Fluoguide A/s · OMXSTO:FLUO
Fluoguide A/s — Investor Presentation (February 2023)
43 slides from Fluoguide A/s's investor presentation, February 2023
Slide 1: Precision surgery improving outcome for cancer patients
Precision surgery improving outcome for cancer patients February 2023
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: Investment highlights
Investment highlights • Location: Copenhagen based, Scandinavian roots and international outlook • Ticker: FLUO (Nasdaq First North Stockholm) • Marked Cap: >500 MSEK • Shares outstanding: 11,814,500 • Ownership: Management & founders, Linc AB, ALB (>8,000) • Lead product: FG001 in phase IIb trial f
Slide 4: FluoGuide market & positioning
FluoGuide market & positioning 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% patients suffer loca
Slide 5: Pipeline and technology
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Slide 6: Advanced clinical pipeline - several near-term milestones
Advanced clinical pipeline - several near-term milestones INDICATION PRE-CLINICAL PHASE I PHASE IIa+b PHASE III NEXT MILESTONE FG001 Aggressive brain cancer FG001-CT-01 part 1 (completed) FG001-CT-01 Top-line results of IIb high-grade glioma part 2 (ongoing) in H1 2023 Lung cancer FG001-CT-02 Top-li
Slide 7: FluoGuide precision surgery
FluoGuide precision surgery uPAR-targeted fluorescent probes light up cancer Fluorescent Probe Injected prior Binding to Guiding during FG001 to surgery cancer surgery 7 Source: FG001-CT-001, data on file
Slide 8: FG001 is a simple solution with a profound effect
FG001 is a simple solution with a profound effect Traditional white light With FluoGuide’s FG001 Provides visual guidance for precision surgery to reduce cancer recurrence and surgical sequalae 8 Source: FG001-CT-001, data on file
Slide 9: 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 10: FG001 – a uPAR targeted imaging agent
FG001 – a uPAR targeted imaging agent • Binds to uPAR after i.v. administration 1. FG001 binds • uPAR’s cancer specificity and low systemic specifically to uPAR expression ensures targeted tumour FG001 fluorescence Absorption ICG 2. FG001 – equals Absorption FG001 ICG spectral Excitation ICG Excitat
Slide 11: FG001: Clinical development
FG001: Clinical development
Slide 12: Precise tumour resection improves patient outcomes in high-grade glioma
Precise tumour resection improves patient outcomes in high-grade glioma Half the patients with high-grade glioma patients The neurosurgeons’ dilemma after having survive only 14 months after diagnosis removed obvious cancerous tissue High-grade glioma is the most common The cavity after removal of o
Slide 13: HGG Phase I/IIa trial demonstrated clinical utility & outstanding tolerability
HGG Phase I/IIa trial demonstrated 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 ou
Slide 14: FluoGuide illuminates cancer
FluoGuide illuminates cancer 14 Source: FG001-CT-001, data on file
Slide 15: Fibrous meningioma case study: FG001 demonstrated signs of efficacy
Fibrous meningioma case study: FG001 demonstrated signs of efficacy High fluorescence signal from FG001 compared to white light and 5-ALA using the same camera A 67y female patient was recruited in the P1/2a trial White light 5-ALA FG001 on suspicion of malignant 5-ALA glioma, later confirmed to • O
Slide 16: Phase IIb ongoing: Top-line results expected in H1 23
Phase IIb ongoing: Top-line results expected in H1 23 Inclusion (n=24) Randomisation Surgery – with light Check of cavity Primary endpoint NIR light ”Proportion of Patients with FG001 (36mg) i.v. adm. 12 patients patients with suspected high-grade relevant change glioma undergoing surgery in surgica
Slide 17: Lung cancer (NSCLC): Ongoing Phase IIa trial with positive interim results
Lung cancer (NSCLC): Ongoing Phase IIa trial with positive interim results Lung cancer is the no.1 cause of cancer death Trial design Exploratory , open-label, non-randomised, single Lung cancer is the second most common and the deadliest among all cancer types > dose, dose-finding, single centre (D
Slide 18: Head & neck squamous cell carcinoma: Ongoing Phase IIa trial positive interim results
Head & neck squamous cell carcinoma: Ongoing Phase IIa trial positive interim results 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, the > Exploratory, open-label, non-randomised, singl
Slide 19: Meningioma & low-grade glioma phase IIa: Commencing in 2023
Meningioma & low-grade glioma phase IIa: Commencing in 2023 Less aggressive but high recurrence brain tumours Trial design Precise surgical excision is key to lower recurrence rate post surgery and reduce side effect from > Exploratory, single centre (Denmark) surgery > Patients with meningioma or l
Slide 20: Preclinical programmes
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Slide 21: FG002: uPAR-targeting probe for gastrointestinal tumours
FG002: uPAR-targeting probe for 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 molecule brightness and
Slide 22: Therapeutic applications with uPAR: FG001 photothermal treatment
Therapeutic applications with uPAR FG001 photothermal treatment Upon excitation, Temperature in cancer cells FG001 is excited FG001 releases 1 FG001 binds to uPAR 2 with light of specific wavelength 3 energy in the form of heat and induces FG001 + Light cancer cell death ICG + Light Water + Light FG
Slide 23: Market & Milestones
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Slide 24: 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 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 Typically used in: Visualisation of small Brain, H&D structures, e.g. brain and head & neck Typically used in: Endoscope Oesophagus, Flexible for
Slide 26: Well-positioned in fluorescence-guided surgery
Well-positioned in fluorescence-guided surgery 2.26 m 2.21 m 1.93 m 1.69 m Annual cumulative incidence of cancers1 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 27: 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 Typically used in: Visualisation of small Brain, H&D structures, e.g. brain and head & neck Typically used in: Endoscope Oesophagus, Flexible for
Slide 28: 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 28
Slide 29: Upcoming clinical milestones & news flow
Upcoming clinical milestones & news flow H2 2022 2023 2024 FG001 very well tolerated in 40 subject (FIM) PIIb top-line Promising efficacy IIa result (HGG) in aggressive brain cancer Brain: (High Grade Glioma) Promising result is one CTA approval Established Listed in First patient meningioma patient
Slide 30: Management & Board of Directors
Management & Board of Directors Management Team MORTEN ALBRECHTSEN OLE LARSEN 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 b
Slide 31: FluoGuide – maximizing surgical outcomes
FluoGuide – maximizing surgical outcomes > FluoGuide is developing imaging agents for fluorescence-guided surgery FluoGuide > Proprietary uPAR-targeting technology delineates margins with high precision intra-operatively Enabling fluorescent guided > Short development & clinical trial time precision
Slide 32: Appendix
Appendix
Slide 33: Preclinical model demonstrates FG001s ability to illuminate malignancies
Preclinical model demonstrates FG001s ability to illuminate malignancies Actively binding to uPAR Binding – FG001 vs ICG uPAR specificity (FG001 +/- uPA co-injection) 33 1) Juhl, K., Christensen, A., Persson, M., Ploug, M., & Kjaer, A. (2016). Peptide-Based Optical uPAR Imaging for Surgery: In Vivo
Slide 34: Histopathology demonstrates uPAR specificity in Head & Neck cancer
Histopathology demonstrates uPAR specificity in Head & Neck cancer uPAR shown to be a superior indicator of cancer presence compared to EGFR and TF Tumour A: → In tumour A, tumour-specific expression pattern is seen for all three targets, EGFR, uPAR and TF with an accurate demarcation of the cancero
Slide 35: Preclinical GBM model demonstrates FG001 ability to illuminate malignancies
Preclinical GBM model demonstrates FG001 ability to illuminate malignancies Orthotopic xenograft glioblastoma model In vivo optical imaging shows TBR values Images recorded by the EleVision IR camera Fingerprint imaging shows precise delineation above 2.5 with PK profiles showing dose- demonstrates
Slide 36: FG001 has game-changing potential in cancer treatment
FG001 has game-changing potential in cancer treatment 1. Cavity after surgery 2. Check with FG001 3. After final removal Cancer left? 36 Source: Skjøth-Rasmussen et al, Acta Neurochir, 2022 Jan;164(1):267-271.
Slide 37: NIR enables deeper tissue visibility
NIR enables deeper tissue visibility Highly optimized 5-ALA imaging Raw FG001 imaging EleVision EleVision Medtronic Medtronic ORBEYE EleVision ORBEYE Olympus Medtronic Olympus 37 Source: Data on file
Slide 38: Double the effect of surgery in mouse clinical trial
Double the effect of surgery in mouse clinical trial Pre-clinical testing of FG001, using a study design Identified and removed local metastases in twice as many like what is required in humans (phase IIb/III) subjects as standard (white light) procedures Fluorescent light • Human cancer (pancreatic
Slide 39: FG001 passes the blood brain barrier - in vitro model
FG001 passes the blood brain barrier - in vitro model Entire sphere One slide of the sphere * * 39 Source: Presented as Poster-SNS2022: Juhl K. Performance and in vivo validation of an optical uPAR-targeted probe, ICG-Glu-Glu-AE105 (FG001), for surgical guidance in an orthotopic human xenograft glio
Slide 40: Identified optimal dose delivers consistent TBR across imaging equipment
Identified optimal dose delivers consistent TBR across imaging equipment FG001 clearly delineates cancer margins Dose Dosing # of # of # of light- % of (mg) time patients surgeries ups light-ups 1 Morning 3 3 2 67% 2 Morning 3 3 3 100% 4 Morning 3 3 2 67% 36 mg FG001 8 Morning 4 3 3 100% selected as
Slide 41: Strong patent protection until 2039
Strong patent protection until 2039 • Patent family WO2016041558 • Protects FG001 (product protection) • Issued in Europe, the US, and Australia • Expires in 2034 • Owned by FluoGuide • Patent application family (PCT/EP2020/069991) • Protects FG002 • The patent family is co-owned by FluoGuide and li
Slide 42: Traded on Nasdaq First North Growth Market Stockholm - Ticker: FLUO
Traded on Nasdaq First North Growth Market Stockholm - Ticker: FLUO Top 10 shareholders as of 30 June 2022 Research coverage Name Shares % Life Science IVS (Andreas Kjaer, 2 126 107 18.00% CSO/CMO)* Wexotec ApS (Morten Albrechtsen, CEO)* 1 488 610 12.60% ✓ ABG Sundal Collier Linc AB 819 630 6.94% Ar
Slide 43: Towards precision surgical therapy for cancer
Towards precision surgical therapy for cancer