5-MeO-DMT

DUBLIN, May 15, 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 announced the acceptance of a Pharmaceutical Pipeline Presentation at the American Society of Clinical Psychopharmacology Annual Meeting (ASCP) in Arizona, United States from May 27 – 30, where Professor Michael E. Thase, MD, Professor of Psychiatry, Perelman School of Medicine, University of Pennsylvania will present clinical data from a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with treatment-resistant depression (TRD) (GH001-TRD-201). “The findings from this double-blind, placebo-controlled Phase 2b trial are truly exciting and - if replicated in larger trials - could prove to be a transformative leap in our efforts to help people with treatment-resistant depression. In clinical research there’s a hierarchy of evidence and this well-controlled trial delivers robust evidence of the treatment’s efficacy and safety. These findings build on prior successes studying drugs formerly pigeonholed as "psychedelics" and bring us closer to offering real hope to patients who have exhausted other options,” said Professor Michael E. Thase, MD, Professor of Psychiatry, Perelman School of Medicine, University of Pennsylvania. Additionally, two late-breaking posters have been accepted 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. “The acceptance of a late-breaking poster for the Phase 2a proof-of-concept trial in postpartum depression highlights the importance of these results. GH001 was well tolerated with no serious adverse events reported. Postpartum depression remains a critical unmet need, often leaving women feeling isolated and overwhelmed during what should be a time of joy. With all ten participants in remission at Day 8, this proof-of-concept trial represents a new beacon of hope, offering the potential for effective treatment that could transform lives,” said Dr William Gann, Sheffield Health and Social Care NHS FT (UK). Finally, a poster has been accepted at the International Society for Bipolar Disorders (ISBD) Annual Conference in Chiba, Japan from September 17 – 19, where PD Dr. med. Philipp Ritter, MD, PhD will present the results of a Phase 2a clinical trial of GH001 in patients with bipolar II disorder and a current major depressive episode. “Bipolar II disorder is often more chronic in its depressive course than bipolar I disorder and remains particularly difficult to treat. Available therapies frequently require weeks before clinically meaningful antidepressant effects emerge. In this proof-of-concept study, a single-day individualized dosing regimen of inhaled GH001 was well-tolerated, with no treatment-emergent serious adverse events and no signs of emerging mania. GH001 produced a 52% mean reduction in depressive symptoms by Day 8, suggesting both rapid onset and substantial efficacy, supporting GH001’s potential as a therapeutic candidate to induce rapid improvement of bipolar II depression,” said PD Dr. med. habil. Philipp Ritter, MBBS, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. Abstract Details: Pharmaceutical Pipeline Presentation (ASCP) Presentation Title: Safety and Efficacy of GH001 in Treatment-Resistant Depression: Results from a Phase 2b, Double-Blind, Randomized Controlled Trial Presenting Author: Michael E. Thase, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA Date and Time: May 27 from 3.30pm MST Late-breaking Poster (ASCP) Poster Title: Safety and Tolerability of GH001 in Treatment-Resistant Depression: Results from a Phase 2b, Double-Blind, Randomized, Controlled Trial Presenting Author: Wiesław J. Cubała, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland Date and Time: May 29 from 11.30am to 1.00pm MST Late-breaking Poster (ASCP) Poster Title: Results of a Phase 2a Clinical Trial of Inhaled Mebufotenin (GH001) in Patients with Postpartum Depression Presenting Author: Claus Bo Svendsen, GH Research, Dublin, Ireland Date and Time: May 29 from 11.30am to 1.00pm MST Poster (ASCP) Poster Title: Results from Early-Stage Trials of Inhaled Mebufotenin (GH001) in Healthy Volunteers and Patients with Treatment-Resistant Depression Presenting Author: Kelly Doolin, GH Research, Dublin, Ireland Date and Time: May 29 from 11.30am to 1.00pm MST Poster (ISBD) Poster Title: Results of a Phase 2a Clinical Trial of Inhaled Mebufotenin (GH001) in Patients with Bipolar II Disorder and a Current Major Depressive Episode Presenting Author: Philipp Ritter, Department of Psychiatry and Psychotherapy, Faculty of Medicine at the University Hospital Carl Gustav Carus, TU-Dresden, 01307, Dresden, Germany 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). 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. 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 Ryan GH Research PLC investors@ghres.com

With clinical momentum across its pipeline, atai strengthens its position as a leader in potentially transformative psychedelic mental health treatments Anticipate topline data midyear from the Phase 2b clinical trial of BPL-003 in patients with treatment-resistant depression (TRD) - the largest controlled trial of mebufotenin and the first and only such trial to investigate mebufotenin in the U.S.Dosed the first patient in the exploratory Phase 2 study of EMP-01 (oral R-MDMA) for the treatment of social anxiety; topline data anticipated in Q1’26Continued enrollment in Elumina, a Phase 2 study of VLS-01 (buccal film DMT) in patients with TRD; topline data are anticipated in Q1’26 Cash, cash equivalents, short-term securities, and public equity holdings expected to fund operations into 2027 NEW YORK and BERLIN, May 14, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, today announced first quarter 2025 financial results and provided corporate updates. “In the first quarter of 2025, we made meaningful progress across our pipeline, thus advancing our mission to transform the treatment of mental health conditions,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of atai. “Dosing the first patient in our exploratory Phase 2 study of EMP-01 in social anxiety disorder represents a significant milestone in our quest to address an area of high unmet need with a novel therapeutic approach. Looking ahead, we are excited about the upcoming mid-year data readouts for BPL-003 in treatment-resistant depression and RL-007 in cognitive impairment associated with schizophrenia. We believe that these milestones have the potential to reinforce our position as a leader in mental health innovation.” “The world is waking up to the scale and urgency of the mental health crisis, and atai remains at the forefront of developing innovative, science-driven solutions to meet this challenge,” stated Christian Angermayer, Co-founder and Chairman of atai. “Our progress this year reinforces my conviction in our mission and the long-term value we’re building, which is why I’ve continued to personally increase my investment in atai. With a robust pipeline, strategic clarity, and growing momentum, we are well-positioned to deliver both transformative outcomes for patients in need and strong returns for shareholders.” Recent Clinical Highlights and Upcoming MilestonesVLS-01: Dimethyltryptamine (DMT) for treatment-resistant depression (TRD) VLS-01 is an investigational proprietary oral transmucosal film formulation of DMT applied to the buccal surface, designed to fit within the established two-hour interventional psychiatry treatment paradigm.Continued to enroll patients in Elumina, a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of repeated doses of VLS-01 in ~142 patients with TRD. Topline data are anticipated in the first quarter of 2026.Presented data from the Phase 1 study of VLS-01 at the Society of Biological Psychiatry (SOBP) annual meeting. EMP-01: R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD) EMP-01 is an oral formulation of R-MDMA that demonstrated unique, dose-dependent subjective effects in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA.Dosed the first patient in the exploratory, randomized, double-blind, placebo-controlled Phase 2 study of EMP-01 to assess the safety, tolerability and efficacy in ~60 adults with SAD. Topline data are anticipated in the first quarter of 2026. BPL-003: Mebufotenin benzoate for TRD and alcohol use disorder (AUD) (strategic investment in Beckley Psytech) BPL-003 is an intranasal transmucosal formulation of mebufotenin benzoate designed to fit within the established two-hour interventional psychiatry treatment paradigm.Beckley Psytech remains on track to report topline results in mid-year 2025 from the eight-week core phase of the randomized, quadruple-masked, global Phase 2b clinical study of BPL-003 in 196 patients with TRD.Beckley Psytech also remains on track to report topline data from Part 2 of its Phase 2a study of BPL-003 in combination with selective serotonin reuptake inhibitors (SSRIs) for TRD in the second quarter of 2025.Beckley Psytech presented data from Part 1 of its open-label Phase 2a trial in patients with TRD at SOBP 2025. Novel 5-HT2A Receptor Agonists (including the discovery of non-hallucinogenic neuroplastogens) Novel 5-HT2A receptor agonists were discovered that maintain non-hallucinogenic potential based on their inability to fully-substitute for a traditional psychedelic in rodent drug discrimination studies. These differentiated 5-HT2A receptor agonists are being further optimized and studied in a series of animal models to assess therapeutic potential.Presented a poster on the Identification of Lead 5-HT2A Receptor Agonists for use in Treatment Resistant Depression with Non-hallucinogenic Potential and Low Valvulopathy Liability at the International Festival of Neuroscience BNA 2025. RL-007: Pro-cognitive neuromodulator for cognitive impairment associated with schizophrenia (CIAS) (strategic investment in Recognify Life Sciences) RL-007 is an orally bioavailable compound that has demonstrated pro-cognitive effects in multiple pre-clinical and clinical studies, including two Phase 1 and two Phase 2 trials.Recognify Life Sciences remains on track to report topline data in mid-2025 from the Phase 2b proof-of-concept study of RL-007 in 234 patients living with CIAS.Recognify Life Sciences presented RL-007 preclinical data at SOBP 2025. Corporate Update On May 2, 2025, the Company repaid in full the outstanding indebtedness of $21.8 million and terminated all commitments and obligations under the Hercules Loan Agreement. The early prepayment saved atai approximately $2.1 million of interest otherwise due under the full amortization payment schedule. Consolidated Financial ResultsCash, cash equivalents, and short-term securities: As of March 31, 2025, the Company had cash, cash equivalents, restricted cash and short-term securities of $108.2 million compared to $72.3 million as of December 31, 2024. The $35.9 million increase in cash is a result of $59.1 million net proceeds from equity financings, net of $17.8 million used in operations and $5.0 million invested in digital assets. The Company expects its cash, cash equivalents, short-term securities, and public equity holdings to be sufficient to fund operations into 2027. Research and development (R&D) expenses: R&D expenses were $11.3 million for the three months ended March 31, 2025, as compared to $11.5 million for the same prior year period. The year-over-year decrease of $0.2 million is primarily attributable to decreases in personnel-related expenses and consulting services, partially offset by increases in contract research organization and intellectual property spend related to our clinical programs. General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2025 were $10.6 million as compared to $12.6 million in the same prior year period. The year-over-year decrease of $2.0 million was primarily attributable to decreases in personnel-related expenses and professional services. The Company expects the reduction in G&A spend over prior years to continue. Net income (loss): Net loss attributable to stockholders for the three months ended March 31, 2025, was $26.4 million as compared to $26.7 million for the three months ended March 31, 2024. About atai Life Sciencesatai is a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes. Our pipeline of psychedelic-based therapies includes VLS-01 (buccal film DMT) for treatment-resistant depression (TRD) and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. We are also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD. These programs aim to address the complex nature of mental health providing commercially scalable interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about our mission, visit www.atai.com or follow us on LinkedIn. Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; the potential, success, cost and timing of development of our product candidates, including the progress of preclinical studies and clinical trials and related milestones; expectations regarding our cash runway; and the plans and objectives of management for future operations, research and development and capital expenditures. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in atai's other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law. Contact InformationInvestor Contact:IR@atai.com Media Contact:PR@atai.com -- Financial Statements Attached -- ATAI LIFE SCIENCES N.V. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands, except share and per share amounts) Three Months Ended March 31, 2025 2024 (unaudited) Revenue $1,555 $— Operating expenses: Research and development 11,328 11,530 General and administrative 10,597 12,555 Total operating expenses 21,925 24,085 Loss from operations (20,370) (24,085) Other expense, net (5,939) (1,596) Net loss before income taxes (26,309) (25,681) Benefit from (provision for) income taxes (156) 4 Losses from investments in equity method investees, net of tax — (1,701) Net loss (26,465) (27,378) Net loss attributable to noncontrolling interests (34) (665) Net loss attributable to ATAI Life Sciences N.V. stockholders $(26,431) $(26,713) Net loss per share attributable to ATAI Life Sciences N.V. stockholders — basic and diluted $(0.15) $(0.17) Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted 176,271,176 158,891,067 ATAI LIFE SCIENCES N.V. CONDENSED CONSOLIDATED BALANCE SHEET (Amounts in thousands) March 31, December 31, 2025 2024 Assets (unaudited) Cash and cash equivalents $48,287 $17,505 Securities carried at fair value 49,917 44,825 Short-term restricted cash for other investments 10,000 10,000 Prepaid expenses and other current assets 7,774 7,795 Property and equipment, net 2,682 2,535 Operating lease right-of-use assets, net 2,905 1,334 Other investments held at fair value 23,053 28,887 Other investments 42,079 42,079 Intangible assets, net 3,157 3,246 Goodwill 331 331 Digital assets 4,788 - Other assets 810 850 Total assets $195,783 $159,387 Liabilities and Stockholders' Equity Accounts payable $2,705 $2,616 Accrued liabilities 8,680 9,847 Current portion of lease liabilities 287 477 Short-term convertible promissory notes and derivative liability - related party 1,205 1,150 Short-term convertible promissory notes and derivative liability 1,923 1,840 Current portion of long-term debt 11,366 6,374 Other current liabilities 2,335 2,647 Contingent consideration liabilities - related parties 110 110 Contingent consideration liabilities 212 212 Noncurrent portion of lease liabilities 2,587 732 Long-term debt, net 9,300 14,133 Other liabilities 2,799 2,695 Total stockholders' equity attributable to ATAI Life Sciences N.V. stockholders 152,053 116,297 Noncontrolling interests 221 257 Total liabilities and stockholders' equity $195,783 $159,387