STOCK TITAN

Psyence BioMed CEO Letter Highlights Clinical Progress, Ethical Sourcing of Ibogaine, Strong Cash Position and Expanding Leadership in Longevity Science

Rhea-AI Impact
(High)
Rhea-AI Sentiment
(Neutral)
Tags

Psyence BioMed (Nasdaq: PBM) CEO Jody Aufrichtig summarized 2025 clinical and corporate milestones and outlined 2026 priorities. Key points include:

  • Initiation and dosing of first patients in a Phase IIb psilocybin-assisted psychotherapy trial for Adjustment Disorder in palliative care.
  • Multi-million-dollar follow-on investment in PsyLabs to secure GMP nature-derived psilocybin and ibogaine supply and a reported breakthrough in high-purity ibogaine production.
  • Regulatory momentum in Australia with a TGA public consultation that could enable supervised access via the Authorised Prescriber framework.
  • Company finished the year debt free with over USD $9 million cash and plans to accelerate enrollment, expand manufacturing, and pursue longevity-focused indications in 2026.

Loading...
Loading translation...

Positive

  • Dosed first patients in a Phase IIb psilocybin trial
  • Follow-on multi-million-dollar investment in PsyLabs secured GMP supply
  • Reported breakthrough in high-purity ibogaine production
  • Ended year debt free with over USD $9 million cash

Negative

  • None.

News Market Reaction

-5.92% 12.5x vol
26 alerts
-5.92% News Effect
+28.8% Peak Tracked
-31.5% Trough Tracked
-$199K Valuation Impact
$3M Market Cap
12.5x Rel. Volume

On the day this news was published, PBM declined 5.92%, reflecting a notable negative market reaction. Argus tracked a peak move of +28.8% during that session. Argus tracked a trough of -31.5% from its starting point during tracking. Our momentum scanner triggered 26 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $199K from the company's valuation, bringing the market cap to $3M at that time. Trading volume was exceptionally heavy at 12.5x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash reserves: USD $9 million
1 metrics
Cash reserves USD $9 million Year-end 2025 cash position noted in CEO letter

Market Reality Check

Price: $0.7700 Vol: Volume 101,318 is well be...
low vol
$0.7700 Last Close
Volume Volume 101,318 is well below the 20-day average of 1,186,087, suggesting limited pre-news positioning. low
Technical Shares at $1.69 are trading below the $4.34 200-day moving average after a prolonged drawdown.

Peers on Argus

PBM fell 3.98% while biotech peers like VRAX (-14.66%), PTIX (-5.71%) and SLRX (...

PBM fell 3.98% while biotech peers like VRAX (-14.66%), PTIX (-5.71%) and SLRX (-4.4%) were also down, indicating broader weakness but without confirmed sector-wide momentum.

Historical Context

5 past events · Latest: Nov 25 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Nov 25 Longevity program launch Positive +6.0% Announced psilocybin longevity research program with academic collaborators.
Nov 20 Ibogaine supply update Positive -38.4% Detailed sustainable, GMP-compliant iboga bark supply via PsyLabs.
Nov 12 Ibogaine operations Africa Positive -4.5% Investment in PsyLabs to build vertically integrated ibogaine operations.
Nov 06 Phase IIb trial progress Positive -7.1% Reported multiple patients dosed and expansion of Australian trial sites.
Nov 03 PsyLabs investment Positive -5.1% USD 3,500,000 follow-on PsyLabs investment securing GMP psychedelic supply.
Pattern Detected

Recent positive operational updates often coincided with negative price reactions, with one notable upside move on longevity research news.

Recent Company History

Over the last several weeks, Psyence BioMed has focused on psilocybin and ibogaine development, vertical integration, and financing. On Nov 3, it deepened its PsyLabs partnership with a USD 3,500,000 follow-on investment. Subsequent releases on the Phase IIb palliative-care trial, African ibogaine operations, and high‑grade ibogaine supply highlighted strategic and clinical execution, yet most drew negative price reactions. An exception came on Nov 25, when launch of a psilocybin longevity research program saw a 5.96% gain. The new CEO letter ties these strands together while emphasizing cash and longevity positioning.

Market Pulse Summary

The stock moved -5.9% in the session following this news. A negative reaction despite operational an...
Analysis

The stock moved -5.9% in the session following this news. A negative reaction despite operational and financial highlights fits a recent pattern where positive trial and supply-chain updates were followed by declines of up to several dozen percent. The CEO letter reiterates Phase IIb momentum, manufacturing integration and a cash position above USD $9 million, yet prior financings and dilution mechanisms described in recent prospectus filings have weighed on sentiment. That backdrop could have reinforced selling pressure after this update.

Key Terms

phase iib, psilocybin-assisted psychotherapy, gmp compliant, therapeutic goods administration, +4 more
8 terms
phase iib medical
"We recruited and dosed our first patients in a Phase IIb study."
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.
psilocybin-assisted psychotherapy medical
"Phase IIb clinical trial evaluating psilocybin-assisted psychotherapy for the treatment of Adjustment Disorder"
A treatment approach that combines a guided course of psychotherapy with supervised doses of psilocybin, the active compound found in certain mushrooms. Investors care because it pairs a novel drug with a structured service model—like pairing a new tool with professional training—so clinical trial results, regulatory approval, and the ability to scale trained providers directly affect potential market size, reimbursement and business risk.
gmp compliant technical
"securing GMP compliant nature-derived psilocybin and ibogaine supply for current and future programs."
GMP compliant means a manufacturer follows established practices and controls to make medicines, medical devices, or related products safely and consistently so each batch meets quality standards. Think of it as a strict recipe and factory checklist that reduces mistakes, contamination, and variability; for investors, GMP compliance lowers the risk of regulatory fines, product recalls, production shutdowns, and costly delays in approvals that can hurt revenue and reputation.
therapeutic goods administration regulatory
"the Australian Therapeutic Goods Administration’s (TGA) public consultation on psilocybin-assisted therapy"
The Therapeutic Goods Administration is the Australian government agency that assesses and regulates medicines, medical devices, vaccines and other health products for safety, quality and effectiveness before they can be marketed. For investors, a TGA decision is like a building inspector’s sign-off: approval opens access to the Australian market and can unlock sales and valuation, while delays, restrictions or safety warnings can limit revenue, force product changes or raise compliance and legal costs.
authorised prescriber framework regulatory
"enable supervised access through the Authorised Prescriber framework and expand the eligible prescriber group"
A government-run authorised prescriber framework lets approved clinicians or health organisations prescribe certain medicines that aren’t available through normal channels, often to defined patient groups or under special rules. For investors, it can speed patient access and early sales for niche or newly approved drugs while changing regulatory risk and uptake patterns—think of it as a licensed shortcut that can boost or limit a product’s early market reach.
palliative care medical
"Adjustment Disorder in palliative care. Multiple patients were dosed across several Australian clinical sites"
Palliative care is medical and supportive treatment focused on easing symptoms, pain and emotional stress for people with serious illness, rather than trying to cure the underlying disease. For investors it matters because demand for palliative services, drugs and devices, staffing and facility types affects health-care spending, reimbursement patterns and market growth—think of it as the comfort and support side of medicine that creates its own steady stream of products and services.
longevity science medical
"positioned itself at the forefront of the convergence between nature-derived psychedelic therapeutics and longevity science."
Longevity science studies biological processes that influence how long and how well people live, including research on aging, age-related diseases, and interventions that may slow, prevent, or reverse decline. For investors, it matters because breakthroughs can create new markets for medicines, diagnostics, devices and consumer products, shift long-term healthcare costs and demand, and offer companies high-growth opportunities similar to how fuel-efficiency advances reshaped the auto industry.
biomarkers medical
"biomarkers for cellular stress, inflammation, mitochondrial function, telomere length and behavioural healthspan indicators"
Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

AI-generated analysis. Not financial advice.

NEW YORK, Dec. 09, 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 released a year-end Letter from Chief Executive Officer Jody Aufrichtig, summarizing the Company’s 2025 achievements and outlining its strategic vision for 2026.

In his year-end letter to shareholders, Aufrichtig described 2025 as a “turning point” in which Psyence BioMed delivered clinical execution, strengthened global manufacturing ties, and positioned itself at the forefront of the convergence between nature-derived psychedelic therapeutics and longevity science.

“We recruited and dosed our first patients in a Phase IIb study. Through a further investment in PsyLabs we secured our psychedelic compound supply chain and became the only listed company with an investment in sustainable Ibogaine at source in Africa. We commenced studies in the exciting field of Longevity and ended the year debt free with over USD $9 million in cash reserves.”

Clinical Progress and Phase IIb Trial Momentum

Psyence BioMed advanced its Phase IIb clinical trial evaluating psilocybin-assisted psychotherapy for the treatment of Adjustment Disorder in palliative care. Multiple patients were dosed across several Australian clinical sites, supported by a partnership with Southern Star Research, one of Australia's leading clinical research organisations.

Advancing Nature-Derived Manufacturing and Supply Chain Leadership

The Company strengthened its vertical integration through a multi-million-dollar follow-on investment in PsyLabs, securing GMP compliant nature-derived psilocybin and ibogaine supply for current and future programs. Psyence BioMed also announced a breakthrough in high purity ibogaine production, reinforcing its manufacturing advantage.

Regulatory Tailwinds in Australia

Aufrichtig noted the importance of the Australian Therapeutic Goods Administration’s (TGA) public consultation on psilocybin-assisted therapy for existential distress in patients with life-limiting illness – a development closely aligned with the Company’s clinical trial. If approved, the amendment would enable supervised access through the Authorised Prescriber framework and expand the eligible prescriber group to include palliative-care specialists.

A Unique Position in Longevity Science

“Psyence BioMed is currently the only publicly listed psychedelics company investing meaningfully in longevity science,” said Aufrichtig. “Our focus is on the emotional, neurobiological, and existential dimensions of aging, and we believe psychedelic-assisted therapy will play a central role in improving healthspan – not just lifespan.”

2026 Outlook

The Company plans to accelerate enrollment in its Phase IIb clinical trial, expand its manufacturing footprint, pursue additional longevity-focused indications, and evaluate strategic partnership opportunities throughout 2026.

The full CEO Letter is available on the Company’s website at: www.psyencebiomed.com.

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.

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 current and future programs, and the expansion of the Company’s manufacturing capabilities. 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 secure the necessary regulatory and other consents required to expand its current and future programs, 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 clinical progress did Psyence BioMed (PBM) report on December 9, 2025?

PBM reported dosing its first patients in a Phase IIb psilocybin-assisted psychotherapy trial for Adjustment Disorder in palliative care.

How much cash did Psyence BioMed (PBM) report at year-end 2025 and what was its debt status?

The company said it ended the year debt free with over USD $9 million in cash reserves.

What supply-chain action did Psyence BioMed (PBM) take to secure psilocybin and ibogaine in 2025?

PBM made a multi-million-dollar follow-on investment in PsyLabs to secure GMP-compliant nature-derived psilocybin and ibogaine supply.

What regulatory development in Australia did Psyence BioMed (PBM) link to its clinical program?

PBM highlighted a TGA public consultation on psilocybin-assisted therapy that could enable supervised access via the Authorised Prescriber framework for palliative-care specialists.

What are Psyence BioMed's (PBM) strategic priorities for 2026?

The company plans to accelerate Phase IIb enrollment, expand manufacturing footprint, pursue longevity-focused indications, and evaluate strategic partnerships.
Psyence Biomedical Ltd.

NASDAQ:PBM

PBM Rankings

PBM Latest News

PBM Latest SEC Filings

PBM Stock Data

645.10k
249.31k
0.48%
44.69%
40.76%
Biotechnology
Healthcare
Link
Canada
Toronto