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FluoGuide A/S publishes year-end and annual report for the fiscal year 2024

Regulatory


February 27, 2025

Copenhagen, Denmark, 27 February 2025 – FluoGuide A/S (“FluoGuide” or the “Company”) hereby publishes its annual report for the fiscal year 2024. The annual report, including the auditor’s report, is attached as a PDF and is also available on FluoGuide’s website www.fluoguide.com under ‘Filings & Reports’.

FINANCIAL HIGHLIGHTS

KEY FIGURES 2024 2023 2022 2021 2020
DKK thousand          
Income Statement
Income before interest and tax (EBIT) -33,040 -43,924 -32,461 -28,809 -22,161
Net financial items -1,419 47 -379 -461 -25
Net result for the year -28,959 -38,377 -27,340 -23,770 -17,460
Balance sheet          
Total assets 28,380 29,609 35,620 53,309 16,742
Equity 23,067 12,720 31,969 38,701 4,411
Cash flow          
Cash flow from:          
  Operating activities -29,152 -31,809 -37,645 -15,062 -8,847
  Investing activities -987 -37 -117 0 -42
  Financing activities 27,080 27,500 17,018 51,183 17,182
The period’s cash flow -3,059 -4,345 -20,745 36,121 8,293
Dividend 0 0 0 0 0
Ratios          
Solvency ratio 81% 43% 90% 73% 26%
Earnings per share (DKK) -2.23 -3.22 -2.33 -2.15 -1.78

 
 
2024 HIGHLIGHTS
Q1 2024

  • Entered a strategic collaboration with Intuitive Surgical, focusing on integrating FG001 into robotic-assisted surgery for head and neck cancer.
  • Provided a strategic update outlining development plans for FG001 towards commercialization.

 Q2 2024

  • Successfully raised SEK 60 million through a directed share issue, strengthening the financial foundation for ongoing clinical development.
  • Selected a laser system for photothermal therapy with FG001, advancing its dual capability as both a surgical guidance and therapeutic tool.

Q3 2024

  • Appointed Jens Ellrich as Chief Medical Officer, bringing critical expertise in clinical development and regulatory strategy.
  • Submitted a Clinical Trial Application (CTA) for FG001 in head and neck cancer, progressing towards regulatory approval.

Q4 2024

  • Published positive Phase II data for FG001 in head and neck cancer, validating its ability to improve surgical precision and outcomes.
  • Progressed FG001 trials in aggressive brain cancer and additional indications such as meningioma and low-grade glioma, with results expected in 2025.
  • Strengthened leadership and governance through key appointments and board adjustments.

Highlights after the period:

  • The Company received approval for phase II trial in head and neck cancer.

“2024 was a pivotal year for FluoGuide, marked by a new strategic partnership, advancements in FG001’s therapeutic potential and successful capital raise” says Morten Albrechtsen, CEO.
 
LOOKING AHEAD – 2025 MILESTONES

  • Advance FG001 toward FDA consultations to confirm the design of the registration trial in aggressive brain cancer.
  • Enroll the first patient in the Phase II trial (FG001-CT-005) for FG001 in head and neck cancer.
  • Deliver interim data from the head and neck cancer trial (FG001-CT-005) to guide regulatory progress.
  • Expand FG001’s applications in photothermal therapy and brain cancer indications.
  • Establish new strategic partnerships to accelerate FG001’s commercialization.

 
PRESENTATION
In connection with the annual report publication, CEO Morten Albrechtsen and CFO Ole Larsen will participate in an interview with Redeye analyst Christian Binder on February 27, 2025.

The interview will be video-recorded and uploaded to FluoGuide’s website under Investor Presentations on February 28, 2025.