PharmaTher Holdings Provides Corporate Update

Company funded to meet upcoming milestones over the next 24 months

Expected FDA approval for KETARX (racemic ketamine) via the ANDA pathway in Q1-2024 and international approvals after that

Company advancing PharmaPatch (microneedle patch) for psychedelics and infectious diseases

Streamlined clinical development programs to focus on near-term investment and revenue opportunities with KETARX and PharmaPatch

TORONTO, June 12, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, provides a corporate update outlining the development and commercialization plans and upcoming milestones for its KETARX (racemic ketamine) products and PharmaPatch (microneedle patch) delivery system. With approximately CAD $6 million in cash as of end-May 2023, the Company is funded to meet its upcoming milestones targeting near-term investment and revenue opportunities over the next 24 months.

Fabio Chianelli, CEO of PharmaTher, commented: “Since our inception, we focused on developing novel uses and delivery forms of ketamine for mental health, neurological and pain disorders. We dedicated our resources to working with the FDA to obtain agreement on our regulatory and clinical development plans for our ketamine-based product pipeline. In parallel, we developed our own racemic ketamine product, KETARX, to meet the growing demand for ketamine in the U.S. and international markets. Currently, ketamine is on the FDA drug shortages list, and we aim to recover ketamine’s shortage issue in the U.S. and become a global leader for ketamine-finished products. We expect to receive FDA approval for KETARX in Q1-2024. Also, we are adding a new investment and revenue stream by partnering our proprietary microneedle patch delivery system, PharmaPatch, with biotech and pharmaceutical companies globally. As for our proposed clinical development programs involving ketamine, we are pausing capital allocations to these programs for 2023 to focus on entering the next phase of our growth cycle in becoming a commercial-focused specialty pharmaceutical company.”