Bifogade filer
FluoGuide-Q3-2022-Final
Prenumeration
Beskrivning
| Land | Danmark |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
In Q3 2022, FluoGuide made important progress and received approvals from Danish authorities to initiate the clinical phase IIb trial with FG001 in aggressive brain cancer as well as clinical phase IIa trial with FG001 in head and neck cancer in Denmark. After Q3, Fluoguide enrolled first patient in both clinical trials. Fluoguide has also received positive interim result from the ongoing phase IIa trail with FG001 in lung cancer.
FluoGuide had no revenue for the period and posted a net loss of TDKK -16,743 for the period 1 January to 31 September 2022 (-15,841). The financial result for the period is in line with the Company's development plans. It is the Board’s opinion that FluoGuide, unlike many other life science companies, may have a comparatively short time from the initiation of product development to revenue generation.
| Summary | Q3 22 | Q3 21 | Q1-Q3 2022 | Q1-Q3 2021 | 2021 |
| 01-jul-22 | 01-jul-21 | 01-jan-22 | 01-jan-21 | 01-jan-21 | |
| (TDKK) | 30-sep-22 | 30-sep-21 | 30-sep-22 | 30-sep-21 | 31-dec-21 |
| Net Revenue | 0 | 0 | 0 | 0 | 0 |
| Operating result | -8,416 | -8,938 | -21,358 | -19,169 | -28,809 |
| Net result | -7,041 | -8,065 | -16,743 | -15,841 | -23,770 |
| Cash and bank | 31,700 | 47,974 | 31,700 | 47,974 | 46,758 |
| Result per share (DKK) *) | -0.60 | -0.71 | -1.43 | -1.45 | -2.15 |
| Solidity (%) **) | 91% | 79% | 91% | 79% | 73% |
| Avarage shares for the period | 11,814,500 | 11,319,500 | 11,689,390 | 10,940,668 | 11,036,155 |
| Net result | -0.60 | -0.71 | -1.43 | -1.45 | -2.15 |
*) 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 Q3
- A publication of clinical data that shows uPAR is highly expressed in oropharyngeal squamous cell carcinoma (Head and Neck cancer). The article is published in ONCOLOGY REPORTS 48: 147, 2022
- Submitted a CTA to initiate a phase II trial in head and neck cancer
- Update on clinical development
- Interim report for the period January – June 2022
- Permission to start phase IIb trial in aggressive brain cancer
- Appointment of Henrik Hang as new CFO
- Received approval from the Danish Medicines Agency to initiate phase II trial with FG001 in head and neck cancer e Department of Neurosurgery, Linköping University Hospital, Sweden to
HIGHLIGHTS AFTER Q3HI
- The phase I/IIa clinical data of FG001 in aggressive brain cancer was presented at the World Molecular Imaging Congress
- The phase l/lla clinical data of FG001 in aggressive brain cancer was presented at the European Congress of Neurosurgery 2022
- First patient enrolled in the phase IIb trial for aggressive brain cancer with FG001
- Positive interims data in phase IIa lung cancer
- FluoGuide reaches milestone with FG001 for phase III clinical supply
- First patient enrolled in the head & neck cancer phase IIa trial
Morten Albrechtsen, CEO says: “On top of the convincing clinical data of FG001 in aggressive brain cancer, the first lung interim result support a broader use of FG001 – so now we can move into late-stage development”