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:
- Continue regulatory evaluation to confirm the design of registration trials for FG001 as an imaging agent in guiding aggressive brain cancer surgery
- Initiate a head & neck phase II trial with benefit endpoint(s)
- Enter into partnership agreement(s) for FG001, in accordance with our partnership strategy
- 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:
- Redeye interview (in English): Morten Albrechtsen (CEO) and Ole Larsen (CFO), will later today participate in an interview with Redeye analyst Christian Binder. Questions are welcome to ir@fluoguide.com or christian.binder@redeye.se at the latest today at 09.00 (CET).
The interview will be video-recorded and uploaded to the FluoGuide website https://fluoguide.com/investor/presentations/ during tomorrow. - Virtual live event with HC Andersen Capital (in English): Morten Albrechtsen (CEO) will today, February 28, do a company presentation at a virtual live event with HC Andersen Capital at 10.45 (CET). Sign-up here: https://www.inderes.dk/videos/introduction-to-fluoguide
- Virtual live event with HC Andersen Capital (in Danish): Morten Albrechtsen (CEO) will tomorrow, February 29, do a company presentation at a virtual live event with HC Andersen Capital at 13.15 (CET). Sign-up here: https://www.inderes.dk/videos/introduktion-til-fluoguide
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