FluoGuide A/S Publishes Interim Report for Q2 2026

KØBENHAVN, DK / ACCESS Newswire / August 25, 2026 / Fluoguide A/S (STO:FLUO) (“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 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		1-Apr-26				1-Apr-25				1-Jan-26				1-Jan-25				1-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

Attachments
FluoGuide Q2 2026

SOURCE: FluoGuide A/S

View the original press release on ACCESS Newswire