Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Corporate Update (August 2020)
15 slides from Immunovant's corporate update, Aug 25, 2020
Slide 1: ASCEND MG Topline Results Conference Call
ASCEND MG Topline Results Conference Call August 25, 2020 Exhibit 99.2
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,” “expect,” “plan,” “anticipate
Slide 3: ASCEND MG topline results are extremely encouraging for patients with Myasthenia Gravis
ASCEND MG topline results are extremely encouraging for patients suffering from Myasthenia Gravis Only subcutaneous injection anti-FcRn agent in clinical development for MG Safety and tolerability findings similar to prior IMVT-1401 studies Robust, dose-dependent, IgG reductions Statistically signif
Slide 4: 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 5: 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 MGC, MG-ADL, QMG, quality of life measures Secondary Endpoints: Biomarkers (gene expression
Slide 6: ASCEND MG: Patient baseline characteristics
ASCEND MG: Patient baseline characteristics Note: SD = standard deviation Placebo (N=5) IMVT-1401 (N=10) Age, Mean + SD 39 + 17 64 + 20 Gender, % Male / % Female 20% / 80% 70% / 30% MGFA Disease Class at Screening, N (%) II III IVa 2 (40%) 3 (60%) 0 (0%) 3 (30%) 6 (60%) 1 (10%) Baseline QMG Score, M
Slide 7: Safety and tolerability findings similar to prior Phase 1 and 2 data
Safety and tolerability findings similar to prior Phase 1 and 2 data Placebo (N=5) IMVT-1401 (N=10) TEAEs reported by > 2 participants (all arms) Injection site erythema Muscle spasms Injection site swelling Headache Dizziness 1 2 1 1 0 2 1 1 1 2 Severe (Grade 3+) TEAEs 0 0 TEAEs resulting in withdr
Slide 8: Robust, dose-dependent, IgG reductions
Robust, dose-dependent, IgG reductions Weekly dosing at 340 mg or 680 mg resulted in mean IgG reductions from baseline of 59% and 76%, respectively, at Day 42 ASCEND MG topline results Note: Red arrows indicate weekly doses of IMVT-1401 at 340 mg or 680 mg. Error bars represent standard deviation of
Slide 9: Statistically significant and clinically meaningful improvements in MG-ADL
Statistically significant and clinically meaningful improvements in MG-ADL IMVT-1401 group represents pooled data from 10 patients receiving either 340 mg or 680 mg IMVT-1401 weekly. * Indicates ANCOVA p = 0.029. Error bars represent standard error of the mean. MG-ADL responders defined as patients
Slide 10: Overview of clinical efficacy measures utilized as endpoints in ASCEND MG
Overview of clinical efficacy measures utilized as endpoints in ASCEND MG Myasthenia Gravis Activities of Daily Living (MG-ADL): Patient-reported questionnaire Comprised of 8 items reflecting ocular, bulbar, respiratory, and limb symptoms and their impact on function Validated FDA regulatory endpoin
Slide 11: Statistically significant and clinically meaningful improvements in MG scales
Statistically significant and clinically meaningful improvements in MG scales Note: IMVT-1401 group represents pooled data from 10 patients receiving either 340 mg or 680 mg IMVT-1401 weekly. * Indicates ANCOVA p = 0.029. ** Indicates ANCOVA p = 0.006. ANCOVA for QMG p = 0.068 ASCEND MG topline resu
Slide 12: High rate of deep responders across MG scales
High rate of deep responders1 across MG scales MG-ADL and QMG deep responder threshold was > 6-point improvement from baseline, MGC threshold was > 10-point improvement from baseline. IMVT-1401 group represents pooled data from 10 patients receiving either 340 mg or 680 mg IMVT-1401 weekly. ASCEND M
Slide 13: ASCEND MG results are extremely encouraging for patients with Myasthenia Gravis
ASCEND MG topline results are extremely encouraging for patients suffering from Myasthenia Gravis Only subcutaneous anti-FcRn agent in clinical development for Myasthenia Gravis Positive clinical results after 6 weeks of treatment Observed to be safe and generally well-tolerated Subcutaneous injecti
Slide 14: IMVT-1401: A pipeline in a product
IMVT-1401: A pipeline in a product Target Indication 2H20 1H21 2H21 Anticipated Milestones Myasthenia Gravis (MG) Phase 3 initiation expected in 1H21 Thyroid Eye Disease (TED) Phase 2b results expected in 1H21 Warm Autoimmune Hemolytic Anemia (WAIHA) Phase 2a Cohort 1 results expected in 1Q21 Indica
Slide 15: Question and answer session
Question and answer session