FluoGuide (FLOU) Q4 2025 earnings summary

Executive summary

• Achieved three positive Phase II trials, regulatory alignment with FDA for U.S. Phase II trial of FG001 in high-grade glioma, and established a clear regulatory path for lead indications.

• Initiated new clinical trials in head and neck cancer and non-malignant brain cancers, with expanded partnerships including Olympus, ZEISS, Intuitive Surgical, and SurgVision.

• Strengthened management and leadership team, and completed significant capital raises to fund ongoing operations and clinical milestones.

Financial highlights

• Reported a full-year net loss of DKK 39.5 million, with Q4 2025 net loss of DKK 13.1 million.

• Assets totaled DKK 88 million, with DKK 79 million in cash and securities at year-end.

• Equity stood at DKK 55 million, with a loan of DKK 28 million and working capital payables of DKK 5 million.

• Cash preparedness rose to DKK 78.8 million at year-end, mainly from capital raise and credit facility.

• Market cap at year-end DKK 389 million, up from DKK 370 million a year earlier.

Outlook and guidance

• IND application submitted and green light received to initiate first U.S. registration trial; first patient enrollment expected in H1 2026.

• Interim results from low-grade glioma and head and neck studies expected in H2 2026.

• Plans to present a comprehensive brain tumor strategy and PDT optimization plan in H2 2026.

• Focus on executing U.S. Phase II trial for FG001 in high-grade glioma and expanding indications.

• Anticipates one additional commercial partnership in 2026.