Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (December 2024)
47 slides from Sun Pharma Advanced Research's investor presentation, Dec 19, 2024
Slide 1: Update on Clinical Programs and R&D Pipeline
Update on Clinical Programs and R&D Pipeline December, 19 2024 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 UPDATE ON STRATEGY AND PRIORITIES ANIL RAGHAVAN 02 SHORT-TERM OPPORTUNITIES: IMMUNOLOGY MUDGAL KOTHEKAR 03 SHORT-TERM OPPORTUNITIES: ONCOLOGY SANDEEP INAMDAR 3
Slide 4: PROSEEK data analysis completed
PROSEEK data analysis completed Full data set confirms IA findings Study did not meet primary endpoint The placebo response in PROSEEK appears to be an outlier compared to historical data Target CSF concentrations of Vodobatinib were achieved in both dosing arms Plasma PK consistent with earlier stu
Slide 5: Turning the page – Post PROSEEK priorities
Turning the page – Post PROSEEK priorities Focus on medium-term clinical PoCs and cash flow Portfolio optimization Business model flexibility Short-term catalysts & costs Oncology and Early stage licensing Multiple levers to Immunology as key drive near-term TA focus Pivoting to smart cash events 10
Slide 6: Turning the page – Post PROSEEK priorities
Turning the page – Post PROSEEK priorities Focus on medium-term clinical PoCs and cash flow Portfolio optimization Business model flexibility Short-term catalysts & costs Oncology and Early stage licensing Multiple levers to Immunology as key drive near-term TA focus Pivoting to smart cash events 10
Slide 7: Narrowing therapeutic area focus
Narrowing therapeutic area focus ONCOLOGY IMMUNOLOGY Smart delivery of chemotherapeutics or immune Topical delivery of novel agents providing activators using targeting mAbs or small molecule ligands potentially safer treatment options to patients ONCOLOGY IMMUNOLOGY Smart delivery Synthetic lethali
Slide 8: Potential first-in-class assets as anchors
Potential first-in-class assets as anchors Prioritized resourcing for SBO-154 and SCD-153 SBO-154 SCD-153 Delivers proven Topical agent for payload with a novel treatment of AA and epitope of tumor Vitiligo targeting antibody and a validated linker Low potential for systemic AEs confirmed in Phase K
Slide 9: SBO-154 leverages the broad success of the modality
SBO-154 leverages the broad success of the modality 15 ADCs approved by USFDA ADC market global forecast to 2028* ADC deals by development phase# 13% Estimated revenue by 2028 $20 Bn 9% 46% CAGR from 2023-2028 15.2% 19% 13% Cumulative deal value in last 5 years $300 Bn Preclinical Phase 1 Phase 2 Ph
Slide 10: SBO-154 offers a distinctive advantage in dynamic ADC space
SBO-154 offers a distinctive advantage in dynamic ADC space Binds to a novel epitope of a cancer associated antigen Number of ADCs under development by target* 120 106 100 Number of ADCs under development ADC field centered 80 around select antigens 60 ~65% of pipeline 48 assets targeting 5 40 antig
Slide 11: SCD-153 expands pathway & modality options
SCD-153 expands pathway & modality options Addressing the need for safer and convenient alternatives in Immunology Patient Proportion by Biologics vs Non-Biologics treatments in 7 major markets* Non-biologic Urticaria Biologic Ulcerative colitis Rheumatoid arthritis Psoriatic arthritis Psoriasis Cro
Slide 12: Turning the page – Post PROSEEK priorities
Turning the page – Post PROSEEK priorities Focus on medium-term clinical PoCs and cash flow Portfolio optimization Business model flexibility Short-term catalysts & costs Oncology and Early stage licensing Multiple levers to Immunology as key drive near-term TA focus Pivoting to smart cash events 10
Slide 13: Business model flexibility to advance assets and leverage capabilities
Business model flexibility to advance assets and leverage capabilities EXPAND PARTNERING EXPLORE INTENT NEW STRUCTURES Openness to explore Beyond traditional licensing partnering options at arrangements including multiple inflection points asset specific NewCos and including IND potential spin-outs
Slide 14: Case in point - A NewCo. to advance Joint IP
Case in point - A NewCo. to advance Joint IP Developed in collaboration with UCSF 2017 2020 2022 2024 Master agreement Task Order Lead candidate Binding LOI executed with signed signed identified UCSF and Tiller Therapeutics Inc. Research collaboration with the University of California San Francisco
Slide 15: SCO-155 enables preferential delivery using a small molecule ligand
SCO-155 enables preferential delivery using a small molecule ligand Offers potential advantages over RLTs SCO-155 is a Small Molecule Drug Conjugate (SMDC) delivering cytotoxic agent targeting prostate-specific membrane antigen (PSMA) as a potential treatment for metastatic Castration Resistant Pros
Slide 16: SCO-155 improves the therapeutic window
SCO-155 improves the therapeutic window Preclinical PoC established In vitro cytotoxicity in PC3 Prostate cancer cells In vivo efficacy in Prostate Cancer PC3 Xenograft model 150 2000 1500 Relative Cell Numbers (%) 100 Tumor volume (mm³) 1000 965x 50 500 0 SCO-155 treated 0.001 0.01 0.1 1 10 100 100
Slide 17: Tiller Therapeutics explores smart delivery with a novel approach
Tiller Therapeutics explores smart delivery with a novel approach SMDCs leveraging synthetic ligands of cancer specific antigens SPARC and UCSF have signed binding LOI with Tiller Therapeutics Inc. (Tiller) granting exclusive worldwide license to Tiller for preclinical oncology asset along with asso
Slide 18: Turning the page – Post PROSEEK priorities
Turning the page – Post PROSEEK priorities Focus on medium-term clinical PoCs and cash flow Portfolio optimization Business model flexibility Short-term catalysts & costs Oncology and Early stage licensing Multiple levers to Immunology as key drive near-term TA focus Pivoting to smart cash events 10
Slide 19: Focus on near-term catalysts & cost efficiency
Focus on near-term catalysts & cost efficiency PURSUE PROGRAMS OPTIMIZE WITH CASH VISIBILITY CASH BURN Execute on short-term Reduce cash burn through catalysts which can provide better alignment of non-dilutive capital to objectives and cost reduce external funding Opportunities with a spectrum Clin
Slide 20: Near-term cash generating milestones
Near-term cash generating milestones Delivering on actionable drivers of identified milestones is a top operational priority Partnering & Approval of Licensing NDA Q4 FY25 Q2 FY27 Sezaby Vodobatinib Sezaby PDP - 716 (SCO-088) Update of PRV Potential removal litigation with of unapproved USFDA produc
Slide 21: Sezaby’s eligibility for PRDV
Sezaby’s eligibility for PRDV Exploring all available options to ensure PRDV resolution USFDA denied SPARC PRDV based on its interpretation of PRDV statute and its requirements SPARC believes the agency’s interpretation led to an unfair denial of PRDV SPARC is committed to exploring all available re
Slide 22: Enforcing Sezaby’s orphan drug exclusivity
Enforcing Sezaby’s orphan drug exclusivity Unapproved phenobarbital injectable formulations may cause serious adverse events in neonates Sezaby is the only approved phenobarbital injectable formulation by the USFDA USFDA stated in a recent guidance that excipients with known toxicity should not be u
Slide 23: FDA agreement on dose for Phase 3 study
Vodobatinib in Chronic Myelogenous Leukemia Phase 3 design agreed with the agency Randomized Phase 2 dose finding FDA agreement on dose for Phase 3 study Vodobatinib Vodobatinib monotherapy monotherapy N= 20 at 200 mg Continuation of dose arm agreed with USFDA Randomized Phase 2 component for Phase
Slide 24: Vibozilimod Phase 2 outcomes later this year
Vibozilimod Phase 2 outcomes later this year Both studies achieved enrolment closure in Q2 FY25 240 patients across three dose levels 240 patients across three dose levels and placebo and placebo Primary endpoint – Proportion of Primary endpoint – Proportion of patients with EASI-75 response at pati
Slide 25: Leaner organization to drive cost optimization
Leaner organization to drive cost optimization Manpower expense expected to be reduced by ~30% FY24 Head Count - 409 FY25 Head Count - 324 Organization Organization Strength (India) Strength (Ex-India) 16 17 60 54 28 92 59 40 37 Number of Employees Number of Employees 57 372 400 317 30 168 20 200 18
Slide 26: Key execution priorities for next 24 months
Key execution priorities for next 24 months Vodobatinib Sezaby (SCO-088) PRV litigation Partnering & outcome Licensing SCO-155 SBO-154 SBO-154 Execution of definitive PDP-716 Phase 1b Initiation IND filing agreement Refiling of NDA Vibozilimod SOLARES-AD-1 topline data Q4 FY25 Q1 FY26 Q2 FY26 Q3 FY2
Slide 27: SCD-153 For treatment of Alopecia Areata
SCD-153 For treatment of Alopecia Areata 27
Slide 28: Alopecia Areata: Autoimmune disease causing spontaneous hair loss
Alopecia Areata: Autoimmune disease causing spontaneous hair loss Current approved oral drugs carry risk of long-term serious side effects Perifollicular infiltrations of Clinical manifestations of AA# inflammatory cells in AA patients* Healthy Alopecia Areata APC CD4+ T cell Inner root CD8+ T cell
Slide 29: SCD-153 induces hair growth in AA disease-relevant C3H/HeJ mouse model
SCD-153 induces hair growth in AA disease-relevant C3H/HeJ mouse model Vehicle, Regimen 1 Potential first-in-class agent for Alopecia Areata SCD-153, Dose 1, Regimen 1 SCD-153, Dose 2, Regimen 1 SCD-153, Dose 3, Regimen 1 SCD-153, Dose 4, Regimen 2 Hair Growth index (HGI) Hair Growth Index (HGI) 300
Slide 30: SCD-153 acts by reducing number of cytotoxic CD8+ T-cells in skin
SCD-153 acts by reducing number of cytotoxic CD8+ T-cells in skin of AA diseased mice IHC readout Flow cytometry readout Vehicle SCD-153, Dose 2 CD8*T-cells CD8*NKG2D*T-cells 12 1.2 Naive (Healthy) **** **** Vehicle, Regimen 1 (Mean+ SEM, n=7-15/group) % of Viable Infiltrating Cells 9 0.9 SCD-153, D
Slide 31: SCD-153 safe & well-tolerated in Phase 1a study
SCD-153 safe & well-tolerated in Phase 1a study Study Title: A Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of topically applied SCD-153 in Healthy Volunteers Cohort 1 SCD-153 Cohort 5 (n=8) Phase 1a (n=8) study Cohort 2 Cohort 4 (n=8
Slide 32: No systemic AEs related to SCD-153 observed in Phase 1a study
No systemic AEs related to SCD-153 observed in Phase 1a study Summary of subjects with drug related AEs (N=40) Doses Adverse Events Dose 1 None Dose 2 None Dose 3 None Dose 4 2 (related: Erythema; score 2 and Burning sensation; n=1) Dose 5 3 (related: Erythema; score 2; n=2, Burning sensation ; n=1)
Slide 33: Phase 1b study in Alopecia Areata patients
Phase 1b study in Alopecia Areata patients A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Topically Applied SCD-153 in Patients With Alopecia Areata (AA) Primary Objective: To determine the maximum safe dose of topical SCD
Slide 34: SCD-153 expands pathway & modality options
SCD-153 expands pathway & modality options Addressing the need for safer and convenient alternatives in Immunology SCD-153 employs Topical Multiple a new mechanism administration of formulation of action to SCD-153 offers options provide address complex possibilities to opportunities to pathogenesis
Slide 35: Next Steps for SCD-153
Next Steps for SCD-153 FY26 Phase 1b study Initiation FY27 Phase 1b study Interim Readout FY27 Phase 2 IND 35
Slide 36: SBO-154 For treatment of multiple tumor types
SBO-154 For treatment of multiple tumor types 36
Slide 37: MUC1 offers an excellent opportunity to preferentially target tumor cells
MUC1 offers an excellent opportunity to preferentially target tumor cells Structure of MUC1 in normal Translocation of MUC1 from apical surface (normal and cancer cells cell) to circumferential display (cancer cell)* Normal Mucosa/Epithelium Cancerous Mucosa/Epithelium Tn O-glycosylation sTn N-termi
Slide 38: SBO-154 targets the membrane proximal SEA domain of MUC1
SBO-154 targets the membrane proximal SEA domain of MUC1 Novel targeting approach makes SBO-154 unlikely to be subject to a sink effect in plasma N MUC1, the glycoprotein antigen on the cell surface consists of two parts - the α & β subunit The junction of α subunit (outside the membrane) & the β su
Slide 39: High MUC1-SEA expression level in human tumors of highly prevalent cancers
High MUC1-SEA expression level in human tumors of highly prevalent cancers Mouse anti-human MUC1-SEA mAb IHC staining in Stage IV cancer 300 293 280 270 270 250 248 H Score 240 200 205 n=16 n=4 n=2 n=12 n=5 n=12 n=13 150 ER+ Breast TNBC NSCLC Adeno Pancreatic Ovarian n=20 n=2 n=17 n=12 n=13 Circumfe
Slide 40: SBO-154: Hypothesis validated
SBO-154: Hypothesis validated SEA targeting ADC relatively unaffected by shed antigen, retains function of tumor-targeting 50 Almost all patients with MUC1+ tumors 40 have levels of shed MUC1-VNTR antigen Concentration in serum (ng/mL) in the plasma 30 This shed MUC1-VNTR binds to therapeutic 20 ADC
Slide 41: Preclinical efficacy of SBO-154 correlates with MUC1-SEA expression level
Preclinical efficacy of SBO-154 correlates with MUC1-SEA expression level In vitro cytotoxicity studies Expression level SBO-154 ADC IC50 Anti-CD20 ADC Carcinoma cell line (by flow cytometry) (µg/mL) (unrelated ADC) IC50 (µg/mL) Colo-357 (Pancreatic) +++ 0.05 3.45 MCF7 (ER+ve Breast cancer) ++ 0.07
Slide 42: Preliminary NHP Tox suggests SBO-154 is well-tolerated
Preliminary NHP Tox suggests SBO-154 is well-tolerated with toxicity profile comparable to other MMAE-based ADCs NHP exploratory 7 week DRF study Doses 1, 3, 6 mpk of SBO-154 Dosing Q3W x 3; Dosing Days: 1, 22 and 43 schedule No mortality or clinical signs No effect on body weight and feed consumpti
Slide 43: SBO-154 development update
SBO-154 development update Preparedness for Phase 1 study Pre-IND meeting USFDA response received at the end of Nov 2024 indicates broad agreement with SPARC’s proposed IND data package with no significant barriers to planned IND submission Phase 1 study Global Phase 1 study planned to include the U
Slide 44: Timelines & Milestones
Timelines & Milestones FY25 IND Filing FY26 Phase 1a Initiation FY27 Phase 1b Initiation 44
Slide 45: Modular platform which can deliver multiple products to the pipeline
Modular platform which can deliver multiple products to the pipeline Cytoskeleton Immune checkpoint disruption MUC1-SEA inhibition DNA Angiogenesis damage inhibition Immune stimulation 45
Slide 46: Pipeline summary - Multiple first-in-class assets under development
Pipeline summary - Multiple first-in-class assets under development Asset / Commercialization MoA Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Registration Approved Program Partner α2 adrenergic PDP-716 agonist Glaucoma Ocular Pain Phospholipase SDN-037 A2 inhibitor & Inflammation BCR-AB
Slide 47: 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 compl
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