Slides
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey Light up cancer maximize surgical outcome SEB Nordic Seminar 7 January 2026 Ole Larsen, CFO
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey Disclaimer 2 This presentation contains forward-looking statements that provide FluoGuide’s expectations or forecasts of future events such as new product developments, regulatory approvals and financial performance. Such forward looking statements are subject to risks, uncertainties and may be impacted by inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of FluoGuide’s forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, breaches or terminations of contracts, government-mandated or market driven price decreases, introduction of competing products, exposure to product liability claims and other lawsuits, changes in reimbursement rules, changes of laws regulations or interpretation thereof, and unexpected cost increases. FluoGuide undertakes no obligation to update forward looking statements.
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey Vision: Maximize surgical outcome Our vision is to play an integral role in the surgical ecosystem in collaboration with MedTech companies and surgeons (hospitals) to provide the surgery of the future. That is a complete system that enhances precision and efficiency, with fluorescence-guided surgery as the foundational innovation that elevates the visualization and decision-making in the operating room, opening the door to new opportunities to advance surgical outcomes to the benefit of cancer patients. Surgical equipment Surgeons and hospitals
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey FluoGuide is improving cancer surgery 4 Cancer is frequent and recure locally after surgery - huge and growing need for precision surgery Unique uPAR-targeted image agent with strong clinical data in multiple indications Orphan Drug Designation in high grade glioma and FDA endorsement Strategic partnerships with leading MedTechs - expanding reach and adoption Financing secured runway into 2027
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey A huge and growing need for precision surgery – 45M procedures by 2030 Sources: World Health Organization, 2022; The University of Texas MD Anderson Cancer Center; Ivy Brain Tumor Center; Zhang et al: Advancements of radiotherapy for recurrent head and neck cancer in modern era, 2023; Company information. Sullivan et al. “Global Cancer Surgery: Delivering Safe, Affordable, and Timely Cancer Surgery.” The Lancet Oncology 16, no. 11 (2015): 1193–224 5 are diagnosed with cancer every year ≈20 million new patients Radiation- and chemotherapies are the two other main options Surgery is the primary treatment ≈12 million cancer patients experience local recurrence of cancer after the surgery 50% of the patients ≈ 90% ≈ 40% each year undergo cancer surgery 45 million surgical procedures needed annually worldwide in 2030
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey FG001 – Guiding surgeons to maximize outcomes 6 FG001 Injected prior to surgery Binding to tumor Guiding during surgery Sources: Company information; FG001-CT-001, data on file. Hours – Days
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey Unique technology platform 7 uPAR plays a central role in cancer spreading Most solid cancers express uPAR uPAR (urokinase-type plasminogen activator receptor) is a cell membrane receptor that plays a key role in breaking down protein Professor Andreas Kjær and his research group at University of Copenhagen plays a central role in the research behind uPAR It is widespread in all solid tumors, and almost non-existent in normal tissue Cancer breaks down protein, when it invades and spread in the body Brain Breast Pancreas Lung Bladder Ovarian Head and neck The use of uPAR is supported by comprehensive scientific documentation Colorectal Positive clinical phase ll data with FG001 FG001 not tested yet – scientific documentation support effect Sources: Company information; Metrangolo V, Ploug M, Engelholm LH. The Urokinase Receptor (uPAR) as a "Trojan Horse" in Targeted Cancer Therapy: Challenges and Opportunities. Cancers (Basel). 2021 Oct 27;13(21):5376. doi: 10.3390/cancers13215376. PMID: 34771541; PMCID: PMC8582577.
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey Pipeline with low risk and long-term patent protection 8 Source: Company information. Terminology: FGS (Fluorescent guided surgery) FG001 patent protected until 2035 (granted in Europe, USA, Canada and Australia) Additional patent applications are pending offering additional protection Patent for several products targeting uPAR until 2040 (pending applications in Europe and USA) INDICATION PRE-CLINICAL PHASE I PHASE II PHASE III FG001 Brain cancer (FGS) High-grade glioma Head and Neck cancer (FGS) Squamous cell carcinoma Photosensitizer therapy Brain cancer
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey Orphan Drug Designation in high grade glioma and positive FDA feedback • In September FluoGuide received positive FDA feedback on FG001 in high-grade glioma • Supports both the upcoming IND submission and future NDA filing • De-risks the overall regulatory strategy toward NDA submission • Orphan drug designation has been granted for high-grade glioma in US • IND to be submitted in Jan 2026 for the US phase 2 clinical trial in HGG • 40 pts with HGG • MRI assessed Gross Total Resection at 48h post surgery as primary end-point • 4-6 US centers • Multiple secondary endpoints • Planned trial initiation: Q2-26
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey Strategic partnerships with leading MedTechs – expanding reach and adoption All benefits from partnerships Non-exclusive partnerships Microscope Open field camera Endoscope Robot Back table histology 10 Intuitive Surgical (robot-assisted surgery) Patients and society: • Provided better surgery to more people Olympus (minimally invasive diagnostics and treatment) Zeiss (microscopes, world leading in HGG) SurgVision (Bracco Group, advance intraoperative imaging) FluoGuide’s objectives: • Build strong collaborative relationships that prepare for deeper market penetration • Support the market entry of FG001 • Ensure smooth integration in surgical workflows • De-risk regulatory approval • Expand the indications for FG001 Partners: • Help more patients • Sell more equipment FG001 works with all surgical equipment
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey Succesful capital raise and extended runway • Directed Issue of SEK 104 million • 6 of Top 10 shareholders participated • 5% discount vs. closing price • Approx. 1% transaction costs • Prolonged SEK 40 million credit facility until April 2027 • Secured runway into 2027
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey De-risked and proven – Positive clinical data across 3 cancer types 12 ✓ FG001: An uPAR binding peptide covalently bound to an indocyanine green (ICG) like molecule ✓ Risk mitigation by design ✓ Pre-clinical studies: Robust preclinical data demonstrated safety and feasibility ✓ Positive clinical results in three cancer indications: Aggressive brain tumor (glioblastoma), head and neck cancer (OPSCC) and lung cancer (NSCLC) ✓ Well tolerated by patients : More than 100 patients have received FG001 ✓ Regulatory: Clear path to approval for glioblastoma in USA Technical risk: Significantly de-risked ✓ Compatibility with existing equipment: Tested with multiple different types of equipment ✓ Pre-clinical treatment potential as photosensitizer: Demonstrated therapeutic effect when combined with laser in pre-clinical models ✓ Partnerships: Established with leading MedTech companies Commercial risk: Significantly de-risked
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey * Brain constitutes of both malignant and non-malignant, primary and secondary brain tumors Sources: Company information; Company homepages, last update Q1-25. Notes: (1) CTA approved. (2) As generally less malignant. Well-positioned in fluorescence-guided surgery 13 Brain* Gastro- intestinal Breast Lung Colorectum Prostate Head & Neck Bladder Pancreatic Melanoma Ovarian Sarcoma Compatible with existing systems Phase 2b Phase 2a Phase 2a √ Approved* (√) Approved Phase 2 Approved (√) Phase 3 Phase 2a (√) Phase 2/3 Phase 1 Phase 1 Phase 1 (√) Phase 1 Phase 1 Approved Phase 1 Phase 1 Phase 1 Approved (√) Phase 1 Phase 2a Phase 2a Phase 2a Phase 2a Phase 2a Phase 2a √ Phase 2 √ Broad applicability uPAR is specific to cancer and is expressed in all solid cancer types Reduced barriers for success compatibility with existing equipment
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey CONFIDENTIAL Large commercial potential for scaling sales of FG001 Total procedures: 45 million per year Incidence in highly relevant cancer types: 9 million per year Incidence of brain and head & neck cancers: 3.7 million per year x70 14 Combination of selling FG001 directly and through selected surgical systems partners Go-to-Market Strategy Pricing and reimbursement Business Model FG001: Recurrent revenue from sales of drug Surgical system: Revenue from deeper and faster market penetration Synergies: From FG001 and surgical system to be explored Fluorescent guided surgery: 4-5.000 USD per dose Photosensitizer therapy: 25.000 USD per dose Sources: World Health Organization, 2022; The University of Texas MD Anderson Cancer Center; Ivy Brain Tumor Center; Zhang et al: Advancements of radiotherapy for recurrent head and neck cancer in modern era, 2023; Company information. Sullivan et al. “Global Cancer Surgery: Delivering Safe, Affordable, and Timely Cancer Surgery.” The Lancet Oncology 16, no. 11 (2015): 1193–224 $ 2.9 billion potential EU & US incidence of brain and head & neck cancers per year: 0.64 million currently eligible for surgery (assuming an average price of 4,500 USD per treatment
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey 2026 catalysts: Phase II-data and initiation of registration trial in HGG 2026 Q1 • Optimizing use of FG001 and the laser system in pre-clinical models (photosensitizer therapy). The treatment claim will not be part of the lead indication for HGG. Plans to be presented • Interim data of 15 patients (first phase of the phase II clinical trial in head and neck cancer (CT-005) Q2 Q3 Q4 • 1 additional partnership • Interim data for additional 10 patients (second phase of the phase II clinical trial in head and neck cancer (CT-005) Brain Head and neck Commercial • Submit Investigational New Drug (IND) application for US clinical trial (CT-006) • First patient enrolled in US phase II registrational trial for HGG (CT-006) • Interim data of the low-grade-glioma IIT clinical trial • FluoGuide brain tumor plan presentation • Initiate enrolment of the remaining 10 patients with presumable low-grade- glioma (investigator-initiated-trial, IIT)
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Light grey Text Green lines Very light Line Background green Contrast red Contrast blue Green 3 Green 2 Green 1 Green 4 Contrast red Dark grey Extreme light grey FluoGuide is improving cancer surgery 16 Q&A Contact: Ole Larsen, CFO Mobile: +45 40 84 28 37 E-mail: ole@fluoguide.com