Detailed Narrative
Vodobatinib PROSEEK Trial Disappointment
SPARC announced the interim analysis results for its Vodobatinib PROSEEK study in Parkinson's Disease, revealing that both low and high dose arms failed to meet the primary endpoint of change in MDS-UPDRS part III score at week 40. Key secondary endpoints also showed a similar trend, leading to the decision to close the trial. The overall budget for this trial was $45 million, with over $35 million already spent, and full data analysis is expected by Q2 FY25.
Strategic Shift for Vodobatinib CML Program
Following the PROSEEK setback, SPARC is re-initiating business development activities for Vodobatinib's oncology leg (SCO-088) for Chronic Myeloid Leukemia (CML). The company aims to out-license this asset, which has established human proof-of-concept and an acceptable safety profile, targeting a deal within the current financial year. Management indicated that internal funding for full US regulatory approval is not an appropriate use of capital, preferring a partnership for this $200-400 million opportunity.
Advancing Other Pipeline Assets
SPARC highlighted other clinical assets, including SCD-153 and SBO-154. SCD-153, for Alopecia Areata, is currently in Phase 1 evaluation in India, with Phase 1 completion expected by FY25 and an early patient study in India by FY26 to establish human PoC. SBO-154, an Antibody Drug Conjugate, is undergoing IND-enabling studies, with an IND filing targeted by the end of the current financial year (FY25).
Cash Position and Future Funding
The company reported a current cash balance of approximately $20 million. Including approved credit and expected cost savings from deprioritizing the Vodobatinib Parkinson's program, SPARC anticipates a cash runway of 12-15 months. Management acknowledged that additional resources might be required in certain scenarios to reach future milestones, but they are not contemplating a near-term equity raise, relying on potential milestones from licensed assets like Vibozilimod.
Vibozilimod and Phenobarbital Updates
Vibozilimod, licensed to Sun Pharma, is currently under Phase 2 assessment, with top-line results for the SOLARES AD study expected in Q4 2024. Regarding Phenobarbital, the product is launched, and SPARC has filed a case against the FDA in the District Court of Columbia, not related to the launch, but to secure a pediatric rare diseases voucher, the value of which would entirely belong to SPARC.
Portfolio Review and Cost Optimization
In light of the PROSEEK results, SPARC plans to conduct a comprehensive review of its clinical and pre-clinical portfolio. The objective is to identify and prioritize high-value programs and optimize the cost base to extend the company's financial runway. This strategic reset aims to ensure efficient allocation of capital towards assets with the highest potential for success and value creation.