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FluoGuide (FLOU) investor relations material
FluoGuide Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Achieved major regulatory, clinical, organizational, and financial milestones, significantly de-risking the path to approval for the lead product FG001 in high-grade glioma (HGG).
Secured FDA alignment on phase II/III trial design for HGG, with IND submission on track for year-end.
Strengthened leadership and board, and completed a SEK 104 million equity raise with minimal dilution.
Entered strategic partnerships with Olympus and ZEISS to accelerate clinical adoption.
Financial highlights
Q3 2025 EBIT loss of DKK 9.1m (Q3 2024: loss of DKK 6.5m); net loss of DKK 8.6m (Q3 2024: DKK 5.5m).
Cash position at September 30, 2025: DKK 13.7m (Sep 2024: DKK 20.2m); equity negative DKK 2.4m (Sep 2024: positive DKK 31.6m).
Market cap DKK 360m (Sep 2024: DKK 366m); solvency ratio -8% (Sep 2024: 90%).
November 2025 directed share issue raised SEK 104m (DKK 71m), expected to lift solvency ratio to ~70% by year-end.
Outlook and guidance
2025: Focus on regulatory milestones for FG001 in HGG, expansion to additional brain tumors, and head & neck cancer.
2026: Initiate US phase II trial for HGG, interim results for low-grade glioma and head & neck cancer trials, and optimize FG001's photosensitizer therapy.
Plan to form 1-2 additional strategic partnerships in 2026 to support commercialization.
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Frequently asked questions
FluoGuide is a Danish clinical-stage biotech company specializing in the development of products used to improve cancer surgery. FluoGuide's main product, FG001, is designed to illuminate brain cancer cells during surgery, enabling surgeons to distinguish them more easily from healthy tissue. FG001 is designed to bind specifically to cancer cells, making them visible under a special light during surgery. This aims to reduce the risk of leaving cancerous tissue behind, potentially increasing the success rate of surgeries. The company is also actively researching whether its fluorescent technology can be employed to potentially improve surgery outcomes for a variety of different cancers. FluoGuide is headquartered in Copenhagen, and its shares are listed on Nasdaq Stockholm.
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