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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

ts

0

1

2

3

4

5

6

7

8

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