Psyence Biomed Announces Phase IIb Clinical Trial Listing on the Australian New Zealand Clinical Trials Registry (ANZCTR)

NEW YORK, April 17, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that details of its upcoming Phase IIb clinical trial of nature-derived psilocybin in patients diagnosed with Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context has been listed on the Australian New Zealand Clinical Trials Registry (“ANZCTR”), under registration number 12624000449538p.

The randomized, double-blind, placebo-controlled Phase IIb study will test three doses (25mg, 10mg and 1mg) of nature-derived psilocybin in 84 patients in conjunction with psychotherapy. Psyence Biomed anticipates enrolling the first subject in the second quarter of 2024 and expects the primary endpoint results to be available in 2025.

“The listing for our Phase IIb clinical trial on ANZCTR reflects the meaningful progress that we are making in the development of a safe and effective psilocybin-based treatment for the roughly 19% of patients who suffer from Adjustment Disorder following an advanced cancer diagnosis¹, with a focus on Palliative Care,” said Neil Maresky, MD, Chief Executive Officer of Psyence Biomed. “Working with our partners, Fluence and iNGENū, we look forward to screening the first patients for this important trial in the coming weeks and efficiently advancing it through to topline data next year.”

More information can be found on the ANZCTR website: .

About Psyence Biomed

Psyence Biomedical Ltd., a corporation organized under the laws of Ontario, Canada, is the world’s first life science biotechnology company traded on The Nasdaq Stock Market LLC (“Nasdaq”) (Nasdaq:PBM) that is focused on the development of botanical (nature derived, or non-synthetic) psilocybin-based psychedelic medicines. 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, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Psyence Biomed is initially focused on mental health disorders in the context of Palliative Care.

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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 commencement of the clinical trial referred to in this news release and the anticipated timeframes for the execution of the clinical trial and receipt of trial results. These forward-looking statements are based on a number of assumptions, including the assumption that Psyence Australia Pty Ltd. (“Psyence Australia”), the Company’s Australian subsidiary, will receive all such regulatory and other approvals as may be required to implement the clinical trial, and that patient recruitment will be successful in accordance with the expected timelines.

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 ability of iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to execute its obligations in respect of the clinical trial; (ii) changes in applicable laws which may impact the clinical trial and/or the conducting thereof; (iii) Psyence Australia’s ability to achieve successful clinical results; (iv) Psyence Biomed’s ability to obtain regulatory approval for its product candidates, and any related restrictions or limitations of any approved products; (v) Psyence Biomed’s ability to obtain licensing of third-party intellectual property rights for future discovery and development of its product candidates; (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 Registration Statement on Form F-1, initially filed by the Company with the SEC on February 9, 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.

¹ Lancet Oncol. 2011 Feb;12(2):160-74