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FluoGuide releases positive interim result of FG001 in head and neck cancer

Regulatory


January 9, 2023

Copenhagen, Denmark, 9 January 2023 – FluoGuide A/S ("FluoGuide" or the "Company") is pleased to announce the positive interim result of FG001 in head and neck cancer that FG001 lights up in 4 out of 4 patients following the interim evaluation of the first four patients dosed in the ongoing explorative phase IIa trial in patients with head and neck squamous cell carcinomas (HNSCC) undergoing surgery.

Detection of light was made from the tissue identified macroscopically as cancer by the surgeon. At the end of the trial, the pathologists will histologically examine the tissue that lights up to determine if the tissue samples contain cancer or normal tissue. Although this is an encouraging interim result, it is important to state that a final conclusion regarding the effect of FG001 cannot be reached until after the histology examinations have been completed at the end of the trial. The optimal dose in patients with head and neck squamous cell carcinomas (HNSCCs) undergoing surgery has not yet been established. FluoGuide has selected head and neck cancer, the 6[th] most common cancer, due to a high unmet need and evidence of uPAR overexpression. The ongoing trial is conducted in cooperation with the Department of Otorhinolaryngology, Head and Neck Surgery & Audiology at the Copenhagen University Hospital – Rigshospitalet, in Denmark.

The phase IIa trial is designed to obtain proof-of-concept in head and neck cancer for our uPAR platform technology used to guide surgical removal of cancer. The plan is to enrol up to 16 patients. The primary endpoint is sensitivity for detection of cancer defined as the relative number of patients, where FG001 lights up the cancer confirmed by histopathology. FluoGuide expects top line results to be available in H1 2023. FluoGuide has selected head and neck cancer due to the high prevalence, a high unmet need, and strong evidence of uPAR being overexpressed in these cancers.

"We are very pleased to see FG001 also lighting up in head and neck cancer, which further supports FG001 as a relevant product for guiding surgery beyond aggressive brain cancer" says Morten Albrechtsen, CEO of FluoGuide.

This disclosure contains information that Fluoguide is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-01-2023 10:30 CET.