Corporate Update, August 2025
Psyence BioMed (NASDAQ: PBM) provided a comprehensive corporate update highlighting significant progress across multiple fronts. The company reported a strong cash position of $11.4 million with no outstanding debt and successfully regained Nasdaq compliance following a 1-for-7.97 reverse stock split.
Key developments include protocol amendments to expand patient eligibility in clinical trials, activation of three clinical sites, and advancement of their Alcohol Use Disorder (AUD) study. The company strengthened its strategic alliance with PsyLabs, achieving GMP-aligned Ibogaine Total Alkaloid extract production. PBM is positioning itself in the projected $3.3 billion psychedelics market by 2031, focusing on developing naturally derived psychedelic therapies for mental health conditions.
Psyence BioMed (NASDAQ: PBM) ha fornito un aggiornamento aziendale completo, evidenziando progressi significativi su pi霉 fronti. L'azienda ha riportato una solida posizione di cassa di 11,4 milioni di dollari senza debiti in essere e ha riconquistato con successo la conformit脿 al Nasdaq dopo uno frazionamento azionario inverso di 1 per 7,97.
Tra gli sviluppi chiave vi sono modifiche ai protocolli per ampliare l'idoneit脿 dei pazienti negli studi clinici, l'attivazione di tre siti clinici e l'avanzamento dello studio sull'Alcohol Use Disorder (AUD). L'azienda ha rafforzato la sua alleanza strategica con PsyLabs, raggiungendo la produzione di estratto di alcaloidi totali di Ibogaine conforme agli standard GMP. PBM si sta posizionando nel mercato dei psichedelici previsto a 3,3 miliardi di dollari entro il 2031, concentrandosi sullo sviluppo di terapie psichedeliche naturali per disturbi mentali.
Psyence BioMed (NASDAQ: PBM) proporcion贸 una actualizaci贸n corporativa completa destacando avances significativos en m煤ltiples 谩reas. La empresa report贸 una s贸lida posici贸n de efectivo de 11,4 millones de d贸lares sin deuda pendiente y recuper贸 con 茅xito el cumplimiento de Nasdaq tras una divisi贸n inversa de acciones de 1 por 7,97.
Los desarrollos clave incluyen enmiendas al protocolo para ampliar la elegibilidad de los pacientes en ensayos cl铆nicos, la activaci贸n de tres sitios cl铆nicos y el avance de su estudio sobre el Trastorno por Consumo de Alcohol (AUD). La compa帽铆a fortaleci贸 su alianza estrat茅gica con PsyLabs, logrando la producci贸n de extracto total de alcaloides de Iboga铆na alineado con GMP. PBM se est谩 posicionando en el mercado proyectado de psicod茅licos de 3,3 mil millones de d贸lares para 2031, enfoc谩ndose en el desarrollo de terapias psicod茅licas naturales para condiciones de salud mental.
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Psyence BioMed (NASDAQ : PBM) a fourni une mise 脿 jour compl猫te de l'entreprise soulignant des progr猫s significatifs sur plusieurs fronts. La soci茅t茅 a annonc茅 une solide tr茅sorerie de 11,4 millions de dollars sans dettes en cours et a r茅ussi 脿 retrouver sa conformit茅 au Nasdaq apr猫s une division invers茅e d'actions de 1 pour 7,97.
Les d茅veloppements cl茅s incluent des modifications de protocole pour 茅largir l'茅ligibilit茅 des patients aux essais cliniques, l'activation de trois sites cliniques et l'avancement de leur 茅tude sur le trouble li茅 脿 la consommation d'alcool (AUD). L'entreprise a renforc茅 son alliance strat茅gique avec PsyLabs, atteignant la production d'extrait total d'alcalo茂des d'iboga茂ne conforme aux normes GMP. PBM se positionne sur le march茅 des psych茅d茅liques estim茅 脿 3,3 milliards de dollars d'ici 2031, en se concentrant sur le d茅veloppement de th茅rapies psych茅d茅liques naturelles pour les troubles mentaux.
Psyence BioMed (NASDAQ: PBM) gab ein umfassendes Unternehmensupdate heraus, das bedeutende Fortschritte in mehreren Bereichen hervorhob. Das Unternehmen meldete eine starke Liquidit盲tsposition von 11,4 Millionen US-Dollar ohne ausstehende Schulden und erreichte nach einem Reverse-Split von 1 zu 7,97 erfolgreich die Nasdaq-Konformit盲t zur眉ck.
Zu den wichtigsten Entwicklungen z盲hlen Protokoll盲nderungen zur Erweiterung der Patientenberechtigung in klinischen Studien, die Aktivierung von drei klinischen Standorten und der Fortschritt ihrer Studie zur Alkoholgebrauchsst枚rung (AUD). Das Unternehmen st盲rkte seine strategische Allianz mit PsyLabs und erzielte die GMP-konforme Produktion von Ibogaine-Totalalkaloid-Extrakten. PBM positioniert sich im prognostizierten 3,3 Milliarden US-Dollar gro脽en Psychedelikamarkt bis 2031 und konzentriert sich auf die Entwicklung nat眉rlich gewonnener psychedelischer Therapien f眉r psychische Erkrankungen.
- Strong cash position of $11.4 million with no debt
- Successfully regained Nasdaq compliance
- Protocol amendment approval expanding patient eligibility pool
- Successful activation of three clinical sites
- Strategic partnership with PsyLabs achieving GMP-aligned Ibogaine production
- Right of First Refusal agreement for ibogaine-based products
- Required reverse stock split (1-for-7.97) to maintain Nasdaq listing
- Early-stage development status with no immediate revenue generation
- Regulatory uncertainties in psychedelics market
Insights
Psyence BioMed advances psychedelic therapy programs while maintaining strong financial position, with promising regulatory tailwinds supporting its multi-asset strategy.
Psyence BioMed's corporate update reveals significant operational progress across multiple development programs. The company has successfully expanded patient eligibility for its lead clinical trial by removing the terminal cancer diagnosis requirement, which should accelerate enrollment across three newly activated clinical sites. This protocol amendment represents a critical de-risking event, as patient recruitment challenges often delay clinical timelines.
The company is strategically diversifying beyond its initial indication with new programs in Alcohol Use Disorder (AUD) and through its PsyLabs partnership for Ibogaine development. This multi-asset approach is particularly valuable in the emerging psychedelics space where regulatory pathways remain uncertain. The Ibogaine collaboration appears especially promising given PsyLabs' recent production of GMP-aligned Total Alkaloid extract and the $50 million Texas investment into Ibogaine research, providing external validation.
Financially, PBM maintains a healthy balance sheet with $11.4 million cash and no debt, providing approximately 12-18 months of runway based on typical burn rates for early clinical-stage biotech companies. The company has also regained Nasdaq compliance following a 1-for-7.97 reverse split, removing a significant near-term overhang.
The broader regulatory environment shows increasing receptivity to psychedelic therapies, with Australia reimbursing MDMA therapy for veterans and projected market growth to $3.3 billion by 2031. These tailwinds support PBM's strategy as a multi-asset, naturally derived psychedelics platform. The most significant catalyst remains initial data from the expanded cancer-related distress trial, which will provide the first substantive efficacy signal for their lead program.
Psyence's diversified psychedelic pipeline shows promising clinical advancement with strong scientific foundation amid growing regulatory acceptance.
Psyence BioMed is pursuing a scientifically sophisticated approach to psychedelic drug development through multiple mechanistically distinct compounds. Their lead psilocybin program for cancer-related distress leverages psilocybin's well-documented effects on default mode network connectivity and 5-HT2A receptor agonism, mechanisms potentially beneficial for existential distress. The protocol amendment removing terminal diagnosis requirements significantly broadens the addressable patient population while maintaining clinical relevance.
Their expansion into Alcohol Use Disorder (AUD) is neurobiologically sound, as psilocybin can modulate glutamatergic transmission and potentially disrupt established addiction pathways. The establishment of a specialized steering committee with substance use disorder experts indicates appropriate focus on protocol design and endpoint selection, critical factors for regulatory success in addiction trials.
Most intriguing is their Ibogaine development program with PsyLabs. Ibogaine's unique pharmacological profile includes NMDA receptor antagonism, kappa-opioid receptor activity, and effects on dopaminergic pathways - mechanisms distinct from classical psychedelics like psilocybin. Achieving GMP-aligned Total Alkaloid extract production represents a significant technical achievement given ibogaine's complex chemistry and extraction challenges.
The company's intellectual property strategy appears to focus on extraction methodology and formulation rather than composition-of-matter patents (difficult with naturally derived compounds). Their cultivation and manufacturing capabilities provide defensibility in a field where quality control and consistency are paramount.
Recent scientific publications cited in the release, particularly regarding psilocybin's potential neuroprotective effects and ibogaine's application in traumatic brain injury, indicate growing mechanistic understanding supporting Psyence's therapeutic approach in a rapidly evolving field gaining scientific legitimacy.
NEW YORK, Aug. 04, 2025 (GLOBE NEWSWIRE) --
From Dr. Neil Maresky, CEO, Psyence BioMed (NASDAQ: PBM)
Dear Shareholders,
Thank you for your continued support as we advance our mission to develop safe, effective, and naturally derived psychedelic therapies for people living with serious mental health challenges.
Over the past few months, Psyence BioMed (PBM) has made meaningful progress across several fronts: clinical development, strategic positioning, regulatory compliance, and manufacturing stability. These developments reflect not only a shift in our momentum but also a broader evolution of the company 鈥� one I鈥檓 excited to share with you.
Clinical Progress & Trial Expansion
Psyence BioMed continues to advance its clinical program with key developments that set the stage for expanded patient access and accelerated enrollment:
- Protocol Amendment & Screening Update: A critical protocol amendment that removes the cancer diagnosis requirement to be terminal was submitted and approved by the Human Ethics Review Board (HREC). This change is expected to significantly broaden our eligible patient pool, future patients and increase the trial鈥檚 clinical relevance and impact.
- Site Activation: Three clinical sites have successfully completed qualification visits and all have been initiated (as of August 5th).
We are pleased to be executing this trial in partnership with Southern Star Research, a leading contract research organization with deep expertise in both oncology and mental health. With the service agreement finalized, full operational rollout is now underway 鈥� positioning us to initiate patient enrollment in the near term.
Our commitment to scientific leadership is anchored by our exceptional Scientific Advisory Board (SAB), which brings together globally recognized experts in neuroscience, psychiatry, and psychedelic medicine. The SAB plays a critical role in shaping our research agenda and guiding the clinical development of our psychedelic therapies.
In the coming weeks, we will host a dedicated webinar featuring our SAB to share deeper insights into our evolving clinical vision for natural psychedelic therapies 鈥� including their potential applications in treating PTSD, substance use disorders, and other complex mental health conditions. Stay tuned for more information.
Alcohol Use Disorder:
PBM has established a Steering Committee (SC) to guide the development of its early-phase study investigating the use of naturally sourced psilocybin for the treatment of Alcohol Use Disorder (AUD). The study is planned to be conducted in South Africa and the SC comprises three experts in substance and alcohol use disorders, including Professor Dan Stein from the University of Cape Town, who also serves on the Psyence BioMed SAB. The SC will provide input on protocol design, advise on key endpoints, and help identify the most appropriate patient population 鈥� particularly in light of cultural nuances surrounding alcohol use.
Ibogaine: Strengthening Our Strategic Alliance with PsyLabs
Psyence BioMed鈥檚 partnership with PsyLabs continues to evolve as a cornerstone of our Ibogaine program. Ibogaine is an incredibly exciting molecule, with powerful psychoactive properties that not only alters perception, mood, and affect, but also interrupts addictive behaviors. Together, we are advancing several key initiatives that reinforce our position as a global leader in the development of naturally derived psychedelic therapies. Last week we that PsyLabs has successfully produced a GMP-aligned Ibogaine Total Alkaloid extract 鈥� a milestone that reflects the impact of our ongoing investment and collaboration in this partnership.
Our collaboration is focused on:
- Elevating Production Standards: Work is underway to achieve GMP-grade ibogaine manufacturing with exceptional purity 鈥� a rare and highly sought-after capability as the psychedelic sector moves toward increased regulatory rigor.
- Expanding Global Footprint: As the only publicly listed psychedelics company with a sustainable source of ibogaine in Africa, we are uniquely positioned to lead in ethical, scalable, and locally rooted production 鈥� offering a distinct competitive advantage in the global psychedelics market.
- Advancing Ethical Sourcing: Strategic relationships are being developed to support responsible, community-conscious harvesting of iboga, ensuring long-term supply chain integrity.
This partnership is more than operational; it is foundational to our long-term strategy. Our licensing portfolio 鈥� including a Right of First Refusal (ROFR) agreement with PsyLabs for the licensing of ibogaine-based products and associated intellectual property 鈥� reinforces our ownership stake in this emerging therapeutic category and will be prominently featured in our upcoming investor communications. All of this work is happening in parallel with global momentum, including recent legislation in Texas, where the state has committed to explore its potential in treating veterans with traumatic brain injury and PTSD. This is a powerful validation of the compound鈥檚 promise.
For additional insight, I encourage shareholders to read where PsyLabs CEO, Tony Budden, outlines a compelling case for nature-derived psychedelics in mainstream medicine. His perspective reflects the broader mission of our collaboration 鈥� one rooted in science, patient-centered care, and scalable infrastructure.
Strong Financial Position & Nasdaq Compliance
We are pleased to report that the Company has a strong cash balance of
Regaining compliance with Nasdaq listing requirements marked an important milestone in our continued growth and credibility as a public company. Psyence BioMed successfully regained full compliance with all applicable Nasdaq continued listing requirements in June 2025.
As part of our compliance strategy, shareholders approved a share consolidation (reverse stock split) at a Special Meeting of Stockholders held on April 16, 2025. The proposal authorized a reverse split at a ratio of up to 1-for-50, or a lesser amount at the discretion of the Company鈥檚 Board of Directors. The Board subsequently approved a final ratio of 1-for-7.97 to comply with Nasdaq鈥檚 minimum bid price requirement under Listing Rule 5550(a)(2).
Commitment to Long-Term Value
At Psyence BioMed, our commitment to long-term value is grounded in a clear strategic vision: to build a resilient, multi-asset biotechnology company that leads in the development of nature-derived psychedelic therapies. We are focused on advancing clinically validated, scalable solutions for complex mental health conditions where current treatments fall short.
Our leadership team brings a unique blend of global expertise in clinical research, pharmaceutical manufacturing, regulatory strategy, and commercialization. This operational strength positions us to efficiently advance drug candidates from early development through to clinical trials and, potentially, toward market access.
We are a multi-asset company with an integrated platform that includes proprietary IP, advanced laboratory infrastructure, CMC expertise to enhance the efficiency and consistency of psychedelic compound extraction, and GMP-compliant manufacturing capabilities. This foundation positions us to pursue a range of opportunities across the psychedelics landscape. Each asset in our pipeline is strategically selected and developed with a clear focus on medical relevance, regulatory alignment, and long-term commercial potential.
As the psychedelic sector moves toward greater scientific and regulatory maturity, investor attention is shifting to companies with well-defined therapeutic targets and disciplined execution. With forecasts projecting a by 2031, Psyence BioMed is positioned to deliver differentiated clinical outcomes and enduring shareholder value.
Our long-term value creation strategy is built on three pillars: scientific rigor, strategic focus, and operational excellence. We are building not just for momentum 鈥� but for meaningful, measurable impact in the years ahead.
Warm regards,
Dr. Neil Maresky
Chief Executive Officer
Psyence BioMed (NASDAQ: PBM)
Psychedelic Medicine & Policy Updates
Slowing aging: Psilocybin helps extend life span in human cells by over
Scientists have reported evidence psilocybin may help protect the body from age-related diseases, such as neurodegeneration, heart disease, and cancer through several health-protecting qualities, via a mouse model. Read .
Texas Will Invest
The state鈥檚 new law marks one of the largest government investments into psychedelics to date, with advocates citing the drug鈥檚 potential to help veterans with traumatic brain injury and PTSD. Read .
Drugs reduced anxiety and PTSD in Nova festival survivors, study finds
Study finds survivors of the Nova music festival massacre who consumed classic psychedelics in the hours before the massacre reported significantly lower anxiety and PTSD symptoms,聽offering real-world insights into potential therapeutic applications. Listen .
Promising' psychedelic therapy aims to help cancer patients
More than
Psychedelics may boost mental health by dampening inflammation
Psychedelic drugs like MDMA and psilocybin may help treat depression, anxiety and other mental health conditions by reducing the number of inflammatory cells around the brain. .
Psychedelics Rewire Brain-Immune Circuits
New research reveals that psychedelics like psilocybin do more than alter brain activity 鈥� they reshape how the brain and immune system communicate. Scientists identified a pathway where chronic stress disrupts amygdala signaling, triggering immune responses that increase fear and anxiety. .
Australia: Government Reimburses MDMA Therapy for Veterans
Australia鈥檚 Department of Veterans鈥� Affairs (DVA) has begun reimbursing MDMA-assisted therapy for veterans with PTSD. This initiative utilizes MDMA capsules supplied by Optimi Health and administered through Mind Medicine Australia鈥檚 Authorized Prescriber network. The move signifies a significant endorsement of psychedelic-assisted therapies at the governmental level. .
Psilocybin Shows Promise in Parkinson鈥檚 Disease Treatment
A pilot study conducted by the University of California, San Francisco, indicates that psilocybin may alleviate symptoms of Parkinson鈥檚 disease. Participants reported improvements in mood, cognition, and motor function, with benefits lasting for weeks post-treatment. The study also suggests psilocybin may reduce brain inflammation and enhance neuroplasticity. .
Global Psilocybin Therapy Market Projected to Reach
According to a report by Forbes, the global market for psilocybin-assisted therapy is projected to grow from
FDA Releases Draft Guidance on AI in Drug Development
The U.S. Food and Drug Administration (FDA) has issued draft guidance outlining considerations for the use of artificial intelligence (AI) in drug and biological product development. The guidance proposes a risk-based framework to assess the credibility of AI models used in regulatory decision-making processes. .
U.S. Surgeon General Nominee Supports Psychedelic Therapy
Dr. Casey Means, nominated for U.S. Surgeon General, has publicly endorsed the use of psychedelic therapies, including psilocybin-assisted treatment. Her stance reflects a growing interest in alternative mental health treatments at the highest levels of government. .
Republican Lawmaker Advocates for Psychedelic Therapy
Congressman Morgan Luttrell (R-Texas), a former Navy SEAL, has become a vocal advocate for psychedelic therapy following his personal experience with ibogaine and DMT treatments for PTSD. His support highlights a bipartisan shift towards considering psychedelic-assisted therapies for mental health conditions, particularly among veterans. .
Learn more at聽聽and on聽
Contact Information for Psyence Biomedical Ltd.
贰尘补颈濒:听
Media Inquiries:聽
General Information:聽
Phone: +1聽416-477-1708
Investor Contact:
Michael Kydd
Investor Relations Advisor聽
Forward Looking Statements
This communication contains 鈥渇orward-looking statements鈥� 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 鈥渨ill likely result,鈥� 鈥渁re expected to,鈥� 鈥渨ill continue,鈥� 鈥渋s anticipated,鈥� 鈥渆stimated,鈥� 鈥渂elieve,鈥� 鈥渋ntend,鈥� 鈥減lan,鈥� 鈥減rojection,鈥� 鈥渙utlook鈥� or words of similar meaning.
Forward-looking statements in this communication include statements regarding the progress of the Phase IIb clinical trial, preparations for the Company鈥檚 second development indication, the growth of the psychedelic mushroom market and the Company's growth potential. 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, topline data from this trial will be positive, there will be no obstacles to the launch of the Company's second indication, 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鈥檚 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鈥檚 business and changes in Psyence BioMed鈥檚 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 鈥淩isk Factors鈥� section of the Company鈥檚 final prospectus (File No. 333-284444) filed with the Securities and Exchange Commission (the 鈥淪EC鈥�) on January 24, 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鈥檚 performance and operations.
FAQ
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