The information contained in this section of the website of Curasight A/S (the "Company") (a) is only intended for, and may only be accessed by, or distributed or disseminated, directly or indirectly, in whole or in part, to persons resident or physically present outside the United States of America (including its territories and possessions, any state of the United States and the District of Columbia, the "United States"), Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, and resident and physically present in a jurisdiction where to do so will not constitute a violation of the local securities laws or regulations of such jurisdiction, and (b) does not constitute an offer to sell or the solicitation of an offer to buy or acquire, any ordinary shares or other securities of the Company in the United States, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which such release, publication or distribution would be unlawful. If you are unable, or have any doubt whether you are able, to provide the necessary confirmation you should press "No" and you will not be able to view information about the offering.
In particular, the information does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, or form part of any offer, invitation or solicitation to purchase, securities to any person in the United States. The shares of the Company referred to in this section of the website (the "Shares") have not been and will not be registered under the Securities Act and may not be offered or sold within the United States absent registration under the Securities Act or pursuant to an available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities laws of any state or other jurisdiction of the United States. There is no intention to register any Shares in the United States or to make a public offering of the Shares in the United States. Furthermore, the Shares have not been and will not be registered under the applicable securities laws of Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which it would be unlawful or would require registration or other measures, and therefore may not be offered or sold or for the account or benefit of any person having a registered address in, or located or resident in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa or any other jurisdiction in which it would be unlawful or would require registration or other measures.
Access to the information and documents contained on the following section of the Company’s website may be illegal in certain jurisdictions, and only certain categories of persons may be authorised to access such information and documents. All persons residing outside of Denmark who wish to have access to the documents contained in this section of the Company’s website should first ensure that they are not subject to local laws or regulations that prohibit or restrict their right to access this section of the website, or require registration or approval for any acquisition of securities by them. No such registration or approval has been or will be obtained outside Denmark. The Company assumes no responsibility if there is a violation of applicable law and regulations by any person.
The contents of this website are not to be incorporated into, or construed to form part of, any of the documents included herein. Except as otherwise explicitly stated herein as applicable to them, no information included on this website should be used by investors in forming their investment decision as to an investment in the Shares.
The use of this section of the website is subject to Danish law and any disputes arising out of or regarding this section of the website is subject to Danish law and the exclusive jurisdictions of the Danish courts.
I therefore certify that each of the following is true and accurate:
- I am resident and physically present outside the United States, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa; and
- I am resident and physically present
- in Denmark or
- outside Denmark, the United States, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa and, in that case, I am authorized to access the information and documents on this website without being subject to any legal restriction and without any further action required by the Company; and
- I have read, understand and agree to comply with all of the restrictions set forth above. I understand that the disclaimer may affect my rights and I accept to be bound by the disclaimer. By clicking "Yes", I confirm that I have permission to access the electronic versions of the information.
The information contained in this section of the website of Curasight A/S (the "Company") is restricted and is not for release, publication or distribution, directly or indirectly, in whole or in part in, into or from the United States of America (including its territories and possessions), any state of the United States and the District of Columbia, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which such release, publication or distribution would be unlawful.
Curasight announces acceleration of therapeutic strategy to strengthen position as a radiopharmaceutical theranostic company
February 13, 2024
· 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, 13 February 2024 - Curasight A/S ("Curasight" or the “Company" – TICKER: 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