Kuros Biosciences Ltd. · SIX:KURN
Kuros Biosciences — Non-Deal Roadshow (March 2021)
33 slides from Kuros Biosciences's roadshow presentation, Mar 22, 2021
Slide 1: Establishing the new gold standard in bone regeneration
Establishing the new gold standard in bone regeneration Targeting the US $2billion spinal fusion market
Slide 2: Disclaimer
Disclaimer This presentation is private and confidential, has been furnished to you solely for your information and may not be reproduced, redistributed or disclosed in any way, in whole or in part, directly or indirectly, in or into the United States or the United Kingdom, Canada, Australia, Japan,
Slide 3: Executive summary
Executive summary Experts in the science of bone regeneration (orthobiologics) 1 Biotech with MedTech risk profile & focus on bone healing / spinal fusion 2 Large, growing market: from USD 2.2bn in 2016 to USD 3.4bn1 expected by 2030 3 MagnetOs: momentum of commercialisation is accelerating 4 Growth
Slide 4: Company overview
Company overview • Founded in 2000 as a spinoff of Swiss Federal Institute of Technology in Zurich • Acquired Xpand Biotechnology in 2017 to strengthen the orthobiologics platform • Listed on the SIX Swiss Exchange (Ticker: KURN) Locations Shareholders3 3,000+ Boston (US) • Marketing & sales Clinica
Slide 5: Executive management team
Executive management team >80 years pharma, MedTech Executive management and Biotech experience Pascal Longlade, MD Alistair Irvine, PhD Chief Medical Officer Chief Business Officer Philippe Saudan, PhD Frank-Jan van der Velden, MBA Chief Development Officer Head of Business Affairs Joost de Bruijn,
Slide 6: Product pipeline
Product pipeline = Priority asset MedTech Product Therapeutic Areas Preclinical Regulatory Submission Market Clearance MagnetOs Granules (EU) and Orthopedics, Spine, Dental MagnetOs Putty (EU) MagnetOs Granules (US) and Granules: Spinal fusion (posterolateral) MagnetOs Putty (US) Putty: Spinal fusio
Slide 7: Why target bone grafting indications?
Why target bone grafting indications? § Bone grafting is often used to augment the body’s own ability to heal bone following trauma or surgery. This ability may be compromised due to numerous patient-related factors. § The “gold-standard” bone grafting technique (autografting), where bone is harvest
Slide 8: A large, growing orthobiologics market
A large, growing orthobiologics market Ageing population and increased treatment rate are expected to drive market growth Focusing on the spinal segment 20161 USD 2.2bn (spine $1.4bn) 20303.4bn (spine $2.0bn) 20301 USD 1 USD 3.4bn DBMs Synthetics, incl. DBMs Synthetics Stem Cells Stem Cells Allograf
Slide 9: Spinal fusion
Spinal fusion • A combination of Kuros products What is spinal fusion? • Surgical procedure where two or more vertebrae are fused together to eliminate painful motion What symptoms does it cure? • Lower back pain and/or leg pain as result of e.g. degenerative disk disease, spondylolisthesis, recurre
Slide 10: On a mission to eliminate non-unions
On a mission to eliminate non-unions A unique business model - combination of MedTech Biotech & Biotech opportunities MedTech Biotech Fibrin-parathyroid Hormone (PTH) Description Description Bone graft substitute (BGS) with advanced submicron surface Drug-biologic combination aimed to deliver topogr
Slide 11: What is MagnetOs?
What is MagnetOs? Revolutionary bone graft with superior surface topography Properties/mechanism Indications & regulatory Benefits & positioning Commercial rollout of action status (Granules & Putty) ü Key differentiator: surface ü Commercial in US & EU since ü Surface topography directs ü US: FDA 5
Slide 12: MagnetOs' key differentiator
MagnetOs’ key differentiator Superior surface structure promotes bone in soft tissues without added cells or growth factors1,*, ¥ Vitoss TCP (market leader, $103m sales) Actifuse ($60m peak sales) fibrous tissue material bone Fibrous tissue Fibrous tissue Bone tissue Chronos (DePuy Synthes) Vitoss (
Slide 13: MagnetOs shows no reduction in fusion mass
MagnetOs shows no reduction in fusion mass Autograft • MagnetOs shows no reduction in fusion mass compared to autograft and market-leading products1, * Novabone Vitoss BA2X Autograft Novabone Vitoss BA2X 1: Clin Spine Surg. 2020 Jul;33(6):E276-E287 * Results from in vitro or in vivo laboratory testi
Slide 14: Retrospective clinical study shows excellent results
Retrospective clinical study shows excellent results “Our center conducted an investigator-led retrospective chart review of 25 cervical and 52 lumbar reconstruction patients, who underwent circumferential- or anterior column only interbody reconstruction surgery with MagnetOs to achieve solid spina
Slide 15: Momentum of MagnetOs commercialisation is accelerating
Momentum of MagnetOs commercialisation is accelerating Since start of commercialisation (H2 2018) to H1 2020 ~$6.4m sales Sales growth of 58% in full year 2020 vs. full year 2019 (despite COVID-19) Distribution Growth Increased agreements for of direct sales number of selective force agents European
Slide 16: What is Fibrin-PTH?
What is Fibrin-PTH? Our latest product candidate, Fibrin-PTH (KUR-113), aims to deliver targeted and controlled bone formation Fibrin-PTH has been implanted in trials with This product candidate functions via ~400 patients, reaching its primary endpoint the well-established mechanism in two human st
Slide 17: Fibrin-PTH is novel & suited to Minimally Invasive Surgery
Fibrin-PTH is novel & suited to the growing field of Minimally Invasive Surgery (MIS) Site of Site crosslinking of crosslinking TGplPTH 1-34 (peptide) TGplPTH 1-34 (peptide) Fibrin sealant Fibrin sealant Plasmin Plasmin cleavage cleavage (Delivery(Delivery matrix) matrix) to fibrin to(by fibrin FXII
Slide 18: Fibrin-PTH has comparable high fusion rates to InFuse and Autograft in sheep
Fibrin-PTH has comparable high fusion rates to InFuse and Autograft in sheep Bone Area in % Fusion % Fusion Micro- (µCT) (Histology) Cage Histology Histology Micro-radiographs Micro- radiographs CT CT Images Images (net tissue %) Histology Micro- CT Images Histology radiographs CT Images radiographs
Slide 19: Phase 2 overview and timelines
Phase 2 overview and timelines Design Treatment Primary endpoint Study Sites and PIs • Prospective, randomized controlled • Single-level TLIF with Fibrin-PTH or • Radiological fusion determined by CT • UCSD, Louisiana Spine, Allegheny, single-blind multi center study which local autograft added in a
Slide 20: Financial highlights for the full year 2020 (1)
Financial highlights for the full year 2020 (1) Condensed Consolidated Income Statement December 31 2020 December 31 2019 • Revenues have increased by IFRS in TCHF 58% compared to 2019 Product sales 4,039 2,561 • G&A costs increased slightly as Total Revenue 4,039 2,561 a result of the capital incre
Slide 21: Financial highlights for the full year 2020 (2)
Financial highlights for the full year 2020 (2) Consolidated balance sheet December 31 2020 December 31 2019 • Cash and cash equivalents IFRS in TCHF trade and other receivables Total non-current assets 60,396 64,562 amount to TCHF 28,388 Current Assets Assets classified as held for sale 2,171 Inven
Slide 22: Reasons to invest in Kuros
Reasons to invest in Kuros Credibility Data Strategy Advocacy Our products work by truly Our go-to-market strategy is Unparalleled depth & breadth Kuros has already secured unique mechanisms that are based on extensive of experience in the the support of leading names expected to be backed by a expe
Slide 23: Backup
Backup
Slide 24: Current treatments either lack efficacy or ease of use
Current treatments either lack efficacy or ease of use Avoids Targeted Low tissue bone Clinical proof procedure Safety/patient Treatment method harvesting regeneration focused complexity recovery time Properties + Complete histocompatibility GOLD AUTOGRAFT − Second surgery often required STANDARD Cr
Slide 25: MagnetOs
MagnetOs MagnetOs, our flagship product, is a revolutionary bone graft with success in the surface. Harnessing the power of macrophage polarization and osteoimmunology Made of biphasic calcium phosphate (BCP), MagnetOs mimics the porous, trabecular structure of cancellous bone1. It has a unique subm
Slide 26: Strategic advisory board
Strategic advisory board Five opinion-leading US spine surgeons and a professor of orthopedic research who are considered experts within their field but with the focus, mentality and motivation to help shape the future of our organization. Dr Patel, MD Dr Sandhu, MD Dr Allen, MD Dr Sama, MD Dr Poels
Slide 27: Proven in real-world application – Lumbar spine
Proven in real-world application – Lumbar spine STUDY SINGLE / MULTILEVEL COMPILATION OF SUCCESSFUL FUSIONS BETWEEN 3-12 MONTHS BACKGROUND INTERBODY LUMBAR SPINE ARTHRODESIS POST-OPERATIVELY PATIENTS (n) LEVELS (n) AIM Total 52 97 Evaluate the clinical and n=52 Fused 49 94 radiographic outcomes 60.9
Slide 28: Proven in real-world application – Cervical spine
Proven in real-world application – Cervical spine COMPILATION OF SUCCESSFUL FUSIONS BETWEEN 3-12 MONTHS STUDY SINGLE / MULTILEVEL POST-OPERATIVELY BACKGROUND CERVICAL SPINE ARTHRODESIS LEVELS PCF Corpectomy Surfaces ACDF Total Levels AIM n=25 82 Total 18 4 60 82 Evaluate the clinical and radiographi
Slide 29: What is Fibrin-PTH?
What is Fibrin-PTH? Drug-biologic combination - Parathyroid hormone (PTH) and fibrin Mechanism of action Indications Benefits & positioning Development stage ü PTH promotes bone formation ü Interbody lumbar spinal fusion ü Effective with superior safety ü De-risked: safe & effective in ü Controlled
Slide 30: Fibrin-PTH for Spinal Fusion
Fibrin-PTH for Spinal Fusion Phase 2 – Single level TLIF (L2-S1) in patients with DDD with up to Grade 1 spondylolisthesis Local autograft Randomized n=10 Fibrin-PTH (PTH conc 1) n=50 n=20 non- Fibrin-PTH (PTH conc 2) randomized n=20 12m 6w, 3, 6, 12 & 24m 1 2 Primary Secondary Radiographic interbod
Slide 31: Fibrin-PTH is significantly de-risked
Fibrin-PTH is significantly de-risked Phase transition success & likelihood of approval (LoA) Fibrin-PTH is significantly de-risked: • Successful completion of two Phase 2 studies (safety/efficacy in nearly 400 patients) related to bone repair in the trauma field (Tibial Plateau Fractures/Tibial Sha
Slide 32: Kuros Biosciences – patent portfolio
Kuros Biosciences – patent portfolio Extensive patent portfolio to protect its products • Kuros has a broad patent portfolio with >100 granted patents and a number of additional patent applications • Patents are focused in the main markets of US and Europe but also include other markets such as Chin
Slide 33: Kuros Biosciences AG registered address
Kuros Biosciences AG is a limited liability company registered in Switzerland. Registered address: Wagistrasse 25, 8952 Schlieren, Switzerland. Register of commerce number CHE-104.785.642