Immunic, Inc. · NASDAQ:IMUX

Immunic — Vital Therapies — Technical Presentation (August 2015)

67 slides from Immunic's technical presentation, Aug 31, 2015

  1. Slide 1: VTI-208 Clinical Study Data Analysis

    VTI-208 Clinical Study Data Analysis August 27 2015 Footer

  2. Slide 2: Summary of Analysis Populations

    Summary of Analysis Populations Randomized (N=203) Allocated to ELAD (n=96) Allocated to Control (n=107) Received ELAD (n=94) Received ELAD (n=1) Received SOC (n=2) Received SOC (n=106) ¥ Received >=72 hrs on ELAD (n=82), Discontinued before 72 hrs due toAE (n=6), by investigator (n=4), withdrew con

  3. Slide 3: Key Conclusions (1)

    Key Conclusions (1) ELAD failed to meet its primary endpoint — Overall survival, ITT analysis — Hazard ratio: 1.027 - p-value: 0.904 « ELAD failed to meet the secondary endpoints - Mortality at 28 days: + ELAD: 24% Control: 19.6% p-value: 0.46 — Mortality at 91 days: * ELAD: 406% Control: 38.3% p-va

  4. Slide 4: Key Conclusions (2)

    Key Conclusions (2) ¢ Subgroup analyses reveal: Footer Lower MELD (< 28) associated with better outcome for ELAD vs Control Younger age (< 46.9) associated with better outcome for ELAD vs Control Patients with acute kidney injury (crea >1.5mg/dL) did poorly on ELAD Patients with blood thinning probl

  5. Slide 5: Key Conclusions (3) Data Summary

    Key Conclusions (3) Data Summary * Overall Study Population ITT Total N=203 ELAD: N=96 Control: N=107 - HR: 1.027 (0.98) p=0.90 - Proportion survivors (91d): ELAD: 59.4% Control: 61.7% p=0.74 PP Total N=187 ELAD: N=82 Control: N=105 - HR: 0.871 (1.15) p=0.52 - Proportion survivors: (91d): ELAD: 64.6

  6. Slide 6: Key Conclusions (4) Data Summary Key Sub Groups

    Key Conclusions (4) Data Summary Key Sub Groups * MELD <28 ITT Total N=120 ELAD: N=51 Control: N=69. - HR: 0.575 (1.74) p=0.077 — Proportion survivors (91d): ELAD: 80.4% Control: 65.2% p=0.068 PP Total N=116 ELAD: N=48 Control: N=68. - HR: 0.538 (1.86) p=0.059 — Proportion survivors (91d): ELAD: 81.

  7. Slide 7: Key Conclusions (5) Data Summary Combined Key Sub Groups

    Key Conclusions (5) Data Summary Combined Key Sub Groups MELD <28, Age <46.9 ITT Total N=59 ELAD: N=26 Control: N=33, HR =0.374 p=0.085 : p=0.006 Footer S$ VITAL THERAPIES:

  8. Slide 8: Overall Analysis

    Overall Analysis Footer

  9. Slide 9: Primary Endpoint

    Primary Endpoint Overall Survival, ITT population, including VTI-208E through 7/30/15 Vital Therapies Page Lofl — viLwex VT Figue 14212 ‘Sunany of Kaplan Meter Analyis of Overall Survival TIT Population HLAD Teamne 0°96) Garret Q¥=I07) (900 ELaD Treamat ajece Cased 50 BOG Geel Sayees Caved 56 Sumiva

  10. Slide 10: Primary Endpoint

    Primary Endpoint Overall Survival, ITT population, including VTI-208E (through 7/30/15) ELAD Treatment Control survival Estimates E96) Qe107) Humber (6) of Subjects who Died 46 G19) 3147.7) [umber (4) of Subjects Censored 30 (52.1) 36 (52.3) Censored reason: Still Alive 4951.0) 33(49.5) Censored rea

  11. Slide 11: Primary Endpoint

    Primary Endpoint Overall Survival, PP population, including VTI-208E igre 421 ‘Samay of Kiplav Mier Abbi of Onl Savin 'P Popution Sanka Dierbutien o m0 ‘an By any ‘wo ‘ao ‘no ao m0 Tm Dy) ‘Wee: Over Surv inchaes dita tot et Sty Day 91, wah followup Feotocol VIE2OGE providing sin unl da pto ema 5 yes

  12. Slide 12: Primary Endpoint

    Primary Endpoint Overall Survival, PP population, including VTI-208E ELAD Treatment Control Survival Estimates (e282) E105) jumber (%) of Subjects who Died 35 (42.7) 49 (46.2) jumber (%) of Subjects Censored 4767.3) 36 (53.3) Censored reason: Still Alive 46 (56.1) 53.(50.5) Censored reason: Lost to

  13. Slide 13: Primary Endpoint — Sensitivity Analysis

    Primary Endpoint — Sensitivity Analysis Overall Survival, ITT population, up to study day 91 Vial terse Page def ‘vi-oez2.vi108 ign 14226 Saumur Kapha Meir Anaya of Oral Sarva to Study Dey 91 TTT Popa, 2.0 mama) rf Cera) 200 Rap emataiipcs Cnonds? BOD Comalsapar Cavaee ce o. pas (0664 » Saka Dicaias

  14. Slide 14: Primary Endpoint — Sensitivity Analysis

    Primary Endpoint — Sensitivity Analysis Overall Survival, ITT population, up to study day 91 ELAD Treatment Control survival Estimates E96) @t=107) Number (%4) of Subjects who Died 39 (40.6) 4168.3) umber (%) of Subjects Censored 57 (69.4) 6661.7) Censored reason: Still Alive 56 (58.3) 6358.9) Censo

  15. Slide 15: Primary Endpoint — Sensitivity Analysis

    Primary Endpoint — Sensitivity Analysis Overall Survival, PP population, up to study day 91 il Ten Pa of view Figur 14.2.2: Sony Kasi As Owl Sani thy Day PP Rep © maptemenen) oo Eamets) Coo mu tenatsbier amend 2 Se comelasyen Cocanes . prs 0061 1 § a2 x » » ° ‘ i 2 > ° 2 @ 7° 2 ” 1” Tie Dap) (Orel S

  16. Slide 16: Primary Endpoint — Sensitivity Analysis

    Primary Endpoint — Sensitivity Analysis Overall Survival, PP population, up to study day 91 ELAD Treatment Control survival Estimates @e82) @=105) Number (%) of Subjects who Died 29 G5.) 40 (38.1) Plumber (%) of Subjects Censored 53 (64.6) 65 (61.9) Censored reason: Still Alive 5263.4) 62.(59.0) Cen

  17. Slide 17: Secondary Endpoint: Proportion of Survivors at d28/91

    Secondary Endpoint: Proportion of Survivors at d28/91 ITT Population PP Population ELAD ELAD ‘Treatment Control Total ‘Treatment Control Total [Characteristic (N=96) (N=107)_ | (N=203)_| [Characteristic (N=82) (N=105) | (N=187) study Day 28 Brudy Day 28 ‘Number (%) of Subjects Number (%) of Subjects

  18. Slide 18: Demographics ITT Population

    Demographics ITT Population Footer

  19. Slide 19: Baseline Demographics: ITT Population

    Baseline Demographics: ITT Population ELAD Treatment Control Total [Characteristic (N=96) (N=107) (N=203) [Ase (years) n 96 107 203 Mean (SD) 46.5 (9.06) 44.8 (10.66) 45.6 (9.95) Median 48.0 45.0 46.0 Min, Max 25,68 25,67 25,68 JAge Category, n (0) 18-35 years 12 (12.5) 25 (23.4) 37 (18.2) 36-50 yea

  20. Slide 20: Baseline Demographics: ITT Population

    Baseline Demographics: ITT Population ELAD Treatment Control Total {Characteristic (N=96) (N=107) (N=203) leteight (cm) [1] a 84 97 181 Mean (SD) 171.2 (10.61) 174.5 (11.00) 173.0 (10.92) Median: 170.0 174.0 173.0 Min, Max 144, 200 150, 201 144, 201 eight (kg) [1] n 84 99 183 Mean (SD) 80.74 (21.601

  21. Slide 21: Baseline Disease Characteristics: ITT population

    Baseline Disease Characteristics: ITT population LAD Tretia Contial Tord haracteristic (N96) (N=107) (v=203) pvalve [1] ele Mb di for Enaage Liver Divas (MELD) Soe a 96. 107 203 ‘Mean (SD) 27.63.94) 713.79) 27.3 (3.36) 0371 Midian 70 70 210 Tin, Wie 7.5 70,35 2 Category, n(%) 0.100 WELD Sor <2 soa D

  22. Slide 22: Baseline Disease Characteristics: ITT population

    Baseline Disease Characteristics: ITT population ELAD Treatment Control Total [Characteristic N=96) (NE107) (N=203) p-value [1] [Baseline Maddrey Discriminant Function (MDF) core a 36 107 203 ‘Mean (SD) 73.4 (27.61) 72.6 (23.36) 73.0 25.43) 0.833 Median 665 70.0 6.0 Min, Max 33,157 32, 140 32, 157 P

  23. Slide 23: Baseline Disease Characteristics: ITT population

    Baseline Disease Characteristics: ITT population ELAD Treakuont Contod Toad characteristic (N=96) (N=107) (N=203) pale (I) renal placement Menpy Gensodajas CVVHD, COVE, itoneal, etc) at randomization, n(¥%) 0.290. ‘Yes 1(1.0) o 1 (05) No 9599.0) 107(100) 202 (99.5) i vasopressors a Baling, no) 992 Y

  24. Slide 24: Baseline Disease Characteristics: ITT population

    Baseline Disease Characteristics: ITT population ‘Treatment | Control Total {Characteristic (N=96) N=107)_ | (@N=203)_| p-value [1] Medical treatments at Baseline, n (06): Steroids 44 (45.8) | 53(49.5) | 97 (47.8) 0.598 Pentoxifylline 3334.4) | 3461.8) | 67 (33.0) 0.694 N-acetyl-cysteine 5 (6.2) 57)

  25. Slide 25: Baseline Liver Disease Characteristics: ITT Population

    Baseline Liver Disease Characteristics: ITT Population ELAD Treatment Control Total Characteristic (N96) (N=107) Qv=203) p-value [1] [Basis for diagnosing subject with acute alcohol-related liver failure, ayo ‘Confirmation by liver biopsy 15 (5.6) T3 (21) 28 (13.8) 0473 Presence of hepatomegaly 7275

  26. Slide 26: Baseline Liver Disease Characteristics: ITT Population

    Baseline Liver Disease Characteristics: ITT Population ELAD Trestent Contel Total [haractenstic (96) (e107) 203) paw (1) [iver Sie (cx Liver size determined by Ultrasound, n(%) Yes ETGE D260) Tas No 1446) 15040) 23 (143) ry 2 92 az ean SD) T1047 BBCI) ICED) Ta Median 19.15 1.95 19.55 Min, Vise 700,2

  27. Slide 27: Baseline Clinical Characteristics: ITT Population

    Baseline Clinical Characteristics: ITT Population ELAD Treatment Control Total Body System (parameter, unit) N=96) Q=107) 203) Liver (bilirubin, mg/dL), n (%) 26.0 to <12.0 44D) 805) 1269) 2120 92. (95.8) 99 (92.5) 191 64.) jidney (creatinine, mg/dL), n (%) <12 68 (70.8) 82 (76.6) 150 73.9) B12 te <

  28. Slide 28: Baseline Clinical Characteristics: ITT Population

    Baseline Clinical Characteristics: ITT Population ELAD Treatment Control Tota jody System (parameter, unit) (N=96) Qe107) (N=203) ‘coagulation (INR), n (%) <1 1.0) oO 10.5) 21.1 to <1.25 3G1) 4G) 7G4) 21.25 to <1.5 6 (6.3) 76.5) 136.4) Bist <25 66-(68.8) 73,(68.2) 139 (68.5) 225 1919.8) 2321.5) 4220

  29. Slide 29: Safety Analysis

    Safety Analysis Footer

  30. Slide 30: Summary of Treatment Emergent Adverse Events

    Summary of Treatment Emergent Adverse Events: Safety Population ELAD Treatment Control Total {characteristic (N95) (N=108) (N=203) Peumber (76) of Subjects Reporting Any TEAE 95 (100) 107 (99.1) 202 (99.5) [lumber ol TEARS 2046 1619 3665 Pier eel of bibj ects Reporting Any TESAE- 73:(76.8) 75 (69.4)

  31. Slide 31: Summary of Treatment Emergent Adverse Events

    Summary of Treatment Emergent Adverse Events: Safety Population ELD Taste = Toad arate 295) gie108) temo Tonba(7) a Subject Rapating hay TERE Esa) THAI Das) junberof TEAEs Dae 1619 3a font a0) of Subecu Raporing Ray TSE, Bsa) Bey TesC23y FfonberoF TESAE: 136 163 ea jobject with TEABs by Highest Seve

  32. Slide 32: Summary of Treatment Emergent Serious Adverse Events

    Summary of Treatment Emergent Serious Adverse Events ELAD Treatment Control Total aracteristic (E95) (Q=108) (E203) lumber of TESAEs 156 168 324 ITESAEs by Severity, n (%) im 6G.8) 120.1) 186.6) foderate 52 (33.3) 48 (28.6) 100 (30.9) jevere 98 (62.8) 108 (64.3) 206 (63.6) [TESAEs by ELAD Relationsh

  33. Slide 33: Subjects with at least one TEAE by System Organ Class / Preferred Term

    Subjects with at least one TEAE by System Organ Class / Preferred Term: Descending Order ELAD Treatment Control Total i=95) qv=i03) aie203) ceferced Tent a a 20) jodie Reporting Lead One TEAB I 95.00) Liven | __ my Tate GED ETGH) ATED) Hepatic eneqphalopathy 22442) 3 G08) 75.69) [anaemia 4648.4) G7)

  34. Slide 34: Subjects with at least one TEAE by System Organ Class / Preferred Term

    Subjects with at least one TEAE by System Organ Class / Preferred Term: Descending Order ELAD Treatment Control Total (N=95) qv=108) u=203) referred Term Et Et Et objects Reporting at Lead One TEAE I 35.0) I 107 GD) I 22 OD lanaiety 2122.1) 963) 30 (14.8) Constipation 19 (20.0) 10.9.3) 2914.3) Hyper

  35. Slide 35: Subjects with at least one TEAE by System Organ Class / Preferred Term

    Subjects with at least one TEAE by System Organ Class / Preferred Term: Descending Order (used t14.3.1.3b) ELAD Treatment Control Total (N=95) qv=108) u=203) referred Term Et Et Et jubjesis Reporting a Lead One TEAR, I 35.0) I 107 GD) I 22 OD Dehydration 704) 666) 1364) Ecchymosis 7074) 666) 1364) E

  36. Slide 36: Subgroup MELD

    Subgroup MELD Footer

  37. Slide 37: Distribution of Baseline MELD Scores

    Distribution of Baseline MELD Scores Footer Plarned Treatment for Period O1 ELAD Treaiment Coteal Histogram of MELD Score Control ELAD 200 ms 230 275 m0 Baseline model for end stage liver dis. 325 350

  38. Slide 38: Subgroup Analyses: Overall Survival incl. VTI-208E: ITT

    Subgroup Analyses: Overall Survival incl. VTI-208E: ITT By MELD (< 28 vs 2 28) MELD Score <28 MELD Score 228 ELAD ELAD Treatment Control Treatment Control Survival Estimates Q51) (E69) Q=45) (E38) fumber (%) of Subjects who Died [15 (29.4) 3043.5) 31 (68.9) 2155.3) Number (%) of Subjects Censored |

  39. Slide 39: Subgroup Analyses: Overall Survival incl. VTI-208E: ITT

    Subgroup Analyses: Overall Survival incl. VTI-208E: ITT Subjects with MELD < 28 Product-Limit Survival Estimates Wih Number of Subjects at Risk 1.0 + Censored ° Nan B 06 2 a 5 04 3B 024 00 1) 0 2 4 0 97 3 1 2 2 2 7 9 2 8 6 8 4 2s: 4 wo 4 97 35 3% 2 2 7 wom 6 2 2 2 2 0 200 400 600 800 Analysis Value

  40. Slide 40: Subgroup Analyses: Overall Survival incl. VTI-208E: PP

    Subgroup Analyses: Overall Survival incl. VTI-208E: PP By MELD (< 28 vs 2 28) MELD Score <28 MELD Score 228 ELAD ELAD Treatment Control Treatment Control Survival Estimates eg) @e68) (N34) (N=37) Number (%) of Subjects who Died 3.27.1) 29 (42.6) 22 (64.1) 20 (54.1) Number (%) of Subjects Censored 35

  41. Slide 41: Secondary Endpoints (MELD < 28, N = 120, ITT)

    Secondary Endpoints (MELD < 28 N = 120, ITT) Footer Censor | ELAD Control Overall Day 28 014 (7.8%) 11 (15.9%) — |15 (12.5%) Day 28 1/47 2.2%) [58 (84.1%) _ [105 (87.5%) Day 28: Chisq 0.1848 [Day 28: CMH 0.1850 Day 91 0/10 19.6%) |24G4.8%) [34 (28.3%) Day 91 1/41 (80.4%) [45 (65.2%) [86 (71.7%) Day

  42. Slide 42: Secondary Endpoints (MELD < 28, N = 116, PP)

    Secondary Endpoints (MELD < 28 N = 116, PP) Footer Censor | ELAD Control Overall Day 28 0/3 6.3%) 11 46.2%) 14. 2.1%) Day 28 1]45 03.8%) 157 (83.8%) _ |102 (87.9%) [Day 28: Chisq 10.1060 ‘Day 28: CMH 10.1051 Day 91 019 8.8%) [23 3.8%) [32 (27.6%) Day 91 1/39 (81.3%) [45 (66.2%) [84 (72.4%) Day 91: C

  43. Slide 43: Demographics (1) MELD <28

    Demographics (1) MELD < 28 ELAD Treatment Control Total ss Characteristic (N51 eso N=120 - Randomization Stratum, n (%) Subject has AILD that is classified as severe A cute Alcoholic Hepatitis 4792.2) 64(928) 1110925) Subject has AILD that is not classified as severe Acute Alcoholic Hepatitis 478) 5

  44. Slide 44: Demographics (2) MELD <28

    Demographics (2) MELD < 28 ELAD ‘Treatment Control Total Characteristic (N=51) (N=69) (N=120) Height (cm) [1] a 45 64 109 Mean (SD) 170.1 (11.84) 173.4 (10.54) 172.0 (11.16) Median 170.0 173.0 172.0 Min, Max 144, 200 150, 193 144, 200 ‘Weight (ke) [1] n 45 62 107 Mean (SD) 76:32 (21.518) 85.96 (20.7

  45. Slide 45: Liver disease characteristics (1) MELD <28

    Liver disease characteristics (1) MELD < 28 ELAD Treatment Control Total Characteristic (N=51) (N=69) (N=120) pevalue [1] Medical treatments at Baseline, n (%): Steroids 24 @7.1) 39 (56.5) 63 (52.5) 0.305 Pentoxifylline 1763.3) 21 80.4) 381.7) 0.736 Neacetyl-cysteine 269) 343) 542) 0.908 Baseline Mo

  46. Slide 46: Liver disease characteristics (2) MELD <28

    Liver disease characteristics (2) MELD < 28 ELAD Treatment Control Characteristic 1 69) Subject had dialysis at least twice in the past week, n (%) Yes 0 0 0 No 51.100) 69 (100) 120 (100) Baseline Maddrey Discriminant Function (MDF) score a 51 69 120 ‘Mean (SD) 59.5(13.97) 61.8(18.00) 60.8 (16.39) 0

  47. Slide 47: Liver disease characteristics (3) MELD <28

    Liver disease characteristics (3) MELD < 28 ELAD Treatment Control Tota Characteristic (N=51) (N=69) (N=120) p-value [1] On renal replacement therapy (hemodialysis, CVVHD, CVVH, peritoneal, etc) at randomization, n (%) Yes 0 0 0 No 51 (100) 69 (100) 120 (100) On vasopressors at Baseline, n (%) 0.404

  48. Slide 48: Safety Summary MELD < 28 (N = 120)

    Safety Summary MELD < 28 (N = 120) ELAD Treatment Control Total Characteristic v=52) (e683) QN=120) Number (%) of Subjects Reporting Any TEAE 52(100) 68 (100) 120 (100) ‘Number of TEAEs 938 984 1922 ‘Namber (%) of Subjects Reporting Any TESAE 3771.2) 43 (63.2) 80 (66.7) ‘Number of TESAEs 69 101 170

  49. Slide 49: Safety Summary MELD < 28 (N = 120)

    Safety Summary MELD < 28 (N = 120) ELAD Treatment Control Total Characteristic QN=52) E68) E120) Number (%) of Subjects Reporting at Least 1 ELAD- Related [2] TESAE 11 (21.2) NWA 11@.2) Related to ELAD Biologic 0 WA 0 Related to ELAD Device 35.8) WA 32.5) Related to ELAD Procedure 611.5) WA 6 (5.0)

  50. Slide 50: Sub Group Age

    Sub Group Age Footer

  51. Slide 51: Distribution of Baseline Age

    Distribution of Baseline Age Histogram of Age Control Controt Percent ELAD PlannedTreament for Pedod OL I ELAD Treatment Percent, Footer

  52. Slide 52: Subgroup Analyses: Overall Survival incl. VTI-208E: ITT

    Subgroup Analyses: Overall Survival incl. VTI-208E: ITT By Age ye < Median Years Age 2 Median Years ELAD ELAD ‘Treatment Control ‘Treatment Control urvival Estimates oe) ay=58) E53) aH19) fumber (74) of Subjects who Died 142.6) 26 (44.8) 32.(60.4) 2551.0) jumber (4) of Subjects Censored 29 (67.4) 32

  53. Slide 53: Subgroup Analyses: Overall Survival incl. VTI-208E: ITT

    Subgroup Analyses: Overall Survival incl. VTI-208E: ITT Subjects < median age (46.9 yrs) Product-Limit Survival Estimates Wih Number of Subjects at Risk 1.0 + Censored os 06 os Sunival Probability 02 oe 2 3% m7 Bw ww 4 1 8 8 4 8 8 2 2|_# 30 35 3 90 2 2 29 16 19 9 4 3 0 0 200 400 600 800 Analysis Val

  54. Slide 54: Secondary Endpoints (< median age N = 101, ITT)

    Secondary Endpoints (< median age N = 101, ITT) Footer Censor |_ELAD Control Overall Day 28 0/5 1.6%) 195.5%) [14 (13.9%) Day 28 1/38 (88.4%) [49 (84.5%) [87 (86.1%) Day 28: Chisq 0.5759 ‘Day 28: CMH 0.6107 Day 91 0}8 (18.6%) 19 32.8%) — |27 (26.7%) Day 91 1]35 (81.4%) 39 (67.2%) —_|74 (73.3%) Day 9

  55. Slide 55: Subgroup Analyses: Overall Survival incl. VTI-208E: PP

    Subgroup Analyses: Overall Survival incl. VTI-208E: PP By Age ‘Age < Median Years Age 2 Median Years ELAD Treatment Control ELAD Treatment Control Survival Estimates (N=38) (N=56) (N=44) (=49) Number (7) of Subjects who Died 1128.9) 24 (42.9) 24 (54.5) 25 (51.0) Number (7) of Subjects Censored 2771.

  56. Slide 56: Secondary Endpoints (< median age N = 94, PP)

    Secondary Endpoints (< median age N = 94, PP) Footer Censor | _ELAD Control | Overall Day 28 0/3 (7.9%) 9(16.1%) [12 (12.8%) Day 28 1]35 (92.1%) —|47 (83.9%) —_|82 (87.2%) [Day 28: Chisq 0.2437 Day 28: CMH 0.2672 Day 91 0]6 (15.8%) 18 2.1%) — [24 (25.5%) Day 91 1/32 (84.2%) [38 (67.9%) [70 (74.5%) D

  57. Slide 57: Liver disease characteristics (1) < median Age

    Liver disease characteristics (1) < median Age ELAD Tiesboent Coto Tet Chamctitic iss) ie: gie10, peahe fl] ‘Madica eaten st Barling, (0): Steroids, 20465) N66 47463) 0997 Rentafpline 14626) 7666) 41406) 0187 Nesceyoptine 300) 362) 669) ons Baseline Mode for Erdstage Liver Disease (MELD) score 8 4%

  58. Slide 58: Liver disease characteristics (2) < median Age

    Liver disease characteristics (2) < median Age ELAD Tratient ——Contol Tos Characteristic “ie i= 58) _(v101) Subject had dale at ast vice in tbe past wee n(%) Yee ° 0 ° No 43(100) 58.(100) 101 (100) Basiline Madey Discrninant Futon (MDE) sore 2 a 38 101 ‘Mean (SD) 713 (23.08) 773:(22.18) 748 (22.65)

  59. Slide 59: Liver disease characteristics (3) < median Age

    Liver disease characteristics (3) < median Age ELAD Treatwent Contot Total Characteristic (N=83 N=58) (e101) peal: (1) On renal placement therapy (hemodialysis, CVVHD, CVVH, peritoneal, ets) at randomization, n(%) Yes 0 0 0 No 43.100) 38400) 101 (100) Onvaspresnts at Baseline, n(%) osts Yes 516) 110

  60. Slide 60: Demographics (1) < median Age

    Demographics (1) < median Age - ELAD Treatment Control Total, = Char acteristic =43) N=58) (N= 101) Randomization Strat, 2(%) Subject has AILD that is classfied a severe Acute Alcoholic Hepatitis 2077) 35.043) 97.60) Subject has AILD that ie not classified as severe Acute Alcoholic Hepatitis 1@3 362

  61. Slide 61: Demographics (2) < median Age

    Demographics (2) < median Age ELAD Treatment Controt Total Characteristic, (Nes) (Ne69 QN=120) Height (cm) [1] n 45 64 109 ‘Mean (SD) 170.1 (11.84) 173.4 (10.54) 172.0(11.16) Median 170.0 173.0 172.0 ‘Min, Max 144, 200 150,193 144, 200 Weight (ke) [1] n 45 62 107 ‘Mean (SD) 76.32(21.518) —85.96(20.7

  62. Slide 62: Safety Summary age < median (N = 101)

    Safety Summary age < median (N = 101) ELAD Treatment Control Total Characteristic i=43) 1-58) Qv=101) Number (%6) of Subjects Reporting Any TEAE 43.100) 57083) 100 @9.0) Number of TEAEs 337 330 1667 Number (%6) of Subjects Reporting Any TESAE 2967.4) 3763.8) 66 653) Number of TESAE s 65 3 143 ‘Subje

  63. Slide 63: MELD < 28 and Age < median

    MELD < 28 and Age < median Footer

  64. Slide 64: Primary Endpoint

    Primary Endpoint Overall Survival, ITT population, including VTI-208E through 7/30/15 Age < median years (46.9 yrs) and Baseline MELD <28 ELAD Treatment Control Survival Estimates E26) QN=33) Number (6) of Subjects who Died 454) 11633) Number (%) of Subjects Censored 22 (84.6) 22 (66.7) Censored rea

  65. Slide 65: Primary Endpoint

    Primary Endpoint Overall Survival, ITT population, including VTI-208E through 7/30/15 Age < median years (46.9yrs) and Baseline MELD <28 ‘Vita Theres Page lot vvmL-soez2_viz2te Fign 142.128 Smmmay of Kep Meier Analysis of Oven Suvialfor Subjects wih Age <Mdian yous xd Beeline MELD <28 TIT Poputiien

  66. Slide 66: Primary Endpoint

    Primary Endpoint Overall Survival, ITT population, up to Study Day 91 Age < median years (46.9 yrs) and Baseline MELD <28 ELAD Treatment Control Survival Estimates (N=26) (N=33) Number (%) of Subjects who Died 0 8 (24.2) Number (%) of Subjects Censored 26 (100) 25 (75.8) Censored reason: Still Alive

  67. Slide 67: Primary Endpoint

    Primary Endpoint Overall Survival, ITT population, up to Study Day 91 Age < median years (46.9 yrs) and Baseline MELD <28 Veal Bangs Rela) ‘VEL O08, WE208 Fare 4220. Sumy Kaplan ese Abs cf Ons Surin to Seay Day? fe Shp wh Age <Matn os end Behe MELD 28 UT Pepabsion aw = * Ene) G0 Emmi conrat ° | « »

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