お知らせ • Apr 17
Psyence Biomedical Ltd Advances Nature-Derived Psilocybin And Ibogaine Therapies Psyence Biomedical Ltd. acknowledged recent reports that the U.S. administration is preparing an executive order to further evaluate the safety and therapeutic potential of ibogaine, a naturally occurring compound being studied for its potential in treating post-traumatic stress disorder (PTSD), addiction, and other serious neurological and mental health conditions. The anticipated executive action reflects growing recognition of the need for rigorous, regulated research into novel therapies, particularly in areas where current treatment options remain limited. Ibogaine remains a Schedule I substance in the United States, and patients often seek access through unregulated settings outside the country. Psyence BioMed believes that advancing controlled clinical research and regulated development pathways is essential to improving both patient safety and long-term access. Through its strategic investment in PsyLabs, Psyence BioMed has established a leading position in the GMP-compliant manufacturing of ibogaine and ibogaine derivatives, with operations aligned to support global clinical research and future therapeutic development. The Company has also previously announced the development of a responsible and ethically sourced ibogaine supply chain, working within the compound’s native African ecosystem to ensure sustainability, traceability, and respect for traditional and environmental considerations. As global interest in ibogaine accelerates, Psyence BioMed’s integrated platform – combining ethical sourcing, GMP manufacturing, and clinical development capabilities – positions the Company to play a meaningful role in supporting the next phase of research and potential regulatory evolution. The availability of standardized, responsibly sourced ibogaine will be critical to enabling credible scientific progress. お知らせ • Mar 03
Psyence Biomedical Ltd. Announces Export Of GMP-Manufactured Natural Psilocybin NPX-5 To Australia For Ongoing Phase IIb Clinical Trial Psyence Biomedical Ltd. had announced the successful export of fully GMP-compliant manufactured psilocybin product NPX-5 (1mg and 5mg capsules) to Australia. The product was manufactured at the Psyence Labs Ltd. GMP-controlled production facility, supporting pharmaceutical-grade psychedelic development. The shipment represents an operational achievement for both Psyence BioMed and PsyLabs, reinforcing their shared commitment to establishing a regulated global supply chain for nature-derived psychedelic therapeutics. 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. Psyence BioMed is currently the only company conducting a Phase IIb clinical trial using natural psilocybin to study Adjustment Disorder in a palliative oncology population. Patient dosing is underway, with initial participants having been dosed in late 2025, and all newly enrolled patients will be dosed with NPX-5. The Phase IIb trial focuses on Adjustment Disorder, an excessive and sometimes debilitating psychological response to a significant life stressor – in this case, advanced cancer. The study aims to evaluate the efficacy, safety, and durability of a psycho-therapeutic approach utilizing nature-derived psilocybin to reduce anxiety and depressive symptoms in this vulnerable patient population. As a regulated, nature-derived formulation rather than a synthetic analogue, Psyence BioMed’s approach represents a differentiated pathway within psychedelic therapeutics – integrating pharmaceutical-grade manufacturing with clinical rigor in palliative mental health care. PsyLabs operates a GMP-compliant production and analytical facility capable of manufacturing pharmaceutical-grade natural psilocybin and ethically sourced ibogaine at scale. The successful export of NPX-5 capsules to Australia demonstrates: Full GMP compliance. International regulatory authorization for shipment. Operational global supply chain capability. Vertical integration across cultivation, extraction, manufacturing, and quality assurance. お知らせ • Feb 11
Psyence Biomedical Ltd. Enters into Settlement Agreement to Resolve Direct Shareholder Claim Made by KAOS Capital Ltd Psyence Biomedical Ltd. has entered into a settlement agreement to resolve a direct shareholder claim made by KAOS Capital Ltd. The claim, originally made on January 14, 2026, and amplified on January 26, 2026, alleged improper and oppressive actions on the part of the Company against KAOS, resulting in KAOS suffering alleged damages. The Company, its board of directors and officers have denied the allegations and believe they are unsubstantiated and meritless. On January 16, 2026, KAOS issued a notice of application in the Ontario Superior Court with respect to the KAOS Allegations and sought, among other remedies, to adjourn the shareholders' meeting of the Company originally scheduled for January 22, 2026. On January 21, 2026, the Court dismissed the Application and ordered KAOS to pay the Company's costs fixed in the amount of CDN 75,000. Under the terms of the settlement, the Company will pay an aggregate amount of USD 1,500,000 to KAOS and the Company has agreed to release KAOS from any obligation to pay the Costs Award. KAOS agrees that it will sell, or cause to be sold, all the common shares held by it in the Company to a third party designated by the Company at a price of USD 5 per share. The settlement also includes a full retraction of the unproven KAOS Allegations, a full mutual release of all claims between the parties and such other customary undertakings of a settlement of this nature. The settlement represents a compromise of disputed claims and does not constitute an admission of liability or wrongdoing by the Company, the Board or any of its officers. The Company expects that the settlement will be funded by cash on hand and will be recorded in accordance with applicable accounting standards. Although the Company, the Board and its officers deny any wrongdoing, they have opted for a settlement to avoid further litigation, disruption to the Company's business, and the significant costs related thereto. お知らせ • Jan 12
Psyence Biomedical Ltd., Annual General Meeting, Jan 22, 2026 Psyence Biomedical Ltd., Annual General Meeting, Jan 22, 2026. Location: venture workspace riverlands, office building 4, riverlands, 51 gogosoa street, observatory, cape town, 7935, United States お知らせ • Jan 05
Psyence Biomedical Ltd. Announces Board Changes Psyence Biomedical Ltd. announced a change to its Board of Directors. Christopher Bull resigned as a director of the Company effective December 1, 2025, and the resulting vacancy has been filled by the appointment of Graham Patrick. Mr. Patrick is a qualified attorney, conveyancer and notary with extensive experience in fiduciary oversight, good governance, management and cross-border transactions. お知らせ • Dec 19
Psyence Biomedical Ltd. Announces Approval for Use of Psylabs' Psilocybin Product in Phase IIb Clinical Trial Psyence Biomedical Ltd. announced that the Bellberry Human Research Ethics Committee (HREC) has formally approved the use of PsyLabs' psilocybin product (NPX5) in the Company's ongoing Phase IIb clinical trial evaluating psilocybin-assisted psychotherapy for Adjustment Disorder in patients with cancer. This approval highlights the Company's distinct evolution toward becoming one of the few vertically integrated psychedelic enterprises with multiple assets across drug and clinical development. With an investment in PsyLabs, significant clinical assets and a strong cash reserves balance of approximately $9.5 million, the Company is now positioned as one of the most differentiated companies in the emerging global psychedelics sector with the cash balance to execute on its strategy. The Company has also begun planning the activation of additional clinical sites to further accelerate patient recruitment and advance the Phase IIb program. The approved amendment confirms PsyLabs' psilocbin as the investigational product used in the double-blind, randomized, low-dose comparator-controlled clinical trial. This positions PsyLabs as a key contributor to Psyence BioMed's clinical-stage infrastructure, reinforcing the Company's ability to oversee the development pathway from ethical raw material sourcing through formulation, clinical evaluation, and eventual commercialisation. The company is dedicated to addressing unmet mental health needs, particularly in palliative care. The company is 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. お知らせ • Mar 25
Psyence Biomedical Ltd. Appoints Dr. Dan J. Stein to Scientific Advisory Board Psyence Group Inc. announced that its NASDAQ-listed associate, Psyence Biomedical Ltd. (PBM or Psyence Biomed), has announced that it has expanded its newly created Scientific Advisory Board (SAB) with the addition of Dr. Dan J. Stein, a recognized leader in the field of psychopharmacology. According to a news release issued by PBM, Dr. Stein is the Professor and Chair of the Dept of Psychiatry and Mental Health at the University of Cape Town (UCT) and Director of the South African Medical Research Council (MRC) Unit on Risk & Resilience in Mental Disorders. Dr. Stein will work closely with SAB chairman, Albert P. Garcia-Romeu, Ph.D, an Associate Professor in the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine. The PBM news release goes on to state that in addition to the continuation of PBM's Phase IIb clinical trial of psilocybin as a potential treatment for Adjustment Disorder in Palliative Care, PBM will also be advancing plans for its second development indication in Alcohol Use Disorder, introducing an entirely new class of psilocybin-based therapeutics to address significant unmet needs in mental health and addiction. お知らせ • Feb 28
Psyence Biomed Names Albert P. Garcia-Romeu as Chair of its Newly Created Scientific Advisory Board Psyence Biomedical Ltd. announced that it will work closely with Albert P. Garcia-Romeu, Ph.D., to chair and develop its newly created Scientific Advisory Board (SAB).Dr. Garcia-Romeu is a leading psychedelics researcher currently serving as Associate Professor in the Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, as well as Associate Director, Johns Hopkins Center for Psychedelic and Consciousness Research and the Susan Hill Ward Professor in Psychedelics and Consciousness. He is a highly sought after speaker on the therapeutic potential of psilocybin, with a particular emphasis on substance use disorder, and has been extensively published. Dr. Garcia-Romeu has also served as co-investigator and co-primary investigator for numerous psilocybin clinical trials. The Company will continue to recruit additional members for its SAB, which also includes Dr. Clive Ward Able, Medical Director of Psyence Biomedical, and Dr. Seth Feuerstein, Department of Psychiatry at Yale University. お知らせ • Dec 25
Psyence Biomedical Ltd. announced that it expects to receive $2 million in funding Psyence Biomedical Ltd announced it has entered into definitive agreement on December 23, 2024. The company will issue 1,000,000 common shares, 1,000,000 pre-funded warrant, series A common warrants to purchase up to 1,000,000 common shares and short-term series B common warrants to purchase up to 1,000,000 common shares at a purchase price of $2.00 per common share for aggregate gross proceeds of $2,000,000. The series A common warrants and short-term series B common warrants will have an exercise price of $2.00 per share and will be exercisable immediately upon issuance. The series A common warrants will expire five years from the date of issuance and the short-term series B common warrants will expire two years from the date of issuance. The private placement is expected to close on or about December 24, 2024. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the common shares underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with investors, the Company has agreed to file a resale registration statement covering the securities described above. お知らせ • Dec 18
Psyence Biomedical Ltd. Highlights Recent Progress on Active Phase IIb Clinical Trial Psyence Biomedical Ltd. highlighted recent progress that has been made with its active Phase IIb clinical trial of nature derived psilocybin, in conjunction with psychotherapy, as a potential treatment for Adjustment Disorder following a life-limiting cancer diagnosis in Palliative Care. To date, two trial sites in Australia - Vitalis and EMPAX - have been activated, and patient screening has commenced. Psyence Biomed anticipates that the first patients will be randomized into the study in January. Additionally, therapist training is ongoing at both sites. Psyence Biomed is also evaluating additional sites to potentially participate in the trial. To augment its own patient enrollment initiatives, Psyence Biomed’s contract research organization (CRO), iNGENu CRO, has engaged ACTioN SMO to focus on patient recruitment strategies through social media as well as direct email communications to physicians, potential clinical trial sites and disease state advocacy groups, including in the areas of oncology, primary care and psychiatry. ACTioN SMO is working closely with the activated sites, and the initial outreach to a broad audience has occurred. お知らせ • Nov 21
Psyence Biomedical Announces Favorable Result of Nasdaq Listing Qualifications Hearing Psyence Biomedical Ltd. announced the favorable outcome of the Nasdaq Listing Qualifications Hearing that was held on October 31, 2024. The Nasdaq Hearings Panel has granted Psyence Biomed an extension until December 31, 2024, to demonstrate compliance with all Nasdaq continued listing rules. During the Company’s Nasdaq Listing Qualifications Hearing, Psyence Biomed presented a comprehensive plan to regain and maintain compliance with Nasdaq’s continued listing requirements, including 5550(a)(2), the $1 minimum bid price requirement, 5550(a)(5), the $1.0 million minimum market value of publicly held shares requirement, and 5550(b)(1), the $2.5 million minimum stockholders' equity requirement. As part of its plan, Psyence Biomed requested to be transferred from The Nasdaq Global Market to The Nasdaq Capital Market pursuant to a Panel exception, effective November 15, 2024. Furthermore, as previously announced, Psyence Biomed obtained shareholder approval during its Annual General Meeting on November 12, 2024, to effect a 1-for-75 share consolidation that, when complete, will satisfy Nasdaq’s $1 minimum bid price requirement. The Company expects to demonstrate compliance with all the applicable requirements for continued listing on The Nasdaq Capital Market within the Panel’s extension.“We are very pleased to have gained alignment with the Nasdaq Hearings Panel on our plan to regain compliance with all applicable listing requirements,” stated Neil Maresky Chief Executive Officer. “Having our shares traded on the Nasdaq exchange is critical to raising awareness of our company among healthcare-focused institutional investors. Once these listing requirements are satisfied, we can focus on advancing our pipeline of nature-derived psilocybin-based therapeutics as potential treatments for underserved conditions in mental health and addiction where more efficacious options are urgently needed.” The Panel reserves the right to reconsider the terms of this extension based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of the Company’s securities on the Exchange inadvisable or unwarranted. Board Change • Nov 18
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. No experienced directors. No highly experienced directors. CEO & Director Neil Maresky is the most experienced director on the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. お知らせ • Sep 14
Psyence Biomedical Ltd. Announces Receipt of Staff Delisting Determination from Nasdaq Psyence Biomedical Ltd. announced that on September 12, 2024, the Company received a staff determination letter (the Determination Letter) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq) notifying the Company that it had not regained compliance with the Market Value of Listed Securities (MVLS) Requirement and the Market Value of Publicly Held Shares (MVPHS) requirement by September 9, 2024. As previously reported in a Current Report on Form 6-K filed on March 15, 2024, the Company received two deficiency letters from the Nasdaq Staff on March 11, 2024, one notifying the Company that for the last 30 consecutive business days, the Company's MVLS was below the minimum of $50 million required for continued listing on The Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(b)(2)(A), and the other notifying the Company that for the last 30 consecutive business days, the Company's MVPHS was below the minimum of $15 million required for continued listing on The Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(b)(2)(C). The Company was provided an initial period of 180 calendar days, or until September 9, 2024, to regain compliance with the MVLS and MVPHS Requirements. As described in the Determination Letter, unless the Company timely requests a hearing before a Hearings Panel (the Panel), the Company's securities would be subject to suspension/delisting. Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. お知らせ • Sep 08
Psyence Biomedical Ltd. (NasdaqGM:PBM) signed a letter of intent to acquire Clairvoyant Therapeutics Inc. Psyence Biomedical Ltd. (NasdaqGM:PBM) signed a letter of intent to acquire Clairvoyant Therapeutics Inc. for $1 million on September 6, 2024. As consideration for the Proposed Acquisition, Psyence Biomed will issue $0.5 of the Company’s common shares upon closing to Clairvoyant’s disposing shareholders, followed by potentially up to two share-based payments of $0.25 each (payable in cash or common shares, at the Company’s election) upon the achievement of pre-specified milestones by December 2026. In addition, Psyence Biomed will advance funds in tranches of up to $1.8in aggregate to Clairvoyant in order to settle its liabilities, which consist primarily of clinical trial costs. The Proposed Acquisition shall be subject to the conclusion of a definitive share purchase agreement between the parties based on the salient terms set out in the binding term sheet. The completion of the Proposed Acquisition is subject to several suspensive conditions, including board approval, regulatory strategy approvals, and satisfactory due diligence, as well as such other customary closing conditions. お知らせ • Jul 25
Psyence Biomedical Ltd. Provides Update on Upcoming Phase IIb Trial Psyence Biomedical Ltd. announced the export of nature-derived psilocybin to Australia and provided an update on its upcoming Phase IIb clinical trial evaluating nature-derived psilocybin as a potential treatment for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context. The Company previously announced that it had entered into partnerships with Fluence, a global leader in professional education and training for psychedelic therapy research, and iNGENu CRO Pty Ltd. (“iNGENu”), an Australian clinical research organization (CRO), to support the study. Following a recent site visit by Psyence Biomed leadership to partners and trial sites in Australia, the Company is preparing to initiate the study shortly following the recent successful export of drug candidate, PEX010, from its current supplier, Filament Health. The randomized, double-blind, placebo-controlled Phase IIb study will evaluate two therapeutic doses of nature-derived psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 84 patients in conjunction with psychotherapy. Psyence aims to execute an efficient yet rigorously designed study that, if successful, would best support advancement into future late-stage studies. New Risk • Apr 17
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.30m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (39% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (US$9.30m market cap). Minor Risks Negative equity (-CA$271k). Shareholders have been diluted in the past year (46% increase in shares outstanding). Board Change • Mar 31
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. No experienced directors. No highly experienced directors. CEO & Director Neil Maresky is the most experienced director on the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. New Risk • Mar 23
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 46% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (42% average weekly change). Revenue is less than US$1m. Minor Risks Negative equity (-CA$271k). Less than 3 years of financial data is available. Shareholders have been diluted in the past year (46% increase in shares outstanding). Market cap is less than US$100m (US$14.7m market cap). お知らせ • Mar 20
Psyence Biomedical Ltd. Announces Results of Recent Study Highlighting Benefits of Nature Derived Psilocybin Vs. Synthetic Psilocybin Psyence Biomedical Ltd. issued a statement welcoming the results of a recent study finding evidence that nature-derived psilocybin may be demonstrably more therapeutic than synthetic psilocybin. Published on February 20, 2024, in the journal Molecular Psychiatry, the study was conducted by a research team from Hebrew University, and supervised by Professor Bernard Lerer, MD, Executive Director of the Hadassah Brain Labs and Center for Psychedelic Research. The study presents evidence that nature (mushroom)-derived psilocybin delivers a more potent and prolonged effect on neuroplasticity than its synthetic analog. Neuroplasticity is increasingly recognized as the gold standard by which the therapeutic efficacy of psychedelic pharmaceutical medicines can be measured. The study in mice also suggests that a potential combination of molecules that the study refers to as the entourage effect may provide enhanced or prolonged therapeutic effects not found in synthetic psilocybin. Palliative Care is a holistic and integrative medical specialty that provides patients who have received a life-limiting diagnosis with treatment for their emotional, physical, or spiritual distress or discomfort. While most psychedelic companies research synthetic psilocybin, Psyence Biomed stands alone as the only Nasdaq traded biopharmaceutical company to research a nature-derived psilocybin candidate to treat Adjustment Disorder in the context of Palliative Care. Psyence Biomed has recently received ethics approval for the trial protocol for its Phase llb clinical trial to move forward. It is expected that the first patients will be randomized in the second quarter of 2024, with topline results available in 2025. The Psyence Biomed study will examine the use of nature-derived psilocybin as a treatment for Adjustment Disorder due to a recent cancer diagnosis in the Palliative Care context. お知らせ • Mar 18
Psyence Biomedical Ltd. Receives Nasdaq Notifications Regarding Market Value of Listed Securities and Market Value of Publicly Held Shares Psyence Biomedical Ltd. (the “Company”) announced that on March 11, 2024, it received two letters from the listing qualifications department staff of The Nasdaq Stock Market (“Nasdaq”), one notifying the Company (the “MVLS Notice”) that for the last 30 consecutive business days, the Company’s Market Value of Listed Securities (“MVLS”) was below the minimum of $50 million required for continued listing on the Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(b)(2)(A) (the “Market Value Standard”), and the other notifying the Company (the “MVPHS Notice”) that for the last 30 consecutive business days, the Company’s Market Value of Publicly Held Shares (“MVPHS”) was below the minimum of $15 million required for continued listing on the Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(b)(2)(C) (the “MVPHS Standard”). The MVLS Notice and the MVPHS Notice are only notifications of deficiencies and have no immediate effect on the listing of the Company’s securities. The Company’s securities continue to trade on Nasdaq. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has 180 calendar days, or until September 9, 2024, to regain compliance with the Market Value Standard and the MVPHS Standard. The MVLS Notice states that to regain compliance, the Company’s MVLS must close at $50 million or more for a minimum of ten consecutive business days during the compliance period ending September 9, 2024, at which time Nasdaq will provide written notification that the Company has achieved compliance under the Market Value Standard and the matter will be closed. The MVPHS Notice states that to regain compliance, the Company’s MVPHS must close at $15 million or more for a minimum of ten consecutive business days during the compliance period ending September 9, 2024, at which time Nasdaq will provide written notification that the Company has achieved compliance under the MVPHS Standard and the matter will be closed. The Company intends to actively monitor its MVLS and MVPHS and will evaluate available options to regain compliance with the Nasdaq continued listing standards. However, there can be no assurance that the Company will be able to regain compliance under the Market Value Standard and the MVPHS Standard, or will otherwise be in compliance with other Nasdaq listing criteria. お知らせ • Mar 13
Psyence Biomedical Ltd. Receives Human Research Ethics Committee Approval to Initiate Phase IIb Study Psyence Biomedical Ltd. received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia. The study will be conducted through PBM’s subsidiary, Psyence Australia (Pty) Ltd. and will examine the use of nature-derived psilocybin as a treatment for Adjustment Disorder due to a recent cancer diagnosis in the palliative care context. Accordingly, an estimated 56.8 million people worldwide require palliative care annually, with a substantial number of these patients exhibiting a high burden of psychosocial distress after diagnosis. The news release goes on to state that Adjustment Disorder is a serious condition affecting around 19% of patients with a life-limiting diagnosis. It severely impacts the quality of life for patients, their families and caregivers, and regularly ranks among the top seven psychiatric diagnoses in the world, according to the World Health Organization. Psyence Australia has partnered with a noted psychedelic Contract Research Organization (CRO), iNGENu Pty Ltd. (‘iNGENu’), to design and execute the clinical trial. iNGENu is an Australia-based, globally focused CRO with extensive experience working in psychedelic pharmaceutical drug research and development. The double-blind, placebo-controlled Phase IIb study will test three doses (25mg, 10mg and 1mg) of nature-derived psilocybin in 84 patients in conjunction with psychotherapy. The primary endpoint is change in HAM-A (Hamilton Anxiety Rating Scale), a widely used tool to measure anxiety severity, over time.