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  • Curasight Announces Enrollment of First Patient in Phase 2 trial with uTRACE[®] in Prostate Cancer

Curasight Announces Enrollment of First Patient in Phase 2 trial with uTRACE[®] in Prostate Cancer

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  • Recruitment of first patient triggers second milestone payment of USD 500.000 to Curasight under the collaboration agreement for uTRACE® in prostate cancer with Curium Inc.
  • Milestone is an important step in the development of the uTRACE PET imaging technology, part of Curasight’s theranostic platform leveraging the uPAR target for improved diagnosis (uTRACE®) and radioligand treatment (uTREAT®) of certain cancers
  • Under the agreement signed with Curium Inc. in 2023, Curasight is eligible to receive up to mUSD 70 in development and commercial milestones plus double-digit royalties on sales upon commercialization

Copenhagen, June 12, 2024 - Curasight A/S (“Curasight” or “the Company” – TICKER: CURAS) today announced the enrolment of the first patient in the Phase 2 trial using uTRACE® PET imaging technology for the improved diagnosis in prostate cancer. The news triggers the second USD 500.000 milestone under the agreement with Curium Inc., signed in May 2023. uTRACE® is part of Curasights Theranostic platform using the uPAR target for improved diagnosis and treatment (uTREAT®) of certain cancers.

“The enrolment of the first patient in our Phase 2 trial under the deal with Curium marks an important step in the development of the diagnosis arm of our theranostic platform. I would like to thank the patients and doctors involved in this trial in supporting our efforts to develop uTRACE® as a potential alternative option to the use of biopsies for people with prostate cancer, said Curasight’s CEO Ulrich Krasilnikoff”. “Today’s news is also testament to the positive collaboration and momentum we have in our collaboration with Curium.”

Under the terms of the deal with Curium signed in May 2023, Curasight will develop its proprietary uTRACE® technology for use in prostate cancer until regulatory approval is granted in the EU and USA with Curium responsible for the commercial manufacture of uTRACE® and world-wide commercialization. Curasight is eligible 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 Phase 2 trial with uTRACE® in prostate cancer 

The primary objective of the phase 2 trial is to investigate Curasight’s first-in-class PET tracer, 64Cu-DOTA-AE105 as a non-invasive grading tool of prostate cancer patients that are followed in active surveillance. Patients in active surveillance are continuously monitored for changes in the aggressiveness of their prostate cancer and can be followed for years without identifying the need for treatment. The trial design is informed from research and earlier studies with uTRACE® as well as protocol discussions with the US Food and Drug Administration (FDA).  The phase 2 trial is part of the development framework agreed under the deal with Curium.

About the uPAR diagnostic platform 

The uTRACE® platform is part of Curasights uPAR theranostic solution, made up of its uTRACE® diagnostic technology and its uTREAT® targeted treatment technology. In prostate cancer, uTRACE® is presently developed for diagnostic purposes only. Curasight’s ambition is to develop both uTREAT® and uTRACE® to improve diagnosis and treatment solutions of certain cancers.

About Curium

Curium is a global leader in radiopharmaceuticals. Curium develops, manufactures, and distributes world-class radiopharmaceutical products to help patients around the globe. Their proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET, and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually.  www.curiumpharma.com.

For more information regarding Curasight, please contact:

Ulrich Krasilnikoff, CEO

Phone: +45 22 83 01 60

E-mail: uk@curasight.com

www.curasight.com

Curasight is a clinical development company based in Copenhagen, Denmark. The Company is a pioneer in the field of exploiting a novel Positron Emissions Tomography (PET) imaging (uTRACE®) and Radioligand Therapy (uTREAT®) Theranostic Platform targeting the urokinase-type plasminogen activator receptor (“uPAR”). The technology is expected to improve diagnosis and provide more gentle and efficient treatment of multiple cancer types.