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FluoGuide develops surgical solutions that is expected to reduce suffering for the patient and increases the likelihood of cure as well as reducing costs for the health care system.

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FluoGuide A/S publishes Year-end and annual report for the fiscal year 2022

Regulatory


February 28, 2023

FluoGuide A/S (“FluoGuide” or the “Company”) hereby publishes its annual report for the fiscal year 2022. The annual report including the auditor’s report is attached as a pdf. The report is also available on FluoGuide’s website https://fluoguide.com under ‘Filings & reports’.

KEY FINANCIAL FIGURES
Full Year 2022 (Audited)

KEY FIGURES 2022 2021 2020 2019 2018
Amounts in DKK ‘000
Income Statement
Operating Loss -32,463 -28,809 -22,161 -10,644 -52
Net financial items -379 -461 -25 -1,062 1
Loss for the period -27,342 -23,770 -17,460 -9,653 -53
Balance sheet
Total assets 35,620 53,309 16,742 5,238 75
Equity 31,968 38,701 4,411 4,542 7
Cash flows
Cash flows from:
Operating activities -37,647 -15,062 -8,847 -10,553 -1
Investing activities -117 0 -42 -390 0
Financing activities 17,019 51,183 17,182 13,228 60
The period’s cash flow -20,745 36,121 8,293 2,285 59
Dividend 0 0 0 0 0
Ratios          
Solvency ratio 90% 73% 26% 87% 9%
Earnings per share (DKK) -2.33 -2.15 -1.78 -1.49 -0.08

HIGHLIGHTS FROM 2022

Q1 

  • FluoGuide completed a directed share issue approximately SEK 25 million.
  • FluoGuide received a grant of approx. DKK 1 million together with Rigshospitalet, Denmark to conduct an explorative phase II trial with FG001 in patients with less aggressive brain cancer.
  • FluoGuide received regulatory approval from the Danish Medicines Agency to initiate an explorative phase II trial with FG001 in patients with lung cancer.

Q2 

  • FluoGuide announced positive top line result from the first part of the ongoing clinical phase I/II trial testing the safety and performance of FG001 in lightening up aggressive brain cancer.
  • FluoGuide presented the clinical data on FG001 at the 68th Scandinavian Neurosurgical Society Congress in Bergen, Norway.
  • FluoGuide hosted a presentation of FG001 results from the first clinical trial with FG001 (phase I/II) in patients with aggressive brain cancer

Q3 

  • Publication of clinical data that showed uPAR is highly expressed in oropharyngeal squamous cell carcinoma (head and neck cancer) in Oncology Report.
  • FluoGuide submitted CTA to initiate an explorative clinical phase II trial with FG001 in patients with head and neck cancer.
  • FluoGuide received regulatory permissions to start clinical phase IIb trial in patients with aggressive brain cancer in Denmark and Sweden.
  • FluoGuide received regulatory approval and initiated clinical phase II trial with FG001 in patients with head and neck cancer.

Q4 

  • The excellent phase I/IIa clinical data of FG001 in aggressive brain cancer was presented at the World Molecular Imaging Congress and the European Congress of Neurosurgery 2022.
  • FluoGuide enrolled first patient in the clinical phase IIb trial with FG001 in patients with aggressive brain cancer.
  • FluoGuide announced positive interims result from FG001 phase IIa trial in lung cancer.
  • FluoGuide enrolled first patient in the explorative clinical phase IIa trial with FG001 in patients with head and neck cancer.

HIGHLIGHTS AFTER THE PERIOD 

  • FluoGuide announced positive interim result of FG001 in the clinical explorative phase II trial in patients with head and neck cancer.
  • FluoGuide appointed Ole Larsen as CFO.
  • FluoGuide updated the clinical timelines for the ongoing clinical phase IIb trial of FG001 in patients with aggressive brain cancer (high grade glioma) undergoing surgery.

For further information, please contact:
Morten Albrechtsen, CEO
FluoGuide A/S
+45 24 25 62 66
ma@fluoguide.com
Certified Adviser:
Svensk Kapitalmarknadsgransking AB
Phone: +46 70 755 95 51
E-mail: ca@skmg.se
About FluoGuide
FluoGuide takes precision surgery to the next level improving the outcome for cancer patients. The Company’s lead product, FG001, is designed to improve surgical precision by illuminating cancer cells intraoperatively. The improved precision enabled by FluoGuide’s products is expected to have a dual benefit – it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, the improved precision will improve a patient’s chance of achieving a complete cure and will lower system-wide healthcare costs. The Company has demonstrated efficacy of F001 as well as it being well tolerated and safe in the completed proof-of-concept clinical study (phase I/IIa) in patients with aggressive brain cancer (high grade glioma) undergoing surgery. A phase IIb trial in aggressive brain cancer is ongoing to obtain valuable information to design the phase III trial. In addition, FluoGuide currently explores FG001 lung and head & neck cancer, and a trial in meningioma and low grade glioma is commencing. FluoGuide is listed on Nasdaq First North Growth Market, Stockholm under the ticker “FLUO”.