Correction: ITM and Lumara Bio Announce Dose-Response Analysis for ¹⁷⁷Lu-edotreotide (ITM-11) and Data Supporting Early-Stage Pipeline at EANM 2026

• Dose-response analysis from Phase 3 COMPETE trial shows an association between higher absorbed doses of ¹⁷⁷Lu-edotreotide in tumors and improved clinical response in GEP-NETs
• Separate independent, investigator-led studies highlight promising clinical and translational data for Ga-DPI-4452, Tb-DOTA-LM3 and n.c.a. ¹⁷⁷Lu-TTM

Vienna, October 20, 2026 — ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Lumara Bio, a dedicated oncology therapeutics division of ITM, today announced that data supporting its targeted precision oncology portfolio were featured in three oral presentations and one e-poster at the European Association of Nuclear Medicine (EANM) 2026 Congress, held from October 17-21 in Vienna, Austria. The presentations further support ITM’s late- and early-stage radiopharmaceutical pipeline, highlighting novel therapeutic and diagnostic candidates across Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs), clear cell Renal Cell Carcinoma (ccRCC), and glioblastoma.

“The data presented at EANM 2026 underscore the therapeutic potential of our deep targeted radiopharmaceutical pipeline, which leverages different targets, both established and novel radioisotopes, and addresses several difficult-to-treat oncology indications,” said Dr. Celine Wilke, chief medical officer of ITM. “Whether derived from ITM’s Phase 3 COMPETE trial or through the valuable insights of independent, investigator-initiated research, this growing evidence base supports the continued development of these novel radiopharmaceuticals across cancers with significant unmet medical need.”

Higher Cumulative Tumor Absorbed Dose of ¹⁷⁷Lu-edotreotide is Associated with Improved Clinical Response in GEP-NETs
Dr. Anthime Flaus of the Hospices Civils de Lyon in Bron, France gave an oral presentation featuring a late-stage dose-response analysis from ITM’s Phase 3 COMPETE trial evaluating non-carrier-added (n.c.a.) ¹⁷⁷Lu-edotreotide (ITM-11) in patients with Grade 1 or 2 GEP-NETs. The analysis assessed the relationship between tumor cumulative absorbed dose and treatment response in 106 evaluable patients who received 4 treatment cycles of ¹⁷⁷Lu-edotreotide therapy.

Higher cumulative tumor absorbed doses were associated with a better Best Overall Response (BOR). The Objective Response Rate (ORR) increased from 12% in the lowest dose quartile (Q1) to 64% in the highest dose quartile (Q4), with three complete responses occurring in patients with a cumulative dose above 86.1 Gy (Q3 and Q4). Cumulative tumor absorbed dose and tumor type were the main predictors of response in multivariate logistic regression models. Lesion-level analysis also identified a statistically significant association between absorbed dose and response.

"The dosimetry data from the COMPETE trial offer insights into how tumor absorbed dose correlates with objective response," said Dr. Anthime Flaus, study author and physician at the Hospices Civils de Lyon. "Understanding this dose-response relationship provides important evidence that could potentially support the development of more individualized radiopharmaceutical treatment approaches, with the goal of optimizing patient care and outcomes."

Early-Stage Pipeline Data Presented at EANM 2026
The conference also highlighted promising clinical and translational data supporting the further development of other ITM pipeline candidates. These data, derived from independent trials and research initiated by investigators, offer valuable clinical insights to support the further development of ITM candidates currently in Phase 1 trials, including: Ga-DPI-4452 (also known as [⁶⁸Ga]Ga-DPI-4452, or CAIX peptide), an investigational diagnostic imaging agent for ccRCC; [¹⁶¹Tb]Tb-DOTA-LM3 (Tb-DOTA-LM3) as a potential therapeutic for somatostatin receptor (SSTR)-positive tumors; and n.c.a. ¹⁷⁷Lu-TTM for intra-cavitary immunoradiotherapy in patients with glioblastoma.

Ga-DPI-4452 Demonstrates High Tumor Uptake and Superior Detection of ccRCC Compared to Conventional CT
Dr. Alina Küper of the Department of Nuclear Medicine at University Hospital Essen in Germany highlighted in an oral presentation the interim results from an independent bicenter retrospective registry evaluating Ga-DPI-4452 PET/CT for imaging 98 patients with suspected or proven ccRCC. In the analysis, Ga-DPI-4452 demonstrated abnormal findings in 91.8% of patients with subsequently confirmed ccRCC. Additionally, Ga-DPI-4452 exhibited high tumor uptake and superior detection efficacy across 153 predefined anatomical regions compared to conventional CT imaging, including in renal primary tumors/recurrence, regional lymph nodes, distant lymph nodes, bone metastases, and visceral metastases.

Lower Peptide Mass of [¹⁶¹Tb]Tb-DOTA-LM3 Increases Tumor Absorbed Dose in Metastatic GEP-NETs
In an oral presentation, Dr. Julia G. Fricke and Prof. Damian Wild, Physician-Scientists and Researchers in Nuclear Medicine and Theranostics at the University Hospital Basel, Switzerland, shared safety, dosimetry, and preliminary efficacy data from the Phase 0b BETA PLUS study for the SSTR2 antagonist [¹⁶¹Tb]Tb-DOTA-LM3. In the study evaluating dosimetry in 6 patients with metastatic GEP-NETs, a peptide mass-dependent effect was observed, wherein a lower peptide mass (<100 µg vs. 300–400 μg) increased the tumor absorbed dose (23.3 vs. 12.5 Gy/GBq, p=<0.001). Improved tumor-to-kidney (8.24 vs. 7.23, p=0.14) and tumor-to-bone marrow (53.4 vs 45.9, p=0.074) absorbed dose ratios were also observed with a lower peptide mass. The radiopharmaceutical candidate showed preliminary evidence of antitumor activity with no dose-limiting toxicities, supporting further clinical evaluation.

Immunohistological Expression Patterns of Carbonic Anhydrase XII in Glioblastoma Support Continued Development of n.c.a. ¹⁷⁷Lu-TTM
An e-poster by Julia Schuler of the Institute of Pathology at the Technical University of Munich in Germany highlighted translational research evaluating the presence of carbonic anhydrase XII (CAXII) in the infiltration zone of primary glioblastomas. Immunohistochemical analysis found high CAXII expression in the infiltration zone. These findings highlight CAXII as a promising target for intracavitary radioimmunotherapies and support the continued investigation of this targeted approach for the treatment of glioblastoma.

¹⁷⁷Lu-edotreotide (ITM-11), Ga-DPI-4452, Tb-DOTA-LM3, and n.c.a. ¹⁷⁷Lu-TTM are investigational products and are not approved by any regulatory authority for the safety and/or efficacy of any intended use.



About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated ¹⁷⁷Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with ¹⁷⁷Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. ¹⁷⁷Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

About Ga-DPI-4452 (ITM-94)
Ga-DPI-4452 (also known as [⁶⁸Ga]Ga-DPI-4452, CA-IX peptide, or ITM-94) is an investigational gallium-68-radiolabeled PET imaging agent targeting carbonic anhydrase IX (CAIX), a cell surface protein that plays a key role in tumor growth, invasion, and metastasis. ITM-94 is designed to non-invasively improve the characterization of indeterminate renal masses and enable more accurate diagnosis and disease staging of clear cell renal cell carcinoma (ccRCC). ITM-94 received Fast Track Designation from the FDA in October 2025. ITM-94 is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.

About Tb-DOTA-LM3 (ITM-63)
Tb-DOTA-LM3 (also known as [¹⁶¹Tb]-DOTA-LM3 or ITM-63) is an investigational terbium-161-radiolabeled targeted therapeutic acting as a somatostatin receptor 2 (SSTR2) antagonist. It is designed to deliver highly localized therapeutic radiation directly to SSTR-positive tumors and is currently being evaluated for the treatment of metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-63 is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.

About n.c.a. ¹⁷⁷Lu-TTM (ITM-31)
N.c.a. ¹⁷⁷Lu-TTM (also known as LuCaFab or ITM-31) is an investigational targeted radiotherapeutic consisting of a carbonic anhydrase XII (CAXII)-specific antibody Fab fragment coupled with ITM’s medical radioisotope, non-carrier-added (n.c.a.) lutetium-177. It targets CAXII, a cell surface protein commonly expressed in the infiltration zone of primary glioblastomas. ITM-31 is designed as an intracavitary radioimmunotherapy to directly target and eliminate remaining tumor cells following surgical resection and standard-of-care therapies in patients with glioblastoma. ITM-31 is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.

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 Lumara Bio
Lumara Bio, a division of ITM, builds on more than two decades of radiopharmaceutical expertise and is advancing a focused pipeline of targeted therapies for cancers where treatment options remain limited. https://lumarabio.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

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• ITM and Lumara Bio Announce Dose-Response Analysis for ¹⁷⁷Lu-edotreotide (ITM-11) and Data Supporting Early-Stage Pipeline at EANM 2026