Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Corporate Update (March 2025)
34 slides from Immunovant's corporate update, Mar 19, 2025
Slide 1: MG & CIDP Results March 2025
Targeted science, Tailored solutions for people with autoimmune disease MG & CIDP Results March 2025 Exhibit 99.2
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
Slide 3: IMVT-1402 has a combination of potentially best-in-class attributes
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 starti
Slide 4: 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 Establish best-in-class efficacy in MG and CIDP Goals for the Batoclimab Myasthenia Gravis and CIDP Programs Settle Lower is Better d
Slide 5: MG Topline Results
“MG Topline Results + + + + + + +++ to + + + +
Slide 6: 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 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; ACh
Slide 7: Baseline characteristics well-balanced across arms
Baseline characteristics well-balanced across arms 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%) 2
Slide 8: 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 -3.6 -4.7 -5.6-6 -5 -4 -3 -2 -1 0 Placebo (Week 12) Batoclimab 340mg QW (Week 12) Batoclimab 680mg QW (Week 12) M ea n C ha ng e fr om B as el
Slide 9: 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 Notes: Vyvgart data reflects Phase 3 ADAPT publication Howard et al., 2021, Figure 2A (MG-ADL reduction), p. 533 (mean IgG reduction); Cycle 1 in
Slide 10: 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 78% 69% 81% 93% 30% 40% 50% 60% 70% 80% 90% 100% Vyvgart 10mg/kg QW (Cycle 1, N=65) Nipocalimab 30mg LD + 15mg/kg Q2W (Weeks 22-24, N=77) Batoclimab 340mg QW (Week 1
Slide 11: 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 56% 44% 56% 65% 40% 33% 39% 54% 27% 26% 21% 40% Vyvgart 10mg/kg (Cycle 1) Nipocalimab 30mg/kg LD + 15mg/kg Q2W (Week 24) Batoclimab 340mg QW (Week 12) Batoclimab 680mg QW (Week 12) Vyvga
Slide 12: Dose-dependent early Super-Responder rates by Week 2
Dose-dependent early Super-Responder rates observed by Week 2 11% 25% 40% 6% 17% 30% 2% 10% 19% Placebo Batoclimab 340mg QW Batoclimab 680mg QW Placebo Batoclimab 340mg QW Batoclimab 680mg QW Placebo Batoclimab 340mg QW Batoclimab 680mg QW Notes: QW: Once Weekly; AChR+: Acetylcholine receptor antibo
Slide 13: Dose-dependent effect with 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 7% 31% 42% Placebo (Week 12) Batoclimab 340mg QW (Week 12) Batoclimab 680mg QW (Week 12) Notes: Argenx’s efgartigimod ADAPT Phase 3 trial and JNJ nipocalimab Vivacity-MG3 P
Slide 14: Strong durability of Minimal Symptom Expression
Batoclimab demonstrates strong durability of Minimal Symptom Expression 0% 39% 75% Placebo (Week 12) Batoclimab 340mg QW (Week 12) Batoclimab 680mg QW (Week 12) 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:
Slide 15: Safety data consistent with previously reported profile
Safety data are consistent with previously reported safety profile for batoclimab 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 TEAE
Slide 16: Maintenance of response observed in period where dosing consistent
Maintenance of response observed in period 2 where dosing consistent 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 antib
Slide 17: CIDP Initial Period Combined Results
CIDP Initial Period 1 Combined Results
Slide 18: Pivotal Phase 2b trial in CIDP
Pivotal Phase 2b trial intended to develop potentially best-in-class anti-FcRn therapy in CIDP 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 cor
Slide 19: Baseline characteristics across Period 1 batoclimab participants
Baseline characteristics across Period 1 batoclimab participants (680mg and 340mg combined) consistent with prior CIDP pivotal studies Notes: Notes: Data are mean or n (%); 1. Represents time from CIDP diagnosis to Period 1 randomization; 2. Included participants who were currently receiving treatme
Slide 20: 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 -0.9 -1.8 Vyvgart Hytrulo 1000mg (Stage A) Batoclimab Combined 340mg & 680mg (Week 12) Mean Change from Baseline in aINCAT Score Notes: Vyvgart Hytrulo based on ADHERE Phase 2b pivotal trial pub
Slide 21: Deeper IgG reductions achieved higher aINCAT response rates
Batoclimab patients with deeper IgG reductions from baseline achieved higher aINCAT response rates at Week 12 44% 84% IgG Reduction <70% IgG Reduction ≥70% Notes: Excludes N=1 patient due to missing IgG values post-baseline. aINCAT: Adjusted Inflammatory Neuropathy Cause and Treatment; IgG: Immunogl
Slide 22: Batoclimab deeper effect than Vyvgart Hytrulo in CIDP
Batoclimab achieves deeper therapeutic effect than Vyvgart Hytrulo in CIDP patients across multiple efficacy endpoints at Week 12 7.7 15.3 Vyvgart Hytrulo 1000mg (Stage A) Batoclimab Combined 340mg & 680mg (Week 12) 3.8 5.6 Vyvgart Hytrulo 1000mg (Stage A) Batoclimab Combined 340mg & 680mg (Week 12)
Slide 23: Lower is Better
Lower is Better
Slide 24: Totality of 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 Best-in-class IgG reduction demonstrated with the 680mg batoclimab dose1 Phase 3 MG data indicated deeper IgG reduction leads to improved clinical o
Slide 25: Strong, dose-dependent results across multiple efficacy endpoints
Strong, dose-dependent results seen across multiple efficacy endpoints evaluated in the Phase 3 MG trial 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: Qu
Slide 26: ≥70% IgG reductions achieved the 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 -4.9 -6.1 IgG Reduction <70% IgG Reduction ≥70% Combined Batoclimab (N=89) Notes: Excludes N=20 patients with invalid or missing Week 12 IgG values. MG
Slide 27: ≥70% IgG reductions achieved the 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 31% 53% IgG Reduction <70% IgG Reduction ≥70% Notes: Excludes N=20 patients with invalid or missing Week 12 IgG values. MG-ADL: Myasthenia Gravis Acti
Slide 28: Settling the Lower is Better debate
Settling the Lower is Better debate Graves’ Phase 2a MG Phase 3 CIDP Phase 2b 23% ATD-Free Responders 60% ATD-Free Responders IgG Reduction < 70% IgG Reduction ≥ 70% ATD-Free Response: % of participants who achieve normal T3 and T4 or have T3 or T4 below LLN, and ceased all ATD medications Minimal S
Slide 29: Path Forward in MG with IMVT-1402
Path Forward in MG with IMVT-1402 Immunovant does not plan to seek regulatory approval for batoclimab in MG or CIDP at present
Slide 30: MG patients and providers indicate need for deeper, more durable disease control
MG patients and providers indicate a need for deeper and more durable disease control Neurologists agree that despite recent advancements with FcRn inhibitors, there is room for greater disease control (e.g., deeper responses)195% Neurologists report that their patients experience breakthrough sympt
Slide 31: Propel: IMVT-1402 registrational MG trial
Propel: IMVT-1402 registrational MG trial is designed to enable demonstration of deep, durable responses Period 1: Induction (12 weeks) 1: 1: 1 R an do m iz at io n (N =2 31 ) Placebo QW SC 600mg IMVT-1402 QW SC Period 2: Maintenance (14 weeks) Primary Analysis Population: AChR Ab+, MuSK+, LRP4+ Pri
Slide 32: Concluding Thoughts: 1402 Positioned to be Best-in-Class
Concluding Thoughts: 1402 Positioned to be Best-in-Class
Slide 33: IMVT-1402's improved tolerability profile 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 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 score
Slide 34: 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 Notes: *Not including any potential patent term extension; IP: Intellectual Property Novel, fully human, monoclonal antibody inhibiting FcRn-mediated recyc