With reference to the recently published positive results from the investigator-initiated phase II studies performed by researchers at Rigshospitalet, using the uTRACE technology in both Neuroendocrine tumors (NET) and head and neck cancer, Curasight has decided also to further develop uTRACE for use in these two indications in order to obtain FDA approval in 2026.

This will be added to the current program with uTRACE in brain cancer, which is still the lead indication both within diagnostics and therapy, in addition to prostate cancer. The expectation is still to get uTRACE approved for use in brain cancer in 2025.

Going forward, Curasight's clinical development in diagnostics (uTRACE) will thus include two additional phase III studies, comprising neuroendocrine tumors (NET) besides head - neck cancer, which strengthens the strategic position with uTRACE as a diagnostic platform and increases the commercial opportunities considerably.

Similarly, Curasight will also develop a therapeutic option (uTREAT) for neuroendocrine tumors (NET) and head and neck cancer in addition to brain cancer.

About neuroendocrine tumors

Each year approximately 35,000 new cases are diagnosed in the US and EU. Due to the long survival of these patients, more than 400,000 patients are living with the disease in the US and EU.  Neuroendocrine tumors are a rare form of cancer that occurs in glandular cells most frequently in the lining of the gastrointestinal tract or in the lungs, but the disease can in principle occur in all organs of the body.

About head and neck cancer

Head and neck squamous cell carcinoma is the 6th most common cancer worldwide with 890,000 new cases and 450,000 deaths in 2018. The incidence is anticipated to increase over the coming years

"With the expansion of our clinical development program, Curasight as a theranostic company will be positioned very strong both technologically and commercially. However, there will be a need to strengthen the financial preparedness in 2023 - just as the company expects to enter into one or more partnerships within some of the cancer indications over the next year. As uTRACE has already been tested in more than 450 patients and has shown its strength in various cancer indications this cross-validation has immensely supported the proof of the technology. Therefore, rather than testing sequentially in different indications, we have decided to pursue a parallel strategy with the addition of two more indications. This will support faster value creation in Curasight and opens up for more partnerships.", says Ulrich Krasilnikoff

A number of online presentations are expected during March, where we will go deeper into the two new indications. However, already in connection with the scheduled online presentation of the annual report 2021 and year-end reports Q4 2021 at HC Andersen Capital on February 24[th], 2022 (Link (https://hcandersencapital.dk/event/curasight-praesentation-af-aarsrapporten/)), there will be an opportunity to ask questions about the expanded strategy.

About uPAR Theranostics

Curasight has developed a novel and innovative Theranostics platform for improved cancer diagnosis and treatment. The combination of using targeted radionuclide therapy to treat cancer, and a non-invasive PET imaging for diagnosing and monitoring, is known as Theranostics (Therapy + Diagnostics = Theranostics). Curasight's solution combines the technologies uTREAT (https://www.curasight.com/technology/utreat/) (targeted radionuclide therapy) and uTRACE (https://www.curasight.com/technology/utrace/) (based on non-invasive PET imaging). Both technologies target uPAR which is why Curasight's solution is called uPAR Theranostics. The benefit of having a Theranostics pair is that by performing imaging, and using the same substance for treatment, it can be exactly predicted where the therapy will go - or what you see is what you treat.