FluoGuide A/S

KØBENHAVN, Denmark I October 07, 2024 I FluoGuide A/S (STO:FLUO) Copenhagen, Denmark – FluoGuide A/S (“FluoGuide” or the “Company”),a biothech company specializing in precision cancer surgery, today announced the submission of the Clinical Trial Application (CTA) for phase II trial in head and neck cancer (oral squamous cell carcinoma cancer). Redeye will host a live streaming event regarding the head and neck trial on 18 October 2024, at 10:00 am CET. The CTA submission follows strong clinical topline data for FG001 tested in a proof-of-concept phase II clinical trial in patients with head and neck cancer and is a step on the path to the patients and commercialization. Feedback from and discussions with key opinion leaders around the globe, has confirmed the ample needs patients with head and neck cancers have and led to a detailed understanding of the clinical trial design. Additionally, the Company obtained feedback on how to optimize the positioning of FG001 from a regulatory, partnering and commercial perspective to fully utilize the opportunities, condensed in the design of the trial (CT-005). Regulatory and clinical evaluation and discussions with Principal Investigator, Prof. Dr. Max Witjes, has led to the submitted trial design. The phase II trial (CT-005) is designed as a single center trial to: First interim data are expected in H2 2025. Depending on data from the trial and feedback from regulatory authorities, the Company is planning to do a multisite registration trial as the next step supporting approval and subsequent commercialization. FluoGuide will review the trial and its outlook at a live streaming event hosted by Redeye on 18 October 2024, at 10:00 am CET, where Redeye analyst Christian Binder will interview CEO Morten Albrechtsen and CSO Andreas Kjær. About FluoGuide FluoGuide is a biotech company specializing in precision cancer surgery. FluoGuide’s lead product, FG001, is designed to enhance surgical accuracy by illuminating cancer cells intraoperatively using fluorescent light, which binds to the uPAR receptor, widely expressed in most solid cancer types. It is anticipated that FG001 will decrease both the incidence of local recurrence after surgery and surgical complications, improving cancer treatment and outcomes for patients, while also reducing healthcare costs. Moreover, FluoGuide’s technology platform may also be utilized for photothermal therapy (PTT), which kills cancer cells through heating them with the use of near-infrared light. A technique that spares healthy surrounding tissue from damage, offering a direct therapeutic effect of FG001, further benefiting patients undergoing cancer surgery. FluoGuide is listed on the Nasdaq First North Growth Market in Stockholm under the ticker symbol “FLUO”. For more information about FluoGuide’s pipeline, technology, and upcoming events, visit www.fluoguide.com About head and neck cancer Head and neck cancer includes cancers in the head and neck region of the body. Head and neck cancers are frequently not completely removed or removed with insufficient margins to the surrounding normal tissue and requires follow up treatment with chemoradiotherapy. Chemoradiotherapy causes both short- and long-term side effects that can be avoided if the surgical removal of the cancer is complete the first time. Head and neck cancers are often occurring in close anatomical proximity to small vital structures such as blood vessels supplying the brain and many important nerves. Further, cosmetic considerations are important for most locations of head and neck cancers. Surgical precision is therefore essential for surgical removal of head and neck cancers. Most head and neck cancers arise from squamous cells and are called squamous cell carcinomas. It is the 6th most common cancer. Worldwide, head and neck cancer accounts for approximately 950,000 newly diagnosed patients (incidence) annually and approximately 450,000 patients die annually due to head and neck cancer. In USA and EU head and neck cancer accounts for approximately 63,000 and 136,000 newly diagnosed patients annually, respectively. Head neck cancer in rest of the world accounts for approximately 750,000 cases annually. Sources: World Health Organization (International Agency for Research on Cancer), Global Cancer Observatory (iarc.fr) , Gal TJ et al. Treatment trends in oropharyngeal carcinoma: Surgical technology meets the epidemic. Oral Oncology, Vol 97, 2019, p 62-68 (2) Cramer JD et al. The changing therapeutic landscape of head and neck cancer. Nat. Rev. Clin. Oncol. 16, 669-683 (2019); For more information on the Company, its uPAR technology platform and pipeline, please visit www.fluoguide.com SOURCE: FluoGuide

KØBENHAVN, DK / ACCESSWIRE / May 30, 2024 / FluoGuide A/S (STO:FLUO) Copenhagen, Denmark, 30 May 2024 - FluoGuide A/S ("FluoGuide" or the "Company") today releases its results for the period 1 January - 31 March 2024. The Q1 report is available as an attached document to this press release and on FluoGuide's website. FluoGuide had no revenue for the period and posted a net loss of DKK 7,521 thousand (DKK 9,535 thousand) for the period 1 January to 31 March 2024. The financial result for the period is in line with the Company's development plans. The total number of shares as of March 31, 2024, amounted to 12,208,384 shares. The total number of shares as of March 31, 2023, amounted to 11,814,500 shares. The average number of shares in Q1 2024 amounted to 12,208,384 shares. KEY FIGURES Q1 24 Q1 23 YTD 2024 YTD 2023 2023 DKK thousand 1-Jan-24 1-Jan-23 1-Jan-24 1-Jan-23 1-Jan-23 31-Mar-24 31-Mar-23 31-Mar-24 31-Mar-23 31-Dec-23 Net Revenue - - - - - Income before interest and tax (EBIT) -8,345 -11,645 -8,345 -11,645 -43,924 Net result for the period -7,521 -9,535 -7,521 -9,535 -38,377 Cash and bank 10,683 16,269 10,683 16,269 21,668 Solvency ratio (%) 29% 82% 29% 82% 43% Result per share (DKK) -0.62 -0.81 -0.62 -0.81 -3.22 HIGHLIGHTS DURING Q1: FluoGuide provides strategic update and outlines development plans towards commercialization of FG001 FluoGuide enters collaboration within robot assisted head & neck cancer surgery with Intuitive Surgical, a world leading robotic-assisted surgery company Two new board members, Donna Haire (regulatory profile) and Roger Gunnarsson (financial profile) HIGHLIGHTS AFTER Q1 FluoGuide selects laser system for photothermal cancer therapy with FG001 "FluoGuide published a collaboration with Intuitive Surgical in head & neck surgery which on top of the three positive clinical study phase II results published last year supports our long-term objective of improving the outcome for patients with cancer." says Morten Albrechtsen, CEO at FluoGuide. Certified Adviser: Svensk Kapitalmarknadsgranskning AB About FluoGuide FluoGuide is a biotech company specializing in precision cancer surgery. FluoGuide's lead product, FG001, is designed to enhance surgical accuracy by illuminating cancer cells intraoperatively using fluorescent light, which binds to the uPAR receptor, widely expressed in most solid cancer types. It is anticipated that FG001 will decrease both the incidence of local recurrence after surgery and surgical complications, improving cancer treatment and outcomes for patients, while also reducing healthcare costs. Moreover, FluoGuide's technology platform may also be utilized for photothermal therapy (PTT), which kills cancer cells through heating them with the use of near-infrared light. A technique that spares healthy surrounding tissue from damage, offering a direct therapeutic effect of FG001, further benefiting patients undergoing cancer surgery. FluoGuide is listed on the Nasdaq First North Growth Market in Stockholm under the ticker symbol "FLUO." For more information about FluoGuide's pipeline, technology, and upcoming events, visit Attachments FluoGuide Q1 2024 SOURCE: FluoGuide A/S View the original press release on accesswire.com

COPENHAGEN, DENMARK / ACCESSWIRE / May 27, 2024 / FluoGuide A/S (STO:FLUO) Copenhagen, Denmark - FluoGuide A/S ("FluoGuide" or the "Company"), a biotech company specializing in precision cancer surgery, has chosen laser system for the development of photothermal therapy (PTT). FluoGuide's lead product, FG001 fluoresces and is designed to bind urokinase-type plasminogen activator receptor (uPAR) making it specific to cancer and with a potential for most patients with solid cancer. Clinical data have demonstrated FG001's efficacy in guiding surgeries for three cancer indications: aggressive brain cancer, head and neck cancer, and lung cancer. In addition to providing visual guidance for surgeons during removal of cancer cells, FG001 also has photothermal therapy (PTT) properties. This therapeutic potential of FG001 is to kill cancer cells using near-infrared light, holding potential to significantly enhance outcomes for cancer patients. The selected laser system provides the specific light necessary to activate FG001 and offers strong support for both clinical development and commercialization. Its potency and adaptability enable various applications, e.g. treating local cancer recurrence and addressing inoperable cancers. "We have now selected the laser system to support the further development of FG001 as photothermal cancer therapy. An application, which holds considerable potential for improving cancer treatment and outcomes for patients," says Morten Albrechtsen, CEO of FluoGuide. While de-risking the phase III program for fluorescence guided surgery in aggressive brain cancer, FluoGuide is investigating the economic potential and synergies in combining its development of PTT in aggressive brain cancer. Aggressive brain cancer recurs locally in more than 90% of patients, and there is presently a significant unmet need to improve the results of surgery. Clinical data show that FG001 is safe and well-tolerated and enhances precision of removal of tumors while preserving healthy tissue. Attachments FluoGuide selects laser system for photothermal cancer therapy with FG001 SOURCE: FluoGuide A/S View the original press release on accesswire.com