ATAI

It has been about a month since the last earnings report for AtaiBeckley Inc (ATAI). Shares have added about 0.8% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is AtaiBeckley Inc due for a pullback? Well, first let's take a quick look at its most recent earnings report in order to get a better handle on the recent catalysts for AtaiBeckley Inc before we dive into how investors and analysts have reacted as of late. AtaiBeckley reported a loss of 9 cents per share in the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 10 cents. In the year-ago quarter, the company had reported a loss of 14 cents. The company reported revenues of $1.7 million in the second quarter of 2026, down 142.8% year over year. Revenues comprised license revenues and research and development services revenues. Research and development expenses rose 153% year over year to $28.1 million in the second quarter, owing to higher clinical development costs and increased personnel-related costs. General and administrative expenses in the second quarter were $17.8 million, up 19.5% year-over-year due to increased legal, intellectual property and professional service expenses. As of June 30, 2026, AtaiBeckley had cash, cash equivalents and marketable securities worth $191.8 million compared with $209.9 million as of March 31, 2026. It turns out, estimates revision have trended downward during the past month. Currently, AtaiBeckley Inc has a subpar Growth Score of D, however its Momentum Score is doing a bit better with a C. However, the stock has a score of F on the value side, putting it in the fifth quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, AtaiBeckley Inc has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. AtaiBeckley Inc belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Rocket Pharmaceuticals (RCKT), has gained 6.5% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Rocket Pharmaceuticals reported revenues of $0 million in the last reported quarter, representing a year-over-year change of 0%. EPS of -$0.15 for the same period compares with -$0.59 a year ago. For the current quarter, Rocket Pharmaceuticals is expected to post a loss of $0.38 per share, indicating a change of +15.6% from the year-ago quarter. The Zacks Consensus Estimate has changed +6.8% over the last 30 days. Rocket Pharmaceuticals has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of F. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AtaiBeckley Inc (ATAI) : Free Stock Analysis Report Rocket Pharmaceuticals, Inc. (RCKT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression on track for Q2 2026 VLS-01 Phase 2 Elumina topline results anticipated in Q4 2026 Consistent, convergent improvements demonstrated in EMP-01 Phase 2a trial across independent clinician-rated and patient-reported outcomes in Social Anxiety Disorder Cash and cash equivalents expected to fund operations through anticipated BPL-003 Phase 3 topline readouts, with runway into 2029 NEW YORK, May 12, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today reported financial results for the first quarter ended March 31, 2026, and provided a business update across its clinical pipeline. First Quarter 2026 Highlights BPL-003 (TRD): Phase 3 pivotal ReConnection program on track to initiate in Q2 2026. VLS-01 (TRD): Elumina Phase 2 topline results anticipated in Q4 2026. EMP-01 (SAD): Phase 2a data provided validation of EMP-01's potential in Social Anxiety Disorder. Corporate: Inclusion during Q1 2026 in the S&P Biotechnology Select Industry Index and CRSP U.S. indices, which are tracked by a broad range of institutional and passive investor exposure. Cash position: Cash and cash equivalents as of March 31, 2026 expected to fund operations through anticipated BPL-003 Phase 3 topline readouts, with runway into 2029. Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley, said: “Our $209.9 million in cash is expected to provide a runway through our anticipated Phase 3 topline readouts for BPL-003, as we advance toward the late-stage execution phase. Our near-term priority is initiating the Phase 3 ReConnection program for BPL-003 this quarter, while VLS-01 continues to progress toward anticipated Phase 2 topline results later this year. The positive Phase 2a data for EMP-01 further demonstrated its potential in Social Anxiety Disorder. Collectively, our capital position, pipeline breadth, and multiple near- and mid-term clinical catalysts position us well as we seek to build sustained clinical and shareholder value.” Program Updates BPL-003: mebufotenin benzoate nasal spray for treatment-resistant depression (TRD) On track to initiate Phase 3 program in Q2 2026, following a successful End-of-Phase 2 meeting with the FDA and incorporating regulatory feedback into a registrational Phase 3 design. Phase 3 program consists of two pivotal studies: ReConnection-1 (~350 patients) ReConnection-2 (~230 patients) Primary endpoint: change from baseline in MADRS total score at Week 4. Both studies include a 52-week open-label extension (OLE), allowing individualized 8mg BPL-003 retreatment at 8-week or 12-week intervals with the aim of maintaining remission and evaluating durability and longer-term safety. Phase 2a Part 4 (two-dose induction + SSRIs) cohort initial data on track for Q4 2026. VLS-01: dimethyltryptamine (DMT) buccal film for TRD Elumina Phase 2 study progressing as planned, with topline results anticipated in Q4 2026. EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD) Phase 2a results demonstrated clinically meaningful and consistent improvements across clinician-rated symptoms, patient-reported experience, and real-world behavioral outcomes, providing further evidence of EMP-01’s therapeutic potential in SAD. Business Updates Index inclusions: During the first quarter of 2026, AtaiBeckley was added to the S&P Biotechnology Select Industry Index and multiple CRSP U.S. equity indices, expanding eligibility for index-tracking and passive investment vehicles. In February 2026, AtaiBeckley appointed Michael Faerm as Chief Financial Officer, effective March 9, 2026, bringing more than 25 years of life sciences and capital markets experience, to lead the Company’s financial strategy as BPL-003 advances toward Phase 3. Anticipated Upcoming Milestones Q2 2026: Initiation of BPL-003 Phase 3 ReConnection program Q4 2026: VLS-01 Elumina Phase 2 topline results Q4 2026: BPL-003 Phase 2a Part 4 initial data Early 2029: BPL-003 Phase 3 topline readouts Consolidated Financial Results Cash, cash equivalents, and short-term securities (primarily US treasuries): As of March 31, 2026, the Company had cash, cash equivalents and short-term securities of $209.9 million compared to $220.7 million as of December 31, 2025. The $10.8 million decrease is primarily attributable to $21.1 million used in operations, partially offset by $9.5 million in proceeds from sale of equity holdings. The Company expects its cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029. Research and development (R&D) expenses: R&D expenses were $17.4 million for the three months ended March 31, 2026 as compared to $11.3 million for the same prior year period. The year-over-year increase of $6.1 million was primarily attributable to higher clinical development and related costs in support of BPL-003, VLS-01 and EMP-01, as well as increased personnel-related expenses as a result of our strategic combination with Beckley Psytech in November 2025. General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2026, were $14.4 million as compared to $10.6 million for the same prior year period. The year-over-year increase of $3.8 million was primarily attributable to increased legal, intellectual property, and professional service expenses and increased personnel-related expenses. Net loss: Net loss attributable to stockholders for the three months ended March 31, 2026, was $29.8 million as compared to $26.4 million for the comparable prior year period. About AtaiBeckley Inc. AtaiBeckley is a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable, and convenient mental health treatments. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (DMT buccal film) for TRD and EMP-01 ((R)-MDMA HCI) for social anxiety disorder. BPL-003 is in Phase 3 planning, VLS-01 and EMP-01 are in Phase 2 clinical development. The Company is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create breakthroughs in mental health through transformative interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X. 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, and Section 21E of the Securities Exchange Act of 1934, as amended. 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 and clinical trials and related milestones; the outcome of past and future interactions with regulatory authorities and our expectations regarding the regulatory pathway for our product candidates; expectations regarding our cash runway and the sufficiency of our cash resources to fund operations through particular milestones; statements regarding our ability to create value for stockholders; 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”) or Quarterly Reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in our other filings with the SEC. Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance or achievements reflected in the forward-looking statements will be achieved or will occur. We disclaim any obligation to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law. Contact Information: Investors: Jason Awe, PhD VP, Investor Relations [email protected] Media: Charlotte Chorley Associate Director, Communications [email protected] – Financial Statements Attached –

Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression remains on track for Q2 2026 following successful End‑of‑Phase 2 meeting with the U.S. Food and Drug Administration On-track for VLS-01 Phase 2 Elumina trial topline data readout anticipated in H2 2026 Exploratory Phase 2a trial of EMP-01 in Social Anxiety Disorder met its primary safety and tolerability objective and demonstrated clinically meaningful improvements across key efficacy measures Cash runway through the planned early-2029 topline readouts from both Phase 3 pivotal studies Virtual Investor Day scheduled for March 6, 2026 NEW YORK, March 06, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today announced fourth quarter and full year 2025 financial results and provided key regulatory, clinical and business updates. “Following our strategic combination of atai Life Sciences and Beckley Psytech, and U.S. redomiciliation, we have entered a pivotal execution phase,” said Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of AtaiBeckley. “We received constructive feedback from the FDA on the Phase 3 development plan for BPL-003 in treatment-resistant depression, positioning us to initiate our pivotal program in the second quarter of 2026. We also reported positive topline results from our exploratory Phase 2a study of EMP-01 in Social Anxiety Disorder, which met its primary safety objective and demonstrated clinically meaningful improvements across key efficacy measures after just two administrations and without adjunct psychotherapy. With multiple clinical catalysts ahead and capital expected to fund operations into 2029, we believe AtaiBeckley is well positioned to advance a differentiated portfolio of rapid-acting mental health therapies.” Program Updates and Anticipated Milestones BPL-003: mebufotenin benzoate nasal spray for TRD In March 2026, the Company announced a successful End‑of‑Phase 2 meeting with the FDA regarding the development of BPL‑003 for treatment‑resistant depression (TRD), a debilitating and chronic condition affecting millions of people around the world but with limited rapid-acting treatment options. The FDA indicated support for advancement into Phase 3 studies in adults with TRD and provided constructive feedback on the overall design and requirements for a potential NDA package for this indication. The Phase 3 program is designed to include two pivotal studies, ReConnection-1 and ReConnection-2, each consisting of a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension (OLE): ReConnection-1: Approximately 350 participants Single-dose of BPL-003 across three treatment arms - 8 mg, 4 mg, and placebo (randomized 2:1:2) Designed to replicate and extend Phase 2b treatment response and further characterize dose–response relationship for BPL-003 ReConnection-2: Approximately 300 participants Two-dose design (Day 1 and Day 15) across two arms - 8 mg BPL-003 and placebo (randomized 1:1) Designed to evaluate if a two-dose induction model increases magnitude and durability of initial response The primary endpoint in both pivotal trials will be the change from baseline in the MADRS total score at Week 4. Both trials include a 52-week OLE allowing individualized 8 mg BPL-003 retreatment at 8- or 12-week intervals with the aim of maintaining remission. Phase 3 program initiation remains on track for Q2 2026. Topline data from the core studies of both ReConnection-1 and –2 anticipated by early 2029. First patient dosed in the Part 4 cohort of the open-label Phase 2a study, evaluating a two-dose induction regimen (8 mg + 8 mg) of BPL-003 in TRD patients receiving defined antidepressants. Initial data expected in Q4 2026. VLS-01: dimethyltryptamine (DMT) buccal film for 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. Phase 2 Elumina study topline data readout is anticipated in H2 2026. EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD) In February 2026, the Company reported topline results from the exploratory, randomized, double‑blind, placebo‑controlled Phase 2a trial of EMP‑01 in SAD: Key findings: Met primary safety and tolerability objective with a generally favorable and manageable profile Clinically meaningful placebo-adjusted least squares mean reduction of 11.85 points on the Liebowitz Social Anxiety Scale (LSAS) at Day 43 (Hedges’ g = 0.45; p-value = 0.036, one-tailed) 49% responder rate on Clinician Global Impression–Improvement (CGI-I) vs. 15% for placebo, corresponding to a Number Needed to Treat (NNT) of 2.95 Demonstrated improvements across Fear and Avoidance sub-domains of LSAS In December 2025, the Company was granted a new U.S. patent covering the EMP‑01 drug substance, extending expected exclusivity through 2043. More detailed analyses of the data will be described in upcoming scientific venues and are expected to inform next development steps. Business Highlights Completed the strategic combination in November 2025 between atai Life Sciences N.V. and Beckley Psytech Limited, creating AtaiBeckley, a global leader in transformative mental health therapies. Completed the redomiciliation to the United States in December 2025 as a Delaware‑incorporated company with headquarters in New York, NY. AtaiBeckley Inc. was added to the NASDAQ Biotechnology Index (NBI) in December 2025. The Company will host a Virtual Investor Day on March 6, 2026, centered on BPL‑003 and the Phase 3 development strategy. The Virtual Investor Day will feature: Detailed overview of the BPL-003 Phase 3 program Discussion of the commercial opportunity in treatment-resistant depression Key opinion leader roundtable discussing the evolving psychedelic therapeutic landscape and operational considerations in interventional psychiatry Upcoming Anticipated Milestones and Events March 6, 2026: Virtual Investor Day Q2 2026: Initiation of BPL-003 Phase 3 ReConnection-1 and ReConnection-2 trials H2 2026: Topline data from VLS-01 Elumina Phase 2 study Q4 2026: Initial data from Phase 2a BPL-003 Part 4 cohort Consolidated Financial Results Cash, cash equivalents, and short-term securities (primarily US treasuries): As of December 31, 2025, the Company had cash, cash equivalents and short-term securities of $220.7 million compared to $72.3 million of cash, cash equivalents, restricted cash and short-term securities as of December 31, 2024. The $148.4 million increase is primarily attributable to $291.1 million in net proceeds from equity-related issuances and $9.1 million in proceeds from sale of equity holdings, partially offset by $102.7 million used in operations, $21.8 million payoff of Hercules debt facility, $20.0 million in payments relating to the Beckley Psytech investment prior to the strategic combination, and $10.0 million investment in digital assets. The Company expects its cash, cash equivalents, short-term investments and other liquid assets to fund operations into 2029. Research and development (R&D) expenses: R&D expenses were $19.0 million and $53.1 million for the three and twelve months ended December 31, 2025, respectively, as compared to $18.9 million and $55.5 million for the same prior year periods. The year-over-year full-year decrease of $2.4 million was primarily attributable to decreased personnel-related expenses and consulting services, partially offset by higher clinical program contract research organizations and manufacturing costs. We recorded non-cash acquisition of in-process R&D expenses of $527.0 million and $530.0 million for the three and twelve months ended December 31, 2025, respectively, primarily relating to the strategic combination with Beckley Psytech. General and administrative (G&A) expenses: G&A expenses for the three and twelve months ended December 31, 2025, were $25.1 million and $65.1 million, respectively, as compared to $11.3 million and $47.5 million in the same prior year periods. The year-over-year increase of $17.6 million was primarily attributable to increased legal and professional service expenses in connection with the Beckley Psytech strategic combination and the Company’s redomiciliation to the United States, partially offset by decreases in personnel-related expenses. Net income (loss): Net loss attributable to stockholders for the three and twelve months ended December 31, 2025, was $544.8 million and $660.0 million, respectively, as compared to $39.0 million and $149.3 million for the comparable prior year periods. Net loss attributable to stockholders for the twelve months ended December 31, 2025, includes $24.4 million non-cash reduction in the fair value of assets and liabilities, net, $14.2 million of non-cash stock-based compensation, and $10.7 million non-cash gain related to the investment in Beckley Psytech. Net loss attributable to stockholders for the twelve months ended December 31, 2024, includes $48.9 million non-cash reduction in the fair value of assets and liabilities, net and $25.5 million of non-cash stock-based compensation. About AtaiBeckley Inc. AtaiBeckley is a clinical-stage biotechnology company with a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (DMT buccal film) for TRD and EMP-01 (oral R-MDMA) for social anxiety disorder. BPL-003 is in Phase 3 planning, VLS-01 and EMP-01 are in Phase 2 clinical development. The Company is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create new breakthroughs in mental health by providing transformative interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X. 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, and Section 21E of the Securities Exchange Act of 1934, as amended. 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 and clinical trials and related milestones and the outcome of related regulatory discussions; expectations regarding our intellectual property portfolio; 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”) or Quarterly Reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in our other filings with the SEC. AtaiBeckley disclaims any obligation to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law. Contact Information: Investors: Jason Awe, PhD VP, Investor Relations [email protected] Media: Charlotte Chorley Associate Director, Communications [email protected] -- Financial Statements Attached –

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

AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) has reported its fourth quarter and full-year 2025 financial results, highlighting progress across several clinical programs targeting mental health disorders and outlining upcoming milestones for its pipeline. The clinical-stage biotechnology company said it remains on track to initiate a Phase 3 pivotal program for BPL-003, its mebufotenin benzoate nasal spray for treatment-resistant depression (TRD), in the second quarter of 2026. The timeline follows a successful End-of-Phase 2 meeting with the US Food and Drug Administration, which indicated support for advancing the therapy into late-stage studies and provided feedback on the potential regulatory pathway. The planned Phase 3 program will consist of two randomized, placebo-controlled trials, ReConnection-1 and ReConnection-2, evaluating the therapy in adults with TRD. Each study will include a 12-week core trial followed by a 52-week open-label extension. Topline results from the core studies are expected by early 2029. The company is also advancing VLS-01, a dimethyltryptamine (DMT) buccal film designed to fit within a two-hour interventional psychiatry treatment model for TRD. Topline data from the Phase 2 Elumina study are anticipated in the second half of 2026. Another program, EMP-01, an oral R-enantiomer of MDMA being studied for social anxiety disorder, recently reported results from an exploratory Phase 2a trial. The study met its primary safety and tolerability objective and showed placebo-adjusted improvements on the Liebowitz Social Anxiety Scale, along with a higher responder rate compared with placebo. During 2025, the company also completed a strategic combination between atai Life Sciences and Beckley Psytech, forming AtaiBeckley. The company subsequently redomiciled to the United States as a Delaware-incorporated firm headquartered in New York and was added to the NASDAQ Biotechnology Index in December. Srinivas Rao, AtaiBeckley’s CEO, said the company has entered a pivotal executions phase following the strategic combination of atai Life Sciences and Beckley Psytech, and US redomiciliation. “We received constructive feedback from the FDA on the Phase 3 development plan for BPL-003 in treatment-resistant depression, positioning us to initiate our pivotal program in the second quarter of 2026,” Rao said. “We also reported positive topline results from our exploratory Phase 2a study of EMP-01 in Social Anxiety Disorder, which met its primary safety objective and demonstrated clinically meaningful improvements across key efficacy measures after just two administrations and without adjunct psychotherapy.” As of December 31, 2025, the company reported cash, cash equivalents, and short-term securities of $220.7 million, up from $72.3 million a year earlier. The increase was primarily driven by $291.1 million in net proceeds from equity-related issuances and $9.1 million from the sale of equity holdings, partially offset by operational spending and other payments related to the Beckley Psytech transaction and debt repayment. Research and development expenses totaled $53.1 million for the full year, compared with $55.5 million in 2024, reflecting lower personnel and consulting costs partly offset by higher clinical and manufacturing spending. General and administrative expenses rose to $65.1 million for the year from $47.5 million, largely due to legal and professional service costs associated with the Beckley Psytech combination and the company’s redomiciliation to the United States. AtaiBeckley reported a net loss attributable to stockholders of $660 million for 2025, compared with a loss of $149.3 million in the prior year. The 2025 results included approximately $530 million in non-cash acquisition-related research and development expenses linked to the Beckley Psytech transaction. The company said its current cash position is expected to fund operations into 2029, including through the anticipated topline readouts from the planned Phase 3 studies of BPL-003. Further, AtaiBeckley plans to discuss the BPL-003 Phase 3 development strategy and the broader commercial opportunity in treatment-resistant depression during a virtual investor day scheduled for March 6. “With multiple clinical catalysts ahead and capital expected to fund operations into 2029, we believe AtaiBeckley is well positioned to advance a differentiated portfolio of rapid-acting mental health therapies,” Rao concluded.