FluoGuide has achieved several important milestones in 2025. Our comprehensive pre-IND package included detailed information on completed development activities to support the upcoming IND (Investigational New Drug) and outlined proposed plans for continued studies. Our development plan includes one Phase 2 and one Phase 3 clinical trial in the U.S. to support a New Drug Application (NDA), the formal submission to the FDA required for approval before a drug can be marketed in the U.S.

Importantly, FluoGuide received FDA alignment on its U.S. high-grade glioma (HGG) Phase 2 clinical trial design and key elements of its future Phase 3 clinical program. This regulatory alignment provides a strong foundation for the IND submission, supports long-term development planning, and in our view, de-risks the overall regulatory strategy toward NDA submission. This positions the company to advance its clinical programs with greater confidence and long-term clarity.

Therefore, we also maintain our milestone to submit an IND application for the U.S. Phase 2 clinical registration trial in HGG in Q4 2025. FluoGuide will provide additional information on the development program following submission of the IND application.

Morten Albrechtsen, CEO of FluoGuide said: “FluoGuide has made substantial progress during 2025. With the constructive feedback from FDA, we believe we have further de-risked the path towards approval, while maintaining our overall plan to submit the IND before year end.”