GHRS

Alignment with FDA on CMC and device plans for Phase 3 Successfully completed GH001-HV-106 and GH001-HV-109 Phase 1 trials Further strengthening of US and EU mebufotenin patent estate Phase 2a results in postpartum depression published in The Journal of Clinical Psychiatry Cash, cash equivalents and marketable securities of $362.7 million as of June 30, 2026 DUBLIN, Aug. 06, 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 June 30, 2026, and provided a business update. Business Updates Global Pivotal Program of GH001 in TRDWe have completed GH001-HV-106, our Phase 1 clinical pharmacology trial of our proprietary aerosol delivery device in healthy volunteers, and GH001-HV-109, our IND-opening Phase 1 trial of GH001 in healthy volunteers in the United States. Based on the results of GH001-HV-106, we have selected the doses for our pivotal program. In July 2026, we received written responses from the FDA confirming that our CMC and device plans appear Phase 3 ready. We continue to engage with the FDA on the design of the pivotal program, which is intended to replicate the Phase 2b trial, including consideration of recent FDA guidance issued in July 2026, and we continue to target initiation of our pivotal program in 2026. Intellectual PropertyIn July 2026, the U.S. Patent and Trademark Office granted U.S. Patent No. 12,685,721, with claims directed to methods of treating major depressive disorder (MDD) and treatment-resistant depression (TRD), by administering an aerosol of mebufotenin, which is expected to expire no earlier than 2043. We continue to be the company with the earliest patent filings relating to treatment of MDD and TRD using mebufotenin and continue prosecution of further claims. Also in July 2026, the main request of our European Patent No. 3 927 337 was maintained following an opposition hearing before the European Patent Office. As maintained, the patent claims mebufotenin, and salts thereof, for use in the treatment of MDD and TRD including, but not limited to, mebufotenin administered through inhalation, intravenous and intranasal routes, and is expected to expire no earlier than 2040. Publications and Scientific PresentationsIn June 2026, the full results of our Phase 2a trial of GH001 in postpartum depression were published in The Journal of Clinical Psychiatry. In addition, an analysis of our Phase 2b GH001-TRD-201 trial showing efficacy independent of the number of prior antidepressant treatment failures was published in Psychopharmacology Bulletin. Data from GH001-TRD-201 were also presented at the American Society of Clinical Psychopharmacology Annual Meeting in May 2026 and at the 37th World Congress of Neuropsychopharmacology in June 2026, and further posters have been accepted for the International Society for Bipolar Disorders Annual Conference in September 2026 and the European College of Neuropsychopharmacology Congress in October 2026, where we will also host an industry symposium. Second Quarter 2026 Financial Highlights Cash positionCash, cash equivalents and marketable securities were $362.7 million as of June 30, 2026, compared to $280.7 million as of December 31, 2025. Gross proceeds from the underwritten offering in Q2 2026 were $117.5 million. Marketable securities are comprised of investment grade bonds. Research and development expensesR&D expenses were $12.4 million for the quarter ended June 30, 2026, compared to $9.0 million for the same quarter in 2025. The increase is primarily due to increased clinical development expenses as well as employee expenses. General and administrative expensesG&A expenses were $7.1 million for the quarter ended June 30, 2026, compared to $5.7 million for the same quarter in 2025. The increase is primarily due to an increase in professional fees. Net lossNet loss was $15.1 million, or $0.23 loss per share, for the quarter ended June 30, 2026, compared to $9.3 million, or $0.15 loss per share, for the same quarter in 2025. 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 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 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 Julie RyanGH Research [email protected]

DUBLIN, June 04, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS) today announced the publication of the full results from its Phase 2a trial in postpartum depression (PPD) and the acceptance of two oral presentations at the 37th World Congress of Neuropsychopharmacology (CINP 2026). The peer-reviewed article, titled “Inhaled Mebufotenin (GH001) for Adult Patients with Postpartum Depression: A Phase 2a Open-Label Clinical Trial,” has been published in The Journal of Clinical Psychiatry (DOI: 10.4088/JCP.25m16284). The article reports the full results from the Phase 2a, single-arm, open-label trial, which enrolled 10 adult women with PPD. Key results: Primary endpoint met: Mean Montgomery–Åsberg Depression Rating Scale (MADRS) reduction of -35.4 points from baseline to Day 8 (P<0.0001) 100% of patients (10/10) achieved remission (MADRS total score ≤10) within two hours of dosing, sustained through Day 8 Improved maternal functioning: Mean 34.1-point (56%) increase on the Barkin Index of Maternal Functioning at Day 8 Well-tolerated: No serious adverse events; all treatment-emergent adverse events mild or moderate; no treatment-emergent suicidal ideation or behavior An analysis of breast milk supports a treatment strategy with only a brief interruption of breastfeeding around GH001 dosing “To our knowledge, this is the first published clinical trial of a psychedelic-based therapeutic specifically in postpartum depression, and the rapid remission achieved by all patients within hours of a single-day inhaled treatment, sustained through Day 8 with a favorable safety profile and only brief interruption of breastfeeding, is encouraging for a population that needs additional rapid-acting therapeutic options. These findings support further investigation of inhaled mebufotenin in larger, randomized, placebo-controlled trials in postpartum depression,” said Kristina M. Deligiannidis, MD, of the Feinstein Institutes for Medical Research at Northwell Health. The Company also announced that two featured communications have been accepted for oral presentation at CINP 2026, to be held June 26–29, 2026 in Glasgow, United Kingdom. Both present data from the Phase 2b GH001-TRD-201 trial of GH001 in treatment-resistant depression (TRD). Details: Featured Communication (Oral Presentation)Presentation Title: Rapid Antidepressant Effects of Inhaled GH001 in Treatment-Resistant Depression: Results from a Phase 2b, Double-Blind, Randomized Controlled Trial With 6-Month Follow-UpPresenting Author: Wiesław J. Cubała, MD, PhD, Medical University of Gdańsk, Gdańsk, PolandDate and Time: Saturday, June 27, 2026, 12:30–12:45 BST Featured Communication (Oral Presentation)Presentation Title: Safety and Tolerability Results from a Phase 2b, Double-Blind Trial With an Open-Label Extension of GH001 in Treatment-Resistant DepressionPresenting Author: Bernhard T. Baune, MD, PhD, MPH, MBA, FRANZCP, University of Münster, Münster, GermanyDate and Time: Sunday, June 28, 2026, 12:15–12:30 BST 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 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 the therapeutic potential of mebufotenin and GH001; strategies and prospects for our business; our plans and expectations for the continued clinical development of GH001 in PPD, TRD and other indications; the timing of scientific publications and presentations; and the development and therapeutic potential of mebufotenin and GH001, 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 preliminary results from small, open-label, proof-of-concept trials, including our Phase 2a trial of GH001 in PPD, may not be predictive of, or replicated in, larger, randomized, placebo-controlled trials; the risk that we may not initiate or complete further clinical development of GH001 on the timelines we are targeting or at all; the risk that future clinical trials of GH001 are placed on clinical hold by the FDA or fail to enroll on the timelines we are targeting; risks relating to adverse public perception of mebufotenin and other psychedelic or controlled substances and their classification under the Controlled Substances Act; 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 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 RyanGH Research [email protected]

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 to review the data yourself and decide quickly where you stand. A good place to start is by checking the 2 important warning signs. If you stop at a single stock, you risk missing other opportunities that fit your style, so use the screener and keep your watchlist sharp and informed. Target potential mispricings by scanning 50 high quality undervalued stocks that combine quality fundamentals with attractive valuations. Prioritise resilience by reviewing 66 resilient stocks with low risk scores that score well on financial health and volatility metrics. Spot early-stage opportunities by checking the 25 elite penny stocks with strong financials that meet strict financial and quality filters. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include GHRS. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

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 of our global pivotal program in late 2026. “The first quarter of 2026 marks progress as planned toward our global GH001 Phase 3 pivotal program,” said Dr. Velichka Valcheva, Chief Executive Officer. First Quarter 2026 Financial Highlights Cash position Cash, cash equivalents and marketable securities were $267.3 million as of March 31, 2026, compared to $280.7 million as of December 31, 2025. Research and development expenses R&D expenses were $12.4 million for the quarter ended March 31, 2026, compared to $7.9 million for the same quarter in 2025. The increase is primarily due to increased expenses relating to our technical development and clinical development expenses, as well as employee expenses; partly offset by a decrease in nonclinical expenses. General and administrative expenses G&A expenses were $6.4 million for the quarter ended March 31, 2026, compared to $4.9 million for the same quarter in 2025. The increase is primarily due to an increase in professional fees. Net loss Net loss was $19.0 million, or $0.31 loss per share, for the quarter ended March 31, 2026, compared to $10.8 million, or $0.19 loss per share, for the same quarter in 2025. 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 respect to progressing development of GH002 including with respect to the timing, scope and likelihood of IND submission and approval with the FDA; 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 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 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 [email protected]

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 does not follow this pattern: Day 8 remission rates ranged from 53.9% to 63.6% across patients with 2 to ≥5 prior lifetime antidepressant failures, with no decline at higher failure counts; End of trial/Month 6 remission rates ranged from 61.5% to 85.7% across the same subgroups; and No meaningful correlation was observed between the number of prior lifetime treatment failures and Montgomery-Åsberg Depression Rating Scale (MADRS) improvement at Day 8 (r=−0.13; P=0.44) or among those who completed the 6-month OLE (r=−0.10; P=0.60). “One interesting, unanticipated finding from this trial is that the benefit of GH001 appeared to be independent of the number of prior lifetime antidepressant failures. Remission rates were consistently high across subgroups – in contrast to the decline seen with each successive treatment that we observed in the STAR*D trial. This suggests patients who have not responded to three or more prior courses of antidepressant therapy might benefit from this novel therapy,” said Michael E. Thase, MD, Professor of Psychiatry, Perelman School of Medicine at the University of Pennsylvania. Consistent with the findings of this article, GH001 efficacy is also independent from prior treatment failures within the current depressive episode in this Phase 2b trial. 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. 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 STAR*D The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial was the largest and most comprehensive prospective study of depression treatment outcomes ever conducted. Funded by the National Institute of Mental Health (NIMH), the trial enrolled 4041 outpatients with major depressive disorder across 41 U.S. clinical sites between 2001 and 2004. The study used a sequential design in which patients who did not achieve remission on an initial antidepressant (citalopram) were moved through up to four successive treatment steps, each involving a switch to or augmentation with a different medication. STAR*D’s central finding was that remission rates declined progressively with each treatment step: 36.8% achieved remission after the first course, 30.6% after the second, 13.7% after the third, and just 13.0% after the fourth (Rush et al., American Journal of Psychiatry, 2006). Cumulatively, after all four steps, approximately one-third of patients had still not achieved remission. This pattern of diminishing returns with increasing treatment resistance has been widely replicated and is now considered a defining characteristic of TRD. 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 our global Phase 3 pivotal program for GH001, strategies and prospects for our business, including the development and therapeutic potential of mebufotenin and GH001, 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 from time to time. 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 [email protected]

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 profile with no drug-related serious adverse events or suicidality-related safety signals. Michael Cola, CEO, said, “Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments. We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients. The Company’s broad intellectual property portfolio has been leveraged once again to create what we feel are best in class products and we are further excited to release the data on HLP003 targeted at major depressive disorder in the fourth quarter of 2026.” ATAIBECKLEY ALIGNS WITH FDA ON BPL-003 PHASE 3 DESIGN: AtaiBeckley (ATAI) announced on Tuesday results of an End‑of‑Phase 2 meeting with the U.S. Food and Drug Administration regarding the development of BPL‑003, the company’s proprietary intranasal formulation of mebufotenin benzoate, for treatment‑resistant depression. Minutes from the meeting show that the FDA indicated support for AtaiBeckley’s proposed BPL-003 pivotal program and the compound’s advancement into Phase 3 studies in adults with TRD. The FDA also provided constructive feedback on the overall design and key components of the proposed program, including the overall size of the safety database for this chronic indication. The Phase 3 program is designed to include two pivotal studies, ReConnection 1 and ReConnection 2, conducted in parallel. Both will include a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension in which participants may receive individualized retreatment with BPL-003, subject to pre-specified eligibility criteria. The core study will enroll approximately 350 participants and will evaluate a single-dose of BPL-003 across three treatment arms – 8 mg, 4 mg, and placebo. This trial is designed to replicate and extend the treatment response observed in the Phase 2b study and to further characterize the dose–response relationship for BPL-003. ReConnection 2 will enroll approximately 300 participants and will evaluate BPL-003 administered on Day 1 and Day 15 across two arms – 8 mg BPL-003 and placebo. This trial is designed to investigate a two-dose induction model of BPL-003 as a potential treatment option to increase magnitude and durability of initial response. The primary endpoint in both pivotal trials will be the change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at Week 4 of the response in the 8 mg BPL-003 treatment arm compared to placebo. In the OLE, participants may receive 8 mg BPL-003 at 8‑ or 12‑week intervals, subject to certain conditions for re-treatment eligibility, with the goal of maintaining remission and assessing long‑term safety, durability of effects, and treatment patterns. “Receiving clear guidance from the FDA at this stage is a major milestone for AtaiBeckley and for the BPL‑003 program,” said Srinivas Rao, CEO. “This feedback builds on our compelling Phase 2b data as well as the Breakthrough Therapy Designation granted to BPL-003 in October 2025 and firmly positions us to advance a robust Phase 3 clinical program designed to maximize the probability of regulatory and commercial success. With this development, we maintain our conviction that BPL-003 has the potential to offer a rapid, durable and convenient treatment option for the millions of people living with treatment-resistant depression.” CLEARMIND GETS DSMB RECOMMENDATION FOR TRIAL CONTINUATION: Clearmind Medicine (CMND) announced Wednesday that its independent Data and Safety Monitoring Board has completed the second scheduled interim review of the company’s ongoing FDA-approved Phase I/IIa clinical trial for CMND-100, a proprietary, non-hallucinogenic neuroplastogen, in the treatment of Alcohol Use Disorder. Based on the additional top-line data from the second cohort, which demonstrated a favorable safety profile, the DSMB recommended that the clinical trial continue. The results of the second cohort, in which twice the dose was administered compared to a single dose in the first cohort, reinforce no serious adverse events and overall good tolerability, consistent with the results reported from the first cohort. The results support the rapid progression enabled by the DSMB’s unanimous approval to advance for the third cohort, for which the dose is 80 mg per administration, which is double the dose administered in the second cohort. GH RESEARCH REPORTS Q4 EARNINGS: GH Research (GHRS) reported FY25 loss per share of (79c) on Thursday, which compared to analyst estimates of a loss per share of (82c). Cash, cash equivalents and marketable securities were $280.7M as of December 31. In 2025, the company completed its Phase 2b trial of GH001 in treatment-resistant depression and presented the full dataset at the 2025 American Society of Clinical Psychopharmacology Annual Meeting in Arizona, and the 2025 European College of Neuropsychopharmacology Congress in Amsterdam. GH Research is now actively seeking 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 MADRS reduction of -15.5 points at Day 8. In the double-blind portion, 57.5% of patients on GH001 achieved remission 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, CEO. “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.” PHARMALA SIGNS SUPPLY, DATA AGREEMENT WITH NAUTILUS SANCTUARY: PharmAla Biotech Holdings (MDXXF) announced Tuesday that it has executed a supply and data agreement with Nautilus Sanctuary of Brooklyn, New York, for the provision of MDMA for use in a Phase 2 clinical trial in the United States. Under the agreement, PharmAla will supply its LaNeo MDMA to Nautilus Sanctuary for use in an open-label clinical trial entitled “An Open Label Study to Treat Post-Traumatic Stress in Frontline Healthcare Workers and First Responders Using MDMA-Assisted Therapy”. In consideration for the supply of LaNeo MDMA, Nautilus Sanctuary will grant PharmAla a perpetual, non-exclusive license to the clinical trial data, which includes pseudonymized and de-identified raw data sets as well as Nautilus Sanctuary’s analysis of the safety and efficacy of the intervention. The license permits PharmAla to use the data for regulatory approvals and any commercial purpose in any jurisdiction globally. “This agreement represents a continuation of our innovative supply-for-data model, which we believe creates significant value for both parties,” said Nicholas Kadysh, CEO. “Frontline healthcare workers and first responders bear an enormous mental health burden, and we are proud to support Nautilus Sanctuary in their efforts to bring MDMA-assisted therapy to these critical populations. The clinical data generated in the United States under this agreement will be an important addition to our growing portfolio of clinical evidence supporting the safety and efficacy of LaNeo MDMA.” PSYENCE BIOMED REPORTS PSILOCYBIN EXPORT: Psyence Biomedical (PBM) announced Tuesday the export of fully GMP-compliant manufactured psilocybin product NPX-5 to Australia. The product was manufactured at the Psyence Labs GMP-controlled production facility, supporting pharmaceutical-grade psychedelic development. The exported NPX-5 product will now be used in Psyence BioMed’s ongoing Phase IIb clinical trial in Australia, a double-blind, randomized, low-dose comparator-controlled, multi-center study evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer in a palliative care context. The trial is enrolling 87 participants across multiple Australian sites, including Melbourne and Perth/ Patient dosing is underway, with initial participants having been dosed in late 2025, and all newly enrolled patients will be dosed with NPX-5. “This export demonstrates more than regulatory clearance – it validates the operational readiness of our vertically integrated model,” said Jody Aufrichtig, CEO. “The successful manufacture and export of GMP-compliant natural psilocybin at this stage of clinical development demonstrates that we are not simply participating in this sector – we are helping define its standards. Operational discipline, supply control, and product excellence are foundational to our platform.” PRICE TARGET RAISES: Maxim raised the firm’s price target on Definium Therapeutics (DFTX) to $40 from $18 and kept a Buy rating on the shares after its Q4 results. The company’s cash on the balance sheet should provide sufficient funding into 2028, through a busy 2026 with three Phase 3 pivotal readouts for DT120, the analyst said. As the readout in major depressive disorder approaches, the firm is factoring in revenues for MDD in 2029, Maxim added. H.C. Wainwright raised the firm’s price target on Bright Minds (DRUG) to $145 from $115 and kept a Buy rating on the shares. The firm says the BREAKTHROUGH Phase 2 data “de-risks” BMB-101 and establishes 5-HT2C agonist as potentially best-in-class. H.C. Wainwright increased its probability of success for the absence epilepsy program to 60% from 25%, reflecting what it believes is a “significant efficacy signal and validation from the trial.” H.C. Wainwright also raised the firm’s price target on NRx Pharmaceuticals (NRXP) to $45 from $40 and kept a Buy rating on the shares. The firm said the Type C FDA meeting “provides a clear” application pathway for NRX-100. This is “supported by real-world evidence and a broader proposed indication, significantly de-risking the program,” the analyst said. H.C. Wainwright expanded the addressable population for NRX-100 and increased its risk-adjusted NRX-100 valuation to $15 per share from $10. OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), BetterLife (BETRF), Compass Pathways (CMPS), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF) and Silo Pharma (SILO). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders’ Hot Stocks on TipRanks >> Read More on HELP: Disclaimer & DisclosureReport an Issue Cybin’s Helus Pharma Posts Strong Phase 2 Data for HLP004 in Hard-to-Treat Anxiety Helus Pharma announces results in Phase 2 signal detection study of HLP004 Cybin Corrects Exhibit References in Form 6-K to Align With Active F-10 Shelf Psychedelic: AtaiBeckley reports EMP-01 met primary objective in Phase 2a trial Helus Pharma Names Former Pfizer CMO Freda Lewis-Hall to Board and Scientific Advisory Role

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-HV-106) is designed to support our global program for GH001, by bridging from the commercially available device we have used in our clinical trials to date to our new proprietary device. We intend to use our proprietary device in our pivotal clinical trial program. Full Year 2025 Financial Highlights Cash position Cash, cash equivalents and marketable securities were $280.7 million as of December 31, 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 Research and development expenses were $38.8 million for the year ended December 31, 2025, compared to $35.0 million for the full year 2024. The increase is primarily due to increased expenses relating to technical development activities, nonclinical activities and employee expenses, partly offset by a decrease in clinical development expenses. General and administrative expenses General and administrative expenses were $22.0 million for the year ended December 31, 2025, compared to $15.3 million for the full year 2024. The increase is primarily due to an increase in professional fees and employee expenses. Net loss Net loss was $48.3 million, or $0.79 per share, for the year ended December 31, 2025, compared to a net loss of $39.0 million, or $0.75 per share, for the full year 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 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 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 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 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 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 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 [email protected]

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, 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 [email protected]

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 continued in the OLE and there were no treatment related serious adverse events across the full 6-month duration of the trial. No treatment-emergent events of suicidal intent or suicidal behavior occurred throughout the 6-month duration of the trial and lower rates of suicidal ideation were observed in comparison to baseline at any timepoint assessed during the study. 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 $308.7 million as of June 30, 2025, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6 million as of December 31, 2024. Gross proceeds from public offering in Q1 2025 were $150.0 million. 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 $9.0 million for the quarter ended June 30, 2025, compared to $9.8 million for same quarter in 2024. The decrease is primarily due to decreased expenses relating to clinical development activities and the recognition of a research and development tax credit, partly offset by an increase in technical development expenses and employee expenses. General and administrative expenses G&A expenses were $5.7 million for the quarter ended June 30, 2025, compared to $3.5 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 $9.3 million, or $0.15 loss per share, for the quarter ended June 30, 2025, compared to $10.4 million, or $0.20 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 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 [email protected] GH RESEARCH PLC Condensed Consolidated Interim Statement of Comprehensive Loss (Unaudited) (in thousands, except share and per share amounts) GH RESEARCH PLC Condensed Consolidated Interim Balance Sheet (Unaudited) (in thousands)

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 Anxiety Disorder. “We are proud to share that all three of our pivotal Phase 3 trials evaluating MM120 ODT in patients with GAD and MDD—Voyage, Panorama, and Emerge—are actively enrolling. Momentum is building, with strong and growing enthusiasm from both clinical sites and patients as recruitment continues to accelerate,” said Rob Barrow, CEO. “We’re on track to report topline data from Voyage in the first half of 2026, followed by Panorama and Emerge in the second half of the year. With our breakthrough therapy designation in GAD, a clearly defined regulatory strategy, and strong operational execution across our programs, we’re delivering on our goal of advancing MM120 ODT as a potential best-in-class, differentiated therapeutic option. Our team remains fully committed to delivering transformational innovation for the over 50 million people in the U.S. living with GAD or MDD as we drive toward commercialization.” CYBIN ANNOUNCES U.S. PATENT GRANT: Cybin (CYBN) announced Thusday that the United States Patent and Trademark Office has granted U.S. patent 12,291,499 in support of its CYB003 program in Major Depressive Disorder. The patent, which is expected to provide exclusivity until 2041, includes claims to pharmaceutical compositions and oral dosage forms within the company’s proprietary deuterated psilocin analog program, CYB003. “Securing an additional patent in support of CYB003 provides important validation of our program and reinforces the commercial potential of our pipeline,” said Doug Drysdale, CEO. “Robust patent protection is essential for drug development companies, and we are proud of our expanding intellectual property portfolio. As we continue to dose patients in our first Phase 3 study, we are focused on execution, delivering shareholder value, and ultimately, creating more effective treatments for those with mental health disorders.” MIRA REPORTS KETAMIR-2 NEUROTOXICITY RESULTS: On Tuesday, MIRA Pharmaceuticals (MIRA) announced results from a neurotoxicity study of Ketamir-2, its novel oral NMDA receptor antagonist. The study was required by the U.S. Food and Drug Administration prior to initiating human dosing in the United States. The preclinical study showed no evidence of brain toxicity, including the absence of Olney lesions-vacuolar brain changes historically associated with older NMDA-targeting drugs such as ketamine and MK-801. The neurotoxicity study was conducted in sexually mature Sprague-Dawley rats. High oral doses of Ketamir-2 were administered, while a positive control group received MK-801, a known neurotoxic NMDA receptor antagonist. Brain tissues were examined through detailed histopathological analysis at two time points. Key outcomes included no adverse clinical signs or mortality in any Ketamir-2-treated animals; No microscopic or macroscopic brain lesions detected at any dose; MK-801-treated animals showed clear evidence of brain toxicity, including vacuolation and neuronal necrosis. “These results represent a key milestone in the development of Ketamir-2,” said Erez Aminov, CEO. “The absence of NMDA-linked neurotoxicity, along with continued clinical progress, reinforces our confidence in Ketamir-2’s potential as a safe next-generation, oral candidate for CNS disorders.” Additionally on Thursday, MIRA announced that its Board of Directors has approved the planned acquisition of SKNY Pharmaceuticals, following the completion of independent valuation reports on both companies. The merger remains subject to MIRA and SKNY’s shareholder approval. A third-party analysis conducted by Moore Financial Consulting assigned SKNY Pharmaceuticals an enterprise value of approximately $30.5M, based on a risk-adjusted net present value of its lead compound, SKNY-1. MIRA was separately valued by Moore at $30M. As outlined in the previously announced binding letter of intent for the merger, upon the closing, SKNY must hold at least $5M in cash or other assets, to be transferred at closing, and the company is preparing a filing with the U.S. Securities and Exchange Commission to seek shareholder approval. BRIGHT MINDS INITIATED WITH BUY: On Wednesday, Chardan initiated coverage of Bright Minds (DRUG) with a Buy rating and $80 price target. The firm cites the potential of the company’s lead asset BMB-101 for the treatment of epilepsy for the Buy rating. Bright Minds is an “interesting story even at current valuation: as BMB-101 could be differentiated verses other 5-HT2C agonists with its unique binding profile, and it could potentially achieve greater than $1B peak sales in epilepsy, the analyst said. NRXP FILES PATENT APPLICATION: NRx Pharmaceuticals (NRXP) announced Monday the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the U.S. Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045. “We are committed to delivering safer, more effective treatments for patients with suicidal depression,” said Jonathan Javitt, CEO. “NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need.” OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Clearmind (CMND), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex (IXHL), Mydecine Innovations (MYCOF), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders’ Hot Stocks on TipRanks >> Read More on CMPS: Disclaimer & DisclosureReport an Issue Compass Pathways reports Q1 EPS (24c), consensus (49c) Compass Pathways enters strategic collaboration with HealthPort Psychedelic: Clearmind completes clinical site initiations for AUD trial Compass Pathways completes dosing in Part A of Phase 3 psilocybin trial COMPASS Pathways Amends Executive Employment Agreements

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 postpartum depression (PPD) (GH001-PPD-203). Close out activities and data analysis for both trials are ongoing and further clinical trial results are expected to be provided at upcoming scientific conferences. Update on IND for GH001 As previously announced, our Investigational New Drug Application (IND) for GH001 administered using our proprietary aerosol delivery device has been placed on clinical hold by the U.S. Food and Drug Administration (FDA), with the FDA requesting that we provide (i) an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, (ii) additional device design verification information and (iii) updates to our investigator brochure, to resolve the hold. We recently announced the completion of all FDA requests to address IND hold. We are working to prepare the full response and are on track to submit in mid-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. First Quarter 2025 Financial Highlights Cash position Cash, cash equivalents, other financial assets and marketable securities were $315.3 million as of March 31, 2025, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6 million as of December 31, 2024. Gross proceeds from public offering in Q1 2025 were $150.0 million. 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 $7.9 million for the quarter ended March 31, 2025, compared to $8.7 million for same quarter in 2024. The decrease was primarily due to decreased clinical development and technical development activities and the recognition of a research and development tax credit, partly offset by increases in nonclinical activities and employee expenses. General and administrative expenses G&A expenses were $4.9 million for the quarter ended March 31, 2025, compared to $2.9 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 $10.8 million, or $0.19 loss per share, for the quarter ended March 31, 2025, compared to $7.7 million, or $0.15 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 treatment of psychiatric and neurological disorders. 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). 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 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 for discussions with the FDA and the outcomes and resolution of such discussions related to 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 RyanGH Research [email protected]

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 filing of a New Drug Application for NRX-100 for the treatment of Suicidal Depression: a major milestone for NRx.  We also moved NRX-101 toward it’s NDA for Accelerated Approval in bipolar depression in patients at risk of akathisia, and made meaningful progress building HOPE’s best-in-class network of Interventional Psychiatry Clinics.  Additionally, two potential strategic transactions that are under negotiation could further accelerate our progress.  These accomplishments advance our mission of preventing and treating suicide: work that is critical to our patients, their families and our country,” said Jonathan Javitt, CEO. CLEARMIND SIGNS LOI WITH POLYRIZON: Clearmind Medicine (CMND) announced Wednesday that it has (PLRZ) to develop a novel intranasal formulation for its psychedelic-based treatment applications. The collaboration will explore the potential of Clearmind’s proprietary drug candidate, 5-Methoxy-2-aminoindane, alone or in combination with Palmitoylethanolamide, through intranasal administration. This initiative aims to enhance bioavailability and optimize the therapeutic effect of Clearmind’s psychedelic-based treatments. Under the terms of the LOI, Clearmind and Polyrizon will conduct research and development efforts to achieve a proof of concept for an intranasal formulation of MEAI and MEAI-PEA combinations. The companies will assess the feasibility of intranasal drug delivery, which offers several potential advantages over traditional administration methods, including faster absorption and onset of action, high bioavailability for increased therapeutic effects and enhanced patient compliance due to non-invasive administration. “This collaboration represents an exciting step forward in our efforts to continue innovating psychedelic-based treatments,” said Adi Zuloff-Shani, CEO. “We believe intranasal administration has the potential to improve patient outcomes by providing a faster-acting, more efficient, and user-friendly treatment option. This agreement aligns with our commitment to developing innovative and accessible solutions for mental health and addiction treatment.” Additionally on Tuesday, Clearmind Medicine announced that it initiated its Phase I/IIa clinical trial investigating the safety, tolerability and full pharmacokinetic profile of its treatment, CMND-100, in Alcohol Use Disorder patients. This study is the first clinical application of the company’s proprietary CMND-100 platform. The first site to be initiated is IMCA in Israel and will be led by Prof. Mark Weiser, head of the Psychiatric Division at the Sheba Medical Center. “Transitioning to a clinical stage pharmaceutical company is a major milestone for our Company, enabling us to evaluate whether the promising results from our animal studies will translate to human clinical trial participants with AUD,” said Zuloff-Shani. “Previously announced preclinical data on alcohol curb supports the potential ofCMND-100 as a novel and effective treatment approach for alcoholism, addressing a significant unmet medical need.” COMPASS REPORTS PUBLICATION OF COMP004 RESULTS: Compass Pathways (CMPS) announced Tuesday the publication of results from the COMP004 study, an observational 52-week follow-up from the Phase 2 COMP001 and COMP003 trials of COMP360 psilocybin treatment in patients with treatment-resistant depression. The COMP004 study’s findings suggest that over a 52-week period, a single administration of 25 mg COMP360 psilocybin demonstrated a longer maintenance of antidepressant effects compared to the 1 mg and 10 mg doses. The results of COMP004 build upon previous findings from the Phase 2b trial COMP001, which showed that a single 25mg dose of COMP360 psilocybin was associated with a rapid and highly statistically significant reduction in depressive symptoms compared to COMP360 1mg dose after three weeks, with durable response for up to 12 weeks. “Treatment-resistant depression is a major public health challenge, affecting approximately 100 million people worldwide, and it is well understood that there is an urgent need for differentiated treatment options,” said Guy Goodwin, CMO. “This study together with the Phase 2b suggest the potential of COMP360 to provide rapid and durable clinical benefits from a single administration. We continue to explore the full profile of COMP360 in our ongoing Phase 3 clinical development program and we look forward to seeing the first phase 3 data from our COMP005 trial in the second quarter.” FILAMENT REPORTS PHASE 2 PEX010 DATA: Filament Health (FLHLF) announced Monday data from an open-label phase 2 clinical trial studying the effects of its botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder at Psychiatric Centre Copenhagen. The results were published in the Journal of Psychopharmacology and found that a single 25mg dose of PEX010 was safe and effective in reducing alcohol consumption in AUD patients. The open-label phase 2 study investigated single-dose psilocybin therapy in 10 treatment-seeking adults with severe AUD. The treatment involved two preparation sessions, a high-dose psilocybin session, and two integration sessions. Alcohol consumption significantly decreased over the 12 weeks following the administration of PEX010. The percentage of heavy drinking days was reduced from 53.6% before receiving PEX010 to 16.1% at week 12 and drinks per day decreased by an average of 3.4 drinks over the 12-week follow up period. This was corroborated by reports of rapid and sustained reductions in craving and temptation and significant increases in self-efficacy. All participants completed the therapy course, and the safety profile was favourable with no serious adverse events. “We are thrilled to announce positive results which support the efficacy of PEX010,” said Benjamin Lightburn, CEO. “These data reinforce our confidence in the potential of botanical psilocybin to help the millions of people suffering from substance use disorders like AUD. We look forward to advancing to the next stage of development.” NUMINUS RECEIVES STATE CERTIFICATION APPROVAL: Numinus Wellness (NUMIF) announced Thursday that its Psychedelic-Assisted Therapy Training Program has been officially approved by the state of Colorado. This approval comes as part of Colorado’s Natural Medicine Health Act, which establishes a legal framework for the facilitation of psilocybin services by trained and licensed professionals. Numinus’ state-approved certification pathway includes coursework in psychedelic-assisted therapy fundamentals, psilocybin-specific training, trauma-informed care, and practical applications, along with clinical practicum placements to ensure hands-on experience. “This is an exciting step forward for both Numinus and for the future of psychedelic-assisted therapy in Colorado,” said Michael Tan, CEO of Numinus Wellness. “We are committed to ensuring that practitioners receive the highest standard of training so they can provide safe, ethical, and transformative psilocybin-assisted therapy in accordance with Colorado’s regulations.” OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Incannex Healthcare (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today’s best-performing stocks on TipRanks >> Read More on ATAI: Questions or Comments about the article? Write to [email protected] ATAI Life Sciences Diversifies Treasury with Bitcoin Investment ATAI Life Sciences: Positioned for Growth in Psychedelic and Neuropsychiatric Treatments with Strong Pipeline and Upcoming Catalysts ATAI Life Sciences: Strong Financial Position and Promising Pipeline Drive Buy Rating Atai Life Sciences reports Q4 EPS (24c), consensus (15c) Psychedelic: atai reports dosing of first patient in Phase 2 VLS-01 trial