Psyence BioMed Receives Approval for Psilocybin Use in Phase IIb Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 19 2025
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Source: Newsfilter
- Clinical Trial Approval: Psyence BioMed's psilocybin product NPX5 has been approved by the Bellberry Human Research Ethics Committee for use in a Phase IIb clinical trial targeting Adjustment Disorder in cancer patients, marking a significant advancement in the mental health sector.
- Strengthened Financial Position: With approximately $9.5 million in cash reserves and an investment in Psylabs, the company is uniquely positioned in the emerging global psychedelics market, enabling effective execution of its strategic initiatives.
- Multi-Center Research Deployment: The approval applies to multiple clinical sites, including Empax Centre and Mind Medicine Australia Clinic, which is expected to accelerate patient recruitment and advance the Phase IIb study.
- Enhanced Supply Chain Control: By utilizing a best-in-class GMP compliant psilocybin product, Psyence BioMed not only boosts production capacity but also ensures comprehensive control from raw material sourcing to clinical evaluation, further solidifying its market position.
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About PBM
Psyence Biomedical Ltd is a multi-asset, vertically integrated biopharmaceutical company specializing in psychedelic-based therapeutics. The Company is focused on developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine. It is dedicated to addressing unmet mental health needs, particularly in palliative care. Its ongoing Phase IIb psilocybin clinical trial in Australia focuses on adjustment disorder in patients diagnosed with cancer.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Supply Chain Assurance: The agreement secures Psyence's access to high-quality pharmaceutical-grade psychedelics, supporting future clinical and commercial programs while mitigating supply chain and regulatory risks.
- Financial Flexibility: The put option structure enables Psyence to maintain financial flexibility without needing to deploy significant capital upfront, optimizing cash use for clinical and regulatory execution.
- Independent Review Mechanism: The company's board established a special committee of two independent directors to review and ratify the agreement, ensuring commercial rationale and transparency, thereby strengthening corporate governance.
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- Court Ruling Impact: On January 21, 2026, the Ontario Superior Court dismissed KAOS's application and ordered it to pay the company CAD $75,000 in costs, demonstrating judicial support for the company's position and reducing potential legal expenses and business disruptions.
- Shareholder Share Handling: Under the settlement terms, KAOS agrees to sell all common shares it holds at $5 per share to a third party designated by the company, which will help the company streamline its shareholder structure and stabilize its stock price.
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See More
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See More
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See More
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See More
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- Impact on Shares: Post-consolidation, the company will reduce its shares from 6,388,604 to 1,022,177, maintaining ownership percentages for shareholders while allowing for minor adjustments due to fractional shares.
- Exchange Agent Information: Continental Stock Transfer & Trust Company will act as the exchange agent for the consolidation, ensuring a smooth process for all shareholders and minimizing potential market disruptions.
See More
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- Supply Chain Assurance: The agreement secures Psyence's access to high-quality pharmaceutical-grade psychedelics, supporting future clinical and commercial programs while mitigating supply chain and regulatory risks.
- Financial Flexibility: The put option structure enables Psyence to maintain financial flexibility without needing to deploy significant capital upfront, optimizing cash use for clinical and regulatory execution.
- Independent Review Mechanism: The company's board established a special committee of two independent directors to review and ratify the agreement, ensuring commercial rationale and transparency, thereby strengthening corporate governance.
See More
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- Settlement Agreement: Psyence Biomedical has entered into a settlement agreement with KAOS Capital, agreeing to pay $1.5 million to resolve a shareholder claim made in January 2026, despite the company denying all allegations as unfounded.
- Court Ruling Impact: On January 21, 2026, the Ontario Superior Court dismissed KAOS's application and ordered it to pay the company CAD $75,000 in costs, demonstrating judicial support for the company's position and reducing potential legal expenses and business disruptions.
- Shareholder Share Handling: Under the settlement terms, KAOS agrees to sell all common shares it holds at $5 per share to a third party designated by the company, which will help the company streamline its shareholder structure and stabilize its stock price.
- Financial Impact Assessment: The company expects to fund the settlement from cash on hand and record it in accordance with applicable accounting standards; although denying any wrongdoing, the decision to settle aims to avoid further litigation and associated costs.
See More
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- Settlement Amount: A biomedical company, Cotopay, has agreed to a settlement of $1.5 million.
- Context of Settlement: The settlement is related to a legal issue involving the company, although specific details of the case are not provided.
See More
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- Earnings Surprise: Teradyne's fourth-quarter earnings report exceeded market expectations on both revenue and earnings per share, leading to a 22.2% surge in pre-market trading to $305.00, indicating strong investor confidence in its financial performance.
- Optimistic Outlook: The company forecasts first-quarter adjusted EPS between $1.89 and $2.25, significantly above the analyst estimate of $1.24, showcasing robust profitability and market demand.
- Revenue Projections Raised: Teradyne anticipates first-quarter revenue in the range of $1.15 billion to $1.25 billion, well above the analyst expectation of $927.72 million, reflecting the company's competitive edge and growth potential in the market.
- Positive Market Reaction: The substantial increase in stock price not only reflects investor approval of the company's performance but may also attract more institutional investors, potentially driving further stock price appreciation.
See More
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- Reverse Split Delay: Psyence Biomedical postponed its planned 1-for-6.25 reverse stock split originally set for January 20, reflecting the company's commitment to shareholder interests following an internal review.
- Significant Share Reduction: The reverse split will reduce outstanding shares from approximately 6.39 million to about 1.02 million, aimed at increasing the per-share trading price to meet Nasdaq's $1 minimum requirement, thereby enhancing market confidence.
- Positive Market Reaction: Following the reverse split, Psyence Biomedical's stock surged around 60% on the Nasdaq Capital Market, indicating strong investor optimism regarding the company's future prospects.
- Strategic Investment Support: Last November, the company approved a $3.5 million investment in PsyLabs, securing its critical position as a supplier of GMP-grade psychedelic active pharmaceutical ingredients, which supports the ongoing development of its clinical pipeline.
See More
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- Share Consolidation Ratio: Psyence BioMed announced a 1-for-6.25 share consolidation effective February 2, 2026, aimed at increasing the stock price to enhance market appeal and investor interest.
- Shareholder Approval: At a special meeting on April 16, 2025, shareholders approved a consolidation authorization of up to 1-for-50, indicating strong support for the company's restructuring plans.
- Impact on Shares: Post-consolidation, the company will reduce its shares from 6,388,604 to 1,022,177, maintaining ownership percentages for shareholders while allowing for minor adjustments due to fractional shares.
- Exchange Agent Information: Continental Stock Transfer & Trust Company will act as the exchange agent for the consolidation, ensuring a smooth process for all shareholders and minimizing potential market disruptions.
See More
