PharmaTher Holdings Ltd., a specialty life sciences company focused on unlocking the therapeutic potential of ketamine for neuropsychiatric disorders, today announced that it has entered into an Exclusive Evaluation and Option-to-License Agreement (the “Agreement”) with Oakwood Laboratories, LLC (“Oakwood”) for the development and commercialization of Oakwood’s patented long-acting injectable (“LAI”) ketamine program.

Fabio Chianelli, Chairman and CEO of PharmaTher, commented: “The long-acting ketamine program is a pivotal step in our strategy to build the most comprehensive ketamine franchise in neuropsychiatric disorders. We believe a convenient, durable LAI profile can expand ketamine’s clinical utility in treatment-resistant depression and major depressive disorders, improve adherence, and open new indications where steady exposure is critical. Importantly, this program leverages and extends the scientific, clinical, and regulatory foundation we have built with ketamine over the past several years, ensuring that our prior investments continue to compound while supporting a clear path to value-creating catalysts.”

Next-Generation Ketamine Franchise

The LAI ketamine program is designed to anchor a next-generation ketamine franchise that is clinically differentiated, indication-rich, and development-efficient. The key elements of this strategy aim to combine innovative delivery technology with high-value neuropsychiatric indications and a streamlined regulatory path to drive meaningful long-term value.

• Differentiated delivery: Leverages Oakwood’s proven sustained-release microsphere platform designed to enable subcutaneous or intramuscular dosing with controlled release over multiple weeks to months.
• Therapeutic breadth: Initial development to focus on neuropsychiatric indications, including treatment-resistant depression (TRD), major depressive disorders, and Parkinson’s disease-related levodopa-induced dyskinesia (LID).
• Regulatory efficiency: The LAI program is intended to pursue a 505(b)(2) pathway, leveraging established ketamine safety and efficacy literature where appropriate, with the goal of an efficient clinical development plan.

LAI Ketamine Market Opportunity in TRD

A differentiated LAI ketamine for TRD has the potential to redefine the standard of care compared with the currently approved intranasal option, SPRAVATO®, which require frequent in-clinic dosing and intensive monitoring. As of the third quarter of 2025, SPRAVATO® generated approximately $1.64 billion in trailing twelve-month (TTM) sales, and Johnson & Johnson projects annual sales between $3 billion and $3.5 billion by 2027 to 2028.

By enabling more convenient, less frequent dosing with controlled exposure over weeks to months, the LAI ketamine approach aims to improve safety by reducing acute adverse events (e.g., dissociation, blood pressure spikes), enhance patient adherence, reduce treatment burden for providers, and broaden access to ketamine-based therapy, while preserving the antidepressant effects associated with steady exposure that make ketamine so compelling. If successful, the LAI ketamine program could represent a next-generation TRD solution with significant commercial and strategic partnering appeal.

Near-Term Value-Creating Milestones

Over the next three months, PharmaTher plans to execute a focused set of value-driving milestones that are expected to rapidly advance the long-acting ketamine program toward clinical development. The Company intends to finalize CMC activities to support upcoming clinical studies and engaging with the U.S. FDA to align on a streamlined 505(b)(2) regulatory path, clinical study design, and safety package – steps that have the potential to significantly compress timelines to key inflection points. In parallel, PharmaTher will initially target treatment-resistant depression, while laying the groundwork for additional label expansion in neuropsychiatric disorders. Together, these initiatives are intended to create a clear catalyst-rich roadmap designed to unlock long-term value.

The Agreement grants PharmaTher an exclusive evaluation period and an exclusive option to obtain a global development and commercialization license for all fields of use to Oakwood’s patented LAI ketamine program over a 12-month period (the “Evaluation Term”). During this period, Oakwood will provide technical information and support to enable PharmaTher’s assessment of CMC, clinical, and regulatory strategy.

About Oakwood Laboratories

Oakwood Laboratories is a U.S. specialty pharmaceutical company focused on the development and manufacture of sustained release injectable products using Chroniject™, its polymer microsphere-based drug delivery technology platform. Oakwood provides end-to-end services from formulation through commercial scale manufacturing for novel and complex long-acting injectable (“LAI”) products.

For more information about Oakwood Labs, please contact:

Mark Ilhan
Director, Business Development
Tel: 1-440-703-3615
Email: milhan@oakwoodlabs.com