ITM to Present Top Line Results from Phase 3 COMPETE Trial with [177Lu]Lu-edotreotide for the Treatment of Grade 1 & Grade 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) at European Neuroendocrine Tumor Society (ENETS) Conference

Garching / Munich, February 25 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that it will provide topline data results from its Phase 3 COMPETE trial in an oral presentation at the 22^nd Annual European Neuroendocrine Tumor Society (ENETS) Conference 2025, held from March 5 – March 7, 2025 in Kraków, Poland.

The COMPETE trial evaluated [¹⁷⁷Lu]Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This follows ITM’s announcement on January 28, 2025, that the trial met its primary endpoint.

Oral Presentation Details
Title: Efficacy and safety of [¹⁷⁷Lu]Lu-edotreotide vs. everolimus in patients with grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumours: COMPETE phase 3 trial

Date and Time: March 6, 2025; 10:05 am – 10:12 am CET

Session and Room Number: Clinical science, Session 1: Theranostics in NENs – Integrating experience for a brighter future; Auditorium Hall (S1)

Presenter: Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona

For further information, please contact:

Media Contact
Corporate Communications
Kathleen Noonan/Julia Westermeir
Phone: +49 89 329 8986 1500
Email: communications@itm-radiopharma.com

Investor Relations
Ben Orzelek
Phone: +49 89 329 8986 1009
Email: investors@itm-radiopharma.com

About ITM Isotope Technologies Munich SE
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com

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• 20250225_ITM to Present Phase 3 COMPETE Trial Results on [177Lu]Lu-edotreotide for GEP-NETs at ENETS Conference 2025