Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Health Sciences Acquisitions — SPAC Merger (November 2019)
44 slides from Immunovant's SPAC merger presentation, Nov 14, 2019
Slide 1: Corporate Overview November 2019
Corporate Overview November 2019
Slide 2: Forward-looking statements
This presentation has been prepared by Immunovant Sciences Ltd. (“we,” “us,” “our,” “Immunovant” or the “Company”) and contai ns forward - looking statements. In some cases, you can identify forward - looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expec t,
Slide 3: Transaction
Transaction
Slide 4: Immunovant and HSAC to merge
4 Immunovant and HSAC to merge • Immunovant Sciences Ltd. (“Immunovant”) and Health Sciences Acquisitions Corporation (“HSAC,” Nasdaq: HSAC) have entered into a definitive business combination agreement − Immunovant is a clinical - stage biopharmaceutical company focused on enabling normal lives for
Slide 5: At a glance: terms of transaction
At a glance: terms of transaction 5 Sources of funds HSAC Cash in Trust $115,341,558 Immunovant Shareholder Equity Rollover $395,000,000 Bridge Financing $35,000,000 Sponsor Promote $10,750,000 Total Sources $556,091,558 Uses of funds Equity Issued to Immunovant Shareholders (inclusive of bridge fin
Slide 6: Immunovant
Immunovant
Slide 7: Our vision: Normal lives for patients with autoimmune diseases
7 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
Slide 8: Immunovant Leadership
8 Immunovant Leadership Management Team • Frank Torti , Immunovant Chairperson • Myrtle Potter • Andrew Fromkin Board of Directors • Douglas Hughes • George Migausky * • Atul Pande • Pete Salzmann *Current HSAC director; expected to remain on board post closing Sandeep Kulkarni, MD Chief Operating O
Slide 9: Program Highlights
9 IMVT - 1401: Program Highlights IMVT - 1401: A novel, fully human monoclonal antibody inhibiting FcRn • Early evidence suggests that anti - FcRn agents could transform the treatment of autoimmune diseases mediated by pathogenic IgG antibodies In Phase 1, IMVT - 1401 generated compelling pharmacody
Slide 10: Pipeline in a Product
10 IMVT - 1401: A Pipeline in a Product Target Indication Pre - clinical Phase 1 Phase 2 Phase 3 Status Myasthenia Gravis (MG) • Phase 2a open for enrollment Graves’ Ophthalmopathy (GO) • Phase 2a open for enrollment • Phase 2b open for enrollment Warm Autoimmune Hemolytic Anemia (WAIHA) • IND submi
Slide 11: Multiple anticipated near-term value inflection points
• Phase 2a open for enrollment − Top - line results of Phase 2a study expected in 1H 2020 • Pivotal Phase 3 study initiation expected in 2020 11 MG GO WAIHA • IND submission expected in 2H 2019 − Initial results of Phase 2a study expected in Q4 2020 Phase 2a open for enrollment − Initial results of
Slide 12: IMVT - 1401
IMVT - 1401
Slide 13: IgG antibodies implicated in certain autoimmune diseases
13 IgG antibodies implicated in certain autoimmune diseases • Antibodies play an important role in immune defense against pathogens 1 − Clearing bacteria, viruses, and other harmful organisms and substances − Eliciting an immune response that leads to inflammation • IgG antibody subclass accounts fo
Slide 14: Mechanism: FcRn inhibition promotes IgG degradation
• 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
Slide 15: Broad range of potential applications for anti-FcRn mechanism
Broad range of potential applications for anti - FcRn mechanism IgG - mediated autoimmune diseases where FcRn mechanism may be relevant: Note: List of diseases is illustrative only and does not necessarily represent our targeted indications 15 Guillain - Barré Syndrome Neuromyelitis Optica Warm Auto
Slide 16: Phase 1 SAD/MAD study design
Phase 1 SAD/MAD study design 16 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
Slide 17: Clinically meaningful IgG reductions in Phase 1 study
-100% -80% -60% -40% -20% 0% 20% 0 7 14 21 28 35 42 49 56 Nominal Day After First Dose Placebo 340 mg SC 680 mg SC IMVT - 1401 produced clinically meaningful IgG reductions in Phase 1 study Preliminary results from Phase 1 SAD/MAD cohorts 17 Mean total IgG reduction after single dose in healthy volu
Slide 18: Reduced levels of all four IgG subtypes
IMVT - 1401 reduced levels of all four IgG subtypes 18 Preliminary results from Phase 1 MAD cohorts IgG2 -100% -80% -60% -40% -20% 0% 20% 0 7 14 21 28 35 42 49 56 Nominal Day After First Dose IgG4 -100% -80% -60% -40% -20% 0% 20% 0 7 14 21 28 35 42 49 56 Nominal Day After First Dose IgG1 -100% -80%
Slide 19: 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 − Occurr
Slide 20: Adverse events reported in Phase 1
Adverse events reported in Phase 1 20 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
Slide 21: Given as a convenient SC injection
IMVT - 1401 has been given as a convenient SC injection 21 Intravenous Infusion Potentially Hours Subcutaneous Injection <10 seconds Subcutaneous Infusion 30 - 60 minutes
Slide 22: Designed from inception to be a potentially class-leading SC injection
22 IMVT - 1401 designed from inception to be a potentially class - leading SC injection 1. Ligand 2019 Analyst Day presentation, presented March 12, 2019 • Fully human monoclonal antibody • Generated from Ligand/OMT’s OmniAb transgenic rat platform − >400 antibody campaigns ongoing that use OmniAb t
Slide 23: Potential to deliver a class-leading profile
IMVT - 1401 has the potential to deliver a class - leading profile 23 IMVT - 1401 attribute Potential patient benefit Clinically meaningful IgG reductions • 680mg SC weekly: 78% reduction after four doses • 340mg SC weekly: 63% reduction after four doses SC injection • Fast and minimally invasive Si
Slide 24: Competitors' anti-FcRn programs with SC injection or infusion
IMVT - 1401 and competitors’ programs with subcutaneous (SC) injection or infusion 24 1. Argenx , corporate presentation, August 2018 2. Argenx , press release, issued June 14, 2018 3. Kiessling P. et al, The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: A randomized phase 1
Slide 25: for Myasthenia Gravis
IMVT - 1401 for Myasthenia Gravis
Slide 26: Myasthenia Gravis overview
Myasthenia Gravis overview 26 1. Meriggioli M.N. & Sanders D.B. Muscle autoantibodies in myasthenia gravis: beyond diagnosis? Expert Rev Clin Immunol, 2012 2. Sudulagunta S.R. et al. Refractory myasthenia gravis – clinical profile, comorbidities and response to rituximab. Ger Med Sci., 2016 • Rare a
Slide 27: Unmet need persists despite availability of treatment options
Unmet need persists despite availability of treatment options Current treatment paradigm 1 27 1 st Line • Acetylcholinesterase inhibitors • Corticosteroids 2 nd Line • Immunosuppressive agents • Thymectomy 3 rd Line • IVIg • Plasma exchange • Immunoadsorption • Rituximab (off - label) 4 th Line • Ec
Slide 28: ASCEND-MG: Phase 2a study design
28 ASCEND - MG: Phase 2a study design • Safety & tolerability • Change from baseline levels of anti - AChR antibodies, total IgG, and IgG by subclasses Primary Endpoints: • IMVT - 1401 pharmacokinetics • Change from baseline in QMG, MG - ADL, quality of life measures Secondary Endpoints: • Biomarker
Slide 29: for Graves' Ophthalmopathy
IMVT - 1401 for Graves’ Ophthalmopathy
Slide 30: Graves' Ophthalmopathy overview
Graves’ Ophthalmopathy overview Bahn, 2010 Figure 1. Patients with Graves’ Ophthalmopathy 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 with bilat
Slide 31: Anti-TSHR autoantibodies drive progression of GO and Graves' disease
Anti - TSHR autoantibodies drive progression of GO and Graves’ disease IMVT - 1401 could address GO and Graves’ disease caused by any IgG autoantibody, whether against TSHR or IGF - 1R • Thyroid - stimulating hormone receptor (TSHR) highly expressed on ocular fibroblasts and adipocytes 1 • Activatio
Slide 32: GO characterized by an active phase, followed by a static phase
GO characterized by an active phase, followed by a static phase 32 Rundle’s Curve describes natural history of disease 1 0 - 2 years (active phase) 2+ years (static phase) Intensity Severity Inflammation • Orbital tissue actively inflamed • Steroids and other immunosuppressive treatments can be effe
Slide 33: Limited treatment options for GO
Limited treatment options for GO Current treatment paradigm 1 33 1 st Line • Corticosteroids 2 nd Line • Orbital radiotherapy • Immunosuppressive agents 3 rd Line • Rituximab (off - label) Inactive disease • Orbital surgery Unmet need • Currently no FDA - approved therapies for GO • Corticosteroids
Slide 34: ASCEND-GO Phase 2 clinical program
34 ASCEND - GO Phase 2 clinical program • Phase 2a − Trial ongoing in Canada − Single arm, open label − N=8 − 6 weeks of dosing ▪ 680mg weekly x 2 doses ▪ 340mg weekly x 4 doses • Phase 2b − Trial ongoing in USA and Europe − Double masked, placebo controlled, randomized − N=77 − 3 drug arms vs place
Slide 35: ASCEND-GO 1: Phase 2a study design
ASCEND - GO 1: Phase 2a study design Screening Treatment Follow - up Key Inclusion Criteria: • Moderate - to - severe active GO • Clinical activity score (CAS) ≥4 • Anti - TSHR antibody positive 3 - 6 weeks 6 weeks 12 weeks IMVT - 1401 680mg/340mg SC N = 8 • Safety & tolerability • Change from basel
Slide 36: ASCEND-GO 2: Phase 2b study design
ASCEND - GO 2: Phase 2b study design Screening Key Inclusion Criteria: • Moderate - to - severe active GO • Clinical activity score (CAS) ≥4 • Anti - TSHR antibody positive 3 - 6 weeks Treatment 12 weeks IMVT - 1401 680mg SC N = 22 IMVT - 1401 340mg SC N = 22 IMVT - 1401 255mg SC N = 11 Placebo N =
Slide 37: for Warm Autoimmune Hemolytic Anemia
IMVT - 1401 for Warm Autoimmune Hemolytic Anemia
Slide 38: Warm Autoimmune Hemolytic Anemia overview
Warm Autoimmune Hemolytic Anemia overview 38 • Blood disorder marked by red blood cell destruction • Estimated prevalence of 42,000 patients in US and 66,000 patients in EU 1 • Presentation typically non - specific and occurs over several weeks to months • Fatigue, weakness, skin pallor, shortness o
Slide 39: Limited options for treating WAIHA
Limited options for treating WAIHA Current treatment paradigm 1,2 39 1 st Line • Corticosteroids • RBC transfusion 2 nd Line • Immunosuppressive agents 3 rd Line • Rituximab (off - label) 4 th Line • Splenectomy Unmet need • Currently no FDA - approved therapies for WAIHA • Only one - third of all p
Slide 40: 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 - in
Slide 41: Immunovant Recap
Immunovant Recap
Slide 42: Our vision: Normal lives for patients with autoimmune diseases
42 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 establishe
Slide 43: Multiple anticipated near-term value inflection points
• Phase 2a open for enrollment − Top - line results of Phase 2a study expected in 1H 2020 • Pivotal Phase 3 study initiation expected in 2020 43 MG GO WAIHA • IND submission expected in 2H 2019 − Initial results of Phase 2a study expected in Q4 2020 Phase 2a open for enrollment − Initial results of
Slide 44: Immunovant
Yf IMMUNOVANT
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