Bonus Biogroup Ltd. · TASE:BONS
Bonus Biogroup — Investor Presentation (August 2016)
27 slides from Bonus Biogroup's investor presentation, August 2016
Slide 1: Bonus BioGroup Investors Presentation
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 4
Slide 5: Bone Tissue Regeneration
Bone Tissue Regeneration The Need • An increasing need has risen for an effective and efficient therapeutic platform to replace current bone restoration modalities characterized by significant shortcomings The Objective • To develop a biological graft designed to renew, replace, or improve the funct
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: 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 • Perso
Slide 11: Properties of BonoFill
Properties of BonoFillTM Autologous cell source: Grown from adipose cells originating in the patient and harvested in a simple procedure termed liposuction, thus eliminating the risk of tissue rejection and surgery failure. Multi-cell bone graft: Contains both mature and premature bone-forming cells
Slide 12: BonoFill Products
BonoFillTM Products Solid cut-to-shape bone graft The solid bone graft is generated by seeding a variety of bone-forming cells collected from the patient on a scaffold geometrically pre-configured in a shape reflecting the patient’s particular bone gap. Injectable void-filling self-setting bone graf
Slide 13: The Solid Pre-Designed Bone Graft
The Solid Pre-Designed Bone Graft Adipose tissue sample is collected from the patient, from which cells are isolated, seeded on a 3D scaffold and grown in a bioreactor. The scaffold is predesigned to precisely match the patient's 3D bone gap previously captured by Computed Tomography (CT) image. The
Slide 14: The Solid Pre-Designed Bone Graft Preclinical Results
The Solid Pre-Designed Bone Graft Preclinical Results 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 - cell tissue Transplantation
Slide 15: The Injectable Void-Filling Self-Setting Bone Graft
The Injectable Void-Filling Self-Setting Bone Graft 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 semi-solid in texture, allowing syringeability. It is suitable for the reconstructi
Slide 16: The Injectable Void-Filling Self-Setting Bone Graft Preclinical Results
The Injectable Void-Filling Self-Setting Bone Graft Preclinical Results 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 6 weeks mm2 20 0 4W 6w 16
Slide 17: The Injectable Void-Filling Self-Setting Bone Graft Preclinical Results
The Injectable Void-Filling Self-Setting Bone Graft Preclinical Results BonoFillTM transplantation in a preclinical model: Intra-femoral bone injection Control BonoFillTM Trabecular bone Intra-femoral injection preclinical model (three wall gap) Saline injection and bone marrow flushing Trabecular m
Slide 18: 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 19: The Injectable Void-Filling Self-Setting Bone Graft Preclinical Results
The Injectable Void-Filling Self-Setting Bone Graft Preclinical Results BonoFillTM transplantation in a severe critical sized bone defect model Day of BonoFillTM BonoFillTM transplantation after 2 months CT after 3 months Total bone repair Empty 3. Full 3.2cm bridging critical gap of the gap 19
Slide 20: The Injectable Void-Filling Self-Setting 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 20 following the tr
Slide 21: Clinical Trials 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: 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 23: Leadership
Leadership Yoni Livne, CPA – Chief Financial Officer Mr. Livne has been serving as Chief Financial Officer since 2014. Before joining Bonus BioGroup, Mr. Livne was Chief Financial Officer at Bee Contact Communication Ltd., a publicly traded company (TASE), and Chief Controller at Dexcel Pharma, a pr
Slide 24: Manufacturing Facility
Manufacturing Facility The facility was designed for the manufacture of live human bone grafts and constructed in compliance with FDA and EMA requirements for manufacturing biological products. The facility is Good Manufacturing Practices (GMP) and ISO-9001-certified. 24
Slide 25: Successful Results
Successful Results • 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 g
Slide 26: Product Pipeline
Product Pipeline Product Candidate Discovery Preclinical Clinical Status Follow-up stages of Bone Graft for Maxillofacial clinical phase I/II study Applications Large animal study completed Bone Graft for Orthopedic Awaiting approval for stage I/II Applications clinical study In collaboration with:
Slide 27: 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 Billion dollars market