Slide 1: Roivant Overview June 2021
ROIVANT SCIENCES Roivant Overview June 2021
Slide 2: Statement of Limitations (1/2)
Statement of Limitations (1/2) This investor presentation (this “Presentation”) was prepared by Montes Archimedes Acquisition Corp. (“SPAC”) and Roivant Sciences Ltd. (the “Company”) in connection with the proposed transactions (the “Business Combination”) contemplated by the Business Combination Ag
Slide 3: Statement of Limitations (2/2)
Statement of Limitations (2/2) 3 Key Performance Indicators This Presentation includes certain key performance indicators (“KPIs”). Management regularly reviews these and other KPIs to assess the Company’s operating results. Realized return on our investments in Vants and technology sold to DSP refl
Slide 4: Table of Contents
Table of Contents 4 Company Transaction Summary 6 Montes Archimedes Investment Thesis 7 Roivant Overview 9 Highlights Dermavant 23 Immunovant 39 Aruvant 53 Small Molecule Discovery Engine 69 Proteovant 81 Appendix Financial Appendix 88 Technologies 98 Genevant 99 Lysovant 101 Kinevant 105 Affivant 1
Slide 5: Introductions
5 Introductions Mr. Momtazee is currently the Managing Partner of Patient Square Capital and has over 24 years of investment and acquisition experience. Prior to Patient Square Capital and Montes Archimedes Acquisition Corp, Mr. Momtazee spent over 21 years at KKR & Co., where he helped form the hea
Slide 6: Transaction Overview
Transaction Overview 6 • Roivant has entered into a definitive agreement to merge with Montes Archimedes Acquisition Corp. (MAAC) • All-primary transaction values the pro forma Company at an enterprise value of $5.0BN, and the Company would have a $2.3BN pro forma net cash balance1,2,3 • The transac
Slide 7: Montes Archimedes Investment Thesis
Montes Archimedes Investment Thesis • Longstanding relationship with Roivant management team • Pattern recognition from experience with other successful biopharma platform companies 7 Management Business Model Important Medicines Ingredients for Success • Investment thesis regarding Roivant: • World
Slide 8: Roivant has advanced pipeline and platform technology with multi-billion dollar valuation comparables
Roivant has advanced pipeline and platform technology with multi-billion dollar valuation comparables 8 Significant Potential Value in Roivant Platform Comparables & $13.41 $5.22 ($ in billions) $1.33 $2.13 $3.63 $2.23 $1.63 $4.93 $3.03 $14.33 $20.63 $6.54 $9.03 $2.43 $7.33 All product candidates at
Slide 9: Roivant: Redefining Big Pharma
Roivant: Redefining “Big Pharma” OUR MISSION Improve the delivery of healthcare to patients by treating every inefficiency as an opportunity WHAT WE DO Develop transformative medicines faster by building technologies and deploying talent in creative ways HOW WE DO IT Leverage the Roivant platform to
Slide 10: What Have We Done?
What Have We Done? 10 Cited figures and associated investment multiples are Key Performance Indicators. Please refer to the information included on Slide 3 with respect to our KPIs. 1. Vant summary statistics include Arbutus, Datavant, and Sio, in which Roivant has a non-controlling interest, and va
Slide 11: Consecutive Positive Phase Studies
8 Consecutive Positive Phase 3 Studies 11 Note: On Dec. 18, 2020, the FDA approved relugolix for the treatment of adult patients with advanced prostate cancer. On Dec. 23, 2020, the FDA approved vibegron for the treatment of adult patients with overactive bladder. Otherwise, the drugs noted above in
Slide 12: Development Pipeline
RNA Therapy Gene Therapy Cell Therapy Topical Biologic Small Molecule Preclin Phase 1 Phase 2 Phase 3 Note: All drugs in current pipeline are investigational and subject to health authority approval. Development Pipeline Modality TAPINAROF Psoriasis | Dermavant ► TAPINAROF Atopic Dermatitis | Dermav
Slide 13: Potential To Transform the Treatment of Psoriasis and Atopic Dermatitis
• Leveraged platform expertise to expand IP with multiple patents expected to provide protection until at least 2036 • Hired leadership and provided investment that together delivered Phase 3 success Value Added by Roivant Platform Psoriasis Phase 3: Statistically significant improvement in PGA scor
Slide 14: Well-Positioned Against Competitors
Well-Positioned Against Competitors1 • Longstanding Roivant relationship with CCHMC enabled initial asset license and strong academic-industry partnership • Manufacturing process improvements have enabled increased hemoglobin F expression and vaso-occlusive event (VOE) reduction Value Added by Roiva
Slide 15: Rapidly initiated multiple Phase trials for IMVT-1401
Rapidly initiated multiple Phase 2 trials to develop anti-FcRn antibody IMVT-1401 as a best-in-class or first-in-class subcutaneous injection 15 Note: All drugs in current pipeline are investigational and subject to health authority approval. All trademarks are property of their respective owners. ꝉ
Slide 16: Vant Model Enables Rapid Scaling
16 All trademarks are property of their respective owners. Altavant, Enzyvant, Myovant, Spirovant, and Urovant were transferred to Sumitovant, a wholly-owned subsidiary of Sumitomo Dainippon Pharma, in December 2019. Vant Model Enables Rapid Scaling
Slide 17: The Roivant Model for Drug Discovery and Development
The Roivant Model for Drug Discovery and Development Find assets externally and in-license Discover drugs internally and advance into the clinic Plan to in-license multiple potentially category-leading drugs per year Develop drugs at Vants Identify drug targets and biological pathways Plan to submit
Slide 18: Roivant Approach to Drug Discovery
18 Roivant Approach to Drug Discovery Leader in Computational Drug Discovery Unique combination of computational physics and machine learning based platforms for in silico design of small molecules Leader in Degrader Discovery Initial pipeline of degraders for targets spanning oncology, immunology a
Slide 19: Leading Computational Discovery Capabilities
Leading Computational Discovery Capabilities 19 Distinctive Roivant Advantage Sample Proprietary in silico Assays Peer to Schrödinger’s FEP+ for speed and accuracy of binding free energy calculations Simulations powered by proprietary supercomputing cluster and restrained by experimental biophysics
Slide 20: Computational Discovery and Degrader Pipeline
Computational Discovery and Degrader Pipeline 20 Target Discovery Lead Optimization IND-Enabling AR ► STAT3 ► BRD4 ► CBP/P300 ► SHP2 ► SMARCA2/4 ► KRASG12D ► WRN ► JAK2-617F ► CRAF ► HIF2A ► ADAR1 ► Undisclosed Additional Programs ► mHTT ► Undisclosed Additional Programs ► STING ► NLRP3 ► Undisclose
Slide 21: Integrated Technologies Underpin an End-to-End Biopharma Platform
21 1. Roivant retains a license to DrugOme, which is owned by DSP and managed by Sumitovant. Roivant’s Integrated Technologies Underpin an End-to-End Biopharma Platform Commercialize / Monetize Discover Develop Optimizing trial operations through real-time trial data analysis Connecting patient-leve
Slide 22: Leadership Team Positioned to Execute on Our Vision
22 Leadership Team Positioned to Execute on Our Vision Vivek Ramaswamy Founder & Executive Chairman Matthew Gline Chief Executive Officer Eric Venker, MD, PharmD Chief Operating Officer Roger Sidhu, MD Head of R&D & Chief Medical Officer Mayukh Sukhatme, MD Chief Investment Officer Frank Torti, MD V
Slide 23: Dermavant
Dermavant
Slide 24: Dermavant Overview
Building a leadership position in immuno-dermatology Dermavant Overview Former CCO and President at Revance Therapeutics; global leadership positions at ZELTIQ and Galderma Todd Zavodnick CHIEF EXECUTIVE OFFICER Preclinical Phase 1 Phase 2 Phase 3 Next Key Milestone TAPINAROF Psoriasis FDA approval
Slide 25: Tapinarof mechanism of action
Decreased inflammation in psoriasis Decreased oxidative stress Skin barrier restoration Decreased inflammation in atopic dermatitis Th17 cytokines*†‡1 Antioxidant activity via Nrf2 pathway*†1-3 Filaggrin, loricrin, and involucrin*1,2 Th2 cytokines*‡4,5 Novel, once daily, cosmetically elegant, steroi
Slide 26: Tapinarof Targets Two of the Largest Markets in Immuno-Dermatology
Psoriasis and atopic dermatitis markets projected to reach ~$25BN in the US and ~$37BN globally by 2026 26 Evaluate Pharma Data: Global Psoriasis and Atopic Dermatitis Prescription Drugs Market and Forecast 2019 – 2026 (excluding Skin Cancer); Psoriasis Indication Profile, USA Market Analysis; Atopi
Slide 27: Plaque psoriasis disease overview
• Chronic, inflammatory disease with skin lesions characterized by red patches and plaques with silvery scales • Affects an estimated 8M people in the US1 • Approximately 80% of US patients have mild to moderate disease2 • Continual and long-term treatment with topical corticosteroids, the most comm
Slide 28: Tapinarof Market Opportunity in Psoriasis
Potential for co-prescription with tapinarof 28 Source: 1. Symphony PrescriberSource May 2018 – October 2020. Market Notes: 1. Market includes Derm Only TRxs for all product groupings. 2. Symphony PrescriberSource includes projected mail service data Market Definition Notes: 1. TCS: Applied 7.5% fac
Slide 29: Phase 3 PSOARING Program – Study Design
Over 1,000 patients enrolled in two identically designed pivotal trials followed by long-term open- label extension study 29 *Patients with PGA of 2 (mild) and PGA of 4 (severe) limited to ~10% each of the total randomized population; ~80% of the total randomized population with PGA of 3 (moderate);
Slide 30: Phase 3 PSOARING Program – Primary Efficacy Results
30 PGA and PASI are global efficacy assessments. Example of one representative target lesion of one tapinarof treated patient from the PSOARING 1 clinical trial. PASI, Psoriasis Area and Severity Index; ITT, intention-to-treat; MI, multiple imputation; SEM, standard error of mean; QD, once daily. 1.
Slide 31: Phase 3 PSOARING Program – Key Secondary Efficacy Results
31 PGA, Physician Global Assessment; ITT, intention-to-treat; MI, multiple imputation; SEM, standard error of mean; QD, once daily. 1. Proportion of subjects with ≥75% improvement in psoriasis area and severity index (PASI) from baseline. 2. P-value based upon Cochran-Mantel-Haenszel analysis strati
Slide 32: Phase 3 PSOARING Safety Profile
Favorable safety results observed with low rate of study discontinuation due to AEs 32 AE, adverse event; TEAE, treatment emergent adverse event; AESI, adverse event of special interest; SAE, severe adverse event. Phase 3 PSOARING Safety Profile ➢ AE profile consistent with previous studies • Most c
Slide 33: Phase 3 PSOARING Extension – Study Design
Over 90% of eligible patients who completed the pivotal trials elected to roll over into the long-term open-label extension trial 33 Note: 4 patients had a missing PGA at baseline. BSA, body surface area; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; QD, once daily. 1. C
Slide 34: Phase 3 PSOARING Extension – Summary Interim Results
Pre-specified interim analysis contains all data from all patients (n=763) as of the cutoff date and includes data over the 44-week study duration 34 1. Proportion of subjects with ≥75% improvement in psoriasis area and severity index (PASI) from baseline. 2. Proportion of subjects with ≥90% improve
Slide 35: Unmet Need In Atopic Dermatitis
Atopic Dermatitis Unmet Need In Atopic Dermatitis 35 1. National Eczema Association 2. Asthma and Allergy Foundation of America. 3. Eichenfield, LF. Guidelines of care for the management of atopic dermatitis.” 4. Coondoo, A. et al. “Side-effects of topical steroids: A long overdue revisit.” Indian D
Slide 36: Tapinarof Market Opportunity in Atopic Dermatitis
36 Source: 1. Symphony PrescriberSource May 2018 – October 2020. Market Notes: 1. Symphony PrescriberSource includes projected mail service data Market Definition Notes: 1. TCS: Applied 39% factor on TCS volume, derived from IQVIA NDTI (Diagnosis Codes: 691801, 691802, 691803, 691804, 692901, 692902
Slide 37: Phase 2b Tapinarof Atopic Dermatitis Trial
37 *Difference vs. vehicle cream is statistically significant at p=0.05 level (the 95% confidence interval excludes 0). NRI analysis to account for higher dropout rates in vehicle group. BID, twice daily; IGA, Investigator Global Assessment; ITT, intention to treat; NRI, non-responder imputation; QD
Slide 38: Promising Earlier-Stage Pipeline
38 Promising Earlier-Stage Pipeline • Novel topical dual JAK and Syk inhibitor being developed as a potential treatment option for vitiligo and other inflammatory skin conditions such as atopic dermatitis • Vitiligo Phase 2a initiated in 2019; topline results met the primary endpoints of safety and
Slide 39: Immunovant
Immunovant
Slide 40: Immunovant Overview
Enabling normal lives for patients with autoimmune diseases 40 Immunovant Overview Preclinical Phase 1 Phase 2 Phase 3 Next Key Milestone IMVT-1401 Myasthenia Gravis Phase 3 initiation expected in late 2021 or early 2022 IMVT-1401 Warm Autoimmune Hemolytic Anemia Phase 2a restart in late 2021 or ear
Slide 41: Potential Immunovant minority interest transaction
• Roivant intends to propose to Immunovant that Roivant and Immunovant evaluate a potential transaction pursuant to which Roivant or an affiliate would acquire the minority interest in Immunovant • Roivant expects that any potential transaction would be at a per share price representing a premium to
Slide 42: Attractive Market in Autoimmune Diseases Mediated by Excess IgG
FcRn inhibition lowers IgG levels, suggesting utility in multiple autoimmune diseases 42 Note: List of diseases is illustrative only and does not represent our targeted indications (for more information, see Immunovant’s most recent Annual Report on Form 10-K filed with the SEC on June 1, 2021). MG:
Slide 43: IMVT-1401 Promotes IgG Degradation
43 1. Collins J. and Jones L, et al. IMVT-1401 (RVT-1401), A Novel Anti-FcRn Monoclonal Antibody, Was Well Treated in Healthy Subjects and Reduced Serum IgG Following Subcutaneous or Intravenous Administration. Presented at American Academy of Neurology Annual Conference., 2019. Program #P5.2-079. 2
Slide 44: ASCEND GO-2 lipid parameters
• In Immunovant’s ASCEND GO-2 trial, lipid parameters were assessed at baseline, at 12 weeks, and at week 20 following eight weeks off study drug • Based on preliminary, unblinded data, median LDL cholesterol at week 12: •Increased by approximately 12 mg/dL in the 255 mg dose group (corresponding to
Slide 45: Favorable Trade-Off in IgG Reductions vs. LDL/Albumin
255 mg dose results in modest changes to LDL & albumin, with potent knockdown in IgG 45 Note: Data in figure from ASCEND GO-2 trial of IMVT-1401 in Thyroid Eye Disease Dashed horizontal line represents the lower limit of normal albumin Data Suggest Favorable Trade-Off in IgG Reductions vs. LDL/Album
Slide 46: HCP Feedback Consistently Suggests LDL Impact is Manageable
46 1. Immunoglobulin Source: HCP survey, n=16 (March 2021). Immunovant 8-K filed June 1, 2021 HCP Feedback Consistently Suggests LDL Impact is Manageable The likelihood to prescribe a hypothetical anti-FcRn without an LDL impact and with an LDL impact of 30% is similar. This applies across a broad r
Slide 47: LDL Was Controlled in Patients who Entered on Statins
47 1. Data presented based on exploratory analyses performed on stored samples 2. Week 6-12 timepoints; each subject shown at the point of maximal duration of blinded treatment period for IMVT-1401 LDL Was Controlled in Patients who Entered on Statins (a Post-Hoc Analysis) • Across a variety of dose
Slide 48: IMVT-1401 for Myasthenia Gravis
Only subcutaneous anti-FcRn agent with results in Myasthenia Gravis 48 1. Meriggioli M.N. and Sanders D.B. Muscle autoantibodies in myasthenia gravis: beyond diagnosis? Expert Review Clinical Immunology, 2012. 2. Sudulagunta S.R., et al. Refractory myasthenia gravis – clinical profile, comorbidities
Slide 49: IMVT-1401 for Warm Autoimmune Hemolytic Anemia
49 1. Immunovant 10-K filed June 1, 2021. 2. Roumier M., et al. Characteristics and outcome of warm autoimmune hemolytic anemia in adults: new insights based on a single-center experience with 60 patients. American Journal of Hematology, 2014. 3. Salama A. Treatment Options for Primary Autoimmune He
Slide 50: Early Data in WAIHA Trial Demonstrate Promise of IMVT-1401
Our outlook on IMVT-1401 efficacy and potential of FcRn class has improved 50 Note: All data from ASCEND WAIHA, a Phase 2 trial of IMVT-1401 in Warm Autoimmune Hemolytic Anemia. Early Data in WAIHA Trial Demonstrate Promise of IMVT-1401 8 9 10 11 12 13 14 0 2 4 6 8 10 12 14 Hemoglobin (g/dL) Week He
Slide 51: IMVT-1401 for Thyroid Eye Disease
Only subcutaneous anti-FcRn therapy in clinical development for Thyroid Eye Disease (TED) 51 1. Davies T. and Burch H.B. Clinical features and diagnosis of Graves' orbitopathy (ophthalmopathy), UpToDate, 2018. 2. McAlinden C. An overview of thyroid eye disease. Eye and Vision, 2014. 3. Bartalena L.,
Slide 52: ASCEND GO-2 Summary
• We observed declines in total IgG and in Thyroid Stimulating Antibodies throughout treatment • Approximately 41 subjects reached the 13-week primary endpoint at the time of study termination vs. 77 planned. The study was therefore significantly underpowered to demonstrate efficacy • We observed ch
Slide 53: Aruvant
Aruvant
Slide 54: Aruvant Overview
Developing transformative gene therapies for rare diseases Aruvant Overview • ARU-1801 uses a self-inactivating lentiviral vector that contains a proprietary, patent protected γ-globin gene for a novel, highly potent variant of fetal hemoglobin (HbF): HbFG16D • ARU-1801’s high potency has allowed fo
Slide 55: Sickle Cell Disease is a Devastating Genetic Disease
Sickle Cell Disease (SCD) is a Devastating Genetic Disease Caused by Abnormal Sickle Hemoglobin • Leads to hemolysis and vaso-occlusive events (VOEs), where sickled red blood cells obstruct circulation, causing severe pain and ischemic tissue injury • Major complications include chronic hemolytic an
Slide 56: ARU-1801's Unique Attributes Drive High Potency that Enables Use of RIC
ARU-1801’s Unique Attributes Drive High Potency that Enables Use of RIC 56 1. ARU-1801 IND. 2. Am J Clin Pathol . 1981 Jun;75(6):843-6. 3. Biochimica et Biophysica Acta 1963 Dec; 78(4):637-643 4. J Biol Chem. 2004 Jun 25;279(26):27518-24. 5. J Clin Invest. 2017 Mar 1; 127(3): 750–760 Proprietary G16
Slide 57: Proprietary Stemness Enhancer Manufacturing Process
Our Cellular Manufacturing Process Leverages a Proprietary Stemness Enhancer to Facilitate Engraftment 57 Long-term engraftment Without stemness enhancer, some HSCs differentiate into progenitors True HSC CD34+ selection Transduction Stemness enhancer: • Promotes HSC self-renewal • Inhibits differen
Slide 58: Reduced intensity conditioning vs busulfan-based regimen
Reduced intensity conditioning (RIC) with melphalan 140mg/m2 may provide significant clinical benefit compared to the busulfan-based regimen used by the other leading SCD gene therapy candidates, including the potential for lower risk of secondary malignancy 58 Table reflects combination of gene the
Slide 59: Secondary malignancy risk with conditioning
59 Bluebird bio disclosed 2 recent cases of MDS / AML on 2/16/21 via press release. 1. Brunson et al. Blood 2017, 130:1597 2. Seminog et al. J R Soc Med 2016, 109:303 3. Kiladjian JJ, et al. Blood. 2008 Nov; 112(11):1746. 4. Nielsen I, et al. Am J Hematol. 2003 Sep;74(1):26-31. 5. Björkholm M, et al
Slide 60: The MOMENTUM Study Phase 1/2 Trial of ARU-1801
The MOMENTUM Study is a Phase 1/2 Trial of ARU-1801 Utilizing Reduced Intensity Conditioning (RIC) in Patients with Severe SCD 60 ACS, acute chest syndrome; PBSC, peripheral blood stem cell. • HbSS / HbSβ0 / HbSβ+ thalassemia • 18-45 years of age • Patients with severe SCD (≥2 VOEs per year, or ≥2 l
Slide 61: ARU-1801 Durable Engraftment Through 36 Months
Data from first three patients to date 61 ARU-1801 Has Demonstrated Durable Engraftment Through 36 Months and Potentially Curative HbF Levels Greater than 30% with Refined Manufacturing Process II ASGCT 2019 Oral Abstract Session 123, Abstract 50, Monday 29 April 2019 by Dr. Punam Malik. Aruvant dat
Slide 62: Durable, Meaningful VOE Reductions in Patients with SCD
62 VCN, vector copy number. Data Demonstrate Potential to Deliver Durable, Meaningful VOE Reductions to Patients with SCD Process I Process II • Process I has shown durable engraftment to 36+ months in Patients 1 and 2 • Process II has shown improved product profile with Patient 3 showing highest VC
Slide 63: CMC Process Improvements For Commercial Supply
63 MOI, Method of induction; VCN, vector copy number. CMC Process Improvements Scheduled For 2H 2021 to Prepare For Commercial Supply Phase 1/2 Phase 3 Process I Process II Process III Commercial G16D mutation ✓ ✓ ✓ ✓ Stemness enhancer ✓ ✓ ✓ ✓ Optimized peripheral apheresis ✓ ✓ ✓ Optimized MOI ✓ ✓ ✓
Slide 64: ARU-1801 Key Market Assumptions
64 *Limiting trial inclusion/exclusion criteria are similar across SCD gene therapy trials (eg BLUE, CRSP, etc.) and include restriction of genotype (HbSS, HbSβ0, HbSβ+), threshold frequency of severe VOEs (≥4 in prior 24 months), and exclusion of pts with severe cerebral vasculopathy ARU-1801 Key M
Slide 65: ARU-2801 for Hypophosphatasia
ARU-2801 is an adeno-associated virus gene therapy designed to treat hypophosphatasia, a devastating, ultra-orphan disorder that affects multiple organ systems and leads to high mortality 65 All drugs are investigational and subject to health authority approval. ERT: enzyme replacement therapy. SOC:
Slide 66: Hypophosphatasia is a Devastating Orphan Disorder
HPP is caused by mutation in the ALPL gene and is characterized by low or no expression of tissue non-specific alkaline phosphatase (TNS-ALP) 66 Hypophosphatasia (HPP) is a Devastating and Potentially Fatal Orphan Disorder with No Gene Therapy Treatments Available All drugs are investigational and s
Slide 67: High Unmet Need with Strensiq that ARU-2801 Could Address
67 Chronic Administration, Injection Site Reactions, and Poor Durability of Strensiq Leave High Unmet Need that ARU-2801 Could Potentially Address • Frequent injection site reactions • Lipohypertrophy shown in 30% of patients, including 70% of juvenile-onset patients AEs at injection site • Up to 6x
Slide 68: ARU-2801 Durable High ALP Levels and Survival in HPP Murine Models
68 In HPP Murine Models, ARU-2801 Results in Durable, High Levels of ALP and Survival to 18 Months All drugs are investigational and subject to health authority approval. 1. Matsumoto T et alt Molecular Therapy Methods and Clinical Development 2021. High ALP levels in HPP murine model (Akp2-/-) Dura
Slide 69: Small Molecule Discovery Engine
Small Molecule Discovery Engine
Slide 70: Platform Combines Computational Physics and Machine Learning
Platform Distinctively Combines Computational Physics and Machine Learning Capabilities 70 Predicts how molecules will interact by computationally modeling (based on quantum physics) the forces and energies of the atomic and sub-atomic particles that comprise the molecular system Predicts how molecu
Slide 71: Machine Learning & Systems Biology Platform
71 Machine Learning & Systems Biology Platform Computational platform powers several core applications In Silico ADMET Task-specific models for ADMET properties that leverage the power of embeddings and transfer learning Ex. VantAI more accurately predicted solubility vs. traditional methods for ~10
Slide 72: Computationally Enabled Physics Platform
72 Computationally Enabled Physics Platform High-Performance Computing All-atom simulations at biologically meaningful timescales with cluster of >500 GPUs Research Infrastructure Rapidly iterate between experiments and computation to drive design cycle Integrated Biophysics Data Incorporate experim
Slide 73: Roivant Biophysics and Structural Biology Advantage
• Generated hundreds of protein samples using 3 expression systems (mammalian, insect, and bacterial) • Produced NMR-labeled ADAR1 and WRN protein Protein Science • Solved high-resolution crystal structures for challenging targets • KRASG12D • HIF2a • SMARCA2/VHL • Complementary to simulations X-ray
Slide 74: Improvements from Combining AI and Physics Approaches
74 Improvements from Combining AI and Physics Approaches 퐸 풓푁; 휁 = ⋯ (ζ) + 푖<푗 푞푖 ∙ 푞푗 풓푖 − 풓푗 + 푖 퐸DNN 풓푗 − 풓푖| ∀푗 s.t. 풓푗 − 풓푖 < 푟 푐 QM Force Field with AI Augmentation Post analysis Improved pKa Predictions QM Model QM+ML Model Acidic Basic Physics — captures key interactions such as hydrogen
Slide 75: Solved Crystal Structures for Challenging, High-Value Targets
Successfully Solved Crystal Structures for Challenging, High-Value Targets 75 Apo: unbound. Holo: bound. KRASG12D • Number of structures: 2 • Best resolution: 1.9 Å • Details • G12D mutant • Inhibitors bound to on/off forms • Structures within 1 month HIF2a SMARCA2/VHL • Number of structures: 3 • Be
Slide 76: Platform Unlocks New Opportunities To Drug High Value Targets
Roivant’s Platform Unlocks New Opportunities To Drug High Value Targets Note: The above are examples of potential applications for our existing platform technologies. Target Category Challenge Opportunity Roivant Edge Phosphatases (SHP2, PP2A) Non-druglike inhibitors due to charged, polar catalytic
Slide 77: Iterative approach beginning with fundamental physical process
We utilize an iterative approach that always begins with the fundamental physical process and where our methods can overcome inefficiencies and bottlenecks 77 Platform Models Key Steps of Degradation Process Solubility Permeability Binding Kinetics Binding Affinity Structure Dynamics Ubiquitination
Slide 78: Most Accurate Ternary Structure Prediction
78 Fully Integrated Binding Simulation with Hydrogen-Deuterium Exchange Data Most Accurate Ternary Structure Prediction Known Integration of experimental hydrogen-deuterium exchange (HDX) data offers unique advantage Final Statistics: • Warhead-interface RMSD = 0.4 Å • Ligand-interface RMSD = 0.65 Å
Slide 79: Small Molecule Discovery Pipeline Spans High-Value Targets
Small Molecule Discovery Pipeline Spans High-Value Targets Across Oncology, Neurology, and Immunology 79 1. Fujita 2019; 2. Brooke 2009; 3. Zou 2020; 4. Shahmarvand 2018; 5. Saenz 2017; 6. Reyes-Garau 2019; 7. Jin 2017; 8. Iyer 2004; 9. Zhang 2015; 10. Chen 2020; 11. Liu 2021; 12. Herpel 2017; 13. J
Slide 80: Small Molecule Discovery Pipeline, continued
Small Molecule Discovery Pipeline Spans High-Value Targets Across Oncology, Neurology, and Immunology, continued 80 1. Lakra 2019; 2. Ast 2018; 3. Elkon 2011; 4. Chin 2019; 5. Fremond 2020; 6. Shen 2018; 7. Li 2020; 8. Wang 2020; 9. Xu 2019; 10. Herbert 2019; 11. Lieb 2019; 12. Zimmer 2020; 13. Chan
Slide 81: Proteovant Overview
Integrating extensive medicinal chemistry intuition and biology insight with deep, proprietary artificial intelligence capabilities 81 Proteovant Overview 20+ years leading teams in accounting, finance, treasury, investor relations and other corporate operations functions. Previously CFO of Respivan
Slide 82: Proteovant's Degrader Discovery Approach
82 Proteovant’s Degrader Discovery Approach Mirrors Roivant’s Drug Discovery Philosophy Leader in Computational Drug Discovery Unique combination of computational physics and machine learning based platforms for in silico design of small molecules Leader in Degrader Discovery Initial pipeline of deg
Slide 83: Proteovant Will Lead, Not Follow
Proteovant is committed to becoming the leader in the discovery and development of novel protein degraders by integrating… 83 Proteovant Will Lead, Not Follow Deep Degrader Expertise Cutting Edge Cell Biology and Chemistry …to deliver treatments to patients with debilitating diseases where unmet med
Slide 84: Computational Discovery and Degrader Pipeline
Computational Discovery and Degrader Pipeline 84 Target Discovery Lead Optimization IND-Enabling AR ► STAT3 ► BRD4 ► CBP/P300 ► SHP2 ► SMARCA2/4 ► KRASG12D ► WRN ► JAK2-617F ► CRAF ► HIF2A ► ADAR1 ► Undisclosed Additional Programs ► mHTT ► Undisclosed Additional Programs ► STING ► NLRP3 ► Undisclose
Slide 85: Antitumor Activity in VCaP Xenograft Tumor Model
Antitumor Activity in VCaP Xenograft Tumor Model Orally-administered androgen receptor (AR) degrader with excellent drug-like properties, broad mutant coverage and potential to move upstream in prostate cancer treatment paradigm 85 1. National Cancer Institute SEER Cancer STAT Facts; 2. Aggarwal 201
Slide 86: Highly Potent STAT3 Degrader
86 1. Beebe 2018; 2. Yu 2009; 3. Lee 2019 Highly Potent STAT3 Degrader Has Potential Applications in STAT3-Driven Hematologic Malignancies and Immuno-Oncology STAT3 Degrader Achieves Deep Responses in Xenograft Tumor Model (Leukemia) with Activated STAT3 Pathway STAT3 Overview • STAT3, a transcripti
Slide 87: Proteovant Summary
• Broad pipeline of targeted protein degraders initially to over 10 targets • Well financed to advance key programs to the next level of value creation and lead degraders into clinical trials • World-class Proteovant team established to discover and develop targeted protein degraders and execute on
Slide 88: Appendix
Appendix
Slide 89: Key Near-Term Potential Catalysts
89 All catalyst timings are based on current expectations but may be subject to change. All trademarks are property of their respective owners. Key Near-Term Potential Catalysts Tapinarof NDA Filing in Psoriasis Mid-2021 FDA Approval Decision on Tapinarof for Psoriasis Mid-2022 Tapinarof Phase 3 Ini
Slide 90: Transaction Overview
Transaction Overview Source: Company filings and estimates. All figures are as of December 31, 2020 unless otherwise noted. 1. Assumes no share redemptions and excludes impact of warrants and 20% and 10% sponsor share earn-outs if stock price closes at or above $15 and $20, respectively, for 20 out
Slide 91: Roivant's Vant and Cash Holdings
All figures as of Dec. 31, 2020 except where otherwise noted 91 Roivant’s Vant and Cash Holdings Cash Position1 $2,153M Consolidated $1,694M Centrally Funded2 Total Debt $166M3 Pro Forma Cash Runway Mid-20244 1. Includes cash, cash equivalents, and restricted cash. Excludes $200 million investment f
Slide 92: Key Cash and Debt Items
Key Cash and Debt Items ($M) Notes Roivant consolidated cash $2,153 Includes cash, cash equivalents, and restricted cash (+) Expected net proceeds from MAAC business combination and PIPE 576 Assumes no redemptions and $55M expenses1 (-) Estimated SiTX cash payment (15) Subject to additional adjustme
Slide 93: Potential Milestone and Royalty Obligations for Selected Assets
93 1. Dermavant also entered into a collaboration and license agreement with Japan Tobacco Inc. (JT) for exclusive rights to develop, register and market Tapinarof in Japan. Dermavant is entitled to up to $53M upon the achievement of certain milestones and royalties on sales. 2. Excludes milestones
Slide 94: Datavant Merger Overview
94 Datavant Merger Overview Key Transaction Terms Structure • Datavant to merge with Ciox Health, with the combined entity to be named Datavant • The implied enterprise value of the combined company at the conversion price cap of the new preferred equity investment being made concurrently with closi
Slide 95: Dermavant Financing Overview
95 Dermavant Financing Overview Key Transaction Terms Structure • $160M revenue interest purchase and sale agreement with three institutional investors, and concurrent $40M senior secured credit facility with one of the institutional investors • Proceeds from the $40M credit facility have been used
Slide 96: Sumitomo Options Termination Overview
Key Transaction Terms Terms • Sumitomo terminated all of its outstanding options to acquire Roivant’s ownership interest in Vants • Sinovant transferred its Greater China rights to lefamulin, vibegron, rodatristat ethyl and RVT-802 to Sumitomo and its affiliates1 • In connection with the termination
Slide 97: Silicon Therapeutics Acquisition Key Terms
Key Transaction Terms Structure • Acquisition (via mergers) of 100% of the Silicon Therapeutics (SiTX) business other than certain rights and obligations related to its STING Agonist Phase 1 candidate Upfront Consideration • Aggregate consideration, payable to SiTX equity holders as follows: o Appro
Slide 98: Growing Technology Capabilities in Discovery, Development, and Commercialization
98 Growing Technology Capabilities in Discovery, Development, and Commercialization Power Successful Outcomes Across Roivant and Vants • DrugOme is a computational ecosystem that enables fast, high- quality, and customized analyses to inform decision-making across the entire drug development continu
Slide 99: Genevant Overview
Genevant Overview 99 Pete Zorn PRESIDENT AND CHIEF LEGAL OFFICER Former Chief Corporate Officer and General Counsel at Albireo Pharma; General Counsel and VP, Communications, Santaris Pharma; General Counsel and SVP, Targacept James Heyes, PhD CHIEF SCIENTIFIC OFFICER Former VP, Drug Delivery at Arb
Slide 100: Genevant Has Two World-Class Delivery Platforms
Genevant Has Two World-Class Delivery Platforms 100 • Proven, best-in-class technology • LNP technology used in FDA-approved RNA Tx (Alnylam’s Onpattro) • Clinically validated for hepatocyte and vaccine use; developing for other tissues and cell types, including lung, eye, stellate and immune cells
Slide 101: Lysovant Overview
Novel endolysin for the potential treatment of Staph aureus bacteremia that may address serious unmet medical need in the treatment of serious bacterial infections 101 Lysovant Overview Potential Treatment of Staph aureus Bacteremia (SAB) and Infective Endocarditis (IE) • LSVT-1701 is a novel bacter
Slide 102: Lysovant High Unmet Need
Clinically validated as a novel class of bacteria treatment 102 Lysovant Overview High Unmet Need • There are an estimated 226,000 patients with SAB and 50,000 with IE each year in the US1 • ~32% of SAB is complicated due to sepsis, comorbidities, or dialysis, and ~28% of SAB is refractory1 • Staph
Slide 103: Strong Value Proposition
• Rapid antibacterial activity: Potential rapid and highly effective lytic action • Species specificity: Anti-staphylococcal endolysins provide pathogen-targeted bacteriolysis and preserve normal flora • Low propensity for resistance: Target binding sites are highly conserved and essential to bacter
Slide 104: LSVT-1701 Significant Clinical Potential
LSVT-1701 has the potential to be the best-in-class treatment on top of standard of care for populations with high medical needs, such as those with complicated MRSA and MSSA bacteremia and left-sided infective endocarditis 104 Significant Clinical Potential All drugs are investigational and subject
Slide 105: Kinevant Overview: Namilumab
• Roivant is developing a fully human anti-GM-CSF monoclonal antibody, namilumab, with broad potential in autoimmune diseases • GM-CSF is a key pathogenic cytokine that acts as a pro- inflammatory signal, prompting macrophages and other activated immune cells to launch an immune cascade that ultimat
Slide 106: Namilumab First-in-Class Potential for Pulmonary Sarcoidosis
106 SQ = subcutaneous; IV = intravenous. Otilimab and mavrilimumab are being studied as IV formulations in their COVID-19 trials. All trademarks are property of their respective owners. Sources: Company announcements; ClinicalTrials.gov. Namilumab has First-in-Class Potential for Pulmonary Sarcoidos
Slide 107: Multiple Data Points Converge on GM-CSF as a Target for Pulmonary Sarcoidosis
107 1. Baughman 2016; 2. ATS Patient Education Series 2006; 3. Lemaire 1996; 4. Zhang 2013; 5. Dougan 2019; 6. Shi 2006; 7. Iannuzzi 2007; 8. Becher 2016; 9. Hamilton 2020 Multiple Data Points Converge on GM-CSF as a Target for Pulmonary Sarcoidosis Pulmonary Sarcoidosis • Namilumab’s lead indicatio
Slide 108: Namilumab for Pulmonary Sarcoidosis
108 1. Khan 2017; 2. Crommelin 2016; 3. Beegle 2013; 4. Key Opinion Leader Discussions; 5. HCP market research; 6. Hamilton 2020; 7. Kiniksa Announces Positive Data from Phase 2 Trial of Mavrilimumab in Giant Cell Arteritis 2020; 8. GSK Presents New Efficacy and Safety Data 12 of an Anti GM-CSF Anti
Slide 109: Affivant Overview
140 Y 140 H 140 Y Affivant Overview • Affimed’s Innate Cell Engagers (ICE) bind CD16A with a unique epitope • CD16A is sufficient to fully activate cell killing by NK cells and macrophages • Differentiated from platforms that can engage NK cells • Highly selective for CD16A • No dilution and sink ef
Slide 110: Recent ROCK Platform Validation
Early preclinical and clinical proof of concept for ROCK platform 110 All drugs are investigational and subject to health authority approval. Source: Affimed Press Releases, March 10, 2021, April 9, 2021 and April 12, 2021. Recent ROCK Platform Validation ICE Monotherapy • In March 2021, Affimed ann
Slide 111: Affimed Collaboration
111 Affimed Collaboration • Affimed’s ROCK platform technology generates diverse, tetravalent, bispecific antibodies known as innate cell engagers (ICE) which can be customized to target specific binding domains on hematologic and solid tumor cells • The partnership grants Roivant a license to AFM32
Slide 112: Cytovant Overview
Differentiated cellular medicines designed to be uniquely suited to Asian patients Cytovant Overview Preclinical Phase 1 Phase 2 Phase 3 Next Key Milestone CVT-TCR-01 Oncologic Malignancies Initiation of CMC activities in 2H 2021 Previously President and CSO of Mab- Legend Biotech; Former CSO of Sha
Slide 113: CVT-TCR-01 (NY-ESO-1) Clinically Validated Initial Target
CVT-TCR-01 (NY-ESO-1): A Clinically Validated Initial Target with Potential Across Multiple Tumor Types 113 1. Cheever MA et al. Clin Cancer Res 15:5323–5337 (2009); 2. Li Y et al. Exp Ther Med 13:3581-3585 (2017); 3. Grah JJ et al. Tumori 100:60-68 (2014); 4. Zhang Y et al. J Cancer Res Clin Oncol
Slide 114: Roivant Sciences
ROIVANT SCIENCES