NEW YORK - Psyence Biomedical Ltd. (NASDAQ:PBM), a biotechnology company specializing in nature-derived psychedelic medicines, has announced the addition of Empax Center in Perth, Australia, as a second site for its Phase IIb clinical trial. The trial is investigating the use of psilocybin, a naturally occurring psychedelic compound, for the treatment of Adjustment Disorder in palliative care patients.
Empax Center, known for its expertise in mental health and psychedelic-assisted therapies, will play a crucial role in patient recruitment and trial execution. Dr. Clive Ward-Able, Medical Director of Psyence Biomed, expressed confidence in the center's ability to conduct the trial efficiently and looked forward to initiating patient treatments soon. The company aims to release topline data from the study in the second half of 2025, which, if positive, could lead to pivotal registration studies.
Michael Winlo, CEO of Empax Centre, conveyed enthusiasm for participating in the trial, emphasizing the center's commitment to innovative care for patients experiencing severe distress due to terminal cancer diagnoses.
Psyence Biomed has partnered with Fluence for professional education and training in psychedelic therapy research and with iNGENū CRO Pty Ltd, an Australian clinical research organization, to support the study. Following the successful export of the drug product PEX010 to Australia in July, the affiliated trial sites are set to begin screening patients, with the first participant expected to be enrolled in early December.
Psyence Biomed is the first company developing non-synthetic psilocybin-based medicines to be listed on Nasdaq. They are focused on addressing the unmet needs of mental health disorders in palliative care settings. Empax Center is a dedicated facility for emerging mental health treatments in Western Australia, staffed by experienced professionals and authorized prescribers of psychedelic-assisted therapies.
This news is based on a press release statement from Psyence Biomedical Ltd. The forward-looking statements in the press release are subject to various risks and uncertainties that could cause actual results to differ materially. These include the ability of the research partners to fulfill their obligations, changes in laws, and the company's ability to obtain regulatory approvals and maintain necessary licensing. The information provided does not imply medical claims or assurances of treatment efficacy, as regulatory evaluations and clinical trials are ongoing.
In other recent news, Psyence Biomedical has been involved in several strategic developments. The company has decided not to proceed with the acquisition of Clairvoyant Therapeutics, despite previous plans. The focus remains on its Phase IIb clinical trial, investigating the use of nature-derived psilocybin for Adjustment Disorder in palliative care. In addition, Psyence Biomedical has acquired an 11.13% stake in PsyLabs, a producer of psychedelic active pharmaceutical ingredients, for $1.1 million. This acquisition is expected to ensure a consistent supply of high-quality psilocybin for the company's ongoing research.
Simultaneously, Psyence Biomedical has entered into an exclusive licensing agreement with PsyLabs to secure a supply of EU GMP nature-derived psilocybin for future clinical trials. However, the company has been notified by Nasdaq of its potential delisting due to failure to meet minimum market value requirements. Psyence Biomedical plans to request a hearing before a Nasdaq Hearings Panel to delay any suspension or delisting actions.
These recent developments reflect Psyence Biomedical's commitment to the development of treatments for mental health conditions using psychedelic substances. As always, these developments are subject to various conditions and approvals.
InvestingPro Insights
Psyence Biomedical Ltd.'s (NASDAQ:PBM) ambitious clinical trial expansion comes at a challenging time for the company's financial performance. According to InvestingPro data, PBM's market capitalization stands at a modest $1.78 million, reflecting the early-stage nature of its psychedelic medicine research. The company's negative operating income of -$2.75 million in the last twelve months underscores the significant investments being made in research and development, typical for biotechnology firms in the clinical trial phase.
InvestingPro Tips highlight that PBM's revenue growth has been decelerating, which is not unusual for a company focused on clinical trials rather than commercialization. Additionally, the stock is trading near its 52-week low, with the price at just 0.73% of its 52-week high. This could indicate investor caution regarding the company's near-term prospects or reflect broader market sentiment towards early-stage biotech firms.
The average daily trading volume of 6.05 million shares over the past three months suggests significant investor interest and liquidity in PBM stock, which could be advantageous as the company progresses through its clinical trials and seeks to communicate results to the market.
For investors considering PBM's potential, it's worth noting that InvestingPro offers 11 additional tips that could provide deeper insights into the company's financial health and market position. These additional tips could be particularly valuable given the speculative nature of investments in early-stage biotech companies conducting novel psychedelic research.
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