FluoGuide (FLOU) SEB Nordic Seminar presentation summary

Vision and market need

• Aims to enhance surgical precision and efficiency through fluorescence-guided surgery, collaborating with MedTech companies and surgeons to improve cancer patient outcomes.

• Cancer surgery demand is rising, with 20 million new cancer diagnoses and 12 million surgeries annually; 50% of patients experience local recurrence.

• By 2030, 45 million surgical procedures are projected annually worldwide.

Technology and clinical progress

• FG001 is a uPAR-targeted imaging agent, injected before surgery to guide tumor removal, with strong clinical data in multiple cancer types.

• uPAR is highly expressed in solid tumors and minimally in normal tissue, supporting broad applicability.

• Positive phase II clinical data in brain, head and neck, and lung cancers; over 100 patients treated with good tolerability.

• Orphan Drug Designation granted for high-grade glioma in the US, with positive FDA feedback and IND submission planned for January 2026.

Partnerships, business model, and financials

• Strategic, non-exclusive partnerships with leading MedTech firms (Zeiss, Olympus, SurgVision, Intuitive Surgical) to expand reach and adoption.

• FG001 is compatible with all major surgical equipment, reducing barriers to adoption.

• Business model includes recurring revenue from FG001 sales and synergies with surgical systems; pricing set at $4,000–5,000 per dose.

• Successful capital raise of SEK 104 million and extended credit facility secure funding into 2027.