Onsdag 27 Maj | 20:52:03 Europe / Stockholm

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Est. tid*
2026-11-26 07:10 Kvartalsrapport 2026-Q3
2026-08-25 07:10 Kvartalsrapport 2026-Q2
2026-05-27 07:10 Kvartalsrapport 2026-Q1
2026-03-26 - X-dag ordinarie utdelning FLUO 0.00 DKK
2026-03-25 - Årsstämma
2026-02-25 - Bokslutskommuniké 2025
2025-11-27 - Kvartalsrapport 2025-Q3
2025-08-28 - Kvartalsrapport 2025-Q2
2025-05-28 - Kvartalsrapport 2025-Q1
2025-03-28 - X-dag ordinarie utdelning FLUO 0.00 DKK
2025-03-27 - Årsstämma
2025-02-27 - Bokslutskommuniké 2024
2024-11-27 - Kvartalsrapport 2024-Q3
2024-08-29 - Kvartalsrapport 2024-Q2
2024-05-30 - Kvartalsrapport 2024-Q1
2024-03-21 - X-dag ordinarie utdelning FLUO 0.00 DKK
2024-03-20 - Årsstämma
2024-02-28 - Bokslutskommuniké 2023
2023-11-29 - Kvartalsrapport 2023-Q3
2023-08-30 - Kvartalsrapport 2023-Q2
2023-05-31 - Kvartalsrapport 2023-Q1
2023-03-22 - X-dag ordinarie utdelning FLUO 0.00 DKK
2023-03-21 - Årsstämma
2023-02-28 - Bokslutskommuniké 2022
2022-11-24 - Kvartalsrapport 2022-Q3
2022-08-25 - Kvartalsrapport 2022-Q2
2022-05-31 - Kvartalsrapport 2022-Q1
2022-05-19 - X-dag ordinarie utdelning FLUO 0.00 DKK
2022-05-18 - Årsstämma
2022-03-30 - Bokslutskommuniké 2021
2021-11-24 - Kvartalsrapport 2021-Q3
2021-08-25 - Kvartalsrapport 2021-Q2
2021-05-26 - Kvartalsrapport 2021-Q1
2021-05-03 - X-dag ordinarie utdelning FLUO 0.00 DKK
2021-02-26 - Bokslutskommuniké 2020
2021-02-09 - Årsstämma
2020-11-20 - Kvartalsrapport 2020-Q3
2020-08-14 - Kvartalsrapport 2020-Q2
2020-05-27 - Kvartalsrapport 2020-Q1
2020-04-09 - X-dag ordinarie utdelning FLUO 0.00 DKK
2020-04-08 - Årsstämma
2020-02-28 - Bokslutskommuniké 2019
2019-11-29 - Kvartalsrapport 2019-Q3
2019-05-31 - Kvartalsrapport 2019-Q1

Beskrivning

LandDanmark
ListaFirst North Stockholm
SektorHälsovård
IndustriMedicinteknik
FluoGuide är ett danskt bolag verksamt inom medicinteknik. Bolaget affärsfokus återfinns inom forskning och utveckling av behandlingar mot olika cancerformer, med störst fokus på utveckling av produkter som vägleder vid kirurgiska ingrepp. Produkterna binder till sig cancercellerna som då lyser upp och är avsedda att användas för att med precision kunna ta bort skadliga tumörer i patientens vävnad.

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2026-05-27 07:09:00

Copenhagen, Denmark, 27 May 2026 – Fluoguide A/S (“FluoGuide” or the “Company”) today releases its results for the period 1 January 2026 – 31 March 2026. The Q1 report is available as attached document to this press release and on FluoGuide’s website.

“The first quarter marked an important step forward for FluoGuide as we advanced FG001 toward registration-directed development in the U.S. The FDA IND authorization and Fast Track Designation provide important regulatory validation of FG001’s potential in high-grade glioma and support the initiation of our first U.S. registration-supporting study. Together with the continued strengthening of our organization and clinical platform, we believe FluoGuide is increasingly well-positioned to execute on the next phase of development and expand the long-term potential of FG001 in precision oncology surgery” – Morten Albrechtsen, CEO of FluoGuide

Advancing toward U.S. registration
In January 2026, FluoGuide submitted an Investigational New Drug (IND) application to the FDA for FG001 to support initiation of the first U.S. trial in high-grade glioma designed to support future registration. Following February 2026, the FDA authorization the IND application, representing a significant regulatory milestone and enabling initiation of the Company’s first U.S. Phase 2 registration-supporting trial.

FDA Fast Track Designation supports development pathway
FluoGuide received FDA Fast Track Designation for FG001 in high-grade glioma. The designation is intended to facilitate the development and regulatory review process for therapies addressing serious conditions and underscores the potential of FG001 to address important unmet needs in cancer surgery.

Head and neck cancer program advances toward interim results
Beyond our brain cancer program, FluoGuide continued progressing its head and neck cancer clinical program during the quarter. Preparations for trial analysis were completed, and following the end of the reporting period, the final patient was enrolled for the first phase of the trial. The program remains an important component of FluoGuide’s broader clinical strategy and represents a potential near-term value driver as the Company advances FG001 across multiple indications. Interim results are expected during the second quarter.

FINANCIAL HIGHLIGHTS

KEY FIGURES (UNAUDITED)Q1 2026Q1 2025YTD 2026YTD 20252025
DKK thousand01-Jan-2601-Jan-2501-Jan-2601-Jan-2501-Jan-25
 31-Mar-2631-Mar-2531-Mar-2631-Mar-2531-Dec-25
Income statement     
Other operating income54365436220
Other external expenses-8,581-5,812-8,581-5,812-23,980
Staff expenses-4,617-3,692-4,617-3,692-15,504
Depreciation and amortization-135-154-135-154-558
Income before interest and tax (EBIT)-13,279-9,621-13,279-9,621-39,822
Net financial items-883-1,055-883-1,055-5,137
Income before tax-14,162-10,676-14,162-10,676-44,959
Tax on income2,3751,8202,3751,8205,500
Net result-11,787-8,856-11,787-8,856-39,459
Balance sheet     
Non-current assets1,4131,9861,4131,9861,548
Current assets74,85030,55674,85030,55686,744
Total assets76,26332,54276,26332,54288,292
Equity43,13114,58443,13114,58454,528
Non-current liabilities27,67160927,67160928,011
Current liabilities5,46217,3485,46217,3485,753
Cash flow statement     
Cash and cash equivalents33,22420,98233,22420,98248,785
Cash flow from:     
Operating activities-15,200-9,627-15,200-9,627-36,957
Investing activities078078-29,904
Financing activities-36011,923-36011,92397,038
The period’s cash flow-15,5612,373-15,5612,37330,176
Key ratios     
Equity share (solvency ratio)57%45%57%45%62%
Earnings per share (DKK)-0.72-0.65-0.72-0.65-2.81

 
PRESENTATION
In connection with the Q1 2026 report publication, CEO Morten Albrechtsen and CFO Ole Larsen will participate in a live webcast, hosted by Biostock, on May 27, 2026, at 14.00 CET.

Please login to the webcast via the following link: https://biostock.se/en/2026/05/live-q1-rapportkommentar-med-fluoguide-27-5/

A recorded version of the presentation will be available on FluoGuide’s website under Investor Presentations after the webcast has concluded.