This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care buprenorphine treatment for Opioid use disorder (OUD). Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with buprenorphine maintenance, quality of life, and mood.

The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.

To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo.

EDEN PRAIRIE, MN, UNITED STATES, November 20, 2025 /EINPresswire.com/ -- The Institute for Integrative Therapies (IIT), Minnesota’s leading psychedelic medicine clinic, is proud to announce its official selection as a clinical trial site for Cybin’s EMBRACE and EXTEND studies—two groundbreaking clinical trials evaluating psilocin-based therapeutics for the treatment of Major Depressive Disorder (MDD).Cybin, a clinical-stage publicly traded company developing next-generation psychedelic-derived mental health therapies, selected IIT as one of its U.S. research partners due to IIT’s established expertise, rigorous clinical infrastructure, and track record of excellence in psychedelic medicine interventions.A Major Milestone for Minnesota’s Psychedelic Research LandscapeThis selection further solidifies IIT as one of the premier destinations for psychedelic research in the Midwest. IIT was the first clinic of its kind in Minnesota and continues to lead the region in delivering innovative, evidence-based psychedelic therapies while contributing to the national research ecosystem.“With the addition of Cybin’s EMBRACE and EXTEND trials, IIT is helping bring the next generation of psychedelic medicines to patients who desperately need new options,” said Manoj Doss, DO, Founder and CEO of IIT and Principal Investigator for the Cybin EMBRACE and EXTEND studies. “We are honored to partner with Cybin in advancing the science and expanding access to modern, transformative care.”About the EMBRACE and EXTEND StudiesCybin’s EMBRACE and EXTEND programs investigate the safety, efficacy, and durability of psilocin-based treatments for individuals living with Major Depressive Disorder. These studies are part of Cybin’s broader mission to create fast-acting, scalable, more predictable psychedelic therapeutics suitable for real-world clinical practice.Enrollment is expected to begin in February 2026 at IIT’s Eden Prairie research clinic, with opportunities for eligible individuals across Minnesota.Strengthening IIT’s Expanding Research Portfolio“We started IIT as a first-of-its-kind clinic in Minnesota, committed to bringing safe, ethical, and effective psychedelic medicine to our community,” said Ranji Varghese, MD, Chief Medical Officer at IIT and Principal Investigator for the COMPASS Pathways psilocybin study. “These partnerships represent the next chapter—one that will help launch a new wave of therapies in the coming years.”Call for Local Clinician PartnershipAs IIT prepares to launch the Cybin trials, the team is seeking to collaborate with clinicians, therapists, mental health professionals, and medical providers across the Twin Cities and the Midwest who may have patients appropriate for referral.Lunch-and-learn sessions with Dr. Doss and Dr. Varghese will be available for organizations wanting to learn more.About the Institute for Integrative TherapiesThe Institute for Integrative Therapies (IIT), located in Eden Prairie, Minnesota, is a pioneering clinic specializing in psychedelic medicine, clinical research, and integrative mental health. Founded by Dr. Manoj Doss, IIT combines clinical excellence, compassionate care, and rigorous research to expand access to innovative treatments for depression, anxiety, trauma, and chronic mental health conditions.Andrea DossInstitute for Integrative Therapiesemail us hereVisit us on social media:LinkedInInstagramLegal Disclaimer:EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

NEW YORK, Nov. 20, 2025 (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 it had established a sustainable supply of high-potency iboga bark from trusted sourcing channels with deep experience in the iboga trade and treatment field through its strategic partner, PsyLabs. This is a significant achievement for the Company as it prepares for the clinical development of ibogaine for substance use disorders and validates its investment in PsyLabs. This collaboration with PsyLabs is an important step in securing a long-term supply of high-quality active pharmaceutical ingredients. PsyLabs’ ibogaine is fully GMP-compliant, ensuring it meets the rigorous standards required for clinical development. The first 50 kg has already been received and is now being processed into ibogaine HCL – the purified, pharmaceutical-grade form of ibogaine designed for precise dosing in clinical research – and into Total Alkaloid Extracts, which preserve the broader spectrum of iboga alkaloids found in the natural plant. Together, these products will be supplied to the legal research and treatment industries, supporting both standardized clinical trials and research into full-spectrum therapeutic approaches. Investing in a sustainable approach ensures that ibogaine and related alkaloids derived from Tabernanthe iboga and Voacanga africana are ethically sourced and pharmaceutical grade. By prioritizing quality, sustainability, and respect for the cultural traditions connected to these plants – including fair benefit-sharing with source communities – the Company is building a vertically integrated supply chain that meets the highest standards while supporting the long-term viability of this essential resource. “A reliable, ethically sourced supply of ibogaine is critical to our development pipeline,” said Jody Aufrichtig, Chief Executive Officer of Psyence BioMed. “This achievement not only strengthens our ability to advance our ibogaine-based clinical programs but also positions Psyence BioMed as a global leader in the emerging ibogaine sector. As international interest in ibogaine continues to accelerate, securing a sustainable and culturally respectful supply chain gives us a meaningful competitive advantage and reinforces our commitment to scientific rigor, responsible innovation, and the preservation of traditional knowledge.” "From soil to science, we will continue to ensure our ibogaine is not only the purest on the market, but the most ethically sourced," said Tony Budden, CEO of PsyLabs. "We’re building a new standard for what ethical psychedelic production can look like – where traditional knowledge holders are partners, not just suppliers." Today’s announcement advances Psyence BioMed – together with PsyLabs – toward a leading role in shaping the future of ibogaine development for substance use disorders and other urgent mental health needs. Learn more at www.psyencebiomed.com and on LinkedIn. 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, particularly in palliative care. The name ‘Psyence’ merges ‘psychedelics’ and ‘science,’ reflecting the company’s commitment to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders. About PsyLabs PsyLabs is a psychedelic Active Pharmaceutical Ingredient (API) development company, federally licensed to cultivate, extract, and export psilocybin mushrooms and other psychedelic compounds including psilocin, mescaline, ibogaine, and dimethyltryptamine (DMT) to legal medical and research markets. The company has successfully exported psilocybin products to Canada, the UK, Portugal, and Slovenia, and supplies purified extracts to its UK-based CMO partner. PsyLabs operates from an ISO 22000-certified facility audited by the British Standards Institution, ensuring the highest standards of safety and traceability. With a focus on natural compound purification, regulatory support, and global distribution, PsyLabs is expanding its product pipeline to include ibogaine and other next-generation psychedelics.www.psylabs.life Contact Information for Psyence Biomedical Ltd.Email: ir@psyencebiomed.com Media Inquiries: media@psyencebiomed.com General Information: info@psyencebiomed.com Phone: +1 416-477-1708 Investor Contact:Michael KyddInvestor Relations Advisormichael@psyencebiomed.com 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 advancement of the clinical development pipeline of ibogaine and the quality of the ibogaine derived or containing products under development. These forward-looking statements are based on a number of assumptions, including the assumption that all parties involved in the ibogaine supply chain will retain such valid permits and licenses as may be required to carry out their activities and that the demand for psychedelic-containing products and related therapy will continue to increase. There can be no assurance that the Company will continue to maintain compliance with Nasdaq’s continued listing requirements. There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) delays in the execution of the Company's drug development and clinical trial pipeline; (ii) the ability of Psyence BioMed to maintain the listing of its common shares and warrants on Nasdaq; (iii) volatility in the price of the securities of Psyence BioMed due to a variety of factors, including the recent share consolidation, changes in the competitive and highly regulated industries in which Psyence BioMed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence BioMed’s business and changes in Psyence BioMed’s capital structure. 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.

– Quarterly performance characterized by higher revenues, reduced cost structure and improved bottom line – – Successful business integration drives 10.9% sequential quarter-over-quarter EEG/ERP scan volumes and 30% sequential revenue growth – KENMORE, N.Y., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, today reported financial results for the three and nine months ended September 30, 2025. Business Highlights Third quarter 2025 revenue grew more than tenfold year-over-year and 30% sequentially quarter-over-quarter, demonstrating both the immediate benefits from Firefly’s May 2025 acquisition of Evoke Neuroscience, Inc. (“Evoke”) and the early success of the two businesses’ integration.Also a reflection of the successful Evoke acquisition and business integration, Firefly’s Q3-2025 EEG/ERP scan volumes grew 10.9% sequentially over the previous quarter.In addition, the Company’s Q3-2025 total operating expenses decreased 35% versus Q3-2024, contributing to a significantly lower net loss ($2.6 million vs. $4.3 million).In a July press release, Firefly highlighted its ongoing collaboration with Prof. Dr. med. Christian Schaaf, Director of the Institute of Human Genetics at Heidelberg University Hospital and Chairman of Human Genetics at the Medical Faculty of Heidelberg University, on a first-of-its-kind study investigating the neurophysiological impact of 15q13.3 copy number variants (CNVs).In August, the Company unveiled its new ‘CLEAR’ ( CL eaning E EG AR tifacts) Platform, a proprietary next-generation preprocessing technology designed to deliver best-in-class electroencephalogram (EEG) data quality. The CLEAR Platform was developed using NVIDIA’s L40S GPU with Ada Lovelace architecture.In September, Firefly partnered with HealingMaps to offer cognitive electrophysiology analytics to over 2,500 ketamine, psilocybin, and TMS clinics across North America. “As demonstrated by our revenue growth, reduced cost structure and improved bottom line in Q3-2025, we have been able to rapidly integrate the Evoke business,” said Greg Lipschitz, Firefly’s Chief Executive Officer. “Moving forward, we remain focused on aggressively executing our commercial growth strategy, while also continuing to deploy NVIDIA’s advanced software development resources and industry-leading frameworks to advance our goal of building the world’s first EEG /ERP-based foundation model of the human brain.” Summary Third Quarter 2025 Financial Results For the quarter ended September 30, 2025, the Company recorded revenue of $388,000, which consists of equipment sales, equipment rentals, per-use fees, and the services related to projects and/or clinical studies. Q3-2025 revenues were up more than tenfold year-over-year from $33,000 for the same period in 2024, primarily due to the Company’s May 2025 acquisition of Evoke Neuroscience, and represented a 30% sequential increase from $299,000 for Q2-2025. Total operating expenses in the third quarter of 2025 were approximately $2.8 million, a 35% decrease from $4.3 million in the prior year period. The decrease in operating expenses was primarily due to reductions in equity vesting, consultant fees associated with rebranding, and legal fees incurred during 2024 in conjunction with the Company’s August 2024 reverse merger with WaveDancer. Third quarter 2025 net loss was approximately $2.6 million, or $0.20 per common share, a 38% improvement compared to approximately $4.3 million, or $0.61 per common share, in the three months ended September 30, 2024. Cash used in operating activities in the 2025 third quarter was approximately $1.5 million. This was down from $2.5 million in the same period of 2024, and was the lowest quarterly amount in the first nine months of 2025. The Company ended the 2025 third quarter with cash of $4.3 million. For complete financial results, please see Firefly’s filings, which are available under its profile at www.sec.gov and on its website here. About Firefly Neuroscience Firefly (NASDAQ: AIFF) is an Artificial Intelligence (“AI”) company developing innovative solutions designed to provide clinicians and researchers with unparalleled insights into brain function. Firefly’s proprietary database currently consists of over 191,000 EEG/ERP brain scans, making it the world’s largest known standardized EEG/ERP repository. Firefly’s EEG-based, AI-driven, and FDA-510(k)-cleared brain analytics technology has the potential to revolutionize diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Please visit www.fireflyneuro.com for more information. Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws concerning Firefly. These forward-looking statements include express or implied statements relating to Firefly’s management team’s expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly’s control) and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in the reports and other filings of Firefly with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of Firefly’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Investor & Media Contact Stephen Kilmer(646) 274-3580stephen.kilmer@fireflyneuro.com