Core Insights - Plus Therapeutics, Inc. announced positive data from the ReSPECT-LM Phase 1 trial, demonstrating a clinical benefit rate of over 75% in three relevant outcome measures for the treatment of leptomeningeal metastases with REYOBIQ [1][2] - The trial showed no dose-limiting toxicities and an overall favorable safety profile, indicating the treatment is feasible and effective [1][4] Study Details - The Phase 1 trial involved 29 subjects across six cohorts receiving varying doses of REYOBIQ, ranging from 6.6 mCi to 75 mCi [2] - Early cohorts exhibited excellent tolerance at higher doses, supporting a broad therapeutic range [4] Efficacy and Safety - The study reported a radiographic response rate of 76% and a clinical response rate of 87% through day 112 [6] - CSF tumor cell enumeration assays showed a maximum reduction of 100% at day 28, with a median overall survival of 9 months across the first four cohorts, which is significantly better than the typical 2-6 months reported in literature [6] Future Directions - The trial results provide a foundation for moving into ongoing dosing optimization and potential approval trials [4] - REYOBIQ is being evaluated for multiple CNS cancers, including recurrent glioblastoma and pediatric brain cancer, with significant funding support from the National Cancer Institute and the Cancer Prevention & Research Institute of Texas [5][7]

Core Insights - Plus Therapeutics is set to launch its CNSide CSF Assay Platform in the U.S. market in the second half of 2025, targeting a significant unmet need in CNS cancer diagnostics with a market opportunity exceeding $6 billion [1][2][4] Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers [14] - The company has invested over $300 million in the CNSide technology, which aims to address the clinical need for better diagnostic tools in CNS cancer [3] Product Details - The CNSide CSF Assay Platform is designed for patients suspected of having CNS cancer metastases, with the first test, CNSide CSF Tumor Cell Enumeration (TCE), expected to be commercialized soon [2][4] - The platform has demonstrated high sensitivity (92%) and specificity (95%) in diagnosing CNS metastases, influencing treatment decisions in 90% of cases [5] Market Opportunity - CNS metastases affect approximately 30% of adult cancer patients, and the current standard of care for diagnosis is outdated, leading to missed or delayed diagnoses [4] - The CNSide platform is positioned to provide superior clinical utility compared to the current standard of care, which has been validated through real-world use and peer-reviewed publications [5] Commercial Strategy - Plus Therapeutics has established a scalable testing laboratory in Houston, TX, and is executing a commercial market access strategy that includes state licensure and reimbursement codes [6][7] - The company anticipates launching the CNSide platform in Texas first, followed by expansion into additional states [6] Financial Outlook - The revenue contributions from the CNSide subsidiary are expected to become meaningful to Plus Therapeutics' operations in fiscal year 2026 [9]