
-
FDA feedback and completed Phase 1 work advanced the planned GH001 TRD pivotal program.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
madrs medical
open-label medical
double-blind medical
randomized medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Novel GH001 Aerosol Delivery System (ADS) device: final results of the GH001-HV-106 trial support going from 3 → 1 doses per treatment visit
- TRD pivotal program — positive initial feedback from FDA, End-of-Phase 2 meeting expected in Q1 2027, initiation shortly after
- PPD pivotal program — initiation targeted for H2 2027
- Vanina Popova, MD, appointed Chief Development Officer — Formerly Clinical Development at J&J, lead author of pivotal Spravato® trial publication
- Cash, cash equivalents and marketable securities of
$350.6 million as of September 30, 2026
DUBLIN, Nov. 13, 2026 (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, 2026, and provided a business update.
Business Updates
Global Pivotal Program of GH001 in TRD
The final results of our Phase 1 trial GH001-HV-106 in healthy volunteers support one fixed dose of GH001 per treatment visit with our novel GH001 Aerosol Delivery System (ADS). Our Phase 2b trial, which used a third-party vaporizer, titrated patients to a peak experience with an individualized dosing regimen (IDR) of up to three doses per treatment visit:
We have received positive initial feedback from the U.S. Food and Drug Administration (FDA) on the design of our pivotal program in treatment-resistant depression (TRD) using the novel GH001 ADS. As currently planned, the pivotal trials will be randomized and double-blind, comparing parallel fixed-dose arms with placebo, with one fixed dose per treatment visit, a primary endpoint of Montgomery-Åsberg Depression Rating Scale (MADRS) change from baseline at Week 4 and a 12-week double-blind period. We expect to hold an End-of-Phase 2 meeting with the FDA in Q1 2027 to finalize the design and to initiate the pivotal program in TRD shortly thereafter, subject to final alignment.
GH001 in Postpartum Depression
In our open-label Phase 2a trial of GH001 in postpartum depression (PPD) (GH001-PPD-203), all ten patients were in remission at 2 hours, on Day 2 and on Day 8 after a single administration day with the IDR, and the primary endpoint was met with a MADRS reduction from baseline of -35.4 points on Day 8 (p<0.0001). We plan to advance GH001 in PPD into a pivotal program with one fixed dose per treatment visit via the ADS and are targeting initiation in the second half of 2027, subject to final regulatory alignment.
“Women with postpartum depression need treatments that work quickly and ask little of them at a time when they are caring for a newborn. In the Phase 2a trial, every patient was in remission within hours of a single treatment day. A single dose given in a visit of about an hour would fit the lives of new mothers, and I am glad to see GH001 move toward a pivotal program in postpartum depression,” said Kristina M. Deligiannidis, MD, of the Feinstein Institutes for Medical Research at Northwell Health.
Corporate Update
In a separate press release issued today, we announced the appointment of Vanina Popova, MD, as Chief Development Officer, to lead the clinical development of GH001 into our pivotal programs. Dr. Popova was previously at Johnson & Johnson, where she worked on the clinical development of Spravato® (esketamine) and was the lead author of the publication of TRANSFORM-2, its pivotal Phase 3 trial in TRD.
Scientific Presentations
In September 2026, we presented a poster at the International Society for Bipolar Disorders (ISBD) 2026 Annual Conference with data from our Phase 2a GH001-BD-202 trial in patients with bipolar II disorder showing rapid and clinically meaningful improvement in anhedonia.
In October 2026, we hosted an industry symposium on rapid-acting antidepressants in TRD and presented three posters at the 39th European College of Neuropsychopharmacology (ECNP) Congress, including data from our Phase 2b GH001-TRD-201 trial showing improvements on Day 8 in patient-reported quality of life (Q-LES-Q-SF change from baseline, 20.6 points, p<0.0001) and in MADRS anhedonia factor score (change from baseline, -9.9 points, p<0.0001), both maintained at Month 6 with infrequent treatment in the open-label extension, as well as efficacy and safety data from GH001-BD-202.
Third Quarter 2026 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 TRD.
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 Montgomery-Åsberg Depression Rating Scale (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.
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 plans and expectations with respect to the initiation, timing, progress and design of our global Phase 3 pivotal program for GH001; our plans and expectations with respect to seeking FDA alignment on the pivotal program design; our plans and expectations with regard to advancing GH001 in PPD into a pivotal program, including initiation, timing, progress and design of such 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 United States, 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 we may not be able to initiate or complete our global Phase 3 pivotal program for GH001 on the timelines we are targeting or at all; the risk that we may not obtain FDA alignment on the pivotal program design on favorable terms or at all; the risk that we may not be able to initiate or complete a pivotal program of GH001 in PPD on the timelines we are targeting or at all; the risk that results from our Phase 1 trial in healthy volunteers and our open-label Phase 2a trial may not be predictive of results in our pivotal trials, the risk that future clinical trials of GH001 or clinical trials of GH002 or other product candidates we propose in future INDs are placed on clinical hold by the FDA; the risk that we may not be able 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
Magnus Halle
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 September 30, | Nine months ended September 30, | ||||
| 2026 | 2025 | 2026 | 2025 | ||
| $’000 | $’000 | $’000 | $’000 | ||
| Operating expenses | |||||
| Research and development | (10,071) | (10,567) | (34,849) | (27,377) | |
| General and administration | (5,285) | (5,998) | (18,711) | (16,624) | |
| Loss from operations | (15,356) | (16,565) | (53,560) | (44,001) | |
| Finance income | 2,992 | 2,783 | 7,843 | 8,616 | |
| Finance expense | (75) | (21) | (242) | (373) | |
| Movement of expected credit loss | 4 | 30 | 12 | 24 | |
| Foreign exchange (loss)/gain | (15) | (247) | (616) | 1,613 | |
| Total other income | 2,906 | 2,545 | 6,997 | 9,880 | |
| Loss before tax | (12,450) | (14,020) | (46,563) | (34,121) | |
| Tax charge/(credit) | - | - | - | - | |
| Loss for the period | (12,450) | (14,020) | (46,563) | (34,121) | |
| Other comprehensive (expense)/income | |||||
| Items that may be reclassified to profit or loss | |||||
| Fair value movement on marketable securities | (38) | (33) | (167) | (55) | |
| Currency translation adjustment | (52) | (63) | (1,791) | 926 | |
| Total comprehensive loss for the period | (12,540) | (14,116) | (48,521) | (33,250) | |
| Attributable to owners: | |||||
| Loss for the period | (12,450) | (14,020) | (46,563) | (34,121) | |
| Total comprehensive loss for the period | (12,540) | (14,116) | (48,521) | (33,250) | |
| Loss per share | |||||
| Basic and diluted loss per share (in USD) | (0.18) | (0.23) | (0.71) | (0.56) | |
| GH RESEARCH PLC Condensed Consolidated Interim Balance Sheet (Unaudited) (in thousands) | ||
| At September 30, | At December 31, | |
| 2026 | 2025 | |
| $’000 | $’000 | |
| ASSETS | ||
| Current assets | ||
| Cash and cash equivalents | 345,088 | 246,251 |
| Marketable securities | 5,501 | 34,457 |
| Other current assets | 6,523 | 5,268 |
| Total current assets | 357,112 | 285,976 |
| Non-current assets | ||
| Property, plant and equipment | 519 | 620 |
| Other non-current assets | 2,281 | 1,634 |
| Total non-current assets | 2,800 | 2,254 |
| Total assets | 359,912 | 288,230 |
| LIABILITIES AND EQUITY | ||
| Current liabilities | ||
| Trade payables | 5,339 | 3,773 |
| Lease liability | 283 | 365 |
| Other current liabilities | 5,263 | 4,242 |
| Total current liabilities | 10,885 | 8,380 |
| Non-current liabilities | ||
| Lease liability | 7 | 147 |
| Total non-current liabilities | 7 | 147 |
| Total liabilities | 10,892 | 8,527 |
| Equity attributable to owners | ||
| Share capital | 1,717 | 1,551 |
| Additional paid-in capital | 542,946 | 431,061 |
| Other reserves | 17,909 | 13,292 |
| Foreign currency translation reserve | (13,567) | (11,776) |
| Accumulated deficit | (199,985) | (154,425) |
| Total equity | 349,020 | 279,703 |
| Total liabilities and equity | 359,912 | 288,230 |
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