Intelligent surgical targeting -light up cancer and increase ......2019/03/29 · 1 Intelligent...
Transcript of Intelligent surgical targeting -light up cancer and increase ......2019/03/29 · 1 Intelligent...
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Intelligent surgical targeting - light up cancer and increase
surgical precision
Investor meeting Stockholm , 29 March 2019
Morten AlbrechtsenAndreas Kjær
IPO prior to listing at Spotlight Stock Market
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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 cancer with FG001
• One patient every third minute could benefit from FG001*)
• FG001 - data protection and patent owned by FluoGuide
• The potential goes beyond cancer surgery – intelligent surgical targeting can increase the speed and quality of all surgical procedures• 5% of Gross Domestic Product (GDP) is spent on surgery – more than €1,000 billion annually world wide
• Strong and experienced team and several near term value inflection points
2*) for FG001’s target indications (glioblastoma and breast cancer in high and upper middle income population)
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The introduction video is available here: http://sciencenews.dk/en/fluorescent-tumours-will-vastly-improve-survival-for-people-with-cancer
A brief introductionThis movie is created by sciencenews.dk
This movie is created by sciencenews.dk
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Cancer recur locally as it is difficult to distinguish from normal tissue• Surgery is a cornerstone in treatment
of cancer – the surgeons want to completely remove the cancer and cure the patient
• In 15-100 % of cancer recur locally after surgery – strongly dependent on type of cancer and disease stage
• The surgeons also risk to remove extensive amount of healthy tissuepotentially leading to severe side effects and cosmetic problems
4Source: Cancer Recurrence Statistics, Nov-2018
0% 20% 40% 60% 80% 100%
Kidney
Colorectal
Lung
Melanoma
Breast
Prostate
Pancreas
Bladder
Ovarian
Glioblastoma
Recurrence rate (%)
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The solution is to light up the cancer
Fluorescent light
White lightLight up the cancer and its invasive growth into surrounding 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 light is switched on during surgery and helps the surgeons remove all the cancer and preserve normal tissue
Fluorescent light indicates that cancer cells are still present
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uPAR is a perfect target to guide surgery
• uPAR is extensively expressed in most solid cancers
• In particular in the aggressive invasive front of the cancer
• Perfect to delineate the cancer and precisely remove the entire cancer
• Several human cancer types have been tested preclinically and demonstrated proof-of-concept in vivo
Source: Natali L. et al., 2018, Nature, Scientific Reports and Juhl, K, 2016, PLoS ONE
FG001 effectively illuminate local metastases
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FluoGuide is based on decades of groundbreaking research• Prof. Andreas Kjær head of a 40 people research
group based on Rigshospitalet and University of Copenhagen
• Decades of research in imaging, cancer and uPAR
• More than DKK 50 million1) in historic indirect research support
• Ongoing Grand Solution project from Innovation Fund Denmark with approx. DKK 13 million support
FluoGuide A/S established in 2018
RigshospitaletDepartment of ClinicalPhysiology, NuclearMedicine & PET
University of Copenhagen Cluster for MolecularImaging
1) DKK 22.9 million in direct research support: Historically (MDKK): 1.0 (Arvid Nilssons Fond), 4.0 (ERC), 0.3 (RH ‘rammebevilling’), 0.5 (Kræftens Bekæmpelse), 1.7 (PhD Anders Christensen), 1.5 (PhD Karina Juhl), Present (MDKK): 13.9 (Innovationsfonden)
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Everyone benefits from FG001
Everyone benefits from FG0011. Patients get additional local metastases
removed
2. Hospitals’ efficiency increase, saving on fewer reoperations
Diagnose
Patient is diagnosed with cancer, typically after several examinations
Cure
50% of patients has local relapse
Surgery is a cornerstone treatment of early and localized cancer
Surgery Histology
Histology check if the margin around the tumor is clean as a predictor for complete recession
Positive margins
Negative margins
May be cured
Follow up
Re-operation and/or other
treatment
Re-operation and/or other treatment
3. Surgeons increase success rate for complete cure
4. Surgical robot suppliers get an argument for improved outcome
REDUCE ! / AVOID $
" INCREASE LIKELIHOOD
REDUCE ! / AVOID $
REDUCE ! / AVOID $
IMPROVE EFFICIENCY
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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
• FG001 has already been proven to illuminate several different human cancers tested in preclinical models:• Glioblastoma (published)
• Head and neck cancer (published) and
• Pancreas cancer (prepared for publication)
Source: Christensen, A. et al (2017), Oncotarget and Juhl, K. et al (2016) PLoS ONE
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FG001 - fast route to the market
• FG001 is classified as a medicinal product, imagining agent
• Few patients and a simple clinical study needed for approval• Clear endpoint: Additional metastases detected
• No placebo arm: Fewer patients needed
• Short time: Enrollment to surgery
• No blinding: First result known after the first few patients
• No competitive treatments: Easy to enroll patients
• First indication qualifies for orphan drug designation
Phase I/IIa
• 10-20 pts
• Optimal dose• Confirmation of
performance in humans• Safety
Phase IIb/III
• Approx. 150 pts
• Statistical proven performance accordingly to regulation
Inclusion
•Patient with cancer undergoing surgery
•Inject FG001
Surgery done under white light
Switch on fluorescent
light
•Remove extra local metastases
•Validate histologically
Result available
Approval
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The concept of FG001 is proven preclinically• FG001 tested preclinically using a design of
the study similar to required for the approval study (phase IIb/III)• Human cancer,
• Operated by human surgeon and
• Using a Da Vinci robot
• FG001 helped to identify and remove local metastases in 50% of the subjects compared to standard white light procedure
• Using standard equipment already available
Source: Data on file, #19
Subjects with metastases found with white and fluorescent light
(n=8)
# su
bjec
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0
1
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5
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White light
Fluorescent light
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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 recurrence nearly 100%
• Qualifies for orphan designation
Diagnosis Treatment planning Surgery Radiation /
Chemo Follow up
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Other potential indications for FG001
• uPAR is extensively expressed in most solid cancers:
• Glioblastoma
• Breast cancer
• Colorectal cancers
• Lung
• Pancreas
• Head and neck cancer0 500.000 1.000.000 1.500.000 2.000.000
Lung
Colorectum
Breast
Pancreas
Head and neck
Brain,nervoussystem
Glioblastoma
Incidence in high and upper middle income
Incidence of cancer
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High value customers served by many Customers Potential partners (examples)
1,000,000 surgeons and 12,000 hospitals
worldwide
Clinical trials, “Key Opinion Leaders”, compassionate use sales
Source: Holmer, H., Lantz, A., Kunjumen, T., Finlayson, S., Hoyler, M., Siyam, A., … Hagander, L. (2015). Global Distribution of Surgeons, Anesthesiologists and Obstetricians. Lancet Global Health, 3(Supplement 2), S9-11.
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Healthy competition
• Direct competitor with active fluorescent targeting• On Target Lab., private, USA: OTL38• SurgiMab, private, France: SMG-101
• Indirect competitors • Passive fluorescent targeting
• PhotoCure, public, Norway (Mar Cap: MNOK 839, Mar-19)• NX DC, private, US (Gliolan®), acquired by SBI Holdings, Inc. (photonamic)
• Other cancer margin enhancing technologies (examples)• Ultra sound guidance (unspecific, low sensitivity) • PET tracer with micro probe, e.g. Light Point Medical• Curadel, private (equipment focused and ZW800-1)
Active targeting
Un-specific / inaccurate during surgery
Research
Ultra soundOCT
Pre-op imaging
5-ALA (bladder, skinand glioblastoma)
OTL38Folic acid
Ovary
FG001uPAR
Glioblastoma etc.
CommercialDevelopment
SGM-101CEA
Colon/Rectal
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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 obligation (< DKK 2m)
• New patent applications being prepared
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Attractive market potentialThe market for intelligent surgical targeting is huge
• € 0.5 billion – the market for active glioblastomasurgical targeting
• € 2.0 billion – the market for active breast cancersurgical targeting
• € 50 billion – the market for robotic surgery
• € 1,000 billion – the market for surgery (equipment and personnel)
Source: Modification after Therapies for Resistant and Recurrent Metastatic Cancer, 2017; Allied market research, Surgical Robotics Market Size, 2017 and Grand View Research, Cancer Diagnostics Market, 2019
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Strong and incentivized leadershipMorten Albrechtsen – CEO• MD, BBA• Seasoned life sciences entrepreneur,
executive and non-executive • Lead launch and implementation of new
treatments and technologies internationally • Boehringer Ingelheim, Nycomed, Nanovi,
RetiPharma, Enkam and many others
• MD, PhD, DMSc, MBA• Professor at the University of Copenhagen and chief
physician at Rigshospitalet, the National University Hospital of Denmark
• Research is focused on molecular imaging with PET, PET/MRI and optical and targeted radionuclide therapies (theranostics) in cancer
• Minerva Imaging and CuraSight
Andreas Kjær – Head of SAB, BoD
Board of directorsArne Ferstad – Chair• Broad experience from
biotech, pharma and medtech, including business development, international marketing and development
• Strong experience from the Swedish public market
• Baxter, Pharmacia and others
Micaela Sjö ̈kvist• Head of Investor Relations at
Securitas AB • More than 20 years experience
in communications and investor relations in listed international companies.
• Previous experience from companies such as Grayling/Sund Kommunikation AB and TeliaSonera AB
Shomit Ghose• Venture partner, Onset Ventures• AB of UC Berkeley College of
Engineering’s Sutardja Center, Innovation Center Denmark’s ScaleIT program, and Lundbeck Foundation Clinical Research Fellowship Program.
• Tumbleweed Communications, BroadVision, Sun Microsystems, Truviso
• Instrumental in several IPOs
ManagementGrethe Rasmussen – CDO
Post IPO, management owns approx. 45% and board of directors owns approx. 6%
• MSc, PhD• Seasoned leader in life science with strong
development record. Latest Senior VP Development, Ascendis.
• Advanced seven projects from research to clinical development (protein, peptide, small molecule)
• Ascendis Pharma, Maxygen, Novo Nordisk
Peter M Eriksen• CEO of BioPorto
(Public, BIOPOR) • More than 20 years of
experience within medtech/life science in Denmark and abroad
• Medtronic (US and DK), Sense A/S, B&K A/S
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Several near term value inflection points
20212019 2020
FG001:
Pipe-line:
Commercial:
Research – Innovation Fund Denmark, Grand Solution project
Production and toxicity
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
2022
CMC and Regulatory advice and first approval
Phase I/II (FluoGuide sponsor)
Phase I/II (InvesFgator driven)
Phase IIb/III (FluoGuide sponsor)
Compassionate use sales, initiated
Partnering preparation
FG002
Other: IPO
Partnering
Production and toxicity
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Summary of the offeringIPO• 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): Approx. MDKK 19.8.
• Pre-subscriptions: Approx. MDKK 9.9, amounting to 62 % of the issue volume.
• Listing at Spotlight Stock Market. Planned first day of trading 7 May 2019.
• All existing shares (pre-IPO) under 100 % lock-up for first 12 months.
Warrants• Exercise period: 16 April – 7 May 2020.
• Exercise price: DKK 5.95. Each warrant entitles to subscription of one (1) new share.
• Issue volume: If fully exercised, the company can be provided with approx. MDKK 6.4.
• Valuation: Approx. MDKK 43.0.
• Warrants will be traded at Spotlight Stock Market.
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Intelligent surgical targeting - light up cancer and increase
surgical precision
Investor meeting Copenhagen, 28 March 2018
Morten AlbrechtsenAndreas Kjær
IPO prior to listing at Spotlight Stock Market