FluoGuide (FLOU) investor relations material

Technology and clinical progress

• Developed a drug that lights up cancer during surgery, enhancing precision and enabling surgeons to distinguish cancerous tissue in real time.

• Proven efficacy in lung, head and neck, and brain cancers, with orphan drug designation in the U.S. and ongoing FDA interactions.

• Clinical trials show strong safety profile with over 100 patients and robust primary endpoints for upcoming studies.

• Product is equipment-independent, compatible with all major imaging and surgical hardware, and supported by nonexclusive partnerships with leading medtech firms.

• Phase II data and additional partnership agreements are expected soon, with IND filing and further clinical milestones on track.

Market opportunity and strategy

• Global market potential estimated at 45 million procedures annually, with near-term focus on 9 million highly relevant cases, especially in Europe and the U.S.

• Product enables surgery in more complex cancer locations, expanding the addressable market and benefiting both surgeons and equipment manufacturers.

• U.S. regulatory pathway prioritized due to higher pricing, more homogeneous hospital sales, and experienced FDA endpoints.

• Anticipated price point is $5,000 per treatment in the U.S., aligning with current competitors; European pricing expected to be slightly lower.

• Market entry strategy focuses on derisking through technical and commercial measures and leveraging partnerships for broader adoption.

Competitive landscape and differentiation

• Competing products exist, but differentiation lies in equipment independence, broad applicability across solid cancers, and superior safety allowing higher dosing.

• Product can be used with less advanced equipment due to low toxicity, increasing accessibility and market reach.

• Partnerships with major medtech companies enhance market penetration and provide mutual benefits for all stakeholders.

• U.S. market targeted first, followed by large European markets, to maximize regulatory and commercial impact.

• Future development may include therapeutic applications with higher price points, pending further research.