New Risk • Jul 27
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swedish stocks, typically moving 12% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. 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). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 38% per year over the past 5 years. Revenue is less than US$1m. Announcement • Jul 27
Curasight A/S Announces Protocol Amendment to Ongoing Phase I Clinical Trial Evaluating UTREAT In Patients with Glioblastoma Curasight A/S announced a protocol amendment to the ongoing Phase I clinical trial evaluating uTREAT in patients with glioblastoma. The amendment has been submitted to the relevant regulatory authorities and is pending approval. The proposed amendment is intended to optimize the clinical study design and broaden the information obtained to design next phase studies. The key proposed changes include: Administration of uTREAT without blood-brain barrier disruption through mannitol for newly enrolled patients. Participants enrolled under the amended protocol will therefore constitute a separate cohort receiving uTREAT without blood-brain barrier disruption. Comparison with the first cohort, will gain information of the effect of blood-brain barrier disruption. Increasing the lowest number of patients to be included to allow for at least 6 patients dosed with uTREAT without blood-brain barrier disruption. General anaesthesia will be introduced during the neurointerventional procedure for participants enrolled under the amended protocol to optimize working conditions and thereby the precise administration of uTREAT. Short-term general anesthesia is considered safe in brain-tumor patients. The protocol amendment has been developed in close collaboration with the investigators and is based on experience gained during the ongoing trial and reflects a desire to further optimize the study design with additional data that will benefit the design of next phase studies. The proposed changes are subject to approval by the relevant regulatory authorities and ethics committees before implementation. The Company expects that the protocol amendment will extend the duration of patient enrolment due to the increased number of participants. Curasight will provide further updates as material developments occur. 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 is 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 5-10% are still alive. The cornerstone in GBM treatment is radical surgery followed by radiation and concomitant chemotherapy (Stupp regime). uTREAT could potentially complement current radiation strategies and reduce radiation exposure to healthy brain tissue due to more specific tumor tissue targeting. 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. 
