FluoGuide (FLOU) Q3 2025 earnings summary

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.