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FluoGuide develops surgical solutions that are expected to reduce suffering for the patient and increase the likelihood of cure as well as reducing costs for the health care system.

Meet FluoGuide

Annual General Meeting (Company's address): 23 April 2020 at 10.00 AM.

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Question and answers

 

Warrants and trading

 

Q: When the T01 warrants be exercised?

The information from different depot holders differs and it is solely your own responsibility to check with your depot holder how they inform you and how they handle exercising or selling warrants on your behalf. The detailed description of the warrants is part of the article of association for FluoGuide A/S which is referred to. You and your bank will, in close connection with the exercise period for the warrants, which can take place from 16 April – 7 May 2020, receive detailed information on how to exercise the warrants. This will also be communicated through a press release once the exercise period starts.

FluoGuide A/S issued units in its IPO in 2019 – three shares and one warrant was issued free of charge. The name of the warrant series is ‘FLUO TO1’ and here referred to as ‘warrant’. Each warrant gives the right to the person owning the warrant to purchase one new share in FluoGuide (‘FLUO’) for DKK 5.95 per new share.

The warrants can be exercised in the period from 16 April until 7 May 2020 (termed the ‘exercise period’).
The warrants are, like the FluoGuide shares, traded on Spotlight Stock Market until the exercise period expires.

A warrant holder has three options: (1) Exercise the warrant within the exercise period by paying DKK 5.95 for each new share in FluoGuide, (2) At any time until the expiry of the exercise period, sell the warrant in regular trade on Spotlight Stock Market, or (3) Do nothing and let the warrant lapse at the expiry of the exercise period.

You can see in your share depot if you have warrants and how many you have. Normally your depot holder will inform you about the deadlines for exercising the warrants, collect your payment, as well as distributing the shares to your account if you decide to exercise your warrants. Please contact your depot holder if you have any questions in this regard. The bank will know this information when getting closer to the exercise period.

Shares from exercised warrants will be available on your depot around the end of May 2020.

 

Q: How to trade FluoGuide shares in Danske Bank?

A: FluoGuide share can be found using the ISIN codes (Share: DK0061123312; TO1: DK0061138773).

 

Questions and answers related to FG001

 

Q: How does the light and FG001 work technically?

A: FG001 contains a molecule with fluorescent properties (a fluorophore). Fluorophores absorb light of a specific wavelength and re-emit light of a longer wavelength. Typically, a laser will create the light and a camera will detect the re-emitted light. Lasers and camera are built into microscope, robotic surgery equipment and endoscopes, and available today at the surgery rooms with the specifications needed for FG001.

 

Q: What is the expected sales price to hospitals for FG001?

A: A price only reflecting the hospital savings on re-operations and other increased costs of care, could be in the range of e.g., approx. EUR 40 000 in patients with glioblastoma and approx. EUR 4 000 per use in patients with breast cancer. This does not include potentially improved survival rate or improved quality of life for the patients.  The price will be determined when the result of clinical trials is known and the magnitude of benefit from FG001 demonstrated.

 

Q: Does the FDA have clear guidelines or endpoints regarding the FG001?

A: Yes. FG001 is a medical product (drug) per definition and there are clear guidelines for medical products. Interactions with the regulatory agencies, such as FDA and EMA, are nevertheless important during the development. This shall secure that the specific issues related to FG001 and guiding of cancer surgery are discussed with the regulatory agencies during the development of FG001. The overall aim is to secure that new important products are brought to patients safely and quickly.

 

Q: What is a good way of measuring the surgical success of the FG001?

A: Post-surgery pathohistological examination is the golden standard and is a good measure for the surgical success. The pathologist investigates if the margins of the removed tissue contain cancer (termed ‘positive margins’) or the margins are clear of cancer (‘negative margins’). A surgical success is removal of all local cancer plus minimally normal tissue with a cancer free (‘negative’) margin. For glioblastoma specifically is post-surgery MRI the golden standard.

 

Q: What is the background of the two avenues to demonstrate safety of FG001?

A: uPAR differs between animal species. FG001 binds to human uPAR why we test its effectiveness in human cancer implanted in mouse. We also know that part of the molecule in FG001 responsible for the uPAR binding does not bind to mouse uPAR. We need to demonstrate FG001 uPAR binding for all the classic toxicity species before we conduct the study to avoid that we are asked to repeat the study before starting the clinical study.