KØBENHAVN, DK / ACCESS Newswire / November 27, 2025 / FluoGuide A/S ("FluoGuide" or the "Company") (STO:FLUO) today releases its results for the period 1 January - 30 September 2025. The Q3 report is available as an attached document to this press release and on FluoGuide's website.
Operational Highlights - Q3 2025
Entered a collaboration with Olympus, a world leading MedTech company in endoscopic imaging
Received positive FDA feedback on FG001 in high-grade glioma
Highlights after the end of Q3 2025
Positive interim FG001 results from an investigator-initiated trial in meningioma and low-grade glioma, presented at EANS, CNS and EANO
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
"During the quarter, we cemented the route to approval for our lead product in the first indication by obtaining regulatory clarity and funding" says Morten Albrechtsen, CEO at FluoGuide.
KEY FIGURES | Q3 2025 | Q3 2024 | YTD 2025 | YTD 2024 | 2024 |
DKK thousand | 01-Jul-25 | 01-Jul-24 | 01-Jan-25 | 01-Jan-24 | 01-Jan-24 |
| 30-Sep-25 | 30-Sep-24 | 30-Sep-25 | 30-Sep-24 | 31-Dec-24 |
Net Revenue | 0 | 0 | 0 | 0 | 0 |
Income before interest and tax (EBIT) | -9,094 | -6,532 | -28,568 | -22,993 | -33,040 |
Net result for the period | -8,567 | -5,495 | -26,369 | -20,218 | -28,959 |
Cash and bank | 13,696 | 20,157 | 13,696 | 20,157 | 18,608 |
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Solvency ratio (%) | -8% | 90% | -8% | 90% | 81% |
Result per share (DKK) | -0.63 | -0.40 | -1.94 | -1.59 | -2.23 |
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FluoGuide had no revenue in Q3 2025 and posted a net loss of DKK 8,567 thousand (net loss of DKK 5,495 thousand).
As of September 30, 2025, the cash position was DKK 13,696 thousand (DKK 20,157 thousand).
The financial result for the period is in line with the Company's expectations.
The total number of shares as of September 30, 2025, amounted to 13,620,149 shares (13,620,149 shares). The average number of shares YTD 2025 amounted to 13,620,149 shares.
On November 3, 2025, the Company completed a directed share issue through which the number of shares and votes increased by 2,729,164 from 13,620,149 to 16,349,313. Proceeds from the directed issue amounted to SEK 104 million (DKK 71 million).
As of September 30, 2025, the Solvency ratio was negative by 8%. As a result of the capital raise in November 2025 the Company expects a solvency ratio in the 70% range by the end of the year.
Outlook 2026
HGG: First patient enrolled in the U.S. Phase II registration trial (H1)
Brain tumors (LGG): Enrolment of remaining 10 patients initiated (H1), and interim results delivered (H2)
Photosensitizer program: Optimization of FG001 with the laser system in pre-clinical models, with development plan presented (H2)
Head & Neck (CT-005): Interim results from the first 15 patients (H1) and from the additional 10 patients (H2)
Partnerships: One additional strategic partnership to be signed in H2
Q3 2025 webcast
A live webcast for shareholders, analysts, investors and representatives of the media will take place today at 14:00 CET.
The webcast is hosted by analyst Christian Binder, Redeye. FluoGuide is represented by CEO Morten Albrechtsen and CFO Ole Larsen.
Please login to the webcast via the following link: https://www.redeye.se/events/1127356/live-q-fluoguide-2
Questions can be sent in advance by email to Christian Binder ( christian.binder@redeye.se ) or can be raised at the question session during the webcast.
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 Q3 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-q3-2025-1112582