Bonus Biogroup Ltd. · TASE:BONS
Bonus Biogroup — Investor Presentation (April 2022)
55 slides from Bonus Biogroup's investor presentation, April 2022
Slide 1: Business Presentation
Innovative Tissue Regeneration Technologies Business Presentation April 2022 All information herein is the proprietary of Bonus BioGroup Ltd.
Slide 2: Disclaimer and Forward-Looking Statement
Disclaimer and Forward-Looking Statement This presentation, both written and oral, includes statements that are, or may be deemed, ‘‘forward-looking statements’’ within the meaning of applicable securities laws. In some cases, these forward-looking statements can be identified by the use of forward-
Slide 3: Who We Are
Who We Are Bonus BioGroup is a clinical-stage biotechnology company focused on developing next-generation therapeutics in the fields of tissue regeneration and biotechnological products based on tissue engineering and cell therapy. Our Vision: BonoFill™, our injectable human live bone graft, grown B
Slide 4: Company Overview
2008 Bonus* was founded by experts in tissue engineering and cell therapy led by Dr. Shai 2013 Meretzki, who pioneered the industrial development of mesenchymal cell therapies Establishment of the world’s first live human bone graft manufacturing facility, in Haifa, Israel. The facility is Good Manu
Slide 5: Bonus' two cellular products set to transform their therapeutic areas
Bonus’ two cellular products set to transform their therapeutic areas Allogeneic, activated Mesenchymal cells (MSC), isolated from the adipose tissue Cell therapy of healthy donors to treat severe and critical Injectable, high-density culture based on cells derived from the COVID Broad, early inhibi
Slide 6: MesenCure and BonoFill market highlights
MesenCure BonoFill Highlights: US only Highlights: US only The total addressable market for The total addressable for treating severe/critical COVID ~953k patients and non-COVID ARDS ~6.2M treating various bone defects Patients patients who could benefit from patients in patients who could benefit M
Slide 7: BonoFill Viable Bone Graft
Bonus BioGroup’s Lead Product: BonoFillTM Viable Bone Graft ▪ BonoFillTM is a tissue-engineered, personalized, injectable bone graft, manufactured from the patient’s own cells for the purpose of bone tissue regeneration ▪ Bonus BioGroup achieved a revolutionary breakthrough in safe, efficient and ra
Slide 8: Bone Grafts - The Need
Currently, two bone-filling alternatives (inferior to Bonus BioGroup’s technology) Autologous transplant (using own bone) requires two procedures: bone harvesting and Bone Grafts - The Need transplantation Limitations: ▪ Millions of patients requiring a • Invasive surgical procedure bone transplant
Slide 9: BonoFill: An Injectable, autologous, viable bone graft
Liposuction Our Solution: BonoFillTM An Injectable, autologous, viable bone graft Cell Isolation 3D Scaffold BonoFillTM is a bone graft made of a 3D culture of Bioreactor mesenchymal cells isolated from the patient’s adipose tissue and grown on natural mineral scaffolds in a specialized bioreactor.
Slide 10: Manufacturing facilities
Manufacturing facilities in the new Bonus BioGroup Center • Two production centers for BonoFill and MesenCure • Constructed according to GMP Grade B level • Designed in compliance with FDA and EMA requirements for the manufacturing of cell therapies • Production capacity suitable for commercial acti
Slide 11: BonoFill Properties and Advantages
BonoFillTM Properties and Advantages: Viability & Comparability Our Solution: High quality bone graft which is BonoFillTM biologically identical to natural bone An Injectable, Autologous, Viable Safety Personalized, autologous bone graft, made from Bone Graft the patient’s own cells, with significan
Slide 12: BonoFill Preclinical Efficacy Results
Complete bridging of the bone gap achieved BonoFillTM within 7 weeks after BonoFill™ transplantation Preclinical Efficacy Results CT at 12 weeks post transplantation Control BonoFillTM Repair and regeneration of a 3.2 cm critical-sized bone defect Control BonoFillTM 1 week New bone 12 weeks 7 weeks
Slide 13: BonoFill Preclinical Efficacy Results
BonoFillTM – Preclinical Efficacy Results The Repair of Large Critical-Sized Bone Defects Bone repair of a 10cm critical-sized bone gap with BonoFillTM was achieved in 2 months Results demonstrate the properties and potential of BonoFillTM injectable bone graft T=2M 13
Slide 14: Preclinical result: Intra femoral injection model
Preclinical result Intra femoral injection model Confined space BonoFillTM Injection Homogenous BonoFillTM spread 14
Slide 15: Preclinical result: Intra femoral injection model
Preclinical result Intra femoral injection model Bone Implant Control Bone Implant 15
Slide 16: BonoFill Clinical Trials
BonoFillTM Clinical Trials Ongoing Clinical Trials: Finalized Clinical Trial - BNS02 Phase I/II clinical trials with BonoFillTM, 2nd generation, in the First-in-human, phase I/II in Maxillofacial Indication with BonoFillTM (1st generation): following indications ▪ Bone augmentation in the sinus ▪ Fi
Slide 17: Clinical Trials Results BNS03 (interim results)
Clinical Trials Results Most of the patients were already treated BNS03 (interim results) and analyzed in the Craniomaxillofacial augmentation indication Clinical Trial interim Results in the Safety Maxillofacial Indication of Bone augmentation in the sinus No treatment-related adverse events occurr
Slide 18: BonoFill Maxillofacial Bone Regeneration
T=0 T=3M T=6M BonoFillTM Maxillofacial Bone Regeneration Preliminary Results BNS03 Pre transplant, all patients suffered Pre transplant, the Three months Six months from low quality residual upper patients’ average following BonoFillTM following BonoFillTM jawbone and insufficient bone residual bone
Slide 19: BonoFill Orthopedic Indication, BNS05
BonoFillTM – Orthopedic Indication Critical Bone Defect, Preliminary Results* - BNS05 Pre-Transplant 12 Months Post Transplant ▪ Non-union fractures of the radius and ulna ▪ Complete healing and closure of the bone gap ▪ Constant pain ▪ No pain ▪ Lack of weight bearing ability ▪ Normal function and
Slide 20: BonoFill Orthopedic Indication, BNS05
BonoFillTM – Orthopedic Indication Critical Bone Defect, Preliminary Results - BNS05 Pre-Transplant 12 Months Post Transplant Two and a half months ▪ 5 cm long bone gap ▪ Complete healing and gap closure after BonoFillTM ▪ Constant pain ▪ No pain Transplantation ▪ Limited weight bearing ability ▪ No
Slide 21: Patient took part in the Iron Man competition
13 months post transplantation, the patient took part in the Iron Man competition When Danny Yaakobson, an extreme sports enthusiast, suffered a serious leg injury following a car accident, he did not imagine he would become the world’s first patient to receive Bonus BioGroup’s lab-grown bone implan
Slide 22: Israeli lab grows bones
Israeli lab grows bones 22
Slide 23: Ongoing Clinical Studies BNS03 and BNS05 Preliminary Results summary
Ongoing Clinical Studies BNS03 and BNS05 Preliminary Results summary BNS03: maxillofacial indication BonoFill safety and currently treating patients within a efficacy were phase II clinical trial. Most of the demonstrated in dozens of patients have been treated, patients for the purpose of completed
Slide 24: BonoFill applications
BonoFill revolutionizes the safety and efficacy of bone grafting Minimized risk for graft rejection Grown from cells obtained from the patient’s adipose tissue Craniomaxillofacial Clinical stage Tailor-made for best healing outcome Designed to precisely fit patients’ anatomical Orthopaedic deficienc
Slide 25: BonoFill could capture a proportion of over 70 Bn USD
In the US alone, BonoFill could capture a proportion of over 70 Bn USD opportunity in 2030 All applications 2k-43k 6M 70 Bn USD1 X patients = USD Orthopaedics Value created per # of eligible procedures or Total Addressable procedure by BonoFill patients per year (US only) Market (US) 31k 15 480k USD
Slide 26: MesenCure
MesenCure An enhanced Mesenchymal Cell Therapy for COVID 26
Slide 27: Immune response during COVID
Immune ARDS response SARS-CoV-2 Neutrophils during COVID ? Pro-inflammatory Type I IFN cytokines ACE2 Monocytes/Macrophages Alveolar epithelium Type II Alveoli and other cells (?) Acute phase: Th1/Th17 ▼ lymphocytes (lymphopenia) ▼ CD4+ and CD8+ T cells ▲ Neutrophils and monocytes Adapted from: Asia
Slide 28: Why MSCs?
Why MSCs? Immunomodu- Beneficial in Approved Safe in Can be readily latory and anti- pneumonia for other allogeneic expanded to inflammatory models indications administration large numbers 28
Slide 29: MSC interactions with host immunity
MSC interactions with host immunity Adapted from: Front. Immunol., 04 June 2019 | https://doi.org/10.3389/fimmu.2019.01191 29
Slide 30: Proposed MoA of MSCs in inflammatory lung diseases
Proposed MoA of MSCs in inflammatory lung diseases Asthma ARDS Adapted from: Stem Cells Int. 2019; 2019: 4236973. doi: 10.1155/2019/4236973 COPD 30
Slide 31: MesenCure: A professionalized cell therapy product
MesenCure: A professionalized cell therapy product based on primed and standardized allogeneic adipose MSCs, dedicated to the treatment of pneumonia and ARDS Professionalization to enhance Highly efficient MSC isolation, MSC potency by a timely expansion, and preservation exposure to a combination o
Slide 32: MesenCure
MesenCure A robust allogeneic, adipose-derived MSC-based therapy enhanced to treat ARDS, including in severe COVID patients 32
Slide 33: MesenCure, but not Non-Activated MSCs, Reduce Lung Edema by 66%
Results from a preclinical model for acute respiratory distress syndrome (ARDS) Reduced lung weights following MesenCure treatment, relative to diseased untreated lungs (Vehicle Control) or lungs treated by non- MesenCure, activated MSCs is indicative of reduced edema that is typical and life- but n
Slide 34: MesenCure Reduced the Levels of Immune Cells in the Lung Fluids
MesenCure Reduced the Levels of Immune Cells in the Lung Fluids by >40% Reduction in the levels of immune cells in the diseased lungs, following MesenCure treatment and relative to diseased untreated lungs (Vehicle Control), is indicative of reduced pneumonia and better prognosis 34
Slide 35: MesenCure
Healthy, non-treated Diseased Lungs MesenCure MesenCure reduces the infiltration of immune cells into the lungs healing pneumonia within less than 24 hours 35
Slide 36: Completed Phase II clinical study
Completed Phase II clinical study • Controlled Phase II study • Treating ARDS in severe COVID patients • 50 severe patients with SpO2 ≤ 93% and/or diffuse pneumonia were treated with MesenCure on top of the SoC • Dose: 1.5•106 cells/kg BW • Up to three doses • Safety and efficacy endpoints tested Sp
Slide 37: Results of treating 50 severe COVID patients with MesenCure
Results of treating 50 severe COVID patients with MesenCure compared to a control group of 150 similar, severe patients that received a standard care 68% reduced mortality (p < 0.05) 9.4 reduced hospital LoS of the most days complicated patients* (p < 0.01) reduced risk of invasive ventilation 57% (
Slide 38: >68% reduced mortality in severe COVID
>68% reduced mortality in severe COVID patients treated with MesenCure 38
Slide 39: Patients treated with MesenCure were discharged after two days
Patients treated with MesenCure were discharged after a median of two days after the last dose 39
Slide 40: MesenCure shortened hospital length of stay
MesenCure shortened the hospital length of stay (LoS) of the most complicated patients (LoS > 7 days) by 9.4 days or 38% Accelerated healing → ❖ Less risk for long Covid and reduced disabilities ❖ Free up hospital and ICU bed allowing better care for other patients ❖ Reduced immediate and long-term
Slide 41: >57% reduced risk of invasive ventilation
>57% reduced risk of deteriorating to invasive ventilation in severe COVID patients treated with MesenCure 41
Slide 42: Pulmonary infiltrates are rapidly cleared
Pulmonary infiltrates are rapidly cleared in severe COVID patients treated with MesenCure Six representative patients, before MesenCure treatment, lungs are congested with inflammatory infiltrates, obstructing breathing Approx. 30 days after MesenCure treatment, inflammation is cleared 42
Slide 43: Pulmonary infiltrates are rapidly cleared in treated patients
Pulmonary infiltrates are rapidly cleared in treated patients Female Male ✱✱✱✱ All ✱✱✱✱ ✱✱✱✱ ✱ ✱✱✱ ✱✱ ✱✱✱✱ ✱ ✱ 100 100 100 Diffuse pneumonia Diffuse pneumonia Diffuse pneumonia (% of lungs area) (% of lungs area) (% of lungs area) 80 80 80 60 60 60 40 40 40 20 20 20 0 0 0 1 6 8 1 6 8 1 6 8 t t t it
Slide 44: CRP levels, Visit 6 and Visit 1
400 400 CRP (mg/L) CRP (mg/L) CRP (mg/L) CRP (mg/L) Female Male All 300 CRP (mg/L) CRP (mg/L) 200 300 ns 500 ns 500 ns 300 200 200 100 400 400 100 100 200 Visit 6 (after treatment) Visit 1 (baseline) 300 300 0 0 0 MesenCure 200 200 t ol ol t l t es o es es tr tr tr 100 -T -T reduced median -T on on
Slide 45: CK levels, Visit 6 and Visit 1
6400 6400 6400 3400 3400 400 Female Male 400 All 3400 ns 400 400 400 ns ns CK (U/L) 400 CK (U/L) CK (U/L) 6400 6400 300 300 6400 3400 300 3400 3400 200 200 400 200 400 400 400 Visit 6 (aftertreatment) Visit 1 (baseline) 400 CK (U/L) 100 400 CK (U/L) 100 100 CK (U/L) 300 300 MesenCure 300 0 0 0 200 r
Slide 46: MesenCure can become an integral part of managing COVID
MesenCure can become an integral part of managing pandemic and endemic COVID Antiviral MesenCure Vaccines Ventilation drugs Population protection Mild-to-moderate patients For severe patients; save Critical patients (alleviate healthcare burden) (alleviate healthcare burden) lives and alleviates ICU
Slide 47: MesenCure applications
MesenCure revolutionizes COVID treatment via cytokine storm control Treatment shown highly effective in severe COVID Culture specifically designed to enhance the cells efficacy in Clinical stage treating COVID Severe/critical COVID MesenCure applications Effective by controlling multiple inflammator
Slide 48: MesenCure could reduce average per patient costs by ~40%
MesenCure could reduce average per patient costs by ~40% ASSESSMENT AS OF 18/06/2021 – BASED ON MESENCURE TRIAL OUTCOME AS OF MAY 2021 – US ONLY Severe3 (ICU w/o MV) Critical2 (ICU + MV1) SoC 22 22 Average length of stay (each bar represents 1 day in hospital) MesenCure 12 12 1 day non-ICU 1 day ICU
Slide 49: MesenCure could capture over 33 Bn USD opportunity in ARDS
In the US, MesenCure could capture, by 2030, a proportion of over 33 Bn USD opportunity in ARDS alone # of eligible patients Value created per per year (US only, post Total addressable patient by MesenCure pandemic) US market All-cause ARDS 32-39k 953k 33 Bn USD1 X patients = USD COVID-related ARDS
Slide 50: Bonus BioGroup - Intellectual Property
Bonus BioGroup - Intellectual Property ▪ 3 patent families include patent applications specific to bone Bonus BioGroup holds rights of graft and bone particles, methods for obtaining de novo bone exclusive use in seven families of graft/particles and methods for treatment of bone pathologies patents
Slide 51: Bonus BioGroup: Product Pipeline
Bonus BioGroup: Product Pipeline CLINICAL CLINICAL PRODUCT CANDIDATE DISCOVERY PRECLINICAL Phase I/II Phase III BonoFillTM - bone graft for maxillofacial applications BonoFillTM - bone graft for orthopedic applications MesenCure – cell therapy for severe COVID patients MesenCure – additional applica
Slide 52: Bonus BioGroup (TASE: BONS) - Listing on the TASE
Bonus BioGroup (TASE: BONS) - Listing on the TASE ▪ Bonus Therapeutics was incorporated under the laws of the State of Israel and commenced operations on 2008, as a private company. As of April 2012, Bonus Therapeutics became a wholly-owned subsidiary of Bonus BioGroup. ▪ Since then, Bonus BioGroup
Slide 53: Bonus BioGroup - Listing on the NASDAQ
Bonus BioGroup - Listing on the NASDAQ ▪ Bonus BioGroup is considering conducting a public offering of its shares on the NASDAQ Capital Market. ▪ One of the goals of listing the company's shares for trading on NASDAQ, is to use a large financial platform to announce the company's achievements in a s
Slide 54: Leadership
Leadership Shai Meretzki, Ph.D., Founder, CEO and President Dror Ben David, Ph.D., Head of R&D Dr. Meretzki has proven operational, Dr. Ben-David is in charge of the company’s R&D management and leadership abilities in Life operations. He is a highly experienced R&D manager who Science companies. Fo
Slide 55: Why Us?
BRIDGING THE GAP Why Us? Ability to manufacture and supply live tissues and cells with demonstrated efficacy and safety Broad R&D pipeline Relatively short regulatory process Versatile technological platforms suitable for various clinical indications Strong IP and high entry barriers for competition