Curasight has enrolled the first patient in its phase II trial with uTRACE in prostate cancer, activating a second USD 500,000 payment from partner Curium. Curasight also announced a capital raise aimed at further strengthening the company’s finances. The fund raise, which includes a directed share issue, a loan facility, and warrants will initially provide DKK 27.8 million, and the package could eventually provide up to DKK 120 million.

Curasight is a Copenhagen-based clinical development company within radiopharmaceuticals, using the uPAR receptor for PET imaging and radioligand therapy. The company aims to enhance cancer diagnosis and treatment through its theranostic uPAR platform, targeting several different types of cancer.  The injection of new capital will support Curasight’s aim to develop in parallel both the diagnosis arm, uTRACE, of its theranostic uPAR solution, and the treatment arm, uTREAT.

The European Medicines Agency (EMA) recently gave its go-ahead to commence a phase II trial, where the company’s diagnostic platform uTRACE is evaluated as a non-invasive diagnostic tool for prostate cancer patients, potentially reducing the need for biopsies. Most of these patients are not given active treatment immediately, but rather monitored for changes in cancer aggressiveness, aiming to avoid unnecessary interventions.

First patient enrolled

The enrolment of the first patient in the uTRACE phase II trial is a pivotal moment in the collaboration between Curasight and its partner, Curium, triggering a USD 500,000 milestone payment.

This is the second milestone payment under the agreement, which could eventually yield up to 70 MUSD in development and commercial milestones for Curasight, along with double-digit royalties on future sales.

Curasight aims to present part I results in the fourth quarter of this year. These results will be instrumental to the company, hopefully validating the body of phase II data already gathered from previous investigator-initiated trials.

Capital raise could provide up to DKK 120 million

Since canceling a rights issue earlier this spring, Curasight has worked tirelessly to secure funding for the ongoing parallel development of its theranostic platform. The company has now announced capital raise package including a directed share issue, a loan facility and warrants which in total could strengthen the company with a total of DKK 120 million.

The directed share issue will raise approximately DKK 6.7 million from external investors at a price of DKK 9.60 per share, which corresponds to a discount of 20 per cent to the DKK 12 volume weighted average price in the share during the last ten trading days. On top of that, a DKK 1,15 million issue is directed toward the management and board of directors, executed at DKK 12 per share, i.e. without the discount offered to external investors.

Together with this immediate capital injection, Curasight also intends to do a preferential issue of units to existing shareholders, to secure longer-term financing. The units issued consist of two series of warrants. The first, series TO2, could potentially add a maximum of DKK 57.3 million in late November this year. The second tranche of warrants, called TO 3, has an exercise period at the beginning of June 2025, and could potentially raise up to an additional DKK 35.7 million for the company.

The exercise price for the warrants will be determined via the volume-weighted average share price 20 days before the start of the exercise period, with a 30 per cent discount and within a predetermined range. For the TO 2 series warrants, the range is set to DKK 11.50 – 15.55 per share. For the TO 3 series warrants, the range is set to DKK 15.55 – 19.40 per share also based on the volume weighted average share price 20 days back, with a discount of 30 percent.

Draws DKK 10 million of a DKK 20 million loan facility

Additionally, Curasight has agreed a DKK 20 million loan facility with Fenja Capital II and the company will draw a first tranche of DKK 10 million from that facility. The second tranche can be drawn once the TO2 and TO3 warrants are available for trading. The first tranche has the maturity date set to the end of December 2024, and the second tranche is to be paid back in July 2025, after the exercise of the TO3 series warrants.

Fenja also has the right to request in part a conversion of the loan through two directed share issues of DKK 5 million respectively. In the first directed issue, Fenja can subscribe for new shares at DKK 14.4 per share. In the second, the subscription price is set to DKK 16.8 per share. If Fenja decides to convert the loan to shares, the company is not obliged to repay the converted part of the loan.

Results and uTREAT trial start

Upon full subscription, this package is estimated to finance the company’s development activities into the second half of 2025. Between now and then Curasight has a number of important triggers, hoping to present results from the first part of the uTRACE prostate cancer study and full recruitment for the second part of that study.

Additionally, the company also plans to initiate a phase I/IIa trial with uTREAT by Q2 2025. Planning for that study and setting the focus indication is currently ongoing.

Comments from the CEO

BioStock contacted Ulrich Krasilnikoff to learn more about the financing package and the plans going forward.

If you secure all DKK 120 million you “will have funds to finance operations into the second half of 2025, when the company expects to be able to onboard larger institutional investors in parallel with ongoing discussions with big pharma”. What needs to happen for those stakeholders to jump on board?

– On the clinical side, we expect to have achieved a number of milestones prior to the redemption of the warrant packages T02 and T03.

– The first milestones we expect in advance of T02 are initially the preliminary efficacy data on uTRACE, phase II, in prostate cancer, which is being run under the partnership agreement with Curium.

– Before the redemption of T03, we expect to have submitted and received approval of Clinical Trial Application by EMA for uTREAT, in a phase I/IIa trial in the first indication. We also expect to have dosed the first patient with uTREAT, in this indication, providing proof-of-concept in relation to uTREAT.

– Of course, as part of our business strategy we are always talking with big pharma but we have not included any partnerships or potential out-licensing agreements in our assumptions.

This capital raise has a somewhat special structure, where you combine share issues and warrants with a loan facility. Why was this structure the most beneficial for the company and the existing shareholders?

– The fundraising consists of three main components – a directed issue, a loan facility and units to all shareholders consisting of two series of warrants – T02 and T03. The purpose has been to satisfy the company’s need for bridge financing in the short term by the directed issue and loan facility, without our shareholders being diluted too much.

– However, as we have a number of important inflection points in the next 12 months, it is important for us to give our shareholders the opportunity to take part in any increased value in the company, and we can do that with the warrant element of the financing package.

Turning the attention to the studies, the prostate cancer study is split into two parts. Can you tell us more about the study design?

– 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 II trial is part of the development framework agreed under the deal with Curium.

– The trial is divided in two parts – part I covering 27 patients and part II covering 141 patients. Part I will include three hospitals – two in Sweden and one in Denmark. In addition to these hospitals, part II will also include hospitals in Germany and the last patient in the trial is expected to be included in Q2 2025 prior to the redemption of warrant package T03.

Is the uTREAT phase I/IIa trial the basket study that was communicated about in March this year?

– Following discussions with big pharma and key opinion leaders we can see that it is important for us to be able to demonstrate clinical “proof-of-concept” for uTREAT as rapidly as possible. Therefore we have identified a route where we can pursue a single indication where we run a relatively small trial that can be completed rapidly to provide this first validation of our uTREAT approach.

– As the uPAR biomarker is cancer specific but not cancer type specific it works across cancer types. So we can document the efficacy and safety in a cost effective and rapid way in a first indication and then run the larger and more complex basket study with five different indications to provide further broader evidence of the application in different cancer types.

The development of uTREAT has mainly revolved around glioblastoma. Is that the indication that you will start with?

– I cannot yet disclose which single indication will be tested in our initial phase I/II trial with uTREAT. However, we have gained much insight testing uTRACE with glioblastoma patients and it remains one of our main indications as the prognosis for glioblastoma patients is very poor and there is a strong unmet medical need for the treatment of this type of cancer.

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