Psyence BioMed Announces Approval for Use of PsyLabs’ Psilocybin Product in Phase IIb Clinical Trial

Rhea-AI Summary

Psyence BioMed (Nasdaq: PBM) announced Bellberry Human Research Ethics Committee approval to use PsyLabs’ psilocybin product (NPX5) in its ongoing Phase IIb trial for adjustment disorder in cancer patients. The amendment covers all participating sites including Empax Centre, Mind Medicine Australia Clinic, and Paratus Clinical Research in Melbourne, and reflects updated protocol, investigator brochure, and participant materials.

The Phase IIb trial will enroll approximately 87 participants, test two therapeutic doses versus a low-dose comparator with structured psychotherapy, and is tracking to deliver top-line results in 2026. The company reports approximately USD $9.5 million in cash and no debt and emphasizes strengthened vertical integration, GMP manufacturing, and supply-chain control via its investment in PsyLabs.

Positive

• HREC approval granted for PsyLabs psilocybin use
• Phase IIb enrollment ~87 participants with two therapeutic doses
• Top-line results in 2026 on current timeline
• Cash balance ~$9.5M and no debt
• GMP manufacturing and vertical integration with PsyLabs

Negative

• None.

Key Figures

Cash reserves USD $9.5 million Company cash reserves cited in trial approval release

Phase IIb enrollment target 87 participants Psilocybin-assisted psychotherapy Phase IIb trial

Net loss $1,992,732 Six months ended September 30, 2025 (424B3 filing)

Prior-year net income $2,960,655 Six months ended September 30, 2024 (424B3 filing)

Cash and restricted cash $7,197,176 As of six months ended September 30, 2025 (424B3 filing)

Working capital $6,686,387 As of six months ended September 30, 2025 (424B3 filing)

Investment in Psyence Labs $4,000,000 Equity investment disclosed in 424B3 filing

Fair value of Psyence Labs stake $5,172,000 Valuation and unrealized gain in 424B3 filing

Market Reality Check

$1.46 Last Close

Volume Volume 125,974 is far below the 20-day average of 2,054,822 (about 6% of typical activity). low

Technical Price $1.46 is trading below the 200-day moving average at $4.03, reflecting a longer-term downtrend.

Peers on Argus

PBM fell 1.35% while biotech peers showed mixed moves: SCNI -11.9%, PTIX -8.51%, VRAX -3.86%, GTBP -0.89%, and SLRX +4.86%, suggesting stock-specific factors.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 09	CEO letter update	Positive	-5.9%	CEO outlined 2025 milestones, cash strength, and 2026 priorities.
Nov 25	Longevity program launch	Positive	+6.0%	Launched psilocybin longevity research with academic collaborators and biomarker focus.
Nov 20	Ibogaine supply secured	Positive	-38.4%	Secured GMP iboga bark supply and began processing into ibogaine products.
Nov 12	PsyLabs investment	Positive	-4.5%	Strategic PsyLabs investment to establish ibogaine operations and EU GMP facility.
Nov 06	Phase IIb dosing update	Positive	-7.1%	Reported multiple patients dosed and site expansion in Phase IIb study.

Pattern Detected

Recent news has generally been positive in tone but followed by negative price reactions, with 4 of 5 events showing divergence.

Recent Company History

Over recent months, Psyence BioMed has emphasized vertical integration and clinical progress. Updates included dosing patients and expanding sites in its 87‑patient Phase IIb trial, securing a 50 kg iboga bark shipment for GMP ibogaine, a strategic PsyLabs investment, and a CEO letter highlighting being debt free with over USD $9 million cash. Despite these advancements, several announcements were followed by share price declines, making today’s clinical product approval part of a broader execution story amid weak market sentiment.

Market Pulse Summary

The stock is dropping -13.8% following this news. A negative reaction despite operational progress fits a pattern where prior positive updates were followed by weakness, including earlier Phase IIb and ibogaine announcements. The news confirms ethics approval for PsyLabs’ GMP psilocybin and continued enrollment toward 87 participants, supported by cash of roughly $9.5 million. Still, past filings highlight ongoing net losses, which could keep sentiment fragile and make drawdowns more severe.

Key Terms

psilocybin medical

"approved the use of PsyLabs’ psilocybin product (NPX5) in the Company’s ongoing Phase IIb"

A naturally occurring psychedelic compound found in certain mushrooms that alters perception, mood and consciousness; when taken the body converts it into an active substance that produces short-term hallucinogenic effects. Investors watch psilocybin because researchers and drug developers are exploring it as a potential treatment for depression, PTSD and other mental health conditions, so clinical trial results, regulatory decisions and changing stigma can create large commercial opportunities or risks—think of it as a new drug category whose approval pathway can drive big swings in company value.

phase iib medical

"psilocybin moves into Phase IIb trialsNEW YORK, Dec. 19, 2025 -- Psyence Biomedical"

Phase IIb is a mid-stage clinical trial that tests whether an experimental treatment works and what dose is best by studying it in a larger group of patients than early tests. For investors, Phase IIb results are important because they substantially reduce uncertainty about a drug’s effectiveness and safety, and positive or negative outcomes often drive company valuation, partnership interest, and the likelihood of advancing to the large, costly Phase III trials.

gmp technical

"best-in-class GMP compliant psilocybin product on the market – developed entirely"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

double-blind medical

"psilocybin as the investigational product used in the double-blind, randomized, low-dose"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

randomized medical

"investigational product used in the double-blind, randomized, low-dose comparator-controlled"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

clinical trial medical

"psilocybin product (NPX5) in the Company’s ongoing Phase IIb clinical trial evaluating"

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

AI-generated analysis. Not financial advice.

With approximately $9.5 million in cash reserves and no debt, the Company is ready to leverage strengthened vertical integration as clinical-grade psilocybin moves into Phase IIb trials

NEW YORK, Dec. 19, 2025 (GLOBE NEWSWIRE) -- 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 that the Bellberry Human Research Ethics Committee (HREC) has formally approved the use of PsyLabs’ psilocybin product (NPX5) in the Company’s ongoing Phase IIb clinical trial evaluating psilocybin-assisted psychotherapy for Adjustment Disorder in patients with cancer.

This approval highlights the Company’s distinct evolution toward becoming one of the few vertically integrated psychedelic enterprises with multiple assets across drug and clinical development. With an investment in Psylabs, significant clinical assets and a strong cash reserves balance of approximately USD $9.5 million, the Company is now positioned as one of the most differentiated companies in the emerging global psychedelics sector with the cash balance to execute on its strategy.

Approval was granted following review of updated clinical documentation, including the amended protocol, investigator brochure, and participant information materials, all reflecting the transition to PsyLabs’ psilocybin formulation. The authorization applies to all participating study sites, including Empax Centre, Mind Medicine Australia Clinic, and Paratus Clinical Research in Melbourne. The Company has also begun planning the activation of additional clinical sites to further accelerate patient recruitment and advance the Phase IIb program.

“We are extremely pleased that PsyLabs’ nature-derived psilocybin product has now been formally approved for use in our Phase IIb study,” said Jody Aufrichtig, CEO of Psyence BioMed. “This is a pivotal advancement in our clinical program and a defining step in our long-term strategy. By incorporating what we believe is the best-in-class GMP compliant psilocybin product on the market – developed entirely within our vertically integrated structure – we are reinforcing supply-chain control, manufacturing excellence, and scalable production capacity that will drive future commercial success.”

The approved amendment confirms PsyLabs’ psilocybin as the investigational product used in the double-blind, randomized, low-dose comparator-controlled clinical trial. This positions PsyLabs as a key contributor to Psyence BioMed’s clinical-stage infrastructure, reinforcing the Company’s ability to oversee the development pathway from ethical raw material sourcing through formulation, clinical evaluation, and eventual commercialisation.

“Having our psilocybin formulation cleared for clinical use is a transformative moment for PsyLabs,” said Tony Budden, CEO of PsyLabs. “It reflects years of scientific, regulatory, and manufacturing preparation to ensure our product meets the highest standards for purity, repeatability, and patient safety. We are proud to support Psyence BioMed’s mission to bring safe, nature-derived psychedelic therapies into regulated medicine.”

The Phase IIb study will enroll approximately 87 participants and evaluate two therapeutic doses of psilocybin against a low-dose comparator, combined with structured psychotherapy. With multiple sites activated and recruitment underway, the study remains on track to deliver top-line results in 2026.

This approval further strengthens Psyence BioMed’s competitive positioning as one of the few companies globally with access to ethically sourced botanical raw materials, GMP manufacturing capabilities, and a fully aligned clinical development network.

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, particularly in palliative care. The company is 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.

About PsyLabs

PsyLabs is a psychedelic Active Pharmaceutical Ingredient (API) development company, federally licensed to cultivate, extract, and export psilocybin mushrooms and other psychedelic compounds including psilocin, mescaline, ibogaine, and dimethyltryptamine (DMT) to legal medical and research markets. The company has successfully exported psilocybin products to Canada, the UK, Portugal, and Slovenia, and supplies purified extracts to its UK-based CMO partner.

PsyLabs operates from an ISO 22000-certified facility audited by the British Standards Institution, ensuring the highest standards of safety and traceability. With a focus on natural compound purification, regulatory support, and global distribution, PsyLabs is expanding its product pipeline to include ibogaine and other next-generation psychedelics.

www.psylabs.life

Contact Information for Psyence Biomedical Ltd.

Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +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 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 progress of the Phase IIb clinical trial, the expansion of the Company’s manufacturing capabilities, the future commercial success of the Company’s vertically integrated structure, and the estimated date of delivery of top-line results. These forward-looking statements are based on a number of assumptions, including the assumption that there will be no delays in the execution of the Phase IIb clinical trial implementation schedule, the Company will retain all such regulatory and other consents required to complete the trial , and that the demand for psychedelic-assisted therapy will continue to increase. There can be no assurance that the Company will continue to maintain compliance with Nasdaq’s continued listing requirements. 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) delays in the execution of the Phase IIb trial; (ii) the ability of Psyence BioMed to maintain the listing of its common shares and warrants on Nasdaq; (iii) volatility in the price of the securities of Psyence BioMed due to a variety of factors, including the recent share consolidation, 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 Company’s final prospectus (File No. 333-289285) 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 on December 19, 2025?

Bellberry HREC approved use of PsyLabs’ NPX5 psilocybin in PBM’s Phase IIb adjustment disorder trial.

How many participants will PBM’s Phase IIb trial enroll and when are results expected?

The study will enroll approximately 87 participants and is on track for top-line results in 2026.

Which clinical sites are authorized to use PsyLabs psilocybin in PBM’s trial?

Authorization applies to Empax Centre, Mind Medicine Australia Clinic, and Paratus Clinical Research in Melbourne.

What is PBM’s reported cash position after the announcement?

PBM reported approximately USD $9.5 million in cash reserves and no debt.

What formulation will be used as the investigational product in PBM’s Phase IIb study?

The investigational product is PsyLabs’ nature-derived psilocybin (NPX5), approved in the trial amendment.