Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Corporate Update (September 2024)
32 slides from Immunovant's corporate update, Sep 9, 2024
Slide 1: Graves' Disease Program Update
Targeted science, Tailored solutions for people with autoimmune disease Graves’ Disease Program Update September 9, 2024 Exhibit 99.2
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: Lower is Better: Deeper IgG reductions drove higher response rates
Lower is Better: Deeper IgG reductions drove meaningfully higher response rates, positioning IMVT-1402 to potentially be best-in-class 3 Proof of concept achieved in Graves’ Disease, positioning IMVT-1402 to potentially be best-in-class and first-in-class >75% Response Rate in Patients Uncontrolled
Slide 4: Agenda
• Graves’ Disease Overview and Unmet Need • Batoclimab Graves’ Disease Phase 2 Data • IMVT-1402 Path Forward in Graves’ Disease • Market Opportunity in Graves’ Disease • Commercial Considerations • Conclusion 1 2 Agenda 3 4 5 6 4
Slide 5: Graves' Disease Overview and Unmet Need
Graves’ Disease Overview and Unmet Need 5
Slide 6: Graves' Disease is a classic autoimmune condition driven by thyroid stimulating antibodies
6 Graves’ Disease is a classic autoimmune condition driven by the presence of thyroid stimulating antibodies Sources: 2024 Medic Drive (https://medicdrive.org/thyroid-disease/hyperthyroidism/graves-disease/). Pathogenesis of Graves’ Disease Normally, TSH produced by the pituitary gland stimulates th
Slide 7: Graves' Disease: high patient burden and significant morbidity
7 Graves’ Disease: high patient burden and significant morbidity ), 6. Sources: 1. Smith et al. (2016), 2. Burch et al. (2015), 3. Okosieme et al. (2019), 4. Chin et al. (2020), 5. Smith et al. (2023 Okosieme et al. (2020), 7. Bourcier et al. (2020) Symptoms impact many organ systems and leave many
Slide 8: Minimal innovation in Graves' Disease treatment options over the past 70+ years
8 Minimal innovation in Graves’ Disease treatment options over the past 70+ years Sources: 1. Roivant / Inovalon Claims Analysis – 2021 incident patient population, first-line treatment is primary treatment in the first-year post diagnosis, claims review included a five-year lookback to define the i
Slide 9: Treatment paradigm shifting away from radioactive iodine and surgery
5% 8% 49% 29%47% 67% 0% 20% 40% 60% 80% 100% 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Surgery Radioiodine (RAI) Antithyroid Drugs (ATDs) 9 In North America, the treatment paradigm for Graves’ Disease continues to shift away from radioactive iodine and surgery Roivant Claims Analysis – 2021
Slide 10: 25-30% of patients relapsed, uncontrolled, or intolerant to ATDs
Shift away from ablation and lack of new medical therapies leaves 25-30% of patients who are relapsed, uncontrolled, or intolerant to ATDs Diagnosed with Graves’ Disease Anti-Thyroid Therapy (ATD) ~85-90% Ablation ~10% 1st Line Treatment Remission / Control with Continued ATD ~60-65% Ablation ~3-5%
Slide 11: Batoclimab Graves' Disease Phase 2 Data
Batoclimab Graves’ Disease Phase 2 Data 11
Slide 12: Goals for the Graves' Disease Phase 2 Program
Enable IND clearance and transition straight to pivotal program for IMVT-1402 Generate ATD tapering data to inform pivotal trial design Lower is better: establish need for deeper IgG reductions to drive higher response rates 12 Generate proof of concept efficacy data for first disease-modifying ther
Slide 13: Phase 2 study design tests two doses of batoclimab
13 Graves’ Disease Phase 2 study design tests two doses of batoclimab 12 weeks of 680mg followed by 12 weeks of 340mg in Graves’ Disease patients uncontrolled on ATDs Treatment Period: 24 weeks N = 25 340mg batoclimab QW SC (Week 12-24) 680mg batoclimab QW SC (Week 0-12) Key Endpoint: Proportion of
Slide 14: Trial population representative of uncontrolled population despite ATD use
The trial population was representative of an uncontrolled population, despite ATD use 14 Batoclimab SC QW N = 25 Mean unless otherwise noted Age, years 47.4 Sex, % female 80% Race, % white 92% BMI, kg/m2 25.4 Median time since diagnosis, months 15.7 Baseline FT3, pmol/L (ULN=6.8 pmol/L) 15.4 Baseli
Slide 15: Batoclimab demonstrated transformational results in ATD uncontrolled patients
15 Batoclimab demonstrated potentially transformational results in ATD uncontrolled patients with greater response driven by higher IgG lowering Note: Includes two patient discontinuations. One patient did not complete Week 12 due to pre-existing gallstones and is counted as a non-responder at Week
Slide 16: ATD-free responders at Weeks 12 and 24
56% ATD-Free Responders 36% ATD-Free Responders Week 12 (N = 14/25) Week 24 (N = 9/25) 16 >50% of patients receiving high-dose batoclimab not only achieved normal T3 and T4 levels but also ceased ATD entirely by 12 weeks Note: Includes two patient discontinuations. One patient did not complete Week
Slide 17: Deeper IgG reduction associated with higher ATD-free responder rate
23% ATD-Free Responders 60% ATD-Free Responders Week 24 IgG Reduction < 70% (N = 3/13) Week 24 IgG Reduction ≥ 70% (N = 6/10) 17 Deeper IgG reduction at 24 weeks was associated with a meaningfully higher ATD-free responder rate Note: Excludes two patient discontinuations given no IgG data available
Slide 18: High-dose batoclimab drives rapid normalization of T3 and T4
18 High-dose batoclimab drives rapid normalization of T3 and T4 and ATD tapering Notes: T3 / T4 data includes up to last measurement available for two patient discontinuations. T3 LLN=3.1 pmol/L and ULN=6.8 pmol/L; T4 LLN=12 pmol/L and ULN=22 pmol/L. T4T3 Treatment Period: (24 weeks) N = 25 340mg ba
Slide 19: Batoclimab was well-tolerated with no new safety signals
19 Batoclimab was well-tolerated with no new safety signals identified Batoclimab SC QW N = 25 n (%) Patients with any TEAE 25 (100) Patients with any Serious TEAE 1 (4) Patients with any Treatment-related Serious TEAE 0 Patients with any Treatment-related TEAE Leading to Study Drug Withdrawal 0 Pat
Slide 20: IMVT-1402 Path Forward in Graves' Disease
IMVT-1402 Path Forward in Graves’ Disease 20
Slide 21: First pivotal trial for IMVT-1402 in Graves' Disease
21 First pivotal trial for IMVT-1402 in Graves’ Disease Treatment Period: 52 weeks N = 240 R an do m iz at io n (1 :1 :1 ) Primary Endpoint at Week 26: Proportion of participants who become euthyroidb and stop ATD Key Secondary Endpoint at Week 52: Proportion of participants who become euthyroidb an
Slide 22: Market Opportunity in Graves' Disease
Market Opportunity in Graves’ Disease 22
Slide 23: Multiple market-sizing analyses confirm high unmet need
23 Multiple market-sizing analyses confirm high unmet need in Graves’ Disease with at least 25-30% of patients relapsed, uncontrolled, or intolerant to ATDs Conservative Inovalon claims analysis yields ~880K prevalent Graves’ Disease patients1 Real-world chart audit of 1,120 Graves’ Disease patients
Slide 24: Analysis #1: Real world claims analysis of prevalent treated market
24 Analysis #1: Real world claims analysis indicates a substantial untapped opportunity in the prevalent treated Graves’ Disease market Diagnosed U.S. Adult Population1 ~880K Prevalent Treated Patients Eligible for ablation but choosing not to pursue it ATD relapse patients choosing not to pursue ab
Slide 25: Analysis #2: Incident US population and annual second line market
Analysis #2: Real world claims analysis conservatively estimates an incident US population of ~65K leading to an annual second line market of ~20K patients Annual Diagnosed & Treated U.S. Adult Population1 65K 1st Line ATD1 58K 1st Line Ablation1 (Surgery & RAI) 7K Remission or Continued ATDs2 42K A
Slide 26: Analysis #3: Surveyed endocrinologists on patients uncontrolled on ATDs
26 Analysis #3: Surveyed endocrinologists indicate that ~25% of their patients remain uncontrolled on ATDs Sources: 1) Graves’ Disease Physician Survey (n=140) by Immunovant Endocrinologist Survey Methodology 1. Board-certified endocrinologists (N=140) were screened based on Graves’ Disease patient
Slide 27: Analysis #4: Real-world chart review of patient records
27 Analysis #4: Real-world in-depth chart review of 1,000+ patient records from 140 endocrinologists indicates ~25% have never achieved euthyroid status on ATDs *Excludes patients who have received definitive treatment; Sources: Patient Chart Audit analysis (n=988 on ATD, n=1120 total) by Immunovant
Slide 28: Analysis #5: Patient survey on difficulty achieving stable thyroid disease
28 Analysis #5: ~35% of Graves’ Disease patients report that they have found it difficult or very difficult to achieve stable thyroid disease while on ATDs Sources: Graves’ Disease Patient Quantitative Survey (n=100) by Immunovant Patient Survey Methodology 1. A double-blinded online survey was cond
Slide 29: Commercial Considerations
Commercial Considerations 29
Slide 30: Tepezza's fast ramp illustrates potential of IMVT-1402 in Graves' Disease
30 Tepezza®’s fast ramp in a TED market dominated by generics and procedures illustrates the potential of IMVT-1402 in Graves’ Disease Thyroid Eye Disease Market Pre-Tepezza Launch Tepezza Net Sales ($M) Notes: Dollars reported in millions. Sources: Horizon Therapeutics PLC 10-K documents, Inovalon
Slide 31: Conclusion
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Slide 32: IMVT-1402 is potentially best and first-in-class in Graves' Disease
32 IMVT-1402 is potentially best and first-in-class in Graves’ Disease High dose batoclimab rapidly achieved a 76% response rate in patients uncontrolled on ATDs, meaningfully exceeding 50% response rate bar01 High dose batoclimab rapidly achieved a 56% ATD-free response rate in patients uncontrolle