Mr. Fabio Chianelli reports

PHARMATHER PROVIDES CORPORATE UPDATE ON KETAMINE DEVELOPMENT AND COMMERCIAL STRATEGY

Pharmather Holdings Ltd. has provided a corporate update following its recently announced sale of the company's abbreviated new drug application (No. 217858) for ketamine hydrochloride injection USP. 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 and complex regional pain syndrome, 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. 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 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 through the 505(b)(2) regulatory pathway, potentially saving substantial time and development costs, since the foundational work has already been reviewed by the Food and Drug Administration.

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 United States, 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 financing 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, chief executive officer 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 Holdings Ltd.

Pharmather is focused on unlocking the pharmaceutical potential of ketamine for mental health, pain and neurological disorders.

We seek Safe Harbor.