Breakeven Date Change • Apr 02
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.44.0m in 2027. New forecast suggests the company will make a loss of kr.109.0m in 2028. 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. New Risk • Mar 17
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 9.2% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (kr.220k revenue, or US$34k). Minor Risks Share price has been volatile over the past 3 months (9.2% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (kr590.2m market cap, or US$63.6m). 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. Board Change • Dec 03
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. New Risk • Nov 28
New major risk - Negative shareholders equity The company has negative equity. Total equity: -kr.2.4m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Negative equity (-kr.2.4m). Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (kr604.9m market cap, or US$63.7m). New Risk • Nov 06
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 20% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (kr678.5m market cap, or US$70.8m). 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 Breakeven Date Change • May 31
Forecast to breakeven in 2027 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.45.0m in 2027. Average annual earnings growth of 68% is required to achieve expected profit on schedule. New Risk • May 30
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 40% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. 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.28m free cash flow). Earnings are forecast to decline by an average of 40% per year for the foreseeable future. Revenue is less than US$1m (kr.395k revenue, or US$60k). Minor Risks Currently unprofitable and not forecast to become profitable next year (kr.47m net loss next year). Market cap is less than US$100m (kr570.7m market cap, or US$59.5m). 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 Breakeven Date Change • Mar 03
Forecast breakeven date pushed back to 2027 The analyst covering FluoGuide previously expected the company to break even in 2026. New forecast suggests the company will make a profit of kr.50.0m in 2027. Average annual earnings growth of 63% is required to achieve expected profit on schedule. 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. New Risk • Jan 03
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. 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$160k). Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (12% increase in shares outstanding). Market cap is less than US$100m (kr708.2m market cap, or US$63.7m). 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 (kr558.0m 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. 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 • Apr 26
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. 4 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. 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. New Risk • Feb 29
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 65% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. 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.32m free cash flow). Earnings are forecast to decline by an average of 65% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (kr.54m net loss next year). Share price has been volatile over the past 3 months (8.8% average weekly change). Shareholders have been diluted in the past year (3.2% increase in shares outstanding). Market cap is less than US$100m (kr661.1m market cap, or US$64.0m). Breakeven Date Change • Feb 29
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. New Risk • Feb 16
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 8.6% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. 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.32m free cash flow). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (8.6% average weekly change). Shareholders have been diluted in the past year (3.2% increase in shares outstanding). Market cap is less than US$100m (kr700.2m market cap, or US$67.0m). 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. New Risk • Jan 02
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.2% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (3.2% increase in shares outstanding). Market cap is less than US$100m (kr746.5m market cap, or US$74.0m). 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. Breakeven Date Change • Sep 06 The analyst covering FluoGuide previously expected the company to break even in 2025. New forecast suggests the company will make a profit of kr.20.0m in 2025.
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$980k). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (kr.18m net loss in 2 years). 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. 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. 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. Aankondiging • Dec 23
FluoGuide A/S to Report Q1, 2023 Results on May 31, 2023 FluoGuide A/S announced that they will report Q1, 2023 results on May 31, 2023 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 • Mar 10
FluoGuide A/S Acquires Rights to Photothermal Therapy Using FG001 FluoGuide A/S announced that the Company has acquired worldwide exclusive rights to use FG001 for photothermal therapy in combination with dedicated light source. Photothermal therapy is an extension of photodynamic therapy, in which a photosensitizer is excited with light of a specific wave length. This light excitation brings a molecule, such as FG001, to an excitation state where it releases energy in the form of heat. Under optimal conditions, the generated heat will kill cancer cells while sparing normal tissue. Photothermal therapy with FG001 has already demonstrated a clear effect in preclinical models and shown to be safe to normal tissue in these models. The combination of FG001 and its binding to uPAR expressing cancer cells potentially gives a very broad use of FG001 for photothermal therapy, including some of the most prevalent cancer types. Near Infered Light (NIR) is used to excite FG001, which has the advantage over visible light of penetrating deeper into the tissue and therefore has potential to precisely destroy cancer tissue 1-2 cm into the tissue while sparing surrounding healthy tissue. In comparison will visible light only penetrates approximately 1-2 mm into the tissue. With the obtained exclusive rights, FluoGuide can now not only guide surgery through FG001, but potentially also help the surgeon to destroy hidden cancer cells, or superficial cancer that cannot be removed, e.g. because it has invaded a vital stucture in, for instance, the brain. The exclusive rights has been aquired from Copenhagen University Hospital. The underlying patent application to use FG001 for photothermal therapy was filed by Rigshospitalet and will be published during 2021. It will, if granted, not expire until 2039. The acquisition of the exclusive rights will not affect FluoGuide's cost budget for 2021, during which the photothermal capabilities will be further evaluated in pre-clinical studies and an optimal development path planned. Future payments to Rigshospitalet will be through royalties as a low single digit percentage of sales by FluoGuide. There will be no cash payments in 2021 by FluoGuide to Rigshospitalet, but FluoGuide will take over the patent costs. Aankondiging • Feb 18
Dose Escalation Committee Approves FluoGuide A/S's Initiation of the Fourth Dose Level in the Ongoing Clinical Phase I/II Trial Evaluating Safety and Efficacy of Fg001 in Patients with High Grade Glioma Undergoing Neurosurgery FluoGuide A/S announced that the dose escalation committee have approved initiation of the fourth dose level in the ongoing clinical phase I/II trial evaluating safety and efficacy of FG001 in patients with high grade glioma undergoing neurosurgery. Evaluation of the results from the third dose level of FG001, including data from three patients, have been finalized and reported to the dose escalation committee. The dose escalation committee has given their approval to proceed and enroll patients at the fourth dose level. The results from the third dose level are in line with data from the first six patients at the two first dose levels, in respect to safety and tolerability. Relevant light was detected in two out of three patients at the third dose level. It is important to underline that the trial is still at an early stage, and that the first phase of the trial (up to 24 patients) must be completed and analyzed before any firm conclusions on tolerability and safety profile can be made. It is also important to state that it is not yet possible to establish the efficacy of FG001 on the basis of findings from these first three dose levels although encouraging to see increased signal intensity with increased dose. Further analysis is needed to confirm that the tissue that lights up is actually cancer and tissue that does not light up is free of cancer. The recruitment of patients over the next months may be slowed down due to the ongoing COVID-19 pandemic. However, as of now FluoGuide still expects to adhere to the following overall timeline previously communicated: (i) Middle of 2021: Result of first phase (safety and selection of optimal dose), subject to number of cohorts; and (ii) Second half of 2021: Efficacy result from the second phase, including estimation of the potential magnitude of benefit of FG001 in guiding surgery of patients with high grade glioma. Executive Departure • Feb 11
Chairman Arne Ferstad has left the company On the 9th of February, Arne Ferstad's tenure in the role of Chairman ended. As of September 2020, Arne personally held 254.22k shares (kr.14m worth at the time). Arne is the only executive to leave the company over the last 12 months. Aankondiging • Feb 10
Fluoguide A/S Announces Management Changes At the Annual General Meeting Held on February 9, 2021 FluoGuide A/S announced management changes at the Annual general meeting held on February 9, 2021. Arne Ferstad did not seek re-election as a board member. Peter Mørch Eriksen was elected as chairman of the board of directors. Aankondiging • Feb 03
Fluoguide A/S Announces Publication of Two Patent Applications Covering the Company's uPAR Technology Platform for Improving Surgery FluoGuide A/S announced that two new patent applications, covering the use of uPAR in enhancing surgical precision by illuminating cancer cells, have been published. FluoGuide hereby updates on the status of its published patents and patent applications. Since prior to the IPO, FluoGuide holds the patent family, relating to the Company's lead compound FG001. FG001 is designed to allow surgeons to clearly delineate cancer from normal tissue during surgery through a novel uPAR-targeted luminescent technology and has demonstrated to be well tolerated and ability to light up cancer in an ongoing phase I/II clinical trial on guiding surgery of high grade glioma. Patents have been issued in Europe, the US, and Australia and expire in 2034. On July 16 2019, FluoGuide submitted applications on two additional patent families; (PCT/EP2020/069991 and PCT/EP2020/070014), which will be covering relevant selected regions/countries worldwide if granted. The first patent family application (PCT/EP2020/069991), relates to FluoGuide's second compound, FG002, and covers an uPAR-targeting peptide conjugate with an optimal pharmacokinetic profile intended for administration in a human body. Further, there is provided an uPAR-targeting peptide conjugate and a composition comprising the uPAR-targeting peptide conjugate for use in optical imaging and for diagnosis and/or treatment of a disease. The patent family is licensed from Copenhagen University Hospital (Rigshospitalet) and University of Copenhagen. The second patent family application (PCT/EP2020/070014), covers a receptor-targeting conjugate with a high receptor binding affinity in combination with an optimal pharmacokinetic profile intended for administration in a human body. The application relates to more uPAR targeted products use to guide surgery. This patent family is owned by FluoGuide. According to standard patent procedure, applications are made public 18 months after submission. There are no guantees that a patent application will lead to grant of a patent. Is New 90 Day High Low • Jan 07
New 90-day high: kr.132 The company is up 124% from its price of kr.58.80 on 09 October 2020. The Swedish market is up 6.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 10.0% over the same period. Aankondiging • Dec 19
FluoGuide A/S Gets Green Light to Proceed to Second Dose Level with FG001 in the Ongoing Clinical Phase I/II Trial in Patients with High Grade Glioma FluoGuide A/S announced that the dose escalation committee has approved that administration of the second dose level can now be initiated in the ongoing trial evaluating safety and effcicacy of FG001 in patients with high grade glioma undergoing neurosurgery. Evaluation of the results from the first dose level of FG001, including data from three patients, has been finalized and reported to the dose escalation committee. The dose escalation committee has earlier been given green light to proceed and enroll the first patient on the second dose level. The first dose was chosen substantially below the expected optimal dose as a safety precaution when dosing a new product to humans for the first time. It is nevertheless encouraging that no safety issues were identified, which is in line with the result of the pre-clinical program. It is important to underline that the first phase of the trial (up to 24 patients) must be completed and analyzed before any conclusions on tolerability and safety profile can be drawn. Despite the very low dose tested in this first dose group of patients, light was detected in two out of the three patients. Although this is encouraging, it is important to state that it is not yet possible to conclude anything on the effect of FG001 on the basis of these findings. Additional results from patients dosed with higher levels of FG001 are needed to evaluate the robustness and further analysis is thereafter needed to confirm that the tissue that lights up is actually cancer and tissue that does not light up is free of cancer, which is determined by the patologist at the end of the first phase of the trial. The clinical phase I/II trial initiation has taken slightly longer than anticipated. However, the set-up is now fully implemented and the following dose groups are expected to be completed faster assuming no impact from the ongoing COVID-19 pandemic takes place. The following timeline is anticipated by FluoGuide: (i) Middle of 2021: Result of first phase (safety and selection of optimal dose); and (ii) Second half of 2021: Efficacy result from the second phase, including estimation of the potential magnitude of benefit of FG001 in guiding surgery of patients with high grade glioma. Is New 90 Day High Low • Nov 23
New 90-day low: kr.46.20 The company is down 25% from its price of kr.61.40 on 25 August 2020. The Swedish market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 8.0% over the same period. Aankondiging • Nov 10
FluoGuide A/S Announces First Patient Enrolled in the Phase I/II Clinical Trial Testing FG001 in Patients with High Grade Glioma FluoGuide A/S informed that the first patient was enrolled in the clinical trial testing safety and efficacy of FG001 in guiding high grade glioma surgery. FluoGuide's phase I/II clinical trial, testing FG001 in patients with high grade glioma consists of two phases; (1) a dose escalation phase to establish safety and proof-of-concept, and (2) an efficacy assessment phase. The total number of patients in the entire phase I/II trial will be up to 36 patients. FluoGuide is pleased to inform that the first patient has now been enrolled in the dose escalation phase of the clinical trial. The results will be evaluated and made available as earlier communicated in the Company's interim report from second quarter, published in August 2020. Aankondiging • Sep 21
FluoGuide Appoints Henrik Moltke as Chief Financial Officer, Effective December 2020 FluoGuide A/S announced the appointment of Henrik Moltke as Chief Financial Officer. Henrik Moltke will begin his employment in December 2020. Henrik Moltke, who will be part of FluoGuide's management team, brings more than 30 years of experience from life sciences and health care sectors, where he has held roles such as CFO and Senior Vice President. 