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 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.
Psyence Biomedical (Nasdaq: PBM) has entered into a conditional share sale agreement with Psyence Group to acquire an 11.13% stake in PsyLabs, a company specializing in psychedelic active pharmaceutical ingredients (APIs) and extracts. The deal, valued at $1.1 million, involves Psyence Biomed issuing common stock at $0.55 per share to Psyence Group. This acquisition follows a previously announced exclusive licensing agreement with PsyLabs for pharmaceutical-grade, nature-derived psilocybin to be used in clinical trials for Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs). PsyLabs' proprietary process is claimed to produce the highest purity, naturally derived psilocybin on the market. The deal is subject to various conditions, including regulatory approvals and a product development milestone to be achieved by October 31, 2024.
Psyence Biomedical (Nasdaq: PBM) has issued a shareholder update highlighting recent progress and upcoming milestones. The company has:
- Initiated a Phase IIb study of nature-derived psilocybin for Adjustment Disorder in Palliative Care
- Expanded its pipeline to include Alcohol Use Disorder (AUD) and Substance Use Disorders (SUDs)
- Announced the acquisition of Clairvoyant, a synthetic psilocybin-based drug developer
- Secured exclusive supply agreements for GMP nature-derived psilocybin
Two Phase II data readouts are anticipated in 2025: Clairvoyant's AUD trial in early 2025 and Psyence's Adjustment Disorder trial in the second half of 2025. The company has also strengthened its financial position to support these initiatives.
Psyence Biomedical (Nasdaq: PBM) has received a staff determination letter from Nasdaq on September 12, 2024, indicating the company's failure to regain compliance with two listing requirements by the September 9, 2024 deadline. The requirements in question are the Market Value of Listed Securities (MVLS) of $50 million and the Market Value of Publicly Held Shares (MVPHS) of $15 million for continued listing on The Nasdaq Global Market.
The company was initially notified of these deficiencies on March 11, 2024, and given 180 calendar days to comply. Facing potential suspension or delisting, Psyence Biomedical intends to request a hearing before the Nasdaq Hearings Panel, which will automatically stay any delisting action pending the hearing and any additional extension period granted by the Panel.
Psyence Biomedical (Nasdaq: PBM) has announced the successful completion of the first site initiation visit for its Phase IIb study of nature-derived psilocybin as a potential treatment for Adjustment Disorder in Palliative Care. The study will be conducted at an Australian clinical trial site, with patient screening set to begin soon and the first subject expected to be randomized in October 2024.
The randomized, double-blind, placebo-controlled study will evaluate two therapeutic doses of psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 87 patients, in conjunction with psychotherapy. Psyence has partnered with Fluence and iNGENū CRO Pty to support the study. The company anticipates topline data in the second half of 2025, which could potentially lead to the initiation of a Phase III clinical program.
Psyence Biomedical (Nasdaq: PBM) has entered into a conditional binding term sheet to acquire Clairvoyant Therapeutics Inc, a Canadian clinical-stage developer of psilocybin-based therapeutics. The acquisition involves issuing US$500,000 in PBM common shares upon closing, with potential additional payments of up to US$500,000 based on milestones. PBM will also advance up to US$1,800,000 to settle Clairvoyant's liabilities.
Clairvoyant is currently conducting a Phase IIb clinical trial evaluating a synthetic psilocybin candidate for Alcohol Use Disorder (AUD). The trial has enrolled and treated 154 randomized double-blinded subjects, with topline results expected in early 2025. This acquisition could expand PBM's pipeline into AUD treatment and potentially transition the company to a commercial-stage, revenue-generating entity.
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