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.
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’s primary focus is to maximize surgical outcomes in oncology. The Company’s lead product, FG001, is designed to improve surgical precision by illuminating cancer cells intraoperatively. The improved precision enabled by FluoGuide’s products has a dual benefit – it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, the improved precision will improve a patient’s chance of achieving a complete cure and will lower system-wide healthcare costs. The Company is has demonstrated early evidence of efficacy of F001 as well as it to be well tolerated and safe in the ongoing proof-of-concept clinical trial (phase I/II) in patients with high grade glioma undergoing surgery. FG001 is also in phase II clinical trial for lung cancer. FluoGuide is listed on Nasdaq First North Sweden under the ticker “FLUO”.