Monitor for patient enrollment updates and any Health Canada regulatory milestones; the Phase 2 MDD trial is not expected to produce data until after 2027, so near-term catalysts are limited to commercial supply growth in Australia or additional trial approvals.
Price Chart
Executive Summary
Optimi Health completed a cGMP production batch of 5mg psilocybin capsules to supply both a Health Canada-approved Phase 2 MDD trial (up to 200 participants, dosing by end of 2027) and its existing commercial TRD supply in Australia. The filing is a routine operational update with no financial data, and the Phase 2 trial is still years from data readout.
Key Facts
- Completed one cGMP batch of 5mg naturally derived psilocybin capsules at its Princeton, BC facility under Health Canada Drug Establishment Licence.
- Batch supplies a Health Canada-authorized Phase 2 open-label MDD trial (up to 200 participants, single supervised dose, dosing expected by end of 2027).
- Same batch supplies Australian commercial customers under TGA Authorised Prescriber Scheme for treatment-resistant depression, with reimbursement from public/private payers.
- Optimi reports no serious adverse events since commercial supply began in 2025; >750 clinicians completed Mind Medicine Australia's Certificate in Psychedelic-Assisted Therapies.
- No psilocybin drug products have received market authorization by Health Canada.
Financial Impact
No financial figures disclosed; commercial supply in Australia is ongoing but revenue not quantified.
Risk Factors
- Phase 2 trial results may not support registration; psilocybin-assisted therapy for MDD remains investigational.
- No Health Canada market authorization for any psilocybin product; regulatory path is uncertain.
- Commercial revenue from Australia is not disclosed and may be immaterial.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001171843-26-006184 |
| Document: f6k_092326.htm | 0001171843-26-006184 |
| Document: 0001171843-26-006184-index-headers.html | 0001171843-26-006184 |
| Document: 0001171843-26-006184-index.html | 0001171843-26-006184 |
| Document: 0001171843-26-006184.txt | 0001171843-26-006184 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 1d ago | 6-K | $3.36 | awaiting T+5 | — | $3.12 (−7.14%) |
Oct 20, 2026 7d ago | 6-K | $3.36 | awaiting T+5 | — | $3.12 (−7.14%) |
Oct 7, 2026 20d ago | 6-K | $4.04 $3.17 | ▼ −21.66% | ▼ −20.68% | $3.12 (−22.77%) |
Oct 5, 2026 21d ago | SC 13G/A | $4.13 $3.50 | ▼ −15.25% | ▼ −15.12% | $3.12 (−24.46%) |
Sep 29, 2026 28d ago | 6-K | $4.78 $4.13 | ▼ −13.60% | ▼ −15.55% | $3.12 (−34.73%) |
Sep 23, 2026 4w ago | 6-K | $4.96 $4.71 | ▼ −5.04% | ▼ −4.37% | $3.12 (−37.10%) |
Sep 22, 2026 5w ago | 6-K | $4.96 $4.78 | ▼ −3.63% | ▼ −2.44% | $3.12 (−37.10%) |
Sep 16, 2026 5w ago | 6-K | $4.90 $4.96 | ▲ +1.22% | ▼ −0.60% | $3.12 (−36.33%) |
Sep 10, 2026 6w ago | 6-K | $4.50 $4.96 | ▲ +10.22% | ▲ +10.72% | $3.12 (−30.67%) |
Aug 26, 2026 8w ago | 6-K | $4.89 $4.70 | ▲ +3.89% | ▲ +4.15% | $3.12 (+36.20%) |
US Market Status
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