On October 30, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported financial results for the third quarter ended September 30, 2025, and provides an overview of recent and upcoming business highlights.
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"Our team continues to execute solidly across the three most important business verticals: diagnostics, therapeutics, and capital structure," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "In the fourth quarter, we plan to build on growing momentum in these three areas as we expand our commercial team and footprint for CNSide, seek to clarify our clinical development and pivotal plan for REYOBIQ with the FDA, and bolster our financial position in the capital markets."
Q3 2025 AND RECENT HIGHLIGHTS
Corporate
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Received additional $1.9 million advance payment from Cancer Prevention and Research Institute of Texas (CPRIT), the second-largest public cancer research funder globally, as part of the Company’s previously awarded non-dilutive $17.6 million grant for leptomeningeal cancer targeted radiotherapeutic development
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Regained compliance with applicable Nasdaq listing criteria, including both Market Value of Listing Securities standard and alternative stockholder’s equity threshold
REYOBIQ Clinical Trials
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Presented positive ReSPECT-LM Phase 1 single dose escalation trial results at SNO/ASCO CNS Metastases Conference. The data demonstrated treatment of leptomeningeal metastases (LM) with REYOBIQ is feasible, has favorable safety profile, and shows promising efficacy signal
CNSide CSF Assay Platform
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Expanded commercial readiness and purpose driven footprint for CNSide to support commercial scale up and patient-led innovative research. Appointed new leadership in commercial strategy and technical operations, in addition to new hires, to meet commercial and operational targets
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Announced first of planned national coverage agreements, with UnitedHealthcare effective September 15, 2025 covering over 51 million people throughout the U.S., to provide the CNSide Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test (LDT)
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Received successful accreditation and certification from Centers for Medicare and Medicaid Services (CMS) under the Clinical Lab Improvement Amendments (CLIA) for the Houston Texas laboratory, which has met all requirements for proficiency testing, personnel qualifications, and quality control. The certification also paves the way for state licensing, commercial payor coverage, access to Medicare/Medicaid, and payment coding expansion
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Presented positive CNSide CSF assay platform results at the 2025 SNO/ASCO CNS Metastases Conference. Data from a retrospective, multi-center analysis of 613 CNSide assays showed that CNSide can quantify LM over time and monitor changes in the expression of multiple targetable mutations. CNSide may also catalyze LM treatment initiation, allowing physicians to adapt treatment with real time shifts in tumor biology
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Provided a CNSide Diagnostics launch update, with our CSF assay platform and testing services commercially available in Texas in August 2025. Initial commercial focus will be on National Cancer Institute Designated Cancer Centers, which treat the highest number of patients at risk for leptomeningeal metastases and previously used CNSide
Q3 2025 FINANCIAL RESULTS
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The Company’s cash and investments balance was $16.6 million on September 30, 2025, up from $6.9 million on June 30, 2025 and $3.6 million on December 31, 2024
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Recognized $1.4 million in grant revenue in the third quarter of 2025 compared to $1.5 million in the same quarter of 2024, which represents CPRIT’s share of the costs incurred for our REYOBIQ platform advancement for the treatment of patients with LM
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Total operating loss for the third quarter of 2025 was $4.5 million compared to a loss of $3.8 million in the same quarter of 2024 with the increase primarily attributed to compensation expense and professional fees
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Net loss for the third quarter of 2025 was $4.4 million, or loss of $0.04 per share, compared to a net loss of $2.9 million, or loss of $0.37 per share, for the same quarter in the prior year; the change in the net loss for the quarter was primarily due to $1 million of change in fair value of derivative instruments in Q3 2024
(Press release, Plus Therapeutics, OCT 30, 2025, View Source [SID1234657146])