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Curasight: Data read-outs pushed to H1 2027, moving out some near-term catalysts

CURASAnalyst Comment2026-08-27 11:16
Michael FriisHead of Equities

Summary

  • Curasight has delayed the timing of its clinical read-outs, with Phase 1 uTREAT® and Phase 2 uTRACE® studies now expected in H1 2027, impacting near-term catalysts.
  • Financially, Curasight reported a reduced gross loss of DKK 9.8m in Q2 2026, with cash reserves covering approximately two and a half quarters, suggesting a potential need for a funding round before the H1 2027 data read-outs.
  • The therapeutic programme has expanded to include six uPAR-expressing indications, reinforcing the investment case despite the delay in data read-outs.
  • Management acknowledges the need for a capital raise, initially planned for H2 2026, may now occur earlier due to the revised timeline for data availability.

This content is generated by AI. You can give feedback on it in the Inderes forum.

Curasight reported Q2 2026 this morning and, alongside the figures, moved the timing of its three remaining clinical read-outs. Topline efficacy data from the Phase 1 uTREAT® study in glioblastoma and data from the partnered Phase 2 uTRACE® study in prostate cancer are now both guided to H1 2027, against Q3 2026 and H2/Q4 2026 respectively at the Q1 report. The reported numbers were light on surprises. The timeline is the news.

Management points to the inherent uncertainty around the timing of final patient enrolment as the primary driver. Running alongside that, Curasight submitted a protocol amendment to the regulatory authorities on 27 July, designed to generate a more robust dataset from the ongoing Phase 1 study and to inform the design of subsequent trials. The amendment is still pending approval. A broader biodistribution and dosimetry package is exactly what the case needs, since CSO Professor Andreas Kjær has consistently framed dosimetry as the evidence that carries weight in radioligand therapy and that has underpinned transactions on data from very few patients.

On the pipeline itself, the therapeutic programme chart has expanded. The planned Phase I/IIa basket trial now covers six uPAR-expressing indications rather than five, with colorectal cancer added to NSCLC, SSTR-negative neuroendocrine neoplasms, head and neck cancer and pancreatic cancer alongside GBM. Curasight also flags next-generation uPAR ligands with higher affinity in parallel. Both point in the same direction: the platform argument is being widened while the lead asset waits on data.

Financially, spend came down in the quarter. Gross loss was DKK 9.8m in Q2 against DKK 17.7m a year earlier, operating loss was DKK 11.5m against DKK 19.0m, and EPS came in at DKK -0.24. The year-over-year improvement is flattered by a heavy Q2 2025 comparator, and H1 gross loss was broadly flat year over year at DKK 22.9m. The sequential step down from Q1 (gross loss DKK 13.1m) is the more useful signal on burn.

Cash was DKK 41.0m at 30 June, up from DKK 35.9m at year end, helped by the DKK 20m directed issue in June at DKK 17.80 per share and DKK 19.3m in loan proceeds during H1. Against that, operating cash outflow was DKK 38.3m in H1 and DKK 15.8m in Q2. At the Q2 run rate, cash on hand covers roughly two and a half quarters, which takes the company close to the H1 2027 read-outs. On that basis, a funding round ahead of the data cannot be ruled out.

The genuinely helpful item is the extension of the DKK 35m convertible loan to mid-2027, which removes the December 2026 repayment wall that the 2025 annual report identified as the source of going concern doubt. That buys time. What it does not do is fund the gap to data.

At Q1, management was explicit that financing was covered for the current year but that a raise would be needed in H2 2026, ideally executed from a position of strength on the back of data. With the data now in H1 2027, that sequencing has inverted. A raise cannot be ruled out in the coming months, but on a preliminary readout rather than a topline one. The size of the eventual dilution is now more a function of timing than of the data itself.

Set against our current investment case, today's report moves one of the four key investment reasons and sharpens one of the two key risks.

The expectation of four high-value read-outs falling within the next six months no longer holds in that form and now stretches into H1 2027. One of the key investment reasons is if anything reinforced, with the planned basket programme widened from five to six uPAR indications and the therapeutic opportunity Curasight estimates at roughly 25x the diagnostic market unchanged. Sector M&A and partnering appetite in radioligand therapy, and the structurally lower R&D spend per milestone that rare disease designations allow, are untouched by today's news.

On the risk side, we flagged clinical and financial risk, including dilution tied to the expected capital raise. The clinical risk is unchanged in substance but is now carried for longer, while the financial risk is the one that has moved more to the fore, since a raise could come before the decisive data rather than after it.

On 31 August at 12:00, CEO Ulrich Krasilnikoff and CSO Professor Andreas Kjær will present the results for the period and provide an update on the company's clinical pipeline, followed by a Q&A session

https://www.inderes.dk/videos/curasight-praesentation-af-delarsrapport-for-forste-halvar-2026

Focus could be drawn to the preliminary readout from the Phase 1 trial with uTREAT® in glioblastoma (GBM), which was the first of the four high-value data read-outs. Other topics of interest include potential partnering, the expansion of the planned Phase I/IIa basket trial, and the funding situation now that data has moved into 2027

Disclaimer: HC Andersen Capital receives payment from Curasight for a Digital IR/Corporate Visibility subscription agreement. /Michael Friis, kl. 11:16 d. 27-08-2026.

Curasight is a Danish biotech company focusing on developing and improving the detection and treatment of cancer in a more gentle and efficient way. The company has two pipeline products that both use radionuclide (nuclear medicine) to facilitate better diagnosis and treatment of various cancer types; uTRACE use the so-called uPAR as a biomarker to diagnose the aggressiveness of cancer, and uTREAT use the uPAR as a attachment to treat the cancer. Based on good phase 2 data that has already been collected or will be in the first half of 2022, Curasight is expected to prepare phase 3 for uTRACE later in 2022 and 2023 for the following four cancer types: prostate, brain, neuroendocrine, and head and neck cancer.

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