CTXR · Citius Pharmaceuticals, Inc.

This filing reports the first international shipment of LYMPHIR™ to Europe — a material commercial milestone for Citius Oncology, Inc., the majority-owned subsidiary of Citius Pharmaceuticals. The shipment occurred on April 29, 2026, and was fulfilled through a regional distribution partner under Named Patient Programs (NPPs), which permit physician-initiated access for eligible patients in jurisdictions where the drug lacks formal marketing authorization. Critically, the document explicitly states that LYMPHIR does not have marketing authorization from the European Medicines Agency or any other non-U.S. regulator; access is therefore strictly governed by local NPP frameworks and carries no regulatory approval pathway implications. This event follows the U.S. commercial launch in December 2025 and builds on FDA approval secured in August 2024 for relapsed or refractory Stage I–III cutaneous T-cell lymphoma. Management characterizes the European shipment as a 'strategic step' in disciplined, targeted market expansion — distinct from broad regulatory filings — and emphasizes its role in extending access for patients with limited treatment options. While operationally significant, the absence of regulatory approvals, revenue disclosures, or financial terms limits near-term financial impact visibility. The milestone reinforces Citius Oncology’s commercial execution capability but does not alter the drug’s regulatory status outside the U.S. or signal imminent broader geographic launches.