Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (October 2022)
51 slides from Sun Pharma Advanced Research's investor presentation, Oct 13, 2022
Slide 1: Cover letter to stock exchanges
SPARC/Sec/SE/2022-23/060 October 13, 2022 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; BS
Slide 2: Update on Clinical Programs and R&D Pipeline
Update on Clinical Programs and R&D Pipeline 13th October 2022 BSE:532872 NSE: SPARC BLOOMBERG: SPADV@IN REUTERS: SPRC.BO CIN:L73100GJ2006PLC047837
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: Agenda
Agenda 01 02 03 04 05 Overview Biologics Financial Update Anil Raghavan Nitin Damle Chetan Rajpara Clinical Programs Preclinical NCE Program Siu-Long Yao Vikram Ramanathan 3 SPARC © 2022
Slide 5: Built a robust R&D organization
Built a robust R&D organization Innovating from India for the world, SPARC offers operating model validation Successful Clinical pipeline Through an track record of targeting high-value innovation-focused development and opportunities R&D platform commercialization 2 3 10+ USFDA approved drugs NCEs
Slide 6: Attractive portfolio built using a cost-efficient structure
Attractive portfolio built using a cost-efficient structure Over 50% funded through non-dilutive revenue generated Promoters’ share Others 2012 2016 2017 2021 26% 25% 7% 46% 74% 75% 93% 54% Rights issue 1 Rights issue 2 Preferential issue of Preferential issue of INR 198 cr / USD 41 mn INR 250 cr /
Slide 7: Our strategy to address unmet clinical need has transformed
Our strategy to address unmet clinical need has transformed With a focus on novel biology as opposed to fast follower approach Increasing proportion of Asset Distribution Asset Distribution programs focusing on novel by Class by type biology (potential first-in- class) 57% 14% Investments in new mod
Slide 8: First-in-class innovation in three therapy areas
First-in-class innovation in three therapy areas With 70% of the preclinical pipeline targeting novel hypotheses Neurology Oncology Immunology Areas of Restoring cellular function in Modality-agnostic, Pursuing novel interest the CNS to modify disease- tumor-targeted targets in immune course by: str
Slide 9: Expected cash inflow from warrants conversion
Expected cash inflow from warrants conversion Cash runway till FY24, with potential extension from milestones and royalties H2 FY23 H1 FY24 H2 FY24 Cash inflow from USD 93 mn warrants conversion by Dec’22 Expected cash burn USD 30 mn USD 30 mn USD 30 mn Cash runway excluding milestones and royalties
Slide 10: Sezaby: benzyl alcohol-free phenobarbital injection for neonatal seizures
Sezaby*: benzyl alcohol-free phenobarbital injection for neonatal seizures Currently marketed Sezaby formulations Classified under DESI products Granted Orphan Drug Designation for treatment of neonatal seizures by USFDA; approved only for Upon approval will be eligible of Orphan Drug Exclusivity sa
Slide 11: Several high-yield assets graduating to next set of data events
Several high-yield assets graduating to next set of data events in the short term Sharp execution focus to deliver key updates in the next 18-24 months Licensing and Continued Early PoC for commercialization progress of new platforms of near-term assets clinical NCEs Driving uptake of Vodobatinib CM
Slide 12: Pipeline overview & key upcoming milestones
Pipeline overview & key upcoming milestones 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 FY24 Vodobatinib c-ABL Lewy Body PoC data in FY24 (SCC-138) Inhibitor Dementia1 Al
Slide 13: Clinical Programs
Clinical Programs Siu-Long Yao
Slide 14: Vodobatinib in CML (SCO-088)
Vodobatinib in CML (SCO-088) A safer, last-line option for heavily pre-treated patients
Slide 15: Vodobatinib for CML (SCO-088) clinical study design
Vodobatinib for CML (SCO-088) Potent and selective inhibitor of BCR-ABL1 Clinical study design Healthy volunteer study Patient studies Enrollment ongoing Single Ascending Dose (SAD) and Pivotal Multiple Ascending Food Effect efficacy study Dose (MAD) study studies in healthy in refractory in patient
Slide 16: Vodobatinib MAD study outcome: cytogenetic response
Vodobatinib (SCO-088) MAD study outcome Major Cytogenetic Response (MCyR) rate more than doubles in CP-CML patients treated with vodobatinib Cytogenetic Response N=42 MCyR (29%) Baseline 71 12 17 MCyR (67%) Best Response 33 10 57 No response Partial CyR 0 20 40 60 80 100 Complete CyR % patients 15 C
Slide 17: Vodobatinib MAD study outcome: molecular response
Vodobatinib (SCO-088) MAD study outcome Twenty-fold improvement in Major Molecular Response (MMR) rate in CP-CML patients treated with vodobatinib Molecular Response N=42 MMR (2.8%) Baseline 98 0.00 2 MMR (43%) Best Response 57 2 41 No response MMR maintained MMR achieved 0 20 40 60 80 100 % patient
Slide 18: Vodobatinib MAD study outcome: efficacy and safety
Vodobatinib (SCO-088) MAD study outcome Excellent efficacy and safety Patients on study after: 1 year: 71.7% 2 years: 52.8% 3 years: 37.7% Median duration on study = 23.9 months (range: 0.1 - 65.17 months) Discontinued study drug On treatment 0 10 20 30 40 50 60 70 Duration in months 17 Data cutoff:
Slide 19: Next steps
Next steps Additional data to be presented at upcoming clinical conferences: the Pivotal study 2022 ESH John Goldman readout in FY24 Conference and the 2022 ASH Annual Meeting 18 SPARC © 2022
Slide 20: Vodobatinib for Neurodegenerative diseases (SCC-138)
Vodobatinib for Neurodegenerative diseases (SCC-138) A potential first- in-class disease modifying therapy targeting c-Abl
Slide 21: c-Abl: a critical component of neurodegeneration
c-Abl: a critical component of neurodegeneration Substantiated by multiple research groups Ubiquitous expression in nucleated cells • Expressed in all parts of the CNS (brain and spinal column, and peripheral neuronal tissue) Pivotal role in promoting neurodegeneration • Under oxidative stress, c-Ab
Slide 22: Vodobatinib improved motor and cognitive function in PFF mouse model
Vodobatinib improved motor and cognitive function in the PFF-induced mouse model1 Turning Time in Pole Test Descending Time in Pole Test 20 20 p=>0.0001 p=0.0205 p=>0.0043 Vodobatinib at 45 mg/ 15 p=>0.9999 15 Descending time (Sec) kg improves PFF-induced p=>0.9999 Turning time (Sec) p=0.0111 moveme
Slide 23: Vodobatinib protects dopaminergic neurons in rat model
Vodobatinib protects dopaminergic neurons in the AAV mutant α-synuclein (hA53T) rat model – dopamine transporter expression 1.0 NS ** ** * NS Vodobatinib treatment protects against dopaminergic neuronal loss measured by radiolabeled 125I labeled 0.8 RTI-121 binding in the striatum Specific Striatal
Slide 24: Vodobatinib for PD: PROSEEK recruitment
Vodobatinib for PD (SCC-138) Recruitment on track to achieve enrollment target in PROSEEK PROSEEK Screening 77 sites across US, Europe and India functional; recruitment ongoing to Randomization complete enrollment in FY23 Over 70% patients randomized (N=349)* Placebo Vodobatinib Vodobatinib (N=168)
Slide 25: Opportunities beyond PD: Lewy Body Dementia
Opportunities beyond PD: Lewy Body Dementia Recruitment ongoing in an investigator-initiated clinical trial at Georgetown University RANDOMIZATION PLACEBO VODOBATINIB VODOBATINIB (N=15) 96mg (N=15) 192mg (N=15) Recruitment ongoing in a 12-week Phase 2 study Safety and tolerability being evaluated as
Slide 26: Next steps
Next steps Parkinson’s Lewy-Body Disease Dementia Complete recruitment in Complete recruitment by PROSEEK FY24 in the Georgetown University study PROSEEK study readout in FY24 Study readout in FY24 25 SPARC © 2022
Slide 27: Vibozilimod (SCD-044) – A selective S1PR1 agonist
Vibozilimod (SCD-044) – A selective S1PR1 agonist A safer alternative to JAK inhibitors
Slide 28: Vibozilimod for Psoriasis and Atopic Dermatitis
Vibozilimod (SCD-044) for Psoriasis and Atopic Dermatitis 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 Developed in col
Slide 29: Vibozilimod for Psoriasis: Phase 2 study design
Vibozilimod (SCD-044) for Psoriasis 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 Primary endpoint Vibozilimod < PASI75 – Proportion of Placebo Intermediate Dose response at Discontinue patients with PASI75 week 28 response at week
Slide 30: Vibozilimod for Atopic Dermatitis: Phase 2 study design
Vibozilimod (SCD-044) for Atopic Dermatitis Phase 2 study design Screening Part I:16 Part II:16-32 Follow-up 3 Weeks Weeks Weeks 4 Weeks Primary endpoint – Proportion of Vibozilimod patients with EASI-75 response at Placebo Intermediate Dose week 16 Vibozilimod High 240 Patients across three dose le
Slide 31: SCO-120 for HR+/HER2- MBC
SCO-120 for HR+/ HER2- MBC An oral SERD with brain penetration
Slide 32: Current treatment paradigm
Current treatment paradigm Dominated by endocrine therapy except in patients with visceral disease Early breast 1st line 2nd line cancer Endocrine backbone AI / Tamoxifen AI Fulvestrant / Exemestane Combination partner CDK 4/6i CDK 4/6i or mTORi or PI3Ki Fulvestrant is currently the only SERD availa
Slide 33: SCO-120: Clinical study design
SCO-120: Oral SERD for HR+/HER2- MBC Clinical study design Single Ascending Food Effect Multiple Ascending Dose (Part A) (Part B) Dose (Part C) Phase 1 Healthy Double blind, placebo Open label, two period, Double blind, placebo Volunteer Study controlled, cross over, single dose, controlled, once da
Slide 34: Next steps
Next steps MAD in patients study Phase 2 Target NDA completion and read initiation in FY24 submission in FY27 out in FY24 33 SPARC © 2022
Slide 35: Biologics
fe] Sparc Biologics Nitin Damle
Slide 36: SBO-154 (Anti-MUC-1 ADC)
SBO-154 (Anti-MUC-1 ADC) Targeting an antigen expressed in a wide spectrum of tumors
Slide 37: SBO-154: Anti-MUC-1 ADC
SBO-154: Anti-MUC-1 ADC Novel approach to target α/β complex, with an opportunity to target multiple tumor types Tumor agnostic opportunity in-licensed from N Biomodifying LLC* MUC-1 expressed extensively in majority of tumors AR20.5 Preclinical PoC of anti-tumour efficacy of C242 PAM4 anti-MUC-1 ta
Slide 38: Anti-MUC-1 mAbs internalize in pancreatic carcinoma cells
Anti-MUC-1 mAbs* internalize in pancreatic carcinoma cells Alexa 647 Alexa 488 labelled 1° Ab labelled 2° Ab Hoechst Merged BF Anti-MUC-1 Rituximab Red fluorescence is associated with anti-MUC-1 antibody, green fluorescence is associated with anti-human Fc-γ antibody & Hoechst dye stains nucleus and
Slide 39: SBO-154 strongly inhibits growth of MUC-1 expressing tumors
SBO-154 strongly inhibits growth of MUC-1 expressing tumors Established in subcutaneous pancreatic carcinoma xenografts 3000 Regimen: Q7D x 3, i.p. 2500 Free Payload Tumor Volume (mm3) 2000 Vehicle, 10ml/kg Rituximab-DC SBO-154, low dose 1500 Nab-PTX SBO-154, medium dose 1000 SBO-154, high dose 500
Slide 40: SBO-154 causes regression of large tumor xenografts
SBO-154 causes regression of large tumor mass xenografts of a pancreatic carcinoma cell line Tumor staging Treatment: ip Q7Dx3 Tumor Volume (mm3) Vehicle Rituximab-DC SBO- 154 Large tumor study is used to determine cytoreductive Treatment potential SBO-154 but not isotype matched control (rituximab-
Slide 41: Next steps
Next steps IND enabling tox Pre-IND IND filing studies completion meeting in FY24 40 SPARC © 2022
Slide 42: Preclinical NCE Program
Preclinical NCE Program Vikram Ramanathan
Slide 43: SCD-153 for Alopecia Areata
SCD-153 for A potential Alopecia Areata first-in-class opportunity in an autoimmune disease with significant unmet need
Slide 44: Alopecia Areata – Autoimmune disease causing hair loss
Alopecia Areata – Autoimmune disease causing hair loss Hair follicles lose immune privilege and they move into Telogen (resting) phase Alopecia Areata is characterized by Rapid progression of hair follicle from anagen (growing) phase to catagen (transition) phase to telogen (resting) phase Collapse
Slide 45: SCD-153 stimulates hair growth in animal models
SCD-153 stimulates hair growth in animal models C57BL/6 telogen - anagen alopecia model Vehicle, QOD, 2 applications SCD-153, QOD, 2 applications Tofacitinib, QOD, 2 applications Female mice, 8.5 weeks, Dorsal hair clipped. Treated on right side, left side is untreated. QOD: every other day SCD-153
Slide 46: SCD-153 stimulates hair growth in animal models
SCD-153 stimulates hair growth in animal models C3H/HeJ alopecia areata immune disease model Before After Untreated Treated Red: Untreated Green: Treated Robust hair growth in a disease model Decrease in CD8+ immunostaining proximal to hair follicles. Reduction in “swarm of bees” Decrease in gamma-i
Slide 47: Next steps
Next steps IND enabling tox IND filing studies completion in FY23 46 SPARC © 2022
Slide 48: Financial Update
Financial Update Chetan Rajpara SPARC © 2022
Slide 49: Financial summary
Financial summary Year FY18 FY19 FY20 FY21 FY22 Q1FY23 USDINR 64.46 69.95 70.91 74.23 74.49 77.16 INR Cr Total Income 83 196 87 258 144 29 Total Expenses 329 342 399 410 347 111 Exceptional Item 49 - - - 0 0 Profit / (Loss) after Tax (197) (145) (312) (151) (203) (82) USD Mn Total Income 12.9 28.1 1
Slide 50: Cash and liquidity
Cash and liquidity Issued convertible warrants for Rs. 1,112 Cr (~USD 148 Mn) in July 2021 by way of preferential issue Received Rs. 409 Cr (~USD 55 Mn) being 25% payable on application & upon conversion of warrants Balance Rs. 703 Cr (~USD 93 Mn) to be received by Dec 2022 upon conversion of warran
Slide 51: Thank you
THANK YOU 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 publications has been used for this presentation. This material is for use during an oral presentation; it is not a com
Sun Pharma Advanced Research Company — Investor Presentation (October 2022) on 6ix