Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — NeoStem — Investor Presentation (January 2012)
27 slides from Lisata Therapeutics's investor presentation, Jan 6, 2012
Slide 1: NeoStem, Inc. Investor Presentation January 2012
NeoStem, Inc. (“NBS”) Investor Presentation January 2012
Slide 2: Forward-looking statements
2 Included in this presentation are “forward - looking” statements within the meaning of the Private Securities Litigation Reform Ac t of 1995, as well as historical information. Such forward - looking statements involve known and unknown risks, uncertainties and other factors which may cause the ac
Slide 3: NeoStem: A Leader in Cell Therapy
3 Cell Therapy Pipeline Regenerative Medicine VSEL TM Technology Cardiovascular Amorcyte P1 Asset T - Reg Cells: Restoring Immune Balance Preclinical Asset VSELs™: Pluripotent Adult Stem Cells P2 Asset AMR - 001: Cardiovascular Disease Autoimmune Athelos NeoStem is a global cell therapy company with
Slide 4: Commercial Scale Manufacturing
4 Commercial Scale Manufacturin g • Industry leader in commercial cell therapy manufacturing • 50,000 square feet of cGMP manufacturing capability located in North America and China • Manufactured 30,000+ cell therapy product procedures and delivered 6,000+ cell therapies to patients worldwide for o
Slide 5: Progenitor Cell Therapy: Extensive Pipeline
5 Progenitor Cell Therapy: Extensive Pipeline • PCT has experience with virtually every cell type including dendritic cells (7 years of manufacturing for Provenge ®) • Partnering relationships with a goal of commercial manufacturing • Active companies in the cell therapy space include: Preclinical I
Slide 6: AMR-001 product overview
6 • An autologous pharmaceutical grade product: purified and enriched natural cell population derived from patients’ bone marrow and intended to preserve heart muscle function and limit MACE following acute myocardial infarction • Clinical biologic dosing threshold established in clinical trial • De
Slide 7: Clear Unmet Medical Need for AMI Patients
7 7 7 • Of the 800,000 annual AMI patients in U.S., 20% (160,000) are STEMI, and experience progressive deterioration in heart muscle function leading to: • Premature Death • Recurrent Myocardial Infarction • Congestive Heart Failure Clear Unmet Medical Need for AMI Patients References: American Hea
Slide 8: CD34+CXCR4+ Cells are a Natural Repair Mechanism
8 Cell Type: CD34⁺CXCR4 + Cells are a Natural Repair Mechanism • A distress signal (HIF) is induced by hypoxia in the peri - infarct zone • HIF induces synthesis of SDF and VEGF, which mobilize CD34 + CXCR4 + cells • The mobilized cells are trophic to the peri - infarct zone, preventing apoptosis th
Slide 9: PreSERVE AMI Trial for AMR-001
9 PreSERVE AMI Trial for AMR - 001 • Patient presents with chest pain + STEMI • All enrolled patients receive a stent • If ejection fraction (EF) ≤ 48%, patient is enrolled in trial & randomized for treatment Day 1 Day 4 • Patient bone marrow harvested • CD34 + CXCR4 + isolated using proprietary tec
Slide 10: AMR-001 Phase 1 Clinical Trial Protocol
10 AMR - 001 Phase 1 Clinical Trial Protocol 10 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
Slide 11: Dose Response Established
11 11 11 Dose Response Established Y = Δ Infarct % LV Mass, X = Dose of SDF1 mobile CD34 cells Increasing doses of AMR - 001 reduced the size of the infarct region by CMR Increasing doses of AMR - 001 reduced RTSS ( hypoperfusion ), and improved perfusion Y= Δ RTSS, X = Dose of SDF1 mobile CD34 cell
Slide 12: Threshold Dose for Efficacy Established
12 12 12 Threshold Dose for Efficacy Established RTSS ( Hypoperfusion ) Baseline correlates with infarct size 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 Patients dose
Slide 13: Subgroup Analyses: Additional Cardiac Function Test Results
13 13 13 Subgroup Analyses: Additional Cardiac Function Test Results RTSS ( Hypoperfusion ) 6 month Base Line 6 Mo. Δ % Δ Below Threshold 385.4 398.1 +12.6 +3.3 Above Threshold 814.3 558.6 - 255.8 - 31.4 (p=0.01)* * change in 10M/15M cells cohorts significant compared to 5M cells/Control cohorts Eje
Slide 14: PreSERVE AMI Trial Phase 2 Clinical Plan
14 PreSERVE AMI Trial Phase 2 Clinical Plan 14 Indication Post - AMI Preservation of Cardiac Function Primary Endpoint Increased Cardiac Perfusion (RTSS) measured by SPECT Other Endpoints A composite of endpoints will be used to determine overall cardiac function (including preservation of LVEF and
Slide 15: AMR-001 Advantages in the Landscape
15 15 15 Clinical Development Stage PII PII PI PI PII PII PII PI PII Field of Use AMI AMI AMI AMI AMI AMI HF HF CMI Defined Mechanism of Action x x x x x Autologous x x x x x x Potential Toxicities /Safety Signals x x x Centralized Manufacturing x x x x x x x x cGMP Defined Product x x x x x x x Thr
Slide 16: Pharmacoeconomic Impact
16 16 16 Pharmacoeconomic Impact • Adverse left ventricular remodeling after STEMI results in an average medical burden of ≥ $50K per patient, per year of life • If the patient’s LVEF declines below 40%, then the cost per year escalates for the balance of the patient’s lifetime • AMR - 001 is design
Slide 17: Additional Potential Indications for AMR-001
17 Additional Potential Indications for AMR - 001 • AMR - 001 platform can be applied to other conditions resulting from underlying ischemia • Chronic Myocardial Ischemia post - AMI • Cardiomyopathy : – Ischemic – Chemotherapy Induced • Congestive Heart Failure • Critical Limb Ischemia • Cryopreserv
Slide 18: Athelos: T-reg Cells - Restoring Immune Balance
18 18 18 Athelos: T - reg Cells - Restoring Immune Balance • Partnership with Becton Dickinson which owns 20% of the Athelos subsidiary • Immune mediated diseases, such as GVHD, autoimmune diseases and allergic diseases, are a result of an imbalance between T - effector cells and T - regulatory cell
Slide 19: VSEL Pluripotent Adult Stem Cells
19 19 19 VSEL™ Pluripotent Adult Stem Cells heart neuron pancreas VSEL™ • VSEL™ (Very Small Embryonic - Like) technology is NeoStem’s proprietary adult stem cell technology platform • Believed to be naturally pluripotent – no manipulation required • iPSCs (induced pluripotent stem cells) are recogni
Slide 20: Financial Highlights
20 20 20 Financial Highlights Key Metrics as of September 30, 2011 Revenue $56.0m (nine months ended 9/30/11) Cash Position $15.6m* Net Loss Excluding Non - Cash Charges $10.0m (nine months ended 9/30/11)* Total Stock and Equivalent Shares Common Shares 100.4m Options 17.7m Warrants 35.2m Series E P
Slide 21: Key Executives
21 21 21 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
Slide 22: Recent and Expected Milestones
22 22 22 • First patient enrollment in PreSERVE AMI Phase 2 trial (Q1 2012 ) • Expansion of intellectual property beyond cardiovascular disease (Q1 2012) • Start of AMR - 001 trial in congestive heart failure (2012) • Athelos – data read - out from investigator sponsored P1 trials in GVHD, diabetes,
Slide 23: Questions
23 23 23 Questions
Slide 24: Board of Directors
24 24 24 Board of Directors Robin Smith, MD, MBA CEO & Chairman of the Board MD – Yale; MBA – Wharton Formerly President & CEO IP2M (HC multimedia), EVP & CMO HealthHelp (radiology management) Experience - Trustee of NYU Medical Center; Chairman of the Board of NYU Hospital for Joint Diseases
Slide 25: Amorcyte Scientific Advisory Board
25 25 25 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 Heart of Greater Cincinnati Douglas L. Mann, MD, FACC Washington University School of Medicine Andrew L. Pecora, MD, FACP, CPE
Slide 26: Athelos Scientific Advisory Board
26 26 26 Athelos Scientific Advisory Board Robert A. Preti, PhD, Chairman Progenitor Cell Therapy Bruce Blazar, MD University of Michigan Masonic Cancer Center Jeffrey Bluestone, PhD University of California, San Francisco, Diabetes Center David A. Horwitz, MD University of Southern Californ
Slide 27: Appendix: GAAP to Non-GAAP Reconciliations
27 27 27 Appendix GAAP to Non-GAAP Reconciliations for the nine months ended September 30, 2011 Cash Position Reconciliation Cash & cash equivalents 11,713,338$ Short term investments 555 Restricted cash 1,427,827 Cash included in Other Assets 2,500,000 (represents cash held in escrow as security as