{"success":true,"data":{"pressRelease":{"id":"150951","rtpr_id":"nGNX1GvY4Q-20260923","ticker":"OPTH","exchange":"NASDAQ","all_tickers":["OPTH","OPTI"],"title":"Optimi Health Completes Psilocybin Production for Health Canada-Approved Phase 2 MDD Trial and Commercial TRD Supply","author":"Globe Newswire","published_at":"2026-09-23T13:00:01.521Z","article_body":"VANCOUVER, British Columbia, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Optimi Health\nCorp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN) (\"Optimi\" or the \"Company\"), a\ncommercial-stage pharmaceutical manufacturer of regulated psychedelic drug\nproducts, today announced the completion and quality release of a production\nbatch of 5mg naturally derived psilocybin capsules, manufactured end to end at\nthe Company’s cGMP facility in Princeton, British Columbia, under a Health\nCanada Drug Establishment Licence. The batch will supply the recently\nannounced Phase 2 clinical trial of psilocybin-assisted therapy\n(https://www.globenewswire.com/Tracker?data=aA7s195XjjLCWXzixPW2USf9C2jv9TJxgqOSv3VdyPVgVQiQc575-a6tAzqnLR5b7CsMQWrA4Lpzr9_luKw2HBkthO39Jz6CBxnvZ5holC8MCR9KIyV2IWMg6ChDrNjYYyUCHVWA-XbpKmjQk50vlXYUqCCwrw0uwjq0zuP17f0-_VjcOt-XHA5x1d3uw-7Qdb9K9EBa3Po43H_zMfq4I91M1FGO-uf7HauGi8I4kaajgH9dkTtF4ydPXExoP3BgbdjNkeS2-4HUQEaSOYXpmw==)\nevaluating psilocybin-assisted therapy in the treatment of major depressive\ndisorder (“MDD”) and commercial customers in Australia.\n\nThis Health Canada-authorized trial is a multisite, open-label study of up to\n200 participants, each receiving a single supervised dose of Optimi’s .\nPatient dosing is expected to be completed by the end of 2027. Data from the\ntrial are intended to assess the safety and efficacy of psychedelic-assisted\ntherapy in the hope of building the necessary evidentiary base to support\nregistration in Canada and other jurisdictions.\n\nThe same batch will also supply the Company’s Australian customer base of\nlicensed clinics, where 5mg psilocybin capsules are prescribed to patients\nwith treatment-resistant depression under the Therapeutic Goods\nAdministration's Authorised Prescriber Scheme, with reimbursement from public\nand private payers including the Department of Veterans' Affairs, the National\nDisability Insurance Scheme, WorkCover and Medibank. More than 750 clinicians\nhave completed Mind Medicine Australia’s Certificate in Psychedelic-Assisted\nTherapies, and Optimi is not aware of any reported serious adverse events\nsince commercial supply began in 2025.\n\n\"Since 2025, Optimi has supplied this psilocybin product commercially to\nlicensed clinics in Australia, where it is prescribed and reimbursed for\ntreatment-resistant depression,\" said Dane Stevens, Optimi Chief Executive\nOfficer and Co-Founder. \"We are excited to be collecting our own clinical data\non the same product in our Health Canada-approved Phase 2 clinical trial for\nmajor depressive disorder. One drug, two indications with significant unmet\nneed, one batch serving both. Because we manufacture, encapsulate and\nrelease-test within our own licensed facility, the trial product and the\ncommercial product are the same formulation from the same batch, and the\nChemistry, Manufacturing and Controls file that supports registration is\nalready ours.\"\n\nThe safety and efficacy of psilocybin assisted therapy to treat MDD is still\nunder investigation and none of Optimi’s psilocybin drug products received\nmarket authorization by Health Canada.\n\nAbout Optimi Health Corp.\n\nOptimi Health Corp. is a commercial-stage pharmaceutical company focused on\nmanufacturing and distributing GMP-grade psychedelic drug products for mental\nhealth therapies. As a Health Canada-licensed pharmaceutical manufacturer,\nOptimi produces validated MDMA and botanical psilocybin drug products at its\nGMP-compliant facilities in British Columbia, Canada. Optimi supplies both\nactive pharmaceutical ingredients and finished dosage forms to regulated\nclinical and therapeutic programs internationally, with products currently\nprescribed to patients in Australia under the country’s Authorised\nPrescriber Scheme and accessible in Canada through the Special Access Program.\n\nFor more information, please visit optimi.net\n(https://www.globenewswire.com/Tracker?data=lJK8rkplUg8ayTNNgj1KP4LuYEeo7eKI5QG-ARq7HxTAAGIvGHCvSDn1bt5RM0cMfmfEyNj-Ae_Eh3zQeESahw==).\n\nFor more information, please contact:\nDane Stevens, CEO\nOptimi Health Corp.\n(778) 761-4551\ninvestors@optimihealth.ca \nwww.optimihealth.ca\n\nInvestor Relations Contact:\nCORE IR \nir@optimi.net\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements and forward-looking\ninformation within the meaning of applicable securities laws, including\nstatements regarding the Phase 2 clinical trial, the availability and\nenrolment of patients in the trial, the utilization of the data derived from\nthe trial, and the anticipated timing of the trial, the potential benefits of\npsilocybin, the Company’s ability to manufacture and ship products from its\nCanadian facility, the anticipated use of the most recent production batch,\nand the Company’s positioning in the regulated psychedelic medicine market.\nForward-looking statements and forward-looking information are often\nidentified by words such as “expects,” “anticipates,” “believes,”\n“intends,” “plans,” “estimates,” “may,” “will,”\n“would,” “could,” or similar expressions. Forward-looking statements\nand forward-looking information are based on several assumptions and are\nsubject to a number of known and unknown risks and uncertainties, many of\nwhich are beyond the Company’s control, which could cause actual results and\nevents to differ materially from those that are disclosed in or implied by\nsuch forward-looking statements. Accordingly, there are or will be important\nfactors that may cause actual results to differ from expected results. These\nfactors include those described under “Risk Factors” in the Company’s\nregistration statement on Form F-1, as amended, and other filings with the\nU.S. Securities and Exchange Commission made from time to time which are\navailable at www.sec.gov and on SEDAR+ at www.sedarplus.ca and in the\nCompany’s continuous disclosure filings available under its SEDAR+ profile\nat www.sedarplus.ca. These forward-looking statements reflect current\nexpectations of management regarding future events and speak only as of the\ndate of this press release. Except as expressly required by applicable law,\nthe Company undertakes no obligation to update or revise any forward-looking\nstatements, whether as a result of new information, future events, or\notherwise. New factors emerge from time to time, and it is not possible for\nthe Company to predict all of them or assess the impact of each factor or the\nextent to which any factor, or combination of factors, may cause results to\ndiffer materially from those contained in any forward-looking statement. Any\nforward-looking statements contained in this press release are expressly\nqualified in their entirety by this cautionary statement.\n\nNeither the Canadian Securities Exchange nor the Canadian Investment\nRegulatory Organization accepts responsibility for the adequacy or accuracy of\nthis release.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/5e3d5f3e-3e70-4e6f-9c1f-78ee2a1df6ee)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX1GvY4Q-20260923","title":"Optimi Health Completes Psilocybin Production for Health Canada-Approved Phase 2 MDD Trial and Commercial TRD Supply","author":"Globe Newswire","ticker":"OPTH","created":"2026-09-23T13:00:01.521Z","tickers":["OPTH","OPTI"],"exchange":"NASDAQ","article_body":"VANCOUVER, British Columbia, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Optimi Health\nCorp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN) (\"Optimi\" or the \"Company\"), a\ncommercial-stage pharmaceutical manufacturer of regulated psychedelic drug\nproducts, today announced the completion and quality release of a production\nbatch of 5mg naturally derived psilocybin capsules, manufactured end to end at\nthe Company’s cGMP facility in Princeton, British Columbia, under a Health\nCanada Drug Establishment Licence. The batch will supply the recently\nannounced Phase 2 clinical trial of psilocybin-assisted therapy\n(https://www.globenewswire.com/Tracker?data=aA7s195XjjLCWXzixPW2USf9C2jv9TJxgqOSv3VdyPVgVQiQc575-a6tAzqnLR5b7CsMQWrA4Lpzr9_luKw2HBkthO39Jz6CBxnvZ5holC8MCR9KIyV2IWMg6ChDrNjYYyUCHVWA-XbpKmjQk50vlXYUqCCwrw0uwjq0zuP17f0-_VjcOt-XHA5x1d3uw-7Qdb9K9EBa3Po43H_zMfq4I91M1FGO-uf7HauGi8I4kaajgH9dkTtF4ydPXExoP3BgbdjNkeS2-4HUQEaSOYXpmw==)\nevaluating psilocybin-assisted therapy in the treatment of major depressive\ndisorder (“MDD”) and commercial customers in Australia.\n\nThis Health Canada-authorized trial is a multisite, open-label study of up to\n200 participants, each receiving a single supervised dose of Optimi’s .\nPatient dosing is expected to be completed by the end of 2027. Data from the\ntrial are intended to assess the safety and efficacy of psychedelic-assisted\ntherapy in the hope of building the necessary evidentiary base to support\nregistration in Canada and other jurisdictions.\n\nThe same batch will also supply the Company’s Australian customer base of\nlicensed clinics, where 5mg psilocybin capsules are prescribed to patients\nwith treatment-resistant depression under the Therapeutic Goods\nAdministration's Authorised Prescriber Scheme, with reimbursement from public\nand private payers including the Department of Veterans' Affairs, the National\nDisability Insurance Scheme, WorkCover and Medibank. More than 750 clinicians\nhave completed Mind Medicine Australia’s Certificate in Psychedelic-Assisted\nTherapies, and Optimi is not aware of any reported serious adverse events\nsince commercial supply began in 2025.\n\n\"Since 2025, Optimi has supplied this psilocybin product commercially to\nlicensed clinics in Australia, where it is prescribed and reimbursed for\ntreatment-resistant depression,\" said Dane Stevens, Optimi Chief Executive\nOfficer and Co-Founder. \"We are excited to be collecting our own clinical data\non the same product in our Health Canada-approved Phase 2 clinical trial for\nmajor depressive disorder. One drug, two indications with significant unmet\nneed, one batch serving both. Because we manufacture, encapsulate and\nrelease-test within our own licensed facility, the trial product and the\ncommercial product are the same formulation from the same batch, and the\nChemistry, Manufacturing and Controls file that supports registration is\nalready ours.\"\n\nThe safety and efficacy of psilocybin assisted therapy to treat MDD is still\nunder investigation and none of Optimi’s psilocybin drug products received\nmarket authorization by Health Canada.\n\nAbout Optimi Health Corp.\n\nOptimi Health Corp. is a commercial-stage pharmaceutical company focused on\nmanufacturing and distributing GMP-grade psychedelic drug products for mental\nhealth therapies. As a Health Canada-licensed pharmaceutical manufacturer,\nOptimi produces validated MDMA and botanical psilocybin drug products at its\nGMP-compliant facilities in British Columbia, Canada. Optimi supplies both\nactive pharmaceutical ingredients and finished dosage forms to regulated\nclinical and therapeutic programs internationally, with products currently\nprescribed to patients in Australia under the country’s Authorised\nPrescriber Scheme and accessible in Canada through the Special Access Program.\n\nFor more information, please visit optimi.net\n(https://www.globenewswire.com/Tracker?data=lJK8rkplUg8ayTNNgj1KP4LuYEeo7eKI5QG-ARq7HxTAAGIvGHCvSDn1bt5RM0cMfmfEyNj-Ae_Eh3zQeESahw==).\n\nFor more information, please contact:\nDane Stevens, CEO\nOptimi Health Corp.\n(778) 761-4551\ninvestors@optimihealth.ca \nwww.optimihealth.ca\n\nInvestor Relations Contact:\nCORE IR \nir@optimi.net\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements and forward-looking\ninformation within the meaning of applicable securities laws, including\nstatements regarding the Phase 2 clinical trial, the availability and\nenrolment of patients in the trial, the utilization of the data derived from\nthe trial, and the anticipated timing of the trial, the potential benefits of\npsilocybin, the Company’s ability to manufacture and ship products from its\nCanadian facility, the anticipated use of the most recent production batch,\nand the Company’s positioning in the regulated psychedelic medicine market.\nForward-looking statements and forward-looking information are often\nidentified by words such as “expects,” “anticipates,” “believes,”\n“intends,” “plans,” “estimates,” “may,” “will,”\n“would,” “could,” or similar expressions. Forward-looking statements\nand forward-looking information are based on several assumptions and are\nsubject to a number of known and unknown risks and uncertainties, many of\nwhich are beyond the Company’s control, which could cause actual results and\nevents to differ materially from those that are disclosed in or implied by\nsuch forward-looking statements. Accordingly, there are or will be important\nfactors that may cause actual results to differ from expected results. These\nfactors include those described under “Risk Factors” in the Company’s\nregistration statement on Form F-1, as amended, and other filings with the\nU.S. Securities and Exchange Commission made from time to time which are\navailable at www.sec.gov and on SEDAR+ at www.sedarplus.ca and in the\nCompany’s continuous disclosure filings available under its SEDAR+ profile\nat www.sedarplus.ca. These forward-looking statements reflect current\nexpectations of management regarding future events and speak only as of the\ndate of this press release. Except as expressly required by applicable law,\nthe Company undertakes no obligation to update or revise any forward-looking\nstatements, whether as a result of new information, future events, or\notherwise. New factors emerge from time to time, and it is not possible for\nthe Company to predict all of them or assess the impact of each factor or the\nextent to which any factor, or combination of factors, may cause results to\ndiffer materially from those contained in any forward-looking statement. Any\nforward-looking statements contained in this press release are expressly\nqualified in their entirety by this cautionary statement.\n\nNeither the Canadian Securities Exchange nor the Canadian Investment\nRegulatory Organization accepts responsibility for the adequacy or accuracy of\nthis release.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/5e3d5f3e-3e70-4e6f-9c1f-78ee2a1df6ee)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-23T13:00:01.653397509Z","server_sent_at_ms":1790168401653},"received_at":"2026-09-23T13:00:01.706Z","source_url":null},"analysis":{"id":"139753","press_release_id":"150951","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["no psilocybin product has Health Canada market authorization","open-label trial design limits evidentiary weight for registration"],"eventType":"clinical_trial","narrative":"Optimi Health completed and quality-released a production batch of 5mg naturally derived psilocybin capsules manufactured at its cGMP facility in Princeton, British Columbia.\n\nThe same batch will supply a Health Canada-authorized Phase 2 open-label trial of psilocybin-assisted therapy in major depressive disorder (up to 200 participants, dosing expected complete by end of 2027) and ongoing commercial supply to licensed Australian clinics treating treatment-resistant depression.\n\nOptimi has supplied the Australian market since 2025 with reimbursement from payers including the Department of Veterans' Affairs and Medibank; no psilocybin product has Health Canada market authorization, and trial data remain investigational.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Dual-use batch strategy — trial and commercial supply from one cGMP production run supports the CMC registration file."},"keyFigures":{"drugName":"psilocybin 5mg capsules (naturally derived)","phaseOfTrial":"Phase 2","customDimensions":{"dosing_completion":"end of 2027","clinicians_trained":"more than 750","trial_participants":"up to 200","commercial_supply_since":"2025"}},"quotedText":"One drug, two indications with significant unmet need, one batch serving both.","namedEntities":{"people":[{"name":"Dane Stevens","role":"CEO and Co-Founder"}],"products":["5mg naturally derived psilocybin capsules","MDMA (GMP-grade)","Certificate in Psychedelic-Assisted Therapies"],"companies":[{"name":"Optimi Health Corp.","ticker":"OPTH","relationship":"filer"},{"name":"Health Canada","relationship":"regulator"},{"name":"Therapeutic Goods Administration","relationship":"regulator (Australia)"},{"name":"Mind Medicine Australia","relationship":"training/industry body"},{"name":"CORE IR","relationship":"investor relations"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Routine manufacturing milestone: quality release of a psilocybin batch that will supply both a Health Canada-authorized Phase 2 MDD trial and existing Australian commercial supply. No new financial figures, regulatory approval, or trial data disclosed."},"tickerRelevance":{"others":[{"ticker":"OPTI","relevance":"Canadian Securities Exchange listing of same company"},{"ticker":"8BN","relevance":"Frankfurt listing of same company"}],"primary":"OPTH"},"globalImportance":18,"audienceRelevance":15,"eventTypeSecondary":["operations_update"],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"manufacturing/clinical milestone, no data readout","sectorWeight":"psychedelic medicine niche","retailFavoriteBoost":0}},"event_type":"clinical_trial","event_type_secondary":["operations_update"],"sentiment":"bullish","material_impact_score":2,"narrative":"Optimi Health completed and quality-released a production batch of 5mg naturally derived psilocybin capsules manufactured at its cGMP facility in Princeton, British Columbia.\n\nThe same batch will supply a Health Canada-authorized Phase 2 open-label trial of psilocybin-assisted therapy in major depressive disorder (up to 200 participants, dosing expected complete by end of 2027) and ongoing commercial supply to licensed Australian clinics treating treatment-resistant depression.\n\nOptimi has supplied the Australian market since 2025 with reimbursement from payers including the Department of Veterans' Affairs and Medibank; no psilocybin product has Health Canada market authorization, and trial data remain investigational.","key_figures":{"drugName":"psilocybin 5mg capsules (naturally derived)","phaseOfTrial":"Phase 2","customDimensions":{"dosing_completion":"end of 2027","clinicians_trained":"more than 750","trial_participants":"up to 200","commercial_supply_since":"2025"}},"named_entities":{"people":[{"name":"Dane Stevens","role":"CEO and Co-Founder"}],"products":["5mg naturally derived psilocybin capsules","MDMA (GMP-grade)","Certificate in Psychedelic-Assisted Therapies"],"companies":[{"name":"Optimi Health Corp.","ticker":"OPTH","relationship":"filer"},{"name":"Health Canada","relationship":"regulator"},{"name":"Therapeutic Goods Administration","relationship":"regulator (Australia)"},{"name":"Mind Medicine Australia","relationship":"training/industry body"},{"name":"CORE IR","relationship":"investor relations"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-23T13:00:13.041Z","global_importance":18,"audience_relevance":15,"importance_components":{"tickerTier":"micro-cap","eventGravity":"manufacturing/clinical milestone, no data readout","sectorWeight":"psychedelic medicine niche","retailFavoriteBoost":0}},"durationMs":6690,"modelName":"glm-5.3-flashx"}}