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.