Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Investor Presentation (January 2023)
52 slides from Immunovant's investor presentation, Jan 9, 2023
Slide 1: Corporate Presentation January 2023
Corporate Presentation January 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: A Tight-knit Group of Experienced Executives
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 NEUROLOGY Myasthenia gravis (MG) Chronic inflammatory demyelinating polyneuropathy (CIDP) M
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 Portion of IgG 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 of IMVT-1402, Efgartigimod and SYNT001
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: Co-crystallization Shows 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 for Maximum IgG Reduction While Minimizing Albumin Interference
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: IMVT-1402 and Batoclimab Rapid and Deep IgG Reduction in 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: IMVT-1402 and Placebo Produced Similar Albumin and LDL Effects
15 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 16: 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 16 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 17: Our Investigational Product Pipeline
Our Investigational Product Pipeline: Only Company with 2 Anti-FcRns Targeting 5 Autoimmune Diseases 17 Anti-FcRn Target Indication / Therapeutic Area Stage of Development Batoclimab Myasthenia Gravis Pivotal Phase 3 Thyroid Eye Disease Pivotal Phase 3 Chronic Inflammatory Demyelinating Polyneuropat
Slide 18: Myasthenia Gravis
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Slide 19: Myasthenia Gravis (MG)
Myasthenia Gravis (MG) An IgG-mediated Autoimmune Disease that Typically Requires Lifestyle Changes 19 • 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 20: Current and Emerging Therapies for Myasthenia Gravis Do Not Fully Address Patient Needs
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 21: Encouraging Efficacy Signals in Phase 2 Trial of Batoclimab in MG
We Observed Encouraging Efficacy Signals in a Phase 2 Trial of Batoclimab in Myasthenia Gravis 21 -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 22: Batoclimab Phase 2 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 22 Keep control MAINTENANCE PHASE Optimize control LONG-TERM EXTENSION Gain control INDUCTION PHASE • High doses included, designed to achieve maximum efficac
Slide 23: Registrational Phase 3 Trial of Batoclimab in MG
Registrational Phase 3 Trial of Batoclimab Designed to Offer Myasthenia Gravis Patients Tailored Dosing 23 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, t
Slide 24: Batoclimab Potentially Well Positioned to Compete in MG Market
24 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
Slide 25: Thyroid Eye Disease
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Slide 26: Thyroid Eye Disease (TED)
Thyroid Eye Disease (TED) A Heterogeneous Condition that Presents with a Variety of Clinical Symptoms 26 • 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 27: Unique Dynamics of TED Market Create Potentially Favorable Commercial Opportunity
27 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 28: Batoclimab is the First and Only FcRn Inhibitor Targeting TED
28 Batoclimab is the first and only 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 tha
Slide 29: Encouraging 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 30: Additional Early Efficacy Signals from Phase 2b Trial 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 31: Two Phase 3 Clinical Trials of Batoclimab in TED Initiated
Two Phase 3 Clinical Trials of Batoclimab in Thyroid Eye Disease Initiated 31 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 32: Chronic Inflammatory Demyelinating Polyneuropathy
Chronic Inflammatory Demyelinating Polyneuropathy
Slide 33: CIDP Disease Background and Market
33 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 34: A Differentiated Approach to Developing an Anti-FcRn for CIDP
A Differentiated Approach to Developing an Anti-FcRn as a Chronic Treatment for CIDP 34 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 35: Key Learnings from Historical and Ongoing CIDP Trials
Key Learnings from Historical and Ongoing CIDP Trials Applied to Address Challenges Unique to CIDP 35 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 inac
Slide 36: 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 37: Graves' Disease
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Slide 38: Systemic Graves' Disease Impacts Multiple Organ Systems
Systemic Graves’ Disease Impacts Multiple Organ Systems Leaving Many Patients with Substantial Symptoms 38 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 39: Current Standards-of-care for Graves' Disease Have Safety and Tolerability Concerns
Current Standards-of-care for Graves’ Disease Have Well- documented, Potentially Serious Safety and Tolerability Concerns 39 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 40: Target Population: Total Addressable Incidence Population in Graves' Disease
Target population: 40 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 41: Graves' Disease Represents Potential First-in-class Opportunity for Anti-FcRns
Graves’ Disease Represents Potential First-in-class Opportunity for Anti-FcRns and Meaningful Expansion in Endocrinology 41 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 42: The First and Only Anti-FcRn Program Targeting Graves' Disease
The First and Only Anti-FcRn Program Targeting Graves’ Disease1,2 42 Sources: 1. Based on clinicaltrial.gov database, last accessed on 1/5/2023. 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 43: 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 44: Warm Autoimmune Hemolytic Anemia
Warm Autoimmune Hemolytic Anemia
Slide 45: WAIHA: Rare Blood Disorder Caused by Pathogenic IgG
01 02 03 Current standard-of-care has high unmet need with the high risk of side effects on steroids and/or immunosuppressants 50-70% of patients relapsed/refractory to standard-of-care and enter into chronic condition; ~30% of total patients require life-time care Estimated prevalence of 42,000 pat
Slide 46: Limited Treatment Options Currently for Patients with WAIHA
Limited Treatment Options Currently for Patients with WAIHA 46 Majority of patients require long-term steroid treatment or additional therapies1 • Only one-third of all patients maintain sustained disease control once steroids are discontinued1 Currently no FDA-approved therapies • Standard-of-care
Slide 47: Building a Leading Anti-FcRn Franchise
Building a Leading Anti-FcRn Franchise
Slide 48: Differentiated Assets to Address a Range of Patient Needs
Differentiated Assets to Address a Range of Patient Needs Only Company with 2 Anti-FcRns Currently Targeting 5 Autoimmune Diseases 48 Tailored dosing to address varying symptom severity across indications and stage of disease • Short term maximal IgG suppression • Lower chronic doses where less IgG
Slide 49: Potential Synergy in Clinical Development
49 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 50: 2023 Expected Cadence of Key Catalysts
2023 Expected Cadence of Key Catalysts Every 6 Months for Sustained Value Creation 50 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 period exp
Slide 51: Our Vision: Normal Lives for People with Autoimmune Disease
51 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 52: Thank you
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