Immunovant, Inc. · NASDAQ:IMVT
Immunovant — Health Sciences Acquisitions — SPAC Merger (October 2019)
43 slides from Immunovant's SPAC merger presentation, Oct 2, 2019
Slide 1: Corporate Overview October 2019
Corporate Overview October 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) $4
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 Pete Salzmann, MD, MBA Chief Executive Officer Robert Zeldin, MD Chief Medical Officer Brad Middlekauff, JD General Counsel Sandeep Kulkarni, MD Chief Operating Officer • Frank Torti , MD, MBA Immunovant Chairperson, Vant Investment Chair, Roivant Pharma • Myr
Slide 9: Program Highlights: novel, fully human monoclonal antibody inhibiting FcRn
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: A 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: IMVT - 1401
IMVT - 1401
Slide 12: IgG antibodies implicated in certain autoimmune diseases
12 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 13: Mechanism shown to promote 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 14: 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 14 Guillain - Barré Syndrome Neuromyelitis Optica Warm Auto
Slide 15: Phase 1 SAD/MAD study design
Phase 1 SAD/MAD study design 15 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 16: 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 340mg SC 680mg SC IMVT - 1401 produced clinically meaningful IgG reductions in Phase 1 study Preliminary results from Phase 1 SAD/MAD cohorts 16 Mean total IgG reduction after single dose in healthy volunt
Slide 17: Reduced levels of all four IgG subtypes
IMVT - 1401 reduced levels of all four IgG subtypes 17 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 18: 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 19: Adverse events reported in Phase 1
Adverse events reported in Phase 1 19 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 20: Given as a convenient SC injection
IMVT - 1401 has been given as a convenient SC injection 20 Subcutaneous Injection <10 seconds Subcutaneous Infusion 30 - 60 minutes Intravenous Infusion Potentially Hours
Slide 21: Designed from inception to be a potentially class-leading SC injection
21 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 22: Potential to deliver a class-leading profile
IMVT - 1401 has the potential to deliver a class - leading profile 22 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 23: Competitors' programs with subcutaneous injection or infusion
IMVT - 1401 and competitors’ programs with subcutaneous (SC) injection or infusion 23 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 24: Myasthenia Gravis
IMVT - 1401 for Myasthenia Gravis
Slide 25: Myasthenia Gravis overview
Myasthenia Gravis overview 25 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 26: Unmet need persists despite availability of treatment options
Unmet need persists despite availability of treatment options Current treatment paradigm 1 26 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 27: ASCEND-MG: Phase 2a study design
27 ASCEND - MG: Phase 2a study design • Safety & tolerability • Change from baseline levels of anti - AChR antibodies, total IgG, and IgG by subclasses Primary Endpoint: • IMVT - 1401 pharmacokinetics • Change from baseline in QMG, MG - ADL, quality of life measures Secondary Endpoints: • Biomarkers
Slide 28: Graves' Ophthalmopathy
IMVT - 1401 for Graves’ Ophthalmopathy
Slide 29: 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 30: 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 31: GO characterized by an active phase, followed by a static phase
GO characterized by an active phase, followed by a static phase 31 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 32: Limited treatment options for GO
Limited treatment options for GO Current treatment paradigm 1 32 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 33: ASCEND-GO Phase 2 clinical program
33 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 34: 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 35: ASCEND-GO 2: Phase 2b study design
ASCEND - GO 2: Phase 2b 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 12 weeks 8 weeks IMVT - 1401 680mg SC N = 22 IMVT - 1401 340mg SC N = 22 IMVT - 1401 255mg SC
Slide 36: Warm Autoimmune Hemolytic Anemia
IMVT - 1401 for Warm Autoimmune Hemolytic Anemia
Slide 37: Warm Autoimmune Hemolytic Anemia overview
Warm Autoimmune Hemolytic Anemia overview 37 • 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 38: Limited options for treating WAIHA
Limited options for treating WAIHA Current treatment paradigm 1,2 38 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 39: ASCEND-WAIHA: Phase 2a study design
ASCEND - WAIHA: Phase 2 study design • Hemoglobin response rate* • Safety & Tolerability Primary Endpoint: • Change in hemoglobin, LDH, bilirubin, & haptoglobin • Time to response • QOL measures • PK/PD • Anti - drug antibody levels Secondary Endpoints: • Biomarkers (gene expression, serum pro - inf
Slide 40: Immunovant Recap
Immunovant Recap
Slide 41: Our vision: Normal lives for patients with autoimmune diseases
41 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 42: 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 42 MG GO WAIHA • IND submission expected in 2H 2019 Phase 2a open for enrollment − Initial results of Phase 2a study in Q1 2020 Phase 2b proof - of - concept
Slide 43: Immunovant
Vf IMMUNOVANT
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