FluoGuide A/S publishes interim report for the period January – June 2023
Regulatory
August 30, 2023
Copenhagen, Denmark, 30 August 2023 – FluoGuide A/S (“FluoGuide” or the “Company”) today releases its results for the period 1 January – 30 June 2023. The Q2 report is available as an attached document to this press release and on FluoGuide’s website.
In Q2 2023, FluoGuide prepared completion of all three clinical phase II trials of FG001 in different types of cancers. Positive results or interim results in all indications and the forthcoming topline result of the phase IIb trial in aggressive brain cancer put FluoGuide in a uniquely promising position. Financial flexibility enables the company to fully capitalize on the good clinical results.
FluoGuide had no revenue for the period and posted a net result of TDKK -7,139 (TDKK -5,749) for the period 1 January to 30 June 2023. The financial result for the period is in line with the Company's development plans.
| Summary | Q2 23 | Q2 22 | YTD 2023 | YTD 2022 | 2022 |
| DKK thousands | 1-Apr-23 | 1-Apr-22 | 1-Jan-23 | 1-Jan-22 | 1-Jan-22 |
| 30-Jun-23 | 30-Jun-22 | 30-Jun-23 | 30-Jun-22 | 31-Dec-22 | |
| Net Revenue | – | – | – | – | – |
| Operating result | -8,656 | -7,514 | -20,302 | -12,942 | -32,461 |
| Net result | -7,139 | -5,749 | -16,674 | -9,701 | -27,340 |
| Cash and bank | 8,064 | 39,136 | 8,064 | 39,136 | 26,013 |
| Result per share (DKK) *) | -0.60 | -0.49 | -1.41 | -0.82 | -2.33 |
| Solidity (%) **) | 83% | 92% | 83% | 92% | 90% |
HIGHLIGHTS DURING Q2:
- FluoGuide provides update on strong clinical trial progress
- FluoGuide announces positive topline results from phase IIa trial of FG001 in lung cancer
- FluoGuide announces positive interim results from phase IIa trial of FG001 in head & neck cancer
HIGHLIGHTS AFTER Q2
- FluoGuide completes a Directed Share Issue raising SEK 15 million. Investors received one warrant per share to exercise in the period 27 November to 1 December
- FluoGuide completes patient enrollment and treatment in FG001 phase llb clinical trial in aggressive brain cancer
- FluoGuide reports further positive interim data from phase IIa trial of FG001 in head & neck cancer
For further information, please contact:
Morten Albrechtsen, CEO,
FluoGuide A/S
+45 24 25 62 66,
ma@fluoguide.com
Certified Adviser:
Svensk Kapitalmarknadsgransking AB
Phone: +46 70 755 95 51
E-mail: ca@skmg.se
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 cells 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. The Company has published key results on the efficacy of FG001 as well as showing it was well tolerated and safe from a proof-of-concept clinical study (phase I/IIa) in patients with aggressive brain cancer (high grade glioma) that undergo surgery. A phase IIb trial in aggressive brain cancer is ongoing to obtain valuable information to design the phase III trial. This IIb trial has completed patient enrollment and treatment, and data complication is ongoing. In addition, FluoGuide has demonstrated effect of FG001 in lung and head & neck cancer, topline and positive interim result, respectively. A trial in meningioma and glioma is commencing.
For more information on the Company, please visit www.fluoguide.com