Psyence Biomedical Ltd. has entered into a binding term sheet giving its Texas subsidiary exclusive U.S. development, supply and wholesale distribution rights for PsyLabs’ pharmaceutical-grade ibogaine. The agreement, signed September 25 and disclosed in a September 28 Form 6-K filing with the U.S. Securities and Exchange Commission, covers PsyLabs’ ibogaine hydrochloride know-how and related manufacturing and regulatory information.
Under the agreement, Texas Ibogaine Research Corporation, or TIRC, will receive exclusive U.S. rights to PsyLabs’ know-how, trade secrets, cultivation, extraction and processing methods, analytical methods, specifications, standard operating procedures, batch records and technical and regulatory information needed to develop, manufacture and commercialize ibogaine drug candidates in the United States. PsyLabs will remain the exclusive supplier to TIRC, while TIRC will serve as PsyLabs’ exclusive U.S. wholesaler and distributor.
The arrangement covers the United States, including Puerto Rico and other U.S. territories, while PsyLabs retains its rights outside the country. TIRC can use the licensed intellectual property and supplied ibogaine to develop and commercialize drug candidates in the U.S., and it can also purchase the product for resale to permitted third parties through lawful channels.
The financial terms include development and regulatory milestone payments of up to approximately $1.3 million for the first drug candidate. TIRC will also owe an annual exclusivity fee beginning on the first anniversary of the first U.S. Food and Drug Administration approval, with that fee creditable against royalties. PsyLabs is additionally entitled to a low-single-digit percentage royalty on net sales of each drug candidate, along with a margin-sharing arrangement for product resold by TIRC.
TIRC’s exclusive status is subject to conditions, including an obligation to source its U.S. ibogaine requirements exclusively from PsyLabs, except in specified supply-failure circumstances. The parties also expect the definitive agreement to establish minimum U.S. development and/or sales performance thresholds. If PsyLabs cannot meet specified supply or regulatory requirements, the term sheet provides TIRC with step-in rights that can allow it to qualify alternative suppliers or self-manufacture during a supply failure.
The transaction is a related-party arrangement. PsyLabs is a significant shareholder of Psyence BioMed, Psyence BioMed holds an ownership interest in PsyLabs, and certain members of Psyence BioMed’s management are affiliates of PsyLabs and have financial interests in the company. The SEC filing therefore identifies the term sheet as a related-party transaction.
The term sheet is binding but is intended to be replaced by a definitive agreement. Psyence BioMed and PsyLabs have agreed to conclude that agreement by November 30, 2026, unless the deadline is extended in writing. If a definitive agreement is not signed by the deadline, the term sheet will automatically lapse, subject to obligations that have already accrued or expressly survive.
The new agreement expands on Psyence BioMed’s efforts to establish a U.S. ibogaine development platform. Earlier in September, the company established TIRC as a dedicated Texas subsidiary intended to coordinate U.S. regulatory, clinical and development activities involving pharmaceutical-grade ibogaine.
Psyence BioMed has also been building its relationship with PsyLabs through a previously announced investment of up to $5 million and a value-matched share exchange. The company said that investment was intended to support scientific development and pharmaceutical-grade manufacturing capabilities associated with its planned U.S. ibogaine program.
The company is evaluating a potential ibogaine clinical trial in Texas, but the program remains subject to regulatory review, authorization, funding, site selection and other requirements. Psyence BioMed has stated that ibogaine has not been approved by the FDA or other relevant regulators for therapeutic use, and that its safety and efficacy have not been established through authorized clinical research.
The latest agreement therefore establishes contractual rights and commercial arrangements rather than an approved ibogaine medicine or an active U.S. clinical program. Its financial obligations and exclusivity provisions remain tied to future development, regulatory and commercial milestones and the completion of the definitive agreement.
