Copenhagen, Denmark, 25 August 2026 – Fluoguide A/S (“FluoGuide” or the “Company”) today releases its results for the period 1 January 2026 – 30 June 2026. The Q2 report is available as attached document to this press release and on FluoGuide’s website.
“The second quarter marked another step forward in the clinical trials with FG001. In our Phase 2 clinical trial in oral head and neck cancer (CT-005) we enrolled the last patient in the first part of the trial and announced positive results from the same trial. In our Phase 2 trial in high-grade glioma the first U.S. site has now received green light to enrol patients. And in the investigator-initiated trial in presumed low-grade glioma enrolment of the remaining 10 patients began.”
Morten Albrechtsen, CEO of FluoGuide
Advancing toward U.S. registration
After receiving FDA authorization to initiate FG001-CT-006 (CT-006) under our U.S. IND, we activated the study’s first U.S. clinical site, marking the initiation of our first U.S. clinical study intended to support registration. This milestone reflects FluoGuide’s evolution from a compelling scientific story to one defined by clinical and regulatory execution.
Building a robust regulatory case
CT-006 represents several important firsts for the company. It is our:
- first clinical study conducted under a U.S. IND;
- first multicenter clinical trial in the United States; and
- first pivotal trial, designed with clinically meaningful endpoints aligned with FDA feedback and intended to support a future application for regulatory approval
Expanding the FG001 Platform
Beyond HGG, we continued to advance the FG001 platform during the quarter, reporting positive results from Part 1 of our Phase 2 trial in oral head and neck cancer. The study met its primary endpoint, identifying 0.30 mg/kg as the optimal FG001 dose, while also confirming that FG001 was very well tolerated and could be detected across all near-infrared imaging systems evaluated and representing leading equipment of the different types.
These findings support the broader applicability of FG001 within existing surgical workflows, and even with a potential to save surgical time. Part 2 of the study will evaluate flexibility in the dosing-to-surgery window and automation of FG001 in intraoperative margin assessment, with the goal of providing surgeons with swift information on inadequate margins while the patient is still in the operating room, within the current workflow.
| KEY FIGURES | Q2 2026 | Q2 2025 | YTD 2026 | YTD 2025 | 2025 |
| DKK thousand | 01-Apr-26 | 01-Apr-25 | 01-Jan-26 | 01-Jan-25 | 01-Jan-25 |
| 30-Jun-26 | 30-Jun-25 | 30-Jun-26 | 30-Jun-25 | 31-Dec-25 | |
| Income statement | |||||
| Other operating income | 92 | 57 | 146 | 93 | 220 |
| Other external expenses | -9,763 | -6,002 | -18,344 | -11,813 | -23,980 |
| Staff expenses | -5,109 | -3,773 | -9,726 | -7,465 | -15,504 |
| Depreciation and amortization | -135 | -135 | -269 | -289 | -558 |
| Income before interest and tax (EBIT) | -14,915 | -9,853 | -28,194 | -19,474 | -39,822 |
| Net financial items | -686 | -784 | -1,569 | -1,838 | -5,137 |
| Income before tax | -15,601 | -10,637 | -29,763 | -21,313 | -44,959 |
| Tax on income | 2,782 | 1,690 | 5,157 | 3,510 | 5,500 |
| Net result | -12,819 | -8,947 | -24,606 | -17,803 | -39,459 |
| Balance sheet | |||||
| Non-current assets | 1,272 | 1,817 | 1,272 | 1,817 | 1,548 |
| Current assets | 63,846 | 31,579 | 63,846 | 31,579 | 86,744 |
| Total assets | 65,118 | 33,396 | 65,118 | 33,396 | 88,292 |
| Equity | 30,677 | 5,945 | 30,677 | 5,945 | 54,528 |
| Non-current liabilities | 422 | 548 | 422 | 548 | 28,038 |
| Current liabilities | 34,019 | 26,903 | 34,019 | 26,903 | 5,727 |
| Cash flow statement | |||||
| Cash, cash equivalents & securities | 49,824 | 19,632 | 49,824 | 19,632 | 78,799 |
| Cash flow from: | |||||
| Operating activities | -12,996 | -11,331 | -28,197 | -20,958 | -36,957 |
| Investing activities | 7 | 34 | 7 | 112 | -29,904 |
| Financing activities | -425 | 9,947 | -786 | 21,870 | 97,038 |
| The period’s cash flow | -13,415 | -1,350 | -28,975 | 1,024 | 30,176 |
| Key ratios | |||||
| Equity share (solvency ratio) | 47% | 18% | 47% | 18% | 62% |
| Earnings per share (DKK) | -0.78 | -0.66 | -1.51 | -1.31 | -2.81 |
PRESENTATION
In connection with the Q2 2026 report publication, CEO Morten Albrechtsen and CFO Ole Larsen will participate in a live webcast, hosted by Biostock, on August 25, 2026, at 14.00 CET.
Please login to the webcast via the following link: https://biostock.se/2026/08/fluoguide-kommenterar-q2/
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. 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