Cerenome, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsPlus Therapeutics, Inc. (PSTV) is a clinical-stage healthcare company developing targeted radiopharmaceuticals and a commercializing diagnostic test for central nervous system cancers.
What they do
Plus Therapeutics develops and commercializes precision diagnostics and targeted radiopharmaceuticals for CNS cancers. Its lead drug candidate, rhenium (186Re) obisbemeda (REYOBIQ), targets recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancers via localized delivery. The company's wholly owned subsidiary, CNSide Diagnostics, markets the CNSide Cerebrospinal Fluid Tumor Cell Enumeration test, a laboratory-developed test for identifying tumor cells that have metastasized to the CNS. The company also holds a candidate, Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere, for liver cancers.
Revenue drivers
- Grant revenue from CPRIT — The company recognizes grant revenue from the Cancer Prevention and Research Institute of Texas (CPRIT) for the ReSPECT-LM clinical trial, contributing to reported revenue.
- CNSide diagnostic billings — CNSide commenced billing for diagnostic revenue in Q1 2026, with initial amounts fully reserved; payer agreements with UnitedHealthcare, Humana, Highmark, and Blue Shield of California expand access to approximately 81 million covered lives.
- CNSide Test volume — The test is currently used in the ReSPECT-LM trial and has been re-introduced commercially; revenue will scale with test volume under payer contracts and Medicare enrollment.
Recent performance
For Q1 2026, Plus Therapeutics reported revenue of $1.0 million, down from $1.1 million in Q1 2025. Operating loss widened to $7.1 million from $3.5 million year-over-year, driven by CNSide commercial expansion and REYOBIQ Phase 2 trial costs. Net loss was $6.9 million ($1.05 per basic share) versus $17.4 million ($29.86 per basic share) in Q1 2025. Cash and investments stood at $15.1 million as of March 31, 2026, up from $8.6 million at year-end 2025, reflecting proceeds from an upsized public offering. Full-year 2025 revenue was $5.2 million with a net loss of $22.4 million and operating cash flow of -$20.8 million.
Strategy
Management is focused on two 2026 priorities: CNSide commercial scale-up and REYOBIQ pivotal-trial readiness. The company is expanding CNSide payer coverage, having added four national/regional payers and received a unique PLA code for billing and Medicare enrollment. For REYOBIQ, it secured FDA Orphan Drug Designation for pediatric malignant gliomas and progressive ependymoma, and added SpectronRx as a second GMP manufacturing site. The company is also strengthening its leadership team with senior appointments in clinical development, market access, and R&D.
Risks
- Clinical and regulatory risk — REYOBIQ is in Phase 2 trials; failure to demonstrate efficacy or obtain regulatory approvals could halt development and impair the business.
- Commercial adoption of CNSide — CNSide has only recently begun billing and revenue is fully reserved; payer contracts and reimbursement may not translate into profitable volumes.
- Cash burn and financing need — The company has persistent negative operating cash flow (e.g., -$20.8M in 2025) and may require additional capital to fund trials and commercial operations.
- Supply chain and manufacturing concentration — Radiopharmaceutical production is complex; reliance on limited manufacturing sites could be disrupted, though SpectronRx was added as a second site.
Outlook
Management reaffirmed its 2026 milestones, including CNSide commercial scale-up and REYOBIQ pivotal-trial readiness. They plan to continue adding payers and expanding CNSide operations, and to progress the ReSPECT-LM and ReSPECT-GBM Phase 2 trials. FDA feedback from a Type B meeting supports the development path toward a pivotal trial for REYOBIQ in leptomeningeal metastases. The company expects to leverage its $15.1 million cash position to execute these goals.