Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (July 2022)
54 slides from Sun Pharma Advanced Research's investor presentation, July 2022
Slide 1: Corporate Overview
Corporate Overview July 2022 ©SPARC
Slide 2: 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 3: Pipeline overview & key short-term catalysts
Pipeline overview & key short-term catalysts Phase 3/ Upcoming Asset / Program MoA Indication Discovery Preclinical Phase 1 Phase 2 Partner Registration Study Catalyst PoC data from Parkinson’s PROSEEK Disease study in 2023 Vodobatinib c-ABL Lewy Body PoC data in 2023 (SCC-138) Inhibitor Dementia1 A
Slide 4: Long term intent – Realize the potential of SPARC operating model
Long term intent – Realize the potential of SPARC operating model to build a high impact institution Access early stage science Efficient translation Maximize value capture and capabilities globally leveraging cost and through ‘asset appropriate’ patient access advantages commercialization Calibrate
Slide 5: Opportunity to further extend the operating model advantages
Opportunity to further extend the operating model advantages SPARC strategic development partnerships Expand the pre-clinical portfolio through targeted partnerships and asset acquisitions in key focus areas SPARC operational footprint Internalization of clinical development operations Increase the
Slide 6: Portfolio strategy focused on moving the 'standards of care'
Portfolio strategy focused on moving the ‘standards of care’ in large unmet medical needs Neurology Oncology Immunology Focus area Neurodegenerative diseases Treatment resistance Autoimmune disorders Stagnant standards of care in past Large basic science effort Limited efficacious oral 10- 15 years
Slide 7: Portfolio strategy focused on building platforms for 'molecular engineering'
Portfolio strategy focused on building platforms for ‘molecular engineering’ precision medicine Focus on modular “plug & Play” platforms which can deliver multiple products to the pipeline Immunofusions combining Tumor Associated Antigens with immuno- enhancers or checkpoint blockers in cancer thera
Slide 8: Summary – key drivers of value
Summary – 5 key drivers of value 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 Biol
Slide 9: Vodobatinib for Neurodegenerative Diseases (SCC-138)
Vodobatinib for Neurodegenerative Diseases (SCC-138) A potential first-in-class disease modifying therapy
Slide 10: 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 11: 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 12: Vodobatinib reverses PFF-induced increases in key biomarkers
Vodobatinib reverses PFF-induced increases in key biomarkers Triton insoluble Fraction PBS / PBS/SCC-138 PFF / PFF/SCC-138 Placebo (45 mg/kg) Placebo (45 mg/kg) 1 2 3 1 23 1 2 3 1 23 10 PBS+Placebo PBS+SCC-138 (45mg/kg) pY245 c-Abl 8 α-Syn PFF+Placebo α-Syn PFF+SCC-138 (45mg/kg) 6 p=<0.0001 p=<0.000
Slide 13: Vodobatinib protects dopaminergic neurons – dopamine transporter expression
Vodobatinib protects dopaminergic neurons in the AAV mutant α-Synuclein (hA53T) rat model – dopamine transporter expression 1.0 NS ** ** * NS 0.8 Specific Striatal 125IRTI-121 Binding Vehicle 0.6 Vehicle 0.4 Vodobatinib 15mg/kg 0.2 Vodobatinib 30mg/kg (nCi/gtissue) Vodobatinib 45mg/kg 0 L R L R L R
Slide 14: Vodobatinib protects dopaminergic neurons – tyrosine hydroxylase expression
Vodobatinib protects dopaminergic neurons in the AAV mutant a-Synuclein (hA53T) rat model – tyrosine hydroxylase expression Nigral TH+ve Cell count (operated side) 8000 Nigral TH+ve cell number 6000 NS * Vehicle (EV) ** *** Vehicle (aSyn) 4000 Vodobatinib (15mg/kg) 2000 Vodobatinib (30mg/kg) Vodobat
Slide 15: 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 Trial Population Status findings route, and in rat by ip route Repeat dose oral tox i
Slide 16: 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 50% patients randomized (N=218) Placebo Vodobatinib V
Slide 17: Opportunities beyond Parkinson's Disease
Opportunities beyond Parkinson’s Disease Vodobatinib reduces the intracellular load of potentially toxic proteins in iPSC-induced neurons iPSC- Analysis of cell lysate Neurons and culture supernatant Vodobatinib DMSO 10 nm Vodobatinib 10 nM 150 p- cAbl (Tyr 412) ELISA detection of Aβ-40 and Aβ-42 in
Slide 18: 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 19: Vibozilimod (SCD-044) - A Selective S1PR1 Agonist
Vibozilimod (SCD-044) - A Selective S1PR1 Agonist A safer alternative to JAK inhibitors
Slide 20: 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 21: Vibozilimod: Pharmacodynamics and safety established in Phase 1
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 22: 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 Primary endpoint – Placebo Proportion of patients Vibozilimod < PASI75 with PASI75 response at High Dose re
Slide 23: 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 Vibozilimod Primary endpoint – Intermediate Dose Proportion of patients with EASI-75 response at week Placebo 16 Vibozilimod High Dose 240 patients ac
Slide 24: Anti MUC-1 Asset
Anti MUC-1 Asset Targeting an antigen expressed in a wide spectrum of tumors
Slide 25: Anti MUC-1 antibody
Anti MUC-1 antibody α/β complex offers a novel approach to target MUC-1 Tumor agnostic opportunity in-licensed from Biomodifying LLC Anti-MUC1α mAbs MUC-1 expressed extensively in majority of tumors Preclinical PoC of anti-tumour efficacy of Anti-MUC1 α /β targeted ADC established Most anti-MUC-1 mA
Slide 26: Localization of SPARC MUC-1 mAb on cell surface and inside the cell
Localization of SPARC MUC-1 mAb on cell surface as well as inside the cell Alexa 647 Alexa 488 labelled 1° Ab labelled 2° Ab Hoechst Merged BF incubation at 4°C 2 hour incubation at 37°C Overnight Red Green Hoechst dye Merge of red and fluorescence is fluorescence is stain nucleus green colour is ye
Slide 27: SPARC MUC-1 ADC binds and exerts cytotoxicity
SPARC MUC-1 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 MUC-1 anti
Slide 28: Antitumor efficacy of SPARC MUC-1 ADC
Antitumor efficacy of SPARC MUC-1 ADC Efficacy established in multiple xenograft models Pancreatic carcinoma xenograft OvarianA carcinoma xenograft 1750 3000 Vehicle Vehicle CD20 ADC CD20 ADC Toxic payload 1500 SPARC ADC mid dose 2500 SPARC ADC mid dose SPARC ADC mid dose SPARC ADC mid dose SPARC AD
Slide 29: SPARC MUC-1 ADC: next steps
SPARC MUC-1 ADC: next steps Advance anti MUC-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 MUC-1 in cancer, create and preclinically evaluate a series of additiona
Slide 30: Vodobatinib in CML (SCO-088)
Vodobatinib in CML (SCO-088) A safer, last-line option for heavily pre-treated patients
Slide 31: 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 to are refract
Slide 32: Vodobatinib for CML: durable long-term responses
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 33: 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 Part A • Market exclusivity in addition to IP coverage volunteers • User fee waiver Multiple Ascendi
Slide 34: SCO-120 for HR+/HER2- MBC
SCO-120 for HR+/HER2- MBC Potent oral SERD with preferential brain penetration
Slide 35: 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 36: Growth inhibition of MCF-7 xenografts expressing ERα Y537S mutant
Growth inhibition of subcutaneous MCF-7 xenografts expressing ERα Y537S mutant 800 Vehicle 700 SCO-120 (12.5 mg/kg) SCO-120 (25 mg/kg) 600 SCO-120 (50 mg/kg) SCO-120 (100 mg/kg) 500 SCO-120 (300 mg/kg) Tumor volume (mm3) 500 Fulvestrant (50 mg/kg) n.s. Fulvestrant (100 mg/kg) ** 400 ** **** RoA: p.o
Slide 37: Growth inhibition of MCF-7 xenografts expressing ERα D538G mutant
Growth inhibition of subcutaneous MCF-7 xenografts expressing ERα D538G mutant 1000 Vehicle 900 SCO-120 (12.5 mg/kg) SCO-120 (25 mg/kg) 800 SCO-120 (50 mg/kg) n.s. 700 SCO-120 (100 mg/kg) SCO-120 (300 mg/kg) 600 Fulvestrant (100 mg/kg) 600 n.s. Tumor volume (mm3) 500 ** 400 **** RoA: p.o., o.d. for
Slide 38: 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 39: Plasma vs brain PK profile in mice
Plasma vs brain PK profile in mice 4000 3500 3000 Brain concentration (ng/gm) Brain PK Parameters Plasma concentration (ng/mL) 2500 Concentratio 2000 1500 n 1000 500 0 0 5 10 1 20 25 30 5 Time (Hrs) SCO-120 effectively crosses blood-brain barrier with a long half-life in the brain SPARC © 2022 39
Slide 40: 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) 60 Fulvestrant (50, 25 mpk) 50 Percent survival 40 30 20 10 8 week treat
Slide 41: 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 42: SPARC Delivery Systems
SPARC Delivery Systems Legacy portfolio leveraging 505-B(2) pathway provides opportunity to deliver non-dilutive funding in the short term
Slide 43: Novel drug delivery systems based 505(b)(2) opportunities
Novel drug delivery systems based 505(b)(2) opportunities Cost effective programs offering non-dilutive cash-flows Technology Liposomal Drug Oral Delivery Liposomal Drug Delivery Technology – Delivery Technology Technologies Sun Pharma (USA) Licensing Oral Delivery Technologies – Sun Pharma (India)
Slide 44: Licensed to Tripoint Therapeutics for commercialization in the US
Licensed to Tripoint Therapeutics for commercialization in the US Commercialization initiated in 2021 Tripoint completed field launch meet and training of sales team • 40 reps promoting ELEPSIA XR TM • ELEPSIA XR active on TX Medicaid TM • ELEPSIA XR contracted with ESI TM TX Medicaid = Texas Medica
Slide 45: PDP-716
PDP-716 Phase 3 study successfully met pre-specified endpoints Equivalent reduction in intraocular pressure was demonstrated across all required time-points Treatment-emergent adverse events were similar; 38.8% in the PDP-716 group vs. 33.2% with Alphagan® P 0.1% group NDA filing planned for 2022 26
Slide 46: SDN-037
SDN-037 Phase 3 trial met primary and secondary objectives Statistically significant proportion of patients treated with SDN-037 achieved an ACC grade of 0 versus vehicle with p-values <0.0001 Generally well tolerated with adverse events consistent with the known safety profile of difluprednate NDA
Slide 47: Phenobarbital
Phenobarbital Preservative-free injection for neonatal seizure Current standard of care for treatment of neonatal seizure Phenobarbital is an “unapproved drug” in USA; Approved before 1938 which did not require proof for safety and / or efficacy Existing marketed product is not approved by US FDA an
Slide 48: SPARC Human Capital
SPARC Human Capital Experienced management team backed by accomplished founder and advisory board
Slide 49: Established and supported by marquee industry leader
Established and supported by marquee industry leader Shareholding (as on 30th Sep. 2021) Public 32% Dilip Shanghvi 57% Promoter group 11% entities Providing continuous support and investments Dilip Shanghvi Rights issue 2: INR250cr/USD 38Mn Preferential issue of convertible warrants 2: INR1112cr/USD
Slide 50: Scientific advisory board consisting of globally recognized experts
Scientific advisory board consisting of globally recognized experts Phil Needleman, PhD Alan Ashworth, PhD, FRS Robert Spiegel MD1 Richard Ulevitch, PhD John DiPersio, MD, PhD Washington University UCSF Weill Cornell Medical Scripps Research Washington University St. Louis ICR London College St. Lou
Slide 51: 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 52: 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 53: 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 54: 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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