Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — NeoStem — Investor Presentation (November 2013)
39 slides from Lisata Therapeutics's investor presentation, Nov 12, 2013
Slide 1: Investor Presentation: Transforming the Treatment of Chronic Disease
NASDAQ: NBS | 1 Investor Presentation NASDAQ: NBS November 2013 Transforming the Treatment of Chronic Disease
Slide 2: Forward-Looking Statements
NASDAQ: NBS | 2 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 f
Slide 3: Company Overview
NASDAQ: NBS | 3 Company Overview • Leader in cell therapy developing potentially transformative treatments for patients in several indications • Founded in 2006 • Integrated entity with 3 pipeline technology platforms and revenue generating contract development and manufacturing organization (CDMO)
Slide 4: Regenerative Medicine
NASDAQ: NBS | 4 Regenerative Medicine •Repair or replace damaged tissue and restore function •Novel regenerative therapies with potential to: Improve clinical outcomes Reduce overall healthcare costs
Slide 5: Investment Highlights
NASDAQ: NBS | 5 Investment Highlights • Unique business model that combines development of novel proprietary cell therapy products with a cell therapy manufacturing business • Diversified product development pipeline focused on cardiovascular disease, autoimmune disorders and tissue regeneration • D
Slide 6: NeoStem Has an Integrated Business Model
NASDAQ: NBS | 6 NeoStem Has an Integrated Business Model • Develops breakthrough therapeutic products in cell therapy for unmet medical needs around a significant IP portfolio • Benefits from growth of the regenerative medicine industry through revenue generating development and manufacturing servic
Slide 7: Developing a Portfolio of Cell Therapy Products
NASDAQ: NBS | 7 Developing a Portfolio of Cell Therapy Products that Leverages the Body’s Natural Ability to Heal and Fight Disease
Slide 8: Built for Success in Regenerative Medicine
NASDAQ: NBS | 8 Built for Success in Regenerative Medicine Cardiovascular disease* • Acute myocardial infarction – PreSERVE Phase 2 Study • Congestive heart failure – Preparing for Phase 1b/2a • Traumatic brain injury – Preclinical * These cells (AMR-001) are autologous and not expanded Autoimmune d
Slide 9: Enhancing the Body's Natural Repair Mechanism to Treat Cardiovascular Disease
NASDAQ: NBS | 9 Enhancing the Body’s Natural Repair Mechanism to Treat Cardiovascular Disease
Slide 10: AMR-001 Brings Repair System to the Heart
NASDAQ: NBS | 10 AMR-001 Brings Repair System to the Heart in Order to Preserve Function After a STEMI • CD34⁺CXCR4+ Cells are a natural repair mechanism • A consequence of inadequate perfusion (microvascular insufficiency) after a heart attack is apoptosis and progressive cardiomyocyte loss in the
Slide 11: PreSERVE Phase 2 Trial Design
NASDAQ: NBS | 11 Indication Post-AMI preservation of cardiac function Key Inclusion Criteria Confirmation of ST Elevation MI (STEMI); ejection fraction < 48% at day 4; state of the art care post stenting Location and Number of Subjects United States, 60 centers, 150 of 160 patients infused as of 11/
Slide 12: Phase 1 Results Point to AMR-001 Potential
NASDAQ: NBS | 12 Phase 1 Results Point to AMR-001 Potential Dose Response Correlated with Mobile CD34+ Cells 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
Slide 13: Intellectual Property
NASDAQ: NBS | 13 • Broad and growing patent portfolio supports cardiac and other ischemic conditions • Amorcyte’s patent claims cover a pharmaceutical composition that contains a therapeutic concentration of non-expanded CD34+ CXCR4+ stem cells that move in response to SDF-1, together with a stabili
Slide 14: What's Next? Congestive Heart Failure
NASDAQ: NBS | 14 What’s Next? Congestive Heart Failure • Additional indication for AMR-001 autologous therapy • Plan to leverage AMI data to accelerate CHF development • Significant need - prevalence of over 23 million worldwide • Preparing for IND filing and Phase 1b/2a clinical trial • Therapy wou
Slide 15: CD34+ Stem Cell Therapy Improves Event Free Survival at 5 Years
NASDAQ: NBS | 15 Adapted from Vrtovec et al, Circ Res published online 10/12/12 Note: 110 patients (open label, 55 treated with cells and 55 standard of care) CD34+ Stem Cell Therapy Significantly Improves Event Free Survival at 5 Years in Patients with Dilated Cardiomyopathy Pump Failure Deaths Sud
Slide 16: Reestablishing Immune Tolerance to Turn Off Autoimmunity
NASDAQ: NBS | 16 The Ability to Reestablish Immune Tolerance in Order to Turn Off Autoimmunity
Slide 17: Using Treg Cells to Restore Immune Balance
NASDAQ: NBS | 17 1) Chai, Jian-Guo et al, Journal of Immunology 2008; 180;858-869 • Treg therapy represents a novel approach for restoring immune balance by enhancing T-regulatory cell number and function1 • Partnership with Becton Dickinson (16.7% ownership of Athelos) • Immune-mediated diseases su
Slide 18: Recent Advancements in the Treg Program
NASDAQ: NBS | 18 • Type 1 diabetes affects over 34 million worldwide • Advancing to Phase 2 study expected to launch in 2014 through collaboration with Drs. Jeffrey Bluestone and Qizhi Tang (UCSF), expected to be partially funded by NeoStem and expected to take two years to complete • Severe asthma
Slide 19: VSELs Hold Promise to Repair Damaged Tissue
NASDAQ: NBS | 19 VSELs™ Hold Promise to Repair Damaged Tissue Throughout a Patient’s Life
Slide 20: VSELs Regenerative Medicine Potential
NASDAQ: NBS | 20 • Preliminary data generated by third party collaborators in animal models have indicated that highly enriched human very small embryonic-like stem cells (VSELs™) are able to integrate, differentiate and potentially regenerate into all basic cell types (mesoderm, ectoderm, endoderm)
Slide 21: Human VSELs Accelerate Healing in Mouse Wound Model
NASDAQ: NBS | 21 • Preliminary data in a preclinical model of severe complex wounds suggest that VSELs™ may be more effective in accelerating healing than mesenchymal stromal cells % R e -ep it he lia liz at io n p < 0.05 Days Post-wounding VSELs vs. MSCs % R e -epi thel ia liz at io n 2,500 human V
Slide 22: Human VSELs Integrate in Mouse Sub-Retinal Space
NASDAQ: NBS | 22 PKH-26/Recoverin PKH-26 positive cells co-labeled with Recoverin (400x). ONL INL GCL RPE PKH-26/rhodopsin PKH-26 positive cells co-labeled with rhodopsin (400x). ONL INL RPE GCL Eminli, S. et al. Exploring the use of human very small embryonic-like stem cells (VSELs) isolated from a
Slide 23: Cell Therapy Companies Outsource Manufacturing
NASDAQ: NBS | 23 Large and Small Companies in The Cell Therapy Industry Outsource Services For All or Part of Their Manufacturing Needs
Slide 24: PCT: 15-Year Track Record of Success
NASDAQ: NBS | 24 • Provides established, high quality manufacturing capabilities and support to developers of cell-based therapies, from preclinical supplies through to commercialization at two strategically located facilities • Outsourcing improves efficiencies and profitability and reduces capital
Slide 25: Contract Engagement Types and Pricing
NASDAQ: NBS | 25 Low Complexity Product Medium Complexity Product High Complexity Product Pre-clinical Drug Discovery Contracts Phase 2 Clinical Trial Manufacturing Contract Phase 1 Clinical Trial Manufacturing Contract Phase 3 Clinical Trial Manufacturing Contract Commercial Manufacturing Contract
Slide 26: Management Highlights
NASDAQ: NBS | 26 Management Highlights Robin Smith, MD, MBA CEO & Chairman of the Board Robert Dickey IV Chief Financial Officer • Over 15 years management experience at life sciences companies, following a career as an investment banker Andrew L. Pecora, MD, FACP Chief Visionary Officer, CMO of PCT
Slide 27: Board of Directors
NASDAQ: NBS | 27 Board of Directors Robin Smith, MD, MBA CEO & Chairman of the Board MD – Yale; MBA – The Wharton School 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 20
Slide 28: Market Metrics and Financial Metrics
NASDAQ: NBS | 28 Market Metrics Market Capitalization(1) $177M Recent Price(2) $6.53 52 Week Range(2) $5.00 - $9.89 Float(1) 23.9M Insider Holdings(2) 11.6% 1) As of November 6, 2013, based on 27.0 million shares outstanding and a $6.53 share price 2) As of November 6, 2013 (Source: NeoStem) 3) As o
Slide 29: NeoStem Milestones
NASDAQ: NBS | 29 • Therapeutic Pipeline - Complete enrollment PreSERVE-AMI Phase 2 trial - 1st data readout 6-8 months after last patient infused - File IND and commence enrollment for Phase 1b/2a AMR-001 CHF trial in 2014 - Advancing towards VSELTM human trials - Advancing Treg cell program to laun
Slide 30: Corporate Goals
NASDAQ: NBS | 30 Drive shareholder value through… 1) Growing a successful global cell therapy contract development and manufacturing business 2) Developing breakthrough therapeutic products in cell therapy for unmet medical needs around a strong IP portfolio, becoming a global leader in regenerative
Slide 31: Contact Information
NASDAQ: NBS | 31 Contact Information NeoStem, Inc. NASDAQ: NBS www.neostem.com Robin Smith, MD, MBA Chairman & CEO Phone: (212) 584-4174 Email: rsmith@neostem.com
Slide 32: Appendix
Appendix 02. NeeStem NASDAQ: NBS | 32
Slide 33: Since 2006, Over $183 Million Accessed and Multiple M&A Transactions
NASDAQ: NBS | 33 Since 2006, We Have Accessed Over $183 Million and Completed Multiple M&A Transactions and One Divestiture Acquired Stem Cell Technologies, Inc. Acquired CBH (51% of Erye) Divested Began partnership with Vatican Acquired 80% Acquired Acquired Phase III Medical, Inc. Acquired NeoStem
Slide 34: Amorcyte Scientific Advisory Board
NASDAQ: NBS | 34 Amorcyte Scientific Advisory Board 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 Medic
Slide 35: Athelos Scientific Advisory Board
NASDAQ: NBS | 35 Athelos Scientific Advisory Board Robert A. Preti, PhD SAB Administrative Chairman CSO of NeoStem and President of PCT Jeffrey Bluestone, PhD University of California, San Francisco, Diabetes Center David A. Horwitz, MD University of Southern California Robert Korngold, PhD Hackensa
Slide 36: VSEL Technology Academic Collaborators
NASDAQ: NBS | 36 VSEL™ Technology Academic Collaborators Mariusz Ratajczak, MD, PhD, Dsci University of Louisville Russell Taichman, DMD, DMSc University of Michigan Vincent Falanga, MD Boston University Kameran Lashkari, MD Schepens Eye Institute, Harvard Medical School Song Li, PhD University of C
Slide 37: High Cost of Cardiovascular Disease
NASDAQ: NBS | 37 High Cost of Cardiovascular Disease • $2.7 trillion dollars is spent annually on health care costs, currently 18% of US GDP1 • Cardiovascular disease costs over $445 billion today and projected to increase to $1 trillion by 20302 1) Center for Medicare and Medicaid, statistics for 2
Slide 38: Phase 1 Trial Design for AMR-001
NASDAQ: NBS | 38 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 fraction ≤ 50% 96 hour
Slide 39: Ex Vivo Expanded Human Tregs Show Safety and Potential Efficacy
NASDAQ: NBS | 39 T effector to nTreg ratio CD4 SS C CD25 CD 1 2 7 Post-sort nTreg : >90% P re -s o rt P o st -s o rt Ex vivo Expanded Human Tregs Show Safety and Potential Efficacy in Early Clinical Trials