COPENHAGEN, DK / ACCESS Newswire / February 25, 2026 / FluoGuide A/S ("FluoGuide" or the "Company")(STO:FLUO) hereby publishes its annual report for the fiscal year 2025. The annual report, including the auditor's report is attached as a PDF and is also available on FluoGuide's website www.fluoguide.com under 'Financial reports'.
Following a year of significant clinical and regulatory progress in 2025, FluoGuide has reached a key inflection point in 2026. With the IND now cleared by FDA, we have further de-risked our lead program and established a well-defined regulatory pathway toward U.S. approval. Our mission remains unchanged: to maximize outcomes in cancer surgery, and we are now well positioned to advance FG001 toward registration." - Morten Albrechtsen, CEO of FluoGuide.
Clinical progress across multiple indications
During 2025, FluoGuide advanced FG001 across multiple clinical programs. The Company received CTA approval and enrolled the first patient in its Phase II trial (CT-005) in head and neck cancer, while clinical data in high-grade glioma were published in Neurosurgery. Positive interim results from an investigator-initiated brain tumor trial were also presented at EANS, CNS and EANO.
Regulatory advancement
During the year, FluoGuide received positive FDA feedback supporting the continued development of FG001. Following the reporting period, the Company submitted an Investigational New Drug (IND) application to initiate the first U.S. registration trial. The IND has afterwards recieved green light from FDA.
Strategic collaborations
In 2025, FluoGuide entered collaboration agreements with Olympus, a world-leading MedTech company in endoscopic imaging, and ZEISS, a global leader in surgical microscopy, supporting the continued clinical and technological development of FG001.
Strengthened financial position
During the year, FluoGuide completed a directed share issue of SEK 104 million, securing funding to support the continued clinical development of FG001 and enabling progression toward late-stage clinical activities.
Organization and leadership
During 2025, FluoGuide strengthened its leadership organization to support clinical development and regulatory execution, including the appointment of a Chief Operating Officer and the election of a new Board member with experience in strategic business development.
FINANCIAL HIGHLIGHTS
KEY FIGURES | 2025 | 2024 | |
DKK thousand |
|
| |
Income statement |
|
| |
Other operating income | 220 | 385 | |
Other external expenses | -23,980 | -17,709 | |
Staff expenses | -15,504 | -15,259 | |
Depreciation and amortization | -558 | -456 | |
Income/(Loss) before interest and tax (EBIT) | -39,822 | -33,040 | |
Net financial items | -5,137 | -1,419 | |
Income/(Loss) before tax | -44,959 | -34,459 | |
Tax on income for the year |
| 5,500 | 5,500 |
Net result for the year | -39,459 | -28,959 | |
Balance sheet |
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| |
Non-current assets | 1,548 | 1,877 | |
Current assets | 86,744 | 26,503 | |
Total assets | 88,292 | 28,380 | |
Equity | 54,528 | 23,067 | |
Non-current liabilities | 28,038 | 395 | |
Current liabilities | 5,727 | 4,918 | |
Cash flow statement |
|
| |
Cash and cash equivalents | 48,785 | 18,608 | |
Cash flow from: |
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| |
Operating activities | -36,957 | -29,152 | |
Investing activities | -29,904 | -987 | |
Financing activities | 97,038 | 27,080 | |
The period's cash flow | 30,176 | -3,059 | |
Key ratios |
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| |
Equity share (solvency ratio) | 62% | 81% | |
Earnings per share (DKK) | -2.81 | -2.23 | |
LOOKING AHEAD - 2026 MILESTONES
In H1 enrol first patient in the U.S. for the Phase 2 clinical trial (CT-006) with FG001 in HGG supporting registration
In H1 initiate enrolment of the remaining 10 patients with presumable low-grade-glioma (investigator-initiated trial) and in H2 interim result from the clinical trial
In H1 interim result of the first 15 patients in the Phase 2 clinical trial (CT-005) in head and neck cancer (CT-005)
In H2 enrol the next cohort of 10 patients in the Phase 2 trial (CT-005) for FG001 in head and neck cancer
In H2 presentation of a FluoGuide brain tumor plan
In H2 to determine the optimization use of FG001 and the laser system in pre-clinical models and to present a plan for further development
During the year FluoGuide anticipates entering an additional non-exclusive strategic partnership
PRESENTATION
In connection with the annual report publication, CEO Morten Albrechtsen and CFO Ole Larsen will participate in a live webcast, hosted by Biostock, on February 25, 2026, at 14.00 CET.
Please login to the webcast via the following link: https://www.youtube.com/live/DlK74aNE86M
A recorded version of the presentation will be available on FluoGuide's website under Investor Presentations after the webcast has concluded.
For further information, please contact:
Morten Albrechtsen, CEO
FluoGuide A/S
Phone: +45 24 25 62 66
E-mail: ma@fluoguide.com
Certified Adviser:
Svensk Kapitalmarknadsgranskning AB
Website: www.skmg.se
About FluoGuide
FluoGuide lights up cancer to maximize surgical outcomes in oncology. FluoGuide's lead product, FG001, is designed to improve surgical precision by lighting up cancer intraoperatively. The improved precision has a dual benefit - it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, the improved precision enhances the likelihood of complete cure and lower healthcare costs. FluoGuide has demonstrated that FG001 is both effective and well tolerated in several phase II clinical trials. The lead indications of FG001 are aggressive brain cancer (glioblastoma) and oral head and neck cancer. FluoGuide has entered partnerships with leading MedTech companies with the aim of accelerating development and commercialization. FluoGuide is listed on Nasdaq First North Sweden under the ticker "FLUO".
For more information on FG001 or FluoGuide's uPAR technology platform, please visit our home page www.fluoguide.com
Attachments
FluoGuide Annual Report 2025
SOURCE: FluoGuide A/S
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/fluoguide-a%2fs-publishes-annual-report-for-the-fiscal-year-2025-1140816
