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18 Apr 2024

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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.

New - New exchange: Nasdaq First North

FluoGuide is moving from Spotlight to Nasdaq First North. Shareholders are strongly encouraged to make sure they will be able to freely trade their shares in the future.

FluoGuide A/S publishes year-end and annual report for the fiscal year 2023

Regulatory


February 28, 2024

  • FluoGuide publishes year-end and annual report for the year 2023
  • Three presentations will be held; one video-recorded Redeye interview and two HC Andersen Capital virtual live events on February 28 (in English) and February 29 (in Danish).

FluoGuide A/S (“FluoGuide” or the “Company”) hereby publishes its annual report for the fiscal year 2023. The annual report including the auditor’s report is attached as a pdf. The report is also available on FluoGuide’s website https://fluoguide.com under ‘Filings & reports’.

Financial highlights:

KEY FIGURES 2023 2022 2021 2020 2019
DKK thousand          
Income Statement
Income before interest and tax (EBIT) -43,924 -32,461 -28,809 -22,161 -10,644
Net financial items 47 -379 -461 -25 -1,062
Net result for the year -38,377 -27,340 -23,770 -17,460 -9,653
Balance sheet          
Total assets 29,609 35,620 53,309 16,742 5,238
Equity 12,720 31,969 38,701 4,411 4,542
Cash flow          
Cash flow from:          
  Operating activities -31,809 -37,645 -15,062 -8,847 -10,553
  Investing activities -37 -117 0 -42 -390
  Financing activities 27,500 17,018 51,183 17,182 13,228
The period’s cash flow -4,345 -20,745 36,121 8,293 2,285
Dividend 0 0 0 0 0
           
Ratios          
Solvency ratio 43% 90% 73% 26% 87%
Earnings per share (DKK) -3.22 -2.33 -2.15 -1.78 -1.49

  
Milestones for the Company in 2024:

  1. Continue regulatory evaluation to confirm the design of registration trials for FG001 as an imaging agent in guiding aggressive brain cancer surgery
  2. Initiate a head & neck phase II trial with benefit endpoint(s)
  3. Enter into partnership agreement(s) for FG001, in accordance with our partnership strategy
  4. Evaluate and implement photothermal therapy into brain cancer development

Highlights from 2023 included:

Q1 

  • Release of positive interim result of FG001 in the phase ll trial with head & neck cancer
  • Awarded a prestigious grant from Innovation Fund Denmark, together with four academic groups (photothermal therapy)
  • Ole Larsen appointed as CFO

Q2 

  • Positive topline results from phase II trial of FG001 in lung cancer
  • Positive interim results from phase II trial of FG001 in head & neck cancer 

Q3

  • Further positive interim data from phase ll trial of FG001 in head & neck cancer
  • Completes patient enrollment and treatment in FG001 phase ll trial in aggressive brain cancer
  • Completes a Directed Share Issue raising SEK 15 million
  • Issue of warrants to Board members, management, and employees, as well as the investors participating in the Directed Share Issue

Q4 

  • Receives FDA Orphan Drug Designation for FG001 in high-grade glioma
  • Confirms positive topline results from phase ll trial of FG001 in head & neck cancer at IAOO
  • Announces FG001 meets primary endpoint in phase ll trial in aggressive brain cancer
  • FluoGuide raises SEK 12 million through exercise of warrants

 Highlights after the period:

  • Strategic update and development plans woards commercialization of FG001
  • Warrants issued to the CFO in relation to the CFO becoming a part of the executive management

Presentations:
In relation to the publishing of the annual report, you have the opportunity to ask questions at the following presentations:

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. FG001 binds to the receptor uPAR being extensively expressed on most solid cancer types. The photothermal potential of FG001 could add a direct treatment effect of FG001 to further benefit for patients with cancer undergoing surgery.

The Company has published strong results from phase II trials demonstrating the efficacy of FG001 as well as showing it was well tolerated and safe from clinical trials in patients undergoing surgery to remove aggressive brain (high-grade glioma), head & neck and lung cancers.

Based on this strong foundation, FluoGuide expands the scope of application of FG001 and advance the development toward approval in aggressive brain cancer.

FluoGuide is listed on Nasdaq First North Growth Market, Stockholm under the ticker “FLUO”.
Read more about FluoGuide’s pipeline, technology, and upcoming events on www.fluoguide.com