Copenhagen-based Curasight focuses on improving the diagnosis and treatment of cancer through its proprietary technology. The company's strategy focuses on urokinase plasminogen activator receptor (uPAR), a protein involved in cancer progression and metastasis. By developing the PET tracer uTRACE and radioligand therapy uTREAT Curasight aims to provide non-invasive tools for the localization, evaluation and treatment of various cancers.
While running the phase II study with uTRACE on prostate cancer patients together with the partner Curium The company is now focusing on getting uTREAT into the clinic. Following feedback from Key Opinion Leaders and industry players, Curasight intends to conduct a smaller Proof-of-Concept-study in a single indication. This way, the company gets a quick proof-of-concept with the drug candidate.
In the Q3 report, the CEO states Ulrich Krasilnikoff that he expects that such a proof-of-concept will lead to significant interest from the industry to collaborate on uTREAT.
– We are very focused on our business development activities and ongoing discussions with large pharmaceutical companies.
Proof-of-Concept in brain cancer
Curasight recently announced that brain cancer will be the first indication to be tested with uTREAT. This follows the publication of full phase II results from a study with the company's diagnostic technology uTRACE in the scientific journal EJNMMI ResearchThe data showed that approximately 94 percent of glioblastomas are uPAR-positive, suggesting the technology's potential in these patients.
The brain cancer study will evaluate the safety and efficacy of uTREAT in patients with uPAR-positive glioblastoma, which will provide important data for future development. The plan is to submit a clinical trial application in early Q1 next year and have the first patient dosed in Q2.
If results are positive, the next step will be to conduct a basket study with the candidate, to demonstrate its broad applicability in different types of cancer.
Secured access to Lutetium-177
The growing interest in radiopharmaceuticals has led to increased competition for access to therapeutic radiometals, such as Lutetium-177, the active component of uTREAT. Supply is low and access provides a significant competitive advantage for companies in the industry.
Curasight recently signed a global supply agreement with its partner Curium, ensuring a reliable supply of Lutetium-177. The ingredients will be delivered from Curium's state-of-the-art facility in Petten, the Netherlands.
Raises capital through redemption of TO 2
To finance planned activities, Curasight announced a financing package with units consisting of warrants of series TO 2 and TO 3 in the spring. Now the exercise of the warrants TO 2 can raise up to DKK 42 million. The subscription period will run until December 5 and gives shareholders the opportunity to invest further in the company for DKK 11,50 per share.
Following this financing round, Curasight can add an additional DKK 35,7 million in June next year by exercising the warrants in the TO 3 series. The price range for that warrant is set at DKK 15,55 – 19,40 per share and will be based on the volume-weighted average share price 20 days prior, with a 30 percent discount.
Comments from the CEO
BioStock has contacted Ulrich Krasilnikoff to get his thoughts on the past quarter and what's next.
Looking back at the last quarter, what are your reflections?
- During Q3, we progressed our plans for clinical trials with uTREAT, and we were happy to be able to announce, after the period, that brain cancer will be the initial indication for testing our therapeutic option in patients. We are now seeing momentum in our strategy to develop uTREAT in parallel with our diagnostic platform uTRACE, which is progressing well in phase II under collaboration with leading radiopharma specialist Curium.
- We were also pleased to have so much interest in our financing package, which the rights issue launched during the quarter was oversubscribed. We look forward to completing this part of the capital raise as the T02 warrants exercise period is underway.
– The major event has been the decision to accelerate dosing uTREAT® to the first patients to obtain valuable Proof-of-Concept. Whereas our technology uniquely works across most (>85%) of solid tumors, we have decided to go for a first indication, brain cancer, before we broaden out in a basket trial of an additional 5 cancer types. This strategy will allow us to dose the first patient in a little more than half a year from now and obtain a valuable inflection point that we expect to accelerate discussion with big pharma on partnering or out-licensing.
In the report, you talk about ongoing discussions with big pharma. What are the components they like about your technology?
- There are two major advantages of our technology that draw the attention of big pharma. Firstly, we are first-in-class with a uPAR-targeting peptide ligand. Secondly, our technology works across almost all solid tumors (>85%). This is in contrast to the majority of radioligand therapies in development and in contrast to the two approved radioligand therapies (Luthathera and Pluvicto) that are directed towards targets on a single cancer type (neuroendocrine tumors and prostate cancer, respectively).
- The attractiveness of our technology is that you only need to develop uTRACE or uTREAT once, and then you can test it in various cancer types. This increases the potential value of the assets immensely.
Could a partnering deal be possible with positive outcomes in the Proof-of-Concept study, or would that come later?
- Yes, definitely. We have been in continuous discussions with big pharma, and there has been great interest in our technology. However, many want to see the first patients dosed, which is exactly why we updated our strategy to move fast into a first indication, brain cancer, to obtain Proof-of-Concept. We cannot comment on the specific timing of our business development activities, but we are focused on gaining the optimal value for our technologies and why we expect 2025 to be a very interesting year for Curasight.
Shifting the focus to the prostate cancer study, how is it progressing?
- The study is moving forward according to plan, and we look forward to the readout of the preliminary efficacy data to be obtained in part I of the study.
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