Summary Links:
* Summaries created by AI. Please verify by checking the actual call transcript.
Interim Analysis Results • Vodobatinib in Parkinson's Disease: • Did not meet primary endpoint; trial will be closed. • Full data review is essential for insights.
Future Projects • Ongoing and Future Programs: • SCO-088 for Chronic Myeloid Leukemia (CML). • SCD-153 for Alopecia Areata. • SBO-154 targeting Muc-1. • Portfolio Optimization: • Focus on high-value programs and effective resource management.
Licensing and Market Opportunities • Licensing Deal for Vodobatinib: • Early discussions for CML; aim to finalize within the financial year. • Market opportunity for CML is smaller than for Parkinson's Disease.
Financial Position • Cash Balance: • Approximately $20 million; no near-term equity raise planned. • Runway of 12-15 months with access to credit.
PROSEEK Study Insights • Study Results: • Full analysis expected by Q2 of the financial year. • High placebo response complicates result interpretation. • Stakeholders advised to discount Vodobatinib in financial models for now.
Strategic Positioning • Regulatory Focus: • Potential shift away from U.S. regulatory approval for Vodobatinib due to resource allocation. • Interest from smaller companies due to promising safety profile.
Other Programs and Updates • Vibozilimod for Psoriasis: • Behind schedule; no timeline for data availability. • SEZABY: • FDA reviewing a citizen's petition; exclusivity establishment takes 2-3 years. • ELEPSIA: • Transition to a new partner in progress. • SCD-153 Development Plan: • Patient study in alopecia areata; potential licensing opportunity after interim analysis.
Conclusion • Call Closure: • Invitation for further questions via email.
Call Overview • Date: January 6, 2024 • Participants: CEO Anil Raghavan, Jaydeep Issrani (Head of Business Development and Investor Relations) • Purpose: Discuss the PROSEEK Program and provide updates.
Key Objectives • Update on the Vodobatinib Program. • Discuss immediate priorities for the 2025 financial year. • Provide a balanced perspective on the program. • Address questions before entering a quiet period for interim analysis.
PROSEEK Program Status • Enrollment: Completed with 513 patients. • Interim Analysis: Scheduled for March-April 2024. • Trial Integrity: Emphasis on maintaining blinding for trial integrity.
Program Design • Dosing Arms: Two arms in the trial. • Primary Endpoint: Focus on MDS-UPDRS Part-III. • Data Availability: Expected in August-September 2024. • Future Goals: Transition to Phase-III development post-data availability.
Risks and Challenges • Clinical Translation: Challenges in translating animal models to clinical outcomes. • Target Engagement: Ensuring effective engagement with targets. • Reproducibility: Concerns about reproducibility of early clinical results.
Market Considerations • Investment Needs: Success in PROSEEK could validate Vodobatinib but requires further investment. • Analyst Coverage: Limited coverage necessitates careful consideration of risks and potential.
Q&A Highlights • Enrollment Rates: 85%-87% rollover from part-I to part-II. • Regulatory Pathway: Initial registration likely involves repeating studies from PROSEEK. • Intellectual Property: Expected patent coverage into the late 2030s. • Interim Data Sharing: No current plans to share interim data with the FDA.
Future Directions • Alzheimer's Exploration: Ongoing preclinical data supports Vodobatinib's exploration for Alzheimer's. • Partnerships: Interest in partnerships for Parkinson's and other indications, with a desire to retain involvement in development.
Conclusion • Data-Driven Decisions: Future studies depend on PROSEEK trial results. • Engagement with Partners: Interim analysis data will be shared with select partners under confidentiality agreements.
Call Overview • Date: January 6, 2024 • Moderator: Jaydeep Issrani • Key Participants: CEO Anil Raghavan and senior management team • Focus: Updates on the PROSEEK Program
Objectives of the Call • Update on the Vodobatinib Program • Discuss immediate priorities for the 2025 financial year • Provide a balanced perspective on the program • Address questions before entering a quiet period for interim analysis
PROSEEK Program Status • Enrollment completed with 513 patients • Interim analysis planned for March-April 2024 • Emphasis on trial integrity and blinding
Program Design and Goals • Two dosing arms with primary endpoint on MDS-UPDRS Part-III • Full data expected by August-September 2024 • Transition to Phase-III development contingent on regulatory agreements
Risks and Challenges • Translating animal models to clinical outcomes • Ensuring target engagement and reproducibility of results • Market-related risks and limited analyst coverage
Future Research Directions • Exploring Vodobatinib's potential in Lewy body dementia and Alzheimer's disease • Importance of demonstrating disease modification in early-stage Parkinson's patients • Need for additional investment and studies for further research opportunities
Q&A Highlights • Enrollment rates: 85%-87% rollover from part-I to part-II • Regulatory pathway post-PROSEEK data: Initial registration likely to repeat studies • Intellectual property status: Expected patent coverage into the late 2030s • Interim data sharing with the FDA: No current plans, next interaction post-full data
Development and Approval Considerations • Potential for accelerated approval pathways is speculative • Preparedness for Phase-III trial depends on PROSEEK data outcomes • Negative results would halt further pursuit of Vodobatinib
Partnership and Analysis Insights • Differences between administrative and full interim analysis explained • Open to partnerships for Parkinson's disease and other indications • Interim analysis aims to engage potential partners early under confidentiality agreements
Conclusion • Management expressed excitement about ongoing exploration in neurodegenerative diseases • Call concluded with thanks and invitation for follow-up questions.
Company Overview • Date of Call: November 2, 2023 • Participants: CEO Anil Raghavan, Dr. Venkat Palle, Dr. Siu-Long Yao, Vikram Ramanathan, CFO Chetan Rajpara • Focus: Updates on clinical programs and R&D pipeline
Key Updates • Strategic Shift: Transition from delivery systems to a modern biotech model with partnerships in academia. • Clinical Programs: • Vodobatinib: Targeting Parkinson’s disease and chronic myeloid leukemia (CML). • Vibozilimod: For atopic dermatitis and psoriasis. • Upcoming Milestones: • Interim analysis for PROSEEK study by Q1 2024. • Full readout and Phase 3 initiation expected shortly thereafter.
Clinical Trials • PROSEEK Study: • Phase 2b trial for early-stage Parkinson’s disease. • Recruitment target achieved; results expected in March 2024. • SCD-153: • Developed for Alopecia Areata; IND filed in India. • Phase 1 study to begin in Q4 2023. • SBO-154: • First antibody-drug conjugate targeting MUC1 antigen; IND filing planned for late 2024.
Financial Overview • Current Status: Net loss reported for FY23 and Q1 FY24. • Funding Strategies: Focus on cash reserves and clinical cost management.
Regulatory and Market Considerations • FDA Engagement: Positive discussions regarding Vodobatinib and CML trial design. • Market Potential: • Vodobatinib for Parkinson’s disease could significantly impact treatment landscape. • CML market valued at $3.5 billion.
Future Directions • Partnerships: Exploring collaborations with large pharmaceutical companies. • Research Focus: Continued emphasis on biologics, antibody-drug conjugates, and RNA therapeutics. • Regulatory Strategy: Establishment of SPARC Life in the US for operational advancements.
Q&A Highlights • Clinical Program Clarifications: • Challenges in recruiting for Vodobatinib's registrational program. • Importance of PROSEEK data for future studies. • Financial Projections: Variability in burn rate due to ongoing developments.
Conclusion • The call emphasized SPARC's commitment to innovation, strategic partnerships, and addressing unmet medical needs through a robust clinical pipeline.