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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 interim report for the period January – September 2023

Regulatory


November 29, 2023

Copenhagen, Denmark, 29 November 2023 – FluoGuide A/S (“FluoGuide” or the “Company”) today releases its results for the period 1 January – 30 September 2023. The Q3 report is available as an attached document to this press release and on FluoGuide’s website.

In Q3 2023, FluoGuide completed patient recruitment for two clinical phase II trials of FG001, in aggressive brain cancer and head and neck cancers. The positive results in these indications, some of which were published after the end of Q3, as well as positive phase II data in lung cancer reported earlier in 2023, put FluoGuide in a uniquely promising position. Financial flexibility enables the Company to fully capitalize on the good clinical results.
 
FluoGuide had no revenue for the period and posted a net result of TDKK -9,314 (TDKK -7,041) for the period 1 January to 30 September 2023. The financial result for the period is in line with the Company's development plans.
 

Summary Q3 23 Q3 22 YTD 2023 YTD 2022 2022
DKK thousands 1-Jul-23 1-Jul-22 1-Jan-23 1-Jan-22 1-Jan-22
  30-Sep-23 30-Sep-22 30-Sep-23 30-Sep-22 31-Dec-22
Net Revenue
Operating result -10,862 -8,416 -31,164 -21,358 -32,461
Net result -9,314 -7,041 -25,990 -16,743 -27,340
Cash and bank 8,945 31,700 8,945 31,700 26,013
           
Result per share (DKK) *) -0.78 -0.60 -2.19 -1.43 -2.33
Solidity (%) **) 73% 91% 73% 91% 90%

 *) Result per share (DKK per share): Operating result divided by the average number of shares during the period.
**) Solidity: Total equity divided by total capital and liability.

HIGHLIGHTS DURING Q2:

  • Positive interim data from phase lla trial of FG001 in head & neck cancer presented as a case report at the World Molecular Imaging Congress in Prague
  • Further positive interim data from phase lla trial of FG001 in head & neck cancer
  • Completes patient enrollment and treatment in FG001 phase llb clinical trial in aggressive brain cancer
  • Completes a Directed Share Issue raising SEK 15 million
  • Issues warrants to Board members, management, and employees, as well as the investors participating in the Directed Share Issue

HIGHLIGHTS AFTER Q2

  • Receives FDA Orphan Drug Designation for FG001 in high-grade glioma
  • Confirms positive topline results from phase lla trial of FG001 in head & neck cancer at IAOO
  • Announces FG001 meets primary endpoint in phase llb trial in aggressive brain cancer

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

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 intraoperatively. This 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, this improved precision will improve a patient’s chance of achieving a complete cure and will lower system-wide healthcare costs.

The Company has published key results on the efficacy of FG001 as well as showing it was well tolerated and safe from clinical trials in patients with aggressive brain cancer (high-grade glioma) that undergo surgery. In addition, FluoGuide has demonstrated the effect of FG001 in lung and head & neck cancers.

For more information on the Company, please visit www.fluoguide.com