Interim Report Third Quarter 2019

FluoGuide A/S ("FluoGuide") today announces its results for the period 01/July/2019 – 30/Sep/2019. The full report is available on the company’s homepage.

Morten Albrechtsen, CEO of FluoGuide, comments:We are very pleased that the supply chain for FG001 has been established to support the first clinical study in humans and the process for FG001 manufacturing was successfully transferred to vendors who can make it to a quality needed for human use. This is good news and a major de-risking for a positive proof-of-concept clinical result in patients with glioblastoma undergoing surgery. Also, we were successful in making the first larger scale batch in an amount that could serve early commercialization through compassionate use sale, ahead of plan.

Result for the third quarter 2019 (July – September)

  • Net revenue was KDKK 0 (0)
  • Operating result was KDKK -5.057 (0)
  • Net result was KDKK -4.047 (0)
  • Cash at bank at end of the period was KDKK 9.630 (1)
  • Result per share[1]  was DKK -0,56 (0)
  • Solidity[2] at end of the period was 65% (100%)

Result for the first nine months (January – September)

  • Net revenue was KDKK 0 (0)
  • Operating result was KDKK -6.842 (0)
  • Net result was KDKK -6.540 (0)
  • Cash at bank at end of the period was KDKK 9.630 (1)

Amount within brackets corresponds to comparable period in the previous year.
[1] Result per share (DKK per share): Operating result divided by the average number of shares during the period. There was no change to the number of shares during third quarter. Total average number of shares was equal to the total number of shares at the beginning of the period (1 July 2019), during the period and at the end of the period (30 September 2019), and amounted to 7,224,274 shares (105,500). The average number of shares for the period from 1 January 2019 to 30 September 2019 was 6,222,256 shares (105,500).
[2] Solidity: Total equity divided by total capital and liability.

Highlights during Q3

  • FluoGuide announces registration of ownership to the key patent family. The patent is valid until 2034.
  • The Company presented data at WMIC*) confirming FG001’s effect in guiding surgical removal of glioblastoma at different doses for use in first clinical study.  
  • A study demonstrating that FG001 helped to identify and remove local additional metastases in 50% of the subjects that were overlooked during the standard white light procedure was also presented at WMIC*) 

Highlights after Q3

  • First result of FG001 tested in pre-clinical safety studies 
  • Additional patent applications submitted, and patents granted
  • Publication of the preclinical data of FG001 tested in pancreatic cancer presented at the WMIC in peer-review scientific paper 
  • FluoGuide holds presentations at Sedermeradagen Stockholm and Investordagen Aalborg 


For further information, please contact:
Morten Albrechtsen, CEO
M: +45 24 25 62 66
ma@fluoguide.com

__________________________________________________________________________________

About FluoGuide 
FluoGuide A/S (Spotlight Stock Market: FLUO:SS) provides solutions for maximizing surgical outcome through intelligent targeting. FluoGuide’s first product FG001 increases precision in cancer surgery by lighting up the cancer and its invasive growth into the surrounding tissue. FG001 is expected to reduce suffering for the patients and increase the likelihood of cure. It can also reduce costs for the health care system for the benefit of society. FluoGuide focuses on demonstrating the effect of FG001 in patients by conducting a human proof-of-concept clinical trial and expects to announce the first result of this study during first half of 2020.

About FG001
FG001, FluoGuide’s first product, lights up the cancer and its invasive growth into the surrounding tissue. It helps the surgeon remove the entire tumor during surgery and increases the chance for complete cure of the patient. The task for the surgeon is simply to "turn the lights on and see the entire tumor". The solution helps surgeons remove a minimal amount of normal tissue while also reducing the risk of leaving cancer tissue behind. This reduces the suffering of the patient and increases the likelihood of cure, and also reduces costs for the health care system. FG001 is currently prepared for a proof-of-concept clinical study.

Tags:

About Us

FluoGuide A/S develops surgical solutions that is expected to reduce suffering for the patient and increases the likelihood of cure as well as reducing costs for the health care system. The first product is the compound FG001, which lights up the cancer and its invasive growth into the surrounding tissue. Preclinical studies have demonstrated the potential of FG001 to vastly improve the likelihood of performing radical surgery (removal of all cancer) and thereby improving outcome and survival. FluoGuide is initially focused on glioblastoma (brain tumor) but the Company plan to expand its business to other solid tumors. Market launch of FG001 in a first country is expected in 2022/2023.

Subscribe

Documents & Links

Quotes

I am very pleased that we now have established a supply chain for FG001 and that we have transferred the process to vendors who can manufacture it for human use. We have made the first larger scale batch in an amount that could serve early commercialization through compassionate use sale. This is according to plan which we consider great news and a major de-risking for first proof-of-concept results from a clinical study in 2020
Grethe Nørskov Rasmussen, CDO
We are very happy to see another series of promising data now obtained with FG001 and demonstrating the relevance of uPAR target product for a number of different cancer types
Morten Albrechtsen, CEO