Roivant Sciences Ltd. · NASDAQ:ROIV

Roivant Sciences — Technical Presentation (March 2025)

36 slides from Roivant Sciences's technical presentation, Mar 19, 2025

  1. Slide 1: MG & CIDP Results March 2025

    Targeted science, Tailored solutionsfor people with autoimmune disease MG & CIDP Results March 2025

  2. Slide 2: Forward-looking statements

    Forward-looking statements This presentation contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," “may,” “might,” “will,” “would,” “should,” “ex

  3. Slide 3: Batoclimab MG and CIDP Data Set New Benchmarks for Efficacy

    Batoclimab MG and CIDP Data Set New Benchmarks for Efficacy and Further Confirm Deeper IgG Reduction is Better Statistically significant and clinically meaningful outcomes across multiple endpoints Clear dose response across endpoints: 340 mg results consistent with other FcRn programs achieving mid

  4. Slide 4: Robust Datasets Support IMVT-1402's Long-Term Value Creation Opportunity

    * Compared to those with IgG reduction <70% in the same study Robust Datasets Support IMVT-1402’s Long-Term Value Creation Opportunity Novel, fully human, monoclonal antibody inhibiting FcRn-mediated recycling of IgG + IMVT-1402 + + + + + Ongoing Clinical Progress with Graves’ Disease pivotal study

  5. Slide 5: IMVT-1402 has a combination of potentially best-in-class attributes

    5 IMVT-1402 has a combination of potentially best-in-class attributes not seen with other FcRn inhibitors Demonstrated best-in-class IgG reductions, similar to batoclimab, in simple subcutaneous form factor1 Demonstrated minimal to no impact on albumin and minimal to no impact on LDL1 IMVT-1402 star

  6. Slide 6: Goals for the Batoclimab Myasthenia Gravis and CIDP Programs

    Create opportunity to accelerate registrational programs for IMVT-1402 in MG and CIDP Demonstrate ability to meet key unmet need of deep and durable clinical response 6 Establish best-in-class efficacy in MG and CIDP Goals for the Batoclimab Myasthenia Gravis and CIDP Programs Settle Lower is Better

  7. Slide 7: MG Topline Results

    “MG Topline Results + + + + + + + +++ + + + + ++

  8. Slide 8: Phase 3 trial designed to demonstrate best-in-class, dose dependent efficacy in MG

    Phase 3 trial designed to potentially demonstrate best-in-class, dose dependent efficacy in MG patients 8 Notes: 1. Responder defined as ≥2-point improvement in MG-ADL score from baseline. Period 2 followed by Long-Term Extension (LTE) study. QW: Weekly; Q2W: Bi-weekly; SC: Subcutaneous injection; A

  9. Slide 9: Baseline characteristics well-balanced across arms

    Baseline characteristics well-balanced across arms 9 AChR+ Population Placebo (N=55) Batoclimab 340mg (N=52) Batoclimab 680mg (N=57) Age 51.9 53.8 54.4 Gender, female 33 (60%) 32 (62%) 32 (56%) Race White 51 (93%) 41 (79%) 52 (91%) Black 1 (2%) 3 (6%) 1 (2%) Asian 1 (2%) 5 (10%) 1 (2%) Other 2 (4%)

  10. Slide 10: Batoclimab met its primary endpoint of change in MG-ADL

    Batoclimab met its primary endpoint of change in MG-ADL from baseline in AChR+ patients, with the 680mg dose setting a new benchmark for magnitude of benefit 10 74% Mean IgG Reduction 64% Mean IgG Reduction p < 0.001 p < 0.05 Notes: Placebo N=55, 340mg Batoclimab N=52, 680mg Batoclimab N=57. QW: Onc

  11. Slide 11: 340mg in line with other FcRns; 680mg breaks the therapeutic ceiling

    340mg performs in line with other FcRn’s; 680mg breaks the therapeutic ceiling by reaching the highest MG-ADL reduction observed in Phase 3 trials to-date 11 Notes: Vyvgart data reflects Phase 3 ADAPT publication Howard et al., 2021, Figure 2A (MG-ADL reduction), p. 533 (mean IgG reduction); Cycle 1

  12. Slide 12: Batoclimab 680mg demonstrates best-in-class MG-ADL response rate

    Batoclimab 680mg demonstrates the best-in-class MG-ADL response rate, raising the ceiling of therapeutic effect observed with any FcRn 12 Notes: MG-ADL response defined as ≥2-point reduction from baseline. Vyvgart data reflects Phase 3 ADAPT publication: Howard et al., 2021, Figure 3A; Cycle 1 inclu

  13. Slide 13: Batoclimab 680mg outperforms other FcRns in deep response rates

    Batoclimab 680mg outperforms other FcRn’s in achieving deep response rates in MG patients across Phase 3 programs 13 Notes: Vyvgart data reflects Phase 3 ADAPT publication: Howard et al., 2021, Figure 3A (N=65); Cycle 1 includes four infusions (1 infusion per week). Nipocalimab data reflects Phase 3

  14. Slide 14: Dose-dependent early Super-Responder rates observed by Week 2

    Dose-dependent early Super-Responder rates observed by Week 2 14 Notes: QW: Once Weekly; AChR+: Acetylcholine receptor antibody-positive; MG-ADL: Myasthenia Gravis Activities of Daily Living scale. Early Super-Responder Rates % of AChR+ Patients Achieving MG-ADL Change from Baseline ≥5, ≥6, ≥7 Point

  15. Slide 15: Strong dose-dependent Minimal Symptom Expression at Week 12

    Strong dose-dependent effect observed with >40% of patients on 680mg batoclimab achieving Minimal Symptom Expression at Week 12 15 Notes: Argenx’s efgartigimod ADAPT Phase 3 trial and JNJ nipocalimab Vivacity-MG3 Phase 3 trial defined MSEs as patients achieving an MG-ADL score of 0 or 1 at any time

  16. Slide 16: Strong durability of Minimal Symptom Expression

    Batoclimab demonstrates strong durability of Minimal Symptom Expression 16 75% of patients who achieved Minimal Symptom Expression (MG-ADL = 0 or 1) on 680mg dose by Week 6 maintained MSE status for ≥6 weeks Notes: MSE defined as MG-ADL = 0 or 1; participants included in analysis had to achieve MSE

  17. Slide 17: Safety data consistent with previously reported profile

    Safety data are consistent with previously reported safety profile for batoclimab 17 AChR+ Population Placebo (N=55) Batoclimab 340mg (N=52) Batoclimab 680mg (N=57) Patients with any Treatment-related TEAE during Period 1 17 (30.9%) 22 (42.3%) 32 (56.1%) Patients with any Treatment-related Serious T

  18. Slide 18: Maintenance of response observed where dosing consistent

    Maintenance of response observed in period 2 where dosing consistent 18 Notes: 1) Responder defined as ≥2-point improvement in MG-ADL score from baseline. Period 2 followed by Long-Term Extension (LTE) study. QW: Weekly; Q2W: Bi-weekly; SC: Subcutaneous injection; AChR Ab+: Acetylcholine receptor an

  19. Slide 19: CIDP Initial Period Combined Results

    CIDP Initial Period 1 Combined Results 19

  20. Slide 20: Pivotal Phase 2b trial in CIDP

    Pivotal Phase 2b trial intended to develop potentially best-in-class anti-FcRn therapy in CIDP 20 Screening1≤ 28 days 4 cohorts Week -12 Week 0 Week 36 analysis Study timeline Cohort A Ig or PLEX Cohort B Corticosteroid Cohort C No treatment Washout2 ≤ 12 weeks Cohort A Stop Ig/PLEX Cohort B Taper c

  21. Slide 21: Baseline characteristics consistent with prior CIDP pivotal studies

    Baseline characteristics across Period 1 batoclimab participants (680mg and 340mg combined) consistent with prior CIDP pivotal studies 21 Notes: Notes: Data are mean or n (%); 1. Represents time from CIDP diagnosis to Period 1 randomization; 2. Included participants who were currently receiving trea

  22. Slide 22: Best-in-class mean change from baseline in aINCAT score

    Batoclimab treated patients achieved a best-in-class mean change from baseline in aINCAT score at Week 12 22 Mean Change from Baseline in aINCAT Score Notes: Vyvgart Hytrulo based on ADHERE Phase 2b pivotal trial publication: Allen et al., 2024 (Supplementary Table 2) reported for Stage A (open-labe

  23. Slide 23: Deeper IgG reductions achieved higher aINCAT response rates

    Batoclimab patients with deeper IgG reductions from baseline achieved higher aINCAT response rates at Week 12 23 Notes: Excludes N=1 patient due to missing IgG values post-baseline. aINCAT: Adjusted Inflammatory Neuropathy Cause and Treatment; IgG: Immunoglobulin G. Week 12 aINCAT Response Rate by %

  24. Slide 24: Deeper therapeutic effect than Vyvgart Hytrulo across endpoints

    Batoclimab achieves deeper therapeutic effect than Vyvgart Hytrulo in CIDP patients across multiple efficacy endpoints at Week 12 24 I-RODS Mean change from baseline in I-RODS score1 MRC-SS Mean change from baseline in MRC-SS score Grip Strength Mean change from baseline in kPa Notes: Vyvgart Hytrul

  25. Slide 25: Lower is Better

    Lower is Better 25

  26. Slide 26: Totality of Phase 3 data confirms lower is better

    The totality of Phase 3 data confirms lower is better, with deeper IgG reductions translating to superior treatment benefit across multiple indications 26 Best-in-class IgG reduction demonstrated with the 680mg batoclimab dose 1 Phase 3 MG data indicated deeper IgG reduction leads to improved clinic

  27. Slide 27: Strong, dose-dependent results across multiple MG efficacy endpoints

    Strong, dose-dependent results seen across multiple efficacy endpoints evaluated in the Phase 3 MG trial 27 Notes: All data reported for acetylcholine receptor antibody-positive population as a reduction from baseline. QW: Once Weekly; MG-ADL: Myasthenia Gravis Activities of Daily Living scale; QMG:

  28. Slide 28: ≥70% IgG reductions achieved highest MG-ADL reduction

    Batoclimab patients achieving ≥70% IgG reductions from baseline achieved the highest MG-ADL reduction from baseline ever seen in an MG Phase 3 trial 28 Combined Batoclimab (N=89) Notes: Excludes N=20 patients with invalid or missing Week 12 IgG values. MG-ADL: Myasthenia Gravis Activities of Daily L

  29. Slide 29: ≥70% IgG reductions achieved highest Minimal Symptom Expression rate

    Batoclimab patients achieving ≥70% IgG reductions from baseline achieved the highest Minimal Symptom Expression rate ever seen in an MG Phase 3 trial 29 Notes: Excludes N=20 patients with invalid or missing Week 12 IgG values. MG-ADL: Myasthenia Gravis Activities of Daily Living scale; IgG: Immunogl

  30. Slide 30: Settling the Lower is Better debate

    30 Settling the Lower is Better debate Graves’ Phase 2a MG Phase 3 CIDP Phase 2b ATD-Free Response: % of participants who achieve normal T3 and T4 or have T3 or T4 below LLN, and ceased all ATD medications Minimal Symptom Expression: % of participants who achieve MG-ADL score of 0 or 1 at Week 12 aI

  31. Slide 31: Path Forward in MG with IMVT-1402

    Path Forward in MG with IMVT-1402 31 Immunovant does not plan to seek regulatory approval for batoclimab in MG or CIDP at present

  32. Slide 32: MG patients and providers indicate a need for deeper, more durable control

    MG patients and providers indicate a need for deeper and more durable disease control 32 Neurologists agree that despite recent advancements with FcRn inhibitors, there is room for greater disease control (e.g., deeper responses)1 95% Neurologists report that their patients experience breakthrough s

  33. Slide 33: Propel: IMVT-1402 registrational MG trial design

    Propel: IMVT-1402 registrational MG trial is designed to enable demonstration of deep, durable responses 33 Period 1: Induction (12 weeks) 1:1:1 Randomization (N=231) Placebo QW SC 600mg IMVT-1402 QW SC Period 2: Maintenance (14 weeks) Primary Analysis Population: AChR Ab+, MuSK+, LRP4+ Primary Endp

  34. Slide 34: Concluding Thoughts: 1402 Positioned to be Best-in-Class

    Concluding Thoughts:1402 Positioned to be Best-in-Class 34

  35. Slide 35: IMVT-1402's improved tolerability positions it for superior benefit

    IMVT-1402’s improved tolerability profile positions it to demonstrate a potentially superior therapeutic benefit vs. batoclimab in MG patients 35 Ad-hoc analysis on cohort of patients with no missed doses in the last 4 weeks of the treatment period shows a >6 point change from baseline in MG-ADL sco

  36. Slide 36: Batoclimab data positions IMVT-1402 as potentially best-in-class FcRn

    Batoclimab data positions IMVT-1402 as potentially best-in-class FcRn and enables acceleration of IMVT-1402 registration programs in MG and CIDP 36 Notes: *Not including any potential patent term extension; IP: Intellectual Property Novel, fully human, monoclonal antibody inhibiting FcRn-mediated re

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