Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — NeoStem — Investor Presentation (February 2013)
35 slides from Lisata Therapeutics's investor presentation, Feb 11, 2013
Slide 1: Investor Presentation
Investor Presentation NYSE MKT: NBS February 2013
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation includes “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as well as historical information. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may
Slide 3: Regenerative Medicine Market Estimated to Grow to $88 Billion by 2014
Regenerative Medicine Market Estimated to Grow to $88 Billion by 2014* Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects. * The Regenerative Medicine Report, MDB Capital Gr
Slide 4: Cell Therapy Development and Commercial Operations
Cell Therapy Development Commercial Operations U.S. East Coast U.S. West Coast Europe Expected 2013 4 NeoStem develops therapies for chronic unmet medical needs around a significant IP portfolio and also operates a revenue generating service division with expertise in contract manufacturing and cell
Slide 5: Transaction Timeline: Through 2012
Acquired Stem Cell Technologies, Inc. Acquired CBH (51% of Erye) Acquired Acquired Divested Began partnership with Vatican Phase III Medical Acquired NeoStem, Inc. Transaction Timeline: Through 2012 Accessed $120 Million 80% Acquired 5 2006 2007 2009 2010 2011 2012
Slide 6: Deloitte's 2012 Technology Fast 500 - #7 Nationwide
6 Deloitte's 2012 Technology Fast 500™ - #7 Nationwide NeoStem Ranked #1 Fastest Growing Company in the New York Tri-State Region 1. Tesla Motors 2. Palo Alto Networks 3. Sagent Pharmaceuticals, Inc. 4. FireEye, Inc. 5. Aerohive Networks, Inc. 6. Avail-TVN 7. NeoStem Technology Fast 500™, conducted
Slide 7: Built for Success
• Dynamic, experienced and nimble management team • Access to capital - $120M total to date • Advancing clinical and preclinical pipeline of cell therapies o Cardiovascular disease o Autoimmune disorders o Regenerative medicine • Expanding IP portfolio • Recognized, state-of-the art contract develop
Slide 8: Clear Unmet Medical Need for AMI Patients
• More than 10 million AMI patients worldwide • 20% are STEMI putting patients at risk of a progressive deterioration in heart muscle function that leads to: o Arrhythmias o Recurrent myocardial infarction o Congestive heart failure o Premature death • According to AHA, the prognosis for STEMI patie
Slide 9: The Peri-Infarct Zone Becomes the Infarct
A consequence of inadequate perfusion (microvascular insufficiency) is apoptosis and progressive cardiomyocyte loss in the peri-infarct zone, leading to infarct expansion. The Peri-Infarct Zone Becomes the Infarct 9
Slide 10: REPAIR-AMI: Effect on Clinical Risk Post-MI of Bone Marrow Derived Cells
REPAIR-AMI: Effect on Clinical Risk Post-MI of Bone Marrow Derived Cells Leistner et al, AHA 2011 10
Slide 11: Cochrane Collaboration Review: Bone Marrow Derived Cells
Cochrane Collaboration Review: Bone Marrow Derived Cells Likely Safe (And Also Likely to Reduce Reinfarction and Hospitalization) Clifford et al, Cochrane Library 2012 11
Slide 12: Phase Trial Design for AMR-001
Phase 1 Trial Design for AMR-001 Indication Post-AMI with LVEF ≤50% and wall motion abnormality in the myocardium of the IRA Primary Endpoint Safety in post-AMI patients Other Endpoints RTSS* (Perfusion); LVEF; ESV; SDF mobility Key Inclusion Criteria Confirmation of ST Elevation MI; Ejection fracti
Slide 13: Phase Trial Results Summary
Phase 1 Trial Results Summary RTSS (Hypoperfusion) Cohort Base Line 6 months Delta % Change Control 259.0 273.5 +14.5 +5.6 5M Cells 714.2 722.0 +7.8 +1.1 10M Cells 998.6 635.8 -362.8 -36.4 15M Cells 584.0 462.0 -122.0 -20.9 DSMB determined that no adverse events were related to therapy 13 Patients d
Slide 14: Phase Trial Results Summary
Phase 1 Trial Results Summary RTSS (Hypoperfusion) Cohort Base Line 6 months Delta % Change Control 259.0 273.5 +14.5 +5.6 5M Cells 714.2 722.0 +7.8 +1.1 10M Cells 998.6 635.8 -362.8 -36.4 15M Cells 584.0 462.0 -122.0 -20.9 DSMB determined that no adverse events were related to therapy 14 Patients d
Slide 15: Phase Trial Results Summary
Phase 1 Trial Results Summary RTSS (Hypoperfusion) Cohort Base Line 6 months Delta % Change Control 259.0 273.5 +14.5 +5.6 5M Cells 714.2 722.0 +7.8 +1.1 10M Cells 998.6 635.8 -362.8 -36.4 15M Cells 584.0 462.0 -122.0 -20.9 DSMB determined that no adverse events were related to therapy 15 Patients d
Slide 16: Phase Trial Results Summary
Phase 1 Trial Results Summary RTSS (Hypoperfusion) Cohort Base Line 6 months Delta % Change Control 259.0 273.5 +14.5 +5.6 5M Cells 714.2 722.0 +7.8 +1.1 10M Cells 998.6 635.8 -362.8 -36.4 15M Cells 584.0 462.0 -122.0 -20.9 DSMB determined that no adverse events were related to therapy 16 Patients d
Slide 17: Phase Trial Results Summary
Phase 1 Trial Results Summary RTSS (Hypoperfusion) Cohort Base Line 6 months Delta % Change Control 259.0 273.5 +14.5 +5.6 5M Cells 714.2 722.0 +7.8 +1.1 10M Cells 998.6 635.8 -362.8 -36.4 15M Cells 584.0 462.0 -122.0 -20.9 DSMB determined that no adverse events were related to therapy 17 Patients d
Slide 18: PreSERVE-AMI Phase Study
PreSERVE-AMI Phase 2 Study 18 Indication Post-AMI preservation of cardiac function Design Randomized (1:1) Primary Endpoint Change in cardiac perfusion (RTSS by SPECT) from baseline to 6 months Other Endpoints Secondary endpoints to determine preservation of cardiac function and clinical events: CMR
Slide 19: Anticipated Time Line to Commercialization
Anticipated Time Line to Commercialization 2011 2012 2013 2014 2015 2016 2017 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 6 mo. MACE 12 mo. MACE 18 mo. MACE Phase 2 Patient Enrollment 36 mo. MACE FDA Meeting Phase 2 US and EU Phase
Slide 20: Additional Potential Indications for AMR-001
Additional Potential Indications for AMR-001 • Broad and growing patent portfolio supports cardiac and other ischemic conditions • 3 issued US composition of matter and methods patents: • U.S. 7,794,705: Issued 9/14/2010. Indication: Cardiac: Post AMI early and late • U.S. 8,088,370: Issued 1/3/2012
Slide 21: Scientific Advisory Board
Scientific Advisory Board 21 Andrew L. Pecora, MD, FACP, CPE SAB Chairman, Chief Medical Officer, NeoStem Hackensack University Medical Center Eugene Braunwald, MD, FRCP Brigham & Women’s Hospital Bernard J. Gersh, MD, ChB, DPhil, FRCP The Mayo Clinic Dean J. Kereiakes, MD, FACC The Christ Hospital
Slide 22: T-reg Cells to Restore Immune Balance
T-reg Cells to Restore Immune Balance • Partnership with Becton Dickinson, which owns 20% of Athelos • Immune-mediated diseases, such as GVHD, autoimmune disorders and allergic conditions, are a result of an imbalance between T-effector cells and T-regulatory cells (T-reg) • T-reg therapy represents
Slide 23: Scientific Advisory Board
Scientific Advisory Board 23 Robert A. Preti, PhD, Chairman Progenitor Cell Therapy Jeffrey Bluestone, PhD University of California, San Francisco, Diabetes Center David A. Horwitz, MD University of Southern California Robert Korngold, PhD Hackensack University Medical Center Robert S. Negrin, MD St
Slide 24: VSELs – Adult Stem Cells
VSELs – Adult Stem Cells heart neuron pancreas VSEL™ • Very small embryonic-like (VSELsTM) stem cells are believed to be naturally pluripotent • Animal models have demonstrated that highly enriched human VSELs are able to integrate, differentiate and potentially regenerate • Indications being explor
Slide 25: Market Opportunity
Market Opportunity Pre-clinical Manufacturing Clinical Manufacturing Commercial Manufacturing • As the cell therapy market matures, contract service opportunities will grow worldwide • PCT’s planned European and commercial manufacturing capabilities and automation plans are designed to meet market d
Slide 26: Track Record of Success
Mountain View, California (25,000 ft2) ISO Class 7 / Class 10,000 suites Allendale, New Jersey (30,000 ft2) ISO Class 7 / Class 10,000 suites ISO Class 6 / Class 1,000 suite 26 • cGMP/GLP Accredited and Certified Facilities • 14 Year Proven Track Record including: • Over 100 Clients Served and Growi
Slide 27: Business Model & Capabilities
• Large and small companies in the cell therapy space outsource services for all or part of their manufacturing needs to improve efficiencies and profitability and to reduce capital investment: • PCT supports NeoStem’s cell therapy development programs with o Lower costs for internal cell therapy de
Slide 28: Key Financial Metrics
28 Key Financial Metrics (as of November 13, 2012) Revenue1 $11.6m (nine months ended September 30, 2012) Cash Position2 $7.9m (as of September 30, 2012) Additional Cash3 $12.0m Total Stock and Equivalent Shares Common Shares 159.4m Options 21.7m (avg. option exercise price of $1.29) Warrants 55.3m
Slide 29: Short Term Milestones and 2013 Goals
• Half way point of the Phase 2 STEMI trial enrollment • Growth in the PCT business o New clients o Renewal and/or expansion of services with current clients o Expansion into Europe • Progress in VSEL™ technology o Publications o Grants • Strategic acquisitions • Business development transactions Sh
Slide 30: Vatican Partnership: Global Exposure
Vatican Partnership: Global Exposure The authors of The Healing Cell: How the Greatest Revolution in Medical History Is Changing Your Life present the first copy of the book to Pope Benedict XVI. Co-authors: Dr. Robin Smith, Monsignor Tomasz Trafny (Head of Science and Faith Dept., Pontifical Counci
Slide 31: Why Invest Now?
Why Invest Now? Exciting Proprietary Cell Therapy Pipeline • Phase 2 AMR-001 PreSERVE trial enrollment expected to be completed in 2013 with data read out six to eight months thereafter • Strong IP portfolio in a rapidly growing industry o $50 billion is spent annually on regenerative medicine o Ind
Slide 32: Contact Information
Contact Information NeoStem, Inc. NYSE MKT: NBS www.neostem.com Robin Smith, MD, MBA Chairman & CEO Phone: (212) 584-4174 Email: rsmith@neostem.com v9 32
Slide 33: Appendix
0°. NeoStem Appendix
Slide 34: Key Executives
Key Executives Robin Smith, MD, MBA CEO & Chairman of the Board MD – Yale; MBA – Wharton Formerly President & CEO IP2M (HC multimedia), EVP & CMO HealthHelp (radiology management) Trustee of NYU Medical Center; Chairman of the Board of NYU Hospital for Joint Diseases (through November 2009) an
Slide 35: Board of Directors
Board of Directors Robin Smith, MD, MBA CEO & Chairman of the Board MD – Yale; MBA – Wharton Formerly President & CEO IP2M, EVP & CMO HealthHelp Experience - Trustee of NYU Medical Center; Chairman of the Board of NYU Hospital for Joint Diseases (through November 2009) and Stem for Life Founda