Copenhagen, Denmark, 27 November 2024 - Fluoguide A/S ("FluoGuide" or the "Company") today releases its results for the period 1 January 2024 - 30 September 2024. The Q3 report is available as attached document to this press release and on FluoGuide's website.
In the third quarter, preparations for the FG001 phase II head and neck trial application (CT-005) were made, informed by feedback from global key opinion leaders about patient needs and trial design. This milestone reflects extensive planning based on positive results from the earlier FG001 trial (CT-003), published in Theranostics, which showed successful cancer detection in all 16 patients. Progress is also being made on clinical and regulatory plans for aggressive brain cancer, with updates expected in the first half of next year.
FluoGuide had no revenue for the period and posted a net loss of DKK 5,495 thousand (net loss of DKK 9,315 thousand) for the period July 1 to September 30, 2024. For the period January 1 - September 30, 2024, FluoGuide posted a net loss for the period of DKK 20,218 thousand (net loss of DKK 25,990 thousand).
The total number of shares as of September 30, 2024, amounted to 13,620,149 shares. The total number of shares as of September 30, 2023, amounted to 11,814,500 shares. The average number of shares in Q3 2024 amounted to 13,620,149 shares as no issuance of new shares have taken place.
| KEY FIGURES | Q3 24 | Q3 23 | YTD 2024 | YTD 2023 | 2023 |
| DKK thousand | 1-Jul-24 | 1-Jul-23 | 1-Jan-24 | 1-Jan-23 | 1-Jan-23 |
| 30-Sep-24 | 30-Sep-23 | 30-Sep-24 | 30-Sep-23 | 31-Dec-23 | |
| Net Revenue | 0 | 0 | 0 | 0 | 0 |
| Income before interest and tax (EBIT) | -6,532 | -10,862 | -22,993 | -31,164 | -43,924 |
| Net result for the period | -5,495 | -9,315 | -20,218 | -25,990 | -38,377 |
| Cash and bank | 20,157 | 8,945 | 20,157 | 8,945 | 21,668 |
| Solvency ratio (%) | 90% | 73% | 90% | 73% | 43% |
| Result per share (DKK) | -0.40 | -0.78 | -1.59 | -2.16 | -3.22 |
Figures in '()' refer to the same period last year.
Highlights during Q3:
- FluoGuide appoints Jens Ellrich as Chief Medical Officer
Highlights after Q3:
- FluoGuide submits Clinical Trial Application for phase II trial in head and neck cancer (CT-005)
- Publication of positive phase II clinical data for FG001 in patients with head and neck cancer (CT-003)
"Submission of the clinical trial application for head and neck cancer marks an important milestone building on the positive interim results for FG001. This represents the culmination of extensive planning moving FG001 toward approval", says Jens Ellrich, CMO at FluoGuide.
Q3 Company updates and presentations:
Interview release
Interview with: Redeye analyst, Christian Binder and for FluoGuide CEO Morten Albrechtsen and CFO Ole Larsen
Release date: Wednesday, 27 November
Questions are welcome to ir@fluoguide.com before Wednesday, 27 November at 10:30 CET
Certified Adviser:
Svensk Kapitalmarknadsgransking AB
Phone: +46 70 755 95 51
E-mail: ca@skmg.se
For further information, please contact:
Morten Albrechtsen, CEO
FluoGuide A/S
Phone: +45 24 25 62 66
E-mail: ma@fluoguide.com
About FluoGuide
FluoGuide is a biotech company specializing in precision cancer surgery. FluoGuide's lead product, FG001, is designed to enhance surgical accuracy by illuminating cancer cells intraoperatively using fluorescent light, which binds to the uPAR receptor, widely expressed in most solid cancer types. It is anticipated that FG001 will decrease both the incidence of local recurrence after surgery and surgical complications, improving cancer treatment and outcomes for patients, while also reducing healthcare costs. Moreover, FluoGuide's technology platform may also be utilized for photothermal therapy (PTT), which kills cancer cells through heating them with the use of near-infrared light. A technique that spares healthy surrounding tissue from damage, offering a direct therapeutic effect of FG001, further benefiting patients undergoing cancer surgery.
FluoGuide is listed on the Nasdaq First North Growth Market in Stockholm under the ticker symbol "FLUO". For more information about FluoGuide's pipeline, technology, and upcoming events, visit www.fluoguide.com
