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Regulatory press release

Curasight Announces Preliminary Readout from its Phase 1 Clinical Trial with uTREAT[®] in Aggressive Brain Cancer (Glioblastoma)

Curasight
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Copenhagen, 8 June 2026 - Curasight A/S ("Curasight" or "the Company" - TICKER: CURAS) announces encouraging preliminary readout from its Phase 1 clinical trial with uTREAT® in patients with aggressive brain cancer (glioblastoma).

A preliminary readout of the Phase 1 clinical trial with uTREAT® in glioblastoma, an aggressive brain cancer, has now been undertaken. The data support:

 

  • The feasibility and safety of the mode of administration, super-selective intra-arterial cerebral injection (super-SIACI) with local, transient opening of the blood-brain barrier (BBB) using mannitol
  • High uptake and retention in tumor
  • Biodistribution and dosimetry compatible with the ability to deliver a therapeutically relevant radiation dose to the tumor without reaching dose limits for healthy organs
  • The data support continued development of Curasight's therapeutic program using uTREAT® in aggressive brain cancer

"The preliminary readout of our Phase 1 clinical trial with uTREAT® in glioblastoma is encouraging and supports the ability of our technology to safely deliver therapeutically relevant radiation doses to the tumor without reaching dose limits for healthy organs. With these data, we are confident in moving forward with the Phase 1 trial and the development program for uTREAT®, with the ambition of developing a potentially game-changing radioligand therapy for patients with glioblastoma," said Curasight's CEO Ulrich Krasilnikoff.

About the Phase 1 trial with uTREAT® in brain cancer

The trial aims to investigate Curasight's uTREAT® as a new targeted radioligand therapy for patients with glioblastoma. Participants in the trial are patients with newly diagnosed, verified or suspected GBM. uTREAT® is administered via a catheter directly into the vessels that feed the tumor (super SIACI). To enhance tumor targeting, the blood-brain barrier is transiently opened with the osmotic compound mannitol. The mode of administration is designed to achieve high binding of uTREAT® in tumors while minimizing radiation exposure to healthy organs.

About Curasight's uPAR theranostic platform

Curasight's uPAR theranostic platform combines two key technologies - uTRACE® and uTREAT® - both targeting uPAR. uTRACE® is designed to deliver sensitive imaging for diagnosis, while uTREAT® offers a targeted radiopharmaceutical therapy solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR. Curasight's ambition is to develop both uTRACE® and uTREAT® to improve diagnosis and treatment of uPAR-expressing cancers.

About high-grade glioma

Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors, and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10% of patients with primary brain tumors are children. The prognosis for individuals with glioblastoma is very poor, as approximately 50% of patients die within 14 months, and after five years from diagnosis, only 5% are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT® could potentially complement current radiation strategies and reduce radiation exposure to healthy brain tissue due to more specific tumor tissue targeting.