What you see is what you treat!

Curasight is a successful Danish theranostic Phase 2 biotech company focused on diagnosing and treating cancer through Targeted Radionuclide Therapy – currently in brain cancer, prostate cancer, head and neck cancer and neuroendocrine cancer. With Curasight’s technology (uTRACE and uTREAT), cancer can be diagnosed and treated at the cellular level without harming healthy cells, so that what you can detect of cancer is what you treat with radiation: What you see is what you treat.

The main points of Curasight’s investment case are therefore a conviction that Cursasight’s targeted radiotherapy and diagnostics will initially achieve positive progress in the development/studies and thus that the company will be interesting for partnerships with e.g. Big Pharma and achieve the company’s objectives. The company has already landed a large deal for uTRACE in prostate cancer in collaboration with Curium, where Curasight will receive up to MUSD 70 in commercial and development milestones and double-digit royalties on sales.

Curasight’s objectives are:

• For uTrace to become an alternative to biopsy in prostate cancer and the method used to monitor patients
• For uTrace + uTreat to gain a significant market share in brain cancer
• Achieve a broad pipeline of cancer indications that will make the company even more attractive for partnerships with Big Pharma

Price triggers:

• Start of Phase 2 trial of uTRACE in prostate cancer Q2 2024
• First clinical data from Phase II study of uTRACE in prostate cancer in collaboration with Curium Q3 2024
• Preclinical results in various cancer indications with uTREAT 2024
• Application to health authorities in the EU and US to start clinical studies with uTREAT 2024
• New milestone payments in the agreement with Curium 2024/2025
• New partner agreements for uTRACE and uTREAT 2024/2025

• Continued expansion of the pipeline, which will particularly strengthen the ability to enter into partnerships

Risks:

• Negative study results in both uTRACE and uTREAT. Especially applicable for the Phase II trial in prostate cancer in collaboration with Curium
• Competition from new or other products
• Lack of partnerships for pipeline development and financing
• Increasing risk aversion in the market, which biotech companies in particular are exposed to

Curasight’s pipeline

Curasight has divided its portfolio into therapeutic programmes for uTREAT, diagnostics for uTRACE and partner programmes with external companies. Curasight has completed preclinical trials for uTREAT and is currently in the planning phase for Phase I/IIa. For uTRACE, the company has conducted phase I trials in a wide range of indications, as well as phase II trials in selected indications. Finally, the partner programme is in Phase II for uTRACE in prostate cancer in collaboration with Curium. Curasight is exploring the possibility of entering into more agreements with partners so that there will eventually be more partner programmes. Please note that the investigator initiated studies with uTRACE are paid for by Rigshospitalet (National University Hospital of Denmark).

What you see is what you treat!

Curasight is a Phase II Targeted Radionuclide Therapy clinical stage company focused on the diagnosis and treatment (theranostic) of cancer.

Both diagnosis and treatment are based on the uPAR receptor, which most solid cancer cells have, but which healthy cells do not. Curasight has developed a uPAR-binding compound that both identifies the cancer cells (uTRACE) and can irradiate the cancer cells (uTREAT).

uTRACE is injected into the patient’s blood vessels and binds to the cancer cells, and only to the cancer cells, as they are the only ones that have the uPAR receptor. uTRACE thus binds to the cancer cells regardless of whether it is the primary tumor or metastases. uTRACE emits radiation that can be detected by an image scanner (PET scanner). This makes it possible to see where the cancer cells are and how widespread they are.

The advantages of this method are numerous and significant compared to, for example, diagnosis by taking a biopsy, as it allows for continuous monitoring of cancer patients and patients with brain cancer. In addition, it allows better assessment of the best treatment options, including whether surgery is needed. It also avoids having to operate on patients who did not need surgery, which for prostate cancer is up to 70% of those operated on.

uTREAT basically works in the same way as uTRACE, by injecting the uPAR-binding substance into the patient’s veins, where it binds to the cancer cells. Unlike uTRACE, the uPAR binding agent has a radionuclide attached to it that can irradiate the cancer cell. As the irradiation has a radius of only 1 mm, only the cancer cells are damaged and not the surrounding healthy tissue.

The advantages of uTREAT over conventional radiotherapy are significant. In conventional radiotherapy, healthy tissue/cells are also affected, as the radiation is delivered from the outside. Therefore, conventional radiotherapy has many and varied side effects, depending on which and how much healthy tissue is damaged. With uTREAT, only the cancer cells are irradiated, thereby minimizing side effects, which is a significant advantage in brain cancer, for example.

The starting point is therefore that if you can visualize the cancer on a scan image – then it is very likely that you can also treat the cancer with targeted radionuclide radiotherapy, as the same biomarker, uPAR, and the same substance is used to bind to the receptor in uTRACE and uTREAT – in other words “What you see – is what you treat”. The studies with uTRACE, which have shown uptake in tumors, thus show that uTREAT will also bind to the tumor and exert its anti-cancer effect through local radiotherapy.

Pipeline and development

Curasight has continuously expanded its pipeline to cover a number of different indications: brain cancer, prostate cancer, head and neck cancer, non-small cell lung cancer (NSCLC), pancreatic cancer and neuroendocrine cancer. The uTRACE diganostic platform is the most advanced and the easiest and least expensive platform to develop. Curasight has completed 5 phase 2 clinical studies and has plans for phase 3 studies in the future.

uTREAT has previously shown efficacy in preclinical studies in prostate and colon cancer, is in preclinical testing in glioblastoma (aggressive brain cancer). The first step in the testing of new targeted radionuclides is the study of biodistribution, where both binding to the implanted human glioblastoma tumors as well as distribution to organs is tested. The binding to the tumor must be sufficiently high to allow a therapeutic response and the biodistribution to organs must be such that serious side effects are unlikely.

uTREAT has now been tested in a human xenograft glioblastoma tumor model and has passed both criteria, paving the way for further efficacy testing.

Phase II data from an investigator-initiated study with Curasight’s uTRACE technology, which showed significant potential to become a valuable future tool in therapy, planning and follow-up in patients with head and neck cancer. The results showed that patients with a high uptake of uTRACE have a significantly worse prognosis regarding recurrence-free survival, strengthening the company’s thesis of uTRACE’s potential as a tool to measure cancer aggressiveness. Researchers from Rigshospitalet also performed a multivariate analysis with a number of commonly used prognostic markers and concluded that only uTRACE remained significant in terms of recurrence-free survival. This means that uTRACE was not only highly prognostic, but also the strongest prognostic marker among those included in the analysis.

Business Case

Curasight’s business model is partly to develop uTRACE and uTREAT in the various indications and partly to expand the number of indications in order to increase the possibilities of entering into partnerships with Big Pharma or obtaining financing for development. Essential elements in this are that the market potential for Curasight’s platforms is large and that a launch can be achieved as soon as possible.

Brain cancer (Glioblastoma)

Approximately 65,000 patients in Europe and the US are diagnosed with brain tumours each year, of which 30,000 are diagnosed with glioma, where treatment prospects are poor. Glioblastoma is a rare disease, which is why there is a possibility of obtaining Orphan Drug Designation and thus a faster path to launch. Approximately 10% of patients are children. The prognosis for people 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.

Non-small cell lung cancer (NSCLC)

NSCLC is the most common type of lung cancer, with 700,000 diagnosed annually in the US and EU. The 5-year survival rate is only 28%, which is why there is a great medical need for more effective therapies. The global market for NSCLC drugs is estimated at USD 15.1bn in 2023 with an annual growth rate of 9.4% to USD 28.3bn in 2030.

Prostate cancer (uTRACE)

Up to 70% of patients undergo unnecessary surgery for prostate cancer. As there can be significant side effects of surgery, including impotence, uTRACE could become the primary alternative to biopsies.

Head and neck cancer

Head and neck cancer is the 6th most common cancer with 890,000 new cases and 450,000 deaths annually. The incidence is expected to increase in the coming years. The main finding from the phase II study with uTRACE was that patients with high uptake on uPAR-PET compared to those with low uptake had an 8.5 times worse prognosis in terms of recurrence-free survival. And when compared to commonly used prognostic markers (FDG-PET, TNM stage and p16 status) in a multivariate analysis, only uPAR-PET remained significant. The study concluded that uPAR-PET could potentially be valuable for treatment planning and follow-up in patients with head and neck cancer. In addition, the presence of uPAR in head and neck cancer patients, and especially in those with the most aggressive disease, also provided the basis for pursuing uPAR-targeted radionuclide therapy (uTREAT) in this cancer type.

Neuroendocrine tumours

Every year, 35,000 new cases of neuroendocrine tumours are diagnosed, which can occur anywhere, but primarily in the lungs and gastrointestinal tract. As the cancer is not particularly fatal, there are more than 400,000 patients with the disease in the US and Europe.

Pancreatic cancer

Pancreatic cancer is the 12th most common cancer worldwide. It is the 12th most common cancer in men and the 11th most common cancer in women. There were more than 495,000 new cases of pancreatic cancer in 2020. Pancreatic cancer begins when abnormal cells in the pancreas grow and divide uncontrollably, forming a tumour. The pancreas is a gland located deep in the abdomen, between the stomach and the spine. It produces enzymes that aid digestion and hormones that control blood sugar levels. More than 66,000 Americans are expected to be diagnosed with pancreatic cancer by 2024.

Overview of the pipeline