Announcement • Jun 09
Curasight Announces Preliminary Readout from Phase 1 Clinical Trial with uTREAT In Aggressive Brain Cancer Curasight A/S announced encouraging preliminary readout from its Phase 1 clinical trial with uTREAT in patients with aggressive brain cancer (glioblastoma). A preliminary readout of the Phase 1 clinical trial with uTREAT in glioblastoma, an aggressive brain cancer, has now been undertaken. The data support: The feasibility and safety of the mode of administration, super-selective intra-arterial cerebral injection (super-SIACI) with local, transient opening of the blood-brain barrier (BBB) using mannitol. High uptake and retention in tumor. Biodistribution and dosimetry compatible with the ability to deliver a therapeutically relevant radiation dose to the tumor without reaching dose limits for healthy organs. The data support continued development of Curasight's therapeutic program using uTREAT in aggressive brain cancer. The trial aims to investigate Curasight's uTREAT as a new targeted radioligand therapy for patients with glioblastoma. Participants in the trial are patients with newly diagnosed, verified or suspected GBM. uTREAT is administered via a catheter directly into the vessels that feed the tumor (super SIACI). To enhance tumor targeting, the blood-brain barrier is transiently opened with the osmotic compound mannitol. The mode of administration is designed to achieve high binding of uTREAT in tumors while minimizing radiation exposure to healthy organs. Curasight's uPAR theranostic platform combines two key technologies - uTRACE and uTREAT - both targeting uPAR. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT offers a targeted radiopharmaceutical therapy solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR. Curasight's ambition is to develop both uTRACE and uTREAT to improve diagnosis and treatment of uPAR-expressing cancers. Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors, and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10% of patients with primary brain tumors are children. The prognosis for individuals 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. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially complement current radiation strategies and reduce radiation exposure to healthy brain tissue due to more specific tumor tissue targeting. New Risk • Jun 01
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.62m free cash flow). Earnings have declined by 38% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Share price has been volatile over the past 3 months (11% average weekly change). Announcement • Mar 25
Curasight A/S Announces Board Changes Curasight A/S announced that Marcel Reichen and Colin Hayward as new board members replacing Lars Trolle and Charlotte Vedel with consent of all votes represented at the general meeting. Andreas Kjær was elected as deputy chairman of the Board of Directors.