Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (December 2021)
38 slides from Sun Pharma Advanced Research's investor presentation, Dec 28, 2021
Slide 1: Exchange filing cover letter: Investor Presentation
SPARC/Sec/SE/2021-22/079 December 28, 2021 National Stock Exchange of India Ltd., BSE Limited, Exchange Plaza, 5th Floor, Market Operations Dept. Plot No. C/1, G Block, P. J. Towers, Bandra Kurla Complex, Dalal Street, Bandra (East), Mumbai – 400 051. Mumbai - 400 001. Ref: Scrip Code: NSE: SPARC; B
Slide 2: Corporate Overview, December 2021
Corporate Overview December 2021 ©SPARC –For Discussion Purposes Only
Slide 3: Disclaimer
Disclaimer This presentation and its contents should not be distributed, published or reproduced, in whole or part, or disclosed by recipients directly or indirectly to any other person. Any failure to comply with these restrictions may constitute a violation of applicable laws. Accordingly, any per
Slide 4: SPARC timeline
SPARC timeline Built a robust R&D engine over 15 years Integrated translation advancing standard of care in difficult-to-treat diseases Incubated out of Sun Initial focus on Medicinal US FDA Approvals of Growing NCE pipeline Pharma, India’s largest Chemistry and Formulations Xelpros and Elepsia 3 mo
Slide 5: Investment highlights
Investment highlights 4 Clinical Stage Programs Targeting Areas of High Unmet Need Targeting large addressable patient populations with USD 20Bn+ combined peak sales potential in 6 indications within Oncology, Neurology, and Immunology Discovery & Development Across Validated & Novel Biology in Orde
Slide 6: Pipeline overview & key milestones
Pipeline overview & key milestones Phase 3/ Upcoming Asset / Program MoA Indication Discovery Preclinical Phase 1 Phase 2 Partner Registration Study Catalyst PoC data from Parkinson’s PROSEEK study Disease in 2023 Vodobatinib c-ABL Lewy Body PoC data in 2023 (SCC-138) Inhibitor Dementia1 Alzheimer’s
Slide 7: Vodobatinib for Neurodegenerative Diseases (SCC-138)
Vodobatinib for Neurodegenerative Diseases (SCC-138) A potential first-in-class disease modifying therapy
Slide 8: Vodobatinib for neurodegenerative diseases
Vodobatinib for neurodegenerative diseases Optimal agent to test the c-Abl hypothesis Mechanism of Action of c-Abl inhibition Vodobatinb is a potential first-in-class c-Abl inhibitor for Parkinson’s disease INACTIVE Augments autophagic flux and prevents inactivation of LYN Parkin-mediated mitochondr
Slide 9: Behavioral assessments in the PFF-induced mouse model
Behavioral assessments in the PFF- induced mouse model Vodobatinib at 45 mg/kg improves PFF-induced movement disorder- related deficits in Turning Time and Descending Time in the Pole test Turning Time in Pole Test Descending Time in Pole Test In the MPTP1 mouse model, 20 20 Vodobatinib prevents neu
Slide 10: Vodobatinib protects dopaminergic neurons in AAV rat model
Vodobatinib protects dopaminergic neurons in the AAV mutant α-synuclein (hA53T) rat model - dopamine transporter expression Specific Striatal 125IRTI-121 Binding (nCi/gtissue) 1.0 NS ** ** * NS 0.8 Vehicle 0.6 Vehicle 0.4 Vodobatinib 15mg/kg 0.2 Vodobatinib 30mg/kg Vodobatinib 45mg/kg 0 L R L R L R
Slide 11: Vodobatinib met the brain exposure targets in early clinical studies
Vodobatinib met the brain exposure targets in early clinical studies Summary of completed toxicology, safety pharmacology and clinical studies Preclinical toxicology update Safety Acute tox in mouse and rat by oral route, and Trial Population Status findings in rat by ip route Repeat dose oral tox i
Slide 12: Vodobatinib for Parkinson's Disease
Vodobatinib for Parkinson's Disease Recruitment on track to achieve Phase 2/PROSEEK enrollment target in 2022 PROSEEK Screening 84 sites across US, Europe and India functional; recruitment ongoing to Randomization complete enrollment in 2022 Over 40% patients randomized (N=218) Placebo Vodobatinib V
Slide 13: Opportunities beyond Parkinson's Disease
Opportunities beyond Parkinson’s Disease Dementia with Lewy Bodies offers an immediate next opportunity DLB is a neurodegenerative condition with progressive cognitive impairment, hallucinations and parkinsonism • Estimated to affect about 1.4 million people in the USA* • 2nd most common cause of de
Slide 14: Vibozilimod (SCD-044) - A Selective S1PR1 Agonist
Vibozilimod (SCD-044) - A Selective S1PR1 Agonist A safer alternative to JAK inhibitors
Slide 15: Vibozilimod (SCD-044)
Vibozilimod (SCD-044) An opportunity to improve oral standard of care in dermatology Vibozilimod is a Best-in-Class S1PR1 modulator with excellent safety S1PR1 Modulator Landscape Vibozilimod (SCD-044) Fingolimod is the First-in-Class S1PR agonist approved, but Developed in collaboration with a Fren
Slide 16: Pharmacodynamics and safety established in Phase 1 study
Vibozilimod (SCD-044) Pharmacodynamics and safety established in Phase 1 study Multi-part Phase 1 study completed in healthy volunteers Lymphocyte count reduction1 Single Ascending Dose % Change from Baseline Six dose levels in males and one dose level in females ~55% lymphocyte count decrease follo
Slide 17: Vibozilimod (SCD-044) for psoriasis
Vibozilimod (SCD-044) for psoriasis Clinical proof-of-concept by 2023 Screening 4 Part I:16 Part II:16-28 Part III:28-52 Follow-up Weeks Weeks Weeks Weeks Week 56 Vibozilimod Intermediate Dose Placebo Primary endpoint – Proportion of patients Vibozilimod < PASI75 with PASI75 response at High Dose re
Slide 18: Vibozilimod (SCD-044) for atopic dermatitis
Vibozilimod (SCD-044) for atopic dermatitis Clinical proof-of-concept by 2023 Screening 3 Part I:16 Part II:16-32 Follow-up Weeks Weeks Weeks 4 Weeks Primary endpoint – Vibozilimod Proportion of patients with Intermediate Dose EASI-75 response at week Placebo 16 Vibozilimod High Dose 240 patients ac
Slide 19: Anti TAA-1 Asset
Anti TAA-1 Asset Targeting an antigen expressed in a wide spectrum of tumors
Slide 20: SPARC ADC binds and exerts cytotoxicity against target-expressing cells
SPARC ADC binds and exerts cytotoxicity against target-expressing cells Cytopathic assay in a pancreatic cancer cell line SPARC ADC D-6A1 aCD20 D-6A5 SPARC ADC D-6A2 aCD20 D-6A6 100 100 75 75 % Survival % Survival 50 50 25 25 0 0 0.1 1 10 100 1000 0.1 1 10 100 1000 nM nM ADC against a novel tumor as
Slide 21: Antitumor efficacy of SPARC ADC
Antitumor efficacy of SPARC ADC Efficacy established in multiple xenograft models Pancreatic carcinoma xenograft Ovarian carcinoma xenograft 3000 1750 Vehicle Vehicle CD20 ADC CD20 ADC 1500 SPARC ADC low dose 2500 Toxic payload SPARC ADC mid dose SPARC ADC low dose SPARC ADC high dose SPARC ADC mid
Slide 22: SPARC ADC: next steps
SPARC ADC: next steps Advance anti TAA-1 ADC through preclinical development with IND submission in 2023 Explore additional tumor-targeting specificities for creation of drug conjugates In light of the broad expression of TAA-1 in cancer, create and preclinically evaluate a series of additional immu
Slide 23: Vodobatinib in CML (SCO-088)
Vodobatinib in CML (SCO-088) A safer, last-line option for heavily pre-treated patients
Slide 24: Vodobatinib for CML (SCO-088)
Vodobatinib for CML (SCO-088) Promising Last Line Therapy CML Market Product Clinical Overview Opportunity Overview Summary CML is caused by a Branded 2nd and 3rd generation TKIs Targeting patients who Phase 1 completed in translocation of the abl gene retain high commercial value due are refractory
Slide 25: Durable long-term responses seen across cohorts
Vodobatinib for CML (SCO-088) Durable long-term responses seen across cohorts 53 Patients on study after: 52 51 50 49 48 47 • 1 year: 68% 46 • 2 years: 47% 45 44 43 Median duration on study (months) = 20.8 42 41 40 39 38 (range: 0.5 – 56 months) 37 36 35 34 33 32 31 Discontinued 30 29 study drug 28
Slide 26: Vodobatinib for CML clinical development plan
Vodobatinib for CML (SCO-088) Clinical Development Plan Pivotal (Part C) study ongoing Clinical Development Plan Orphan Drug Designation approved by USFDA and EMA Single Ascending Dose study (SAD) in • Market exclusivity in addition to IP coverage Part A volunteers • User fee waiver Multiple Ascendi
Slide 27: SCO-120 for HR+/HER2- MBC
SCO-120 for HR+/HER2- MBC Potent oral SERD with preferential brain penetration
Slide 28: Oral SERD for Breast Cancer (SCO-120)
Oral SERD for Breast Cancer (SCO-120) Breast Cancer Market Product Clinical Overview Opportunity Overview Summary Breast cancer is the Hormonal therapy is SoC SCO-120 is a novel orally-active SERD US IND filed in Jan second most common for ~70% of HR+/HER2- for the treatment of HR+/HER2- breast 2020
Slide 29: In vivo efficacy of SCO-120 in combination with palbociclib
In vivo efficacy of SCO-120 in combination with palbociclib Promising activity against resistant mutants alone and in combination with palbociclib Tumor staging Treatment duration and tumor monitoring Day 28 Combination of palbociclib with SCO120 or fulvestrant: Dosing Completion E2 Pellet# Cell inj
Slide 30: SCO-120 advantage in brain metastases
SCO-120 advantage in brain metastases Prolonged survival in preclinical brain-metastasis model expressing wild type ERα 100 Vehicle 90 SCO -120 (low dose) SCO -120 (mid dose) ** 80 *** SCO -120 (high dose) 70 RAD-1901 (100 mpk) Percent survival 60 Fulvestrant (50, 25 mpk) 50 40 30 20 10 8 week treat
Slide 31: SCO-120 enters patient trials in 2022
SCO-120 enters patient trials in 2022 Clinical development plan and upcoming milestones Key Study Sample size assumptions design of the study for endpoints Part I - Dose Part 1 – Up to 15 Part 1 – PK, Safety escalation – Up to patients three cohorts Part 2 – ESR1, Tumor Part 2 – Up to 30 Biopsy (Bio
Slide 32: Concluding Remarks
sparc Concluding Remarks
Slide 33: Company highlights
Company highlights Successful Track Record Targeting Through an Innovation- of Development and High Value focused R&D Platform with Commercialization along Opportunities an Efficient Cost Structure with a Robust Pipeline 2 USD 20Bn+ 350+ USFDA approved drugs Combined peak sales potential for NCEs Sc
Slide 34: Highly experienced management team with global experience
Highly experienced management team with global experience 7 27 7 36 7 25 Anil Raghavan Nitin Damle Siu-Long Yao Chief Executive Officer Chief Innovation Officer Head, Clinical Development & Operations Responsible for strategic Leads the development of Biologics Oversees design & execution of priorit
Slide 35: Highly experienced management team with global experience
Highly experienced management team with global experience 3 25 13 22 14 22 Vikram Ramanathan Shravanti Bhowmik Yashoraj Zala Head, Translational Development Head, Program Management Head, Drug Delivery Systems Responsible for Preclinical Pharmacology, Oversees all aspects of the development / Respon
Slide 36: Scientific advisory board consisting of globally recognized experts
Scientific advisory board consisting of globally recognized experts Phil Needleman, PhD Rakesh Jain, PhD Robert Spiegel MD, FACP1 Mark Simon, MBA2 Washington University in Massachusetts General Weill Cornell Medical Torreya Partners, Citigroup, St. Louis HospitalHospital College, PTC Therapeu
Slide 37: Established and supported by marquee industry leader
Established and supported by marquee industry leader Shareholding (as on 30th Sep. 2021) Dilip Shanghvi 11% Public 32% Promoter group entities 57% Providing continuous support and investments Dilip Shanghvi Rights issue 2: INR250cr/USD 38Mn Preferential issue of convertible warrants 2: INR1112cr/USD
Slide 38: Thank You
Thank You The SPARC Logo is a trademark of Sun Pharma Advanced Research Company Ltd . In addition to Company data, data from market research agencies, Stock Exchanges and industry publications has been used for this presentation. This material is for use during an oral presentation; it is not a comp
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