6-K
Psyence Biomedical Ltd. (PBM)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TORULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the month of December 2024
Commission File Number: 001-41937
Psyence BiomedicalLtd.
(Translation of registrant’s name into English)
121 Richmond Street West
Penthouse Suite 1300
Toronto, Ontario M5H 2K1
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
x Form 20-F ¨ Form 40-F
EXHIBIT INDEX
EXHIBIT INDEX
| Exhibit | Description |
|---|---|
| 99.1 | Press Release |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: December 18, 2024
| Psyence Biomedical Ltd. | |
|---|---|
| By: | /s/<br> Neil Maresky |
| Name: | Dr. Neil Maresky |
| Title: | Chief<br> Executive Officer and Director |
Exhibit 99.1

Psyence Biomed Highlights Recent Progress onActive Phase IIb Clinical Trial
Patient screening underway; first patient expectedto be randomized into the study in January
A leading clinical trial site management organization(SMO), Australian Clinical Trial Network (ACTioN), has been engaged to implement patient recruitment and retention strategies
NEW YORK, December 17, 2024 -- Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed" or the "Company") today highlighted recent progress that has been made with its active 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.
To date, two trial sites in Australia - Vitalis and EMPAX - have been activated, and patient screening has commenced. Psyence Biomed anticipates that the first patients will be randomized into the study in January. Additionally, therapist training is ongoing at both sites. Psyence Biomed is also evaluating additional sites to potentially participate in the trial.
To augment its own patient enrollment initiatives, Psyence Biomed’s contract research organization (CRO), iNGENū CRO, has engaged ACTioN SMO to focus on patient recruitment strategies through social media as well as direct email communications to physicians, potential clinical trial sites and disease state advocacy groups, including in the areas of oncology, primary care and psychiatry. ACTioN SMO is working closely with the activated sites, and the initial outreach to a broad audience has occurred.
Dr. Clive Ward-Able, Medical Director of Psyence Biomed, commented, “In collaboration with iNGENū and ACTioN, we have made substantial progress advancing start-up activities related to our Phase IIb trial, and we are poised to commence patient randomization and treatments shortly after this holiday season. With assistance from the team at ACTioN and their proven patient and provider outreach capabilities, we anticipate that the desired recruitment rate will progress smoothly. We look forward to topline results from this trial in the second half of 2025.”
David Harford, Managing Director of ACTioN, added, “We are proud to support Psyence Biomed’s innovative research into the potential of nature-derived psilocybin as a treatment for Adjustment Disorder in the Palliative Care setting. This study aligns with our mission to foster groundbreaking clinical advancements. At ACTioN, we will focus on patient recruitment and retention strategies, which are critical to the study’s success. We are committed to assisting sites in achieving their recruitment goals and ensuring the study’s smooth execution.”
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicines 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, regulatory-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Learn more at www.psyencebiomed.com and on LinkedIn.
Contact Information
Email: [email protected]
Media Inquiries: [email protected]
General Information: [email protected]
Phone: +1 416-477-1708
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors

Forward Looking Statements
This communication contains "forward-lookingstatements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limitedto, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to futureoperations, products and services; and other statements identified by words such as "will likely result," "are expectedto," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning.
Forward-looking statements in this communicationinclude statements regarding the advancement of Psyence Biomed's Phase IIb clinical trial and patient recruitment, and the productionof topline results from this trial. These forward-looking statements are based on a number of assumptions, including the assumptionsthat the parties will obtain all such regulatory approvals as may be required to execute on the Phase IIb clinical trial, and that therewill not be any unforeseen delays in the implementation schedule of the clinical trial.
There are numerous risks and uncertaintiesthat 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) delays in the implementation schedule of Psyence Biomed's Phase IIb clinicaltrials; (ii) the ability of Psyence Biomed to execute its obligations in respect of its product development objectives; (iii) changesin applicable laws which may impact drug development, clinical trials and/or the conducting thereof; (iv) Psyence Biomed’sability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approvedproducts; (v) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vi) volatilityin the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulatedindustries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affectingPsyence 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" sectionof the final prospectus (File No. 333-282468) filed with the Securities and Exchange Commission on October 10, 2024 and otherdocuments filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertaintiesthat could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual resultsand future events could differ materially from those anticipated in such information. Nothing in this communication should be regardedas a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplatedresults of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, whichspeak 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 orhealth benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similarregulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticalproducts. 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 proposedproducts. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified suchin clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary tocommercialize its business, it may have a material adverse effect on the Company’s performance and operations.