Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
On October 21, 2026, the Company issued a press
release titled “Psyence BioMed Completes PsyLabs Investment as Ibogaine Milestones Are Met.”
A copy of this press release is furnished as Exhibit 99.1 to this Form
6-K and is incorporated herein by reference.
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.
Exhibit 99.1
Psyence BioMed Completes PsyLabs Investment
as Ibogaine Milestones Are Met
Ibogaine regulatory readiness pack completed
and U.S. cGMP manufacturing agreement concluded with DEA-registered Benuvia in Texas; investment supports PsyLabs’ intended supply
of pharmaceutical-grade ibogaine for the planned U.S. development program
NEW YORK, October 21, 2026 (GLOBE NEWSWIRE)
-- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”) today announced that both milestones
attached to its backstop subscription commitment in Psyence Labs Ltd. (“PsyLabs”) have been achieved and that the Company,
through its wholly-owned subsidiary Psyence Biomed II Corp., has completed its additional investment in PsyLabs of US$2,599,896. The milestones
include the completion of an ibogaine regulatory readiness documentation package and the execution of a U.S. current Good Manufacturing
Practice (“cGMP”) manufacturing agreement with Benuvia Operations, LLC (“Benuvia”), representing important progress
in advancing the Company’s planned U.S. pharmaceutical-grade ibogaine development program.
As previously announced on September 23, 2026,
Psyence BioMed agreed to invest up to US$5 million in PsyLabs, comprising an irrevocable commitment of US$2.4 million (936 PsyLabs ordinary
shares at US$2,564 per share) under its pro rata pre-emption entitlement in PsyLabs’ current financing round and a backstop commitment
of up to US$2.6 million to subscribe for shares in that financing round not taken up by other PsyLabs shareholders, payable in up to two
tranches of up to US$1.3 million each upon the achievement of specified milestones. The backstop tranches were required to be called and
completed by December 31, 2026.
Key Development Milestones Achieved
Regulatory Readiness Documentation
PsyLabs has completed its ibogaine regulatory
readiness pack, a documentation package intended to support future regulatory interactions relating to pharmaceutical-grade ibogaine hydrochloride
(HCl).
The completion of this documentation represents
an important preparatory step in supporting the regulatory development activities contemplated under the Company’s U.S. ibogaine
program.
U.S. cGMP Manufacturing Agreement
A manufacturing services agreement has been entered
into with Benuvia by Texas Ibogaine Research Corporation (“TIRC”), the Company’s wholly-owned Texas subsidiary. Benuvia
operates a controlled-substance manufacturing facility in Round Rock, Texas registered with the U.S. Drug Enforcement Administration (“DEA”).
As previously announced on October 5, 2026, the
agreement is intended to support the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient (“API”)
under cGMP standards, subject to applicable regulatory requirements.
The agreement establishes a U.S. manufacturing
relationship intended to support future nonclinical and clinical development activities.
Advancing a Coordinated U.S. Ibogaine Development
Strategy
In structuring the planned U.S. manufacturing
program, the Company and PsyLabs agreed that the Benuvia agreement would be entered into by TIRC rather than by PsyLabs. TIRC was established
to carry out the manufacturing, nonclinical and regulatory development work required before any human clinical trial could be proposed
in the United States, and, as a U.S. developer, may be positioned to pursue domestic funding and grant opportunities that may be available
for that work. This structure is intended to allow PsyLabs to remain focused on cultivating, extracting and supplying pharmaceutical-grade
ibogaine HCl. Under the binding term sheet between TIRC and PsyLabs announced on September 28, 2026, PsyLabs is expected to serve as TIRC’s
exclusive ibogaine supplier for the United States, subject to the conclusion of a definitive agreement, which the parties have agreed
to conclude on or before November 30, 2026.
Additional Investment in PsyLabs Completed
Following certification by the PsyLabs board of
directors that both development milestones had been achieved, PsyLabs called both backstop tranches ahead of the December 31, 2026, deadline.
Psyence Biomed II Corp. subscribed for 1,014 ordinary
shares of PsyLabs at US$2,564 per share, reflecting the US$54 million pre-money equity valuation set for the financing round, for aggregate
subscription proceeds of US$2,599,896. Immediately prior to the investment, the Company held approximately 41.13% of PsyLabs’ issued
and outstanding shares. Following completion of the investment, and after giving effect to the previously announced share exchange which
closed October 1, 2026, the Company holds approximately 43.37% of PsyLabs’ issued and outstanding shares. The investment was funded
from the Company’s existing cash resources.
Management Commentary
“Achieving both milestones well ahead of
the December 31 deadline is a clear signal that the ibogaine program is moving from planning into execution,” said Jody Aufrichtig,
Chief Executive Officer of Psyence BioMed and TIRC. “PsyLabs now has the regulatory documentation and additional capital to support
the supply of pharmaceutical-grade ibogaine, and TIRC has a U.S. cGMP manufacturing partner in place to support the development work we
are planning. Each company is doing what it is best equipped to do, which we believe is the right structure for building long-term value
for our shareholders.”
Related-Party Transaction
PsyLabs is a related party of the Company and
a significant shareholder of Psyence BioMed. The investment, including the backstop commitment, was reviewed and approved by a special
committee of the Company’s independent directors and by its audit committee, in accordance with the Company’s related-party
transaction policies and applicable Nasdaq requirements.
ABOUT PSYENCE BIOMED
Psyence Biomedical Ltd. (Nasdaq: PBM) is a Nasdaq-listed
company with its wholly-owned subsidiary, Texas Ibogaine Research Corporation, headquartered in Texas. It is one of the few multi-asset,
vertically integrated biopharmaceutical companies specializing in neuroplastogen-based therapeutics and the manufacture of pharmaceutical-grade
drug candidates. It is the first life sciences biotechnology company focused on developing nature-derived, non-synthetic psilocybin and
ibogaine-based neuroplastogen medicine to be listed on Nasdaq. The Company is dedicated to addressing unmet mental health needs and is
committed to an evidence-based approach to developing safe, effective and FDA-approved nature-derived neuroplastogen treatments across
a range of mental health disorders.
ABOUT PSYLABS
PsyLabs is a neuroplastogen active pharmaceutical
ingredient development company, federally licensed in its operating jurisdiction to cultivate, extract and export psilocybin mushrooms
and other neuroplastogen compounds, including psilocybin, psilocin, mescaline, ibogaine and dimethyltryptamine, to lawful medical and
research markets. PsyLabs operates from an ISO 22000 and GMP-compliant facility, with a focus on natural compound purification, regulatory
support and global distribution. www.psylabs.life
CONTACTS
Psyence Biomedical Ltd. ir@psyencebiomed.com media@psyencebiomed.com
info@psyencebiomed.com · +1 416-477-1708
Investor contact: Michael Kydd, Investor Relations Advisor —
michael@psyencebiomed.com
FORWARD-LOOKING STATEMENTS
This communication contains “forward-looking
statements” within the meaning of applicable securities laws, including the U.S. Private Securities Litigation Reform Act of 1995.
These include statements regarding the investment by Psyence BioMed in PsyLabs, including the achievement and certification of the related
milestones and the anticipated effects of the investment; the application of the proceeds of that investment; the resulting shareholding
of Psyence BioMed in PsyLabs; the completion and effects of the previously announced share exchange; the manufacturing services agreement
between TIRC and Benuvia, including the planned U.S. manufacture of pharmaceutical-grade ibogaine active pharmaceutical ingredient and
the timing, scale and cost of such manufacture; the capitalization, funding and intended role of TIRC, including its ability to access
U.S. funding and grant opportunities; the expected conclusion of a definitive license and supply agreement between TIRC and PsyLabs, including
PsyLabs’ expected role as TIRC’s exclusive ibogaine supplier; the Company’s ability to secure pharmaceutical-grade drug
substance and the regulatory documentation required to support a United States program; the evaluation, funding, design, timing and conduct
of any clinical trial in Texas; the Company’s ability to obtain and maintain required registrations, permits, quotas and licenses;
its ability to participate in federal or state ibogaine programs; and its expected role in future research, development and commercialization
activities relating to ibogaine. Forward-looking statements may be identified by words such as “will,” “expects,”
“intends,” “plans,” “anticipates,” “believes,” “estimates” and similar expressions.
These statements are based on assumptions regarding
government policy, continued interest in regulated neuroplastogen research, the availability of lawful development pathways, and the Company’s
ability to maintain licenses, permits, supply arrangements and third-party relationships, as well as assumptions that PsyLabs will apply
the investment proceeds as intended and maintain its licenses, permits and facility standards; that Benuvia will perform its obligations
under the manufacturing services agreement; that required DEA and other regulatory authorizations will be obtained on a timely basis;
and that the Company will have access to sufficient financing to fund TIRC’s development activities. These assumptions may prove
incorrect. Risks and uncertainties that could cause actual results to differ materially include: that the anticipated benefits of the
investment in PsyLabs are not realized, or that PsyLabs does not apply the investment proceeds as intended; that the regulatory readiness
documentation completed by PsyLabs does not support, or is not accepted by regulatory authorities in connection with, any future regulatory
submission; that required board, shareholder, regulatory or stock exchange approvals are not obtained; that the previously announced share
exchange is not completed, or is completed on terms that differ from those announced; that the cash investment and the other arrangements
with PsyLabs are transactions between related parties, and that the terms agreed may differ from those that would be agreed between unrelated
parties; that the valuation used to price the cash investment is not indicative of realizable value, and that the Company’s interest
in PsyLabs, a privately held company, is illiquid; the reduction in the Company’s cash resources resulting from the investment;
that a definitive agreement between TIRC and PsyLabs is not concluded by November 30, 2026, or at all, or is concluded on terms that differ
from the term sheet; the Company’s dependence on PsyLabs, a related party, as exclusive supplier of ibogaine, and the risk of any
interruption or failure in that supply; that DEA import permits, quotas, registrations or other regulatory approvals are delayed, limited
or refused; that the Benuvia arrangements are terminated, not performed or do not proceed as intended; reliance on a single manufacturing
partner and manufacturing, analytical or supply-chain failures; the capital commitments, regulatory obligations and contractual liabilities
assumed by TIRC under the manufacturing services agreement and the Company’s ability to fund them; that U.S. funding or grant opportunities
are not available to TIRC or are not obtained; changes in law, regulation or enforcement priorities in the United States, Southern Africa
or elsewhere; the continuing status of ibogaine as a controlled substance; clinical, regulatory and approval risk; competition and market
adoption risk; financing risk; and the Company’s ability to maintain compliance with Nasdaq continued listing standards. This list
is not exhaustive. These risks should be considered together with the risk factors described in the “Risk Factors” section
of the Company’s Annual Report on Form 20-F for the fiscal year ended March 31, 2026 and in the Company’s other filings with
the U.S. Securities and Exchange Commission. 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. Readers should not place undue reliance on forward-looking statements, which speak only as of the date made. Except
as required by law, the Company undertakes no obligation to update such statements.
The Company makes no medical, treatment or health
benefit claims regarding its proposed products. The U.S. Food and Drug Administration, Health Canada and other regulatory authorities
have not approved ibogaine or the Company’s other neuroplastogen compounds for therapeutic use, and their safety and efficacy have
not been established through authorized clinical research. Rigorous scientific research and clinical trials are required. Any references
to ibogaine stock, inventory or doses are the Company’s best estimates only. References to GMP-compliant or cGMP mean production
in a facility designed, operated and controlled in accordance with applicable Good Manufacturing Practice standards, and do not themselves
constitute a representation of formal certification or approval by any regulatory authority unless expressly stated. Information regarding
Benuvia and its facility is based on information provided by Benuvia and has not been independently verified by the Company. References
to a planned clinical trial describe an activity under evaluation only; no trial has been commenced, and no regulatory application in
respect of it has been filed or accepted. This communication is not an offer to sell or a solicitation of an offer to buy any securities.
