ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company from Garching near Munich, 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. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide).
ITM-11 recently met the primary endpoint in the COMPETE Phase 3 study as a potential treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 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.
Following these positive Phase 3 results, ITM plans to submit a New Drug Application (NDA) for this asset to the U.S. FDA in 2025. The Flexible funding structure enables continued advancement of ITM’s targeted radiopharmaceutical pipeline and leading radioisotope manufacturing business.
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.
ITM had raised EUR 188 million in mid-2024 with Temasek as lead investor.