Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — NeoStem — Investor Presentation (November 2012)
26 slides from Lisata Therapeutics's investor presentation, Nov 14, 2012
Slide 1: Investor Presentation
Investor Presentation NYSE MKT: NBS November 2012
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: Cell Therapy Development and Commercial Operations
3 Cell Therapy Development Commercial Operations U.S. East Coast U.S. West Coast Europe* *2013
Slide 4: Transaction Timeline
2006 2007 2008 2009 2010 2011 2012 2013 Acquired Stem Cell Technologies, Inc. Acquired CBH (51% of Erye) Acquired Acquired Divested Commercial and European Expansion Began 5 year partnership with Vatican for adult stem cell education Phase III Medical Acquired NeoStem, Inc. NYSE MKT: NBS Transaction
Slide 5: The Ingredients for Success
• Strong and nimble management team • Access to Capital o Over $100M raised to date o Secured $15m of non-dilutive capital • Pipeline of Cell therapies in development • Expanding IP portfolio • State-of-the Art contract manufacturing and research organization (East and West Coast operations) The Ing
Slide 6: 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 7: 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 7
Slide 8: The Body's Natural Repair Mechanism Is Not Sufficient After AMI
Hypoxic/ischemic myocardium in peri-infarct zone signals need for perfusion (and cells will soon undergo apoptosis) CD34+CXCR4+ angiogenic & anti- apoptotic (via akt) cells could migrate to SDF-1 but don’t respond to cardiac signal The Body’s Natural Repair Mechanism Is Not Sufficient After Acute My
Slide 9: AMR-001 Brings Repair System to the Heart
AMR-001 Brings Repair System to the Heart in Order to Preserve Function CD34⁺CXCR4+ Cells are a natural repair mechanism 9
Slide 10: Phase 1 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 11: Phase 1 Study Results: AMR-001 Preserves Function
Phase 1 Study Results: AMR-001 Preserves Function • Myocardial Perfusion Improved: o Dose-related improvement of perfusion via CD34+/ SDF-1 mobile cells (SPECT measured RTSS) • Myocardial Tissue Preserved: o Dose-related improvement in tissue preserved via CD34+/ SDF-1 mobile cells (% infarct size b
Slide 12: Increasing Doses Reduced Ischemic Tissue Effect
Phase 1 Study Results: Increasing Doses of CD34+/ SDF-1 Mobile Cells Reduced Ischemic Tissue Effect measured as RTSS via SPECT-Sestamibi Quyyumi AA et al 2011, American Heart Journal; 161(1) 98-105 Y= Δ RTSS, X = Dose of SDF1 mobile CD34 cells 12
Slide 13: Increasing Doses Reduced Infarct Size Effect
Phase 1 Study Results: Increasing Doses of CD34+/ SDF-1 Mobile Cells Reduced Infarct Size Effect measured by reduced percent infarct size by CMR Quyyumi AA et al 2011, American Heart Journal; 161(1) 98-105 Y= Δ Infract % LV Mass, X = Dose of SDF1 mobile CD34 cells 13
Slide 14: CD34+ Cell Therapy Improves Blood Flow and Preserves Heart Function
Delivery of CD34+ Cell Therapy Improves Blood Flow and Oxygen Delivery While Preserving Heart Function AMR-001 (CD34+ cells) delivered via coronary artery to hypoxic heart tissue New blood vessel growth starts within days to preserve cells and restore heart function 14
Slide 15: PreSERVE-AMI Phase 2 Study
PreSERVE-AMI Phase 2 Study 15 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 16: 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 17: Additional Potential Indications for AMR-001
Additional Potential Indications for AMR-001 • AMR-001 platform can be applied to other conditions caused by underlying ischemia o Chronic myocardial ischemia post-AMI o Congestive heart failure o Critical limb ischemia o Ischemic brain injury • Broad and growing patent portfolio supports cardiac an
Slide 18: 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 19: 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 20: Intellectual Property
• NeoStem develops therapies for chronic unmet medical needs around a strong IP portfolio • NeoStem’s patent estate includes: o Amorcyte – 3 patents granted and multiple patents pending o Athelos – 20 patents granted/3 pending patents o VSEL Technology – 8 patent families pending o Composition of ma
Slide 21: Progenitor Cell Therapy Contract Development and Manufacturing Organization
Progenitor Cell Therapy Contract Development and Manufacturing Organization Manufacturing Experience • Numerous cell types • Various cell processes • Several therapeutic applications • Immunotherapy • Hematopoietic replacement • Tissue repair 13 Year Proven Track Record 21
Slide 22: Capacity
Capacity 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 22
Slide 23: Business Model & Capabilities
• Large and small companies in the cell therapy space outsource services for all or part of their manufacturing needs: • Currently operates 55,000 square feet of North American facilities with cGMP manufacturing capacity – Enables lower costs for internal cell therapy development – Cash flow that ca
Slide 24: Key Financial Metrics
24 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 25: Why Invest Now?
Why Invest Now? Exciting Proprietary Cell Therapy Pipeline • Phase 2 AMR-001 PreSERVE trial enrollment underway and data read-out expected in late 2013 o Patient accrual is underway • Strong IP portfolio in a rapidly growing industry o $50 billion is spent annually on regenerative medicine o Industr
Slide 26: 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 v4 26