Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — NeoStem — Investor Presentation (January 2012)
42 slides from Lisata Therapeutics's investor presentation, Jan 26, 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: Leader in the Development and Manufacture of Cellular Therapies
3 3 3 NeoStem , Inc. (AMEX : NBS) Leader i n t he Development and Manufacture of Cellular T herapies S trategic combination of revenues including stem cell therapies, contract manufacturing and stem cell services Clinical Development Manufacturing & Services
Slide 4: Cell Therapy Has Already Shown Promise Towards Unmet Therapeutic Needs
4 4 4 Cell Therapy Has Already Shown Promise Towards Unmet Therapeutic Needs • Provide exquisite control of glucose and insulin level (diabetes) • Immune tolerance regimens to combat autoimmunity • MS • Lupus • Osteoarthritis • GvHD • Solid organ rejection Reverse neurological damage Reset the immun
Slide 5: NeoStem's Approach
5 NeoStem’s Approach Therapeutics Development • Autologous Stem Cell based Therapeutic for Cardiovascular Disease (Amorcyte) • T - Regulatory Program for Auto - Immune Disorders, GVHD & Solid Organ Rejection (Athelos) • Regenerative Medicine Program Using Autologous VSELs TM NeoStem is uniquely posi
Slide 6: Clinical Development AMR
6 Clinical Development AMR 001
Slide 7: NeoStem's Cell Therapeutics Pipeline
7 NeoStem’s Cell Therapeutics Pipeline
Slide 8: Clear Unmet Medical Need for AMI Patients
8 8 8 • Of the approximately 800,000 annual AMI patients in the U.S., 20% (160,000) are STEMI, and are at risk to experience progressive deterioration in heart muscle function leading to: • Premature Death • Recurrent Myocardial Infarction • Congestive Heart Failure Clear Unmet Medical Need for AMI
Slide 9: Amorcyte - AMR 001
9 • AMR - 001 is an autologous bone marrow derived pharmaceutical grade therapeutic intended to preserve heart muscle function and limit MACE and other adverse clinical events following an acute myocardial infarction. • Pharmaceutical grade: Defined identity, purity, potency, relevant biologic stabi
Slide 10: CD34+CXCR4+ Cells are a Natural Repair Mechanism
10 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 - 1 which mobilizes CD34 + CXCR4 + cells • The mobilized cells are trophic to the peri - infarct zone, preventing apoptosis throug
Slide 11: AMR-001 Phase 1 Clinical Trial Completed
11 AMR - 001 Phase 1 Clinical Trial Completed 11 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 12: Dose Response Established
12 12 12 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 indicating improved perfusion Y= Δ RTSS, X = Dose of SDF1 mobile CD34 cells Quyyumi AA
Slide 13: Threshold Dose for Efficacy Established
13 13 13 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 14: Subgroup Analyses: Additional Cardiac Function Test Results
14 14 14 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)* * Threshold 10m cells or more Ejection Fraction 6 month BL 6 Mo. Δ % % Δ Below Thresho
Slide 15: Phase 2 PreSERVE AMI Trial Using AMR-001
15 Phase 2 PreSERVE AMI Trial Using AMR - 001 • Patient presents with chest pain + STEMI • All enrolled patients receive a stent • If ejection fraction (EF) ≤ 48% (96 hours post stenting), patient is enrolled in trial & randomized for treatment Day 1 Day 4 • Patient bone marrow harvested • CD34 + CX
Slide 16: PreSERVE AMI Trial Phase 2 Clinical Plan
16 PreSERVE AMI Trial Phase 2 Clinical Plan 16 Indication Post - AMI Preservation of Cardiac Function Primary Endpoint Increased Cardiac Perfusion (RTSS) measured by SPECT at baseline and 6 months Other Endpoints A composite of endpoints will be used to determine overall cardiac function (including
Slide 17: Pharmacoeconomic Impact
17 17 17 Pharmacoeconomic Impact • Adverse left ventricular remodeling after STEMI results in an average medical burden of ≥ $50K per patient, per year of life • If a patient’s LVEF declines below 40%, then the cost per year escalates for the balance of the patient’s lifetime • AMR - 001 is designed
Slide 18: Additional Potential Indications for AMR-001
18 Additional Potential Indications for AMR - 001 • AMR - 001 platform can be applied to other conditions resulting from underlying ischemia • Chronic myocardial ischemia post - AMI • Congestive heart failure • Critical limb ischemia • Cryopreserved preparations of AMR - 001 for future vascular insu
Slide 19: Athelos: T-reg Cells - Restoring Immune Balance
19 19 19 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 20: VSEL Pluripotent Adult Stem Cells
20 20 20 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 recogn
Slide 21: Manufacturing & Services
Manufacturing & Services ° 2. Prégenitor" Neesiem ® Sarpy ttc FAM STENCH EAN Kseeee 2
Slide 22: Progenitor Cell Therapy (PCT): Commercial Scale Manufacturing
22 Progenitor Cell Therapy (PCT): Commercial Scale Manufacturin g • Recognized industry leader in commercial cell therapy manufacturing • Manufactured 30,000+ cell therapy product procedures and delivered 6,000+ cell therapies to patients worldwide for more than 100 clients • 50,000 square feet of c
Slide 23: PCT's Extensive CMO Pipeline
23 PCT’s Extensive CMO Pipeline • PCT has experience with virtually every cell type including dendritic cells (7 years of manufacturing for Dendreon’s Provenge ®) • Establish early partnering relationships with goals of commercial manufacturing, equity participation and back - end royalties • Active
Slide 24: Additional Revenue-Generating Businesses
24 24 24 Additional Revenue - Generating Businesses 174 215 1400 4000 0 1000 2000 3000 4000 5000 CBR* ViaCord* StemCyte* NeoStem Stem Cell Transplant Experience NeoStem Family Storage - Stem cell collection and storage for infants and adults Stem cell units provided for transplants *Source - Informa
Slide 25: Suzhou Erye - a Significant Asset
25 25 25 Vertically-integrated manufacturer of generic antibiotic products and APIs with extensive distribution throughout China – Multiple cGMP-certified production lines – Extensive distribution network throughout PRC – No significant customer concentration Pharmaceutical market forecasted to
Slide 26: Financials, Milestones & Key Executives
26 Financials, Milestones & Key Executives
Slide 27: Financial Highlights
27 27 27 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
Slide 28: Recent and Expected Milestones
28 28 28 Recent and Expected Milestones Recent Accomplishments: • Expansion of intellectual property beyond cardiovascular disease to all of vascular insufficiency • Manufacturing contract that includes ownership in the client company, back end royalty of the product being produced and locked in com
Slide 29: Expected NeoStem Events
29 29 29 Expected NeoStem Events (over 12 months) The Divestiture of Erye Amorcyte – Clinical progress on Phase 2 STEMI “Preserve” trial Amorcyte : Expanding IP and its implications on the space Amorcyte : CHF trial begins NeoStem & Amorcyte : EU strategy BD Opportunities Athelos : Move into the cli
Slide 30: Key Executives
30 30 30 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 31: Questions
31 31 31 Questions
Slide 32: Patents and Patent Applications
32 32 32 • Composition of matter patents granted for Athelos (2023) & AMR - 001 (2028) • NeoStem’s patent estate includes: • Over 30 issued patents • Over 90 pending patent applications • Composition of matter and methods claims • Geographic breadth of filings including North America, Europe, Asia,
Slide 33: NeoStem: Ideally Positioned for the Year Ahead
33 33 33 NeoStem : Ideally Positioned for the Year Ahead Clinical Philosophy is a Differentiating Factor Internal CMO : Cost - Effective Manufacturing Solution for Internal Development, Potential for Positive Cash Flow, Manufacturing Currency Allows Royalty Deals, Risk Diversification. Dominant Land
Slide 34: Board of Directors
34 34 34 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 35: Amorcyte Scientific Advisory Board
35 35 35 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 36: Athelos Scientific Advisory Board
36 36 36 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 37: GAAP to Non-GAAP Reconciliations
37 37 37 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
Slide 38: Value Creation in the Biotechnology Industry
38 38 38 1980 1990 2000 1x 10x 100x 1000x 2010 Aggregate Industry Valuation Value Creation in the Biotechnology Industry Evolution of a Paradigm Shift Irrational Exuberance Reality Break - through Take Off First Recombinant Protein Therapeutic: Humulin ® First Recombinant Monoclonal Antibody: ORTHOC
Slide 39: AMR-001 Advantages in the Landscape
39 39 39 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 40: Reduce Cost, Time and Risk of Cell Therapy Development
40 To Be Successful You Must Demonstrate Ability to Reduce Cost, Time and Risk of Cell Therapy Development • Autologous vs. allogeneic • Patient - specific vs. multi - patient use • Sources of cells: bone marrow derived, adipose, IPS , embryonic, etc. • Fresh vs. cryopreserved • Shelf - life from so
Slide 41: Capturing the Paradigm Shift to Cell Based Therapy
41 41 41 Capturing the Paradigm Shift to Cell Based Therapy Appendix
Slide 42: Contact Information
42 42 42 Contact Information NeoStem , Inc. (NYSE AMEX: NBS) www.neostem.com Robin Smith, MD, MBA Chairman & CEO Phone: (212) 584 - 4174 Email: rsmith@neostem.com Andrew Pecora , MD, FACP Chief Medical Officer Phone: (201) 996 - 5814 Email: apecora@humed.com Jason Kolbert , MBA Vice President of Str