{"url_path":"/sec/pbm/10-k/2026/item-4","section_key":"item-4","section_title":"Item 4 INFORMATION ON THE COMPANY","topic":"sec","document":{"doc_type":"20-F","doc_date":"2026-06-22","source_url":"https://www.sec.gov/Archives/edgar/data/1985062/0001213900-26-070607-index.html","accession_number":"0001213900-26-070607","cik":"0001985062","ticker":"PBM","issuer_name":"PSYENCE BIOMEDICAL LTD.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1985062/0001213900-26-070607-index.html","primary_entity_key":"0001985062","primary_entity_name":"PSYENCE BIOMEDICAL LTD."},"word_count":11054,"has_tables":true,"body_markdown":"ITEM 4. INFORMATION ON THE COMPANY\n\n* *\n\n*The following terms, as used in this section shall have\nthe following meanings:*\n\n* *\n\nAjD\n \nAdjustment Disorder\n\nAPI\n \nActive Pharmaceutical Ingredient\n\nNPX-5\n \nCapsules containing 25mg naturally sourced psilocybin, being the product being used in Psyence’s Phase IIb Study\n\nPEX010\n \nCapsule containing 25mg naturally sourced psilocybin\n\nPhase IIb Field of Use\n \nAnxiety and depression, including associated ailments, such as PTSD, stress, grief, and AjD within the context of palliative care\n\n \n\nA. Corporate History and Development* *\n\n** **\n\n**The Business Combination**\n\n \n\nOn January 9, 2023 Psyence Group Inc. (“**PGI**”\nor “**Psyence Group**”) entered into a definitive business combination agreement, as amended (the “**Business Combination\nAgreement**” or “**BCA**”) with Newcourt Acquisition Corp. (NASDAQ: NCAC), a special purpose acquisition company\n(“**SPAC**”). The agreement aimed to create a public company leveraging natural psilocybin for palliative care treatment.\nPGI is a listed Canadian company that contributed its clinical trial activities to the Company as described below.\n\n \n\nThe transaction concluded on January 25, 2024,\nwith PBM’s listing on NASDAQ. This transaction involved PBM acquiring the SPAC through a merger, thereby making the SPAC a wholly-owned\nsubsidiary of PBM.\n\n \n\n*Transaction Overview:*\n\n \n\nOn January 25, 2024 (the “**Closing Date**”),\nthe Company, a corporation organized under the laws of Ontario, Canada, completed the previously announced business combination (the “**RTO\nTransaction**”) as per the BCA. The parties involved in the BCA included:\n\n \n\n-PGI;\n\n \n\n-Newcourt\nAcquisition Corp., a Cayman Islands exempted company (“**NCAC**”);\n\n \n\n-Newcourt\nSPAC Sponsor LLC, a Delaware limited liability company (“**NCAC Sponsor**”);\n\n \n\n-Psyence\n(Cayman) Merger Sub, a Cayman Islands exempted company and a wholly owned subsidiary of Psyence Group (“**Merger Sub**”);\n\n \n\n-Psyence\nBiomed Corp., a corporation organized under the laws of British Columbia, Canada (“**Original Target**”);\n\n \n\n-Psyence\nBiomed II Corp., a corporation organized under the laws of Ontario, Canada (“**Psyence Biomed II**”);\n\n \n\n-Psyence\nAustralia (Pty) Ltd (“**Psyence Australia**”)\n\n \n\n*Key Transactions (collectively, the “**Business\nCombination**”):*\n\n* *\n\n*Formation of Subsidiaries*: Prior to the\nClosing Date, PGI formed three wholly owned subsidiaries: Psyence Biomed II, Psyence Australia and PBM.\n\n* *\n\n*Amalgamation*: Prior to the Closing Date,\nPGI amalgamated with the Original Target. Consequently, PGI transferred shares of Psyence Australia and related business assets previously\nowned by the Original Target to Psyence Biomed II.\n\n* *\n\n*Share Exchange*: PGI contributed Psyence\nBiomed II to PBM in a share-for-share exchange (the “**Company Exchange**”).\n\n \n\n*Merger*: Following the Company Exchange,\nPsyence (Cayman) Merger Sub merged with Newcourt Acquisition Corp., with Newcourt Acquisition Corp. being the surviving entity. Each outstanding\nordinary share of Newcourt Acquisition Corp. was converted into the right to receive one common share of PBM.\n\n* *\n\n*Warrant Conversion*: Each outstanding warrant\nto purchase Newcourt Acquisition Corp. Class A ordinary shares was converted into warrants to acquire one common share of PBM on substantially\nthe same terms as the original warrants.\n\n \n\n28\n\n \n\n \n\nThe Common Shares and the Public Warrants are\ntraded on The Nasdaq Stock Market LLC (“**Nasdaq**”) under the symbols “PBM” and “PBMWW,” respectively.\n\n \n\nPsyence Biomedical Ltd was\nincorporated as a corporation under the laws of Ontario, Canada on June 29, 2023.\n\n \n\n**Investment in Psyence Labs Ltd**\n\n \n\nDuring the year ended March\n31, 2026, the Company made additional investment in PsyLabs to establish a multi-asset, vertically integrated biopharmaceutical platform\nfocused on psychedelic-based therapeutics, with pharmaceutical-grade drug candidates manufactured through its investment in PsyLabs. During\nthe fiscal year ended March 31, 2025, the Company acquired 1,000 shares of PsyLabs in exchange for 5,695 common shares of the Company,\nhaving an aggregate fair value of approximately $722,033, which was recorded as the cost of the investment. On April 15, 2025, the Company\nacquired an additional 250 PsyLabs shares for total cash consideration of $500,000, and on August 15, 2025, it acquired a further 1,750\nPsyLabs shares for total cash consideration of $3,500,000, increasing its holding to 3,000 PsyLabs shares, or approximately 16.46% of\nPsyLabs’ outstanding shares. In February 2026, the Company exercised a put option and issued 1,146,159 of its common shares, having\na fair value of approximately $2,934,167, to acquire an additional 2,900 PsyLabs shares, increasing its ownership to approximately 27.93%.\nAs a result of acquiring significant influence, the Company has accounted for its investment in PsyLabs under the equity method as an\ninvestment in an associate from February 25, 2026. The carrying amount of the Company’s investment in PsyLabs as of March 31, 2026\nwas approximately $8,060,928. PsyLabs is a privately held company headquartered in the British Virgin Islands that focuses on the production\nof psychedelic active pharmaceutical ingredients and extracts, and is an affiliate of the Company.\n\n \n\n**Principal Capital Expenditures and Divestitures**\n\n \n\nThe Company is a clinical-stage biopharmaceutical company and has not\nhistorically made material expenditures on property, plant and equipment. Since the beginning of the fiscal year ended March 31, 2024\nthrough the date of this Report, the Company’s principal capital expenditures and divestitures have consisted principally of its\nacquisition of equity interests in, and licensing arrangements with, PsyLabs. and its affiliates, and\nthe disposition of its prior licensing arrangement with Filament Health Corp. (“Filament”), as described below. The Company\nhas not made any other individually material capital expenditures or divestitures, including any other material interests in other companies,\nduring this period.\n\n  \n\n**Disposition of Filament licensing arrangement.**\n\n \n\nIn December 2022, the Company had entered into a royalty-bearing, binding\nterm sheet with Filament for the worldwide right to commercialize Filament’s proprietary botanical drug candidate, PEX010, within\nthe Company’s designated fields of use. On July 22, 2024, the parties entered into an addendum (the “Filament Addendum”),\nand the parties subsequently agreed to terminate the Filament term sheet and transition from PEX010 to PsyLabs’ NPX-5 as the product\ncandidate used in the Company’s Phase IIb Study. The Company did not receive cash proceeds in connection with this disposition.\n\n \n\n**Capital Expenditures and Divestitures Currently in Progress;\nGeographic Distribution and Financing**\n\n \n\nAs of the date of this Report, the Company’s principal capital\nexpenditures currently in progress consist of the continued funding of its Phase IIb clinical trial in Australia, conducted through its\nAustralian contract research organization, Southern Star Research Pty Ltd, and its Australian subsidiary, Psyence Australia (Pty) Ltd,\ntogether with its ongoing investment in and licensing arrangements with PsyLabs. These investments are located principally outside of\nCanada: the Company’s equity investment in PsyLabs relates to an entity domiciled in the British Virgin Islands, and the Company’s\nclinical-development expenditures are incurred principally in Australia. The Company has no material capital expenditures in progress\nwithin Canada, its country of incorporation.\n\n \n\nThe Company has financed\nthese capital expenditures and investments through a combination of internal and external sources. The cash portions of the PsyLabs share\nacquisitions and the funding of the Company’s clinical-development activities have been financed from the Company’s available\ncash resources, which have been generated principally from sales of equity securities and convertible debt financings, while the February\n2026 increase in the Company’s PsyLabs interest was financed through the issuance of the Company’s common shares rather than\ncash. The Company expects to finance its capital expenditures and investments currently in progress through its existing cash resources\nand, as needed, additional external financing. See “Item 3.D — Risk Factors” and “Item 5 — Operating and\nFinancial Review and Prospects.”\n\n \n\n29\n\n \n\n** **\n\n**Other Information**\n\n \n\nOur registered address and principal executive\noffice is 121 Richmond Street West, Penthouse Suite 1300, Toronto, Ontario M5H 2K1, and our telephone number is +1 (416) 477-1708.\n\n \n\nOur U.S. transfer agent and registrar is\nContinental Stock Transfer & Trust Company, located at 1 State Street, 30th Floor, New York, NY 10004.\n\n \n\nWe file reports and other\ninformation with the SEC pursuant to the SEC’s rules and regulations that apply to foreign private issuers. The SEC maintains\nan Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically\nwith the SEC. Our electronic filings are available for viewing on the SEC’s website at http:// www.sec.gov). The website address\nof the Company is *www.psyencebiomed.com*. The information contained on the website does not form a part of, and is not incorporated\nby reference into, this Report.\n\n \n\nB. Business Overview\n\n \n\nThe Company is a multi-asset,\nvertically integrated biopharmaceutical company focused on psychedelic-based therapeutics, with pharmaceutical-grade drug candidates manufactured\nthrough its investment in PsyLabs. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic)\npsilocybin and ibogaine-based psychedelic medicine to be listed on Nasdaq. We are dedicated to addressing unmet mental health needs and\nare committed to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for\na broad range of mental health disorders. The Company is currently conducting research through clinical trials to evaluate the safety\nand effectiveness of natural psilocybin in treating adjustment disorder in patients with a cancer diagnosis in a palliative care context.\n\n \n\nWe strive to set the global standard for excellence\nand consistency in drug development using nature-based psilocybin products. Psyence’s priority is developing pharmaceutical grade\npsilocybin to help heal psychological trauma and the diagnosable disorders that can result therefrom, including AjD, alcohol use disorder\n(“**AUD**”), other substance use disorders (“**SUDs**”), anxiety, depression, post-traumatic stress disorder\n(“**PTSD**”), and grief and bereavement, especially in the context of palliative care. Our focus includes therapeutic protocols\nfor medical and scientific research including observational studies.\n\n \n\nNPX-5, capsules containing 25mg naturally sourced\npsilocybin, is being used in our Phase IIb Study, replacing PEX010 as the lead product candidate. Psyence has entered into the PsyLabs\nIP Agreement with PsyLabs, a psychedelic Active Pharmaceutical Ingredient (API) development company, federally licensed to cultivate,\nextract, and export psilocybin mushrooms and other psychedelic compounds including psilocin, mescaline, ibogaine, and dimethyltryptamine\n(DMT) to legal medical and research markets, and the proprietary owner of NPX-5, for the licensing of NPX-5 with respect to Psyence’s\ndesignated fields of use: anxiety and depression, including associated ailments, such as PTSD, stress, grief, and adjustment disorder\nwithin the context of palliative care. See “— *Licensing of PEX010 – Palliative Care*” and “— *Licensing\nof NPX-5 – Palliative Care*” below.\n\n \n\nWe have contracted Southern Star Research, a full-service\nAustralian CRO, to conduct the Phase IIb Study, which is a double-blind, randomized, low-dose controlled clinical trial to assess\nthe efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of AjD due to incurable cancer. Outsourcing the\nstudy to a CRO assists the company in operating in a more capital efficient manner without the overhead of handling in-house.\n\n** ** \n\nPsyence Biomedical conducts its operations through\nits subsidiaries based in Ontario and Australia and also owns a subsidiary in the Cayman Islands, as listed below:\n\n \n\n**Name**\n \n**Country of Incorporation and Place of Business**\n \n**Proportion of Ordinary Shares\nHeld by Psyence Biomedical**\n \n\nPsyence Biomed II Corp\n \nOntario, Canada\n \n \n100\n%\n\nPsyence Australia Pty Ltd.\n \nAustralia\n \n \nIndirect 100\n%\n\nNewcourt Acquisition Corp\n \nCayman Islands\n \n \n100\n%\n\n \n\n30\n\n \n\n \n\nThe diagram below depicts a current version of\nPsyence Biomedical.\n\n \n\n \n\nThe Company is subject to certain of the informational\nfiling requirements of the Exchange Act. Since the Company is a “foreign private issuer,” it is exempt from the rules and\nregulations under the Exchange Act prescribing the furnishing and content of proxy statements, and the officers, directors and principal\nshareholders of the Company are exempt from the reporting and “short-swing” profit recovery provisions contained in Section 16\nof the Exchange Act with respect to their purchase and sale of Common Shares. In addition, the Company is not required to file reports\nand financial statements with the SEC as frequently or as promptly as U.S. public companies whose securities are registered under the\nExchange Act. However, the Company is required to file with the SEC an Annual Report on Form 20-F containing financial statements\naudited by an independent accounting firm. The SEC also maintains a website at www.sec.gov that contains reports and other information\nthat the Company files with or furnishes electronically to the SEC.\n\n \n\nThe website address of the Company is *www.\npsyencebiomed.com*. The information contained on the website does not form a part of, and is not incorporated by reference into, this\nReport.\n\n** **\n\n**Phase IIb Study - Palliative Care Clinical Trial**\n\n \n\nOn January 9, 2023, Psyence and iNGENū\nCRO Pty Ltd (“**iNGENū**”) signed a letter of intent to further develop Psyence’s licensed natural psilocybin\ndrug product, starting with a Phase IIb Study in order to lead a pre-IND meeting with the FDA. In May 2025, the Company transferred\nall clinical trial execution duties from iNGENū to Southern Star Research and entered into a Master Services Agreement (the “**MSA**”)\nwith Southern Star Research. Under the MSA, Southern Star Research will provide comprehensive CRO services for the Phase IIb Study.\n\n \n\nThe product to be used in this Phase IIb\nStudy will be the proprietary botanical drug candidate NPX-5 (25mg), which Psyence sources from PsyLabs. The planned randomized double-blind\nstudy will evaluate the use of psilocybin-assisted psychotherapy versus psychotherapy alone and will test 87 patients utilizing the HAM\n- A scale as the primary endpoint, which is an FDA validated endpoint, and safety data will be collected throughout the study.\n\n \n\nFor safety, there are no specific endpoints as\nall safety findings are captured as adverse events. The primary and secondary efficacy endpoints are all established in the protocol before\nit is reviewed and approved by the Ethics Committee before the study can start.\n\n \n\n31\n\n \n\n \n\nThe HAM-A is a rating scale developed to measure\nthe severity of anxiety symptoms and is widely used in both clinical and research settings. The scale consists of 14 items, each defined\nby a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical\ncomplaints related to anxiety). During the Phase IIb Study, the HAM-A scale will be used to measure change in anxiety levels over time\nas the primary endpoint.\n\n \n\nThe 87-patient Phase IIb Study being conducted\nby the CRO, Southern Star Research, in Australia is the one that has been referred to in discussions with the FDA in the pre-IND process,\nwhich is in the late planning stage, and estimated to commence enrollment in the second half of 2025.\n\n \n\nThe estimated costs of this Phase IIb Study were\ninitially $5,575,000 made on the basis of milestones completed. Included in this original estimate were costs for 75 participants; an\nend of Phase II meeting preparation and attendance after the completion of the Phase IIb Study with the FDA as well as psychotherapy training,\npsychotherapy sessions and therapist fees for participants. Subsequently, the Phase IIb Study was increased to 87 patients, and we anticipate\nthe estimated cost of this study to be increased by approximately 5%.\n\n \n\nOn September 15, 2022, we received full approval\nof a study (the “**UK Trial**”) in the United Kingdom from the UK Medicines and Healthcare products Regulatory Agency (“**MHRA**”) using\nnatural psilocybin in the field of palliative care with oncology patients. For this study, we had partnered with Clerkenwell Clinics Limited\n(“**Clerkenwell Health**”), which would have been responsible for jointly designing and delivering the UK Trial. Following\nsuch approval, we opted to forego proceeding with the UK Trial in order to pursue the opportunity to conduct the Phase IIb Study\nin Australia, as Psyence could benefit from the Australian Federal Government’s Research & Development tax incentive program,\nwhich could provide up to a 43.5% rebate on Psyence’s R&D expenses in Australia, making it a more cost-effective endeavor. In\naddition, the Phase IIb Study adds a dose-finding arm, which allows us to accelerate our development strategy, seeking input from\nthe FDA with our pre-IND application. On March 5, 2024, Psyence received full approval of the Phase IIb Study from to the Australian Human\nResearch Ethics Committees (HRECs), the body responsible for the review of research proposals involving human participants to ensure that\nthey are ethically acceptable. If the outcome of the Phase IIb Study is positive, we believe we may be able to proceed directly to a Phase\nIII trial in the United States, subject to FDA review and the opening of an IND; however, there is no guarantee that the FDA will accept\ndata from trials conducted outside of the United States.\n\n** **\n\n**Licensing of PEX010 - Palliative Care**\n\n \n\nIn April 2022, Psyence entered into a research\nlicensing agreement with Filament for the licensing of PEX010 and its associated intellectual property, as well as for the supply of PEX010\nfor the specific intention of the clinical development of the product for use in palliative care patients (“**Filament Research\nIP Agreement**”). Pursuant to the Filament Research IP Agreement, Filament granted Psyence an irrevocable, royalty free, worldwide\nlicense (with the right to sub-license, subject to certain restrictions) to use and distribute PEX010 and certain related intellectual\nproperty (such as delivery mechanism, preparation methods and know-how) solely for use in connection with pre-clinical and clinical studies\nand trials to be conducted in Canada, the UK and world-wide in the treatment of anxiety and depression, including associated ailments,\nsuch as PTSD, stress, grief, and adjustment disorder within the context of palliative care. This license is granted in respect of the\nclinical trial phase of Psyence’s activities, specifically phase II clinical trials which consisted of the Phase IIb Study. The\nlicense was granted on an exclusive basis solely within the territory of the UK with respect to the designated fields of use, and Psyence\nhad a right of first refusal to extend its exclusive license beyond the territory of the UK. Psyence did not have any rights to use PEX010\nfor any profit-making or commercial purposes under the Filament Research IP Agreement. Any results of testing, research, conduct of and\nany information derived from the clinical studies and trials using PEX010 became the sole property of Psyence. Under the Filament Research\nIP Agreement, Filament was entitled to receive milestone payments of up to CAD$250,000 in aggregate based on four distinct phase II clinical\ntrial milestones to be achieved by Psyence. If Psyence were to pursue a second or multiple indications, such aggregate milestone payments\nwould have been increased accordingly. For the year ended March 31, 2024, Psyence incurred $167,306 costs under the Filament\nResearch IP Agreement related to milestone payments, which was accounted for as research and development costs.\n\n \n\n32\n\n \n\n \n\nIn addition to the licensing rights described\nabove, Filament undertook to support Psyence’s clinical trial efforts through the supply of the required quantities of PEX010 to\nPsyence, for no additional charge, based on Psyence’s good faith forecasts of its needs. Filament also committed to the creation\nand provision of such information, assistance and support for the execution of the dossiers, IMBP and other documents required to\nconduct Psyence’s clinical trials in accordance with the trial schedules. The license term was 5 years, expiring in April 2027.\nOn July 22, 2024, the parties concluded an addendum to the Filament Research IP Agreement (“**Filament Addendum**”)\nwhereby Filament undertook to provide a sufficient supply of PEX010 to Psyence in order to facilitate the substitution of an alternative\ndrug candidate for use in Phase III trials and for commercialization purposes following the conclusion of the Phase IIb Study, however\nthe parties later agreed to transition to NPX-5 as part of the Phase IIb Study.\n\n \n\nIn December 2022, Psyence entered into a\nroyalty-bearing, binding term sheet for the commercial licensing of intellectual property (with the right to sub-license) from Filament,\nwhich was subject to the terms of a definitive license agreement, and which granted Psyence the worldwide right to commercialize PEX010\nwithin the designated fields of use, being anxiety and depression, including associated ailments, such as PTSD, stress, grief, and adjustment\ndisorder within the context of palliative care. The term sheet remained subject to further negotiations between the parties and the execution\nof a subsequent definitive agreement within a predefined time period. Following further discussions, Psyence and Filament mutually agreed\nto terminate the term sheet by way of the Filament Addendum, whereafter Psyence transitioned to an alternative supplier, PsyLabs for purposes\nof the ongoing Phase IIb Study.\n\n \n\nPsyence has successfully negotiated and executed\nsupply agreements and licensing agreements for the use of PsyLabs’ intellectual property within the Phase IIb Field of Use and indications\nof AUD and other SUDs respectively. See *“*— *Licensing of NPX-5 – Palliative Care”* and — *Licensing\nof additional API for use in AUD and SUD”.*\n\n \n\nPsyence has not performed any pre-clinical or\nclinical trials on PEX010 or NPX-5. NPX-5 is manufactured by or on behalf of PsyLabs in accordance with applicable quality standards for\nthe intended stage of development and proposed clinical or authorised patient-access use. PsyLabs has not yet completed pre-clinical or\nclinical trials on NPX-5. In December 2025, the Bellberry Human Research Ethics Committee (“**HREC**”) formally approved\nthe use of PsyLabs’ NPX-5 in Psyence’s ongoing Phase IIb study evaluating psilocybin-assisted psychotherapy for Adjustment\nDisorder in patients with cancer.\n\n** **\n\n**Licensing of NPX-5 - Palliative Care**\n\n \n\nAs stated above,\nPsyence has transitioned to NPX-5 as part of the ongoing Phase IIb Study. In December 2025, the Company entered into an exclusive\n(with respect to the territory of Australia), royalty-bearing IP licensing agreement with PsyLabs, in terms of which PsyLabs will\nsupply the Company with pharmaceutical-grade, GMP-compliant, nature-derived (non-synthetic) psilocybin for use in the Phase IIb\nStudy, future clinical trials, and eventual commercialization in the Phase IIb Field of Use (“**PsyLabs IP\nAgreement**”).\n\n \n\nThe license was granted on an exclusive basis\nsolely within the territory of Australia with respect to the Phase IIb Field of Use, however Psyence has a right of first refusal to extend\nits exclusive license beyond the territory of Australia. Any results of testing, research, conduct of and any information derived from\nthe clinical studies and trials using NPX-5 shall become the sole property of Psyence. Under the PsyLabs IP Agreement, PsyLabs is entitled\nto receive milestone payments of up to $95,000 in aggregate based on two distinct phase II clinical trial milestones, up to $876,000 in\naggregate based on two distinct commercialization milestones in respect of the first marketing approval permitting commercial sales and\nup to $584,000 in aggregate based on two distinct commercialization milestones in respect of any other marketing approval permitting commercial\nsales thereafter, as achieved by Psyence. For the year ended March 31, 2026, Psyence incurred $75,000 costs under the PsyLabs\nIP Agreement related to milestone payments, which was accounted for as research and development costs.\n\n \n\n**Licensing of additional API for use in AUD\nand SUD**\n\n \n\nIn September 2024, the Company entered into an\nexclusive, royalty-bearing IP licensing agreement with PsyLabs, following an initial investment whereby the Company acquired a minority\nstake in PsyLabs. Under the terms of this agreement, PsyLabs will supply the Company with pharmaceutical-grade, EU-GMP, nature-derived\n(non-synthetic) psilocybin for use in future clinical trials and eventual commercialization in SUD, including AUD.\n\n \n\nIn parallel with an additional financial commitment\nin PsyLabs in April 2025, the Company has secured an exclusive right of first refusal in respect of the worldwide supply of pharmaceutical-grade,\nnature-derived ibogaine. Under this agreement, PsyLabs will grant the Company the right of first refusal to acquire the exclusive rights\nto a dedicated supply of ibogaine for evaluation in the treatment of SUD, including AUD.\n\n \n\nThese exclusive partnerships further strengthens\nthe Company’s integrated development strategy, ensuring access to high-quality psychedelic compounds to support its growing clinical pipeline\nand diversification into multiple therapeutic areas.\n\n \n\n33\n\n \n\n \n\n**Relationships with Third Parties**\n\n \n\nPsyence’s Australian-based research and\ndevelopment will be conducted by its CRO partner, Southern Star Research, in Australia. As stated above, PsyLabs’ NPX-5 will serve as\nthe product candidate under investigation during the Phase IIb Study.\n\n** **\n\n**Psyence’s R&D capabilities**\n\n \n\nPsyence’s Global Head of Clinical Development\n(Dr. Neil Maresky) and Scientific Advisor (Dr. Clive Ward-Able) are both medically trained physicians with close to 60 years\nof experience between them within the pharmaceutical industry related to R&D and the commercialization of new products. This experience\nprovides the foundations for an excellent understanding of the clinical development, regulatory and commercialization needs of various\npharmaceutical markets to design the optimal development program.\n\n \n\nPsyence plans on working with various CROs and\nconsultancy agencies to prepare and operationalize their protocols for the various phases of the clinical development program.\n\n** **\n\n**Intellectual Property**\n\n \n\nPsyence engages a team of lawyers and advisors\nthat helps strengthen the protection of its IP assets. As psilocybin is a naturally occurring substance, it cannot be patented. However,\npatents may be granted on formulations, methods of use, compositions of matter and formulation processes, provided that such items are\nnovel, non-obvious and have significant improvements to existing inventions.\n\n \n\nPsyence’s IP strategy is built around:\n\n \n\n●Establishing\nand maintaining a competitive advantage on formulation, dosage and administration of psilocybin, as well as psychedelic-assisted therapy\nmodules for palliative care indications; and\n\n \n\n●Ensuring\nbusiness flexibility through directing its research in areas which maintain freedom to operate (relative to third party patent positions)\nand secures the most favorable commercial terms in agreements with other companies in collaborating on later research, and the commercialization\nof Psyence’s IP assets.\n\n \n\nPsyence has a specialist, experienced in-house\nteam focused on delivery of this strategy, including internationally recognized patent professionals working directly with Psyence’s\nboard on these issues.\n\n \n\nSpecific actions are being taken towards delivery\nof this strategy include:\n\n \n\n●Ongoing\npatent landscaping on the competitor patent landscape. Psyence has completed a patent landscaping review and has ongoing patent watching\nsearches in place on the back of this to identify any new filings made in this space;\n\n \n\n●Actively\nconsidering potential patent filings, with the intention to identify, file, prosecute and eventually maintain Psyence’s patent\nportfolio. This patent portfolio is intended to be built out incrementally across the proprietary formulation and treatment technologies\nthat are under development by Psyence;\n\n \n\n●Active\nmanagement of key know-how and trade secrets (in order to supplement the patent portfolio); and\n\n \n\n●Thoughtful\nnegotiation of in-licensing arrangements of third-party IP rights that can enhance or accelerate the building of our business.\n\n \n\nPsyence does not currently hold any patents. Psyence\nwill be dependent, to an extent, on PsyLabs to maintain and defend the intellectual property currently being licensed to Psyence under\nthe PsyLabs IP Agreement, which is relevant for use in Psyence’s Phase IIb Study.\n\n \n\n**Competitive Environment**\n\n \n\nThere are currently no pharmaceutical agents with\nFDA regulatory approval for the treatment of AjD within palliative care or any other arena. The current treatment of AjD is empirical,\nwith either psychotherapy or off-label pharmacological agents, such as anti-depressants or anxiolytics, or a combination of both.\n\n \n\nWe believe that the competitive landscape analysis\nof other commercial psychedelic-assisted treatments in clinical trials strongly suggests that Psyence’s clinical asset has a first-mover\nadvantage in both the palliative care and cancer-related AjD market upon approval. NPX-5 and its associated IP has been licensed to Psyence,\ngiving it exclusivity for the Phase IIb Field of Use in Australia for R&D and commercialization purposes. Psyence plans to expand\ntheir targeted indication of cancer-related AjD to address different types of AjD and other secondary indications both in a palliative\nand non-palliative context.\n\n \n\n34\n\n \n\n \n\nIn 2019, the FDA designated psilocybin therapy\nas “breakthrough therapy” for the treatment of severe depressive disorder. This precedent provides the possibility that psilocybin-based\ndrug candidates, such as NPX-5, may be eligible for a number of processes that could result in expedited marketing approval of such psilocybin-based\ndrug candidates, such as Fast Track, Accelerated Approval, Priority Review and Breakthrough Status. Breakthrough therapy designation is\nintended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy\ndesignation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically\nsignificant endpoint over available therapy.\n\n \n\nA breakthrough therapy designation conveys all\nof the fast track program features (see below for more details on fast track designation), more intensive FDA guidance on an efficient\ndrug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.\n\n \n\nAdditionally, even if we are granted an accelerated\napproval pathway, that may or may not lead to a faster development or regulatory review or approval process and may or may not increase\nthe likelihood that our other product candidate will receive marketing approval. The European Medicines Agency (EMA) PRIME program, similar\nto the Food and Drug Administration (FDA) breakthrough therapy designation program, was launched in March 2016 to enhance support\nfor the development of medicines that target an unmet medical need. PRIME and the U.S. breakthrough therapy designation share the same\nobjective (timely patient access to innovative medicines).\n\n** **\n\n**Business Objectives**\n\n \n\nPsyence intends to further expand the development\nof its product candidates for additional indications. While Psyence’s initial focus will be on the development of NPX-5 for the\ntreatment of AjD in patients with a recent diagnosis of cancer in its Phase IIb Study, indication expansion will focus on other causes\nof AjD potentially leading to an increased opportunity within the indication. Further indications will be considered once the AjD program\nis ongoing in areas such as AUD and other SUDs and potentially with the use of other in-licensed candidates, however no such agreements\nhave been reached at this stage.\n\n** **\n\n**Psyence’s Psilocybin Asset**\n\n \n\nIn order to accelerate clinical development of\na palliative care, psilocybin-based asset, Psyence had initially licensed Filament’s proprietary botanical drug candidate, PEX010,\nand its associated IP, however Psyence has now transitioned to NPX-5 as part of the Phase IIb Study. PsyLabs has developed innovative\ntechnology to extract and standardize stable doses of natural compounds from mushrooms. In December 2025 the HREC formally approved the\nuse of PsyLabs’ NPX-5 in Psyence’s ongoing Phase IIb Study. Pursuant to the PsyLabs IP Agreement, Psyence will own all the data,\nresults of testing, research, any information and any other IP derived or arising from any clinical trials, with the exclusion of IP\nrelated to the manufacture, processing or production of the PsyLabs input material, which will vest in PsyLabs.\n\n \n\nNPX-5 is a pharmaceutical-grade, natural psilocybin\ndrug candidate. It consists of five oral capsules containing 5mg of naturally derived psilocybin each (totaling 25mg of naturally derived\npsilocybin). NPX-5 will be used as an adjunct to psychotherapy for the treatment of AjD due to an incurable cancer diagnosis versus psychotherapy\nalone within a palliative care context.\n\n** **\n\n**Description of NPX-5**\n\n \n\nNPX-5 is extracted and purified from the psilocybes\nspecies of mushroom. Psilocybin is rapidly metabolized in the body to form psilocin, a psychoactive molecule. There has recently been\na resurgence in the study of the use of psychedelics in a multitude of potential indications such as depression, anxiety disorders, PTSD,\naddictions and within palliative care, which is the focus area for Psyence’s development of NPX-5.\n\n \n\nAs part of the ongoing Phase\nIIb Study, NPX-5 is being tested in patients with a recent cancer diagnosis and who have developed AjD which can severely affect their\nquality of life as well as those closely related to them.\n\n** **\n\n35\n\n \n\n**  **\n\nOral psilocybin has about a 50% bioavailability\nand psilocin is detectable in plasma within 15 minutes of administration of the parent compound.1, 2 The half-life of\npsilocin in blood is 2-3 hours. Onset of noticeable psychoactive effects for a 25 mg dose typically occur within one hour, peaks at two\nhours after a dose and finishes at six hours after the dose.\n\n \n\nThe investigational medicinal product, NPX-5,\nis an oral capsule containing a naturally derived Psilocybe cubensis mushroom extract standardized for psilocybin content. Psilocybin\nis chemically described as 4-phosphoryloxy-N,N-dimethyltryptamine (4-PO-DMT). Each NPX-5 capsule is formulated to contain 5 mg of psilocybin,\ntogether with appropriate excipients, in a hydroxypropyl methylcellulose capsule shell. \n\n** **\n\n**Indication and Treatments**\n\n** **\n\n**Adjustment Disorder**\n\n \n\nIncurable cancer is predictably associated with\nchallenges and burdens that may lead to symptoms of depression, demoralization, and fears of suffering, dependency, and mortality.3 Up\nto 50% of individuals with advanced cancer report symptoms that are sufficiently severe to reach clinical levels, exacerbating physical\nsymptoms and impairing quality of life.4, 5 Multiple physical symptoms, dramatic alteration in support needs and personal\nrelationships, difficulty navigating a complex health care system, and the threat of impending mortality all may constitute pathways to\ndistress.6\n\n \n\nAjD is defined in International Classification\nof Diseases 11th Revision (ICD-11) as a maladaptive reaction, which usually emerges within one month of a significant life-stressor,\nsuch as illness, family or partnership problems, job-related issues, or financial difficulties. 7 There are two core\ncategories of symptoms that characterize AjD: a preoccupation with the stressor or its consequences, and failure to adapt. Preoccupation\nincludes recurring distressing thoughts about the stressor, constant worry, and rumination. Failure to adapt describes a generalized stress-response\n(e.g., sleep disturbances or concentration problems) that results in significant impairment in social, interpersonal, occupational, educational,\nor other significant areas of functioning\n\n \n\nAjD is also defined in the Diagnostic and Statistical\nManual of Mental Disorders (DSM) diagnostic criteria,8 and while there is great overlap with the definition and symptomatology\ncompared to the ICD 11 classification, the DSM definition separates AjD into 6 different subtypes, Both the ICD and DSM have had substantial\nimpact on global psychiatric practice and research. While the DSM has been used more often in research around the world,9 a\nstudy of nearly 5,000 psychiatrists in 44 countries demonstrated that the majority of psychiatrists outside the U.S. utilize ICD classifications\nin their daily clinical practice.10 The DSM-5 conceptualizes AjD as a stress-related syndrome in a separate chapter of\n“Trauma and Stress Related Disorders”,11 representing the most significant change from DSM-IV.12 However,\nthe current diagnostic construct is crucially dependent on an exclusion criterion, so that a diagnosis of AjD is rarely applicable when\nanother mental disorder is present.\n\n \n\n \n\n1Brown\nRT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, et al. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy\nAdults. Clin Pharmacokinet. 2017;56:1543–1554.\n\n2Hasler\nF, Bourquin D, Brenneisen R, Bär T, Vollenweider FX. Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD\nand pharmacokinetic profiles of oral and intravenous psilocybin in man. Pharm Acta Helv. 1997;72:175 – 184.\n\n3Lo\nC, Zimmermann C, Rydall A, Walsh A, Jones JM, Moore MJ, et al. Longitudinal study of depressive symptoms in patients with metastatic\ngastrointestinal and lung cancer. J Clin Oncol. 2010;28:3084 – 3089.\n\n4Hopwood\nP, Stephens RJ. Depression in patients with lung cancer: prevalence and risk factors derived from quality-of-life data. J Clin Oncol.\n2000;18:893 – 903.\n\n5Delgado-Guay\nM, Parsons HA, Li Z, Palmer JL, Bruera E. Symptom distress in advanced cancer patients with anxiety and depression in the palliative\ncare setting. Support Care Cancer. 2009;17:573 – 579.\n\n6Rodin\nG, Lo C, Mikulincer M, Donner A, Gagliese L, Zimmermann C. Pathways to distress: the multiple determinants of depression, hopelessness,\nand the desire for hastened death in metastatic cancer patients. Soc Sci Med. 2009;68:562 – 569.\n\n7Maercker\nA, Brewin CR, Bryant RA, Cloitre M, van Ommeren M, Jones LM, et al. Diagnosis and classification of disorders specifically associated\nwith stress: proposals for ICD-11. World Psychiatry. 2013;12:198 – 206.\n\n8Casey\nP, Doherty A. AjD: implications for ICD-11 and DSM-5. Br J Psychiatry. 2012;201:90 – 92.\n\n9Clark\nLA, Cuthbert B, Lewis-Fernández R, Narrow WE, Reed GM. Three Approaches to Understanding and Classifying Mental Disorder: ICD-11,\nDSM-5, and the National Institute of Mental Health’s Research Domain Criteria (RDoC). Psychol Sci Public Interest. 2017;18:72 – 145.\n\n10Reed\nGM, Mendonça Correia J, Esparza P, Saxena S, Maj M. The WPA-WHO Global Survey of psychiatrists’ attitudes towards mental\ndisorders classification. World Psychiatry. 2011;10:118 – 131.\n\n11Kangas\nM. DSM-5 Trauma and Stress-Related Disorders: Implications for Screening for Cancer-Related Stress. Front Psychiatry. 2013;4:122.\n\n12Strain\nJJ, Friedman MJ. Considering AjDs as stress response syndromes for DSM-5. Depress Anxiety. 2011;28:818 – 823.\n\n \n\n36\n\n \n\n \n\n**Treatment Plans**\n\n** **\n\n**Traditional Treatments**\n\n \n\nEvidence suggests that addressing\npsychosocial, emotional, and physical symptoms early in the cancer trajectory, through such steps as palliative care or psychological\ninterventions, may positively influence survival outcomes.13,14,15,16 Comorbid depression with cancer leads to worsened\nquality of life, increased sensitivity to pain, difficulties with treatment, communication difficulties, caregiver burnout, increased\nrisk of suicide, longer periods of hospitalization, and a reduced expectation of survival.17,18,19,20,21 The National\nInstitute for Clinical Excellence Palliative Cancer Care Guidelines22  recommend that if experiencing more severe\ntypes of psychological distress — which would include moderate to severe AjD — patients should\nbe offered specialist psychological interventions such as psychotherapy, including cognitive behavioral therapy (“**CBT**”).\n\n \n\n \n\n13Temel\nJS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, et al. Early palliative care for patients with metastatic non-small-cell\nlung cancer. N Engl J Med. 2010;363:733 – 742.\n\n14Bakitas\nMA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, et al. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient\nOutcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015;33:1438 – 1445.\n\n15Giese-Davis\nJ, Collie K, Rancourt KMS, Neri E, Kraemer HC, Spiegel D. Decrease in depression symptoms is associated with longer survival in patients\nwith metastatic breast cancer: a secondary analysis. J Clin Oncol. 2011;29:413 – 420.\n\n16Spiegel\nD, Giese-Davis J. Depression and cancer: mechanisms and disease progression. Biol Psychiatry. 2003;54:269 – 282.\n\n17Skarstein\nJ, Aass N, Fosså SD, Skovlund E, Dahl AA. Anxiety and depression in cancer patients: relation between the Hospital Anxiety and\nDepression Scale and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire. J Psychosom Res.\n2000;49:27 – 34.\n\n18Depression\nas a predictor of disease progression and mortality in cancer patients: a meta-analysis. Centre for Reviews and Dissemination (UK); 2009.\n\n19Prieto\nJM, Blanch J, Atala J, Carreras E, Rovira M, Cirera E, et al. Psychiatric morbidity and impact on hospital length of stay among hematologic\ncancer patients receiving stem-cell transplantation. J Clin Oncol. 2002;20:1907 – 1917.\n\n20Misono\nS, Weiss NS, Fann JR, Redman M, Yueh B. Incidence of suicide in persons with cancer. J Clin Oncol. 2008;26:4731 – 4738.\n\n21Colleoni\nM, Mandala M, Peruzzotti G, Robertson C, Bredart A, Goldhirsch A. Depression and degree of acceptance of adjuvant cytotoxic drugs. Lancet.\n2000;356:1326 – 1327.\n\n22Nice\nN. Improving supportive and palliative care for adults with cancer. London: NICE. 2004. 2004.\n\n \n\n37\n\n \n\n \n\n**Psilocybin-assisted psychotherapy**\n\n \n\nCBT has been shown to improve anxiety in patients\ndiagnosed with incurable cancer, but appears to be less effective at improving depressive symptoms.23 Several recently\npublished trials have examined the efficacy of psilocybin, a classic serotonergic psychedelic drug that induces its acute subjective effects\nthrough the agonism of serotonin 2A (5-HT2A) receptors, to treat depression and anxiety in patients with life -threatening cancer,\namongst other psychiatric conditions.24,25,26,27 Psilocybin-assisted psychotherapy is a course of therapy involving single\nor multiple sessions in which a dose of psilocybin is administered in conjunction with psychotherapy, delivered by a suitably trained\ntherapist in a controlled setting. This intervention consists of three therapy stages: (1) preparation, (2) dosing session(s),\nand (3) integration, which allow for a more patient-centric approach compared to other therapy models. The pharmacological effects\nof psilocybin, in synergy with the psychotherapy, are considered to give rise to increased neuroplasticity, which facilitates rapid and\ndeep psychological transformation that may accelerate and augment the effects of the psychotherapy process.27\n\n \n\nPAP has been demonstrated in various academic\nstudies to cause expeditious, substantial, and sustained improvements in cancer-related anxiety and depression, existential distress,\nquality of life, and orientation toward death.25,26 For example, in an academic study 15 of 29 patients with\ncancer-related depression and anxiety, at the 6.5-month follow up, psilocybin was associated with enduring anxiolytic and anti-depressant\neffects (approximately 60-80% of participants continued with clinically significant reductions in depression or anxiety respectively),\nsustained benefits in existential distress and quality of life, as well as improved attitudes towards death.28 In another\nstudy of 51 patients,25 similar results were reported. At 6-month follow-up, these changes were sustained, with about\n80% of participants continuing to show clinically significant decreases in depressed mood and anxiety. Participants attributed improvements\nin attitudes about life/self, mood, relationships, and spirituality to the “high” experience resulting from the psilocybin,\nwith over 80% endorsing moderately or greater increased well-being/life satisfaction.29,30,31,32,33,34,35\n\n \n\n \n\n23Hayes\nSC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006;44:1 – 25.\n\n24Carhart-Harris\nR, Giribaldi B, Watts R, Baker-Jones M, Murphy-Beiner A, Murphy R, et al. Trial of Psilocybin versus Escitalopram for Depression. N Engl\nJ Med. 2021;384:1402 – 1411.\n\n25Grob\nCS, Danforth AL, Chopra GS, Hagerty M, McKay CR, Halberstadt AL, et al. Pilot study of psilocybin treatment for anxiety in patients with\nadvanced-stage cancer. Arch Gen Psychiatry. 2011;68:71 – 78.\n\n26Griffiths\nRR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, et al. Psilocybin produces substantial and sustained decreases in\ndepression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016;30:1181 – 1197.\n\n27Brouwer\nA, Carhart-Harris RL. Pivotal mental states. J Psychopharmacol. 2021;35:319 – 352.\n\n28Agin-Liebes\nGI, Malone T, Yalch MM, Mennenga SE, Ponté KL, Guss J, et al. Long-term follow-up of PAP for psychiatric and existential distress\nin patients with life-threatening cancer. J Psychopharmacol. 2020;34:155 – 166.\n\n29Carhart-Harris\nRL, Bolstridge M, Rucker J, Day CMJ, Erritzoe D, Kaelen M, et al. Psilocybin with psychological support for treatment-resistant depression:\nan open-label feasibility study. Lancet Psychiatry. 2016;3:619 – 627.\n\n30Carhart-Harris\nRL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, et al. Psilocybin with psychological support for treatment-resistant depression:\nsix-month follow-up. Psychopharmacology. 2018;235:399 – 408.\n\n31Davis\nAK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, et al. Effects of PAP on Major Depressive Disorder: A Randomized Clinical\nTrial. JAMA Psychiatry. 2021;78:481 – 489.\n\n32Bogenschutz\nMP, Forcehimes AA, Pommy JA, Wilcox CE, Barbosa PCR, Strassman RJ. Psilocybin- assisted treatment for alcohol dependence: a proof-of-concept\nstudy. J Psychopharmacol. 2015;29:289 – 299.\n\n33Johnson\nMW, Garcia-Romeu A, Cosimano MP, Griffiths RR. Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction. J\nPsychopharmacol. 2014;28:983 – 992.\n\n34Moreno\nFA, Wiegand CB, Taitano EK, Delgado PL. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder.\nJ Clin Psychiatry. 2006;67:1735 – 1740.\n\n35Griffiths\nRR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, et al. Psilocybin produces substantial and sustained decreases in\ndepression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016;30:1181 – 1197.\n\n \n\n38\n\n \n\n \n\nA number of factors provide rationale for focusing\non patients with AjD following a diagnosis of incurable cancer as the target population. The size of the cancer population, which generally\nmakes up approximately 30% of target country palliative patients, provides justification for research, in regard to both the magnitude\nof needs and the access to participant recruitment. Additionally, previous clinical trials have demonstrated the feasibility and efficacy\nof PAP for people with depression and anxiety symptoms, both within and outside of the palliative care setting, highlighting the versatility\nand universality of this intervention. Moreover, the sustained reductions in anxiety and depression amongst palliative care patients suggest\nthe longevity of positive outcomes mediated by PAP and the potential to dramatically improve patient quality of life, in what remains\nof their life.\n\n \n\nClassic psychedelics, a term referring to naturally-derived\npsychedelics including mescaline, lysergic acid diethylamide and psilocybin, all share a common mechanism of action via the serotonergic\npathways. Psilocybin is a prodrug that, when ingested, is metabolized into the psychoactive compound psilocin. Psilocin acts as a partial\nagonist at the serotonergic 5-HT2A receptor, and research has demonstrated that activation of the 5-HT2A receptor subtype is integral\nto the mechanism of action leading to subjective psychedelic experience.36,37,38,39,40\n\n \n\nThe pharmacological effects of psilocybin, in\nsynergy with psychotherapy, are considered to give rise to increased neuroplasticity and create a ‘pivotal mental state,’\nwhich facilitates rapid and deep psychological transformation that may accelerate and augment the effects of the psychotherapy process.27 This\nis thought to underlie the transdiagnostic efficacy of PAP for a wide range of difficult to treat psychiatric conditions, including treatment-resistant\ndepression, PTSD, substance use disorders, psychological distress with a life-threatening illness and obsessive-compulsive disorder.\n\n** **\n\n**Clinical Studies**\n\n \n\nIn recent palliative care clinical trials conducted\nat New York School of Medicine and Johns Hopkins University School of Medicine, in which participants received PAP at doses of 22 mg/70\nkg, 30 mg/70 kg, and 0.3 mg/kg, no serious adverse events (“**SAEs**”) were reported. Adverse effects of PAP amongst\nparticipants had all been previously described for psilocybin and were mild and transient, and included physical discomfort, psychological\ndiscomfort, increased systolic and diastolic blood pressure without criteria for medical intervention, increased heart rate with a mild\nsympathomimetic effect, nausea and vomiting, transient anxiety and headaches or migraines. None of the participants experienced prolonged\npsychosis or hallucinogen persisting perception disorder (“**HPPD**”).\n\n \n\n \n\n36Willins\nDL, Meltzer HY. Direct injection of 5-HT2A receptor agonists into the medial prefrontal cortex produces a head-twitch response in rats.\nJ Pharmacol Exp Ther. 1997;282:699 – 706.\n\n37Glennon\nRA, Teitler M, Sanders-Bush E. Hallucinogens and serotonergic mechanisms. NIDA Res Monogr. 1992;119:131 – 135.\n\n38Vollenweider\nFX, Vollenweider-Scherpenhuyzen MF, Bäbler A, Vogel H, Hell D. Psilocybin induces schizophrenia-like psychosis in humans via a serotonin-2\nagonist action. Neuroreport. 1998;9:3897 – 3902.\n\n39Ray\nTS. Psychedelics and the human receptorome. PLoS One. 2010;5:e9019.\n\n40González-Maeso\nJ, Weisstaub NV, Zhou M, Chan P, Ivic L, Ang R, et al. Hallucinogens Recruit Specific Cortical 5-HT2A Receptor-Mediated Signaling\nPathways to Affect Behavior. Neuron. 2007;53:439 – 452.\n\n \n\n39\n\n \n\n \n\nThere are currently 16 registered studies in Clinical\nTrials.Gov in the investigating the efficacy of PAP to treat depression, anxiety and demoralization in patients with incurable illnesses:\n\n \n\n**NCT Number**\n \n**Study Title**\n \n**Study Status**\n \n**Conditions**\n \n**Sponsor**\n\nNCT06001749\n \nPsilocybin in Cancer Pain Study\n \nRECRUITING\n \nOpioid-Related Disorders|Pain Management|Pain Management and Care|Advanced Cancer|Advanced Cancers\n \nYvan Beaussant, MD, MSci\n\nNCT06430541\n \nStudy of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence\n \nRECRUITING\n \nBreast Cancer|Ovarian Cancer\n \nUniversity of Colorado, Denver\n\nNCT04522804\n \nStudy of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer\n \nCOMPLETED\n \nCancer\n \nUniversity of Utah\n\nNCT05220046\n \nPalliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal Cancers\n \nRECRUITING\n \nPancreas Cancer|Biliary Tract Cancer|Psychological Distress|Gastrointestinal Cancer\n \nUniversity of Nebraska\n\nNCT05847686\n \nPsilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer\n \nCOMPLETED\n \nHematopoietic and Lymphatic System Neoplasm|Metastatic Malignant Solid Neoplasm\n \nUniversity of Washington\n\nNCT06416085\n \nPsilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer\n \nRECRUITING\n \nAdvanced Cancer|Stage IV Solid Tumor Cancer|Stage IV Sarcoma of Bone|Stage IV Lymphoma|Stage IV Melanoma|Endocrine Cancer\n \nUniversity Health Network, Toronto\n\nNCT04593563\n \nThe Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder\n \nUNKNOWN\n \nMajor Depressive Disorder\n \nMaryland Oncology Hematology, PA\n\nNCT00465595\n \nPsychopharmacology of Psilocybin in Cancer Patients\n \nCOMPLETED\n \nDepressive Symptoms|Anxiety|Cancer\n \nJohns Hopkins University\n\nNCT00957359\n \nPsilocybin Cancer Anxiety Study\n \nCOMPLETED\n \nCancer\n \nNYU Langone Health\n\nNCT06319378\n \nCancer Related Major Depression Treated With a Single Dose of Psilocybin\n \nRECRUITING\n \nMDD\n \nSection for Affective Disorders; Northern Stockholm Psychiatry\n\nNCT05947383\n \nA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer\n \nRECRUITING\n \nCancer|Major Depressive Disorder\n \nSunstone Medical\n\nNCT04950608\n \nPilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care\n \nACTIVE_NOT_RECRUITING\n \nHospice|Psilocybin|Demoralization|Terminal Illness|Cancer-related Problem/Condition|Psychotherapy|Terminal Cancer|Cancer Terminal\n \nYvan Beaussant, MD, MSci\n\nNCT06200155\n \nPsilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy\n \nRECRUITING\n \nDepression, Anxiety|Psilocybin-Assisted Psychotherapy|Advanced Cancer\n \nM.D. Anderson Cancer Center\n\nNCT06644170\n \nA Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer\n \nRECRUITING\n \nHematopoietic and Lymphatic System Neoplasm|Metastatic Malignant Solid Neoplasm\n \nUniversity of Washington\n\nNCT05506982\n \nPsilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain\n \nACTIVE_NOT_RECRUITING\n \nHematopoietic and Lymphoid Cell Neoplasm|Malignant Solid Neoplasm\n \nEmory University\n\nNCT05398484\n \nPsilocybin Therapy in Advanced Cancer\n \nRECRUITING\n \nAdvanced Cancer\n \nNYU Langone Health\n\n** **\n\n40\n\n \n\n** **\n\n**Known and Potential Risks of Psilocybin**\n\n** **\n\n**Abuse Potential**\n\n \n\nTo date, there have been no confirmed reports\nof an overdose of pharmaceutical psilocybin. Currently, psilocybin is placed in Schedule 1 in the UK Misuse of Drugs Regulations 2001,\ndefined as having no medical use, possessing high abuse liability, and lack of accepted safety when used under medical supervision. However,\nin preclinical studies using non-human primates, psilocybin, mescaline and N,N-Dimethyltryptamine did not serve as positive reinforcers\nin 3,4-Methylenedioxy methamphetamine (MDMA) experienced rhesus monkeys. This suggests that non-human primates do not find the psychoactive\neffects of the 5-HT2A receptor agonists addictive.\n\n \n\nAnalysis of long-term follow-up data from eight\npooled experimental trials with healthy volunteers indicated no subsequent drug abuse, no changes to overall drug consumption habits (including\nalcohol, nicotine, cannabis and MDMA) or functional impairment following exposure to psilocybin in the laboratory. Where changes in drug\nconsumption habits were noted, most respondents described decreased consumption, particularly with reference to psilocybin use. Large-scale\nsurvey research indicates that hallucinogens are selected as a primary substance of abuse in only a fraction of responders.\n\n \n\nIn clinical studies with psilocybin, exposing\nindividuals with either no history of hallucinogen use, or a history of minimal use (less than ten times in total and not within the previous\nfive years) have not resulted in reported instances of subsequent illicit hallucinogen abuse. Additionally, studies have shown side\neffects that are potentially predictive of low abuse potential, such as elevations in fear and anxiety. Based on available literature,\nit is not expected that either psilocybin-naïve or experienced individuals will develop dependence after exposure.\n\n \n\n**Safety**\n\n \n\nPsilocybin has been found to be of very low toxicity\nin humans and research animals.\n\n \n\nIn recent palliative care clinical trials conducted\nat New York School of Medicine and Johns Hopkins University School of Medicine, in which participants received PAP at a dose of 22 mg/70\nkg, 30 mg/70 kg, and 0.3 mg/kg, no serious adverse events (“**SAEs**”) were reported. Adverse effects of PAP amongst participants\nhad all been previously described for psilocybin and were mild and transient, and included physical discomfort, psychological discomfort,\nincreased systolic and diastolic blood pressure without criteria for medical intervention, increased heart rate with a mild sympathomimetic\neffect, nausea and vomiting, transient anxiety and headaches or migraines. None of the participants experienced prolonged psychosis or\nhallucinogen persisting perception disorder (“**HPPD**”).\n\n \n\nThe clinical safety of psilocybin has been extensively\nstudied in open-label and double-blind, controlled trials, both as a single agent and as adjunctive treatment in a number of clinical\nand non-clinical adult populations. Dosing regimens used in previous clinical trials with psilocybin have ranged from 0.014 mg/kg to 0.6\nmg/kg, administered orally as either a single dose, or multiple doses weeks apart. Thousands of participants have received psilocybin\nunder controlled conditions in a clinical setting for various indications, with results published in peer-reviewed journals. Knowledge\ngained from previous clinical trials with psilocybin and discussions with researchers leading other randomized control trials in this\narea has directed the design of Psyence’s planned Phase IIb Study.\n\n** **\n\n41\n\n \n\n \n\nPsilocybin (also known as ‘magic mushrooms’)\nis rated as one of the least harmful recreational drugs. Commonly cited risks include prolonged psychotic reactions, flashback phenomena/HPPD,\nand bad trips. Prolonged psychotic responses are extremely rare in clinical studies with psilocybin (<1%), even at very high doses,\nand none have been reported in modern studies or studies with patients. The risk of flashback phenomena is minimal (or even negligible),\nand no cases have been observed in other studies with psilocybin. Periods of psychological challenge (for example, increased anxiety)\nare more commonly reported, but may be predictive of positive clinical outcomes.\n\n** **\n\n**Psilocybin Related Adverse Events by Incidence (at 25 mg)**\n\n \n\n**Common\n> 20%**\n \n**Less common\n< 15%**\n \n**Rare\n< 2%**\n\n1)\n \n1)\n \n1)\n\n \n \n \n \n \n\nIncreased anxiety, particularly at the onset of the drug effects\n \nParanoia or suspiciousness.\n \nHPPD/flashbacks\n\n \n \n \n \n \n\n2)\n \n2)\n \n2)\n\n \n \n \n \n \n\nMild-moderate increase in heart rate\n \nNausea\n \nWorsening of mental state after the drug experience\n\n \n \n \n \n \n\n3)\n \n3)\n \n \n\n \n \n \n \n \n\nVisual hallucinations\n \nDizziness\n \n \n\n \n \n \n \n \n\n4)\n \n4)\n \n \n\n \n \n \n \n \n\nTransient headaches, lasting for one to two days (maximum) post-dosing\n \nA ‘bad trip’ i.e. negative thoughts and mood during the acute drug effects\n \n \n\n \n\nIt is not uncommon for people to experience some\nnegative psychological content during a psilocybin ‘trip’, particularly if they suffer from ongoing psychological distress,\nas is characteristic of depression. Typically, this is managed by ensuring good preparation before, support during, and integration after\nthe experience. While challenging episodes have been relatively commonly reported in previous trials, some of these have contributed to\na psychological ‘breakthrough’ on the part of the participant. Recent evidence indicates that challenging psychological experiences\ncan produce therapeutic benefits, improving psychological well-being in the long-term.\n\n \n\nNegative aftereffects of\nchallenging psychological experiences under psychedelics are thought to be a consequence of inadequate ‘set and setting’\nand post-session integration work — and they may also relate to the duration of the challenging period. In the Phase IIb\nStudy and further studies, such risks will be reduced via thorough psychological preparation and integration, good patient-staff rapport\nand a positive, supportive environment. Challenging experiences/periods will be managed principally through psychological support, but\noral and injectable lorazepam and olanzapine, as rescue medications, will be available. These would only be used in cases of severe panic\nthat were unresponsive to psychological intervention, and where the patient’s behavior was putting themselves and/or staff in danger.\nConsent for such medication will be sought from the patient ahead of study participation.\n\n \n\n42\n\n \n\n \n\nBefore, during and after the dosing session, patients\nwill receive psychological support from therapists who have been specifically trained to deliver PAP in the context of research studies,\nincluding clinical trials. An onsite psychiatrist will also be available to support where needed. Monitoring of participants’ vital\nsigns, behavior and mood will be conducted prior to the psilocybin being administered, and prior to the participant being discharged.\nOn the dosing day, patients will only be allowed to return home only once the study psychiatrist is confident they are fit to do so, and\nauthorizes the patient’s release. 24-hour emergency contact numbers will be provided for a member of the study team, and localized\nsupport and crisis services will also be provided.\n\n \n\nDue to the psychoactive nature of psilocybin,\nthe safety of participants in clinical trials can be enhanced by testing psilocybin within a “set and setting” protocol. By\naddressing the set (the emotional, cognitive, behavioral states, mindset and expectations of study participants just prior to psilocybin\nexposure) and setting (the physical environment in which the exposure occurs) of the experience, the risk of the subject reporting an\nevent which is distressing or injuring themselves can be reduced. This approach generally incorporates three components: (1) preparation,\n(2) drug session and (3) post -session meetings to integrate the classic psychedelic experience.\n\n \n\nDuring the preparation phase, participants undergo\npre-exposure sessions designed to build rapport with the therapist who will be present during the drug dosing session and to identify\npersonal themes and struggles that might be especially likely to impact the session experience. The drug session itself is conducted by\na trained therapist (the gender of which is selected by the participant) and an appropriately trained member of the study team, who are\npresent throughout the session. Sessions are typically conducted in a room designed to be quiet, comfortable, and aesthetically pleasing,\nand participants are encouraged to wear eyeshades and listen to a program of music through headphones during the drug exposure to aid\nthem in focusing their attention inwards. In the third phase, participants are engaged in a series of drug-free therapy sessions to discuss\ntheir dosing session experience thoroughly, with the goal of maximizing its therapeutic benefit.\n\n** **\n\n**Suicide**\n\n \n\nWhile most trials with psilocybin have demonstrated\nreduced suicidality following dosing, one recent large-scale study conducted by Compass Pathways with 233 participants on the efficacy\nof psilocybin in a treatment-resistant depression (TRD) population reported that suicidal ideation and intentional self-injury were seen\nin all treatment groups, as is common in TRD studies. Most cases occurred more than a week after the COMP360 psilocybin session. There\nwas no mean worsening of suicidal ideation scores on the MADRS scale in any treatment group. Suicidal behaviors were reported at least\none month after COMP360 administration for three non-responders in the 25mg arm.\n\n \n\nIt is important to note that subjects with AjD\nand patients with a cancer diagnosis are also at increased risk of suicide. As such, in the Psyence Phase IIb Study, the risk of suicide\nand other AE’s will be assessed by thorough and regular screening using the Sheehan-Suicide Tracking Scale (S-STS) at every study\nvisit. Participants with suicidal tendencies and histories of suicide attempts will be excluded from the study. The study psychiatrist\nand psychotherapist contact details will be provided to patients in case of emergency, in addition to providing localized information\nfor support services and crisis management. A standard operating procedure for dealing with both AEs and any unexpected suicide attempt\nhas been prepared. As such, we believe that the risk of suicide and other AEs will be reduced by thoroughly screening participants for\nany suicidal tendencies, by excluding patients with histories of suicide attempts and by regular monitoring of suicidal ideation and behavior.\n\n** **\n\n43\n\n \n\n \n\n**Target Population and Market — Palliative Care\nPatients**\n\n \n\nPrevious trials have demonstrated that PAP is\nwell tolerated in samples of palliative care patients, with no SAEs. Recruitment of palliative care participants may require screening\nof large samples in order to achieve the intended sample size. In previous PAP trials with palliative care participants, 10%-27% of screened\nindividuals were enrolled in the study. Recruitment for trials of psychiatric disorders is complex, as such conditions may affect motivation\nand adherence, relating to both the physical and mental health of participants with a cancer diagnosis. Moreover, there is an exogenous\nrisk of participant death during the trial for clinical trials in the palliative care setting. Similarly, as cancer may metastasize further,\ndiligence must be paid to exclude participants with metastatic cancer to the brain, considering the potential impact on cognitive function.\nTogether, this indicates that the success of recruitment and screening relies on the selection of participants with appropriate life expectancy,\nextent of cancer, and post-diagnosis time for the inclusion/exclusion criteria in PAP trials with palliative care patients.\n\n  \n\n**Business Model**\n\n \n\nPsilocybin-assisted psychotherapy, once approved,\nwill have to be delivered to patients in a guided manner over a period of 6 – 8 weeks, including the intention setting\nmeetings, the psychedelic event (dosing session) and the subsequent integration meetings. This implies having trained guides who will\nspend a long time with patients over the course of the PAP, suitable clinic settings and psychologists’ oversight.\n\n \n\nThe final business model for the provision of\nNPX-5 will depend on a number of aspects, including the final outcomes of the studies, the indication(s) that will be allowed by\nthe regulatory agencies and the state of the environment and market to provide psychedelic therapy at the time of approval. It is expected\nthat the number of clinics available to be able to provide PAP will increase dramatically once the first psychedelic is approved for any\nindication.\n\n \n\nOur possible business models will take into consideration\nof whether to merely supply NPX-5 for clinics to administer, through including a premium price for the intellectual property of a proprietary\nPAP, to enter into partnerships with clinics to administer PAP, or even to own dedicated clinics for administration of PAP.\n\n \n\nThe target audience for\nthe initial indication will be oncology sites, including their oncologists and other health care professionals to create awareness of\nthe effectiveness of PAP for cancer patients who have AjD. The principal marketing message will be to offer patients a better quality\nof life for their remaining years with a single administration of NPX-5 within a PAP. It has been shown that patients in palliative\ncare who are less anxious or depressed utilize fewer healthcare resources, which is an aspect that will help justify the costs of the\nPAP.\n\n \n\n44\n\n \n\n \n\n**Alcohol Use Disorder (AUD)**\n\n \n\nPsyence Biomed have intentions to study the use\nof psilocybin in the treatment of AUD and possibly Substance Use Disorder (SUD). There are a number of academic studies showing the efficacy\nof PAP in the treatment of both disorders although they have tended to be smaller studies. In the current planning phase, the creation\nof a steering committee for the AUD study has been initiated and preliminary market research is being conducted to identify the best patient\nto target in the study, to help identify the appropriate design, as well as to choose which endpoints should be used.\n\n \n\nThere is a big unmet medical need for an effective\ntherapy to treat AUD despite the fact that there are a few products authorized regulatorily. However, those treatments have low long-term\nefficacy, and their indications are not particularly broad.\n\n \n\nThe deleterious societal and economic impact of\nAUD is enormous and to develop an effective, sustainable treatment for the disorder would be a great advance for patients, their families\nas well as the general public.\n\n** **\n\n**Legal and Regulatory Framework**\n\n** **\n\n**Current Regulatory Landscape of Target Markets**\n\n \n\nPsyence will focus on the initial countries and\nregions to perform their clinical development and to commercialize the final product, being North America (US & Canada), EU,\nUK and Australia. Introductions into other regions will be contemplated at a later phase.\n\n \n\nIn the United States, foods, drugs and dietary\nsupplements are subject to extensive regulation. The U.S. Food, Drug, and Cosmetic Act (the “**FDCA**”) and other federal\nand state statutes and regulations govern, among other things, the research, development, testing, manufacturing, storage, recordkeeping,\napproval, labelling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of\npharmaceutical products. We must ensure that all promotion and marketing, distribution, and labeling of any pharmaceutical products comply\nwith the U.S. regulations, including the FDCA and the U.S. Food and Drug Administration (the “**FDA**”).\n\n \n\nPsilocybin and psilocin are strictly controlled\nunder the U.S. Controlled Substances Act (“**CSA**”) as Schedule I substances. By definition, Schedule I substances\nhave no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential\nfor abuse. Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing and procurement quotas,\nsecurity requirements and criteria for importation. Anyone wishing to conduct research on substances listed in Schedule I under the\nCSA must register with the DEA and obtain DEA approval of the research proposal. A majority of state laws in the United States also classify\npsilocybin and psilocin as Schedule I controlled substances. For any product containing psilocybin or any Schedule I substance\nto be available for commercial marketing in the United States, such substance must be rescheduled, or the product itself must be scheduled,\nby the DEA to Schedule II, III, IV or V. Scheduling determinations by the DEA are dependent on FDA approval of a substance\nor a specific formulation of a substance.\n\n \n\nPrescription drugs are classified and regulated\nunder the federal Food and Drugs Act (Canada). Labeling, marketing and selling of any prescription drug must comply with Health Canada.\nThe regulations in the European Union are similar to those in the U.S. and Canada.\n\n \n\nPsyence will focus the phase IIb portion of its\nclinical development program in Australia. The TGA is Australia’s government authority responsible for evaluating, assessing and\nmonitoring products that are defined as therapeutic goods, and the use of therapeutic goods supplied in clinical trials in Australia under\nthe therapeutic goods legislation. Such legislation includes The Therapeutic Goods Act 1989 (“**TG Act**”), Regulations\nand Orders which set out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG).\n\n \n\nFor a prescription medicine to be registered in\nthe ARTG, a sponsor of the product (usually a pharmaceutical company such as Psyence) is required to submit a dossier of evidence on the\nclinical efficacy, safety and manufacturing quality for evaluation by the TGA. Clinical trials of medicines and biologicals regulated\nunder the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes are subject to the TGA’s Good Clinical Practice\n(GCP) Inspection Program. The TGA has issued a handbook which provides guidance on the legislative, regulatory and good clinical practice\n(GCP) requirements when conducting clinical trials in Australia using ‘unapproved’ therapeutic goods in order to assist trial\nsponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) in understanding their roles\nand responsibilities under the therapeutic goods legislation.\n\n \n\n45\n\n \n\n \n\nUntil recently, psilocybin\nwas included in Schedule 9 (Prohibited Substances) of the Poisons Standard which, because of interaction with state and territory regulation,\nlargely restricted the lawful supply of goods containing psilocybin to clinical trial settings only. However, effective as of July 1,\n2023, the TGA made the decision to down schedule psilocybin to Schedule 8 in the Poisons Standard when used in respect of certain conditions,\nnamely for the treatment of treatment-resistant depression.\n\n \n\nTo\nimport products that contain a controlled substance (such as psilocybin), the importer requires both an exemption, approval or authority\nunder the TG Act and a license and/or permit to import from the Office of Drug Control under the Customs (Prohibited Imports) Regulations\n1956. Licenses and permits to import psilocybin are only granted by the Office of Drug Control where the use of the substance is\npermitted by the relevant state or territory under their respective medicines and poisons legislation and the use of the of psilocybin\nis to be prescribed by an Authorized Prescriber or for an authorized clinical trial.\n\n \n\nPsyence will monitor\nthe evolution of Australia’s regulations as they pertain to psilocybin and the conduct of clinical trials in Australia.\n\n** **\n\n**Regulatory Changes on the Horizon for\nTherapeutic Psychedelics**\n\n \n\nWith\nthe reintroduction of the Breakthrough Therapies Act in March 2023, there appears to be momentum to develop a legal-regulatory framework\nfor therapeutic psychedelics. Congress also announced on November 17, 2022, the bipartisan Congressional Psychedelics Advancing\nClinical Treatments Caucus (the PACT Caucus). The PACT Caucus will focus on exploring psychedelic research to alleviate the U.S. mental\nhealth crisis.\n\n \n\nIn April 2026, US President Donald Trump signed an executive order easing restrictions on mental health treatments, including\nibogaine, to accelerate research and approval of psychedelic-based therapies for conditions such as PTSD, depression, and addiction.\nSigned on April 18, 2026, the order directs the FDA to issue Commissioner's National Priority Vouchers to psychedelic drugs that have\nreceived Breakthrough Therapy designation, aiming to expedite the FDA's review process for qualifying treatments. It also directs the\nFDA and DEA to establish a Right to Try pathway allowing eligible patients to access investigational psychedelic drugs, including ibogaine,\nthat are under FDA review. Separately, the order allocates US$50 million in US Department of Health and Human Services funding to match\nstate-level investments in psychedelic research, a provision widely seen as responding to Texas's state-funded ibogaine research program.\nPsychedelics such as ibogaine and psilocybin remain federally classified as Schedule I substances, and the order does not itself reschedule\nthem or lower the evidentiary bar the FDA requires for approval.\n\n \n\nC. Organizational Structure\n\n \n\nThe information set forth above in Item 4.\nA. is incorporated herein by reference.\n\n \n\nD. Property, Plants and Equipment\n\n** **\n\n**Headquarters and Operational Office**\n\n \n\nPsyence’s headquarters address is 121 Richmond\nStreet West, Penthouse Suite 1300, Toronto, Ontario, M5H 2K1, Canada. The Company has an operational office in South Africa at Building\n#4, Riverlands Mall, Podium Level, 51 Gogosoa St, Observatory, Cape Town, 7935."}