Slide 1: Targeted science, Tailored solutions for people with autoimmune disease
Targeted science, Tailored solutionsfor people with autoimmune disease Portfolio Update November 28, 2023
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 3 Love Trailblazing AllVoices Bolder, Faster What we do: We are developing targeted therapies that are designed to address the complex and variable needs of people with autoimmune diseases.
Slide 4: Goals for the Phase 1 Program
Achieve all of the above with a simple, commercially attractive subcutaneous injection Demonstrate minimal to no impact on LDL Demonstrate minimal to no impact on albumin 4 Goals for the Phase 1 Program Demonstrate potential best-in-class IgG reductions similar to batoclimab Note: Based on data to d
Slide 5: Best-in-Class Potential for IMVT-1402 – Why it Matters
5 Best-in-Class Potential for IMVT-1402 – Why it Matters FcRn inhibition is a proven mechanism with broad potential applicability based on targeted reduction of IgG as an improved and more targeted modality Evidence across broad range of auto-antibody conditions that deeper IgG reduction correlates
Slide 6: Multiple-Ascending Subcutaneous Doses
Multiple-Ascending Subcutaneous Doses(Once-weekly dosing x 4 weeks)
Slide 7: IMVT-1402 600mg MAD Data Consistent with 300mg MAD Data
IgG % change over time IMVT-1402 600mg MAD Data Consistent with 300mg MAD Data 7 Dose administration Albumin % change over time LDL % change over time
Slide 8: IMVT-1402 MAD Data Suggests Potential Best-in-Class IgG Reduction
IgG % change over time IMVT-1402 MAD Data Suggests Potential Best-in-Class IgG Reduction 8 Dose administration All IgG values starting with day 4 in the IMVT-1402 arm showed a significant decrease from baseline (all nominal p-values < 0.05) All IgG values starting with day 4 in the IMVT-1402 arm sho
Slide 9: IMVT-1402 MAD Data Suggests IgG Reduction Similar to Batoclimab
IMVT-1402 MAD Data Suggests Potential Best-in-Class IgG Reduction Similar to Batoclimab* 9 Dose administration *Data presented are from separate clinical trials, not a head-to-head study, conducted by Immunovant IgG % change over time
Slide 10: IMVT-1402 MAD Data: Minimal to No Albumin Reduction
Albumin % change over time IMVT-1402 MAD Data: Minimal to No Albumin Reduction, Similar to Placebo, After Four Weeks of Dosing 10 Dose administration Albumin value at Day 29 (peak pharmacodynamic impact) did not show a significant decrease from baseline (nominal p-values > 0.05) Albumin value at Day
Slide 11: IMVT-1402 MAD Data: Minimal to No LDL Increase
LDL % change over time IMVT-1402 MAD Data: Minimal to No LDL Increase, Similar to Placebo, After Four Weeks of Dosing 11 Dose administration LDL value at Day 29 (peak pharmacodynamic impact) did not show a significant increase from baseline (nominal p-values > 0.05) LDL value at Day 29 (peak pharmac
Slide 12: IMVT-1402 Showed a Favorable Safety Profile in Initial Phase 1 Data Set
12 SC SAD SC MAD Placebo 300mg 600mg Placebo 300mg 600mg N = 4 n (%) N = 6 n (%) N = 6 n (%) N = 4 n (%) N = 10 n (%) N = 10 n (%) Participants with at least one TEAE 3 (75) 4 (67) 5 (83) 4 (100) 7 (70) 6 (60) Participants with at least one TESAE 0 0 0 0 0 0 Participants discontinued study due to TE
Slide 13: IgG Reduction and Clinical Efficacy Correlation
IgG Reduction and Clinical Efficacy Correlation
Slide 14: Best-in-Class Potential for IMVT-1402 – Why it Matters
14 Best-in-Class Potential for IMVT-1402 – Why it Matters FcRn inhibition is a proven mechanism with broad potential applicability based on targeted reduction of IgG as an improved and more targeted modality Evidence across broad range of auto-antibody conditions that deeper IgG reduction correlates
Slide 15: Greater IgG Reduction Leads to Greater Efficacy Across Programs
Consistent Evidence Across Programs and Indications that Greater IgG Reduction Leads to Greater Efficacy* Company Evidence of Greater IgG Reductions Translating to Clinical Benefit MG TED ITP Patient-level scatter plot showed that greater IgG declines greater MG-ADL improvements Greater IgG reduct
Slide 16: Efgartigimod MG and PV Data Showed Higher Clinical Response with Deeper IgG Reduction
Efgartigimod MG and PV Data Showed Higher Clinical Response with Deeper IgG Reduction ADAPT Phase 3 trial of IV efgartigimod in MG showed a correlation between IgG reductions and clinical response 16 argenx phase 2 PV/PF publication, Br J Dermatol. 2022 Mar;186(3):429-439; * Estimated by WebPlotDigi
Slide 17: Nipocalimab MG and RA Data Showed Higher Clinical Response
Nipocalimab MG and RA Data Showed Higher Clinical Response with Deeper IgG Reduction Nipocalimab Phase 2 trial in MG showed a correlation between IgG reductions and clinical response 17 Nipocalimab Phase 2 trial in RA showed a correlation between auto-Ab reductions and clinical response Source: Phar
Slide 18: Batoclimab TED Data Showed Higher Clinical Response with Deeper IgG Reduction
Batoclimab TED Data Showed Higher Clinical Response with Deeper IgG Reduction 18 Deeper IgG reduction led to greater restoration of normal levels of pathogenic antibodies and greater proptosis response in Phase 2 trial in TED Placebo Batoclimab 255 mg Batoclimab 340 mg Batoclimab 680 mg Median Max %
Slide 19: Rozanolixizumab ITP Data Showed Higher Clinical Response
Rozanolixizumab ITP Data Showed Higher Clinical Response with Deeper IgG Reduction 19 In UCB’s Phase 2 trial in ITP, higher doses and greater IgG reductions were associated with better platelet responses Single Dose of Rozanolixizumab Data at Day 8 Estimated IgG Reduction Mean platelet count (x109/L
Slide 20: Portfolio Development for IMVT-1402
Portfolio Development for IMVT-1402
Slide 21: Best-in-Class Potential for IMVT-1402 – Why it Matters
21 Best-in-Class Potential for IMVT-1402 – Why it Matters FcRn inhibition is a proven mechanism with broad potential applicability based on targeted reduction of IgG as an improved and more targeted modality Evidence across broad range of auto-antibody conditions that deeper IgG reduction correlates
Slide 22: Creating the Best Portfolio of Indications for IMVT-1402
Creating the Best Portfolio of Indications for IMVT-1402 22 Potential to address multiple indications in an exciting class Guided by IgG biomarker in proven mechanism with well-characterized safety profile Addressable population Unmet patient need Competitive differentiation Technical success probab
Slide 23: 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 23 Best-in-Class Other underserved patient populations Potential to enhance PTS via focus on subset of patients with autoantibodies of interest and leverage 1402 potency Examples – Refractory rheumato
Slide 24: Graves' Disease and Rheumatoid Arthritis
Graves’ Disease Large unmet need between oral anti-thyroid medications (ATD) that work for many & definitive therapies that many others require Ablative 2L therapy (30K/yr in the US) carries radiation or surgical risks and commits the patient to lifelong thyroid replacement therapy Remaining euthyro
Slide 25: Concluding Thoughts
Concluding Thoughts + + ++ +++ + +++ + t+ + x t+ + ff imMunovant
Slide 26: IMVT-1402 Has Potentially Best-In-Class Attributes
Favorable Analyte Profile Initial Phase 1 data supports a favorable analyte profile with no or minimal effect on albumin and LDL * Not including any potential patent term extension 26 IMVT-1402 Has Potentially Best-In-Class Attributes to Address Large Unmet Need in Autoimmune Disease Novel, fully hu
Slide 27: Concluding Thoughts
Concluding Thoughts 27 The proven anti-FcRn class keeps getting more exciting IMIVT-1402’s profile and potency creates an exciting range of potential indications 2024 will be a big year for IMVT-1402 as we announce a broad portfolio of pivotal trials and POCs