Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Corporate Update (January 2022)
14 slides from Immunovant's corporate update, Jan 5, 2022
Slide 1: Phase 3 Development for Batoclimab in Myasthenia Gravis
Phase 3 Development for Batoclimab in Myasthenia Gravis Corporate Update January 2022 eExhibit 99.1
Slide 2: Forward-looking statements
Forward-looking statements 2 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 “may,” “might,” “will,” “would,” “should,” “expect,
Slide 3: We have achieved alignment with the FDA to move forward in MG
3 We have achieved alignment with the FDA to move forward in MG. We plan to start a Phase 3 study for batoclimab (IMVT-1401) in MG in the first half of calendar year (CY) 2022. Alignment to move forward in myasthenia gravis (MG) is important for patients, with the potential to offer a differentiated
Slide 4: Aligned with FDA on required safety exposures and safety/monitoring plan for pivotal MG study
Aligned with FDA on required safety exposures and safety/monitoring plan for pivotal MG study 4 Inclusion and exclusion criteria for MG Ph3 trial enable access to broad population Statins will be permitted as concomitant medication but don’t need to be initiated during blinded treatment periods. Sta
Slide 5: People with MG recognize limitations of current therapies
People with MG recognize limitations of current therapies, which keep them from living their normal lives Historical standards of care have important limitations Episodic or cyclical treatment – especially steroids and IVIg Prolonged time to onset for other immunosuppressants Potential trade-offs to
Slide 6: Nearly 80% of people with MG reported moderate or major lifestyle modifications
Nearly 80% of people with MG (on treatment) reported moderate or major lifestyle modifications 6 MG patient survey feedback, specifically incorporated into batoclimab trial design Source: MG Patient Quantitative Survey (n=50). Q: What is the extent of lifestyle modifications you make around your mya
Slide 7: Chronic Dosing: patients prefer chronic versus intermittent dosing
Chronic Dosing: “I want to stay on my MG treatment, even when my symptoms are under control, so that I can maintain a response and avoid potential symptom flares” "It's easier to schedule life around something so consistent" 94% of MG patients surveyed preferred a chronic versus intermittent dosing
Slide 8: Phase 3 trial in MG is designed to address unmet patient needs and differentiate batoclimab
Phase 3 trial in MG is designed to address unmet patient needs and differentiate batoclimab 8 Flexible dosing to match disease fluctuations: Myasthenia gravis waxes and wanes over time; clinicians and patients desire a data-driven approach to optimize care over time Peace of mind over time: Chronic
Slide 9: Flexible Phase 3 design that is a first for an MG trial
Flexible Phase 3 design that is common in immunology trials but a first for an MG trial 9 Gain control INDUCTION PHASE Keep control MAINTENANCE PHASE Optimize control LONG-TERM EXTENSION (LTE)
Slide 10: MG Phase 3 trial design (N ~ 200)
MG Phase 3 trial design (N ~ 200) 10 QW = weekly; Q2W = bi-weekly; SC = subcutaneous injection; AChR Ab+ = acetylcholine receptor antibody-positive; MG-ADL = Myasthenia Gravis Activities of Daily Living scale Placebo-controlled, two dose regimens: Period 1: Induction (12 weeks) Maximize efficacy thr
Slide 11: Batoclimab's Phase 3 trial in MG designed to deliver differentiated value
11 NIPOCALIMAB 15 mg/kg Q2W for 22 weeks, after single loading dose of 30 mg/kg Down titration allowed in long term extension (LTE) IV administration EFGARTIGIMOD BATOCLIMAB Down titration allowed and rescue for symptomatic exacerbations in LTE Routine SC administration Fast onset, induction period4
Slide 12: Potential for anti-FcRn technology to help a broad range of people impacted by autoimmune disease
Potential for anti-FcRn technology to help a broad range of people impacted by autoimmune disease 12 Autoimmune diseases* driven by pathogenic IgG + estimated prevalence (2021) 66,000 42,000 33,000 222,000 281,000 137,000 65,000 112,000 88,000 49,000 32,000 28,000 2,000 104,000 67,000 52,000 348,000
Slide 13: Plan to initiate three pivotal trials in 2022
Plan to initiate three pivotal trials in 2022 13 Target Indication Phase 1 Phase 2 Phase 3 Anticipated Milestones Myasthenia Gravis (MG) Top Line Results expected 2024 Thyroid Eye Disease (TED) Expecting to initiate pivotal trials in 2022 for two of these four indications Warm Autoimmune Hemolytic A
Slide 14: Thank you
, Thank you +++ t+ ++ + + t+ + + + YY IMMUNOVANT