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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 – March 2023

Regulatory


May 31, 2023

Copenhagen, Denmark, 31 May 2023 – FluoGuide A/S (“FluoGuide” or the “Company”) today releases its results for the period 1 January – 31 March 2023. The Q1 report is available as an attached document to this press release and on FluoGuide’s website: Financial reports – FluoGuide A/S (https://fluoguide.com/investor/financial-reports/)

In Q1 2023, FluoGuide advanced clinical testing of FG001 in three different types of cancers. Favorable interim results from the phase lla trial in head & neck cancer was reported at the beginning of the quarter. After end of the quarter, further positive interim results were reported from both the lung and the head & neck trial. A prestigious grant from Innovation Fund Denmark was awarded to FluoGuide together with four other academic groups for optimizing molecules for photothermal therapy using FG001 as a model drug. Photothermal therapy could become a new pillar in the treatment of cancer and has the potential to significantly contribute to the long-term growth of FluoGuide.

FluoGuide had no revenue for the period and posted a net result of TDKK -9,535 (-3,952) for the period 1 January to 31 March 2023. The financial result for the period is in line with the Company's development plans.

Summary Q1 23 Q1 22 2022
DKK thousands 1-Jan-23 1-Jan-22 1-Jan-22
  31-Mar-23 31-Mar-22 31-Dec-22
Net Revenue
Operating result -11,645 -5,428 -32,461
Net result -9,535 -3,952 -27,340
Cash and bank 16,269 50,021 26,013
Result per share (DKK) *) -0.81 -0.35 -2.33
Solidity (%) **) 82% 91% 90%

Highlights during Q1:

  • Release of positive interim result of FG001 in the phase lla trial with head & neck cancer
  • Ole Larsen appointed as CFO
  • Update of clinical timelines for the ongoing phase llb in aggressive brain cancer
  • Announcement on FluoGuide being awarded the prestigious grant together with four academic groups

Highlights after Q1:

  • Release of FluoGuide providing update on strong clinical trial progress including:
    • Interim results in phase lla lung cancer trial show consistent activity of FG001
    • Encouraging data from head & neck cancer phase lla merits cohort expansion
    • Phase llb trial in brain cancer remains on track

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”.

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