COPENHAGEN, DK / ACCESS Newswire / February 25, 2026 / Fluoguide A/S ("FluoGuide" or the "Company")(STO:FLUO) today releases its results for the period 1 January 2025 - 31 December 2025. The Q4 report is available as attached document to this press release and on FluoGuide's website.
"In 2025, FluoGuide achieved several defining milestones that significantly advanced FG001 toward late-stage clinical development and established a clear regulatory pathway toward U.S. approval. The positive clinical data, strengthened organization, successful financing, and strategic collaboration with ZEISS collectively mark our transition from early clinical validation to execution toward registration and future commercialization. As we enter 2026, our focus is clear: advancing FG001 into registration studies and bringing innovative fluorescence-guided surgery closer to patients and surgeons worldwide." - Morten Albrechtsen, CEO of FluoGuide.
Clinical progress strengthens FG001 foundation
In the fourth quarter, the Company reported positive interim results from an investigator-initiated FG001 trial in meningioma and low-grade glioma. The results were presented at EANS, CNS and EANO.
Organization and leadership
During Q4 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.
Strengthened financial position
During the quarter, 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.
Strategic collaboration with ZEISS
In November 2025, FluoGuide entered into a collaboration agreement with ZEISS, a global leader in surgical microscopy. The collaboration supports the integration of FG001 within advanced surgical visualization workflows and represents an important step toward future clinical adoption.
Advancing toward U.S. registration Following the end of the reporting period, FluoGuide submitted an Investigational New Drug (IND) application for FG001. The IND has afterwards been cleared by FDA. The clearance represents a key regulatory milestone, establishing a clear pathway toward U.S. registration, with initiation of the first registration trial expected in Q2 2026.
Financial results and share information
FluoGuide had no revenue Q4 2025 and posted a net loss of DKK 13,090 thousand (Q4 2024: a loss of DKK 8.741 thousand).
FluoGuide had no revenue in 2025 and posted a net loss of DKK 39,459 thousand (2024: a net loss of DKK 28,959 thousand).
As of December 31, 2025, FluoGuide's share capital amounted to 1,634,931.30 divided into 16,349,313 shares of nominal value SEK 0.10 each.
KEY FIGURES | Q4 2025 | Q4 2024 | 2025 | 2024 |
DKK thousand | 01-Oct-25 | 01-Oct-24 | 01-Jan-25 | 01-Jan-24 |
| 31-Dec-25 | 31-Dec-24 | 31-Dec-25 | 31-Dec-24 |
Income statement |
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Other operating income | 54 | -642 | 220 | 385 |
Other external expenses | -6,336 | -5,467 | -23,980 | -17,709 |
Staff expenses | -4,837 | -3,805 | -15,504 | -15,259 |
Depreciation and amortization | -135 | -134 | -558 | -456 |
Income/(Loss) before interest and tax (EBIT) | -11,253 | -10,048 | -39,822 | -33,040 |
Net financial items | -2,166 | -143 | -5,137 | -1,419 |
Income/(Loss) before tax | -13,420 | -10,191 | -44,959 | -34,459 |
Tax on income | 330 | 1,450 | 5,500 | 5,500 |
Net result | -13,090 | -8,741 | -39,459 | -28,959 |
Balance sheet |
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Non-current assets | 1,548 | 1,877 | 1,548 | 1,877 |
Current assets | 86,744 | 26,503 | 86,744 | 26,503 |
Total assets | 88,292 | 28,380 | 88,292 | 28,380 |
Equity | 54,528 | 23,067 | 54,528 | 23,067 |
Non-current liabilities | 28,038 | 395 | 623 | 0 |
Current liabilities | 5,727 | 4,918 | 5,727 | 4,918 |
Cash flow statement |
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Cash and cash equivalents | 48,785 | 18,608 | 48,785 | 18,608 |
Cash flow from: |
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Operating activities | -5,032 | -1,476 | -36,957 | -29,152 |
Investing activities | -30,015 | -20 | -29,904 | -987 |
Financing activities | 70,137 | -53 | 97,038 | 27,080 |
The period's cash flow | 35,089 | -1,548 | 30,176 | -3,059 |
Key ratios |
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Equity share (solvency ratio) | 62% | 81% | 62% | 81% |
Earnings per share (DKK) | -0.85 | -0.64 | -2.81 | -2.23 |
Highlights during Q4:
Completed a directed share issue of SEK 104 million
Strengthened leadership to advance clinical program and regulatory approval strategy
Collaboration agreement signed with ZEISS, a world-leading company in surgical microscopy
Highlights after Q4:
The Company submits an IND for FG001, to initiate first U.S. registration trial
FDA clears the IND which represents a key regulatory milestone for FluoGuide and marks the transition of FG001 to late-clinical development, advancing the program toward U.S. registration. Initiation of the first registration trial remains on track, with enrollment of the first patient expected in Q2 2026.
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 Q4 2025
SOURCE: FluoGuide A/S
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/fluoguide-a%2fs-publishes-interim-report-for-q4-2025-1140815
