Curasight’s eventful half-year crowned by EMA approval

While the diagnostic tool uTRACE has already been tested in patients, the recent EMA approval will allow the therapeutic candidate uTREAT to also move into the clinic. Developing both technologies in tandem is central to Curasights theranostic strategy, which combines precise cancer imaging with targeted treatment in a single platform.

In a recent interview with BioStock, CEO Ulrich Krasilnikoff said:

– The EMA approval for the phase I study with uTREAT in aggressive brain cancer means we can soon start enrolling patients and be on track to deliver first data by the end of the year. The recent capital injection means we are now well equipped to deliver on this plus other key milestones in our clinical development pipeline.

Financing secures momentum

Despite a challenging financing environment in the biotech sector, Curasight strengthened its financial foundation in Q2. The company raised DKK 47 million in a rights issue and secured DKK 18 million through loans. Nearly half of the equity investment came from new investors, including Curium International Trading BV and Pentwater Capital Management Europe LLP.

This capital ensures that the company can continue to advance its clinical programs, especially the phase II prostate cancer study with uTRACE and the upcoming glioblastoma trial with uTREAT. Patient recruitment in the uTRACE study has recently been expanded with new sites in Germany to accelerate progress.

A new chapter for uTREAT

For Curasight, traditional radiotherapy for brain cancer is like using a floodlight – it shines everywhere, including on healthy brain tissue, often leading to severe side effects. uTREAT, by contrast, works more like a laser pointer. By locking onto a molecular “address label” on the surface of tumor cells, it delivers radiation exactly where it’s needed. The company believes this could allow doctors to fight aggressive cancers more effectively while giving patients a better quality of life.

Against this backdrop, the EMA’s decision to approve Curasight’s application for a phase I study of uTREAT in glioblastoma is an important development.

Outlook for 2025 and beyond

Looking ahead, Curasight expects to enroll the first glioblastoma patients in Q4 2025 and deliver preliminary efficacy data before year-end. Meanwhile, the uTRACE prostate cancer trial continues, with top-line results planned for H1 2026.

Commenting on the developments so far in 2025, CEO Ulrich Krasilnikoff told BioStock:

– Looking ahead to the rest of 2025, the cash injection from the rights issue allows us to maintain momentum, with preliminary data from the glioblastoma phase I study expected by year-end. The “proof-of-concept” will be useful as it validates our uTREAT platform for clinicians, patients and potential partners.

– If a cancer can be imaged with uTRACE, it can also likely be treated with uTREAT. This dual strategy has the potential to make cancer treatment both more precise and less damaging. Glioblastoma is just the first step.