COPENHAGEN, DK / ACCESS Newswire / July 1, 2026 / FluoGuide A/S ("FluoGuide" or the "Company")(STO:FLUO), a clinical-stage biotech company focused on precision cancer surgery, is pleased to share an update on the 2026 Outlook and ongoing progress. As part of this update, FluoGuide has refined timing of some milestones. There are no changes to the overall development.
"FluoGuide has made substantial progress during the first half of 2026. We are proud having reported positive results on all milestones with only minor adjustment in timing that has no impact on the corporate development. We remain committed to setting ambitious milestones and maintain high transparency" said Morten Albrechtsen, CEO of FluoGuide.
The 2026 milestones:
Brain cancer:
a) Submission of an Investigational New Drug (IND) application for the first clinical trial in the U.S. supporting registration of FG001 as an imaging agent for guiding surgery in patients with aggressive brain cancer, high-grade glioma (HGG):
The Company submitted the IND application on 21 January 2026 to initiate U.S. clinical trial(s) of FG001 as an imaging agent to guide surgery in patients with aggressive brain cancer (HGG). On 20 February 2026, FDA provided authorization for FluoGuide to proceed with the first clinical study of FG001 in the U.S. In connection with the IND submission, the Company also applied for Fast Track Designation which was granted by FDA on 18 March 2026.
b) Enrollment of first patient in the clinical trial in the U.S. supporting registration of FG001 as an imaging agent for guiding surgery in patients with high-grade glioma:
The first U.S. clinical site to complete site initiation is the University of Texas Medical Branch (UTMB Health) in Galveston, Texas.
The trial will be led at UTMB Health by Dr. Pablo Valdes, MD, PhD, FAANS, Director of Neurosurgical Oncology, a board-certified neurosurgeon and bioengineer whose work bridges neurosurgical oncology, advanced brain mapping, and precision-guided biomedical optics.
The first patient is anticipated to be enrolled in July 2026.
c) Initiate enrollment of the remaining 10 patients with presumable low-grade-glioma (investigator-initiated trial):
In April 2026, the Company was informed by Dr. Jane Skjøth-Rasmussen, MD, PhD., a neurosurgeon at Rigshospitalet and the lead investigator for the investigator-initiated trial in presumed low-grade glioma, that the first patient has been enrolled.
d) Interim result from the remaining 10 patients with presumable low-grade-glioma (investigator-initiated trial):
As enrollment was initiated in April 2026, interim results from the remaining 10 patients are expected to be available in H2 2026 as planned.
Further details of the results are expected to become available once the investigator presents the data at a scientific conference, as this is an investigator-initiated trial.
e) FluoGuide brain tumor plan presentation:
The finalization of the brain tumor plan is closely linked to the initiation of the Phase 2 U.S trial in high-grade glioma and the results from the investigator-initiated trial in presumed low-grade glioma. The Company expects to present the brain tumor plan in H2 2026 as planned.
f) Completion of optimization of FG001 in combination with the laser system in pre-clinical models:
The Company continues to explore FG001's potential in brain tumor indications beyond the lead HGG imaging indication, including potential photothermal and photodynamic therapeutic applications. Preclinical work has shown that FG001 has a photothermal effect when activated with a compatible laser system, resulting in heat-mediated effects on cancer cells. In addition, the Company is investigating whether FG001 may also have a photodynamic effect through a light-activated chemical process.
These potential therapeutic indications remain at an early stage of development and are expected to follow separate development paths from the lead HGG imaging indication. A treatment claim will not be part of the lead indication for HGG. The Company expects to provide an initial photothermal development plan in H2 2026.
Head and neck cancer:
g) Interim data from first 15 patients (part one of CT-005):
On 29 June the Company announced key data from the first 15 patients in the oral head and neck cancer clinical trial (CT-005). The key data was as follows:
19 patients screened, 15 patients enrolled and completed surgery, completing the first part of the trial and allowing release of the primary endpoint results
The primary endpoint for the first part of the trial was achieved identifying the optimal FG001 dose (0.30 mg/kg)
FG001 was very well tolerated consistent with prior clinical experience
All near infrared imaging systems evaluated in the study could detect FG001 in all patients
h) Interim result for 10 patients (part two of CT-005):
An amendment to the trial is being prepared to incorporate changes from the current protocol regarding timing of administration of FG001 and integration of FG001 into the surgical workflow for assessing margins of excised tumor tissue during surgery, with the goal of supporting timely identification of incomplete margins in the operating room. The amendment is prepared for submission, and enrollment of the remaining ten patients is planned to start during Q4 2026 with the topline result to be expected in H1 2027. Previously planned for H2 2026.
Partnering:
i) 1 additional imaging system manufacturer partnership expected in H2 2026:
The Company continues to expect one additional partnership with an imaging system manufacturer in H2 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. 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
Update on 2026 Outlook and Company progress
SOURCE: FluoGuide A/S
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/update-on-2026-outlook-and-company-progress-1184999
