Fluoguide A/s · OMXSTO:FLUO
Fluoguide A/s — Investor Presentation (January 2024)
51 slides from Fluoguide A/s's investor presentation, January 2024
Slide 1: Precision surgery improving outcome for cancer patients
Precision surgery improving outcome for cancer patients January 2024
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 1 Publicly listed with dense news flow • Ticker: FLUO (Nasdaq First North Stockholm) • Market cap: ≈75 MEUR • Location: Copenhagen, Denmark • Major investors include Arbejdernes Landsbank and Linc AB 2 Unique uPAR-targeting technology platform • Lead product FG001 guides cancer
Slide 4: Cancer surgery today
Cancer surgery today Cancer remains to be one of the Surgery is a primary treatment leading causes of death globally option for patients with localized cancer is surgery 18.1 million 80% of patients new patients undergo are diagnosed with cancer every year surgery Local recurrence of cancer followin
Slide 5: FluoGuide illuminates cancer
FluoGuide illuminates cancer 5 Source: FG001-CT-001, data on file
Slide 6: FluoGuide-powered precision surgery: Proprietary uPAR probe
FluoGuide-powered precision surgery: Proprietary uPAR probe Fluorescent Probe Injected prior Binding to Guiding during FG001 to surgery cancer surgery 6 Source: FG001-CT-001, data on file
Slide 7: FG001 – a uPAR targeted imaging agent
FG001 – a uPAR targeted imaging agent 1. FG001 binds to uPAR 2. Robust • Based on well-known components – ICG is approved in US pre-clinical data since 1959 with good safety data • Binds to uPAR after i.v. demonstrated safety • Well tolerated - No-observed-adverse-effect-level dose • administration
Slide 8: 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 9: uPAR expression and FG001 binding to cancer
uPAR expression and FG001 binding to cancer Macro imaging Micro imaging FG001 H&E uPAR Fresh tissue Formalin fixed tissue 10 Source: International Academy of Oral Oncology (IAOO), 2023 Incheon, South Korea, Christensen, A et al
Slide 10: Therapeutic applications with uPAR targeted photothermal treatment (FG001)
Therapeutic applications with uPAR targeted photothermal treatment (FG001) FG001 releases Temperature in cancer cells FG001 is excited 1 FG001 binds to uPAR 2 with light of specific wavelength 3 energy in the form of light emission and heat FG001 + Light ICG + Light Water + Light FG001 - Phototherma
Slide 11: Advanced pipeline
Advanced pipeline INDICATION PRE-CLINICAL PHASE I PHASE II PHASE III FG001 Brain cancer (FGS) High-grade glioma Head and neck cancer (FGS) Squamous cell carcinoma Lung cancer (FGS) Non-small cell Brain cancer (PTT) High-grade glioma FG002 Undisclosed Indication Completed Ongoing 12 FGS (Fluorescent
Slide 12: The surgeon’s dilemma: balancing disability risk and cancer recurrence
The surgeon’s dilemma: balancing disability risk and cancer recurrence The cavity after removal of obvious cancerous tissue “Do I risk to remove too much and “Do I risk to leave cancer behind disable the patient?” leading to recurrence of the cancer?” Malignant brain cancers Non-malignant brain canc
Slide 13: Precise tumor resection improves patient outcomes in brain cancers
Precise tumor resection improves patient outcomes in brain cancers Primary cancers Secondary cancers Nonmalignant cancers Malignant cancers 15% Malignant cancers High-grade Meningioma 50% 50% 50% 50% glioma 35% Others Metastases, typically Others Number of patients originating in the breast, Number
Slide 14: Aggressive brain cancer
Aggressive brain cancer Phase I/II Phase II Trial results (FG001-CT-001) Status Top line results presented All patients receiving FG001 (12/12) had additional cancer detected showing FG001 was superior to white light. The result for 5-ALA was 12/12. Patients with suspected high-grade glioma Inclusio
Slide 15: Phase I/II key result: FG001 is well tolerated and works in HGG
Phase I/II key result: FG001 is well tolerated and works in HGG Outstanding safety profile 0 Serious related AEs No Dose Limiting Toxicities Clinical data confirm outstanding tolerability profile Grade 1: n=3 shown in pre-clinical testing 4 Related mild AEs Grade 2: n=1 Optimal dose with 36 mg FG001
Slide 16: Primary endpoint in phase II supporting regulatory approval
Primary endpoint in phase II supporting regulatory approval Primary end-point FG001 5-ALA Additional cancer tissue removed1) 12 / 12 (100 %) patients 12 / 12 (100 %) patients (CI: 73.5;100) (CI: 73.5;100) FG001 met primary end-point in phase II 1) Proportion of patients with indeterminated or unexpe
Slide 17: Transition zone (Primary Endpoint biopsy sampling - cancer)
Transition zone (Primary Endpoint biopsy sampling - cancer)
Slide 18: FG001 - deep visualization of cancer
FG001 - deep visualization of cancer Phase I/II FG001 5-ALA Fluorescence visualization of tumor after removal of dura and prior to incision (same patient) Phase II FG001 5-ALA Fluorescence visualization of tumor 4 / 12 (33 %) patients 0 / 12 (0%) patients on dura prior to incision 21 Source: FG001-C
Slide 19: FG001 is well tolerated
FG001 is well tolerated Related Adverse Events FG001 5-ALA N=12 N=12 Serious Related Adverse Events 0 0 Related Adverse Events 2 10 Severity grading of Related Adverse Events: Grade ≥ 3 0 0 Grade 2 0 2 Grade 1 2 8 22 Source: FG001-CT-001
Slide 20: FG001 demonstrated signs of clinical efficacy in meningioma
FG001 demonstrated signs of clinical efficacy in meningioma Both FG001 and 5-ALA were Nothing 5-ALA FG001 administered prior to surgery (“white light”) (“blue light”) (“NIR light”) (8mg low dose) Brain before surgery (cancer marked): Cancer tissue after removal: FG001’s potential in brain cancer goe
Slide 21: 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 structures, e.g., brain and head & neck Several surgical lasers could work with PTT Potential part
Slide 22: Feedback from FDA
Feedback from FDA FDA’s feedback on FG001 in high grade glioma Exposure to ≥300 patients to provide evidence of safety for first Including photothermal indication. Pooling across trials gives flexibility in the trial design. therapy in the regulatory trial is anticipated to require a slight increase
Slide 23: Plans for FG001 in brain cancer 2024
Plans for FG001 in brain cancer 2024 1 Expand the label of FG001 in HGG expanding the commercial potential 2 Evaluate inclusion of PTT in the label of FG001 based on the result • Initiate phase II trial • Assessing the potential of photothermal therapy (PTT) in aggressive brain cancer (HGG) 3 Obtain
Slide 24: More than 230,000 patients gets diagnosed with brain cancer each year
More than 230,000 patients gets diagnosed with brain cancer each year Potential to expand across geographies Brain cancer patients in US Potential of photothermal therapy 150,000 Brain metastases The potential of photothermal therapy gives access to additional 15,000 Other brain cancers expansion ac
Slide 25: The challenges in head and neck cancer surgery
The challenges in head and neck cancer surgery “Near margin” Tonsil Oropharynx “Difficult to reach” cause re-surgery, cause chemo- and chemo- and radiotherapy radiotherapy Base of tongue Pharynx The solution: More precise surgery Enable reachability by Check for margins during surgery minimal invasi
Slide 26: Precise tumor resection enables close margins & reachability
Precise tumor resection enables close margins & reachability Pharynx cancer New patients pr year Oroharynx cancer US & EU Rest of the world New patients pr year ≈13,000 ≈8,000 US & EU Rest of the world ≈37,000 ≈24,000 4% 12% Tonsil Tonsil cancer Tongue cancer Base of 45% tongue New patients pr year
Slide 27: Head and neck (FG001-CT-003)
Head and neck (FG001-CT-003) Phase II Trial results Status Top line result presented FG001 shown relevant contrast (TBR) in all patients (16) Oral and oropharyngeal Inclusion squamous-cell carcinoma FG001 was safe and well tolerated in all patients scheduled for surgery # 16 Normal image as the surg
Slide 28: Head and neck (FG001-CT-003)
Head and neck (FG001-CT-003) Phase II Trial results Status Top line result presented FG001 shown relevant contrast (TBR) in all patients (16) Oral and oropharyngeal Inclusion squamous-cell carcinoma FG001 was safe and well tolerated in all patients scheduled for surgery # 16 After the near Infrared
Slide 29: The initial focus is margins and use of robotic equipment in HGG
The initial focus is margins and use of robotic equipment in HGG Additional potential to expand across geographies Brain cancer patients in US & Europe Robotic surgery Enable by minimal 50.000 invasive surgery 267.000 Clean margins 35 1) Ene CI and Ferguson SD (2022) Surgical Management of brain Met
Slide 30: A range of opportunities for the patients and hospitals
A range of opportunities for the patients and hospitals Potential clinical benefits 1) Resection Cavity • Pre-operative planning of surgery: • Spare hospital time, • Spare tung and speech function and • Improve cosmetic result • Reduce and/or immediately check margins for cancer 1) 1) Back-table ima
Slide 31: Head and neck cancer surgery offers multiple potential partnerships
Head and neck cancer surgery offers multiple potential partnerships Compatible with existing imaging systems Potential partnerships Penetrated in Microscope and e.g. brain surgery useful in other open field types of surgery Visualisation of small structures or superficial cancers Penetrated in GI or
Slide 32: Plans for FG001 in head & neck cancer in 2024
Plans for FG001 in head & neck cancer in 2024 1 Advance development of FG00 toward registration in head & neck cancer 2 Explore different clinical end-points and regulatory feedback • Initiate phase ll trial • Determine multiple positioning of FG001 in head & neck cancer 3 Expanding commercial oppor
Slide 33: Market potential and approach
Market potential and approach Brain cancer market potential Head & neck cancer market potential The neurosurgeon’s challenge of removing too much vs. Precision surgery can solve the challenges of near- 1 leaving cancer behind can be solved with precision surgery through detection & removal and at th
Slide 34: 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 35: 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 MICHAEL ENGSIG Ch
Slide 36: Key elements in strategy
Key elements in strategy uPAR target technology • Fluorescence guided surgery (FGS) price: approx. USD 5,000 per surgery with potential for broadened • uPAR target in fluorescence guided surgery relevant for high number of patients : ca. 3,500,000 annually use in guiding surgery • Potential to incre
Slide 37: Upcoming clinical milestones and news flow
Upcoming clinical milestones and news flow Archived until 2023 Anticipated in 2024 Anticipated in 2025 • Demonstrated FG001 to be safe and • Assessing potential of photothermal • Clinical result of adding PTT into the well tolerated therapy (PTT) in aggressive brain clinical trial label of FG001 for
Slide 38: Precision surgery improving outcome for cancer patients
Precision surgery improving outcome for cancer patients
Slide 39: Appendix
Appendix
Slide 40: 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) 48 1) Juhl, K., Christensen, A., Persson, M., Ploug, M., & Kjaer, A. (2016). Peptide-Based Optical uPAR Imaging for Surgery: In Vivo
Slide 41: uPAR expressed in all CNS tumors and predictive for aggressivity
uPAR expressed in all CNS tumors (including low grade glioma) and predictive for aggressivity Salajegheh M, Rudnicki A, Smith TW. Expression of urokinase-type plasminogen activator receptor (uPAR) in primary central nervous system neoplasms. Appl Immunohistochem Mol Morphol. 2005 Jun;13(2):184-9. do
Slide 42: FG002: uPAR-targeting probe for gastrointestinal tumors
FG002: uPAR-targeting probe for gastrointestinal tumors 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 Dye I
Slide 43: Fibrous meningioma case study: FG001 demonstrated signs of clinical efficacy
Fibrous meningioma case study: FG001 demonstrated signs of clinical 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 PI/IIa trial on White light 5-ALA FG001 suspicion of malignant 5-ALA glioma, later confir
Slide 44: FluoGuide illuminates cancer
FluoGuide illuminates cancer
Slide 45: FG001 tested in blood-brain-barrier organoids model
FG001 tested in blood-brain-barrier organoids model strongly suggest transcellular uptake A) Bar chart plotting the fold change in FG001 signal within organoids compared to untreated controls as a measurement of degree of penetration. B) Representative images of organoids (Z-projection of whole orga
Slide 46: 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 47: 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 48: 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 tumor A: → In tumor A, tumor-specific expression pattern is seen for all three targets, EGFR, uPAR and TF with an accurate demarcation of the cancerous
Slide 49: 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 50: FluoGuide awarded prestigious grant
FluoGuide awarded prestigious grant Tumor survival in mice Grant awarded to FluoGuide and four academic partners FG001 + PTT • The grant aims to support the research and ICG + PTT development of the optimal molecule for Water + PTT FG001 photothermal therapy while using FG001 as a - model molecule •
Slide 51: Traded on Nasdaq First North Growth Market Stockholm - Ticker: FLUO
Traded on Nasdaq First North Growth Market Stockholm - Ticker: FLUO Shareholders Number of shares Percentage ownership Research coverage Flagged Life Science ApS 1) 2,126,107 18.0% 2) Wexotec ApS 1,488,610 12.6% Linc AB 819,630 6.9% Arbejdernes Landsbank A/S 797,973 6.8% Management & Board of Direct