PharmaTher Advances Strategy to Build Next-Generation Ketamine Franchise for Neuropsychiatric Disorders; Secures Exclusive Rights to Evaluate and License Patented Long-Acting Ketamine Program

Rhea-AI Summary

PharmaTher (OTCQB: PHRRF) entered an Exclusive Evaluation and Option-to-License Agreement with Oakwood Laboratories to evaluate and potentially license a patented long-acting injectable (LAI) ketamine program on a 12-month exclusive evaluation term dated November 17, 2025.

The LAI program uses Oakwood's sustained-release microsphere platform for subcutaneous or intramuscular dosing, targets treatment-resistant depression (TRD), major depressive disorders and Parkinson's disease-related LID, and is planned to pursue a 505(b)(2) regulatory pathway. Management cites SPRAVATO® as a $1.64B TTM market reference and notes projected annual sales of $3.0–$3.5B by 2027–2028 for that market.

Near-term actions include finalizing CMC, engaging FDA on development strategy, and preparing for clinical studies to advance the program toward an option exercise and potential global license.

Positive

• Exclusive option to license global LAI ketamine program for 12 months
• Program targets TRD, MDD, and LID indications
• 505(b)(2) pathway planned to leverage existing ketamine data
• References SPRAVATO TTM sales of $1.64B as market context

Negative

• License requires PharmaTher to complete evaluation and exercise option within 12 months
• Program advancement depends on FDA alignment and successful CMC completion

Toronto, Ontario--(Newsfile Corp. - November 17, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), 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, visit www.oakwoodlabs.com.

For more information about Oakwood Labs, please contact:

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

About PharmaTher

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty life sciences company focused on unlocking the therapeutic potential of ketamine for neuropsychiatric disorders. For more information, visit PharmaTher.com.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary and Forward-Looking Statements

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. There can be no assurance that the Company will proceed with the clinical development and that the FDA will support any potential request for an expedited path to approval. These risks include, among others, the development and commercial performance of its ketamine programs, FDA acceptance of the regulatory plan, clinical development, CMC package, regulatory approvals, market acceptance and opportunities, competition, market size, the Company programs being partnered. Readers are cautioned not to place undue reliance on forward-looking statements. PharmaTher disclaims any obligation to update or revise forward-looking statements except as required by law. In addition, this press release contains cautionary and forward looking statements and information within the meaning of applicable Canadian securities legislation. These relate to future events or future performance. The use of any of the words "aim", "anticipate", "before", "believe", "closer", "confident", "could", "eligible", "enable", "ensure", "estimated", "expect", "intend", "lead", "leverage", "makes", "may", "mitigate", "plan", "position", "potential", "prior", "promise", "projected", "proposed", "provide", "purpose", "ready", "significant", "strong", "toward", "will", "would", and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in the Company's management's discussion and analysis for the year ended May 31, 2025, dated September 26, 2025, which is available on the Company's profile at www.sedarplus.ca.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/274734

FAQ

What did PharmaTher (PHRRF) announce on November 17, 2025 about the LAI ketamine program?

PharmaTher announced an Exclusive Evaluation and Option-to-License Agreement with Oakwood to evaluate Oakwood's patented long-acting injectable ketamine over a 12-month exclusive evaluation term.

Which indications will PharmaTher (PHRRF) initially target with the Oakwood LAI ketamine program?

Initial development will focus on treatment-resistant depression (TRD), major depressive disorders, and Parkinson's disease-related levodopa-induced dyskinesia (LID).

What regulatory path will PharmaTher (PHRRF) pursue for the LAI ketamine program?

PharmaTher intends to pursue a 505(b)(2) pathway, leveraging established ketamine safety and efficacy literature where appropriate.

How does PharmaTher (PHRRF) frame the commercial opportunity for LAI ketamine in TRD?

The company cites SPRAVATO® TTM sales of $1.64 billion and projected annual sales of $3.0–$3.5 billion by 2027–2028 as market context for a differentiated LAI solution.

What near-term milestones did PharmaTher (PHRRF) set to advance the LAI ketamine program?

PharmaTher plans to finalize CMC activities, engage the FDA on the 505(b)(2) path and clinical design, and prepare for upcoming clinical studies within the near term.