Sun Pharma Advanced Research : Update on Clinical Programs and R&D Pipeline

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Update on

Clinical Programs and R&D Pipeline

Nov 2, 2023

BSE: 532872

NSE: SPARC BLOOMBERG: SPADV@IN RETURNS:

SPRC.BO CIN: L73100GI2006PLCO47837

Disclaimer

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Agenda

01 Strategic Overview

Anil Raghavan

03 SCD-153

Vikram Ramanathan

05 Financial Update

Chetan Rajpara

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02 Clinical Programs Siu-LongYao

04 SBO-154Nitin Damle

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Strategic overview

Anil Raghavan

Maturing portfolio & operating model

Cost competitive translation with global access to science

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Innovative	Narrower	Continuously	Strategic	Active
Therapeutic	Improving	Portfolio
Portfolio	Partnerships
Focus	Execution	Churn

Pivot from	Oncology,	Competency	Plug into	Rigorous review
505(b)2	Neurology &	development	global	and prioritization
Embrace risk	Immunology	Sharper	innovation	External
Focus on	ecosystem
	execution focus	engagement
Scalable
specific pathways
platforms
& approaches

In-house competencies and infrastructure to prosecute an idea from 'bench to bedside' with an ability to scale across modalities

3 NDAs approved by the USFDA and commercialized by partners, contributing significant 'non dilutive' cash to support the portfolio and operating model build-up

Robust pipeline with 3 NCEs under clinical development in 6 indications including two 'first-in-class' opportunities

NDA: New Drug Application| USFDA: United States Food & Drug Administration | NCE: New Chemical Entity

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Year 2024 promises several value inflection points

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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 SAD	PROSEEK full data	IND submission
readout
analysis readout	study results
	Vibozilimod*		Vibozilimod*
		Atopic dermatitis
	Atopic dermatitis
		Interim analysis and
	Phase 2 study
		topline results
	enrollment
	completion		SCD-153
			Phase 1 MAD study
			initiation

PoC: Proof of Concept | PROSEEK: Phase 2 study in early Parkinson's disease patients evaluating the safety and efficacy of Abl tyrosine kinase inhibition using K0706 | PD: Parkinson's Disease |

SAD: Single Ascending Dose | MAD: Multiple Ascending Dose | IND: Investigational New Drug | *Vibozilimod licensed to Sun Pharmaceutical Industries Limited

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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 for early PD patients (pre L-Dopa)

Study met enrollment target, 504 evaluable patients

Treatment duration of 40 weeks followed by 40 weeks' extension study

Data from interim analysis expected in March 2024

Geared up for post PROSEEK outcome

State of readiness for initiation of Phase 3 study

Engaging partners for potential collaboration

Oxidative stress in PD and related α-synucleinopathies1

Data cut-off: 20 Oct 2023

1. c-Abl and Parkinson's Disease: Mechanisms and Therapeutic Potential - J Parkinsons Dis. 2017; 7(4): 589-601 cAbl: Cellular Abelson Kinase | L-Dopa: Levodopa

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PROSEEK opens up a broad opportunity set

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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 PoC for the pathway in diseases driven by α-synuclein

Key disorders having α-synuclein aggregation as a pivotal process include PD, MSA & DLB

PRE-DIAGNOSIS

PARKINSON'S DISEASE DIAGNOSIS

				EARLY STAGES	ADVANCED STAGES
			Sensory symptoms	PROSEEK		Vodobatinib		Treatment
			and unspecific pain	target population	future development	Psychosis	Complications
progression			Impaired olfaction				Hallucinations
					OCD
		Visual abnormalities			Dyskinesia
		Sleep Disorders:			On-Off	Postural changes	Motor
					symptoms
		REM sleep behaviour disorder				Dysphagia
					Gait's apraxia
		Daytime somnolence
Disease						Freezing
		Restless legs syndrome
					Falls
Gastrointestinal symptoms and		Periodic limb movement in sleep	Tremor
			Dystonia
constipation		Depression	Rigidity
		Bradykinesia
Autonomic dysfuction:
		Cognitive impairment
	Orthostatic hypotension						Non-motor
	Urogenital dysfunction					Dysphagia		symptoms
				Pain in medial		Urinary symptoms
				Orthostatic hypotension
				collateral ligament
					Dementia
	-20	-10	0			10	20

Time from diagnosis (years)

Vodobatinib can emerge as the protective backbone across the continuum of care for synucleopathies

and other neurodegenerative disorders resulting from misfolded proteins

Chart adapted from Is insulin-like growth factor-1 involved in Parkinson's disease development? Castilla-Cortázar et al. J Transl Med (2020) 18:70 MSA: Multiple System Atrophy | DLB: Dementia with Lewy Bodies | OCD: Obsessive Compulsive Disorder

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Optionality beyond PROSEEK

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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 modalities

Additional bets to understand underlying mechanisms in neurodegenerative diseases - UK DRI collaboration

Immunology

Led by 3rd generation S1PR1 agonist, Vibozilimod with potential to be best-in-class asset in Dermatology - Clinical PoC in 2024

SCD-153 program to explore a novel pathway with a topical agent for Alopecia Areata - Safety PoC in 2024

Potential additional indications

Oncology

Vodobatinib in CML - Recalibrating to a changing regulatory and market landscape

MUC-1 program - A differentiated targeting approach which can become a pipeline in itself beyond the first ADC

UCSF collaboration for Small Molecule Drug Conjugates in mPC

Strong preclinical interest in antibody mediated delivery, RNA targeted therapeutics, & collateral lethality

Additional shots on goal & enabling competencies differentiate SPARC's risk profile

UKDRI: UK Dementia Research Institute | S1PR1: Sphingosine-1-Phosphate Receptor 1 | CML: Chronic Myelogenous Leukemia | MUC-1:Mucin-1 | ADC: Antibody Drug Conjugate |

UCSF: University of California San Francisco | mPC: metastatic Prostate Cancer | RNA: Ribonucleic Acid

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Immunology program focused on autoimmune disorders in dermatology

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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 Dermatitis

Provides an alternate mechanism to IL-4/IL-13 antibodies and JAK inhibitors Studies being expanded to Europe and Canada

SCD-153

Topical application may potentially provide a safer alternative to currently approved JAK inhibitors for treatment of AA

Phase 1 study initiated for AA

Preclinical evaluation ongoing in other autoimmune diseases of epidermis

SoC: Standard of Care | IL-4:Interleukin-4 | IL-13:Interleukin-13 | JAK: Janus Kinase | AA: Alopecia Areata

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