Curasight announces brain cancer as first indication for uTREAT[®]: First patient to be dosed Q2 2025

• Brain cancer (high-grade glioma (HGG)) selected as first indication for uTREAT^®
• Addresses a clear unmet medical need
• Clinical development plan established
• Clinical trial application (CTA) submission anticipated early Q1 2025
• First patient dosed with uTREAT late Q2 2025

Copenhagen, Denmark, 11 November 2024 - Curasight A/S ("Curasight" or the “Company" - TICKER: CURAS) announces today that it has chosen brain cancer (high-grade glioma (HGG)) as the first indication for uTREAT^® as a potential cancer therapeutic. The company aims to dose the first patient with uTREAT^® end of Q2 2025.

Curasight previously communicated that for uTREAT^®, uPAR-targeted radioligand therapy, it is planned as a first step to go for a single indication trial where uTREAT^® has its greatest promise.

The accelerated strategy for uTREAT^® in a first indication has now been decided upon and a comprehensive clinical development plan (CDP) for uTREAT^® in high-grade gliomas has been established. The decision on high-grade glioma as a first indication is based on the combination of a high unmet medical need, clinical evidence of expression of the uTREAT^® target uPAR in almost all of the patients (recently published phase II trial with uTRACE^®) as well as strong preclinical efficacy data in brain cancer.

Over the past month, the clinical development team at Curasight has materialised in detail the best path to make Curasight a clinical stage company also in therapy.

Curasight expects submission of a clinical trial application (CTA) early in Q1 2025 and first patient dosed with uTREAT^® late in Q2 2025; only 7 months from now.

Curasight uses its theranostic uPAR-platform to combine diagnosis and treatment of certain types of cancer. Building on the idea that “what you see - is what you treat”, the company recently updated its strategy to develop diagnosis (uTRACE^®) and treatment (uTREAT^®) in parallel.

“The recently published Phase II uTRACE^® data in EJNMMI Research highlights the importance of both uTRACE^® and uTREAT^® in treating brain cancer, particularly glioblastoma. The study revealed that 94% of glioblastomas were uPAR-positive, strongly supporting the need for further exploration of uTREAT^® for this cancer type,” said CEO Ulrich Krasilnikoff, and continues “We are extremely proud of announcing high-grade glioma as the first indication for testing uTREAT^®. The cancer has a poor prognosis, with essentially no improvement in outcome over the last decades. Accordingly, there is a large unmet medical need and we hope that uTREAT^® will prove to be a game-changer in this aggressive cancer. The development team has worked hard to finalize a clinical development plan with an accelerated timeline and we very much look forward to dose the first cancer patient with uTREAT^® soon”.

About high grade glioma

Treatment of high-grade gliomas (WHO grades III or IV) 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 the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50% of the patients die within 14 months and after five years from diagnosis only 5% are still alive.