FluoGuide AS’s shares rose 7.4% on Tuesday after the Danish biotechnology company reported progress in preparing its U.S. registration trial for FG001, its lead uPAR-targeting cancer imaging candidate. The stock closed at $33.40, up $2.30 from the prior session, within a 52-week range of $28.00 to $47.80.
The company reported a net loss of DKK 24.6 million in the first half of 2026, with total liquid assets of approximately DKK 61 million, including DKK 50 million in cash and securities and DKK 11 million in expected tax credits. External operating costs reached DKK 18.3 million, driven by DKK 13.2 million in research and development expenses for trials CT-005 and CT-006. Cash burn totaled DKK 29 million, including DKK 28.2 million from operations, while liabilities included a DKK 27 million loan from Fenja Capital. Total assets stood at DKK 65 million as of June 30, 2026, with equity of DKK 31 million and a current ratio of 13.7.
FluoGuide secured FDA Fast Track designation for its high-grade glioma (HGG) registration trial, complementing prior Orphan Drug status. The company also received approval to open the first U.S. trial site, with seven additional sites nearing activation. The primary endpoint for the HGG trial is the completeness of tumor resection, measured by pre- and post-operative MRI scans. Morten Albrechtsen, CEO, highlighted the clinical significance of uPAR as a biomarker, stating it is "expressed the most where you need it the most."
In parallel, the head and neck cancer trial CT-005 completed dose selection with 15 patients enrolled at the University Medical Center Groningen. Data from the trial demonstrated compatibility with multiple camera systems, with future cohorts expected to incorporate automated margin assessment. Interim results for CT-005 have been delayed into early 2027 following a protocol amendment announced on July 2.
The company also reported progress in its low-grade glioma trial at Rigshospitalet, where the first patient was enrolled in May. Data from this study is anticipated in the second half of 2026. Albrechtsen described the potential of uPAR imaging as a "game-changer" for brain tumor surgery, particularly in overcoming the challenges posed by the blood-brain barrier.
