FluoGuide A/S publishes Year-end and annual report for the fiscal year 2021
Copenhagen, Denmark, 30 March 2022 – FluoGuide A/S (“FluoGuide” or the “Company”) hereby publishes its annual report for the fiscal year 2021. The annual report including the auditor’s report is attached as a pdf. The report is also available on FluoGuide’s website www.fluoguide.com under ‘Filings & reports’. https://fluoguide.com/investor/filings-reports/
KEY FINANCIAL FIGUES
Q4 2021
| Summary | Q4 2021 | Q4 2020 | Q1-Q4 2021 | Q1-Q4 2020 |
| 01-okt-21 | 01-okt-21 | 01-jan-21 | 01-jan-20 | |
| (KDKK) | 31-dec-21 | 31-dec-21 | 31-dec-21 | 31-dec-21 |
| Net Revenue | ||||
| Operating result | -9.640 | -8.532 | -28.809 | -22.161 |
| Net result | -7.930 | -6.497 | -23.770 | -17.460 |
| Cash and bank | 46.758 | 10.637 | 46.758 | 10.637 |
| Result per share (DKK) *) | -0,70 | -0,62 | -2,15 | -1,78 |
| Solidity (%) **) | 73% | 26% | 73% | 26% |
Full Year 2021 (Audited)
| KEY FIGURES | 2021 | 2020 | 2019 | 2018 | |
| Amounts in DKK ‘000 | |||||
| Income Statement | |||||
| Operating Loss | -28.809 | -22.161 | -10.644 | -52 | |
| Net financial items | -461 | -25 | -1.062 | 1 | |
| Loss for the period | -23.770 | -17.460 | -9.653 | -53 | |
| Balance sheet | |||||
| Total assets | 53.309 | 16.742 | 5.238 | 75 | |
| Equity | 38.701 | 4.411 | 4.542 | 7 | |
| Cash flows | |||||
| Cash flows from: | |||||
| Operating activities | -15.062 | -8.847 | -10.553 | -1 | |
| Investing activities | 0 | -42 | -390 | 0 | |
| Financing activities | 51.183 | 17.182 | 13.228 | 60 | |
| The period’s cash flow | 36.121 | 8.293 | 2.285 | 59 | |
| Dividend | 0 | 0 | 0 | 0 | |
| Ratios | |||||
| Solvency ratio | 73% | 26% | 87% | 9% | |
| Earnings per share (DKK) | -2,15 | -1,78 | -1,49 | -0,08 | |
HIGHLIGHTS FROM 2021
Q1
- FluoGuide receives green light to proceed to third dose level with FG001 in the ongoing clinical phase I/II trial in patients with high grade glioma
- Announces publication of two patent applications covering the company’s uPAR technology platform for improving surgery
- Announces approval for listing on Nasdaq First North Growth Market Sweden on the 24 February 2021
- Receives green light to proceed to fourth dose level with FG001 in the ongoing clinical phase I/II trial in patients with high grade glioma
- Acquires rights to photothermal therapy using FG001
Q2
- Receives green light to proceed to fifth dose level with FG001
- Completes a directed share issue raising SEK 75 million
- Receives approval from ethical committee and the Danish Medicines Agency to commence with FG001 in evening dosing
- Announces the initiation of evening dosing after a satisfactory conclusion of the fifth dose level with FG001
- Issues new warrants by issuing 272,700 warrants to employees and management, and 50,000 warrants to the Board of Directors
- Arbejdernes Landsbank informs the Company that they have 581,604 shares which corresponds to 5.14 percent of all shares in the Company
- Mats Thorén is elected a new member of the Company’s Board of Directors
- New article reveals promising preclinical results of using FluoGuide’s FG002 technology in guiding surgical removal of cancer
Q3
- Enters an agreement with Swedish University Hospital for the second phase of the ongoing FG001 clinical trial
- Proceeds to sixth dose level of FG001 in the ongoing clinical phase I/II trial
- Receives tranche of EUR 750,000 under its ongoing grant from EIC Accelerator
- First publication of preclinical data where FG001 is used as a photothermal therapy agent for treatment of cancer
- Announces regulatory approval from Swedish Authorities (MPA and Ethics committee) to commence Phase II clinical trial of FG001
- Proceeds to seventh dose level (36 mg) with FG001 in the ongoing clinical phase I/II trial
- Executive management members and members of the Board of Directors buy shares and board member Shomit Ghose sells shares
Q4
- FG001 is proven safe in patients undergoing surgery for cancer – a significant milestone for FluoGuide to further advance clinical development in aggressive brain cancer, which is a prevalent indication
- Redeye initiates commissioned research on FluoGuide
- FluoGuide initiates preclinical development with FG002
- Publication of a case report showing the first promising clinical data on FG001s use in treatment of a meningioma brain tumor
- Lung cancer selected as the second phase II indication for FG001
- Submits a Clinical Trial Application (CTA) to the Danish Medicines Agency to initiate phase II trial with FG001 in lung cancer
HIGHLIGHTS AFTER THE PERIOD
- On 10 March 2022 FluoGuide raised SEK 25 million in directed issue
- Received a grant of approx. DKK 1,0 million together with Rigshospitalet to partly finance the phase II clinical trial in meningioma and low-grade glioma
- Permission from the Danish health authorities to start phase II clinical trial in lung cancer with FG001
- On 29 March 2022, the Board of Directors of FluoGuide has exercised its authorization to issue new warrants by issuing 40,000 warrants to employees and management.