Press release from Companies
Publicerat: 2020-12-29 16:36:21
Copenhagen, Denmark, 29 December 2020 - FluoGuide A/S ("FluoGuide" or "the Company") board member Peter Mørch Eriksen has, through his company PME Consult ApS, sold 14,000 shares in FluoGuide on 29 December 2020 to pay capital gain tax on his shareholding in FluoGuide under Danish tax regulations. Peter Mørch Eriksen is an active and committed Board member and with a long-term interest in the Company. After the transaction, Peter Mørch Eriksen owns 117,297 shares in FluoGuide through his company PME Consult ApS, corresponding to 1.1 percent of the shares and votes in the Company.
"Due to Danish corporate tax regulations and the success of FluoGuide during 2020, I have to pay capital gain tax in my holding company. I have decided to partly finance this by selling some of my shares in FluoGuide", says Peter Mørch Eriksen, member of the Board of Directors of FluoGuide and continues "I have strong confidence in FluoGuide and I am very committed and proud to be part of its exciting development." Under Danish tax law, capital gain tax is due for shares in a publicly traded company (such as FluoGuide) when the shares are held in a limited liability company (‘Holding company’) and the total shareholding is less than 10% of the publicly traded company. The capital gain tax is calculated based on the public share price at the last day in the fiscal year of the Holding company. This is regardless if the gain is materialized by selling the shares or not. For further information: About the clinical trial About high grade glioma and glioblastoma About FluoGuide
Morten Albrechtsen, CEO
M: +45 24 25 62 66
ma@fluoguide.com
The ongoing first phase of the clinical phase I/II trial with the objective to test the safety and determine the optimal dose of FG001 in patients with high grade glioma undergoing neurosurgery, is designed with three patients in each dose group, with up to 8 dose groups in total resulting in up to 24 patients in total for the first phase. The second phase will based on the optimal dose selected in the first phase of the trial evaluate the efficacy of FG001 in guiding neurosurgery. The second phase includes 12 patients resulting in the total number of patients in the entire trial of up to 36 patients in total. The dose escalation committee’s role is to evaluate the result after each dose level and only if the dose escalation committee identifies no issues they will give clearance to proceed to the next dose level. The commitee consists of three people, the Principle Investigator, an independent anesthesiologist and a medical doctor from FluoGuide.
The first indication for FG001 is glioblastoma but FG001 has potential in several indications. Almost all patients with glioblastoma have a cancer expressing uPAR. A total of 60,000 patients gets high grade glioma and more than 30.000 patients are diagnosed with glioblastoma annually in the EU and US. Approximately 8-12 % of the patients are children. The prognosis for individuals with glioblastoma is very poor. Approximately 50 % of the patients die within 14 months and only 5 % are alive after five years from diagnosis. Precise removal of glioblastoma tumors is very difficult due the brain contains vital structures often near the cancer. Local reoccurrence of glioblastoma is common and happens in almost 100% of all patients.
FluoGuide’s primary focus is to maximize surgical outcomes in oncology. The Company’s first product, FG001, is designed to improve surgical precision by illuminating cancer cells intraoperatively. The improved precision enabled by FluoGuide’s products has a dual benefit – it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, these improvements will improve a patient’s chance of achieving a complete cure and will lower system-wide healthcare costs. The Company is undertaking a proof-of-concept clinical trial (phase I/II) to demonstrate the effect of FG001 in patients with high grade glioma including glioblastoma.This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 954904.
