Lutetium (177Lu) edotreotide

Debt capital to support commercial readiness and potential U.S. launch of n.c.a. 177 Lu-edotreotide (ITM-11), following positive Phase 3 results Flexible funding structure enables continued advancement of ITM’s targeted radiopharmaceutical pipeline and leading radioisotope manufacturing business Garching / Munich, Germany, May 27, 2025 – ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, today announced a debt financing agreement for up to USD 262.5 million from funds managed by Blue Owl Capital, Inc (“Blue Owl”). The capital will be used to prepare for commercial readiness and potential market launch of the company’s lead candidate, n.c.a. 177 Lu-edotreotide (also known as ITM-11 or 177 Lu-edotreotide). ITM-11 recently met the primary endpoint in the COMPETE Phase 3 study as a potential treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM plans to submit a New Drug Application (NDA) for this asset to the U.S. FDA in 2025. In addition, the company will continue to accelerate the development of its innovative targeted radiopharmaceutical pipeline and the scale-up of Actinium-225 manufacturing through its joint venture, Actineer. Under the terms of the agreement, ITM will receive USD 140 million upon closing and can exercise additional tranches. Further details of the agreement have not been disclosed. “ Blue Owl is a highly regarded investor with a deep appreciation for the potential of radiopharmaceuticals, and we see their debt capital for ITM as a validation of our position as a cornerstone of the radiopharmaceutical industry ,” said Dr. Andrew Cavey, CEO of ITM . “ This strategic funding agreement enables us to move rapidly toward the potential U.S. commercialization of ITM-11, subject to FDA approval, and provides flexibility for the development and expansion of our innovative pipeline of targeted radiopharmaceuticals across a broad range of indications .” “ With its vertically integrated approach that combines a profitable radioisotope manufacturing business with radiopharmaceutical pipeline development, we believe ITM is uniquely positioned to positively impact the precision oncology sector. We look forward to supporting ITM’s continued growth and mission to bring innovative treatment options to people living with cancer ,” said Sandip Agarwala, Managing Director and Head of Life Sciences at Blue Owl . About n.c.a. 177 Lu-edotreotide (ITM-11) 177 Lu-edotreotide is a radiolabeled peptide conjugate that delivers beta radiation specifically to SSTR-positive tumor cells, sparing healthy organs and tissue. The drug candidate, delivered intravenously, is comprised of non-carrier-added Lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a synthetic SSTR agonist. 177 Lu-edotreotide was granted orphan drug designation in the E.U. and the U.S., and fast track designation in the U.S. for the treatment of GEP-NETs, based on positive results from a retrospective Phase 2 study with 177 Lu-edotreotide. 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 of medical radioisotopes. 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 About Blue Owl Blue Owl (NYSE: OWL) is a leading asset manager that is redefining alternatives ® . With $273 billion in assets under management as of March 31, 2025, Blue Owl invests across three multi-strategy platforms: Credit, GP Strategic Capital, and Real Assets. Anchored by a strong permanent capital base, we provide businesses with private capital solutions to drive long-term growth and offer institutional investors, individual investors, and insurance companies differentiated alternative investment opportunities that aim to deliver strong performance, risk-adjusted returns, and capital preservation. Together with over 1,200 experienced professionals globally, Blue Owl brings the vision and discipline to create the exceptional. To learn more, visit www.blueowl.com . ITM 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 Attachment 20250527_ITM Secures Up to $262.5m in Non-dilutive Debt Financing with Blue Owl Managed Funds Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

ITM Isotope Technologies said Tuesday it secured up to $262.5 million in debt financing to help  advance its lead cancer treatment toward potential US commercialisation. Specifically, the non-dilutive financing from Blue Owl Capital will support preparation for the market launch of ITM-11 (177Lu-edotreotide) following positive results from the Phase III COMPETE trial.The study demonstrated that ITM-11 significantly outperformed Novartis' Afinitor (everolimus) in treating patients with Grade 1 or 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), extending median progression-free survival to 23.9 months compared with 14.1 months for the established therapy. That translated to a 33% reduction in the risk of disease progression or death, with ITM-11 also demonstrating a more favourable safety profile, according to results unveiled in March.ITM reiterated plans to submit a filing to the FDA in 2025. ITM-11 — which combines the therapeutic β-emitting radioisotope lutetium-177 with the synthetic SSTR agonist edotreotide — is also being investigated in the Phase III COMPOSE trial in patients with well-differentiated, aggressive Grade 2 or 3 SSTR-positive GEP-NETs.The German radiopharmaceutical biotech will receive $140 million upon closing the Blue Owl agreement, with additional tranches available as needed."This strategic funding agreement enables us to move rapidly toward the potential US commercialisation of ITM-11, subject to FDA approval, and provides flexibility for the development and expansion of our innovative pipeline of targeted radiopharmaceuticals across a broad range of indications," stated CEO Andrew Cavey.The radiopharmaceuticals space has gained momentum following successful launches by companies like Novartis, which already markets the radionuclide therapy Lutathera (lutetium Lu 177 dotatate) for GEP-NETs that are positive for the somatostatin receptor. Lutathera brought in sales of $724 million last year.Something that differentiates ITM from other players, however, is that it has worked in the radiopharma space for over 20 years and has manufacturing in-house, in addition to its drug development programmes, a combination that has attracted backing from previous investors including Temasek and BlackRock in earlier funding rounds totalling about €615 million ($700 million) since 2022.