KØBENHAVN, DENMARK / ACCESSWIRE / November 29, 2023 / FluoGuide A/S (STO:FLUO) Copenhagen, Denmark, 29 November 2023 - FluoGuide A/S ("FluoGuide" or the "Company") today releases its results for the period 1 January - 30 September 2023. The Q3 report is available as an attached document to this press release and on FluoGuide's website.
In Q3 2023, FluoGuide completed patient recruitment for two clinical phase II trials of FG001, in aggressive brain cancer and head and neck cancers. The positive results in these indications, some of which were published after the end of Q3, as well as positive phase II data in lung cancer reported earlier in 2023, 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 -9,314 (TDKK -7,041) for the period 1 January to 30 September 2023. The financial result for the period is in line with the Company's development plans.
Summary
Q3 23
Q3 22
YTD 2023
YTD 2022
2022
DKK thousands
1-Jul-23
1-Jul-22
1-Jan-23
1-Jan-22
1-Jan-22
30-Sep-23
30-Sep-22
30-Sep-23
30-Sep-22
31-Dec-22
Net Revenue
-
-
-
-
-
Operating result
-10,862
-8,416
-31,164
-21,358
-32,461
Net result
-9,314
-7,041
-25,990
-16,743
-27,340
Cash and bank
8,945
31,700
8,945
31,700
26,013
Result per share (DKK) *)
-0.78
-0.60
-2.19
-1.43
-2.33
Solidity (%) **)
73%
91%
73%
91%
90%
*) Result per share (DKK per share): Operating result divided by the average number of shares during the period.
**) Solidity: Total equity divided by total capital and liability.
HIGHLIGHTS DURING Q2:
Positive interim data from phase lla trial of FG001 in head & neck cancer presented as a case report at the World Molecular Imaging Congress in Prague
Further positive interim data from phase lla trial of FG001 in head & neck cancer
Completes patient enrollment and treatment in FG001 phase llb clinical trial in aggressive brain cancer
Completes a Directed Share Issue raising SEK 15 million
Issues warrants to Board members, management, and employees, as well as the investors participating in the Directed Share Issue
HIGHLIGHTS AFTER Q2
Receives FDA Orphan Drug Designation for FG001 in high-grade glioma
Confirms positive topline results from phase lla trial of FG001 in head & neck cancer at IAOO
Announces FG001 meets primary endpoint in phase llb trial in aggressive brain cancer
About FluoGuideFluoGuide 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.
The Company has published key results on the efficacy of FG001 as well as showing it was well tolerated and safe from clinical trials in patients with aggressive brain cancer (high-grade glioma) that undergo surgery. In addition, FluoGuide has demonstrated the effect of FG001 in lung and head & neck cancers.
For more information on the Company, please visit
Attachments
FluoGuide Q3 2023
SOURCE: FluoGuide A/S
View source version on accesswire.com:
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