Core Insights - PolTREG S.A. has established a wholly owned subsidiary, Immuthera, in Delaware to enhance its presence in the U.S. market [2] - The company is focusing on the execution of its growth strategy in the American market by bringing existing therapies and exploring new assets [3] - PolTREG has received a positive opinion from the European Medicines Agency's Pediatric Committee for its investigational therapy PTG-007 aimed at preventing symptomatic type 1 diabetes in children [6] Company Developments - Immuthera will develop cell-based therapies initially created by PolTREG under the U.S. FDA regulatory framework [10] - PolTREG has formed strategic partnerships with Noble Capital Markets, Inc. and Antion Biosciences to support its growth strategy [3] - The company is in discussions with leading American academic and clinical centers to establish collaborations and evaluate new technologies [4] Clinical and Regulatory Progress - A Pre-IND meeting request was submitted to the FDA in mid-May for TREG therapies [3] - The Pediatric Investigation Plan (PIP) for PTG-007 has been positively reviewed, suggesting a broadening of the eligible patient population [6] - PolTREG's lead product, PTG-007, is ready for Phase 2/3 clinical testing, and the company is seeking partnerships for this phase [9] Manufacturing and Infrastructure - PolTREG operates a GMP-certified manufacturing facility, one of Europe's largest, with over 2,100 sqm of laboratory space and 15 production lines [8] - The facility has the potential for substantial expansion to accommodate next-generation engineered therapies and cell therapies [8] Upcoming Events - Key executives from PolTREG will participate in the BIO International Convention 2025 to promote the company's clinical and developmental pipeline [5]