Breakeven Date Change • May 20
No longer forecast to breakeven The analyst covering FluoGuide no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of kr.52.0m in 2027. New forecast suggests the company will make a loss of kr.36.1m in 2027. Aankondiging • Mar 26
FluoGuide A/S Elects Kim D. Kjøller as New Member of Board of Directors FluoGuide A/S at its Annual General Meeting held on March 25, 2026, elected Kim D. Kjøller as new member of the board of directors. Aankondiging • Mar 12
FluoGuide A/S, Annual General Meeting, Mar 25, 2026 FluoGuide A/S, Annual General Meeting, Mar 25, 2026, at 15:00 Romance Standard Time. Location: at the companys premises, titanhus, titangade 9-13, meeting room herakles, dk-2200, copenhagen n Denmark Aankondiging • Feb 21
FluoGuide A/S Announces U.S. Food and Drug Administration Review Milestone for FG001 FluoGuide A/S announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it can proceed with the proposed clinical investigation for FG001. The IND supports the initiation of the Company's first trial supporting registration in patients with high-grade glioma (HGG). The IND submission represents a key regulatory milestone for FluoGuide and marks the transition of FG001 to late-clinical development, advancing the program toward U.S. registration. Initiation of the first U.S. trial supporting registration remains on track, with enrollment of the first patient expected in second quarter 2026. Following the FDA green light on FluoGuide's IND, the Company will continue preparations to initiate the planned U.S. Phase 2 registration trial of FG001 in high-grade glioma. The Company will provide updates as appropriate, with first patient planned to enroll in second quarter. An Investigational New Drug (IND) application is required to obtain U.S. regulatory authorization to initiate clinical trials of a new drug. FG001 is a well-advanced, clinical-stage product, and significant portions of the submitted IND package, including the preclinical section, are expected to form the basis of the future New Drug Application (NDA) required to obtain approval to market FG001 in the U.S. Across the pre-IND and IND processes, FluoGuide engaged with the FDA to review a comprehensive development package covering completed work and proposed plans for ongoing studies. Importantly, through these interactions and the subsequent IND submission, FluoGuide received FDA alignment on the design of its U.S. Phase 2 clinical trial in HGG to support registration, as well as on key elements of the subsequent Phase 3 program. This regulatory alignment provides a strong foundation for long-term development planning, and in view, de-risks the regulatory process as advance toward NDA submission and future U. S. approval of FG001. Clear regulatory path. FluoGuide anticipates that two U.S. clinical trials will be required to support U.S. regulatory approval of FG001 for HGG. Both trials are expected to enroll patients over approximately one year, with final timelines and enrollment subject to emerging data and regulatory feedback. This program establishes a clear, structured and capital-efficient path toward U.S. approval of FG001 in HGG - a devastating brain cancer with poor outcomes and limited effective treatment options. Aankondiging • Jan 22
FluoGuide A/S to Report Q3, 2026 Results on Nov 26, 2026 FluoGuide A/S announced that they will report Q3, 2026 results on Nov 26, 2026 Aankondiging • Jan 21
FluoGuide A/S Submits an IND for FG001, to Initiate First U.S. Registration Trial FluoGuide A/S announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for FG001. The IND supports the initiation of the Company's first registration trial in patients with high-grade glioma (HGG). The IND submission represents a key regulatory milestone for FluoGuide and marks the transition of FG001 to late-clinical development, advancing the program toward U.S. registration. Initiation of the first registration trial remains on track, with enrollment of the first patient expected in second quarter 2026. An Investigational New Drug (IND") application is required to obtain U.S. regulatory authorization to initiate clinical trials of a new drug. FG001 is a well-advanced, clinical-stage product, and significant portions of the submitted IND package, including the preclinical section, are expected to form the basis of the future New Drug Application (NDA) required to obtain approval to market FG001 in the U.S. Prior to submission, FluoGuide held a pre-IND meeting with FDA, during which the agency reviewed a comprehensive development package covering completed work and proposed plans for ongoing studies. Importantly, FluoGuide received FDA alignment on the design of its U.S. Phase 2 clinical trial in HGG to support registration, as well as on key elements of the subsequent Phase 3 program. This regulatory alignment provides a strong foundation for the long-term development planning, and in its view, de-risks the regulatory process as it advance toward NDA submission and future U.S. approval of FG001. First registration trial - clear regulatory path. FluoGuide anticipates that two clinical trials will be required to support U.S. approval ofFG001 for HGG. Both trials are expected to enroll patients over approximately one year, with final timelines and enrollment subject to emerging data and regulatory feedback. This program establishes a clear, structured and capital-efficient path toward U.S. approval of AG001 in HGG - one of the most aggressive forms of cancer. Aankondiging • Dec 20
Fluoguide A/S Updates Ind Submission Timing for Fg001 - Trial Initiation Agree FluoGuide A/S announced an update to the submission date for its for its Investigational New Drug (IND) application to mid-January 2026. The updated timeline relates to the IND application supporting the first of two planned registration trials for FG001 in patients with high-grade glioma (HGG). The Company expects to submit the IND in mid-January 2026, compared to end-December 2025 as previously communicated. Importantly, this updated submission timing will have no impact on the planned initiation of the first registration trial for FG001. Aankondiging • Aug 29
FluoGuide A/S to Report Q2, 2026 Results on Aug 25, 2026 FluoGuide A/S announced that they will report Q2, 2026 results on Aug 25, 2026 Aankondiging • Apr 15
FluoGuide A/S Announces Inclusion of the First Patient in its Phase II Clinical Trial (CT-005) Investigating FG001 in Head and Neck Cancer FluoGuide A/S announced the inclusion of the first patient in its phase II clinical trial (CT-005) investigating FG001 in head and neck cancer. The trial is conducted in collaboration with the University Medical Center Groningen and is led by Principal Investigator Prof. Dr. Max Witjes. It aims to evaluate the effectiveness of FG001, a novel optical imaging agent that light up cancerous tissue to improve surgical precision in patients undergoing surgery for oral squamous cell carcinoma, a type of head and neck cancer. By improving tumor visibility, FG001 helps surgeons achieve more complete removal of the cancerous tissue while preserving healthy tissue. The trial will also explore the use of different types of surgical equipment to access FG001' application across a variety of surgical environments. The trial is a single-center trial (FG001-CT-005) designed to: Evaluate multiple endpoints for measuring surgical completeness using FG001. explore the different benefits of FG001 in assisting head and neck cancer surgery. Assess the use of different surgical equipment types. The first interim date is anticipated in the second half of 2025 and will serve as a key data trigger point. Upon completion of this phase II trial and guided by data, FluoGuide plans to initiate a multi-site registration trial as the next step toward regulatory approval and commercialization of FG001. Aankondiging • Mar 12
FluoGuide A/S, Annual General Meeting, Mar 27, 2025 FluoGuide A/S, Annual General Meeting, Mar 27, 2025, at 14:00 Romance Standard Time. Location: at the companys premises, titanhus, titangade 9-13, meeting room - kronos, dk-2200 copenhagen n, Denmark Aankondiging • Jan 16
FluoGuide A/S Receives Approval for Phase II Trial in Head and Neck Cancer FluoGuide A/S announced approval of its phase II Clinical Trial Application for FG001 in head and neck cancer (oral squamous cell carcinoma cancer). The Phase II Clinical Trial Application (CTA) for FG001 in head and Neck cancer, announced on October 7, 2024, has been granted approval under the new European process by the Dutch Central Committee on Research Involving Human Subjects and the Medical Ethical Committee of the University Medical Center Groningen. The CTA submission followed strong clinical topline data from a proof-of-concept Phase II clinical trial of FG001 in patients with head and neck cancer. The trial evaluated surgical precision using various surgical equipment and advanced FG001 to help patients with head and neck cancer, which will be conduct a single center trial to: Evaluate multiple endpoints for measuring surgical completeness with FG001 in patients with head & neck cancer. Explore different benefits of FG001 in assisting these patients. Access the use of various surgical equipment types. Enroll 25-30 patients, with enrollment starting in First Quarter 2025. The interim data is expected in the second half of 2025 being the data trigger point. The trial completing in H2 2026. Depending on trial data and regulatory feedback, the FluoGuide plans to conduct a multisite registration trial as the next step toward approval and commercialization. Aankondiging • Nov 22
FluoGuide A/S Announces Publication of Positive Phase II Clinical Data for FG001 in Patients with Head and Neck Cancer FluoGuide A/S announced publication of the first clinical data on FG001, a novel imaging agent tested in patients undergoing surgery for head and neck cancer. The data has been published in, a prestigious journal with a high impact factor of Theranostics 12.4. The article is entitled " Optical molecular imaging in oral- and oropharyngeal squamous cell carcinoma using a novel uPAR-targeting near-infrared imaging agent FG001 (ICG-Glu-Glu-- and identified with doi:10.7150/thno.100042. AE105): An explorative phase II clinical trial. FG001, is designed to enhance surgical accuracy by illuminating cancer cells intraoperatively using fluorescent light. It selectively binds to the uPAR receptor, widely expressed in most solid cancer types. The use of FG001 is expected to reduce the incidence of local recurrence after surgery and surgical complications, ultimately improving treatment outcomes for patients while also reducing healthcare costs. Key findings from the study. Patient Enrollment: The trial included 16 patients diagnosed with oral or oropharyngeal squ Famous cell carcinoma undergoing surgery. Efficacy. FG001 successfully illuminated cancerous tissues in all enrolled patients, achieving a 100% sensitivity rate, the primary endpoint of the study.osage Variability.: Consistent results were observed across a broad range of doses (4, 16 and 36 mg per patient) Imaging Contrast. The tumor-to- background ratio exceeded 2.0 in all patients with an average of 2.99, significantly above the threshold for usefulness (1.5 - 2.0). Tolerability.: FG001 demonstrated excellent tolerability, with no drug related adverse events reported. Time Frame for Use.: The agent remained effective within the relevant time window, detectable from 2 hours up to at least 19 hours post-administration, based on the longitudinal data. Specificity. FG001 was shown to be specific to cancer, as confirmed by the colocalization of FG001 fluorescence and histology. Clinical Applications: The trial identified several relevant applications in the surgical workflow for head and neck cancer surgery, including guiding surgery, evaluating surgery (margin detection), and real time evaluation of lymph node spread. Aankondiging • Oct 22
Fluoguide A/S Announces Roger Gunnarsson Resigns as Board Member FluoGuide A/S announces that Roger Gunnarsson will resign from his position as member of the board of directors in FluoGuide, effective 31 October 2023. Aankondiging • Oct 07
FluoGuide A/S Submits Clinical Trial Application for Phase II Trial in Head and Neck Cancer FluoGuide A/S 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: Evaluate multiple end-points with clinical applications of FG001 in patients undergoing surgery for head and neck cancer, Prepare utilization of different kind of surgical equipment, Enroll 25-30 patients, with first patient planned to be enrolled in first quarter of 2025, and last patient expected enrolled in second half of 2026. First interim data are expected in second half of 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. New Risk • Aug 30
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr.34m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.34m free cash flow). Revenue is less than US$1m (kr.1.2m revenue, or US$182k). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr.20m net loss in 2 years). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (€49.2m market cap, or US$54.5m). Aankondiging • Aug 26
Fluoguide A/S Announces Executive Changes FluoGuide A/S announced appointment of Jens Ellrich as Chief Medical Officer, effective November 1, 2024. Jens Ellrich, a German physician and medical scientist, brings over 30 years of extensive experience in translational neuroscience, medical devices, biotechnology, pharmacology, and digital therapeutics. His proven track record spans both academia and the start-up ecosystem, where he has successfully advanced innovative medical solutions across drugs, devices, and their combinations. Jens Ellrich has played a key role in the development and launch of groundbreaking therapies at international companies such as the start-up Sapiens Steering Brain Stimulation acquired by Medtronic. At FluoGuide, Jens Ellrich will lead the execution of late-stage clinical trials and spearhead the preparation for commercialization of the company's lead product, FG001. This technology has shown significant promise in illuminating cancerous tissues, enhancing the precision and effectiveness of surgeries for aggressive brain cancers, head and neck cancers (oropharyngeal squamous cell carcinoma), and lung cancer (non-small cell lung cancer). Jens Ellrich will succeed Co-Founder and Chief Scientific Officer Andreas Kjaer in the role of Chief Medical Officer, a position Andreas Kjaer has also been overseeing since 2020. The appointment of Jens Ellrich follows the recent addition of two new board members, Donna Haire and Roger Gunnarsson to strengthen FluoGuide's organization as it advances late-stage clinical trials and prepares for the commercialization of its lead product, FG001. Donna Haire brings extensive expertise across regulatory and clinical affairs, operations, and R&D, while Roger Gunnarsson is a leading financial and M&A advisor with a global network in healthcare. New Risk • Jun 02
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr.36m Forecast net loss in 2 years: kr.54m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.34m free cash flow). Revenue is less than US$1m (kr.383k revenue, or US$56k). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr.54m net loss in 2 years). Share price has been volatile over the past 3 months (8.7% average weekly change). Shareholders have been diluted in the past year (3.3% increase in shares outstanding). Market cap is less than US$100m (€51.2m market cap, or US$55.5m). Aankondiging • May 30
FluoGuide A/S to Report Fiscal Year 2024 Final Results on Feb 27, 2025 FluoGuide A/S announced that they will report fiscal year 2024 final results on Feb 27, 2025 Board Change • Mar 24
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Michael Engsig was the last independent director to join the board, commencing their role in 2023. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Aankondiging • Mar 21
FluoGuide A/S Approves Board Changes FluoGuide A/S at its annual general meeting held on 20 March 2024, approved Lisa Micaela Sjökvist and Shomit Adhip Ghose resign from the board of directors. The general meeting also elected Donna Haire and Roger Gunnarsson as new members of the board of directors. The board of directors hereafter consists of the following members: Peter Mørch Eriksen (chairman); Mats Thorén (deputy chairman); Michael Thyrring Engsig; Andreas Kjær; Donna Haire and Roger Gunnarsson. Breakeven Date Change • Feb 28
No longer forecast to breakeven The analyst covering FluoGuide no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of kr.20.0m in 2025. New forecast suggests the company will make a loss of kr.31.0m in 2025. Aankondiging • Jan 08
FluoGuide A/S Provides Strategic Update and Outlines Development Plans Towards Commercialization of FG001 FluoGuide A/S provided an update on its corporate strategy and plans for further clinical development and commercialization of its lead product FG001. FluoGuide has obtained clinical proof of concept of FG001, a fluorescent molecule targeting the cancer specific uPAR receptor, which lights up cancer cells to improve outcomes of surgery. This includes positive phase II data across three indications: aggressive brain cancer (high grade glioma), head & neck cancer, and lung cancer. FG001 has been granted U.S. Orphan Drug Designation in aggressive brain cancer (high grade glioma). Based on this strong foundation, FluoGuide plans to expand the scope of application of FG001 and advance its development toward approval in aggressive brain cancer. Photothermal therapy (PTT) using FG001 has the potential to selectively eliminate cancer cells with a notable sparing of surrounding normal tissue and represents a significant commercial opportunity. FluoGuide has decided to evaluate FG001's potential in PTT in aggressive brain cancer. FluoGuide plans to advance FG001 into the first clinical trial for registration of FG001 in fluorescence guided surgery (FGS) of aggressive brain cancer, based on feedback from the U.S. Food and Drug Administration (FDA). The benefit of potentially including a treatment effect from PTT in the development of FG001 in this indication will offer considerable potential additional value, significantly reducing the combined development costs for FGS and PTT, which will more than outweigh a delay to the start of regulatory trial. FluoGuide also aims to initiate a phase II trial in head & neck cancer as it offers several valuable positionings of FG001 for patients as well as several partnering opportunities. Hence FluoGuide will explore partnering options across indications with manufacturers of imaging systems, with the aim of accelerating and expanding the commercial opportunities while retaining the maximum value for its shareholders. Breakeven Date Change • Nov 29
Forecast to breakeven in 2025 The analyst covering FluoGuide expects the company to break even for the first time. New forecast suggests the company will make a profit of kr.20.0m in 2025. Average annual earnings growth of 30% is required to achieve expected profit on schedule. Aankondiging • Nov 15
FluoGuide A/S Announces FG001 Meets Primary Endpoint in Phase LLB Trial in Aggressive Brain Cancer FluoGuide A/S announced positive topline efficacy and safety results in the phase IIb trial with the lead product FG001 for guiding surgery in aggressive brain cancer (high-grade glioma). The controlled, randomized, multi-center phase llb trial (FG001-CT-001) investigated the effect of FG001 in guiding surgery of patients with aggressive brain cancer and compared FG001’s effect to 5-ALA. The patients were randomized 1:1 to FG001 or 5-ALA. Fluorescence-guided surgery using FG001 or 5-ALA were compared to white light surgery with each patient serving as its own control. The trial was not designed to show statistical difference (superiority, non-inferiority). The results are used to plan further clinical development. The topline results are: All patients receiving FG001 (12/12) or 5-ALA (12/12) had additional cancer detected by optical guidance, showing FG001 was superior to white light, FG001 was safe and well tolerated with 2 mild (grade 1) related adverse events, FG001 lit up 12/12 patients’ cancer with a tumor to background ratio (TBR) larger than 2, No statistically significant differences were observed between FG001 and 5-ALA in histopathology (sensitivity, specificity, negative predictive value and positive predictive value) or gross total resection (GTR) measured on MRI, Pharmacokinetics of FG001: T1/2 was 13 hours and Cmax was 9.35 mg/L. FG001 is a fluorophore targeting uPAR, which is a cancer-specific target expressed extensively in most solid tumors. It is injected into a patient’s vein prior to surgery and lights up the cancer during surgery, helping to guide the surgeon in removing all cancer while sparing healthy tissue. The fluorophore has the same spectral specifications as indocyanine green (ICG), which is an approved compound used clinically. Accordingly, FG001 can be visualized with ICG compatible imaging systems. Aankondiging • Nov 07
FluoGuide A/S Confirms Positive Topline Results from Phase IIa Trial of FG001 in Head & Neck Cancer at International Academy of Oral Oncology Conference FluoGuide A/S announced that topline results from the phase IIa trial of its lead product FG001 in guiding surgery in patients with head & neck cancer, confirming positive efficacy and safety, were presented at the International Academy of Oral Oncology (IAOO) 2023 conference in Incheon, South Korea. The open-label, single-center non-randomized explorative phase lla trial investigated the effect of FG001 in guiding surgery of patients with head & neck cancer (oral and oropharyngeal squamous cell carcinomas – OPSCC). The purpose was to obtain proof-of-concept in this indication for the uPAR platform technology used to guide surgical removal of cancer. Data from the trial will be valuable to guide further development of FG001 in head & neck cancer including potential clinical benefits. The topline results were: 4 patients were dosed with 4mg, 8 patients were dosed with 16 mg and 4 patients were dosed with 36mg. The cancer lit up in all patients with a relevant Tumor To Background Ratio (TBR). Safety: No Serious Adverse Events or drug-related Adverse Events were reported. Several applications for potential clinical benefit were hypothesized and will be explored in further trials. Aankondiging • Sep 08
Pfluoguide A/S Provides Positive Interim Data from Phase Lla Trial of Fg001 in Head & Neck Cancer Presented as A Case Report At the World Molecular Imaging Congress in Prague FluoGuide A/S pleased to see the first data from FG001 study guiding cancer surgery in patients with head & neck cancer presented at the World Molecular Imaging Congress (WMIC) 2023 in Prague. The presentation contains a patient case. The poster "Optical-Guided Surgery in Patients with Oral and Oropharyngeal Squamous Cell Carcinoma (OSCC & OPSCC) Using a Novel uPAR-targeting Near-Infrared Imaging Agent FG001: An Explorative Phase II Clinical Trial a Case Example " (presenter: Dr. Amanda Øster Andersen, PI: Dr. Anders Christensen both from Rigshospitalet) presents a case from the phase lla study for FG001 in patients with head & neck cancer, showcasing the specificity of FluoGuide' s uPAR-targeting optical imaging agent FG001, for detection of oral squamous cell carcinoma (OSCC). The poster further builds on the positive interim data from the phase lla trial for FG001 in patients with head & neck cancer, on which topline results are expected during H2 2023. New Risk • Aug 31
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr.34m Forecast net loss in 2 years: kr.18m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.31m free cash flow). Revenue is less than US$1m (kr.6.7m revenue, or US$987k). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr.18m net loss in 2 years). Share price has been volatile over the past 3 months (7.4% average weekly change). Aankondiging • Aug 29
Fluoguide A/S Announces Completion of Patient Enrollment and Treatment in the Phase IIb Trial with Fg001 in Patients with Aggressive Brain Cancer FluoGuide A/S announced the successful completion of patient enrollment and treatment in the phase l/lla trial with FG001 in patients with aggressive brain cancer. This means the trial is on track to read out topline results in 2-3 months from now. FG001 is a fluorophore targeting uPAR, which is a cancer specific target expressed extensively in most solid cancers. The fluorophore has the same spectral specifications as indocyanine green, which is already approved, and this means FG001 can be used on current imaging equipment without adaptation. It is administered into a patient's vein prior to surgery and lights up the cancer during surgery, helping to guide the surgeon in removing all cancer while sparing healthy tissue. The controlled, randomized, multi-center phase llb trial (FG001-CT-001) investigates the effect of FG001 in guiding surgery of patients with aggressive brain cancer and compares FG001's effect compared to 5-ALA and white light. The patients are randomized in 1:1 between FG001 and 5-ALA. FG001 and 5-AL A are compared to white light in their respective arm with the patients as their own control. The trial was based on the highly promising results from a phase l/lla trial in the same indication, where 100% of the biopsies from patients treated with FG001 illuminated cancer. With recruitment completed, the topline results of the phase IIb trial are expected in 2-3 months and will be conducted with analysis of biopsies and MRI scans. These analyses are blinded and initiated after last patient is enrolled and treated. The main aim of this phase IIb trial is to generate the required data to inform design of a phase III trial of FG001 in aggressive brain cancer, and it is not powered to demonstrate significant superiority or non-inferiority of any of FG001, white light or 5-ALA.FG001 has several technological advantages over 5-ALA, such as being based on near infrared light which gives deeper visibility (1-2 cm versus 1-2 mm) and hence an anticipated higher chance of detecting cancer which is located deeper in tissue. Patients included in the trial were diagnosed with suspected high-grade glioma where the surgeon expected to be able to make a complete removal of the tumor. The 24 patients were equally randomized between FG001 and 5- ALA. The primary endpoint is the proportion of patients who benefit from the imaging agent, measured by removal of more of the cancer at the end of surgery. Aankondiging • Jun 22
FluoGuide A/S Announces Positive Interim Results from Phase IIa Trial of FG001 in Head & Neck Cancer FluoGuide A/S announced positive interim results from the phase IIa trial of its lead product FG001 in head & neck cancer. FG001 was shown to illuminate tumors in all of the patients. FG001 was shown to light up tumors in 100% of the patients. In line with the efficacy data in brain and lung cancers, underscoring FG001's potential for broad applicability. Topline results from the trials in brain and head & neck cancers expected in second half of 2023. Data show all 12 patients in the first two cohorts, undergoing surgery for head & neck squamous cell carcinomas (HNSCC), had their tumors lit up with FG001. FG001 is a fluorophore targeting uPAR, which is a cancer specific target expressed extensively in most solid cancers. The fluorophore has the same spectral specifications as indocyanine green, which is already approved, and this means FG001 can be used on current imaging equipment without adaptation. It is administered into a patient's vein prior to surgery and lights up the cancer during surgery, helping to guide the surgeon in removing all cancer while sparing healthy tissue. The third cohort of a further 4 patients has been initiated on a low dose of FG001 to enable investigation of a broad dose range, which will inform dose selection for a future phase IIb trial. It is therefore expected that some cancers in the third cohort of patients will not light up. FluoGuide expects enrollment of the last patient in its phase IIb trial of FG001 in aggressive brain cancer (high grade glioma) during the summer of 2023 and the topline result approximately 2 months after that. The topline result from the phase IIa trial the phase IIa trial of FG001 in Head & neck cancer is expected in second half 2023. Aankondiging • Jun 08
Fluoguide A/S Announces Positive Topline Results from Phase Iia Trial of Fg001 in Lung Cancer FluoGuide A/S announced positive topline results from a phase IIa trial of its lead product FG001 in lung cancer. FG001 was shown to illuminate the majority of the patients' lung tumors and was well tolerated in all patients. These results support further clinical development in this indication. FG001 was shown to light up lung cancer in 73% of the patients and was safe and well tolerated. This marks the third cancer indication for which FG001 shows efficacy, underscoring its potential for broad applicability. Further data in brain and head & neck cancers are expected in H2-2023. FG001 is a fluorophore targeting uPAR, which is a cancer specific target expressed extensively in most solid types of cancers. The fluorophore has the same spectral specifications as indocyanine green, which is already approved, and this means FG001 can be used on current imaging equipment without adaptation. It is injected into a patient's vein prior to surgery and lights up the cancer during surgery, helping to guide the surgeon in removing all cancer while sparing healthy tissue. A total of 15 patients with non-small cell lung cancer (NSCLC), undergoing lung surgery (lobectomy), completed the trial, with a gender distribution of 9 females and 6 males a weight range of 50-92 kg and age range of 50-83 years. FG001 was shown to be safe and well tolerated in all patients. The pharmacokinetic (PK) profile for FG001 was determined in lung cancer patients and the half-life (t1/2) was found to be comparable with that of aggressive brain cancer (high grade glioma). Globally, 2.2 million individuals are diagnosed with lung cancers annually and 1.8 million patients die every year with lung cancer. It is the second most commonly diagnosed type of cancer and the leading cause of cancer death in 2020. lung cancer is typically diagnosed when the cancer already has spread being an important reason for its high mortality. Breakeven Date Change • May 18
Forecast breakeven date pushed back to 2025 The analyst covering FluoGuide previously expected the company to break even in 2024. New forecast suggests the company will make a profit of kr.37.0m in 2025. Average annual earnings growth of 36% is required to achieve expected profit on schedule. Breakeven Date Change • Apr 21
Forecast breakeven date pushed back to 2025 The analyst covering FluoGuide previously expected the company to break even in 2024. New forecast suggests the company will make a profit of kr.37.0m in 2025. Average annual earnings growth of 36% is required to achieve expected profit on schedule. Breakeven Date Change • Mar 21
Forecast breakeven date pushed back to 2025 The analyst covering FluoGuide previously expected the company to break even in 2024. New forecast suggests the company will make a profit of kr.37.0m in 2025. Average annual earnings growth of 36% is required to achieve expected profit on schedule. Breakeven Date Change • Feb 23
Forecast to breakeven in 2024 The analyst covering FluoGuide expects the company to break even for the first time. New forecast suggests the company will make a profit of kr.52.0m in 2024. Average annual earnings growth of 71% is required to achieve expected profit on schedule. Aankondiging • Feb 02
FluoGuide A/S Appoints Ole Larsen as Chief Financial Officer FluoGuide A/S appointed Ole Larsen as Chief Financial Officer. Ole Larsen has taken up the position as CFO with immediate effect. Ole is an experienced CFO with a strong history of working in various industries in both listed and unlisted companies, including Bavarian Nordic, BioPorto, Nordisk Film and Berlingske Tidende. He is skilled in growth/start-ups, M&A and Corporate Finance, and has a finance professional background with a MSc focused on Economics from Copenhagen Business School. Henrik Hang is leaving the position for personal reasons. Breakeven Date Change • Jan 30
Forecast to breakeven in 2024 The analyst covering FluoGuide expects the company to break even for the first time. New forecast suggests the company will make a profit of kr.52.0m in 2024. Average annual earnings growth of 71% is required to achieve expected profit on schedule. Aankondiging • Jan 10
FluoGuide A/S Releases Positive Interim Result of FG001 in Head and Neck Cancer FluoGuide A/S announced the positive interim result of FG001 in head and neck cancer that FG001 lights up in 4 out of 4 patients following the interim evaluation of the first four patients dosed in the ongoing explorative phase II a trial in patients with head and neck squamous cell carcinomas (HNSCC) undergoing surgery. Detection of light was made from the tissue identified macroscopically as cancer by the surgeon. At the end of the trial, the pathologists will histologically examine the tissue that lights up to determine if the tissue samples contain cancer or normal tissue. Although this is an encouraging interim result, it is important to state that a final conclusion regarding the effect of FG001 cannot be reached until after the histology examinations have been completed at the end of the trial. The optimal dose in patients with head and neck squamous cell carcinomas (HNSCCs) undergoing surgery has not yet been established. FluoGuide has selected head and neck cancer, the 6th most common cancer, due to a high unmet need and evidence of uPAR overexpression. The ongoing trial is conducted in cooperation with the Department of Otorhinolaryngology, Head and Neck Surgery & Audiology at the Copenhagen University Hospital - Rigshospitalet, in Denmark. The phase IIa trial is designed to obtain proof-of-concept in head and neck cancer for uPAR platform technology used to guide surgical removal of cancer. The plan is to enrol up to 16 patients. The primary endpoint is sensitivity for detection of cancer defined as the relative number of patients, where FG001 lights up the cancer confirmed by histopathology. FluoGuide expects top line results to be available in H1 2023. FluoGuide has selected head and neck cancer due to the high prevalence, a high unmet need, and strong evidence of uPAR being overexpressed in these cancers. Breakeven Date Change • Dec 20
Forecast to breakeven in 2024 The analyst covering FluoGuide expects the company to break even for the first time. New forecast suggests the company will make a profit of kr.52.0m in 2024. Average annual earnings growth of 71% is required to achieve expected profit on schedule. Aankondiging • Nov 30
FluoGuide A/S to Report Fiscal Year 2022 Results on Feb 28, 2023 FluoGuide A/S announced that they will report fiscal year 2022 results at 12:00 PM, Central European Standard Time on Feb 28, 2023 Aankondiging • Nov 22
FluoGuide A/S Enrolls First Patient in the Phase IIa Trial in Head and Neck Cancer FluoGuide A/S announced that the company has enrolled the first patient in the phase IIa trial with FG001 in head and neck cancer. The ongoing phase IIa trial is conducted in collaboration with Department of Otolaryngology, Head & Neck Surgery and Audiology at the University Hospital, Rigshospitalet in Denmark. The phase IIa trial is designed to obtain proof-of-concept in head and neck cancer for uPAR platform technology used to guide surgical removal of cancer. The primary endpoint is sensitivity defined as the relative number of patients, where FG001 lights up the cancer confirmed by histopathology. FluoGuide plans to enrol up to 16 patients and the top-line results are expected to be available in H1 2023. FluoGuide has selected head and neck cancer due to a high unmet need, and evidence of uPAR being overexpressed in these cancers. Aankondiging • Nov 09
FluoGuide A/S Reaches Milestone with FG001 for Phase III Clinical Supply FluoGuide A/S informed that the first large scale batch for its lead product FG001 has been successfully manufactured in preparation for phase III clinical development. FluoGuide has successfully collaborated with its supplier PolyPeptide since the very first synthesis of the FG001 API (Active Pharmaceutical Ingredient). FG001 is a clinical development project that was started in 2020 for the novel treatment of aggressive brain cancer. A first large scale batch has now been successfully manufactured by PolyPeptide in preparation for phase III clinical development. For the pivotal phase III clinical trials, FluoGuide with the support of PolyPeptide has scaled up the manufacturing of FG001 to commercial scale. As part of the clinical process, FluoGuide now plans for three validation batches in commercial scale to be documented and included in the registration package for commercial approval. Obtaining success with the first Phase III batch is therefore an important milestone for the preparation of any phase III trials and commercialization of FG001. Aankondiging • Nov 07
FluoGuide A/S Releases Positive Interim Result of FG001-CT002 FluoGuide A/S announced that FG001 lights up in 5 out of 7 patients in an interim evaluation in the ongoing phase IIa trial in non-small cell lung cancer (NSCLC) FluoGuide has evaluated data from 8 patients in the exploratory phase IIa trial in patients with non-small cell lung cancer (NSCLC) undergoing surgery. FG001 was well tolerated in all 8 patients. One patient was not diagnosed with non-small cell lung cancer (NSCLC) but lung metastases from bladder cancer. In 5 of the 7 patients with NSCLC, FG001 lighted up the cancer. FG001 did also light up in the patient diagnosed with metastases from bladder cancer, however, this patient was excluded from the analysis as the patient did not have NSCLC. Detection of light was made from the tissue identified macroscopically as cancer by the surgeon. At the end of the trial, the pathologists will histologically examinate the tissue that lights up to determine if the tissue samples contain cancer or normal tissue. Although this is an encouraging interim result, it is important to state that the final conclusion regarding the effect of FG001 will not be reached until after the histology examinations have been completed at end of the trial. The optimal dose in patients with NSCLC undergoing surgery is not yet established, which also means that the result in the optimal dose is anticipated to be similar or better. Moving forward, the time of administration of FG001 prior to surgery will be investigated to select the optimal dosing in patient with lung cancer (NSCLC) undergoing surgery. The primary endpoint is sensitivity defined as the relative number of patients, whose cancer is illuminated by FG001. The trial is conducted at the Department of Cardiothoracic Surgery at the University Hospital, Rigshospitalet, in Denmark. The top line result is expected in H1 2023. FluoGuide has selected lung cancer due to a high unmet need, evidence of uPAR overexpression and surgeon familiarity with using optical endoscopes during surgery. Aankondiging • Oct 21
FluoGuide A/S Enrolls the First Patient in the Phase IIb Trial in Aggressive Brain Cancer FluoGuide A/S announced that the first patient has now enrolled in the phase IIb clinical trial with FG001 in aggressive brain cancer. In the phase IIb trial, FG001 is being tested as a standalone treatment compared to Gliolan (5-ALA), which is the only approved product for intraoperative guidance during aggressive brain cancer surgery. 24 patients will be randomized 1:1 against Gliolan (5-ALA). The primary endpoint of the phase IIb trial measures the proportion of patients with relevant change in clinical strategy, which is aligned with regulatory position for pivotal trials in fluorescence guided surgery. The trial aims to demonstrate non-inferiority to 5-ALA, and the result will be used to calculate the number of patients needed for the phase III trial. The trial is not powered to show significance. The patients are being recruited at two sites: Linköping, Sweden and Copenhagen, Denmark. The results of the phase IIb trial are expected to be available in H1 2023. The phase IIb trial follows the highly promising phase I/IIa results in aggressive brain cancer (high grade glioma) that FluoGuide announced in April 2022. FG001 was demonstrated to be well tolerated with only few patients reporting mild side effects (3 out of 40 patients). Furthermore, 100% of the biopsies from patients in the optimal dose (n=8, with 33 biopsies obtained) showed cancer illumination with high sensitivity and specificity. Aankondiging • Oct 04
FluoGuide A/S Presents the Outstanding Clinical Data from the Completed Phase I/IIa Trial with FG001 in Patients with Aggressive Brain Cancer Undergoing Surgery, At the World Molecular Imaging Congress FluoGuide A/S informed of presentation of the outstanding clinical data from the completed phase I/IIa trial with FG001 in patients with aggressive brain cancer undergoing surgery, at the World Molecular Imaging Congress (WMIC) held 28 September - 1 October 2022 in Miami, US. Promising pre-clinical data on FG002 was also presented at the same conference. Andreas Kjaer, Professor and CSO at FluoGuide presented the excellent phase I/IIa clinical data of FG001 in aggressive brain cancer data at the World Molecular Imaging Congress (WMIC). In the phase I/IIa trial, which had Chief Surgeon Jane Skjøth-Rasmussen as Principal Investigator, the neurosurgeon collected 31 tissue samples during surgery from the 8 patients dosed with FG001, at 36 and 48 mg in the evening. This included both tissue that lit up and tissue that did not lit up. After surgery, two histopathologists evaluated the samples independently and determined if the tissue samples contained cancer or not. The histopathologists read the samples in a blinded manner, meaning that they did not know where the neurosurgeon had taken the samples or if the samples had lightened up. 100% of the biopsies that lit up during surgery contained cancer. In the 40 patients FG001 were administered to, FG001 was shown to be safe and well-tolerated. No serious drug related adverse events were reported. Only a few (4) drug-related mild adverse events (grade 1 and 2) were reported in 3 patients out of the 40 included patients. Based on the excellent clinical data, FG001 is advanced into a phase IIb trial in aggressive brain cancer where the top line result is expected in H1 2023. Aankondiging • Oct 01
FluoGuide A/S Ordinary Shares to Be Deleted from OTC Equity FluoGuide A/S Ordinary Shares will be deleted from OTC Equity effective from October 03, 2022, due to Inactive Security. Aankondiging • Sep 07
FluoGuide A/S Receives Approval from the Danish Medicines Agency to Initiate Phase Ii Trial with Fg001 in Head and Neck Cancer FluoGuide A/S announced that the company has received approvals to initiate the phase II trial in head and neck cancer. The trial is expected to enrol first patient in Fourth Quarter 2022. Following the approval from the Danish Medicines Agency, FluoGuide is initiating the phase II trial in collaboration with Department of Otolaryngology, Head & Neck Surgery and Audiology at the University Hospital, Rigshospitalet, in Denmark. Principal investigator is Anders Christensen, MD, Ph.D. The phase IIa trial is designed to obtain proof-of-concept in head and neck cancer for uPAR platform technology used to guide surgical removal of cancer. The plan is to enrol up to 16 patients. The primary endpoint is sensitivity defined as the relative number of patients, where FG001 lights up the cancer confirmed by histopathology. FluoGuide expects top line results to be available in 1H 2023. FluoGuide has selected head and neck cancer due to a high unmet need, and evidence of uPAR being overexpressed in these cancers. Aankondiging • Sep 01
FluoGuide Announces CFO Changes FluoGuide A/S has appointed Henrik Hang as Chief Financial Officer. Henrik Hang has substantial experience as CFO from international companies to biotech company listed on Nasdaq First North Growth Market, Stockholm Henrik Hang comes most recently from the role as CFO at Cyxone AB (publ). Henrik Hang has a degree in finance from University of Linné, Sweden and will be part of FluoGuide´s management team. Henrik Hang will start at FluoGuide on the 15th of November 2022. Henrik Hang will replace the current CFO Henrik Moltke, who wished to step down as CFO to devote more time on board work and family. Henrik Moltke will continue as senior advisor for the company with special focus on investor relations and communication. Aankondiging • Aug 31
FluoGuide Receives Permission to Start Phase IIb Trial in Aggressive Brain Cancer FluoGuide A/S announced that the company now has received the permission to start the phase IIb clinical trial with FG001. FluoGuide has now received approval from the Danish Ethical Committee and the trial can start in Denmark. FluoGuide announced in April FG001's highly promising results in aggressive brain cancer (high grade glioma) following its phase I/IIa trial. FG001 was demonstrated to be well tolerated with only few patients reporting mild side effects (3 out of 40 patients). Furthermore, 100% of the biopsies from patients in the optimal dose (n=8, with 33 biopsies obtained) that illuminate contained cancer. Based on these strong results, FluoGuide has decided to expand the design of the phase IIb trial. FG001 will now be tested as a standalone treatment compared to Gliolan (5-ALA), which is the only approved product for intraoperative guidance during aggressive brain cancer surgery. 24 patients (compared to the originally planned 12 patients), will be randomized 1:1 against Gliolan (5-ALA). The design of the phase IIb trial aims at non-inferiority to 5-ALA on the primary endpoint. The trial is not powered to show significance, and the result will be used to calculate the number of patients needed for the phase III trial. The patients will be recruited at two sites: Linköping, Sweden and Copenhagen, Denmark. The results of the phase IIb trial are expected to be available in H1 2023. Aankondiging • Aug 25
Fluoguide A/S Update on Fg001's Clinical Development FluoGuide A/S provided an update on the clinical development of FG001. FluoGuide announced in April FG001's highly promising results in aggressive brain cancer (high grade glioma) following its phase I/IIa trial. FG001 was demonstrated to be well tolerated with only few patients reporting mild side effects (3 out of 40 patients). Furthermore, 100% of the biopsies from patients in the optimal dose (n=8, with 33 biopsies obtained) had their cancer illuminated. Based on these strong results, FluoGuide has decided to expand the design of the phase IIb trial in aggressive brain cancer with 24 patients instead of 12. Furthermore, FluoGuide has decided to explore FG001 in phase IIa clinical trials in three other severe cancer indications. Status and plans for the clinical development of FG001: FG001 - Phase IIb trial in aggressive brain cancer: Based on the positive data, FG001 will be tested in a clinical phase IIb trial as a standalone treatment compared to Gliolan (5-ALA), which is the only approved product for intraoperative guidance during aggressive brain cancer surgery. 24 patients (compared to the originally planned 12patients), will be randomized 1:1 against Gliolan (5-ALA). The patients will be recruited at two sites: Linköping, Sweden and Copenhagen, Denmark. FluoGuide has received approvals from Swedish Medical Products Agency and Swedish Ethical Committee, and the first patient is planned to be enrolled in the beginning of October. In Denmark, FluoGuide has received approval from Danish Medicines Agency (DMA) and is awaiting approval from the Ethical Committee, which is expected at the latest by November. The first patient in Denmark will be enrolled as soon as the Ethical Committee approval has been granted. The results of the phase IIb trial are expected to be available in H1 2023. FG001 - Phase IIa trial in lung cancer: The trial is designed to enroll up to 24 patients. First interim analysis following evaluation of 8 patients is anticipated in Fourth Quarter 2022 and top line data in H1 2023. The trial was approved in March 2022 and initiated in May 2022. Due to slower-than-anticipated patient enrollment, FluoGuide has amended the protocol with broader inclusion criteria, which has now been approved by both the Ethical Committee and the DMA in Denmark. FG001 - Phase IIa trial in head and neck cancer: The Clinical Trial Application (CTA) in Denmark has been filed. The trial is designed as a phase IIa trial to obtain proof-of-concept for the use of FG001 in head and neck cancer. The plan is to enroll up to 16 patients. The primary edpoint is sensitivity, defined as the relative number of patients where FG001 lights up the cancer, as confirmed by histopathology. Top line results for this trial are anticipated in H1 2023. FG001 - Phase IIa trial in meningioma and low grade glioma: The trial is designed as a phase IIa trial to obtain proof-of-concept for the use of FG001 in meningioma and low grade glioma. The primary endpoint is expected to be sensitivity, defined as the relative number of patients where FG001 lights up the cancer, as confirmed by histopathology. The Company is finalizing the protocol prior to the CTA submission. The results from this trial are expected in H2 2023. Aankondiging • May 24
FluoGuide Publish the Presentation of FG001 Results from the First Clinical Trial in Aggressive Brain Cancer FluoGuide A/S informed that the presentation of the results from the clinical trial of FG001 used to guide surgery in patients with aggressive high-grade glioma brain cancer. As a follow-up on the award-winning presentation done by Principal Investigator and Chief Surgeon Jane Skjøth-Rasmussen at the 68th Scandinavian Neurosurgical Society (SNS) Congress held 14-16 May 2022, in Bergen, Norway, FluoGuide held a company presentation on the 17 May 2022 where Chief Surgeon Jane Skjøth-Rasmussen, did a presentation of the same data that will be presented at the SNS congress follow up by comments from the FluoGuide management. Aankondiging • Apr 03
FluoGuide A/S Announces Positive Top Line Result from Ongoing Clinical Phase I/II Trial FluoGuide A/S announced that FG001 has been shown safe and well tolerated in 40 patients. The early evidence of efficacy has been demonstrated by strong illumination of brain tumors and histology data has now confirmed that the tissue lighted up is cancer. The optimal dose and time of FG001 administration has been decided to be 36 mg administered the evening before surgery. In total, 40 patients have been administered and FG001 has been shown safe and well tolerated (please see table). No serious drug related adverse events have been reported. Only a few drug-related adverse events were reported as grades 1 or 2 and no pattern or dose relation was observed. Four patients had other diagnoses than aggressive brain cancer (high grade glioma ('HGG')): One patient had a lung cancer metastasis (adenocarcinoma metastasis) in the brain, one patient had meningioma, and two patients had malignant melanoma metastases in the brain. Intriguingly, the patients with lung cancer metastasis and meningioma demonstrated good illumination of the cancers. One patient with HGG received FG001 but did not undergo surgery, and only safety was monitored. The pharmacokinetic (PK) profile for FG001 was assessed for the eight dose levels. FG001 showed dose-dependent increases in exposure across dose levels in a linear manner. Tumor-to-background ratio (TBR) is a measure of the contrast. At the optimal dose and time, 36 mg administered the evening before, all patients revealed a clinically relevant TBR value. The histology samples from dose cohort 7a (36 mg, evening) and dose cohort 8a (48 mg, evening) have been unblinded and analyzed. The histology results confirm that FG001 lights up aggressive brain cancer. Aankondiging • Dec 23
FluoGuide Submits Clinical Trial Application to the Danish Medicines Agency to Initiate Phase Ii Trial with Fg001 in Lung Cancer FluoGuide A/S announce that the company has submitted a CTA to initiate the phase II trial in lung cancer. The clinical trial will be conducted at Rigshospitalet in Denmark. Following approval from the Danish Medicines Agency, FluoGuide will initiate the phase II trial in lung cancer in collaboration with Department of Cardiothoracic Surgery at the University Hospital, Rigshospitalet, in Denmark. The phase II trial is designed to enrol up to 24 patients with non small cell lung cancer (NSCLC). The primary endpoint is sensitivity defined as the relative number of patients, where FG001 lights up the cancer. FluoGuide expects the patients to be enrolled during 2022 and top line results to be available late 2022. The trial includes 2 interim evaluations after 8 and 16 patients, respectively. FluoGuide has selected lung cancer as the second indication to investigate after malignant glioma. The selection of lung cancer is due to a high unmet need, evidence uPAR being overexpressed in the lung cancer and that the surgeons are familiar with using optical endoscopes during surgery. Aankondiging • Sep 15
Fluoguide Proceeds to Seventh Dose Level with Fg001 in the Ongoing Clinical Phase I/II Trial Following Continued Improvement of Tumor Illumination with Increasing Doses FluoGuide A/S announced that FG001 was well tolerated, and light was detected in all patients in the sixth cohort (24 mg), administered in the morning before surgery. The data from the sixth dose (24 mg) showed a continued improvement and clear illumination of the tumors in all three patients. The dose escalation committee has therefore recommended to initiate the seventh dose level (36 mg) in the ongoing clinical phase I/II trial. FluoGuide is conducting a clinical phase I/II trial evaluating safety and efficacy of its lead asset, FG001, in patients with aggressive brain cancer (high grade glioma) undergoing neurosurgery. The Company announced thatFG001 was well tolerated, and an increased illumination of the tumors were detected in all three patients at the sixth dose level (24 mg), administered in the morning before surgery. Based on the strong data, the Company has decided to generate additional safety and dose-selection data by testing 36 mg the morning before surgery, which has been approved by the dose escalation committee. Regarding the illumination, the protocol is designed to continue dose escalation as long as illuminations improve. As this has continuously been observed including with the latest dose of 24 mg, the dose escalation will continue to the next dose level of 36 mg. Aankondiging • Aug 27
FluoGuide Announces Regulatory Approval from Swedish Authorities to Commence Phase II Clinical Trial with FG001 in Guiding Surgery of High Grade Glioma in Sweden FluoGuide A/S announced that the company has received regulatory approval for expanding the ongoing clinical phase I/II trial to Sweden with FG001. The ongoing clinical phase I/II trial with FG001 is designed as a two-phased trial, where the first phase aims to identify the optimal dose and investigate safety and tolerability. Phase II will provide efficacy data that will be used to design the following pivotal phase III trial intended to support regulatory approval of FG001 in high grade glioma, aggressive brain cancer. After the approval in Sweden, Linköping University Hospital will be the second site investigating FG001's effect. Sweden and Linköping University Hospital is added to phase II of the clinical phase I/II trial, to provide diversity to the trial by working with different centers in different counties. First patient enrollment is expected after the reporting of phase I of the ongoing I/II clinical trial. Aankondiging • Aug 25
FluoGuide A/S Announces Publication of Promising Preclinical Data on FG001 Effect in Treatment of Cancer FluoGuide A/S announced the first publication of preclinical data where the company's compound FG001 is used as a photothermal therapy agent for treatment of cancer. The new feature of FG001 complements the surgical targeting and opens new opportunities for the realization of clinical and commercial potential of the Company's uPAR-targeting technology platform. Earlier this year the Company announced it had acquired worldwide exclusive rights to use FG001 for photothermal therapy. Now the first preclinical study using the technology has been published demonstrating effect of FG001 when used as a photothermal therapy agent in precise treatment of cancer. The results further substantiate FluoGuide's strategy of developing a multiple-products, multiple indications portfolio that maximizes surgical outcome in cancer treatment. The promising preclinical data now published on FG001s photothermal therapy means that an even larger share of cancer patients can be helped, as surgeons through the new feature of FG001 potentially can remove cancer previously not possible to see or reach. The preclinical study demonstrates effect of FG001 used as photothermal therapy agent in precise treatment of cancer. Photothermal therapy is a technique where a suitable fluorophore is heated by light which cause destruction of the surrounding tissue. It is a known characteristic of the fluorophore used in FG001 that it has potential as a photothermal therapy agent. The main finding in the new study, a xenograft preclinical model using human glioblastoma cells, is that FG001 targeted the photothermal therapy effect specifically to cancer tissue while saving the surrounding tissue. FG001 is selectively bound to uPAR, being a specific cancer target present on most solid cancers. Aankondiging • Jun 17
FluoGuide A/S Announces Promising Preclinical Data with Fg002 Technology in Guiding Surgical Removal of Cancer FluoGuide A/S announced that promising preclinical data with the Company's compound FG002 has been published in a peer reviewed journal. FG002 lights up the invasive growth of cancer and thereby has the potential to improve cancer surgery. The preclinical study demonstrated FG002 to light up cancer with several promising features holding great promises for the use of guiding surgical removal of cancer. FG002 was tested in an orthotopic xenograft model using human glioblastoma cells. Aankondiging • May 19
FluoGuide has Received Green Light to Proceed to the Next Dose Level with FG001 in the Ongoing Clinical Phase I/II Trial in Patients Undergoing Surgical Treatment of High Grade Glioma FluoGuide A/S announced that the dose escalation committee has reviewed the data from the fifth dose level and approved initiation of the next dose level. In addition, the company has received approval to commence with an evening dosing of the fifth dose level with FG001. The results from the patients in the fifth dose level show, in line with the previous dose levels, that FG001 was well tolerated. The light intensity continues to increase with higher dose levels and light was detected in all patients. FluoGuide can now in collaboration with the principal investigator chose to either increase the dose level with a morning administration or administer an already tested morning dose in the evening. The Company has decided to proceed with the fifth dose level in an evening administration. Coming cohorts of patients will initially receive higher doses of FG001 in the morning to assess safety prior to being evaluated in an evening administration, It is important to underline that the first part of the trial must be completed and analyzed before any final conclusions on tolerability and safety profile can be made. It is also important to state that the pathology examination at the end of the first part is needed to confirm that the tissue that lights up is cancer and tissue that does not light up is free of cancer. There is still a risk that the recruitment of patients over the next months may be slowed down due to the ongoing COVID-19 pandemic but FluoGuide expects to have data from the first part of the trial available within third quarter 2021, also being the starting point to apply for new phase II clinical trials in other cancer indications, including a prevalent cancer such as lung or breast cancer. Aankondiging • May 12
FluoGuide Receives Approval to Commence with FG001 in Evening Dosing in the Ongoing Clinical Phase I/II Trial in Patients with High Grade Glioma FluoGuide A/S announced that the Danish Medicines Agency and Ethical Committee has approved administration of FG001 in the evening before surgery. The data from the ongoing dose finding trial suggests that background light intensity might be further reduced if FG001 is administered in the evening prior to surgery. This would presumably give an even better image quality and tumor delineation. To ensure that the best possible combination of FG001 dose and time of administration is carried forward in clinical development, the company has therefore made a protocol amendment to explore also evening administration. This allows for a comparison of morning and evening administration during the ongoing phase I/II trial. The protocol amendment has now been approved by the Danish Medicines Agency and Ethical Committee. FG001 is currently being tested at the fifth dose level. The results from the first fourth dose levels showed that FG001 is well tolerated, and the light intensity continues to increase with higher dose levels. It is important to underline that the first part of the trial must be completed and analyzed before any final conclusions on tolerability and safety profile can be made. It is also important to state that the pathology examination at the end of the first part is needed to confirm that the tissue that lights up is cancer and tissue that does not light up is free of cancer. Regarding the timeline, there is still a risk that recruitment of patients over the next months may be slowed down due to the ongoing COVID-19 pandemic but FluoGuide expects to have data from the first part of the trial available within third quarter of 2021. 
