Fluoguide A/s · OMXSTO:FLUO
Fluoguide A/s — IPO Roadshow (March 2019)
20 slides from Fluoguide A/s's IPO roadshow presentation, March 2019
Slide 1: Intelligent surgical targeting - light up cancer and increase surgical precision
Intelligent surgical targeting Investor meeting - light up cancer and increase March 2018 surgical precision Morten Albrechtsen Andreas Kjær IPO prior to listing at Spotlight Stock Market 1
Slide 2: FluoGuide at a glance
FluoGuide at a glance • Cancer affects everyone and represents a tremendous burden on patients, families and societies • The quality of cancer treatment constantly improves but cancer still recur locally after surgery • FluoGuide is committed to contribute to the improvement of care by lighten up the
Slide 3: A brief introduction
A brief introduction This movie is created by sciencenews.dk The introduction video is available here: http://sciencenews.dk/en/fluorescent-tumours-will-vastly- improve-survival-for-people-with-cancer 3 This movie is created by sciencenews.dk
Slide 4: Cancer recur locally as it is difficult to distinguish from normal tissue
Cancer recur locally as it is difficult to distinguish from normal tissue • Surgery is a cornerstone in treatment of cancer – the surgeons want to Recurrence rate (%) completely remove the cancer and cure Glioblastoma the patient Ovarian Bladder • In 15-100 % of cancer recur locally after Pancreas sur
Slide 5: The solution is to light up the cancer
The solution is to light up the cancer Light up the cancer and its invasive growth into surrounding White light normal tissue 1. Inject FG001 into the patients’ vein during anesthesia as part of the surgery 2. FG001 binds to cells expressing a protein called urokinase receptor - uPAR 3. Fluorescent
Slide 6: uPAR is a perfect target to guide surgery
uPAR is a perfect target to guide surgery • uPAR is extensively expressed in most solid cancers FG001 effectively illuminate local • In particular in the aggressive invasive metastases front of the cancer • Perfect to delineate the cancer and precisely remove the entire cancer • Several human cancer
Slide 7: FluoGuide is based on decades of groundbreaking research
FluoGuide is based on decades of groundbreaking research • Prof. Andreas Kjær head of a 40 people research University of Copenhagen Cluster for Molecular group based on Rigshospitalet and University of Imaging Copenhagen • Decades of research in imaging, cancer and uPAR • More than DKK 50 million1)
Slide 8: Everyone benefits from FG001
Everyone benefits from FG001 Diagnose Surgery Histology May be cured Negative margins Y MPROV E EFFICIENC / AVOID UCE !margins Positive $ I RED Patient is diagnosed with Surgery is a cornerstone Histology check if the margin cancer, typically after several treatment of early and around the tumor is c
Slide 9: The concept of FG001 already proven in preclinical models
The concept of FG001 already proven in preclinical models • FG001 can be be made - it has been synthesizes by two independent manufactures • The tolerability of FG001 by humans is very likely as both the targeting molecule and the fluorophore have been demonstrated to be well tolerated in humans • FG
Slide 10: FG001 - fast route to the market
FG001 - fast route to the market Inclusion Surgery done under Switch on fluorescent Result • FG001 is classified as a medicinal product, imagining available white light light agent •Patient with •Remove extra cancer local undergoing metastases • Few patients and a simple clinical study needed for surg
Slide 11: The concept of FG001 is proven preclinically
The concept of FG001 is proven preclinically • FG001 tested preclinically using a design of Subjects with metastases found with white and fluorescent light the study similar to required for the approval (n=8) study (phase IIb/III) 8 • Human cancer, Fluorescent light 7 • Operated by human surgeon and
Slide 12: First indication for FG001 is brain tumor
First indication for FG001 is brain tumor • Approx. 60.000 patients are diagnosed with Glioblastoma (aggressive brain tumor) annually in EU & US • Approx. 8-12% are children • Poor prognosis with 50% dying within 14 months and only 5% alive after five years • Precise removal is difficult – local recurr
Slide 13: Other potential indications for FG001
Other potential indications for FG001 • uPAR is extensively expressed in most Incidence of cancer solid cancers: Glioblastoma • Glioblastoma Brain,nervoussystem • Breast cancer Head and ne ck • Colorectal cancers Pancreas • Lung Breast • Pancreas Colorectum • Head and neck cancer Lung 0 500.000 1.00
Slide 14: High value customers served by many
High value customers served by many Customers Potential partners (examples) Clinical trials, “Key Opinion Leaders”, compassionate use sales 1,000,000 surgeons and 12,000 hospitals worldwide Source: Holmer, H., Lantz, A., Kunjumen, T., Finlayson, S., Hoyler, M., Siyam, A., … Hagander, L. (2015). Glob
Slide 15: Healthy competition
Healthy competition • Direct competitor with active fluorescent targeting Active targeting • On Target Lab., private, USA: OTL38 FG001 OTL38 • SurgiMab, private, France: SMG-101 uPAR Folic acid Glioblastoma Ovary etc. SGM-101 • Indirect competitors CEA Colon/Rectal • Passive fluorescent targeting Re
Slide 16: Strong protection
Strong protection • Data protection (Regulatory exclusivity) • Orphan drug designation likely • Patent protection (WO2016041558A1): • ”uPAR targeting peptide for use in peroperative optical imaging of invasive cancer” • Priority: 17-SEP-2014 • Issued in USA • Owned by FluoGuide A/S with royalty obli
Slide 17: Attractive market potential
Attractive market potential The market for intelligent surgical targeting is huge • € 0.5 billion – the market for active glioblastoma surgical targeting • € 2.0 billion – the market for active breast cancer surgical targeting • € 50 billion – the market for robotic surgery • € 1,000 billion – the m
Slide 18: Strong and incentivized leadership
Strong and incentivized leadership Management Morten Albrechtsen – CEO Andreas Kjær – Head of SAB, BoD Grethe Rasmussen – CDO • MD, BBA • MD, PhD, DMSc, MBA • MSc, PhD • Seasoned life sciences entrepreneur, • Professor at the University of Copenhagen and chief • Seasoned leader in life science with
Slide 19: Several near term value inflection points
Several near term value inflection points Approx. MDKK 20 will provide a clinical phase I/II proof-of-concept for FG001 and establish a commercial basis for FG001 and a prioritized pipe-line 2019 2020 2021 2022 FG001: Produc.on and toxicity CMC and Regulatory advice and first approval Phase I/II (Fluo
Slide 20: Summary of the offering
Summary of the offering IPO • Subscription period: 1 – 15 April 2019. • Subscription price: DKK 14.85 per unit. One (1) unit consists of three (3) shares and one (1) warrant. • Issue volume: 3,224,274 shares and 1,074,758 warrants, initially corresponding to approx. MDKK 15.9. • Valuation (pre-money)