Psyence Biomedical is the world’s first life science biotechnology company traded on the Nasdaq.
The name Psyence combines the words psychedelics and science, a testament to the company’s evidence-based approach to innovation and its focus is on the development of safe and effective, natural, botanical psilocybin-based psychedelic medicines for the treatment of a broad range of mental health disorders.
DRUG PROGRAMS TARGET: Palliative care. Adjustment Disorder/Undisclosed CNS indication
SUBSTANCE FOCUS: Psilocybin.
OWNERSHIP:
50% – Goodmind which brings a range of functional mushroom products to market through the production, commercialization and the sales of its products.
11.13%+ – PsyLabsis an international supplier of pharmaceutical grade psychoactive compounds.
PsyLabs also owns a 30.05% stake in Psyence Biomedical.
NEWS & PARTNERSHIPS:
2022
The company entered into a royalty-bearing, worldwide commercial licensing agreement with Filament Health which gives Psyence Biomed the worldwide right to commercialize Filament’s natural psilocybin drug candidate, PEX010 within palliative care. The agreement provides exclusivity in the UK, the US and the EU within palliative care and Filament is designated as exclusive supplier of drug products within this context. Filament will receive milestone payments worth up to 3 million CAD over the course of Psyence Biomedical’s clinical development and marketing authorizations as well as a percentage of future net sales in the low double digits.
2024
Psyence Biomed entered into a partnership with Fluence, a global leader in professional education and training for psychedelic therapy research and iNGENū to support an upcoming Phase llb clinical trial where the Filament Health’s psilocybin drug, PEX010 will be tested for its efficacy.
The company signed a conditional binding term sheet for the acquisition of psilocybin-based drug developer Clairvoyant. The company later decided to not acquire Clairvoyant.
The company acquired an 11.13% stake in PsyLabs from Psyence Group.
2025
The company announced future evaluation of GMP nature-derived psilocybin as a potential treatment for Substance Use Disorders with a focus on Alcohol Use Disorder. The company signed an agreement with Psylabs to be its exclusive supplier of highly purified psilocybin extract, exclusively for these indications.
The company exported nature-derived psilocybin to Fluence in Australia for the clinical trials of PEX010 which the company does in partnership with Fluence and iNGENū.
The company signed a non-binding agreement with Optimi Health to be its exclusive supplier of GMP nature-derived psilocybin extract for future Phase III trials as well as for future commercialization.
Optimi will provide comprehensive chemistry, manufacturing and control support for regulatory submissions related to the trials and any future investigational new drug applications and Psyence Biomedical will obtain exclusive rights to Optimi’s drug candidate for FDA-approved use in palliative care.
The commercial licensing agreement with Filament Health was terminated by both parties.
The company and PsyLabs evolved their relationship into a deeply integrated strategic partnership centered on the development and production of nature-derived psychedelic therapies and PsyLabs holds a 30.05% equity stake in the company. Operationally, the partnership is currently focused on Psyence Biomedical’s Phase IIb clinical trial, which is testing a natural psilocybin formulation called NPX-5. This study is specifically looking at whether this treatment can help reduce anxiety and depression in cancer patients who are struggling to adjust to their diagnosis while in palliative care. Beyond this psilocybin work, the partnership has also expanded to include the development and manufacturing of pharmaceutical-grade ibogaine, positioning the company as a leader in creating a reliable, high-quality supply of these nature-derived psychedelic medicines for global research.
The company entered into a binding agreement with Optimi Health to secure Optimi as an exclusive supplier of GMP-certified, nature-derived psilocybin for Psyence’s clinical trials and commercial initiatives in Palliative Care.
The company finalized a service agreement with Southern Star Research, an Australian contract research organization, to support and expand its ongoing Phase IIb clinical trial. The trial is focused on psilocybin-assisted therapy for adjustment disorder in cancer patients, a condition that affects millions globally and currently has no FDA-approved treatments.
The company announced a $500,000 follow-on investment in PsyLabs which helped them obtain a right of first refusal for the global supply of pharmaceutical-grade ibogaine from PsyLabs. This agreement gives the company the opportunity to secure exclusive access to ibogaine for research into substance use disorders, including alcohol use disorder, further expanding its therapeutic pipeline.
The company later announced a further $3.5 million follow-on investment in PsyLabs.
The company announced a new psilocybin longevity research program claiming it to be the first publicly listed company actively studying psilocybin’s potential effects on aging-related biomarkers. The preclinical work will examine markers such as cellular stress, inflammation, mitochondrial function, and behavioral indicators associated with aging.
The company received formal approval from the Bellberry Human Research Ethics Committee to utilize PsyLabs’ psilocybin product, known as NPX5, in its ongoing Phase IIb clinical trial. This trial is investigating the efficacy of psilocybin-assisted psychotherapy for patients suffering from Adjustment Disorder related to cancer. The approval covers all current clinical sites, including the Empax Centre, Mind Medicine Australia Clinic and Paratus Clinical Research, with plans underway to expand to additional locations to accelerate recruitment.
2026
The company became the first Nasdaq-listed company to produce GMP-compliant, high-purity ibogaine hydrochloride.
The company entered into a put option agreement with PsyLabs where PsyLabs holds the right to require Psyence BioMed to make an equity investment through a share-for-share exchange at fair market value. This is done in order to secure a supply a long-term, reliable supply of pharmaceutical-grade psychedelic compounds while establishing a pathway for potential future equity ownership. Soon after the agreement, PsyLabs executed on it and Psyence BioMed gave 1,146,159 of its shares to PsyLabs and in return Psyence BioMed was given shares of PsyLabs for a total value of $5 M.
The company successfully exported its pharmaceutical-grade psilocybin product, NPX-5, to Australia to support its ongoing Phase IIb clinical trial. The NPX-5 capsules are being used in a multi-center study evaluating the efficacy of nature-derived psilocybin for treating Adjustment Disorder in patients facing a palliative cancer diagnosis, with sites currently active in Melbourne and Perth.
The company accelerated its clinical trial network from 3 to 5 sites adding Ramsay Health Care and NeuroCentrix.
The company positioned itself as the world’s only licensed supplier of pharmaceutical-grade, source-derived ibogaine.
The company launched a strategic engagement initiative in the United States to advocate for and support the advancement of ibogaine research.