Lördag 5 Juli | 06:54:58 Europe / Stockholm

Prenumeration

Kalender

Est. tid*
2025-11-27 07:10 Kvartalsrapport 2025-Q3
2025-08-28 07:10 Kvartalsrapport 2025-Q2
2025-05-28 - Kvartalsrapport 2025-Q1
2025-03-28 - X-dag ordinarie utdelning FLUO 0.00 DKK
2025-03-27 - Årsstämma
2025-02-27 - Bokslutskommuniké 2024
2024-11-27 - Kvartalsrapport 2024-Q3
2024-08-29 - Kvartalsrapport 2024-Q2
2024-05-30 - Kvartalsrapport 2024-Q1
2024-03-21 - X-dag ordinarie utdelning FLUO 0.00 DKK
2024-03-20 - Årsstämma
2024-02-28 - Bokslutskommuniké 2023
2023-11-29 - Kvartalsrapport 2023-Q3
2023-08-30 - Kvartalsrapport 2023-Q2
2023-05-31 - Kvartalsrapport 2023-Q1
2023-03-22 - X-dag ordinarie utdelning FLUO 0.00 DKK
2023-03-21 - Årsstämma
2023-02-28 - Bokslutskommuniké 2022
2022-11-24 - Kvartalsrapport 2022-Q3
2022-08-25 - Kvartalsrapport 2022-Q2
2022-05-31 - Kvartalsrapport 2022-Q1
2022-05-19 - X-dag ordinarie utdelning FLUO 0.00 DKK
2022-05-18 - Årsstämma
2022-03-30 - Bokslutskommuniké 2021
2021-11-24 - Kvartalsrapport 2021-Q3
2021-08-25 - Kvartalsrapport 2021-Q2
2021-05-26 - Kvartalsrapport 2021-Q1
2021-05-03 - X-dag ordinarie utdelning FLUO 0.00 DKK
2021-02-26 - Bokslutskommuniké 2020
2021-02-09 - Årsstämma
2020-11-20 - Kvartalsrapport 2020-Q3
2020-08-14 - Kvartalsrapport 2020-Q2
2020-05-27 - Kvartalsrapport 2020-Q1
2020-04-09 - X-dag ordinarie utdelning FLUO 0.00 DKK
2020-04-08 - Årsstämma
2020-02-28 - Bokslutskommuniké 2019
2019-11-29 - Kvartalsrapport 2019-Q3
2019-05-31 - Kvartalsrapport 2019-Q1

Beskrivning

LandDanmark
ListaFirst North Stockholm
SektorHälsovård
IndustriMedicinteknik
FluoGuide är ett danskt bolag verksamt inom medicinteknik. Bolaget affärsfokus återfinns inom forskning och utveckling av behandlingar mot olika cancerformer, med störst fokus på utveckling av produkter som vägleder vid kirurgiska ingrepp. Produkterna binder till sig cancercellerna som då lyser upp och är avsedda att användas för att med precision kunna ta bort skadliga tumörer i patientens vävnad.
2025-07-03 14:56:00

Copenhagen, Denmark, 3 July 2025 – FluoGuide A/S ("FluoGuide" or the "Company"), a clinical-stage biotech company focused on precision cancer surgery, is pleased to share an update on the 2025 Outlook and ongoing progress. As part of this update, FluoGuide has refined timing of some milestones - some are progressing ahead of schedule, while others are slightly delayed. There are no changes to the overall development.

FluoGuide has made significant progress during the first half of 2025. Beginning with the Q3 2024 report, we began to forecast milestones for the coming year (2025) to enhance transparency and make it easier to track our progress. In keeping with this approach, we now provide a update on our 2025 outlook and we plan to present the 2026 milestones later in the year. We will also organize sessions in the second half of the year to outline the development path and trial design in greater detail.

“FluoGuide has made substantial progress during the first half of 2025. While this may not yet be reflected in a high number of press releases, the groundwork we are laying is critical to our long-term success – and the momentum is building,” said Morten Albrechtsen, CEO of FluoGuide.

The 2025 milestones:

Brain cancer:

a) Submission of an Investigational New Drug (IND) application in the U.S. for a clinical trial to support the registration of FG001 as an imaging agent for guiding surgery in aggressive brain cancer (glioblastoma):

The Company remains on track to submit the IND application in H2 2025 to initiate U.S. clinical trial(s) of FG001 as an imaging agent to guide surgery in patients with aggressive brain cancer (glioblastoma). The trial(s) is intended to support a future New Drug Application (NDA) submission to FDA.

b) Continuing discussions with FDA to finalize the design of the upcoming U.S. clinical trial(s) that will support registration of FG001 as an imaging agent to guide surgery in aggressive brain cancer:

Prior to submitting the IND, FluoGuide plans to consult with FDA and expects to submit a pre-IND meeting request in July. Feedback from the FDA is anticipated by the end of Q3 or early Q4. To de-risk the IND process and enable focused FDA feedback, FluoGuide is preparing a robust pre-IND package that includes detailed information on completed development and proposed plans for remaining data generation. This approach is intended to provide the FDA with a strong foundation for evaluating key components of the IND prior to its submission, and de-risking the regulatory process.

c) Preliminary data from an investigator-initiated trial involving 20 patients with meningioma and low-grade glioma:
The trial, initiated and conducted as an investigator-initiated trial, enrolled 10 patients with meningioma and 10 with low-grade glioma. While meningioma and low-grade glioma are considered benign tumors, they both typically recure after surgery and disabilities last lifelong in those younger patients than patients with glioblastoma. The two indications represent distinct brain tumor indications that could support future expansion of FG001’s use beyond glioblastoma.

The principal investigator has submitted the first results from the trial as an abstract to scientific conferences scheduled to take place in the second half of 2025. Although FluoGuide cannot share the data prior to its presentation, this study provides valuable insights that can strengthen the design and execution of FluoGuide’s upcoming U.S. clinical trial in glioblastoma.

d) Completion of optimization of FG001 in combination with the laser system in pre-clinical models:
The photothermal effect of FG001, which involves heat-mediated killing of cancer cells, has been confirmed using a laser system that is compatible with use throughout clinical development and potential drug approval. In addition, FG001 is expected to demonstrate a photodynamic effect, in which cancer cells are destroyed through a light-activated chemical process, and this is currently under investigation. These two mode-of-actions represent distinct potential in brain tumor indications, each with its own development path. FluoGuide sees this progress as a potential opportunity to advance its glioblastoma program, expand into additional brain cancer indications, and broaden its footprint in the larger brain cancer market. Further updates on timing, development plans, and expected impact will be provided in H2 2025.
 

Head and neck cancer:

e) Enrollment of first patient and interim data from first 15 patients (CT-005):

Enrollment is ahead of schedule, even though the first patient was enrolled in April. FluoGuide remains on track to present interim data from the first 15 patients in H2 2025. While enrollment has progressed well so far, FluoGuide notes that enrollment timing can vary.

f) Submission for FDA feedback on a U.S. trial in head and neck cancer:
FluoGuide remains on track to submit for U.S. FDA regulatory feedback in H2 2025 on a trial of FG001 in head and neck cancer. This represents yet another potential indication expansion beyond the current glioblastoma program. Further, an indication with profound partner interest.

Partnering:

g) 1-2 additional partnerships expected in H1 2025:
Earlier this year, FluoGuide entered into an agreement with SurgVision, a Bracco-owned company, as noted in the Q1 2025 report. In the clinical trial evaluating FG001 in oral head and neck surgery, five different imaging systems are being investigated. Two of these systems are from Intuitive Surgical and SurgVision, while the remaining three have not yet been disclosed. FluoGuide expects to announce at least one additional partnership in 2025.