Form 8-K Asterias Biotherapeutics For: May 08

 AST-OPC1 Development Program for Spinal Cord Injury Asterias Biotherapeutics Inc. NYSE MKT: ASTInvestor DayMay 8, 2015  * 

 Forward Looking Statements  Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ Registration Statement on Form S-3 and Prospectus, as well as its other periodic reports, filed with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.  * 

 *  Asterias Biotherapeutics, Inc  Issuer:  Asterias Biotherapeutics, Inc.  Exchange / Tickers:  NYSE MKT / AST  Shares outstanding:  32.3 M  Market cap:  $341M (based on share price of $10.54 as of May 1, 2015)  Major institutional holders:  Romulus, Fidelity, Scarsdale Equities, First Eagle  Key financials (as of February 2015):  ~$7.4M cash1~$19M marketable securities2Potential near-term proceeds of $11.7M from 5M “in the money” warrants at $2.34 which expire June 15, 2015  Guidance for 2015:  Expected net cash burn of $15-17M  1 $4.1M (unaudited) as of January 31, 2015 plus estimated $5.3M net proceeds from financing closed February 5, 20152 3.8M shares of BioTime (NYSE MKT: BTX) as of Mar 31, 2015 

 Two transformative platforms: Industry-leading Pluripotent Stem Cells Dendritic Cell ImmunotherapyBoth lead products entering the clinicClinical development focused on de-risked indications with robust proof-of concept dataPartnerships with leading institutions $14.3mm in non-dilutive funding from California Institute of Regenerative Medicine (CIRM) to launch AST-OPC1 Phase 1/2a for spinal cord injuryPartnered with Cancer Research UK (CRUK) to conduct AST-VAC2 Phase 1/2a for lung cancer with ~$20-30mm funded by CRUKAddressing large markets with significant unmet medical needs – multiple milestones over the next 24 monthsAST-OPC1 Phase 1/2a trial and FDA pending potential expansion cohort may result in path to registration study  *  Key Highlights of Asterias 

 *  Today’s Agenda: AST-OPC1 Development Program for SCI  9:30AM: Welcome and Introduction to Asterias: Pedro Lichtinger (10’)9:40AM: Introduction to Spinal Cord Injury and AST-OPC1: Jane Lebkowski (25’) 10:05AM: Design, Objectives and Status of Asterias’ Current Spinal Cord Injury Clinical Trial: Ed Wirth (25’) 10:30AM: Clinical Foundations for the Endpoints and Outcome Measures in Asterias’ Spinal Cord Injury Trials: John Steeves. (30’)  11:00AM: Future Clinical Development Plan for AST-OPC1: Ed Wirth (30’)11:30AM: Summary and Questions: Jane Lebkowski: Moderator (30’) 

 Introduction to Spinal Cord Injury and AST-OPC1 Jane Lebkowski Ph.D. President of R&D Investor DayMay 8, 2015  * 

 *  Spinal Cord Injury: Multiple Devastating Life-Changing Effects  Loss of limb functionImpaired cardiovascular controlImpaired bowel and bladder controlChronic neurgenic painIncrease pain sensationDecreased sexual functionIncreased frequency of pressure soresUrinary tract infections SpasticityDebilitating burning/tingling sensations 

 Spinal Cord Injury: Incidence and Costs  Devastating Condition with High Unmet Medical Need and High Costs to the SystemAffects 12,000 patients per year in US1 alonePrimarily affects young and previously healthy males in their 20s and 30s at time of injuryNo currently approved therapiesLifetime cost of care per patient of $2-4mm1Healthcare costs to system of $14.5bn per year in US alone, plus $5.5bn in lost productivity2Multi-billion dollar annual market opportunity3  *  1 National Spinal Cord Injury Statistical Center, Facts and Figures 20132 Berkowitz et al, Spinal Cord Injury: An Analysis of Medical and Social Costs, 19983 Internal estimates  Cervical SCI has highest incidence and is most prevalent SCI typeFirst year cost of care is ~$1 million for cervical complete SCI and ongoing care and support thereafter exceeds $150,000/yearIntegration back into a work environment for patients with cervical complete injuries is rare. Average life expectancy is now 75% of able bodied population, which means a person injured as a young adult could live with SCI for ~ 50 years Lifetime costs for ongoing care and support for a severe cervical injury can exceed $8.5 million/person  Cervical Spinal Cord injury is a High Priority Target 

 Human Spinal Cord Injury Causes Tissue Destruction and Ectopic Tissue Formation in the Spinal Cord  Trauma to the spinal cord causes hemorrhagic necrosisSecondary damage includes cell death, cavity formation, demyelination, and scarringChronic stage: gray matter replaced by either a lesion cavity or collagenous scarTypical spared rim of white matter  Kakulas, Paraplegia, 25:212-216, 1987   Cervical SCI at C5; 10 days post-injury  Normal Spinal Cord  Solid Cord Injury  Contusion Cavity  Norenberg et al., J. Neurotrauma, 21(4):429-440, 2004  * 

 *  Rationale for Oligodendrocyte Progenitor Cells  Cavitation  Aubourg, P., Nature Genetics 2007  Obermair, Schröter and Thallmair, Physiology 2008  Pathology of the lesion provides rationale for oligodendrocyte progenitor transplantation 

 AST-OPC1: hESC-Derived Oligodendrocyte Progenitor Cells (OPCs)  Cryopreserved Allogeneic Cell PopulationDerived from Human Embryonic Stem Cells (hESCs)Characterized Composition of Cells:Oligodendrocyte progenitorsNeural progenitorsInfrequent mature neural cells and Rare other characterized cell typesThree identified functionsProduces neurotrophic factorsInduces remyelinationInduces vascularization“Off the shelf” administrationFirst indication: spinal cord injuryPotential line extensions in other neurodegenerative diseases  AST-OPC1  * 

 AST-OPC1: Three Major Physiologically Relevant Functional Activities  2. Produces neurotrophic factors and stimulates neurite outgrowth  Promote increased neurite outgrowth  1. Wraps host neuronsand forms compact myelin sheaths  Host Endothelial Cells  AST-OPC1  Rat spinal cord 9 months post transplantation  Rag2-/- γc-/- /shi mouse + AST-OPC1  TubIII  *  Zhang et al Stem Cells and Development (2006) 15: 943; Manuscript in preparation  3. Stimulates neovascularization 

 Models of Spinal Cord Injury Used to Evaluate Safety/Activity of AST-OPC1  MidlineContusion Injury at T10   Unilateral ContusionInjury at C5/C6  Thoracic Injury   Cervical Injury   Transplant AST-OPC1 7 days post- injury at injury site  EvaluateEfficacy & ActivityHistological EffectsCell SurvivalCell PhenotypeCell MigrationToxicity   T10  C5  * 

 AST-OPC1 Improves Locomotor Recovery When Transplanted in Rats with Sub-acute Thoracic and Cervical SCI  Locomotor Improvement in Thoracic SCI  Locomotor Improvement in Cervical SCI  Increased Running SpeedIncreased Right Forelimb Stride LengthIncreased Right Forelimb Maximal Longtudinal DeviationIncreased Right Rear Stride Frequency   Increased Weight BearingImproved HL-FL Coordination Improved Hind Paw Clearance Improved Trunk StabilityDecreased Tail Drag  * 

 AST-OPC1: Improved Locomotor Activity  *  Control (no cells)  AST-OPC1 Treated 

 AST-OPC1 Decreases Parenchymal Cavitation In Injured Rats   AST-OPC1  HBSS  Area of Parenchymal Cavitation (mm2)  p<0.05  AST-OPC1  HBSS  * 

 AST-OPC1 Reduces SCI Cavity Formation and Induces Persistent Myelination  Brown: antibody to human nuclear antigen labels AST-OPC1; Blue: Eriochrome Cyanine stains myelin  hNucEC  1 mm  100 µm  50 µm  AST-OPC1 in SCI Lesion; Significantly Reduced Cavity Formation  Robust AST-OPC1 survival (brown)  Myelinated Fibers (blue)  Rat Thoracic Spinal Cord Injury Model  hNucEC  1 mm  100 µm  50 µm  Cavity forms in untreated SCI lesion  Myelinated axons do not extend across cavity  * 

  Activity/ Efficacy Biodistribution Dosing/Delivery Toxicity Tumorigenicity Ectopic Tissue Immune Rejection  Survives in the Spinal CordPredominantly Neural Cell TypesGreatest Activity in Subacute InjuryImproves Locomotor ActivityReduces Parenchymal CavitationActive Doses EstablishedMigrates Up 5cm in Spinal CordNo Distribution Outside CNSDoes Not Increase MortalityDoes Not Induce AllodyniaDoes Not Induce Systemic ToxicityDoes Not Produce TeratomasProduces Low Frequency (1-2%) Small Ectopic Tissue at Injury Site Not Highly Susceptible to Direct Immune Responses  28 Animal Studies >3000 Rodents and Pigs  Safety/Efficacy Profile of AST-OPC1 in Nonclinical Studies   * 

 *  Overall Development Path for AST-OPC1 and Regulatory Status  IND  Potential for:Orphan Drug StatusBreakthrough Designation  Safety in Complete Thoracic SCI  Safety and Activity in Complete Cervical SCI Dose Escalation  Safety and Efficacy in Complete Cervical SCI   Pivotal Clinical Trial  INDAmendment  Long-term Follow-up  Open for Enrollment  Future Expansion Trial  INDAmendment 

 *  Partnership with CIRM Provides Project Validation and Non-dilutive Funding  $14.3 Million Grant  Includes funding for:Execution of Phase 1/2a studyProcess and assay development activities to prepare for pivotal trials and commercializationFacilities and indirect costsPotential follow-on grants to expand and accelerate trial 

 Design, Objectives, and Status ofAsterias’ Current Spinal Cord InjuryClinical Trial Edward Wirth, III, M.D., Ph.D. Chief Medical Officer Investor DayMay 8, 2015  * 

 AST-OPC1: Phase 1 Safety Study in Complete Thoracic SCI  *  MRI  MRI  MRI  MRI  MRI  MRI  MRI  MRI  MRI  MRI  Primary Assessment: SafetySecondary Assessment: ISNCSCI examsExploratory AssessmentsUAB-IMRSCIMSCI Pain Basic Data SetBowel and Bladder Basic Data Set  Open Label TrialMulti-Center (7 sites)8-10 SubjectsSubacute, Neurologically Complete T3-T11 Lesions2x106 CellsTransplant 7-14 Days Post InjuryTemporary Immunosuppression  

 AST-OPC1: Subject Demographics  Demographic and Baseline Disease Characteristics – All Treated Subjects  Demographic and Baseline Disease Characteristics – All Treated Subjects  Demographic and Baseline Disease Characteristics – All Treated Subjects  Demographic and Baseline Disease Characteristics – All Treated Subjects  Demographic and Baseline Disease Characteristics – All Treated Subjects  Age(years)  Sex  Level of Injury  Cause of Injury    21  Male  T6  Motor vehicle accident    23  Male  T8  Restrained driver in rollover motor vehicle collision with ejection    32  Male  T6  Motorcross    31  Male  T7  Fell 30 feet down rock embankment    23  Female  T3  Car accident    Dr. David Apple  Dr. Gary SteinbergDr. Steve McKenna  Dr. Richard FesslerDr. David Chen  Enrolling Sites  * 

 Delivery of AST-OPC1 in Complete Thoracic SCI Was Feasible and Safe  *  All Subjects Received AST-OPC1 (2 x 106 cells) at 1-2 weeks of post-injuryInjections performed using a Syringe Positioning Device (SPD)No intraoperative complicationsNo SAEs Associated with Delivery of Cells9 Adverse Events Possibly Related to Injection Procedure All Grade 1 or 2: Post-Operative Pain, Transient Fever (1) or Urinary Tract Infection (1) 

 Immunosuppression Regimen Was Well-Tolerated   All Subjects Completed Tacrolimus Immunosuppression RegimenNo SAE’s Associated with Immunosuppression16 Grade 1 or 2 Adverse Events Possibly Associated with ImmunosuppressionNausea, Urinary Tract Infection, Low Magnesium Blood Levels  * 

 No Evidence of AST-OPC1 Directed Immune Responses One Year After Administration  Immune monitoring shows no evidence of antibodies or cellular immune responses to AST-OPC1 through 1 year in all subjects Some subjects complete mismatch with AST-OPC1: Closest match was 5 of 10 alleles  PRA Assay  ELISpot Assay  Day Post AST-OPC1 Transplant  Day Post AST-OPC1 Transplant  * 

  AST-OPC1 Was Well Tolerated   No SAE’s Associated with AST-OPC1No Evidence of adverse findings on MRI scans5 Adverse Events Possibly Associated with AST-OPC1Transient Low Grade Fever (1)Burning Sensation in Trunk and Lower Extremities (4 in one subject)  Subject  SAE  Timeframe  Related to AST-OPC1  1101  Pyelonephritis: Grade 2  Day 215  Not Related  1204  Urinary tract infection: Grade 3  Day 325  Not Related  1204  Autonomic Dysreflexia/Dyspnea: Grade 3  Year 2  Not Related  *  Three SAEs to date 

 No Major Sensory Neurological Changes Observed      Neurological Level  Neurological Level  Zone of Partial Preservation  Zone of Partial Preservation  Subject  Visit  Right Side Sensory  Left Side Sensory  Right Side Sensory  Left Side Sensory  1002  Baseline  T6  T6  T7  T7    Year 1  T6  T7  T7  T7    Year 2  T6  T6  T7  T7    Year 3  T6  T6  T7  T7  1003  Baseline  T8  T8  T9  T9    Year 1  T8  T8  T10*  T10*    Year 2  T8  T9  T10  T10  1101  Baseline   T6  T6  T8  T8    Year 1  T6  T6  T8  T8    Year 2  T5  T5  T7  T7  1203  Baseline  T7  T8  T8  T9    Year 1  T7  T8  T9  T10    Year 2  T8  T8  T9  T9  1204  Baseline   T3  T3  T4  T4    Year 1  T4  T4  T6  T5    Year 2  T4  T4  T6  T5  * Day 270  * 

 MRI Results: Evidence Consistent with Prevention of Lesion Cavity Formation  No adverse findings on primary MRI safety readsIn 4 of 5 subjects, graft sites are hyperintense on T2, but signal intensity is < CSFSuggests lesion cavity formation may have been prevented by formation of a tissue matrix  Image on right is axial T2 at 3 years post-grafting through center of lesion/graft site – Slice 22 on sagittal image above)  * 

 Summary of Findings from First in Man Study of AST-OPC1  AST-OPC1 is extremely well tolerated, with no SAEs to date deemed related to the cells, delivery method, or immunosuppressive regimen4 of 5 patients have completed 3 year follow up visit, one has completed 4 years of follow-up5th patient will complete 3 year follow up in early NovemberImmune response monitoring shows no evidence of rejection of AST-OPC1, even 10 months after removal of all immunosuppressionDespite significant HLA mismatches between AST-OPC1 and subjectsSuggests well tolerated low dose, transient immunosuppressive regimen likely sufficient to enable long term engraftment of cellsMRI results consistent with continued, stable engraftment in 4 of 5 subjects at 2-3 years post-transplantNo evidence of significant changes in neurological functionNo evidence for ascending loss of function from cells or deliveryEfficacy not anticipated in this study due to low dose (5-10x below predicted efficacious range) and suboptimal patient population (complete thoracic injuries)  * 

 AST-OPC1: Scientific Rationale for Evaluation in Cervical SCI Patients  Repair/regeneration of axons only required over a short distance to reinnervate motor neurons for arms & handsFor example, with an SCI at C6 (last intact motor level at C5), repair of axons to C7 could yield return of 2 motor levels  Cervical SCIRepair  Thoracic SCIRepair  * 

 AST-OPC1: Medical Rationale for Evaluation in Cervical SCI Patients  Few complete cervical SCI patients recover >= 2 motor levels with current standard of careRecovery of >= 2 motor levels leads to significant improvement in self-care abilitySelf-care ability could be a clinically meaningful endpoint for a pivotal trial and BLA approval  Analysis by SCOPE (Spinal Cord Outcomes Partnership Endeavor)Steeves et al., 2012. Top Spinal Cord Inj Rehabil 18:1-14  * 

 Design of Phase 1/2a Study of AST-OPC1 in Complete Cervical SCI  6m efficacy data  10M cell cohort (N=5)  20M cell cohort (N=5)  2M cell cohort (N=3)  Key Design ElementsAST-OPC1 Injection 14-30 days post-injury10 day stagger within cohortsDMC review prior to dose escalation  Efficacy TargetRecovery of >= 2 motor levels at 6 months or 12 months  * 

 AST-OPC1 Phase 1/2a Study Schema  *  Acute completecervical SCI  Protocol AST-OPC1-01  Protocol AST-OPC1-02  Day 0  Day 7  Day 30  Day 60  Day 90  Day 180  1 Year  5 Years  15 Years  In personvisits  Phone f/u  DiscontinueImmunosuppression  Days 46-60ImmunosuppressionTaper  AST-OPC1Injection14-30 DaysPost-SCI  Day -1  Screening  Baseline  Day -3  Day -11  MRI  MRI  MRI  MRI  MRI  Primary Assessment: SafetySecondary Assessment: ISNCSCI examsExploratory Assessments: SCIM, GRASSP   Open Label TrialMulti-Center (8 sites)Complete cervical SCI (C5-C7)Temporary Immunosuppression  

 Operational Update  First two clinical sites are open for enrollment (Shepherd Center, Atlanta; Rush University, Chicago)Third clinical site expected to open in May (Stanford/Santa Clara Valley Medical Center)Patient recruitment efforts initiatedStudy website landing page to go live in MayBranding and messaging for health care providers developedOutreach to referral centers for open sites has begun  * 

 AST-OPC1 Phase 1/2a Trial: Design and Milestones  *  Cohort 1:3 subjects2 million cells  Cohort 2:5 subjects10 million cells  Cohort 3:5 subjects20 million cells  Q1’15: Study initiates  Q3’15: Dose escalation  Q1’16: Dose escalation  1H’16: 6 mo efficacy, cohort 2 

 Future Clinical Development Plan forAST-OPC1 Edward Wirth, III, M.D., Ph.D. Chief Medical Officer Investor DayMay 8, 2015  * 

 Work of the SCOPE Consortium Has Defined Clinical Development Path in Complete Cervical Spinal Cord Injury  *  Target Product Profile for AST-OPC1 in Complete Cervical SCI: Increase of ≥20% in the percentage of patients regaining two or motor levels of function  Enables powering of trial with only ~200 subjectsTranslates into clinically significant improvements in ability to self-care, significant reductions in cost of care  Steeves et al., Top Spinal Cord Inj Rehabil 2012; 18(1): 1-14  

 AST-OPC1 Phase 1/2a Trial: Expansion Cohort  *  Cohort 1:3 subjects2 million cells  Cohort 2:5 subjects10 million cells  Cohort 3:5 subjects20 million cells  Expansion Cohort*:Up to 27 additional patients10 and/or 20 million cellsAdaptive Design  File IND amendment for study expansion based on initial safety data in Cohort 2  Q1’15: Study initiates  Q3’15: Dose escalation  Q1’16: Dose escalation  1H’16: 6 mo efficacy, cohort 2  Open label trial enables use of adaptive design for selection of dose in expansion cohortWork of SCOPE enables comparison to robust historical outcomes databases  *Subject to FDA clearance for expansion from 13 to 40 subjects 

 AST-OPC1 Future Clinical Development Plan in Complete Cervical SCI  *  Cohort 13 subjects with C5-C7 cervical SCI Dose 2x106 AST-OPC1  Objectives of TrialEstablish safety of AST-OPC1 in cervical sensorimotor complete SCIAssess effects on upper extremity motor functionInvestigate effects on additional measures of neurological function  Cohort 25 subjects with C5-C7 cervical SCIDose 1x107 AST-OPC1  Cohort 35 subjects with C5-C7 cervical SCIDose 2x107 AST-OPC1  Dose Escalation  Dose Escalation  Breakthrough therapy designationPhase 2 expansion cohortRandomized pivotal trial in cervical complete SCITrials in additional indications (e.g., MS, Stroke)  Results from Phase 1/2 Clinical Trial Could Enable:  Confirm low-dose safety in cervical SCI  Confirm mid-dose safetyEfficacy readouts at 6m & 12m  Confirm high-dose safetyEfficacy readouts at 6m & 12m 

 A Pivotal Randomized Trial Could be Feasible with 200 Total Subjects  *  Feasible number that could be enrolledin a pivotal SCI trial in North America  Analysis: A 200 patient pivotal trial (100 per arm) could show a statistically significant difference in self-care ability (functional endpoint) if >40% of AST-OPC1 recipients recover>= 2 motor levels at 6 months post-injection 

 AST-OPC1: Follow-on Indications in Other Neurodegenerative Diseases  Revascularization of Injury Site  Indication Multiple SclerosisWhite Matter Stroke  RationaleRemyelination of axons in lesion site could restore function Leverage safety data & delivery system for OPC1 transplantation in spinal cordOligodendroglial dysfunction prominent in white matter (subcortical) stroke  StatusPOC in primate model of chemical demyelination (Jeff Kocsis, Yale)Clinical advisory panel heldPreclinical collaboration underway to test AST-OPC1 in a white matter stroke model(Tom Carmichael, UCLA)  * 

 *  Asterias Milestones and Newsflow Next 24 Months  Asterias 24 Month Milestone and Catalyst Outlook  Timing  Milestone / Catalyst / Event  Q4’14 - completed  Sign CIRM grant – triggers disbursement of CIRM funds  Q1’15 – completed  Initiate AST-OPC1 Phase 1/2a clinical trial  AST-OPC1  AST-OPC1  Q3’15  Safety readout from 2M cell cohortInitiation of 10M cell cohort  H1’16  6 month efficacy data from 10M cell cohort  H2’16  12 month efficacy data from 10M cell cohort6 month efficacy data from 20M cell cohort