Exhibit 99.1
Psyence BioMed Initiates Patient Dosing in Phase
IIb Trial Evaluating NPX-5 for Adjustment Disorder
Dosing initiates clinical evaluation of NPX-5,
a GMP-compliant, nature-derived psilocybin candidate across an expanded Australian site network
NEW YORK – April 23, 2026 –
Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a clinical-stage biopharmaceutical
company developing nature-derived psychedelic therapeutics, today announced that the first patient has been dosed in its Phase IIb clinical
trial evaluating NPX-5 (25mg of nature-derived psilocybin) for the treatment of Adjustment Disorder in patients with cancer in a palliative
care setting.
The initiation of dosing represents the first
active clinical evaluation of NPX-5 and marks the Company’s transition into systematic human data generation across its Australian
clinical network.
NPX-5 is a GMP-compliant, nature-derived psilocybin
candidate, developed as part of Psyence BioMed’s vertically integrated platform through its investment in PsyLabs. The program is
designed to address a significant unmet need in palliative care by targeting the psychological distress associated with life-limiting
illness through a structured, therapy-supported treatment model.
“Initiating patient dosing is an important
step forward for our clinical program and, more importantly, for the patients we aim to support,” said Jody Aufrichtig, Chief Executive
Officer of Psyence BioMed. “This study is designed to better understand both the safety and therapeutic potential of a 25mg dose
of psilocybin in individuals facing significant emotional distress alongside serious illness. As we advance this work, we remain focused
on generating meaningful data while building a platform that can responsibly bring new treatment options to those who need them most.”
Clinical Study Design and Objectives
The Phase IIb study is a randomized, double-blind,
three arm study (three dose levels) trial designed to evaluate the safety and efficacy of 25mg of psilocybin in patients experiencing
Adjustment Disorder related to a cancer diagnosis. The study is currently advancing across five clinical sites in Australia, including
established research centers in Perth and Melbourne.
The trial is expected to generate data on:
| - | Clinical response and symptom reduction |
| - | Safety and tolerability of NPX-5 |
| - | Treatment durability in patients with cancer |
These data are intended to inform future development
strategy and potential regulatory pathways.
“This study is designed to generate clinically
meaningful insights into both the therapeutic potential and tolerability of a 25mg dose of psilocybin,” said Dr. Neil Maresky, Global
Head Clinical Development. “Our focus is on disciplined execution, consistent patient recruitment, and the generation of high-quality
data to support the advancement of this program.”
Further information about the study can be found
on ClinicalTrials.gov (study identifier: NCT07072728).
Positioning Within Psyence BioMed’s Platform
Strategy
The Company’s psilocybin program is a core
component of Psyence BioMed’s strategy to build a vertically integrated biopharmaceutical platform, combining GMP-compliant manufacturing,
clinical development, and global supply capabilities.
By aligning production and clinical execution,
the Company is positioned to support both ongoing trial activity and future commercialization pathways.
About Psyence BioMed
Psyence Biomedical Ltd. (Nasdaq: PBM) is
one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. It is the
first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin and ibogaine-based psychedelic
medicine to be listed on Nasdaq. We are dedicated to addressing unmet mental health needs. We are committed to an evidence-based approach
in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders.
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 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) risks related to the initiation, timing, progress, expansion, conduct and results of the Company’s clinical trials and the possibility
that clinical results may not support further development of NPX-5 on the anticipated timeline or at all; (ii) potential volatility in
the Company’s share price; (iii) changes in the regulatory, competitive, and economic landscape; and (iv) the Company’s ability
to maintain compliance with Nasdaq’s continued listing standards. 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 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.
For purposes of this release, references to “GMP-compliant”
mean that the relevant product is produced in a facility designed, operated and controlled in accordance with applicable Good Manufacturing
Practice standards. Such references do not, in themselves, constitute a representation that the product, process or facility has been
formally certified, approved or endorsed by any particular regulatory authority unless expressly stated.
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