Curasight announces acceleration of therapeutic strategy to strengthen position as a radiopharmaceutical theranostic company

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• USA - English

• Coming Phase I/IIa basket trial planned to include five select cancer indications
• Study will apply Curasight's uPAR theranostic platform approach combining diagnosis (uTRACE^®) and therapy (uTREAT^®)
• First patients expected to be dosed in the beginning of 2025 with expected first efficacy data in 2025.

COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design. The trial will investigate Curasight's theranostic (therapeutics/diagnostics) approach by testing the diagnostic platform uTRACE^® and the treatment platform uTREAT^® in brain cancer (Glioblastoma), neuroendocrine tumors (NET), head-and-neck cancer (HNSCC), non-small cell lung cancer (NSCLC), and pancreatic cancer. To strengthen the Company's capital structure and secure funding for the acceleration of clinical activities, Curasight intends to launch a rights issue during the first quarter of 2024. Details of the rights issue are to be announced in a separate press release immediately following this release.

"We believe the theranostic approach using radiopharmaceuticals to both diagnose and treat certain types of cancer has the potential to provide important new solutions to clinicians and patients," said Curasight's CEO, Ulrich Krasilnikoff. "We have already achieved important results in most of the indications with our diagnostics platform uTRACE as well as positive preclinical results in brain and lung cancer using our therapeutic solution uTREAT. By launching this basket trial, we can accelerate development of both uTRACE and uTREAT (theranostic) in parallel and potentially have therapeutic efficacy data already during 2025. The trial of five cancer types in parallel takes advantage of our theranostic platform working across tumor types as uPAR is expressed in the majority of all solid cancers. This also increases the likelihood of entering into partnering with pharma companies."

The Phase I/IIa basket trial is part of Curasight's strategy to be a leader in the field of theranostics within radiopharmaceuticals and diagnostics, combining improved diagnosis with more targeted, gentler and efficient treatment of cancers.

The new study is in addition to Curasight's ongoing Phase II trial investigating uTRACE in prostate cancer as part of the partnership agreement with Curium Inc., where the first interim data is expected Q3 2024. Under the terms of the deal, Curasight is responsible for development until regulatory approval with Curium responsible for manufacturing and commercialisation. Curasight is entitled to receive up to mUSD 70 in development and commercial milestones as well as double-digit percentage royalties on sales in major markets upon eventual commercialization.

About the uPAR Theranostics platform

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 (targeted radionuclide therapy) and uTRACE (based on non-invasive PET imaging), both of which target uPAR. By performing imaging, and using the same substance for treatment, it can be more precisely predicted where the therapy will go.

This information is such information that Curasight A/S is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the care of the above contact person, for publication on 13 February 2024.

For more information regarding Curasight, please contact:

Ulrich Krasilnikoff, CEO
Phone: +45 22 83 01 60
E-mail: [email protected]
www.curasight.com

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SOURCE Curasight