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Research

Curasight (One-pager): Entering Clinical Validation of a uPAR Theranostic Platform

Curasight
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Summary

  • Curasight has advanced its uPAR-based theranostic platform into clinical development, with the Phase I uTREAT® trial in glioblastoma and the Phase II uTRACE® prostate cancer study progressing under a partnership with Curium.
  • The transition of uTREAT® into human trials expands Curasight's market potential and shifts investor focus towards the therapeutic prospects of the platform, despite the program being at an early clinical stage.
  • The upcoming initial data read-out for uTREAT®, expected by the end of 2025, is a critical milestone that could validate the combined uTRACE®/uTREAT® approach and influence future multi-indication trials.
  • Market valuation reflects increased sensitivity and risk, with potential success in the basket trial possibly leading to a larger partnership agreement in 2026.

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Curasight has entered a new clinical phase with both arms of its uPAR-based theranostic platform now in clinical development, following the successful first patient dosing in the Phase I uTREAT® trial in glioblastoma and continued progress in the Phase II uTRACE® prostate cancer study under the partnership with Curium. With diagnostic proof-of-concept already established across multiple indications, the transition of uTREAT® into human trials materially expands the company’s addressable market and shifts investor focus toward the therapeutic upside embedded in the platform.

At current valuation levels, we believe the market is increasingly pricing in optionality around uTREAT®, despite the program remaining at an early clinical stage. The initiation of first-in-human dosing increases both upside potential and execution risk, as the upcoming preliminary data read-out will be the first indication of whether preclinical efficacy can translate into a clinically viable therapeutic signal.

Looking ahead, the initial uTREAT® data read-out, expected before year-end 2025, represents a key inflection point for Curasight’s theranostic ambitions. Supportive safety and feasibility data could validate the combined uTRACE®/uTREAT® approach and enable progression toward a broader multi-indication basket trial in 2026. As a result, near-term valuation sensitivity has risen, with the market now implicitly pricing in some probability of success for the basket trial and hence raising near-term clinical risk relating to the data. The potential of Curasight’s theranostic approach based on uPAR remains significant, and a positive read-out can open the door for a larger partnership agreement in 2026.

Disclaimer: HC Andersen Capital receives payment for a digitalIR/Corporate visibility subscription agreement. / Philip Coombes 12:35 22/12-2025

Curasight is a Danish biotech company focusing on developing and improving the detection and treatment of cancer in a more gentle and efficient way. The company has two pipeline products that both use radionuclide (nuclear medicine) to facilitate better diagnosis and treatment of various cancer types; uTRACE use the so-called uPAR as a biomarker to diagnose the aggressiveness of cancer, and uTREAT use the uPAR as a attachment to treat the cancer. Based on good phase 2 data that has already been collected or will be in the first half of 2022, Curasight is expected to prepare phase 3 for uTRACE later in 2022 and 2023 for the following four cancer types: prostate, brain, neuroendocrine, and head and neck cancer.

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