Plus Therapeutics (PSTV) Q3 2024 earnings summary

Executive summary

• Advanced clinical progress in ReSPECT-LM and ReSPECT-GBM trials, with new data showing strong safety and efficacy signals for RNL in leptomeningeal metastases and glioblastoma, and completed enrollment in Phase 1 RESPECT-GBM trial with expanded sites.

• CNSide cerebrospinal fluid assay platform acquired in April 2024, positioned for commercial launch with regulatory and reimbursement milestones targeted for early 2025.

• Expanded manufacturing capabilities and new partnerships, including Brainlab and SpectronRx, to support future commercial demand and late-stage clinical needs.

• Plus Therapeutics focuses on targeted radiotherapeutics for CNS cancers, advancing rhenium-based drug candidates and diagnostics, with ongoing clinical trials in glioblastoma, leptomeningeal metastases, and pediatric brain cancer.

Financial highlights

• Cash and investments at $4.8 million as of September 2024, down from $8.6 million at December 2023; cash and cash equivalents were $1.2 million as of September 30, 2024.

• Year-to-date 2024 grant revenue of $4.4 million, up from $3.6 million in 2023; Q3 2024 grant revenue was $1.5 million.

• Year-to-date operating loss of $10.8 million, compared to $9.5 million in 2023; net loss of $9.1 million or $1.46 per share.

• Working capital deficit increased to $6.7 million at September 30, 2024, from $0.9 million at December 31, 2023.

• Net cash used in operating activities was $9.3 million for the nine months ended September 30, 2024.

Outlook and guidance

• Completion of ReSPECT-LM single administration trial by year-end 2024; initiation of multiple administration trial in Q1 2025.

• Limited commercial release of CNSide platform as an LDT in early 2025, with expanded reimbursement and payer agreements in progress.

• Completion of ReSPECT-GBM phase II enrollment by mid-2025, with data readout in the second half of 2025.

• Pediatric brain cancer trial IND approval and enrollment expected in 2025, supported by a $3 million DoD award.

• Research and development expenses are expected to increase for the remainder of 2024 as clinical programs expand.