Welcome to our dedicated page for Psyence Biomedical Ltd. Common Shares news (Ticker: PBM), a resource for investors and traders seeking the latest updates and insights on Psyence Biomedical Ltd. Common Shares stock.
Psyence Biomedical Ltd (NASDAQ: PBM) is a pioneering life science biotechnology company focused on the development of natural psychedelics for mental health and wellbeing, particularly in the context of palliative care. The company's primary area of research involves developing natural psilocybin products aimed at addressing psychological trauma and its mental health consequences.
Psyence Biomed cultivates natural psilocybin mushrooms at its ISO22000 certified facility in Southern Africa. These mushrooms are used to produce standardized encapsulated products for export to partners around the world. The company is dedicated to advancing its product candidates through rigorous clinical trials to evaluate their safety and efficacy.
Recently, Psyence Biomed has initiated a double-blind, placebo-controlled Phase IIb clinical trial in Australia, testing three doses (25mg, 10mg, and 1mg) of nature-derived psilocybin in combination with psychotherapy. This study aims to improve the quality of life for patients suffering from Adjustment Disorder, especially those with life-limiting illnesses. The primary endpoint of the trial is the change in the Hamilton Anxiety Rating Scale (HAM-A) over time. The company's partnership with the Contract Research Organization (CRO) iNGENū Pty Ltd is crucial for executing this trial. Psyence expects to enroll the first patient in Q2 2024, with primary endpoint results anticipated in 2025.
The approval from Australia's Human Research Ethics Committee (HREC) is a significant milestone for Psyence Biomed, allowing the company to proceed with this groundbreaking trial. CEO Dr. Neil Maresky emphasized the potential for this research to revolutionize the treatment of patients with life-limiting illnesses, highlighting both the clinical and economic benefits of psilocybin-assisted psychotherapy.
Psyence Biomed's research is further validated by a recent independent study from Hebrew University, which found that nature-derived psilocybin may offer more potent and prolonged therapeutic effects compared to synthetic variants. This positions Psyence Biomed as a leader in the field of nature-derived psychedelic medicine.
Financially, Psyence Biomed is well-capitalized, with up to US$10 million in cash and equivalents, sufficient to complete the Phase IIb study. The company's strategic merger with Newcourt Acquisition Corp. and subsequent listing on NASDAQ have expanded its access to capital and increased its visibility among institutional life sciences investors.
In summary, Psyence Biomedical Ltd stands at the forefront of the biotechnology sector, leveraging natural psychedelics to address significant unmet medical needs. With a robust clinical trial pipeline, strong financial backing, and strategic partnerships, Psyence Biomed is well-positioned to make a substantial impact on the field of mental health and palliative care.
Psyence Biomed (Nasdaq: PBM) reports progress on its Phase IIb clinical trial testing nature-derived psilocybin with psychotherapy for Adjustment Disorder in palliative care cancer patients. Two Australian trial sites, Vitalis and EMPAX, have been activated with patient screening underway. The company expects to begin patient randomization in January.
The company has engaged Australian Clinical Trial Network (ACTioN) as their site management organization to implement recruitment strategies through social media and direct communications with physicians, trial sites, and advocacy groups. Therapist training continues at both sites, and additional trial locations are being evaluated. Topline results are expected in the second half of 2025.
Psyence Biomed (Nasdaq: PBM) has executed binding agreements with Optimi Health Corp, advancing from their previous non-binding Letter of Intent. Under the agreements, Optimi becomes the exclusive worldwide supplier of GMP-certified, nature-derived psilocybin for Psyence's drug development and commercialization initiatives in Palliative Care.
Optimi will provide comprehensive Chemistry, Manufacturing, and Control (CMC) support for regulatory submissions related to Psyence's clinical trials and future Investigational New Drug applications. The company is currently advancing its Phase IIb clinical trial for Adjustment Disorder in Palliative Care, with plans for Phase III studies.
Psyence Biomedical (Nasdaq: PBM) provided a shareholder update highlighting significant progress. The company's Phase IIb clinical trial for nature-derived psilocybin in Palliative Care patients with Adjustment Disorder is advancing, with patient screening commenced. Their stake in PsyLabs has doubled in value to approximately $2 million following an independent valuation. The company has strengthened its financial position through debt-for-equity swap agreements with Psyence Group and Newcourt SPAC Sponsor. PBM expects to enter 2025 substantially debt-free and is on track to regain compliance with Nasdaq listing requirements by year-end. Topline data from the Phase IIb trial is expected in H2 2025.
Psyence Biomedical (Nasdaq: PBM) has received a favorable outcome from its Nasdaq Listing Qualifications Hearing. The Nasdaq Hearings Panel granted the company an extension until December 31st, 2024, to meet all continued listing requirements. The company plans to transfer from The Nasdaq Global Market to The Nasdaq Capital Market and implement a 1-for-75 share consolidation to meet the $1 minimum bid price requirement. Shareholders approved this consolidation during the November 12th Annual General Meeting. The company must comply with requirements including $1.0 million minimum market value of publicly held shares and $2.5 million minimum stockholders' equity.
Psyence Biomedical (Nasdaq: PBM) has announced the implementation of a 1-for-75 share consolidation, effective November 26, 2024. This consolidation, approved by shareholders on November 12, 2024, aims to regain compliance with Nasdaq's minimum bid price requirement. Every 75 existing common shares will be combined into one share, with fractional shares rounded up or down accordingly. The company will continue trading under the symbol 'PBM' with a new CUSIP number 74449F209. The consolidation will uniformly affect all shareholders and adjust the company's outstanding warrants and equity awards proportionally.
Psyence Biomedical (Nasdaq: PBM) held its annual and special meeting with 43.5% shareholder participation, approving five key resolutions. Shareholders approved the appointment of auditors (90.84%), share consolidation (84.1%), 2023 Equity Incentive Plan (76.57%), and nomination of directors (>79.32%). The company will implement a 75-to-1 share consolidation effective November 22, 2024, to meet Nasdaq's minimum bid price requirements. Trading under PBM symbol will continue on November 25, 2024. Additionally, PBM received a Nasdaq Staff determination letter on November 7, noting non-compliance with the Low Priced Stocks Rule, as shares traded at $0.10 or less for ten consecutive days.
Psyence Biomedical (Nasdaq: PBM) has completed the acquisition of Psyence Group's 11.13% stake in PsyLabs, a private company specializing in psychedelic APIs and extracts production. The deal involves a debt-for-equity swap where Psyence Biomed issued 845,394 common shares at $0.50 per share to Psyence Group. PsyLabs has granted Psyence Biomed an exclusive, worldwide, royalty-bearing IP license to supply pharmaceutical-grade, EU GMP nature-derived psilocybin for potential treatment of Alcohol Use Disorder and other Substance Use Disorders. The agreement includes a 'make whole payment' provision if share prices fall below $0.50 by January 15, 2025.
Psyence Biomed (Nasdaq: PBM) has announced the addition of Empax Center in Perth, Australia as the second trial site for its ongoing Phase IIb clinical trial. The study evaluates nature-derived psilocybin for treating Adjustment Disorder in Palliative Care. The company expects to begin patient recruitment this quarter, with topline data anticipated in the second half of 2025. The trial is supported by partnerships with Fluence and iNGENū CRO. In July, Psyence successfully exported its drug product PEX010 to Australia, and patient screening is set to begin with first subject randomization expected in early December.
Psyence Biomedical (Nasdaq: PBM) has provided an update on its strategic acquisition of an equity stake in PsyLabs and the progress of PsyLabs' collaboration with a contract drug manufacturing organization (CDMO). This collaboration aims to advance the development of nature-derived psychedelic active pharmaceutical ingredients (APIs) towards E.U. Good Manufacturing Practices (GMP) certification.
Key points:
- PsyLabs has entered phase two of its development process, focusing on upscaling the purification process for commercial viability.
- The CDMO is working to validate that PsyLabs' high-purity psilocybin extraction methods can be replicated on a commercial scale.
- This progress is important for meeting global health regulator demands and advancing through Phase III clinical trials.
- Psyence Biomed's pending acquisition of PsyLabs aligns with its strategy to secure access to pharmaceutical-grade, naturally derived APIs for future clinical trials and FDA-approved drug development.
Psyence Biomedical (Nasdaq: PBM) has decided not to proceed with the previously announced acquisition of Clairvoyant Therapeutics, Inc. following due diligence. The company continues to advance its Phase IIb clinical trial of nature-derived psilocybin for Adjustment Disorder in Palliative Care, with the first patient expected to be randomized this quarter and topline data anticipated in H2 2025.
Psyence Biomed is also progressing its program for Substance Use Disorders (SUDs), focusing on Alcohol Use Disorder (AUD). The company recently announced an exclusive IP licensing agreement with PsyLabs and plans to acquire an 11.13% stake in the company. Psyence Biomed remains committed to developing nature-derived psilocybin-based therapeutics for mental health and addiction-related conditions.
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