NEW YORK, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed" or the "Company"), a developer of psilocybin-based therapeutics, today provided an update on its previously announced proposed acquisition of Clairvoyant Therapeutics, Inc. Following the completion of necessary due diligence and other pre-closing activities specified in the conditional binding term sheet that was announced on September 9, 2024, Psyence Biomed has decided not to proceed with the acquisition at this time.
Psyence Biomed continues to advance its recently initiated Phase IIb clinical trial of nature derived psilocybin in conjunction with psychotherapy as a potential treatment for Adjustment Disorder following a life-limiting cancer diagnosis in Palliative Care. The first patient is expected to be randomized into the study this quarter, and topline data from the study is anticipated in the second half of 2025.
Additionally, the Company is progressing its second development program, which will evaluate nature derived psilocybin in conjunction with psychotherapy as a potential treatment for Substance Use Disorders (SUDs), leading with Alcohol Use Disorder (AUD). To support its AUD program, Psyence Biomed recently announced a worldwide, exclusive royalty-bearing IP licensing agreement with PsyLabs, a private company focused on the production of highly purified psychedelic active pharmaceutical ingredients and extracts. Psyence Biomed also subsequently agreed to acquire an 11.13% stake in Psylabs (the "Proposed Acquisition") as it evolves into a leading, vertically integrated developer of psychedelic-based therapeutics. Due diligence is ongoing, and Psyence Biomed plans to issue a further update on this pending acquisition shortly.
"After completing the specified due diligence process, we unfortunately were not able to close the acquisition of Clairvoyant," stated Dr. Neil Maresky, M.D., Chief Executive Officer of Psyence Biomed. "We continue to remain focused on being a leader in the development of nature derived psilocybin-based therapeutics that have the potential to treat a broad range of mental health and addiction related conditions. We are very enthusiastic about our own development programs in Adjustment Disorder and AUD, which continue to advance without interruption, and we look forward to the achievement of multiple potentially value creating milestones in the months ahead. We will also remain opportunistic in exploring other assets that may fit within our core clinical strategy."
About Psyence Biomed Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the world’s few biopharmas with a focus on psychedelic-based pharmaceutical therapeutics. As the first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq, Psyence is initially working to address the unmet needs of patients who suffer from mental health disorders in the context of Palliative Care. The name "Psyence" combines the words "psychedelics" and "science" to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, FDA-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Learn more at www.psyencebiomed.com and on LinkedIn.
Forward Looking Statements This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning.
Forward-looking statements in this communication include statements regarding the fulfilment of the conditions to the closing of the Proposed Acquisition, access to the capital and liquidity required for Psyence Biomed to execute on the AUD strategy and PsyLabs' ability to successfully deliver its intended drug product. These forward-looking statements are based on a number of assumptions, including the assumptions that the parties will obtain all such regulatory, corporate, shareholder and other approvals as may be required to implement the Proposed Acquisition, the continuation of PsyLabs' product development strategy as referred to in this news release on schedule, and the safety and effectiveness of psilocybin as a treatment option for AUD.
There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the inability to complete the Proposed Acquisition; (ii) the inability to recognize the anticipated benefits of the Proposed Acquisition (iii) the ability of PsyLabs to execute its obligations in respect of its product development objectives; (iv) changes in applicable laws which may impact drug development, clinical trials and/or the conducting thereof; (v) Psyence Biomed’s ability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approved products; (vi) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the final prospectus (File No. 333 276973) filed with the Securities and Exchange Commission on August 30, 2024 and other documents filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company does not intend to update these forward-looking statements.
The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
