kuros biosciences ag · any persons reading this document should inform themselves of and observe...

A new era in Orthobiologicsthrough unique Biologics & Clinically proven portfolio

Ivan Cohen-Tanugi MD – CEOHarry Welten - CFO

Kuros Biosciences AG«A new era in Bone Regeneration»

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Kuros Biosciences Table of Contents

Company Overview - Investment highlights

Orthobiologics

MagnetOs: Orthobiologic ready for commercialization

Fibrin PTH: Innovative Pipeline moving toward Phase II & III

Neuroseal: Dural sealant: obtained EU clearance

Kuros Biosciences: Supportive information

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Public Swiss/Netherlands based company (SIX: KURN), headquartered in Zurich-Switzerland

World recognized scientific foundersClemens van Blitterswijk, Jeff Hubbell, Joost de Bruijn

Over 1,200 international publications

Technology platform focusing on enhancing tissue regeneration, with primary focus on Bone

Commercial & late stage clinical innovative pipeline: Fibrin-PTH & MagnetOs with potential >$1B

Kuros Biosciences / Investment highlights

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A breakthrough approach in Orthobiologicsthrough unique Biologics & Clinically proven portfolio

• Introducing “Controlled Bone Regeneration” harnessing the body repair system through

• MagnetOs, Next Generation synthetic BGS

• Fibrin-PTH, Next Gold Standard, bioactive growth factor

• $2.3B+ market expected to grow to $3.5-4B by 2030*

* Kuros estimates


* Data on file Kuros estimates; ** only one study needed in EU; *** EU study serves as pilot for US; ****First clinical study will be a Phase II study utilizing safety data from tibial shaft fracture trial to be confirmed with regulators

• A late stage, high value pipeline of Orthobiologics & sealant

Pipeline

Neuroseal(CE Mark/PMA)

Initial IndicationsNon

clinicalPilot Pivotal Registration

Market leader peak sales*

EU Dural sealant (cranial)

>US$60MUS Dural sealant (cranial)

MagnetOs(CE Mark/ 510K)


clinicalRegistration

MarketApproval

Market leader peak sales*

Granules EU Orthopedics, spinal, dental

>US$140MGranules US Spinal fusion

Putty EU Orthopedics, spinal, dental

Putty US Spinal fusion

Fibrin/PTH(NDA/MAA)


clinicalPhase 1 Phase 2 Phase 3

Market leader global peak sales*

KUR-111 Tibial plateau fractures

>US$600MKUR-113

Tibial shaft fractures

Spinal interbody fusion

KUR-112 Solitary bone cyst N.A.

Ort

ho

bio

log

ics

Seala

nt

5




Orthobiologics





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Orthobiologics

What are Orthobiologics?

• Orthobiologics are used daily by orthopedic & spinal surgeons to repair & regenerate tissue. A major segment of orthobiologics is bone graft substitutes

• Bone graft substitutes are increasingly used instead of iliac crest autograft, the gold standard (morbidity, extra procedure cost)which is harvested from the patient

• Bone graft substitutes are used to repair or generate bone during fracture repair or spinal fusion (growing bone across two vertebrae in

the spine to alleviate pain and nerve compression)

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Orthopedic surgery evolutionFrom Mechanics to «Biologics & Controlled Regeneration»

«Replace»

Years 1800’

Level

of

Scie

nti

fic P

roo

f &

Ad

ded

Valu

e

Orthotics

Implants

Metal,

screws…

CaPh

Bioglass…

Growth

Factors

Biologics &

Controlled

Instructive

Materials

1960’ 1990’ 2005 >2018

«Integrate» «Regenerate»«Support»«Regenerate

& Control»

MagnetOs

Fibrin PTH

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Kuros Unique Scientific & Clinical ApproachUnique “Controlled Bone Regeneration” Portfolio

• Controlled new bone generation to avoid ectopic bone formation

• Strong Clinical Evidences

• Improved Safety

• Broader Access

Fibrin PTH No Ectopic Bone

Controlled New Bone Quantity

No inflammation

Safety

Controlled Admin

Broader UsageMagnetOs

Building Strong Clinical Evidence

Bone Graft Substitute,

Critical Unmet Needs Controlled Bone Regeneration

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Fibrin PTH

MagnetOs

Growth Factors

Stem Cells

Synthetics

DBMs

Kuros Orthobiologics Breakthrough PipelineMagnetOs & Fibrin PTH will cover all critical needs of the market expected to grow from $2.3 to $3.5-4B by 2030*

* Data on file, Kuros estimate

Allografts



Orthobiologics





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MagnetOsFirst Controlled Instructive Bone Regeneration Graft

Composition Instructive, surface structured ceramic (HA/TCP)

M. o. A. MagnetOs Surface Technology utilizes the body’s potential to

generate bone by activating local (stem) cells

Approved Indications

Bone void filler for broad orthopedic, spine, and dental use in EU

Bone graft extender for posterolateral spine fusion (US label to be expanded)

Efficacy Demonstrated equivalent efficacy to the “standard of care”

autograft in key preclinical models. Clinical data to be initiated

Safety No issues

ValueProposition

Highly efficacious new class of instructive bone graft substitute

Rapid osteoinductive effect/bone formation (EU claim)

Improved resorption profile

Expected to demonstrate superior efficacy through clinical usage

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MagnetOsFirst Controlled Instructive Bone Regeneration Graft

For patients having a spinal fusion (USA) / spinal fusion or trauma procedure (EU) requiring bone grafting

MagnetOs is a new generation of BGS , with unique proprietary surface structure

That Can promote progressive bone formation comparable to current gold standard autograft

Because it has demonstrated efficacy through the recruitment & stimulation of bone regenerating cells and rapid induction together with an optimized resorption profile

So That Surgeons can now make a difference for their patients by offering them a new and cost effective BGS

Key Messages

For patients with severe back pain, MagnetOs due to its unique proprietary surface structure, hence its mechanism of action designed to extend bone graft (bioactive submicron structured surface topography, rapid induction and faster resorption)

1. Instruct stem cells to form bone

2. Optimized resorption profile

3. No inflammatory & swelling from putty synthetic polymer, no safety issues

4. Handling improvement with putty polymer allows bone generation

5. Enhancing patients benefits and cost effectiveness



Orthobiologics





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Fibrin/PTH product FamilyNew Gold Standard Bioactive Topical Growth FactorProlonged cell mediated release at site of need

Fibrin sealant (Biologic)(ARTISS, approved BAXTER)

MBCP Granules(HA/TCP)

(approved, Biomatlante )

ASN GLN GLU LEU TYRGLN VAL SER PRO LYS ASN ARG Val SerSer Glu Ile Gln Leu Met His Asn

Leu

Gly

His LysSer LeuAsnGlu MetArgValGlu

Val HisLeu AspGlnLys LysArg

Leu

Trp

Asn Phe

Site of

crosslinking

to fibrin

TGplPTH1-34 (Drug)

Synthetic peptide developed by Kuros together with

world leading CMO for peptide manufacturing

(Bachem)

Plasmin

cleavage

sites

1 10

20

30 34

OH

H

TG-Hook

PTH1-34

(Forteo)

• PTH promotes bone

formation by direct

action on osteoblast

• Only cells primed to form

bone are activated

(proliferation/

differentiation)

• PTH responsive cells are

present where bone is

damaged (periosteum

and bone marrow)

Prolonged, local delivery

of PTH boost the natural

bone repair process

KUR-111 – Best in Class Option for Tibial Plateau Fracture

Composition Fibrin, variant PTH with HA/TCP granules

Moldable paste that solidifies in situ

Initial Indication Treatment of tibial plateau fractures as alternative to autograft

Potential Uses Treatment of other long bone defects requiring grafting

Efficacy Non-inferior to autograft in Phase 2b trial (183 patients)

Safety Safe and well tolerated in clinical trials (183 patients)

Does not cause ectopic bone formation

ValueProposition

Improved targeted product profile vs. leading growth-factor

Safely and effectively remodels bone without need for autograft

Moldable putty form for easy placement

Avoids cost and morbidity associated with autograft harvesting

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Fibrin PTHKUR-111 - Innovative Controlled & Instructive growth factors

Fibrin PTHKUR-111

Tibial Plateau Fracture: KUR 111 demonstrated non-inferiority vs Autograft in randomized & controlled PIIb in 183 patients

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Primary End-point: Proportion of patients (%) with radiological fracture union 16 weeks after implantation of the graft (ITT)

66.1%

83.6% 84.5%96% 100% 98.2%

0

20

40

60

80

100

120

I-0401 0.4mg/mL

I-0401 1.0mg/mL

Autograft I-0401 0.4mg/mL

I-0401 1.0mg/mL

Autograft

% p

ati

en

ts

52 week16 week

Spine Fusion Trauma & Tibial Shaft Fracture

Composition Fibrin + variant PTH Injectable gel that withstands irrigation & limits further bleeding

Intended use Spinal Lumbar Interbody Fusion Open tibial shaft fractures as an

adjunct to standard-of-care

Potential Uses

Potential for use in all long bone fractures, and other fusion proceed.

Efficacy Comparable to autograft and

InFuse in preclinical model Significant improvement in

fracture healing vs standard care

Safety Safe and well tolerated in clinical trials (200 patients)

ValueProposition

Improved targeted P.P. vs. leading growth-factor InFuse

Avoids the cost and morbidity associated with autograft

Can be applied in indications not targetable with other BGS

Reduces number of repeat operations (improved healing)

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KUR-113 - Innovative Controlled & Instructive growth factorsFibrin PTH

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Fibrin PTHKUR-113 Superior Fracture Healing vs. Standard of Care in a randomized and controlled 200 patient Phase IIb Clinical Trial

Trial Design: Randomized trial of 200 patients with tibial shaft fractures; patients randomized to four treatment groups: 0.133 mg/mL active† (n=50), 0.4 mg/mL active† (n=50), 1.0 mg/mL active† (n=50), standard of care alone** (n=50) with follow-up at 6 months

75.6%80.4%

69.2% 64.6%

0

10

20

30

40

50

60

70

80

90

100

I-040202 0.133 mg/mL I-040202 0.4 mg/mL I-040202 1.0 mg/mL SoC

% p

ati

en

ts

p=0.084 (10% sig level)

Fibrin/PTH 0.4 mg/ml statistically significant vs SoC alone

* Statistically significant difference vs. standard of care

Fibrin PTHKUR-113 Reduction by over 50% of secondary intervention rate

(due to persistent tibial non-union)

Clinically significantly less patients in the Fibrin/PTH groups required

secondary interventions

6.8%

8.7%7.5%

19.1%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

0.133 mg/ml(n= 44)

0.4 mg/ml(n=46)

1 mg/ml(n=40)

SoC (n=47)

12 month

4.4% 4.3%

7.7%

12.5%

0.0%

3.0%

6.0%

9.0%

12.0%

15.0%

0.133 mg/ml(n= 45)

0.4 mg/ml(n=46)

1 mg/ml(n=39)

SoC (n=48)

6 month

MagnetOs & Fibrin PTH portfolio positioning

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Risk of non healing (incl according to patient profile & comorbidities)

Spine Accessibility

Fracture type

Broader access New indication

Patient Access(insurance and/or

patients)

MagnetOs Use preferably if Low Risk of Non

Consolidation

PLFFill large bone

voidsFibrin PTH

access denied

Fibrin PTH Use preferably if High Risk of Non Consolidation or

Comorbidities

Minimal invasiveInterbody fusion

procedures

Long bone fractures

Fibrin PTHaccess

Together for tibial

plateau or spine

fusion (PLF portion)

Incl. Fibrin PTH

Incl. MagnetOs

Growth Factors

Stem Cells

Synthetics

DBMs

Allografts

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Kuros Orthobiologics: A Breakthrough PipelineMagnetOs & Fibrin PTH will cover all critical needs of the market expected to grow from $2.3 to ~4B by 2030

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* Data on file, Kuros estimate

Growth Factors

Stem CellsSynthetics

DBMs

Allografts

2016

$2.3B+Est. 2030*

$3.5 - 4B

By 2030 MagnetOs & Fibrin PTH expected to be the gold standard in their respective segment

Composition Fibrin, variant PTH

Injectable gel that solidifies in situ

Intended use Solitary Bone Cysts – a rare pediatric disease -> pathological

fractures

Efficacy Efficacious in clinical cases of osteochondral cysts in horses

Efficacious technology for bone generation (KUR-111 and -113)

Safety Significant body of safety data available in hundreds of patients

ValueProposition

Phase II/III to demonstrate improved clinical efficacy compared to current standard of care

Avoids the cost and morbidity associated with frequent need for repeat treatment with current practice

Orphan drug designation (US & EU) + Rare Pediatric Disease designation (US) ->> Priority Review Voucher +++

2323

Fibrin PTHKUR-112 for Solitary Bone Cysts – Pediatric Rare Disease



Orthobiologics





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Neuroseal Sealant – EU approvalDural Sealant Overview

• The dura surrounds the brain and spinal cord. It is the barrier that separates the cerebrospinal fluid (CSF) from the body

• Dural sealants are developed as an adjunct to suturing after cranial or spinal surgery to avoid CSF leakage

• Post-operative CSF leaks result in significantly increased costs (140%) due to increased hospital stay and additional treatment costs (Grotenhuis , J. 2005)

• Current market leading dural sealant (cranial & spine) is generating peak sales of US$60M in the US (Data on file, Kuros estimates)

Dura

Brain

Spinal cord

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Neuroseal™

Composition Sprayable, synthetic, fully biodegradable gel

Mechanismof Action

Gel that efficiently adheres to and seals the dura

TherapeuticUse

Adjunct to suturing to provide water-tight closure of the dura in cranial surgery

Potential for use in spinal dural closure (not approved)

Efficacy Intra-operative sealing successful in all evaluable patients in

clinical trial

Safety Safe and well tolerated

ValueProposition

Highly efficient sealing

Significantly less swelling expected vs competition and fewer complications due to nerve compression

• Slower degradation and higher mechanical strength

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Neuroseal™ – Received EU clearance in June 2017Overview

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Neuroseal – Road Map

Primary focus EU5 until new clinical trials initiated 1

Initiate usage and build confidence with EU KOLs in 20182

Evaluate broader indications, partnerships, distributors, licensing3



Orthobiologics





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Kuros Biosciences

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No debt

Number of shares outstanding: 7.8 mln*

Key shareholders:- Incubation/Aldabra/Huipin (Xpand sellers) 17.5%- Banque Pictet 9.0%- LSP 7.6%- Eckenstein-Geigy Foundation 6.1%- Venture Incubator 5.8%- Omega Funds 6.0%- FCPI 3.6%- Didier Cowling 3.1%

*As of 8/31/2017

Kuros Biosciences

2017 Achievements

• January: Acquisition X-pand BV (including MagnetOs)

• February: Kuros achieves ISO certification for surgical sealants

• February: Kuros receives US clearance for MagnetOs granules

• June: EU clearance (CE mark) Neuroseal

• June: Kuros raised CHF16.9M

• August: US clearance (510k) MagnetOs putty

• August: EU filing MagnetOs putty

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Kuros BiosciencesKey Critical Next Steps

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• MagnetOs putty clearance EU

• MagnetOs launch & initiation of supportive clinical trial

• Initiation Fibrin PTH PII clinical trial in Spine

• Initiation Fibrin PTH PIIb/III clinical trial in pediatric SBC

• Initiation Fibrin PTH PIII clinical trial in trauma indication

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A breakthrough approach in Orthobiologicsthrough unique Biologics & Clinically proven portfolio

• Introducing “Controlled Bone Regeneration” harnessing the body repair system through

• MagnetOs, Next Generation synthetic BGS

• Fibrin-PTH, Next Gold Standard, bioactive growth factor

• $2.3B+ market expected to grow to $3.5-4B by 2030*

* Kuros estimates


Thank you

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