Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Investor Day (2025)
56 slides from Immunovant's investor day presentation, 2025
Slide 1: IMVT-1402
IMVT-1402 Matt Gline CEO, Roivant Eric Venker CEO, Immunovant 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements Roivant Forward-Looking Statements All forward-looking statements are based on estimates and assumptions by Immunovant’s management This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that, although Immunovant belie
Slide 3: Key Takeaways: IMVT-1402
Key Takeaways: IMVT-1402 IMVT-1402 drives deep dose-dependent reductions of pathogenic IgG autoantibodies; expected to reach best-in-class IgG reductions of ~80%, unmatched by current anti-FcRn competitors Significant evidence across late-stage clinical trials shows deeper IgG reductions are correla
Slide 4: IMVT-1402 Has the Potential to Be a First- and Best-in-Class Therapy in Autoantibody-Driven Disease
IMVT-1402 Has the Potential to Be a First- and Best-in-Class Therapy in Autoantibody-Driven Disease Potential Best-in-Class Efficacy IMVT-1402 achieves deep, rapid, dose- dependent IgG reductions; consistent evidence across external and internal clinical trials validate that deeper IgG reductions le
Slide 5: Settling the "Deeper Is Better" Debate With Batoclimab Proof-of-Concept Trials
Settling the “Deeper Is Better” Debate With Batoclimab Proof-of-Concept Trials Our clinical data generated across multiple indications consistently shows that deeper IgG reduction leads to improved clinical outcomes for patients Graves’ Phase 2a1 MG Phase 31 CIDP Phase 2b1,3 ATD-Free Response: % of
Slide 6: IMVT-1402 Development Well Underway With Potentially Registrational Datasets Expected in Next 36 Months
IMVT-1402 Development Well Underway With 5 Potentially Registrational Datasets Expected in Next 36 Months CIDP GD SjD MG D2T RA CLE First-in-Class / Best-in-Class Best-in-Class Best-in-Class / “Upside” Potential best-in-class product in Well-established markets; potential to Multi-year head-start wi
Slide 7: IMVT-1402 Indication Selection Optimizes Across Both Clinical Validation and Commercial Potential
IMVT-1402 Indication Selection Optimizes Across Both Clinical Validation and Commercial Potential Commercial Opportunity GD D2T RA SjD CIDP MG CLE Higher Low Clinical Clinical Risk Risk Exploring Other Potential Opportunities for IMVT-1402 Across the Spectrum Note: Bubble placement is illustrative a
Slide 8: Anti-FcRns Have Pipeline-in-a-Product Potential Across Autoimmune Diseases
Anti-FcRns Have Pipeline-in-a-Product Potential Across Autoimmune Diseases Driven by Harmful IgG Autoantibodies With Continued Room for Growth Exploring Potential: First gMG 1 wave of anti-FcRn PoC CIDP wAIHA ITP PV/PF NMSOD TED HDFN SjD GD D2T-RA CLE Rapid Expansion: Current 2 anti-FcRn indications
Slide 9: Anti-FcRn Antibody Development Has Seen Explosive Growth Since 2020
Anti-FcRn Antibody Development Has Seen Explosive Growth Since 2020 2020 2025 8 ~700K 20+ ~4M ~$7BN Total Indications Total Addressable Total Indications in Total Addressable Cumulative Anti-FcRn in Development Patient Population Development Patient Population Sales in MG & CIDP1 NEUROLOGY HEMATOLOG
Slide 10: In Both TNF-α and JAKi Classes, a Later Product Launch With a Better Profile
In Both TNF-α and JAKi Classes, a Later Product Launch With a Better Profile Rapidly Captured Dominant Market Share in Autoimmune Disease TNF-α Inhibitor WW Net Sales1 JAK Inhibitor WW Net Sales2 $20 $7 $18 $6 $16 $14 $5 WW Net Sales ($BN) WW Net Sales ($BN) $12 $4 $10 $3 $8 $6 Vyvgart outpacing $2
Slide 11: IMVT-1402 Is Expected to Potentially Address >600K US Patients
IMVT-1402 Is Expected to Potentially Address >600K US Patients Opportunity for IMVT-1402 to be first-/best-in-class for hundreds 700 of thousands additional patients 600 Addressable US Patient Population (‘000s) 500 400 300 200 ~$7BN global anti-FcRn sales across two indications in 4 years 100 0 MG
Slide 12: Near-Term Upside Catalysts for IMVT-1402
Near-Term Upside Catalysts for IMVT-1402
Slide 13: IMVT-1402 Is Leading in First-/Best-in-Class Indications With Key Catalysts Expected
IMVT-1402 Is Leading in 3 First-/Best-in-Class Indications With Key Catalysts Expected in D2T RA and CLE in 2026 Difficult-to- Treat Cutaneous Lupus Graves’ Rheumatoid Erythematosus Disease Arthritis Multi-year lead with Rapidly enrolling Strong PoC data remarkable PoC trial; topline results from IM
Slide 14: Difficult-to-Treat Rheumatoid Arthritis (D2T RA) Represents an Unmet Medical Need
Difficult-to-Treat Rheumatoid Arthritis (D2T RA) Represents an Unmet Medical Need With Few Current Treatment Options D2T RA Patients Have Failed on • 5-20% of RA patients are difficult-to-treat (D2T), with inadequate or loss of response to Multiple Lines multiple classes of advanced therapies1 of Th
Slide 15: Of the 1.5M US RA Patients, a Subset Progresses to D2T Status
Of the 1.5M US RA Patients, a Subset Progresses to D2T Status in a Relatively Short Period of Time and Requires New Therapeutic Options1 Market Opportunity Patient Journey Learnings Fewer than 50% of ~50% of patients fail their first RA patients remain b/tsDMARD therapy within the US Prevalence of o
Slide 16: Cutaneous Lupus Erythematosus (CLE) Is a Debilitating Skin Condition With Minimal Current Treatment Options
Cutaneous Lupus Erythematosus (CLE) Is a Debilitating Skin Condition With Minimal Current Treatment Options • CLE is a rare, chronic autoimmune disease affecting the skin, with limited available Limited Treatment treatment options and high unmet need Options for CLE • No novel targeted treatment opt
Slide 17: Dermatologists Desire a Skin-Focused, Targeted Biologic That Addresses Unmet Needs in CLE
Dermatologists Desire a Skin-Focused, Targeted Biologic That Addresses Unmet Needs in CLE1 IMVT-1402 has potential to be the first novel dermatology therapy for CLE in >50 years2 Market Opportunity Potential Differentiated Profile Dermatologists are frustrated by Targeted Biologic the skin-specific
Slide 18: Introducing Dr. Mark Lupo
Introducing Dr. Mark Lupo Graves’ Disease Thought Leader Mark A. Lupo, MD, FACE, ECNU Thyroid & Endocrine Center of Florida Assistant Clinical Professor of Medicine Florida State University, College of Medicine Sarasota, Florida
Slide 19: Why Are We Still Treating Graves' Disease Like It's 1950?
Why Are We Still Treating Graves’ Disease Like It’s 1950? Mark A. Lupo, MD, FACE, ECNU Thyroid & Endocrine Center of Florida Assistant Clinical Professor of Medicine Florida State University, College of Medicine Sarasota, Florida 19 For investor audiences only
Slide 20: Disclosures
Disclosures Mark A. Lupo, MD Speaking, research, and/or consulting: AbbVie, Amgen, argenx, Eisai, Immunovant, Interpace Diagnostics, Lycia Therapeutics, QuidelOrtho, Takeda, Viridian 20 For investor audiences only
Slide 21: My Practice
My Practice Established in 2002 Independent center focused on thyroid and parathyroid disease 3 Endocrinologists We see/follow hundreds of Graves’ disease patients About half still on long-term antithyroid drug treatment 21 For investor audiences only
Slide 22: Patient Phenotypes
Patient Phenotypes MILD (~50%) MODERATE (~35-40%) SEVERE (~10-15%) • Small goiter • +/- Goiter • Large Goiter • +/- Slightly high T4/T3 • Overt hyper (T4/T3 elevation) • T4/T3 levels >4-5x normal • No TED/mild TED • +/- TED mild-moderate • TED present, often severe • Modest TRAb elevation • TRAb ele
Slide 23: For investor audiences only
23 For investor audiences only
Slide 24: Consequences of Uncontrolled Graves'
Consequences of Uncontrolled Graves’ Cardiovascular Atrial Fibrillation Stroke/Death High Output Heart Failure Morbidity/Death Increased Clotting Risks Stroke/Blood Clots Bone Loss Osteoporosis/Fracture Thyroid Eye Disease Vision Threatening Quality of Life Impact Anxiety,
Slide 25: Atrial Fibrillation Risk with Hyperthyroidism
Atrial Fibrillation Risk with Hyperthyroidism Registry Data of 586,460 Adults No Prior Atrial Fibrillation or Recorded Thyroid Disease 16,170 Atrial Fibrillation Events 25 Selmer C et al. BMJ 2012. For investor audiences only
Slide 26: Fracture Risk by TSH
Fracture Risk by TSH 26 Blum M et al. JAMA 2015 For investor audiences only
Slide 27: Graves' disease treatment mechanism of action and survey references
aAll respondents were residing in the US. GD, Graves’ disease; MOA, mechanism of action. References: 1. Kahaly GJ. J Clin Endocrinol Metab. 2020;105(12):3704-20. 2. PrPROPYL-THYRACIL (propylthiouracil tablets USP) [prescribing information]. Paladin Labs Inc.; 2020. 27 3. Methimazole tablet [prescrib
Slide 28: Definitive Treatment Discussion
Definitive Treatment Discussion Radioactive Iodine Thyroidectomy Increased risk TED Indicated if concern for cancer TRAb elevation or large obstructive goiter Radiation exposure Higher risk* Hypoparathyroidism Permanent hypothyroidism Post-operative bleeding Tracheostomy Scar
Slide 29: Quality of Life after Definitive Treatment
Quality of Life after Definitive Treatment Hypothyroid patients consistently report lower scores on QOL scales compared to general population Treatment specific complications 1 in 4 patients still feel “unwell” but often told they are fine due to normal thyroid labs 29 For investor audiences o
Slide 30: Long-term Outcomes
Long-term Outcomes 2430 GD patients diagnosed 2003-2005 60% had follow-up data mean 8 years Remission rates: ATD-45%, RAI-82%, Surgery-96% ATD, second course 29% remission rate Patients receiving ATD had 50% chance of avoiding definitive treatment and 40% chance of achieving euthyroid stat
Slide 31: TED, thyroid eye disease
TED, thyroid eye disease. 31 For investor audiences only Reference: Villagelin D, et al. J Clin Endocrinol Metab. 2024;109(11):2956-2966.
Slide 32: For investor audiences only
For investor audiences only 32
Slide 33: Real-World Treatment Patterns of Methimazole (MMI) Use in the United States
Real-World Treatment Patterns of Methimazole (MMI) Use in the United States Study Objective To evaluate dosage and treatment patterns following MMI initiation among patients with Graves’ disease in the US Study Methods Data Source IQVIA Open Claims and PharMetrics Plus databases Time Period Analyzed
Slide 34: Longitudinal Patient Dose Journey After First MMI Dose, by Starting Dose
Longitudinal Patient Dose Journey After First MMI Dose, by Starting Dose (N = 46,373) 5% 4% 10% 9% 8% 7% At 56 weeks, ~46% of patients were still on 15% 14% 12% 10% 8% 6% Moderate MMIs or higher, ATD-break, or discontinued due to 34% 28% 25% ablation/levothyroxine Proportion of patients, % 27% 21% 1
Slide 35: ATD, antithyroid drug; GD, Graves' disease; RAI; TRAb references
ATD, antithyroid drug; GD, Graves’ disease; RAI, radioactive iodine; TRAb, thyroid-stimulating hormone receptor antibodies. References: 1. Kahaly GJ, et al. Eur Thyroid J. 2018;7:167-86. 2. Ross DS, et al. Thyroid. 2016;26(10):1343-421. 35 For investor audiences only 3. Cooper DS. Curr Opin Endocrin
Slide 36: Unmet Needs in Graves' Disease
Unmet Needs in Graves’ Disease Thyroid cell proliferation Thyroid gland Colloid Hyperthyroidism ↑T4 and T3 Standard of Care TSHR • Current therapies do not target the underlying autoimmune response1 TRAb • While a significant proportion of patients respond to ATD therapy, up to ~25% are unable to co
Slide 37: Rationale for Treatment of GD With an FcRn Blocker
Rationale for Treatment of GD With an FcRn Blocker Endothelial cell recycles FcRn blocker blocks FcRn-mediated Thyroid follicles activated by anti-TSHR autoantibodies (TRAb) IgG recycling in circulation natural ligand, TSH T3, T4 ON/OFF Endosome Lysosome FcRn blocker Reduced TRAb In the presence of
Slide 38: Dr. Mark Lupo
Dr. Mark Lupo Graves’ Disease Thought Leader Mark A. Lupo, MD, FACE, ECNU Thyroid & Endocrine Center of Florida Assistant Clinical Professor of Medicine Florida State University, College of Medicine Sarasota, Florida
Slide 39: Paving the Path Forward in Graves' Disease
Paving the Path Forward in Graves’ Disease
Slide 40: Graves' Disease Patients Have Higher Risk of Sequelae of Severe Comorbidities
Graves’ Disease Patients Have Higher Risk of Sequelae of Severe Comorbidities Relative to Healthy Controls, Graves’ Patients Are at Untreated or Insufficiently Treated Graves’ Patients Increased Risk of Developing Several Severe Comorbidities Experience Substantial Morbidity and Loss of Quality of L
Slide 41: Shift Away From Ablation and Lack of New Medical Therapies Leaves 25-30% of Patients
Shift Away From Ablation and Lack of New Medical Therapies Leaves 25-30% of Patients Who Are Relapsed, Uncontrolled, or Intolerant to ATDs Graves’ Disease Patient Journey: Unmet Need 1st Line Treatment 2nd Line Treatment • 25-30% of patients are relapsed, uncontrolled on or intolerant to ATDs Contin
Slide 42: Graves' Patients Uncontrolled on ATDs Experience Significant Disease Burden
Graves’ Patients Uncontrolled on ATDs Experience Significant Disease Burden and Risk of Adverse Events With Limited Alternative Treatment Options Uncontrolled Graves’ RAI and surgery are Chronic ATD use can be patients are at risk for a associated with significant associated with risk of sequelae of
Slide 43: Follow-Up of Graves' Disease Patient Methimazole Dosing Shows Significant Percent Remaining on ATDs
Follow-Up of Graves’ Disease Patient Methimazole Dosing Shows Significant Percent of Patients Remaining on ATDs After 5-Years 5-Year MMI Longitudinal Journey (N = 59,603) 3% Switch to PTU 5% THR 7% RAI 34% 7% Thyroidectomy • In a 5-year follow-up 20 mg + 2% 5% Break 20 mg + period, only 42% of patie
Slide 44: Graves' Disease Market Opportunity Includes Annual Incident Population and Untapped Prevalent Pool
Graves’ Disease Market Opportunity Includes Annual Incident Population and a Significant Untapped Prevalent Patient Pool Incident Graves’ Disease Patients Prevalent Graves’ Disease Patients ~65K ~880K Annual Diagnosed & Treated U.S. Adult Diagnosed U.S. Adult Population5 Population1 ~7K ~58K ~760K ~
Slide 45: Potential for Disease Modification With Responders Demonstrating Strong Durability of Response
Potential for Disease Modification With Responders Demonstrating Strong Durability of Response Through Six Months Off-Treatment Treatment Period: 24 weeks Follow-up: 24 weeks 680 mg 340 mg Off-Treatment batoclimab QW batoclimab QW (Week 24-48) SC (Week 0-12) SC (Week 12-24) Week 12 Baseline Pts rece
Slide 46: ~50% of Responders at Week 48 Achieved ATD-Free Remission
~50% of Responders at Week 48 Achieved ATD-Free Remission, Demonstrating Strong Potential for Disease Modification by a High-Dose FcRn Treatment Period: 24 weeks Follow-up: 24 weeks 680 mg 340 mg Off-Treatment batoclimab QW batoclimab QW (Week 24-48) SC (Week 0-12) SC (Week 12-24) 13/17 responders o
Slide 47: Sustained TRAb Reductions Post-Batoclimab Treatment Further Demonstrate Potential for Disease Modification
Sustained TRAb Reductions Post-Batoclimab Treatment Further Demonstrate Potential for Disease Modification Treatment Period: 24 weeks Follow-up: 24 weeks 680 mg 340 mg Off-Treatment batoclimab QW batoclimab QW (Week 24-48) SC (Week 0-12) SC (Week 12-24) 20% Step-down Mean percent change from baselin
Slide 48: IMVT-1402 Could Potentially Be the First-in-Class Disease-Modifying Therapy in Graves' Disease
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 01 treated with batoclimab are responders at Week 24 Durable off-drug response: of the 21 patients who entered the off-dru
Slide 49: Opportunities for IMVT-1402 to Win on Efficacy
Opportunities for IMVT- 1402 to Win on Efficacy
Slide 50: IMVT-1402 Has the Potential to Be Best-in-Class in MG, SjD and CIDP
IMVT-1402 Has the Potential to Be Best-in-Class in MG, SjD and CIDP, With Room to Penetrate Large, Well-Validated Markets Chronic Myasthenia Sjögren’s Inflammatory Gravis Disease Demyelinating Polyneuropathy Market rapidly Expected to be best- Market quickly expanding with in-class with limited grow
Slide 51: Sjögren's Disease (SjD) Is a Chronic Autoimmune Disease
Sjögren’s Disease (SjD) Is a Chronic Autoimmune Disease Characterized by Lymphocytic Infiltration of the Salivary and Lacrimal Glands • SjD symptoms include severe dryness of the eyes and mouth; the latter frequently Limited Treatment associated with difficulty swallowing or speaking, tooth decay, g
Slide 52: Sizable SjD Patient Group With Unmet Need for an Approved Treatment Option
Sizable SjD Patient Group With Unmet Need for an Approved Treatment Option Sizable Unmet Need Expansion Opportunities Potential to impact conditions Secondary US Prevalence of with shared autoimmune Sjögren’s Primary Sjögren’s pathology Disease: 290K1 X Unmet need to improve Glandular Disease glandu
Slide 53: IMVT-1402 Has the Potential to Improve Myasthenia Gravis (MG) Treatment Outcomes
IMVT-1402 Has the Potential to Improve Myasthenia Gravis (MG) Treatment Outcomes as a Best-in-Class Therapy • 95% of neurologists agree there is opportunity for greater disease control (e.g., deeper High Unmet Need responses)1 Up to ~35k • Of the ~60-120K MG patients in the US, ~30% are AChR autoant
Slide 54: IMVT-1402 Has the Potential to Deliver Best-in-Class Efficacy in CIDP
IMVT-1402 Has the Potential to Deliver Best-in-Class Efficacy in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) High Unmet Need • 30-50% of CIDP patients are inadequately controlled with existing therapies1 Up to ~16k Addressable • Of the ~58K CIDP patients in the US, ~30% are inadequately
Slide 55: Rich Catalyst Calendar Over the Next 36 Months
Rich Catalyst Calendar Over the Next 36 Months Pivotal / Potentially Registrational 2026 2027 2028 1H 2026 Topline data in D2T RA Topline data in GD Topline data in SjD Topline data in TED* (formerly expected in 2027) Topline data in MG Topline data in CIDP 2026 2027 2028 2027+ 2026 Future PoC study
Slide 56: In Summary: IMVT-1402
In Summary: IMVT-1402 Multiple shots on goal: IMVT-1402 offers best-in-class profile in 5 late-stage indications and 1 PoC The anti-FcRn class is rapidly growing; precedent best-in-class products have won significant market share in I&I indications Graves’ disease has extraordinary unmet need; we ha