(MENAFN- Newsfile Corp) Toronto, Ontario--(Newsfile Corp. - December 2, 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 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.

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