Shareprice
13 Jul 2024

About

FluoGuide A/S is a clinical stage biotechnology company focused on developing drugs for maximizing surgical outcomes by making cancer fluorescent.

New - New exchange: Nasdaq First North

FluoGuide is moving from Spotlight to Nasdaq First North. Shareholders are strongly encouraged to make sure they will be able to freely trade their shares in the future.

History

  - 2023 FluoGuide

2023

In 2023, FluoGuide expanded the clinical validation of FG001 to include new indications and to target the market in aggressive brain cancer (high-grade glioma). FG001 demonstrated proof-of-concept in head and neck cancer (oral and oropharyngeal squamous cell carcinomas) and lung cancer (non-small cell squamous cell carcinomas). It was a year that provided high confidence that FG001 would not only reach the market but also help patients undergoing cancer surgery.

Additionally, 2023 was the year in which the foundation for photothermal therapy was established. FluoGuide announced the receipt of a prestigious grant from Innovation Fund Denmark. Valued at DKK 49 million, the grant was awarded to FluoGuide and two academic partners, providing crucial support for the ongoing research and development of photothermal therapy.

FG001 also received FDA Orphan Drug Designation for its application in high-grade glioma.

  - 2022 FluoGuide

2022

In 2022, FluoGuide reached several important milestones in the clinical development and demonstrated that FG001 is well tolerated and significantly de –risked. From the positive top-line results of FG001 in aggressive brain cancer showed that the tissue lit up by FG001 contained cancer. On the back of a successful outcome, FluoGuide initiated phase IIa/IIb trials with FG001 in lung cancer, head and neck cancer and aggressive brain cancer and reported positive interim result for the lung cancer and the head and neck cancer.

To maintain financial flexibility, FluoGuide completed a directed share issue and raised SEK 25 million in the beginning of the year.

  - 2021 FluoGuide

2021

In 2021, FluoGuide reported that FG001 is demonstrated safe and well-tolerated in patients. Further, light was observed with increasing intensity proportional with increasing dose. During the year, FluoGuide received permission multiple times to increase the dose level of FG001 administered to patients in the clinical phase I/II trial in high-grade glioma.

Another positive piece of news, published in 2021, was that the company’s product FG002 also showed promising features, as a preclinical study demonstrated FG002 to light up cancer when tested in an orthotopic xenograft model of human glioblastoma. Later in 2021, the company announced that it had initiated preclinical development with FG002.

In March, FluoGuide acquired rights to photothermal therapy using FG001. Under optimal conditions, photothermal treatment will generate heat that will kill cancer cells while sparing normal tissue. In August, research data was published demonstrating the effect of FG001 when used as a photothermal therapy agent in the precise treatment of cancer.

Early in 2021, the company changed its trading venue from the Spotlight Stock Market to Nasdaq First North Sweden, which was followed up with a capital increase of 75 million SEK for the funding of FluoGuide’s development activities.

 

 

 

  - 2020 – clinical trials commence and strategy begins to materialize FluoGuide

2020 – clinical trials commence and strategy begins to materialize

In January 2020, FluoGuide’s first clinical trials commenced, starting with a safety study in January 2020, which was successfully concluded in May 2020. Another significant event happened in May 2020, as FluoGuide received an official acknowledgment of its IPO success: The independent Swedish “IPO Guide” selected FluoGuide as the winner of the 2019 share price development award in the micro-cap category and also awarded FluoGuide an honorary IPO quality award.

Moreover, FluoGuide was awarded a grant of EUR 2.5 million by the European Innovation Council (EIC), contributing to the financing of FluoGuide’s manufacturing (CMC) and clinical work supporting the clinical trials.

2020 was also the year when FluoGuide secured a pipeline of uPAR targeting products by signing an agreement with Rigshospitalet and the University of Copenhagen, securing exclusive rights to a product patent covering a range of uPAR-targeting molecules.

In the autumn of 2020, FluoGuide received regulatory approval from the Danish Medicines Agency to commence Phase I/II clinical trial with FG001 in guiding surgery of high-grade glioma (including glioblastoma). In November, the first patient was enrolled in this trial, and following a positive result of this first trial, a positive dose-escalation was allowed.

In 2020, FluoGuide further expanded its patent coverage by securing patent protection for its lead clinical asset FG001 in Australia. The patent will remain valid until September 2035.

 

 

 

  - 2019 – establishing a professional board and going public FluoGuide

2019 – establishing a professional board and going public

An experienced board was established in 2019, composed of experienced professionals with relevant background experience. The preparations for an IPO on the Swedish Spotlight Stock Exchange also commenced.

FluoGuide’s IPO was oversubscribed and completed on April 17, 2019. The total subscription ratio was 244 percent. Trading in the FluoGuide share started on May 7, 2019.

In 2019, FluoGuide completed the acquisition of a key patent family (WO/2016/041558A1), including FG001 issued nationally in the USA in 2018, with validity until 2034.

FluoGuide presented at the World Molecular Imaging Congress 2019 in Montreal, demonstrating how FG001 for in vivo fluorescent guidance improved surgical resection of metastatic pancreatic cancer in comparison with traditional white light surgery.

 

 

 

  - 2018 – Incorporation and preparing for manufacturing of FG001 (CMC) FluoGuide

2018 – Incorporation and preparing for manufacturing of FG001 (CMC)

FluoGuide was incorporated in January 2018. The incorporation of FluoGuide was preceded by decades of research conducted by Andreas Kjaer, who is an MD, Ph.D., DMSc, and MBA, and holds a position as professor at the University of Copenhagen and chief physician at Rigshospitalet, the National University Hospital of Denmark. Professor Kjaer’s research has been focused on molecular imaging with PET, PET/MRI, and optical imaging, as well as targeted radionuclide therapies (theranostics) in cancer.

After the incorporation of FluoGuide, the manufacturing process was initiated, and the initial organization was established.

 

 

 

  - 2017 – before FluoGuide’s incorporation FluoGuide

2017 – before FluoGuide’s incorporation

In 2017 the article “uPAR-targeted optical near-infrared (NIR) fluorescence imaging and PET for image-guided surgery in head and neck cancer: proof-of-concept in orthotopic xenograft model” was published in Oncotarget, a primarily oncology-focused, peer-reviewed, open access, biweekly journal. Amongst the authors was Andreas Kjaer.

As project leader, Professor Andreas Kjaer received the prestigious Grand Solutions grant from Innovation Fund Denmark for the FluoGuide project. The project had the objective to expand the pipeline for fluorophore-based products.