Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — NeoStem — Investor Presentation (September 2011)
48 slides from Lisata Therapeutics's investor presentation, Sep 12, 2011
Slide 1: NeoStem, Inc. Investor Presentation
NeoStem, Inc. (“NBS”) Investor Presentation September 2011
Slide 2: Forward-Looking Statements
<') Forward-Looking Statements tne rnin een 8 hn sherri fe hate ees non Rl 1995, ase hit frat Suh oe com anny etary oes etrsare sien re ns no teeta a ert sored nh Compe spre Hing wh he Sart ans cage Crashes een ‘Seetenredbrictt sees Scie mhediees whore na ee Scriven rem naan as ar beans 2
Slide 3: Investment Highlights
2 Investment Highlights contract manufacturer * Robust proprietary product pipeline ° ° and diabetes) © VSEL™ partnerships * Experienced management team 2
Slide 4: Leader in Cell Therapy Development and Contract Manufacturing
Leader in Cell Therapy Development and Contract Manufacturing development Founded Amorcyte, Inc. (cardiovascular programs) and Athelos Corporation (T-ree programs) + Asthe product mmercialization,
Slide 5: Cell Therapy Industry
Cell Therapy Industry Revenue Poten rows as Product Advances Phase? Phase 3 Commercial | Patients Revenue Patients Revenue | Patients Revenue | | ia | 25 $625,000 | 100 $2,000,000 30,000 $50,000,000 | “Amorcytes pio tp @ opp FN aus .., Osiris. éinvitrogen- @B iol S Ocoee = “O. BAXl!r fohoon-fohwon B
Slide 6: Clinical Philosophy: Potency Assay
x Clinical Philosophy: Potency Assay Our mission is to develop a product portfolio of cell therapy products that leverage the body's, Teuulcbhires oliscllenalnenecieeae, aness meee therapies in regenerative medicine, immunology or using an immunological basis to fight c: uch as: ‘active ingredient”)
Slide 7: Amorcyte — Addressing an Unmet Medical Need
e) Amorcyte — Addressing an Unmet Medical Need s, wAmorcyteés * Biologic dosing threshold established * Pharmacoeconomic value
Slide 8: Proposed Phase 3 Clinical Plan for AMR-001
Proposed Phase 2 Clinical Plan for AMR-001 g Indication _Post-AMI Preservation of Cardiac Function Primary Endpoint i i Other Endpoints A composite of endpoints wl be used to determine overall cardiac function (including preservation of LVEF Ta cue Eee RE STH eh Life (KCC 1a") Safety Reduction in cu
Slide 9: AMR-001 — Preservation of Heart Muscle
R-001 — Preservation of Heart Muscle cies and Decrease in MACE ‘An autologous bone marr enriched for CD34*CXCR4 Homogeneo CD34°CXCRA" cells eniMechanienn ot; + Phase 2 to start by end of 1012 ‘auyyumi ad etal 2011, Ameren Heat Journal 1612) 98-105 A ee
Slide 10: Cell Type: CD34+CXCR4+ Cells and Repair Mechanism
cell Lyne: CD34*CXCR4* Cells area nism ral Repair Mechani remodeling: s sae signal (HIF) is induced poxia in the peri-infarct HIF induces synthesis of SDF anc, ei wisi wl 5 cD34*CXCR * The retinas Y — to the peri-infar sor rant preventing Bee Tou coats cell paracrine effects and effecting pa eae neo
Slide 11: Clear Unmet Medical Need for AMI Patients
2 Clear Unmet Medical Need for AMI Patients Infarct extension due to apoptosis of hibernating myocardium * Premature Death Recurrent Myocardial Infarction Pertiofaret * Congestive Heart Fail Zone lequi te perfusion (microvascular InfaretedZone diomyocyte loss due to apoptosis Relerences ‘American He
Slide 12: A Cost-Effective Solution To Fill the Treatment Gap
2 A Cost-Effective Solution To Fill the Treatment Gap a * Asolution is needed to: hibernation and apoptosis + Preserve heart muscle function + Prevent downstream MACE + Improve QOL & longevity * Pharmacoeconomic impact: balance of the patient’s lifetime
Slide 13: AMR-001 Phase 2 Clinical Trial Protocol
x AMR-001 Phase 1 Clinical Trial Protocol Indication A brormality in the myocardium of the IRA Primary Endpoint Safety in post-AMI Patients Other Endpoints. RTSS (Perfusion); LVEF; ESV; SDF Mobility 50% Dosing Frequency Single dose Groupsand 3 dose cohorts (5, 10, 15 million cells, randomized Random
Slide 14: Dose Response Established
<) Dose Response Established —— - a . — ‘Quyyumi Ad t a 2011, American Heart Journal; 161(1) 98-105. Increasing doses of AMR-001 reece the size ai the infarci regio! Increasing doses of AMR-001 reduced RTSS. ssouse (hypoperfusion)
Slide 15: RTSS (Hypoperfusion)
RTSS (Hypoperfusion) Cohort —_ Base Line 6 months Delta % Change Control 259.0 273.5 414.5 5M 714.2 722.0 +78 10M 998.6 635.8 -362.8 15M 584.0 462.0 -122.0 Patients dosed >= the threshold dose n cells showed significant improvement in pation ‘uyyum AA et a 2011, American Heart Journal; 161(1) 98-205
Slide 16: Subgroup Analyses
Subgroup Analyse Additional Cardiac Function Test Results RTSS (Hypoperfusion) Ejection Fraction month a 6 ee Seow, [suo ste 07 Threshold a mes Above 43252745 aon Threshold Drop in Ejection Fraction nth = ar ‘Above Threshold 30% Below m7 83436 Threshold Ejection Fraction Improvement +9.4% Above a1 8
Slide 17: Additional Potential Indications for AMR-001
= Additional Potential Indications for AMR-001 rved Sion of AMR-001 11 platform can be applied to other conditions resulting from under! ‘onsen 072008 fein al ros ce ip ce Coy Crete 01100 238218 eure wth auclogous aut ste el transplantation: A prospectne andoted Soyer Vane 90s ages 18110 ration of e
Slide 18: Cell Therapy Shipping and Protective Case
Kony) "Gost" /eosd™" "Toureos ""excee™ Purity Viability Cells 10m! Celis. Migration’ Cell Therapy Protective Case protects from physical damage Cell Therapy Refrigerated Shipping Package preserves cell activity in variable external temperatures = After 24h in PCT Designed Cell Therapy Shipping Conta
Slide 19: T-reg Cells - Restoring Immune Balance
2 T-reg Cells - Restoring Immune Balance regulatory cells (T-reg) reg cells are col ees cD4s, lect i Gi, FoxP3+), activated and expanded ex vivo approximately 500 fold in 20 days * Potential applications include: GvHD ° Solid organ rejecti ‘© Autoimmune disease such as asthma and diabetes nex i an.
Slide 20: VSEL Pluripotent Adult Stem Cells
x VSEL™ Pluripotent Adult Stem Cells NeoStem’s proprietary adult stem cell technology platform required {even as an autologous product) inflammation (the “paracrine effect”), BUT, target cell types /SEL™s are unique versus other cell types entially represent the most powerful regenerative cell as nt
Slide 21: Patents & Patent Applications
Patents & Patent Applications edge technologies Nessie S spatent estate includes: 0 issued patents on Fy pending patent applications © Composition of matter and methods claims ° South Africa Cell therapy focus of NeoStem’s IP includes: Immunology Orthopedic Wound healing ‘Age related tissue restorat
Slide 22: NeoStem's Asia Entities
2 NeoStem’s Asia Entities + PCT-CMO Laboratory & Plant in Beijing A ‘ities j (© Built to same design and standards serhnoby for Orthopedics asi MSCs leng Hospital — Launched June ©. Shijiazhuang Third Hospital - Signed December 2010 Tianjin Nankai Hospital - ere May 2011 : Posing Divesture of Suzhou
Slide 23: Key Financial Metrics
<') Key Financial Metrics (1) (2) or Ended Scone Ende December 3.2010 Canary 7 Ganequaiens $B $A yraceasast «$84 ag Peon A sencelndctes jay, ln) G ae Tova aes $ wos $m cee g 2 70289 cae $ mes $n aD Eper 37688 s: aa sae 2M exattaines S$ ses7 $a Operating Loss $8) $801) saat coy a et oe) (20779) oulla
Slide 24: Capitalization Table
<') Capitalization Table ation (Common Share Equivalent in 000s) Shares Outstanding % Outstanding 82,247" 62.8% Se 2 (common share equivalents) 4,609. 0) 3.5% Total Warrants (average exe ) 25,008" @) Tees One (veser ures pied S17) 19,086 Fully-diluted Shares Outstanding 130,950 Equity Dato sof 6/30/
Slide 25: Key Executives
2 Key Executives ‘arin ae 4 ote Pe reset and Oe Scene Ofer of ‘NeoStem Management Team Eset rent 0 2M (mind) EMO Hi alma) oan: Dy Beech ig bat trop nth seeing Poghin sen Newey Proanansin Nnatlgy New en Use Cnet eey teeter nt ger ee stone da ‘Sintec
Slide 26: PCT Leadership
PCT Leadership Clinical Asy Cell of Cll Therapy engin ering Andrew L.Pozors, MO Rober A re, PRO Charscntaton © | Development ry Buen Sy tS. Goldberger aniseed in ata Siting Mari Devito cGMP Quality Systems Ag Vc = id ie ath Buns MB) 20y20 2 vsconcats, Pro ecu Quay head: Systems & Training cGMP Facil
Slide 27: Board of Directors
<') Board of Directors ‘NeoStem Board Members ain Sith, MO, MA + More an GoeCarmenofoetoed + emery resent CEOWMNC mde VCO Ha ado mngrne) + Spina een Cnr chim Bxt eg rt hee oh Nwenbr op and temtor ewe +S athematis& Economic ~ Anbar Cals Nenper ow nk Cpt rf anaphase sd ee Cpa Pert Poorer ee ogre 1+ se
Slide 28: What's on the Horizon?
% What's on the Horizon? * Closing of the acquisition of Amorcyte autoimmune disease * Leveraging and creating partnerships
Slide 29: Investment Highlights
2 Investment Highlights contract manufacturer * Robust proprietary product pipeline ° ° and diabetes) © VSEL™ partnerships * Experienced management team 29
Slide 30: Appendix
Appendix
Slide 31: Eugene Braunwald, MD and clinical investigators
Eugene Braunwald, Mi rer ono DPhil, FRCP Dean. Kereiakes, Ml 1omasKltzner, MD, PhO om Mann, MO, FAC 1 Pecora, MO, FACP, CPE Cart Pepine, MO {Emerson C. Pein, MD, PhD, FACC Bertram Pitt, MD ‘Arshed Quyyumi, MO, FRCP, ACC Brigham & Women’s Hospital ‘The Mayo Clinic Christ Hospital Heat of Greater Cinc
Slide 32: Athelos Scientific Advisory Board
xe) Athelos Scientific Advisory Board ngold, Pht Wayne A. nee MD, PhD ae S. Negrin, Peritt, PAD on Recordi, MD ‘Noel L. Warner, PhD = Has ee a ‘+ Progenitor Cell Therapy uni ledicine, ae of California al Center Dana-Farber Cancer inst Stanford University Hospira University of Miami Diabetes Research
Slide 33: AMR-001 Advantages in the Landscape
e AMR-001 Advantages in the Landscape AMR-001 Advantages + Functionality of CD34*CXCR4* cells = Confirmed mechanism of action that stabilizes the CD34*CXCR4’ cells + Potency, viability, stability, sterility, and variability assays * Threshold dose is established at 10 million cells ‘T= Aes Moca lr =
Slide 34: Phase 2 Clinical Trial Process
x Phase 2 Clinical Trial Process resents with chest pain 2. Patent receives 3. Patient screened, and 4. Patient Ssromans ssid a senting ud usa ewroledin il ecion randori ito \Ventrculography (EF <45%) medical ction (EF) S ‘Treatment or Control | oars 5. Patient Bone 6. cosaroxces* Tinta card Marrow
Slide 35: Once Lost, Cardiomyocytes Are Unable to Significantly Regenerate
Once Lost, Cardiomyocytes Are Unab! le to Significantly Regenerate to Restore Cardiac Function + 10-10? cardiomyocytes may mies pele Eee in . in, et al, measured the oa esos a into DNA of cardiomyocytes in humans : psy report Talore resonate at 1% each year up to the age of 25 and then annual regene
Slide 36: Post STEMI Complications Are a Function of Ejection Fraction
Post STEMI Complications Are a Functi Left Ventricular Ejection Fraction (ME Non CV doath (ZZ Sudden Death sete tatty Sart 18 Soot pura opaeren Pl poplin we Seen, Sia einen ae iaace ‘oa Secegaarnabetea yu anor Solomon 2006 TEL survival declines dramatically when left cme entricular ejection fraction
Slide 37: Cell Type: Circulating CD34+ Cell Levels and Cardiac Function
c Function Cell Type: Circulating CD34*Cell Levels and h Car Migratory Capacity Correlate Wit! '* Circulating CD34° cell quantity 1 year post-MI significantly correlates (positive) to left : : a Ae Se systolic volume 4" CDI greater nae 40% (p=0.02) 23) is SDF (not VEG) contrast MRI®) 1. eran et Natu
Slide 38: IRA Infusion of Bone Marrow MNCs Preserve Cardiac Function
IRA Infusion of Bone Marrow-MINCs Preserve Cardiac Function Reduce nts Early and Late Post AMI + Over 1000 AMI patients have received IRA Infusion of Bone Marrow MNC (BMC) Post ‘AMI and have had si tres ie int + LVEF (siren incr a 3.7%) ie mi) . inte se a ebsolite ps by 4-6%) ;creased incidence of r
Slide 39: Cell Type: Isolated CD34+ Cells Most Able to Improve Perfusion
Cell Type: Isolated CD34*Cells Most Able to Improve Perfusion, Prevent Apoptosis and Rescue Hibernating Cardiomyocytes CD34* Cells Exhibit Increased Potency and Safety for Therapeutic Neovascularization after AMI Compared with Total Mononuclear Cells in Nude Rats: 1200, Capillary lea aa on ” : 0) ew
Slide 40: Cell Type: Isolated CD34+ Cells Best Able to Maintain Function
Cell Type: Isolated CD34* Cells Best Able to ion Maintain eae Functi superior improvement in capillary density and decrease in fibrosis seen wh purified CD34" cells infusion correlates with superior improvement in (%) Fractional Shortening Regional Wall Motion Score 40 Peon (%) P<0.001 PBS = Phospha
Slide 41: CD34+ Cells Localize in the Peri-infarct Zone
= CD34* Cells Localize in the Peri-infarct Zone Al. Three-dimension ‘Quyyumi AR et a 2012, American Heart Journal: 161(1) 98-105.
Slide 42: CD34+ Cells Survive in the Heart For Over Months
x CD34* Cells Survive in the Heart For Over 12 Months Long-term BLI of TGL-CD34 in SCID mice: The bioluminescent signal in Ee heart was superimposed on a cane iph of a SCID mouse for \dicated time points after rae cell injection (representative mouse) B. BLI intensity in SCID mice injected with CD34
Slide 43: LVEF Significantly Improved in Treated Mice
LVEF Significantly Imp: ved in Treated Mice Compared to Control Mice For Up to 52 Weeks cD3é* cells pana of cardiac function using A een sequent images of the ES and ED v nt vs CD34* cell-transplanted mice 0 expressed in mean + = (of except for week 52). NS: PNS; FPG Post injection of CD34* Cel ‘Wan
Slide 44: In Vivo Antibody Treatments Inhibit Myogenesis/Angiogenesis
In Vivo Antibody Treatments Inhibit Myogenesis/Angiogenesis and Affect Cardiac Function Induced by Injection of CD34* Cells Into Mice After MI £, Ant- 48, but not anti-VEGF, c “ antibodies inhibited the formation of 41 hhuman-derved cardiomyocytes (HUA [troponin T), as determined by FACS i analysis
Slide 45: Source of Cells: Autologous vs. Allogeneic and Mesenchymal
Source of Cells: Autologous vs. Allogeneic and Mesenchymal Autologous aan Allogeneic and Mesenchymal Immunogenicity + non-immunogenic Inflammation * non-inflammatory _* Lymphocytic inflammatory infiltrates directed at foci of non-self stem celsin three species (dog, swine, sheep) Tells and macrophag
Slide 46: Product Development: Controlled vs. Unmanipulated Cell Preparation
Product Development: Controlled vs. Unmanipulated Cell Preparation Controlled Cell Preparation Unmanipulated Bone Marrow Cells (AMR-001) Potency Sterility Stability * Consistent formulation delivers potent preparation for effective therapy + Production facility and quality control of end. product ar
Slide 47: Potential for positive response to therapy
potential for positive response to therapy. —— High risk patients are those with ejection fractions of <40% At-risk patients are those with ejection fractions of <48% + Future risk patients are those with ejection fraction >48% and those who could be candidates for a second course of therapy
Slide 48: AMR-001 Pricing Will Allow for Appropriate Commercial Margins
AMR-001 Pricing Will Allow for Appropriate Commercial Margins Bone Marrow $26,090 $125 - 150,000 Peripheral Blood $25,620 $85 - $125,000 (PBSC) Cord Blood $34,045 $43,025 $150 - 300,000 Transplant Provenge® $93,000 (3Trt) Not Available ‘AMR-001 TD TD TeD There are > 400,000 STEMI patients/year with