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Psyence BioMed (NASDAQ: PBM) expands to five Australian sites for NPX-5 trial

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(Neutral)
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(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Psyence BioMed Ltd. is expanding its Australian clinical site network from three to five locations to support its ongoing Phase IIb trial of natural psilocybin (NPX-5) for Adjustment Disorder in cancer patients in palliative care. New partners Ramsay Health Care and NeuroCentrix join existing sites in Perth and Melbourne. Psyence BioMed is supplying fully GMP-compliant NPX-5 capsules (1mg and 5mg) through PsyLabs’ GMP-controlled facility, supporting patient dosing and advancing NPX-5 as its lead clinical drug candidate.

Positive

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Australian clinical sites 5 sites Total sites in Australian network after expansion
Previous Australian sites 3 sites Number of sites before adding Ramsay Health Care and NeuroCentrix
Trial phase Phase IIb Natural psilocybin trial for Adjustment Disorder in cancer patients
NPX-5 capsule strengths 1mg and 5mg Dosage strengths of GMP-compliant NPX-5 psilocybin capsules
Phase IIb clinical trial medical
"The ongoing Phase IIb clinical trial, conducted by Southern Star Research, is evaluating natural psilocybin"
A Phase IIb clinical trial is a mid-stage study that tests whether a drug works at one or more specific doses in the patients it intends to treat, while continuing to monitor safety. Think of it as a dress rehearsal that aims to prove the treatment actually delivers the benefit seen in early tests before a large, expensive final trial. For investors, positive Phase IIb results significantly reduce scientific risk and can lift a drug’s commercial and valuation prospects, while failures often trigger sharp reassessments.
GMP-compliant technical
"supplying its fully GMP-compliant, pharmaceutical-grade psilocybin product, NPX-5"
Good Manufacturing Practice (GMP) compliant means a maker follows established, inspectable rules for producing medicines, medical devices, or other regulated products so each batch is safe, consistent and of expected quality. For investors, GMP compliance lowers the chance of regulatory shutdowns, recalls or delays and increases the likelihood products can be sold; think of it as a verified recipe and checklist that keeps a factory from making faulty batches.
Adjustment Disorder medical
"evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer"
palliative care setting medical
"for the treatment of Adjustment Disorder in patients with cancer in a palliative care setting"
forward-looking statements regulatory
"This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

 

 

UNITED STATES

 

SECURITIES AND EXCHANGE COMMISSION

 

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of April 2026

 

Commission File Number: 001-41937

 

Psyence Biomedical Ltd.

 

(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.

 

☒ Form 20-F Form 40-F 

 

 

 

 

 

 

EXPLANATORY NOTE

 

On April 8, 2026, the Company issued a press release titled “Psyence BioMed Expands Australian Clinical Site Network to Five Sites, Advancing NPX-5–Supported Clinical Activities.”

 

A copy of this press release is furnished as Exhibit 99.1 to this Form 6-K and is incorporated herein by reference.

 

EXHIBIT INDEX

 

Exhibit No.   Description
99.1   Press Release, dated April 8, 2026, titled “Psyence BioMed Expands Australian Clinical Site Network to Five Sites, Advancing NPX-5–Supported Clinical Activities.”

 

1

 

 

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: April 14, 2026

 

Psyence Biomedical Ltd.  
     
By: /s/ Warwick Corden-Lloyd  
Name:  Warwick Corden-Lloyd  
Title: Chief Financial Officer  

 

 

2

 

 

Exhibit 99.1

 

Psyence BioMed Expands Australian Clinical Site Network to Five Sites, Advancing NPX-5–Supported Clinical Activities

 

Expansion supports accelerated enrollment and advancement of the Company’s lead clinical asset

 

NEW YORK – April 8, 2026 – Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced the expansion of its clinical site network in Australia from three to five sites supporting its ongoing clinical activities.

 

The expansion includes the addition of Ramsay Health Care and NeuroCentrix, which enhances the Company’s clinical network with experienced hospital and specialist research partners. The Company believes that their inclusion strengthens the Company’s clinical program and enhances its ability to support ongoing clinical activities with high-quality, experienced site partners.

 

The ongoing Phase IIb clinical trial, conducted by Southern Star Research, is evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer in a palliative care setting. The study is currently operating across three established sites: Empax Centre in Perth, the Mind Medicine Australia Clinic in Melbourne, and Paratus Clinical Research in Melbourne, where initial patient dosing began in late 2025.

 

Building on this foundation, the addition of Ramsay Health Care and NeuroCentrix expands the program to five sites, which is expected to strengthen recruitment, accelerate enrollment, and advance an ongoing, multi-site Phase IIb natural psilocybin trial in a palliative oncology population.

 

In support of this clinical activity, Psyence BioMed is supplying its fully GMP-compliant, pharmaceutical-grade psilocybin product, NPX-5 (1mg and 5mg capsules), manufactured at PsyLabs’ GMP-controlled production facility; a private company and asset in which the Company has made strategic investments.  This supply underpins the continued advancement of NPX-5, Psyence BioMed’s lead clinical  drug candidate, and positions the Company to accelerate patient enrollment, broaden geographic reach, and improve operational efficiency across study sites.

 

“This expansion marks an important step forward in scaling the clinical infrastructure required to advance NPX-5 and support ongoing patient dosing,” said Jody Aufrichtig, CEO of Psyence BioMed. “By adding high-quality clinical partners such as Ramsay Health Care and NeuroCentrix, we are strengthening our ability to execute efficiently, accelerate enrollment, and generate meaningful clinical data. As patients continue to be dosed with NPX-5, our focus remains on advancing the program through a disciplined, regulatory-aligned pathway.”

 

Learn more at www.psyencebiomed.com and on LinkedIn.

 

Contact Information for Psyence Biomedical Ltd.

Email: ir@psyencebiomed.com

Media Inquiries: media@psyencebiomed.com

General Information: info@psyencebiomed.com

 

Investor Contact:

Michael Kydd

Investor Relations Advisor

michael@psyencebiomed.com

 

 

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, without limitation, statements regarding the expected benefits of the expansion of the Company’s clinical site network from three to five sites in Australia, including the anticipated impact on patient recruitment, enrollment timelines, geographic reach, and operational efficiency; the continued progress, timing, and execution of the Company’s ongoing Phase IIb clinical trial evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer in a palliative care setting; the ability of newly added site partners, including Ramsay Health Care and NeuroCentrix, to support clinical trial activities; the Company’s ability to supply GMP-compliant psilocybin product (NPX-5) for use in the trial; and the potential for the trial to generate meaningful clinical data. These statements are based on current assumptions and expectations, including assumptions that the addition of new clinical sites will improve recruitment and enrollment rates, that patient dosing and enrollment will continue as anticipated, that the Company will maintain sufficient product supply and manufacturing capabilities, that site partners will perform as expected, and that the Company will obtain and maintain all necessary regulatory and other approvals required to conduct the trial. These assumptions may prove incorrect. There are numerous risks and uncertainties that may cause actual results or performance to differ materially from those expressed or implied by these forward-looking statements, including risks related to delays in site activation, patient recruitment or enrollment, variability in clinical trial outcomes, supply chain or manufacturing disruptions, and the Company’s ability to execute its clinical development strategy.

 

These risks and uncertainties include, among others: (i) the Company’s ability to maintain compliance with Nasdaq’s continued listing standards; (ii) potential volatility in the Company’s share price; (iii) changes in the regulatory, competitive, and economic landscape; and (iv) risks associated with the Company’s development plans and clinical trials. 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 Company’s final prospectus (File No. 333-298285) filed with the Securities and Exchange Commission (the “SEC”) on November 3, 2025 and other documents filed by Psyence BioMed 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 statements. 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, Psyence BioMed does not intend to update these forward-looking statements.

 

The Company does not make any medical, treatment or health benefit claims about its 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 authorized clinical 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 the proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company has 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.

 

 

 

 

FAQ

What did Psyence BioMed (PBM) announce in its latest 6-K filing?

Psyence BioMed announced it expanded its Australian clinical site network from three to five locations to support an ongoing Phase IIb trial of natural psilocybin (NPX-5) for Adjustment Disorder in cancer patients receiving palliative care, aiming to strengthen recruitment and trial execution.

How many clinical sites does Psyence BioMed (PBM) now have in Australia?

Psyence BioMed now has five clinical sites in Australia. It added Ramsay Health Care and NeuroCentrix to three existing locations in Perth and Melbourne, with the goal of enhancing patient recruitment, accelerating enrollment, and supporting its multi-site Phase IIb psilocybin trial.

What is Psyence BioMed’s NPX-5 and how is it used in the trial?

NPX-5 is Psyence BioMed’s fully GMP-compliant, pharmaceutical-grade psilocybin product in 1mg and 5mg capsules. It is being supplied to Australian clinical sites from a GMP-controlled facility to support dosing in the Phase IIb trial for Adjustment Disorder in palliative oncology patients.

Which condition is Psyence BioMed (PBM) targeting in its Phase IIb psilocybin trial?

The Phase IIb trial targets Adjustment Disorder in patients with cancer in a palliative care setting. The study evaluates natural psilocybin (NPX-5) across multiple Australian sites, aiming to generate meaningful clinical data in this specific mental health condition linked to serious illness.

Who are the new clinical partners added by Psyence BioMed (PBM)?

Psyence BioMed added Ramsay Health Care and NeuroCentrix as new Australian clinical partners. The company believes these experienced hospital and specialist research organizations will strengthen its clinical program and help support ongoing enrollment and dosing in the NPX-5 Phase IIb trial.

What risks and uncertainties does Psyence BioMed highlight around this trial expansion?

Psyence BioMed notes risks including potential delays in site activation, patient recruitment or enrollment, variability in clinical outcomes, supply chain or manufacturing disruptions, regulatory challenges, and broader market and listing risks, which could cause actual results to differ from current expectations.

Filing Exhibits & Attachments

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