Immunic, Inc. · NASDAQ:IMUX

Immunic — Technical Presentation (December 2021)

99 slides from Immunic's technical presentation, Dec 14, 2021

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  2. Slide 2: Cautionary Note Regarding Forward-Looking Statements

    Cautionary Note Regarding Forward-Looking Statements This presentation contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 216 of the Securities

  3. Slide 3: Development Pipeline

    Development Pipeline Program _| Target Preclinical Phase 1 Phase 2 Phase 3 Key 2021/22 Milestones vidofludimus calcium DHODH Phase 2 UC: top-line data expected in Q2/2022 (mu-838) itial data expected in Q2/2022 IMU-935 RORyt Phase 1 CRPC: initial data expected in Q3/2022 IMu-856 ae Phase 1healthy vo

  4. Slide 4: IMU-935: Phase 1 SAD/MAD Data in Healthy Human Subjects and Preclinical Update

    IMU-935: Phase 1 SAD/MAD Data in Healthy Human Subjects and Preclinical Update 01 Phase 1 Clinical Trial of IMU-935 Trial Design and Status Results Part A: Single Ascending Doses Results Part B: Multiple Ascending Doses Ongoing Part C in Psoriasis Patients Newly Obtained /n Vivo Data Summary 4 | ©im

  5. Slide 5: Autoimmune Diseases and IMU-935

    Autoimmune Diseases and IMU-935 . 2 : Unmet Need in Psoriasis Care IL-17 in Autoimmune Diseases = Autoimmune diseases affect millions of patients worldwide! = Th17/IL-17/RORyt axis plays an important role in auto immunity-related diseases!) * Antibodies targeting this axis corroborate IL-17’s role i

  6. Slide 6: Results Part A / Results Part B

    Results Part A: Results Part B: Single Multiple Ascending Doses Ascending Doses Trial Design and Status Ongoing Part Cin Psoriasis Patients

  7. Slide 7: Phase 1 Clinical Trial of IMU-935

    Phase 1 Clinical Trial of IMU-935 01

  8. Slide 8: Clinical Trial Design Phase 1 IMU-935 and Current Status

    Clinical Trial Design Phase 1 IMU-935 and Current Status PART A Evaluation of single ascending doses (SAD) Healthy volunteers randomized to receive single dose of either IMU-935 or placebo part B Evaluation of multiple ascending doses (MAD) Healthy volunteers randomized to receive 14-day treatment o

  9. Slide 9: Phase 1 Clinical Trial of IMU-935

    Phase 1 Clinical Trial of IMU-935 01

  10. Slide 10: Dose Escalation Scheme

    Dose Escalation Scheme Part A: Single Ascending Doses Part A: Initial Lipid-Based Pilot Formulation Part A-N: Powder-in-Capsule Formulation Cohort 4 Bridging cohort Cohort 6N 200mgiMU-935 fu] 100mg IMU-935 BID ‘400mg IMU-335 or placebo (ratio 6:2) or placebo (ratio 6:2) or placebo (ratio 6:2) Cohort

  11. Slide 11: Summary of Safety and Tolerability Findings

    Summary of Safety and Tolerability Findings Part A-N 11 | ©immunic, inc. | Dec/14/2021 Single Doses of IMU-935 in Healthy Human Subjects Were Found to Have a Favorable Safety and Tolerability Profile a No serious adverse events No dose-dependency in adverse events No maximum tolerated dose reached N

  12. Slide 12: Most Common Treatment-Emergent Adverse Events

    Most Common Treatment-Emergent Adverse Events Part A-N Number (%) of subjects with TEAEs occurring in more than 2 subjects [Number of TEAEs reported] Epica pote (ote | ere eee rat eee eter te (N=6) | (N=6) rete - [sam] | oe] seme] vos Catheter site pain ei a - - - - sce ae Constipation : a - - . aes

  13. Slide 13: Summary of Safety and Tolerability Profile

    Summary of Safety and Tolerability Profile Part A-N = Serious AEs (SAE) = Summary of laboratory variables — None (N=0) —No trend for changes over time for any parameter = Treatment discontinuations due to AEs — Shift tables showed no trend of individual changes — None (N=0) beyond the normal range f

  14. Slide 14: Laboratory Parameters: No Change in Neutrophils Compared to Placebo

    Laboratory Parameters: No Change in Neutrophils Compared to Placebo Part A-N roy Laboratory Values Over Time Individual Laboratory Values Hematology - Neutrophils Hematology - Neutrophils ‘essa Boos Neen BSD feesome| ‘rast Sosehnaronle (at) ou esa Neutrophils (10°9/L) fet rere Group mean time respon

  15. Slide 15: Laboratory Parameters: No Increase of ALT Compared to Placebo

    Laboratory Parameters: No Increase of ALT Compared to Placebo Part A-N roy Laboratory Values Over Time Biochemistry - ALT Individual Laboratory Values Biochemistry - ALT Alanine Aminotransferase (U/L) ‘Mean time response curves +/- standard deviation Alanine Aminotransferase (UL) ee 10 s Day Dayt Da

  16. Slide 16: Laboratory Parameters: No Hy's Law Range Cases Observed

    Laboratory Parameters: No Hy’s Law Range Cases Observed Part A and Part A-N Combined Bilirubin vs. ALT Showed No Evidence of DIL! Potential Bilirubin vs. AST Showed No Evidence of DIL! Potential Hy’s Law Plot: BIL vs ALT across all post-dose visits Hy’s Law Plot: BIL vs AST across all post-dose visi

  17. Slide 17: Conclusions

    Conclusions Part A-N: Single Ascending Doses = The powder-in-capsule formulation provided favorable pharmaceutical properties in Part A-N of this clinical trial. = Its favorable safety and tolerability allowed smooth transition from Part A (SAD) to Part B (MAD) in healthy human subjects.

  18. Slide 18: Phase 1 Clinical Trial of IMU-935

    Phase 1 Clinical Trial of IMU-935 01

  19. Slide 19: Design of Part B: Multiple Ascending Doses of IMU-935

    Design of Part B: Multiple Ascending Doses of IMU-935 Dose Escalation Scheme Study Period Cohorts D-28 D1 D4 Dis Dis D238 150 mg IMU-935 or placebo BID over 14 days (ratio 5:2) D-1to4 D7 D13 to 16 D17|D18 D238 Cohort7 150 mg IMU-935 or placebo QD over 14 days (ratio 6:2) D13 to 16 ‘ap: quaque die ~o

  20. Slide 20: Pharmacokinetic Results

    Pharmacokinetic Results Part B: Summary of QD and BID Dosing Regimen for IMU-935 IMU-935 concentration time profiles (log-linear scale) 4&2 Favorable PK Properties for IMU-935 at Steady-State Observed Time [days] ie) ed 14 — - Pharmacokinetic parameters ENTLOR asMccm £ in steady-state (mean) 2 100 C

  21. Slide 21: Summary of Safety and Tolerability Findings

    Summary of Safety and Tolerability Findings Part B 21 | ©immunic, inc. | Dec/14/2021 Daily Dosing of IMU-935 in Healthy Human Subjects Over 14 Days Was Found to Have a Favorable Safety and Tolerability Profile a No serious adverse events No dose-dependency in adverse events No maximum tolerated dose

  22. Slide 22: Overall Summary of TEAE, SAE and AE Severity

    Overall Summary of TEAE, SAE and AE Severity Part B Treatment Category 150 mg QD 150 mg BID Active Placebo (N=6) (N=5) (N=11) (N=4) Subjects with mild TEAEs, n (%) 6 (100%) 4 (80%) 10 (91%) 4 (100%) Subjects with moderate TEAEs, n (%) - 1 (20%) 1 (9%) 1 (25%) Subjects with severe TEAEs, n (%) - - =

  23. Slide 23: Most Common Treatment-Emergent Adverse Events

    Most Common Treatment-Emergent Adverse Events Part B Number (%) of subjects with TEAEs occurring in more than 1 subject [Number of TEAEs reported] MedDRA. Protenedacnn 150mg QD 150mg BID Active Placebo (N=6) (N=5) (N=11) (N=4) 2 (33%) 3 (60%) 5 (45%) 2 (50%) Headache (2] 3] (5) (5] A 1(17%) 1 (20%)

  24. Slide 24: Summary of Safety and Tolerability Profile

    Summary of Safety and Tolerability Profile Part B = Serious AEs (SAE) = Summary of laboratory variables — None (N=0) —No trend for changes over time for any parameter = Treatment discontinuations due to AEs — Shift tables showed no trend of individual changes — None (N=0) beyond the normal range for

  25. Slide 25: Laboratory Parameters: No Change in Neutrophils Compared to Placebo

    Laboratory Parameters: No Change in Neutrophils Compared to Placebo Part B roy Laboratory Values Over Time Hematology - Neutrophils ==) Individual Laboratory Values Hematology - Neutrophils Neutrophils (108@/L) Neutrophils (10*8/L) ‘Mean time response curves +/- standard deviation [=e ena ieee wa el

  26. Slide 26: Laboratory Parameters: No Increase in ALT Compared to Placebo

    Laboratory Parameters: No Increase in ALT Compared to Placebo Part B roy Laboratory Values Over Time [=== Individual Laboratory Values Biochemistry - ALT Biochemistry - ALT Alanine Aminotransferase (U/L) ‘Mean time response curves +/- standard deviation 40 i i : Za Pa a 3 2 30 8 3 zs E = 2 = ce i- 1

  27. Slide 27: Laboratory Parameters: No Hy's Law Range Cases Observed

    Laboratory Parameters: No Hy’s Law Range Cases Observed Part B Bilirubin vs. ALT Showed No Evidence of DIL! Potential Bilirubin vs. AST Showed No Evidence of DIL! Potential Hy's Law Plot BIL vs ALT across all post-dose visits Hy's Law Plot BIL vs AST across all post-dose visits. WN WN 10 EES 10 ecie

  28. Slide 28: Conclusions

    Conclusions Part B: 14-Days Multiple Ascending Doses = Multiple ascending doses of IMU-935 demonstrated a favorable safety, tolerability and pharmacokinetic profile. = This allowed smooth transition from Part B (MAD) to Part C (28-day dosing in psoriasis patients) which is currently ongoing.

  29. Slide 29: Phase 1 Clinical Trial of IMU-935

    Phase 1 Clinical Trial of IMU-935 01

  30. Slide 30: Ongoing First-in-Human Study

    Ongoing First-in-Human Study Part C: IMU-935 in Psoriasis Patients Study Design = Double-blind, placebo-controlled dose escalation study to evaluate safety, tolerability, pharmacodynamics and exploratory efficacy of IMU-935 in patients with moderate-to-severe psoriasis = Psoriasis patients will rece

  31. Slide 31: Ongoing First-in-Human Study

    Ongoing First-in-Human Study Part C: IMU-935 in Psoriasis Patients Dose Escalation Scheme Study Period Cohort 11 (N=36) 150 mg IMU-935 or placebo BID over 28 days (ratio 3:1) D1 028 029 pss p56 Cohort 10 (N=16) ‘Dover 28 days (retioS) HEE [2 [02 [os [oz [ozs] [bs] [bss] fy Recruitment of cohort 10 c

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  33. Slide 33: IMU-935 Selectively Inhibits Th17 Differentiation and IL-17 Secretion

    IMU-935 Selectively Inhibits Th17 Differentiation and IL-17 Secretion Differentiation “ 5 The differentiation towards Th17 cells is inhibited by IMU-935 ay 00a Cytokine ay \2IL-A7A The production of IL-17A and Production f IFNy. IL-17F is inhibited by IMU-935 f out ey Normal remarry Unchanged The ph

  34. Slide 34: IMU-935's in vitro Selectivity on Th17 Suppression Confirmed

    IMU-935’s in vitro Selectivity on Th17 Suppression Confirmed, Well Differentiated to Other RORyt Inhibitors LATA ry + RORgt* 140 e © DMSO = 5% Cintirorgon (agonist) y IM105935 2 $ co MRL871 $ & Vehicle = 100: ——+ % Cintrorgon (agonist) as = 5 3% IMi05935 peg ee Cost 38 a0. £2 1 Sa ES 00. Ware ae = 4

  35. Slide 35: IMU-935 Allows Normal Thymocyte Maturation in vivo

    IMU-935 Allows Normal Thymocyte Maturation in vivo Acute Model, 3 Days of Treatment In contrast to = 15 ? MRL-871, Vehicle IMU-935 MRL-871 Cintirorgon 'o ® Vehicle oe x Neg Hae IMU-935 does f 2 ibs - MRL-871 not impact g cA _= Cintirorgon thymussize, 5 > es thymocyte cell e numbers or 2 0 F thymocyt

  36. Slide 36: IMU-935 Allows Normal Thymocyte Maturation in vivo

    IMU-935 Allows Normal Thymocyte Maturation in vivo Chronic Model, 28 Days of Treatment 15 Vehicle IMU-935 Cpd-1 — Cintirorgon = add ate Pat ‘ i : gon 8 . In contrast to a Cpd1, IMU-935 2 q does not impact 3 silt thymus size, € . thymocyte cell = numbers or 7 thymocyte © ae & maturationin a chronic m

  37. Slide 37: IMU-935 Has Shown a Favorable Safety Profile in Preclinical Studies

    IMU-935 Has Shown a Favorable Safety Profile in Preclinical Studies 6-months (rats) and 9-months (dog) long- term safety studies scheduled for 2022 3-months in rats and dogs completed in 2021 fety studies = 3-months tox studies confirmed NOAEL seen in 28-day studies: —There were no IMU-935-related c

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  39. Slide 39: IMU-935: A Potentially Best-in-Class Oral IL-17 Inhibitor

    IMU-935: A Potentially Best-in-Class Oral IL-17 Inhibitor = |MU-935 showed a very favorable safety, tolerability and PK profile in this phase 1 clinical trial with no serious adverse events seen in the SAD and MAD parts. = In particular, IMU-935 was safe and well-toleratedin 14-day repeated oral dos

  40. Slide 40: Outlook: Multiple Value Inflection Points Expected in 2022

    Outlook: Multiple Value Inflection Points Expected in 2022 vidofludimus calcium (IMU-838) = Phase 2 top-line data in ulcerative colitis expected to be available in Q2/2022 IMU-935 In phase 1b psoriasis data expected to be available in Q2/2022 = Initial phase 1 CRPC data expected to be available in Q

  41. Slide 41: Thank You!

    Thank You! Head of IR & Communications Phone: +49-89-2080477-09 Email: ir@imux.com w.imux.com 41 | ©immunic, inc. | Dec/14/2021 Immunic, Inc. 1200 Avenue of the Americas Immunic AG New York City, NY 10036 Gréfelfing (Munich) USA Germany Immunic Research GmbH Weinberg Campus Halle (Saale) Germany Imm

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  44. Slide 44: Demographics

    Demographics Part A: Lipid-Based Formulation Treatment 25 mg na Been 100 mg 200 mg one Active Placebo (N=6) i (N=6) (N=6) es] (N=30) (N=10) ‘Age (years), mean 27.0 37.8 32.3 23.8 30.5 30.3 31.4 Gender Male, n (%) 2(33%) | 6 (100%) | 3(50%) | 5 (83%) 2 16 (53%) | 7 (70%) Female, n (%) 4 (67%) : 3(50%

  45. Slide 45: Pharmacokinetic Results

    Pharmacokinetic Results Part A: Pharmacokinetic Properties of Lipid-Based Formulation Dose-Proportional Pharmacokinetics of Lipid- Based Formulation of IMU-935 IMU-935 concentration time profiles (log-linear scale) = —*-200 mg Pharmacokinetic = 25mg 50mg 100mg | 200mg $ 100 parameters (mean) § Crrax

  46. Slide 46: Overall Summary of TEAEs

    Overall Summary of TEAEs Part A: Lipid-Based Formulation Treatment es 25mg a a oa 100 mg 200 mg 100 mg BID Placebo category e o oe e (N=6) el ai (N=6) (N=6) (N=6) (N=10) Subjects with mild TEAEs, n (2%) 6 (100%) (67%) 5 (83%) 5 (83%) 5 (83%) 5 (83%) 27 (90%) 9 (90%) Subjects with moderate TEAEs, n (

  47. Slide 47: Dose-Dependent Increase of Some Local Gastrointestinal Events

    Dose-Dependent Increase of Some Local Gastrointestinal Events Part A: Lipid-Based Formulation Number (%) of subjects with related TEAEs [Number of related TEAEs reported] Active Treatment IMU-935 Placebo Treatment Pace Ter 25mg | fated | tear | 190me | 200me | “EO | pete | 256 | feated | tea | 202m¢

  48. Slide 48: Analysis of TEAEs

    Analysis of TEAEs Part A: Lipid-Based Formulation = SAEs —None = Severe TEAES — Headache After a single dose of placebo, subject RO101-001 reported 40 minutes post-dose an episode of severe headache. The TEAE lasted 3.5 hours, was unrelated to study treatment and recovered without sequelae. = Modera

  49. Slide 49: Analysis of Laboratory Parameters

    Analysis of Laboratory Parameters Part A: Lipid-Based Formulation = Laboratory values over time — Descriptive statistics showed no trend of values over time for any parameter = Individual changes — Shift tables showed no trend of individual changes beyond the normal range for any parameter = Individ

  50. Slide 50: Laboratory Parameters

    La boratory Parameters Part A: Lipid-Based Formulation = Narratives of TEAEs associated with laboratory parameters — Blood creatine kinase increased After a single dose of placebo, subject RO101-008 had elevated CK (mild, unrelated) at the end-of-study visit (day 14). All other post-dose values of c

  51. Slide 51: Pharmacokinetic Results

    Pharmacokinetic Results Part A: Comparison of Lipid-Based and Powder-in-Capsule Formulation IMU-935 concentration time profiles (log-linear scale) Formulations of IMU-935 Ee Comparable PK for the Two Different Oral =e 100 mg New Formulation #100 mg Lipid-Based 100 10 Mean plasma concentration [ng/mL

  52. Slide 52: Conclusions

    Conclusions Part A: Lipid-Based Formulation = The semi-solid lipid-based formulation was adequate to enable initial non-clinical and clinical evaluations of IMU-935. = However, an ongoing effort to improve the formulation led to its replacement with a new and improved powder-in-capsule formulation d

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  54. Slide 54: Demographics

    Demographics Part A-N Treatment 100 mg 200 mg 300 mg pone ct | 400 me Placebo (N=5) (N=6) (N=6) i) (N=6) (N=10) ‘Age (years), mean 26.8 35.3 23.3 21.3 33.5 28.1 33.4 Gender Male, n (%) 4(s0%) | (67% | 5y83%) | 233%) | 1(17%) | 16 (55%) | 6 (60%) Female, n (%) 1(20%) | 2(33% | 1(17%) | 4(67%) | 5(s3%

  55. Slide 55: Pharmacokinetic Results

    Pharmacokinetic Results Part A-N IMU-935 concentration time profiles (log-linear scale) 100 10 Mean plasma concentration [ng/mL] Interim dats, PK anahsisongeing 24 36 Time [hours] 48 4&2 Dose-Proportional PK of New Powder-in- Capsule Formulation of IMU-935 60 72 cram net 100mg | 200mg | 300mg | 400m

  56. Slide 56: Pharmacokinetic Results

    Pharmacokinetic Results Part A-N IMU-935 concentration time profiles (log-linear scale) 100 10 Mean plasma concentration [ng/mL] Interim dats, PK anahsisongeing 24 36 Time [hours] 4&2 Minimal Food Effect of New Powder-in- Capsule Formulation of IMU-935 —=-300 mg, fasted -2~300 mg, fed 48 60 72 eee 3

  57. Slide 57: Overall Summary of TEAEs

    Overall Summary of TEAEs Part A-N Treatment eet 100 mg 200 mg 300 mg ree 72 eye 400 mg Active Placebo (N=5) (N=6) (N=6) a res} (N=6) (N=29) (N=10) Subjects with mild TEAES, n (%) 4 (80%) 4 (67%) 3 (50%) 5 (83%) 41(17%) 4 (67%) 20 (68%) 8 (80%) Subjects with moderate TEAES, n (%) - 41(17%) = 2 (33%)

  58. Slide 58: Analysis of Laboratory Parameters

    Analysis of Laboratory Parameters Part A-N = Laboratory values over time — Descriptive statistics showed no trend of values over time for any parameter = Individual changes — Shift tables showed no trend of individual changes beyond the normal range for any parameter = Individual clinically signific

  59. Slide 59: Laboratory Parameters

    Laboratory Parameters Part A- N = Narratives of TEAEs associated with laboratory parameters Active Treatment Subject RO1SNF-707 Blood creatine kinase increased, Aspartate aminotransferase increased After a single dose of 300 mg IMU-935 in the fed state, the subject had elevated CK (severe, unrelated

  60. Slide 60: Laboratory Parameters

    TEAE: Treatment-Emergent Adverse Event 60 Laboratory Parameters Part A-N = Narratives of TEAEs associated with laboratory parameters — Blood creatine kinase increased After a single dose of 300 mg IMU-935 in the fed state, subject RO1SNF-707 had elevated CK (severe, unrelated) at the end-of-study vi

  61. Slide 61: Laboratory Parameters

    Laboratory Parameters Part A-N = Narratives of TEAEs associated with laboratory parameters — Aspartate aminotransferase increased After a single dose of 300 mg IMU-935 in the fed state, subject ROISNF-707 had elevated AST (moderate, unrelated) at the end-of- study visit. The subject reported increas

  62. Slide 62: Laboratory Parameters

    Laboratory Parameters Part A-N = Narratives of TEAEs associated with laboratory parameters — Neutropenia After a single dose of 100 mg IMU-935, subject RO13N-204 had a neutropenia (mild, unrelated) on day 1. The subject was seen to have neutropenia already at screening (but not at baseline), hence t

  63. Slide 63: Laboratory Parameters

    Laboratory Parameters Part A-N = Narratives of TEAEs associated with laboratory parameters — Lipase increased After a single dose of placebo, subject RO16N-202 had elevated lipase (mild, related) on day 2. All other post-dose values of lipase were in the normal range. The lipase increase was asympto

  64. Slide 64: Laboratory Parameters

    ‘TEAE: Treatment-Emergent Adverse Event ALT: Alanine Aminctransferase; AST Aspartate Aminctransferase 64 Laboratory Parameters Part A-N = Narratives of TEAEs associated with laboratory parameters — Transaminases increased After a single dose of 300 mg IMU-935, subject RO15N-208 had elevated AST and

  65. Slide 65: Laboratory Parameters

    ‘TEAE: Treatment-Emergent Adverse Event ALT: Alanine Aminctransferase; AST Aspartate Aminctransferase 65 Laboratory Parameters Part A-N = Narratives of TEAEs associated with laboratory parameters — Transaminases increased (cont.) After a single dose of 300 mg IMU-935, subject RO15N-208 had elevated

  66. Slide 66: Laboratory Parameters: Leukocytes

    Laboratory Parameters: Leukocytes Part A-N roy Laboratory Values Over Time Individual Laboratory Values Hematology - Leukocytes Hematology - Leukocytes ere ere Leukocytes (10°2L) nay amare Group mean time response curves standard deviation ‘Absolute change from baseline 5 ‘ 3! 3 a2 3s ze, tat Se S S

  67. Slide 67: Laboratory Parameters: Erythrocytes

    Laboratory Parameters: Erythrocytes Part A-N roy Laboratory Values Over Time Hematology - Erythrocytes Individual Laboratory Values Hematology - Erythrocytes Erythrocytes (10*12/L) ‘Mean time response curves +/- standard deviation Erythrocytes (102/L) 40 Day-t Day! Day2 Days End of Study Vist Pooled

  68. Slide 68: Laboratory Parameters: Platelets

    Laboratory Parameters: Platelets Part A-N gq Laboratory Values Over Time Hematology - Platelets Individual Laboratory Values Hematology - Platelets 225 300 275 250 Platelets (10°9L) 225 200 Platelets (10*9/L) ‘Mean time response curves +/- standard deviation Day-t Dayt Day2 Vist Pooled NF treatment

  69. Slide 69: Laboratory Parameters: AST

    Laboratory Parameters: AST Part A-N Individual Laboratory Values Biochemistry - AST roy Laboratory Values Over Time Biochemistry - AST Aspartate Aminotransferase (U/L) ‘Mean time response curves +/- standard deviation 20 Aspartate Amninotransferase (UL) 8 bay ays bey? Devt End Study * £ vist Pooled

  70. Slide 70: Laboratory Parameters: Bilirubin

    Laboratory Parameters: Bilirubin Part A-N gq Laboratory Values Over Time Biochemistry - Bilirubin Individual Laboratory Values Biochemistry - Bilirubin 20 Bilirubin (umovL) Bilirubin (umol/L) ‘Mean time response curves /- standard deviation Day Dayt Day2 Visit Pooled NF treatment IMU-935NF Day = Pla

  71. Slide 71: Analysis of Vital Signs

    Analysis of Vital Signs Part A-N = Vital signs over time — Descriptive statistics showed no trend of values over time for any parameter = Individual changes — Shift tables showed no trend of individual changes beyond the normal range for any parameter = Individual clinically significant abnormalitie

  72. Slide 72: Vital Signs: Pulse Rate

    gq Vital Signs: Pulse Rate Part A-N Vital Signs Over Time Pulse Rate Individual Vital Signs Pulse Rate Pulse Rete (beats/rrin) 50 Pulse Rete (beats/min) Mean time response curves +# standard deviation ‘Re apace Om {oe venta To ‘Pal ane om hoa ear D1 pre Di Shpost Dighpost D1 14hpost Day2 — Day3. Day

  73. Slide 73: Vital Signs: Diastolic Blood Pressure

    gq Vital Signs: Diastolic Blood Pressure Part A-N Vital Signs Over Time Diastolic Blood Pressure Individual Vital Signs Diastolic Blood Pressure Diastolic Bload Pressure (rommHa) 60 Diastolic Blood Pressure (mmHg) Mean time response curves +# standard deviation ‘avo eos Peer ern o8 | ob ve Sen Te ‘D

  74. Slide 74: Vital Signs: Systolic Blood Pressure

    Vital Signs: Systolic Blood Pressure Part A-N Vital Signs Over Time Systolic Blood Pressure Individual Vital Signs Systolic Blood Pressure ‘Systolic Blood Pressure (mmHg) — Mean time response curves ++ standard deviation ~ - 190 3 ? = = £10 8 i 110 100 Dipre D13hpast DI GhpostD1 14h post Day2 Dad -—

  75. Slide 75: Analysis of 12-Lead Electrocardiograms

    Analysis of 12-Lead Electrocardiograms Part A-N = 12-lead ECG parameters over time — Descriptive statistics showed no trend of values over time for any parameter = Individual changes — Shift tables showed no trend of individual changes beyond the normal range for any parameter —In subjects with norm

  76. Slide 76: 12-Lead Electrocardiograms: PR Interval

    12-Lead Electrocardiograms: PR Interval Part A-N ql 12-Lead ECGs Over Time Individual 12-Lead ECGs PR Interval PR Interval PR [msec] Bin lariat ad Mean time response curves +# standard deviation »={—t + 200 = & He = 1. on af aS 180 =| 14. . = = E160 140 = “ jo oy Dipie D1ahpost Di shpostD1 Whpost Da

  77. Slide 77: 12-Lead Electrocardiograms: QRS Duration

    12-Lead Electrocardiograms: QRS Duration Part A-N Individual 12-Lead ECGs roy 12-Lead ECGs Over Time QRS Duration QRS Duration QRS [msec] Mean time response curves +/ standard deviation “ ; 105 : i i 100 ae i Zs £ @ 5 0 6 : Le. 4 ‘- : } aut te Dipre D1 3h post DishpostD11ahpost Day2 Day3 —Dayd =o ~

  78. Slide 78: 12-Lead Electrocardiograms: QTcF Interval

    12-Lead Electrocardiograms: QTcF Interval Part A-N Individual 12-Lead ECGs QITcF Interval roy 12-Lead ECGs Over Time QITcF Interval QTcF [msec] Mean time response curves +f standard deviation 440 4 u 5 400 380 Dipre DI Shpost D1GhpestD1 Hhpost Day? Dy3 Days —«EUS 7 Vici “ " Pcled NF eater» MU-SGENF_

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  80. Slide 80: Demographics

    Demographics Part B Treatment 150 mg QD 150 mg BID Active Placebo In total, 15 a es) (Nea (Ne) healthy male and ‘Age (years), mean 34.8 36.4 35.5 31.0 female subjects Sender entered part B Male, n (%) 4 (67%) 20%) ee a2) multiple dose Female, n (%) 2 (33%) 3 (60%) plea) 28) escalation with R = the n

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