PharmaTher Provides Corporate Update on Ketamine Development and Commercial Strategy

TORONTO, Oct. 02, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, is pleased to provide a corporate update following its recently announced sale of the Company’s Abbreviated New Drug Application (ANDA #217858) for Ketamine Hydrochloride Injection USP (the “Ketamine ANDA”). The transaction was a strategic sale of a single generic ketamine asset and the sale did not include PharmaTher’s broader ketamine portfolio. The Company continues to own its ketamine-based programs, including for Parkinson’s disease, amyotrophic lateral sclerosis (ALS), complex regional pain syndrome (CRPS), as well as its ketamine microneedle patch and wearable pump programs for mental health, neurological, and pain disorders.

Building Value Beyond the Ketamine ANDA

The sale of the Ketamine ANDA was a strategic decision that provides PharmaTher with potential non-dilutive capital tied to U.S. commercial sales only. Successfully launching and scaling a generic ketamine injectable on its own would require significant capital, inventory commitments, sales infrastructure, and specialized expertise. By partnering with a well-established global pharmaceutical company specializing in sterile injectables and complex generics, as well as having a growing U.S. commercial division, the Ketamine ANDA would have a better chance of achieving its commercial potential. The pharmaceutical partner has the manufacturing scale, regulatory track record, and commercial infrastructure to compete directly with existing generic ketamine competitors in the U.S. market.

Importantly, the investment made in developing the Ketamine ANDA was also intended to support and strengthen PharmaTher’s broader ketamine strategy, advancing its other proprietary ketamine-based programs. The work completed to secure the Ketamine ANDA also provides a validated CMC (Chemistry, Manufacturing and Controls) package that would be leveraged for future New Drug Applications (NDAs) via the 505(b)(2) regulatory pathway, potentially saving substantial time and development costs since the foundational work has already been reviewed by the FDA.

The Ketamine ANDA sale does not limit PharmaTher’s ability to research, develop, manufacture, and commercialize any strengths, dosage forms, or formulations of ketamine for any indications in any territories worldwide, including the U.S., provided that the Company does not, directly or indirectly, develop, file, or seek regulatory approval for the exact same product approved under the Ketamine ANDA, which the Company would not seek since future ketamine products will be differentiated and non-generic. The pharmaceutical partner has requested that specific terms remain confidential at this time for competitive and regulatory reasons.

Next Steps

Over the next six months, PharmaTher is concentrating on several key initiatives aimed at realizing the commercial potential of its ketamine portfolio.

• International Partnerships: The Company is actively pursuing new global partnerships that could provide additional non-dilutive funding and accelerate the development and commercialization of its ketamine-based products.
  
• Regulatory Engagements: PharmaTher is planning meetings with the U.S. FDA to define an expedited clinical and regulatory path for ketamine in CRPS and to seek agreement on a Phase 3 study design for Parkinson’s disease.
  
• Pharma Opportunities: Both the CRPS and Parkinson’s programs, if supported by positive FDA guidance and outcomes, would be positioned as attractive candidates for potential partnerships with larger pharmaceutical companies, as well as for the Company’s ketamine microneedle patch and wearable pump programs.
  
  

Fabio Chianelli, CEO of PharmaTher, stated:

“Our investment in developing the Ketamine ANDA was a strategic move, designed not only for near-term monetization but also to establish a long-term foundation for our proprietary ketamine pipeline. The sale of the Ketamine ANDA allows us to capitalize on the generic injectable ketamine market while simultaneously advancing our proprietary ketamine-based programs into larger market opportunities. We've partnered with a pharmaceutical company that possesses the necessary scale and infrastructure to effectively compete with existing generic ketamine competitors in the U.S. market. Concurrently, we are pursuing international partnerships to fully realize the global potential of our ketamine portfolio.”

About PharmaTher

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on unlocking the pharmaceutical potential of ketamine for mental health, pain, and neurological 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

This press release contains forward-looking statements, including, but not limited to, statements regarding potential milestone and profit-sharing payments, the commercial success of the ANDA, and the Company’s ability to advance next-generation ketamine programs. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks include, among others, the commercial performance of the ANDA product, regulatory approvals, market acceptance, competition, and the Buyer’s and Company’s ability to execute its business strategy. 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 “closer”, "could", “confident”, "would", "intend", "expect", “eligible”, “ensure”, “enable”, "believe", "will", "projected", "estimated", "potential", “promise”, “strong”, "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, “provide”, “position”, “leverage”, “mitigate”, “makes”, “before”, “prior”, 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 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.

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