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. New Risk • Feb 28
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.52m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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.52m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings have declined by 39% per year over the past 5 years. Shareholders have been substantially diluted in the past year (127% increase in shares outstanding). Revenue is less than US$1m. Announcement • Jan 28
Curasight A/S to Report Fiscal Year 2025 Results on Feb 26, 2026 Curasight A/S announced that they will report fiscal year 2025 results on Feb 26, 2026 Announcement • Jan 13
Curasight A/S Announces Encouraging Preliminary Data from Phase 1 Trial Evaluating First-In-Class Radiopharmaceutical Utreat in High-Grade Gliomas Curasight A/S announced encouraging preliminary data from the first patient dosed in ongoing Phase 1 clinical trial in patients with high-grade gliomas. Position emission tomography (PET)- images from the first treated patient showed clear and sustained uptake of uTREAT in the tumor, confirming that the drug successfully targets cancer tissue. The signal remained visible for at least 24 hours, indicating prolonged tumor binding and supporting the potential for effective radiation delivery to the tumor. The patient's PET signal persisted until the last PET scan (24 hours), demonstrating that uTREAT has protracted binding kinetics, translating to a maximized tumor absorbed dose. These early results provide support for Curasight's uPAR-targeted approach in radiopharmaceuticals and the potential of uTREAT as a novel therapy for patients with high- grade gliomas and other uPAR expressing aggressive solid tumors (>85% of solid tumors). The preliminary dosimetry readout of uTREAT was in line with expectations and supports to continue with additional GBM patients. Currently more patients are enrolled, and top-line data is expected in second quarter of 2026. The phase 1 clinical trial is designed to evaluate the dosimetry and safety of Curasight's drug candidate uTREAT as a first-in-class uPAR targeted radiopharmaceutical therapy in patients with newly diagnosed, verified or suspected glioblastoma (GBM). Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE as well as protocol discussions with Key Opinion Leaders. Curasight's uPAR theranostic platform combines two key technologies - uTRACE (highly precise PET imaging diagnostic) and uTREAT (highly precise radiopharmaceutical therapy) both targeting uPAR (urokinase-type plasminogen activator receptor) with the same uPAR binding peptide AE105. Together, they form an integrated approach to next generation radiopharmaceuticals in aggressive solid tumors. uTRACE is fully developed, GMP manufactured and validated in 9 clinical trials (450 patients). uTRACE is partnered with Curium Inc. in the field of diagnostics for prostate cancer. 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 the patients are children. Announcement • Dec 19
Curasight A/S Announces Successful Dosing of First Patient in Phase 1 Trial with Utreat®? in Brain Cancer Curasight A/S announced the successful and safe dosing of the first patient in the Phase 1 trial using uTREAT in brain cancer (high grade gliomas). The news marks the initiation of the first clinical trial under the company's therapeutic platform uTREAT, investigating it as a potential treatment option for glioblastoma. The start of the phase 1 study with uTREAT means that Curasight is now in the clinical phase with both parts of its theranostic platform aimed at improving treatment and diagnosis of certain cancers. The company's diagnostic platform uTRACE is currently in a Phase 2 trial for prostate cancer under the strategic partnership with Curium Inc. The trial aims to investigate Curasight's uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE® as well as protocol discussions with Key Opinion Leaders. Announcement • Nov 26
Curasight A/S Announces Its Phase 1 Trial Investigating uTREAT in Aggressive Brain Cancer Is Now Open for Patient Enrollment Curasight A/S announced its phase 1 trial investigating uTREAT in aggressive brain cancer is now open for patient enrollment. Regulatory approval from the Health Authority and ethical committee approval has been obtained, and all practical and logistical preparations at the trial site have been completed. Dosing the first patient is expected in the coming weeks. The phase 1 trial is part of Curasight's theranostic strategy developing more gentle and targeted diagnosis and treatment of certain types of cancer. The trial aims to investigate Curasight's uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from clinical studies with the ligand forming the backbone of uTRACE, demonstrating that almost all GBM patients (94%), express uPAR on the tumour. Announcement • Oct 31
Curasight Advances Phase 2 uTRACE Prostate Cancer Trial with All European Clinical Sites in Part 2 Now Recruiting Curasight A/S announced strong momentum in part 2 of the Phase 2 Study investigating the company's diagnostic platform uTRACE®? in prostate cancer. All nine sites across Germany, Sweden and Denmark are now fully activated and recruiting patients following the completion of part 1 of the study earlier in 2025. This milestone illustrates Curasight's operational execution and marks an important step towards establishing uTRACE®? as a novel non-invasive imaging tool to provide better diagnosis and risk stratification of prostate cancer patients. The Phase 2 study is being run under the strategic collaboration with Curium Inc., a global leader in nuclear medicine. Under the agreement Curasight is eligible for up to USD 70 million in milestone payments and double-digit percentage royalties upon commercialization of uTRACE®?. As well as the Phase 2 study in prostate cancer, Curasight anticipates launching a Phase 1 trial testing its therapeutic platform uTREAT®? in brain cancer during the current quarter. The phase 2 trial evaluates Curasight's first-in-class PET tracer, 64Cu-DOTA-AE105 (uTRACE) as a non-invasive grading tool for assessing tumor aggressiveness in prostate cancer patients managed under active surveillance. Patients are monitored over time for changes in their tumor biology, with imaging of uTRACE®? helping clinicians to better distinguish indolent from aggressive disease and potentially reducing unnecessary treatment and improving patient outcomes. 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). New Risk • Aug 31
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.40m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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.40m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings have declined by 40% per year over the past 5 years. Shareholders have been substantially diluted in the past year (122% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr.211.4m market cap, or US$33.1m). Announcement • Aug 26
Curasight A/S Announces Acceptance of Clinical Trial Application (CTA) for Phase 1 Trial with uTREAT®? in Brain Cancer Patients Curasight A/S announced the European Medicines Agency (EMA) has approved the company's clinical trial application (CTA) for the investigation of uTREAT®? in a phase 1 trial. The phase 1 trial is part of Curasight's theranostic strategy developing more gentle and targeted diagnosis and treatment of certain types of cancer. Dosing the first patient in the trial is expected to occur before the end of the year. news means Curasight is now in clinical development with both its diagnostic (uTRACE) and therapeutic (uTREAT) platforms. The trial aims to investigate Curasight's uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE®? as well as protocol discussions with Key Opinion Leaders. Announcement • Jun 19
Curasight A/S Submits Clinical Trial Application for Phase 1 Trial with uTREAT®? in Brain Cancer Patients Curasight A/S announced submission of clinical trial application (CTA) to the European Medicines Agency (EMA) for the phase 1 trial of uTREAT®? as a treatment for glioblastoma. The CTA was submitted under the application pathway Clinical Trials Information System (CTIS) and paves the way for patients to be recruited into a phase 1 trial of uT REAT in brain cancer patients diagnosed with glioblastoma. Announcement • Jun 04
Curasight A/S has filed a Follow-on Equity Offering in the amount of DKK 1.935981 million. Curasight A/S has filed a Follow-on Equity Offering in the amount of DKK 1.935981 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 977,768
Price\Range: DKK 1.98
Transaction Features: Subsequent Direct Listing New Risk • May 31
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 126% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (29% average weekly change). Earnings have declined by 41% per year over the past 5 years. Shareholders have been substantially diluted in the past year (126% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr.165.6m market cap, or US$25.2m). New Risk • Apr 30
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: kr.62.2m (US$9.44m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings have declined by 42% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (kr.62.2m market cap, or US$9.44m). New Risk • Apr 25
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 15% 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 Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings have declined by 45% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr.122.7m market cap, or US$18.7m). Announcement • Apr 25
Curasight A/S to Report Fiscal Year 2024 Final Results on Apr 25, 2025 Curasight A/S announced that they will report fiscal year 2024 final results on Apr 25, 2025 Announcement • Apr 05
Curasight A/S has filed a Follow-on Equity Offering in the amount of DKK 100 million. Curasight A/S has filed a Follow-on Equity Offering in the amount of DKK 100 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 9,765,625
Price(maximum): DKK 10.24
Transaction Features: Rights Offering Announcement • Mar 26
Curasight A/S to Report Fiscal Year 2024 Results on May 13, 2025 Curasight A/S announced that they will report fiscal year 2024 results on May 13, 2025 Announcement • Feb 27
Curasight A/S to Report Fiscal Year 2024 Final Results on Mar 26, 2025 Curasight A/S announced that they will report fiscal year 2024 final results on Mar 26, 2025 Announcement • Jan 22
Curasight A/S to Report Fiscal Year 2024 Results on Feb 20, 2025 Curasight A/S announced that they will report fiscal year 2024 results on Feb 20, 2025 Announcement • Nov 22
Curasight A/S Announces Clinical Supply Agreement with Curium for uTREAT® Development and Commercialization Curasight A/S announced it has entered into a clinical supply agreement with Curium - a global leader in radiopharmaceuticals - for the supply of non-carrier-added Lutetium-177 for Curasight's uTREAT®. The agreement announced leverages Curium's uniquely diversified irradiation network and large-scale manufacturing capacity recently announced in its Petten, Netherlands facility, which will largely cover the future requirements for uTREAT® Phase III trials and commercialization, in particular in the US and Europe. Chait Tatineni, Curium Chief M&A Officer and Head of Curium's licensing and partnership programs added - "As the global leader in nuclear medicine, Curium is dedicated to developing life-saving diagnostic and treatment solutions for cancer patients. The company is excited about the opportunity to partner again with Curasight by ensuring a continuous supply of Lutetium-177 for their uTREAT® development program as well as in the longer term for commercial scale production. This comes in addition, to ongoing partnering of uTRACE® for prostate cancer announced in mid-2023." The rapidly increasing interest from the major pharmaceutical companies in this area for use in the diagnosis and treatment of many types of cancer - means that access to these radiometals and associated supply chains very quickly becomes a scarce factor and an important competitive parameter for the development and commercialization of new products such as uTREAT and uTRACE. Therefore, this agreement is strategically very important for Curasight. The uTREAT® platform is part of Curasights uPAR theranostic solution, made up of its uTRACE® diagnostic technology and its uTREAT® targeted treatment technology. By visualizing the cancer in an enhanced and intelligent way, the uTRACE® platform aims to provide a more accurate diagnosis in certain types of cancer including brain cancer, which can support a personalized treatment solution for each patient. The technology has been tested in multiple Phase II clinical trials with uTRACE®. Curasight will keep all rights to develop and commercialize uTREAT® in all indications. Announcement • Nov 13
Curasight A/S Announces International Patent Application for uTREAT® to Broaden IP Protection Curasight A/S announced the publication of its international patent application for uTREAT®. The patent application is in addition to already granted patents covering the company's peptide-based uPAR-targeting technology and if granted will extend patent protection to 2043. The international patent application WO2024/153756 A1 was filed in 2023 and covers the use of additional alpha-emitters and beta-emitters radionuclides in 2023. Existing patents covering the company's technology have previously been granted in the US, Canada, Europe, Japan, China and Hong Kong with protection lasting into 2033. These patents relate to the use of the beta-emitting radionuclide Lutetium-177 (177Lu). About the application: The patent application (international publication WO2024/153756 A1) covers the use of additional radionuclides - both alpha-emitters and beta-emitters. The alpha-emitters covered by the application include Actinium-225 (225Ac), Lead-212 (212Pb), and Terbium-149 (149Tb). For beta-emitters, Copper-67 (67Cu), and Terbium-161 (161Tb) are now covered in addition to the previously granted patents on 177Lu. Announcement • Nov 07
Curasight A/S Publishes Clinical Phase II Trial of uPAR-PET in Brain Cancer Patients; Data Supports Development of uTREAT for Brain Cancer Curasight A/S announced that the investigator-initiated phase II study using uPAR-PET in brain cancer has been published The investigator-initiated clinical trial testing 68Ga-NOTA-AE105 uPAR-PET/MR in patients with gliomas (most common primary brain cancers), where the oral presentation was reported in 2023, has now been published in the scientific journal EJNMMI Research. The prospective phase II trial that was carried out at Copenhagen's Rigshospitalet, investigated the prognostic value of uPAR-PET with 68Ga-NOTA-AE105 (uTRACE) in 24 patients with primary gliomas. In addition, the study analysed the proportion of patients that were uPAR-PET positive to estimate the potential number of candidates for future uPAR-targeted radioligand therapy (uTREAT). Of the 24 patients, 16 (67%) were diagnosed with WHO grade 4 gliomas, 6 (25%) with grade 3, and 2 (8%) with grade 2. Almost all (94%) of the grade 4 gliomas (glioblastomas) were uPAR-PET positive. At median follow up of 18.8 (2.1-45.6) months, 19 patients had disease progression and 14 had died. uPAR expression dichotomized into high and low, revealed significant worse prognosis for the high uPAR group for overall survival (OS) and progression free survival with hazard ratio of 14.3 (95% CI, 1.8-112.3; P=0.011), and hazard ratio of 26.5 (95% CI, 3.3-214.0; P=0.0021), respectively. New Risk • Nov 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.34m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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.34m free cash flow). Earnings have declined by 47% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (4.0% increase in shares outstanding). Market cap is less than US$100m (kr.218.2m market cap, or US$31.8m). Announcement • Oct 23
Curasight A/S to Report Q3, 2024 Results on Nov 21, 2024 Curasight A/S announced that they will report Q3, 2024 results on Nov 21, 2024 New Risk • Jul 28
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 4.0% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. 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.32m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings have declined by 50% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (4.0% increase in shares outstanding). Market cap is less than US$100m (kr.227.5m market cap, or US$33.1m). Announcement • Jul 24
Curasight A/S to Report Q2, 2024 Results on Aug 22, 2024 Curasight A/S announced that they will report Q2, 2024 results on Aug 22, 2024 Announcement • Jun 18
Curasight A/S to Report Q3, 2024 Results on Jul 02, 2024 Curasight A/S announced that they will report Q3, 2024 results on Jul 02, 2024 New Risk • Jun 01
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 13% 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.32m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 50% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr.228.8m market cap, or US$33.3m). New Risk • May 24
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.32m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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.32m free cash flow). Earnings have declined by 50% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (kr.204.9m market cap, or US$29.8m). Announcement • Apr 24
Curasight A/S to Report Q1, 2024 Results on May 23, 2024 Curasight A/S announced that they will report Q1, 2024 results on May 23, 2024 Board Change • Apr 19
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Deputy Chairman of the Board Charlotte Vedel was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Apr 17
Curasight A/S Announces Approval of Clinical Trial Application (CTA) for Phase 2 Trial with uTRACE in Prostate Cancer Patients Curasight A/S announced approval of clinical trial application (CTA) from the European Medicines Agency (EMA) for the investigation of uTRACE in a phase 2 trial as a non-invasive alternative or supplement to traditional biopsies in prostate cancer patients in active surveillance. The phase 2 trial is part of Curasight’s collaboration with Curium for uTRACE in prostate cancer, announced in May 2023 and the first patient is expected to be dosed in Second Quarter 2024. The trial is aimed at providing clinical insight into the use of uTRACE as a non-invasive way of providing more accurate diagnosing and grading of prostate cancer, an area with a recognized high unmet medical need. 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 radiopharmaceutical theranostic solution, made up of its uTRACE diagnostic technology and its uTREAT radioligand therapy 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 several solid cancers. Announcement • Apr 12
Curasight A/S Announces Board Changes Curasight A/S announced that the chairperson of the Board of Directors, Per Falholt wishes to step down from the Board of Directors with immediate effect due to personal reasons. Kirsten Drejer has been elected as the new chairperson of the Board of Directors. Kirsten Drejer holds a PhD in pharmacology and has been involved in drug development throughout her career. She is probably best known as co-founder and CEO of Symphogen A/S for 16 years. During her leadership at Symphogen A/S, she raised more than 300 million EUR from prominent international investors, 250 million EUR in non-dilutive cash through partnerships and grew the company to become one of the most prominent biotech companies within oncology with more than 100 employees. Kirsten Drejer serves currently as Vice Chair of the Board of Zealand Pharma A/S and holds a board position in Malin Corporation. Announcement • Mar 12
Curasight A/S has withdrawn its Follow-on Equity Offering in the amount of SEK 51.155712 million. Curasight A/S has withdrawn its Follow-on Equity Offering in the amount of SEK 51.155712 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 2,841,984
Price\Range: SEK 18
Transaction Features: Rights Offering Announcement • Feb 21
Curasight A/S, Annual General Meeting, Mar 21, 2024 Curasight A/S, Annual General Meeting, Mar 21, 2024. Announcement • Jan 24
Curasight A/S to Report Fiscal Year 2023 Results on Feb 22, 2024 Curasight A/S announced that they will report fiscal year 2023 results on Feb 22, 2024 Announcement • Dec 22
Curasight Gears Up for Phase II Study in Prostate Cancer Following the Curium deal this spring, Curasight has now submitted a clinical trial application and selected a CRO to carry out a phase II trial with uTRACE. The trial intends to evaluate the uTRACE for the diagnosis of prostate cancer patients. BioStock contacted Curasight CEO Ulrich Krasilnikoff to learn more. Based on a focus on the uPAR receptor, a well-established marker for cancer aggressiveness, Curasight’s uTRACE is leveraging non-invasive assessment of the severity of cancer across various cancer types. Following up on the promising phase II results obtained in 2021, Curasight’s uTRACE has shown potential in prostate cancer, head and neck cancer, and neuroendocrine tumours. Licensing deal with Curium: This spring the company signed a licensing agreement with Curium, a leading name in the field of radiopharmaceuticals, for the development of uTRACE as a prostate cancer diagnostics tool. Curasight’s vision is to establish uTRACE as either an alternative or a complementary solution to conventional biopsy procedures in prostate cancer patient monitoring. Financially, the agreement entitles Curasight to receive up to 70 MUSD in milestone payments, along with double-digit royalties on future sales, while maintaining responsibility for the ongoing development of uTRACE. Meanwhile, Curium will handle the manufacturing and commercialisation aspects of the product. Curasight retains the rights to further develop and commercialise uTRACE in imaging indications outside prostate cancer and therapy in any indication using the company’s second product, uTREAT. Assigns CRO for phase II trial: Taking the next step in the partnership, Curasight announced that it had submitted a clinical trial application to the European Medicines Agency (EMA) for a phase II trial with uTRACE in prostate cancer. The company has also assigned ABX-CRO for the execution of the study. ABX-CRO is a German-based CRO with extensive experience in conducting international diagnostic and therapeutic trials with radiopharmaceutical agents. The study is a significant component of the agreement with Curium and the target is to dose the first patient in Second Quarter of 2024. Evaluates copper version of uTRACE: The phase II trial’s primary goal is to evaluate uTRACE, specifically the Copper-64-labeled version, as a non-invasive grading tool for prostate cancer patients under active surveillance. In connection with the Curium deal, Curasight disclosed that they had received constructive feedback from the FDA in a pre-IND meeting regarding this version of uTRACE, which is seen as a substantial commercial step for the company. The copper labelled version of uTRACE offers logistical advantages due to its long shelf-life, allowing for centralised distribution from a limited number of production sites, thereby potentially streamlining the supply chain and improving market reach. The trial design, informed by previous research and FDA discussions, will be conducted in two parts across university hospitals in Denmark, Sweden, Germany, and the US. Announcement • Oct 26
Curasight A/S to Report Q3, 2023 Results on Nov 24, 2023 Curasight A/S announced that they will report Q3, 2023 results on Nov 24, 2023 New Risk • Oct 23
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 8.3% 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 Risk Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (8.3% average weekly change). Market cap is less than US$100m (kr.417.8m market cap, or US$59.7m). Announcement • Oct 18
Curasight A/S Reports Positive Preclinical Results with uTREAT[®] in lung cancer (NSCLC) Curasight A/S announced preclinical data demonstrating preclinical proof of concept of uTREAT® in treating non-small cell lung cancer (NSCLC). Today's news follows the announcement earlier this year of positive preclinical results of uTREAT® in glioblastoma. Data from the study showed that uTREAT®, when administered to a preclinical mouse model of non-small cell lung cancer (NSCLC), effectively inhibited tumor growth. This data demonstrates the potential for uTREAT® to be used as a radioligand therapy for the treatment of NSCLC and supports further development for this indication. Curasight's uPAR theranostic platform is based on two-pronged approach to enable better and more targeted cancer detection and treatment. Using intelligent cancer imaging with uTRACE® platform the company can more accurately detect and classified certain cancers. This understanding can then be utilised with uTREAT® platform to provide more targeted and gentle treatment for certain cancers. Announcement • Sep 15
Curasight A/S Announces Positive Results from the Phase II Study of uTRACE in Brain Cancer Presented at the World Molecular Imaging Congress (WMIC) 2023 in Prague Curasight A/S announced that the previously announced results from the investigator-initiated phase II study using uPAR-PET (uTRACE®?) in primary brain cancer have been presented in an oral presentation at the World Molecular Imaging Congress (WMIC) 2023 in Prague. The oral presentation expanded on the topline results released earlier this year on June 29th and were presented in the session "Prospective Phase II Trial of [68Ga-NOTA-AE105] uPAR-PET/MRI in Patients with Primary Gliomas: Prognostic Value and Implications for uPAR-Targeted Radionuclide Therapy" by Dr. Aleena Azam from Rigshospitalet and University of Copenhagen. The abstract of the presentation will, together with the other abstracts presented at the WMIC, be published in an upcoming issue of the medical journal Molecular Imaging andiology (Springer Publisher). The Phase II study was carried out in 24 glioma patients, 22 with high-grade gliomas and 2 with low-grade gliomas. Of the high-grade gliomas, 16 were grade IV (Glioblastomas). All 24 patients underwent a uPAR-PET scan with 68Ga-NOTA-AE 105 (uTRACE®?), and tumor uptake was evaluated as SUV values. The patients were followed over time to assess progression-free survival (PFS) and overall survival (OS). Patients were divided into high and low uPAR groups. Of the Glioblastomas 94% (15 of 16) were uPAR-PET positive. uPAR-PET was highly prognosis, and the high uptake group compared to the low uptake group had a more than 10-fold poorer prognosis (hazard ratio). Treatment of glioblastoma presents a significant unmet medical need, necessitating innovative and effective treatments. Curasight's research and development efforts aim to address this challenge and improve the lives of patients facing aggressive brain cancer. Glioblastoma is the first indication for uTREAT®?, but uTREAT®? has also potential in several other cancer types expressing the biomarker uPAR. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed with the aggressive form, glioblastoma, annually in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50 % of the patients die within 14 months and after five years from diagnosis only 5 % are still alive. Announcement • Jul 26
Curasight A/S to Report Q2, 2023 Results on Aug 24, 2023 Curasight A/S announced that they will report Q2, 2023 results on Aug 24, 2023 Announcement • Jun 29
Curasight A/S Announces Positive Results in Upar-Pet/MR Phase II Study in Brain Cancer Curasight A/S announced positive results from the investigator-initiated phase II study using uPAR-PET (uTRACE®?) in primary brain cancer. The study found that uPAR-PET/MR was a suitable target for the detection and prognosis of primary glioblastomas, the most common type of primary brain cancer. The investigator-initiated trial tested 68Ga-NOTA-AE105 uPAR-PET/MR in a total of 24 glioma patients of which 16 (67%) were WHO grade 4 (glioblastomas), 6 (25%) were WHO grade 3 and 2 (8%) were WHO grade 2. Among glioblastoma patients, 94% had uPAR-PET positive tumors. uPAR-PET positivity indicates that a patient may be eligible for future uPAR-targeted radionuclide therapy, e.g. uTREAT®?. Results from the study, carried out at Rigshospitalet in Copenhagen, will be presented at the World Molecular Imaging Congress (WMIC) in Prague, September 2023. Treatment of glioblastoma presents a significant unmet medical need, necessitating innovative and effective treatments. Curasight's research and development efforts aim to address this challenge and improve the lives of patients facing aggressive brain cancer. Glioblastoma is the first indication for uTREAT®?, but uTREAT®? has also potential in several other cancer types expressing the biomarker uPAR. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed with the aggressive form, glioblastoma, annually in the US and EU. Approximately 10% of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50% of the patients die within 14 months and after five years from diagnosis only 5% are still alive. Announcement • Jun 07
Curasight A/S Reports Positive Preclinical Results with uTREAT in Aggressive Brain Cancer (Glioblastoma) Curasight A/S announced preclinical data demonstrating the effectiveness of uTREAT in treating aggressive brain cancer (glioblastoma). The results from the study validate Curasight's strategic focus on developing uTREAT as a viable treatment option for patients with aggressive brain cancer. Data from the study showed that uTREAT, when administered to a preclinical model of human aggressive brain cancer, effectively inhibited tumor growth. Animals receiving uTREAT survived longer compared to animals not treated with uTREAT. These data demonstrates the potential for uTREAT to be used as a radioligand therapy for the treatment of aggressive brain cancer and supports further development for this treatment. Announcement • Jan 25
Curasight A/S to Report Fiscal Year 2022 Results on Feb 23, 2023 Curasight A/S announced that they will report fiscal year 2022 results on Feb 23, 2023 Announcement • Oct 14
Curasight A/S Initiates Pre-Clinical Studies with uTREAT Therapy in Head and Neck Cancer and Neuroendocrine Tumors Curasight A/S announced that it has initiated pre-clinical studies of uPAR targeted radionuclide therapy in head and neck cancer and in neuroendocrine tumors. Results are expected to be available during first half of 2023. The study starts are in line with Curasight's expanded strategy to pursue therapy as well as diagnostics within head & neck cancer and neurodocrine tumors as announced in February this year. The decision to expand into new therapeutic areas is based on the published positive results from investigator-initiated phase-II studies with diagnostic uTRACE in both indications. Announcement • Jun 30
Curasight A/S Announces Recruitment Completes in uPAR-PET Study in Brain Cancer Curasight A/S announced that the investigator-initiated phase II study using uPAR-PET in brain cancer has now completed the inclusion of patients. The investigator-initiated trial testing 68Ga-NOTA-AE105 uPAR-PET/MR in patients with gliomas (most common primary brain cancers) aimed to collect data on 30 patients out of a total of 35 patients recruited to the trial. This number has now been reached and the first data analysis can begin according to the primary investigator. The trial, being carried out at Rigshospitalet in Copenhagen, is designed to investigate the diagnostic performance of uPAR-PET in brain cancer. First data from the study is expected to be published during H2 2022. Announcement • Jun 25
Curasight A/S Announces Positive Data of uTREAT® in Glioblastoma Provides "Green Light" to Proceed with Next Steps The biodistribution results from Curasight A/S' ("Curasight") testing of uTREAT® for the treatment of glioblastoma are now available. The results are positive and provide "green light" to proceed to the next step. As previously communicated, Curasight's therapeutic technology uTREAT®, a uPAR-targeted radionuclide therapy, entered into preclinical testing in glioblastoma. The first step in testing new targeted radionuclides is the study of biodistribution, where both the binding to the implanted human glioblastoma tumors as well as distribution to organs are tested. The binding to the tumor needs to be sufficiently high to make a therapeutic response likely, and the biodistribution to organs needs to be such that severe side effects are unlikely. uTREAT® has now been tested in a human xenograft glioblastoma tumor model and passed both criteria, which is encouraging and constitutes a "green light" to proceed into further efficacy testing. Is New 90 Day High Low • Feb 09
New 90-day high: kr.41.50 The company is up 112% from its price of kr.19.60 on 11 November 2020. The Swedish market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Healthcare Services industry, which is up 17% over the same period. Is New 90 Day High Low • Jan 07
New 90-day high: kr.34.45 The company is up 25% from its price of kr.27.50 on 09 October 2020. The Swedish market is up 6.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Healthcare Services industry, which is up 2.0% over the same period. Announcement • Dec 23
Curasight Announces Results from Phase II Study in Prostate Cancer to Be Published in the Journal of Nuclear Medicine Curasight announced results from the phase II study performed by researchers at Rigshospitalet were available in 2020. Following data analysis, a scientific manuscript covering the results has been submitted by the research group to the Journal of Nuclear Medicine where it underwent a stringent peer-review process. Following this process, the manuscript has been accepted for publication in an upcoming issue of the Journal of Nuclear Medicine probably during H1 2021. The phase II study: The aim of the phase II study was to evaluate the correlation between uptake on uPAR-PET with [68]Ga-NOTA-AE105 (uTRACE[®]) and Gleason Score in prostate cancer patients undergoing prostate biopsy. SUV[*)] measurements from uPAR PET in primary tumors as delineated by mpMRI showed a significant correlation with Gleason score, and tumor SUVmax was able to discriminate between low-risk and intermediate risk Gleason score profiles with high diagnostic accuracy. Consequently, uPAR PET/MRI could be a promising method for non-invasive evaluation of prostate cancer, which may in the future potentially reduce the need for repeated biopsies, e.g. in active surveillance. The Journal of Nuclear Medicine is the official publication of the Society for Nuclear Medicine and Molecular Imaging and the highest ranked journal within nuclear medicine based on number of citations (impact factor). Before the final version of the article can be published, it will undergo copyediting, proofreading and author review, which may lead to some differences between the accepted and final, published version. Once the final version is published, this will be communicated. Announcement • Nov 14
Curasight A/S Initiates Pre-Clinical Study on Therapy in Brain Cancer and Signs CRO-Agreement Curasight A/S announced that it has initiated the pre-clinical study of uPAR targeted radionuclide therapy in brain cancer and signed an agreement with the Danish CRO Minerva Imaging A/S to conduct the pre-clinical study. The initiation of the pre-clinical study is thus in line with previously communicated targets. Minerva Imaging has provided the company with a cost-efficient proposal that ensures that the Company's communicated timelines are kept. Results are, as earlier communicated, expected to be available during 2021. In connection with company's issue of units in September 2020, the Company announced in the prospectus its plans to initiate a (uTREAT[]) pre-clinical therapeutic study in brain cancer before the end of 2020, with results available in 2021. The company has now signed an agreement with Minerva Imaging, a Danish CRO with expertise in targeted radionuclide therapy and extensive experience in conducting pre-clinical studies for drug development within the oncology space, to execute the study according to the previously communicated schedule. Announcement • Oct 10
Curasight A/S has completed an IPO in the amount of DKK 32.688 million. Curasight A/S has completed an IPO in the amount of DKK 32.688 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 283,750
Price\Range: DKK 115.2 
