SPARCNSEJanuary 06, 2024

Sun Pharma Advanced Research Company Limited

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Key numbers — 3 extracted
rs,
Kurla Complex, Bandra (East), Mumbai – 400 051. BSE Limited, Market Operations Dept. P. J. Towers, Dalal Street, Mumbai - 400 001. Scrip Symbol: SPARC Scrip Code: 532872 Dear Sir/Madam, Sub:
rs. 2
und by the foregoing limitations. All brand names and trademarks are the property of respective owners. 2 SPARC © 2024 Vodobatinib for Parkinson’s disease Study status updates Vodobatinib PoC study – PRO
85%
obatinib PoC study – PROSEEK is fully enrolled – 513 patients; Interim analysis is planned for ~ 85% of patients enrolled in Part 1 of the study (441 patients); Broader organization will continue t
Guidance — 3 items
Upcoming milestones
opening
Registrational plan to be agreed with regulators; Completing the studies required by regulators for NDA submission; Any additional preclinical work that regulators may suggest; and Manufacturing readiness and risk mitigation.
Upcoming milestones
opening
4 SPARC © 2024 Vodobatinib for Parkinson’s disease Program risks Vodbatinib addresses a significant unmet need, but translation risks remain: Translatability of animal models of Parkinson’s Disease; Lack of validated target engagement markers; Reproducibility of clinical Proof of Concept studies; and PROSEEK clinical design addresses the translational challenges to the extent possible.
Upcoming milestones
opening
5 SPARC © 2024 Vodobatinib for Parkinson’s disease Market risks Biotechs’ approaching key data events attract significant speculative activity: Exploitative or uninformed attempts to manufacture positive or negative outlook; Significant risks in speculative trading involving uncertain data events; and Investors who intend to ‘price-in’ Vodobatinib’s impact needs to do so after deliberate analysis of sales potential, costs, time to market and potential risks.
Risks & concerns — 3 flagged
Registrational plan to be agreed with regulators; Completing the studies required by regulators for NDA submission; Any additional preclinical work that regulators may suggest; and Manufacturing readiness and risk mitigation.
Upcoming milestones
5 SPARC © 2024 Vodobatinib for Parkinson’s disease Market risks Biotechs’ approaching key data events attract significant speculative activity: Exploitative or uninformed attempts to manufacture positive or negative outlook; Significant risks in speculative trading involving uncertain data events; and Investors who intend to ‘price-in’ Vodobatinib’s impact needs to do so after deliberate analysis of sales potential, costs, time to market and potential risks.
Upcoming milestones
SPARC will disclose the topline as soon as such information can be safely shared after full analysis and without compromising underlying data; SPARC plans to continue exploration of Vodbatinib in PD and other relevant conditions based on data flow; and We remain committed to exploring c-Abl inhibition, oxidative stress response modulation and other appropriately validated pathways to advance standards of care in neurodegenerative diseases.
Neurodegenerative diseases
Speaking time
Upcoming milestones
1
Neurodegenerative diseases
1
Opening remarks
Upcoming milestones
Administrative Interim Analysis data availability – Apr 2024; PROSEEK topline data – Aug 2024; 3 SPARC © 2024 Vodobatinib for Parkinson’s disease Near term priorities Immediate priorities post PROSEEK read-out include the following: End of Phase 2 consultation with the USFDA and other regulatory agencies; Completion of the Long Term Extension study; Initiation of Phase 3 studies globally; Finalization and execution of partnering strategy; and Resource mobilization including additional fund raises to fully explore the asset. Registrational plan to be agreed with regulators; Completing the studies required by regulators for NDA submission; Any additional preclinical work that regulators may suggest; and Manufacturing readiness and risk mitigation. 4 SPARC © 2024 Vodobatinib for Parkinson’s disease Program risks Vodbatinib addresses a significant unmet need, but translation risks remain: Translatability of animal models of Parkinson’s Disease; Lack of validated target engagement markers;
Neurodegenerative diseases
SPARC will disclose the topline as soon as such information can be safely shared after full analysis and without compromising underlying data; SPARC plans to continue exploration of Vodbatinib in PD and other relevant conditions based on data flow; and We remain committed to exploring c-Abl inhibition, oxidative stress response modulation and other appropriately validated pathways to advance standards of care in neurodegenerative diseases. 6 SPARC © 2024 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 complete record of the discussion. This work may not be used, sold, transferred, adapted, abridged, copied or reproduced in whole on or in part in any manner or form or in any media without the prior written consent. All product names and company names a
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