Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (December 2021)
44 slides from Sun Pharma Advanced Research's investor presentation, Dec 9, 2021
Slide 1: Update on SPARC strategy and portfolio
Update on SPARC strategy and portfolio 9th December 2021 BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837
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: Agenda
Agenda 01 Portfolio strategy & update Anil Raghavan 02 Clinical NCE assets Siu-Long Yao 03 04 Anti TAA-1 & other Financial update preclinical programs Chetan Rajpara Nitin Damle 05 Q&A SPARC © 2021 3
Slide 4: SPARC – Taking stock of our journey
SPARC – Taking stock of our journey 4 Clinical Stage Programs Targeting Areas of High Unmet Need Targeting large addressable patient populations with $20B+ combined peak sales potential in 6 indications within Oncology, Neurology & Immunology Discovery & Development Across Validated & Novel Biology
Slide 5: Differentiated operating model
Differentiated operating model DISCOVERY DEVELOPMENT COMMERCIALIZATION Internal Ideation Full service bricks and mortar Multiple assets out-licensed to • Deliberate process with a value chain partners providing validation robust evaluation framework Significant global development for the model • Mat
Slide 6: Portfolio strategy
Portfolio strategy Focus on innovation in three TAs ripe for disruption Neurology Oncology Immunology Focus area Neurodegenerative diseases Treatment resistance Autoimmune disorders Stagnant standards of care in past 10- Evolving disease landscape Limited efficacious oral 15 years driven by treatmen
Slide 7: Robust portfolio
Robust portfolio High-value clinical/late preclinical portfolio that can deliver significant value going forward Successful partnering and NCEs for validated targets Targeting novel biology commercialization of assets and best-in-class assets and newer treatment modalities Leveraging formulation Bui
Slide 8: 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 9: 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 10: 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 11: Recently concluded licensing deals
Recently concluded licensing deals Validation of the platform Antibody in-licensed from Biomodifying LLC Ophthalmology assets out-licensed to Visiox LLC 1st biologic in-licensed by SPARC PDP-716 and SDN-037 global rights (excluding India and Greater China) out-licensed to Visiox Tumor agnostic oppor
Slide 12: Impact of COVID-19
Impact of COVID-19 Measured response by SPARC to ensure continuity of operations Hybrid working model to ensure that lab operations Clinical trial disruptions in pharma industry are minimally impacted 1,400 All Disrupted Trials Delayed Initiation SPARC’s ongoing clinical trials saw lower recruitment
Slide 13: Fund raise
Fund raise Preferential issue of convertible Rights issue 2: INR250cr/US$38.2mn warrants 2: INR1112cr/US$148mn 24.95% 45.95% 75.05% 54.05% 2016 2021 2012 2017 6.60% 26.29% 73.71% 93.40% Preferential issue of convertible Rights issue 1: INR198cr/US$41.4mn warrants 1: INR500cr/US$74.5mn Promoters’ con
Slide 14: Short to near term catalysts driving valuation
Short to near term catalysts driving valuation Licensing & Continued commercialization Early PoC for progress of of near term new platforms clinical NCEs assets Driving uptake of Vodobatinib PD phase 2 IND filing for 2 and ELEPSIA XR readout in 2023 preclinical assets in TM 2023 NDA filing of PDP-71
Slide 15: 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 16: Clinical NCE assets
Clinical NCE assets Siu-Long Yao BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 SPARC © 2021 16
Slide 17: Vodobatinib for CML (SCO-088)
Vodobatinib for CML (SCO-088) Potent and highly-selective BCR-ABL inhibitor with good oral bioavailability Addresses unmet need for patients failing ≥ 3 lines of TKI Kinome analysis demonstrates very therapy in CML limited off-target activity No QT prolongation observed in Phase 1 studies in CML pat
Slide 18: Vodobatinib for CML (SCO-088)
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 19: Vodobatinib for CML (SCO-088)
Vodobatinib for CML (SCO-088) Clinical Development Plan and current enrollment status Healthy volunteer study Patient study Single Ascending Dose Multiple Ascending Dose (SAD) and Food Effect (MAD) study in patients studies in healthy (N = 53) volunteers (N = 40) BP-CML N = 43 Pivotal study: Single
Slide 20: Vodobatinib for neurological diseases
Vodobatinib for neurological diseases Optimal agent to test the c-Abl hypothesis Mechanism of Action of c-Abl inhibition Sub-nanomolar potency against human c-Abl INACTIVE Very limited off-target activity, leading LYN to improved safety profile FYN Robust brain penetration (Brain/ OXSTRESS PGC1α Pla
Slide 21: Vodobatinib for PD (SCC-138)
Vodobatinib for PD (SCC-138) Potentially first-in-class disease-modifying treatment for Parkinson’s Disease Descending time in pole test 20 p=<0.0001 p=0.0205 p=0.0003 15 Descending time (Sec) p=>0.9999 10 5 0 PBS+ PBS+ PFF+ PFF+ PFF+ Vodobatinib Vodobatinib Vodobatinib Vodobatinib Vodobatinib Place
Slide 22: Completed toxicology and safety pharmacology studies
Completed toxicology and safety pharmacology studies Acute tox in the mouse and rat by oral route, and in rat by ip route Repeat dose oral tox • Rat: 1 month, 3 month and 6 month • Beagle dog: 14 day, 3 month, 9 month Genotoxicity • In-vitro Ames test and chromosomal aberration • In-vivo mouse micro
Slide 23: Superior pharmacological properties of vodobatinib compared to that of nilotinib
Superior pharmacological properties of vodobatinib compared to that of nilotinib CSF levels associated with efficacy in the PFF mouse model have been determined and provide the target level for human Vodobatinib has been dosed up in human with concomitant CSF concentration measurements and the targe
Slide 24: Vodobatinib for PD (SCC-138)
Vodobatinib for PD (SCC-138) Recruitment on track to achieve enrollment target in PROSEEK 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 Vodobatinib Phase 2 r
Slide 25: PROSEEK outcome measures
PROSEEK outcome measures Primary outcome: change in MDS-UPDRS part 2 + part 3 (combination of subject report and neurological exam) from baseline to end of treatment Secondary outcomes: • Time to start of symptomatic medication • CGIS - clinician global impression of severity • PK/PD correlations Ex
Slide 26: Vodobatinib for Lewy Body Dementia
Vodobatinib for Lewy Body Dementia RANDOMIZATION PLACEBO VODOBATINIB VODOBATINIB (N=15) 96mg (N=15) 192mg (N=15) Recruitment ongoing in a 12-week Phase 2 study Concentration of LBD related plasma and CSF in collaboration with Georgetown University biomarkers form the set of secondary outcome measure
Slide 27: Vibozilimod (SCD-044)
Vibozilimod (SCD-044) Highly-selective S1PR1 modulator with better safety profile than fingolimod S1PR1 Modulator Landscape Multiple approved S1PR1 modulators including fingolimod, ozanimod and etrasimod in Phase 3 EC50 (GTPϒ35S assay) S1PR1 agonists Fingolimod is the 1st in class S1P receptor agoni
Slide 28: Vibozilimod (SCD-044): Pharmacodynamic and Safety Established in Phase 1 Study
Vibozilimod (SCD-044) Pharmacodynamic 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 follow
Slide 29: Vibozilimod (SCD-044): Psoriasis Phase study design
Vibozilimod (SCD-044) Psoriasis Phase 2 study design 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 response Discontinu
Slide 30: Vibozilimod (SCD-044): Atopic Dermatitis Phase study design
Vibozilimod (SCD-044) Atopic Dermatitis Phase 2 study design Screening 3 Part I:16 Part II:16-32 Follow-up Primary endpoint – Weeks Weeks Weeks 4 Weeks Proportion of patients with EASI-75 response at week 16 Vibozilimod 240 Patients across three Intermediate Dose dose levels and placebo. Placebo Cur
Slide 31: SCO-120
SCO-120 Novel orally-active selective ERα degrader for the treatment of HR+/HER2- breast cancer About 200,000 women are estimated to be diagnosed 5-Year relative survival* with HR+/HER2- breast cancer in 2021 in US • 20% to 30% acquire ESR1 mutations IM fulvestrant is the only approved SERD for pati
Slide 32: SCO-120
SCO-120 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 treatment 0 7 14 21 28 35 42 49 56
Slide 33: SCO-120
SCO-120 Clinical development plan and upcoming milestones Key Study Sample size assumptions design of the study for endpoints Part I - Dose escalation – Part 1 – Up to 15 Part 1 – PK, Safety Up to three cohorts patients Part 2 – ESR1, Tumor Biopsy Part 2 – Efficacy exploration Part 2 – Up to 30 (Bio
Slide 34: Phenobarbital injection
Phenobarbital injection Preservative-free injection of phenobarbital for treatment of neonatal seizure 80% of the neonatal seizure patients respond to phenobarbital injection vs. 28% responding to Levetiracetam injection Existing marketed product is not approved by USFDA and contains benzyl alcohol
Slide 35: Anti TAA-1 & other preclinical programs
Anti TAA-1 & other preclinical programs Nitin Damle BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 SPARC © 2021 35
Slide 36: Molecularly engineered precision medicine
Molecularly engineered precision medicine For oncology and/or inflammatory diseases Modular platform Tumor-targeted Tumor-targeted Bispecific Bivalent or scFvFc T-cell engager Cis scFvFvFc Multiple product opportunities scFv Anti-CD3 scFv Immuno-enhancing IgG Anti-tumor immunofusions for cancer Fc s
Slide 37: SPARC ADC binds and exerts cytotoxicity against target-expressing cells
SPARC ADC binds and exerts cytotoxicity against target-expressing cells SPARC-ADC 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 Evidence of potent
Slide 38: 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 39: Anti TAA-1 platform, next steps and medium term vision
Anti TAA-1 platform, next steps and medium term vision Advance the Anti TAA-1ADC 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
Slide 40: Overview of key pre-clinical programs
Overview of key pre-clinical programs Programs Summary Anti TAA-1 Platform Cancer resistance Tumor agnostic opportunity, ADC & Immunofusions. First-in-class mAb against a tumor antigen Cancer resistance Tumor agnostic opportunity, Potential ADC & Immunofusions. Synthetic conjugate Cancer resistance
Slide 41: Financial update
Financial update Chetan Rajpara BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 SPARC © 2021 41
Slide 42: Financial summary
Financial summary Year FY17 FY18 FY19 FY20 FY21 H1 FY22 USDINR 67.07 64.46 69.95 70.91 74.23 73.92 Rs. Cr Total Income 195 83 196 87 258 56 Total Expenses 314 329 342 399 410 173 Exceptional Item - 49 - - - - Profit / (Loss) after Tax (119) (197) (145) (312) (151) (117) USD Mn Total Income 29.0 12.9
Slide 43: Cash and liquidity
Cash and liquidity Raised Rs. 1,112 Cr (~USD 148 Mn) in July 2021 by way of preferential issue Of this, contribution by promoters Rs. 600 Cr (~USD 80 Mn), balance Rs. 512 Cr (~USD 68 Mn) by 30 external investors, including 8 FPIs Received Rs. 278 Cr (~USD 37 Mn) being 25% payable on application Bala
Slide 44: Thank You
eo] sparc Thank You
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