Year-End Report 2019

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FluoGuide A/S ("FluoGuide") today announces its results for the period 1 January– 31 December 2019. The report is available here.

Morten Albrechtsen, CEO of FluoGuide, comments: “I would like to thank all shareholders – new and from the IPO for the strong confidence in our business, our product and us. Together with an extraordinary team, I am looking forward to transform FluoGuide from a pre-clinical company into a phase III company with a pipeline of indications and products during 2021 - a very exciting year ahead

Fourth quarter 2019 (October – December)

  • Net revenue was KDKK 0 (0)
  • Operating result was KDKK -3,700 (-52)
  • Net result was KDKK -3,113 (-53)
  • Cash at bank at end of the period was KDKK 2,344 (59)
  • Result per share* was DKK -0.43 (-0.02)
  • Solidity** at end of the period was 87% (9%) 

Full year 2019 (January – December)

  • Net revenue was KDKK 0 (0)
  • Operating result was KDKK -10,645 (-52)
  • Net result was KDKK -9,653 (-53)
  • Cash at bank at end of the period was DKK 2,344 (59)

*) 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 2019 amounted to 7,224,274 shares (105,500). There was no change to the number of shares during the fourth quarter 2019, hence the average number of shares for the fourth quarter was 7,224,274 shares (2,203,143). The average number of shares for the period from 1 January 2019 to 31 December 2019 was 6,475,514 shares (675,307). Note that the number of shares in the Company after the end of the period, through a directed issue of shares, has increased to 9,455,268 shares registered on the 27 February 2020.

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

Amount within brackets corresponds to the same period in the previous year. 

 

Highlights during Q4

  • The manufacturing process was successfully upscaled
  • A formulation was successfully developed for early commercialization through compassionate use sales
  • The safety program for F001 was initiated

Highlights after Q4

  • FluoGuide announced the grant of European patent No. EP3193945 “uPAR targeting peptide for use in peroperative optical imaging of invasive cancer”, which is the core patent protecting FG001 in Europe. The patent protection is valid until September 2034
  • FluoGuide announced FG001 has demonstrated lack of acute toxicity in doses far beyond the expected human dose
  • FluoGuide strengthen its ownership and can reduce the time to initiation of the phase IIb/III clinical study by 6-12 months through a directed share issu


For further information, please contact:
Morten Albrechtsen, CEO
M: +45 24 25 62 66
ma@fluoguide.com

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About FluoGuide 
FluoGuide A/S (Spotlight Stock Market: FLUO:SS) provides solutions for maximizing surgical outcome through intelligent targeting. FluoGuide’s first product FG001 increases precision in cancer surgery by lighting up the cancer and its invasive growth into the surrounding tissue. FG001 is expected to reduce suffering for the patients and increase the likelihood of cure. It can also reduce costs for the health care system for the benefit of society. FluoGuide focuses on demonstrating the effect of FG001 in patients by conducting a human proof-of-concept clinical trial and expects to announce the first result of this study during first half of 2020.

About FG001
FG001, FluoGuide’s first product, lights up the cancer and its invasive growth into the surrounding tissue. It helps the surgeon remove the entire tumor during surgery and increases the chance for complete cure of the patient. The task for the surgeon is simply to "turn the lights on and see the entire tumor". The solution helps surgeons remove a minimal amount of normal tissue while also reducing the risk of leaving cancer tissue behind. This reduces the suffering of the patient and increases the likelihood of cure, and also reduces costs for the health care system. FG001 is currently prepared for a proof-of-concept clinical study.

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Quotes

I would like to thank all shareholders – new and from the IPO for the strong confidence in our business, our product and us. Together with an extraordinary team, I am looking forward to transform FluoGuide from a pre-clinical company into a phase III company with a pipeline of indications and products during 2021 - a very exciting year ahead
Morten Albrechtsen, CEO of FluoGuide
Based on the combination of successful production of the compound, pre-clinical safety data and consistently positive preclinical data on FG001 lightening glioblastomas, we now strongly believe it is no longer a question of whether FG001 will work in humans but rather how well it will perform
Morten Albrechtsen, CEO of FluoGuide