Slide 1: Batoclimab Graves' Disease Proof-of-Concept Study Remission Data
Targeted science, Tailored solutions for people with autoimmune disease Batoclimab Graves’ Disease Proof-of-Concept Study Remission Data September 2025
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: First-ever potentially disease-modifying therapy for uncontrolled Graves' disease patients
3 First-ever potentially disease-modifying therapy for uncontrolled Graves’ disease patients Notes: Responders: Patients who have T3 and T4 values ≤ULN and no increase in ATD dose from baseline; ATD: Anti-thyroid drug. ~80% (17/21) of patients who entered off-treatment follow-up period demonstrated
Slide 4: Background: Graves' Disease
Background: Graves’ Disease 4
Slide 5: Graves' disease is a classic autoimmune condition driven by autoantibodies to the TSH receptor
5 Graves’ disease is a classic autoimmune condition driven by the presence of autoantibodies to the thyroid stimulating hormone receptor Sources: McIver, B. and Morris, J. The Pathogenesis of Graves’ Disease (1996), Davies, T, Andersen, S, Latif, R. et al. Graves disease (2020). Image created using
Slide 6: Shift away from ablation leaves 25-30% of patients relapsed, uncontrolled, or intolerant to ATDs
Shift away from ablation and lack of new medical therapies leaves 25-30% of patients who are relapsed, uncontrolled, or intolerant to ATDs Diagnosed with Graves’ Disease Anti-Thyroid Drug (ATD) ~85-90% Ablation ~10% Continued Control with ATDs ~60-65% Ablation ~3-5% Relapse / Uncontrolled / Intolera
Slide 7: Graves' disease patients are at higher risk of severe comorbidities
7 Scientific literature indicates that Graves’ disease patients are at a higher risk of a sequelae of severe comorbidities Sources: 1) Okosieme et al., 2019, 2) Aggarwal et al., 2014, 3) Chin et al., 2020, 4) Potvin et al., 2023, 5) Galindo et al., 2019, 6) Bourcier et al., 2020, 7) Pellgriti et al.
Slide 8: Graves' disease represents a high unmet need, underserved patient population
Classic autoimmune condition where disease pathology is driven by autoantibodies to thyroid stimulating hormone receptor High unmet need with 25-30% of ATD treatment patients either uncontrolled, relapsed, or intolerant to ATDs No existing disease modifying therapy; ablative options continue to be u
Slide 9: Batoclimab Phase 2 Remission Data
Batoclimab Phase 2 Remission Data 9
Slide 10: Batoclimab proof-of-concept study design with dose step-down and off-treatment follow-up
10 Batoclimab Graves’ disease proof-of-concept study included a treatment period with a dose step-down, followed by an off-treatment follow-up period a: Additional inclusion and exclusion criteria not listed on slide; b. Excludes 3 patients who chose not to enter the follow-up period and 1 patient w
Slide 11: Baseline characteristics representative of an uncontrolled population despite ATD use
11 Baseline characteristics were representative of an uncontrolled population, despite ATD use Batoclimab SC QW N = 25 Mean unless otherwise noted Age, years 47.4 Sex, % female 80% Race, % white 92% BMI, kg/m2 25.4 Median time since diagnosis, months 15.7 Baseline FT3, pmol/L (ULN=6.8 pmol/L) 15.4 B
Slide 12: Responders demonstrate strong durability of response through six months off-treatment
12 Potential for disease modification with batoclimab responders demonstrating strong durability of response through six months off-treatment at end of follow-up 25 Uncontrolled Graves’ disease patients Baseline Week 48 Patients off-drug for 24 weeksa,b Week 12 Pts receive 12 weeks of 680 mg QW bato
Slide 13: ~50% of responders at Week 48 achieved ATD-free remission
13 ~50% of responders at Week 48 achieved ATD-free remission, demonstrating strong potential for disease modification by a high-dose FcRn 8 of 17 patients with normal T3/T4 at Week 48 were in ATD-free remission Notes: Responders: Patients who have T3 and T4 values ≤ULN and no increase in ATD dose fr
Slide 14: Sustained TRAb reductions post-batoclimab treatment
Off-Treatment Follow-up -100% -80% -60% -40% -20% 0% 20% IgG TRAb Mean percent change from baseline Baseline Week 4 Week 8 Week 12 Week 24 Week 48 340 mg batoclimab QW SC 680 mg batoclimab QW SC Step-down Sustained TRAb reductions post-batoclimab treatment further demonstrate the potential for disea
Slide 15: Batoclimab was well-tolerated with no new safety signals
15 Batoclimab was well-tolerated with no new safety signals identified Batoclimab SC QW N = 25 n (%) Patients with any TEAE 25 (100) Patients with any Serious TEAE 1 (4) Patients with any Treatment-related Serious TEAE 0 Patients with any Treatment-related TEAE Leading to Study Drug Withdrawal 0 Pat
Slide 16: IMVT-1402-2502 trial design optimized based on Phase 2 batoclimab learnings
16 Potentially registrational IMVT-1402-2502 trial design is optimized based on Phase 2 batoclimab learnings and could result in improved disease modification Batoclimab Phase 2 IMVT-1402 Pivotal Trial (1 of 2 Potentially Registrational Trials Ongoing) 12W 340 mg SC QW 80% Responsea 72% Responsea 12
Slide 17: IMVT-1402 could potentially be the first-in-class disease-modifying therapy in Graves' disease
17 IMVT-1402 could potentially be the first-in-class disease-modifying therapy in Graves’ disease Remarkable effect seen in uncontrolled Graves’ disease patients: 18 of 25 patients treated with batoclimab are responders at Week 24 01 Durable off-drug response: Of the 21 patients who entered the off-
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Slide 19: Batoclimab demonstrated potentially transformational results in ATD-uncontrolled patients
19 Batoclimab demonstrated potentially transformational results in ATD-uncontrolled patients with greater response driven by higher IgG lowering Notes: a. Includes N=1 additional responder vs. September 2024 disclosure. Patient discontinued prior to Week 12 and was counted as a non-responder per pro
Slide 20: ATD-free responders at Week 12 and Week 24
60% ATD-Free Respondersa 40% ATD-Free Respondersa 20 60% of patients receiving high-dose batoclimab not only achieved normal T3 and T4 levels but also ceased ATD entirely by 12 weeks Notes: a. Includes N=1 additional responder vs. September 2024 disclosure. Patient discontinued prior to Week 12 and
Slide 21: Graves' disease market opportunity: incident and untapped prevalent patient pool
21 Graves’ disease market opportunity includes annual incident opportunity and a significant untapped prevalent patient pool 5. 6. 8. 9. Roivant Claims Analysis – 2022 prevalent patient population based on a two-year lookback for diagnosis Of the 120K patients ablated, ~80K were ablated prior to 202
Slide 22: IMVT-1402 potentially registrational trial in Graves' disease
22 IMVT-1402 potentially registrational trial in Graves’ disease Treatment Period: 52 weeks N = 240 Randomization (1:1:1) Primary Endpoint at Week 26: Proportion of participants who become euthyroidb and stop ATD Key Secondary Endpoint at Week 52: Proportion of participants who become euthyroidb and
Slide 23: IMVT-1402 second potentially registrational trial in Graves' disease
Primary Endpoint at Week 26: Proportion of participants on 600 mg who become euthyroidb and off ATD versus placebo Secondary Endpoint at Week 26: Proportion of participants on 600 mg who have T3 (Total T3 or FT3) and FT4 ≤ ULN and off ATD Inclusiona Adults with active Graves’ disease who are hyperth