Slide 1: Immunovant Announces Plans to Study Batoclimab in Two New Indications
Immunovant Announces Plans to Study Batoclimab in Two New Indications Committed to enabling normal lives for people with autoimmune disease September 7, 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 "can," “may,” “might,” “will,” “would,” “should,” “
Slide 3: Q&A housekeeping
Q&A housekeeping 3 You may submit questions through the Q&A function at the bottom of the webcast player. Please see the image here for reference. For Investor Audiences Only
Slide 4: Today's agenda
Today’s agenda Immunovant and batoclimab Introduction • Pete Salzmann, MD, CEO Immunovant Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Differentiated development program to optimize effect size • Jonathan Katz1, MD, Director Neuromuscular Clinic, California Pacific Medical Center • Todd
Slide 5: Pipeline expansion: CIDP & Graves' Disease
Pipeline expansion: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) & Graves' Disease 5 01 02 03 SC = Subcutaneous administration; MG = Myasthenia Gravis; TED = Thyroid Eye Disease 1. As of June 30, 2022, per most recent Quarterly Report on Form 10-Q filed with the SEC on August 5, 2022 2.
Slide 6: Pete Salzmann, MD Chief Executive Officer: Immunovant and Batoclimab
Pete Salzmann, MD Chief Executive Officer Immunovant and Batoclimab
Slide 7: Pursuing a broad development program with batoclimab
Pursuing a broad development program with batoclimab 7*Registrational package for CIDP may include 1 or 2 pivotal trials depending on a variety of factors **WAIHA design to be finalized after FDA interaction expected in 2H of calendar 2022 For Investor Audiences Only GD: Phase 2 trial initiation GD:
Slide 8: IgG antibodies play a role in autoimmune disease pathogenesis
• In many autoimmune diseases, IgG antibodies develop that bind to normal tissues1 • Some IgG autoantibodies trigger harmful immune responses resulting in autoimmune symptoms and tissue damage • Some IgG autoantibodies bind cell-surface receptors that may be activated • Disease severity may correlat
Slide 9: FcRn promotes recycling of IgG antibodies
FcRn promotes recycling of IgG antibodies 9 FcRn Mechanism of Action 1. IgG is taken up into cells in endocytic vesicle 2. FcRn-IgG complexes are sorted from unbound proteins 3. Unbound proteins are trafficked to lysosome for degradation 4. IgG is recycled back into circulation FcRn maintains levels
Slide 10: Batoclimab inhibits FcRn, promoting IgG degradation
Blood Endocytic vesicle Endosome LysosomeMonocyte or endothelial cell Key: Serum proteinIgG FcRn 1 2 3 4 Batoclimab inhibits FcRn, promoting IgG degradation 10 Batoclimab Mechanism of Action 1. IgG and batoclimab are taken up into cells in endocytic vesicles 2. Batoclimab binds to FcRn in endosomes
Slide 11: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) New Indication Announcement 2022
1 1 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) New Indication Announcement 2022
Slide 12: CIDP represents an exciting opportunity
CIDP represents an exciting opportunity 12 Batcoclimab has the potential to enhance CIDP-IVIG market with a favorable risk- benefit-tolerability profile Sources: 1. Broers M, et al (2019) Incidence and prevalence of CIDP: a systematic review and meta-analysis. Neuroepidemiology 52(3–4):161–172; 2. Q
Slide 13: Fireside chat on CIDP
1 3 Fireside chat on CIDP Pete Salzmann, MD Chief Executive Officer, Immunovant Todd Levine, MD Medical Director, Neurology Department, Honor Health Scottsdale, Arizona Jonathan Katz, MD Director Neuromuscular Clinic, California Pacific Medical Center
Slide 14: Key Takeaways from CIDP Discussion
Key Takeaways from CIDP Discussion 14 01 02 03 Diagnosis of CIDP is challenging and must be done carefully. Algorithms may improve diagnostic accuracy, which is paramount for clinical trial success. IVIG = intravenous immunoglobulin We believe CIDP is a very important disease in neurology and an exc
Slide 15: Response to IVIG and Plasma Exchange supports potential benefit of anti-FcRn mechanism
Response to IVIG and Plasma Exchange creates strong rationale for potential benefit of anti-FcRn mechanism even in cases without known auto-antibody 15 axon Myelin Sheath (produced by Schwann cells) anti-myelinated peripheral nerve IgG in 30-40% patients1 autoantibodies neuron CIDP is characterized
Slide 16: Anti-FcRn mechanism of action degrades IgG, potentially protecting the myelin sheath in CIDP
Anti-FcRn mechanism of action degrades IgG, potentially protecting the myelin sheath from pathogenic IgG autoantibody attack in CIDP 16 Endothelial Cell Myelin Sheath In the absence of batoclimab, FcRn binds to the IgG autoantibodies, inhibiting their degradation and returning them into circulation.
Slide 17: Batoclimab CIDP trial uses a novel triple enrichment strategy
Batoclimab trial in CIDP builds on learning from recent trials with a novel triple enrichment strategy Inclusion criteria for primary analysis cohort: Patients treated with Ig or PLEX Washout: Only participants who worsen (off standard of care) advance to the next period Period 2 Placebo controlled
Slide 18: Restricting primary analysis to Cohort A patients previously on Ig/PLEX
Restricting the primary analysis to Cohort A patients previously on Ig/PLEX maximizes the number of participants fully off prior therapy for the primary endpoint and may improve separation from placebo 18For Investor Audiences Only 3 cohorts Screening ≤ 28 days Washout ≤ 12 weeks Cohort A Ig or PLEX
Slide 19: CIDP pivotal Phase 2b trial design
CIDP pivotal Phase 2b trial design intended to enable development of potentially best-in-anti-FcRn-class chronic therapy for CIDP 19 A: Cohorts are defined by CIDP treatment at Screening., B: Participants who fail to worsen by Week 0 will be withdrawn from the study at Week 0., C: Period 1 Non-Respo
Slide 20: Development approach applies learnings from historical and ongoing CIDP trials
Our development approach applies key learnings from historical and ongoing CIDP trials to address challenges unique to CIDP 20For Investor Audiences Only Trial risks Mitigations Mitigation included in other anti-FcRn Trials* Mitigation included in IMVT trial Disease heterogeneity and challenging dia
Slide 21: Differentiated approach to developing batoclimab as a chronic treatment for CIDP
Immunovant pursuing a differentiated approach to developing batoclimab as a chronic treatment for CIDP 21 CIDP is an exciting indication that is ripe for disruption Our pivotal study is optimized versus historical and current studies Batoclimab has potential best-in-class efficacy and could be first
Slide 22: Graves' Disease New Indication Announcement 2022
2 2 Graves' Disease New Indication Announcement 2022
Slide 23: Systemic Graves' Disease symptoms impact many organ systems
Systemic Graves' Disease symptoms impact many organ systems and leave many patients with substantial symptoms despite maximal tolerated medical therapy 23 Sources: 1. Stern RA, et al., Jr. A survey study of neuropsychiatric complaints in patients with Graves' disease. J Neuropsychiatry Clin Neurosci
Slide 24: Anti-TR autoantibodies stimulate Thyrotropin Receptor on thyroid follicles
24 anti-TR autoantibodies (TR Ab) stimulate Thyrotropin Receptor on thyroid follicles Hyperplastic thyroid follicle T3 T4ON TR ON T3, T4 ON/OFF Pathogenic anti-Thyrotropin Receptor (TR) autoantibodies turn ‘ON’ the TR signaling pathways leading to thyroid hyperplasia and systemic1-7 Graves’ disease
Slide 25: Inhibiting FcRn to foster degradation of circulating autoantibodies
Inhibiting FcRn to foster degradation of circulating autoantibodies may reduce thyroid hyperactivity and alleviate systemic1-7 symptoms 25 Anti-TR autoantibodies FcRNLegend: Batoclimab blocks FcRn-mediated IgG recycling in circulation Thyroid follicles activated by natural ligand, TSH Reduced TR Abs
Slide 26: Target population: Total Addressable Incidence Population of 41K-53K per year (US)
Target population: 26 A Total Addressable Incidence Population of 41K – 53K per year (US) beyond ATD Persistent need for ATD and wish to avoid thyroid ablation (12K-15K) Moderate-severe symptoms not controlled with ATD (29K-38K) Sources: 1. Zimmermann MB, Boelaert K. Iodine deficiency and thyroid di
Slide 27: Many patients with Graves' Disease remain symptomatic despite current treatments
Many patients with Graves’ Disease remain symptomatic despite maximally tolerated anti-thyroid medications and ablation can be problematic 27 Safety Tolerability SoC Treatments Risk of liver damage Risk of secondary cancers Risk of low blood cell counts Invasive Rash/Itching Hypothyroidism risk and
Slide 28: Observed reductions in stimulatory anti-TSHR antibodies with batoclimab
Observed reductions in stimulatory anti-TSHR antibodies with batoclimab from paused TED Phase 2b trial provide encouraging anecdotes for batoclimab in Graves’ Disease 28For Investor Audiences Only Source: Data on File, Immunovant, Inc. 1SRR is the “Sample to Reference Ratio”. This cell-based assay r
Slide 29: Fireside chat on Graves' Disease
2 9 Fireside chat on Graves' Disease Pete Salzmann, MD Chief Executive Officer, Immunovant George J. Kahaly, MD, PhD Professor of Medicine and Endocrinology/Metabolism Johannes Gutenberg University (JGU) Medical Center Department of Medicine I ORPHAN Disease Center for Graves' Orbitopathy and Autoim
Slide 30: Key Takeaways from Graves' Disease Discussion
Key Takeaways from Graves' Disease Discussion 01 02 03 Diverse and bothersome symptoms primarily relate to elevated thyroid hormone levels (measured as increased T3 and T4) are a direct result of overstimulation of the thyroid gland by anti-TSHR auto-antibodies Standard of care for Graves' Disease i
Slide 31: Graves' Disease Phase 2 trial design
Graves' Disease Phase 2 trial measures clinically relevant biomarkers / hormone levels to assess efficacy and to inform a Phase 3 development strategy 31A: Additional inclusion and exclusion criteria not listed on slide GD = Graves' Disease; ATD = anti-thyroid medications; QW = weekly; SC = subcutan
Slide 32: Batoclimab represents a potential targeted therapy for Graves' Disease
Batoclimab represents a potential targeted therapy for Graves’ Disease where unmet need is high For Investor Audiences Only * From TED P2b study, observed reduction in anti-TSHR antibodies and post-hoc, anecdotal observations of patients whose anti-thyroid medication dose was reduced. Initial Phase
Slide 33: NY MIVINIOINONZANEE
NY MIVINIOINONZANEE +++ t+ + + + +++ ++ 33,
Slide 34: Pipeline expansion: CIDP & Graves' Disease
Pipeline expansion: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) & Graves' Disease 34 01 02 03 SC = Subcutaneous administration; MG = Myasthenia Gravis; TED = Thyroid Eye Disease 1. As of June 30, 2022, per most recent Quarterly Report on Form 10-Q filed with the SEC on August 5, 2022 2.
Slide 35: Pursuing a broad development program with batoclimab
Pursuing a broad development program with batoclimab 35*Registrational package for CIDP may include 1 or 2 pivotal trials depending on a variety of factors **WAIHA design to be finalized after FDA interaction expected in 2H of calendar 2022 For Investor Audiences Only GD: Phase 2 trial initiation GD
Slide 36: Investor Q&A
Pete Salzmann, MD Chief Executive Officer Bill Macias, MD Chief Medical Officer Investor Q&A