FluoGuide accelererar precisionskirurgi vid cancer

FluoGuide grundades 2018 i Köpenhamn och utvecklar precisionsavbildande läkemedel som hjälper kirurger att tydligt identifiera cancervävnad under operation. Bolagets ledande produkt, FG001, riktar in sig på uPAR – en biomarkör som uttrycks starkt i solida tumörer – och får cancerceller att lysa upp med hjälp av fluorescensavbildning. Målet är att göra cancerkirurgi både säkrare och mer exakt genom att ge kirurger möjlighet att i realtid skilja mellan frisk och sjuk vävnad.

Under de senaste åren har FluoGuide rapporterat kliniska data inom höggradigt gliom (HGG) och presenterat positiva interimsresultat från en forskarinitierad studie i meningiom och låggradiga gliom. Samtidigt har bolaget utökat sin pipeline till att även omfatta huvud- och halscancer.

Viktiga milstolpar under 2025

Under 2025 har FluoGuide nått flera betydande milstolpar. Bolaget fick positiv återkoppling från den amerikanska läkemedelsmyndigheten FDA i ett så kallat pre-IND-möte inför de planerade fas II- och fas III-studierna, som ska ligga till grund för en framtida NDA-ansökan inom höggradigt gliom. FDA:s godkännande av den föreslagna studiedesignen bekräftar bolagets strategi och stödjer planen att lämna in en IND-ansökan innan årsskiftet 2025.

Tidigare under året fick FluoGuide dessutom godkännande och inkluderade den första patienten i sin fas II-studie (CT-005) inom huvud- och halscancer. Bolaget publicerade även kliniska data i tidskriften Neurosurgery, som bekräftade säkerheten och den målsökande effekten hos FG001 i patienter med gliom.

Strategiska samarbeten med ledande medtechbolag

FluoGuide har fortsatt att bygga upp ett starkt nätverk av strategiska samarbeten som knyter samman bioteknik med kirurgisk innovation. I juli 2025 ingick bolaget ett partnerskap med Olympus, en global ledare inom medicinteknik, för att vidareutveckla FG001 för tumöravbildning och bedömning av operationsmarginaler vid huvud- och halscancer.

FluoGuide har även icke-exklusiva samarbeten med Intuitive Surgical och Braccoägda SurgVission. Dessa partnerskap stärker bolagets strategi att arbeta nära världsledande leverantörer av avbildningssystem för att påskynda den kliniska och kommersiella utvecklingen.

Finansiell styrka och tillväxt

För att säkerställa fortsatt kliniskt avancemang genomförde FluoGuide en riktad nyemission på 104 miljoner kronor tidigare i November. Kapitalet ska användas för att finansiera de amerikanska fas II-studierna inom både höggradigt gliom och huvud- och halscancer samt förbereda framtida fas III-program. Bolaget har även förlängt sin kreditfacilitet på 40 miljoner kronor till april 2027, vilket stärker den finansiella flexibiliteten i takt med att utvecklingen fortskrider.

Under första halvåret 2025 höll FluoGuide en stabil operationell takt och en balanserad kostnadskontroll. Per den 30 juni 2025 uppgick kassan till 19,6 miljoner danska kronor, och resultatet för halvåret låg i linje med förväntningarna. I halvårsrapporten betonade vd Morten Albrechtsen att varje uppnådd milstolpe – från vetenskapliga publikationer till strategiska partnerskap – för bolaget närmare målet att maximera de kirurgiska behandlingsresultaten för cancerpatienter.

Bolagets rapport för det tredje kvartalet publiceras den 27 november.

Vd kommenterar

BioStock kontaktade vd Morten Albrechtsen för att prata om bolagets utveckling och om riktningen framåt.

First out, FluoGuide’s technology aims to guide surgeons in real time. Can you explain the scientific basis for FG001 and how it benefits both patients and surgical teams?

– FG001 is a fluorescent imaging agent designed to bind to uPAR – a biomarker broadly expressed in solid tumours and involved in cancer invasion. Once injected into the bloodstream, FG001 attaches to cancer tissue and lights it up in the near-infrared light spectrum. This enables surgeons to clearly distinguish malignant tissue from healthy tissue in real time. For patients, it supports safer, more complete tumour removal. For surgeons, it provides greater precision and confidence at the margins, where accuracy matters most.

How does FG001 differentiate itself from other imaging agents in development?

– FG001 differentiates itself from other imaging agents through its uPAR-targeted binding. While older agents like 5-ALA or blue-light dyes rely on metabolic activity visible only on the surface, FG001 operates in the near-infrared spectrum, allowing surgeons to visualise cancer up to 1–2 cm below the tissue surface.

– It is compatible with all imaging systems that detect indocyanine green (ICG), making it system-agnostic and easy to integrate into existing surgical workflows. Combined with its strong safety profile and broad applicability across solid tumours, FG001 offers a next-generation solution to improve surgical precision and patient outcomes.

What are your expectations for the phase II trials in high-grade glioma and head and neck cancer, respectively?

– Both ongoing phase II studies are designed to confirm safety and consistent tumour visualisation to prepare for phase III. FG001 is an image agent under the drug regulation. The first clinical trial is proving safety, which is unrelated to indications. FG001 has been demonstrated to be well tolerated.

– The next clinical trial is testing FG001’s capability to light up the cancer, which is cancer type specific. FG001 has been demonstrated clinically to light up: high grade glioma (grade III and grade IV also termed glioblastoma), oral head and neck cancer (squamous cell carcinoma), lung cancer (non-small cell lung cancer), meningioma (brain tumor), low grade glioma (brain tumor), and some types of brain metastasis (cases only).

– To obtain regulatory approval, two independent clinical trials demonstrating clinical benefit is required as a default demand from the agencies. The clinical benefit can for example be completeness of surgery, additional tissue to be removed due to the use of the drug.

– The lead indication for FG001 is high-grade glioma, where principal alignment with FDA has been obtained for two clinical trials needed to demonstrate clinical benefit; the phase II trial where the IND is in preparation and planned submitted by end of the 2025 (CT-006). The endpoint is completion of resection evaluated by imaging (MRI post operatively).

– The ongoing phase II trial in head and neck is one step behind high-grade glioma, the ongoing trial (CT-005) evaluates a range of different clinical benefit endpoints as well as equipment types. When the result is available, the next step can for example be a combined phase II/III trial or one phase II and one phase III trial. This must be agreed to with the agencies and depends on the result from the ongoing trial.

You recently strengthened your financial position. How will the new capital be used to support clinical programmes and manufacturing?

– The proceeds from the SEK 104 million directed share issue will be used to advance our phase II programme in high-grade glioma in the U.S., conduct the phase II trial in head and neck cancer (either the first of two registration trials or the first part of a combined phase II/III trial), and support CMC and manufacturing preparations for phase III, as well as general corporate purposes.

Can you describe the strategic thinking behind your existing partnerships and why medtech actors are your counterpart?

– The surgical treatment for cancer patients depends on advanced equipment such as microscopes and endoscopes. FluoGuide’s imaging agents lights up cancer and contribute significantly to a precision during surgery in real time. Different types of equipment are used in different types of cancer surgeries, and FluoGuide therefore collaborates with leading MedTech companies to ensure the best possible integration and strong penetration.

What role do these partnerships have in your overall growth plan?

– These partnerships play a central role in FluoGuide’s growth plan by supporting both clinical and commercial execution. By validating FG001 across imaging systems that already detect ICG, we ensure compatibility and ease of use for surgeons — key factors for clinical validation and workflow integration. This collaboration-driven approach accelerates market adoption and prepares the company for late-stage development and commercial launch.

Can collaborations with companies like Olympus, Intuitive Surgical, and SurgVision impact adoption of FG001 in surgical practice at a large scale, and, if so, how?

– Yes. Working with established platform providers ensures compatibility, training pathways and market reach, which are essential to drive adoption at scale in surgical oncology.

Looking ahead, what are your main strategic priorities for 2026 in terms of partnerships, clinical development, and global expansion?

– We expect to secure 1–2 additional partnerships in the next 5-10 months to further support platform integration and commercial readiness. A more detailed roadmap for 2026 will be presented in the Q3 report on 27 November.

How does FluoGuide balance innovation in its imaging agents with integration into existing surgical platforms?

– Our development philosophy is to combine focused innovation with seamless integration into existing surgical workflows. We design uPAR-targeted imaging agents that work across multiple surgical platforms and indications – initially focusing on high-grade glioma and head and neck cancer- so hospitals and surgeons can adopt FG001 without changing equipment or procedures.

Finishing on a more personal note, where do you envision FluoGuide to be in 5 years, and how do you plan to get the company there?

– In five years FluoGuide aims to be is a commercial stage company recognised as a leader in precision imaging with multiple partnerships supporting the use of FGI in cancer surgery. Our focus will be on executing the clinical plan, expanding strategic collaborations, and building long term value through partnerships that combine technology, funding and market access – rather than short term exit scenarios.