PBM

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

NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced the voting results from its Annual and Special Meeting of Shareholders (the “Meeting”), held at 9:00 a.m. Eastern Time on February 12, 2026. Shareholders voted in favour of all matters of business presented at the Meeting, including the election of directors, the appointment of auditors and the approval of share consolidation authority for the board of directors (the “Board”). All director nominees listed in the Company’s management information circular dated January 2, 2026 were duly elected as directors of the Company to hold office until the next annual meeting of shareholders or until their successors are elected or appointed. Shareholders approved the appointment of MNP LLP as the Company’s auditors for the ensuing year and authorized the Board to fix the auditors’ remuneration. Shareholders further approved a special resolution authorizing the Board, in its sole discretion, to implement one or more consolidations of the Company’s issued and outstanding common shares, at a ratio of up to 250:1, with such consolidation(s) to be implemented, if at all, at a time and ratio to be determined by the Board. The Company will provide additional disclosure if and when the Board determines to implement any share consolidation, including the final consolidation ratio and effective date, subject to applicable regulatory and exchange approvals. Further details regarding the matters voted on at the Meeting are set out in the Company’s management information circular, which is available under the Company’s profile on EDGAR. About Psyence BioMed Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin and ibogaine-based psychedelic medicine to be listed on Nasdaq. We are dedicated to addressing unmet mental health needs. We are committed to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders. Learn more at www.psyencebiomed.com and on LinkedIn. Contact Information for Psyence Biomedical Ltd. Email: [email protected] Media Inquiries: [email protected] General Information: [email protected] Investor Contact: Michael Kydd Investor Relations Advisor [email protected] Forward Looking Statements This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations, and intentions with respect to future operations, products and services; and other statements identified by words such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “believe,” “intend,” “plan,” “projection,” “outlook” or words of similar meaning. Forward-looking statements in this communication include statements regarding the discretion of the Board to implement a share consolidation of the Company's issued and outstanding common shares. These statements are based on current assumptions and expectations, including assumptions regarding the Company’s ability to maintain compliance with Nasdaq’s continued listing standards. These assumptions may prove incorrect. There can be no assurance as to when a share consolidation will be implemented, if at all. There are numerous risks and uncertainties that may cause actual results or performance to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the Company’s ability to maintain compliance with Nasdaq’s continued listing standards; (ii) potential volatility in the Company’s share price following the results of the Meeting; (iii) changes in the regulatory, competitive, and economic landscape; and (iv) risks associated with the Company’s development plans and clinical trials. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the Company’s final prospectus (File No. 333-298285) filed with the Securities and Exchange Commission (the “SEC”) on November 3, 2025 and other documents filed by Psyence BioMed from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, Psyence BioMed does not intend to update these forward-looking statements. The Company does not make any medical, treatment or health benefit claims about its proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by authorized clinical research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of the proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company has verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.