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PharmaTher CEO Publishes Letter to Shareholders

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Executive Summary
- CEO Fabio Chianelli issued a shareholder letter outlining PharmaTher’s 2025 achievements—including FDA approval and the closed sale of its U.S. Ketamine ANDA—and detailing 2026 strategic objectives focused on asset monetization, international expansion, and partnership development.
- The Ketamine ANDA sale was completed in December 2025 under an agreement that may generate > US$25 million through upfront cash, sales‑based milestones and profit‑sharing.
- PharmaTher plans to pursue non‑dilutive financing via strategic partnerships, explore a sale or spin‑out of its 49 % stake in Sairiyo Therapeutics, and advance next‑generation ketamine programs.
Key Details
- 2025 Highlights
- FDA approval of Ketamine ANDA (Application #217858).
- Sale of Ketamine ANDA closed in December 2025; transaction includes upfront cash, sales‑based milestones, and profit‑sharing with potential total consideration exceeding US$25 million.
- Introduction of platform tools KetaVault™ and KetAImine™ to facilitate commercial partnerships.
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Exclusive evaluation & option‑to‑license agreement with Oakwood Laboratories for a long‑acting injectable ketamine program (neuropsychiatric indications).
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2026 Objectives
- Realize economics from the ANDA sale as milestones are met and profit‑sharing accrues.
- Expand ketamine commercialization internationally through partnerships or region‑specific monetization structures.
- Seek strategic alliances for ketamine pipeline (including Parkinson’s disease and drug‑delivery programs) on an upfront‑milestone‑royalty basis to fund development without diluting equity.
- Evaluate options to monetize the 49 % equity interest in Sairiyo Therapeutics (sale, spin‑out, or other public‑company transaction).
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Continue assessment and potential advancement of a next‑generation long‑acting injectable ketamine product, selecting the most promising candidate for future development.
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Financial Outlook
- Reduced cash burn in Q4 2025; current cash balance deemed sufficient to fund 2026 asset‑monetization plans without additional operating capital.
- Anticipated ANDA receipt and milestone payments expected to provide primary funding source for 2026 activities.
Notable Quotes
- “With the Ketamine ANDA sale closed, PharmaTher enters 2026 stronger… Our strategy prioritizes non‑dilutive value creation through disciplined cost control.” – Fabio Chianelli, Founder, Chairman & CEO
All forward‑looking statements are subject to risks and uncertainties that could cause actual results to differ materially.
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May 27, 2026 · 08:01