ITM Isotope Technologies Munich SE is a radiopharmaceutical biotech based in Garching, Germany focused on advancing radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. Its lead candidate is n.c.a. 177Lu-edotreotide (ITM-11 / 177Lu-edotreotide), and the company supports a broad precision oncology pipeline including multiple Phase 3 studies. The company is led by CEO Dr. Andrew Cavey. ITM plans to use new capital to prepare for commercial readiness and potential market launch of its lead candidate. The company announced a non-dilutive debt financing agreement that will support late-stage development and commercial preparation. ITM is a radiopharmaceutical biotech company dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. Led by CEO Steffen Schuster and based in Munich, Germany, the company focuses on advancing radiopharmaceutical candidates. ITM intends to use the funds to advance and expand its radiopharmaceutical pipeline and to foster its development platform. The company will prepare commercial readiness for the potential market launch of its phase III lead candidate, ITM-11 (n.c.a. 177Lu-edotreotide), for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Proceeds will also enable expansion of manufacturing capabilities for production of alpha- and beta-emitting radioisotopes, including Lutetium-177(177Lu) and Actinium-225(225Ac). ITM Isotope Technologies Munich SE is a radiopharmaceutical biotech focused on radiomolecular precision therapeutics and diagnostics (theranostics) and a broad Targeted Radionuclide Therapies (TRT) oncology pipeline. Its lead candidate ITM-11 (n.c.a. 177Lu-edotreotide) is nearing the final stages of phase III development in gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and ITM-31 (Lu-177 labeled 6A10 Fab-fragments) is in clinical studies for glioblastoma. The company is also a major radioisotope supplier and is expanding manufacturing and GMP capabilities for n.c.a. 177Lu and scaling GMP manufacturing for 225Ac to meet growing demand. Planned investments include a second state-of-the-art manufacturing facility in Germany, expanded in-house drug product manufacturing, and broader commercial infrastructure to accelerate global access. ITM has opened a U.S. headquarters in Princeton, New Jersey and established a subsidiary in Shanghai to support regional introduction of precision oncology products. The company says it will leverage nearly two decades of radiopharma expertise and its global network to improve patient access to targeted treatments. ITM develops targeted radiopharmaceutical diagnostics and therapeutics by combining medical radioisotopes with targeting molecules to treat hard-to-treat cancers. The company produces and supplies high-quality medical radioisotopes through a wide-reaching international supply network and leverages nearly two decades of radiopharma expertise. Its lead therapeutic candidate, ITM-11 (n.c.a. 177Lu-edotreotide), is being evaluated in two phase III trials (COMPETE and COMPOSE) for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM plans to use recent financing to finalize late-stage development of ITM-11, support potential commercialization and market launch efforts if approved, accelerate development of additional radiopharmaceutical candidates, and expand radioisotope supply capabilities. The company emphasizes precision oncology approaches that deliver radiation directly to tumors while minimizing exposure to healthy tissue. ITM is positioned as a global player in nuclear medicine, aiming to advance a broad proprietary pipeline and enable wider clinical adoption of targeted radionuclide therapies. ITM Isotope Technologies Munich SE is a radiopharmaceutical biotech company focused on development, production and global supply of targeted radionuclide diagnostics and therapeutics. The company produces high-quality medical radioisotopes and leverages nearly two decades of radiopharma expertise and an established global supply network. ITM has forward-integrated to build a broad pipeline, including lead candidate ITM-11 (n.c.a. 177Lu-edotreotide) which is undergoing two phase III trials (COMPETE and COMPOSE), and companion diagnostic TOCscan® (68Ga-edotreotide). ITM-41 (n.c.a. 177Lu-zoledronate) is in preclinical development for osteosarcoma and bone metastases. The company is focused on expanding its presence in Asia and Greater China to meet growing patient needs. A recent strategic equity investment is intended to support late-stage development and broader commercialization efforts in the region.

Total raised

$913M

Funding rounds

6

Latest round

Debt Financing

Latest activity

May 2025