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FluoGuide A/S publishes interim report for the period January – September 2022

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Copenhagen, Denmark, 24 November 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) today releases its results for the period 1 January – 30 September 2022. The Q3 report is available as an attached document to this press release and on FluoGuide’s website: Filings & reports - FluoGuide A/S

In Q3 2022, FluoGuide made important progress and received approvals from Danish authorities to initiate the clinical phase IIb trial with FG001 in aggressive brain cancer as well as clinical phase IIa trial with FG001 in head and neck cancer in Denmark. After Q3, Fluoguide enrolled first patient in both clinical trials. Fluoguide has also received positive interim result from the ongoing phase IIa trail with FG001 in lung cancer.

FluoGuide had no revenue for the period and posted a net loss of TDKK -16,743 for the period 1 January to 31 September 2022 (-15,841).  The financial result for the period is in line with the Company's development plans.  It is the Board’s opinion that FluoGuide, unlike many other life science companies, may have a comparatively short time from the initiation of product development to revenue generation.

Summary Q3 22 Q3 21 Q1-Q3 2022 Q1-Q3 2021 2021
01-jul-22 01-jul-21 01-jan-22 01-jan-21 01-jan-21
(TDKK) 30-sep-22 30-sep-21 30-sep-22 30-sep-21 31-dec-21
Net Revenue  0 0 0 0 0
Operating result -8,416 -8,938 -21,358 -19,169 -28,809
Net result  -7,041 -8,065 -16,743 -15,841 -23,770
Cash and bank  31,700 47,974 31,700 47,974 46,758
Result per share (DKK) *) -0.60 -0.71 -1.43 -1.45 -2.15
Solidity (%) **) 91% 79% 91% 79% 73%
Avarage shares for the period 11,814,500 11,319,500 11,689,390 10,940,668 11,036,155
Net result  -0.60 -0.71 -1.43 -1.45 -2.15

 *) 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 Q3

  • A publication of clinical data that shows uPAR is highly expressed in oropharyngeal squamous cell carcinoma (Head and Neck cancer). The article is published in ONCOLOGY REPORTS 48: 147, 2022
  • Submitted a CTA to initiate a phase II trial in head and neck cancer
  • Update on clinical development
  • Interim report for the period January – June 2022
  • Permission to start phase IIb trial in aggressive brain cancer
  • Appointment of Henrik Hang as new CFO
  • Received approval from the Danish Medicines Agency to initiate phase II trial with FG001 in head and neck cancer e Department of Neurosurgery, Linköping University Hospital, Sweden to

HIGHLIGHTS AFTER Q3HI

  • The phase I/IIa clinical data of FG001 in aggressive brain cancer was presented at the World Molecular Imaging Congress
  • The phase l/lla clinical data of FG001 in aggressive brain cancer was presented at the European Congress of Neurosurgery 2022
  • First patient enrolled in the phase IIb trial for aggressive brain cancer with FG001
  • Positive interims data in phase IIa lung cancer
  •  FluoGuide reaches milestone with FG001 for phase III clinical supply
  • First patient enrolled in the head & neck cancer phase IIa trial

Morten Albrechtsen, CEO says: “On top of the convincing clinical data of FG001 in aggressive brain cancer, the first lung interim result support a broader use of FG001 – so now we can move into late-stage development”

For more information:

FluoGuide A/S
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 lead 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, the improved precision will improve a patient’s chance of achieving a complete cure and will lower system-wide healthcare costs. The Company is has demonstrated efficacy of F001 as well as it to be well tolerated and safe in the ongoing proof-of-concept clinical study (phase I/II) in patients with high grade glioma undergoing surgery. FluoGuide has decided to explore FG001 in three other severe cancer indications, namely lung, head & neck, meningioma and low grade glioma. FluoGuide is listed on Nasdaq First North Sweden under the ticker “FLUO”.

For more information on the Company’s uPAR technology platform and our pipeline please visit our home page www.fluoguide.com

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