Psyence BioMed secures exclusive US ibogaine licence for Texas unit

Psyence BioMed's Texas subsidiary has signed a binding term sheet granting exclusive US rights to PsyLabs' pharmaceutical-grade ibogaine, ahead of a planned development

Automated stainless steel machinery processes clear vials with blue caps on a conveyor belt in a brightly lit cleanroom.

Psyence Biomedical Ltd. (Nasdaq: PBM) has announced that its wholly-owned subsidiary, Texas Ibogaine Research Corporation (TIRC), has entered into a binding term sheet with PsyLabs Ltd. that would grant TIRC an exclusive licence, supply, and wholesale distribution arrangement for PsyLabs' pharmaceutical-grade ibogaine hydrochloride across the United States.

Under the proposed terms, PsyLabs would transfer to TIRC the rights to use its know-how, trade secrets, cultivation and extraction methods, analytical processes, standard operating procedures, and associated regulatory documentation, to the extent required for TIRC to develop, manufacture, and commercialise ibogaine drug candidates in the US market. PsyLabs retains all rights outside the United States. A definitive agreement must be signed by 30 November 2026; if that deadline passes without execution, the term sheet lapses.

Deal structure and financial terms

The financial terms are relatively modest at this stage of development. TIRC will pay development and regulatory milestone payments totalling up to approximately US$1.3 million for the first drug candidate, an annual exclusivity fee beginning on the first anniversary of the first FDA approval, and a low single-digit royalty on net sales of each candidate. A margin-sharing arrangement on any product resale by TIRC is also included. TIRC's exclusivity is conditional on sourcing all US ibogaine requirements from PsyLabs, and is expected to be subject to minimum development or sales performance thresholds to be set out in the definitive agreement.

Jody Aufrichtig, chief executive of both Psyence BioMed and TIRC, framed the arrangement as a positioning move: "Exclusivity matters. This term sheet is intended to give TIRC a defined position in U.S. ibogaine development, backed by access to PsyLabs' material, manufacturing know-how and technical documentation."

It is worth noting that PsyLabs is both a significant shareholder in Psyence BioMed and a company in which Psyence BioMed holds an ownership interest. That related-party structure means the agreed terms may differ from those that would emerge from an arm's-length negotiation, a risk the company itself flags in its forward-looking statements.

Regulatory and market context

Ibogaine sits in an unusual regulatory position in the United States. It remains a Schedule I controlled substance under federal law, meaning no clinical investigation can begin without navigating a complex Drug Enforcement Administration and FDA process. TIRC has acknowledged that significant manufacturing, nonclinical, and regulatory work is required before any clinical trial application can be filed.

The broader psychedelic therapeutics sector has attracted growing institutional interest since early-phase psilocybin studies demonstrated proof-of-concept in depression and addiction. Ibogaine, derived from the West African Tabernanthe iboga plant, has attracted particular attention for its reported single-dose interruption of opioid dependence, a profile that has drawn interest from the US Department of Veterans Affairs and several state-level programmes targeting veterans. The Stanford-led VETS study, published in 2024, provided observational data on ibogaine in veterans with traumatic brain injury and substance use disorders, and helped catalyse a wave of legislative and research activity.

Several academic centres and smaller clinical-stage companies are pursuing ibogaine research programmes, though the field remains early and fragmented. No ibogaine product has received FDA approval, and the agency has not issued specific guidance on development pathways for the compound. Psyence BioMed will need to navigate that undefined regulatory terrain before TIRC's exclusivity position translates into a clinical-stage asset.

The company said it will provide further updates as TIRC advances through manufacturing, regulatory, and clinical milestones, beginning with conclusion of the definitive agreement.