FluoGuide A/S Due Diligence

Run due diligence on FluoGuide A/S: check compliance and get alerts when suppliers or ownership change.

Denmark · owned by Independent (Denmark) · fluoguide.com · 15 vendors

FluoGuide A/S is a clinical-stage biotechnology company focused on developing drugs that make cancer fluorescent to maximize surgical outcomes. Their technology aims to improve precision surgery for cancer patients by enabling surgeons to better visualize and remove cancerous tissue. The company is headquartered in Denmark.

Resilience scores

Technology vendors

Services catalogue

1 service in catalogue across 1 category; runs on 15 sub-vendors.

Insights

Last updated 2026-09-26 · revision 13

15 direct vendors, 130 subvendors

Direct vendors by controlling owner country (sample)

Subvendors by controlling owner country (sample)

Compliance

8 in-scope frameworks identified; showing 3.

EU Clinical Trials Regulation — No public evidence

Evidence: https://fluoguide.com/pipeline/pipeline/, https://fluoguide.com/pipeline/fg001/, https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines, https://euclinicaltrials.eu/, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R0536

EU Medical Device Regulation — No public evidence

Evidence: https://fluoguide.com/technology/fluorescent-guidance-to-surgical-oncologists/, https://fluoguide.com/about/fluoguide/, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745, https://www.dkma.dk/en/medical-devices

Nasdaq First North Growth Market — No public evidence

Evidence: https://fluoguide.com/investor/filings-archive/, https://fluoguide.com/investor/compliance/, https://fluoguide.com/mfn_news/, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R0596, https://www.nasdaq.com/solutions/nasdaq-first-north

Financials

Three-year financials

Financial Resilience Score: 3/10

FluoGuide A/S is a pre-commercial clinical-stage biotech with no revenue and persistent operating losses driven by R&D spending on its FG001 program. The company relies entirely on equity funding to reach commercialisation or a partnering deal, with multiple capital raises since its 2020 IPO on Spotlight Stock Market. Operating losses have widened from approximately DKK -15 to -20 million in FY2021 to DKK -30 to -40 million in FY2023 as Phase II trials ramped up across two indications. While the company has demonstrated clinical validation with positive Phase II readouts in glioblastoma and head-and-neck cancer, giving it partnering/out-licensing optionality, its financial resilience is inherently weak due to single-asset concentration on FG001, absence of revenue, and continuous cash burn. The 2025-2026 strategic repositioning, including the planned move from Spotlight to Nasdaq First North and updated 2026 outlook, suggests a phase of financial and strategic uncertainty with significant dilution risk for shareholders. The capital-light model relative to systemic oncology developers and access to Nordic biotech grants (e.g., Danish skattekredit) provide some support, but overall resilience remains low.

Key strengths: Positive Phase II clinical readouts in glioblastoma and head-and-neck cancer, Access to public equity markets via Spotlight (moving to Nasdaq First North), Capital-light business model relative to systemic oncology drug developers, Support from Nordic biotech ecosystem (grants, tax credits, academic partnerships), Partnering/out-licensing optionality from clinical validation

Risk factors: No revenue and persistent operating losses (DKK -30 to -40M annually), Complete reliance on equity funding with significant dilution risk, Single-asset concentration on FG001 / uPAR targeting, Small scale with high key-person risk (10-20 employees), Competitive landscape with approved alternatives (Lumisight, Cytalux, Gleolan/5-ALA), Strategic repositioning and exchange move signals financial uncertainty

Workforce by country

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