Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Investor Presentation (March 2023)
56 slides from Immunovant's investor presentation, Mar 27, 2023
Slide 1: Targeted Science, Tailored Solutions
Targeted Science, Tailored Solutions Corporate Presentation March 2023 Exhibit 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: Our Vision: Normal Lives for People with Autoimmune Disease
Our Vision: Normal Lives for People with Autoimmune Disease Core Values 3 Love Trailblazing All Voices Bolder, Faster
Slide 4: Our Mission: Build a Leading Anti-FcRn Franchise
Our Mission: Build a Leading Anti-FcRn Franchise Targeting Multiple Underserved Autoimmune Disease Indications 4 Leadership Team Intellectual Property Financial Strength Validated Target Product Candidates Market Opportunity • Approximately 100 years of combined experience in drug development and co
Slide 5: Our Leadership Team
Our Leadership Team: A Tight-knit Group of Experienced Executives 5 Peter Salzmann, MD MBA Chief Executive Officer William L. Macias, MD PhD Chief Medical Officer Eva Renee Barnett, MBA Chief Financial Officer Julia G. Butchko, PhD Chief Development and Technology Officer Mark S. Levine Chief Legal
Slide 6: Our Focus: The Neonatal Fc Receptor (FcRn)
Our Focus: The Neonatal Fc Receptor (FcRn) 6 Blood Endocytic vesicle Endosome LysosomeMonocyte or endothelial cell 1 2 3 4 Key: Serum proteinIgG FcRn FcRn inhibitor Blood Endocytic vesicle Endosome LysosomeMonocyte or endothelial cell 1 2 3 4 FcRn maintains levels of antibodies (IgG) in circulation
Slide 7: Our Opportunity: Autoimmune Diseases Driven by Pathogenic IgG
Our Opportunity: Autoimmune Diseases Driven by Pathogenic IgG 7 ENDOCRINOLOGY Thyroid eye disease (TED) Graves’ disease RHEUMATOLOGY Primary Sjogrens syndrome Systemic lupus erythematosus Rheumatoid arthritis Antineutrophil cytoplasmic antibody (ANCA)- associated vasculitis Severe fibromyalgia syndr
Slide 8: Anti-FcRn Inhibitors Have Unique Characteristics
Anti-FcRn Inhibitors Have Unique Characteristics No clinical head-to-head comparisons of Immunovant product candidates and third party anti-FcRn assets has been conducted. Binding affinities are determined by surface plasmon resonance. Sources: 1. On file at Immunovant; 2. Ulrichts 2018; 3.Ling, 201
Slide 9: Fc and Albumin Have Different Binding Sites on FcRn
Fc Portion of Endogenous IgG (Fc) and Albumin Have Different Binding Sites on FcRn 9 Albumin FcRn Fc FcRn Albumin FcRn Fc Note: Ribbon representations generated from X-Ray co-crystal structure
Slide 10: Co-crystal Structures for FcRn Complexes
Co-crystal Structures for FcRn Complexes of IMVT-1402, Efgartigimod and SYNT001 10 FcRn SYNT001 IMVT-1402 Efgartigimod* SYNT001** FcRn IMVT-1402 FcRn Efgartigimod *https://www.rcsb.org/structure/7Q15; **Blumberg et al., Sci. Adv. 2019 Dec 18;5(12):eaax9586 Note: Ribbon representations generated from
Slide 11: IMVT-1402-FcRn Complex Orients Differently from Batoclimab
Co-crystallization Shows IMVT-1402-FcRn Complex Orients Differently from Batoclimab-FcRn Complex 11Note: Ribbon representations generated from X-Ray co-crystal structure. Batoclimab solved at 2.4Å resolution. IMVT-1402 solved at 2.6Å resolution. FcRn IMVT-1402 Albumin FcRn Fc FcRn Batoclimab FcRn
Slide 12: IMVT-1402 Selected to Minimize Interference with Albumin Recycling
IMVT-1402 Selected to Deliver Maximum IgG Reduction While Minimizing Interference with Albumin Recycling Batoclimab: overlay with albumin and FcIMVT-1402: overlay with albumin and Fc 12Note: Ribbon representations generated from X-Ray crystal structure. Batoclimab solved at 2.4Å resolution. IMVT-140
Slide 13: Our Value Proposition: Three Potentially Unique Attributes
Our Value Proposition: Three Potentially Unique Attributes to Address Unmet Patient Needs 13 % • Strong correlation between deep IgG reduction and increased clinical efficacy Rapid & Deep IgG Reduction • For patients with varying symptom severity and stage of disease Tailored Dosing • To enable self
Slide 14: Rapid and Deep IgG Reduction in Head-to-Head Monkey Study
IMVT-1402 and Batoclimab Each Demonstrated Rapid and Deep IgG Reduction in a Head-to-Head Monkey Study 14 1. Source: Lledo-Garcia, et al, Pharmacokinetic-pharmacodynamic modelling of the anti-FcRn monoclonal antibody rozanolixizumab: Translation from preclinical stages to the clinic, UCB Pharma, 202
Slide 15: Correlation Between Deep IgG Reduction and Efficacy in MG
Strong Correlation Between Deep IgG Reduction and Increased Clinical Efficacy in MG Across Anti-FcRn Assets The ADAPT Phase 3 trial of IV efgartigimod demonstrated that patients with deeper IgG reductions saw greater improvements in their disease activity (MG-ADL) compared to patients with lesser Ig
Slide 16: Other Indications Suggest IgG Reduction and Efficacy Correlation
Multiple Other Autoantibody-Driven Indications Also Suggest Strong Correlation Between IgG Reduction and Clinical Efficacy Immunovant’s Phase 2 trial in TED indicated that reduction in IgG led to greater restoration of normal levels of pathogenic Abs and greater proptosis response rates In efgartigi
Slide 17: Consistent Evidence That Greater IgG Reduction Leads to Greater Efficacy
Consistent Evidence Across All Programs and All Indicators that Greater IgG Reduction Leads to Greater Efficacy Company Evidence of Greater IgG Reductions Translating to Clinical Benefit M G TE D IT P Greater IgG reductions across arms greater anti-AChR autoantibody reductions and greater MG-ADL i
Slide 18: Monkey Study: Albumin and LDL Effects
18 In a Head-to-Head Monkey Study, We Observed That IMVT-1402 and Placebo Produced Similar Albumin and LDL Effects Day SD, standard deviation; ULN, upper limit of normal; LLN, lower limit of normal; Arrows indicate time of dosing. Data on file at Immunovant Day Batoclimab 50 mg/kg (n=3) IMVT-1402 50
Slide 19: Albumin Impact in Non-human Primates Translatable to Humans
Albumin Impact in Non-human Primates Translatable to Humans Translatability Observed Across Multiple Anti-FcRn Inhibitors 19 1. Ulrichts P.J Clin Invest. 2018 Oct 1;128(10):4372-4386 2. Efgartigimod EMA assessment report - EMA/641081/2022 3. Efgartigimod FDA integrated review - 761195Orig1s000 4. Bl
Slide 20: Cholesterol Elevations with Batoclimab Manageable
Cholesterol Elevations Observed with Batoclimab Predictable, Well-understood, and Manageable 680mg batoclimab dose with and without 40mg atorvastatin: Treatment Period 1 6 weeks *40mg atorvastatin dosing initiated 14 days prior to initiation of 680mg batoclimab dosing 680mg batoclimab QW SC + Placeb
Slide 21: LDL Cholesterol vs. Time with Atorvastatin
-2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Nominal Time (weeks post first dose) 0 50 100 150 200 C ho les te ro l i n Se ru m (m m ol /L ) M ea n (S D ) C on ce nt ra tio ns o f L D L Cohort 2 Batoclimab 680 mg QW (N=9)Cohort 1 Batoclimab 680 mg QW (N=8) Nominal Time (weeks post first batoclimab dose)
Slide 22: Key Takeaways on Impact of Batoclimab on LDL Cholesterol
Key Takeaways on Impact of Batoclimab on LDL Cholesterol 22 Mechanism is not unique to batoclimab Cholesterol changes are reversible Cholesterol changes expected to be manageable 1 2 3 LDL changes correlated with on target changes in albumin Dose dependent changes in LDL returned to normal with cess
Slide 23: Our Investigational Product Pipeline
Our Investigational Product Pipeline 23 Anti-FcRn Target Indication / Therapeutic Area Stage of Development Batoclimab Myasthenia Gravis Pivotal Phase 3 Thyroid Eye Disease Pivotal Phase 3 Chronic Inflammatory Demyelinating Polyneuropathy Pivotal Phase 2b* Graves' Disease Phase 2 IMVT-1402 Rheumatol
Slide 24: Myasthenia Gravis
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Slide 25: Myasthenia Gravis (MG)
Myasthenia Gravis (MG) An IgG-mediated Autoimmune Disease that Typically Requires Lifestyle Changes 25 • One of the larger IgG-mediated autoimmune disease o ~65,000 patients estimated in the US and ~100,000 in Europe • ~80% of patients require life-long therapy • Substantial share of population on s
Slide 26: Current and Emerging Therapies for Myasthenia Gravis
Drug Name Manufacturer Mechanism of Action Phase of Development Route of Administration Note Efgartigimod FcRn inhibitor Approved (12/2021) Intravenous Halozyme-enhanced SC pending FDA review Nipocalimab FcRn inhibitor Phase 3 Intravenous Albumin reduction reported1 Rozanolixizumab FcRn inhibitor BL
Slide 27: Efficacy Signals in Phase 2 Batoclimab Trial in MG
We Observed Encouraging Efficacy Signals in a Phase 2 Trial of Batoclimab in Myasthenia Gravis 27 -3% -59% 2% 3% -23% -3% -38% -76% -54% -87% -100% -90% -80% -70% -60% -50% -40% -30% -20% -10% 0% 10% Data at Week 7, End of Controlled Portion of Study Placebo (N=6) Batoclimab 340mg/week (N=5) Batocli
Slide 28: Batoclimab Trial Designed to Address Unmet Patient Needs
Batoclimab Phase 3 Trial Designed to Address Unmet Patient Needs Flexible Design First for a Myasthenia Gravis Trial but Common in Immunology 28 Keep control MAINTENANCE PHASE Optimize control LONG-TERM EXTENSION Gain control INDUCTION PHASE • High doses included, designed to achieve maximum efficac
Slide 29: Registrational Phase 3 Trial Designed for Tailored Dosing
Registrational Phase 3 Trial of Batoclimab Designed to Offer Myasthenia Gravis Patients Tailored Dosing 29QW = weekly; Q2W = bi-weekly; SC = subcutaneous injection; AChR Ab+ = acetylcholine receptor antibody-positive; MG-ADL = Myasthenia Gravis Activities of Daily Living scale Placebo-controlled, tw
Slide 30: Batoclimab Positioned to Compete in MG Market
30 Batoclimab Potentially Well Positioned to Compete in Myasthenia Gravis Market Continuous dosing via induction, maintenance (3 different doses) Dose increase and dose decrease allowed in LTE based on symptoms Simple SC administration Batoclimab IV administration, bridging to Halozyme-enhanced SC a
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Slide 32: Thyroid Eye Disease (TED)
Thyroid Eye Disease (TED) A Heterogeneous Condition that Presents with a Variety of Clinical Symptoms 32 • Teprotumumab is the only approved treatment specifically for TED o Treatment period is relatively short (~24 weeks) and disease recurrence is common • 14% of TED patients, and a far higher prop
Slide 33: Unique Dynamics of TED Market
33 Unique Dynamics of TED Market Create Potentially Favorable Commercial Opportunity for New Therapeutic Approaches Reimbursement is often strictly to label for specialty products TED products will likely continue to be labeled for a fixed duration equal to the controlled period of the registration
Slide 34: Batoclimab Positioned to Capture TED Market Share
34 Batoclimab is the first FcRn inhibitor targeting TED1,2 Residual symptoms or recurrent symptoms after teprotumumab (3K-11K) Moderate symptoms not yet treated with teprotumumab (5K-7K) 1/3 of the 15-20K US patients with active, moderate- to-severe TED annually have less severe disease that may ben
Slide 35: Pharmacodynamic Signals from Phase 2b Trial in TED
Encouraging Pharmacodynamic Signals Observed from Phase 2b Trial of Batoclimab in Thyroid Eye Disease Source: Batoclimab Phase 2b TED trial data on file at Immunovant, Inc. 1SRR is the “Sample to Reference Ratio”. This cell-based assay readout is the ratio of the sample signal to that of a reference
Slide 36: Additional Early Efficacy Signals in TED
1 Proptosis response defined as proptosis reduction ≥2 mm in study eye, without ≥2 mm increase in non- study eye at same visit. Week 6 data selected as it represents the latest time point at which the largest amount of patient data is available prior to the voluntary pause –35.0 –30.0 –25.0 –20.0 –1
Slide 37: Two Phase 3 Trials of Batoclimab in TED Initiated
Two Phase 3 Clinical Trials of Batoclimab in Thyroid Eye Disease Initiated 37 Note: subset of inclusion criteria for TED Phase 3 trial shown on slide CAS = Clinical Activity Score, anti-TSHR-Ab = anti-TSHR antibody, QW = weekly; SC = subcutaneous injection Placebo-controlled, two dose regimens: Stud
Slide 38: Chronic Inflammatory Demyelinating Polyneuropathy
Chronic Inflammatory Demyelinating Polyneuropathy
Slide 39: CIDP Patient Population and Current Therapies
39 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. Querol, L., et al. Systematic literature review of burden of illness in chronic inflammatory demyelinating polyneuropathy (CIDP). J Neurol 268, 3706–37
Slide 40: Differentiated Approach to Anti-FcRn for CIDP
A Differentiated Approach to Developing an Anti-FcRn as a Chronic Treatment for CIDP 40 CIDP is an exciting indication that is ripe for disruption Pivotal study optimized versus historical and current studies Potential best-in-class efficacy and simple subcutaneous administration • Representing mean
Slide 41: Key Learnings from CIDP Trials
Key Learnings from Historical and Ongoing CIDP Trials Applied to Address Challenges Unique to CIDP 41 Trial risks Mitigations Mitigation included in other anti-FcRn Trials* Mitigation included in IMVT trial Disease heterogeneity and challenging diagnosis Diagnostic algorithm X Mix of active and in
Slide 42: Pivotal Phase 2b Trial in CIDP
Pivotal Phase 2b Trial Intended to Develop Potentially Best-in-class Chronic Anti-FcRn Therapy in CIDP 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-Responders who complete Period 1 wi
Slide 43: Batoclimab and IMVT-1402 Provide Strategic Options in CIDP
43 Batoclimab and IMVT-1402 Provide Strategic Options in CIDP Learnings from both trials combined to determine which asset(s) to develop in CIDP Open-label period from batoclimab Phase 2b trial in CIDP to potentially inform IgG reduction and clinical efficacy Planned Phase 1 trial of IMVT-1402 to pr
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Slide 45: Systemic Graves' Disease Impacts Multiple Organ Systems
Systemic Graves’ Disease Impacts Multiple Organ Systems Leaving Many Patients with Substantial Symptoms 45 Sources: 1. Stern RA, et al. J Neuropsychiatry Clin Neurosci. 1996 Spring;8(2):181-5. 2. Arruda et al A survey study of neuropsychiatric complaints in patients with Graves' disease: A reassessm
Slide 46: Graves' Disease Standards of Care Safety Concerns
Current Standards-of-care for Graves’ Disease Have Well- documented, Potentially Serious Safety and Tolerability Concerns 46 Safety Tolerability SoC Treatments Risk of liver damage Risk of secondary cancers Risk of low blood cell counts Invasive Rash/Itching Hypothyroidism risk and fatigue Anti-Thyr
Slide 47: Graves' Disease Target Population
Target population: 47 Total addressable incidence population of 41K – 53K per year (U.S.) beyond anti-thyroid drug (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 defic
Slide 48: Graves' Disease Potential First-in-class Opportunity
Graves’ Disease Represents Potential First-in-class Opportunity for Anti-FcRns and Meaningful Expansion in Endocrinology 48 Graves’ disease represents first-in-class opportunity for anti- FcRns in an indication with substantial need beyond 1L therapy with ATD Poor QOL in Graves’ disease patients who
Slide 49: The First and Only Anti-FcRn Program Targeting Graves' Disease
The First and Only Anti-FcRn Program Targeting Graves’ Disease1,2 49 Sources: 1. Based on clinicaltrial.gov database, last accessed on 3/24/2023. 2. Lane LC, et al. Endocr Rev. 2020 Dec 1;41(6):873–84 A: Additional inclusion and exclusion criteria not listed on slide GD = Graves' Disease; ATD = anti
Slide 50: A Potential Targeted Therapy for Graves' Disease
A Potential Targeted Therapy for Graves’ Disease * 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 2 data expected in the second half of 2023 Large unmet need in Graves’ dise
Slide 51: Building a Leading Anti-FcRn Franchise
Building a Leading Anti-FcRn Franchise
Slide 52: Differentiated Assets to Address a Range of Patient Needs
Differentiated Assets to Address a Range of Patient Needs Are the Goals of Our Development 52 Tailored dosing to address varying symptom severity across indications and stage of disease • Short term maximal IgG suppression • Lower chronic doses where less IgG suppression needed • Fixed duration dosi
Slide 53: Potential Synergy in Clinical Development
53 Potential Synergy in Clinical Development Learnings from Batoclimab Potentially Leverageable to Accelerate IMVT-1402 Development Potential synergy for IMVT-1402 development in Graves’ disease Learnings from both trials combined to potentially accelerate IMVT-1402 to pivotal trial in Graves’ disea
Slide 54: 2023 Expected Cadence of Key Catalysts
2023 Expected Cadence of Key Catalysts Every 6 Months for Potential Sustained Value Creation 54 GD: Initial results at 12 and 24 weeks expected in 2H 2023 MG: Topline results expected in 2H 2024 2024 2025 TED: Topline results for both trials expected in 1H 2025 CIDP: Initial results from open label
Slide 55: Our Vision: Normal Lives for People with Autoimmune Disease
55 Potentially first to develop subcutaneous anti-FcRn that can be administered in seconds Complementary anti-FcRns potentially enable accelerated development pathways Cultivating broad network of experts to optimize multi- indication development plan Love Trailblazing Bolder, Faster All Voices Our
Slide 56: Thank you
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