PharmaTher Provides Update on Ketamine Program for LID-Parkinson's Disease

• Phase 3 program targeting a potential US$2.2B U.S. market opportunity
• 505(b)(2) regulatory path leveraging prior human data to reduce risk, cost, and time
• FDA-reviewed CMC package validated through prior ANDA approval
• Patent coverage to 2036 for ketamine in Parkinson's and related motor disorders
• Active pharmaceutical partnering discussions
• Upcoming catalysts (Q4 2025 - Q2 2026): FDA meeting, pivotal study readiness, pharma partnership

Toronto, Ontario--(Newsfile Corp. - October 8, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, today announced an update regarding its initiative to develop ketamine as a treatment for levodopa-induced dyskinesia (LID-PD) in patients with Parkinson's disease.

PharmaTher's objective is to continue the development of its ketamine program for LID-PD via the 505(b)(2) regulatory pathway, leveraging existing scientific and clinical evidence together with the Company's FDA-reviewed Chemistry, Manufacturing and Controls (CMC) foundation to reduce development risk, cost and timelines. The Company is preparing for a Phase 3, well-controlled clinical study designed to evaluate efficacy and safety in support of a potential New Drug Application (NDA), subject to FDA feedback.

Four-Pillar Strategy

1. Regulatory alignment. PharmaTher intends to request a Pre-Phase 3 meeting with the FDA to obtain clarity on a Phase 3-enabling path and confirm key components of a registrational plan for LID-PD.

2. Clinical plan. The Company plans to pursue FDA acceptance for a single, well-controlled Phase 3 study to support NDA submission. The protocol will include safety monitoring aligned with the ketamine class and will assess pain and depression as exploratory secondary outcomes, alongside dyskinesia-focused primary endpoints.

3. CMC leverage. PharmaTher will utilize the work completed for its FDA-reviewed Ketamine ANDA to streamline analytical methods, specifications and stability programs for intended clinical and commercial presentations under 505(b)(2).

4. Partnering & capital efficiency. The Company is engaged in active discussions with prospective pharmaceutical partners that could acquire or license the program, supporting a capital-efficient advancement to and through pivotal development.