What you see is what you treat!

Curasight is a successful Danish theranostic (both diagnostic and treatment) Phase 2 biotech company focusing 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, so that what you can detect of cancer is what you treat with radiation: What you see is what you treat.

The mainstay of Curasight’s investment case is 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.

Curasight’s objectives are:

• That uTrace becomes 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:

• H1 2023: Results from preclinical studies in brain cancer with uTREAT
• H1 2023: Phase IIb results in gliobastoma with uTRACE
• H2 2023: Results from preclinical studies in new cancer types with uTREAT
• H2 2023: Clinical trial application forprostate cancer (EU)
• H2 2023: New drug applications for prostate cancer (US)
• New partnerships that will contribute to the financing of Phase III studies and fund parts of the go-to-market strategy
• Continued expansion of the pipeline, which will particularly strengthen the ability to enter into partnership

Risks:

• uTRACE Phase II data in glioblastoma (brain cancer) proves to be unsuccessful
• uTREAT proves not to be efficacious in the treatment of glioblastoma
• Competition from new or other products
• Curasight has capital into 2024, but the possibility of a capital injection during 2023 may have a negative impact on the share price this year
• Increasing risk aversion in the market, which biotech companies in particular are exposed to

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 now cover four indications: brain cancer, prostate cancer, head and neck cancer and neuroendocrine cancer. The uTRACE diganostic platform is the most advanced and the easiest and least costly platform to develop. Curasight has completed 5 Phase 2 clinical studies and has 3 ongoing Phase 2 clinical studies.

For all indications, results are expected in 2023 from both the preclinical and clinical studies with uTRACE and uTREAT. See Price triggers under the tab “Why invest in Curasight”.

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

Approximately 65,000 patients in Europe and the US are diagnosed with brain tumors 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 route to launch.

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.

Neuroendocrine tumors

Every year, 35,000 new cases of neuroendocrine tumors are diagnosed, which can occur anywhere, but mainly 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 United States and Europe.