Bonus Biogroup Ltd. · TASE:BONS
Bonus Biogroup — Investor Presentation (2025)
42 slides from Bonus Biogroup's investor presentation, 2025
Slide 1: Bonus Biogroup (TASE: BONS)
(TASE: BONS) 1 All information herein is proprietary to Bonus Biogroup Ltd.
Slide 2: Disclaimer
This presentation has been prepared by Bonus Biogroup Ltd. (“we” or the “Company”) and is made for information purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sales of any securities in any state or jurisdiction in which
Slide 3: We are priming regenerative mesenchymal stem cells
We are priming regenerative mesenchymal stem cells to develop novel tissue engineering and cell therapy solutions 3
Slide 4: Management team
Founder & CEO Executive Chairman Dr. Meretzki is a biotech entrepreneur who Mr. Rauch served as Chief Economist and founded multiple companies, including Manager of the Economics Department at Pluristem (NASDAQ: PLUR), where he served Leumi PIA and held additional leadership as CEO and CTO. He holds
Slide 5: Investment Highlights
Proprietary mesenchymal stem cell (MSC) technology provides 1 operational and developmental efficiencies with broad applicability for treating widespread, urgent, and unmet clinical needs Investment Highlights Bonus Biogroup (TASE: BONS) is Two advanced clinical programs – MesenCure and BonoFill – s
Slide 6: Two lead assets in late-stage clinical trials
Two lead assets in late-stage clinical trials Tissue Engineering Cell Therapy (autologous) (allogeneic) BonoFill™ MesenCure™ A regenerative medicine advanced therapy An enhanced allogeneic cell therapy product product candidate of a live human bone candidate consisting of next-generation graft for t
Slide 7: Proprietary Approach to Harness and Enhance MSC Potency
Proprietary Approach to Harness and Enhance MSC Potency Provides significant upside opportunity in light of negative noise around prior MSC therapies Our Cell Priming and Our GMP-Certified Cell Culturing Our Proprietary Differentiation Methodologies Systems and Processes Cell Formulation • Create no
Slide 8: BonoFill Applications
BonoFill Applications osteoporosis (PC) osteoporosis osteoporosis (PC) (PC) joint reconstruction maxillofacial joint reconstruction (PC) joint reconstruction maxillofacialbones bones (P3) (P3) (PC) (PC) limb bones (P2) spine (PC) limb bones (P2) spine (PC) Clinical stage Preclinical Preclinical deve
Slide 9: BonoFill is a live human bone graft
Liposuction Isolate Seeding on a Semi-automatic Injectable graft Various applications in osteoprogenitors 3D scaffold culturing formulation bone regeneration BonoFill is a live human bone graft composed of mesenchymal cells sampled from the patient's own adipose tissue The cells are seeded onto biod
Slide 10: Bone Autografting: A Century-old Gold Standard Despite Challenges
Bone Autografting: A Century-old Gold Standard Still Used to Treat Bone Defects Despite Challenges Autologous bone grafting account for >30% of non-dental bone grafting procedures Persistent infection rate or non-union Harvesting bone from the patient's body and transplanting it to another site rema
Slide 11: Designed for Scale-Up and Scale-Out
Designed for Scale-Up and Scale-Out BonoFill manufacturing leverages a single-use, disposable bioreactor system ready for automation and designed to mimic the physiological microenvironment of living bone—generating cost-effective, high-density viable bone grafts in just 2-3 weeks. Scale-Up: Meets t
Slide 12: BonoFill versus alternatives
Potentially more A live human bone Designed to provide all effective, accessible, graft potentially ingredients for bone and affordable than suitable for large, regeneration; in current standard of small, and advanced clinical care treatment-refractory development stage bone defects vs• vs• vs• Bone
Slide 13: The BonoFill Market Opportunity
The BonoFill Market Opportunity Total Addressable Market (TAM) Highlights: United States Only (2030) ~5.0M ~$25B ~655K procedures procedures per year USD per year Elective bone grafting TAM opportunity in current Minimal Serviceable Available procedures in orthopedic and study indications based on M
Slide 14: BonoFill Clinical Results
BonoFill Clinical Results 14
Slide 15: Phase 2 trial for maxillofacial bone deficiencies
Phase 2 clinical trial for treating maxillofacial bone deficiencies targeting sinus augmentation and bone void filling in the jaw Study Design Top Line Results • Design: Open-label, single-arm ✔ Complete success in bone reconstruction was achieved in 90% of the transplantations • Enrolment and Demogra
Slide 16: Regeneration of bone in the lower and upper jaw
Regeneration of bone in the lower jaw1 Regeneration of bone in the upper jaw Three months after Dental implants six Three months after Six months after Before treatment BonoFill months after BonoFill Before treatment BonoFill BonoFill T=0 T=3M T=6M • Before treatment, the bone height was 2.9 mm • Be
Slide 17: Phase 2 trial for large-limb fractures and large-bone defects
Phase 2 clinical trial for treating multiple large-limb fractures and large-bone defects incapable of self-healing Study Design Current Status • Design: Open-label, single-arm ✔ As of February 2025, twenty-four subjects aged 23 to 78 years old were enrolled and treated • Enrolment and Demographics:
Slide 18: Forearm fracture and knee bone defect cases
Rehabilitation from complex Regeneration of a large 40 cc bone fracture of the forearm bones defect following valgus knee repair Before treatment A year after BonoFill Before treatment A year after BonoFill • Constant pain • Complete bone bridging • Impaired walking • Improved walking • No weight be
Slide 19: Examples of Using BonoFill to Treat Critical Bone Defects in the Limbs
Examples of Using BonoFill to Treat Critical Bone Defects in the Limbs Rehabilitation from a critical- The world’s first joint fusion sized bone defect in the tibia with BonoFill After 6 Before treatment A year after BonoFill months • Significant constant pain • Rapid healing After 9 • Limited weigh
Slide 20: BonoFill is Well-Positioned for Reimbursement Negotiations
BonoFill is Well-Positioned for Reimbursement Negotiations Based on 55% Estimated Savings vs. SOC Cost of autologous bone grafting in limb bone defects using $26K (residual cost with $31K (55% potential savings from $57K BonoFill) adopting BonoFill) SOC, including: Products used during the procedure
Slide 21: Additional Sources
Additional Sources BonoFill Ben-David, D. et al. (2019). Autologous cell-coated particles for the treatment of segmental bone defects—a new cell therapy approach. Journal of Orthopaedic Surgery and Research, 14(1), 198. [LINK] Tzur, E. et al. (2021). Safety and Efficacy Results of BonoFill First-in-
Slide 22: MesenCure: A Next-Generation Cell Therapy for Inflammation and Tissue Damage
MesenCure: A Next-Generation Cell Therapy for Inflammation and Tissue Damage MesenCure Applications Osteoarthritis, Chronic Kidney Disease, and Cytokine Release Syndrome (PC) Other inflammatory conditions: Respiratory distress, including ARDS (P3) local and systemic, acute and chronic (FO) Clinical
Slide 23: The Unresolved Global Challenge of ARDS
The Unresolved Global Challenge of ARDS* No cure — the current SOC for ARDS is mainly supportive, focusing on symptom management ARDS Healthcare Burden Cost Burden • A critical condition characterized by the • 27% - 45% mortality • $108K - $158K in direct lungs’ inability to supply enough oxygen hos
Slide 24: ARDS Challenges and MSC Challenges
ARDS Challenges • Heterogeneity in etiology and patient profiles • Systemic involvement and comorbidities • Variability in clinical outcomes MSC Challenges • Donor and source tissue variabilities • Loss of therapeutic potency due to overexpansion and cryopreservation • Lack of standardization in MSC
Slide 25: MesenCure: Differentiated by a Proprietary Approach to MSC Therapy
MesenCure: Differentiated by a Proprietary Approach to MSC Therapy The MesenCure innovation rests on multiple technological breakthroughs to overcome the limitations of conventional MSC therapies and to enhance their tissue regenerative and immune-modulatory potency: Priming Bioprocess Formulation U
Slide 26: Key Morphological Distinctions: Natural MSCs vs MesenCure cells
Key Morphological Distinctions: Natural MSCs MesenCure cells M — Mitochondria (Cellular Powerhouse) M MesenCure mitochondria appear more electron-dense N (darker and more pronounced), suggesting improved energy efficiency and greater cellular resilience. N M N — Nucleus (Cell’s Command Center) The nu
Slide 27: MesenCure advanced allogeneic cell therapy
MesenCure is an advanced allogeneic cell therapy and investigational new drug designed to overcome cell therapy limitations in treating inflammation and tissue damage, utilizing primed, proprietary MSCs with a lead indication in respiratory distress, including all-cause ARDS A proprietary composition
Slide 28: MesenCure Reduces Immune Cell Infiltration into the Lungs — Preclinical Study
MesenCure Reduces the Infiltration of Immune Cells Into the Lungs, Healing Pneumonia within 24 Hours — Preclinical Study (murine model) Healthy lungs Pneumonia MesenCure * Alveoli → Alveoli walls 28
Slide 29: MesenCure versus alternatives
Designed as a curative Targets both MesenCure is the only solution for Acute inflammation and cell therapy for ARDS Respiratory Distress tissue damage via that achieved success in Syndrome (ARDS) multiple mechanisms clinical development vs• vs• vs• Standard of Care: Off-label & Cell therapies Steroid
Slide 30: Total Addressable Market (TAM) Highlights
Total Addressable Market (TAM) Highlights >229K cases >$9•4B ~$69B per year The minimal target patient TAM opportunity in all-cause Combined follow-on global population for MesenCure lead ARDS in the United States market for pneumonia, asthma, indication in the United States alone by 2030, based on
Slide 31: Phase 2 completed, IND cleared, Phase 3 pending
P2 Completed a Phase 2 trial in severely ill patients with respiratory distress due to COVID-19 pneumonia, demonstrating a 68% reduction in mortality rate and a 57% decrease in invasive ventilation for patients treated with MesenCure vs. the SOC IND IND application cleared February 2025 for Phase 3
Slide 32: MesenCure Clinical Results
MesenCure Clinical Results 32
Slide 33: Phase 2 study in COVID-19 pneumonia respiratory distress
Severely ill patients with respiratory distress due to COVID-19 pneumonia diagnosed with SpO2 ≤93% in room atmosphere and presenting bilateral pulmonary infiltrates (inclusive of Phase 1). Design: Open-label, retrospectively controlled, multi-center Enrollment and Demographics: The test group consist
Slide 34: MesenCure Phase 2 efficacy results
68% Reduction in 30-day all-cause mortality (p < 0.05) Reduction in length of hospital stay in those patients 9•4 admitted for greater than seven days (p < 0.01) 57% Reduction in the need for invasive ventilation (p < 0.05) Patients treated with MesenCure discharged from the 59% hospital up to two d
Slide 35: Lung congestion before and after MesenCure treatment
Before MesenCure treatment, a median of 53% of the patients’ lung area was congested with inflammatory infiltrates (IQR: 25%-65%), which obstructed breathing (six representative patients are presented below). One month after MesenCure treatment, breathing is normal, and pneumonia has dramatically redu
Slide 36: MesenCure is Well-Positioned for Reimbursement Negotiations
MesenCure is Well-Positioned for Reimbursement Negotiations Based on <40% Estimated Savings vs. SOC Outcomes from a Phase 2 trial to treat 68% less mortality respiratory distress using MesenCure 57% less invasive ventilation 38% less hospital stay* ARDS is associated with prolonged 17 – 47 days in t
Slide 37: Additional Sources
Additional Sources MesenCure Bronshtein, T. et al. MesenCure—an enhanced cell therapy explicitly developed for treating acute respiratory distress in covid-19: from benchtop to bedside. Cytotherapy 23, S21-22 (2021). [LINK] Bronshtein, T. et al. Possible Divergent Local and Peripheral Immunological
Slide 38: GMP-compliant manufacturing facilities
• GMP compliant according to FDA and EMA • Two production halls for BonoFill and MesenCure • Production capacity suitable for commercial activity • Advanced R&D center for cell therapy and tissue engineering BonoFill and MesenCure are certified to comply with Good Manufacturing Practices (cGMP) accor
Slide 39: Patent portfolio
71 approved patents 10 pending applications 6 patent families In the US, Europe, and Asia 39
Slide 40: Product candidate pipeline and upcoming events
Product Candidate Preclinical Phase 1 Phase 2 Phase 3 Upcoming Event BonoFill for maxillofacial bone Phase 3 trial planned for 2026 in the U.S. defects in jaw bones BonoFill for defects in limb bones Phase 3 trial planned for 2027 in the U.S. incapable of healing or untreatable BonoFill for bone aug
Slide 41: Investment Highlights
Proprietary mesenchymal stem cell (MSC) technology provides 1 operational and developmental efficiencies with broad applicability for treating widespread, urgent, and unmet clinical needs Investment Highlights Bonus Biogroup (TASE: BONS) is Two advanced clinical programs – MesenCure and BonoFill – s
Slide 42: The 2024 Advanced Therapies Award in Cell Therapy Biotech Innovation
The 2024 Advanced Therapies Award in Cell Therapy Biotech Innovation L4t2 42 All information herein is proprietary to Bonus Biogroup Ltd. d.