Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Investor Presentation (March 2020)
38 slides from Immunovant's investor presentation, Mar 30, 2020
Slide 1: Corporate Overview April 2020
Corporate Overview April 2020 EXHIBIT 99.2
Slide 2: 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,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “
Slide 3: Immunovant
Immunovant
Slide 4: Our vision: Normal lives for patients with autoimmune diseases
Our vision: Normal lives for patients with autoimmune diseases Our asset: IMVT-1401, a novel, fully human monoclonal antibody inhibiting FcRn-mediated recycling of IgG Our strategy for IMVT-1401: Be best-in-class in target indications where anti-FcRn mechanism has already established clinical proof-
Slide 5: IMVT-1401: A pipeline in a product
IMVT-1401: A pipeline in a product Target Indication H1:20 H2:20 H1:21 Anticipated Milestones Myasthenia Gravis (MG) Phase 2a topline results expected in Q3 2020 Thyroid Eye Disease (TED) Phase 2b topline results expected in H1 2021 Warm Autoimmune Hemolytic Anemia (WAIHA) Phase 2a initial results e
Slide 6: Attractive market in autoimmune diseases mediated by excess IgG
Attractive market in autoimmune diseases mediated by excess IgG Inhibiting FcRn lowers IgG levels, suggestive of utility in these autoimmune disorders Note: List of diseases is illustrative only and does not represent our targeted indications (for more information, see Immunovant’s most recent Quart
Slide 7: IMVT-1401
IMVT-1401
Slide 8: IgG antibodies implicated in certain autoimmune diseases
IgG antibodies implicated in certain autoimmune diseases Antibodies play an important role in immune defense against pathogens1 Clearing bacteria, viruses, and other harmful organisms and substances Eliciting an immune response that leads to inflammation IgG antibody subclass accounts for ~75% of an
Slide 9: FcRn intercepts IgG, which would otherwise be degraded in lysosomes
FcRn intercepts IgG, which would otherwise be degraded in lysosomes The FcRn–IgG complex is then recycled to the cell surface and free IgG is released back into circulation IMVT-1401 binds to FcRn, thereby preventing it from recycling IgG antibodies back to circulation As a result, IgG is increasing
Slide 10: Phase 1 SAD/MAD study design
Phase 1 SAD/MAD study design Single Ascending Dose SC Single Ascending Dose IV Multiple Ascending Dose SC 0.5 mg/kg N = 3:0 1.5 mg/kg N = 6:2 5.0 mg/kg N = 6:2 Fixed 340 mg N = 6:2 Fixed 500 mg N = 6:2 Fixed 765 mg N = 6:2 Fixed 100 mg N = 6:2 Fixed 340 mg N = 6:2 Fixed 765 mg N = 6:2 Fixed 1530 mg
Slide 11: IMVT-1401 produced clinically meaningful IgG reductions in Phase 1 study
IMVT-1401 produced clinically meaningful IgG reductions in Phase 1 study Preliminary results from Phase 1 SAD/MAD cohorts Mean total IgG reduction after single dose in healthy volunteers Mean total IgG reduction after 4 weekly doses in healthy volunteers Single-dose administration produced dose-depe
Slide 12: IMVT-1401 reduced levels of all four IgG subtypes
IMVT-1401 reduced levels of all four IgG subtypes Preliminary results from Phase 1 MAD cohorts IgG2 IgG4 IgG1 Percent Serum IgG Reduction from Baseline IgG3 Percent Serum IgG Reduction from Baseline
Slide 13: Generally well-tolerated in Phase 1 study
Generally well-tolerated in Phase 1 study 99 subjects dosed to date through SAD and MAD portions of Phase 1 IMVT-1401: 77 subjects Placebo: 22 subjects Most common AEs were mild erythema and swelling at injection site Injection site reactions were not dose or frequency related Occurred at similar in
Slide 14: Adverse events reported in Phase 1
Adverse events reported in Phase 1 Single-Ascending Dose Multiple-Ascending Dose Intravenous Infusion Subcutaneous Injection Subcutaneous Injection 0.1 mg/kg 100 mg 340 mg 765 mg 1530 mg Placebo 0.5 mg/kg 1.5 mg/kg 5 mg/kg 340 mg 500 mg 765 mg Placebo 340 mg 680 mg Placebo n=4 n=6 n=6 n=6 n=6 n=8 n=
Slide 15: IMVT-1401 has been given as a SC injection
IMVT-1401 has been given as a SC injection Intravenous Infusion Potentially Hours Subcutaneous Injection <10 seconds Subcutaneous Infusion 30-60 minutes
Slide 16: IMVT-1401 designed from inception to be a potentially class-leading SC injection
IMVT-1401 designed from inception to be a potentially class-leading SC injection Ligand 2019 Analyst Day presentation, presented March 12, 2019 IMVT-1401 Fully human monoclonal antibody Generated from Ligand/OMT’s OmniAb transgenic rat platform >400 antibody campaigns ongoing that use OmniAb technol
Slide 17: IMVT-1401 has the potential to deliver a class-leading profile
IMVT-1401 has the potential to deliver a class-leading profile IMVT-1401 attribute Potential patient benefit Clinically meaningful IgG reductions 680 mg SC weekly: 78% reduction after four doses 340 mg SC weekly: 63% reduction after four doses SC injection Fast and minimally invasive Simple dosing s
Slide 18: IMVT-1401 for Thyroid Eye Disease
IMVT-1401 for Thyroid Eye Disease
Slide 19: Thyroid Eye Disease (TED): the clinical features
Thyroid Eye Disease (TED): the clinical features Bahn, 2010 Figure 1. Patients with Thyroid Eye Disease Panel A shows a 59-year-old woman with excess proptosis, moderate eyelid edema, and erythema with moderate eyelid retraction affecting all four eyelids. Conjunctival chemosis (edema) and erythema
Slide 20: Thyroid Eye Disease characterized by an active phase, followed by a static phase
Thyroid Eye Disease characterized by an active phase, followed by a static phase Rundle’s Curve describes natural history of disease1 0-2 years (active phase) 2+ years (static phase) Intensity Severity Inflammation Orbital tissue actively inflamed Steroids and other immunosuppressive treatments can
Slide 21: Limited treatment options for Thyroid Eye Disease
Limited treatment options for Thyroid Eye Disease Current treatment paradigm1 1st Line Corticosteroids 2nd Line Orbital radiotherapy Immunosuppressive agents 3rd Line Rituximab2 Inactive disease Orbital surgery Unmet need Only one approved therapy for Thyroid Eye Disease (Tepezza) Corticosteroids ar
Slide 22: Clinical program includes a lower dose proof of concept study and a multi-dose randomized trial
Clinical program includes a lower dose proof of concept study and a multi-dose randomized trial Phase 2a Trial ongoing in Canada Subcutaneous dosing Single arm, open label N=7* 6 weeks of dosing 680 mg weekly x 2 doses 340 mg weekly x 4 doses *Planned 8th patient enrolled in ASCEND GO-2 instead of A
Slide 23: ASCEND GO-1: the first proof of concept study of an anti-FcRn in TED
ASCEND GO-1: the first proof of concept study of an anti-FcRn in Thyroid Eye Disease Screening Treatment Follow-up Key Inclusion Criteria: Moderate-to-severe active TED Clinical activity score (CAS) ≥4 Anti-TSHR antibody positive 3-6 weeks 6 weeks 12 weeks IMVT-1401 680 mg/ 340 mg SC N = 7 Safety &
Slide 24: Three clinical measures of disease activity used to measure response in trials
Three clinical measures of disease activity used to measure response in trials Source: Bartalena, et al. Eur Thyroid J 2016; 5: 9–26. Chemosis: Swelling of conjunctiva, which is the mucous membrane that covers the front of the eye and lines the inside of the eyelids. Caruncle: Small, pink, globular
Slide 25: ASCEND GO-1: Patient baseline characteristics
ASCEND GO-1: Patient baseline characteristics Note: SD = standard deviation. Proptosis values are for study eye. Variable Mean + SD (N =7) CAS (0-7) 5.0 + 1.0 Proptosis (mm) 23.1 + 3.3 Diplopia (1-4) 2.3 + 0.8 IgG (g/L) 11.3 + 1.7 Albumin (g/L) 48.3 + 3.7
Slide 26: ASCEND GO-1: Summary clinical observations
ASCEND GO-1: Summary clinical observations Clinical Activity Score (CAS): 4/7 patients (57%) improved by > 2 points 3/7 patients (43%) were CAS responders (achieved a 0 or 1 score) Proptosis: 3/7 patients (43%) were proptosis responders Responders met standard criteria > 2mm improvement study eye wi
Slide 27: ASCEND GO-1: Labs, safety, and tolerability were in-line with Phase 1 data
ASCEND GO-1: Labs, safety, and tolerability were in-line with Phase 1 data Total IgG: Average reduction of 65% from baseline to end of treatment Pharmacodynamic curves as expected Safety and tolerability: No SAEs No withdrawals due to AEs All AEs were mild or moderate No headaches reported Albumin:
Slide 28: ASCEND GO-1 results provide positive proof-of-concept for IMVT-1401 in TED
ASCEND GO-1 results provide positive proof-of-concept for IMVT-1401 in Thyroid Eye Disease Only subcutaneous therapy in clinical development for Thyroid Eye Disease (TED) Positive clinical results after 6 weeks of treatment Observed to be safe and generally well-tolerated Subcutaneous injection No s
Slide 29: ASCEND GO-2: Phase 2b study design
ASCEND GO-2: Phase 2b study design Screening Key Inclusion Criteria: Moderate-to-severe active TED Clinical activity score (CAS) ≥4 Anti-TSHR antibody positive 3-6 weeks Treatment 12 weeks IMVT-1401 680 mg SC N = 22 IMVT-1401 340 mg SC N = 22 IMVT-1401 255 mg SC N = 11 Placebo N = 22 Follow-up 8 wee
Slide 30: IMVT-1401 for Myasthenia Gravis
IMVT-1401 for Myasthenia Gravis
Slide 31: Myasthenia Gravis overview
Myasthenia Gravis overview Meriggioli M.N. and Sanders D.B. Muscle autoantibodies in myasthenia gravis: beyond diagnosis? Expert Review Clinical Immunology, 2012 Sudulagunta S.R., et al. Refractory myasthenia gravis – clinical profile, comorbidities and response to rituximab. German Medical Science,
Slide 32: Unmet need persists despite availability of treatment options
Unmet need persists despite availability of treatment options Current treatment paradigm1 1st Line Acetylcholinesterase inhibitors Corticosteroids 2nd Line Immunosuppressive agents Thymectomy 3rd Line IVIg Plasma exchange Immunoadsorption Rituximab1 4th Line Eculizumab Unmet need ~10% of MG patients
Slide 33: ASCEND MG: Phase 2a study design
ASCEND MG: Phase 2a study design Safety & tolerability Change from baseline levels of anti-AChR antibodies, total IgG, and IgG by subclass Primary Endpoints: IMVT-1401 pharmacokinetics Change from baseline in QMG, MG-ADL, quality of life measures Secondary Endpoints: Biomarkers (gene expression, ser
Slide 34: IMVT-1401 for Warm Autoimmune Hemolytic Anemia
IMVT-1401 for Warm Autoimmune Hemolytic Anemia
Slide 35: Warm Autoimmune Hemolytic Anemia overview
Warm Autoimmune Hemolytic Anemia overview Blood disorder marked by red blood cell destruction Estimated prevalence of 42,000 patients in US and 66,000 patients in EU1 Presentation typically non-specific and occurs over several weeks to months Fatigue, weakness, skin pallor, shortness of breath Sever
Slide 36: Limited options for treating WAIHA
Limited options for treating WAIHA Current treatment paradigm1,2 1st Line Corticosteroids RBC transfusion 2nd Line Immunosuppressive agents 3rd Line Rituximab3 4th Line Splenectomy Unmet need Currently no FDA-approved therapies for WAIHA Only one-third of all patients maintain sustained disease cont
Slide 37: ASCEND WAIHA: Phase 2a study design
ASCEND WAIHA: Phase 2 study design Hemoglobin response rate* Safety & tolerability Primary Endpoints: Change in hemoglobin, LDH, bilirubin, & haptoglobin Time to response QOL measures PK/PD Anti-drug antibody levels Secondary Endpoints: Biomarkers (gene expression, serum pro-inflammatory markers, re
Slide 38: Immunovant
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