ITM Isotope Technologies Munich SE announced a debt financing agreement for up to $262.5 million from funds managed by Blue Owl Capital, Inc., marking a significant milestone for the radiopharmaceutical biotech company as it prepares for the potential commercial launch of its lead candidate ITM-11. The financing comes following positive Phase 3 results for the targeted radiopharmaceutical in treating gastroenteropancreatic neuroendocrine tumors.
Phase 3 Success Drives Commercial Preparation
ITM-11, also known as n.c.a.177Lu-edotreotide, recently met the primary endpoint in the COMPETE Phase 3 study as a potential treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The company plans to submit a New Drug Application (NDA) for this asset to the U.S. FDA in 2025, positioning ITM for potential market entry in the competitive oncology space.
The drug candidate has already received significant regulatory recognition, having been granted orphan drug designation in both the European Union and the United States, as well as fast track designation in the U.S. for the treatment of GEP-NETs. These designations were based on positive results from a retrospective Phase 2 study with 177Lu-edotreotide.
Financing Structure and Strategic Impact
Under the terms of the agreement, ITM will receive $140 million upon closing and can exercise additional tranches to access the full $262.5 million. The non-dilutive debt structure provides the company with flexibility to advance its commercial preparations without diluting existing shareholders.
"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."
Mechanism of Action and Clinical Approach
177Lu-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.
This targeted approach represents the precision oncology strategy that ITM has been developing through its vertically integrated business model, which combines radioisotope manufacturing with radiopharmaceutical pipeline development.
Broader Pipeline and Manufacturing Expansion
Beyond ITM-11, the financing will support the continued advancement of ITM's targeted radiopharmaceutical pipeline and the scale-up of Actinium-225 manufacturing through its joint venture, Actineer. The company maintains a broad precision oncology pipeline, including multiple Phase 3 studies, combining high-quality radioisotopes with a range of targeting molecules.
"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," said Sandip Agarwala, Managing Director and Head of Life Sciences at Blue Owl. "We look forward to supporting ITM's continued growth and mission to bring innovative treatment options to people living with cancer."
The financing positions ITM to leverage its two decades of pioneering radiopharmaceutical expertise and established global network as it prepares for potential commercial launch while continuing to advance its broader pipeline of targeted cancer treatments.
