Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Corporate Update (November 2023)
49 slides from Sun Pharma Advanced Research's corporate update, Nov 2, 2023
Slide 1: Update on Clinical Programs and R&D Pipeline
sparc Update on Clinical Programs and R&D Pipeline Nov 2, 2023 BSE: 532872 NSE: SPARC BLOOMBERG: SPADV@IN RETURNS: SPRC.BO CIN: L73100GI2006PLCO47837
Slide 2: Disclaimer
Disclaimer sparc 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, a
Slide 3: Agenda
Agenda sparc 01 Strategic Overview 02 Clinical Programs Anil Raghavan Siu-Long Yao 03 SCD-153 04 SBO-154 Vikram Ramanathan Nitin Damle 05 Financial Update Chetan Rajpara SPARC © 2023 3
Slide 4: Strategic overview
sparc Strategic overview Anil Raghavan
Slide 5: Maturing portfolio & operating model
Maturing portfolio & operating model sparc Cost competitive translation with global access to science Narrower Continuously Active Innovative Strategic Therapeutic Improving Portfolio Portfolio Partnerships Focus Execution Churn Pivot from Oncology, Competency Plug into Rigorous review 505(b)2 Neuro
Slide 6: Year 2024 promises several value inflection points
Year 2024 promises several value inflection sparc points High-yield assets set to read out clinical PoCs and proceed to pivotal programs Key catalytic events coming up every quarter during next year Q1 Q2 Q3 Q4 2024 2024 2024 2024 Vodobatinib PD SCD-153 Vodobatinib PD SBO-154 PROSEEK Interim Phase 1
Slide 7: Vodobatinib reached Phase 2 enrollment target
Vodobatinib reached Phase 2 enrollment target sparc PROSEEK read out to provide definitive PoC for the cAbl hypothesis and oxidative stress response modulation as an approach for neuroprotection Phase 2 study of Abl tyrosine kinase inhibition with Vodobatinib One of the largest Phase 2 study ongoing
Slide 8: PROSEEK opens up a broad opportunity set
PROSEEK opens up a broad opportunity set sparc Unlocks significant value for SPARC with potential use across PD progression and in disorders driven by α-synuclein Potential to combine with symptomatic therapies in PD Potential for early interventions in precursor conditions PROSEEK offers a powerful
Slide 9: Optionality beyond PROSEEK
Optionality beyond PROSEEK Vibozilimod* sparc SPARC pipeline includes multiple high value assets with platform potential SPARC’s immunology program will provide additional efficacy and safety data points in 2024 Oncology offers a potential hedge and anchor for future portfolio build across modalitie
Slide 10: Immunology program focused on autoimmune disorders in dermatology
Immunology program focused on sparc autoimmune disorders in dermatology Opportunity to become safer oral alternative to the current SoC; offers a path to build an immunology franchise Vibozilimod Two Phase 2b studies recruiting patients in Psoriasis and Atopic Dermatitis; lead indication Atopic Derm
Slide 11: Oncology pipeline with multiple near-term clinical options
Oncology pipeline with multiple near-term sparc clinical options… …backed up by an active preclinical effort involving multiple targets and modalities Vodobatinib for CML (SCO-088) writes down the PROSEEK risk Validated target; efficacy established in patients Being developed under Frontrunner progr
Slide 12: Rigorous translational focus
Rigorous translational focus sparc Focused on patient needs, developability considerations & asset appropriateness High BUILD COST FOCUS Investment, Resource prioritization optimization & move faster of success Probability R&D Strategy STOP Divest & Reallocate EVALUATE resources Risk mitigation Low
Slide 13: Additional non-dilutive cash flows from commercial/partnered assets
SPARC expects additional non-dilutive cash sparc flows from its commercial/partnered assets ELEPSIA & XELPROS SEZABY PDP-716 VIBOZILIMOD Strong uptake Licensed to SPI Inc. USFDA issued CRL SPARC eligible to post launch to PDP-716 NDA receive regulatory & Safeguarding due to inspection sales mileston
Slide 14: Pipeline overview
Pipeline overview sparc Phase 3/ Asset / Program MoA Indication Discovery Preclinical Phase 1 Phase 2 Registration Study Parkinson’s Disease Vodobatinib c-ABL Lewy Body (SCC-138) Inhibitor Dementia 1 Alzheimer’s Disease Vodobatinib BCR-ABL Refractory (SCO-088) Inhibitor CML SB0-154 Anti-MUC-1 Solid
Slide 15: Key priorities for next year
Key priorities for next year sparc Execution focus is the objective Clinical studies Regulatory filing Strategic priorities PROSEEK completion Elepsia site transfer Resourcing to ensure and data readout smooth operations PDP-716 re-filing In-licensing of potential Vodobatinib Phase 3 study initiatio
Slide 16: Clinical programs
sparc Clinical programs Siu-Long Yao
Slide 17: Vodobatinib (SCC-138) for neurodegenerative diseases
sparc Vodobatinib (SCC-138) for neurodegenerative diseases Siu-Long Yao
Slide 18: Parkinson's disease epidemiology
Parkinson’s disease epidemiology sparc PD affects ~7 mn people globally; expected to grow above 14 mn by 2040 PD population outgrowing overall population (2-4% growth in PD vs. 1% global population growth) DMTs can make significant impact to the lives of PD patients by changing the trajectory of dis
Slide 19: PROSEEK study update
sparc study update Enrollment target met Screening g Randomization Part 1 Data from interim analysis expected to be available by March 2024 Vodobatinib Vodobatinib PART 1 Placebo 384mg Weeks 0 to 40 (N=168) (N=168) 192mg Part 2 (N=168) Study initiated in Q4 2021 ~87% of eligible patients enrolled in
Slide 20: PROSEEK study update: safety and enrollment
sparc study update No significant cardiac events reported in the patients recruited Number of patients randomized Over 40% patients enrolled from the US 250 216 Grade 3/4 events reported in 6.1% patients 200 GI and rash were the most common AEs reported 150 No changes in study protocol recommended 8
Slide 21: PROSEEK study update: biomarkers
sparc study update Biomarkers under evaluation Target biomarker cohort enrolment – 150 total (random assignment) Further randomization to placebo, low dose, or high dose Vodobatinib – 50 assigned to each arm Exploratory samples (CSF, plasma, serum) at baseline, 8 & 40 weeks (EOT) Trial Entrance/Exit
Slide 22: Vodobatinib development
Vodobatinib development sparc Activities running in parallel before EoP2 meeting with FDA 2023 2024 Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Rat Carcinogenicity study Relative BA study DDI studies hADME study EoP2 EoP2 meeting with FDA planned in Nov 2024 22 BA: Bioavailability | DDI:
Slide 23: Opportunities beyond Parkinson's disease
Opportunities beyond Parkinson’s disease sparc Vodobatinib reduces the intracellular load of potentially toxic proteins in iPSC - induced neurons SCC-138 DMSO 10 nM 150 p- cAbl (Tyr 412) 150 Total cAbl 100 Lamp-1 50 phospho Tau (AT8) 50 Total Tau 15 a-Syn 37 Synaptophysin 37 Actin Vodobatinib downre
Slide 24: Vodobatinib (SCO-088) for chronic myeloid leukemia
sparc Vodobatinib (SC0-088) for chronic myeloid leukemia Siu-Long Yao
Slide 25: Chronic myeloid leukemia
Chronic myeloid leukemia sparc Use of 2nd and 3rd generation agents increasing US epidemiology1 4000 US sales (US$ mn)2 2.5 3500 0 67 209 2.0 3000 Rate Per 100,000 Persons 225 225 234 1.5 2500 741 771 791 1.0 2000 334 391 444 1500 0.5 1000 1419 1591 1727 0.0 1992 1996 2000 2004 2008 2012 2016 2020 Y
Slide 26: Vodobatinib (SCO-088) Phase 1/2 study results
Vodobatinib (SCO-088) Phase 1/2 study results sparc Patients continue to benefit over a long period of time Major Molecular Response (MMR) in CML-CP* 0 20 40 60 80 100 3 Baseline 97 3 Best response 55 42 % patients No response Maintaining response Achieving response Over 1/3rd patients on study drug
Slide 27: Preclinical data confirms superiority of Vodobatinib over 2nd generation TKI
Preclinical data confirms superiority of sparc Vodobatinib over 2nd generation TKI Anti-leukemic activity in Ba/F3-WT xenografts 2000 Vehicle (10 mL/kg, p.o. o.d. x 14) Vodobatinib (15 mg/kg, p.o. o.d. x 14) Vodobatinib (30 mg/kg, p.o. o.d. x 14) 1500 Nilotinib (15 mg/kg, p.o. o.d. x 14) (Mean ± S.E
Slide 28: Vodobatinib (SCO-088) registration plan alignment with FDA
Vodobatinib (SCO-088) registration plan sparc alignment with FDA Vodobatinib being developed under project Frontrunner Frontrunner is a program launched to make newer disease modifying therapies in earlier lines of treatment instead of late line setting Registration path Randomized control study in
Slide 29: Vibozilimod for autoimmune disorders
sparc Vibozilimod for autoimmune disorders Siu-Long Yao
Slide 30: Vibozilimod (SCD-044): Targeting fragmented dermatology market
Vibozilimod (SCD-044) sparc Targeting fragmented dermatology market Highly selective S1PR1 agonist Leading agent in the class under development for Psoriasis and Atopic Dermatitis Psoriasis Atopic Dermatitis US Prevalence ~ 8 mn US prevalence ~ 18 mn Dominated by biologics (injectables), limited ora
Slide 31: Vibozilimod (SCD-044) for Psoriasis
Vibozilimod (SCD-044) for Psoriasis sparc Phase 2 Study design Screening Part I:16 Part II:16-28 Part III:28-52 Follow-up 4 Weeks Weeks Weeks Weeks Week 56 Study open in the US, Latin America and Europe Vibozilimod Placebo Intermediate Dose < PASI75 response at Discontinue 15 sites in the US week 28
Slide 32: Vibozilimod (SCD-044) for Atopic Dermatitis
Vibozilimod (SCD-044) for Atopic Dermatitis sparc Phase 2 Study design Screening Part I Part II Follow-up Study open in the US, 3 Weeks 16 Week 16-32 Week 4 Weeks Latin America and Europe 18 sites in the US Vibozilimod Placebo Intermediate Dose 15 sites in Europe Primary endpoint – Treatment Free Fo
Slide 33: Next steps
Next steps sparc Interim analysis Complete data Futility Analysis readout for Atopic readout for Q2 2024 Dermatitis study Atopic Dermatitis Q4 2024 Q2 2025 SPARC © 2023 33
Slide 34: SCD-153 for Alopecia Areata
sparc SCD-153 for Alopecia Areata Vikram Ramanathan
Slide 35: Alopecia Areata: Autoimmune disease that causes hair loss
Alopecia Areata: Autoimmune disease that sparc causes hair loss Current treatment approaches are limited Clinical manifestations of Alopecia Areata1 Estimated 6.7 mn people in the US and 160 mn people worldwide have AA2 ~ 50% can experience spontaneous hair regrowth within one year, the majority oft
Slide 36: SCD-153: Novel topical drug for Alopecia Areata
SCD-153 sparc Novel topical drug for treatment of Alopecia Areata SCD-153 blocks key inflammatory cytokines implicated in AA1 Healthy Alopecia Areata MHC Class I & Class II CD4+ T cell CD8+ T cell Antigen Outer root sheath Presenting cells Sebaceous gland Hair shaft Bulb Immune-privileged Breakdown
Slide 37: SCD-153 has demonstrated promising preclinical data
SCD-153 has demonstrated promising sparc preclinical data Hair growth in mouse Alopecia Areata model Hair Growth Index Week 0 Week# Week 16# (Before treatment) 400 Vehicle, Thrice-a-week (Mean ± SD, n = 7-8/group) SCD-153, 3%, Thrice-a-week Vehicle Hair Growth Index 300 *** thrice -a- ** week 200 10
Slide 38: SCD-153 inhibited IFN signature gene expression in skin of AA diseased mice
SCD-153 inhibited IFN signature gene sparc expression in skin of AA diseased mice qPCR analysis of AA diseased skin Naive (Healthy) Vehicle, Thrice-a-week SCD-153, 3%, Thrice-a-week SCD-153, 3%, Twice-a-week Significant reduction in IFN signature genes in treated skin at different administered doses
Slide 39: SCD-153 Phase 1 study
SCD-153 Phase 1 study sparc A Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of topically applied SCD-153 in Healthy Volunteers IND Approved by DCGI Phase 1 SAD Phase 1 SAD study initiated in India 5 dose levels Cohort 1 Cohort 2 Cohort
Slide 40: SCD-153: potential to expand in other epidermal diseases
SCD-153: potential to expand in other sparc epidermal diseases Trigger Melanocyte-containing Disease-causing skin cell (target cell) immune cell CXCR3 JAK1/2 IFNγ IFNγ receptor CXCL9 CD8+ STAT1 CXCL10 T cell Skin cell IFNγ induces CXCL9, CXCL10 & CXCL11 in vitiligous skin. These chemokines recruit p
Slide 41: SBO-154 for multiple cancer indications
sparc SBO-154 for multiple cancer indications Nitin Damle
Slide 42: Antibody drug conjugates
Antibody drug conjugates sparc Large market expected to reach ~ 25 bn by 2038 12 FDA US$ 25.34 Bn 24.19% CAGR FDA Approved ADCs Projected ADC market from 2023 to 2028 by 2028 Approved ADCs 2017 2020 2022 2023 2019 2021 & Onward Besponsa® Polivy® Akalux® Zynlonta® ElahereTM 2023 and Beyond Enhertu® B
Slide 43: SBO-154 (Anti-MUC-1 ADC)
SBO-154 (Anti-MUC-1 ADC) sparc Novel antigen & approach to target MUC1-SEA domain, with an opportunity to therapeutically address multiple cancer indications Tumor agnostic opportunity in-licensed AR205 C242 from Biomodifying LLC PAM4 DS4 VNTR α Sub unit KL6 5E5 SEA targeting hypothesis validated 2D
Slide 44: SBO-154: Efficacy demonstrated in large established tumors
SBO-154: Efficacy demonstrated in large sparc established tumors MUC-1 High Expression Cell Line MUC-1 Intermediate Expression Cell Line MUC-1 Low Expression Cell Line Tumor Volume (cm3) Tumor Volume (cm3) Tumor Tumor Volume (cm3) Tumor Staging Staging Tumor Staging Treatment Treatment Treatment Day
Slide 45: SBO-154 development update
SBO-154 development update sparc INTERACT meeting granted by FDA INTERACT Meeting (Initial Targeted Engagement for Regulatory Advice on CBER CDER Products) Request Meeting to seek early advice from the FDA to validate preclinical developmental strategy for the IND-enablement of the product and serve
Slide 46: Financial update
sparc Financial update Chetan Rajpara
Slide 47: Financial summary
Financial summary sparc Year FY19 FY20 FY21 FY22 FY23 Q1FY24 USD INR 69.95 70.91 74.23 74.49 80.37 82.17 INR Cr Total Income 196 87 258 144 250 34 Total Expenses 342 399 410 347 472 129 Profit/(Loss) after Tax -145 -312 -151 -203 -223 -95 USD Mn Total Income 28.1 12.2 34.8 19.3 31.1 4.2 Total Expens
Slide 48: Cash and liquidity
Cash and liquidity sparc Out-licensed SEZABY to SPI Inc. in Q4 2022 and received an upfront sum of US$ 10mn. In addition, SPARC is eligible to receive regulatory and sales linked milestone payments and tiered royalties on sales Received `703 Cr (US$ 93mn) in Jan-2023 against the conversion of warran
Slide 49: Thank you
sparc> THANK YOU For updates and specific queries, please visit www.sparc.life or write to us at bus.dev@sparcmail.com The SPARC Logo is a trademarks of Sun Pharma Advanced Research Company Ltd. In addition to Company data, data from market research agencies, Stock Exchanges and industry publication
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