Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — NeoStem — Investor Presentation (March 2012)
30 slides from Lisata Therapeutics's investor presentation, Mar 20, 2012
Slide 1: Investor Presentation March 2012
Investor Presentation NYSE Amex: NBS March 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 th e a
Slide 3: NeoStem at a Glance
3 Clinical Development Manufacturing & Services NeoStem at a Glance • Revenue generating services – contract manufacturing and stem cell services • Strong asset that can be monetized to extend capital runway • Pipeline of cell therapies in development with strong IP portfolio • Research grants and c
Slide 4: Progenitor Cell Therapy (PCT): Commercial Scale Manufacturing
4 Progenitor Cell Therapy (PCT): Commercial Scale Manufacturin g • Recognized industry leader in commercial cell therapy manufacturing experience with virtually every cell type including dendritic cells (7 years of manufacturing for Dendreon’s Provenge®) • Manufactured 30,000+ cell therapy product p
Slide 5: PCT's Extensive CMO Pipeline
5 PCT’s Extensive CMO Pipeline • Establish early partnering relationships with goals of commercial manufacturing, equity participation and back - end royalties • Active companies in the cell therapy space include:
Slide 6: Clinical Development
6 Clinical Development * Work being done pursuant to independent physician INDs that will help determine the Company’s clinical direction ** Work being done pursuant to exclusive license agreement and independent physician IND *** Based on equity interest and right to back - end royalties and manufa
Slide 7: Clear Unmet Medical Need for AMI Patients
7 7 7 • 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 References: American Heart Associ
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 - 1 which mobilizes CD34 + CXCR4 + cells • The mobilized cells are trophic to the peri - infarct zone, preventing apoptosis through
Slide 9: AMR-001: Preservation of Heart Muscle Function
9 • AMR - 001 is an autologous bone marrow derived therapeutic intended to preserve heart muscle function and limit MACE following Acute Myocardial Infarction (AMI) • Pharmaceutical grade: Defined identity, purity, potency, relevant biologic stability (mobility in an SDF - 1 gradient), sterility and
Slide 10: Phase 2 Trial Design for AMR-001
10 Phase 1 Trial Design for AMR - 001 • Patient presents with chest pain + STEMI • Receives a stent • If ejection fraction (EF) ≤ 50% (96 hours post stenting), patient is eligible for treatment Day 1 Day 4 • Patient bone marrow harvested • CD34 + CXCR4 + cells isolated using proprietary technology •
Slide 11: Dose Response of Mobile CD34+ Cells Established
11 11 11 Dose Response of Mobile CD34+ Cells 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
Slide 12: Establishment of a Threshold Dose of CD34+ Cells for Efficacy
12 12 12 Establishment of a Threshold Dose of CD34+ Cells for Efficacy 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.
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)* * Threshold 10m cells or more Ejection Fraction 6 month BL 6 Mo. Δ % % Δ Below Thresho
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 at baseline and 6 months Other Endpoints Secondary endpoints to determine preservation of cardiac function and clinical events:
Slide 15: Additional Potential Indications for AMR-001
15 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 16: Development Cost and Pharmacoeconomics
16 16 16 Development Cost and Pharmacoeconomics • From pre - clinical through Phase 2, PCT’s manufacturing and development experience has translated to significantly lower than average development cost for AMR - 001 • Adverse left ventricular remodeling after STEMI can result in an average medical b
Slide 17: AMR-001 Advantages in the Landscape
17 17 17 Clinical Development Stage PII PIII PII PIII PII/PIII PII PII PI PIII Field of Use AMI AMI AMI HF AMI AMI DCM HF CMI Defined Mechanism of Action x x x x x Autologous x x x x x x No Potential Toxicities /Safety Signals x x x x x x Centralized Manufacturing x x x x x x x x cGMP Defined Produc
Slide 18: Amorcyte Scientific Advisory Board
18 18 18 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 19: Financials, Milestones & Key Executives
19 Financials, Milestones & Key Executives
Slide 20: Financial Highlights
20 20 20 Financial Highlights Key Metrics as of December 31, 2011 Revenue $73.7m (twelve months ended 12/31/11) Cash Position $15.2m* Net Loss Excluding Non - Cash Charges $15.5m (twelve months ended 12/31/11)* Total Stock and Equivalent Shares Common Shares 109.3m Options 17.1m (avg. option exercis
Slide 21: NeoStem Events and Milestones
21 NeoStem Events and Milestones Product Indication Event Timing AMR - 001 STEMI Enrollment of first patient Completed AMR - 001 STEMI Enrollment completion 1Q - 2013 AMR - 001 STEMI Data readout 2H - 2013 AMR - 001 STEMI EU strategy 2012 AMR - 001 CHF Begin Phase 1 trial 2012/2013 Athelos Autoimmun
Slide 22: Key Executives
22 22 22 Key Executives Robin Smith, MD, MBA CEO & Chairman of the Board MD – Yale; MBA – Wharton Formerly President & CEO IP2M (HC multimedia), EVP & CMO HealthHelp (radiology management) Trustee of NYU Medical Center; Chairman of the Board of NYU Hospital for Joint Diseases (through November
Slide 23: Board of Directors
23 23 23 Board of Directors Robin Smith, MD, MBA CEO & Chairman of the Board MD – Yale; MBA – Wharton Formerly President & CEO IP2M (HC multimedia), EVP & CMO HealthHelp (radiology management) Experience - Trustee of NYU Medical Center; Chairman of the Board of NYU Hospital for Joint Diseases
Slide 24: Questions
24 Questions
Slide 25: GAAP to Non-GAAP Reconciliations for the twelve months ended December 31, 2011
25 25 25 GAAP to Non-GAAP Reconciliations for the twelve months ended December 31, 2011 Cash Position Reconciliation Cash & cash equivalents 12,745,432$ Short term investments 559 Cash included in Other Assets 2,500,000 (represents cash held in escrow as security associated with Preferred Series E o
Slide 26: Patents and Patent Applications
26 26 26 • 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 27: VSEL Pluripotent Adult Stem Cells
27 27 27 VSEL™ Pluripotent Adult Stem Cells heart neuron pancreas VSEL™ • Very small embryonic - like (VSELs TM ) stem cells are believed to be naturally pluripotent • VSELs™ have been shown in animal research to home to sites of injury, up - regulate angiogenesis, down - regulate inflammation (the
Slide 28: Athelos: T-reg Cells - Restoring Immune Balance
28 28 28 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 29: Athelos Scientific Advisory Board
29 29 29 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 30: Contact Information
30 30 30 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 Strat