KØBENHAVN, DK / ACCESS Newswire / May 27, 2026 / Fluoguide A/S (STO:FLUO) ("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 2026 | Q1 2025 | YTD 2026 | YTD 2025 | 2025 |
DKK thousand | 01-Jan-26 | 01-Jan-25 | 01-Jan-26 | 01-Jan-25 | 01-Jan-25 |
| 31-Mar-26 | 31-Mar-25 | 31-Mar-26 | 31-Mar-25 | 31-Dec-25 |
Income statement |
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Other operating income | 54 | 36 | 54 | 36 | 220 |
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 income | 2,375 | 1,820 | 2,375 | 1,820 | 5,500 |
Net result | -11,787 | -8,856 | -11,787 | -8,856 | -39,459 |
Balance sheet |
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Non-current assets | 1,413 | 1,986 | 1,413 | 1,986 | 1,548 |
Current assets | 74,850 | 30,556 | 74,850 | 30,556 | 86,744 |
Total assets | 76,263 | 32,542 | 76,263 | 32,542 | 88,292 |
Equity | 43,131 | 14,584 | 43,131 | 14,584 | 54,528 |
Non-current liabilities | 27,671 | 609 | 27,671 | 609 | 28,011 |
Current liabilities | 5,462 | 17,348 | 5,462 | 17,348 | 5,753 |
Cash flow statement |
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Cash and cash equivalents | 33,224 | 20,982 | 33,224 | 20,982 | 48,785 |
Cash flow from: |
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Operating activities | -15,200 | -9,627 | -15,200 | -9,627 | -36,957 |
Investing activities | 0 | 78 | 0 | 78 | -29,904 |
Financing activities | -360 | 11,923 | -360 | 11,923 | 97,038 |
The period's cash flow | -15,561 | 2,373 | -15,561 | 2,373 | 30,176 |
Key ratios |
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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.
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 Q1 2026 Fv
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-q1-2026-1170917
