Fluoguide A/s · OMXSTO:FLUO
Fluoguide A/s — Investor Presentation (November 2022)
29 slides from Fluoguide A/s's investor presentation, November 2022
Slide 1: Towards precision surgical therapy for cancer
Towards precision surgical therapy for cancer November 2022
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements that provide FluoGuide’s expectations or forecasts of future events such as new product developments, regulatory approvals and financial performance. Such forward looking statements are subject to risks, uncertainties and may be impact
Slide 3: Fluoguide – Illuminating Cancer
Fluoguide – Illuminating Cancer 3
Slide 4: Towards precision surgical therapy for cancer
Towards precision surgical therapy for cancer Surgery is a primary • 80% of cancer patients undergo surgeries treatment option for • Prognosis correlates with degree of cancer resection most cancer types • The goal of curative surgery is complete removal of cancerous tissue • Approximately 50% patie
Slide 5: Technology highlights & Pipeline
Technology highlights & Pipeline
Slide 6: uPAR-targeted fluorescent probes light up cancer during surgery
uPAR-targeted fluorescent probes light up cancer during surgery 1 2 3 4 Fluorescent Injected prior to Binding to Precision guided probe surgery cancer surgery Fluorescence White light Guidance by FG001 Provides visual guidance for precision surgery to reduce cancer recurrence and surgical sequalae 6
Slide 7: Unique uPAR-targeting technology platform
Unique uPAR-targeting technology platform uPAR plays a central role in cancer invasion >80% of solid cancers express uPAR uPAR (urokinase-type Plasminogen activator receptor) is a cell membrane receptor that plays a key role in proteolytic activity Brain Highly specific & extensively expressed in so
Slide 8: FG001 – a novel uPAR binding imaging agent
FG001 – a novel uPAR binding imaging agent FG001 technical features → uPAR’s cancer specificity and low systemic expression ensures 1. FG001 binds targeted tumour fluorescence specifically to → Binds to uPAR after i.v. administration uPAR → NIR excitation during surgery enables real-time margin deli
Slide 9: Advanced clinical pipeline with several near-term milestones
Advanced clinical pipeline with several near-term milestones INDICATION PRE-CLINICAL PHASE I PHASE II PHASE III NEXT MILESTONE FG001 High-grade glioma (HGG) Top-line results in H1 2023 (incl. Glioblastoma) Lung Cancer (NSCLC) Top-line results in H1 2023 Head & Neck (H&N) – First patient in Q4 2022 s
Slide 10: FG001: Clinical Development
FG001: Clinical Development
Slide 11: Precise tumour resection improves patient outcomes in high-grade glioma
Precise tumour resection improves patient outcomes in high-grade glioma High-grade glioma patients suffer high recurrence & poor prognosis Cavity post initial surgery - High-grade glioma is the most common primary cancer left? malignant brain tumour with an annual incidence of ~ 3.6/100,0001 Despite
Slide 12: Phase 1/2a trial demonstrates clinical utility & outstanding tolerability
Phase 1/2a trial demonstrates clinical utility & outstanding tolerability Trial design Outstanding safety profile 0 Serious related AEs > Open-label, non-randomised, dose- escalation, single-centre 4 Related mild AEs Grade 1: n=3 Grade 2: n=1 No Dose Limiting Toxicities Clinical data confirm outstan
Slide 13: Case study – FG001 demonstrates signs of efficacy in fibrous meningioma
Case study – FG001 demonstrates signs of efficacy in fibrous meningioma High fluorescence signal from FG001 compared to white light and 5-ALA using the same camera A 67y female patient was recruited in the Ph1/2a trial White light 5-ALA FG001 on suspicion of malignant 5-ALA glioma, later confirmed t
Slide 14: Top-line results from Phase 2b trial expected for H1 2023
Top-line results from Phase 2b trial expected for H1 2023 Trial design Current SoC as study control arm Primary endpoint selected for pivotal Aim to inform pivotal trial design > Two-arms, multicentre (Denmark & Sweden) trial design & power calculation • 5-ALA is the only imaging agent • Efficacy en
Slide 15: Top-line results from Phase 2b trial expected for H1 2023
Top-line results from Phase 2b trial expected for H1 2023 Inclusion (n=24) Randomisation Surgery – with light Check of cavity Check by pathologist NIR light FG001 (36mg), n = 12 → Intravenous administration ”Proportion of patients with Suspected high grade relevant change in surgical glioma patients
Slide 16: Ongoing Phase 2a trial in lung (NSCLC) with positive interim results
Ongoing Phase 2a trial in lung (NSCLC) with positive interim results Lung cancer is the No.1 cause of cancer death Trial design Explorative, open-label, non-randomised, single Lung cancer is the second most common and the deadliest among all cancer types > dose, dose-finding, single centre (Denmark)
Slide 17: Phase 2a trial in head & neck squamous cell carcinoma to commence in 2022
Phase 2a trial in head & neck squamous cell carcinoma to commence in 2022 Extending FG001’s benefits to head & neck cancer patients Trial design Oral and oropharyngeal squamous cell carcinoma as the initial focus in head & neck cancer > Single arm, single centre (Denmark) > Up to 16 patients with he
Slide 18: Phase 2a trial in meningioma & low-grade glioma to commence in 2023
Phase 2a trial in meningioma & low-grade glioma to commence in 2023 Less aggressive but high recurrence brain tumours Trial design Precise surgical excision is key to lower recurrence rate post surgery > Single arm, single centre (Denmark) > Patients with meningioma or low-grade glioma scheduled for
Slide 19: Preclinical programmes
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Slide 20: FG002 – second uPAR-targeting probe for use in gastrointestinal tumours
FG002 – second uPAR-targeting probe for use in gastrointestinal tumours uPAR-targeting probe with a novel fluorophore FG001 FG002 Development Phase 2b Preclinical stage FG002 utilises a novel fluorophore - IRDye® 800CW infrared dyes, which have potentially superior uPAR binding AE105 AE344 brightnes
Slide 21: Photothermal treatment – uPAR based therapeutic applications
Photothermal treatment – uPAR based therapeutic applications Upon excitation, Temperature in cancer cells FG001 is excited FG001 releases FG001 binds 1 to uPAR 2 with light of specific wavelength 3 energy in the form of heat and induces cancer cell death FG001 + Light ICG + Light Water + Light FG001
Slide 22: Market & Milestones
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Slide 23: Imaging agents & equipment for surgical guidance are gaining momentum
Imaging agents & equipment for surgical guidance are gaining momentum Precision surgery - a rapidly growing segment Improved visualisation for better surgical outcomes 2022 Getinge acquired Fluoptics Fluorescent agents further advance visualisation to the cellular level A niche market with significa
Slide 24: Well-positioned in fluorescence-guided surgery
Well-positioned in fluorescence-guided surgery 2.26 m 2.21 m 1.93 m Annual cumulative incidence of cancers1 1.69 m 1.41 m 0.93 m 0.57 m 0.50 m 0.32 m 0.31 m 0.31 m 0.06 m 0.03 m Gastro- Head & Malignant Compatible with Company Breast Lung Colorectal Prostate Bladder Pancreatic Melanoma Ovarian Brain
Slide 25: Compatibility with existing systems enables fast adoption by clinical practice
Compatibility with existing systems enables fast adoption by clinical practice Compatible with existing imaging systems Potential partnerships Microscope Visualisation of small Typically used in: structures, e.g. brain Brain, H&D and head & neck Endoscope Typically used in: Flexible for visualisatio
Slide 26: Plan for US
Plan for US Regulatory Pre-IND - End of phase II - NDA Clinical development – Brain cancer KOL engagement - Phase III heavy US centric Commercial – Brain cancer Reimbursement assessment - Own sales - Collaborative partnering Commercial - other indications / geography Partnering 26
Slide 27: Upcoming clinical milestones & newsflow
Upcoming clinical milestones & newsflow H2 2022 2023 2024 CTA for Ph2a Ph2a top-line Ph2b top-line (meningioma & (meningioma (HGG) LGG) & LGG) Brain Start of Ph2a Established Listed in First patient Start of Ph2b Start of Ph3 (meningioma in 2018 2019 treated in 2020 (HGG) pivotal trial (HGG) & LGG)
Slide 28: Management & Board of Directors
Management & Board of Directors Management Team MORTEN ALBRECHTSEN HENRIK HANG ANDREAS KJAER GRETHE NØRSKOV RASMUSSEN DORTHE GRØNNEGAARD MEJER CEO CFO CSO & CMO CDO VP Clinical Development Board of Directors PETER MØRCH ERIKSEN MATS THORÈN ANDREAS KJAER MICAELA SJÖKVIST SHOMIT GHOSE Chairman of the
Slide 29: FluoGuide – maximizing surgical outcomes
FluoGuide – maximizing surgical outcomes > Fluoguide is developing imaging agents for fluorescence-guided surgery FluoGuide Enabling fluorescent guided > Proprietary uPAR-targeting technology delineates margins with high precision intra-operatively precision surgery > Target with broader applicabili