Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (November 2023)
49 slides from Sun Pharma Advanced Research's investor presentation, Nov 2, 2023
Slide 1: Update on Clinical Programs and R&D Pipeline
sparc0 • ••• • • • • • •• • • • •• • 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 sparc0 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,
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
sparc0 Strategic overview Anil Raghavan
Slide 5: Maturing portfolio & operating model
Maturing portfolio & operating model sparc0 Cost competitive translation with global access to science Narrower Continuously Active Innovative Strategic Therapeutic Improving Portfolio Portfolio Partnerships Focus Execution Churn 0 Pivot from 0 Oncology, 0 Competency 0 Plug into 0 Rigorous review 50
Slide 6: Year 2024 promises several value inflections points
Year 2024 promises several value inflection sparc0 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
Slide 7: Vodobatinib reached Phase 2 enrollment target
Vodobatinib reached Phase 2 enrollment target sparc 0 PROSEEK read out to provide definitive PoC for the cAbl hypothesis and oxidative stress response modulation as an approach for neuroprotection Sporadic PD i Mitochondrial Dysfunction PROSEEK ~ Oxidative Stress i Phase 2 study '!'Activated c-Abl /
Slide 8: PROSEEK opens up a broad opportunity set
PROSEEK opens up a broad opportunity set sparc0 Unlocks significant value for SPARC with potential use across PD progression and in disorders driven by α-synuclein 0 Potential to combine with symptomatic therapies in PD 0 Potential for early interventions in precursor conditions 0 PROSEEK offers a p
Slide 9: Optionality beyond PROSEEK
Optionality beyond PROSEEK Vibozilimod* sparc0 SPARC pipeline includes multiple high value assets with platform potential 0 SPARC’s immunology program will provide additional efficacy and safety data points in 2024 0 Oncology offers a potential hedge and anchor for future portfolio build across moda
Slide 10: Immunology program focused on autoimmune disorders in dermatology
Immunology program focused on sparc0 autoimmune disorders in dermatology Opportunity to become safer oral alternative to the current SoC; offers a path to build an immunology franchise Vibozilimod 0 Two Phase 2b studies recruiting patients in Psoriasis and Atopic Dermatitis; lead indication Atopic D
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 0 Vodobatinib for CML (SCO-088) writes down the PROSEEK risk 0 Validated target; efficacy established in patients 0 Being developed under Frontrunner
Slide 12: Rigorous translational focus
Rigorous translational focus sparc0 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: SPARC expects additional non-dilutive cash flows from commercial/partnered assets
SPARC expects additional non-dilutive cash sparc0 flows from its commercial/partnered assets ELEPSIA & XELPROS SEZABY PDP-716 VIBOZILIMOD 0 Strong uptake 0 Licensed to SPI Inc. USFDA issued CRL SPARC eligible to post launch to PDP-716 NDA receive regulatory & 0 Safeguarding due to inspection sales m
Slide 14: Pipeline overview
Pipeline overview sparc0 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 sparc0 Execution focus is the objective Clinical studies Regulatory filing Strategic priorities PROSEEK completion Elepsia site transfer Resourcing to ensure and data readout smooth operations 0 PDP-716 re-filing In-licensing of potential 0 Vodobatinib Phase 3 0 study in
Slide 16: Clinical programs
sparc0 Clinical programs Siu-Long Yao
Slide 17: Vodobatinib (SCC-138) for neurodegenerative diseases
sparc0 Vodobatinib (SCC-138) for neurodegenerative diseases Siu-Long Yao
Slide 18: Parkinson's disease epidemiology
Parkinson’s disease epidemiology sparc0 PD affects ~7 mn people globally; expected to grow above 14 mn by 2040 0 PD population outgrowing overall population (2-4% growth in PD vs. 1% global population growth) 0 DMTs can make significant impact to the lives of PD patients by changing the trajectory o
Slide 19: PROSEEK study update
sparc PROSEEK study update Enrollment target met Screening g Randomization Part 1 0 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) 0 Study initiated in Q4 2021 I Vodobatinib 384mg l Vod
Slide 20: PROSEEK study update
sparc PROSEEK study update No significant cardiac events reported in the patients recruited Number of patients randomized 0 Over 40% patients enrolled from the US 250 216 0 Grade 3/4 events reported in 6.1% patients 200 0 GI and rash were the most common AEs reported 150 No changes in study protocol
Slide 21: PROSEEK study update
sparc PROSEEK study update Biomarkers under evaluation 0 Target biomarker cohort enrolment – 150 total (random assignment) 0 Further randomization to placebo, low dose, or high dose Vodobatinib – 50 assigned to each arm 0 Exploratory samples (CSF, plasma, serum) at baseline, 8 & 40 weeks (EOT) Trial
Slide 22: Vodobatinib development
Vodobatinib development sparc0 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 I ■ EoP2 meeting with FDA planned in Nov 2024 22 BA: Bioavailability |
Slide 23: Opportunities beyond Parkinson's disease
sparc Q Opportunities beyond Parkinson’s disease Vodobatinib reduces the intracellular load of potentially toxic proteins in iPSC - induced neurons SCC-138 I J DMSO 10 nM 3 a ii) iI g_ I u II . f i i 150 p- cAbl (Tyr 412) . , ; , i~( ii PD .. Ii ·::==:. ====------ ,- Q1 classical o•synuclefnopathles
Slide 24: Vodobatinib (SCO-088) for chronic myeloid leukemia
sparc0 Vodobatinib (SC0-088) for chronic myeloid leukemia Siu-Long Yao
Slide 25: Chronic myeloid leukemia
Chronic myeloid leukemia sparc0 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 ■ ■ 11 ■■ • --■ I Rate Per 100,000 Persons I I 225 225 234 ----Y ■ ■ ■-- I I ■I I I ■ I I I I I I 2500 1.5 741 771 791 1.0 2000 334 391 444 1500 0.5 100
Slide 26: Vodobatinib (SCO-088) Phase 1/2 study results
Vodobatinib (SCO-088) Phase 1/2 study results sparc0 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 0 Over 1/3rd patients on s
Slide 27: Preclinical data confirms superiority of Vodobatinib over 2nd generation TKI
Preclinical data confirms superiority of sparc0 Vodobatinib over 2nd generation TKI Anti-leukemic activity in Ba/F3-WT xenografts 2000 -0- 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
Slide 28: Vodobatinib (SCO-088) registration plan alignment with FDA
Vodobatinib (SCO-088) registration plan sparc0 alignment with FDA Vodobatinib being developed under project Frontrunner 0 Frontrunner is a program launched to make newer disease modifying therapies in earlier lines of treatment instead of late line setting 0 Registration path 0 Randomized control st
Slide 29: Vibozilimod for autoimmune disorders
sparc0 Vibozilimod for autoimmune disorders Siu-Long Yao
Slide 30: Vibozilimod (SCD-044): Targeting fragmented dermatology market
Vibozilimod (SCD-044) sparc0 Targeting fragmented dermatology market 0 Highly selective S1PR1 agonist 0 Leading agent in the class under development for Psoriasis and Atopic Dermatitis Psoriasis Atopic Dermatitis 0 US Prevalence ~ 8 mn 0 US prevalence ~ 18 mn 0 Dominated by biologics (injectables),
Slide 31: Vibozilimod (SCD-044) for Psoriasis
Vibozilimod (SCD-044) for Psoriasis sparc0 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 0 Study open in the US, Latin America and Europe Vibozilimod Placebo Intermediate Dose < PASI75 response at Discontinue 15 sites in the US week
Slide 32: Vibozilimod (SCD-044) for Atopic Dermatitis
0 Vibozilimod (SCD-044) for Atopic Dermatitis sparc Phase 2 Study design 0 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 0 18 sites in the US Vibozilimod 0 Placebo Intermediate Dose 15 sites in Europe t t 0 Primary endpoint – Vib
Slide 33: Next steps
Next steps sparc0 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
sparc0 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 0 Estimated 6.7 mn people in the US and 160 mn people worldwide have AA2 0 ~ 50% can experience spontaneous hair regrowth within one year, the majority
Slide 36: SCD-153: Novel topical drug for treatment of 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 //II __ Outer root sheath :CD4+ T cell CD8+ T cell •Antigen Presenting cells Sebaceous gland Hair shaft Bulb Immune-privileged
Slide 37: SCD-153 has demonstrated promising preclinical data
SCD-153 has demonstrated promising sparc 0 preclinical data Hair growth in mouse Alopecia Areata model Hair Growth Index Week 0 Week# Week 16# (Before treatment) 400 Vehicle, Thrice-a-week ...... SCD-153, 3%, Thrice-a-week (Mean ± SD, n = 7-8/group) Vehicle Hair Growth Index 300 *** thrice -a- ** we
Slide 38: SCD-153 inhibited IFN signature gene expression in skin of AA diseased mice
SCD-153 inhibited IFN signature gene sparc0 expression in skin of AA diseased mice qPCR analysis of AA diseased skin .. QI c- .. a. CXCl-9 CXCL-10 CXCL-11 IFN-y • MX-1 STAT-1 J;; :, **** •• U 0 ~ ~ 160 **** 120 480 • 48 u • 0 C) r7 **** * ** •• 12 r7 '+C ID ""' 120 • 90 **** 360 **** 36 9 • I 9 0 11
Slide 39: SCD-153 Phase 1 study
SCD-153 Phase 1 study sparc0 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 0 Phase 1 SAD study initiated in India 0 5 dose levels Cohort 1 Cohort 2 Co
Slide 40: SCD-153: potential to expand in other epidermal diseases
SCD-153: potential to expand in other sparc0 epidermal diseases Trigger Melanocyte-containing Disease-causing skin cell (target cell) immune cell 0 CXCR3 -----+ ~ JAK1/2 ---+------, 0 0 ~ IFNγ IFNγ ~ 0 - receptor CXCL9 CD8+ C=:> STAT1 CXCL10 T cell c=) Skin cell 0 IFNγ induces CXCL9, CXCL10 & CXCL11
Slide 41: SBO-154 for multiple cancer indications
sparc0 SBO-154 for multiple cancer indications Nitin Damle
Slide 42: Antibody drug conjugates
Antibody drug conjugates sparc0 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 t t t 0 Besponsa ® 0 Polivy ® 0 Akalux® 0 Zynlonta ® 0 Elahere TM 0 202
Slide 43: SBO-154 (Anti-MUC-1 ADC)
SBO-154 (Anti-MUC-1 ADC) sparc0 Novel antigen & approach to target MUC1-SEA domain, with an opportunity to therapeutically address multiple cancer indications 0 Tumor agnostic opportunity in-licensed AR205 C242 from Biomodifying LLC PAM4 - DS4 VNTR α Sub unit KL6 5E5 0 SEA targeting hypothesis valid
Slide 44: SBO-154: Efficacy demonstrated in large established tumors
SBO-154: Efficacy demonstrated in large sparc0 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 t
Slide 45: SBO-154 development update
SBO-154 development update sparc0 INTERACT meeting granted by FDA 0 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 se
Slide 46: Financial update
sparc0 Financial update Chetan Rajpara
Slide 47: Financial summary
Financial summary sparc0 Year FY19 FY20 FY21 FY22 FY23 Q1FY24 USD INR 69.95 70.91 74.23 I 74.49 80.37 82.17 INR Cr Total Income 196 87 258 144 250 34 I I I Total Expenses 342 399 410 347 472 129 Profit/(Loss) after Tax -145 -312 -151 -203 -223 -95 I I I USD Mn Total Income 28.1 12.2 34.8 19.3 31.1 4
Slide 48: Cash and liquidity
Cash and liquidity sparc0 0 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 0 Received `703 Cr (US$ 93mn) in Jan-2023 against the conversion of w
Slide 49: Thank you
sparc0 THANK YOU For updates and specific queries, please visit www.sparc.life or write to us at bus.dev@sparcmail.com The SPARC l ogo is a trademarks of Sun Pharma Advanced Research Company ltd. In addition to Company data, data from market research agencies, Stock Exchanges and industr y publicati
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