Bone Biologics Corp · NASDAQ:BBLG
Bone Biologics — Investor Presentation (December 2024)
17 slides from Bone Biologics's investor presentation, December 2024
Slide 1: Regenerative Medicine for Bone
NASDAQ: BBLG Regenerative Medicine for Bone INVESTMENT PRESENTATION / DECEMBER 2024
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains “forward-looking” of past preclinical studies and clinical trials may not be statements, including, without limitation, statements predictive of subsequent trials; our reliance on third relating to: the future of Bone Biologics; our business parties t
Slide 3: Bone Biologics is redefining bone regeneration with NELL-1
Bone Biologics is redefining bone regeneration with NELL-1, a growth factor that has already demonstrated an increase in the quantity and quality of bone in large animal models, while displaying a strong safety profile. 3
Slide 4: A Disruptive Technology in Clinical Development
INVESTMENT THESIS A Disruptive Technology in Clinical Development 01 • Addressing a clinical unmet • Pilot clinical study data BUSINESS need for hard healers with a readout is next major distinct safety profile milestone $3B $11.2B $8B 02 OPPORTUNITY Global spine fusion market Osteoporosis market Tr
Slide 5: Large Addressable Orthobiologics Market
Large Addressable Orthobiologics Market STEM CELLS GROWTH FACTORS 14% 34% NON-PROPRIETARY ALLOGRAFT 6% $3B Global Bone Graft Substitute SYNTHETICS Market 27% DBM 19% Sources: Orthopedic Network News 5
Slide 6: Hard Healer Fusion Remains a Critical Clinical Unmet Need
BONE BIOLOGIC’S SOLUTION Hard Healer Fusion Remains a Critical Clinical Unmet Need A major challenge in orthopedic surgery is effective bone regeneration – especially in hard healers. CHALLENGES WITH rhBMP PROPOSED NELL-1 SOLUTION Rapid, uncontrolled bone growth can cause Rapid, controlled, guided b
Slide 7: Improved Safety From Later Pathway Interaction
NELL-1 MECHANISM OF ACTION Improved Safety From rhBMP Later Pathway Interaction Mesenchymal Stem Cells • NELL-1 acts later in the pathway of bone formation and only grows Differentiates bone in presence of bone to bone (improved safety) Runx2 • Runx2 protein is known as the “Master Switch” which act
Slide 8: Nell-1 Demonstrates Technology Viability
NELL-1 WELL ESTABLISHED IN LITERATURE Nell-1 Demonstrates Technology Viability Over 45 peer-reviewed publications support MOA and its potential for better bone formation. Novel Wnt Regulator NEL-Like Molecule-1 Antagonizes Adipogenesis and Augments Osteogenesis Induced by Bone Morphogenetic Protein-
Slide 9: No Change to Protocol with Orthobiologic Prep and Implantation
SURGICAL PROCEDURE REMAINS THE SAME No Change to Protocol with Orthobiologic Prep and Implantation NB-1 rhNELL-1 DBM A vial of NELL-1 and A delivery device will allow NELL-1 + DBM mixture is Demineralized Bone Matrix the surgeon to deliver the then inserted into cage, just (DBM) will be sold in a re
Slide 10: Studies Demonstrate Safety & Effectiveness
Studies Demonstrate Safety & Effectiveness • Spine fusion effectiveness demonstrated across 3 animal species (rodent, sheep, NHP) • Extensive outcome measures including micro CT, x-ray, histology, and biomechanics • Completed two clinically relevant sheep studies that demonstrated that rhNELL-1 had
Slide 11: A Thoughtful Sequence of Clinical Trials
CLINICAL STRATEGY A Thoughtful Sequence of Clinical Trials Trial Design Primary Endpoint Secondary Endpoints 30 patients: • 12 @ 2.0 mg/mL • Fusion success rate @ 12- months from radiological • Adverse events • 12 @ 1.5 mg/mL assessment • Surgical measurements • 6 @ local autograft • Change from bas
Slide 12: Focus on Fusion Provides a Differentiated Product in Clinical Need
NEXT OPPORTUNITIES FOR NELL-1 Focus on Fusion Provides a Differentiated Product in Clinical Need CLINICAL INDICATION DISCOVERY PRECLINICAL PILOT PIVOTAL Spine SPINE Fusion FUSION Trauma TRAUMA Osteoporosis OSTEOPOROSIS 12
Slide 13: A Clear Pathway to Approval
EXPECTED MILESTONES & ACHIEVEMENTS A Clear Pathway to Approval FDA INITIATIVE STABILITY PILOT INITIATE APPROVAL PILOT STUDY STUDY PIVOTAL STUDY EXPANDED 12-MOS DATA STUDY 2024 2025 2026 2027 2028 2029 PILOT PIVOTAL ENROLL 1ST STUDY SUBMIT STUDY PATIENT INTERIM IDE 24-MOS DATA UPDATE 13
Slide 14: Strong IP Barrier
Strong IP Barrier Patent No. Title Issued U.S. Patent No. 9,511,115 Pharmaceutical compositions for treating or preventing bone conditions 12/6/2016 U.S. Patent No. 7,833,968 Pharmaceutical compositions for treating or preventing bone conditions 11/16/2010 U.S. Patent No. 9,447,155 Isoform NELL-1 pe
Slide 15: Leadership Team
Leadership Team Jeffrey Frelick The board of directors are all President & CEO independent and have executive COO Life Science Enterprises operational experience in life science Med-Tech analyst, Canaccord, ThinkEquity, companies. Lazard, Leerink Consultant, Boston Biomedical Consultants Reg
Slide 16: Summary
Summary MARKET OPPORTUNITY • Near-term $3B global market opportunity in spine fusion • Surgeon concern is hard healers - Fusion rates are low - Longer recovery times lead to poorer outcomes • Longer-term potential the $11B osteoporosis and $8B trauma markets NELL-1 SOLUTION • NELL-1 provides rapid,
Slide 17: Contact
Contact Alliance Advisors Investor Relations Jody Cain 310-691-7100 [email protected] bonebiologics.com NASDAQ: BBLG17
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