Financial Data and Key Metrics Changes - The cash and investments balance was 8.6 million at December 2023 [20] - Year-to-date operating loss for 2024 was 9.5 million in the same period of 2023, primarily due to increased spending related to the ReSPECT-LM trial [21] - Net loss year-to-date 2024 was 1.46 per share, compared to a net loss of 3.54 per share for the same period in the prior year [21] Business Line Data and Key Metrics Changes - The ReSPECT-LM program is advancing with a Phase 1 single-administration trial showing favorable safety and efficacy results, with a median overall survival of 12 months compared to a historical average of four months [7][8] - The CNSide Cerebrospinal Fluid Assay platform is being recognized for its diagnostic value, with plans for a limited market release in January 2025 [12][14] Market Data and Key Metrics Changes - The company is expanding its market access activities for the CNSide platform, including obtaining necessary certifications and negotiating with commercial payers [13][14] - The ReSPECT-GBM trial continues to enroll patients, with 42 patients enrolled across three sites, and the average absorbed radiation dose to tumors in Phase 2 was 300 gray, correlating with increased overall survival [15][16] Company Strategy and Development Direction - The company is focused on advancing its clinical programs, including the ReSPECT-LM and ReSPECT-GBM trials, while also expanding its diagnostic capabilities with the CNSide platform [10][12] - A research collaboration with Brainlab aims to enhance treatment planning and drug delivery for brain cancer patients [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about grant funding opportunities, particularly from CPRIT, and indicated that the company is well-positioned for continued success in Texas despite potential federal changes [39][40] - The company anticipates significant milestones in 2024, including presentations at major conferences and the initiation of new clinical trials [25][30] Other Important Information - The company has received a $3 million grant from the US Department of Defense to support a Phase 1 trial for pediatric brain cancer [18] - A second GMP manufacturing partnership has been established to support future commercial demand projections for RNL [19] Q&A Session Summary Question: Opportunities for CNSide and RNL in LM - Management sees increasing synergies between CNSide and RNL, with potential to double or quadruple the addressable market for LM by improving diagnostic sensitivity [34] Question: Landscape for Grants - Management believes there are continued opportunities for grants, particularly from CPRIT, and expects to maintain a strong position in Texas [38][40] Question: LM Multi-Dose Study Dose Selection - The selected dose of 13.2 millicuries for the multi-dose study was based on safety and response data from previous cohorts, with a Bayesian approach to clinical development being utilized [44] Question: Timeline for CNSide Assay Compliance and Reimbursement - The company aims to commercialize the CNSide test in Q4 2024, with CLIA compliance and reimbursement negotiations ongoing [46]
Plus Therapeutics(PSTV) - 2024 Q3 - Earnings Call Transcript