Radiopharmaceutical biotech firm ITM Isotope Technologies Munich SE, headquartered in Germany, has announced a major debt financing agreement of up to $262.5 million with funds managed by Blue Owl Capital.
The funding will accelerate commercial readiness and potential market launch of ITM’s lead candidate, n.c.a.¹⁷⁷Lu-edotreotide (ITM-11). This compound is being developed for treating hard-to-treat neuroendocrine tumours and is currently in late-stage clinical trials, including multiple Phase 3 studies. Notably, ITM-11 has already met its primary endpoint in the pivotal Phase 3 COMPETE trial for gastroenteropancreatic neuroendocrine tumours (GEP-NETs), and ITM plans to submit a New Drug Application (NDA) to the U.S. FDA in 2025. The drug also received orphan drug designation from the FDA in 2015, underscoring its potential to address unmet medical needs
Under the agreement, ITM will receive $140 million upfront, with the option to access additional capital through multiple tranches. The funding underpins ITM’s broader ambition: to establish a global supply of non-carrier-added (n.c.a.) Lutetium-177, a radioisotope key to precision oncology.
As the demand for precision cancer therapies grows, ITM’s radiopharmaceutical pipeline positions it at the forefront of next-generation oncology treatments, especially for indications with limited therapeutic options. The global radiopharmaceutical market is booming, projected to reach between $14 billion and $35 billion by 2034, with annual growth rates as high as 11.5%. This surge is fueled by ageing populations, advances in theranostics, and a shift toward personalised cancer care.
But what sets ITM apart in the burgeoning field of radiopharmaceuticals? Here are three key insights:
A pioneer in radiopharmaceutical cancer therapies
ITM is not an average biotech. Founded in 2004 by Dr. Andrew Cavey, it has grown into a world-leading radiopharmaceutical company focused on theranostics, a cutting-edge approach that combines therapeutic and diagnostic nuclear medicine. Its therapies deliver radioactive isotopes directly to cancer cells, minimising damage to healthy tissue. The company has built a reputation for treating hard-to-treat tumors, such as neuroendocrine and bone metastases, using precision-targeted radioisotopes. This scientific niche, though highly specialised, is gaining momentum globally as radiopharma offers new hope for patients with limited treatment options. With over 20 years of research and development, ITM’s long-term vision is aligned with the future of personalised cancer care, giving it a first-mover advantage in the space.
Fully integrated supply chain for rare medical isotopes
One of ITM’s greatest strengths is its vertically integrated operations spanning radioisotope production to global distribution. The company is one of the few worldwide with large-scale capabilities to produce non-carrier-added Lutetium-177 (n.c.a. 177Lu) and Actinium-225 essential isotopes in next-generation radiotherapies. This level of supply chain control enables ITM to ensure a stable, high-purity, and scalable isotope supply, which is crucial in a field where radioisotopes have short half-lives and global shortages are common.
Strategic partnerships and joint ventures further reinforce ITM’s integration. Its Actineer joint venture with Canadian Nuclear Laboratories has begun producing GMP-grade Actinium-225 (Ac-225), a critical isotope for targeted alpha therapies, with commercial supply expected by mid-2025. Additionally, ITM’s joint venture with Chengdu Gaotong Isotope Co. Ltd. in China is expanding the company’s reach in the world’s fastest-growing radiopharmaceutical market.
These partnerships secure ITM’s pipeline and position the company as a key supplier to third-party developers globally. In January 2025, ITM signed a supply agreement with Ariceum Therapeutics to provide Ac-225 for Ariceum’s targeted radiopharmaceutical pipeline, further underscoring ITM’s central role in the industry’s supply ecosystem.
By building and operating its own production and logistics infrastructure, ITM has positioned itself as a key supplier for its internal drug pipeline and third-party research and development globally. This autonomy over isotope production is a rare competitive advantage, reducing operational risk and supporting partnerships across the nuclear medicine ecosystem.
Advancing a late-stage pipeline for precision oncology
ITM isn’t just about isotope production. It’s actively advancing a robust clinical pipeline. Its lead candidate, ITM-11, is currently in late-stage development and has already met the primary endpoint in its Phase 3 COMPETE trial, showing efficacy in treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The company is preparing a New Drug Application (NDA) submission to the U.S. FDA in 2025, marking a key step toward commercialisation.
Beyond ITM-11, the company is running multiple clinical trials exploring combinations of its radioisotopes with targeted molecules for various cancers, including glioblastoma and metastatic bone disease. This broad pipeline reflects ITM’s ambition to redefine how cancer is diagnosed and treated, moving away from one-size-fits-all therapies toward precision-guided treatments tailored to tumor biology. With increasing demand for radiopharmaceuticals, ITM is well-positioned to lead the field into a new era of oncology care.
Recent industry trends validate the company’s strategic focus: Novartis’s Lutathera, a competing radiopharmaceutical, generated $291 million in sales in the first half of 2023—a 57% increase over the previous year—and recently succeeded in a Phase 3 first-line treatment trial for gastrointestinal cancer, highlighting the commercial potential for ITM’s pipeline.
Funding and future outlook
The current debt financing builds on ITM’s successful equity fundraising history, including a €33 million equity round in March 2022 and a €25 million strategic investment from Grand Pharma, bringing total 2022 funding to €58 million. The move from equity to debt financing reflects ITM’s maturation and commercial readiness, with non-dilutive capital supporting its transition to a revenue-generating company.
“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. 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.”
“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.
