FluoGuide (FLOU) Q2 2026 earnings summary

Executive summary

• Achieved FDA approval and Fast Track designation for first U.S. regulatory trial in high-grade glioma, with first U.S. clinical site now open for patient enrollment and pivotal Phase 2 trial (CT-006) underway.

• Positive Phase 2 results in oral head and neck cancer; optimal FG001 dose identified and well tolerated.

• Expanded FG001 platform with new clinical trials and investigator-initiated studies in low-grade glioma and robotic surgery.

• Focus on enabling complete cancer resection using fluorescence-guided surgery, aiming for broad equipment compatibility and commercial viability.

• Focused on disciplined execution of clinical trials and strategic partnerships to drive commercialization.

Financial highlights

• H1 2026 net loss was DKK 24.6 million, mainly due to higher R&D expenses; Q2 2026 net loss DKK 12.8 million.

• Cash, cash equivalents, and securities at June 30 were DKK 50 million; total assets DKK 65 million.

• Cash burn in H1 was DKK 29 million, with DKK 28.2 million from operations.

• Equity increased to DKK 31 million; solvency ratio improved to 47%.

• November 2025 capital raise of DKK 70.4 million significantly increased cash position.

Outlook and guidance

• All H1 goals met except for first U.S. patient enrollment, now resolved with site approval.

• H2/2026 priorities: optimize FG001 and laser system use, present brain tumor plan, interim results from low-grade glioma and head/neck cancer trials, and secure new partnership.

• Long-term objectives: first U.S. approval for FG001, expansion into broader brain tumor and head/neck cancer markets, and commercialization with partners.

• Head and neck trial protocol amendment delays interim results for 10 patients to early 2027.