Roivant Sciences Ltd. · NASDAQ:ROIV
Roivant Sciences — SPAC Merger (May 2021)
95 slides from Roivant Sciences's SPAC merger presentation, May 3, 2021
Slide 1: Roivant Overview May 2021
ROIVANT SCIENCES Roivant Overview May 2021
Slide 2: Disclaimer
This confidential investor presentation (this “Presentation”) was prepared by Montes Archimedes Acquisition Corp. (“SPAC”) an d Roivant Sciences Ltd. (the “Company”). This Presentation is for its intended audience and for informational purposes only, and is not intended for reproduction or a ny furt
Slide 3: Key Performance Indicators and Use of Projections
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 reflect the value realized directly f
Slide 4: Table of Contents
Table of Contents Company Transaction Summary 6 Montes Archimedes Investment Thesis Roivant Overview 9 Highlights Dermavant 23 Immunovant 37 Aruvant 51 ‘Small Molecule Discovery Engine 62 Appendix Financial Appendix 3 Technologies at Genevant 82 Lysovant 84 Kinevant 86 Affivant 89 Cytovant 1 Arbutus
Slide 5: Leadership: Vivek Ramaswamy and Matthew Gline
Vivek Ramaswamy Founder & Executive Chairman Mr. Ramaswamy graduated summa cum laude in Biology from Harvard University in 2007 and began his career as a successful biotech investor where he oversaw investments in numerous companies, including those that helped develop curative treatment regimens fo
Slide 6: Roivant definitive agreement to merge with Montes Archimedes
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 $2.3BN pro forma net cash balance1,2,3 The transaction will result in gross pro
Slide 7: Montes Archimedes investment thesis regarding Roivant
Longstanding relationship with Roivant management team Pattern recognition from experience with other successful biopharma platform companies (Mar’16 – Present) (Feb’04 – Jan’14) Ingredients for Success ManagementBusiness ModelImportant Medicines Investment thesis regarding Roivant: World-class team
Slide 8: Pipeline and platform with multi-billion dollar valuation comparables
Roivant has advanced pipeline and platform technology with multi-billion dollar valuation comparables ($ in billions) $13.41 $21.23 $9.93 $3.43 & $7.23 Comparables $1.73 $14.73 $6.54 $2.53 $2.03 $2.03 $1.43 $5.43 $2.93 All product candidates at the Vants are investigational and subject to regulatory
Slide 9: Our Mission, What We Do, How We Do It
OUR MISSIONImprove the delivery of healthcare to patients by treating every inefficiency as an opportunity WHAT WE DODevelop transformative medicines faster by building technologies and deploying talent in creative ways HOW WE DO ITLeverage the Roivant platform to launch Vants – nimble companies foc
Slide 10: Select Achievements Improving ROI on Pharma R&D
Select Achievements Improving ROI on Pharma R&D 8 positive Phase 3 trials of 9 total1 2 FDA approvals from Vants launched by Roivant and owned by Sumitovant1 $3BN upfront transaction with Sumitomo Dainippon Pharma (DSP) Multiple technology platforms powering Roivant programs while generating growing
Slide 11: Vant approvals and trial results
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, 11 the drugs noted above in current pipeline are investigational a
Slide 12: Development Pipeline
Development Pipeline TAPINAROF Psoriasis | Dermavant ► TAPINAROF Atopic Dermatitis | Dermavant ► CERDULATINIB Vitiligo | Dermavant ► IMVT-1401 Myasthenia Gravis | Immunovant ► IMVT-1401 Thyroid Eye Disease | Immunovant ► IMVT-1401 Warm Autoimmune Hemolytic Anemia | Immunovant ► ARU-1801 Sickle Cell
Slide 13: Tapinarof: value added by Roivant platform
Novel steroid-free topical tapinarof, if approved, could be uniquely positioned to transform two of the largest global immuno-dermatology markets Value Added by Roivant Platform Potential To Transform the Treatment of Psoriasis and Atopic Dermatitis Leveraged platform expertise to expand IP with mul
Slide 14: IMVT-1401 anti-FcRn antibody: value added by Roivant
Rapidly initiated multiple Phase 2 trials to develop anti-FcRn antibody IMVT-1401 as a best-in-class or first-in-class subcutaneous injection Value Added by Roivant Platform Peer Landscape Highlights Optionality1 Identified and licensed drug from HanAll Biopharma and expanded potential patient reach
Slide 15: ARU-1801 gene therapy for sickle cell disease
Only one-time potentially curative gene therapy for sickle cell disease with demonstrated ability to engraft with reduced intensity conditioning (RIC) Value Added by Roivant Platform Well-Positioned Against Competitors1 Longstanding Roivant relationship with CCHMC enabled initial asset license and s
Slide 16: The Vants
Immunovant DermavantAruvant Genevant Datavant VantAI SiTX New Vants from Internal Discovery Engine Lysovant Myovant Cytovant AlyvantLokavant New Vants from Additional In-Licensing Urovant Altavant Sumitovant (owned by DSP) KinevantAffivant Enzyvant Spirovant Sio Arbutus All trademarks are property o
Slide 17: Develop drugs at Vants
Develop drugs at Vants Identify drug targets and biological pathways Find assets externally and in-license Plan to in-license multiple potentially category-leading drugs per year Discover drugs internally and advance into the clinic Plan to submit multiple INDs for novel drug candidates each year, s
Slide 18: Discovery engine capabilities
Target Selection “Investment lens” for target identification, powered by computational tools and interdisciplinary team of R&D experts, investors and data scientists Degrader Expertise Novel ligands, multi-year partnership with premier academic lab and modality-specific medicinal chemistry expertise
Slide 19: Distinctive Roivant Advantage
Distinctive Roivant AdvantageSample Proprietary in silico Assays Woody Sherman, Chief Computational Scientist Internationally renowned pioneer in computational chemistry;13-year career as technical and scientific leader at Schrödinger before joining Silicon Therapeutics / Roivant Computational Physi
Slide 20: Discovery pipeline: target to IND-enabling
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 ► Undisclosed Additional Programs ► Degrader 20 Inhibitor
Slide 21: Integrated technologies underpin end-to-end biopharma platform
Roivant’s Integrated Technologies Underpin an End-to-End Biopharma Platform DiscoverDevelop Commercialize / Monetize & Computational platforms for de novo drug discovery and optimization 1 Enabling data-driven asset diligence, market landscaping, target identification, trial design, cost estimation,
Slide 22: Leadership Team Positioned to Execute
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 Vant
Slide 23: Dermavant
Dermavant
Slide 24: Building a leadership position in immuno-dermatology
Building a leadership position in immuno-dermatology Lead asset tapinarof, if approved, could be uniquely positioned to transform two of the largest global immuno-Todd Zavodnick CHIEF EXECUTIVE OFFICER Former CCO and President at Revance Therapeutics; global leadership positions at ZELTIQ and Galder
Slide 25: Tapinarof mechanism of action
Novel, once daily, cosmetically elegant, steroid-free therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream TAMA is designed to inhibit two pro-inflammatory pathways implicated in psoriasis and atopic dermatitis; AhR modulation by tapinarof also increases antioxidant activity a
Slide 26: Psoriasis and atopic dermatitis market projections
Psoriasis and atopic dermatitis markets projected to reach ~$25BN in the US and ~$37BN globally by 2026 2026 Other $7.9 2019 $27.7BN Globally Psoriasis Other $17.2 Atopic $54.2BN Globally Psoriasis $27.7 6%‘19-‘26 CAGR Atopic Dermatitis $2.9 $16.9 ‘19-‘26 CAGR 16% Dermatitis $9.3 US Sales US Sales P
Slide 27: Tapinarof potential first novel topical for plaque psoriasis
Tapinarof has the potential to be the first novel topical therapy approved by the FDA for plaque psoriasis in over 20 years Psoriasis Overview Tapinarof Positioning in Psoriasis Chronic, inflammatory disease with skin lesions characterized by red patches and plaques with silvery scales Affects an es
Slide 28: Pivotal trial design in psoriasis
Over 1,000 patients enrolled in two identically designed pivotal trials followed by long-term open-label extension study Double-blind Treatment (12 weeks) Long-term Open Label Extension† (40 weeks) Follow-Up (4 weeks) Patients with Plaque Psoriasis Aged 18–75 years old PGA score ≥2* ➢ BSA ≥3% – ≤20%
Slide 29: Primary endpoint achieved: PGA score
Primary Endpoint AchievedPGA Score of 0 or 1 and ≥2-Grade Improvement from Baseline at Week 12 (ITT, MI) In two replicate Phase 3 trials, PSOARING 1 and PSOARING 2, tapinarof demonstrated superior PGA response rates at week 12 as evidenced by statistically significant difference vs. vehicle (p<0.000
Slide 30: Key secondary endpoint: PASI75
Key Secondary Endpoint: PASI751 (ITT, MI) PASI75 at week 12 was statistically significantly higher in both tapinarof groups compared with vehicle groups (p<0.0001 and p<0.0001)1,2 36.1% and 47.6% of patients achieved PASI75 at week 12 with tapinarof 1% cream QD vs. 10.2% and 6.9% for vehicle The PAS
Slide 31: Favorable safety results
Favorable safety results observed with low rate of study discontinuation due to AEs AE profile consistent with previous studies Most common AEs (≥5%) were folliculitis, nasophyngitis, and contact dermatitis Low rate of study discontinuation due to AEs on tapinarof (5.6% in PSOARING 1 and 5.8% in PSO
Slide 32: Long-term open-label extension rollover
Over 90% of eligible patients who completed the pivotal trials elected to roll over into the long-term open-label extension trial Pivotal Trials1,2 Double-blind Treatment (12 weeks) Long-term Open-Label Extension3 (40 weeks) Follow-Up (4 weeks) Tapinarof 1% QD (Pivotal) (n=508) PGA=0 (n=78) PGA=0 Of
Slide 33: PSOARING 3 interim analysis
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 Treatment Effect 39.2% (299/763) of PSOARING 3 patients achieved complete disease clearance (PGA score=0) 57.3% (298/520) patients who entered the study
Slide 34: Tapinarof in atopic dermatitis
Tapinarof offers novel mechanism of action for atopic dermatitis market Atopic DermatitisUnmet Need In Atopic Dermatitis Chronic, inflammatory skin disease characterized by dry, itchy skin, with a complex pathophysiology involving genetic, immunologic and environmental factors Affects more than 9.6
Slide 35: Atopic dermatitis Phase 2 results
Percentage of patients achieving treatment success at week 12 was much higher than vehicle cream for both tapinarof concentrations, with a robust dose response 53% of patients who applied tapinarof cream 1% BID and 46% of those who applied it QD were considered a IGA Score 0 or 1 and ≥2-Grade Improv
Slide 36: Cerdulatinib for vitiligo
Cerdulatinib 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, with topline results expected in the first half of 2021 Multiple published reports
Slide 37: Immunovant
Immunovant
Slide 38: Enabling normal lives for patients with autoimmune diseases
Enabling normal lives for patients with autoimmune diseases Pete Salzmann, MD CHIEF EXECUTIVE OFFICER Former Global Development Leader in Immunology, Head of US Immunology, in addition to various other leadership roles at Eli Lilly Michael J. Elliot, PhD CHIEF SCIENTIFIC OFFICER Previously VP, Immun
Slide 39: Roivant 13D/A regarding Immunovant minority interest
On March 8, Roivant filed a 13D/A disclosing the following: 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
Slide 40: FcRn inhibition in multiple autoimmune diseases
FcRn inhibition lowers IgG levels, suggesting utility in multiple autoimmune diseases Illustrative list of autoimmune diseases driven by pathogenic IgG and their estimated prevalence (2019) MG WAIHA TED ITP PV 66,000 42,000 33,000 31,000 28,000 52,000 50,000 45,000 67,000 104,000 Initial Opportunity
Slide 41: FcRn and IgG mechanism
FcRn Prolongs the Half-Life of IgG2 Inhibiting FcRn Promotes IgG Degradation2 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 fr
Slide 42: IgG reductions in Phase 1 study
IMVT-1401 produced clinically meaningful and predicable IgG reductions in Phase 1 study Repeat Dosing at 680 mg Subcutaneous Resulted in a 78% IgG Reduction Without the Need for IV Induction Mean total IgG reduction after 4 weekly doses in healthy volunteers 20% 0% -20% -40% -60% -80% Placebo 340 mg
Slide 43: Phase 1 SAD/MAD safety results
Results from Phase 1 SAD/MAD Cohorts 99 subjects dosed in 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 incidence for drug a
Slide 44: Voluntary dosing pause due to cholesterol and LDL levels
Immunovant voluntarily paused dosing in ASCEND GO-2 and ASCEND-WAIHA trials of IMVT-1401 due to elevated total cholesterol and LDL levels In Immunovant’s ASCEND GO-2 trial, lipid parameters are assessed at baseline, at 12 weeks, and at week 20 following eight weeks off study drug. Based on prelimina
Slide 45: Myasthenia Gravis overview
Only subcutaneous anti-FcRn agent with results in Myasthenia Gravis Myasthenia Gravis Overview Rare autoimmune disorder affecting an estimated 66,000 people in the US1 Characterized by weakness of voluntary muscles including ocular, facial, oropharyngeal, limb, and respiratory muscles1 15-20% of MG
Slide 46: ASCEND MG topline results
ASCEND MG Topline Results Are Extremely Encouraging for Patients Suffering from Myasthenia Gravis Only subcutaneous anti-FcRn agent with results in Myasthenia Gravis MG-ADL: Myasthenia Gravis Activities of Daily Living; MGC: Myasthenia Gravis Composite. *MG-ADL deep responders defined as patients sh
Slide 47: Improvements in MG scales
Statistically significant and clinically meaningful improvements in MG scales 6.0 MG-ADLQMGMGC Point Change From Baseline Day 42 0.0 -3.0 -6.0 -9.0 -12.0 0.6 -3.8 * p = 0.029 -0.4 -3.9 p = 0.068 1.4 -8.0 ** PlaceboIMVT-1401 p = 0.006 Note: IMVT-1401 group represents pooled data from 10 patients rece
Slide 48: Thyroid Eye Disease overview
Only subcutaneous anti-FcRn therapy in clinical development for Thyroid Eye Disease (TED) Thyroid Eye Disease Overview TED is also called Graves’ ophthalmopathy (GO) 15,000-20,000 patients with active TED in the US per year Clinical features1: Eye bulging (“Proptosis”) Eye pain Double vision (“Diplo
Slide 49: ASCEND GO-1 results in Thyroid Eye Disease
ASCEND GO-1 Results Provide Positive Proof-of-Concept for IMVT-1401 in Thyroid Eye Disease Only subcutaneous anti-FcRn therapy in clinical development for Thyroid Eye Disease (TED) *Proptosis responders improved ≥ 2mm in study eye without significant deterioration in fellow eye. **CAS responders ach
Slide 50: IMVT-1401 for Warm Autoimmune Hemolytic Anemia
IMVT-1401 for Warm Autoimmune Hemolytic Anemia Warm Autoimmune Hemolytic Anemia (WAIHA) OverviewLimited Treatment Options Blood disorder marked by red blood cell destruction Estimated prevalence of 42,000 patients in the US and 66,000 patients in the EU1 Presentation typically non-specific and occur
Slide 51: Aruvant
Aruvant
Slide 52: Aruvant Overview
Aruvant Overview Developing transformative gene therapies for rare diseases Aruvant aims to deliver a potential cure for sickle cell disease Will Chou, MD (SCD) utilizing a more patient-friendly conditioning regimen CHIEF EXECUTIVE OFFICER Former Global Commercial Head of Kymriah, Novartis; Head Lym
Slide 53: Sickle Cell Disease is a devastating genetic disease
Sickle Cell Disease (SCD) is a Devastating Genetic Disease Caused by Abnormal Sickle Hemoglobin Sickle Cell Disease Leads to hemolysis and vaso-occlusive events (VOEs), where sickled red blood cells obstruct circulation, causing severe pain and ischemic tissue injury HbF is the Most Potent Anti-Sick
Slide 54: ARU-1801 unique attributes enable RIC
ARU-1801’s Unique Attributes Drive High Potency that Enables Use of RIC Proprietary G16D Modification Drives Higher HbF Payload Per Vector Copy in Preclinical Studies G16D mutation in γ-globin increases HbF formation HbFG16D Payload May Have a More Potent Clinical Anti-Sickling Effect Than Endogenou
Slide 55: Stemness enhancer in manufacturing process
CD34+ selection Stimulation Transduction Long-term engraftment Stemness enhancer: Promotes HSC self-renewal Inhibits differentiation For any given product VCN, higher chance of engraftment and long-term durability True HSC More true stem cells transduced / transplanted Without stemness enhancer, som
Slide 56: Reduced intensity conditioning vs busulfan regimens
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 Note: no head-to-head studies of these pr
Slide 57: Thoughts on bluebird bio MDS/AML announcement
Thoughts on bluebird bio MDS/AML Announcement SCD patients at increased risk for malignancy Population studies show SCD patients have a 1.5-11x increased risk for hematological malignancies1,2 Concomitant therapies, such as hydroxyurea, are associated with leukemogenesis3,4,5,6 and we believe may ex
Slide 58: MOMENTUM Phase 1/2 trial design
The MOMENTUM Study is a Phase 1/2 Trial of ARU-1801 Utilizing Reduced Intensity Conditioning (RIC) in Patients with Severe SCD Key Inclusion Criteria HbSS / HbSβ0 / HbSβ+ thalassemia 18-45 years of age Patients with severe SCD (frequent painful VOEs, 2 or more lifetime ACS, or one ACS requiring ICU
Slide 59: Durable engraftment and HbF levels
ARU-1801 Has Demonstrated Durable Engraftment Through 36 Months and Potentially Curative HbF Levels Greater than 30% with Refined Manufacturing Process II Data from first three patients to date Process I manufacturingProcess II manufacturing 50% Patient 1 50% Patient 2Patient 3 50% Hemoglobin (% of
Slide 60: VOE reductions in patients
Hospitalized VOEs Total VOEs Pre-treatment (24 mo) Post-treatment (24 mo) Reduction (%) Pre-treatment (24 mo) Post-treatment (24 mo) Reduction (%) Patient 1 7 1 86% 41 3 93% Patient 2 1 0 100% 20 3 85% Patient 3 6 0 at 10 mos 100% 12 0 at 10 mos 100% Process I Process II Process I has shown durable
Slide 61: CMC process improvements for commercial supply
CMC Process Improvements Scheduled For 2H 2021 to Prepare For Commercial Supply 1H 20212H 2021 1H 2022+ MOI, Method of induction; VCN, vector copy number. 61
Slide 62: Small Molecule Discovery Engine
Small Molecule Discovery Engine
Slide 63: Computationally powered drug discovery engine
Roivant’s Computationally Powered Drug Discovery Engine Internal discovery engine built from complementary expertise and differentiated through integrated feedback loop between computation and experimentation Target SelectionComputational Capabilities MedChem Expertise and Experimental Capabilities
Slide 64: Computational physics and machine learning platform
Platform Distinctively Combines Computational Physics and Machine Learning Capabilities COMPUTATIONAL PHYSICS How it WorksKey to Success Predicts how molecules will Higher likelihood of identifying novel binding pockets on previously MACHINE LEARNING interact by computationally modeling (based on qu
Slide 65: Distinctive Roivant Advantage
Distinctive Roivant AdvantageSample Proprietary in silico Assays Woody Sherman, Chief Computational Scientist Internationally renowned pioneer in computational chemistry;13-year career as technical and scientific leader at Schrödinger before joining Silicon Therapeutics / Roivant Computational Physi
Slide 66: Targeting difficult protein classes
Phosphatases (SHP2, PP2A) Non-druglike inhibitors due to charged, polar catalytic site Allosteric inhibitors and/or heterobifunctional degraders/glues Advanced simulations and integrated biophysics to identify novel, druggable allosteric sites; ML-based protein-protein interface modeling to design o
Slide 67: Discovery pipeline programs
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 ► Undisclosed Additional Programs ► Degrader 67 Inhibitor
Slide 68: References
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. Jelinic 2014; 14. Fernando 2020; 15. 68 Hasselblatt 2014; 16. Huang 2020; 17. Uras 2020; 18. Ghimessy 2019
Slide 69: References
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 2018; 14. Vannucchi 2008; 15. Gotlib 2010; 16.69 Kilpivaara 2009; 17. Kaplan 2012; 18. Lito 2014; 19. McCormick 201
Slide 70: Potential best-in-class AR degrader
Potential Best-in-Class AR Degrader Expected to Initiate Phase 1 in 2021 Orally-administered androgen receptor (AR) degrader with excellent drug-like properties, broad mutant coverage and potential to move upstream in prostate cancer treatment paradigm Lead Candidate (ARD-1671) Demonstrates Inhibiti
Slide 71: STAT3 degrader overview
STAT3 Overview STAT3, a transcription factor, has been implicated as a direct driver of multiple tumor types and contributes to an immune-suppressive tumor microenvironment (TME), suggesting an important role in immuno-oncology1-3 STAT3 Degrader Achieves Deep Responses in Xenograft Tumor Model (Leuk
Slide 72: KRAS computational physics edge
KRAS Simulate all waters Energy & atomic decompositions Rigorous binding predictions Computational Physics Edge Predictive Druggability Novel binding hotspots identified via advanced molecular dynamics simulations that capture protein flexibility, entropy, and water Atom-by-Atom Design Binding hotsp
Slide 73: Appendix
Appendix
Slide 74: Upcoming catalysts
Tapinarof NDA Filing in PsoriasisMid-2021 FDA Approval Decision on Tapinarof for PsoriasisMid-2022 Tapinarof Phase 3 Initiation in Atopic Dermatitis2H 2021 Resume IMVT-1401 Trials Across Multiple IndicationsTBD First Patient Dosed with ARU-1801 Manufacturing Process III2H 2021 Clinical Data from Add
Slide 75: Transaction Overview
Transaction Overview ($M, except share data) Pro Forma Ownership Pro forma shares outstanding (M)1 732.2 (x) Illustrative share price $10 Common equity value $7,322 (-) Pro forma net cash2 (2,322) Firm value $5,000 PIPE Investors %Sponsor Shares Silicon Therapeutics Shareholders 4.6% 1.0% Roivant Sh
Slide 76: Cash position and Vant ownership
All figures as of Dec. 31, 2020 except where otherwise noted Cash Position1$2,153M Consolidated $1,694M Centrally Funded2 Total Debt$166M3Pro Forma Cash Runway Mid-20244 Private Vant Ownership Vant % Basic Dermavant 100% Aruvant5 88% Targeted Protein Degradation Platform6 60% Genevant7 83% Lysovant
Slide 77: Sources and uses footnotes
All figures as of Dec. 31, 2020 except where otherwise noted Source: Company filings and estimates. Amounts may not add up due to rounding. 77 Estimated transaction fees and expenses for both SPAC and target including deferred underwriting fees, PIPE fee, financing fees and advisory, legal and other
Slide 78: Dermavant license agreement with Japan Tobacco
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 of78 certain milestones and royalties on sales. Excludes milestones due und
Slide 79: Transferred rights footnote
1. For lefamulin, transferred rights cover Greater China (Mainland China, Taiwan, HK, Macau); for vibegron, transferred rights cover Mainland China; for each of RVT-802 and rodatristat ethyl, transferred rights cover Greater China and 79 South Korea.
Slide 80: Closing consideration footnote
1. At closing, Roivant issued approximately 28.2M shares (pro forma for the Montes Archimedes business combination) and paid approximately $14.0M in cash, net of cash received. Additional shares and cash are expected to be issued80 and paid as certain holdbacks are released.
Slide 81: Growing technology capabilities across Roivant and Vants
Growing Technology Capabilities in Discovery, Development, and Commercialization Power Successful Outcomes Across Roivant and Vants 1 DrugOme is a computational ecosystem that enables fast, high-quality, and customized analyses to inform decision-making across the entire drug development continuum D
Slide 82: Genevant nucleic acid delivery company
Pete Lutwyche, PhD CHIEF EXECUTIVE OFFICER Former Chief Technology Officer at Arbutus Biopharma; Head of Pharmaceutical Development at QLT; 20+ years experience in development of LNP products Pete Zorn PRESIDENT AND CHIEF LEGAL OFFICER Former Chief Corporate Officer and General Counsel at Albireo Ph
Slide 83: LNP and ligand conjugate technologies
Lipid Nanoparticle (LNP) Ligand Conjugate 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 Validated furthe
Slide 84: Lysovant overview
Lysovant Overview Novel Endolysin for the Potential Treatment of Staph Aureus Bacteremia (SAB) and Infective Endocarditis (IE) LSVT-1701 is a novel bacteriophage-derived biologic candidate with potent, Novel Endolysin Mechanism of Action Compared to the Standard of Care Antibiotics Inhibition of pro
Slide 85: LSVT-1701 in vitro, in vivo and clinical data
In Vitro Data In Vivo Data Clinical Data Narrow and well-defined LSVT-1701 MIC range (MIC90 2 ug/ml) across a diverse collection of current clinical aureus isolates including MRSA, MSSA, vancomycin-intermediate S. aureus (VISA), and glycopeptide-intermediate S. aureus (GISA)1 Comparable MIC range fo
Slide 86: Kinevant namilumab program
Mid-stage program with a potentially fast path to market in an orphan indication 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 macrophag
Slide 87: Kiniksa and Humanigen expansion avenues
Kiniksa Multiple avenues for expansion across validated indications + white space indications Humanigen Sources: Company announcements; ClinicalTrials.gov.
Slide 88: GM-CSF as a target for pulmonary sarcoidosis
Multiple Data Points Converge on GM-CSF as a Target for Pulmonary Sarcoidosis Pulmonary Sarcoidosis Namilumab’s lead indication, pulmonary sarcoidosis, is an autoimmune disease characterized by the accumulation of granuloma nodules in the lungs Prevalence is 150-200K patients in the US alone1 20-30%
Slide 89: Bispecific antibodies and innate cell engagers
Bispecific Antibodies: A Novel Class that Directs the Immune System to Kill Tumors AC Tumor Associated Antigen (TAA) binding domain: Causes high affinity, high specificity binding to tumor surface Immune cell binding domain: Binds and activates specific immune cell subsets, resulting in tumor cell d
Slide 90: Affimed ROCK platform partnership
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, a preclinical ICE candidate
Slide 91: Cytovant cellular medicines for Asian patients
Differentiated cellular medicines designed to be uniquely suited to Asian patients Preclinical Phase 1 Phase 2 Phase 3 Next Key Milestone CVT-TCR-01 Oncologic Malignancies Initiation of CMC activities in 2H 2021 PRESIDENT Previously President and CSO of Mab-Legend Biotech; Former CSO of Shanghai Ben
Slide 92: CVT-TCR-01 NY-ESO-1 target
CVT-TCR-01 (NY-ESO-1): A Clinically Validated Initial Target with Potential Across Multiple Tumor Types NY-ESO-1 is Highly Prioritized in the Scientific Community for Translational Research Opportunities in Cancer1 NY-ESO-1 is Highly Expressed Across Many Fatal Cancers in Asia Promising Preclinical
Slide 93: Arbutus: cure for chronic Hepatitis B
Seeking to develop a cure for chronic Hepatitis B Virus (HBV) infection William H. Collier PRESIDENT AND CEO Previously President and General Manager, North America at ViiV Healthcare, where he led industry-leading launches of new treatments for HIV Michael J. Sofia, PhD CHIEF SCIENTIFIC OFFICER Co-
Slide 94: Sio Gene Therapies
Developing gene therapies to improve the lives of patients with neurodegenerative diseases Pavan Cheruvu, MD CHIEF EXECUTIVE OFFICER Former executive team member at Roivant; trained as a cardiologist; former strategy consultant at McKinsey & Co. Gavin Corcoran, MD CHIEF R&D OFFICER Former CMO of All
Slide 95: Roivant Sciences
ROIVANT SCIENCES