Optimi Health Completes Psilocybin Export to Australia for Patients With Treatment-Resistant Depression

Rhea-AI Summary

Optimi Health (NASDAQ: OPTH) completed its latest export of 1,000 5mg psilocybin capsules to Australia, its third commercial shipment since launching the product in September 2025.

The capsules are prescribed for treatment-resistant depression under Australia's Authorized Prescriber Scheme, with reimbursement from public and private payers and recurring orders contributing to commercial revenue.

Positive

• Third commercial shipment of 5mg psilocybin capsules since September 2025
• Export of 1,000 psilocybin capsules to Australian market
• Products reimbursed by public and private Australian payers
• More than 750 clinicians trained to deliver psilocybin therapy
• Recurring Australian orders contribute to commercial revenue
• GMP-licensed in-house production under Health Canada authorization

Negative

• None.

News Market Reaction – OPTH

+8.80%

13 alerts

+8.80% Session close to close

+23.2% Peak in 27 hr 59 min

$30.15M Market Cap

1.2x Rel. Volume

In the Jun 29 session, OPTH gained 8.80%, reflecting a notable positive market reaction. Argus tracked a peak move of +23.2% during that session. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +8.8% in the session following this news. A strong positive reaction aligns with pri...

Analysis

The stock moved +8.8% in the session following this news. A strong positive reaction aligns with prior upbeat responses to access and production news, such as gains of 18.64% and 5.58%. However, heavy operating losses and low cash from recent filings could reintroduce dilution or funding concerns.

Key Figures

Capsule strength: 5 mg psilocybin Shipment size: 1,000 capsules Product launch date: September 2025 +3 more

6 metrics

Capsule strength 5 mg psilocybin Dose per capsule used for treatment-resistant depression in Australia

Shipment size 1,000 capsules Third commercial export batch of 5 mg psilocybin to Australia

Product launch date September 2025 Launch of 5 mg psilocybin capsules later exported to Australia

Reschedule effective date July 1, 2023 Australia rescheduled psilocybin for treatment-resistant depression

Trained clinicians More than 750 clinicians Clinicians trained to deliver psychedelic-assisted therapy in Australia

Duration of regulated use More than two years Period of regulated commercial psilocybin use under Australian scheme

Historical Context

5 past events · Latest: Jun 16 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 16	Clinical product launch	Positive	-12.9%	Launch of 1 mg and 2 mg microdose psilocybin capsules for research.
Jun 10	Export for trial	Positive	-5.0%	First export of psilocybin to UK to support a Phase 2 trial.
Jun 08	Ibogaine initiative	Positive	+18.6%	Securing ibogaine supply and starting finished product development.
Jun 02	Psilocybin production run	Positive	+3.7%	Completion of GMP production run of 5 mg psilocybin capsules.
May 29	Access framework update	Positive	+5.6%	Expanded Australian Authorized Prescriber access and reimbursement for psychedelics.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news often triggers sharp moves, mostly positive but with occasional selloffs on favorable announcements.

Key Terms

treatment-resistant depression, psilocybin, mdma, authorized prescriber scheme, +2 more

6 terms

treatment-resistant depression medical

"5mg psilocybin capsules are prescribed in Australia for treatment-resistant depression"

A form of major depression that does not improve after a person has tried standard treatments such as common antidepressant medications and therapy; think of it as a stubborn problem that doesn’t respond to the usual fixes. It matters to investors because it represents a large unmet medical need and a higher-risk, higher-reward area for drug developers, with potential for premium pricing, regulatory scrutiny, and durable demand if an effective new therapy is approved.

psilocybin medical

"completion of its latest export of 5mg psilocybin finished drug product to Australia"

A naturally occurring psychedelic compound found in certain mushrooms that alters perception, mood and consciousness; when taken the body converts it into an active substance that produces short-term hallucinogenic effects. Investors watch psilocybin because researchers and drug developers are exploring it as a potential treatment for depression, PTSD and other mental health conditions, so clinical trial results, regulatory decisions and changing stigma can create large commercial opportunities or risks—think of it as a new drug category whose approval pathway can drive big swings in company value.

mdma medical

"MDMA was rescheduled for the treatment of post-traumatic stress disorder on the same day"

MDMA (3,4-methylenedioxymethamphetamine) is a synthetic psychoactive compound best known for producing strong mood and empathy effects; it appears both as a recreational drug and as an experimental medicine used alongside psychotherapy. Investors watch MDMA because positive clinical results or regulatory changes can create a new prescription market—like discovering a potent new ingredient for treatments—while legal controls, safety data, and public perception can sharply limit commercial and financial upside.

authorized prescriber scheme regulatory

"Under the Therapeutic Goods Administration's Authorized Prescriber Scheme, Optimi's psilocybin is being prescribed"

An authorized prescriber scheme lets a qualified clinician or group of clinicians prescribe a specific medicine to eligible patients without obtaining individual approvals each time, under rules set by health regulators. For investors, it matters because the scheme can speed access to medicines and broaden sales once clinicians are approved, similar to giving a trusted shopkeeper a standing license to sell a product rather than requiring a new permit for every sale.

gmp technical

"wholly owned GMP facility in Princeton, British Columbia, Canada, under its Health Canada Drug Establishment Licence"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

therapeutic goods administration regulatory

"Under the Therapeutic Goods Administration's Authorized Prescriber Scheme, Optimi's psilocybin is being prescribed"

The Therapeutic Goods Administration is the Australian government agency that assesses and regulates medicines, medical devices, vaccines and other health products for safety, quality and effectiveness before they can be marketed. For investors, a TGA decision is like a building inspector’s sign-off: approval opens access to the Australian market and can unlock sales and valuation, while delays, restrictions or safety warnings can limit revenue, force product changes or raise compliance and legal costs.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Optimi's 5mg psilocybin capsules are prescribed in Australia for treatment-resistant depression.
The export marks Optimi's third commercial shipment since launching the 5mg psilocybin capsules in September 2025.

VANCOUVER, BC, June 29, 2026 /PRNewswire/ - Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN0) (the "Company" or "Optimi"), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, today announced the completion of its latest export of 5mg psilocybin finished drug product to Australia, marking its third commercial shipment since the September 2025 launch of its 5mg psilocybin capsules.

The shipment included 1,000 capsules of 5mg psilocybin, which are being prescribed in Australia for treatment-resistant depression ("TRD"), an indication for which regulated patient access is available. TRD refers to major depression that has not responded to multiple standard antidepressant treatments and represents a significant unmet medical need.

"We are proud to be among the few Nasdaq-listed companies commercially supplying psilocybin to patients with treatment-resistant depression outside of clinical trials," said Dane Stevens, CEO and Co-Founder of Optimi. "Our medicine is produced start to finish in Canada and shipped to pharmacy partners globally, and we are seeing expanding reimbursement coverage from both private and public insurers. We believe Australia is providing an early model for how naturally derived psilocybin can be safely prescribed for TRD in real-world practice, and we are not aware of any serious adverse events reported since inception based on data collected through December 31, 2025."

Australia became the first country in the world to recognize psilocybin as a medicine, rescheduling it from a prohibited substance to a controlled medicine for the treatment of TRD, effective July 1, 2023. MDMA was rescheduled for the treatment of post-traumatic stress disorder on the same day, and Optimi manufactures both psilocybin and MDMA. Patients have since gained broader access under an updated Authorized Prescriber framework that expanded therapist eligibility and treatment settings, as detailed in the Company's news release dated May 29, 2026.

Under the Therapeutic Goods Administration's Authorized Prescriber Scheme, Optimi's psilocybin is being prescribed to patients in Australia and reimbursed by both public and private payers, including the Department of Veterans' Affairs, the National Disability Insurance Scheme, WorkCover, and Medibank. More than 750 clinicians have been trained to deliver the therapy, and the Company is not aware of any serious adverse events that have been reported under the scheme after more than two years of regulated commercial use.

The exported capsules were produced start to finish in-house at Optimi's wholly owned GMP facility in Princeton, British Columbia, Canada, under its Health Canada Drug Establishment Licence, and shipped under export authorization issued by Health Canada. Optimi is among a small number of GMP-licensed manufacturers supplying naturally derived psilocybin to the Australian market, where recurring orders contribute to commercial revenue for the Company.

Optimi supplies finished psilocybin and MDMA drug products to regulated markets internationally, in support of both patient access and clinical research. Inquiries regarding product for special access programs and clinical trial supply may be directed to sales@optimihealth.ca.

About Optimi Health Corp.

Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN0) is a commercial-stage pharmaceutical company focused on manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies. As a Health Canada-licensed pharmaceutical manufacturer, Optimi produces validated MDMA and botanical psilocybin drug products at its GMP-compliant facilities in British Columbia, Canada. Optimi supplies both active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally, with products currently prescribed to patients in Australia under the country's Authorized Prescriber Scheme and accessible in Canada through the Special Access Program.

For more information, please visit www.optimihealth.ca or optimi.net.

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws, including statements regarding the continued and future exports and supply of the Company's psilocybin products to Australia, continued prescribing, patient access and reimbursement in the Australian market, recurring commercial orders and revenue, the Company's ability to manufacture and ship products from its Canadian facility, and the Company's positioning in the regulated psychedelic medicine market. Forward-looking statements are often identified by words such as "expects," "anticipates," "believes," "intends," "plans," "estimates," "may," "will," "would," "could," or similar expressions. Forward-looking statements are based on several assumptions and are subject to a number of known and unknown risks and uncertainties, many of which are beyond the Company's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Accordingly, there are or will be important factors that may cause actual results to differ from expected results. These factors include those described under "Risk Factors" in the Company's registration statement on Form F-1, as amended, and other filings with the U.S. Securities and Exchange Commission made from time to time which are available at www.sec.gov or in the Company's continuous disclosure filings available under its SEDAR+ profile at www.sedarplus.ca. These forward-looking statements reflect current expectations of management regarding future events and speak only as of the date of this press release. Except as expressly required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. New factors emerge from time to time, and it is not possible for the Company to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement.

Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.

View original content to download multimedia:https://www.prnewswire.com/news-releases/optimi-health-completes-psilocybin-export-to-australia-for-patients-with-treatment-resistant-depression-302813353.html

SOURCE Optimi Health Corp

FAQ

What did Optimi Health (NASDAQ: OPTH) announce on June 29, 2026?

Optimi Health announced completion of an export of 1,000 5mg psilocybin capsules to Australia. According to Optimi, this marks its third commercial shipment of the capsules since their September 2025 launch, further supporting treatment-resistant depression access under Australia’s Authorized Prescriber Scheme.

How are Optimi Health’s psilocybin capsules used for treatment-resistant depression in Australia?

Optimi’s 5mg psilocybin capsules are prescribed in Australia for treatment-resistant depression. According to Optimi, prescriptions occur under the Therapeutic Goods Administration’s Authorized Prescriber Scheme, where patients access regulated treatment and costs can be reimbursed by public and private payers, including several national programs and insurers.

Which Australian payers reimburse Optimi Health’s psilocybin products for TRD?

Optimi reports that both public and private payers reimburse its psilocybin for treatment-resistant depression. According to Optimi, these include the Department of Veterans’ Affairs, the National Disability Insurance Scheme, WorkCover, Medibank, and other insurers operating under the Therapeutic Goods Administration’s Authorized Prescriber Scheme.

What safety experience has Optimi Health reported for psilocybin use in Australia?

Optimi states it is not aware of any serious adverse events reported under the scheme. According to Optimi, this conclusion is based on data collected through December 31, 2025, covering more than two years of regulated commercial psilocybin use in Australia.

How does the Australian psilocybin export impact Optimi Health’s revenue outlook?

The export supports recurring commercial revenue from Australia for Optimi Health. According to Optimi, it is among a small number of GMP-licensed manufacturers supplying naturally derived psilocybin to Australia, where ongoing orders of its 5mg capsules contribute to the company’s commercial revenue base.

Where and how does Optimi Health manufacture its psilocybin capsules for export?

Optimi manufactures its psilocybin capsules in-house at a GMP facility in Princeton, British Columbia. According to Optimi, production occurs under a Health Canada Drug Establishment Licence, and exports to Australia are shipped with Health Canada export authorization, supporting global patient access and clinical research supply.