Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Investor Presentation (June 2022)
14 slides from Immunovant's investor presentation, Jun 8, 2022
Slide 1: Phase 3 Development for Batoclimab in Thyroid Eye Disease
Phase 3 Development for Batoclimab in Thyroid Eye Disease Investor Presentation June 8, 2022
Slide 2: Forward-looking statements
Forward-looking statements 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 “may,” “might,” “will,” “would,” “should,” “expect,”
Slide 3: We have achieved alignment with the FDA to move forward in Thyroid Eye Disease
We have achieved alignment with the FDA to move forward in Thyroid Eye Disease (TED) as our second pivotal program with batoclimab TED represents a meaningful and unique opportunity – program designed to show a differentiated clinical benefit in an exciting indication Pivotal program to include two
Slide 4: Batoclimab's MOA is designed to foster the degradation of autoantibodies
Batoclimab’s MOA is designed to foster the degradation of autoantibodies, such as pathogenic IgG anti-TSHR autoantibodies Endothelial Cell Ocular orbit Thyroid In the absence of batoclimab, FcRn binds to the anti-TSHR autoantibodies, inhibiting their degradation and returning them into the circulati
Slide 5: Thyroid eye disease is a heterogeneous condition that presents with a variety of clinical symptoms
Thyroid eye disease is a heterogeneous condition that presents with a variety of clinical symptoms UNDERSTANDING TED: • Progressive disease marked by inflammation that can lead to fibrosis • Clinical features are variable, including but not limited to1: • Eye bulging (“proptosis”) • Swollen/red eyes
Slide 6: People with active TED prioritize different treatment goals
Not surprisingly for a heterogeneous disease, people with active TED prioritize different treatment goals Most Important Treatment Goals to be Addressed Potential to address Improves physical the multiple symptoms appearance, 2% associated with my TED, 10% Addresses the early signs of disease Improv
Slide 7: Unique dynamics of thyroid eye disease market make this a very favorable commercial opportunity
Unique dynamics of thyroid eye disease market make this a very favorable commercial opportunity for new mechanisms of action 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 reg
Slide 8: Many TED patients can benefit from a new therapy
Many TED patients can benefit from a new therapy A Total Addressable Population of 8K – 18K (US) 1/3 of the 15-20K US patients with active, moderate- to-severe TED annually have less severe disease that Moderate symptoms may benefit from batoclimab1,2 not yet treated with teprotumumab (5K-7K) 20%-35
Slide 9: Observed reductions in stimulatory anti-TSHR antibodies with batoclimab TED Phase 2b trial
Observed reductions in stimulatory anti-TSHR antibodies with batoclimab TED Phase 2b clinical trial Source: Data on File, 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 control, expressed as %. A value
Slide 10: Post-hoc analysis of proptosis response at week 6
Post-hoc analysis of proptosis response at week 61 50 40 Subjects, % 30 20 10 0 0 Batoclimab 680 Batoclimab 340 Batoclimab 255 Placebo mg mg mg n=16 n=14 n=17 n=9 Effect size similar at week 12 though confidence intervals wide 1 Proptosis response defined as proptosis reduction ≥2 mm in study eye, w
Slide 11: Total muscle volume at 12 weeks post-baseline
Total muscle volume at 12 weeks post-baseline in all subjects with baseline and end of treatment CT scans 10.0 5.0 Volume (cc), mean % change from baseline to 12 weeks 0 –5.0 post-baseline –10.0 –15.0 –20.0 –25.0 –30.0 –35.0 Batoclimab Batoclimab Batoclimab Placebo 680 mg 340 mg 255 mg n=3 n=3 n=3 n
Slide 12: TED Phase 3 clinical trial design – two studies to be run in parallel
TED Phase 3 clinical trial design – two studies to be run in parallel Inclusion Study 1 and 2: Active Treatment Phase Primary endpoint: proptosis responders at Placebo-controlled, Week 24 vs placebo where two dose regimens: responders defined as ≥ 2 Randomization (2:1) mm reduction from Follow up (4
Slide 13: Pursuing a broad development program with batoclimab
Pursuing a broad development program with batoclimab $494M1 in cash expected to fund Immunovant’s operating plans into calendar year 20252 Target Indication Phase 1 Phase 2 Phase 3 Anticipated Milestones Phase 3 initiation planned by end of June Myasthenia Gravis (MG) 2022; topline results expected
Slide 14: Thank you
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