GHRS
GH ResearchBDocument history
Earnings documents stored for GHRS.
Investor releaseQuarter not tagged2026-05-16Assessing GH Research (GHRS) Valuation After Key Phase 2b Results And Phase 3 Trial Plans
Simply Wall St.
Assessing GH Research (GHRS) Valuation After Key Phase 2b Results And Phase 3 Trial Plans
Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. GH Research (NasdaqGM:GHRS) has drawn fresh attention after publishing Phase 2b results for its lead depression treatment in JAMA Psychiatry, advancing Phase 1 programs and outlining a global Phase 3 plan, while reporting a sizeable cash position. See our latest analysis for GH Research. Those clinical updates and fresh financing plans sit against a share price of US$21.39, with a 30-day share price return of 20.57% and a 90-day share price return of 45.51%. The 1-year total shareholder return of 94.81% points to strong, longer term momentum. If you are interested in other high growth healthcare stories, this is a good moment to scan the market using our screener for 32 healthcare AI stocks After a strong run and high profile clinical updates, the key question is whether GH Research’s current valuation still leaves upside or if the stock is already reflecting the market’s expectations for future growth. At a last close of $21.39, GH Research trades on a P/B of 5x, which places a clear valuation premium against many peers in its sector. The P/B ratio compares the company’s market value with the book value of its net assets. It is often used for early stage or unprofitable biopharma stocks where earnings and revenue are not yet meaningful. For GH Research, this means investors are currently paying around five times the company’s net assets, even though it reports no revenue and a net loss of $56.41m. Relative to similar companies covered in the data, GH Research screens as good value against a peer average P/B of 12.7x. This suggests investors are paying less per dollar of net assets than in that broader peer set. However, when compared specifically with the US Pharmaceuticals industry average of 2.3x, the stock looks expensive, with its 5x P/B sitting at more than double that industry benchmark. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-book of 5x (ABOUT RIGHT) However, the story still hinges on clinical outcomes and financing, with any trial setbacks or challenges in raising fresh capital potentially shifting sentiment quickly. Find out about the key risks to this GH Research narrative. The recent gains and premium valuation raise fair questions, so it makes sense t...
Investor releaseQuarter not tagged2026-05-14GH Research Reports First Quarter 2026 Financial Results and Provides Business Update
GlobeNewswire
GH Research Reports First Quarter 2026 Financial Results and Provides Business Update
Phase 2b results in TRD published in JAMA Psychiatry GH001-HV-106 study enrolment completed; doses selected for the global Phase 3 pivotal program of GH001 in TRD GH001-HV-109 US IND-opening study enrolment completed Cash, cash equivalents and marketable securities of $267.3 million as of March 31, 2026 Net cash proceeds of an additional $111.2 million from underwritten offering received in April 2026 DUBLIN, May 14, 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 March 31, 2026, and provided a business update. Business Updates Scientific Presentations and Publications In March 2026, the results of our Phase 2b trial in TRD (GH001-TRD-201) were published in JAMA Psychiatry. A post-hoc analysis reported alongside the publication demonstrated efficacy independent of the number of prior antidepressant treatment failures, with Day 8 remission rates of 53.9%-63.6% across subgroups. In January 2026, data from our clinical trials in TRD and bipolar II depression were presented in three posters at the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP). An additional three posters have been accepted to the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting 2026 in Miami (May 26–29), featuring data from our Phase 2b trial in TRD (GH001-TRD-201), including the post-hoc analysis of efficacy by prior antidepressant failure, secondary endpoints covering anxiety and quality of life, and impact on anhedonia. Proprietary Aerosol Delivery Device Study and Dose Selection We have completed enrolment in our Phase 1 clinical pharmacology trial in the UK, evaluating our proprietary aerosol delivery device for administration of GH001 in healthy volunteers (GH001-HV-106). We have selected the doses for our global Phase 3 pivotal program based on the results from this trial. IND-Opening Study for GH001 in the United States We have completed enrolment in our IND-opening Phase 1 trial of GH001 in healthy volunteers (GH001-HV-109) in the United States. Global Pivotal Program Plans We are seeking FDA alignment on the global Phase 3 pivotal program, which is intended to replicate the Phase 2b design. We continue to target initiation...
Investor releaseQuarter not tagged2026-03-25GH Research Announces Publication of Phase 2b Results for Mebufotenin (GH001) in JAMA Psychiatry and Reports New Finding of Severity-Independent Efficacy in TRD
GlobeNewswire
GH Research Announces Publication of Phase 2b Results for Mebufotenin (GH001) in JAMA Psychiatry and Reports New Finding of Severity-Independent Efficacy in TRD
Phase 2b results for GH001 in TRD now published and peer-reviewed in JAMA Psychiatry New peer-reviewed article in forthcoming issue of Psychopharmacology Bulletin demonstrates that GH001 efficacy is independent of prior antidepressant treatment failures DUBLIN, March 25, 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 announced two peer-reviewed publications from its Phase 2b clinical program of GH001 in treatment-resistant depression (TRD): the primary trial results in JAMA Psychiatry, and a new analysis demonstrating that efficacy is independent of the number of prior lifetime treatment failures in a forthcoming issue of Psychopharmacology Bulletin. JAMA Psychiatry Publication The peer-reviewed article, titled “GH001 vs Placebo in Patients with Treatment-Resistant Depression” has been published today in JAMA Psychiatry (DOI: 10.1001/jamapsychiatry.2026.0096). The publication includes the complete results from the randomized, double-blind, placebo-controlled Phase 2b trial of mebufotenin in patients with TRD, including all primary and secondary efficacy endpoints, safety and tolerability data, and initial results from the 6-month open-label extension. These results were previously reported in topline form. “Publication in JAMA Psychiatry provides independent peer-reviewed validation of our Phase 2b findings,” said Dr. Velichka Valcheva, Chief Executive Officer. “This supports our ongoing efforts to advance GH001 into global pivotal trials.” New Finding: GH001 Efficacy Is Independent of Prior Treatment Failures A supporting peer-reviewed article, titled “GH001 Efficacy is Independent of Prior Antidepressant Treatment Failures in Treatment-Resistant Depression: A Post Hoc Analysis of a Phase 2b Randomized Controlled Trial,” will be published in a forthcoming issue of Psychopharmacology Bulletin. In TRD, a well-established finding across multiple treatment modalities is that remission rates decline significantly with each successive antidepressant treatment failure. This pattern, first quantified in the landmark STAR*D trial (see About STAR*D below), represents a fundamental challenge in treating patients with extensive treatment histories. The new analysis of Phase 2b data demonstrates that GH001...
Investor releaseQuarter not tagged2026-03-06Psychedelic: Helus Pharma reports HLP004 Phase 2 signal detection study results
TipRanks
Psychedelic: Helus Pharma reports HLP004 Phase 2 signal detection study results
In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on study results, FDA alignment and a DSMB recommendation. Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential HELUS PHARMA REPORTS PHASE 2 HLP004 RESULTS: Helus Pharma (HELP) announced Thursday topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening. All study participants were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment. Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points in the HAM-A from baseline at six weeks. The study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy. At six months, the pooled study population showed 67% responders and 39% remitters. Participants randomized to both 20 mg and 2mg dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59% meeting the criteria for response and 32% for remission in the 20mg arm and a 30% responder and remitter rate in the 2mg arm at week 6. The study also found a short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours, fitting within the treatment paradigm of existing interventional psychiatry clinics. Additionally, results show a favorable tolerability p...
Investor releaseQuarter not tagged2026-03-05GH Research Reports Full Year 2025 Financial Results and Provides Business Update
GlobeNewswire
GH Research Reports Full Year 2025 Financial Results and Provides Business Update
Completed Phase 2b trial of GH001 in TRD and presented the full dataset at the 2025 ASCP and ECNP congresses GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment Cash, cash equivalents and marketable securities of $280.7 million as of December 31, 2025 DUBLIN, Ireland, March 05, 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 year ended December 31, 2025, and provided a business update. Business Update In 2025, the Company completed its Phase 2b trial of GH001 in treatment-resistant depression (TRD) and presented the full dataset at the 2025 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Arizona, and the 2025 European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam. GH Research is now actively seeking U.S. Food and Drug Administration (FDA) alignment on the design of its global Phase 3 pivotal program, which is intended to replicate the Phase 2b study. The Phase 2b trial met its primary endpoint with a placebo-adjusted Montgomery-Åsberg Depression Rating Scale (MADRS) reduction of -15.5 points at Day 8 (p<0.0001). In the double-blind portion, 57.5% of patients on GH001 achieved remission (MADRS ≤10) at Day 8 versus 0% on placebo. The open-label extension confirmed durable efficacy, with a 73% remission rate at six months achieved with infrequent retreatment visits and no mandated psychotherapy. The median duration of psychoactive experience was ~11 minutes, with 99% of patients deemed discharge-ready within one hour of dosing. Safety was favorable, with no treatment-related serious adverse events and no treatment emergent suicidal intent or behavior. “Our Phase 2b results reinforce our conviction that GH001 has the potential to be a practice-changing therapy for patients with TRD,” said Dr. Velichka Valcheva, Chief Executive Officer. “We look forward to aligning with the FDA on our global Phase 3 program, replicating phase 2b design, and advancing this innovative program with initiation targeted for 2026.” 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...
Investor releaseQuarter not tagged2025-11-06GH Research Reports Third Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
GH Research Reports Third Quarter 2025 Financial Results and Provides Business Updates
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 Wiesław J. Cubała, MD, PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk. In addition...
Investor releaseQuarter not tagged2025-08-07GH Research Reports Second Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
GH Research Reports Second Quarter 2025 Financial Results and Provides Business Updates
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 73% remission rate at 6 months with infrequent treatment visits and no mandated psychotherapeutic intervention. Safety analysis confirmed that 100% of patients from the double-blind part conti...
Investor releaseQuarter not tagged2025-05-09Psychedelic: Compass, GH Research, MindMed report quarterly earnings
TipRanks
Psychedelic: Compass, GH Research, MindMed report quarterly earnings
In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a patent grant and study results. Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. Q1 EARNINGS: On Thursday, Compass Pathways (CMPS) reported a first quarter loss per share of (24c), which compared to analyst estimates of a loss per share of (49c). The company said cash and cash equivalents were $260.1M as of March 31, compared with $165.1M as of December 31. Compass also guided to full year 2025 net cash used in operating activities in the range of $120M to $145M. The cash position at March 31 is expected to be sufficient to fund operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from the COMP006 study, which is expected in the second half of 2026. “We eagerly await the upcoming topline 6-week data readout, on track for late June, the first data from our pivotal phase 3 COMP360 program in treatment resistant depression.” said Kabir Nath, CEO. “Our continued progress reinforces Compass’ leadership in psychedelic therapy development, which we believe represents the next generation of mental health therapeutic options and can lead to significant value creation.” GH Research (GHRS) also reported Q1 results Thursday with a loss per share of (19c), which compared to analyst consensus of a loss per share of (20c). Cash, cash equivalents, other financial assets and marketable securities were $315.3M as of March 31, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6M as of December 31. Gross proceeds from public offering in Q1 were $150M. Additionally on Thursday, Mind Medicine (MNMD) reported a Q1 loss per share of (35c), which compared to analyst estimates of a loss per share of (37c). Cash, cash equivalents and investments totaled $245.5M as of March 31. The company believes that its cash, cash equivalents, and investments as of March 31 will be sufficient to fund the company’s operations into 2027. Based on the company’s current operating plan and anticipated R&D milestones, the company expects its cash runway to extend at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in General Anxie...
Investor releaseQuarter not tagged2025-05-08GH Research Reports First Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
GH Research Reports First Quarter 2025 Financial Results and Provides Business Updates
Primary endpoint met in Phase 2b trial with GH001 in TRD demonstrating -15.5 Point placebo-adjusted MADRS reduction Full response to the IND hold on track for submission in mid-2025 Cash, cash equivalents, other financial assets and marketable securities of $315.3 million as of March 31, 2025 DUBLIN, May 08, 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 March 31, 2025, and provided updates on its business. Business Updates GH001 in Patients with TRD Our multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in 81 patients with treatment-resistant depression (TRD) (GH001-TRD-201) has completed, with last patient visit in the open-label extension (OLE) occurring in Q1 2025. As recently announced, the trial met its primary endpoint with a significant placebo-adjusted Montgomery-Åsberg Depression Rating Scale (MADRS) reduction from baseline of -15.5 on Day 8 (p<0.0001). The majority of the patients treated with GH001 achieved remission (MADRS≤10) with a 57.5% remission rate on Day 8 compared with 0% in the placebo group (p<0.0001). All other secondary endpoints were met with clinically and statistically significant improvements on Day 8, compared with placebo. During the double-blind part, GH001 was well tolerated and no serious adverse events (SAE) were reported. There was no evidence of treatment-emergent suicidal ideation or behavior. Safety analysis has not yet been completed for the OLE, but as of January 22, 2025, no SAEs were reported throughout the OLE. As of January 22, 2025, 77.8% of the OLE completers were in remission at the 6-month visit, with infrequent treatments. Patients who had remission on Day 8 after their first active treatment had a 91.7% remission rate at 6 months. Further clinical trial results from the double-blind part and open-label extension of the trial are expected to be provided at upcoming scientific conferences. Proof-of-Concept Trials with GH001 We previously announced that the primary endpoint was met in two Phase 2a proof-of-concept trials with GH001, one in bipolar II disorder in patients with a current depressive episode (BDII) (GH001-BD-202) and, separately, another in patients with p...
Investor releaseQuarter not tagged2025-03-21Psychedelic: atai Life Sciences, NRx report quarterly results
TipRanks
Psychedelic: atai Life Sciences, NRx report quarterly results
In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a collaboration LOI and a study publication. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. EARNINGS: On Monday, atai Life Sciences (ATAI) reported a fourth quarter loss per share of (24c) on revenue loss of ($5,000), which compared to analyst estimates of a loss per share of (15c) and revenue of $18,000 for the same period last year. As of December 31, the company had cash, cash equivalents, restricted cash and short-term securities of $72.3M compared to $154.2M as of December 31, 2023. In February, the company completed an equity offering with net proceeds of $59.2M and now expects its cash, short-term securities, and public equity holdings to be sufficient to fund operations into 2027. “We are beginning the year in a strong financial position, thanks to the recent capital raise, which extends our runway into 2027, beyond when we expect the topline data readouts from the Phase 2 clinical trials of our two core programs, VLS-01 and EMP-01, in 1Q26” stated Srinivas Rao, CEO. “Our team is focused on executing these trials rigorously and efficiently to drive forward our mission to transform patient outcomes in mental health. We also look forward to several key milestones this year, notably Beckley Psytech’s BPL-003 Phase 2b topline results in patients with treatment-resistant depression as well as RL-007 in patients with cognitive impairment associated with schizophrenia, both expected mid-2025.” Additionally on Monday, NRx Pharmaceuticals (NRXP) reported a FY24 loss per share of ($2.36), which compared to a loss per share of ($3.98) for the same period last year. As of December 31, the company had approximately $1.4M in cash and cash equivalents. In January, the company completed two financings with aggregate gross proceeds of approximately $8.5M. Management believes that current available cash resources will be sufficient to support ongoing operations through at least the end of 2025. “Our work in the fourth quarter of 2024 and into 2025 has driven significant advances for our company and investors. We have retired debt that was impeding the launch of HOPE Therapeutics and brought new investors into the Company who are aligned with our objectives. We launched the fili...

