(MENAFN- Newsfile Corp) Toronto, Ontario--(Newsfile Corp. - October 16, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine, today announced that it has begun preparing its U.S. Food and Drug Administration ("FDA") briefing materials to discuss a Phase 3 program for ketamine in levodopa-induced dyskinesia in Parkinson's disease ("LID-PD") and that prospective pharma partners are currently evaluating potential collaboration structures for the registrational program and commercialization.

Key Updates

PharmaTher is preparing a Pre-Phase 3 (Type B) FDA package to confirm the registrational study design-including primary and key secondary endpoints-along with the safety monitoring plan and other requirements for a 505(b)(2) NDA in LID-PD, consistent with prior Agency feedback that a single, well-controlled trial may be sufficient in appropriate settings. The planned Phase 3 is designed to be de-risked by leveraging the 505(b)(2) pathway and existing clinical evidence, PharmaTher's FDA-reviewed CMC foundation, and intellectual-property coverage through 2036 (U.S. Patent No. 11,426,366). Prior Phase I/II work showed reductions in dyskinesias on the UDysRS at multiple time points (51% during Infusion 2; 49% at 3 weeks; 41% at 3 months), with ketamine generally safe and well tolerated; these data will inform the Phase 3 design. In parallel, the Company is in discussions with potential partners covering potential co-development and licensing.

Market Opportunity

As previously communicated, PharmaTher estimates a U.S. treated market opportunity of approximately US$0.75-$2.2 billion for an effective LID-PD therapy, informed by PD prevalence, LID incidence among levodopa-treated patients, and plausible treatment penetration and pricing assumptions.

Planned Near-Term Milestones

• Q4 2025 - Q1 2026: Submit Pre-Phase 3 meeting request and briefing package; hold FDA meeting and receive minutes.
• Q1 - Q2 2026: Finalize Phase 3 protocol (primary and key secondary endpoints, inclusion/exclusion, statistical plan) per FDA feedback.
• 1H 2026 onward: Initiate Phase 3 activities, contingent on FDA alignment and partnering/financing.

"We're moving from planning to execution-securing FDA alignment for a Phase 3 path while also advancing active discussions with multiple partners who recognize the potential for ketamine in LID-Parkinson's," said Fabio Chianelli, Chief Executive Officer of PharmaTher. "Our strategy builds on the 505(b)(2) pathway, strong clinical signals, and an FDA-reviewed CMC foundation. We believe a well-structured partnership can accelerate timelines, optimize commercial reach, and unlock meaningful value for shareholders."

About the Phase 3 Strategy

PharmaTher's Phase 3 strategy seeks FDA agreement that a single, well-controlled Phase 3 study conducted under the 505(b)(2) pathway could support an NDA, with an appropriate safety monitoring plan and treatment duration suited to a chronic condition. The planned efficacy approach will center on dyskinesia severity and impact-such as the Unified Dyskinesia Rating Scale (UDysRS)-while pain and mood will be assessed as exploratory domains given their relevance in Parkinson's disease and ketamine's potential influence. On the CMC front, the Company intends to leverage validated analytical methods, specifications, and stability programs derived from its FDA-reviewed manufacturing foundation to streamline Phase 3 drug supply and reduce time and risk on the path to NDA submission.

About PharmaTher

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine. For more information, visit PharmaTher.

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