Bonus Biogroup Ltd. · TASE:BONS
Bonus Biogroup — Investor Presentation (March 2018)
35 slides from Bonus Biogroup's investor presentation, March 2018
Slide 1: Innovative Tissue Regeneration Technologies
Innovative Tissue Regeneration Technologies Bonus BioGroup Investors Presentation
Slide 2: Disclaimer and Forward-Looking Statement
Disclaimer and Forward-Looking Statement This presentation includes statements that are, or may be deemed, ‘‘forward-looking statements.’’ In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “antici
Slide 3: Overview
Overview Bonus BioGroup is a biotechnology company applying an innovative technology to generate viable tissue- engineered bone grafts. The company is targeting a multi-billion dollar worldwide market for the treatment of skeletal disorders. Foundation of the company by experts in the field of tissu
Slide 4: Vision
Vision Bonus BioGroup strives to become a global leader in the field of tissue engineering and production of viable tissue-regenerating bone grafts 4
Slide 5: Bone Tissue Regeneration
Bone Tissue Regeneration An increasing need has risen for an effective and efficient therapeutic The Need platform to replace current bone restoration modalities characterized by significant shortcomings To develop a biological graft designed to renew, replace, or improve the The Objective function
Slide 6: The Bone Regeneration Market
The Bone Regeneration Market Natural bone has the ability to repair itself in response to injury. However, in complex clinical Market growth is driven by: conditions, normal bone regeneration is impaired. These cases include large bone defects created by aging, infection, tumor resection, trauma and
Slide 7: Bone Grafts: Current Modalities
Bone Grafts: Current Modalities Autologous bone graft – the gold standard Bone is relocated from one location to another in the patient's body. Limitations: Invasive surgical procedure, donor site morbidity, insufficient graft volume and quality. 9% 16% Allografts/DBM 48% Bone grafts obtained from h
Slide 8: Our Solution: BonoFill
Our Solution: BonoFillTM BonoFill is a novel, autologous, tissue-engineered viable bone graft designed to replace current inferior solutions. Advantages of BonoFillTM: • Demonstrates high quality • Available in large quantities Viability & Availability & bone properties which are • Repairs a broad r
Slide 9: Technology
Technology Bonus BioGroup has developed a unique technology to grow viable bone grafts from cells isolated from patients’ fat tissue. Bone Liposuction t ra n s p l a ntat i o n B o n e fo r ma t i o n Cell isolation C e l l g ro w t h o n s ca f fo l d i n a b i o re a c to r 9
Slide 10: Properties of BonoFill
Properties of BonoFillTM Autologous cell source: Grown from adipose cells originating in the patient and harvested in a simple liposuction, thus eliminating the risk of tissue rejection and surgery failure. Multi-cell bone graft: Contains both mature and premature bone-forming cells which maintain t
Slide 11: Key Benefits of BonoFill
Key Benefits of BonoFillTM Accommodates a broad range of skeletal deficiencies resulting from aging, trauma and disease Fully integrates with the patient’s body and avoids any immunological response Demonstrates expedited and improved clinical outcomes compared to existing alternatives Personalized
Slide 12: BonoFill Products
BonoFillTM Products Injectable void-filling Solid cut-to-shape bone graft self-setting bone graft The solid bone graft is generated by seeding a The injectable bone graft is generated by seeding a variety of bone-forming cells collected from the variety of bone-forming cells collected from the patie
Slide 13: The Solid Cut-to-shape Bone Graft
The Solid Cut-to-shape Bone Graft The scaffold is predesigned to precisely match the patient's 3D bone gap previously captured by Computed Tomography (CT) image Adipose tissue sample is collected from the patient, from which cells are isolated, seeded on a 3D scaffold and grown in a bioreactor The c
Slide 14: Preclinical Results - The Solid Cut-to-shape Bone Graft
Preclinical Results - The Solid Cut-to-shape Bone Graft BonoFillTM transplantation into critical sized bone defect in an animal model A scanning electron microscope image of a A B solid bone graft following 21 days of cell cultivation. Blue arrow - scaffold D Yellow arrow - bone tissue Transplantati
Slide 15: The Injectable Void-Filling Self-Setting Bone Graft
The Injectable Void-Filling Self-Setting Bone Graft The injectable BonoFillTM is semi-solid in texture, allowing syringeability Adipose tissue sample is collected from the patient. Cells are then isolated, seeded on mineral 3D particles and grown in a bioreactor The injectable BonoFillTM is suitable
Slide 16: Preclinical Results - Critical Sized Bone Defect
Preclinical Results - Critical Sized Bone Defect The Injectable Void-Filling Self-Setting Bone Graft BonoFillTM transplantation into a cranial critical sized bone defect in an animal model Control Bone Volume Control BonoFillTM BonoFillTM 8 6 mm3 0 weeks 4 2 0 4W 6w 4 weeks Bone Surface 60 40 mm2 6
Slide 17: Bone Graft Analysis Reveals Normal Bone Properties
Bone Graft Analysis Reveals Normal Bone Properties Scanning electron microscope image of the solid bone graft following 21 days of cell cultivation. Blue arrow – scaffold, yellow arrow - cell tissue. Histology and immunohistochemical staining of adipose tissue-derived mesenchymal stem cells grown on
Slide 18: Preclinical Results - Critical Sized Bone Defect
Preclinical Results - Critical Sized Bone Defect The Injectable Void-Filling Self-Setting Bone Graft BonoFillTM transplantation in a severe critical sized bone defect model DAY OF TRANSPLANTATION BonoFillTM XRAY AFTER 2 MONTHS BonoFillTM CT AFTER 3 MONTHS 3. Empty 3.2cm 3. Full bridging Total bone c
Slide 19: Injectable Bone Graft Preclinical Results
The Injectable Void-Filling Self-Setting Bone Graft Preclinical Results BonoFillTM transplantation in an over-sized critical bone defect model BonoFillTM transplantation in an over-sized critical bone defect in the tibia severe bone gap model prior to transplantation and 3 months following the trans
Slide 20: Manufacturing Facility
Manufacturing Facility The facility was designed and constructed in compliance with FDA and EMA requirements for manufacturing biological products. The facility is Good Manufacturing Practices (GMP)- and ISO-9001-certified. 4 20
Slide 21: Maxillofacial Bone Regeneration (2014, 2016)
Clinical Trials Maxillofacial Bone Regeneration (2014, 2016) Clinical evaluation of BonoFillTM as bone graft for the repair of maxillofacial deficiencies has so far been performed in two phase I/II, open label, first-in-human, clinical trials. The two clinical indications are: 1. Bone augmentation 2
Slide 22: Maxillofacial Bone Regeneration (2014-2016) Results
Maxillofacial Bone Regeneration (2014-2016) Results BonoFill was demonstrated to be safe and effective for treating maxillofacial bone deficiency Safety No safety issues arose in either indication. The treatment with BonoFill is stable. BonoFill remained in the treatment site, and no infections no
Slide 23: Maxillofacial Bone Regeneration (2014-2016) Results
Maxillofacial Bone Regeneration (2014-2016) Results Main outcomes BonoFill treatment has achieved the goal of regenerating and augmenting bone tissue in the transplantation site in all subjects treated without exception. There were no statistical differences relating to age, sex, clinical indica
Slide 24: Bone void filling following cyst removal
Maxillofacial Bone Regeneration (2014-2016) Results Bone void filling following cyst removal Bone void in the lower jaw prior to BonoFill transplantation 24
Slide 25: Maxillofacial Bone Regeneration (2014-2016) Results
Maxillofacial Bone Regeneration (2014-2016) Results CT at 0, 3, 6 months following transplantation 25
Slide 26: Maxillofacial Bone Regeneration (2014-2016) Results
Maxillofacial Bone Regeneration (2014-2016) Results CT at T=0, 3, 6 months following transplantation Before transplantation After 3 months After 6 months 26
Slide 27: Maxillofacial Bone Regeneration (2014-2016) Results
Maxillofacial Bone Regeneration (2014-2016) Results X-ray 6 mnths following transplantation 6 months following transplantation, dental implants were inserted in to the newly formed bone. 27
Slide 28: Bone augmentation for sinus elevation
Maxillofacial Bone Regeneration (2014-2016) Results Bone augmentation for sinus elevation CT at T=0 and 3 months following transplantation demonstrate bone gap healing T=0 T=3M 3 weeks following BonoFill T=6M transplantation bone void becomes less radiolucent and more opaque. Tissue regeneration pro
Slide 29: Bone density
Maxillofacial Bone Regeneration (2014-2016) Results CT cross sections T=0, 3 Months and 6 Months following transplant Before transplantation After 3 months After 6 months Bone augmentation in the maxilla 6 months from transplantation Bone density Time T=0 T=3M T=6M Height (mm) 4 16.9 20.9 20.9mm Ini
Slide 30: Maxillofacial Bone Regeneration (2014-2016) Results
Maxillofacial Bone Regeneration (2014-2016) Results Placement of dental implants following BonoFill transplantation Time T=0 T=6M Height (mm) 4 20.9 30
Slide 31: Maxillofacial Bone Regeneration (2014-2016) Results
Maxillofacial Bone Regeneration (2014-2016) Results Histological analysis of biopsies 6 months following transplantation Marks bone formation H&E stain, x40 magnification Arrows mark newly formed bone tissue 31
Slide 32: Successful Milestones
Successful Milestones Bonus BioGroup has been conducting successful preclinical studies since 2009 Bonus BioGroup isolates and grows bone-forming tissue-regenerating cells on 3D scaffolds to produce live transplantable bone grafts In preclinical models, Bonus BioGroup’s live transplantable bone graf
Slide 33: Product Pipeline
Product Pipeline PRODUCT CANDIDATE DISCOVERY PRECLINICAL CLINICAL STATUS Phase I/II, 2nd generation, clinical Bone Graft for study, after successful completion Maxillofacial Applications of Phase I/II, 1st generation, clinical study Bone Graft for Phase I/II, 2nd generation, clinical Orthopedic Appl
Slide 34: Leadership
Leadership Shai Meretzki, Ph.D., Founder, CEO and President Dr. Meretzki has proven operational, management and leadership abilities in Life Science companies. Former founder, CEO and CTO of Pluristem Life Systems, Inc. (NASDAQ: PSTI; TASE: PLTR). Also serves as chairman of the board at Biological I
Slide 35: Why Us?
Why Us? Proven ability to manufacture and supply live tissue, including viable bone grafts Broad R&D pipeline Short and inexpensive regulation process Versatile technological platform suitable for a variety of clinical indications High entry barrier for competition Multi-billion dollar m