Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Corporate Update (November 2024)
29 slides from Immunovant's corporate update, Nov 7, 2024
Slide 1: Immunovant Development Update
Immunovant Development Update November 7, 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: Agenda
• Significant progress on IMVT-1402 development plan • Graves' Disease, potential First-in-Class Opportunity, with impact on thyroidal and extrathyroidal disease • Difficult-to-Treat Rheumatoid Arthritis, potential Best-in-Class Opportunity • Conclusion Agenda 3 1 . 2 3 4
Slide 4: IMVT-1402 Development Progress
IMVT-1402 Development Progress 4
Slide 5: Favorable Analyte Profile
Favorable Analyte Profile Phase 1 data supports a favorable analyte profile with no or minimal effect on albumin and LDL 1. Not including any potential patent term extension 5 Our lead asset: IMVT-1402 has a combination of potentially best-in-class attributes not seen with other anti-FcRns Novel, fu
Slide 6: Potential best-in-class product profile opens broad range of indication opportunities
Potential best-in-class product profile opens broad range of indication opportunities for IMVT-1402 6 Best-in-Class • Other underserved patient populations • Potential to enhance PTS via focus on subset of patients with autoantibodies of interest and leverage IMVT-1402 potency • Examples – ACPA+ Dif
Slide 7: Significant progress in advancing lead asset IMVT-1402 to potentially pivotal study initiations
Significant progress in advancing lead asset IMVT-1402 to potentially pivotal study initiations across broad development portfolio 7 Five INDs cleared across a range of therapeutic areas and FDA divisions, including GD (Endocrinology) and RA (Rheumatology) On track to initiate an exciting portfolio
Slide 8: Graves' Disease First-in-class Potential
Graves’ Disease First-in-class Potential 8
Slide 9: 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 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 on
Slide 10: Graves' Disease Phase study design tests two doses of batoclimab
10 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 11: Deeper IgG reduction at 24 weeks 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) 11 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 12: Improvements in proptosis and lid aperture with batoclimab
680mg QW 340mg QW 12 We observed meaningful improvements in proptosis and lid aperture in Graves’ Disease patients treated with batoclimab Note: Excludes one patient discontinuation at Week 12 (N=24) and two patient discontinuations at Week 24 (N=23) given no data available for these patients at the
Slide 13: ATD-free responders reported more pronounced quality of life improvements
13 ATD-free responders reported more pronounced improvements to quality of life, with ~90% experiencing normal quality of life by Week 24 Notes: ThyPRO-39: Thyroid-Related Patient-Reported Outcome; 1) Includes N=14 patients who were not ATD-free responders at Week 24; 2) Patients represented if sele
Slide 14: Real-world chart review of 1,000+ patient records from 140 endocrinologists
14 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 Real World C
Slide 15: First pivotal trial for IMVT-1402 in Graves' Disease
15 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 16: IMVT-1402 is potentially best and first-in-class in Graves' Disease
16 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
Slide 17: Difficult-to-Treat Rheumatoid Arthritis Best-in-Class Potential
Difficult-to-Treat Rheumatoid Arthritis Best-in-Class Potential 17
Slide 18: KOL Discussion
KOL Discussion 18 Pete Salzmann, MD Chief Executive Officer, Immunovant Peter Taylor, MA, PhD, FRCP, FRCPE University of Oxford
Slide 19: A subset of RA patients do not respond well to available therapies
Despite tremendous progress in the treatment of rheumatoid arthritis (RA), a subset of patients do not respond well to available therapies 191. Aletaha D, Smolen JS. JAMA. 2018;320(13):1360. DMARDs: disease-modifying antirheumatic drugs Key Takeaways1 • RA is a chronic, progressive disease that caus
Slide 20: Anti-FcRn mechanism may lower pathogenic IgG autoantibodies and immune complexes
Anti-FcRn mechanism may lower pathogenic IgG autoantibodies and immune complexes In addition to cellular autoimmunity and cytokine dysregulation, autoantibodies also play a role in the pathophysiology of RA Rheumatoid factor (RF) and ACPA autoantibodies are present in ~75% of RA patients1 1. Okada e
Slide 21: Pathophysiologic relevance of ACPA autoantibodies in rheumatoid arthritis
Understanding the pathophysiologic relevance of ACPA autoantibodies in rheumatoid arthritis Antigen presenting cells (APCs) process and present citrullinated peptides to T cells T cells activate B cells to generate autoantibodies Immune complex formation upregulates pro-inflammatory cytokines
Slide 22: What is difficult-to-treat RA and why is innovation needed?
What is difficult-to-treat RA and why is innovation needed? 221. Roodenrijs NMT et al. Ann Rheum Dis 2018;1705 -09, 2. Nagy G, et al. Ann Rheum Dis 2021; 80: 31-35 EULAR: European League Against Rheumatism Collaborative Initiative; DMARD: disease-modifying antirheumatic drug; QoL: Quality of Life Ne
Slide 23: Publicly available nipocalimab data in RA showed deeper ACPA IgG reduction correlated with response
Publicly available nipocalimab data in RA demonstrated proof of mechanism and showed that deeper ACPA IgG reduction correlated with clinical response1 23 Percent Changes from Baseline at Trough in ACPA IgG Levels versus (A) DAS-28 CRP Remission and (B) ACR50 Response at Week 12 1. Pharmacodynamic ef
Slide 24: Subset of US RA patients progresses to D2T status and requires new options
Of the 1.5M US RA patients1, a subset progresses to D2T status in a relatively short period of time and requires new therapeutic options 1. Aletaha D, Smolen JS. JAMA. 2018;320(13):1360. 2. GlobalData Analysis and Forecast, 2023. 3. Okada et al. Ann Rheum Dis 2019;78; 446-453. 4. Murray K et al. Art
Slide 25: IMVT-1402 Path Forward in Difficult-to-Treat Rheumatoid Arthritis
IMVT-1402 Path Forward in Difficult-to-Treat Rheumatoid Arthritis 25
Slide 26: Pivotal study design in rheumatoid arthritis
Period 2: Blinded randomized withdrawal (12 wks) Period 1 : Open-label, active treatment lead-in (16 wks) Pivotal study design in rheumatoid arthritis Inclusion • CRP > upper limit of normal (ULN) • Active RA defined as ≥ 6/68 tender/painful joints (TJC), ≥ 6/66 swollen joints (SJC), and DAS28-CRP >
Slide 27: With pivotal program in RA, IMVT-1402 has potential best-in-class profile
With pivotal program in RA, IMVT-1402 has the potential to achieve a best-in-class profile for people with difficult-to-treat RA 271. Paudel ML. Rheumatology (Oxford) 2024: 318. 2. Taylor PC et al. “Efficacy and Safety of Nipocalimab in Patients with Moderate to Severe Active Rheumatoid Arthritis (R
Slide 28: Two opportunities for lead asset IMVT-1402
Two opportunities for lead asset IMVT-1402 to potentially transform the treatment paradigm for patients struggling to achieve success with existing therapies 28 01 02 03 04 Graves' Disease First-in-Class Potential Rheumatoid Arthritis Best-in-Class Potential Meaningful unmet need for subset of patie
Slide 29: Multiple near-term milestones for enhanced value creation
Jul 2025 Multiple near-term milestones for enhanced value creation 29 Jan 2025 TED: Topline results for both trials expected in 2H 2025 MG: Topline Phase 3 results, and CIDP: Initial Phase 2b period 1 data expected by March 31, 20252 Apr 2026 1. Indications #1 through #5 will be potentially registra