PharmaTher Closes Sale of Ketamine ANDA, Sharpening Focus on Long-Acting Injectable Ketamine Franchise

TORONTO — December 2, 2025 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF; CSE: PHRM), a specialty life sciences company focused on unlocking the therapeutic potential of ketamine for neuropsychiatric disorders, today announced it has closed the previously announced sale of its Abbreviated New Drug Application (ANDA #217858) for Ketamine Hydrochloride Injection USP to a leading sterile-injectables pharmaceutical company.

At closing, PharmaTher received a confidential upfront cash payment and remains eligible to receive additional milestone payments based on cumulative sales thresholds, as well as profit-sharing payments for seven years following first commercial sale. In total, the transaction provides the potential to generate more than US$25 million over time, subject to commercial performance.

The sale strengthens PharmaTher’s focus on the development and commercialization of the patented long-acting injectable (“LAI”) ketamine program being advanced under an exclusive evaluation and option-to-license agreement with Oakwood Laboratories, LLC.

“Closing the ANDA sale marks the start of PharmaTher’s next chapter,” said Fabio Chianelli, Chairman and Chief Executive Officer of PharmaTher. “We have converted a legacy generic asset into non-dilutive capital and long-term upside, and we are now fully focused on building a differentiated, long-acting ketamine franchise for neuropsychiatric disorders.”

PharmaTher’s LAI ketamine program leverages Oakwood’s microsphere-based sustained-release technology, designed to enable subcutaneous or intramuscular administration with controlled drug release over weeks to months. The Company intends to pursue a 505(b)(2) regulatory pathway with an initial focus on high-value neuropsychiatric indications such as treatment-resistant depression (TRD), major depressive disorder (MDD), and Parkinson’s disease.

“We believe long-acting ketamine is the natural evolution of today’s ketamine treatment model,” added Mr. Chianelli. “A convenient, less frequent injectable option has the potential to improve adherence, reduce clinic burden, and expand access while preserving ketamine’s rapid antidepressant benefits.”

Near-Term Value-Creating Milestones

With the ANDA sale closed and its LAI strategy defined, PharmaTher is focused on executing a clear, catalyst-rich plan over the coming quarters. The Company’s priorities include:

• Advancing formulation and CMC activities in collaboration with Oakwood to support clinical-grade supply;
• Refining the 505(b)(2) regulatory strategy and planned clinical development pathway for TRD, MDD and Parkinson’s disease;
• Preparing for formal FDA interactions, including potential pre-IND discussions to align on study design and safety requirements;
• Prioritizing additional neuropsychiatric indications where long-acting ketamine may offer differentiated benefit and attractive market opportunities; and
• Evaluating strategic partnering and non-dilutive funding opportunities as the program matures.

PharmaTher expects that successful execution of these milestones could create multiple data, regulatory, and partnering inflection points over the next 6 months.

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

This press release contains “forward-looking statements” within the meaning of applicable securities laws, which reflect the Company’s current expectations regarding future events. Forward-looking statements are often, but not always, identified by words such as “aim”, “anticipate”, “believe”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “potential”, “projected”, “proposed”, “seek”, “should”, “will”, “would”, and similar expressions. Forward-looking statements in this press release include, without limitation, statements relating to (i) potential milestone and profit-sharing payments under the ANDA sale, (ii) the commercial performance of the ANDA product, (iii) the development, regulatory pathway, and potential approval of the Company’s LAI ketamine program, (iv) the size and growth of the market opportunity for ketamine-based therapies, and (v) the Company’s ability to achieve future development, regulatory, partnering, and financial milestones. These forward-looking statements are based on reasonable assumptions made by the Company as of the date hereof but are subject to a number of known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, among others: the commercial performance of the ANDA product; the Buyer’s ability to obtain and maintain all necessary regulatory approvals; the Company’s ability to successfully develop, manufacture, and commercialize its LAI ketamine program; the outcome and timing of regulatory interactions and clinical trials; market acceptance and competitive dynamics; the availability of capital; and the other risk factors described under the heading “Risk Factors” in the Company’s management’s discussion and analysis for the year ended May 31, 2025, dated September 26, 2025, available under the Company’s profile on SEDAR+ at www.sedarplus.ca.

Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and the Company does not undertake any obligation to update or revise such 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.

This news release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful.