Immunic, Inc. · NASDAQ:IMUX

Immunic — Vital Therapies — Investor Presentation (September 2015)

77 slides from Immunic's investor presentation, Sep 28, 2015

  1. Slide 1: Vital Therapies: Targeting Liver Disease Corporate Overview

    VITAL THERAPIES’ TARGETING LIVER DISEASE Corporate Overview as of September 28, 2015

  2. Slide 2: Forward Looking Statements

    Forward Looking Statements “This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation are forward-looking statements, including, among others, statements relating to plans and objectives of management for future ope

  3. Slide 3: Table of Contents

    Table of Contents |. Overview Il. Investment Highlights lll. The ELAD System |\V. VTI-208 Trial Results and the Path Forward V. Market Opportunity for ELAD VI. Background: Financial, Management and Board VII. Key Challenges VIII. Review of Highlights IX. Appendix

  4. Slide 4: VTI-208 Overall Intent-to-Treat (ITT) Did Not Work

    VTI-208 Overall Intent-to-Treat (ITT) Did Not Work August 21, 2015 Announcement: VTI-208, a randomized, controlled open label phase 3 trial in subjects with alcohol-induced liver decompensation (AILD) did not achieve its primary (Kaplan Meier survival analysis through at least day 91) or secondary (

  5. Slide 5: VTI-208 Subset of MELD < 28

    VTI-208 Subset of MELD < 28 Apre-specified subset analysis of subjects with baseline MELD Score less than 28 revealed a strong trend in overall survival favoring ELAD (p=0.077, non-significant or NS)". 100) 90 (%) Control N=69 Total N=120 Survival probability (' 10 —— _ = Control Yoo 200 300-400-600

  6. Slide 6: VTI-208 Subset of Subjects Below Median Age

    VTI-208 Subset of Subjects Below Median Age A pre-specified subset analysis of subjects with age less than the median (46.9 years) revealed a trend in overall survival favoring ELAD (p=0.167, NS)". 100 90) 20 70) gs é p=0.167 2 HR=0.634 3 ELAD N=43 Sooo Control N=58 e Total N=101 5 3 sf g & xf ELAD

  7. Slide 7: VTI-208 Post Hoc Analysis of Combined Subsets

    VTI-208 Post Hoc Analysis of Combined Subsets MELD < 28 and Age < Median at least through 7/30/15 Apost-hoc subset analysis of subjects with baseline MELD < 28 and age < 46.9 would have revealeda strong trend in favor of ELAD had this analysis been pre-specified (p<0.10)t. oS es oer amg gn =e 2 @ FA

  8. Slide 8: VTI-208 Post-Hoc Analysis: Overall Survival, ITT

    VTI-208 Post-Hoc Analysis: Overall Survival, ITT population, Age <50, INR $2.5, Creatinine <1.3 A post-hoc subsetanalysis of 71 subjects with baseline age < 50 and restrictions on MELD components creatinine < 1.3 mg/dLand INR < 2.5 through 7/30/15, conducted to optimize exclusion criteria for VTL-30

  9. Slide 9: The Path Forward: Anticipated Next Steps

    The Path Forward: Anticipated Next Steps GOAL: Complete a successful phase 3 confirmatory trial focused on the type of subjects who responded to ELAD in VTI-208 TIMELINE: Q4:2015 Complete analysis of VTI-208 Proposed VTL-308 trial design sent to FDA Confer with FDA Finalize design of VTL-308 Present

  10. Slide 10: The Path Forward: Proposed Confirmatory Trial

    The Path Forward: Proposed Confirmatory Trial GOAL: Modify as little as possible from VTI-208 to create a confirmatory trial focusing on most promising population * Focus on sites with VTI-208 experience in US and Europe (40 sites enrolled subjects) * Anticipate narrowing of eligibility based on age

  11. Slide 11: Hypothesis of ELAD Mechanism of Action

    Hypothesis of ELAD Mechanism of Action* The ELAD System contains over one hundred billion human liver-derived cells which are believed to perform key aspects of liver function in response to patient-specific stimuli. These functions include: + Modulation of inflammation, which is thoughtto be a majo

  12. Slide 12: Acute Liver Failure: A Significant Market

    Acute Liver Failure: A Significant Market + Estimated 80,000 patients in the US and Europe with addressable forms of liver failure: predominantly alcohol-induced liver decompensation * Expert consultant recommended price range from $150 to $275K for ELAD: - Substantial pricing precedence with orphan

  13. Slide 13: Investment Highlights

    Investment Highlights ELAD: Bio-artificial liver system designed to improve overall survival in acute forms of liver failure, incorporating hundreds of billions of human liver-derived cells - OrphanBiologic in United States and Europe — Research shows performance of key aspects of liver function, in

  14. Slide 14: Investment Highlights

    Investment Highlights Unique market position - No known bio-artificial liver competitors in clinical trials in US or EU - Key US patent into April 2027; follow-on applications pending — Orphan designation provides market exclusivity of 7 years in the US and 10 years EU, if first to market - Ifapprov

  15. Slide 15: ELAD System: Bio-artificial liver system

    ELAD System: Bio-artificial liver system designed to improve overall survival in acute forms of liver failure The ELAD System is limited by federal law to investigational use only, and is not approved for commercial distribution.

  16. Slide 16: The ELAD System

    The ELAD® System + Bio-artificial liver system designed to improve survival in acute forms of liver failure + Combination product regulated as a biologic by FDA (CBER*); ATMP* by EMA + Allogeneic cellular therapy: continuous treatment for 3 to 5 days — 440g of immortal human C3A liver-derived cells

  17. Slide 17: Key Differentiator: Human Liver-Derived C3A Cells

    Key Differentiator: Human Liver-Derived C3A Cells Allogeneic cellular therapy based on VTL C3A cells — Human No animal safety issues with the cells - Scalable Can be grown in large quantities — Allogeneic Simpler than autologous therapies — Stable Can be maintained for 50 days; shipped up to 60 hour

  18. Slide 18: New Phase Program to be Guided by Large Clinical Data Subset

    New Phase 3 Program to be Guided by Large Clinical Data Subset SK vita Tr

  19. Slide 19: VTI-208 Results Inform Future Phase Design

    VTI-208 Results Inform Future Phase 3 Design + VTI-208: phase 3 randomized, controlled, open-label trial in subjects with alcohol-induced liver decompensation (AILD) enrolled 203 subjects — Primary endpoint: Kaplan Meier overall survival through at least 91 days — Secondary endpoint: proportion of s

  20. Slide 20: VTI-208 Safety Profile

    VTI-208 Safety Profile * Treatment emergent serious adverse events (TESAEs) were similar between the treated and control groups Safety Population ELAD Control N=95 N=108 n(%) n Of Subjects 73 (76.8) 75 (69.4) 148 (72.9) sporting At Number of TESAEs 156 168 324 ELAD Control Total (N=95) (N=108) (N=20

  21. Slide 21: VTI-208 Revealed Two Very Different Responses to ELAD

    ‘Survival probability (%) VTI-208 Revealed Two Very Different Responses to ELAD Overall Survival, ITT Population al «| > 0.904 a HR 1.027 ELAD N=95 ai Control i107 Total N=203, a Days ELAD Pre-specified Exploratory Analysis Based on MELD AY Overall Survival, MELD <28 ‘Sunival probability (%) HK Days

  22. Slide 22: ELAD Outcomes varied significantly by MELD Score

    ELAD Outcomes varied significantly by MELD Score ELAD Response Determined by MELD Category: MELD Score <28 MELD Score 228 ELAD Treatment Control ELAD Treatment Control Survival Estimates (N=51) (N=69) (N=45) (N=38) [Number (%) Subjects who Died 15 (29.4) 30 (43.5) 31 (68.9) 21 (65.3) ‘Stil Alive 35

  23. Slide 23: MELD is Clinically Validated

    MELD is Clinically Validated * The Model for End-stage Liver Disease (MELD) score is the most widely used and validated predictor of 90-day mortality in liver failure. - MELD= _— 3.78xiIn[serum bilirubin (mg/dL)] + Liver function 11.2xIn(INR] + Clotting function 9.57xIn[serum creatinine (mg/dL)]. Ki

  24. Slide 24: Creatinine Analysis Helps Explain MELD Finding

    Creatinine Analysis Helps Explain MELD Finding * Subjects with poor kidney function (high creatinine levels) appear not to tolerate ELAD: Creatinine <1.5 mgidL_| Creatinine > 1.5 mg/dL. ELAD | Control ELAD Control Survival Estimates (N=78) | (N=92) (N=18) (N=15) Number (%) of Subjects Died 33(42.9)

  25. Slide 25: INR Analysis Helps Explain MELD Finding

    INR Analysis Helps Explain MELD Finding + Subjects with high INR levels appear not to tolerate ELAD: INR S25 INR> 25 ELAD Control ELAD Control Survival Estimates (N=80) (N=87) (N=16) (N=20) Number (%) of Subjects Died 34(42.5) | 43(49.4) | 12(75.0) 8 (40.0) Still Alive 45(66.3)_ | 42(48.3) 4 (25.0)

  26. Slide 26: VTI-208 Revealed Two Very Different Responses to ELAD

    VTI-208 Revealed Two Very Different Responses to ELAD " Pre-specified Exploratory Analysis Based on Age J Overall Survival Age < Median o 3) 0h ies 27 Se ee. al 5 ay 2-0.167 Overall Survival, ITT Population Be is Len a Cone es 34 Seatnerot 5 a i =f ‘Days [ 0904 . ; HR=1.027 Overall Survival Age 2 Me

  27. Slide 27: ELAD Outcomes Varied by Age

    ELAD Outcomes Varied by Age ELAD Response by Age Category: ‘Age <median ‘Age 2 median ELAD Treatment Control ELAD Treatment Control ‘Survival Estimates (N=43) (N=58) (N=53) (N=49) Number (%) of Subjects Died 14 (32.6) 26 (44.8) 32 (60.4) 125 (61.0) ‘Still Alive 29 (67.4) 32 (55.2) 21 (39.6) 24 (49.0

  28. Slide 28: Younger Patients Fare Better on ELAD Treatment

    Younger Patients Fare Better on ELAD Treatment ¢ Akey observation from VTI-208 is that younger patients experience better outcomes on ELAD treatment - Younger patients are believed to have more regenerable livers’ - Older patients may be more likely to have undetected cirrhosis? - Older patients may

  29. Slide 29: VTI-208 Post-Hoc Analysis: Overall Survival, ITT

    VTI-208 Post-Hoc Analysis: Overall Survival, ITT population, Age <50, INR $2.5, Creatinine <1.3 ‘A post-hoc subset analysis of 71 subjects with baseline age <50 and restrictions on MELD components creatinine < 1.3 mg/dL and INR < 2.5 through 7/30/18, conducted to optimize exclusion criteria for VTL-

  30. Slide 30: VTI-208 Insights

    VTI-208 Insights ¢ Although VTI-208 trial failed to achieve its primary endpoint, we believe it... — Provides key insights into most promising population for ELAD: + ELAD outcome appears better in those with baseline MELD Scores less than 28 — Subjects with creatinine < 1.3 mg/dL had better survival

  31. Slide 31: Potential Multi-Billion Dollar Addressable Market

    Potential Multi-Billion Dollar Addressable Market SK vita Tr

  32. Slide 32: Acute Liver Failure: A Significant Market

    Acute Liver Failure: A Significant Market * Sizeable market for orphan indication(s)*: Surgery-induced Acute Liver Failure United States 30,000 2,000 10,000+ 40,000+ validated validated estimated Europe’ 30,000+ 2,000+ 10,000+ 40,000+ estimated _—_ estimated estimated * MELD and age may restrict AIL

  33. Slide 33: Market Size Impact

    Market Size Impact * Does lower MELD lead to a smaller market? — InAILD, MELD progresses from normal to mid-20’s and above over the course of weeks / months + Patients with MELD > 28 typically had a MELD < 28 several weeks beforehand — MELD restriction requires capturing patients earlier + More proa

  34. Slide 34: ROW Also Presents Large Opportunity

    ROW Also Presents Large Opportunity + ELAD market in ROW anticipated to focus on future indications: + Acute flares of viral hepatitis (see VTIC-301 for clinical data) + Supporting resections of liver cancer (anecdotal evidence from compassionate use; formal trial would likely be required) + Large p

  35. Slide 35: Pricing Flexibility

    Pricing Flexibility + MME has provided reimbursement support - Completed>125 US and EU launch price strategies in the last 3 years - Vast orphan drug experience, assisting clients with > 20 ultra-orphan compounds in> 30 disease states across > 40 countries * MME recommended price range from $150 to

  36. Slide 36: Liver Transplant Cost / Benefit

    Liver Transplant Cost / Benefit + Costof approximately $577,100in 2011 for7 months surrounding transplant (and can total over $1 million over the life of a patient*): - _ Inaddition $40K per year for immunosuppression alone; high risk of cancer, infection, kidney failure Transplant Physician —_—_180

  37. Slide 37: ELAD Presents Potential Multi-Billion Dollar Opportunity

    ELAD Presents Potential Multi-Billion Dollar Opportunity + Estimated annual addressable market in US & EU 80,000 patients Preliminary pricing guidance of $150,000-$275,000* Total market size (using low end of anticipated price range) estimated to be roughly $12 billion Reduction in market size due t

  38. Slide 38: Unique Market Position

    Unique Market Position

  39. Slide 39: Intellectual Property and Exclusivity

    Intellectual Property and Exclusivity Patent Protection - KeyU.S. Patent Issued in 2012, term to April 2027 ‘iiuinaw es + Covers use of the C3A celtline in ELAD System to treat liver "tame failure ey - December 2013 patent covers bedside unit; term to May 2025 — Other patents granted and pending in

  40. Slide 40: Financial Summary

    Financial Summary

  41. Slide 41: Cash Position and Cap Table

    Cash Position and Cap Table Cash Position Cash of $63 million as of August 31, 2015 Capitalization Table As of June 30, 2015: Common shares outstanding 24.0M Options outstanding 3.3M Total 27.3M Other Options available for grant 1.0M Warrants (average exercise price of 0.3M $95.21, expiring between

  42. Slide 42: Team

    Team XYelyv RAP] AT~ VITAL THERAP

  43. Slide 43: Executive Team with Operational Experience

    Executive Team with Operational Experience Terry Winters, PhD (CEO since 2003 restart SBORTHOLOGIC* ae ditector of 3 IPO companies Rob Ashley, MA ‘Amersham, Bri Couagenen PE se ae fA callaenes ¢ 22 amenham : to market @® Bisa myers Squibd Duane Nash, MD, JD, MBA STARMINE ‘WEDBUSH EUS CRO. Transplant

  44. Slide 44: Strong Board of Directors

    Strong Board of Directors Muneer A. Satter * Chairman - Satter Investment Mgmt.; Chairman — Akebia Therapeutics Co-Chairman/Lead Director * Former partner for 16 years at Goldman Sachs Merchant Bank Terry Winters, PhD * CEO of Vital Therapies Co-Chairman CEO of BioMarin Pharmaceutical President & CE

  45. Slide 45: World-Class Clinical Advisory Boards

    World-Class Clinical Advisory Boards UNITED STATES Michael Millis, MD, Chief of Transplant, University of Chicago — CHAIRMAN Robert Brown, MD, MPH, Director of Center for Liver Disease and Transplantation, Columbia University Steve Conrad, MD, PhD, Director of Critical Care, Louisiana State Universi

  46. Slide 46: Key Challenges

    Key Challenges 1. ELADis notyetproventowork: Our VTI-208 trial failed to achieve its primary and secondary endpoints, and ELAD has not yet been proven to be effective and safe based on prospectively defined criteria in a US or European trial. This evidence will be necessary for future commercializat

  47. Slide 47: Investment Highlights

    Investment Highlights ELAD: Bio-artificial liver system designed to improve overall survival in acute forms of liver failure, incorporating hundreds of billions of human liver-derived cells - OrphanBiologic in United States and Europe — Research shows performance of key aspects of liver function, in

  48. Slide 48: Investment Highlights

    Investment Highlights Unique market position - No known bio-artificial liver competitors in clinical trials in US or EU - Key US patent into April 2027; follow-on applications pending — Orphan designation provides market exclusivity of 7 years in the US and 10 years EU, if first to market - Ifapprov

  49. Slide 49: Appendix

    APPENDIX SK vita Tr

  50. Slide 50: Additional VTI-208 Post Hoc Subset Analyses

    Additional VTI-208 Post Hoc Subset Analyses MOV SSX VITALT!

  51. Slide 51: Overall Survival, ITT population, including VTI-208E through 7/30/15

    Overall Survival, ITT population, including VTI-208E through 7/30/15 Age < 50, Creatinine<1.3 and INR<=2.5 ELAD Treatment Control Survival Estimates (N=33) (N=38) Number (%) of Subjects who Died 6 (18.2) 15 (39.5) Number (%) of Subjects Censored 27 (81.8) 23 (60.5) Censored reason: Still Alive 27 (8

  52. Slide 52: Overall Survival, ITT population, including VTI-208E through 7/30/15

    Overall Survival, ITT population, including VTI-208E through 7/30/15 Age < 50, Creatinine<1.3 and INR<=2.5 ‘Vital Thies Pye lofl viLine VTiane 2318 Figue Sumanaryof Kapa Miar Analysis cf Oval Sunil for Subjects wath AGE <SD and INR==25 and Ceatinires1 3 (FromBaseline UnenghDay2) TTT Population. sup

  53. Slide 53: Overall Survival, ITT population, up to Study Day 91

    Overall Survival, ITT population, up to Study Day 91 Age < 50, Creatinine<1.3 and INR<=2.5 ELAD Treatment Control Survival Estimates (N=33) (N=38) Number (%) of Subjects who Died 2 (6.1) 12 (31.6) Number (%) of Subjects Censored 31 (93.9) 26 (68.4) Censored reason: Still Alive 31 (93.9) 24 (63.2) Ce

  54. Slide 54: Overall Survival, ITT population, up to Study Day 91

    Overall Survival, ITT population, up to Study Day 91 Age < 50, Creatinine<1.3 and INR<=2.5 ‘Wit Theis "Page lofi viLinee vans Figue 2412 Surrmany f Kalan Meier Analyt of Ovenll Survival up to Study Day fr Subject with AGECSO and INRe®2 5 and Creatinine<1 3 FromBaselive toaghDay2) TITPopaltion 100 ——

  55. Slide 55: Proportion of Survivors at Study Days 28 and 91

    Proportion of Survivors at Study Days 28 and 91 Age < 50, Creatinine<1.3 and INR<=2.5 ELAD Treatment Control Total Characteristic (N=33) (N=38) (N=74) ‘Study Day 28 Number (%) of Subjects who Died 1030) 3179) 466) Number (%) of Subjects Still Alive 32 (97.0) 35 (92.1) 67 (94.4) p-value [1] 0.375 p-v

  56. Slide 56: Demographics (1) Age < 50, Creatinine<1.3 and INR<=2.5

    Demographics (1) Age < 50, Creatinine<1.3 and INR<=2.5 — - ELAD Treatment Contol . - 7 Characteristic (N=33) (N=38) = Randomization Stratum, n(%) Subjecthas AILD thatis classified as severe Acute AlcoholicHepattis — ereany seas) Subjecthas ALD thatisnotclassitedas severe Acute AlcoholcHepatis = 9) r

  57. Slide 57: Demographics (2) Age < 50, Creatinine<1.3 and INR<=2.5

    Demographics (2) Age < 50, Creatinine<1.3 and INR<=2.5 ELAD Treatment Control! Total Characteristic (N=33) (N=38) (N=71) Height (cm) n 29 36 65 Mean (SD) 169.0(10.50) 171.5 (10.54) 170.4 (10.52) Median 167.0 173.0 170.0 Min, Max 152, 200 150, 193 150, 200 Weight (kg) n 29 36 65 Mean (SD) 76.51 (24.2

  58. Slide 58: Liver disease characteristics (1)

    Liver disease characteristics (1) Age < 50, Creatinine<1.3 and INR<=2.5 ELAD Treatment Controt Total Characteristic (N=33) (N=38) (e741) pevalue Medical treatments atBaseline,n (4): Steroids 18 (645) 25 (658) 43 (60.6) 0.334 Pentoxifylline 410(30.3) 1231.6) 22(31.0) 0.908 Neacety-cysteine 26.1) 128)

  59. Slide 59: Liver disease characteristics (2)

    Liver disease characteristics (2) Age < 50, Creatinine<1.3 and INR<=2.5 ELAD Treatment Control Total Characteristic (N=33) (N=38) (N=74) pyvalue ‘Subject had dialysis at least twice in the past week, n (%) Yes 0 0 0 No 33 (100) 38 (100) 74 (100) Baseline Maddrey Discriminant Function (MDF) score n 3

  60. Slide 60: Liver disease characteristics (3)

    Liver disease characteristics (3) Age < 50, Creatinine<1.3 and INR<=2.5 —_—, i ELAD Treatment Control - — me Characteristic (233) pevale . (on rena replacement therapy hemodiaiysis, CVVHD, CVVH, prtoneat, etc) t randomization, n(%) : Yes ° ° o No 33.100) 38,100) 74 (100) (on vasopressorsatSaseine, 9

  61. Slide 61: Safety Summary

    Safety Summary Age < 50, Creatinine<1.3 and INR<=2.5 (N=71) ELAD Treatment Control Total Characteristic (N=34) (N=37) (N=71) Number (2%) of Subjects Reporting Any TEAE 34 (100) 37 (100) 74 (100) Number of TEAES 609 545 1154 Number (2%) of Subjects Reporting Any TESAE 24 (61.8) 23 (62.2) 44 (62.0) Nu

  62. Slide 62: Additional VTI-208 Information

    Additional VTI-208 Information SK vita Tr

  63. Slide 63: VTI-208 Clinical Trial Sites

    ial Sites | Tr inica -208 Cl VTI: Number of subjects enrolled by site

  64. Slide 64: Prior Clinical Data Lend Support to VTI-208 Subset Analysis

    Prior Clinical Data Lend Support to VTI-208 Subset Analysis MOV SSX VITALT!

  65. Slide 65: China Trial: Enrolled Younger, Lower MELD Subjects

    China Trial*: Enrolled Younger, Lower MELD Subjects Kaplan-Meier Plot of Transplant-Free Survival 5-year Follow up x, = B é 2 be 5 Bo. = Bs & ea 3 3° g P=0.027 (Log-rank) zo @ Ea g Bo 3 gs g £6 E Bo. 5 e3 & Bas 5 ee p< 0.05, Wileoxon eee ELAD® r a] nzas He Control oo mw 2 @ 6&7 m8 ry Days from Basel

  66. Slide 66: China Data (VTIC-301) Distribution at Baseline

    China Data (VTIC-301) Distribution at Baseline China: MELD analysis is consistent with VTI-208 MELD < 28 MELD 2 28 ‘Alive Dancearea in i a 15 (71.4%) | 5 (23.8%) 1 (4.8%) 11 6 (64.5%) 5 (45.5%) 0 1 9 5 (55.6%) 2(22.2%) 2(22.2%) 8 2(25%) — 3(37.5%) 3 (37.5%) China: very few older patients limits age

  67. Slide 67: ELAD VTI-206: Trend to Increased Survival in AILD

    ELAD VTI-206: Trend to Increased Survival in AILD 100 Overall survival: 70 60 Survival probability (%) S0f n=29* (per-protocol) —, * Per protocolpopulation (PP) acute 40h 4 fi ; F i alcoholic hepattis (AH) cohort (n=28) Time (days) Baseline parameters comparison: VTI-206 PP vs VTI-208 MELD < 28 Coho

  68. Slide 68: VTI-206 Data Distribution at Baseline

    VTI-206 Data Distribution at Baseline VTI-206 PP AAH: MELD analysis is consistent with VTI-208 MELD < 28 MELD 2 28 Total | Alive Dead__| Transplant Total | Alive | Dead | Transplant 5 4 (80%) 4 (20%), 0 8 4 (50%) 3 (87.5%) 1 (12.5%) 3 4 (33.3%) 2 (66.7%) 0 B 6 (46.2%) 7 (53.8%) 0 VTI-206 PP AAH: no

  69. Slide 69: ELAD Mechanism of Action Appendix

    ELAD Mechanism of Action Appendix Research Shows Key Aspects of Liver Function

  70. Slide 70: Hypothesis of ELAD Mechanism of Action

    Hypothesis of ELAD Mechanism of Action* The ELAD System contains over one hundred billion human liver-derived cells which are believed to perform key aspects of liver function in response to patient-specific stimuli. These functions include: + Modulation of inflammation, which is thoughtto be a majo

  71. Slide 71: Modulation of Liver Inflammation: International Liver Transplant Society (ILTS) 2015

    Modulation of Liver Inflammation: International Liver Transplant Society (ILTS) 2015 AILD involves unregulated systemic inflammation’ and elevated plasma levels of inflammatory factors such as IL-1, IL-6, lipopolysaccharide (LPS), and TNF-a2° Hepatocytes have been found to be a major source of acute

  72. Slide 72: Modulation of Liver Inflammation: ILTS 2015

    Modulation of Liver Inflammation: ILTS 2015 VTL C3A cells have been shown in bench studies to secrete anti- inflammatory factors IL-1Ra and AAT - Constitutively — In response to co-incubation with IL-18 and IL-6. — In response to LPS Response is dynamic — Temporal - Dose-dependent May contribute to

  73. Slide 73: Support of Hepatocellular Metabolic Function: EASL 2015

    Support of Hepatocellular Metabolic Function: EASL 2015 * Acute-on-chronic liver failure and acute liver failure are characterized by impaired liver function * Cell-based support of liver function could have therapeutic benefit if the cell therapy was demonstrated to provide metabolic functions requ

  74. Slide 74: Support of Hepatocellular Metabolic Function: EASL 2015

    Support of Hepatocellular Metabolic Function: EASL 2015 * Laboratory studies carried out by VTL show that C3A cells exhibit a diverse expression of various critical cytochrome P450 isozymes including those involved in drug metabolism such as CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4 and CYP3A5. — The

  75. Slide 75: Regeneration and Restoration of Liver Function: AASLD 2015

    Regeneration and Restoration of Liver Function: AASLD 2015 ¢ Liver has remarkable capacity for regeneration « VTL C3A cells produce several growth factors’ e.g.; — TGF-alpha — VEGF — HGF « Abstract accepted for poster presentation AASLD (November 2015) « Further work is aimed at understanding whethe

  76. Slide 76: Mechanism of Action — Conclusion

    Mechanism of Action — Conclusion * The precise mechanism of action for the ELAD System is unknown. * Laboratory studies conducted by VTL and presented at medical meetings suggest: — Simultaneous targeting of multiple processes associated with liver failure — Dynamic, patient specific responses * Fin

  77. Slide 77: Vital Therapies: Targeting Liver Disease

    er “W~ VITAL THERAPIES’ TARGETING LIVER DISEASE

Vital Therapies — Investor Presentation (September 2015) on 6ix