PharmaTher Announces Path to Ketamine Commercialization with No Planned Financing, Confirms FDA Approval Goal Date of August 9th, 2025 for Ketamine

Core Insights - PharmaTher Holdings Ltd. aims to become a global leader in ketamine-based pharmaceuticals, with a clear strategy for regulatory approval and international expansion [1][3] Regulatory Milestones - The FDA has set an approval goal date of August 9, 2025, which is a significant milestone for the company, potentially unlocking a multi-billion-dollar market opportunity [3][7] - The current global market for ketamine is valued at $750 million and is projected to grow at a CAGR of 16.4%, reaching approximately $3.42 billion by 2034 [3] Financial Position - The company is fully funded for all planned operations leading up to the FDA approval goal date and the initial U.S. commercial launch of its ketamine product [5][7] - PharmaTher has no plans for new equity or debt financing before the FDA approval date, indicating confidence in its current financial position [6][7] Commercial Strategy - The manufacturing of the ketamine product is based in the U.S., ensuring supply chain security and quality control [7][8] - PharmaTher is preparing for international regulatory submissions in Europe, the UK, Canada, Japan, and the APAC regions, expected to begin in the second half of 2025 [7][8] Expansion and Innovation - The company is exploring new therapeutic applications for ketamine, inspired by bipartisan support for psychedelic-assisted therapies [9] - PharmaTher aims to broaden its clinical pipeline, focusing on indications such as Parkinson's disease, ALS, and CRPS, as well as novel delivery systems [7][9] Leadership Vision - The CEO emphasizes the upcoming FDA approval goal date as a critical starting point for global expansion and new therapeutic indications [10]