FG-001

FINANCIAL HIGHLIGHTS 2024 HIGHLIGHTS Q1 2024 Entered a strategic collaboration with Intuitive Surgical, focusing on integrating FG001 into robotic-assisted surgery for head and neck cancer. Provided a strategic update outlining development plans for FG001 towards commercialization. Q2 2024 Successfully raised SEK 60 million through a directed share issue, strengthening the financial foundation for ongoing clinical development. Selected a laser system for photothermal therapy with FG001, advancing its dual capability as both a surgical guidance and therapeutic tool. Q3 2024 Appointed Jens Ellrich as Chief Medical Officer, bringing critical expertise in clinical development and regulatory strategy. Submitted a Clinical Trial Application (CTA) for FG001 in head and neck cancer, progressing towards regulatory approval. Q4 2024 Published positive Phase II data for FG001 in head and neck cancer, validating its ability to improve surgical precision and outcomes. Progressed FG001 trials in aggressive brain cancer and additional indications such as meningioma and low-grade glioma, with results expected in 2025. Strengthened leadership and governance through key appointments and board adjustments. Highlights after the period: The Company received approval for phase II trial in head and neck cancer. “2024 was a pivotal year for FluoGuide, marked by a new strategic partnership, advancements in FG001’s therapeutic potential and successful capital raise” says Morten Albrechtsen, CEO. LOOKING AHEAD – 2025 MILESTONES Advance FG001 toward FDA consultations to confirm the design of the registration trial in aggressive brain cancer. Enroll the first patient in the Phase II trial (FG001-CT-005) for FG001 in head and neck cancer. Deliver interim data from the head and neck cancer trial (FG001-CT-005) to guide regulatory progress. Expand FG001’s applications in photothermal therapy and brain cancer indications. Establish new strategic partnerships to accelerate FG001’s commercialization. PRESENTATION In connection with the annual report publication, CEO Morten Albrechtsen and CFO Ole Larsen will participate in an interview with Redeye analyst Christian Binder on February 27, 2025. The interview will be video-recorded and uploaded to FluoGuide’s website under Investor Presentations on February 28, 2025.

The Phase II Clinical Trial Application (CTA) for FG001 in head and neck cancer, announced on October 7, 2024, has been granted approval under the new European process by the Dutch Central Committee on Research Involving Human Subjects and the Medical Ethical Committee of the University Medical Center Groningen. The CTA submission followed strong clinical topline data from a proof-of-concept Phase II clinical trial of FG001 in patients with head and neck cancer. The trial evaluated surgical precision using various surgical equipment and advanced FG001 to help patients with head and neck cancer.” Morten Albrechtsen, CEO at FluoGuide states: "The approval is a significant milestone to advance FG001 helping patients with head and neck cancer. We are on track to enroll first patient in first quarter of 2025 and the key data trigger point is expected in the second half of 2025 with the interim data.” FluoGuide and Principal Investigator Prof. Dr. Max Witjes are now preparing to initiate the Phase II trial (CT-005) in head and neck cancer, which will be conduct a single center trial to: Evaluate multiple endpoints for measuring surgical completeness with FG001 in patients with head and neck cancer Explore different benefits of FG001 in assisting these patients Access the use of various surgical equipment types Enroll 25-30 patients, with enrollment starting in Q1 2025 The interim data is expected in the second half of 2025 being the data trigger point The trial completing in H2 2026 Depending on trial data and regulatory feedback, the FluoGuide plans to conduct a multisite registration trial as the next step toward approval and commercialization.