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FluoGuide A/S publishes annual report for the fiscal year 2020

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Copenhagen, Denmark, 26 January 2021  – FluoGuide A/S (“FluoGuide” or the “Company”) hereby publishes its annual report for the fiscal year 2020. The annual report including the auditor’s report is attached as a pdf. The report is also available on FluoGuide’s website www.fluoguide.com under ‘Filings & reports’ and on Spotlight Stock Market (www.spotlightstockmarket.com).

Fourth quarter 2020 (1 October – 31 December):

  • Net revenue was KDKK 0 (0)
  • Operating result was KDKK -8,532 (-3,700)
  • Net result was KDKK -6,497 (-3,113)
  • Cash and bank was KDKK 10,637 (2,344)
  • Result per share* was DKK -0.62 (-0.43)
  • Solidity** was 26% (87%)

Full year 2020 (1 January – 31 December):

  • Net revenue was KDKK 0 (0)
  • Operating result was KDKK -22,161 (-10,645)
  • Net result was KDKK -17,460 (-9,653)
  • Cash and bank was KDKK 10,637 (2,344)
  • Result per share* was DKK -1.78 (-1.49)
  • Solidity** at end of the period was 50% (65%)

*) Result per share (DKK per share): Operating result divided by the average number of shares during the period.  The total number of shares as of 31 December 2020 totaled 10,530,026 shares (7,224,274).  The average number of shares for the fourth quarter 2020 was 10,530,026 shares (7,224,274).  The average number of shares for the period 1 January – 31 December 2020 was 9,552,070 shares (6,225,927).

**) Solidity:  Total equity divided by total capital and liability.

Highlights during Q1

  • European patent granted “uPAR targeting peptide for use in peroperative optical imaging of invasive cancer” (EP3193945)
  • Excellent results published on FluoGuide’s FG001 guided surgical removal of cancer
  • Safety study initiated for FG001
  • Directed share issue strengthened FluoGuide’s ownership, and is expected to shorten the time to market for FG001
  • FluoGuide is shortlisted for an EU grant

Highlights during Q2

  • Warrants of series TO 1 subscribed at 100%
  • FluoGuide secures a pipeline of uPAR targeting molecules
  • FluoGuide was awarded Best IPO in 2019 by the independent IPO Guide
  • FG001 successfully completed all toxicity studies
  • FluoGuide was selected as a top innovator and awarded €2.5 million by the European Innovation Council
  • Appointed Dorthe Grønnegaard Mejer as Vice President of Clinical Development

Highlights during Q3

  • Submitted the Clinical Trial Application for the phase I/II proof-of-concept clinical trial for FG001 in patients with high-grade glioma undergoing surgery
  • FluoGuide A/S and LI-COR Biosciences signed an agreement to develop uPAR targeted products to guide oncology surgery using LI-COR’s proprietary next-generation fluorophore, IRDye 800CW
  • Obtained regulatory approval from the Danish Medicines Agency to commence the phase I/II clinical trial of FG001 in patients with high-grade glioma (including glioblastoma) undergoing surgery
  • Appointed Henrik Moltke as Chief Financial Officer

Highlights during Q4

  • FluoGuide awarded post doc grant from Innovation Fund Denmark to expand the pipeline
  • First patient enrolled in the phase I/II clinical trial testing FG001 in patients with high-grade glioma
  • SEB initiates commissioned research on FluoGuide
  • FluoGuide gets green light to proceed to second dose level with FG001 in the ongoing clinical phase I/II trial in patients with high-grade glioma

For further information: Morten Albrechtsen, CEO (+45 24 25 62 66, ma@fluoguide.com)

About FluoGuide

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.

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