PharmaTher Announces Update on FDA New Drug Application for Ketamine Page 1

TORONTO, Sept. 4, 2024 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced an update to its U.S. Food and Drug Administration (the “FDA”) New Drug Application for Ketamine with an assigned Generic Drug User Fee Amendments of 2022 (“GDUFA”) target date of October 29, 2024. On September 3, 2024, the FDA communicated with the Company that the review is ongoing and that no additional information is needed, but that this is subject to change. The Company will continue to provide updates as they arise.

Following anticipated FDA approval and U.S. launch, the Company aims to pursue international approvals to support global demand for ketamine and its commercial development strategy for the treatment of Parkinson’s disease. Additionally, the Company will pursue novel applications and delivery methods of ketamine for mental health, pain, neurological, and medical countermeasures indications.